| PROSPECTUS SUPPLEMENT NO. 3 |
Filed Pursuant to Rule 424(b)(3) |
| (to prospectus dated November 29, 2023) |
Registration Statement No. 333-275558 |
Up to 12,080,000 shares of Common Stock
This prospectus supplement (the “Prospectus Supplement”) updates and supplements the prospectus dated November 29, 2023 (the
“Prospectus”), which forms a part of our Registration Statement on Form S-1 (Registration No. 333-275558) (the “Registration
Statement”). This prospectus supplement is being filed to update and supplement the information in the Prospectus with the information
contained in (i) our current report on Form 8-K as filed with the Securities and Exchange Commission on July 31, 2024 (the “Current
Report”) and (ii) our 2023 annual report on Form 10-K/A (the “Annual Report”) and our quarterly report on Form 10-Q
for the period ended June 30, 2024 (the “Quarterly Report”) each as filed with the Securities and Exchange Commission (the
“Commission”) on August 15, 2024. Accordingly, we have attached the Current Report, Annual Report and Quarterly Report, without
exhibits, to this Prospectus Supplement.
This Prospectus Supplement
relates to the offering on a resale basis an aggregate of up to 12,080,000 shares of common stock of Coeptis Therapeutics Holdings, Inc.
(the “Company,” “we,” “us” or our”), par value $0.0001 per share, consisting of (a) 6,527,000
shares of the Company’s common stock that are currently issued, (b) 1,223,000 shares of common stock that are issuable upon exercise
of certain pre-funded warrants (the “Pre-Funded Warrants”), (c) 2,000,000 shares of common stock that are issuable upon exercise
of certain Series A Warrants (the “Series A Warrants”), (d) 2,000,000 shares of common stock that are issuable upon exercise
of Series B Warrants (the “Series B Warrants”, and together with the Series A Warrants (the “Common Warrants”)
and together with the Pre-Funded Warrants, the “Warrants”), (e) 210,000 shares of common stock that are issuable to the applicable
Selling Stockholders upon the exercise of the underwriter warrants (“Underwriter Warrants”) issued in connection with the
Company’s June 2023 public offering (the “June Offering”), and (f) 120,000 shares of common stock that are issuable
to the applicable Selling Stockholder upon the exercise of the placement agent warrants (“Placement Agent Warrants”, together
with the Underwriter Warrants, the “Offering Warrants”), issued in connection with the Company’s October 2023 private
placement. The Selling Stockholders acquired the shares of common stock offered by this prospectus from us in private placement transactions
in reliance on exemptions from registration under the Securities Act of 1933, as amended (the “Securities Act”) as more fully
described herein. We are registering the resale of these shares of common stock by the Selling Stockholders to satisfy registration rights
we have granted to the Selling Stockholders.
This Prospectus Supplement should be read in conjunction
with the Prospectus, which is to be delivered with this Prospectus Supplement. This Prospectus Supplement updates and supplements the
information in the Prospectus. If there is any inconsistency between the information in the Prospectus and this Prospectus Supplement,
you should rely on the information in this Prospectus Supplement. This Prospectus Supplement is not complete without, and may not
be delivered or used except in conjunction with, the Prospectus, including any amendments or supplements to it.
Our common stock is listed on The Nasdaq Capital
Market under the symbol “COEP”. As of August 15, 2024, the closing price of our common stock as reported on The Nasdaq Capital
Market was $0.21 per share.
Investing in our securities involves a high
degree of risk. You should review carefully the risks and uncertainties described under the heading “Risk Factors” beginning
on page 11 of the Prospectus and as updated and supplemented by the section entitled “Risk Factors” in this Prospectus Supplement
and under similar headings in any further amendments or supplements to the Prospectus before you decide whether to invest in our securities.
Neither the Commission nor any state securities commission has approved
or disapproved of these securities or determined if the Prospectus or this Prospectus Supplement is truthful or complete. Any representation
to the contrary is a criminal offense.
The date of this Prospectus Supplement is August
16, 2024.
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_____________________
FORM 8-K
_____________________
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of Earliest Event Reported):
August 9, 2024
_____________________
COEPTIS THERAPEUTICS HOLDINGS, INC.
(Exact name of registrant as specified in its
charter)
| Delaware |
001-39669 |
98-1465952 |
|
(State or other jurisdiction
of incorporation) |
(Commission
File Number) |
(I.R.S. Employer
Identification No.) |
| |
|
|
|
105 Bradford Rd, Suite 420
Wexford, Pennsylvania |
|
15090 |
| (Address of principal executive offices) |
|
(Zip Code) |
724-934-6467
(Registrant’s telephone number, including area code)
____________________________________________________________
(Former name or former address, if changed since
last report)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| |
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b)
of the Act:
| Title of each class |
|
Trading
Symbol(s) |
|
Name of each exchange
on which registered |
| Common Stock, par value $0.0001 per share |
|
COEP
|
|
Nasdaq Capital Market |
| Warrants, each whole warrant exercisable for one-half of one share of Common Stock for $11.50 per whole share |
|
COEPW |
|
Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant
to Section 13(a) of the Exchange Act. ☐
Item 4.02 Non-Reliance on Previously
Issued Financial Statements or a Related Audit Report or Completed Interim Report
On August 9, 2024, the Audit
Committee of Coeptis Therapeutics Holdings, Inc. (“the Company”), after discussions with Management, determined that, due
to certain accounting errors described below, the following may no longer be relied upon: (i) the unaudited condensed consolidated financial
statements for the period September 30, 2023, included in the Company’s Form 10-Q/A for the period then ended; (ii) the audited
consolidated financial statements for the year ended December 31, 2023, included in the Company’s Form 10-K/A for the year ended
December 31, 2023; (iii) the unaudited condensed consolidated financial statements for the period ended March 31, 2024, included in the
Company’s Form 10-Q for the period then ended (the financial statements in (i), (ii) and (iii), the “Financial Statements”
and the periods covered thereby the “Affected Periods”); and (iv) the Financial Statements included in the Company’s
Registration Statements on Forms S-1 (Registration Nos. 333-269782, and 333-275558) initially filed with the SEC on February 14, 2023,
and November 15, 2023 (together with any prospectus supplements thereto, the “Registration Statements”), respectively, which
include the Financial Statements, as well as the relevant portions of any communication which describe or are based on the Financial Statements,
should no longer be relied upon.
Management reached such conclusions
following an internal review of certain transactions and the related accounting treatment, and consultations with their independent auditor,
Turner, Stone & Company, L.L.P. Based upon Management’s evaluation, the Company concluded that its accounting for note agreements
recorded as notes receivable on the Company’s consolidated balance sheet did not give full effect to the transactions, and the notes
receivable should have been recorded as subscription receivables on the Company’s Financial Statements. As of August 12, 2024, the
balance of the subscription receivables has been satisfied.
The Company expects to file
the applicable restated Financial Statements as soon as practicable. The Company’s Chief Financial Officer has discussed these matters
with the Company’s independent auditors and with the Company’s Audit Committee.
Previously, the Company’s
management had evaluated the effectiveness of the Company's disclosure controls and procedures as well as its internal control over financial
reporting as of December 31, 2022 and during the relevant portions of 2023. As previously disclosed, management had concluded that the
Company’s disclosure controls and procedures had weaknesses during such periods and in response thereto in 2023 hired a full-time
Chief Financial Officer, which the Company believes has and will continue to provide for improved processes related to such controls and
procedures.
A copy of this Form 8-K was
provided to the Company’s auditors, Turner, Stone & Company, L.L.P., prior to its filing with the SEC.
Forward-Looking Statements
This Current Report on Form
8-K contains forward-looking statements within the meaning of the federal securities laws, and any statements other than statements of
historical fact could be deemed to be forward-looking statements. Such statements may include, without limitation, statements with respect
to the Company’s plans and objectives, projections, expectations and intentions. These forward-looking statements are based on current
expectations, estimates and projections about the Company’s industry, management’s beliefs and certain assumptions made by
management. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to
certain risks, uncertainties and assumptions that are difficult to predict. Because such statements involve risks and uncertainties, the
actual results and performance of the Company may differ materially from the results expressed or implied by such forward-looking statements.
These risks include, among other things (1) the ability to complete the restatements of the Financial Statements covering the Affected
Period and address any material weaknesses, the timing of the completion of necessary restatements, interim reviews and audits by the
Company’s independent registered public accounting firm, (2) risks relating to the substantial costs and diversion of personnel’s
attention and resources deployed to address the restatements of the Financial Statements covering the Affected Period and internal control
matters, (3) the risk of litigation or regulatory action arising from the restatements of the Financial Statements during the Affected
Period, (4) the timing of the review by, and the conclusions of, the Company’s independent auditor regarding the restatements, (5)
the ability of the Company to remediate any material weaknesses in internal control over financial reporting, (6) potential reputational
damage that the Company may suffer as a result of the restatements of the Financial Statements during the Affected Period, (7) the impact
of the Restatement of the Financial Statements on the value of the Company’s common stock, and (8) the risk that the filing of the
Restatement of the Financial Statements will take longer than anticipated. Given these risks and uncertainties, readers are cautioned
not to place undue reliance on such forward-looking statements. Unless otherwise required by law, the Company also disclaims any obligation
to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements
made here. Additional information concerning certain risks and uncertainties that could cause actual results to differ materially from
those projected or suggested in the Company’s filings with the Securities and Exchange Commission (the “SEC”), copies
of which are available from the SEC or may be obtained upon request from the Company.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
Coeptis Therapeutics Holdings, Inc. |
| |
|
|
| Date: August 16, 2024 |
By: |
/s/ Brian Cogley |
| |
|
Brian Cogley
Chief Financial Officer |
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-K/A
(Amendment No. 1)
(Mark One)
| ☒ |
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the Fiscal Year Ended December 31, 2023
Or
| ☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _____________
to _____________
Commission File Number: 001-39669
Coeptis Therapeutics Holdings, Inc.
(Exact name of registrant as specified in its charter)
| Delaware |
98-1465952 |
| (State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
105 Bradford Rd, Suite 420
Wexford, Pennsylvania 15090
(Address of Principal Executive Offices) (Zip Code)
(Registrant’s Telephone Number, Including
Area Code): (724) 934-6467
Securities registered pursuant to Section 12(b)
of the Act:
| Title of Each Class |
|
Trading Symbol(s) |
|
Name of Each Exchange on which Registered |
| Common Stock, par value $0.0001 per share |
|
COEP
|
|
Nasdaq Capital Market |
| Warrants, each whole warrant exercisable for one-half of one share of Common Stock for $11.50 per whole share |
|
COEPW |
|
Nasdaq Capital Market |
Indicate by check mark if the registrant is a well-known
seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No ☒
Indicate by check mark if the registrant is not
required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐ No ☒
Indicate by check mark whether the registrant (1)
has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months
(or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has
submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of
this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files.) Yes ☒
No ☐
Indicate by check mark whether the registrant is
a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.
See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company”
and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ☐ |
Accelerated filer ☐ |
| Non-accelerated filer ☒ |
Smaller reporting company ☒ |
| Emerging growth company ☒ |
|
If an emerging growth company, indicate by a check
mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant has
filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting
under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its
audit report. ☐
If securities are registered pursuant to Section
12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction
of an error to previously issued financial statements. ☐
Indicate by check mark whether any of those error
corrections are restatements that required a recovery analysis of incentive- based compensation received by any of the registrant’s
executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate by a check mark whether the registrant
is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
The aggregate market value
of the voting and non-voting common equity held by non-affiliates of the registrant, as of the last business day of the registrant’s
most recently completed second fiscal quarter, based on the closing sale price of $1.55 reported on the Nasdaq Capital
Market was: $28,807,680.
The number of shares outstanding
of each of the registrant’s classes of common stock as of the latest practicable date was: 36,089,917 shares of $0.0001 par
value common stock outstanding as of March 22, 2024.
Coeptis Therapeutics Holdings, Inc.
Annual Report on Form 10-K for the Year Ended
December 31, 2023
TABLE OF CONTENTS
EXPLANATORY NOTE
The Company filed its Annual Report on Form
10-K for the year ended December 31, 2023 with the Securities and Exchange Commission (“SEC”) on March 25, 2024. This Amendment
No. 1 on Form 10-K/A (“Amendment No. 1” or “Form 10-K/A”) is being filed to reflect the reclassification of Subscriptions
receivable (the “Reclassification”) in the Consolidated Balance Sheet as of the year ended December 31, 2023.
The Reclassification is due to the Company
performing an evaluation of its accounting for note agreements recorded as notes receivable. Management determined the originally filed
10-K does not give full effect to the transactions, and the notes receivable should have been recorded as subscription receivables. On
August 9, 2024, Management concluded its evaluation and determined that the identified errors required the filing of this 10-K/A, as
further discussed in the accompanying condensed consolidated financial statements included in this form 10-K/A.
PRESENTATION OF FINANCIAL AND OTHER INFORMATION
On October 28, 2022, Coeptis Therapeutics Holdings,
Inc. (“Coeptis”, ‘‘we’’, ‘‘us’’ or the “Company”), formerly Bull
Horn Holdings Corp., acquired Coeptis Therapeutics, Inc. (“Coeptis Sub”) in an all-stock transaction. The acquisition of Coeptis
Sub was accomplished through a reverse merger of our wholly owned subsidiary BH Merger Sub, Inc. with and into Coeptis Sub, with Coeptis
Sub determined to be the accounting acquirer of us (the “Merger”). As such, the historical financial statements of the registrant
for periods prior to October 28, 2022, are those of Coeptis Sub and, in connection with the acquisition, Coeptis Sub’s equity was
exchanged for shares of our common stock. The acquisition of Coeptis Sub was treated as a “reverse merger.” Unless otherwise
stated or the context otherwise requires, the historical business information described in this Annual Report on Form 10-K prior to consummation
of the acquisition of Coeptis Sub is that of Coeptis Sub and, following consummation of the acquisition of Coeptis Sub, reflects business
information of us and Coeptis Sub on a consolidated basis.
This report includes our audited consolidated financial
statements as of and for the year ended December 31, 2023. This report also includes our audited financial statements as of and for the
year ended December 31, 2022.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be
covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended
(the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
All statements other than statements of historical facts contained in this Annual Report on Form 10-K are “forward-looking statements”
for purposes of federal and state securities laws, including statements regarding our expectations and projections regarding future developments,
operations and financial conditions, and the anticipated impact of our acquisitions, business strategy, and strategic priorities. These
statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or
achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking
statements.
In some cases, you can identify forward-looking
statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,”
“could,” “intend,” “target,” “project,” “contemplate,” “believe,”
“estimate,” “predict,” “potential” or “continue” or the negative of these terms or other
similar expressions, although not all forward-looking statements contain these words. The forward-looking statements in this Annual Report
on Form 10-K are only predictions and are based largely on our current expectations and projections about future events and financial
trends that we believe may affect our business, financial condition and results of operations. These forward-looking statements speak
only as of the date of this Annual Report on Form 10-K and are subject to a number of known and unknown risks, uncertainties and assumptions.
Although we believe the expectations reflected in any of our forward-looking statements are reasonable, actual results could differ materially
from those projected or assumed in any of our forward-looking statements. Our future financial condition and results of operations, as
well as any forward-looking statements, are subject to change and inherent risks and uncertainties.
These forward-looking statements present
our estimates and assumptions only as of the date of this Annual Report on Form 10-K. Accordingly, you are cautioned not to place undue
reliance on forward-looking statements, which speak only as of the dates on which they are made. Except as required by applicable law,
we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information,
future events, changed circumstances or otherwise. Important factors that could cause actual results to differ materially from those in
the forward-looking statements include, but are not limited to, those summarized below:
| · | Adverse impacts from the pandemic involving the novel coronavirus
known as COVID-19; |
| · | We may not be able to successfully implement our growth strategy
on a timely basis or at all; |
| · | We may have difficulties managing our anticipated growth, or
we may not grow at all; |
| · | We have a history of losses, we expect to incur losses in the
future and we may not be able to achieve or maintain profitability; |
| · | We may not be able to initiate and complete preclinical studies
and clinical trials for our product candidates which could adversely affect our business; |
| · | We may not be able to obtain and maintain the third-party relationships
that are necessary to develop, commercialize and manufacture some or all of our product candidates; |
| · | We may encounter difficulties in managing our growth, which could
adversely affect our operations; |
| · | We need to obtain financing in order to continue our operations; |
| · | The drug development and approval process is uncertain, time-consuming
and expensive; |
| · | Competition in the biotechnology and pharmaceutical industries
may result in competing products, superior marketing of other products and lower revenues or profits for us; |
| · | Federal laws or regulations on drug importation could make lower
cost versions of our future products available, which could adversely affect our revenues, if any; |
| · | The regulatory approval process is costly and lengthy, and we
may not be able to successfully obtain all required regulatory approvals; |
| · | Healthcare reform measures could adversely affect our business; |
| · | Protecting and defending against intellectual property claims
may have a material adverse effect on our business; |
| · | If we are not able to retain our current senior management team
and our scientific advisors or continue to attract and retain qualified scientific, technical and business personnel, our business will
suffer; |
| · | There is a substantial doubt about our ability to continue as
a going concern; and |
| · | The other risks identified in this Annual Report on Form 10-K
including, without limitation, those under Part I, Item 1A. “Risk Factors” and Part II, Item 7. “Management’s
Discussion and Analysis of Financial Condition and Results of Operations,” as such factors may updated from time to time in our
other filings with the SEC. |
Given these uncertainties, you should not place
undue reliance on these forward-looking statements. These forward-looking statements represent our estimates and assumptions only as of
the date of this Annual Report on Form 10-K and, except as required by law, we undertake no obligation to update or revise publicly any
forward-looking statements, whether as a result of new information, future events or otherwise after the date of this Annual Report on
Form 10-K. We qualify all of our forward-looking statements by these cautionary statements.
NOTE REGARDING TRADEMARKS
We own or have rights to use the trademarks and
trade names that we use in conjunction with the operation of our business. Each trademark or trade name of any other company appearing
in this Annual Report on Form 10-K is, to our knowledge, owned by such other company. Solely for convenience, our trademarks and trade
names referred to in this Annual Report on Form 10-K may appear without the ® or ™ symbols, but those references are not intended
to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable
licensor to these trademarks and trade names.
PART I
ITEM 1. BUSINESS
As discussed elsewhere
in this Annual Report on Form 10-K, pursuant to the Merger, we acquired our primary operating subsidiary Coeptis Therapeutics, Inc. Since
prior to the Merger the Company was a shell company, the business description below is a description of the Company’s business based
on our subsidiaries’ operations.
Company History
General. We
were originally incorporated in the British Virgin Islands on November 27, 2018, under the name Bull Horn Holdings Corp. On October 27,
2022, Bull Horn Holdings Corp. domesticated from the British Virgin Islands to the State of Delaware. On October 28, 2022, in connection
with the closing of the Merger, we changed our corporate name from Bull Horn Holdings Corp. to “Coeptis Therapeutics Holdings, Inc.”
The Merger Transaction. On
October 28, 2022, a wholly owned subsidiary of Bull Horn Holdings Corp., merged with and into Coeptis Therapeutics, Inc., with Coeptis
Therapeutics, Inc. as the surviving corporation of the Merger. As a result of the Merger, we acquired the business of Coeptis Therapeutics,
Inc., which we now continue to operate as our wholly owned subsidiary.
About the Company’s
Subsidiaries. We are now a holding company that currently operates through our direct and indirect wholly owned subsidiaries
Coeptis Therapeutics, Inc., Coeptis Pharmaceuticals, Inc. and Coeptis Pharmaceuticals, LLC.
Our current business model
is designed around furthering the development of our current product portfolio. We are continually exploring partnership opportunities
with companies that have novel therapies in various stages of development or companies with technologies that improve the way that drugs
are delivered to patients. We seek the best strategic relationships, which relationships could include in-license agreements, out-license
agreements, co-development arrangements and other strategic partnerships in new and exciting therapeutic areas such as oncology, respiratory
viral infections, and autoimmune diseases.
Collaborations for Product Development — Research
and Development
We believe that there is significant
market opportunity related to each of the assets we are currently pursuing. Set forth below is a brief summary of our current target assets.
Product Pipeline
| Program |
Target Indication |
Pre-Clinical |
Phase I |
Phase II |
Phase III |
| CD38-GEAR-NK |
Protect CD38+ NK Cells from destruction by anti-CD38 monoclonal antibodies |
|
|
|
|
| CD38-Diagnostic |
Diagnostic tool to analyze if cancer patients might be appropriate candidates for anti-CD38 mAB therapy |
|
|
|
|
| SNAP-CAR Platform |
SNAP-CAR cells co-administered with one or more antibody adaptors |
|
|
|
|
|
Unmodified Natural Killer Cells
|
Acute Myeloid Leukemia |
 |
|
|
|
Unmodified Natural Killer Cells
|
Acute Respiratory Diseases |
 |
|
|
License of Stem Cell
Expansion Platform & Acquisition of Phase 1 Studies
On August
16, 2023, we entered into an exclusive licensing arrangement (the “License Agreement”) with Deverra Therapeutics Inc. (“Deverra”),
pursuant to which we completed the exclusive license of key patent families and related intellectual property related to a proprietary
allogeneic stem cell expansion and directed differentiation platform for the generation of multiple distinct immune effector cell types,
including natural killer (NK) and monocyte/macrophages. The License Agreement provides us with exclusive rights to use the license patents
and related intellectual property in connection with development and commercialization efforts in the defined field of use (the “Field”)
of (a) use of unmodified NK cells as anti-viral therapeutic for viral infections, and/or as a therapeutic approach for treatment of relapsed/refractory
AML and high-risk MDS; (b) use of Deverra’s cell therapy platform to generate NK cells for the purpose of engineering with Coeptis
SNAP-CARs and/or Coeptis GEAR Technology; and (c) use of Deverra’s cell therapy platform to generate myeloid cells for the purpose
of engineering with the Company’s current SNAP-CAR and GEAR technologies. In support of the exclusive license, the Company also
entered into with Deverra (i) an asset purchase agreement (the “APA”) pursuant to which we purchased certain assets from Deverra,
including but not limited to two Investigational New Drug (IND) applications and two Phase 1 clinical trial stage programs (NCT04901416,
NCT04900454) investigating infusion of DVX201, an unmodified natural killer (NK) cell therapy generated from pooled donor CD34+ cells,
in hematologic malignancies and viral infections and (ii) a non-exclusive sublicense agreement (the “Sublicense Agreement”),
in support of the assets obtained by the exclusive license, pursuant to which the Company sublicensed from Deverra certain assets which
Deverra has rights to pursuant a license agreement (“FHCRC Agreement”) by and between Deverra and The Fred Hutchinson Cancer
Research Center (“FHCRC”).
As consideration for the Deverra
transaction described above, we paid Deverra approximately $570,000 in cash, issued to Deverra 4,000,000 shares of the Company’s
common stock and assumed certain liabilities related to the ongoing clinical trials. In addition, in accordance with the terms of the
Sublicense Agreement, the Company agreed to pay FHCRC certain specified contingent running royalty payments and milestone payments under
the FHCRC Agreement, in each case to the extent such payments are triggered by the Company’s development activities.
In October 2023 we entered
into a Shared Services Agreement (“SSA”) with Deverra, in accordance with requirements set forth in the APA. Under the terms
of the SSA, Coeptis and Deverra will share resources and collaborate to further the development of Coeptis’ GEAR and SNAP-CAR platforms,
as well as the purchased and licensed assets under the License Agreement and APA. The term of the SSA is six months from the effective
date.
CD38 Therapeutic and
Diagnostic; Vy-Gen Bio, Inc.
In May 2021, we entered into
two exclusive option agreements (the “CD38 Agreements”) relating to separate technologies (described below) designed to improve
the treatment of CD38-related cancers (e.g., multiple myeloma, chronic lymphocytic leukemia, and acute myeloid leukemia) with Vy-Gen-Bio,
Inc. (“Vy-Gen”), a majority-owned subsidiary of Vycellix, Inc., a Tampa, Florida-based private, immune-centric discovery life
science company focused on the development of transformational platform technologies to enhance and optimize next-generation cell and
gene-based therapies, including T-cell and Natural Killer (NK) cell-based cancer therapies. In August 2021, we exercised those two options
and acquired a 50% ownership interest in such technologies. In December 2021, we completed our purchase of the 50% ownership interest
in the CD38-Diagnostic, and subsequently in November 2022 we completed our purchase of the 50% ownership interest for the CD38-GEAR-NK
product candidate.
The CD38 Agreements relate
to two separate Vy-Gen drug product candidates, as follows:
| - | CD38-GEAR-NK. This Vy-Gen drug product
candidate is designed to protect CD38+ NK cells from destruction by anti-CD38 monoclonal antibodies, or mAbs. CD38-GEAR-NK is an autologous,
NK cell-based therapeutic that is derived from a patient’s own cells and gene-edited to enable combination therapy with anti-CD38
mAbs. We believe CD38-GEAR-NK possesses the potential to minimize the risks and side effects from CD38-positive NK cell fratricide. While
third party license or collaboration agreements are not required in order for Vy-Gen to develop the product to commercial use, potential
strategic relationships will be considered on an ongoing basis as a potential strategy. No licenses or collaborations are currently being
actively pursued. |
Market Opportunity. We
believe CD38-GEAR-NK could potentially revolutionize how CD38-related cancers are treated, by protecting CD38+ NK cells from destruction
by anti-CD38 mAbs, thereby promoting the opportunity to improve the treatment of CD38-related cancers, including multiple myeloma, chronic
lymphocytic leukemia, and acute myeloid leukemia.
Multiple myeloma is the first cancer indication
targeted with CD38-GEAR-NK. Our intent is to seek regulatory approval in the 8 major markets comprised of the United States, the UK, Germany,
Spain, France, Italy, China, and Japan. The total multiple myeloma market size in these 8 countries was $16.27 billion in 2019 and
is expected to increase modestly through 2030, according to DelveInsight.
GEAR-NK Product Plan Overview. GEAR-NK
is an autologous, gene-edited, natural killer cell-based therapeutic development platform that allows for modified NK cells to be co-administered
with targeted mAbs, which, in the absence of the GEAR-NK, would otherwise be neutralized by mAb therapy. GEAR-NK is a pre-clinical in
vitro proof-of-concept product with in vivo evaluations planned for 2023. Vy-Gen is actively engaged in the research and development of
GEAR-NK, and through the joint steering committee, we are assessing market opportunities, intellectual property protection and potential
regulatory strategy. No human clinical trials have been conducted for GEAR-NK but are planned for 2025.
| - | CD38-Diagnostic. This Vy-Gen drug product candidate
is an in vitro diagnostic tool to analyze if cancer patients might be appropriate candidates for anti-CD38 mAb therapy. CD38-Diagnostic
is an in vitro screening tool that is intended to provide the ability to pre-determine which cancer patients are most likely to benefit
from targeted anti-CD38 mAb therapies, either as monotherapy or in combination with CD38-GEAR-NK. Our management believes that CD38-Diagnostic
also has the potential to develop as a platform technology beyond CD38, including to identify patients likely to benefit for broad range
of mAb therapies across myriad indications. CD38-Diagnostic is a discovery-stage product that is advancing towards pre-clinical activities.
Vy-Gen is actively engaged in the research and development of CD38-Diagnostic, and through the joint steering committee, and we are assessing
market opportunities, intellectual property protection and potential regulatory strategy are all areas of focus. No human clinical trials
have been conducted for CD38-Diagnostic as the clinical study requirements are not yet defined. |
Market Opportunity. We believe
CD38-Diagnostic provides opportunity to make more cost-effective medical decisions for the treatment of B cell malignancies with high
CD38 expression, including multiple myeloma, which may help to avoid unnecessary administration of anti-CD38 therapies. CD38-Diagnostic
is anticipated to reduce the number of patients that are subjected to ineffective therapy and to potentially result in significant savings
to healthcare systems.
CD38-Diagnostic is viewed as a potential
in-vitro diagnostic for determining patient suitability and likelihood of positive treatment outcomes for CD38-GEAR-NK and/or CD38 monoclonal
antibody therapies.
On
September 28, 2023, we received FDA’s response to our 513(g) request for information submission pertaining to the classification
of the CD38-Diagnostic. The CD38-Diagnostic has been designated a Class II type device. The confirmation of this classification is beneficial
as we’re now better able to plan for and execute future development activities.
In May 2021, we made initial payments totaling $750,000
under the CD38 Agreements, to acquire the exclusive options to acquire co-development rights with respect to CD38-GEAR-NK and CD38-Diagnostic.
On August 15, 2021, we entered into amendments to each of the CD38 Agreements. In connection with the two amendments, we delivered
to Vy-Gen promissory notes aggregating $3,250,000 with maturity dates of December 31, 2021, and made a cash payment of $1,000,000,
upon which cash payment we exercised the two definitive option purchase agreements. In December 2021, we completed our payment obligations
to secure our rights to 50% of the net revenue stream related to the CD38-Diagnostic, and in November 2022 we completed our purchase
of the 50% ownership interest for the CD38-GEAR-NK product candidate. Details of the two August amendments and the December amendment
are summarized in the amendments attached at Exhibits 4.1 and 4.2 to our Current Report on Form 8-K dated August 19, 2021,
and Exhibit 4.2 to our Current Report on Form 8-K dated December 27, 2021.
In connection with the Vy-Gen
relationship and the Company’s rights in respect of the two product candidates described above, in December 2021 we entered
into a co-development and steering committee agreement with Vy-Gen. The co-development and steering committee agreement provides for the
governance and economic agreements between the Company and Vy-Gen related of the development of the two Vy-Gen drug product candidates
and the revenue sharing related thereto, including each company having a 50% representation on the steering committee and each company
receiving 50% of the net revenues related to the Vy-Gen product candidates. Related to the joint development, under the direction of the
joint steering committee, we are currently assessing market opportunities, intellectual property protection and potential regulatory strategies
for the CD38 Assets, and Vy-Gen is overseeing the development activities being conducted through the scientists at Karolinska Institute.
Details of the co-development and steering committee agreement are summarized in the agreement attached as Exhibit 4.1 to our Current
Report on Form 8-K dated December 27, 2021.
SNAP-CAR Technologies; University
of Pittsburgh
The SNAP-CAR License:
On August 31, 2022, we entered into an exclusive license agreement with the University of Pittsburgh for certain intellectual property
rights related to the universal self-labeling SynNotch and CARs for programable antigen-targeting technology platform. We paid the University
of Pittsburgh a non-refundable fee in the amount of $75,000 for the exclusive patent rights to the licensed technology.
In September 2023, we executed
the first amendment to the SNAP-CAR License in which we expanded the field of use to include natural killer cells. We believe this is
a valuable addition as we continue to develop the SNAP-CAR platform as a universal therapeutic.
A key potential benefit that we see in
the licensed technology is its potential application in therapeutic treatments that involve solid tumors. While there are currently a
number of FDA-approved CAR-T therapies for hematologic malignancies, there are currently no CAR-T therapies marketed that are indicated
for the treatment of solid tumors.
Under the terms of the agreement,
we have been assigned the worldwide development and commercialization rights to the licensed technology in the field of human treatment
of cancer with antibody or antibody fragments using SNAP-CAR T-cell technology, along with (i) an intellectual property portfolio consisting
of issued and pending patents and (ii) options regarding future add-on technologies and developments. In consideration of these rights,
we paid an initial license fee of $75,000, and will have annual maintenance fees ranging between $15,000 and $25,000, as well as developmental
milestone payments (as defined in the agreement and royalties equal to 3.5% of net sales. Additionally, the agreement contemplates that
we will enter into a Sponsored Research Agreement with the University of Pittsburgh within ninety days of the execution of the agreement,
with the goal of further researching and optimizing the SNAP-CAR platform.
The Sponsored Research Agreement:
In January 2023 we entered into a sponsored research agreement (“SRA”) with the University of Pittsburgh, the focus of which
is to perform pre-clinical research as it relates to our SNAP-CAR program. Our target objectives are to: (i) test and validate CRO antibody
conjugation chemistry and improve the activity of adaptors by investigating alternative chemical composition, (ii) investigate HER2 and
other solid-tumor model in mice for both breast and ovarian cancers, (iii) identify and test other non-HER2 targets, (iv) further investigate
multi-antigen targeting by dosing multiple adaptors simultaneously to address tumor heterogeneity/resistance in hematological and/or solid
tumors and (v) expand the potential impact of SNAP-CAR by performing in vitro screening of many additional antigen-antibody combinations
in hematological and/or solid tumors. The term of the SRA is two years, and we have committed financing in the amount of $716,714 over
the next two years towards achieving the target objectives.
The SNAP-CAR Platform:
Chimeric antigen receptor (CAR) therapy is a treatment for cancer in which a patient’s T-cells (a type of immune cell) are genetically
engineered to recognize cancer cells to target and destroy them. Cells are extracted from the patient and then genetically engineered
to make the CAR and are re-introduced back into the patient. This therapy is revolutionizing the treatment of many blood cancers including
B cell leukemias and lymphomas by targeting specific proteins found on these cancers, and there is hope in treating additional cancers
including solid tumors by having them recognize new targets. The “SNAP-CAR” CAR cell therapy platform is being developed to
be a universal therapeutic. The SNAP-CAR technology is in the preclinical stage of development at the University of Pittsburgh. Instead
of directly binding to a target on the tumor cell, the CAR T-cells are co-administered with one or more antibody adaptors that bind to
the tumor cells and are fitted with a chemical group that irreversibly connects them to the SNAP-CAR on the therapeutic cells via a covalent
bond. A covalent bond is the highest affinity bond possible, and we believe this binding could translate into highly potent therapeutic
activity.
Pre-clinical studies in mice
have demonstrated a potential benefit that by targeting solid tumors via antibody adaptor molecules, the SNAP-CAR therapy may be able
to provide a highly programmable therapeutic platform, one that we envision could deliver several potential advantages over standard CAR-T
treatments, including:
| - | Reduction of Potential Toxicity: The therapeutic
activity of the SNAP-CAR T-cells is being developed to allow controls by way of the antibody dose, which we envision would allow clinicians
to mitigate toxicity from over-activity. We also envision that the immune response against cancer may also be boosted in patients administered
with additional doses of the tagged tumor-specific antibody; and |
| | | |
| - | Reduction in Cancer Relapse: Relapse from
CAR T-cell therapy often results from the loss or down-regulation of the targeted protein on the cancer. Our research and development
will continue the pre-clinical development efforts to date, which focuses in part on the potential avoidance of or reduction in relapses
by combining SNAP-CAR T-cells with antibodies targeting multiple antigens at once. |
Market Opportunity:
Due to its unique targeting and binding properties, we believe the SNAP-CAR platform could help accelerate the utilization and effectiveness
of CAR T-cell therapies for the treatment of solid tumors. By way of market size, according to Polaris Market Research, the CAR T-cell
therapy market size is expected to reach $20.56 billion by 2029 (from $1.96 billion in 2021), representing a compound annual growth rate
(CAGR) of 31.6% during the forecast period from 2022 to 2029. However, based on the anticipated application of the licensed technology
(i.e. initially focusing on solid tumor treatment) we cannot at this time project the market size of our target market until we further
develop the licensed technology and settle on the initial target indications and follow-up indications. Additional research and analysis
are being conducted which will aid us in the proper identification and selection of the cancer indication(s) we intend to further study.
Once the optimal indication(s) are selected and the overall development strategy is further identified, the market opportunity can be
further defined.
CPT60621; Vici Health
Sciences, LLC
In 2019, we entered into a
co-development agreement with Vici Health Sciences, LLC (“Vici”). Through this partnership, we would co-develop, seek FDA
approval and share ownership rights with Vici to CPT60621, a novel, ready to use, easy to swallow, oral liquid version of an already approved
drug used for the treatment of Parkinson’s Disease (PD). As we continue to direct its operational focus towards the Vy-Gen opportunities
previously described, we have recently stopped allocating priority resources to the development of CPT60621. We are currently in negotiations
in which Vici intends to buy-out most or all of our remaining ownership rights.
Current Opportunity
Vy-Gen-Bio, Inc. We
are currently exploring on a non-exclusive basis a previously announced strategic opportunity that we believe would add to our current
GEAR development platform and provide additional growth opportunities to our assets in the area of cellular immunotherapy. The acquisition
of these assets, if completed, would allow us to expand our collaboration with Vy-Gen-Bio, beyond its current focus on the use of
CD38-GEAR-NK, a natural killer (NK) cell therapy for the treatment of CD38+ cancers for the treatment of multiple myeloma, and the development
of CD38-Diagnostic, an in vitro diagnostic tool aimed toward identifying cancer patients who may be appropriate candidates for anti-CD38
mAb therapy.
Our Growth Strategy
To achieve our goals, we intend
to deploy an aggressive, four-pronged, growth strategy listed below that we believe will help us maximize our success and deleverage some
of the risk of finding, solely developing and funding our own products.
Portfolio Optimization —
We will continue to evaluate, prioritize, optimize, and make appropriate changes in our pipeline portfolio as market development dynamics
and/or product opportunities change. For example, it may be a strategic business decision for us to divest certain products and/or agreements
to other companies so we can best focus on its core assets.
Strategic Partnerships —
We will focus on expanding our existing pipeline through establishing strategic partnerships with companies that have interesting products
and technologies. We intend to focus on novel, preclinical and clinical assets in a variety of therapeutic areas, including oncology.
Business
Development — We are actively seeking partnerships and/or strategic collaborations with companies that share in
our vision and therapeutic focus. Our platform technologies have expansive capabilities and thus we believe they are conducive to
partnerships beyond our current focus.
Sales and Marketing
We currently do not have in-house
commercial capabilities required to market and distribute FDA-approved products. Therefore, we will be required to partner with firms
who are capable of conducting all sales, marketing, distribution, contracting and pricing for our future products. There is no assurance
that we will be able to secure the services of such a firm or that any such firm will be able to achieve sales expectations.
Employees
Currently, we have seven employees,
of which five are full-time employees and two are part-time employees. Our employees are not represented by any labor union or any collective
bargaining arrangement with respect to their employment with the Company. We have never experienced any work stoppages or strikes as a
result of labor disputes. We believe that our employee relations are good.
Certain of our employees
have been reporting to work remotely and may continue to do so moving forward.
Recent Developments
October 2023 Private Placement
As previously disclosed in
a Current Report on Form 8-K filed on October 26, 2023, we issued to an institutional investor in a private placement (i) 777,000
Shares of the Company’s common stock, (ii) Pre-Funded Warrants to purchase up to 1,223,000 shares of Common Stock, (iii) Series
A Warrants to purchase up to 2,000,000 shares of Common Stock, and (iv) Series B Warrants (the “Series B Warrants” and together
with the Pre-Funded Warrants and the Series A Warrants , the “Warrants”) to purchase up to 2,000,000 shares of Common Stock
for gross proceeds to the Company of $2,000,000. In connection with the private placement we also issued Private Placement Warrants to
purchase up to 120,000 shares of Common Stock. The resale of these shares of common stock, as well as the shares of common stock issuable
upon exercise of the Warrants and Private Placement Warrants, were registered and previously disclosed in a Current Report on Form S-1
filed on November 15, 2023 to satisfy certain registration rights granted to this investor.
In
addition, in consideration for the Investor’s participation in the October Private Placement, the Company also agreed to amend the
Investor’s existing Series A warrants to purchase up to 3,062,500 shares at an exercise price of $1.65 per share and Series B warrants
to purchase up 3,062,500 shares of Common Stock at an exercise price of $1.65 per share issued on June 16, 2023 (collectively the “Existing
Warrants”), by (i) reducing the exercise price of the Existing Warrants to $1.36 per share and the exercise and (ii) amending the
Initial Exercise Date (as defined therein) of the Existing Warrants to be the earlier of (a) the Shareholder Approval Date (as defined
in the Purchase Agreement) or (b) April 26, 2024 (the “Warrant Amendment”). The Warrant Amendment became effective upon closing
of the October Private Placement.
September 2023 Private Sales
As previously disclosed in a Current
Report on Form 8-K filed on October 12, 2023, we issued to two separate investors 2,400,000 shares and 600,000 shares of common stock
of the Company, respectively, in private placements, for gross proceeds to the Company of $3,000,000 comprised of $500,000 in cash and
$2,500,000 in promissory notes. The resale of these shares of common stock were registered and previously disclosed in a Current Report
on Form S-1 filed on November 15, 2023 to satisfy certain registration rights granted to these investors.
June 2023 Offering
As previously disclosed in
the Company’s S-1 Registration Statement, on June 13, 2023, the Company entered into an Underwriting Agreement (the “Underwriting
Agreement”) with Ladenburg Thalmann & Co. Inc. (the “Underwriter”), pursuant to which the Company issued and sold,
in a registered public offering by the Company, (i) 2,150,000 shares of common stock (the “Shares”), (ii) 1,350,000 pre-funded
warrants (the “Pre-funded Warrants”), and (iii) 3,062,500 Series A Warrants with an exercise price of $1.65 per share and
which are exercisable for a period of five years commencing six months after the issuance date (the “June Series A Warrants”),
and (iv) 3,062,500 Series B Warrants with an exercise price of $1.65 per share and which are exercisable for a period of five years commencing
six months after the issuance date (the “June Series B Warrants, and together with the June Series A Warrants, the “June Warrants”).
In addition to the June Warrants the Company also issued to the Underwriter an underwriter’s warrants exercisable to acquire up
to 210,000 shares of common stock. The resale of the shares of common stock issuable upon exercise of the Underwriter Warrants were
registered and previously disclosed in a Current Report on Form S-1 filed on November 15, 2023.
Risks Associated with our Business
There are a number of risks
related to us and our operations. You should carefully review the risks described in “Risk Factors and Special Considerations”
beginning on page 9. If any of these risks actually occurs, our business, financial condition, results of operations and prospects would
likely be materially, adversely affected. In that event, the trading price of our Common Stock could be adversely impacted, and you could
lose part or all of your investment. Below is a summary of some of the principal risks we face:
| · | We may not be able to successfully implement our growth strategy
on a timely basis or at all; |
| · | We may have difficulties managing our anticipated growth, or
we may not grow at all; |
| · | We have a history of losses, we expect to incur losses in the
future and we may not be able to achieve or maintain profitability; |
| · | We may not be able to initiate and complete preclinical studies
and clinical trials for our product candidates which could adversely affect our business; |
| · | We may not be able to obtain and maintain the third-party relationships
that are necessary to develop, commercialize and manufacture some or all of our product candidates; |
| · | We may encounter difficulties in managing our growth, which could
adversely affect our operations; |
| · | We need to obtain financing in order to continue our operations; |
| · | The drug development and approval process is uncertain, time-consuming
and expensive; |
| · | Competition in the biotechnology and pharmaceutical industries
may result in competing products, superior marketing of other products and lower revenues or profits for us; |
| · | Federal laws or regulations on drug importation could make lower
cost versions of our future products available, which could adversely affect our revenues, if any; |
| · | The regulatory approval process is costly and lengthy, and we
may not be able to successfully obtain all required regulatory approvals; |
| · | Healthcare reform measures could adversely affect our business; |
| · | Protecting and defending against intellectual property claims
may have a material adverse effect on our business; |
| · | If we are not able to retain our current senior management team
and our scientific advisors or continue to attract and retain qualified scientific, technical and business personnel, our business will
suffer; and |
| · | We may not be able to maintain our listing on the Nasdaq Capital
Market; and |
| · | There is a substantial doubt about our ability to continue as
a going concern. |
Emerging Growth Company
As a company with less than
$1.07 billion in revenue during our last fiscal year, we qualify as an emerging growth company, as defined in the JOBS Act. As an
emerging growth company, we have elected to take advantage of specified reduced disclosure and other requirements that are otherwise applicable
generally to public companies. These provisions include:
| · | Only two years of audited financial statements in addition to any required unaudited interim
financial statements with correspondingly reduced Management’s Discussion and Analysis of Financial Condition and Results of
Operations disclosure. |
| · | Reduced disclosure about our executive compensation arrangements. |
| · | Not having to obtain non-binding advisory votes on executive
compensation or golden parachute arrangements. |
| · | Exemption from the auditor attestation requirement in the assessment
of our internal control over financial reporting. |
We
may take advantage of these exemptions for up to five years or such earlier time that we are no longer an emerging growth company.
We would cease to be an emerging growth company if we have more than $1.07 billion in annual revenue, we have more than $700 million
in market value of our stock held by non-affiliates, or we issue more than $1 billion of non-convertible debt over a three-year period.
We may choose to take advantage of some but not all of these reduced burdens. We have taken advantage of these reduced reporting burdens
herein, and the information that we provide may be different than what you might get from other public companies in which you hold stock.
Available Information
We file annual, quarterly
and current reports and other information with the United States Securities and Exchange Commission (“SEC”) that are publicly
available through the SEC’s website at www.sec.gov. Our SEC filings will also be available free of charge through
the home page of our website https://coeptistx.com as soon as reasonably practicable after they are filed with or furnished to the SEC.
Our website and the information contained on or connected to that site are not incorporated into this Annual Report on Form 10-K.
As
a smaller reporting company, we are not required to provide a statement of risk factors. Nonetheless, we are voluntarily providing risk
factors herein. You should consider carefully the following risk factors, together with all the other information in this Annual Report
on Form 10-K, including our consolidated financial statements and notes thereto, and in our other public filings with the SEC. The risk
factors discussed below cover not only our current products, product candidates and relationships, but also the risks we expect to encounter
when and if we add new product candidates and approved products to our proprietary portfolio, which new products, if added, we expect
to be a various stages of pre-clinical and perhaps clinical development. The occurrence of any of the following risks could
harm our business, financial condition, results of operations and/or growth prospects or cause our actual results to differ materially
from those contained in forward-looking statements we have made in this report and those we may make from time to time. You should consider
all of the risk factors described when evaluating our business.
We operate in a highly
competitive and highly regulated business environment. Our business can be expected to be affected by government regulation, economic,
political and social conditions, business’ response to new and existing products and services, technological developments and the
ability to obtain and maintain patent and/or other intellectual property protection for our products and intellectual property. Our actual
results could differ materially from management’s expectations because of changes both within and outside of our control. Reviewers
of this Annual Report on Form 10-K are cautioned not to place undue reliance upon such forward-looking statements. Such forward-looking
statements may include projections with respect to market size and acceptance, revenues and earnings, marketing and sales strategies and
business operations, as well as efficacy of our products. The risk factors discussed below cover not only our current products, product
candidates and relationships, but also the risks we expect to encounter when and if we add new product candidates and approved products
to our proprietary portfolio, which new products, if added, we expect to be at various stages of pre-clinical and perhaps clinical development.
Throughout this section,
references to “Company,” “Coeptis,” “we,” “us,” “our” and similar terms refer
collectively to Coeptis Therapeutics Holdings, Inc., a Delaware corporation, and its operating subsidiaries, as the context so requires.
Risks Related to the Development and Regulatory
Approval of Our Product Candidates
Clinical trials are expensive, time consuming,
difficult to design and implement, and involve uncertain outcomes. Results of previous pre-clinical studies and clinical trials may not
be predictive of future results, and the results of our current and planned clinical trials may not satisfy the requirements of the FDA
or other regulatory authorities.
Positive or timely results
from pre-clinical or early-stage trials do not ensure positive or timely results in late-stage clinical trials or product approval by
the FDA or comparable foreign regulatory authorities. We will be required to demonstrate with substantial evidence through well-controlled
clinical trials that our product candidates are safe and effective for use in a diverse population before we can seek regulatory approvals
for their commercialization. Our planned clinical trials may produce negative or inconclusive results, and we or any of our current and
future strategic partners may decide, or regulators may require us, to conduct additional clinical or pre-clinical testing.
Success
in pre-clinical studies or early-stage clinical trials does not mean that future clinical trials or registration clinical trials will
be successful because product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy to the
satisfaction of the FDA and foreign regulatory authorities, despite having progressed through pre-clinical studies and initial clinical
trials. Product candidates that have shown promising results in early clinical trials may still suffer significant setbacks in subsequent
clinical trials or registration clinical trials. For example, a number of companies in the biopharmaceutical industry, including those
with greater resources and experience than us, have suffered significant setbacks in advanced clinical trials, even after obtaining promising
results in earlier clinical trials. Similarly, pre-clinical interim results of a clinical trial are not necessarily predictive of final
results.
If clinical trials for our product candidates
are prolonged, delayed or stopped, we may be unable to obtain regulatory approval and commercialize our product candidates on a timely
basis, or at all, which would require us to incur additional costs and delay our receipt of any product revenue.
We may experience delays in
our ongoing or future pre-clinical studies or clinical trials, and we do not know whether future pre-clinical studies or clinical trials
will begin on time, need to be redesigned, enroll an adequate number of patients or be completed on schedule, if at all. The commencement
or completion of these planned clinical trials could be substantially delayed or prevented by many factors, including, but not limited
to:
| · | discussions with the FDA or other regulatory agencies regarding
the scope or design of our clinical trials; |
| · | the limited number of, and competition for, suitable sites
to conduct our clinical trials, many of which may already be engaged in other clinical trial programs, including some that may be for
the same indication as our product candidates; |
| · | any delay or failure to obtain approval or agreement to commence
a clinical trial in any of the countries where enrollment is planned; |
| · | inability to obtain sufficient funds required for a clinical
trial; |
| · | clinical holds on, or other regulatory objections to, a new
or ongoing clinical trial; |
| · | delay or failure to manufacture sufficient supplies of product
candidates for our clinical trials; |
| · | delay or failure to reach agreement on acceptable clinical
trial agreement terms or clinical trial protocols with prospective sites or clinical research organizations (“CROs”), the
terms of which can be subject to extensive negotiation and may vary significantly among different sites or CROs; |
| · | delay or failure to obtain institutional review board (“IRB”)
approval to conduct a clinical trial at a prospective site; |
| · | slower than expected rates of patient recruitment and enrollment; |
| · | failure of patients to complete the clinical trial; |
| · | the inability to enroll a sufficient number of patients in
studies to ensure adequate statistical power to detect statistically significant treatment effects; |
| · | unforeseen safety issues, including severe or unexpected drug-related
adverse effects experienced by patients, including possible deaths; |
| · | lack of efficacy during clinical trials; |
| · | termination of our clinical trials by one or more clinical
trial sites; |
| · | inability or unwillingness of patients or clinical investigators
to follow our clinical trial protocols; |
| · | inability to monitor patients adequately during or after treatment; |
| · | clinical study sites failing to comply with regulatory requirements
or meet their contractual obligations to us in a timely manner, or at all, deviating from the protocol or dropping out of a study; |
| · | inability to address any non-compliance with regulatory requirements
or safety concerns that arise during the course of a clinical trial; |
| · | the need to repeat or terminate clinical trials as a result
of inconclusive or negative results or unforeseen complications in testing; and |
| · | our clinical trials may be suspended or terminated upon a
breach or pursuant to the terms of any agreement with, or for any other reason by, current or future strategic partners that have responsibility
for the clinical development of any of our product candidates. |
Changes in regulatory requirements,
policies and guidelines may also occur and we may need to significantly amend clinical trial protocols to reflect these changes with appropriate
regulatory authorities. These changes may require us to renegotiate terms with CROs or resubmit clinical trial protocols to IRBs for re-examination,
which may impact the costs, timing or successful completion of a clinical trial. Our clinical trials may be suspended or terminated at
any time by the FDA, other regulatory authorities, the IRB overseeing the clinical trial at issue, any of our clinical trial sites with
respect to that site, or us. Any failure or significant delay in commencing or completing clinical trials for our product candidates may
adversely affect our ability to obtain regulatory approval and our commercial prospects and our ability to generate product revenue will
be diminished.
The design or our execution of clinical
trials may not support regulatory approval.
The design or execution of
a clinical trial can determine whether its results will support regulatory approval and flaws in the design or execution of a clinical
trial may not become apparent until the clinical trial is well advanced. In some instances, there can be significant variability in safety
or efficacy results between different trials of the same product candidate due to numerous factors, including changes in trial protocols,
differences in size and type of the patient populations, adherence to the dosing regimen and other trial protocols and the rate of dropout
among clinical trial participants. We do not know whether any clinical trials we may conduct will demonstrate consistent or adequate efficacy
and safety to obtain regulatory approval to market our product candidates.
Further, the FDA and comparable
foreign regulatory authorities have substantial discretion in the approval process and in determining when or whether regulatory approval
will be obtained for any of our product candidates. Our product candidates may not be approved even if they achieve their primary endpoints
in future clinical trials. The FDA or foreign regulatory authorities may disagree with our trial design and our interpretation of data
from pre-clinical studies and clinical trials. In addition, any of these regulatory authorities may change requirements for the approval
of a product candidate even after reviewing and providing comments or advice on a protocol for clinical trial that has the potential to
result in FDA or other agencies’ approval. In addition, such regulatory authorities may also approve a product candidate for fewer
or more limited indications than we request or may grant approval contingent on the performance of costly post-marketing clinical trials.
The FDA or foreign regulatory authorities may not approve the labeling claims that we believe would be necessary or desirable for the
successful commercialization of our product candidates which may have a material adverse effect on our business.
We may find it difficult to enroll patients
in our clinical trials given the limited number of patients who have the diseases for which our product candidates are being studied which
could delay or prevent the start of clinical trials for our product candidates.
Identifying
and qualifying patients to participate in clinical trials of our product candidate is essential to our success. The timing of our clinical
trials depends in part on the rate at which we can recruit patients to participate in clinical trials of our product candidates, and we
may experience delays in our clinical trials if we encounter difficulties in enrollment. If we experience delays in our clinical trials,
the timeline for obtaining regulatory approval of our product candidates will most likely be delayed.
Many factors may affect our
ability to identify, enroll and maintain qualified patients, including the following:
| · | eligibility criteria of our ongoing and planned clinical trials
with specific characteristics appropriate for inclusion in our clinical trials; |
| · | design of the clinical trial; |
| · | size and nature of the patient population; |
| · | patients’ perceptions as to risks and benefits of the
product candidate under study and the participation in a clinical trial generally in relation to other available therapies, including
any new drugs that may be approved for the indications we are investigating; |
| · | the availability and efficacy of competing therapies and clinical
trials; |
| · | pendency of other trials underway in the same patient population; |
| · | willingness of physicians to participate in our planned clinical
trials; |
| · | severity of the disease under investigation; |
| · | proximity of patients to clinical sites; |
| · | patients who do not complete the trials for personal reasons;
and |
| · | issues with CROs and/or with other vendors that handle our
clinical trials. |
General Risks
There is a substantial doubt about our ability
to continue as a going concern.
The report of our independent
registered public accounting firm that accompanies our consolidated financial statements includes an explanatory paragraph indicating
there is a substantial doubt about our ability to continue as a going concern, citing our need for additional capital for the future planned
expansion of our activities and to service our ordinary course activities (which may include servicing of indebtedness). The inclusion
of a going concern explanatory paragraph in the report of our independent registered public accounting firm will make it more difficult
for us to secure additional financing or enter into strategic relationships on terms acceptable to us, if at all, and likely will materially
and adversely affect the terms of any financing that we might obtain. Our financial statements do not include any adjustments that may
result from the outcome of this uncertainty.
We have incurred significant losses in prior
periods, and losses in the future could cause the quoted price of our Common Stock to decline or have a material adverse effect on our
financial condition, our ability to pay its debts as they become due, and on its cash flows.
For
the year ended December 31, 2023, we incurred a net loss of $21,266,537 and, as of that date,
we had an accumulated deficit of $87,356,260. For the year ended December 31, 2022, we incurred
a net loss of $37,574,217 and, as of that date, had an accumulated deficit of $66,089,723.
Any losses in the future could cause the quoted price of our Common Stock to decline or have
a material adverse effect on our financial condition, its ability to pay its debts as they
become due, and on its cash flows.
To date, we have generated only minimal product revenue. We expect that our
planned product development and strategic expansion pursuits will increase losses significantly over the next five years. In order to
achieve profitability, we will be required to generate significant revenue. We cannot be certain that we will generate sufficient revenue
to achieve profitability. We anticipate that we will continue to generate operating losses and experience negative cash flow from operations
at least through the end of 2023 or longer. We cannot be certain that we will ever achieve profitability or that, if profitability is
achieved, that is will be maintained. If our revenue grows at a slower rate than we anticipate or if our product development, marketing
and operating expenses exceed our expectations or cannot be adjusted accordingly, our business, results of operation and financial condition
will be materially adversely affected and we may be unable to continue operations.
We will not be able to generate
meaningful product revenue unless and until one of our product candidates or co-development products successfully completes clinical trials
and receives regulatory approval. As some of our current and projected future product candidates or co-development products are, and we
expect will be, at an early proof-of-concept stage, we do not expect to receive revenue from any of these products for several years,
if at all. We intend to seek to obtain revenue from collaboration or licensing agreements with third parties. We expect that we will need
to rely on key third-party agreements, in order to be in a position to realize material revenues in the future, and we may never enter
into any such agreements or realize material, ongoing future revenue. Even if we eventually generate revenues, we may never be profitable,
and, if we do achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis.
The COVID-19 pandemic could have a material
adverse impact on our business, results of operations and financial condition.
In December 2019, a novel
strain of coronavirus was reported to have surfaced in Wuhan, China. In January 2020, the World Health Organization declared the
COVID-19 outbreak a “Public Health Emergency of International Concern.” This worldwide outbreak has resulted in the implementation
of significant governmental measures, including lockdowns, closures, quarantines and travel bans intended to control the spread of the
virus. Companies are also taking precautions, such as requiring employees to work remotely, imposing travel restrictions and temporarily
closing businesses and facilities. These restrictions, and future prevention and mitigation measures, have had an adverse impact on global
economic conditions and are likely to have an adverse impact on consumer confidence and spending, which could materially adversely affect
the supply of, as well as the demand for, our products. Uncertainties regarding the economic impact of COVID-19 is likely to result in
sustained market turmoil, which could also negatively impact our business, financial condition and cash flows.
If our operations or productivity
continue to be impacted throughout the duration of the COVID-19 outbreak and government-mandated closures, which may negatively impact
our business, financial condition and cash flows. The extent to which the COVID-19 pandemic will further impact our business will depend
on future developments and, given the uncertainty around the extent and timing of the potential future spread or mitigation and around
the imposition or relaxation of protective measures, we cannot reasonably estimate the impact to our business at this time.
The extent of COVID-19’s
effect on our operational and financial performance will depend on future developments, including the duration, spread and intensity of
the outbreak, all of which are uncertain and difficult to predict considering the rapidly evolving landscape. As a result, it is not currently
possible to ascertain the overall impact of COVID-19 on our business. However, if the pandemic continues for a prolonged period it could
have a material adverse effect on our business, results of operations, financial condition and cash flows and adversely impact the trading
price of our Common Stock.
If we are unable to manage future expansion
effectively, our business may be adversely impacted.
In
the future, we may experience rapid growth in our business, which could place a significant strain on our operations, in general, and
our internal controls and other managerial, operating and financial resources, in particular. If we are unable to manage future expansion
effectively, our business would be harmed. There is, of course, no assurance that we will enjoy rapid development in our business.
The Company’s ability to be successful
will depend upon the efforts of the Company’s Board and our key personnel and the loss of such persons could negatively impact the
operations and profitability of the Company’s business.
The Company’s ability
to be successful is dependent upon the efforts of the Company’s board members and key personnel, in particular our President and
Chief Executive Officer David Mehalick. We cannot assure you that the Company’s board members and key personnel will be effective
or successful or remain with the Company. In addition to the other challenges they will face, such individuals may be unfamiliar with
the requirements of operating a public company, which could cause the Company’s management to expend time and resources becoming
familiar with such requirements. We have employment agreements in place with Mr. Mehalick, Colleen Delaney and Daniel Yerace, but no other
persons. The loss of service of Mr. Mehalick, in particular, for any reason, could seriously impair our ability to effectuate our business
plan, which could have a materially adverse effect on our business and future results of operations. We also have not purchased any key-man
life insurance.
If we are unable to recruit and retain key
personnel, our business may be harmed.
If we are unable to attract
and retain key personnel, our business may be harmed. Our failure to enable the effective transfer of knowledge and facilitate smooth
transitions with regard to our key employees could adversely affect our long-term strategic planning and execution.
Our business plan is not based on independent
market studies.
We have not commissioned any
independent market studies concerning our business plans. Rather, our plans for implementing our business strategy and achieving profitability
are based on the experience, judgment and assumptions of our management. If these assumptions prove to be incorrect, we may not be successful
in our business operations.
Our Board of Directors may change our policies
without shareholder approval.
Our policies, including any
policies with respect to investments, leverage, financing, growth, debt and capitalization, will be determined by our Board of Directors
or officers to whom our Board of Directors delegate such authority. Our Board of Directors will also establish the amount of any dividends
or other distributions that we may pay to our shareholders. Our Board of Directors or officers to which such decisions are delegated will
have the ability to amend or revise these and our other policies at any time without shareholder vote. Accordingly, our shareholders will
not be entitled to approve changes in our policies, which policy changes may have a material adverse effect on our financial condition
and results of operations.
We need to obtain financing in order to
continue our operations and pursue strategic transactions.
On a prospective basis, we
will require both short-term financing for operations and long-term capital to fund our expected growth. We currently have no existing
bank lines of credit and have not established any definitive sources for additional financing. We believe that cash on hand will be sufficient
to meet our short-term financial requirements through the 1st quarter of 2024 assuming that we elect not to pursue and consummate
strategic transactions prior to that time. However, we will require additional funds if we want to fully implement our business plan
and growth strategy, including strategic transactions, which funds could come in the form of equity, debt (including secured debt) or
a combination of the two. Additional financing may not be available to us, or if available, then it may not be available upon terms and
conditions acceptable to us. If adequate funds are not available, then we may be required to delay, reduce or eliminate product development
or clinical programs. Our inability to take advantage of opportunities in the industry because of capital constraints may have a material
adverse effect on our business and our prospects. If we fail to obtain the capital necessary to fund our operations, we will be unable
to advance our development programs and complete our clinical trials.
In addition, our research and development expenses could exceed
our current expectations. This could occur for many reasons, including:
| · | some or all of our product candidates and co-development candidates
fail in clinical or preclinical studies and we are forced to seek additional product candidates; |
| · | our product candidates and co-development candidates require
more extensive clinical or preclinical testing than we currently expect; |
| · | we advance more of our product candidates and co-development
candidates than expected into costly later stage clinical trials; |
| · | we advance more preclinical product candidates and co-development
candidates than expected into early-stage clinical trials; |
| · | we are required, or consider it advisable, to acquire or license
rights from one or more third parties; or |
| · | we determine to acquire or license rights to additional product
candidates and co-development candidates or new technologies. |
While we expect to seek additional
funding through public or private financings, we may not be able to obtain financing on acceptable terms, or at all. In addition, the
terms of our financings may be dilutive to, or otherwise adversely affect, holders of our common stock and other capital securities. We
may also seek additional funds through arrangements with collaborators or other third parties. These arrangements would generally require
us to relinquish rights to some of our technologies, product candidates or products, and we may not be able to enter into such agreements,
on acceptable terms, if at all. If we are unable to obtain additional funding on a timely basis, we may be required to curtail or terminate
some or all of our development programs, including some or all of our product candidates.
We currently do not have sufficient cash
to fully implement our business plan.
We have experienced a lack
of adequate capital resources causing us to be unable to fully implement our full business plan. We believe that we need to raise or otherwise
obtain additional financing beyond our current cash position in order to satisfy our existing obligations and fully implement our business
plan. We do not expect to have positive cash flow for the foreseeable future. If we are not successful in obtaining additional financing
we will not be able to fully implement our business plan and we may not be able to continue our operations.
We have a limited operating history and
a history of operating losses, and expect to incur significant additional operating losses.
We began our business in 2017
and have a limited operating history. Although we have enlisted the assistance of pharmaceutical experts, our lack of experience may cause
us to encounter unforeseen problems that could have a material adverse effect on our business and financial condition. Further, there
is limited historical financial information upon which to base an evaluation of our performance.
The drug development and approval process
is uncertain, time-consuming and expensive.
The
process of obtaining and maintaining regulatory approvals for new therapeutic products is lengthy, expensive and uncertain. It also can
vary substantially based on the type, complexity, and novelty of the product. We, or our co-development partners, must provide the FDA
and foreign regulatory authorities with preclinical and clinical data demonstrating that our products are safe and effective before they
can be approved for commercial sale. Clinical development, including preclinical testing, is a long, expensive and uncertain process.
It may take us several years to complete our testing, and failure can occur at any stage of testing. Any preclinical or clinical
test may fail to produce results satisfactory to the FDA. Preclinical and clinical data can be interpreted in different ways, which
could delay, limit or prevent regulatory approval. Negative or inconclusive results from a preclinical study or clinical trial, adverse
medical events during a clinical trial or safety issues resulting from products of the same class of drug could cause a preclinical study
or clinical trial to be repeated or a program to be terminated, even if other studies or trials relating to the program are successful.
We will be required to sustain and further
build our intellectual property rights.
We do not currently have any
intellectual property rights in our name in respect of our current assets, and instead have rights in respect of our current assets through
agreements with third parties. We intend to fully protect any product, formulation and process that we develop with appropriate intellectual
property registrations. If we fail to sustain and further build our direct and indirect intellectual property rights, competitors will
be able to take advantage of our research and development efforts to develop competing products. If we are not able to protect our proprietary
technology, trade secrets, and know-how, our competitors may use our inventions to develop competing products. Our future patents and
patent applications, even if granted, may not protect us against our competitors. Patent positions generally, including those of other
pharmaceutical and biotechnology companies, are or will be generally uncertain and involve complex legal, scientific and factual questions.
The standards which the United States Patent and Trademark Office uses to grant patents, and the standards which courts use to interpret
patents, are not always applied predictably or uniformly and can change, particularly as new technologies develop. Consequently, the level
of protection, if any, that will be provided by our direct or indirect patent rights from time to time if we attempt to enforce them,
and they are challenged, is uncertain. In addition, the type and extent of patent claims that will be issued to us in the future is uncertain.
Any patents that are issued may not contain claims that permit us to stop competitors from using similar technology.
In addition, we may also rely
on unpatented technology, trade secrets, and confidential information. We may not be able to effectively protect our rights to this technology
or information. Other parties may independently develop substantially equivalent information and techniques or otherwise gain access to
or disclose our technology. We will generally require each of our employees, consultants, collaborators, and certain contractors to execute
a confidentiality agreement at the commencement of an employment, consulting, collaborative, or contractual relationship with us. However,
these agreements may not provide effective protection of our technology or information or, in the event of unauthorized use or disclosure,
they may not provide adequate remedies.
Patent positions are often
uncertain and involve complex legal and factual questions. In addition, the laws of some foreign countries do not protect proprietary
rights to the same extent as the laws of the United States. Whether filed in the United States or abroad, our patent applications
may be challenged or may fail to result in issued patents. In addition, any future patents we obtain may not be sufficiently broad to
prevent others from practicing our technologies or from developing or commercializing competing products. Furthermore, others may independently
develop or commercialize similar or alternative technologies or drugs, or design around our patents. Our patents may be challenged, invalidated
or fail to provide us with any competitive advantages. We may not have the funds available to protect our patents or other technology;
such protection is costly and can result in further litigation expenses.
If we do not obtain or we
are unable to maintain adequate patent or trade secret protection for our products in the United States, competitors could duplicate
them without repeating the extensive testing that we will be required to undertake to obtain approval of the products by the FDA. Regardless
of any patent protection, under the current statutory framework the FDA is prohibited by law from approving any generic version of any
of our products for a period of years that would be determined based on the nature of the product (i.e. an orphan drugs would get
7 years, a new chemical entity would get 5 years and a new clinical investigation would get 3 years). Upon the expiration
of that period, or if that time period is altered, the FDA could approve a generic version of our product unless we have patent protection
sufficient for us to block that generic version. Without sufficient patent protection, the applicant for a generic version of our product
would be required only to conduct a relatively inexpensive study to show that its product is bioequivalent to our product and may not
have to repeat the studies that we will need to conduct to demonstrate that the product is safe and effective. In the absence of adequate
patent protection in other countries, competitors may similarly be able to obtain regulatory approval in those countries of products that
duplicate our products.
We will be required to comply with our obligations
in our intellectual property licenses and other agreements with third parties.
If
we fail to comply with our obligations in our intellectual property licenses and other agreements with third parties, we could lose license
rights that are important to our business. We are not currently party to any intellectual property license agreement with any third parties,
but we anticipate that in-licensing and co-development will be strategies that we utilize as we continue to pursue our growth strategy.
We expect to enter into licenses and co-development and other agreements in the future, and we expect these agreements to impose, various
diligences, milestone payment, royalty, insurance and other obligations on us. If we fail to comply with these obligations, the licensor
may have the right to terminate the license, in which event we might not be able to market any product that is covered by the licensed
patents.
We may need to resort to litigation
to enforce or defend our intellectual property rights, including any patents issued to us. If a competitor or collaborator files a patent
application claiming technology also invented by us, in order to protect our rights, we may have to participate in an expensive and time-consuming
interference proceeding before the United States Patent and Trademark Office. We cannot guarantee that our product candidates will
be free of claims by third parties alleging that we have infringed their intellectual property rights. Third parties may assert that we
are employing their proprietary technologies without authorization and they may resort to litigation to attempt to enforce their rights.
Third parties may have or obtain patents in the future and claim that the use of our technology or any of our product candidates infringes
their patents. We may not be able to develop or commercialize combination product candidates because of patent protection others have.
Our business will be harmed if we cannot obtain a necessary or desirable license, can obtain such a license only on terms we consider
to be unattractive or unacceptable, or if we are unable to redesign our product candidates or processes to avoid actual or potential patent
or other intellectual property infringement. Obtaining, protecting and defending patent and other intellectual property rights can be
expensive and may require us to incur substantial costs, including the diversion of management and technical personnel. An unfavorable
ruling in patent or intellectual property litigation could subject us to significant liabilities to third parties, require us to cease
developing, manufacturing or selling the affected products or using the affected processes, require us to license the disputed rights
from third parties, or result in awards of substantial damages against us.
There can be no assurance
that we would prevail in any intellectual property infringement action, will be able to obtain a license to any third-party intellectual
property on commercially reasonable terms, successfully develop non-infringing alternatives on a timely basis, or license non-infringing
alternatives, if any exist, on commercially reasonable terms. Any significant intellectual property impediment to our ability to develop
and commercialize our products could seriously harm our business and prospects.
Patent litigation or other litigation in
connection with our intellectual property rights may lead to publicity that may harm our reputation and the value of our common stock
may decline.
During the course of any patent
litigation, there may be public announcements of the results of hearings, motions, and other interim proceedings or developments in the
litigation. If securities analysts or investors regard these announcements as negative, the value of our common stock may decline. General
proclamations or statements by key public figures may also have a negative impact on the perceived value of our intellectual property.
Protecting and defending against intellectual
property claims may have a material adverse effect on our business.
From time to time, we may
receive notice that others have infringed on our proprietary rights or that we have infringed on the intellectual property rights of others.
There can be no assurance that infringement or invalidity claims will not materially adversely affect our business, financial condition
or results of operations. Regardless of the validity or the success of the assertion of claims, we could incur significant costs and diversion
of resources in protecting or defending against claims, which could have a material adverse effect on our business, financial condition
or results of operations. We may not have the funds or resources available to protect our intellectual property.
Our competitors and potential competitors
may develop products and technologies that make ours less attractive or obsolete.
Many
companies, universities, and research organizations developing competing product candidates have greater resources and significantly greater
experience in financial, research and development, manufacturing, marketing, sales, distribution, and technical regulatory matters than
we have. In addition, many competitors have greater name recognition and more extensive collaborative relationships. Our competitors could
commence and complete clinical testing of their product candidates, obtain regulatory approvals, and begin commercial-scale manufacturing
of their products faster than we or our co-development partners are able to for our products. They could develop products that would render
our product candidates and co-development candidates, and those of our collaborators, obsolete and noncompetitive. If we are unable to
compete effectively against these companies, then we may not be able to commercialize our product candidates or achieve a competitive
position in the market. This would adversely affect our ability to generate revenues.
Competition in the biotechnology and pharmaceutical
industries may result in competing products, superior marketing of other products and lower revenues or profits for us.
There are many companies that
are seeking to develop products and therapies for the treatment of the same diseases that we are currently targeting. Many of our competitors
have substantially greater financial, technical, human and other resources than we do and may be better equipped to develop, manufacture
and market technologically superior products. In addition, many of these competitors have significantly greater experience than we do
in undertaking preclinical testing and human clinical studies of new pharmaceutical products and in obtaining regulatory approvals of
human therapeutic products. Accordingly, our competitors may succeed in obtaining FDA approval for superior products.
Other risks and uncertainties
include:
| · | our ability to successfully complete preclinical and clinical
development of our products and services. |
| · | our ability to manufacture sufficient amounts of products
for development and commercialization activities. |
| · | our ability to obtain, maintain and successfully enforce adequate
patent and other proprietary rights protection of our products and services. |
| · | the scope, validity and enforceability of patents and other
proprietary rights held by third parties and their impact on our ability to commercialize our products and services. |
| · | the accuracy of our estimates of the size and characteristics
of the markets to be addressed by our products and services, including growth projections. |
| · | market acceptance of our products and services. |
| · | our ability to identify new patients for our products and
services. |
| · | the accuracy of our information regarding the products and
resources of our competitors and potential competitors. |
| · | the content and timing of submissions to and decisions made
by the US Food and Drug Administration (FDA) and other regulatory agencies. |
| · | our ability to obtain reimbursement for our products and services
from third-party payors, and the extent of such coverage. |
| · | our ability to establish and maintain strategic license, collaboration
and distribution arrangements. |
| · | the continued funding of our collaborations and joint ventures,
if any are ultimately established. |
| · | the possible disruption of our operations due to terrorist
activities and armed conflict, including as a result of the disruption of operation of our subsidiaries and our customers, suppliers,
distributors, couriers, collaborative partners, licensees and clinical trial sites. |
Positive
or timely results from preclinical studies and early clinical trials do not ensure positive or timely results in late-stage clinical trials
or product approval by the FDA or any other regulatory authority. Product candidates that show positive preclinical or early clinical
results often fail in later stage clinical trials. Data obtained from preclinical and clinical activities is susceptible to varying interpretations,
which could delay, limit, or prevent regulatory approvals.
We have limited experience
in conducting the clinical trials required to obtain regulatory approval. We may not be able to conduct clinical trials at preferred sites,
enlist clinical investigators, enroll sufficient numbers of participants, or begin or successfully complete clinical trials in a timely
fashion, if at all. Any failure to perform may delay or terminate the trials. Once Phase 1 human trials are initiated, the pre-defined
clinical outcome(s) may not be achieved. As a result, additional clinical trials may be required if clinical trial results are negative
or inconclusive, which will require us to incur additional costs and significant delays. If we do not receive the necessary regulatory
approvals, we will not be able to generate product revenues and may not become profitable.
The Company’s business and operations
could be negatively affected if it becomes subject to any securities litigation or shareholder activism, which could cause the Company
to incur significant expense, hinder execution of business and growth strategy and impact its stock price.
In the past, following periods
of volatility in the market price of a company’s securities, securities class action litigation has often been brought against that
company. Shareholder activism, which could take many forms or arise in a variety of situations, has been increasing recently. Volatility
in the stock price of the common stock or other reasons may in the future cause it to become the target of securities litigation or shareholder
activism. Securities litigation and shareholder activism, including potential proxy contests, could result in substantial costs and divert
management’s and board of directors’ attention and resources from the Company’s business. Additionally, such securities
litigation and shareholder activism could give rise to perceived uncertainties as to the Company’s future, adversely affect its
relationships with service providers and make it more difficult to attract and retain qualified personnel. Also, the Company may be required
to incur significant legal fees and other expenses related to any securities litigation and activist shareholder matters. Further, its
stock price could be subject to significant fluctuation or otherwise be adversely affected by the events, risks and uncertainties of any
securities litigation and shareholder activism.
Risk Related to Regulation
The regulatory approval process is costly
and lengthy, and we may not be able to successfully obtain all required regulatory approvals.
The preclinical development,
clinical trials, manufacturing, marketing and labeling of pharmaceuticals are all subject to extensive regulation by numerous governmental
authorities and agencies in the United States and other countries. We must obtain regulatory approval for each of our product candidates
before marketing or selling any of them. It is not possible to predict how long the approval processes of the FDA or any other applicable
federal or foreign regulatory authority or agency for any of our products will take or whether any such approvals ultimately will be granted.
The FDA and foreign regulatory agencies have substantial discretion in the drug approval process, and positive results in preclinical
testing or early phases of clinical studies offer no assurance of success in later phases of the approval process. Generally, preclinical
and clinical testing of products can take many years and require the expenditure of substantial resources, and the data obtained
from these tests and trials can be susceptible to varying interpretations that could delay, limit or prevent regulatory approval. If we
encounter significant delays in the regulatory process that result in excessive costs, this may prevent us from continuing to develop
our product candidates. Any delay in obtaining, or failure to obtain, approvals could adversely affect the marketing of our products and
our ability to generate product revenue. The risks associated with the approval process include:
| · | failure of our product candidates to meet a regulatory agency’s
requirements for safety, efficacy and quality; |
| · | limitation on the indicated uses for which a product may be
marketed; |
| · | unforeseen safety issues or side effects; and |
| · | governmental or regulatory delays and changes in regulatory
requirements and guidelines. |
Even if we receive regulatory approvals
for marketing our product candidates, if we fail to comply with continuing regulatory requirements, we could lose our regulatory approvals,
and our business would be adversely affected.
The FDA continues to review
products even after they receive initial approval. If we receive approval to commercialize any product candidates, the manufacturing,
marketing and sale of these drugs will be subject to continuing regulation, including compliance with quality systems regulations, good
manufacturing practices, adverse event requirements, and prohibitions on promoting a product for unapproved uses. Enforcement actions
resulting from our failure to comply with government and regulatory requirements could result in fines, suspension of approvals, withdrawal
of approvals, product recalls, product seizures, mandatory operating restrictions, criminal prosecution, civil penalties and other actions
that could impair the manufacturing, marketing and sale of our potential products and our ability to conduct our business.
Even if we are able to obtain regulatory
approvals for any of our product candidates, if they exhibit harmful side effects after approval, our regulatory approvals could be revoked
or otherwise negatively impacted, and we could be subject to costly and damaging product liability claims.
Even if we receive regulatory
approval for our product candidates, we will have tested them in only a small number of patients during our clinical trials. If our applications
for marketing are approved and more patients begin to use our product, new risks and side effects associated with our products may be
discovered. As a result, regulatory authorities may revoke their approvals; we may be required to conduct additional clinical trials,
make changes in labeling of our product, reformulate our product or make changes and obtain new approvals for our and our suppliers’
manufacturing facilities. We might have to withdraw or recall our products from the marketplace. We may also experience a significant
drop in the potential sales of our product if and when regulatory approvals for such product are obtained, experience harm to our reputation
in the marketplace or become subject to lawsuits, including class actions. Any of these results could decrease or prevent any sales of
our approved product or substantially increase the costs and expenses of commercializing and marketing our product.
Healthcare reform measures could adversely
affect our business.
The efforts of governmental
and third-party payers to contain or reduce the costs of healthcare may adversely affect the business and financial condition of pharmaceutical
companies. In the United States and in foreign jurisdictions there have been, and we expect that there will continue to be, a number
of legislative and regulatory proposals aimed at changing the healthcare system. For example, in some countries other than the United States,
pricing of prescription drugs is subject to government control, and we expect proposals to implement similar controls in the United States
to continue. The pendency or approval of such proposals could result in a decrease in our common stock value or limit our ability to raise
capital or to enter into collaborations or license rights to our products.
Federal legislation may increase the pressure
to reduce prices of pharmaceutical products paid for by Medicare, which could adversely affect our revenues, if any.
The Medicare Prescription
Drug Improvement and Modernization Act of 2003, or MMA, expanded Medicare coverage for drug purchases by the elderly and disabled
beginning in 2006. The legislation uses formularies, preferred drug lists and similar mechanisms that may limit the number of drugs that
will be covered in any therapeutic class or reduce the reimbursement for some of the drugs in a class. More recently, the Patient Protection
and Affordable Care Act of 2010 also contained certain provisions with the potential to affect pricing of pharmaceutical products.
As
a result of the expansion of legislation, including recent healthcare insurance legislation, and the expansion of federal coverage of
drug products, we expect that there will be additional pressure to contain and reduce costs. These cost reduction initiatives could decrease
the coverage and price that we receive for our products in the future and could seriously harm our business. While the MMA applies only
to drug benefits for Medicare beneficiaries, private payers often follow Medicare coverage policy and payment limitations in setting their
own reimbursement systems, and any limits on or reductions in reimbursement that occur in the Medicare program may result in similar limits
on or reductions in payments from private payers.
Federal laws or regulations on drug importation
could make lower cost versions of our future products available, which could adversely affect our revenues, if any.
The prices of some drugs are
lower in other countries than in the United States because of government regulation and market conditions. Various proposals have
been advanced to permit the importation of drugs from other countries to provide lower cost alternatives to the products available in
the United States. In addition, the MMA requires the Secretary of Health and Human Services to promulgate regulations for drug reimportation
from Canada into the United States under some circumstances, including when the drugs are sold at a lower price than in the United States.
A prime example of the effort to provide safe, lower cost drugs to consumers is Safe Importation Action Plan that was released by the
Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA), which plan is describes steps the HHS and FDA
will take to allow the safe importation of certain drugs originally intended for non-US markets. If the laws or regulations are changed
to permit or more easily permit the importation of drugs into the United States in circumstances that are currently not permitted,
such a change could have an adverse effect on our business by making available lower priced alternatives to our future products.
Failure to obtain regulatory and pricing
approvals in foreign jurisdictions could delay or prevent commercialization of our products abroad.
If we succeed in developing
any products, we intend to market them in the European Union and other foreign jurisdictions. In order to do so, we must obtain separate
regulatory approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can
involve additional testing. The time required to obtain approval abroad may differ from that required to obtain FDA approval. The foreign
regulatory approval process may include all of the risks associated with obtaining FDA approval and additional risks associated with requirements
particular to those foreign jurisdictions where we will seek regulatory approval of our products. We may not obtain foreign regulatory
approvals on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries, and
approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA.
We and our collaborators may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our
products in any market outside the United States. The failure to obtain these approvals could materially adversely affect our business,
financial condition and results of operations.
Risks Related to Our Organization and Structure
Our holding company structure makes us dependent
on our subsidiaries for our cash flow and could serve to subordinate the rights of our shareholders to the rights of creditors of our
subsidiaries, in the event of an insolvency or liquidation of any such subsidiary.
Our Company acts as a holding
company and, accordingly, substantially all of our operations are conducted through our subsidiaries. Such subsidiaries will be separate
and distinct legal entities. As a result, substantially all of our cash flow will depend upon the earnings of our subsidiaries. In addition,
we will depend on the distribution of earnings, loans or other payments by our subsidiaries. No subsidiary will have any obligation to
provide our company with funds for our payment obligations. If there is an insolvency, liquidation or other reorganization of any of our
subsidiaries, our shareholders will have no right to proceed against their assets. Creditors of those subsidiaries will be entitled to
payment in full from the sale or other disposal of the assets of those subsidiaries before our company, as a shareholder, would be entitled
to receive any distribution from that sale or disposal.
Delaware law
and the Amended and Restated Certificate of Incorporation and Bylaws contain certain provisions, including anti-takeover provisions that
limit the ability of stockholders to take certain actions and could delay or discourage takeover attempts that stockholders may consider
favorable.
The Company’s Amended
and Restated Certificate of Incorporation and Bylaws, and the DGCL, contain provisions that could have the effect of rendering more difficult,
delaying, or preventing an acquisition deemed undesirable by the Company Board and therefore depress the trading price of the common stock.
These provisions could also make it difficult for stockholders to take certain actions, including electing directors who are not nominated
by the current members of the Company Board or taking other corporate actions, including effecting changes in management. Among other
things, the Amended and Restated Certificate of Incorporation and Bylaws include provisions regarding:
| · | the ability of the Company Board to issue shares of preferred
stock, including “blank check” preferred stock and to determine the price and other terms of those shares, including preferences
and voting rights, without stockholder approval, which could be used to significantly dilute the ownership of a hostile acquirer; |
| · | the limitation of the liability of, and the indemnification
of, the Company’s directors and officers; |
| · | the right of the Company Board to elect a director to fill
a vacancy created by the expansion of the Company Board or the resignation, death or removal of a director, which prevents stockholders
from being able to fill vacancies on the Company Board; |
| · | a prohibition on stockholder action by written consent (except
as required for holders of future series of preferred stock), which forces stockholder action to be taken at an annual or special meeting
of stockholders and could delay the ability of stockholders to force consideration of a stockholder proposal or to take action, including
the removal of directors; |
| · | the requirement that a special meeting of stockholders may
be called only by the Company Board, the chairman of the Company Board, which could delay the ability of stockholders to force consideration
of a proposal or to take action, including the removal of directors; |
| · | controlling the procedures for the conduct and scheduling
of the Company Board and stockholder meetings; |
| · | the requirement for the affirmative vote of holders of at
least a majority of the voting power of all of the voting power of the then outstanding shares of the voting stock, voting as a single
class, to amend, alter, change or repeal any provision of the Company’s Bylaws and certain provisions in the Amended and Restated
Certificate of Incorporation, respectively, which could preclude stockholders from bringing matters before annual or special meetings
of stockholders and delay changes in the Company Board and also may inhibit the ability of an acquirer to effect such amendments to facilitate
an unsolicited takeover attempt; |
| · | the ability of the Company Board to amend the Bylaws by an
affirmative vote of a majority of the Board, which may allow the Company Board to take additional actions to prevent an unsolicited takeover
and inhibit the ability of an acquirer to amend the Bylaws to facilitate an unsolicited takeover attempt; and |
| · | advance notice procedures with which stockholders must comply
to nominate candidates to the Company Board or to propose matters to be acted upon at a stockholders’ meeting, which could preclude
stockholders from bringing matters before annual or special meetings of stockholders and delay changes in the Company Board and also
may discourage or deter a potential acquirer from conducting a solicitation of proxies to elect the acquirer’s own slate of directors
or otherwise attempting to obtain control of Company. |
These provisions, alone or
together, could delay or prevent hostile takeovers and changes in control or changes in the Company Board or management.
In
addition, as a Delaware corporation, the Company will generally be subject to provisions of Delaware law, including Section 203 of
the DGCL.
Any provision of the Amended
and Restated Certificate of Incorporation, Bylaws or Delaware law that has the effect of delaying or preventing a change in control could
limit the opportunity for stockholders to receive a premium for their shares of the Company’s capital stock and could also affect
the price that some investors are willing to pay for the common stock.
The Amended and Restated Certificate of
Incorporation designates a state or federal court located within the State of Delaware as the exclusive forum for substantially all disputes
between the Company and its stockholders, which could limit the Company’s stockholders’ ability to choose the judicial forum
for disputes with the Company or its directors, officers, or employees.
The Amended and Restated Certificate
of Incorporation will provide that, unless the Company consents in writing to the selection of an alternative forum, the Court of Chancery
of the State of Delaware, or if such court does not have subject matter jurisdiction, any other court located in the State of Delaware
with subject matter jurisdiction, will be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf
of the Company, (ii) any action asserting a claim of breach of a fiduciary duty owed by any current or former director, officer,
other employee or stockholder of the Company to the Company or the Company’s stockholders, (iii) any action asserting a claim
against the Company or its officers or directors arising pursuant to any provision of the DGCL or the Amended and Restated Certificate
of Incorporation or Bylaws or as to which the DGCL confers jurisdiction on the Court of Chancery of the State of Delaware, or (iv) any
action asserting a claim against the Company or any director or officer of the Company governed by the internal affairs doctrine of the
law of the State of Delaware; provided, that, if and only if the Court of Chancery of the State of Delaware dismisses any such action
for lack of subject matter jurisdiction, such action may be brought in another state court sitting in the State of Delaware. Additionally,
the Amended and Restated Certificate of Incorporation will provide that, unless the Company consents to the selection of an alternative
forum, the federal district courts of the United States of America shall, to the fullest extent permitted by law, be the sole and
exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act; provided, however, that
such provision will not apply to suits brought to enforce any liability or duty created by the Exchange Act, or any other claim for
which the federal courts have exclusive jurisdiction. However, there is uncertainty as to whether a court would enforce this provision
and investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Section 22 of the Securities
Act creates concurrent jurisdiction for state and federal courts over all suits brought to enforce any duty or liability created by the
Securities Act or the rules and regulations thereunder.
Any person or entity purchasing
or otherwise acquiring any interest in any of the securities of the Company will be deemed to have notice of and consented to these provisions.
These exclusive-forum provisions may limit or make more costly a stockholder’s ability to bring a claim in a judicial forum of its
choosing for disputes with the Company or its directors, officers, or other employees, which may discourage lawsuits against the Company
and its directors, officers, and other employees. If a court were to find these exclusive-forum provisions to be inapplicable or unenforceable
in an action, the Company may incur additional costs associated with resolving the dispute in other jurisdictions, which could harm its
results of operations.
Risks Related to Our Capital Requirements and
Capital Structure
Nasdaq may delist the Company’s securities
from trading on its exchange, which could limit investors’ ability to make transactions in the Company’s securities and subject
the Company to additional trading restrictions.
The
Company’s securities are currently listed on The Nasdaq Capital Market (“Nasdaq”) effective as of the opening of business
on June 13, 2023, and it is anticipated that the Company’s securities will continue to be listed on The Nasdaq Capital Market. However,
there can be no assurance that the Company’s securities will maintain such listing at all times. To maintain the listing of the
Company’s securities on Nasdaq, the Company must maintain certain financial, distribution, liquidity and stock price levels to satisfy
Nasdaq’s continued listing requirements. The Company must, among other things, maintain a minimum bid price of $1.00 per share,
a minimum market value of listed securities of $35 million and a minimum of 300 public shareholders. The foregoing is a brief description
of The Nasdaq Capital Market continued listing requirements applicable to the Company’s securities, and more detailed information
about such requirements is set forth in Nasdaq Rules 5550 and 5560. If the Company is unable to maintain a minimum bid price for its shares
of $1.00 per share, or to satisfy any other continued listing requirement, Nasdaq may delist the Company’s securities from trading
on its exchange. Such a delisting would likely have a negative effect on the price of the Company’s securities and may impair your
ability to sell or purchase the Company’s securities when you wish to do so.
On January 29, 2024, we received
notice from the Listing Qualifications Staff of Nasdaq indicating that, based upon the closing bid price of our common stock for the prior
30 consecutive business days, we were not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued
listing on Nasdaq as set forth In Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has
been provided an initial period of 180 calendar days, or until July 29, 2024, to regain compliance. If we do not regain compliance during
the compliance period ending July 29, 2024, then Nasdaq may grant us a second 180 calendar day period to regain compliance, provided we
meet the continued listing requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq
Capital Market, other than the minimum closing bid price requirement, and notify Nasdaq of our intent to cure the deficiency. If we do
not regain compliance within the allotted compliance periods, including any extensions that may be granted by Nasdaq, we may be subject
to delisting. If Nasdaq determines to delist our common stock, we will have the right to appeal to a Nasdaq hearing panel.
If Nasdaq delists the Company’s
securities from trading on its exchange and the Company is not able to list its securities on another Nasdaq trading tier or on another
national securities exchange, the Company’s securities may be quoted on an over-the-counter market. However, if this were to occur,
the Company could face significant material adverse consequences, including:
| · | a limited availability of market quotations for its securities; |
| · | reduced liquidity for its securities; |
| · | a determination that the Common Stock is a “penny stock”
which will require brokers trading in the common stock to adhere to more stringent rules and possibly result in a reduced level of trading
activity in the secondary trading market for the Company’s securities; |
| · | a limited amount of news and analyst coverage; and |
| · | a decreased ability to issue additional securities or obtain
additional financing in the future. |
We have previously identified weaknesses in
our internal control over financial reporting and we may identify additional weaknesses in the future or otherwise fail to maintain effective
internal control over financial reporting, which may result in material misstatements of our Consolidated Financial Statements or cause
us to fail to meet our periodic reporting obligations or cause our access to the global markets to be impaired.
In connection with the preparation
of our 2022 financial statements, Management self-identified material weaknesses in our internal control over financial reporting. In
the past we have not designed and maintained an effective control environment or sufficient accounting and reporting protocols or effectively
selected and developed control activities that mitigate risks. The material weaknesses were self-diagnosed, and were not issued by our
independent auditors, Turner, Stone & Company, LLP. These self-diagnosed material weaknesses resulted in deficiencies surrounding
the controls related to the preparation, review, and analysis of accounting information and financial statements. Those controls were
not adequately designed or appropriately implemented to identify material misstatements in financial reporting on a timely basis.
We have begun an implementation
plan to remediate these self-diagnosed material weaknesses. With the oversight of senior management and our audit committee, we are focused
on hiring additional accounting personnel with technical accounting and financial reporting experience and have implemented improved process
level and management review controls with respect to the completeness, accuracy, and validity of complex accounting measurements on a
timely basis. We also have supplemented internal accounting resources with external advisors to assist with performing technical accounting
activities. These measures are expected to result in future costs for the Company.
On May 17, 2023, the Company
announced that Brian Cogley was appointed as the Company’s new Chief Financial Officer, effective immediately. He replaced Christine
Sheehy, who remains with the Company to support the finance team and also in her new role as Vice President of Compliance and Corporate
Secretary. Mr. Cogley has over 15 years of accounting and finance experience, having previously held positions of increasing authority
at two “Big 4” accounting firms and served on the management teams of multiple companies in diverse industries. An accountant
by training, Mr. Cogley arrives at Coeptis with a career in corporate finance and accounting during which he advised and led the financial
operations for companies in multiple industries including life sciences, pharmaceuticals, financial services, and manufacturing. Mr. Cogley’s
diverse experience and knowledge of the Sarbanes-Oxley control environment and SEC reporting requirements will help bolster the Company’s
internal controls and operational efficiency.
Our efforts may not remediate
these self-diagnosed material weaknesses in our internal control over financial reporting and may not prevent additional material weaknesses
from being identified in the future. Our failure to implement and maintain effective internal control over financial reporting could
result in errors in our Consolidated Financial Statements that could result in a restatement of our Consolidated Financial Statements,
and could cause us to fail to meet our reporting obligations, any of which could diminish investor confidence in us and cause a decline
in our equity value.
If securities or industry analysts do not
publish research or reports about our business or publish negative reports about our business or our industry, the trading price and volume
of our securities could decline.
The trading market for our
securities will depend in part on the research and reports that securities or industry analysts publish about us or our business, our
market and our competitors. We do not have any control over these analysts. If one or more of the analysts who cover us downgrade our
shares or change their opinion of our shares, the trading price for our securities would likely decline. If one or more of these analysts
cease coverage of our company or fail to regularly publish reports on us, we could lose visibility in the financial markets, which could
cause the trading price or volume of our securities to decline.
We are an “emerging growth company”
and the reduced disclosure requirements applicable to emerging growth companies may make our securities less attractive to investors.
We are an “emerging
growth company,” as defined in the JOBS Act. For so long as we remain an emerging growth company, we are permitted and plan to rely
on exemptions from certain disclosure requirements that are applicable to public companies that are not emerging growth companies. These
provisions include, but are not limited to: an exemption from compliance with the auditor attestation requirement in the assessment of
our internal control over financial reporting pursuant to Section 404 of the Sarbanes-Oxley Act; reduced disclosure obligations regarding
executive compensation arrangements in our periodic reports, registration statements and proxy statements; and exemptions from the requirements
of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously
approved. In addition, the JOBS Act permits emerging growth companies to take advantage of an extended transition period to comply with
new or revised accounting standards applicable to public companies. We intend to take advantage of the exemptions discussed above. As
a result, the information we provide will be different than the information that is available with respect to other public companies that
are not emerging growth companies or that are not taking advantage of such exemptions.
We will remain an emerging
growth company until the earliest of (i) December 31, 2025, (ii) the first fiscal year after our annual gross revenue
exceed $1.07 billion, (iii) the date on which we have, during the immediately preceding three-year period, issued more than $1.00
billion in non-convertible debt securities, or (iv) the end of any fiscal year in which the market value of our common stock
held by non-affiliates exceeds $700.0 million as of the end of the second quarter of that fiscal year.
We cannot predict whether
investors will find our common stock less attractive if we rely on these exemptions. If some investors find our common stock less attractive
as a result, there may be a less active trading market for our securities, and the market price of our securities may be more volatile.
| ITEM 1B. |
UNRESOLVED STAFF COMMENTS |
None.
None.
Our principal place of business
is located at 105 Bradford Street, Suite 420, Wexford, Pennsylvania 15090, which we lease. The lease is scheduled to expire on May 31,
2026.
We do not own any properties or land.
We believe our facilities
are adequate and suitable for our current needs and that, should it be needed, suitable additional or alternative space will be available.
| ITEM 3. |
LEGAL PROCEEDINGS |
We are from time to time subject
to litigation and other proceedings that arise in the ordinary course of our business. Subject to the inherent uncertainties of litigation
and although no assurances are possible, we believe that there are no pending lawsuits or claims that, individually or in the aggregate,
will have a material adverse effect on our business, financial condition or our yearly results of operations.
| ITEM 4. |
MINE SAFETY DISCLOSURES |
Not applicable.
PART II
| ITEM 5. |
MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES |
Market Information
Our common stock is listed on
the Nasdaq Global Market under the symbol “COEP.” The closing price of our common stock on Nasdaq on December 29, 2023
was $0.78 per share.
Holders of Common Stock
As of March 22, 2024, we had 36,089,917 shares of our common stock
issued and outstanding, and there were 112 record holders of our common stock. Certain shares are
held in “street” name and accordingly, the number of beneficial owners of such shares is not known or included in the foregoing
number. This number of holders of record also does not include stockholders whose shares may be held in trust by other entities.
Dividend Policy
We have never declared or
paid dividends. We do not intend to pay cash dividends on our Common Stock for the foreseeable future, but currently intend to retain
any future earnings to fund the development and growth of our business. The payment of dividends if any, on our common stock will rest
solely within the discretion of our board of directors and will depend, among other things, upon our earnings, capital requirements, financial
condition, and other relevant factors.
Securities Authorized for Issuance under Equity Compensation Plans
The following is a summary
of the principal features of the 2022 Equity Incentive Plan (the “Plan”). This summary does not purport to be a complete description
of all of the provisions of the 2022 Equity Incentive Plan and it is qualified in its entirety by reference to the full text of the 2022
Equity Incentive Plan.
Eligibility
and Administration. Employees, consultants and directors of the Company and its subsidiaries may be
eligible to receive awards under the 2022 Equity Incentive Plan. Currently, we have seven employees and five non-employee directors. All
seven employees, and all five non-employee directors and two consultants have received awards under the 2022 Equity Incentive Plan.
Awards. The
2022 Equity Incentive Plan provides for the grant of ISOs within the meaning of Section 422 of the Internal Revenue Code (the “Code”)
to employees, including employees of any parent or subsidiary, and for the grant of nonstatutory stock options (“NSOs”), stock
appreciation rights (“SARs”), Restricted Stock Awards, Restricted Stock Unit (“RSU”) awards, Performance Awards
and other forms of awards to employees, directors and consultants, including employees and consultants of our affiliates.
Authorized Shares. The
initial maximum number of shares of our Common Stock that may be issued under the 2022 Equity Incentive Plan was 2,340,000. As approved
by the Company’s shareholders in December 2023, the maximum number of shares under the Plan was increased to 7,340,000. As of December
31, 2023, a total of 1,657,500 stock options to purchase shares of common stock were granted under the Plan.
Shares subject to stock awards
granted under the Plan that expire or terminate without being exercised in full or that are paid out in cash rather than in shares do
not reduce the number of shares available for issuance under our Plan. Shares withheld under a stock award to satisfy the exercise, strike
or purchase price of a stock award or to satisfy a tax withholding obligation do not reduce the number of shares available for issuance
under our Plan. If any shares of our Common Stock issued pursuant to a stock award are forfeited back to or repurchased or reacquired
by us (i) because of a failure to meet a contingency or condition required for the vesting of such shares, (ii) to satisfy the
exercise, strike or purchase price of an award or (iii) to a tax withholding obligation in connection with an award, the shares that
are forfeited or repurchased or satisfy reacquired will revert to and again become available for issuance under the Plan. Any shares previously
issued which are reacquired in satisfaction of tax withholding obligations or as consideration for the exercise or purchase price of a
stock award will again become available for issuance under the Plan.
Plan Administration. Our
Board, or, if assigned authority by the Board, the Compensation Committee of the Board (the “Committee”), will have the authority
to administer the Plan, unless and until the Board delegates some or all of the administration of the Plan to a different Committee or
Committees of the Board. The Committee may delegate to one or more of our officers the authority to (i) designate employees (other
than officers) to receive specified stock awards and (ii) determine the number of shares subject to such stock awards. The Committee
will have the power, subject to, and within the limitations of, the express provisions of the Plan to determine from time to time (1) which
of the persons eligible under the Plan will be granted Awards; (2) when and how each Award will be granted; (3) what type or
combination of types of Award will be granted; (4) the provisions of each Award granted (which need not be identical), including
the time or times when a person will be permitted to receive an issuance of Common Stock or other payment pursuant to an Award; (5) the
number of shares of Common Stock or cash equivalent with respect to which an Award will be granted to each such person; and (6) the
Fair Market Value applicable to an Award. The Committee will also be granted with the power to construe and interpret the Plan and Awards
granted under it, correct any deficiencies or omissions in the Plan to make the Plan or Award fully effective, to settle all controversies
regarding the Plan and any Award, to accelerate the time at which an Award may first be exercised or the time during which an Award will
vest, to prohibit the exercise of any Option, SAR or exercisable award for administrative convenience, to approve forms of Award Agreements
under the Plan, and to exercise such powers and to perform such acts as the Committee deems necessary or expedient to promote the best
interests of the Company.
Stock Options. ISOs
and NSOs are granted under stock option agreements in a form approved by the Committee. The Committee determines the exercise price for
stock options, within the terms and conditions of the Plan, provided that the exercise price of a stock option generally cannot be less
than 100% of the fair market value of our Common Stock on the date of grant. Options granted under the Plan vest at the rate specified
in the stock option agreement as determined by the Committee.
The
Committee determines the term of stock options granted under the Plan, up to a maximum of 10 years. Unless the terms of an option
holder’s stock option agreement, or other written agreement between us and the recipient approved by the Committee, provide otherwise,
if an option holder’s service relationship with us or any of our affiliates ceases for any reason other than disability, death or
Cause (as defined in the Plan), the option holder may generally exercise any vested options for a period of three months following
the cessation of service. If an option holder’s service relationship with us or any of our affiliates ceases due to death, or an
option holder dies within a certain period following cessation of service, the option holder or a beneficiary may generally exercise any
vested options for a period of 18 months following the date of death. If an option holder’s service relationship with us or
any of our affiliates ceases due to disability, the option holder may generally exercise any vested options for a period of 12 months
following the cessation of service. In the event of a termination for cause, options generally terminate upon the termination date. In
no event may an option be exercised beyond the expiration of its term.
Acceptable consideration for
the purchase of Common Stock issued upon the exercise of a stock option will be determined by the Committee and may include (i) cash,
check, bank draft or money order, (ii) a broker-assisted cashless exercise, (iii) the tender of shares of our Common Stock previously
owned by the option holder, (iv) a net exercise of the option if it is an NSO or (v) other legal consideration approved by the
Board.
Unless the Committee provides
otherwise, options or stock appreciation rights generally are not transferable except by will or the laws of descent and distribution.
Subject to approval of the Committee or a duly authorized officer, an option may be transferred pursuant to a domestic relations order,
official marital settlement agreement or other divorce or separation instrument.
Tax Limitations on
ISOs. The aggregate fair market value, determined at the time of grant, of our Common Stock with respect
to ISOs that are exercisable for the first time by an award holder during any calendar year under all of our stock plans may not exceed
$100,000. Options or portions thereof that exceed such limit will generally be treated as NSOs. No ISO may be granted to any person who,
at the time of the grant, owns or is deemed to own stock possessing more than 10% of our total combined voting power or that of any of
our parent or subsidiary corporations unless (i) the option exercise price is at least 110% of the fair market value of the stock
subject to the option on the date of grant and (ii) the term of the ISO does not exceed five years from the date of grant.
Restricted Stock
Unit Awards. Restricted stock unit awards are granted under restricted stock unit award agreements
in a form approved by the Committee. Restricted stock unit awards may be granted in consideration for any form of legal consideration
that may be acceptable to our board of directors and permissible under applicable law. A restricted stock unit award may be settled by
cash, delivery of stock, a combination of cash and stock as deemed appropriate by the Committee or in any other form of consideration
set forth in the restricted stock unit award agreement. Additionally, dividend equivalents may be credited in respect of shares covered
by a restricted stock unit award. Except as otherwise provided in the applicable award agreement, or other written agreement between us
and the recipient approved by the Committee, restricted stock unit awards that have not vested will be forfeited once the participant’s
continuous service ends for any reason.
Restricted Stock
Awards. Restricted stock awards are granted under restricted stock award agreements in a form approved
by the Committee. A restricted stock award may be awarded in consideration for cash, check, bank draft or money order, past or future
services to us or any other form of legal consideration that may be acceptable to our board of directors and permissible under applicable
law. The Committee determines the terms and conditions of restricted stock awards, including vesting and forfeiture terms. If a participant’s
service relationship with us ends for any reason, we may receive any or all of the shares of Common Stock held by the participant that
have not vested as of the date the participant terminates service with us through a forfeiture condition or a repurchase right.
Stock Appreciation
Rights. Stock appreciation rights are granted under stock appreciation right agreements in a form approved
by the Committee. The Committee determines the strike price for a stock appreciation right, which generally cannot be less than 100% of
the fair market value of our Common Stock on the date of grant. A stock appreciation right granted under the Plan vests at the rate specified
in the stock appreciation right agreement as determined by the Committee. Stock appreciation rights may be settled in cash or shares of
Common Stock or in any other form of payment as determined by the Board and specified in the stock appreciation right agreement.
The Committee determines the
term of stock appreciation rights granted under the Plan, up to a maximum of 10 years. If a participant’s service relationship
with us or any of our affiliates ceases for any reason other than cause, disability or death, the participant may generally exercise any
vested stock appreciation right for a period of three months following the cessation of service. This period may be further extended
in the event that exercise of the stock appreciation right following such a termination of service is prohibited by applicable securities
laws. If a participant’s service relationship with us, or any of our affiliates, ceases due to disability or death, or a participant
dies within a certain period following cessation of service, the participant or a beneficiary may generally exercise any vested stock
appreciation right for a period of 12 months in the event of disability and 18 months in the event of death. In the event of
a termination for cause, stock appreciation rights generally terminate immediately upon the occurrence of the event giving rise to the
termination of the individual for cause. In no event may a stock appreciation right be exercised beyond the expiration of its term.
Performance Awards. The
Plan permits the grant of performance awards that may be settled in stock, cash or other property. Performance awards may be structured
so that the stock or cash will be issued or paid only following the achievement of certain pre-established performance goals during a
designated performance period. Performance awards that are settled in cash or other property are not required to be valued in whole or
in part by reference to, or otherwise based on, the Common Stock.
The performance goals may
be based on any measure of performance selected by the board of directors or the Committee. The performance goals may be based on company-wide
performance or performance of one or more business units, divisions, affiliates or business segments, and may be either absolute or relative
to the performance of one or more comparable companies or the performance of one or more relevant indices.
Other Stock Awards. The
Committee may grant other awards based in whole or in part by reference to our Common Stock. The Compensation Committee will set the number
of shares under the stock award (or cash equivalent) and all other terms and conditions of such awards.
Non-Employee Director
Compensation Limit. The aggregate value of all compensation granted or paid to any non-employee director
with respect to any calendar year, including awards granted and cash fees paid by us to such non-employee director, will not exceed $200,000
in total value; provided that such amount will increase to $400,000 for the first year for newly appointed or elected non-employee directors.
Changes to Capital
Structure. In the event there is a specified type of change in our capital structure, such as a stock
split, reverse stock split or recapitalization, appropriate adjustments will be made to (i) the class and maximum number of shares
reserved for issuance under the Plan, (ii) the class and maximum number of shares by which the share reserve may increase automatically
each year, (iii) the class and maximum number of shares that may be issued on the exercise of ISOs and (iv) the class and number
of shares and exercise price, strike price or purchase price, if applicable, of all outstanding stock awards.
Corporate Transactions. The
following applies to stock awards under the Plan in the event of a corporate transaction (as defined in the Plan), unless otherwise provided
in a participant’s stock award agreement or other written agreement with us or one of our affiliates or unless otherwise expressly
provided by the Committee at the time of grant.
In the event of a corporate
transaction, any stock awards outstanding under the Plan may be assumed, continued or substituted for by any surviving or acquiring corporation
(or its parent company), and any reacquisition or repurchase rights held by us with respect to the stock award may be assigned to the
successor (or its parent company). If the surviving or acquiring corporation (or its parent company) does not assume, continue or substitute
for such stock awards, then (i) with respect to any such stock awards that are held by participants whose continuous service has
not terminated prior to the effective time of the corporate transaction, or current participants, the vesting (and exercisability, if
applicable) of such stock awards will be accelerated in full to a date prior to the effective time of the corporate transaction (contingent
upon the effectiveness of the corporate transaction), and such stock awards will terminate if not exercised (if applicable) at or prior
to the effective time of the corporate transaction, and any reacquisition or repurchase rights held by us with respect to such stock awards
will lapse (contingent upon the effectiveness of the corporate transaction), and (ii) any such stock awards that are held by persons
other than current participants will terminate if not exercised (if applicable) prior to the effective time of the corporate transaction,
except that any reacquisition or repurchase rights held by us with respect to such stock awards will not terminate and may continue to
be exercised notwithstanding the corporate transaction.
In the event a stock award
will terminate if not exercised prior to the effective time of a corporate transaction, the board of directors may provide, in its sole
discretion, that the holder of such stock award may not exercise such stock award but instead will receive a payment equal in value to
the excess (if any) of (i) the per share amount payable to holders of Common Stock in connection with the corporate transaction over
(ii) any per share exercise price payable by such holder, if applicable. In addition, any escrow, holdback, earn out or similar provisions
in the definitive agreement for the corporate transaction may apply to such payment to the same extent and in the same manner as such
provisions apply to the holders of Common Stock.
Plan Amendment or
Termination. Our board of directors has the authority to amend, suspend or terminate our Plan, provided
that such action does not materially impair the existing rights of any participant without such participant’s written consent. Certain
material amendments also require the approval of our stockholders. No ISOs may be granted after the tenth anniversary of the date our
board of directors adopts our Plan. No stock awards may be granted under our Plan while it is suspended or after it is terminated.
Summary of Material United States Federal
Income Tax Consequences of the 2022 Equity Incentive Plan
The following is a summary
of the principal federal income tax consequences of option grants and other awards under the 2022 Equity Incentive Plan. Optionees and
recipients of other rights and awards granted under the 2022 Equity Incentive Plan are advised to consult their personal tax advisors
before exercising an option or stock appreciation right or disposing of any stock received pursuant to the exercise of an option or stock
appreciation right or following vesting of a restricted stock award or restricted stock unit or upon grant of an unrestricted stock award.
In addition, the following summary is based upon an analysis of the Code as currently in effect, existing laws, judicial decisions, administrative
rulings, regulations and proposed regulations, all of which are subject to change and does not address state, local or other tax laws.
Nonstatutory Stock Options. Generally,
there is no taxation upon the grant of a NSO. Upon exercise, a participant will recognize ordinary income equal to the excess, if
any, of the fair market value of the underlying stock on the date of exercise of the stock option over the exercise price. If the participant
is employed by the Company or one of its affiliates, that income will be subject to withholding taxes. The participant’s tax basis
in those shares will be equal to their fair market value on the date of exercise of the stock option, and the participant’s capital
gain holding period for those shares will begin on the day after they are transferred to the participant. Subject to the requirement
of reasonableness, the deduction limits under Section 162(m) of the Code and the satisfaction of a tax reporting obligation,
the Company will generally be entitled to a tax deduction equal to the taxable ordinary income realized by the participant.
Incentive
Stock Options. The 2022 Equity Incentive Plan provides for the grant of stock options that are intended
to qualify as “incentive stock options,” as defined in Section 422 of the Code. Under the Code, a participant generally
is not subject to ordinary income tax upon the grant or exercise of an ISO. If the participant holds a share received upon exercise
of an ISO for more than two years from the date the stock option was granted and more than one year from the date the stock option
was exercised, which is referred to as the required holding period, the difference, if any, between the amount realized on a sale or other
taxable disposition of that share and the participant’s tax basis in that share will be long-term capital gain or loss. If, however,
a participant disposes of a share acquired upon exercise of an ISO before the end of the required holding period, which is referred to
as a disqualifying disposition, the participant generally will recognize ordinary income in the year of the disqualifying disposition
equal to the excess, if any, of the fair market value of the share on the date of exercise of the stock option over the exercise price.
However, if the sales proceeds are less than the fair market value of the share on the date of exercise of the stock option, the amount
of ordinary income recognized by the participant will not exceed the gain, if any, realized on the sale. If the amount realized on a disqualifying
disposition exceeds the fair market value of the share on the date of exercise of the stock option, that excess will be short-term or
long-term capital gain, depending on whether the holding period for the share exceeds one year. For purposes of the alternative minimum
tax, the amount by which the fair market value of a share of stock acquired upon exercise of an ISO exceeds the exercise price of the
stock option generally will be an adjustment included in the participant’s alternative minimum taxable income for the year in which
the stock option is exercised. If, however, there is a disqualifying disposition of the share in the year in which the stock option is
exercised, there will be no adjustment for alternative minimum tax purposes with respect to that share. In computing alternative minimum
taxable income, the tax basis of a share acquired upon exercise of an ISO is increased by the amount of the adjustment taken into account
with respect to that share for alternative minimum tax purposes in the year the stock option is exercised. The Company is not allowed
a tax deduction with respect to the grant or exercise of an ISO or the disposition of a share acquired upon exercise of an ISO after the
required holding period. If there is a disqualifying disposition of a share, however, the Company will generally be entitled to a tax
deduction equal to the taxable ordinary income realized by the participant, subject to the requirement of reasonableness, the deduction
limits under Section 162(m) of the Code and provided that either the employee includes that amount in income or the Company
timely satisfies its reporting requirements with respect to that amount.
Restricted Stock Awards. Generally,
the recipient of a restricted stock award will recognize ordinary income at the time the stock is received equal to the excess, if any,
of the fair market value of the stock received over any amount paid by the recipient in exchange for the stock. If, however, the stock
is subject to restrictions constituting a substantial risk of forfeiture when it is received (for example, if the employee is required
to work for a period of time in order to have the right to transfer or sell the stock), the recipient generally will not recognize income
until the restrictions constituting a substantial risk of forfeiture lapse, at which time the recipient will recognize ordinary income
equal to the excess, if any, of the fair market value of the stock on the date it becomes vested over any amount paid by the recipient
in exchange for the stock. A recipient may, however, file an election with the Internal Revenue Service, within 30 days following
the date of grant, to recognize ordinary income, as of the date of grant, equal to the excess, if any, of the fair market value of the
stock on the date the award is granted over any amount paid by the recipient for the stock. The recipient’s basis for the determination
of gain or loss upon the subsequent disposition of shares acquired from a restricted stock award will be the amount paid for such shares
plus any ordinary income recognized either when the stock is received or when the restrictions constituting a substantial risk of forfeiture
lapse. Subject to the requirement of reasonableness, the deduction limits under Section 162(m) of the Code and the satisfaction
of a tax reporting obligation, the Company will generally be entitled to a tax deduction equal to the taxable ordinary income realized
by the recipient of the restricted stock award.
Restricted Stock Unit
Awards. Generally, the recipient of a restricted stock unit award will generally recognize ordinary income
at the time the stock is delivered equal to the excess, if any, of (i) the fair market value of the stock received over any amount
paid by the recipient in exchange for the stock or (ii) the amount of cash paid to the participant. The recipient’s basis for
the determination of gain or loss upon the subsequent disposition of shares acquired from a restricted stock unit award will be the amount
paid for such shares plus any ordinary income recognized when the stock is delivered, and the participant’s capital gain holding
period for those shares will begin on the day after they are transferred to the participant. Subject to the requirement of reasonableness,
the deduction limits under Section 162(m) of the Code and the satisfaction of a tax reporting obligation, the Company will generally
be entitled to a tax deduction equal to the taxable ordinary income realized by the recipient of the restricted stock unit award.
Stock Appreciation Rights. Generally,
the recipient of a stock appreciation right will recognize ordinary income equal to the fair market value of the stock or cash received
upon such exercise. Subject to the requirement of reasonableness, the deduction limits under Section 162(m) of the Code and
the satisfaction of a tax reporting obligation, the Company will generally be entitled to a tax deduction equal to the taxable ordinary
income realized by the recipient of the stock appreciation right.
THE FOREGOING IS ONLY A SUMMARY OF THE EFFECT
OF THE U.S. FEDERAL INCOME TAXATION UPON PARTICIPANTS AND THE COMPANY UNDER THE 2022 EQUITY INCENTIVE PLAN. IT DOES NOT PURPORT
TO BE COMPLETE AND DOES NOT DISCUSS THE TAX CONSEQUENCES OF A PARTICIPANT’S DEATH OR THE PROVISIONS OF THE INCOME TAX LAWS OF ANY
MUNICIPALITY, STATE, OR FOREIGN COUNTRY IN WHICH THE PARTICIPANT MAY RESIDE.
Recent Sales of Unregistered Securities
Set forth below is information
regarding shares of capital stock issued by us within the past three years.
On October 28, 2022, in connection
with the Merger, the Company assumed warrants from Coeptis Therapeutics, Inc. and delivered to the holders thereof replacement warrants
to purchase 1,563,912 shares of the Company’s common stock at an average exercise price of approximately $7.93.
In January 2023 the Company
issued an aggregate of 874,197 shares of its common stock to service providers as compensation for services.
In January 2023 the Company
granted options to purchase an aggregate of 1,357,500 shares of its common stock under the 2022 Equity Incentive Plan, to various officers,
directors, employees and consultants, at an average exercise price of $1.63 per share. In October 2023 the Company granted options to
purchase an aggregate of 300,000 shares of its common stock under the 2022 Equity Incentive Plan, to two officers/employees and consultants,
at an exercise price of $1.07 per share The Company has also granted a stand-alone option to a former employee to purchase up to 100,000
shares of our common stock at an exercise price of $10 per share.
In April 2023 the Company
issued an aggregate of 1,000,000 shares of common stock in connection with the termination of several investment banking agreements and
all future rights and obligations under such agreements.
In June 2023, in connection
with the June 2023 Offering, the Company issued warrants to the underwriter of such offering to acquire up to 210,000 shares of the Company’s
common stock at an exercise price of $1.25.
On
August 16, 2023, Coeptis Therapeutics Holdings, Inc. (the “Company”) entered into an exclusive licensing arrangement (with
Deverra Therapeutics Inc., and, issued to Deverra 4,000,000 shares of the Company’s common stock and assumed certain liabilities
related to the ongoing clinical trials.
On September 29, 2023, the
Company issued 2,400,000 shares of common stock of the Company to a private investor in exchange for $2,400,000, $400,000 of which was
paid in cash and the balance of which was paid with a promissory note.
On September 29, 2023, the
Company issued 600,000 shares of common stock of the Company to a private investor in exchange for $600,000, $100,000 of which was paid
in cash and the balance of which was paid with a promissory note.
On October 26, 2023, in connection
with the private placement described elsewhere in the Annual Report on Form 10-K, the Company issued to an institutional investor (i)
777,000 Shares of the Company’s common stock, (ii) Pre-Funded Warrants to purchase up to 1,223,000 shares of Common Stock, (iii)
Series A Warrants to purchase up to 2,000,000 shares of Common Stock with an exercise price of $1.36 per share, and (iv) Series B Warrants
(the “Series B Warrants” and together with the Pre-Funded Warrants and the Series A Warrants , the “Warrants”)
to purchase up to 2,000,000 shares of Common Stock with an exercise price of $1.36 per share, for gross proceeds to the Company of $2,000,000.
In connection with the October 2023 private placement, the Company also issued placement agent warrants (the “Placement Agent Warrants”)
to purchase 120,000 shares of our common stock at an exercise price of $1.40 per share.
These foregoing securities
were issued pursuant to exemptions from registration under the Securities Act in transactions not involving an underwriter.
Description of our Capital Stock
The following description summarizes
the most important terms of our capital stock. Because it is only a summary of the provisions of our certificate of incorporation, as
amended (the “Certificate of Incorporation”), and bylaws, as amended (the “Bylaws”), it does not contain all of
the information that may be important to you. For a complete description of the matters set forth in this “Description of Capital
Stock,” you should refer to our Certificate of Incorporation and Bylaws, each of which are included as exhibits to the registration
statement of which this prospectus is a part, and to the applicable provisions of Delaware law.
Authorized and Outstanding Stock
The Company’s authorized
capital stock consists of:
| · | 150,000,000 shares of common stock, par value $0.0001 per
share; and |
| · | 10,000,000 shares of preferred stock, par value $0.0001 per
share. |
Common Stock
Voting. The holders
of common stock will be entitled to one vote for each share held of record on all matters on which the holders are entitled to vote (or
consent pursuant to written consent). Directors will be elected by a plurality of the votes present in person or represented by proxy
and entitled to vote.
Dividends. The
holders of common stock will be entitled to receive, ratably, dividends only if, when and as declared by the Company Board out of funds
legally available therefor and after provision is made for each class of capital stock having preference over the Common Stock.
Liquidation Rights. In
the event of the Company’s liquidation, dissolution or winding-up, the holders of common stock will be entitled to share, ratably,
in all assets remaining available for distribution after payment of all liabilities and after provision is made for each class of capital
stock having preference over the common stock.
Conversion Right. The
holders of common stock will have no conversion rights.
Preemptive and Similar
Rights. The holders of common stock will have no preemptive or similar rights.
Redemption/Put Rights. There
will be no redemption or sinking fund provisions applicable to the Common Stock. All of the outstanding shares of common stock are fully-paid
and nonassessable.
Options/Stock Awards. There
were no outstanding stock options at December 31, 2022. The Company subsequently granted in 2023 options to purchase an
aggregate of 1,657,500 shares of our common stock under the 2022 Equity Incentive Plan, to various officers, directors, employees
and consultants, at an average exercise price of $1.50 per share. The Company had also granted a stand-alone option to a former
employee to purchase up to 100,000 shares of our common stock at an exercise price of $10 per share, which the stand-alone option
expired by its terms on January 31, 2024.
Preferred Stock
The Company Board has the
authority to issue shares of preferred stock from time to time on terms it may determine, to divide shares of preferred stock into one
or more series and to fix the designations, preferences, privileges, and restrictions of preferred stock, including dividend rights, conversion
rights, voting rights, terms of redemption, liquidation preference, sinking fund terms, and the number of shares constituting any series
or the designation of any series to the fullest extent permitted by the DGCL.
Warrants
The Company has warrants outstanding
to purchase (i) 1,913,912 shares of our common stock at an average exercise price of approximately $6.86 per share which were assumed
from Coeptis Therapeutics, Inc. as part of the Merger, and (ii) 7,500,000 shares of our common stock at an exercise price of $11.50 per
share, which were issued prior to the Merger.
| ITEM 6. |
SELECTED FINANCIAL DATA |
The Company is a smaller reporting company as defined
by Rule 12b-2 of the Exchange Act and is not required to provide the information under this Item.
| ITEM 7. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS. |
As discussed elsewhere
in this Annual Report on Form 10-K, pursuant to the Merger, we acquired our primary operating subsidiary Coeptis Therapeutics, Inc. The
Merger was accounted for as a “reverse merger,” and Coeptis Therapeutics, Inc. was deemed to be the accounting acquirer in
the Merger. Consequently, the financial condition, results of operations and cash flows discussed in this Management’s Discussion and Analysis of Financial Condition and Results of Operations discussed below are those of Coeptis Therapeutics, Inc. and its consolidated
subsidiaries. When we use words in this section like “we,” “us”, “our,” the “Company”
and words of the like, unless otherwise indicated, we are referring to the operations of our wholly-owned subsidiaries, including Coeptis
Therapeutics, Inc.
These statements represent
projections, beliefs, and expectations based on current circumstances and conditions and in light of recent events and trends, and you
should not construe these statements either as assurances of performance or as promises of a given course of action. Instead, various
known and unknown factors are likely to cause our actual performance and management’s actions to vary, and the results of these
variances may be both material and adverse. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements,
which reflect management’s analysis only as of the date hereof. We undertake no obligation to publicly release the results of any
revision to these forward-looking statements which may be made to reflect events or circumstances after the date hereof or to reflect
the occurrence of unanticipated events.
Cautionary Statement
The following discussion and
analysis should be read in conjunction with our financial statements and related notes included beginning at page F-1 of this Annual Report
on Form 10-K.
Our actual results may differ
materially from those anticipated in the following discussion, as a result of a variety of risks and uncertainties, including those described
under “Risk Factors and Special Considerations” beginning on page 9 of this Annual Report on Form 10-K. We assume
no obligation to update any of the forward-looking statements included herein except as expressly required by law.
Implications of Being an Emerging Growth Company
As a company with less than
$1.07 billion in revenue during our last fiscal year, we qualify as an emerging growth company, as defined in the JOBS Act. As an
emerging growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable generally
to public companies. These provisions include:
| · | Only two years of audited financial statements in addition
to any required unaudited interim financial statements with correspondingly reduced Management’s Discussion and Analysis of Financial
Condition and Results of Operations disclosure. |
| · | Reduced disclosure about our executive compensation arrangements. |
| · | Not having to obtain non-binding advisory votes on executive
compensation or golden parachute arrangements. |
| · | Exemption from the auditor attestation requirement in the
assessment of our internal control over financial reporting. |
We may take advantage of these
exemptions for up to five years or such earlier time that we are no longer an emerging growth company. We would cease to be an emerging
growth company if we have more than $1.07 billion in annual revenue, we have more than $700 million in market value of our stock
held by non-affiliates, or we issue more than $1 billion of non-convertible debt over a three-year period. We may choose to take
advantage of some but not all of these reduced burdens. We have taken advantage of these reduced reporting burdens herein, and the information
that we provide may be different than what you might get from other public companies in which you hold stock.
Company History
General. The
Company was originally incorporated in the British Virgin Islands on November 27, 2018 under the name Bull Horn Holdings Corp. On October
27, 2022, Bull Horn Holdings Corp. domesticated from the British Virgin Islands to the State of Delaware. On October 28, 2022, in connection
with the closing of the Merger, the Company changed its corporate name from Bull Horn Holdings Corp. to “Coeptis Therapeutics Holdings,
Inc.”
The Merger Transaction. On
October 28, 2022, a wholly-owned subsidiary of Bull Horn Holdings Corp., merged with and into Coeptis Therapeutics, Inc., with Coeptis
Therapeutics, Inc. as the surviving corporation of the Merger. As a result of the Merger, the Company acquired the business of Coeptis
Therapeutics, Inc., which now continues its existing business operations as the Company’s wholly-owned subsidiary.
About the Company’s
Subsidiaries. The Company now operates through its direct and indirect wholly-owned subsidiaries Coeptis Therapeutics, Inc.,
Coeptis Pharmaceuticals, Inc. and Coeptis Pharmaceuticals, LLC.
Issuance under Merger
Transaction. Simultaneously with the closing of the Merger, all of the issued and outstanding shares of Coeptis Therapeutics,
Inc. common stock (including the shares of common stock underlying Coeptis’ series B preferred stock) converted, on a 2.96851721
for 1 basis, into shares of our Common Stock. As of the Merger, there were no Coeptis options outstanding, and there were warrants outstanding
to purchase an aggregate of 4,642,500 shares of Coeptis common stock at an average exercise price of $2.67 per share, which warrants converted
on the closing of the Merger into warrants to purchase an aggregate of 1,563,912 shares of our Common Stock at an average exercise price
of $7.93 per share.
On the closing of the Merger,
the former Coeptis common stock was exchanged for the right to receive 17,270,079 shares of our Common Stock (including 2,694,948 shares
of Common Stock issued in exchange for the Coeptis series B preferred stock issued and outstanding). Our common stockholders before the
Merger retained 2,246,760 shares of our Common Stock. As a result, immediately following the closing of the Merger, Coeptis’ former
stockholders and our then existing stockholders held approximately 88% and 12%, respectively, of the total combined voting power of all
classes of our stock entitled to vote.
As discussed elsewhere in
this Annual Report on Form 10-K, the Merger was treated as a recapitalization of the Company, and was accounted for as a “reverse
merger,” and Coeptis was deemed to be the acquirer in the reverse merger. Consequently, the assets and liabilities and the historical
operations that will be reflected in the financial statements prior to the Merger will be those of Coeptis, and the consolidated financial
statements after completion of the Merger will include the assets and liabilities of Coeptis, historical operations of Coeptis and operations
of Coeptis from the closing of the Merger.
Company History of Coeptis Therapeutics, Inc.
Coeptis
Pharmaceuticals, LLC was formed in July 12, 2017 as a Pennsylvania multi-member limited liability company. On December 1, 2018, the members
of LLC contributed their interest to a newly formed corporation, Coeptis Pharmaceuticals, Inc. As of December 1, 2018, the LLC became
a disregarded single-member limited liability company which is wholly owned by the newly formed corporation. On February 12, 2021, Vinings
Holdings, Inc., a Delaware corporation (“Vinings”), merged (the “Merger”) with and into Coeptis Pharmaceuticals,
Inc. On July 12, 2021, Vinings has legally changed its name from Vinings Holdings, Inc. to Coeptis Therapeutics, Inc. Coeptis was the
surviving corporation of that Merger. As a result of the Merger, Vinings acquired the business of Coeptis and will continue the existing
business operations of Coeptis as a wholly owned subsidiary. The Merger was treated as a recapitalization of the Company for financial
accounting purposes. The historical financial statements of Vinings before the Merger were replaced with the historical financial statements
of Coeptis before the Merger in all future filings with the Securities and Exchange Commission (the “SEC”).
Overview and Outlook
We are a biopharmaceutical company
which owns, acquires, and develops cell therapy technologies for cancer and other diseases Our products and technologies are intended
to be commercialized in the US and other major markets throughout the world. Since our inception in 2017, we have acquired and commercialized
two drug products for the US market, which were approved as 505b2 applications. These anti-hypertension products were launched into the
US market during 2020 through a marketing partner. At launch, the sales and promotional efforts were significantly impeded by the limitation
of the global pandemic and as such, we have since abandoned all activities and ownership pertaining to both products. We also began the
development of several ANDA products which we divested in 2019 to a larger generic pharmaceutical drug manufacturer, and have moved away
from focusing on the commercialization of generic products. In early 2021, we entered into strategic partnerships to co-develop improved
therapies for the auto-immune and oncology markets. Following the reverse merger transaction, we continue to focus on identifying and
investing resources into innovative products and technologies which we believe will significantly transform our current products and therapies.
During 2020 and continuing
through 2021, we faced several operational challenges related to the COVID-19 global pandemic, which we continue to work to overcome.
The launch of both 5050b2 products was impacted because of various COVID-19 limitations, most notably field sales personnel were not able
to make healthcare provider visits in person; thereby limiting the awareness of the availability of these products. We explored and implemented
several non-personal promotion efforts, but given the global limitations and dynamics, it was challenging to achieve expected sales. We
have since abandoned all activities and ownership pertaining to both products.
Vy-Gen-Bio, Inc.
In May 2021, we entered into
two exclusive option agreements (the “CD38 Agreements”) relating to separate technologies designed to improve the treatment
of CD38-related cancers (e.g., multiple myeloma, chronic lymphocytic leukemia, and acute myeloid leukemia) with Vy-Gen-Bio, Inc. (“Vy-Gen”),
a majority-owned subsidiary of Vycellix, Inc., a Tampa, Florida-based private, immuno-centric discovery life science company focused on
the development of transformational platform technologies to enhance and optimize next-generation cell and gene-based therapies, including
T-cell and Natural Killer (NK) cell-based cancer therapies.
The CD38 Agreements relate to two separate Vy-Gen
drug product candidates, as follows:
CD38-GEAR-NK.
This Vy-Gen drug product candidate is designed to protect CD38+ NK cells from destruction by anti-CD38 monoclonal antibodies, or mAbs.
CD38-GEAR-NK is an autologous, NK cell-based therapeutic that is derived from a patient’s own cells and gene-edited to enable combination
therapy with anti-CD38 mAbs. We believe CD38-GEAR-NK possesses the potential to minimize the risks and side effects from CD38-positive
NK cell fratricide.
Market Opportunity.
We believe CD38-GEAR-NK could potentially revolutionize how CD38-related cancers are treated, by protecting CD38+ NK cells from destruction
by anti-CD38 mAbs, thereby promoting the opportunity to improve the treatment of CD38-related cancers, including multiple myeloma, chronic
lymphocytic leukemia, and acute myeloid leukemia.
Multiple myeloma is the first
cancer indication targeted with CD38-GEAR-NK. The global multiple myeloma market was $19.48B in 2018 and is expected to reach $31B by
2026 [Source: Fortune Business Reports].
CD38-Diagnostic.
This Vy-Gen product candidate is an in vitro diagnostic tool to analyze if cancer patients might be appropriate candidates for anti-CD38
mAb therapy. CD38-Diagnostic is an in vitro screening tool that provides the ability to pre-determine which cancer patients are most likely
to benefit from targeted anti-CD38 mAb therapies, either as monotherapy or in combination with CD38-GEAR-NK. CD38-Diagnostic also has
the potential to develop as a platform technology beyond CD38, to identify patients likely to benefit for broad range of mAb therapies
across myriad indications.
Market Opportunity.
We believe CD38-Diagnostic provides opportunity to make more cost-effective medical decisions for the treatment of B cell malignancies
with high CD38 expression, including multiple myeloma, which may help to avoid unnecessary administration of anti-CD38 therapies. CD38-Diagnostic
could prevent patients from being subjected to ineffective therapy and enable significant savings to healthcare systems.
CD38-Diagnostic could be offered
as an in-vitro diagnostic for determining patient suitability and likelihood of positive treatment outcomes for CD38-GEAR-NK and/or CD38
monoclonal antibody therapies.
On September 28, 2023, we
received FDA’s response to our 513(g) request for information submission pertaining to the classification of the CD38-Diagnostic.
The CD38-Diagnostic has been designated a Class II type device. The confirmation of this classification is beneficial as we’re now
better able to plan for and execute future development activities.
GEAR-NK Product Overview.
GEAR-NK is an autologous, gene-edited, natural killer cell-based therapeutic development platform that allows for modified NK cells to
be co-administered with targeted mAbs, which, in the absence of the GEAR-NK, would otherwise be neutralized by mAb therapy.
In May 2021, we made initial
payments totaling $750,000 under the CD38 Agreements, to acquire the exclusive options to acquire co-development rights with respect to
CD38-GEAR-NK and CD38-Diagnostic. On August 15, 2021, we entered into amendments to each of the CD38 Agreements. In connection with the
two amendments, we delivered to Vy-Gen promissory notes aggregating $3,250,000 with maturity dates of December 31, 2021, and made a cash
payment of $1,000,000, upon which cash payment we exercised the two definitive option purchase agreements. In December 2021, we completed
our payment obligations to secure the 50% ownership interest in the CD38-Diagnostic, and subsequently in November 2022 we completed our
purchase of the 50% ownership interest for the CD38-GEAR-NK product candidate. Details of the two August amendments and the December amendment
are summarized in the amendments attached at Exhibits 4.1 and 4.2 to our Current Report on Form 8-K dated August 19, 2021 and Exhibits
4.2 to the our Current Report on Form 8-K dated December 27, 2021.
In connection with the Vy-Gen
relationship and the Company’s ownership in the two product candidates described above, in December 2021 the Company and Vy-Gen
entered into a co-development and steering committee agreement. The co-development and steering committee agreement provides for the governance
and economic agreements between the Company and Vy-Gen related of the development of the two Vy-Gen drug product candidates and the revenue
sharing related thereto, including each company having a 50% representation on the steering committee and each company receiving 50% of
the net revenues related to the Vy-Gen product candidates. Details of the co-development and steering committee agreement are summarized
in our Current Report on Form 8-K dated December 27, 2021, including Exhibits 4.1 and 4.2 thereto.
Deverra Therapeutics, Inc.
On August
16, 2023, the Company entered into an exclusive licensing arrangement (the “License Agreement”) with Deverra Therapeutics
Inc. (“Deverra”), pursuant to which the Company completed the exclusive license of key patent families and related intellectual
property related to a proprietary allogeneic stem cell expansion and directed differentiation platform for the generation of multiple
distinct immune effector cell types, including natural killer (NK) and monocyte/macrophages. The License Agreement provides the Company
with exclusive rights to use the license patents and related intellectual property in connection with development and commercialization
efforts in the defined field of use (the “Field”) of (a) use of unmodified NK cells as anti-viral therapeutic for viral infections,
and/or as a therapeutic approach for treatment of relapsed/refractory AML and high-risk MDS; (b) use of Deverra’s cell therapy platform
to generate NK cells for the purpose of engineering with Coeptis SNAP-CARs and/or Coeptis GEAR Technology; and (c) use of Deverra’s
cell therapy platform to generate myeloid cells for the purpose of engineering with the Company’s current SNAP-CAR and GEAR technologies.
In support of the exclusive license, the Company also entered into with Deverra (i) an asset purchase agreement (the “APA”)
pursuant to which the Company purchased certain assets from Deverra, including but not limited to two Investigational New Drug (IND) applications
and two Phase 1 clinical trial stage programs (NCT04901416, NCT04900454) investigating infusion of DVX201, an unmodified natural killer
(NK) cell therapy generated from pooled donor CD34+ cells, in hematologic malignancies and viral infections and (ii) a non-exclusive sublicense
agreement (the “Sublicense Agreement”), in support of the assets obtained by the exclusive license, pursuant to which the
Company sublicensed from Deverra certain assets which Deverra has rights to pursuant a license agreement (“FHCRC Agreement”)
by and between Deverra and The Fred Hutchinson Cancer Research Center (“FHCRC”).
As consideration
for the transactions described above, the Company paid Deverra approximately $570,000 in cash, issued to Deverra 4,000,000 shares of
the Company’s common stock and assumed certain liabilities related to the ongoing clinical trials. Total consideration paid was
$4,937,609, which was fully expensed in accordance with ASC 730, and is reflected within research and development in the accompanying
condensed consolidated statement of operations for the year ended December 31, 2023. In addition, in accordance with the terms of the
Sublicense Agreement, the Company agreed to pay FHCRC certain specified contingent running royalty payments and milestone payments under
the FHCRC Agreement, in each case to the extent such payments are triggered by the Company’s development activities.
On October
26, 2023, the Company entered into a Shared Services Agreement (“SSA”) with Deverra, in accordance with requirements set
forth in the APA. Under the terms of the SSA, Coeptis and Deverra will share resources and collaborate to further the development of
Coeptis’ GEAR and SNAP-CAR platforms, as well as the purchased and licensed assets under the License Agreement and APA. The term
of the SSA is six months from the effective date.
Vici Health Sciences,
LLC.
In 2019, we entered into a co-development agreement with Vici Health Sciences, LLC (“Vici”). Through this partnership, we
would co-develop, seek FDA approval and share ownership rights with Vici to CPT60621, a novel, ready to use, easy to swallow, oral liquid
version of an already approved drug used for the treatment of Parkinson’s Disease (PD). As we continue to direct its operational
focus towards the Vy-Gen opportunities previously described, we have recently stopped allocating priority resources to the development
of CPT60621. We are currently in negotiations in which Vici intends to buy-out most or all of our remaining ownership rights.
Our Results of Operations
In General
Revenue. To
date, we have generated minimal revenue mostly from consulting arrangements and product sales. Due to the COVID-19 global pandemic and
the resulting market dynamics, it is uncertain if the current marketed products can generate sufficient sales to cover expenses.
Operating Expenses.
General and administrative expenses consist primarily of warrant expense related to strategic financing costs, salaries and related
costs for personnel and professional fees for consulting services related to regulatory, pharmacovigilance, quality, legal, and business
development. We expect that our general and administrative expenses will increase in the future as we increase our headcount to support
the business growth. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance, insurance, and
investor relation expenses associated with operating as a public company.
Research and Development
Costs. Research and developments costs will continue to be dependent on the strategic business collaborations and agreements
will are anticipating in the future. We expect development costs to increase to support our new strategic initiatives.
Comparison of the years ended December 31,
2023 and December 31, 2022.
Revenues. Revenues
recorded in the years ended December 31, 2023 and 2022 respectively, continue to be minimal. The Company’s activities primarily
include product development, raising capital, and building infrastructure. Management does not expect the Company to generate any significant
revenue for at least the next two years, during which time drug development will continue toward the goal of commercializing, through
a partnership or otherwise, one or more of the Company’s target products or technologies.
Operating Expenses.
Overview. Operating
expenses decreased from $34,195,965 in the year ended December 31, 2022 to $21,482,767 in the year ended December 31, 2023.
The decrease in 2023 is a result of less strategic financing costs, including merger expenses incurred in 2022.
General and Administrative
Expenses. For the year ended December 31, 2022 and 2023, general and administrative expenses are included in operating expenses.
All costs incurred can be attributed to the planned principal operations of product development, raising capital, and building infrastructure.
Interest Expense.
Interest expense was $218,412 for the year ended December 31, 2022 and was $107,685 for the year ended December 31, 2023. Interest
was related to notes payable, which are discussed in detail in the Footnotes to the consolidated financial statements, incorporated by
reference herein. Management expects that in 2024 and thereafter, interest expense will increase, as it may take on debt from insiders
or independent third parties to fund operations either while awaiting receipt of the proceeds of equity capital financings or as a stand-alone
strategy in addition to raising capital through equity capital financings.
Financial Resources and
Liquidity. The Company had limited financial resources during the year ended December 31, 2022 with cash of $3,791,302. For the year ended December 31, 2023, cash decreased to $1,469,134. During both these time periods,
the Company continues to operate a minimal infrastructure in order to maintain its ability to fund operations, keep full focus on all
product development targets and to stay current with all of the Company’s scientist consultants, legal counsel, and accountants.
David Mehalick, our President and Chief Executive Officer, Colleen Delaney, M.D., M.Sc., our Chief Scientific and Medical Officer, and
Daniel Yerace, our Vice President of Operations, and all agreed to waive their rights to a 2023 guaranteed bonus payment under their
respective employment agreements to further maintain our ability to fund operations. During 2024, the Company believes that the ability
to raise capital through equity transactions will increase liquidity and enable the execution of management’s operating strategy.
Financial Condition, Liquidity and Capital
Resources
At December 31, 2023.
For the year ended December 31, 2023, cash decreased to $1,469,134. During this time period, the Company continues
to operate a minimal infrastructure in order to maintain its ability to fund operations, keep full focus on all product development targets
and to stay current with all of the Company’s scientist consultants, legal counsel, and accountants. During 2024, the Company believes
that the ability to raise capital through equity transactions will increase liquidity and enable the execution of management’s operating
strategy.
At December 31,
2022. Our Company had limited financial resources during the year ended December 31, 2021, with cash of $2,179,558 at December 31, 2021. Cash increased at December 31, 2022 to $3,791,302. We continue to operate a minimal
infrastructure, in order to maintain our ability to fund operations, keep full focus on all product development targets and to stay current
with all of our scientist consultants, legal counsel and accountants.
| ITEM 7A. |
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK |
The Company is a smaller reporting
company as defined by Rule 12b-2 of the Exchange Act and is not required to provide the information under this Item.
| ITEM 8. |
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA |
The financial statements required
to be filed pursuant to this Item 8 are appended to this report and are incorporated herein by reference. An index of those financial
statements is found in Item 15 of Part IV of this Annual Report on Form 10-K.
| ITEM 9. |
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE |
As previously disclosed, in
connection with the Merger and the adoption of Coeptis’ historical business as that of the Company, Turner, Stone & Company,
L.L.P, Coeptis Therapeutics, Inc.’s independent registered public accounting firm, became our auditors.
| ITEM 9A. |
CONTROLS AND PROCEDURES |
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures
as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act are controls and other procedures that are designed to ensure that
information required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported,
within the time periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures
include, without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed
or submitted under the Exchange Act is accumulated and communicated to management, including our principal executive and principal financial
officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Our management, with the participation
of our chief executive officer (our principal executive officer) and our chief financial officer (our principal financial officer) evaluated
the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Annual Report on Form 10-K. Based
upon that evaluation, and as a result of the 2022 self-diagnosed material weaknesses described below, our principal executive officer
and principal financial officer concluded that, as of December 31, 2023, our disclosure controls and procedures were not effective. Management
anticipates that such disclosure controls and procedures will not be effective until the self-diagnosed material weaknesses are remediated.
Management’s Annual Report on Internal Control Over Financial
Reporting
Management is responsible
for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) and 15d-15(f) under the
Exchange Act. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.
Also, projection of any evaluation of effectiveness to future periods is subject to the risk that controls may become inadequate because
of changes in conditions, or that the degree of compliance with policies or procedures may deteriorate. In making this assessment, management
used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control –
Integrated Framework (2013 Framework). Based on this assessment, management concluded that, as of December 31, 2023, the Company’s
internal control over financial reporting was not effective, due to the self-diagnosed material weakness described below. The material
weaknesses were self-diagnosed as of December 31, 2023, and were not issued by our independent auditors, Turner, Stone & Company,
LLP. A material weakness is a deficiency or combination of deficiencies, in internal control over financial reporting such that there
is a reasonable possibility that a material misstatement of our annual or interim consolidated financial statements will not be prevented
or detected on a timely basis. The Company self-identified the following material weaknesses as of December 31, 2023:
| |
1. |
The Company’s system of internal controls, as designed and implemented, is not operating effectively. The Company continues to improve and implement (i) segregation of duties and evidence of fiduciary oversight related to the financial statement close process, cash disbursements process, contract approval process and time and expense reimbursement process; (ii) formally documented accounting policies and procedures that are effective and consistently applied in accordance with GAAP; and (iii) effective controls and resources to address the accounting requirements for new accounting pronouncements. |
| |
|
|
| |
2. |
The Company’s financial statement close process and disclosure controls and procedures, including the secondary review and approval of financial information generated to prepare the consolidated financial statements, are ineffective. |
Over the course of the year ended
December 31, 2023, the Company has worked toward remediation of these self-diagnosed material weaknesses by (i) hiring additional resources
to effectively allow for segregation of duties, formally documenting accounting policies, and ensuring compliance with accounting requirements
and (ii) adopting processes and procedures that support a timely financial statement close, and secondary reviews, and (iii) appointing
Brian Cogley as the Company’s new Chief Financial Officer on May 17, 2023. Mr. Cogley arrived at Coeptis with a career in corporate
finance and accounting during which he advised and led the financial operations for companies in multiple industries including life sciences,
pharmaceuticals, financial services, and manufacturing. Mr. Cogley’s diverse experience and knowledge of the Sarbanes-Oxley control
environment and SEC reporting requirements helped bolster the Company’s internal controls and operational efficiency. The Company
is confident that after one full year under new financial leadership, remediation of the self-diagnosed material weaknesses will be achieved.
Changes in Internal Control Over Financial Reporting
In an effort to address the Company’s
internal accounting personnel deficiencies, we appointed Brian Cogley as our new Chief Financial Officer in May 2023, as described above.
Attestation Report of Independent Registered Public Accounting Firm
This Annual Report on Form
10-K does not include an attestation report of the Company’s registered public accounting firm, as non-accelerated filers are exempt
from the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act.
| ITEM 9B. |
OTHER INFORMATION |
During the quarter ended December 31, 2023, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading
arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a) of Regulation
S-K.
PART III
| ITEM 10. |
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE |
The following persons are our executive officers
and directors and hold the positions set forth opposite their name.
| Executive Officers and Directors |
|
Age |
|
Position |
| David Mehalick |
|
55 |
|
Chairman, Chief Executive Officer and President |
| Daniel Yerace |
|
41 |
|
Director and Vice President of Operations |
| Brian Cogley |
|
37 |
|
Chief Financial Officer |
| Colleen Delaney |
|
56 |
|
Chief Scientific and Medical Officer |
| Christine Sheehy |
|
56 |
|
Vice President of Compliance and Secretary |
| Christopher Calise |
|
50 |
|
Director |
| Tara Maria DeSilva |
|
55 |
|
Director |
| Philippe Deschamps |
|
61 |
|
Director |
| Christopher Cochran |
|
54 |
|
Director |
| Gene Salkind |
|
70 |
|
Director |
David Mehalick — Chairman,
Chief Executive Officer and President: Mr. Mehalick has over 30 years of experience across a variety of industries including
life sciences, technology, financial services, military contracting, entertainment, and consumer products. He has served as our Chief
Executive Officer since October 2016. Since March 2004, Mr. Mehalick has served as the Managing Director of Steeltown Consulting Group,
a business consulting company through which he advises clients on business organizational and management strategies and solutions. Mr.
Mehalick was the Chief Financial Officer of Information Technology Procurement Sourcing, Inc. (“ITPS”), a computer hardware
and software company, from March 2017 to September 2017. In January 2019, ITPS filed a petition for voluntary reorganization under Chapter
11 of the U.S. Bankruptcy Code. Mr. Mehalick was the First Vice President at Gruntal and Co. from March 1992 to April 1995 and Senior
Vice President at First Union Capital Markets from May 1995 to June 1998 and Senior Vice President at Ferris, Baker Watts, Inc., an investment
banking firm from June 1998 to January 2001. Mr. Mehalick attended the University of Pittsburgh. We believe that Mr. Mehalick’s
three decades in business management and more than a decade in life sciences qualifies him to serve as a director of the Company.
Daniel Yerace
— Director and Vice President of Operations: Dan Yerace is a co-founder of Coeptis Pharmaceuticals and serves as the
Vice President of Operations. Mr. Yerace has over ten years of experience in the pharmaceutical industry and is a key strategist responsible
for supply chain management, business development, portfolio management, and corporate strategy. Mr. Yerace has broad operational experience
and has held leadership positions in procurement, global supply chain management, operations, and business development for small private
firms and fortune 500 multi-national corporations. Prior to joining Coeptis, Mr. Yerace served as Senior Director of Global Supply Chain
and Commercial Business Development for Kadmon Pharmaceuticals. Mr. Yerace holds a bachelor’s degree in economics, and a masters
of business administration from Waynesburg University.
Brian Cogley — Chief Financial Officer: Mr.
Cogley has over 15 years of accounting and finance experience, having previously held positions of increasing authority at two “Big
4” accounting firms and served on the management teams of multiple companies in diverse industries. An accountant by training, Mr.
Cogley arrives at Coeptis with a career in corporate finance and accounting during which he advised and led the financial operations for
companies spanning multiple industries including life sciences, pharmaceuticals, financial services, and manufacturing. From February
2022 until joining Coeptis, Mr. Cogley was a Senior Manager, Accounting Advisory at CFGI, LLC where he served pharmaceutical and financial
services clients in technical accounting implementations and execution, interim Controller roles, interim SEC Reporting Manager roles,
segment reporting and carve-out engagements. From 2017-2022 Mr. Cogley held the position of Vice President of Finance & Accounting
at NexTier Bank where he was a member of the Company’s senior management team and led its accounting and finance operations, including
the general ledger, financial planning and analysis, internal and external financial reporting, and human resources. From 2015-2017 Mr.
Cogley held the position of Global Cash Manager for Calgon Carbon Corporation, where he was responsible for all daily cash decisions across
the global enterprise. From 2012-2015 Mr. Cogley was a Financial Analyst at TriState Capital Bank where he was responsible for building
its Sarbanes-Oxley control environment, SEC/regulatory reporting and new system implementation, while also working on various process
improvement projects. Mr. Cogley began his career at KPMG, LLP, providing audit and assurance services to a variety of clients in the
financial services industry. Mr. Cogley earned a B.A. with a concentration in accounting and a Master of Business Administration with
a concentration in finance from Duquesne University.
Colleen Delaney - Chief Scientific
and Medical Officer: Colleen Delaney, M.D., M.Sc. recently joined Coeptis, and brings more than two decades of experience to the
Company. Dr. Delaney, is a trained oncologist and stem cell transplant physician scientist. A highly accomplished and greatly respected
leader, Dr. Delaney is pioneering methods to make umbilical cord blood transplants more available and successful worldwide. As a trained
oncologist and stem cell transplant physician scientist with expertise in the translation of scientific discovery to clinical practice,
she is proficient in all aspects of cell therapy product development, from initial discovery to pre-clinical and Investigational New Drug
(IND)-enabling studies, manufacturing, global regulatory experience, and clinical trial design. She has served on federal advisory committees
focused on multiple cell and gene therapy and acted as a director for several nonprofit associations. In addition to her industry experience,
Dr. Delaney is a clinical professor at the University of Washington, Division of Pediatric Hematology/Oncology, and is an affiliate and
former professor at the Fred Hutchinson Cancer Research Center, where she also held the Madeline Dabney Adams Endowed Chair in Acute Myeloid
Leukemia research. She earned her B.A in Molecular Biology and Biochemistry from Wesleyan University, her MSc in Social Research and Social
Policy from Oxford University and her M.D. from Harvard Medical School.
Christine Sheehy — Vice
President of Compliance and Secretary: Ms. Sheehy has over 25 years of experience in the pharmaceutical business, including
globally commercializing drug products and working in development of targeted therapeutics including cell and gene therapies. Since 2017,
she has served as our Director, Chief Financial Officer and Secretary. From 2010 to 2016, Ms. Sheehy served as the Senior Vice-President
of Operations for Kadmon Pharmaceuticals, a clinical and commercial phase pharmaceutical company. From 2001 to 2010, she served as the
Vice-President of Operations of Three Rivers Pharmaceuticals, a start-up pharmaceutical company which was acquired by Kadmon Pharmaceuticals
in 2010. During that time, she launched branded and generic products in the U.S., leading the operational business. Ms. Sheehy earned
a bachelor’s degree in accounting from Penn State University.
Christopher
Calise – Director: Mr. Calise has served as a director since our inception, and has remained a member of the Company’s
board of directors following the Merger. He has over 15 years of experience in the finance and insurance industries and has been responsible
for setting the strategic vision for Crown Global, a domestic and international private placement insurance holding company, as well as
overseeing its day-to-day management, including finance, operations and sales, since 2010. He also works closely with both internal and
external sales and marketing in the development of new product initiatives, as well as evaluating new markets. Prior to joining Crown
Global, Mr. Calise was a principal at LSC Investors, LLC, from 2001 to 2009, where he advised The Second City, Inc. and Narciso Rodriguez
and restructured Phillips de Pury & Luxembourg, a large global auction house. From 1999 to 2001, he was an associate with Crown Capital
Group, Inc., a private equity investment firm focused on assisting middle-market companies build value over the long term and was one
of the founding members of Fresh Direct, LLC. Mr. Calise was also a consultant with the Industrial Products Group at PriceWaterhouse in
its Chicago office, from 1997 to 1999. Mr. Calise is a member of the board of Song4Life and Student Finance League Inc. Mr. Calise received
a Bachelor of Arts in Economics from the University of Chicago, as well as certifications in insurance and finance. We believe Mr. Calise
is qualified to serve as our director due to his operational and executive experience.
Tara Maria DeSilva, Ph.D. –
Director: Dr. DeSilva has been an Associate Professor at the Cleveland Clinic and Case Western Reserve University School
of Medicine since March 2016. She serves as Vice Chair for the Department of Neurosciences, Lerner Research Institute, Cleveland Clinic.
She was an Assistant Professor at University of Alabama at Birmingham from January 2010 to February 2016. Dr. DeSilva receives funding
from the National Institutes of Health, National Science Foundation, and the National Multiple Sclerosis Society. She serves on many government
and foundation scientific grant review panels including the National Institutes of Health and National Multiple Sclerosis Society. Dr. DeSilva
received her B.S. in Biochemistry from Albright College, her M.S. and Ph.D. in Biological Chemistry from the University of Pennsylvania
and completed her postdoctoral training at Children’s Hospital Boston, Harvard Medical School. We believe Dr. DeSilva is well qualified
to serve on the board due to her expertise in neuroscience and research.
Philippe Deschamps – Director: Mr.
Deschamps is an experienced healthcare executive who has served as CEO of four companies over the last 20 years. Since March 2022, Mr.
Deschamps has served as the President and CEO of ChitogenX Inc. (formerly Ortho Regenerative Technologies), where he is focused primarily
on expansion of commercial uses for the company’s proprietary bio-polymer drug combination products. From 2012 to 2020, he co-founded
and served as CEO of Helius Medical Technologies (Nasdaq: HSDT), a neurotech company. From 2002 to 2011, he served as President and CEO
of GSW Worldwide, a leading healthcare commercialization company, and from 2011 to 2012 served as CEO of MediMedia Health, a private equity
owned company. Prior to his CEO experience he spent 13 years at Bristol-Myers Squibb (NYSE: BMY) from 1986 to 1998, including serving
as director of neuroscience marketing from where he oversaw the company’s neuroscience products including BuSpar and Serzone and
Stadol NS. Mr. Deschamps also holds the position as President of Deschamps Global Commercialization LLC, a healthcare commercialization
consulting company he founded where he has served clients as a consultant in the pharmaceutical and medical tech industries from 2020
to 2022. Mr. Deschamps received a BSc. from the University of Ottawa in Canada. We believe Mr. Deschamps is well qualified to serve on
the board due to his extensive experience in the healthcare industry and his public company experience.
Christopher Cochran – Director: Mr.
Cochran is currently the President of BluChip Solutions, a provider of IT solutions for complex problems, an entity that he founded in
2008. From March 2012 to May 2013, Mr. Cochran held leadership positions within different companies, including serving as the EVP of Sales
& Marketing for Velocity World Media, a private experiential television network. Additionally, from March 2010 to February 2012, Mr.
Cochran worked as an Enterprise Cloud Sales Executive for Hewlett Packard Enterprise. From April 2008 to January 2010, Mr. Cochran served
as the Executive Director of Sales and Operations for ASGN Inc. (NYSE: ASGN), formerly Apex Systems, a leading provider of IT services.
From 2008 to 2010, Mr. Cochran worked at Mastech Digital (Nasdaq: MHH), a publicly-traded company, where he held various roles, including
Senior Vice President of Global Sales and Operations from February 2004 to April 2008, where he reported directly to the CEO. From May
2014 to May 2016, Mr. Cochran served on the Board of Trustees for the Pine-Richland Opportunities Fund, a non-profit educational foundation
providing staff grants and student scholarships, and he currently serves as Director of the Christian Cochran Legacy Fund through the
Pittsburgh Foundation. Mr. Cochran received his Bachelor of Science in Public Administration and International Law from the University
of Tennessee in 1993. We believe Mr. Cochran is well qualified to serve on the board due to his public company experience and expertise
in business operations.
Gene Salkind, M.D. –
Director: Mr. Salkind has been a practicing neurosurgeon within the Philadelphia area for more than 35 years. He graduated
from the University of Pennsylvania in 1974 with a B.A., Cum Laude, and received his medical degree from the Lewis Katz School of Medicine
in 1979. He returned to the University of Pennsylvania for his neurosurgical residency, and in 1985 was selected as the Chief Resident
in Neurosurgery at the Hospital of the University of Pennsylvania. Since 1985, Dr. Salkind has served in a university affiliated practice
of general neurological surgery. Since 2005, Dr. Salkind has served as the Chief of Neurosurgery at Holy Redeemer Hospital. He previously
served as the Chief of Neurosurgery at Albert Einstein Medical Center and Jeanes Hospital in Philadelphia in the late 1990s. He has authored
numerous peer reviewed journal articles and has given lectures throughout the country on various neurosurgical topics. He has also held
professorships at the University of Pennsylvania, the Allegheny Health Education and Research Foundation, and is currently at the Lewis
Katz School of Medicine. Since 2019, Dr. Salkind has also been on the board of directors of Cure Pharmaceutical Corporation (OTCMKTS:
CURR), a biopharmaceutical company focusing on the development and manufacturing of drug formulation and drug delivery technologies in
novel dosage forms, and has been the Chairman of Mobiquity Technologies Inc. (Nasdaq: MOBQ), a leading provider of next-generation advertising
technology. Dr. Salkind is also a member of the Strategic Advisory Board of BioSymetrics Inc., a company that has built data servicing
tools to benefit health and health and hospital systems, biopharma, drug discovery, and the precision medicine field. In addition, from
2004 to 2019, Dr. Salkind served as a board member of Derm Tech International, a global leader in non-invasive dermatological molecular
diagnostics. We believe Dr. Salkind is well qualified to serve on the board due to his expertise in life science industry.
Independence of the Board
The Common Stock is listed
on Nasdaq. Under the rules of Nasdaq, independent directors must comprise a majority of a listed company’s board of directors. In
addition, the rules of Nasdaq require that, subject to specified exceptions, each member of a listed company’s audit, compensation
and nominating and corporate governance committees be independent. Under the rules of Nasdaq, a director will only qualify as an “independent
director” if, in the opinion of that company’s board of directors, that person does not have a relationship that would interfere
with the exercise of independent judgment in carrying out the responsibilities of a director. Audit committee members must also satisfy
the additional independence criteria set forth in Rule 10A-3 of the Exchange Act and the rules of Nasdaq. Compensation committee
members must also satisfy the additional independence criteria set forth in Rule 10C-1 under the Exchange Act and the rules
of Nasdaq.
In order to be considered
independent for purposes of Rule 10A-3 under the Exchange Act and under the rules of Nasdaq, a member of an audit committee
of a listed company may not, other than in his or her capacity as a member of the committee, the board of directors, or any other board
committee: (1) accept, directly or indirectly, any consulting, advisory, or other compensatory fee from the listed company or any
of its subsidiaries; or (2) be an affiliated person of the listed company or any of its subsidiaries.
To be considered independent
for purposes of Rule 10C-1 under the Exchange Act and under the rules of Nasdaq, the board of directors must affirmatively determine
that the member of the compensation committee is independent, including a consideration of all factors specifically relevant to determining
whether the director has a relationship to the company which is material to that director’s ability to be independent from management
in connection with the duties of a compensation committee member, including, but not limited to: (i) the source of compensation of
such director, including any consulting, advisory or other compensatory fee paid by the company to such director; and (ii) whether
such director is affiliated with the company, a subsidiary of the company or an affiliate of a subsidiary of the company.
The Company has undertaken
a review of the independence of each director and considered whether each director of the Company has a material relationship with the
Company that could compromise his or her ability to exercise independent judgment in carrying out his or her responsibilities. As a result
of this review, Tara Maria DeSilva, Philippe Deschamps, Christopher Cochran and Gene Salkind are considered “independent directors”
as defined under the listing requirements and rules of Nasdaq and the applicable rules of the Exchange Act and Christopher Calise
is considered an “independent director” as defined under the listing requirements and rules of Nasdaq.
Committees of the Company Board
The Company Board has an audit
committee, compensation committee and nominating and corporate governance committee. All of the committees will comply with all applicable
requirements of the Sarbanes-Oxley Act, Nasdaq and SEC rules and regulations as further described below. The responsibilities of each
of the committees of the Company Board is described below. Members will serve on these committees until their resignation or until as
otherwise determined by the Company Board.
Audit Committee
The Company Board has an
audit committee. The audit committee currently consists of Philippe Deschamps, Christopher Cochran and Gene Salkind, with Mr. Deschamps
serving as the chair of the committee. Each of the members of the Company’s audit committee satisfy the requirements for independence
and financial literacy under the applicable rules and regulations of the SEC and rules of Nasdaq. The Company also determines that Mr.
Deschamps qualifies as an “audit committee financial expert” as defined in the SEC rules and will satisfy the financial sophistication
requirements of Nasdaq. The Company’s audit committee will be responsible for, among other things:
| · | appointing (and recommending that the Company Board submit
for stockholder ratification, if applicable) compensate, retain and oversee the work performed by the independent auditor retained for
the purpose of preparing or issuing an audit report or performing other audit or audit-related services; |
| · | reviewing the performance and independence of the independent
auditor; |
| · | pre-approving all audit, review, and non-audit services (including
any internal control-related services) to be provided to the Company or its subsidiaries by the independent auditor; |
| · | discussing the scope and results of the audit with the independent
registered public accounting firm and reviewing, with management and the independent registered public accounting firm, the Company’s
interim and year-end financial statements; |
| · | developing procedures for employees to submit concerns anonymously
about questionable accounting or audit matters; |
| · | reviewing the Company’s policies on and overseeing risk
assessment and risk management, including enterprise risk management; and |
| · | reviewing the adequacy and effectiveness of internal control
policies and procedures and the Company’s disclosure controls and procedures. |
The Company Board has adopted
a written charter for the audit committee, which is available on the Company’s website.
Compensation Committee
The Company Board has a compensation
committee. The compensation committee currently consists of Tara Maria DeSilva, Christopher Cochran and Gene Salkind, with Mr. Cochran
serving as the chair of the committee. Each of the members of the Company’s compensation committee meet the requirements for independence
under the under the applicable rules and regulations of the SEC and rules of Nasdaq. The Company’s compensation committee will be
responsible for, among other things:
| · | developing and reviewing compensation policies and practices
applicable to executive officers; |
| · | reviewing, approving or recommending for approval by the Board,
compensation for executive officers, including without limitation salary, bonus, incentive compensation, perquisites and equity compensation; |
| · | reviewing, approving and determining compensation and benefits,
including equity awards, to directors for service on the Company Board or any committee thereof; |
| · | supervising, administering and evaluating incentive, equity-based
and other compensatory plans of the Company in which executive officers and key employees participate; and |
| · | reviewing, approving and making recommendations to the Company
Board regarding incentive compensation and equity compensation plans |
The
Company Board has adopted a written charter for the compensation committee, which is available on its website.
Nominating and Corporate Governance Committee
The Company Board has a nominating and corporate
governance committee. The nominating and corporate governance committee currently consists of Tara Maria DeSilva, Philippe Deschamps and
Christopher Cochran, with Mr. Cochran serving as the chair of the committee. Each of the members of the nominating and corporate governance
committee meets the requirements for independence under the applicable rules and regulations of the SEC and rules of Nasdaq. The nominating
and corporate governance committee is responsible for, among other things:
| · | identifying individuals qualified to become Board members,
consistent with criteria approved by the Board; |
| · | recommending to the Board the persons to be nominated for
election as directors by stockholders and the persons (if any) to be elected by the Board to fill any vacancies on the Board; |
| · | recommending to the Board the directors to be appointed to
each committee of the Board; |
| · | developing and recommending to the Board corporate governance
guidelines; and |
| · | overseeing the evaluation of the Board. |
The Company Board has adopted
a written charter for the nominating and corporate governance committee, which is available on its website.
Code of Business Conduct and Ethics
The Company Board has adopted
a Code of Business Conduct and Ethics that applies to all of its employees, officers and directors, including its Chief Executive Officer,
Chief Financial Officer and other executive and senior financial officers. The full text of the Company’s Code of Business Conduct
and Ethics is posted on the Corporate Governance portion of the Company’s website. The Company will post amendments to its Code
of Business Conduct and Ethics or waivers of its Code of Business Conduct and Ethics for directors and officers on the same website or
in a current report on Form 8-K.
Family Relationships
Christopher Calise and Tara
Maria DeSilva are first cousins. Other than that, there are no family relationships among any of our executive officers or directors.
Compensation Committee Interlocks and Insider
Participation
None
of the Company’s officers currently serves, and in the past year has not served, (i) as a member of the compensation committee
or the board of directors of another entity, one of whose officers served on the Company’s compensation committee, or (ii) as
a member of the compensation committee of another entity, one of whose officers served on the Company Board.
Consultants and Advisors
The Company has several fee-for-service
consultancy arrangements with highly qualified firms and individuals who provide consulting services in the areas of regulatory affairs,
quality assurance, chemistry, manufacturing and control (CMC), and clinical/medical affairs. We don’t anticipate the expenses related
to these agreements to be material to the Company.
Involvement in Certain Legal Proceedings
To our knowledge, during the
past ten years, none of our directors, executive officers, promoters, control persons, or nominees has:
| · | been convicted in a criminal proceeding or been subject to
a pending criminal proceeding (excluding traffic violations and other minor offenses); |
| · | had any bankruptcy petition filed by or against the business
or property of the person, or of any partnership, corporation or business association of which he was a general partner or executive
officer, either at the time of the bankruptcy filing or within two years prior to that time; except that in 2019, a private limited liability
company with which Mr. Mehalick had previously held an executive officer position, but from which he had previously resigned and then
returned as interim CEO, filed for bankruptcy protection; |
| · | been subject to any order, judgment, or decree, not subsequently
reversed, suspended or vacated, of any court of competent jurisdiction or federal or state authority, permanently or temporarily enjoining,
barring, suspending or otherwise limiting, his involvement in any type of business, securities, futures, commodities, investment, banking,
savings and loan, or insurance activities, or to be associated with persons engaged in any such activity; |
| · | been found by a court of competent jurisdiction in a civil
action or by the SEC or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and
the judgment has not been reversed, suspended, or vacated; |
| · | been the subject of, or a party to, any federal or state judicial
or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated (not including any settlement
of a civil proceeding among private litigants), relating to an alleged violation of any federal or state securities or commodities law
or regulation, any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary
or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order,
or removal or prohibition order, or any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity;
or |
| · | been the subject of, or a party to, any sanction or order,
not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange
Act), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act), or any equivalent exchange, association,
entity or organization that has disciplinary authority over its members or persons associated with a member. |
Indemnification under Certificate of Incorporation
and Bylaws; Indemnification Agreements
Our
bylaws provide that we will indemnify our directors and officers to the fullest extent permitted by the DGCL, subject to certain exceptions
contained in our bylaws. In addition, our certificate of incorporation provides that our directors will not be liable for monetary damages
for breach of fiduciary duty.
We intend to enter into indemnification
agreements with each of our directors and executive officers. We expect the indemnification agreement to provide, among other things,
that we will indemnify and hold harmless each person subject to an indemnification agreement (each, an “Indemnified Party”)
to the fullest extent permitted by applicable law from and against all losses, costs, liabilities, judgments, penalties, fines, expenses
and other matters that may result or arise in connection with such Indemnified Party serving in his or her capacity as a director of ours
or serving at our direction as a director, officer, employee, fiduciary or agent of another entity. We expect the indemnification agreement
to further provide that, upon an Indemnified Party’s request, we will advance expenses to the Indemnified Party to the fullest extent
permitted by applicable law. Pursuant to the indemnification agreement, we will intend that an Indemnified Party is presumed to be entitled
to indemnification and we have the burden of proving otherwise. We also intend to secure and maintain in full force and effect directors’
liability insurance. If indemnification under an indemnification agreement is unavailable to an Indemnified Party for any reason, we,
in lieu of indemnifying the Indemnified Party, will contribute to any amounts incurred by the Indemnified Party in connection with any
claim relating to an indemnifiable event in such proportion as is deemed fair and reasonable in light of all of the circumstances to reflect
the relative benefits received or relative fault of the parties in connection with such event.
Insofar as indemnification
for liabilities arising under the Securities Act may be permitted to our directors, officers, and controlling persons pursuant to the
foregoing provisions, or otherwise, we have been advised that in the opinion of the Securities and Exchange Commission such indemnification
is against public policy as expressed in the Securities Act and is, therefore, unenforceable.
Scientific and Clinical Advisory Board
In 2022 we formed a Scientific
Advisory Board, which contributes key guidance on the advancement of our product portfolio. The Scientific Advisory Board is comprised
of three renowned scientific researchers from the Karolinska Institutet, Stockholm, Sweden; Evren Alici, M.D., Ph.D.; Hans-Gustaf Ljunggren,
M.D., Ph.D; and Arnika Kathleen Wagner, Ph.D.
| ITEM 11. |
EXECUTIVE COMPENSATION |
The following table sets forth
information regarding each element of compensation that we paid or awarded to our named executive officers and for years ended December
31, 2022 and 2023.
Summary Compensation Table
Name
and
Principal
Position |
|
Year |
|
Salary
($) |
|
Bonus
($) |
|
Stock
Awards
($) |
|
Option
Awards
($) |
|
Non-Equity
Incentive
Plan
Compensation ($) |
|
Non-qualified
Deferred
Compensation
Earnings
($) |
|
All
Other
Compensation
($) |
|
Total
($) |
|
| David Mehalick |
|
2023 |
|
360,000 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
360,000 |
|
| Chairman, CEO and President |
|
2022 |
|
286,615 |
|
75,000 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
361,615 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Daniel Yerace |
|
2023 |
|
360,000 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
360,000 |
|
| Vice President of Operations |
|
2022 |
|
285,346 |
|
75,000 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
360,346 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Brian Cogley |
|
2023 |
|
200,000 |
|
8,000 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
208,000 |
|
| Chief Financial Officer |
|
2022 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Colleen Delaney |
|
2023 |
|
360,000 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
360,000 |
|
| Chief Scientific and Medical Officer |
|
2022 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Christine Sheehy |
|
2023 |
|
150,999 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
– |
|
150,999 |
|
| Former Chief Financial Officer |
|
2022 |
|
150,999 |
|
75,000 |
|
– |
|
– |
|
– |
|
– |
|
– |
|
225,999 |
|
* Ms. Sheehy stepped down as Chief Financial Officer
in 2023 and remains with the Company as Vice President of Compliance and Secretary.
Employment Agreements with Directors and Officers
The
Company is party to employment agreements with David Mehalick, Colleen Delaney and Daniel Yerace, each of which are described below.
The Company does not currently have employment agreements with any of its other officers and directors.
David
Mehalick: David Mehalick, our President and Chief Executive Officer, entered into an employment
agreement with Coeptis Therapeutics, Inc. on February 21, 2022 (the “Effective Date”) covering Coeptis and its
subsidiary, Coeptis Pharmaceuticals. The employment agreement is in effect immediately and will remain in effect until the
termination of the employment agreement by either party in accordance with Section 5 of the employment agreement.
Mr. Mehalick shall report to the Board of Directors and shall have the duties, responsibilities and authority as may from time
to time be assigned to him by the Board of Directors. Under the employment agreement, Coeptis currently pays to Mr. Mehalick an
annualized salary at the rate of $360,000. Mr. Mehalick will also receive a guaranteed bonus equal to twenty (20%) of his base
salary for each calendar year (which amount Mr. Mehalick has waived for calendar year 2023), and will be eligible to receive merit
bonuses, certain milestone bonuses and awards of stock options, restricted stock units or other equity awards pursuant to any plans
or arrangements that Coeptis may have in effect from time to time. The foregoing summary does not purport to be complete and is
qualified in its entirety by reference Mr. Mehalick’s employment agreement, which is filed as Exhibit 4.1 to Coeptis’
Current Report on Form 8-K filed on February 21, 2022. This employment agreement was assumed by the Company in connection
with the Merger.
Daniel
Yerace: Daniel A. Yerace, our Vice President of Operations, entered into an employment agreement
with Coeptis on the Effective Date covering Coeptis and its subsidiary, Coeptis Pharmaceuticals. The employment agreement is in
effect immediately and will be effective from the Effective Date until the termination of the employment agreement by either party
in accordance with Section 5 of the employment agreement. Mr. Yerace reports to the President of Coeptis and has the duties,
responsibilities and authority as may from time to time be assigned to him by Coeptis’ President. Under the employment
agreement, Coeptis currently pays to Mr. Yerace an annualized salary at the rate of $360,000. Mr. Yerace will also receive a
guaranteed bonus equal to twenty (20%) of his base salary for each calendar year (which amount Mr. Yerace has waived for calendar
year 2023), and will be eligible to receive merit bonuses, certain milestone bonuses and awards of stock options, restricted stock
units or other equity awards pursuant to any plans or arrangements that Coeptis may have in effect from time to time. The foregoing
summary does not purport to be complete and is qualified in its entirety by reference Mr. Yerace’s employment agreement,
which is filed as Exhibit 4.1 to Coeptis’ Current Report on Form 8-K filed on February 21, 2022. This employment
agreement was assumed by the Company in connection with the Merger.
Brian Cogley: Mr.
Cogley joined the Company in 2023. For 2023, Mr. Cogley is currently to receive, (i) an initial base salary of $200,000 per year, (ii)
eligibility for annual discretionary bonus, (iii) participation in the Company’s stock incentive plan with the number of stock options
to be determined and (iv) additional benefits generally available to other salaried employees of the Company. Mr. Cogley’s employment
is “at will”.
Collen Delaney.
Dr. Delaney joined the Company in 2023. For 2023, Dr. Delaney is currently to receive, (i) an initial base salary of $360,000 per year,
(ii) an annual bonus of 20% of base salary (which amount Dr. Delaney has waived for calendar year 2023) plus eligibility for additional
annual discretionary bonus, (iii) participation in the Company’s stock incentive plan with the number of stock options to be determined
and (iv) additional benefits generally available to other salaried employees of the Company. Dr. Delaney’s employment is “at
will”.
Outstanding Equity Awards at Fiscal Year End
The Company had unexercised options (including stock
options that have not vested) to purchase an aggregate of 1,657,000 shares of Common Stock outstanding for executive officers and directors
as of December 31, 2023. The Company had no outstanding equity awards at December 31, 2022.
Employee, Director and Consultant Stock Plan
General
See “ITEM 5. MARKET FOR REGISTRANT’S
COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES - Securities Authorized for Issuance under Equity
Compensation Plans” for a full description of the Company’s 2022 Equity Incentive Plan.
Option Grants and Stock Awards
On January 27, 2023, the Company
granted options to purchase an aggregate of 1,357,500 shares of our common stock under the 2022 Equity Incentive Plan, to various officers,
directors, employees and consultants, at an average exercise price of $1.63 per share. On February 1, 2023, the Company also granted a
stand-alone option to a former employee to purchase up to 100,000 shares of our common stock at an exercise price of $10 per share. The
stand-alone option expired on January 31, 2024.
On October 2, 2023, the Company granted additional
options to purchase an aggregate of 300,000 shares of our common stock to two employees at an average price of $1.07 per share.
The following table provides
certain information regarding unexercised options to purchase Common Stock, stock options that have not vested and equity-incentive plan
awards outstanding as of December 31, 2023, for each named executive officer and director.
| | |
Option
Awards (1) | | |
Stock
Awards | |
| Name | |
Number of
Securities
Underlying
Unexercised
Options
(#) Exercisable | | |
Number of
Securities
Underlying
Unexercised
Options
(#) Unexercisable | | |
Equity
Incentive
Plan
Awards:
Number of
Securities
Underlying
Unexercised
Unearned
Options
(#) | | |
Option
Exercise
Price
($) | | |
Option
Expiration
Date | | |
Number of
Shares or
Units of
Stock
That
Have Not
Vested
(#) | | |
Market
Value of
Shares or
Units of
Stock
That
Have Not
Vested
($) | | |
Equity
Incentive
Plan
Awards:
Number of
Unearned
Shares,
Units or
Other
Rights
That
Have Not
Vested
(#) | | |
Equity
Incentive
Plan
Awards:
Market or Payout
Value of
Unearned
Shares,
Units or
Other
Rights
That
Have Not
Vested
($) | |
| David Mehalick | |
– | | |
– | | |
625,000 | | |
(2) | | |
(2) | | |
– | | |
– | | |
– | | |
– | |
| Daniel Yerace | |
– | | |
– | | |
200,000 | | |
1.60 | | |
1/27/2033 | | |
– | | |
– | | |
– | | |
– | |
| Christine Sheehy | |
– | | |
– | | |
200,000 | | |
1.60 | | |
1/27/2033 | | |
– | | |
– | | |
– | | |
– | |
| Christopher Calise | |
– | | |
– | | |
30,000 | | |
1.60 | | |
1/27/2033 | | |
– | | |
– | | |
– | | |
– | |
| Tara DeSilva | |
– | | |
– | | |
30,000 | | |
1.60 | | |
1/27/2033 | | |
– | | |
– | | |
– | | |
– | |
| Gene Salkind | |
– | | |
– | | |
30,000 | | |
1.60 | | |
1/27/2033 | | |
– | | |
– | | |
– | | |
– | |
| Philippe Deschamps | |
– | | |
– | | |
30,000 | | |
1.60 | | |
1/27/2033 | | |
– | | |
– | | |
– | | |
– | |
| Christopher Cochran | |
– | | |
– | | |
30,000 | | |
1.60 | | |
1/27/2033 | | |
– | | |
– | | |
– | | |
– | |
| Brian Cogley | |
– | | |
– | | |
100,000 | | |
1.07 | | |
10/2/2033 | | |
– | | |
– | | |
– | | |
– | |
| Colleen Delaney | |
– | | |
– | | |
200,000 | | |
1.07 | | |
10/2/2033 | | |
– | | |
– | | |
– | | |
– | |
(1) All options were issued
(a) to Mr. Cogley and Dr. Delaney on October 2, 2023 and (b) to the officers and directors on January 27, 2023 (as applicable, the “Grant
Date”).
(2) Includes (i) 250,000 incentive
stock options with an exercise price of $1.76 and an expiration date of January 27, 2028 and (ii) 375,000 nonqualified stock options with
an exercise price of $1.60 and an expiration date of January 27, 2033.
2022 and 2023 Director Compensation
Non-employee directors were each paid a total of $18,333
for service as a director during 2023. No compensation was earned or paid to any non-employee director for service as a director during
2022.
| ITEM 12. |
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS |
The following table sets forth
certain information regarding our Common Stock beneficially owned on March 22, 2024, for (i) each stockholder known to be the beneficial
owner of more than 5% of our outstanding common stock; (ii) all directors; (iii) all named executive officers; and (iv) all directors
and executive officers as a group. Beneficial ownership is determined in accordance with the rules of the SEC that deem shares to be beneficially
owned by any person who has voting or investment power with respect to such shares. Shares of common stock subject to options or warrants
that are exercisable as of the date of this Annual Report on Form 10-K or are exercisable within 60 days of such date are deemed to be
outstanding and to be beneficially owned by the person holding such options for the purpose of calculating the percentage ownership of
such person but are not treated as outstanding for the purpose of calculating the percentage ownership of any other person. Applicable
percentage ownership is based on 36,089,917 shares of common stock outstanding as the date of this Annual Report on Form 10-K.
Unless otherwise indicated
and subject to applicable community property and similar laws, we believe that all persons named in the table below have sole voting and
investment power with respect to the voting securities beneficially owned by them.
| Name of Beneficial Ownership(1) |
|
Shares
Owned |
|
|
Percentage |
|
| Executive Officers and Directors |
|
|
|
|
|
|
|
|
| David Mehalick |
|
|
2,796,624 |
(2) |
|
|
7.74% |
|
| Daniel Yerace |
|
|
1,073,105 |
(3) |
|
|
2.97% |
|
| Christopher Calise |
|
|
1,484,565 |
(4) |
|
|
4.11% |
|
| Tara DeSilva |
|
|
38,750 |
(5) |
|
|
* |
|
| Philippe Deschamps |
|
|
38,750 |
(5) |
|
|
* |
|
| Christopher Cochran |
|
|
38,750 |
(5) |
|
|
* |
|
| Gene Salkind |
|
|
281,296 |
(6) |
|
|
* |
|
| Brian Cogley |
|
|
25,000 |
(7) |
|
|
* |
|
| Christine Sheehy |
|
|
1,073,105 |
(8) |
|
|
2.97% |
|
| Colleen Delaney |
|
|
50,000 |
(9) |
|
|
* |
|
| Officer and Directors as a Group (10 persons) |
|
|
6,899,945 |
|
|
|
17.79% |
|
| Greater than 5% Holders (1 person) |
|
|
|
|
|
|
|
|
| Biofin Ventures, LLC (10) |
|
|
2,400,000 |
|
|
|
6.65% |
|
| * |
Less than 1.0%. |
| (1) |
Unless otherwise indicated, the business address of each of the individuals is c/o Coeptis Therapeutics, Inc., 105 Bradford Rd, Suite 420, Wexford, PA 15090. |
| (2) |
Includes 195,313 (rounded to the nearest share) shares of common stock that are issuable upon exercise of options that are or will become exercisable in the next 60 days. Does not include 816,630 shares of common stock that are issuable upon exercise of options that are not currently exercisable and will not become exercisable in the next 60 days. |
| (3) |
Includes 62,500 shares of common stock that are issuable upon exercise of options that are or will become exercisable in the next 60 days. Does not include 337,500 shares of common stock that are issuable upon exercise of options that are not currently exercisable and will not become exercisable in the next 60 days. |
| (4) |
Includes (i) 942,117 shares of common stock that are issuable under currently exercisable options and (ii) 38,750 shares of common stock that are issuable upon exercise of options that are or will become exercisable in the next 60 days. Does not include 26,250 shares of common stock that are issuable upon exercise of options that are not currently exercisable and will not become exercisable in the next 60 days. |
| (5) |
Represents 38,750 shares of common stock that are issuable upon exercise of options that are or will become exercisable in the next 60 days. Does not include 26,250 shares of common stock that are issuable upon exercise of options that are not currently exercisable and will not become exercisable in the next 60 days. |
| (6) |
Includes (i) 84,217 shares of common stock that are held as JTWROS with Catherine Salkind, (ii) 57,268 shares of common stock issuable upon exercise of currently exercisable warrants held as JTWROS with Catherine Salkind, (iii) 101,061 shares of common stock that are issuable upon currently exercisable warrants and (iv) 38,750 shares of common stock that are issuable upon exercise of options that are or will become exercisable in the next 60 days. Does not include 26,250 shares of common stock that are issuable upon exercise of options that are not currently exercisable and will not become exercisable in the next 60 days. |
| (7) |
Represents 25,000 shares of common stock
that are issuable upon exercise of options that are or will become exercisable in the next 60 days. Does not include 225,000 shares of
common stock that are issuable upon exercise of options that are not currently exercisable and will not become exercisable in the next
60 days. |
| (8) |
Includes 62,500 shares of common stock
that are issuable upon exercise of options that are or will become exercisable in the next 60 days. Does not include 187,500 shares of
common stock that are issuable upon exercise of options that are not currently exercisable and will not become exercisable in the next
60 days. |
|
(9) |
Represents 50,000 shares of common stock
that are issuable upon exercise of options that are or will become exercisable in the next 60 days. Does not include 550,000 shares of
common stock that are issuable upon exercise of options that are not currently exercisable and will not become exercisable in the next
60 days. |
| (10) |
Joshua Lewis is the manager of this entity and possesses voting control over securities owned by it. |
Changes in Control
We are not aware of any arrangements
or a party to arrangements, including any pledge by any person of our securities, the operation of which may at a subsequent date result
in a change of control.
| ITEM 13. |
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS, AND DIRECTOR INDEPENDENCE |
For purposes of this section
of this Annual Report on Form 10-K, “Predecessor” refers to the Company before giving effect to the Merger, and the term “Coeptis”
refers to Coeptis Therapeutics, Inc., before giving effect to the Merger.
Predecessor Related Person Transactions Prior
to the Merger
In connection with the Merger,
Predecessor’s sponsor, officers and directors and/or their affiliates were reimbursed for certain out-of-pocket expenses incurred
in connection with activities on Predecessor’s behalf.
Predecessor has entered into
a registration and shareholder rights agreement with respect to the Private Placement Warrants, the warrants issuable upon conversion
of working capital loans (if any) and the shares issuable upon exercise of the foregoing and upon conversion of the founder shares.
Coeptis Related Person Transactions Prior to
the Merger
Prior to the closing of the
merger in 2021 involving Coeptis and an entity named Vinings Holdings, Inc. (which is now Coeptis Therapeutics, Inc.), Vinings had a 100%
ownership interest in an entity named NDYN Delaware, Inc. In December 2020, prior to the closing of the 2021 merger, Vinings divested
its 100% ownership interest NDYN Delaware, LLC to Sterling Acquisition I, LLC, an entity controlled by Vinings’ then control person
Erik Nelson. The divestiture was accomplished through the sale of all of Vinings’ share ownership of NDYN Delaware, Inc. pursuant
to a Divestiture Agreement, a copy of which is attached as Exhibit 10.1 to Vinings Holdings Inc.’s Current Report on Form 8-K that
was filed on December 31, 2020.
On February 12, 2021, David
Mehalick purchased 8,000 shares of Series B Preferred Stock from Coral Investment Partners, LP for an aggregate purchase price of $1,000.
These shares of Series B Preferred Stock were exchanged for our Common Stock in connection with the closing of the Merger.
Director Independence and Committees
The Common Stock is listed
on Nasdaq. Under the rules of Nasdaq, independent directors must comprise a majority of a listed company’s board of directors. In
addition, the rules of Nasdaq require that, subject to specified exceptions, each member of a listed company’s audit, compensation
and nominating and corporate governance committees be independent. Under the rules of Nasdaq, a director will only qualify as an “independent
director” if, in the opinion of that company’s board of directors, that person does not have a relationship that would interfere
with the exercise of independent judgment in carrying out the responsibilities of a director. Audit committee members must also satisfy
the additional independence criteria set forth in Rule 10A-3 of the Exchange Act and the rules of Nasdaq. Compensation committee
members must also satisfy the additional independence criteria set forth in Rule 10C-1 under the Exchange Act and the rules
of Nasdaq.
In order to be considered
independent for purposes of Rule 10A-3 under the Exchange Act and under the rules of Nasdaq, a member of an audit committee
of a listed company may not, other than in his or her capacity as a member of the committee, the board of directors, or any other board
committee: (1) accept, directly or indirectly, any consulting, advisory, or other compensatory fee from the listed company or any
of its subsidiaries; or (2) be an affiliated person of the listed company or any of its subsidiaries.
To be considered independent
for purposes of Rule 10C-1 under the Exchange Act and under the rules of Nasdaq, the board of directors must affirmatively determine
that the member of the compensation committee is independent, including a consideration of all factors specifically relevant to determining
whether the director has a relationship to the company which is material to that director’s ability to be independent from management
in connection with the duties of a compensation committee member, including, but not limited to: (i) the source of compensation of
such director, including any consulting, advisory or other compensatory fee paid by the company to such director; and (ii) whether
such director is affiliated with the company, a subsidiary of the company or an affiliate of a subsidiary of the company.
The Company has undertaken
a review of the independence of each director and considered whether each director of the Company has a material relationship with the
Company that could compromise his or her ability to exercise independent judgment in carrying out his or her responsibilities. As a result
of this review, Tara Maria DeSilva, Philippe Deschamps, Christopher Cochran and Gene Salkind are considered “independent directors”
as defined under the listing requirements and rules of Nasdaq and the applicable rules of the Exchange Act and Christopher Calise
is considered an “independent director” as defined under the listing requirements and rules of Nasdaq.
Committees of the Company Board
The Company Board has an audit
committee, compensation committee and nominating and corporate governance committee. All of the committees will comply with all applicable
requirements of the Sarbanes-Oxley Act, Nasdaq and SEC rules and regulations as further described below. The responsibilities of each
of the committees of the Company Board is described below. Members will serve on these committees until their resignation or until as
otherwise determined by the Company Board.
Audit Committee
The Company Board has an audit
committee. The audit committee currently consists of Philippe Deschamps, Christopher Cochran and Gene Salkind, with Mr. Deschamps serving
as the chair of the committee. Each of the members of the Company’s audit committee satisfy the requirements for independence and
financial literacy under the applicable rules and regulations of the SEC and rules of Nasdaq. The Company also determines that Mr. Deschamps
qualifies as an “audit committee financial expert” as defined in the SEC rules and will satisfy the financial
sophistication requirements of Nasdaq. The Company’s
audit committee will be responsible for, among other things:
| · | appointing (and recommending that the Company Board submit
for stockholder ratification, if applicable) compensate, retain and oversee the work performed by the independent auditor retained for
the purpose of preparing or issuing an audit report or performing other audit or audit-related services; |
| · | reviewing the performance and independence of the independent
auditor; |
| · | pre-approving all audit, review, and non-audit services (including
any internal control-related services) to be provided to the Company or its subsidiaries by the independent auditor; |
| · | discussing the scope and results of the audit with the independent
registered public accounting firm and reviewing, with management and the independent registered public accounting firm, the Company’s
interim and year-end financial statements; |
| · | developing procedures for employees to submit concerns anonymously
about questionable accounting or audit matters; |
| · | reviewing the Company’s policies on and overseeing risk
assessment and risk management, including enterprise risk management; and |
| · | reviewing the adequacy and effectiveness of internal control
policies and procedures and the Company’s disclosure controls and procedures. |
The Company Board has adopted
a written charter for the audit committee, which is available on the Company’s website.
Compensation Committee
The Company Board has a compensation
committee. The compensation committee currently consists of Tara Maria DeSilva, Christopher Cochran and Gene Salkind, with Mr. Cochran
serving as the chair of the committee. Each of the members of the Company’s compensation committee meet the requirements for independence
under the under the applicable rules and regulations of the SEC and rules of Nasdaq. The Company’s compensation committee will be
responsible for, among other things:
| · | developing and reviewing compensation policies and practices
applicable to executive officers; |
| · | reviewing, approving or recommending for approval by the Board,
compensation for executive officers, including without limitation salary, bonus, incentive compensation, perquisites and equity compensation; |
| · | reviewing, approving and determining compensation and benefits,
including equity awards, to directors for service on the Company Board or any committee thereof; |
| · | supervising, administering and evaluating incentive, equity-based
and other compensatory plans of the Company in which executive officers and key employees participate; and |
| · | reviewing, approving and making recommendations to the Company
Board regarding incentive compensation and equity compensation plans |
The Company Board has adopted
a written charter for the compensation committee, which is available on its website.
Nominating and Corporate Governance Committee
The Company Board has a nominating
and corporate governance committee. The nominating and corporate governance committee currently consists of Tara Maria DeSilva, Philippe
Deschamps and Christopher Cochran, with Mr. Cochran serving as the chair of the committee. Each of the members of the nominating and corporate
governance committee meets the requirements for independence under the applicable rules and regulations of the SEC and rules of Nasdaq.
The nominating and corporate governance committee is responsible for, among other things:
| · | identifying individuals qualified to become Board members,
consistent with criteria approved by the Board; |
| · | recommending to the Board the persons to be nominated for
election as directors by stockholders and the persons (if any) to be elected by the Board to fill any vacancies on the Board; |
| · | recommending to the Board the directors to be appointed to
each committee of the Board; |
| · | developing and recommending to the Board corporate governance
guidelines; and |
| · | overseeing the evaluation of the Board. |
The Company Board has adopted
a written charter for the nominating and corporate governance committee, which is available on its website.
Code of Business Conduct and Ethics
The Company Board has adopted
a Code of Business Conduct and Ethics that applies to all of its employees, officers and directors, including its Chief Executive Officer,
Chief Financial Officer and other executive and senior financial officers. The full text of the Company’s Code of Business Conduct
and Ethics is posted on the Corporate Governance portion of the Company’s website. The Company will post amendments to its Code
of Business Conduct and Ethics or waivers of its Code of Business Conduct and Ethics for directors and officers on the same website or
in a current report on Form 8-K.
Family Relationships
Christopher Calise and Tara
Maria DeSilva are first cousins. Other than that, there are no family relationships among any of our executive officers or directors.
Compensation Committee Interlocks and Insider
Participation
None
of the Company’s officers currently serves, and in the past year has not served, (i) as a member of the compensation committee
or the board of directors of another entity, one of whose officers served on the Company’s compensation committee, or (ii) as
a member of the compensation committee of another entity, one of whose officers served on the Company Board.
Consultants and Advisors
The Company has several fee-for-service
consultancy arrangements with highly qualified firms and individuals who provide consulting services in the areas of regulatory affairs,
quality assurance, chemistry, manufacturing and control (CMC), and clinical/medical affairs. We don’t anticipate the expenses related
to these agreements to be material to the Company.
Involvement in Certain Legal Proceedings
To our knowledge, during the
past ten years, none of our directors, executive officers, promoters, control persons, or nominees has:
| · | been convicted in a criminal proceeding or been subject to
a pending criminal proceeding (excluding traffic violations and other minor offenses); |
| · | had any bankruptcy petition filed by or against the business
or property of the person, or of any partnership, corporation or business association of which he was a general partner or executive
officer, either at the time of the bankruptcy filing or within two years prior to that time; except that in 2019, a private limited liability
company with which Mr. Mehalick had previously held an executive officer position, but from which he had previously resigned and then
returned as interim CEO, filed for bankruptcy protection; |
| · | been subject to any order, judgment, or decree, not subsequently
reversed, suspended or vacated, of any court of competent jurisdiction or federal or state authority, permanently or temporarily enjoining,
barring, suspending or otherwise limiting, his involvement in any type of business, securities, futures, commodities, investment, banking,
savings and loan, or insurance activities, or to be associated with persons engaged in any such activity; |
| · | been found by a court of competent jurisdiction in a civil
action or by the SEC or the Commodity Futures Trading Commission to have violated a federal or state securities or commodities law, and
the judgment has not been reversed, suspended, or vacated; |
| · | been the subject of, or a party to, any federal or state judicial
or administrative order, judgment, decree, or finding, not subsequently reversed, suspended or vacated (not including any settlement
of a civil proceeding among private litigants), relating to an alleged violation of any federal or state securities or commodities law
or regulation, any law or regulation respecting financial institutions or insurance companies including, but not limited to, a temporary
or permanent injunction, order of disgorgement or restitution, civil money penalty or temporary or permanent cease-and-desist order,
or removal or prohibition order, or any law or regulation prohibiting mail or wire fraud or fraud in connection with any business entity;
or |
| · | been the subject of, or a party to, any sanction or order,
not subsequently reversed, suspended or vacated, of any self-regulatory organization (as defined in Section 3(a)(26) of the Exchange
Act), any registered entity (as defined in Section 1(a)(29) of the Commodity Exchange Act), or any equivalent exchange, association,
entity or organization that has disciplinary authority over its members or persons associated with a member. |
Indemnification under Certificate of Incorporation
and Bylaws; Indemnification Agreements
Our
bylaws provide that we will indemnify our directors and officers to the fullest extent permitted by the DGCL, subject to certain exceptions
contained in our bylaws. In addition, our certificate of incorporation provides that our directors will not be liable for monetary damages
for breach of fiduciary duty.
We intend to enter into indemnification
agreements with each of our directors and executive officers. We expect the indemnification agreement to provide, among other things,
that we will indemnify and hold harmless each person subject to an indemnification agreement (each, an “Indemnified Party”)
to the fullest extent permitted by applicable law from and against all losses, costs, liabilities, judgments, penalties, fines, expenses
and other matters that may result or arise in connection with such Indemnified Party serving in his or her capacity as a director of ours
or serving at our direction as a director, officer, employee, fiduciary or agent of another entity. We expect the indemnification agreement
to further provide that, upon an Indemnified Party’s request, we will advance expenses to the Indemnified Party to the fullest extent
permitted by applicable law. Pursuant to the indemnification agreement, we will intend that an Indemnified Party is presumed to be entitled
to indemnification and we have the burden of proving otherwise. We also intend to secure and maintain in full force and effect directors’
liability insurance. If indemnification under an indemnification agreement is unavailable to an Indemnified Party for any reason, we,
in lieu of indemnifying the Indemnified Party, will contribute to any amounts incurred by the Indemnified Party in connection with any
claim relating to an indemnifiable event in such proportion as is deemed fair and reasonable in light of all of the circumstances to reflect
the relative benefits received or relative fault of the parties in connection with such event.
Insofar as indemnification
for liabilities arising under the Securities Act may be permitted to our directors, officers, and controlling persons pursuant to the
foregoing provisions, or otherwise, we have been advised that in the opinion of the Securities and Exchange Commission such indemnification
is against public policy as expressed in the Securities Act and is, therefore, unenforceable.
Scientific and Clinical Advisory Board
In 2022 we formed a Scientific
Advisory Board, which contributes key guidance on the advancement of our product portfolio. The Scientific Advisory Board is comprised
of three renowned scientific researchers from the Karolinska Institutet, Stockholm, Sweden; Evren Alici, M.D., Ph.D.; Hans-Gustaf Ljunggren,
M.D., Ph.D; and Arnika Kathleen Wagner, Ph.D.
| ITEM 14. |
PRINCIPAL ACCOUNTANT FEES AND SERVICES |
The following table shows the fees paid or accrued
for the audit and other services provided by Tuner, Stone & Company, LLP, our independent registered public accounting firm for the
years ended December 31, 2023 and 2022.
| | |
12-31-2023 | | |
12-31-2022 | |
| Audit fees | |
$ | 73,912 | | |
$ | 49,886 | |
| Other Service Fees | |
| 145,440 | | |
| 61,995 | |
| Total | |
$ | 219,352 | | |
$ | 111,881 | |
Audit fees consist of fees billed for services
rendered for the audit of our consolidated financial statements included in this Annual Report on Form 10–K, and reviews of our
quarterly condensed consolidated financial statements included in the Company’s quarterly filings on Form 10-Q.
Audit–related fees consist of fees reasonably
related to the performance of the audit or review of the Company’s financial statements that are not reported as “Audit Fees.”
Tax fees consist of fees billed for professional
services related to the preparation of our U.S. federal and state income tax returns and tax advice.
All other fees consist of fees for other miscellaneous
items.
PART IV
| ITEM 15. |
EXHIBITS AND FINANCIAL STATEMENT SCHEDULES |
| (a) |
The following documents are filed as part of this report: |
| |
(2) |
Financial Statement Schedules—Financial statement schedules have been omitted in this Annual Report on Form 10-K because they are not applicable, not required under the instructions, or the information requested is set forth in the consolidated financial statements or related notes thereto. |
| |
(3) |
Exhibits—The exhibits listed in the accompanying index to exhibits are filed as part of, or incorporated by reference into, this Annual Report on Form 10-K. |
| ITEM 16. |
FORM 10-K SUMMARY |
None.
EXHIBIT INDEX
|
Exhibit
No. |
|
Description |
| |
|
|
| 2.1 |
|
Agreement and Plan of Merger and Reorganization, dated as of April 18, 2022, by and among Bull Horn Holdings Corp., a British Virgin Island corporation, BH Acquisition Sub, a Delaware corporation and Coeptis Therapeutics, Inc., a Delaware corporation (incorporated by reference from Exhibit 2.1 to Bull Horn Holdings Corp.’s Current Report on Form 8-K, as filed with the SEC on April 19, 2022) |
| 2.2 |
|
Certificate of Merger as filed with the Delaware Secretary of State effective October 28, 2022 (incorporated by reference to Exhibit 2.2 of Coeptis Therapeutics Holdings, Inc.’s Form 8-K, filed with the SEC on November 3, 2022) |
| 3.1 |
|
Amended and Restated Certificate of Incorporation of Coeptis Therapeutics Holdings, Inc. (incorporated by reference to Exhibit 3.1 of Coeptis Therapeutics Holdings, Inc.’s Form 8-K, filed with the SEC on November 3, 2022) |
| 3.2 |
|
Certificate of Incorporation of Coeptis Therapeutics, Inc. (incorporated by reference from the Certificate of Merger included at Exhibit 2.2 to the Current Report on Form 8-K) |
| 3.3 |
|
Amended and Restated Bylaws of Coeptis Therapeutics Holdings, Inc. (incorporated by reference to Exhibit 3.3 of Coeptis Therapeutics Holdings, Inc.’s Form 8-K, filed with the SEC on November 3, 2022) |
| 10.1 |
|
Registration Rights Agreement, dated October 29, 2020, by and among Bull Horn and certain security holders (incorporated by reference to Exhibit 10.3 of Bull Horn’s Form 8-K, filed with the SEC on November 3, 2020). |
| 10.2 |
|
Private Placement Warrants Purchase Agreement, dated October 29, 2020, by and between Bull Horn and Imperial Capital LLC, I-Bankers Securities, Inc. and Northland Securities, Inc. (incorporated by reference to Exhibit 10.4 of Bull Horn’s Form 8-K, filed with the SEC on November 3, 2020). |
| 10.3 |
|
Private Placements Warrants Purchase Agreement, dated October 29, 2020, by and between Bull Horn and Sponsor (incorporated by reference to Exhibit 10.5 of Bull Horn’s Form 8-K, filed with the SEC on November 3, 2020). |
| 10.4 |
|
Co-Development Option Purchase Agreement (SNP) between Coeptis and Vy-Gen Bio, Inc. (incorporated by reference to Exhibit 4.1 to Coeptis Therapeutics, Inc.’s Form 8-K, filed with the SEC on May 11, 2021). |
| 10.5 |
|
Co-Development Option Purchase Agreement (GEAR) between Coeptis and Vy-Gen Bio, Inc. (incorporated by reference to Exhibit 4.2 to Coeptis’ Form 8-K, filed with the SEC on May 11, 2021). |
| 10.6 |
|
Amendment No. 1 to Co-Development Option Purchase Agreement (SNP) between Coeptis and VyGen-Bio, Inc. (incorporated by reference to Exhibit 4.1 to Coeptis Therapeutics, Inc.’s Form 8-K, filed with the SEC on August 19, 2021). |
| 10.7 |
|
Co-development and Steering Committee Agreement with VyGen-Bio, Inc. (incorporated by reference to Exhibit 4.1 to Coeptis’ Therapeutics, Inc.’s Form 8-K, filed with the SEC on December 27, 2021). |
| 10.8 |
|
Employment Agreement between Coeptis and David Mehalick (incorporated by reference to Exhibit 4.1 to Coeptis Therapeutics, Inc.’s Form 8-K filed with the SEC on February 25, 2022). |
| 10.9 |
|
Employment Agreement between Coeptis and Daniel Yerace (incorporated by reference to Exhibit 4.2 to Coeptis Therapeutics, Inc.’s Form 8-K filed with the SEC on February 25, 2022). |
| 10.10 |
|
2022 Equity Incentive Plan (incorporated by reference to Exhibit 4.1 of Coeptis Therapeutics Holdings, Inc.’s Form 8-K, filed with the SEC on November 3, 2022) |
| 10.11 |
|
Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 of Coeptis Therapeutics Holdings, Inc.’s Form 8-K, filed with
the SEC on October 27, 2023) |
| 10.12 |
|
Registration Rights Agreement (incorporated
by reference to Exhibit 10.2 of Coeptis Therapeutics Holdings, Inc.’s Form 8-K, filed with the SEC on October 27, 2023) |
| 10.13 |
|
Form of Placement Agency Agreement (incorporated
by reference to Exhibit 10.4 of Coeptis Therapeutics Holdings, Inc.’s Form 8-K, filed with the SEC on October 27, 2023) |
| 10.14 |
|
Form of Warrant Amendment Agreement (incorporated
by reference to Exhibit 10.5 of Coeptis Therapeutics Holdings, Inc.’s Form 8-K, filed with the SEC on October 27, 2023) |
| 10.15 |
|
License Agreement, dated as of August 16, 2023, by and between Coeptis Therapeutics Holdings, Inc. and Deverra Therapeutics, Inc. (incorporated by reference to Exhibit 10.1 of Coeptis Therapeutics
Holdings, Inc.’s Form 8-K, filed with the SEC on August 22, 2023) |
| 10.16 |
|
Sublicense
Agreement, dated as of August 16, 2023, by and between Coeptis Therapeutics Holdings, Inc. and Deverra Therapeutics, Inc.
(incorporated by reference to Exhibit 10.2 of Coeptis Therapeutics Holdings, Inc.’s Form 8-K, filed with the SEC on August 22,
2023) |
|
10.17 |
|
Asset Purchase Agreement, dated as of August 16, 2023, by and between Coeptis Therapeutics Holdings, Inc. and Deverra Therapeutics, Inc. (incorporated
by reference to Exhibit 10.3 of Coeptis Therapeutics Holdings, Inc.’s Form 8-K, filed with the SEC on August 22, 2023) |
| 21.1 |
|
Subsidiaries of Coeptis Therapeutics Holdings, Inc. * |
| 31.1 |
|
Certification of the Principal Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.* |
| 31.2 |
|
Certification of the Principal Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.* |
| 32.1 |
|
Certification of the Principal Executive Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.* |
| 32.2 |
|
Certification of the Principal Financial Officer pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.* |
| 101.INS |
|
XBRL Instance Document* |
| 101.SCH |
|
XBRL Taxonomy Extension Schema* |
| 101.CAL |
|
XBRL Taxonomy Calculation Linkbase* |
| 101.LAB |
|
XBRL Taxonomy Label Linkbase* |
| 101.PRE |
|
XBRL Definition Linkbase Document* |
| 101.DEF |
|
XBRL Definition Linkbase Document* |
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d)
of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
| |
COEPTIS THERAPEUTICS HOLDINGS, INC. |
| |
|
| Date: August 15, 2024 |
By: |
/s/ David Mehalick |
| |
|
David Mehalick |
| |
|
Chief Executive Officer
(Principal Executive Officer) |
| |
|
|
| Date: August 15, 2024 |
By: |
/s/ Brian Cogley |
| |
|
Brian Cogley |
| |
|
Chief Financial Officer
(Principal Financial and Accounting Officer) |
Pursuant to the requirements of the Securities
Exchange Act of 1934, as amended, this Report has been signed below by the following persons on behalf of the Registrant in the capacities
and on the dates indicated.
| Signature |
|
Title |
|
Date |
| |
|
|
|
|
| /s/ David Mehalick |
|
Chief Executive Officer |
|
August 15, 2024 |
| David Mehalick |
|
(Principal Executive Officer) and Director |
|
|
| |
|
|
|
|
| /s/ Brian Cogley |
|
Chief Financial Officer (Principal Financial and |
|
August 15, 2024 |
| Brian Cogley |
|
Accounting Officer) and Director |
|
|
| |
|
|
|
|
| /s/ Daniel Yerace |
|
Director |
|
August 15, 2024 |
| Daniel Yerace |
|
|
|
|
| |
|
|
|
|
| /s/ Christopher Calise |
|
Director |
|
August 15, 2024 |
| Christopher Calise |
|
|
|
|
| |
|
|
|
|
| /s/ Christopher Cochran |
|
Director |
|
August 15, 2024 |
| Christopher Cochran |
|
|
|
|
| |
|
|
|
|
| /s/ Philippe Deschamps |
|
Director |
|
August 15, 2024 |
| Philippe Deschamps |
|
|
|
|
| |
|
|
|
|
| /s/ Tara DeSilva |
|
Director |
|
August 15, 2024 |
| Tara DeSilva |
|
|
|
|
| |
|
|
|
|
| /s/ Gene Salkind |
|
Director |
|
August 15, 2024 |
| Gene Salkind |
|
|
|
|
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Coeptis Therapeutics Holdings, Inc.
Consolidated Financial Statements
Years Ended December 31, 2023 and 2022
Your
Vision Our Focus
REPORT OF INDEPENDENT REGISTERED PUBLIC
ACCOUNTING FIRM
To the Stockholders and Board of Directors of
Coeptis Therapeutics Holdings, Inc.
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated
balance sheets of Coeptis Therapeutics Holdings, Inc. (the “Company”) as of December 31, 2023 and 2022 and the related consolidated
statements of operations, stockholders’ equity, and cash flows for each of the two years in the period ended December 31, 2023,
and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated
financial statements present fairly, in all material respects, the consolidated financial position of the Company as of December 31, 2023
and 2022, and the consolidated results of its operations and its cash flows for each of the two years in the period ended December 31,
2023, in conformity with accounting principles generally accepted in the United States of America.
Going Concern
The accompanying consolidated financial statements
have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 of the notes to consolidated financial
statements, the Company has suffered recurring losses from operations since inception and has insufficient working capital to fund future
operations both of which raise substantial doubt about its ability to continue as a going concern. Management’s plans in regard
to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result
from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the
responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial
statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United
States) (“PCAOB”) and are required to be independent with respect to the Company in accordance with the U.S. federal securities
laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated
financial statements are free of material misstatements, whether due to error or fraud. The Company is not required to have, nor were
we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an
understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the
Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess
the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures
that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the
consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by
management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide
a reasonable basis for our opinion.
/s/ Turner, Stone & Company, LLP
We have served as the Company’s auditor since 2020
Dallas, Texas
March 25, 2024, except for Note 2, as to which the date is August 15,
2024
COEPTIS
THERAPEUTICS HOLDINGS, INC.
CONSOLIDATED BALANCE
SHEETS
| | |
| | | |
| | |
| | |
As of | |
| | |
December 31, 2023 | | |
December 31, 2022 | |
| ASSETS | |
| | | |
| | |
| CURRENT ASSETS | |
| | | |
| | |
| Cash | |
$ | 1,469,134 | | |
$ | 3,791,302 | |
| Accounts receivable | |
| – | | |
| 8,075 | |
| Interest receivable | |
| 38,978 | | |
| – | |
| Prepaid assets, current portion | |
| 241,601 | | |
| 142,356 | |
| TOTAL CURRENT ASSETS | |
| 1,749,713 | | |
| 3,941,733 | |
| | |
| | | |
| | |
| PROPERTY AND EQUIPMENT | |
| | | |
| | |
| Furniture and fixtures | |
| 25,237 | | |
| 25,237 | |
| Less: accumulated depreciation | |
| 13,931 | | |
| 12,695 | |
| Furniture and fixtures, net | |
| 11,306 | | |
| 12,542 | |
| | |
| | | |
| | |
| OTHER ASSETS | |
| | | |
| | |
| Prepaid assets, net of current portion | |
| 158,333 | | |
| 348,333 | |
| Co-development options | |
| 2,554,166 | | |
| 3,554,167 | |
| Right of use asset, net of accumulated amortization | |
| 97,571 | | |
| 58,914 | |
| Total other assets | |
| 2,810,070 | | |
| 3,961,414 | |
| TOTAL ASSETS | |
$ | 4,571,089 | | |
$ | 7,915,689 | |
| | |
| | | |
| | |
| LIABILITIES AND STOCKHOLDERS' EQUITY | |
| | | |
| | |
| CURRENT LIABILITIES | |
| | | |
| | |
| Accounts payable | |
$ | 1,419,699 | | |
$ | 99,021 | |
| Accrued expenses | |
| 555,950 | | |
| 181,998 | |
| Notes payable, current portion | |
| 975,000 | | |
| 1,850,000 | |
| Right of use liability, current portion | |
| 38,047 | | |
| 41,618 | |
| TOTAL CURRENT LIABILITIES | |
| 2,988,696 | | |
| 2,172,637 | |
| | |
| | | |
| | |
| LONG TERM LIABILITIES | |
| | | |
| | |
| Note payable, net of current portion | |
| 150,000 | | |
| 150,000 | |
| Derivative liability warrants | |
| 557,250 | | |
| 1,125,000 | |
| Right of use liability, non-current portion | |
| 61,179 | | |
| 14,723 | |
| TOTAL LONG TERM LIABILITIES | |
| 768,429 | | |
| 1,289,723 | |
| TOTAL LIABILITIES | |
$ | 3,757,125 | | |
$ | 3,462,360 | |
| | |
| | | |
| | |
| COMMITMENTS AND CONTINGENCIES (NOTE 6) | |
| – | | |
| – | |
| | |
| | | |
| | |
| STOCKHOLDERS' EQUITY | |
| | | |
| | |
| Common stock, $0.0001 par value, 150,000,000 shares authorized, 35,331,036 shares issued and outstanding at December 31, 2023, and 19,566,839 shares issued and outstanding at December 31, 2022 | |
$ | 3,533 | | |
$ | 1,957 | |
| Additional paid-in capital | |
| 91,666,691 | | |
| 70,541,095 | |
| Subscription receivable | |
| (3,500,000 | ) | |
| – | |
| Accumulated deficit | |
| (87,356,260 | ) | |
| (66,089,723 | ) |
| TOTAL STOCKHOLDERS' EQUITY | |
| 813,964 | | |
| 4,453,329 | |
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | |
$ | 4,571,089 | | |
$ | 7,915,689 | |
The accompanying notes are an integral part of the consolidated financial
statements.
COEPTIS
THERAPEUTICS HOLDINGS, INC.
CONSOLIDATED STATEMENTS
OF OPERATIONS
| | |
| | | |
| | |
| | |
Year Ended | |
| | |
December 31, 2023 | | |
December 31, 2022 | |
| SALES | |
| | | |
| | |
| Consulting services | |
$ | – | | |
$ | – | |
| Sales | |
| – | | |
| – | |
| Total sales | |
| – | | |
| – | |
| Cost of goods | |
| – | | |
| – | |
| Gross profit | |
| – | | |
| – | |
| | |
| | | |
| | |
| COST OF OPERATIONS | |
| | | |
| | |
| Research and development | |
| 6,668,244 | | |
| 20,887 | |
| Professional services | |
| 10,864,640 | | |
| 31,114,208 | |
| General and administrative expenses | |
| 3,945,531 | | |
| 3,052,538 | |
| Selling and marketing | |
| 12,710 | | |
| 8,331 | |
| Total cost of operations | |
| 21,491,125 | | |
| 34,195,964 | |
| | |
| | | |
| | |
| LOSS FROM OPERATIONS | |
| (21,491,125 | ) | |
| (34,195,964 | ) |
| | |
| | | |
| | |
| OTHER INCOME (EXPENSE) | |
| | | |
| | |
| | |
| | | |
| | |
| Royalties and licensing fees | |
| (15,000 | ) | |
| (90,000 | ) |
| Other income (expense) | |
| (220,477 | ) | |
| 98,701 | |
| Loss on extinguishment of debt and write down of assets | |
| – | | |
| (3,393,542 | ) |
| Gain on change in fair value of derivative liability warrants | |
| 567,750 | | |
| – | |
| Gain on write down of liabilities | |
| – | | |
| 225,000 | |
| Interest expense | |
| (107,685 | ) | |
| (218,412 | ) |
| TOTAL OTHER INCOME (EXPENSE), net | |
| 224,588 | | |
| (3,378,253 | ) |
| | |
| | | |
| | |
| LOSS BEFORE INCOME TAXES | |
| (21,266,537 | ) | |
| (37,574,217 | ) |
| | |
| | | |
| | |
| PROVISION FOR INCOME TAXES (BENEFIT) | |
| – | | |
| – | |
| NET LOSS | |
$ | (21,266,537 | ) | |
$ | (37,574,217 | ) |
| | |
| | | |
| | |
| LOSS PER SHARE | |
| | | |
| | |
| | |
| | | |
| | |
| Loss per share, basic and fully diluted | |
$ | (0.83 | ) | |
$ | (2.63 | ) |
| | |
| | | |
| | |
| Weighted average number of common shares outstanding | |
| 25,689,989 | | |
| 14,295,678 | |
The accompanying notes
are an integral part of the consolidated financial statements.
COEPTIS
THERAPEUTICS HOLDINGS, INC.
CONSOLIDATED STATEMENTS
OF STOCKHOLDERS' EQUITY
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| | |
SERIES B
PREFERRED STOCK | | |
COMMON STOCK | |
|
ADDITIONAL
PAID-IN | |
|
SUBSCRIPTION |
| |
TREASURY | | |
ACCUMULATED | | |
| |
| | |
SHARES | | |
AMOUNT | | |
SHARES | | |
AMOUNT | |
|
CAPITAL | |
|
RECEIVABLE |
| |
STOCK | | |
DEFICIT | | |
TOTAL | |
| | |
| | |
| | |
| | |
| |
|
| |
|
|
|
| |
| | |
| | |
| |
| BALANCE AT DECEMBER 31, 2021 | |
| 8,000 | | |
$ | 1 | | |
| 12,492,050 | | |
$ | 1,196 | |
|
$ | 30,146,728 | |
|
$ |
– |
| |
$ | (247,165 | ) | |
$ | (27,550,126 | ) | |
$ | 2,350,634 | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Shares issued for cash | |
| – | | |
| – | | |
| 404,410 | | |
| 41 | |
|
| 3,271,445 | |
|
|
– |
| |
| – | | |
| – | | |
| 3,271,486 | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Shares issued for services | |
| – | | |
| – | | |
| 588,990 | | |
| 58 | |
|
| 4,983,442 | |
|
|
– |
| |
| – | | |
| – | | |
| 4,983,500 | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Retirement of shares | |
| – | | |
| – | | |
| (110,762 | ) | |
| – | |
|
| (247,165 | ) |
|
|
– |
| |
| 247,165 | | |
| – | | |
| – | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Warrants converted to shares | |
| – | | |
| – | | |
| 1,250,658 | | |
| 125 | |
|
| 5,247,524 | |
|
|
– |
| |
| – | | |
| – | | |
| 5,247,649 | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Warrants issued for services | |
| – | | |
| – | | |
| – | | |
| – | |
|
| 23,730,298 | |
|
|
– |
| |
| – | | |
| – | | |
| 23,730,298 | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Warrants issued for extinguishment of debt | |
| – | | |
| – | | |
| – | | |
| – | |
|
| 3,408,559 | |
|
|
– |
| |
| – | | |
| – | | |
| 3,408,559 | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Merger | |
| (8,000 | ) | |
| (1 | ) | |
| 4,941,493 | | |
| 537 | |
|
| 264 | |
|
|
– |
| |
| – | | |
| (965,380 | ) | |
| (964,580 | ) |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Net loss | |
| – | | |
| – | | |
| – | | |
| – | |
|
| – | |
|
|
– |
| |
| – | | |
| (37,574,217 | ) | |
| (37,574,217 | ) |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| BALANCE AT DECEMBER 31, 2022 | |
| – | | |
$ | – | | |
| 19,566,839 | | |
$ | 1,957 | |
|
$ | 70,541,095 | |
|
$ |
– |
| |
$ | – | | |
$ | (66,089,723 | ) | |
$ | 4,453,329 | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Shares issued for cash | |
| – | | |
| – | | |
| 500,000 | | |
| 50 | |
|
| 499,950 | |
|
|
– |
| |
| – | | |
| – | | |
| 500,000 | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Shares issued in exchange for note receivable | |
| – | | |
| – | | |
| 2,500,000 | | |
| 250 | |
|
| 2,499,750 | |
|
|
(2,500,000 |
) | |
| – | | |
| – | | |
| – | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Shares issued for services | |
| – | | |
| – | | |
| 2,964,197 | | |
| 296 | |
|
| 4,420,918 | |
|
|
– |
| |
| – | | |
| – | | |
| 4,421,214 | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Warrants issued for services | |
| – | | |
| – | | |
| – | | |
| – | |
|
| 2,613,183 | |
|
|
– |
| |
| – | | |
| – | | |
| 2,613,183 | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Warrants issued for cash | |
| – | | |
| – | | |
| – | | |
| – | |
|
| 200,000 | |
|
|
– |
| |
| – | | |
| – | | |
| 200,000 | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Warrants issued in exchange for note receivable | |
| – | | |
| – | | |
| – | | |
| – | |
|
| 1,000,000 | |
|
|
(1,000,000 |
) | |
| – | | |
| – | | |
| – | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Stock based compensation | |
| – | | |
| – | | |
| – | | |
| – | |
|
| 477,503 | |
|
|
– |
| |
| – | | |
| – | | |
| 477,503 | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Issuance of common stock and warrants, net of issuance costs | |
| – | | |
| – | | |
| 5,500,000 | | |
| 550 | |
|
| 4,791,796 | |
|
|
– |
| |
| – | | |
| – | | |
| 4,792,346 | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Shares issued for the conversion of debt | |
| – | | |
| – | | |
| 300,000 | | |
| 30 | |
|
| 302,896 | |
|
|
– |
| |
| – | | |
| – | | |
| 302,926 | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Shares issued in connection with asset purchase agreement | |
| – | | |
| – | | |
| 4,000,000 | | |
| 400 | |
|
| 4,319,600 | |
|
|
– |
| |
| – | | |
| – | | |
| 4,320,000 | |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| Net loss | |
| – | | |
| – | | |
| – | | |
| – | |
|
| – | |
|
|
– |
| |
| – | | |
| (21,266,537 | ) | |
| (21,266,537 | ) |
| | |
| | | |
| | | |
| | | |
| | |
|
| | |
|
|
|
| |
| | | |
| | | |
| | |
| BALANCE AT DECEMBER 31, 2023 | |
| – | | |
$ | – | | |
| 35,331,036 | | |
$ | 3,533 | |
|
$ | 91,666,691 | |
|
$ |
(3,500,000 |
) | |
$ | – | | |
$ | (87,356,260 | ) | |
$ | 813,964 | |
The accompanying notes are an integral part
of the consolidated financial statements.
COEPTIS
THERAPEUTICS HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
| | |
| | | |
| | |
| | |
Year Ended | |
| | |
December 31, 2023 | | |
December 31, 2022 | |
| OPERATING ACTIVITIES | |
| | | |
| | |
| | |
| | | |
| | |
| Net loss | |
$ | (21,266,537 | ) | |
$ | (37,574,217 | ) |
| Adjustments to reconcile net loss to net
cash used in operating activities | |
| | | |
| | |
| Depreciation and amortization | |
| 1,001,237 | | |
| 1,001,384 | |
| Shares issued for non-employee services | |
| 4,421,214 | | |
| 4,983,500 | |
| Stock based compensation | |
| 477,503 | | |
| – | |
| Warrants issued for services | |
| 2,613,183 | | |
| 23,730,298 | |
| Warrants issued for extinguishment of debt | |
| – | | |
| 3,408,559 | |
| (Gain) loss on change in fair value of derivative liability warrants | |
| (567,750 | ) | |
| 1,125,000 | |
| Shares issued in connection with asset purchase agreement | |
| 4,320,000 | | |
| – | |
| | |
| | | |
| | |
| (Increase) decrease in: | |
| | | |
| | |
| Accounts receivable | |
| 8,075 | | |
| (8,075 | ) |
| Interest receivable | |
| (38,978 | ) | |
| – | |
| Right of use asset/liability | |
| 4,228 | | |
| 628 | |
| Prepaid assets | |
| 90,755 | | |
| (490,689 | ) |
| Increase (decrease) in: | |
| | | |
| | |
| Accounts payable | |
| 1,320,678 | | |
| (35,071 | ) |
| Accrued expenses | |
| 376,878 | | |
| (17,128 | ) |
| NET CASH USED IN OPERATING ACTIVITIES | |
| (7,239,514 | ) | |
| (3,875,811 | ) |
| | |
| | | |
| | |
| INVESTING ACTIVITIES | |
| | | |
| | |
| | |
| | | |
| | |
| NET CASH USED IN INVESTING ACTIVITIES | |
| – | | |
| – | |
| | |
| | | |
| | |
| FINANCING ACTIVITIES | |
| | | |
| | |
| | |
| | | |
| | |
| Proceeds from note payable | |
| 650,000 | | |
| – | |
| Repayment of notes payable | |
| (1,225,000 | ) | |
| (2,417,000 | ) |
| Cash paid for debt as part of merger/recapitalization | |
| – | | |
| (614,580 | ) |
| Proceeds from issuance of common stock and warrants, net of issuance costs | |
| 4,792,346 | | |
| – | |
| Shares issued for cash | |
| 500,000 | | |
| 3,271,486 | |
| Shares issued for cash for the conversion warrants | |
| – | | |
| 5,247,649 | |
| Warrants issued for cash | |
| 200,000 | | |
| – | |
| NET CASH PROVIDED BY FINANCING ACTIVITIES | |
| 4,917,346 | | |
| 5,487,555 | |
| NET INCREASE IN CASH | |
| (2,322,168 | ) | |
| 1,611,744 | |
| CASH AT BEGINNING OF YEAR | |
| 3,791,302 | | |
| 2,179,558 | |
| CASH AT END OF YEAR | |
$ | 1,469,134 | | |
$ | 3,791,302 | |
| | |
| | | |
| | |
| SUPPLEMENTAL CASH FLOW DISCLOSURES | |
| | | |
| | |
| Interest paid | |
$ | – | | |
$ | – | |
| Taxes paid (refunded) | |
$ | – | | |
$ | – | |
| | |
| | | |
| | |
| SUPPLEMENTAL NON-CASH DISCLOSURES | |
| | | |
| | |
| Shares and warrants issued in exchange for notes receivable | |
$ | 3,500,000 | | |
$ | – | |
| Shares issued for the conversion of debt | |
$ | 302,926 | | |
$ | – | |
The accompanying notes are an integral part
of the consolidated financial statements.
COEPTIS THERAPEUTICS HOLDINGS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1 – DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
Nature of Business
General. Coeptis Therapeutics Holdings,
Inc. (“Coeptis”, the “Company” or “we” or “our”) was originally incorporated in the British
Virgin Islands on November 27, 2018, under the name Bull Horn Holdings Corp. On October 27, 2022, Bull Horn Holdings Corp. domesticated
from the British Virgin Islands to the State of Delaware. On October 28, 2022, in connection with the closing of the Merger, we changed
our corporate name from Bull Horn Holdings Corp. to “Coeptis Therapeutics Holdings, Inc.”
The Merger Transaction. On October 28,
2022, a wholly owned subsidiary of Bull Horn Holdings Corp., merged with and into Coeptis Therapeutics, Inc., with Coeptis Therapeutics,
Inc. as the surviving corporation of the Merger. As a result of the Merger, we acquired the business of Coeptis Therapeutics, Inc., which
we now continue to operate as our wholly owned subsidiary.
About the Company’s Subsidiaries.
We are now a holding company that currently operates through our direct and indirect wholly owned subsidiaries Coeptis Therapeutics, Inc.,
Coeptis Pharmaceuticals, Inc. and Coeptis Pharmaceuticals, LLC.
Our current business model is designed around
furthering the development of our current product portfolio. We are continually exploring partnership opportunities with companies that
have novel therapies in various stages of development or companies with technologies that improve the way that drugs are delivered to
patients. We seek the best strategic relationships, which relationships could include in-license agreements, out-license agreements, co-development
arrangements and other strategic partnerships in new and exciting therapeutic areas such as auto-immune disease and oncology.
Basis of Presentation – The accompanying
audited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United
States of America (“GAAP”) for financial information and with the instructions to Form 10-K and Rule 8-03 of Regulation S-X.
Accordingly, they include all of the information and notes required by GAAP for complete financial statements. In the opinion of the Company’s
management, any adjustments contained in the accompanying audited consolidated financial statements are of a normal recurring nature,
and are necessary to fairly present the financial position and operating results of the Company as of December 31, 2023
and 2022 and for the years then ended.
As a result of the Merger, the consolidated financial
statements included in this report reflect (1) the historical operating results of Coeptis prior to the Merger; (2) the combined results
of the Company and Coeptis following the closing of the Merger; (3) the assets and liabilities of Coeptis at their historical cost; and
(4) the Company’s equity structure for all periods presented.
Principles of Consolidation –
The accompanying audited consolidated financial statements include the accounts of Coeptis Therapeutics Holdings Inc. (formerly Bull
Horn Holdings Corp.), Coeptis Therapeutics, Inc., Coeptis Pharmaceuticals, Inc. and its wholly-owned subsidiary, Coeptis
Pharmaceuticals, LLC. All material intercompany accounts, balances and transactions have been eliminated.
Risks and Uncertainties – In late
2019, an outbreak of a novel strain of the Coronavirus 2019 Disease (“COVID-19”) was identified and infections have been found
in a number of countries around the world, including the United States. COVID-19 and its impact on trade including customer demand, travel,
employee productivity, supply chain, and other economic activities has had, and may continue to have, a potentially significant effect
on financial markets and business activity. The COVID-19 pandemic continues to evolve and the duration of its impact on the Company’s
operations and financial performance is currently uncertain and cannot be predicted with confidence.
NOTE 2 – SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Restatement of Previously
Issued Financial Statements
Subsequent to the issuance of the consolidated
financial statements as of and for the year ended December 31, 2023, the Company performed an evaluation of its accounting for note agreements
recorded as notes receivable. Management determined the previously issued consolidated financial statements did not give full effect to
the transactions, and the notes receivable should have been recorded as subscription receivables. On August 9, 2024, Management concluded
its evaluation and determined that the identified errors required the restatement of the accompanying consolidated financial statements.
The following table sets
forth the effects of the adjustments on affected items within the Company’s previously reported consolidated balance sheets, condensed
consolidated statements of operations, condensed consolidated statements of stockholders’ equity, and condensed consolidated statements
of cash flows for the period ended December 31, 2023.
| | |
As Reported | | |
Adjustment | | |
As Restated | |
| Consolidated Balance Sheet as of December 31, 2023 | |
| | | |
| | | |
| | |
| Notes receivable | |
$ | 3,500,000 | | |
$ | (3,500,000 | ) | |
$ | – | |
| Total current assets | |
| 5,249,713 | | |
| (3,500,000 | ) | |
| 1,749,713 | |
| Total assets | |
| 8,071,089 | | |
| (3,500,000 | ) | |
| 4,571,089 | |
| Subscription receivable | |
| – | | |
| (3,500,000 | ) | |
| (3,500,000 | ) |
| Total stockholders' equity | |
| 4,313,964 | | |
| (3,500,000 | ) | |
| 813,964 | |
| Total liabilities and stockholders' equity | |
| 8,071,089 | | |
| (3,500,000 | ) | |
| 4,571,089 | |
| | |
| | | |
| | | |
| | |
| Consolidated Statements of Stockholders' Equity for the year ended December 31, 2023 | |
| | | |
| | | |
| | |
| Subscription receivable (Shares issued in exchange for note receivable) | |
$ | – | | |
$ | (2,500,000 | ) | |
$ | (2,500,000 | ) |
| Subscription receivable (Warrants issued in exchange for note receivable) | |
| – | | |
| (1,000,000 | ) | |
| (1,000,000 | ) |
| Subscription receivable (Balance at December 31, 2023) | |
| – | | |
| (3,500,000 | ) | |
| (3,500,000 | ) |
| Shares issued in exchange for note receivable (Balance at December 31, 2023) | |
| 2,500,000 | | |
| (2,500,000 | ) | |
| – | |
| Warrants issued in exchange for note receivable (Balance at December 31, 2023) | |
| 1,000,000 | | |
| (1,000,000 | ) | |
| – | |
| Total equity | |
| 4,313,964 | | |
| (3,500,000 | ) | |
| 813,964 | |
Additionally, please refer to Note 5, Capital
Structure, where the Company has included additional disclosure related to the subscription receivable.
Cash – For purposes of the statement
of cash flows, the Company considers all highly liquid investments purchased with maturities of three months or less to be cash equivalents.
At times, balances of cash and cash equivalents at financial banking institutions exceeded the federally insured limit of $250,000. Uninsured balances approximated $1,219,000 and $3,541,000 at December
31, 2023 and 2022, respectively. The
Company regularly monitors the financial condition of the institution in which it has depository accounts and believes the risk of loss
is minimal.
Property and Equipment – Fixed assets
are stated at cost and depreciation is computed using the straight-line method for financial statement purposes.
Intangible Assets – Intangibles
are being amortized using the straight-line method over estimated useful lives of between five and forty years. For the years ended December
31, 2023 and 2022, depreciation expense totaled $1,235
and $1,384 respectively.
Research and Development – Research
and development costs are expensed when incurred. During the years ended December 31, 2023 and 2022, research and development expenses
totaled $6,668,244 and $20,887, respectively.
Impairment - The Company’s property
and equipment and other non-current assets are reviewed for possible impairment when events or changes in circumstances indicate that
the carrying amount may not be recoverable. An impairment loss would be recognized if and when the estimated future cash flows expected
to result from the use of the asset and its eventual disposition is less than its carrying amount. There was no impairment recognized
for the years ended December 31, 2023 and 2022.
Derivative
Liability Warrants - The Company accounts for the Public Warrants and Private Placement Warrants (the
“Warrants”) in accordance with the guidance contained in Financial Accounting Standards Board (“FASB”)
Accounting Standards Codification (“ASC”) 815-40, Derivatives and Hedging, under which the Warrants do not meet
the criteria for equity treatment and must be recorded as liabilities. Accordingly, the Company classifies the Warrants as
liabilities at their fair value and adjusts the Warrants to fair value in each respective reporting period. This liability is
subject to re-measurement at each consolidated balance sheet date until the Warrants are exercised, and any change in fair value is
recognized in the consolidated statements of operations. The Private Placement Warrants and the Public Warrants for periods where no
observable traded price was available are valued using a binomial lattice simulation model. For periods subsequent to the detachment
of the Public Warrants from the Units, the Public Warrant quoted market price was used as the fair value as of each relevant
date.
Income
Taxes – Income taxes are provided for the tax effects of transactions reported in the consolidated financial
statements and consist of taxes currently due plus deferred taxes related primarily to temporary differences between reporting of
income and expenses for financial reporting purposes and income tax purposes. The deferred tax assets and liabilities represent the
future tax return consequences of those differences, which will either be taxable or deductible when the assets and liabilities are
recovered or settled. Deferred taxes also are recognized for operating losses that are available to offset future federal income
taxes.
The Income Taxes Topic of FASB ASC clarifies the
accounting and reporting for uncertainties in income tax law within subtopic FASB ASC 740-10-25-5. The guidance prescribes a comprehensive
model for the financial statement recognition, measurement, presentation, and disclosure of uncertain tax positions taken or expected
to be taken in income tax returns. Management believes that there is no liability related to uncertain tax positions during the years
ended December 31, 2023 and 2022.
Use of Estimates - The preparation of financial
statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues
and expenses during the reporting period. Actual results could differ from those estimates.
Employee
and Non-Employee Share-Based Compensation – The Company applies ASC 718-10, Share-Based Payment, which requires
the measurement and recognition of compensation expenses for all share-based payment awards made to employees and directors including
employee stock options equity awards issued to employees and non-employees based on estimated fair values.
ASC 718-10 requires companies to estimate the
fair value of equity-based option awards on the date of grant using an option-pricing model. The fair value of the award is recognized
as an expense on a straight-line basis over the requisite service periods in the Company’s consolidated statements of
operations. The Company recognizes share-based award forfeitures as they occur.
The Company estimates the fair value of granted
option equity awards using a Black-Scholes option pricing model. The option-pricing model requires a number of assumptions, of which the
most significant are share price, expected volatility and the expected option term (the time from the grant date until the options are
exercised or expire). Expected volatility is estimated based on volatility of the Company. The Company has historically not paid dividends
and has no foreseeable plans to issue dividends. The risk-free interest rate is based on the yield from governmental zero-coupon bonds
with an equivalent term. The expected option term is calculated for options granted to employees and directors using the “simplified”
method. Changes in the determination of each of the inputs can affect the fair value of the options granted and the results of operations
of the Company.
Adoption
of New Accounting Pronouncements – During the years ended December 31, 2023 and 2022, there were several new accounting
pronouncements issued by the FASB. Each of these pronouncements, as applicable, has been or will be adopted by the Company. Management
does not believe the adoption of any of these accounting pronouncements has had or will have a material impact on the Company’s
consolidated financial statements.
Revenue
Recognition – Revenues are recognized when services are provided to its customers or the product is sold, in an amount
that reflects the consideration the Company expects to be entitled to in exchange for those services or goods as the respective performance
obligations are met. Sales and other taxes the Company collects concurrent with revenue-producing activities are excluded from revenue.
Incidental items that are immaterial in the context of the contract are recognized as expense. There were no amounts received for consulting
services for the years ended December 31, 2023 and 2022.
Earnings
Per Share – Basic earnings per share (or loss per share), is computed by dividing the earnings (loss)
for the period by the weighted average number of common stock shares outstanding for the period. Diluted earnings per share reflects
potential dilution of securities by including other potentially issuable shares of common stock, including shares issuable upon
conversion of convertible securities or exercise of outstanding stock options and warrants, in the weighted average number of common
shares outstanding for the period. Therefore, because including shares issuable upon conversion of convertible securities and/or
exercise of outstanding options and warrants would have an anti-dilutive effect on the loss per share, only the basic earnings
(loss) per share is reported in the accompanying consolidated financial statements. The Company does not have other potentially
issuable shares of stock.
Going Concern – The accompanying consolidated
financial statements have been prepared in conformity with GAAP, which contemplate continuation of the Company as a going concern, which
is dependent upon the Company’s ability to obtain sufficient financials or establish itself as a profitable business. As of December
31, 2023, the Company had an accumulated deficit of $87,356,260, and for the year ended December 31, 2023, the Company had a net loss
of $21,266,537. These conditions raise substantial doubt about the Company’s ability
to continue as a going concern. Management’s plans with respect to operations include raising additional capital through sales of
equity or debt securities as may be necessary to pursue its business plans and sustain operations until such time as the Company can achieve
profitability. Management believes that additional financing as necessary will result in improved operations and cash flow. However, there
can be no assurance that management will be successful in obtaining additional funding or in attaining profitable operations.
Fair Value of Financial Instruments – The
Company calculates the fair value of its assets and liabilities which qualify as financial instruments and includes this additional information
in the notes to consolidated financial statements when the fair value is different than the carrying value of those financial instruments.
The methods and assumptions applied in determining the fair value of each class of financial assets and financial liabilities of the Company
are disclosed in the respective accounting policies. The estimated fair value of cash, accounts receivable, notes receivable, and notes
payable approximate their carrying amounts due to the short-term nature of these instruments.
NOTE 3 – CO-DEVELOPMENT OPTIONS
Prior to 2022, the Company entered into an agreement
with Purple Biotech (“Purple”) to market, distribute, and sell the Consensi product (the “Product”) on an exclusive
basis within the United States and Puerto Rico. Upon execution of the Agreement the Company paid $1,000,000 to Purple. Two additional
milestone payments of $1,500,000 and $1,000,000 were due and paid upon completion of the milestones including the first commercial sale
of the Product which occurred and the payments were made prior to 2022.
In September of 2021, the Company executed a license termination agreement
with Purple to cease all efforts for sales and promotion of the Product in the United States and Puerto Rico. The termination included
(i) issuance of $1,500,000 of convertible debt due in 2023 to satisfy amounts owed for the license, (ii) the issue of warrants (See NOTE
5) and (iii) transfer of inventory ownership back to Purple. In conjunction with this termination, the Company also terminated its marketing
agreement with a third party for the Product’s sales and promotion. On July 14, 2023, the Company executed an amendment to revise
the note’s payment schedule. The revised payment schedule has four milestone payments (the first three of which were paid on July
17, 2023, September 30, 2023, and January 3, 2024 with the remaining payment due on March 31, 2024). The outstanding balance due under
the convertible note for the years ended December 31, 2023 and 2022 was $625,000
and $1,500,000 respectively.
During the year ended December 31, 2021, the
Company and Vy-Gen-Bio, Inc. (“Vy-Gen”) entered into agreements to jointly develop and commercialize two Vy-Gen product candidates,
CD38-GEAR-NK and CD38-Diagnostic (the “CD38 Assets”). The Company paid $1,750,000
and issued promissory notes totaling $3,250,000
to Vy-Gen in accordance with the agreements. The collaboration arrangement provides the right for the Company to participate,
under the direction of a joint steering committee, in the development and commercialization of the CD38 Assets and a 50/50 profit share,
with the profit share subject to contingent automatic downward adjustment up to 25% upon an event of default in connection with the promissory
notes. The Company capitalized $5,000,000
to be amortized over a five-year period in which the CD38 Assets are expected to contribute to future cash flows. In March of
2022, a $250,000
payment was made toward the promissory notes. In November of 2022, a $1,500,000
payment was made toward the promissory notes, which paid them in full, and the accrued interest was forgiven.
The Company made certain judgments as the basis
in determining the accounting treatment of these options. The CD38 Assets represent a platform technology and a diagnostic tool which
have multiple applications and uses. Both projects are intended to be used in more than one therapy or diagnostic option. For example,
GEAR-NK is a technology which allows for the gene editing of human natural killer cells, so that these cells can no longer bind and be
destroyed by targeted monoclonal antibody treatments. The GEAR-NK technology can be modified to work concomitantly with many different
monoclonal antibody treatments in which there are currently over 100 approved by the FDA. Anti-CD38 is only the first class of monoclonal
antibody treatments being developed under the GEAR-NK platform. Therefore, the pursuit of FDA approval for the use of CD38 assets for
at least one indication or medical device approval is at least reasonably expected. Further, as the diagnostic asset may be used as an
in vitro technology, it could be classified as a medical device, and therefore toxicity studies would not be a contingency to be resolved
before reasonably establishing future value assumptions. In addition, there is perceived value in the CD38 assets, based on publicly disclosed
current business deals in cell therapies, the developing market for these innovative technologies, and current interest from third parties
in these technologies. The Company may sell or license its right to another party, with the written consent of Vy-Gen, which cannot
be unreasonably withheld. Furthermore, the Company believes that any negative results from ongoing development of a single therapy or
use, would not result in abandoning the project. Given these considerations, The Company has determined that these options have alternative
future use and should be recorded as assets pursuant to ASC 730-10-25-2, Research and Development.
Related to the joint development, the
Company, under the direction of the joint steering committee, is assessing market opportunities, intellectual property protection,
and potential regulatory strategies for the CD38 Assets. Vy-Gen is responsible for development activities conducted and overseen by
the scientists at Karolinska Institute. The agreement does not currently require additional payments for research and development
costs by the Company and no additional payments are required upon development or regulatory milestones.
NOTE 4 – DEBT
In January 2020, the Company entered into a senior
secured note agreement with an unrelated party. The principal amount of $500,000, which is secured by a security agreement, together with
interest at 8%, plus additional 2% in the event of default, was due February 8, 2021. On April 14, 2022, the Company entered into a debt
modification agreement with the note holder, extending the maturity to July 31, 2022. The extension was executed in exchange for consideration
of warrants exchangeable for 400,000 shares of common stock at a price of $1.50 per share issued to the debt holders on January 28, 2022.
See Note 5 for details of warrants. In December of 2022, a $500,000 payment was made, along with an interest payment of $135,671, which
satisfied the note in full.
In January 2020, the Company entered into a senior
secured note agreement with an unrelated party. The principal amount of $167,000, which is secured by a security agreement, together with
interest at 8%, plus additional 2% in the event of default, was due February 8, 2021. On April 14, 2022, the Company entered into a debt
modification agreement with the note holder, extending the maturity to July 31, 2022. The extension was executed in exchange for consideration
of warrants exchangeable for 250,000 shares of common stock at a price of $1.50 per share issued to the debt holders on January 28, 2022.
See Note 5 for details of warrants. In July of 2022, a $50,000 payment was made toward principal. In November of 2022, a $117,000 payment
was made, along with an interest payment of $42,893, which satisfied the note in full.
In September 2021, as part of a termination
of a license agreement with Purple (see Note 3), the Company issued a convertible note in the principal amount of $1,500,000
that was payable on or before the Maturity Date in February 2023, bearing interest of 5%
per annum and convertible in whole or in part at any time by Purple into shares of common stock of the Company. The conversion price
is $5 per share of common stock, subject to certain adjustments under such terms and conditions as agreed between the parties. The
Company may prepay the principal amount of the note plus accrued and unpaid interest at any time, prior to the Maturity Date.
Inventory, which has been fully written-off on the Company’s accompanying consolidated balance sheets, will be transferred
back to Purple at Purple’s cost. On July 14, 2023, the Company and Purple executed an amendment to revise the note’s
payment schedule, extending the maturity date to March 31, 2024. The outstanding balance due under the convertible note for the
years ended December 31, 2023 and 2022 was $625,000 and $1,500,000, respectively.
In October 2022, as a result of the Merger, the
Company entered into a convertible promissory note agreement with an unrelated third party in the principal amount of $350,000
with no accruing interest and was due on October 28, 2023 for legal services rendered to the Company. The noteholder may elect, in its sole discretion upon written notice
to the Company, at any time prior to, as of or following the maturity date, to require that all or any portion of the principal amount
not then repaid be converted, without any further action on the part of the noteholder, into shares of common stock, par value $0.0001
per share, of the Company’s common stock. The conversion price as set forth by the note is equal to $10.00 per share, provided that
the conversion price shall be subject to a one-time adjustment on January 3, 2023, with the conversion price adjustable to a price equal
to the thirty-day volume weighted average price of the stock as traded on the Nasdaq. However, the conversion price following such adjustment
shall not be lower than a floor of $5.00 per share nor greater than $10.00 per share. Upon full conversion of the remaining principal
amount due, the note will, for all purposes be deemed cancelled and all obligations shall be deemed paid in full. On October 27, 2023, a
$200,000
payment was made, and on December 15, 2023, another $50,000
payment was made. The outstanding balance due under the convertible note for the years
ended December 31, 2023 and 2022 was $100,000
and $350,000 respectively. As of December 31, 2023, the note is in
default.
In May 2023, the Company entered into an unsecured
note agreement with an unrelated party in the principal amount of $200,000, together with interest at 4.5%, which was due on June 15,
2023. On October 27, 2023, a $100,000 payment was made. On October 31, 2023, the Company and the unrelated party signed an amendment to
the note that extended the maturity date to March 31, 2024. The note had an outstanding balance of $100,000 as of December 31, 2023.
In June 2023, the Company entered into an unsecured
note agreement with an unrelated party in the principal amount of $150,000. In August 2023, this Note was converted into shares of the
Company’s common stock.
In September 2023, the Company entered into an
unsecured convertible note agreement in the principal amount of $150,000. Shortly thereafter, prior to September 30, 2023, this Note was
converted into shares of the Company’s common stock. The note had no outstanding balance as of December 31, 2023.
In December 2023, the Company entered into an
unsecured note agreement with an unrelated party in the principal amount of $150,000 together with interest at 5%, which is due on June
30, 2024. The note had an outstanding balance of $150,000 as of December 31,
2023.
Loans under the CARES Act -- On July 8,
2020, the Company received a loan of $150,000 from the United States Small Business Administration (the “SBA”) under its Economic
Injury Disaster Loan (“EIDL”) assistance program in light of the impact of the COVID-19 pandemic on the Company’s business.
Proceeds are intended to be used for working capital purposes. Interest on the EIDL Loan accrues at the rate of 3.75% per annum and installment
payments, including principal and interest, are due monthly in the amount of $731. Each payment will be applied first to interest accrued
to the date of receipt of each payment, and the balance, if any, will be applied to principal. Installment payments have been deferred
by the SBA until January 2023. The balance of principal and interest is payable thirty years from the date of the promissory note. The
balance of the loan is $150,000, as of December 31, 2023 and 2022.
Maturities of notes payable are as follows for the years ended December
31,
| Schedule of maturities for long-term debt | |
| |
| 2024 | |
$ | 975,000 | |
| 2025 | |
| – | |
| 2026 | |
| – | |
| 2027 | |
| 1,420 | |
| 2028 | |
| 3,256 | |
| Thereafter | |
| 145,324 | |
| Total notes payable | |
$ | 1,125,000 | |
Derivative Liability Warrants -
At December 31, 2023 and 2022, there were (i)
7,500,000 public warrants (the “Public Warrants”) outstanding that were issued as part of Bull Horn’s November 2020
initial public offering, which warrants are exercisable in the aggregate to acquire 3,750,000 shares of our common stock at an exercise
price of $11.50 per share and (ii) 3,750,000 private warrants (the “Private Placement Warrants”) outstanding that were issued
to our sponsor Bull Horn Holdings Sponsor LC and the underwriters in Bull Horn’s initial public offering November 2020, which warrants
are exercisable in the aggregate to acquire 3,750,000 shares of our common stock at an exercise price of $11.50 per share. These warrants
became exercisable on the consummation of our Business Combination in October 2022. No Public Warrants will be exercisable for cash unless
the Company has an effective and current registration statement covering the ordinary shares issuable upon exercise of the Public Warrants
and a current prospectus relating to such ordinary shares. Notwithstanding the foregoing, if a registration statement covering the ordinary
shares issuable upon the exercise of the Public Warrants is not effective within 90 days from the consummation of a Business Combination,
the holders may, until such time as there is an effective registration statement and during any period when the Company shall have failed
to maintain an effective registration statement, exercise the Public Warrants on a cashless basis pursuant to an available exemption from
registration under the Securities Act. If an exemption from registration is not available, holders will not be able to exercise their
Public Warrants on a cashless basis. The Public Warrants will expire five years from the consummation of a Business Combination
or earlier upon redemption or liquidation.
The Company may call the Public Warrants for redemption,
in whole and not in part, at a price of $0.01 per warrant:
| |
· |
at any time while the Public Warrants are exercisable, |
| |
|
|
| |
· |
upon not less than 30 days’ prior written notice of redemption to each Public Warrant holder, |
| |
|
|
| |
· |
if, and only if, the reported last sale price of the ordinary shares equals or exceeds $16.50 per share, for any 20 trading days within a 30-trading day period ending on the third trading day prior to the notice of redemption to Public Warrant holders, and |
| |
|
|
| |
· |
if, and only if, there is a current registration statement in effect with respect to the ordinary shares underlying such warrants at the time of redemption and for the entire 30-day trading period referred to above and continuing each day thereafter until the date of redemption. |
If the Company calls the Public Warrants for redemption,
management will have the option to require all holders that wish to exercise the Public Warrants to do so on a “cashless basis,”
as described in the warrant agreement. The exercise price and number of ordinary shares issuable upon exercise of the warrants may be
adjusted in certain circumstances including in the event of a share dividend, extraordinary dividend or recapitalization, reorganization,
merger or consolidation. However, except as described above, the warrants will not be adjusted for issuances of ordinary shares at a price
below its exercise price. Additionally, in no event will the Company be required to net cash settle the warrants. If the Company is unable
to complete a Business Combination within the Combination Period and the Company liquidates the funds held in the Trust Account, holders
of warrants will not receive any of such funds with respect to their warrants, nor will they receive any distribution from the Company’s
assets held outside of the Trust Account with respect to such warrants. Accordingly, the warrants may expire worthless.
The Private Placement Warrants are identical to
the Public Warrants, except that the Private Placement Warrants only allow the holder thereof to one ordinary share. Additionally, the
Private Placement Warrants will be exercisable on a cashless basis and be non-redeemable so long as they are held by the initial purchasers
or their permitted transferees. If the Private Placement Warrants are held by someone other than the initial purchasers or their permitted
transferees, the Private Placement Warrants will be redeemable by the Company and exercisable by such holders on the same basis as the
Public Warrants.
Within ASC 815, Derivative and Hedging,
Section 815-40-15 addresses equity versus liability treatment and classification of equity-linked financial instruments, including warrants,
and states that a warrant may be classified as a component of equity only if, among other things, the warrant is indexed to the issuer’s
ordinary share. Under ASC Section 815-40-15, a warrant is not indexed to the issuer’s ordinary share if the terms of the warrant
require an adjustment to the exercise price upon a specified event and that event is not an input to the fair value of the warrant. Based
on management’s evaluation, the Company’s audit committee, in consultation with management, concluded that the Company’s
Private Placement Warrants and Public Warrants are not indexed to the Company’s ordinary share in the manner contemplated by ASC
Section 815-40-15 because the holder of the instrument is not an input into the pricing of a fixed-for-fixed option on equity shares.
In addition, based on management’s evaluation, the Company’s audit committee, in consultation with management, concluded
that certain warrant provisions preclude equity treatment as by ASC Section 815-10-15.
The Company accounts for its Public Warrants and
Private Placement Warrants as liabilities as set forth in ASC 815-40-15-7D and 7F. See below for details over the methodology and valuation
of the Warrants.
The Company follows the guidance in ASC Topic
820, Fair Value Measurement for its financial assets and liabilities that are re-measured and reported at fair value at each reporting
period, and non-financial assets and liabilities that are re-measured and reported at fair value at least annually.
The fair value of the Company’s financial
assets and liabilities reflects management’s estimate of amounts that the Company would have received in connection with the sale
of the assets or paid in connection with the transfer of the liabilities in an orderly transaction between market participants at the
measurement date. In connection with measuring the fair value of its assets and liabilities, the Company seeks to maximize the use of
observable inputs (market data obtained from independent sources) and to minimize the use of unobservable inputs (internal assumptions
about how market participants would price assets and liabilities). The following fair value hierarchy is used to classify assets and liabilities
based on the observable inputs and unobservable inputs used in order to value the assets and liabilities:
| |
Level 1: |
Quoted prices in active markets for identical assets or liabilities. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. |
| |
Level 2: |
Observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active. |
| |
Level 3: |
Unobservable inputs based on our assessment of the assumptions that market participants would use in pricing the asset or liability. |
The following table presents information about
the Company’s assets that are measured at fair value on a recurring basis at December 31, 2023 and 2022 and indicates the fair value
hierarchy of the valuation inputs the Company utilized to determine such fair value:
| Schedule of fair value hierarchy |
|
|
|
|
|
|
|
|
|
|
|
|
| Description |
|
Level |
|
|
December 31,
2023 |
|
|
December 31,
2022 |
|
| Warrant Liability – Public Warrants |
|
|
1 |
|
|
$ |
232,500 |
|
|
$ |
750,000 |
|
| Warrant Liability – Private Placement Warrants |
|
|
3 |
|
|
$ |
324,750 |
|
|
$ |
375,000 |
|
The Warrants are accounted for as liabilities
in accordance with ASC 815-40 and are presented within warrant liabilities on the accompanying consolidated balance sheets. The warrant
liabilities are measured at fair value at inception and on a recurring basis, with changes in fair value presented in the consolidated
statements of operations.
The Warrants were valued using a binomial lattice
model, which is considered to be a Level 3 fair value measurement. The binomial lattice model’s primary unobservable input utilized
in determining the fair value of the Warrants is the expected volatility of the ordinary shares. The expected volatility as of the Initial
Public Offering date was derived from observable public warrant pricing on comparable ‘blank-check’ companies without an identified
target. For periods subsequent to the detachment of the Public Warrants from the Units, the close price of the Public Warrant price will
be used as the fair value as of each relevant date.
The following table provides quantitative information
regarding Level 3 fair value measurements:
| Schedule of fair value assumptions | |
| | |
| |
| | |
December 31,
2023 | | |
December 31,
2022 | |
| Risk-free interest rate | |
| 3.84% | | |
| 3.97% | |
| Expected volatility | |
| 82.12% | | |
| 67.1% | |
| Exercise price | |
$ | 11.50 | | |
$ | 11.50 | |
| Stock Price | |
$ | 0.78 | | |
$ | 1.53 | |
The following table presents the changes in the
fair value of warrant liabilities:
| Schedule of changes in fair value of warrant liabilities | |
| | |
| | |
| |
| | |
Private Placement | | |
Public | | |
Warrant Liabilities | |
| Fair value as of December 31, 2022 | |
$ | 375,000 | | |
$ | 750,000 | | |
$ | 1,125,000 | |
| Change in valuation inputs | |
| 1,012,500 | | |
| 375,000 | | |
| 1,387,500 | |
| Fair value as of March 31, 2023 | |
| 1,387,500 | | |
| 1,125,000 | | |
| 2,512,500 | |
| Change in valuation inputs | |
| 75,000 | | |
| (600,000 | ) | |
| (525,000 | ) |
| Fair value as of June 30, 2023 | |
| 1,462,500 | | |
| 525,000 | | |
| 1,987,500 | |
| Change in valuation inputs | |
| (1,253,625 | ) | |
| (355,500 | ) | |
| (1,609,125 | ) |
| Fair value as of September 30, 2023 | |
| 208,875 | | |
| 169,500 | | |
| 378,375 | |
| Change in valuation inputs | |
| 115,875 | | |
| 63,000 | | |
| 178,875 | |
| Fair value as of December 31, 2023 | |
$ | 324,750 | | |
$ | 232,500 | | |
$ | 557,250 | |
There were no transfers in or out of Level 3 from
other levels in the fair value hierarchy during the years ended December 31, 2023 and 2022.
NOTE 5 – CAPITAL STRUCTURE
The total number of shares of stock which the
corporation shall have authority to issue is 160,000,000 shares, of which 150,000,000 shares of $0.0001 par value shall be designated
as common stock and 10,000,000 shares of $0.0001 shall be designated as preferred stock. The preferred stock authorized by the Company’s
Articles of Incorporation may be issued in one or more series. The Board of Directors of the Corporation is authorized to determine or
alter the rights, preferences, privileges, and restrictions granted or imposed upon any wholly unissued series of preferred stock, and
within the limitations or restrictions stated in any resolution or resolutions of the Board of Directors originally fixing the number
of shares constituting any series, to increase or decrease (but not below the number of shares of any such series then outstanding) the
number of shares of any such series subsequent to the issue of shares of that series, to determine the designation and par value of any
series and to fix the numbers of shares of any series.
Common Stock - As of December 31, 2023
the Company had 35,331,036 shares of its common stock issued and outstanding, and on December 31, 2022 the Company had 19,566,839 shares
of its common stock issued.
In 2023 and 2022, the Company raised capital
by issuance of common stock above the stated par value. The contributed capital recognized as additional paid in capital during the
years ended December 31, 2023 and 2022 was $499,950
and $3,271,445,
respectively. During the years ended December 31, 2023 and 2022, there were no
capital distributions.
On June 16, 2023, the Company completed a
public offering issuing 2,150,000 shares of our
common stock, 1,350,000 pre-funded
warrants, 3,062,500 Series
A Warrants and 3,062,500 Series
B Warrants, for net proceeds of approximately $3.0 million,
after offering costs. The pre-funded warrants are immediately exercisable, at a price of $0.0001 per
share, with no expiration date. As of December 31, 2023, all of the pre-funded warrants had been exercised for a total of 3,500,000 shares
of common stock issued as a result of the public offering. The Series A Warrants and the Series B Warrants are referred to herein
together as the “Series Warrants.” The shares of common stock and Series Warrants were purchased together and then
immediately separable and were issued separately. Each Series Warrant to purchase one share of common stock has an exercise price of
$1.65
per share, and is initially exercisable commencing six months from the date of the offering. The Series Warrants are exercisable for
a term of five years following the initial exercise date.
On October 26, 2023, the Company completed a private
placement of 777,000 shares of our common stock, pre-funded warrants exercisable to acquire up to 1,223,000 shares of our common stock,
Series A Warrants exercisable to acquire up to 2,000,000 shares of our common stock and Series B Warrants exercisable to acquire up to
2,000,000 shares of our common stock, for net proceeds of approximately $1.8 million, after offering costs. The pre-funded warrants are
immediately exercisable, at a price of $0.001 per share, with no expiration date. The Series A Warrants and the Series B Warrants are
referred to herein together as the “Series Warrants.” The shares of common stock and Series Warrants were purchased together
and then immediately separable and were issued separately. The Series A Warrants and Series B Warrants are exercisable on or after the
earlier of (i) the date on which the Company’s stockholders approve the issuance of the shares issuable upon exercise of the Series
Warrants or (ii) April 26, 2024 at an exercise price of $1.36 per share. The Series A Warrants have a term of exercise equal to eighteen
(18) months and the Series B Warrants have a term of exercise equal to five and one-half (5.5) years. This private placement was conducted
with the same underwriter as the June public offering, and as a result, each Series Warrant issued in connection with the June offering
was repriced from an exercise price of $1.65 per share to $1.36 per share. In connection with the private placement the Company also issued
to the exclusive placement agent warrants exercisable to acquire up to 120,000 shares of our common stock at an exercise price of $1.40
per share, warrant holders 22, 23, and 24.
On December 28, 2023, the Company granted pre-funded
warrants exercisable to acquire up to 1,200,000 shares of our common stock for net proceeds of $1,200,000. The pre-funded common stock
purchase warrants can only be exercised on or after January 31, 2024 at a price of $0.0001 per share, with no expiration date. The aggregate
exercise price of this Warrant was partially pre-funded in connection with $200,000 and a $1,000,000 note receivable at a 6% per annum
interest rate due on November 29, 2024.
Treasury Stock – As part of the Merger
in February of 2021, Coeptis Therapeutics, Inc., our wholly-owned subsidiary, repurchased 110,762 shares of its common stock previously
held by shareholders of Vinings Holdings Inc. (the former name of Coeptis Therapeutics, Inc.). The stock was recorded at the cost paid
for it, of $247,165 and held as treasury stock for the duration of 2021. Subsequent to year end, the Company retired the 110,762 shares
of treasury stock, as of February 18, 2022. There was no treasury stock at December 31, 2023 and 2022.
Preferred Stock – As of December 31, 2023
and 2022 the Company had no shares of preferred stock issued and outstanding. As of December 31, 2021, Coeptis Therapeutics, Inc, our
wholly-owned subsidiary, had 8,000 shares of its Series B Preferred Stock issued and outstanding. The Series B Preferred Stock was converted
into common equity immediately prior to the consummation of the Business Combination, and the shares of common stock received in such
conversion were exchanged for shares of common stock in the Company at the closing of the Business Combination.
Stock Based Compensation –
Stock Based Compensation
A summary of the Company’s stock option activity is as follows:
| Schedule of stock option activity | |
| | |
| | |
| | |
| |
| | |
Shares Underlying Options | | |
Weighted Average Exercise Price | | |
Weighted Average Contractual Life (Years) | | |
Intrinsic Value | |
| Outstanding at December 31, 2022 | |
| – | | |
| – | | |
| | | |
| | |
| Granted | |
| 1,757,500 | | |
$ | 2.01 | | |
| 8.78 | | |
$ | – | |
| Forfeited | |
| – | | |
| – | | |
| | | |
| | |
| Exercised | |
| – | | |
| – | | |
| | | |
| | |
| Outstanding at December 31, 2023 | |
| 1,757,500 | | |
$ | 2.01 | | |
| 7.97 | | |
$ | – | |
For the year ended December 31, 2023 and 2022, the
Company recorded $477,503 and $0, respectively, for stock-based compensation expense related to stock options. As of December 31, 2023,
unamortized stock-based compensation for stock options was $1,223,502 to be recognized through December 31, 2027.
The options granted during the year ended December
31, 2023 were valued using the Black-Scholes option pricing model using the following weighted average assumptions:
| Schedule of options assumptions | |
| |
| | |
For the year ended December 31, 2023 | |
| Expected term, in years | |
| 5.53 | |
| Expected volatility | |
| 79.87% | |
| Risk-free interest rate | |
| 3.85% | |
| Dividend yield | |
| – | |
Common Stock Warrants –
As a result of the Merger on October 28, 2022,
all surviving warrants from Coeptis Therapeutics, Inc. were converted using a 2.9685:1 ratio, and became exercisable to acquire shares
of the Company’s common stock.
On November 23, 2020, Coeptis Therapeutics, Inc.
(under its prior name Vinings Holdings Inc.) issued a class A and a class B warrant to Coral Investment Partners, LP (“CIP”),
with each warrant granting CIP the right to purchase 500,000
shares of common stock at a price of $2 for
Class A or $5
for Class B. The warrants expired on November
30, 2023.
Warrant Holder 1 – On May
28, 2021, Coeptis Therapeutics, Inc. issued a warrant to a third party in exchange for professional services, granting the warrant
holder the right to purchase 500,000
shares of common stock at a price of $1 per
share, 500,000
shares at $2 per
share, and 500,000
shares at $5 per
share. The warrants expire on June
1, 2026. As part of the call, 2,500
warrants at $1 per share were exercised on July 28, 2022. As of December 31, 2023, the remaining warrants outstanding are
exercisable to acquire 504,460
shares of the Company’s common stock on an as converted basis resulting from the consummation of the Business Combination in
October 2022.
Warrant Holder 2 – On July
30, 2021, Coeptis Therapeutics, Inc. issued a warrant to a third party in exchange for professional services, granting the warrant
holder the right to purchase 200,000
shares of common stock at a price of $1 per
share, 100,000
shares at $2 per
share, and 100,000
shares at $5 per
share. The warrants expire on July
26, 2026. As part of the call, 5,000
warrants at $1 per share were exercised on March 1, 2022, and 195,000
warrants at $1 per share and 75,000
warrants at $2 per share were exercised on June 27, 2022. 25,000
warrants at $2 per share expired on September 13, 2022 as a result of the call. As of December 31, 2023, the remaining warrants
outstanding are exercisable to acquire 33,687
shares of the Company’s common stock on an as converted basis resulting from the consummation of the Business Combination in
October 2022.
On September 22, 2021, Coeptis Therapeutics,
Inc. issued a warrant in conjunction with the termination of the license right (see Note 3) with Purple, granting Purple the right
to purchase 300,000 shares
of common stock at $5 per
share, subject to certain adjustments. During 2021, the Company recorded $1,897,585 as
general and administrative expense in condensed consolidated statement of operations upon immediate vesting of the Warrant. The
warrant was valued using the Black-Scholes option pricing model using the following assumptions: 1) exercise price of $5.00 per
share, 2) fair value of $6.50 per share, 3) discount rate of 0.48%, 3) dividend rate of 0%, and 4) a term of 3 years. As of December
31, 2023, all warrants remain outstanding and are exercisable to acquire 101,061 shares
of the Company’s common stock on an as converted basis resulting from the consummation of the Business Combination in October
2022.
Warrant
Holder 3 – On December 20, 2021, Coeptis Therapeutics, Inc. issued a warrant to a third party in exchange for
services to be provided, granting the warrant holder the right to purchase 600,000
shares of common stock at a price of $1 per
share. The warrants expire on December
20, 2026. As part of the call, 300,000
of the warrants were transferred to Warrant Holder 4, and 175,000 of
the warrants were transferred to Warrant Holder 5. The remaining 115,000
warrants at $1 per share were exercised on August 19, 2022, and 10,000
warrants at $1 per share expired on September 13, 2022 as a result of the call. As of December 31, 2023, none
of these warrants were outstanding.
Warrant Holder 4 – On July
13, 2022, Warrant Holder 3 transferred 300,000
warrants to Warrant Holder 4 with the same terms. As part of a call, 300,000
warrants at $1 per share were exercised on August 19, 2022. As of December 31, 2023, none
of these warrants were outstanding.
Warrant Holder 5 – On
September 6, 2022, Warrant Holder 3 transferred 175,000
warrants to Warrant Holder 5 with the same terms, and Warrant Holder 9 transferred 200,000
to Warrant Holder 5 with the same terms. December 31, 2023, all warrants remain outstanding and are exercisable to acquire 126,326
shares of the Company’s common stock on an as converted basis resulting from the consummation of the Business Combination in
October 2022.
Warrant Holder 6 – On
January 28, 2022, Coeptis Therapeutics, Inc. issued a warrant to a third party in exchange for contemplation of a debt extension,
granting the warrant holder the right to purchase 250,000
shares of common stock at a price of $1.50 per
share. The warrants expire on January
31, 2024. The warrants were expensed immediately as a loss on extinguishment of debt. Subsequently, on April 14, 2022, an
agreement was executed with the debt holder extending the maturity of the debt to July 31, 2022 in recognition of the warrants
issued on January 28, 2022. This amendment was treated as a debt modification. As of December 31, 2023, all warrants remain
outstanding and are exercisable to acquire 84,217
shares of the Company’s common stock on an as converted basis resulting from the consummation of the Business Combination in
October 2022
Warrant Holder 7 – On
January 28, 2022, Coeptis Therapeutics, Inc. issued a warrant to a third party in exchange for contemplation of a debt extension,
granting the warrant holder the right to purchase 400,000
shares of common stock at a price of $1.50 per
share. The warrants expire on January
31, 2024. The warrants expire on January 31, 2024. The warrants were expensed immediately as a loss on extinguishment of
debt. Subsequently, on April 14, 2022, an agreement was executed with the debt holder extending the maturity of the debt to July 31,
2022 in recognition of the warrants issued on January 28, 2022. This amendment was treated as a debt modification. As of December
31, 2023, all warrants remain outstanding and are exercisable to acquire 134,747 shares
of the Company’s common stock on an as converted basis resulting from the consummation of the Business Combination in October
2022.
Warrant Holder 8 – On January
28, 2022, Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the warrant holder
the right to purchase 775,000 shares of common stock at a price of $1.50 per share. The warrants expire on January
31, 2024. As part of the call, 775,000 warrants at $1.50 per share were exercised on September 14, 2022. As of December 31,
2023, none of these warrants were outstanding.
Warrant Holder 9 – On
January 28, 2022, Coeptis Therapeutics, Inc. issued a warrant to a third party in exchange for professional services, granting the
warrant holder the right to purchase 200,000
shares of common stock at a price of $1.50
per share. The warrants expire on January
31, 2024. As part of the call, all 200,000
warrants at $1.50 per share were transferred to Warrant Holder 5. As of December 31, 2023, none of these
warrants were outstanding.
Warrant Holder 10 – On
January 28, 2022, Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the
warrant holder the right to purchase 350,000
shares of common stock at a price of $1.50
per share. The warrants expire on January
31, 2024. As part of the call, 53,334
warrants at $1.50 per share were exercised on March 1, 2022, 50,000
warrants at $1.50 per share were exercised on August 19, 2022 and 246,666
warrants at $1.50 per share were exercised on September 14, 2022. As of December 31, 2023, none of these
warrants were outstanding.
Warrant Holder 11 – On
January 28, 2022, Coeptis Therapeutics, Inc. issued a warrant to a third party in exchange for professional services, granting the
warrant holder the right to purchase 150,000 shares
of common stock at a price of $1 per
share and 150,000
shares at $2 per
share. The warrants expire on January
31, 2024. On April 14, 2022, the Company issued an additional warrant in exchange for professional services, granting the
warrant holder the right to purchase an additional 170,000
shares of common stock at a price of $1.50
per share. The warrants expire on January
31, 2024. As of December 31, 2023, all warrants remain outstanding and are exercisable to acquire 158,328
shares of the Company’s common stock on an as converted basis resulting from the consummation of the Business Combination in
October 2022.
Warrant Holder 12 – On
January 28, 2022, Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the
warrant holder the right to purchase 1,018,050 shares
of common stock at a price of $1.50 per
share. The warrants expire on January
31, 2024. As part of the call, 100,000
warrants at $1.50 per share were exercised on August 19, 2022, and 918,050
warrants at $1.50 per share were exercised on September 14, 2022. As of December 31, 2023, none of these
warrants were outstanding.
Warrant Holder 13 – On
January 28, 2022, Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the
warrant holder the right to purchase 225,000 shares
of common stock at a price of $1.50 per
share. The warrants expire on January
31, 2024. As part of the call, 15,000
warrants at $1.50 per share were exercised on March 1, 2022, and 210,000
warrants at $1.50 per share were exercised on September 14, 2022. As of December 31, 2023, none of these
warrants were outstanding.
Warrant Holder 14 – On
January 28, 2022, Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the
warrant holder the right to purchase 100,000
shares of common stock at a price of $1 per
share. The warrants expire on January
31, 2024. As part of the call, 100,000
warrants at $1 per share were exercised on August 19, 2022. As of December 31, 2023, none
of these warrants were outstanding.
Warrant Holder 15 – On
January 28, 2022, Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the
warrant holder the right to purchase 100,000
shares of common stock at a price of $1.50 per
share. The warrants expire on January
31, 2024. As part of the call, 100,000
warrants at $1.50 per share were exercised on September 14, 2022. As of December 31, 2023, none of these
warrants were outstanding.
Warrant Holder 16 – On
January 28, 2022, Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the
warrant holder the right to purchase 100,000
shares of common stock at a price of $1.50 per
share. The warrants expire on January
31, 2024. As part of the call, 25,000
warrants at $1.50 per share were exercised on June 27, 2022, and 75,000
warrants at $1.50 per share were exercised on September 14, 2022. As of December 31, 2023, none of these
warrants were outstanding.
Warrant Holder 17 – On
January 28, 2022, Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the
warrant holder the right to purchase 52,050
shares of common stock at a price of $1.50 per
share. The warrants expire on January
31, 2024. As part of the call, 52,050
warrants at $1.50 per share were exercised on September 14, 2022. As of December 31, 2023, none of these warrants
were outstanding.
Warrant Holder 18 – On
March 30, 2022, Coeptis Therapeutics, Inc., issued a warrant to a third party in conjunction with an investment, granting the
warrant holder the right to purchase 250,000
shares of common stock at a price of $3 per
share. The warrants expire on March
30, 2024. As of December 31, 2023, all warrants remain outstanding and are exercisable to acquire 84,217
shares of the Company’s common stock on an as converted basis resulting from the consummation of the Business Combination in
October 2022.
Warrant Holder 19 – On
March 30, 2022, Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the
warrant holder the right to purchase 300,000 shares
of common stock at a price of $1.50 per
share. The warrants expire on April
1, 2027. As part of the call, 300,000
warrants at $1.50 per share were exercised on September 14, 2022. As of December 31, 2023, none of these
warrants were outstanding.
Warrant Holder 20 – On
January 3, 2023, Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the
warrant holder the right to purchase 100,000
shares of common stock at a price of $2.50 per
share. The warrants expire on January
2, 2027. As of December 31, 2023, all warrants remain outstanding.
Warrant Holder 21 – On January
3, 2023, Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the warrant holder
the right to purchase 250,000 shares of common stock at a price of $1.90 per share. The warrants expire on January
19, 2027. As of December 31, 2023, all warrants remain outstanding.
Warrant Holder 22 – On
June 16, 2023, Coeptis Therapeutics, Inc., issued a warrant to a third party in conjunction with an investment, granting the warrant
holder the right to purchase 126,000 shares
of common stock at a price of $1.25 per
share. The warrants expire on December
16, 2028. On October 23, 2023, the Company issued an additional warrant in conjunction with an investment, granting the
warrant holder the right to purchase an additional 66,000
shares of common stock at a price of $1.40 per
share. The warrants expire on April
26, 2029. As of December 31, 2023, all warrants remain outstanding.
Warrant Holder 23 – On
June 16, 2023, Coeptis Therapeutics, Inc., issued a warrant to a third party in conjunction with an investment, granting the warrant
holder the right to purchase 84,000
shares of common stock at a price of $1.25 per
share. The warrants expire on December
16, 2028. On October 23, 2023, the Company issued an additional warrant in conjunction with an investment, granting the
warrant holder the right to purchase an additional 48,000
shares of common stock at a price of $1.40 per
share. The warrants expire on April
26, 2029. As of December 31, 2023, all warrants remain outstanding.
Warrant
Holder 24 – On October 23, 2023, Coeptis Therapeutics, Inc., issued a warrant to a third party in conjunction with an
investment, granting the warrant holder the right to purchase 6,000
shares of common stock at a price of $1.40
per share. The warrants expire on April
26, 2029. As of December 31, 2023, all warrants remain outstanding.
On April 19, 2022, Coeptis Therapeutics, Inc.
initiated a warrant conversion call for certain warrants and on April 20, 2022, for additional warrants. The original expiration for
the warrant conversions was set as May 19, 2022, and May 20, 2022. The expiration date was extended and moved to June 30, 2022. A second
extension moved the expiration to July 15, 2022, and the third extension moved the expiration date for the warrant conversions to August
1, 2022. The final extension was extended and moved to September 13, 2022. Warrants that were part of the call and not exercised by this
date have expired.
The warrants listed above and issued since May
28, 2021 and as of December 31, 2023 were valued using the Black-Scholes option pricing model using the following assumptions: 1) exercise
price ranging from $1.40 to $14.84 per share, 2) fair value ranging from $1.36 to $6.00 per share, 3) discount rate ranging from 1.15%
to 4.81%, 3) dividend rate of 0%, and 4) a term ranging from 2 to 5 years. The warrants listed below were not valued using the Black-Scholes
option pricing model.
As above, on June 16, 2023, the Company completed
a public offering issuing 1,350,000 pre-funded warrants, 3,062,500 Series A Warrants and 3,062,500 Series B Warrants. The Pre-funded warrants
are immediately exercisable, at a price of $0.0001 per share, with no expiration date. As of December 31, 2023, all of the of the pre-funded
warrants had been exercised for a total of 3,500,000 shares of common stock issued as a result of the public offering. The Series A Warrants
and the Series B Warrants are referred to herein together as the “Series Warrants.” The shares of common stock and Series
Warrants were purchased together and then immediately separable and were issued separately. Each Series Warrant to purchase one share
of common stock has an exercise price of $1.65 per share, and is initially exercisable commencing 6 months from the date of the offering.
The Series Warrants are exercisable for a term of five years following the initial exercise date.
As above, on October 26, 2023, the Company completed
a private placement of pre-funded warrants exercisable to acquire up to 1,223,000 shares of our common stock, Series A Warrants exercisable
to acquire up to 2,000,000 shares of our common stock and Series B Warrants exercisable to acquire up to 2,000,000 shares of our common
stock. The Pre-funded warrants are immediately exercisable, at a price of $0.001 per share, with no expiration date. The Series A Warrants
and the Series B Warrants are referred to herein together as the “Series Warrants.” The shares of common stock and Series
Warrants were purchased together and then immediately separable and were issued separately. The Series A Warrants and Series B Warrants
are exercisable on or after the earlier of (i) the date on which the Company’s stockholders approve the issuance of the shares issuable
upon exercise of the Series Warrants or (ii) April 26, 2024 at an exercise price of $1.36 per share. The Series A Warrants have a term
of exercise equal to eighteen (18) months and the Series B Warrants have a term of exercise equal to 5 and one-half (5.5) years. This
private placement was conducted with the same underwriter as the June public offering, and as a result, each Series Warrant issued in
connection with the June offering was repriced from an exercise price of $1.65 per share to $1.36 per share. In connection with the private
placement the Company also issued to the exclusive placement agent warrants exercisable to acquire up to 120,000 shares of our common
stock at an exercise price of $1.40 per share.
As above, on December 28, 2023, the Company granted
pre-funded warrants exercisable to acquire up to 1,200,000 shares of our common stock for net proceeds of $1,200,000. The pre-funded common
stock purchase warrants can only be exercised on or after January 31, 2024 at a price of $0.0001 per share, with no expiration date. The
aggregate exercise price of this Warrant was partially pre-funded in connection with $200,000 and a $1,000,000 note receivable at a 6%
per annum interest rate due on November 29, 2024.
All warrants outstanding, regardless of valuation
method are listed below:
| Schedule of warrants outstanding | |
| |
| |
| |
| | | |
| | |
| | |
| |
| |
| |
Outstanding at | |
| Reference | |
Date Issued | |
Exercise price | |
Expiration | |
December 31, 2023 | | |
December 31, 2022 | |
| Coral Investment Partners | |
11/23/2020 | |
$5.94 | |
11/23/2023 | |
| – | | |
| 168,434 | |
| Coral Investment Partners | |
11/23/2020 | |
$14.84 | |
11/23/2023 | |
| – | | |
| 168,435 | |
| Warrant Holder 1 | |
5/28/2021 | |
$2.97 | |
5/13/2026 | |
| 167,593 | | |
| 167,592 | |
| Warrant Holder 1 | |
5/28/2021 | |
$5.94 | |
5/13/2026 | |
| 168,434 | | |
| 168,434 | |
| Warrant Holder 1 | |
5/28/2021 | |
$14.84 | |
5/13/2026 | |
| 168,434 | | |
| 168,434 | |
| Warrant Holder 2 | |
7/30/2021 | |
$2.97 | |
7/30/2026 | |
| 8,422 | | |
| 8,422 | |
| Warrant Holder 2 | |
7/30/2021 | |
$14.84 | |
6/1/2026 | |
| 25,265 | | |
| 25,265 | |
| Kitov/Purple Biotech | |
9/23/2021 | |
$14.84 | |
9/21/2024 | |
| 101,061 | | |
| 101,061 | |
| Warrant Holder 5 | |
12/20/2021 | |
$2.97 | |
12/20/2026 | |
| 58,952 | | |
| 58,952 | |
| Warrant Holder 5 | |
1/28/2022 | |
$4.45 | |
1/31/2024 | |
| 67,374 | | |
| 67,374 | |
| Warrant Holder 6 | |
1/28/2022 | |
$4.45 | |
1/31/2024 | |
| 84,217 | | |
| 84,217 | |
| Warrant Holder 7 | |
1/28/2022 | |
$4.45 | |
1/31/2024 | |
| 134,747 | | |
| 134,747 | |
| Warrant Holder 11 | |
1/28/2022 | |
$2.97 | |
1/31/2024 | |
| 50,530 | | |
| 50,530 | |
| Warrant Holder 11 | |
1/28/2022 | |
$5.94 | |
1/31/2024 | |
| 50,530 | | |
| 50,530 | |
| Warrant Holder 11 | |
4/14/2022 | |
$4.45 | |
1/31/2024 | |
| 57,268 | | |
| 57,268 | |
| Warrant Holder 18 | |
3/30/2022 | |
$8.91 | |
3/30/2024 | |
| 84,217 | | |
| 84,217 | |
| Warrant Holder 20 | |
1/3/2023 | |
$2.50 | |
1/2/2027 | |
| 100,000 | | |
| – | |
| Warrant Holder 21 | |
1/20/2023 | |
$1.90 | |
1/19/2027 | |
| 250,000 | | |
| – | |
| Pre-Funded Warrants 1 | |
6/16/2023 | |
$0.0001 | |
– * | |
| – | | |
| – | |
| Series Warrants A & B | |
6/16/2023 | |
$1.36 | |
12/16/2028 | |
| 6,125,000 | | |
| – | |
| Series Warrants A | |
10/23/2023 | |
$1.36 | |
4/26/2025 | |
| 2,000,000 | | |
| – | |
| Series Warrants B | |
10/23/2023 | |
$1.36 | |
4/26/2029 | |
| 2,000,000 | | |
| – | |
| Warrant Holder 22 | |
6/16/2023 | |
$1.25 | |
12/16/2028 | |
| 126,000 | | |
| – | |
| Warrant Holder 22 | |
10/23/2023 | |
$1.40 | |
4/26/2029 | |
| 66,000 | | |
| – | |
| Warrant Holder 23 | |
6/16/2023 | |
$1.25 | |
12/16/2028 | |
| 84,000 | | |
| – | |
| Warrant Holder 23 | |
10/23/2023 | |
$1.40 | |
4/26/2029 | |
| 48,000 | | |
| – | |
| Warrant Holder 24 | |
10/23/2023 | |
$1.40 | |
4/26/2029 | |
| 6,000 | | |
| – | |
| Pre-Funded Warrants 2 | |
12/28/2023 | |
$0.0000 | |
– * | |
| 1,200,000 | | |
| – | |
| | |
Total Warrants outstanding | |
| |
| 13,232,043 | | |
| 1,563,911 | |
| | |
| |
| |
| |
| | | |
| | |
| | |
*Pre-funded warrants, do not expire. | |
| | | |
| | |
Options/Stock Awards – On
January 27, 2023, the Company granted options to purchase an aggregate of 1,357,500 shares of our common stock under the 2022 Equity
Incentive Plan, to various officers, directors, employees and consultants, at an average exercise price of $1.63 per share. The
Company had also granted a stand-alone option to a former employee to purchase up to 100,000 shares of our common stock at an
exercise price of $10 per share, however, the stand-alone option expired by its terms on January 31,
2024. On October 2, 2023, the Company granted additional options to purchase an aggregate of 300,000
shares of our common stock to two employees at an average price of $1.07.
Subscription receivable - In September
2023, the Company agreed to issue 500,000 shares of common stock to the borrower for a principal sum amount of $500,000. The outstanding
balance of the receivable is $500,000 in subscription receivable at December 31, 2023. See Note 10 for further detail.
In September 2023, the Company agreed to issue
2,000,000 shares of common stock to the borrower for a principal sum amount of $2,000,000. The outstanding balance of the receivable is
$2,000,000 in subscription receivable at December 31, 2023.
In December 2023, the Company agreed to grant pre-funded warrants exercisable
to acquire up to 1,200,000 shares of common stock to the borrower for a principal sum amount of $1,000,000. The outstanding balance of
the receivable is $1,000,000 in subscription receivable at December 31, 2023.
NOTE 6 – COMMITMENTS AND CONTINGENCIES
Leases - The Company leases office space under
an operating lease commencing December 1, 2017 through November 30, 2019 and a first lease extension commending December 1, 2019 through
May 31, 2020. The second lease extension extends the lease for twenty-four months, beginning on June 1, 2020 and ending on May 31, 2022.
The third lease extension extends the lease for twenty-four months, beginning on June 1, 2022 and ending on May 31, 2024. The fourth lease
extension, signed on January 30, 2024, extends the lease for twenty-four months, beginning on June 1, 2024 and ending on May 31, 2026.
The monthly rent is $3,750 and increasing to $3,805 for the first year of the extension and $3,860 for the second year of the extension.
On January 1, 2019, the Company adopted ASC Topic
842, Leases, requiring this lease to be recorded as an asset and corresponding liability on its consolidated balance sheet. The
Company records rent expense associated with this lease on the straight-line basis in conjunction with the terms of the underlying lease.
During both the years ended December 31, 2023 and 2022, rents paid totaled $45,000.
Future minimum rental payments required under
the lease are as follows:
| Schedule of future minimum rental payments | |
| |
| 2024 | |
$ | 45,385 | |
| 2025 | |
| 46,046 | |
| 2026 | |
| 23,161 | |
| Total minimum lease payments: | |
| 114,592 | |
| Less amount representing interest | |
| (15,366 | ) |
| Present value of minimum lease payments: | |
$ | 99,226 | |
As of December 31, 2023, the Company had recorded
a right of use asset of $97,571 and current and non-current lease liabilities of $38,047 and $61,179 respectively.
Legal Matters – The Company is currently
not a defendant in any litigation or threatened litigation that could have a material effect on the Company’s consolidated financial
statements.
University of
Pittsburgh Option Agreement – On April 29, 2022, the Company entered into an exclusive option agreement with University
of Pittsburgh for rights to three chimeric antigen receptor T-cell (“CAR T”) technologies that offer the potential to address
a range of hematologic and solid tumors. Among the initial cancer indications under development are pre-clinical programs targeting breast
cancer and ovarian cancer. The exclusive option agreement involves the intellectual property rights to three technologies jointly developed
in the laboratories of Jason Lohmueller, Ph.D., Assistant Professor of Immunology; Alexander Deiters, Ph.D., Professor of Chemistry; and
Olivera Finn, Ph.D., Professor of Immunology: 1) mSA2 affinity-enhanced biotin-binding CAR, 2) universal self-labeling SynNotch and CARs
for programable antigen-targeting, and 3) conditional control of universal CAR T-cells through stimulus-reactive adaptors. Per the option
agreement, the Company paid the University of Pittsburgh a non-refundable fee of $5,000 for the exclusive option to license the patent
rights to each of the three technologies. On October 16, 2023, the Company terminated the remaining portion of the option agreement with
the University of Pittsburgh.
CAR T License – On August
31, 2022, the Company entered into an exclusive license agreement with the University of Pittsburgh for certain intellectual
property rights related to the universal self-labeling SynNotch and CARs for programable antigen-targeting technology platform. The
Company paid the University of Pittsburgh a non-refundable fee in the amount of $75,000 for the exclusive patent rights to the
licensed technology. Under the terms of the agreement, the Company has been assigned the worldwide development and commercialization
rights to the licensed technology in the field of human treatment of cancer with antibody or antibody fragments using SNAP-CAR
T-cell technology, along with (i) an intellectual property portfolio consisting of issued and pending patents and (ii) options
regarding future add-on technologies and developments. In consideration of these rights, the Company paid an initial license fee of
$75,000,
and will have annual
maintenance fees ranging between $15,000 and $25,000, as well as developmental milestone payments (as defined in the
agreement) and royalties equal to 3.5% of net sales. On January 25, 2023, the Company entered into a corporate research agreement
with the University of Pittsburgh for the pre-clinical development of SNAP-CAR T-cells targeting HER2. The Company agreed to pay
$716,714
for performance-based milestones over a two-year term, and no payments have been made as of December 31, 2023.
In September 2023, the Company expanded its exclusive
license agreement with the University of Pittsburgh to include the SNAP-CAR technology platform in natural killer (NK) cells. The Company
agreed to pay $2,000 to amend the agreement.
Deverra Therapeutics, Inc. –
On August 16, 2023, the Company entered into an exclusive licensing arrangement (the “License Agreement”) with Deverra Therapeutics
Inc. (“Deverra”), pursuant to which the Company completed the exclusive license of key patent families and related intellectual
property related to a proprietary allogeneic stem cell expansion and directed differentiation platform for the generation of multiple
distinct immune effector cell types, including natural killer (NK) and monocyte/macrophages. The License Agreement provides the Company
with exclusive rights to use the license patents and related intellectual property in connection with development and commercialization
efforts in the defined field of use (the “Field”) of (a) use of unmodified NK cells as anti-viral therapeutic for viral infections,
and/or as a therapeutic approach for treatment of relapsed/refractory AML and high-risk MDS; (b) use of Deverra’s cell therapy platform
to generate NK cells for the purpose of engineering with Coeptis SNAP-CARs and/or Coeptis GEAR Technology; and (c) use of Deverra’s
cell therapy platform to generate myeloid cells for the purpose of engineering with the Company’s current SNAP-CAR and GEAR technologies.
In support of the exclusive license, the Company also entered into with Deverra (i) an asset purchase agreement (the “APA”)
pursuant to which the Company purchased certain assets from Deverra, including but not limited to two Investigational New Drug (IND) applications
and two Phase 1 clinical trial stage programs (NCT04901416, NCT04900454) investigating infusion of DVX201, an unmodified natural killer
(NK) cell therapy generated from pooled donor CD34+ cells, in hematologic malignancies and viral infections and (ii) a non-exclusive sublicense
agreement (the “Sublicense Agreement”), in support of the assets obtained by the exclusive license, pursuant to which the
Company sublicensed from Deverra certain assets which Deverra has rights to pursuant a license agreement (“FHCRC Agreement”)
by and between Deverra and The Fred Hutchinson Cancer Research Center (“FHCRC”).
As consideration for the transactions
described above, the Company paid Deverra approximately $570,000 in
cash, issued to Deverra 4,000,000 shares
of the Company’s common stock and assumed certain liabilities related to the ongoing clinical trials. Total consideration paid
was $4,937,609, which was fully expensed in accordance with ASC 730, and is reflected within research and development in the
accompanying consolidated statement of operations for the year ended December 31, 2023. In
addition, in accordance with the terms of the Sublicense Agreement, the Company agreed to pay FHCRC certain specified contingent
running royalty payments and milestone payments under the FHCRC Agreement, in each case to the extent such payments are triggered by
the Company’s development activities.
On October 26, 2023, the Company entered into
a Shared Services Agreement (“SSA”) with Deverra, in accordance with requirements set forth in the APA. Under the terms of
the SSA, Coeptis and Deverra will share resources and collaborate to further the development of Coeptis’ GEAR and SNAP-CAR platforms,
as well as the purchased and licensed assets under the License Agreement and APA. The term of the SSA is six months from the effective
date.
Registration Rights
Pursuant to a registration rights agreement entered
into on October 29, 2020, the holders of the founder shares, the Private Placement Warrants and underlying securities, and any securities
issued upon conversion of Working Capital Loans (and underlying securities) would be entitled to registration rights pursuant to a registration
rights agreement. The holders of at least a majority in interest of the then-outstanding number of these securities were entitled to make
up to three demands, excluding short form demands, that the Company register such securities. In addition, the holders have certain “piggy-back”
registration rights with respect to registration statements filed subsequent to the consummation of a Business Combination. Notwithstanding
the foregoing, Imperial, I-Bankers and Northland did not exercise their demand and “piggyback” registration rights after five
(5) and seven (7) years after the effective date of the registration statement and did not exercise its demand rights on more than one
occasion. The registration rights agreement did not contain liquidating damages or other cash settlement provisions resulting from delays
in registering the Company’s securities. The Company would bear the expenses incurred in connection with the filing of any such
registration statements.
NOTE 7 – 401(k) PROFIT-SHARING PLAN
The Company sponsors a qualified profit-sharing
plan with a 401(k) feature that covers all eligible employees. Participation in the 401(k) feature of the plan is voluntary. Participating
employees may defer up to 100% of their compensation up to the maximum prescribed by the Internal Revenue Code. The plan permits for employee
elective deferrals but has no contribution requirements for the Company. During the years ended December 31, 2023 and 2022, no employer
contributions were made.
NOTE 8 – INCOME TAXES
The Company has established deferred tax assets and
liabilities for the recognition of future deductions or taxable amounts and operating loss carry forward. Deferred tax assets and liabilities
for the recognition of future deductions or taxable amounts and operating loss carry forwards. Deferred federal and state income tax expense
or benefit is recognized as a result of the change in the deferred tax asset or liability during the year using the currently enacted
tax laws and rates that apply to the period in which they are expected to affect taxable income. Valuation allowances are established,
if necessary, to reduce deferred tax assets to the amount that will more likely than not be realized.
During the years ended December 31, 2023 and 2022,
a reconciliation of income tax benefit at the statutory rate of 30.0% and 30.8%, respectively, to income tax benefit at the Company’s
effective tax rate is as follows:
| Schedule of effective income tax reconciliation | |
| | |
| |
| | |
2023 | | |
2022 | |
| Income tax benefit at statutory rate | |
$ | 4,357,970 | | |
$ | 11,648,000 | |
| Change in valuation allowance | |
| (4,357,970 | ) | |
| (11,648,000 | ) |
| | |
| | | |
| | |
| Provision for federal/state income taxes | |
$ | – | | |
$ | – | |
The income tax provision differs from the expense
that would result from applying federal statutory rates to income before income taxes as follows:
| Schedule of income tax provision | |
| | | |
| | | |
| | | |
| | |
| | |
2023 | | |
2022 | |
| Expected federal statutory income tax provision/rate | |
$ | (2,965,619 | ) | |
$ | (21.0% | ) | |
$ | (7,906,850 | ) | |
| (21.0% | ) |
| State income taxes, net of federal benefit | |
| (1,392,351 | ) | |
| (9.0% | ) | |
| (3,765,167 | ) | |
| (10.0% | ) |
| Other | |
$ | – | | |
$ | – | | |
$ | 24,017 | | |
| 0.2% | |
| | |
| | | |
| | | |
| | | |
| | |
| Income tax benefit at statutory rate | |
$ | (4,357,970 | ) | |
$ | (30.0% | ) | |
$ | (11,648,000 | ) | |
| (30.8% | ) |
| Change in valuation allowance | |
| 4,357,970 | | |
| 30.0% | | |
| 11,648,000 | | |
| 30.8% | |
| Provision for income taxes (benefit) | |
$ | – | | |
$ | – | | |
$ | – | | |
| – | |
The Company’s calculation of net operating
loss carryforwards:
| Schedule of net operating loss
carryforwards | |
| | | |
| | |
| | |
As of December 31, | |
| | |
2023 | | |
2022 | |
| Deferred tax assets | |
| | | |
| | |
| Net operating loss carryforwards | |
$ | 22,473,712 | | |
$ | 18,429,000 | |
| Derivative liability warrants | |
| – | | |
| 349,000 | |
| Section 174 research and development | |
| 1,799,825 | | |
| – | |
| PPE and intangible assets | |
| 416,708 | | |
| – | |
| State taxes | |
| (1,554,275 | ) | |
| – | |
| Total deferred tax assets | |
| 23,135,970 | | |
| 18,778,000 | |
| Less valuation allowance | |
| (23,135,970 | ) | |
| (18,778,000 | ) |
| Net deferred tax assets | |
$ | – | | |
$ | – | |
At December 31, 2023, the Company has
approximately $75,000,000
of unused net operating loss carry forwards. Unused net operating loss carry forwards may provide future benefits, although there
can be no assurance that these net operating losses will be realized in the future. The tax benefits of these loss carry forwards
have been fully offset by a valuation allowance. These losses may be used to offset future taxable income and will carry forward
indefinitely.
NOTE 9 – NOTE RECEIVABLE
On July 19, 2023 the Company entered into a
promissory note agreement with Deverra. The Company agreed to make advances of principal to Deverra of up to an aggregate
amount equal to $572,000.
Any advances are at the sole discretion of the Company. The outstanding unpaid principal balance of the note bears interest at 3%
per annum and was due and payable on the Maturity Date, September
30, 2023.
In the event that a certain business
transaction between the Company and Deverra as contemplated by that certain binding term sheet dated April 13, 2023, and referenced
in Note 6, is consummated prior to the Maturity Date, the full amounts due under this note shall be applied against the cash portion
of any closing payment due from the Company in connection with such transaction and any excess amounts under this note shall be
treated as additional purchase price in connection with the transaction.
As of September 30, 2023, and in relation to the
Deverra asset purchase referenced in Note 6, $567,609 of principal and $2,892 of interest were applied against the cash portion of the
closing payment with the Company in connection with such transaction. The note is considered paid in full.
In September 2023, the Company entered into a
note agreement with a third-party borrower. The Company agreed to issue 600,000 shares of common stock to the borrower for a
principal sum amount of $500,000. The outstanding unpaid principal balance of the note bears interest at 6% per annum and is due
and payable to the Company on the Maturity Date, August 30, 2024. See Note 10 below.
NOTE 10 – RELATED PARTY TRANSACTION
In September 2023, the Company entered into
a transaction with AG Bio Life Capital I LP (“AG”), a Delaware limited partnership, where an employee of the Company is
the general partner. The Company agreed to issue 600,000
shares of common stock of the Company (“AG Shares”) to AG, in exchange for $600,000,
$100,000
payable in cash and the balance payable under a promissory note (“AG Note”). The principal amount including all interest
under the AG Note is due and payable by AG no later than August 30, 2024 (the “AG Maturity Date”). The outstanding
unpaid principal balance of the AG Note bears interest commencing as of the Company’s next registration statement at the rate
of six (6%) percent per annum, which interest rate will increase to eighteen (18%) percent per annum in the event an event of
default occurs under the AG Note, computed on the basis of the actual number of days elapsed and a year of 365 days. AG has the
option of repaying the obligations under the AG Note in advance of the AG Maturity Date, in whole or in part, at any time upon at
least thirty (30) days prior written notice delivered to the Company. AG has certain obligations to contribute the proceeds of the
sale of its AG Shares to the Company, in the event that any AG Shares are sold prior to the AG Maturity Date.
NOTE 11 – SUBSEQUENT EVENTS
Management of the Company has performed a review
of all events and transactions occurring after the consolidated balance sheet date of December 31, 2023 for items that would require adjustment
to or disclosure in the accompanying consolidated financial statements and noted there were no such events or transactions other than
the following.
On January 3, 2024, the Company entered into an
unsecured note agreement with an unrelated third party in the principal amount of $1,500,000, which was issued with a 10% original
issue discount. The original principal amount, together with interest of 8%, is payable by the Company on April 15, 2024, and may be
extended at the option of the holder.
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
| ☒ |
Quarterly REPORT PURSUANT to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the quarterly period ended June 30, 2024
or
| ☐ |
TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transaction period from _____________
to _____________
Commission File No. 001-39669
COEPTIS THERAPEUTICS HOLDINGS, INC.
| Delaware |
98-1465952 |
(State or other jurisdiction of
incorporation or organization) |
(I.R.S. Employer
Identification No.) |
105 Bradford Rd, Suite 420
Wexford, Pennsylvania 15090
(724) 934-6467
coeptistx.com
Securities registered pursuant to Section 12(b) of
the Act:
| Title of each class |
Trading Symbol(s) |
Name of exchange on which registered |
| Common Stock, par value $0.0001 per share |
COEP |
Nasdaq Capital Market |
| Warrants, each whole warrant exercisable for one-half of one share of Common Stock for $11.50 per whole share |
COEPW |
Nasdaq Capital Market |
Securities registered pursuant to Section 12(g) of
the Act: Common Stock, par value $0.0001 per share
Indicate
by check mark whether the registrant: (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act of 1934 during
the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant
is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company.
See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and
“emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large Accelerated
Filer ☐ |
Accelerated
Filer ☐ |
| Non-accelerated Filer ☒ |
Smaller Reporting Company
☒ |
| |
Emerging Growth Company
☒ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12(b)-2 of the Exchange Act). Yes ☐ No
☒
Indicate the number of shares outstanding of each
of the issuer's classes of common stock, as of the latest practicable date:
The number of shares outstanding of the registrant’s common
stock, par value $0.0001 per share, August 13, 2024 was 39,718,593.
COEPTIS THERAPEUTICS, INC.
FORM 10-Q
For the Quarter Ended June 30, 2024
TABLE OF CONTENTS
PART I — FINANCIAL INFORMATION
| Item 1. |
Unaudited Financial Statements |
COEPTIS THERAPEUTICS HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
| |
|
|
|
|
|
|
|
|
| ASSETS |
|
| | |
As of | |
| | |
June 30, 2024 | | |
December 31, 2023 | |
| CURRENT ASSETS | |
| | | |
| | |
| Cash | |
$ | 1,555,075 | | |
$ | 1,469,134 | |
| Interest receivable | |
| 191,082 | | |
| 38,978 | |
| Prepaid assets, current portion | |
| 244,776 | | |
| 241,601 | |
| TOTAL CURRENT ASSETS | |
| 1,990,933 | | |
| 1,749,713 | |
| | |
| | | |
| | |
| PROPERTY AND EQUIPMENT | |
| | | |
| | |
| Furniture and fixtures | |
| 25,237 | | |
| 25,237 | |
| Less: accumulated depreciation | |
| 14,354 | | |
| 13,931 | |
| Furniture and fixtures, net | |
| 10,883 | | |
| 11,306 | |
| | |
| | | |
| | |
| OTHER ASSETS | |
| | | |
| | |
| Prepaid assets, net of current portion | |
| 63,333 | | |
| 158,333 | |
| Co-development options | |
| 2,054,167 | | |
| 2,554,166 | |
| Right of use asset, net of accumulated amortization | |
| 79,104 | | |
| 97,571 | |
| Total other assets | |
| 2,196,604 | | |
| 2,810,070 | |
| TOTAL ASSETS | |
$ | 4,198,420 | | |
$ | 4,571,089 | |
| | |
| | | |
| | |
| | |
| | | |
| | |
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | |
| | | |
| | |
| CURRENT LIABILITIES | |
| | | |
| | |
| Accounts payable | |
$ | 1,281,152 | | |
$ | 1,419,699 | |
| Accrued expenses | |
| 771,035 | | |
| 555,950 | |
| Notes payable, current portion | |
| 1,553,929 | | |
| 975,000 | |
| Right of use liability, current portion | |
| 19,560 | | |
| 38,047 | |
| TOTAL CURRENT LIABILITIES | |
| 3,625,676 | | |
| 2,988,696 | |
| | |
| | | |
| | |
| LONG TERM LIABILITIES | |
| | | |
| | |
| Note payable, net of current portion | |
| 150,000 | | |
| 150,000 | |
| Derivative liability warrants | |
| 671,625 | | |
| 557,250 | |
| Right of use liability, non-current portion | |
| 61,179 | | |
| 61,179 | |
| TOTAL LONG TERM LIABILITIES | |
| 882,804 | | |
| 768,429 | |
| TOTAL LIABILITIES | |
| 4,508,480 | | |
| 3,757,125 | |
| | |
| | | |
| | |
| COMMITMENTS AND CONTINGENCIES (NOTE 7) | |
| – | | |
| – | |
| | |
| | | |
| | |
| STOCKHOLDERS' EQUITY (DEFICIT) | |
| | | |
| | |
| Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 4,300 shares issued and outstanding at June 30, 2024 | |
| 2 | | |
| – | |
| Common stock, $0.0001 par value, 150,000,000 shares authorized, 39,718,593 shares issued and outstanding at June 30, 2024, and 35,331,036 shares issued and outstanding at December 31, 2023 | |
| 3,972 | | |
| 3,533 | |
| Additional paid-in capital | |
| 100,496,465 | | |
| 91,666,691 | |
| Subscription receivable | |
| (7,600,000 | ) | |
| (3,500,000 | ) |
| Common stock subscribed | |
| 50,000 | | |
| – | |
| Accumulated deficit | |
| (93,392,993 | ) | |
| (87,356,260 | ) |
| TOTAL STOCKHOLDERS' EQUITY (DEFICIT)- CONTROLLING INTERESTS | |
| (442,554 | ) | |
| 813,964 | |
| TOTAL STOCKHOLDERS' EQUITY - NONCONTROLLING INTERESTS | |
| 132,494 | | |
| – | |
| TOTAL STOCKHOLDERS' EQUITY (DEFICIT) | |
| (310,060 | ) | |
| 813,964 | |
| TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | |
$ | 4,198,420 | | |
$ | 4,571,089 | |
The accompanying notes are an integral part
of the condensed consolidated financial statements.
COEPTIS THERAPEUTICS HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
| | |
| | | |
| | | |
| | | |
| | |
| | |
Three Months Ended | | |
Six Months Ended | |
| | |
June 30, 2024 | | |
June 30, 2023 | | |
June 30, 2024 | | |
June 30, 2023 | |
| SALES | |
| | |
| | |
| | |
| |
| Consulting services | |
$ | – | | |
$ | – | | |
$ | – | | |
$ | – | |
| Sales | |
| – | | |
| – | | |
| – | | |
| – | |
| Total sales | |
| – | | |
| – | | |
| – | | |
| – | |
| Cost of goods | |
| – | | |
| – | | |
| – | | |
| – | |
| Gross profit | |
| – | | |
| – | | |
| – | | |
| – | |
| | |
| | | |
| | | |
| | | |
| | |
| COST OF OPERATIONS | |
| | | |
| | | |
| | | |
| | |
| Research and development expense | |
| 398,817 | | |
| 466,629 | | |
| 1,175,886 | | |
| 581,959 | |
| Salary expense | |
| 459,099 | | |
| 355,927 | | |
| 904,458 | | |
| 639,844 | |
| Amortization expense | |
| 250,000 | | |
| 250,000 | | |
| 500,000 | | |
| 500,000 | |
| Professional services expense | |
| 864,588 | | |
| 2,298,224 | | |
| 2,045,087 | | |
| 7,850,310 | |
| Stock based compensation expense | |
| 611,570 | | |
| 113,391 | | |
| 708,459 | | |
| 235,692 | |
| General and administrative expenses | |
| 239,028 | | |
| 200,513 | | |
| 411,595 | | |
| 415,831 | |
| Selling and marketing expense | |
| 5,000 | | |
| 300 | | |
| 5,000 | | |
| 300 | |
| Total cost of operations | |
| 2,828,102 | | |
| 3,684,984 | | |
| 5,750,485 | | |
| 10,223,936 | |
| | |
| | | |
| | | |
| | | |
| | |
| LOSS FROM OPERATIONS | |
| (2,828,102 | ) | |
| (3,684,984 | ) | |
| (5,750,485 | ) | |
| (10,223,936 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| OTHER INCOME (EXPENSE) | |
| | | |
| | | |
| | | |
| | |
| | |
| | | |
| | | |
| | | |
| | |
| Interest expense | |
| (66,056 | ) | |
| (42,636 | ) | |
| (266,561 | ) | |
| (74,053 | ) |
| Other income | |
| 8,063 | | |
| – | | |
| 94,688 | | |
| 35 | |
| Change in fair value of derivative liability warrants | |
| (149,250 | ) | |
| 525,000 | | |
| (114,375 | ) | |
| (862,500 | ) |
| TOTAL OTHER INCOME (EXPENSE), net | |
| (207,243 | ) | |
| 482,364 | | |
| (286,248 | ) | |
| (936,518 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| LOSS BEFORE INCOME TAXES | |
| (3,035,345 | ) | |
| (3,202,620 | ) | |
| (6,036,733 | ) | |
| (11,160,454 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| PROVISION FOR INCOME TAXES (BENEFIT) | |
| – | | |
| – | | |
| – | | |
| – | |
| NET LOSS | |
| (3,035,345 | ) | |
| (3,202,620 | ) | |
| (6,036,733 | ) | |
| (11,160,454 | ) |
| Net loss attributable to noncontrolling interests | |
| – | | |
| – | | |
| – | | |
| – | |
| NET LOSS ATTRIBUTABLE TO COEPTIS THERAPEUTICS HOLDINGS, INC. | |
$ | (3,035,345 | ) | |
$ | (3,202,620 | ) | |
$ | (6,036,733 | ) | |
$ | (11,160,454 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| LOSS PER SHARE | |
| | | |
| | | |
| | | |
| | |
| | |
| | | |
| | | |
| | | |
| | |
| Loss per share, basic and fully diluted | |
$ | (0.08 | ) | |
$ | (0.15 | ) | |
$ | (0.17 | ) | |
$ | (0.53 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Weighted average number of common shares outstanding | |
| 37,569,312 | | |
| 21,808,563 | | |
| 36,551,418 | | |
| 21,080,395 | |
The accompanying notes are an integral part
of the condensed consolidated financial statements.
COEPTIS THERAPEUTICS HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS'
EQUITY
For the Three and Six Months Ended June 30,
2024 and 2023
(Unaudited)
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| | |
PREFERRED
STOCK | | |
COMMON
STOCK | | |
ADDITIONAL
PAID-IN | | |
SHARES | | |
SUBSCRIPTION | | |
ACCUMULATED | | |
TOTAL
COEPTIS | | |
NON-
CONTROLLING | | |
TOTAL | |
| | |
SHARES | | |
AMOUNT | | |
SHARES | | |
AMOUNT | | |
CAPITAL | | |
SUBSCRIBED | | |
RECEIVABLE | | |
DEFICIT | | |
EQUITY | | |
INTERESTS | | |
EQUITY | |
| | |
| | |
| | | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| BALANCE AT DECEMBER
31, 2022 | |
– | | |
$ | – | | |
19,566,839 | | |
$ | 1,957 | | |
$ | 70,541,095 | | |
$ | – | | |
$ | – | | |
$ | (66,089,723 | ) | |
$ | 4,453,329 | | |
$ | – | | |
$ | 4,453,329 | |
| | |
| | |
| | | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Shares subscribed for non-employee services | |
– | | |
| – | | |
1,374,197 | | |
| 137 | | |
| 2,396,677 | | |
| 720,000 | | |
| – | | |
| – | | |
| 3,116,814 | | |
| – | | |
| 3,116,814 | |
| | |
| | |
| | | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Warrants issued for services | |
– | | |
| – | | |
– | | |
| – | | |
| 1,111,706 | | |
| – | | |
| – | | |
| | | |
| 1,111,706 | | |
| – | | |
| 1,111,706 | |
| | |
| | |
| | | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Stock based compensation | |
– | | |
| – | | |
– | | |
| – | | |
| 122,391 | | |
| – | | |
| – | | |
| – | | |
| 122,391 | | |
| – | | |
| 122,391 | |
| | |
| | |
| | | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Net loss | |
– | | |
| – | | |
– | | |
| – | | |
| – | | |
| – | | |
| – | | |
| (7,957,833 | ) | |
| (7,957,833 | ) | |
| – | | |
| (7,957,833 | ) |
| | |
| | |
| | | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| BALANCE AT MARCH 31, 2023 | |
– | | |
$ | – | | |
20,941,036 | | |
$ | 2,094 | | |
$ | 74,171,869 | | |
$ | 720,000 | | |
$ | – | | |
$ | (74,047,556 | ) | |
$ | 846,407 | | |
$ | – | | |
$ | 846,407 | |
| | |
| | |
| | | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Shares subscribed for non-employee services | |
– | | |
| – | | |
700,000 | | |
| 70 | | |
| 1,070,930 | | |
| (720,000 | ) | |
| – | | |
| – | | |
| 351,000 | | |
| – | | |
| 351,000 | |
| | |
| | |
| | | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Warrants issued for services | |
– | | |
| – | | |
– | | |
| – | | |
| 811,500 | | |
| – | | |
| – | | |
| – | | |
| 811,500 | | |
| – | | |
| 811,500 | |
| | |
| | |
| | | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Stock based compensation | |
– | | |
| – | | |
– | | |
| – | | |
| 113,301 | | |
| – | | |
| – | | |
| – | | |
| 113,301 | | |
| – | | |
| 113,301 | |
| | |
| | |
| | | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Issuance of common stock and warrants, net of issuance
costs | |
– | | |
| – | | |
2,755,000 | | |
| 276 | | |
| 3,040,585 | | |
| – | | |
| – | | |
| – | | |
| 3,040,861 | | |
| – | | |
| 3,040,861 | |
| | |
| | |
| | | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Net loss | |
– | | |
| – | | |
– | | |
| – | | |
| – | | |
| – | | |
| – | | |
| (3,202,620 | ) | |
| (3,202,620 | ) | |
| – | | |
| (3,202,620 | ) |
| | |
| | |
| | | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| BALANCE AT JUNE 30, 2023 | |
– | | |
$ | – | | |
24,396,036 | | |
$ | 2,440 | | |
$ | 79,208,185 | | |
$ | – | | |
$ | – | | |
$ | (77,250,176 | ) | |
$ | 1,960,449 | | |
$ | – | | |
$ | 1,960,449 | |
(continued)
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| | |
PREFERRED STOCK | | |
COMMON STOCK | | |
ADDITIONAL PAID-IN | | |
SHARES | | |
SUBSCRIPTION | | |
ACCUMULATED | | |
TOTAL COEPTIS | | |
NON- CONTROLLING | | |
TOTAL | |
| | |
SHARES | | |
AMOUNT | | |
SHARES | | |
AMOUNT | | |
CAPITAL | | |
SUBSCRIBED | | |
RECEIVABLE | | |
DEFICIT | | |
EQUITY | | |
INTERESTS | | |
EQUITY | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| |
| BALANCE AT DECEMBER 31, 2023 | |
| – | | |
$ | – | | |
| 35,331,036 | | |
$ | 3,533 | | |
$ | 91,666,691 | | |
$ | – | | |
$ | (3,500,000 | ) | |
$ | (87,356,260 | ) | |
$ | 813,964 | | |
$ | – | | |
$ | 813,964 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Shares issued for non-employee services | |
| – | | |
| – | | |
| 1,096,381 | | |
| 110 | | |
| 541,640 | | |
| – | | |
| – | | |
| – | | |
| 541,750 | | |
| – | | |
| 541,750 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Warrants issued for cash | |
| – | | |
| – | | |
| – | | |
| – | | |
| 500,000 | | |
| – | | |
| – | | |
| – | | |
| 500,000 | | |
| – | | |
| 500,000 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Warrants issued for services | |
| – | | |
| – | | |
| – | | |
| – | | |
| 8,150 | | |
| – | | |
| – | | |
| – | | |
| 8,150 | | |
| – | | |
| 8,150 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Warrants issued in exchange for note receivable | |
| – | | |
| – | | |
| – | | |
| – | | |
| 1,900,000 | | |
| – | | |
| (2,000,000 | ) | |
| – | | |
| (100,000 | ) | |
| – | | |
| (100,000 | ) |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Stock based compensation | |
| – | | |
| – | | |
| – | | |
| – | | |
| 96,889 | | |
| – | | |
| – | | |
| – | | |
| 96,889 | | |
| – | | |
| 96,889 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Net loss | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| (3,001,388 | ) | |
| (3,001,388 | ) | |
| – | | |
| (3,001,388 | ) |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| BALANCE AT MARCH 31, 2024 | |
| – | | |
$ | – | | |
| 36,427,417 | | |
$ | 3,643 | | |
$ | 94,713,370 | | |
$ | – | | |
$ | (5,500,000 | ) | |
$ | (90,357,648 | ) | |
$ | (1,140,635 | ) | |
$ | – | | |
$ | (1,140,635 | ) |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Shares issued for services | |
| – | | |
| – | | |
| 1,850,000 | | |
| 185 | | |
| 558,165 | | |
| – | | |
| – | | |
| – | | |
| 558,350 | | |
| – | | |
| 558,350 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Shares issued for the conversion of debt | |
| 506 | | |
| 1 | | |
| 1,441,176 | | |
| 144 | | |
| 951,855 | | |
| – | | |
| – | | |
| – | | |
| 952,000 | | |
| – | | |
| 952,000 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Preferred share offering | |
| 3,794 | | |
| 1 | | |
| – | | |
| – | | |
| 3,661,505 | | |
| 50,000 | | |
| (2,100,000 | ) | |
| – | | |
| 1,611,506 | | |
| 132,494 | | |
| 1,744,000 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Stock based compensation | |
| – | | |
| – | | |
| – | | |
| – | | |
| 611,570 | | |
| – | | |
| – | | |
| – | | |
| 611,570 | | |
| – | | |
| 611,570 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| Net loss | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| – | | |
| (3,035,345 | ) | |
| (3,035,345 | ) | |
| – | | |
| (3,035,345 | ) |
| | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
| BALANCE AT JUNE 30, 2024 | |
| 4,300 | | |
$ | 2 | | |
| 39,718,593 | | |
$ | 3,972 | | |
$ | 100,496,465 | | |
$ | 50,000 | | |
$ | (7,600,000 | ) | |
$ | (93,392,993 | ) | |
$ | (442,554 | ) | |
$ | 132,494 | | |
$ | (310,060 | ) |
The accompanying notes are an integral part
of the condensed consolidated financial statements.
COEPTIS THERAPEUTICS HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
| | |
| | | |
| | |
| | |
Six Months Ended | |
| | |
June 30, 2024 | | |
June 30, 2023 | |
| OPERATING ACTIVITIES | |
| | | |
| | |
| | |
| | | |
| | |
| Net loss | |
$ | (6,036,733 | ) | |
$ | (11,160,454 | ) |
| Adjustments to reconcile net loss to net cash used in operating activities | |
| | | |
| | |
| Depreciation and amortization | |
| 500,422 | | |
| 500,619 | |
| Amortization of debt discount | |
| 150,000 | | |
| – | |
| Change in fair value of derivative liability warrants | |
| 114,375 | | |
| 862,500 | |
| Stock based compensation | |
| 708,459 | | |
| 235,692 | |
| Shares issued for non-employee services | |
| 1,100,100 | | |
| 3,467,814 | |
| Warrants issued for services | |
| 8,150 | | |
| 1,923,206 | |
| Loss on shares issued for conversion of debt | |
| 77,250 | | |
| – | |
| (Increase) decrease in: | |
| | | |
| | |
| Accounts receivable | |
| – | | |
| 8,075 | |
| Interest receivable | |
| (152,104 | ) | |
| – | |
| Prepaid assets | |
| 91,825 | | |
| 34,880 | |
| Right of use asset/liability | |
| (20 | ) | |
| (415 | ) |
| Increase (decrease) in: | |
| | | |
| | |
| Accounts payable | |
| (138,547 | ) | |
| 296,211 | |
| Accrued expenses | |
| 256,702 | | |
| 244,521 | |
| NET CASH USED IN OPERATING ACTIVITIES | |
| (3,320,121 | ) | |
| (3,587,351 | ) |
| | |
| | | |
| | |
| INVESTING ACTIVITIES | |
| | | |
| | |
| | |
| | | |
| | |
| Increase in subscription receivable in exchange for cash | |
| (100,000 | ) | |
| (350,000 | ) |
| NET CASH USED IN INVESTING ACTIVITIES | |
| (100,000 | ) | |
| (350,000 | ) |
| | |
| | | |
| | |
| FINANCING ACTIVITIES | |
| | | |
| | |
| | |
| | | |
| | |
| Proceeds from notes payable | |
| 1,850,000 | | |
| 350,000 | |
| Repayment of notes payable | |
| (587,500 | ) | |
| 3,040,861 | |
| Warrants issued for cash | |
| 500,000 | | |
| – | |
| Cash received for stock subscription | |
| 50,000 | | |
| – | |
| Preferred stock offering | |
| 1,693,562 | | |
| – | |
| NET CASH PROVIDED BY FINANCING ACTIVITIES | |
| 3,506,062 | | |
| 3,390,861 | |
| NET INCREASE (DECREASE) IN CASH | |
| 85,941 | | |
| (546,490 | ) |
| CASH AT BEGINNING OF PERIOD | |
| 1,469,134 | | |
| 3,791,302 | |
| CASH AT END OF PERIOD | |
$ | 1,555,075 | | |
$ | 3,244,812 | |
| | |
| | | |
| | |
| SUPPLEMENTAL DISCLOSURES | |
| | | |
| | |
| Subscriptions receivable | |
$ | 4,100,000 | | |
$ | – | |
| Shares issued for the conversion of debt | |
$ | 868,750 | | |
$ | – | |
| Interest paid | |
$ | – | | |
$ | – | |
| Taxes paid (refunded) | |
$ | – | | |
$ | – | |
The accompanying notes are an integral part
of the condensed consolidated financial statements.
COEPTIS THERAPEUTICS HOLDINGS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Six months ended June 30, 2024 and 2023 (unaudited)
NOTE 1 – DESCRIPTION OF BUSINESS AND BASIS OF PRESENTATION
Nature of Business
General. Coeptis Therapeutics Holdings,
Inc. (“Coeptis”, the “Company” or “we” or “our”) was originally incorporated in the British
Virgin Islands on November 27, 2018, under the name Bull Horn Holdings Corp. On October 27, 2022, Bull Horn Holdings Corp. domesticated
from the British Virgin Islands to the State of Delaware. On October 28, 2022, in connection with the closing of the Merger, we changed
our corporate name from Bull Horn Holdings Corp. to “Coeptis Therapeutics Holdings, Inc.”
The Merger Transaction. On October 28,
2022, a wholly owned subsidiary of Bull Horn Holdings Corp., merged with and into Coeptis Therapeutics, Inc., with Coeptis Therapeutics,
Inc. as the surviving corporation of the Merger. As a result of the Merger, we acquired the business of Coeptis Therapeutics, Inc., which
we now continue to operate as our wholly owned subsidiary.
About the Company’s Subsidiaries.
We are now a holding company that currently operates through our direct and indirect wholly owned subsidiaries Coeptis Therapeutics, Inc.,
Coeptis Pharmaceuticals, Inc. and Coeptis Pharmaceuticals, LLC. The Company formed two new subsidiaries, SNAP Biosciences Inc. and GEAR
Therapeutics Inc., in connection with the Series A Preferred Stock offering. See Note 5, Capital Structure, for more information on the
Series A Preferred Stock offering.
Our current business model is designed around
furthering the development of our current product portfolio. We are continually exploring partnership opportunities with companies that
have novel therapies in various stages of development or companies with technologies that improve the way that drugs are delivered to
patients. We seek the best strategic relationships, which relationships could include in-license agreements, out-license agreements, co-development
arrangements and other strategic partnerships in new and exciting therapeutic areas such as auto-immune disease and oncology.
Basis of Presentation – The accompanying
unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in
the United States of America (“GAAP”). In the opinion of management, the accompanying unaudited condensed consolidated financial
statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly the Company’s
consolidated financial position, results of operations, and cash flows. The interim results of operations are not necessarily indicative
of the results that may occur for the full fiscal year. Certain information and footnote disclosure normally included in the consolidated
financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to instructions, rules, and regulations
prescribed by the United States Securities and Exchange Commission (“SEC”). The accompanying interim condensed consolidated
financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in our
Annual Report on Form 10-K for the year ended December 31, 2023 that was filed with the SEC on March 26, 2024.
Principles of Consolidation – The
accompanying unaudited condensed consolidated financial statements include the accounts of Coeptis Therapeutics, Inc., SNAP Biosciences
Inc., GEAR Therapeutics Inc., Coeptis Pharmaceuticals, Inc. and its wholly-owned subsidiary, Coeptis Pharmaceuticals, LLC. All material
intercompany accounts, balances and transactions have been eliminated.
NOTE 2 – SUMMARY OF SIGNIFICANT
ACCOUNTING POLICIES
Use of Estimates – The preparation of condensed consolidated financial statements in conformity
with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues
and expenses during the reporting period. Actual results could differ from those estimates.
Employee and Non-Employee Share-Based Compensation
– The Company applies Accounting Standards Codification (“ASC”) 718-10, Share-Based Payment, which requires the
measurement and recognition of compensation expenses for all share-based payment awards made to employees and directors including employee
stock options equity awards issued to employees and non-employees based on estimated fair values.
ASC 718-10 requires companies to estimate the
fair value of equity-based option awards on the date of grant using an option-pricing model. The fair value of the award is recognized
as an expense on a straight-line basis over the requisite service periods in the Company’s condensed consolidated statements of
operations. The Company recognizes share-based award forfeitures as they occur.
The Company estimates the fair value of granted
option equity awards using a Black-Scholes option pricing model. The option-pricing model requires a number of assumptions, of which the
most significant are share price, expected volatility and the expected option term (the time from the grant date until the options are
exercised or expire). Expected volatility is estimated based on volatility of the Company. The Company has historically not paid dividends
and has no foreseeable plans to issue dividends. The risk-free interest rate is based on the yield from governmental zero-coupon bonds
with an equivalent term. The expected option term is calculated for options granted to employees and directors using the “simplified”
method. Changes in the determination of each of the inputs can affect the fair value of the options granted and the results of operations
of the Company.
Adoption of New Accounting Pronouncements
– During the three months and six months ended June 30, 2024 and 2023, there were new accounting pronouncements issued by the Financial
Accounting Standards Board (“FASB”). Each of these pronouncements, as applicable, has been or will be adopted by the Company.
Management does not believe the adoption of any of these accounting pronouncements has had or will have a material impact on the Company’s
condensed consolidated financial statements.
Reclassifications – During the six
months ended June 30, 2024, the Company reclassified certain Note receivables to Subscription receivables. As a result, $5,500,000 was
reclassified on the Company’s Condensed Consolidated Balance Sheet as of June 30, 2024. The comparative figures for the year ended
December 31, 2023 have been adjusted accordingly.
Going Concern – The accompanying
condensed consolidated financial statements have been prepared in conformity with GAAP in the United States of America, which contemplate
continuation of the Company as a going concern, which is dependent upon the Company’s ability to obtain sufficient financials or
establish itself as a profitable business. As of June 30, 2024, the Company had an accumulated deficit of $93,392,993, and for the six
months ended June 30, 2024, the Company had a net loss of $6,036,733. These conditions raise substantial doubt about the Company’s
ability to continue as a going concern. Management’s plans with respect to operations include raising additional capital through
sales of equity or debt securities as may be necessary to pursue its business plans and sustain operations until such time as the Company
can achieve profitability. Management believes that additional financing as necessary will result in improved operations and cash flow.
However, there can be no assurance that management will be successful in obtaining additional funding or in attaining profitable operations.
NOTE 3 – CO-DEVELOPMENT OPTIONS
Prior to 2022, the Company entered into an agreement
with Purple Biotech (“Purple”) to market, distribute, and sell the Consensi product (the “Product”) on an exclusive
basis within the United States and Puerto Rico. Upon execution of the Agreement the Company paid $1,000,000 to Purple. Two additional
milestone payments of $1,500,000 and $1,000,000 were due and paid upon completion of the milestones including the first commercial sale
of the Product which occurred and the payments were made prior to 2022.
In September of 2021, the Company executed a license
termination agreement with Purple to cease all efforts for sales and promotion of the Product in the United States and Puerto Rico. The
termination included (i) issuance of $1,500,000 of convertible debt due in February 2023 to satisfy amounts owed for the license, (ii)
the issuance of warrants (See Note 5) and (iii) transfer of inventory ownership back to Purple. In conjunction with this termination, the
Company also terminated its marketing agreement with a third party for the Product’s sales and promotion. On July 14, 2023, the
Company and Purple executed an amendment to revise the note’s payment schedule, extending the maturity date to March 31, 2024. On
June 19, 2024, the Company and Purple executed another amendment to extend the maturity date to August 31, 2024. The outstanding principal
balance due under the convertible note at June 30, 2024 and December 31, 2023 was $218,750 and $625,000, respectively.
During the year ended December 31, 2021, the Company
and Vy-Gen-Bio, Inc. (“Vy-Gen”) entered into agreements to jointly develop and commercialize two Vy-Gen product candidates,
CD38-GEAR-NK and CD38-Diagnostic (the “CD38 Assets”). The Company paid $1,750,000 and issued promissory notes totaling $3,250,000
to Vy-Gen in accordance with the agreements. The collaboration arrangement provides the right for the Company to participate, under the
direction of a joint steering committee, in the development and commercialization of the CD38 Assets and a 50/50 profit share, with the
profit share subject to contingent automatic downward adjustment up to 25% upon an event of default in connection with the promissory
notes. The Company capitalized $5,000,000 to be amortized over a five-year period in which the CD38 Assets are expected to contribute
to future cash flows. In March of 2022, a $250,000 payment was made toward the promissory notes. In November of 2022, a $1,500,000 payment
was made toward the promissory notes, which paid them in full, and the accrued interest was forgiven.
The Company made certain judgements as the basis
in determining the accounting treatment of these options. The CD38 Assets represent a platform technology and a diagnostic tool which
have multiple applications and uses. Both projects are intended to be used in more than one therapy or diagnostic option. For example,
GEAR-NK is a technology which allows for the gene editing of human natural killer cells, so that these cells can no longer bind and be
destroyed by targeted monoclonal antibody treatments. The GEAR-NK technology can be modified to work concomitantly with many different
monoclonal antibody treatments in which there are currently over 100 approved by the FDA. Anti-CD38 is only the first class of monoclonal
antibody treatments being developed under the GEAR-NK platform. Therefore, the pursuit of FDA approval for the use of CD38 assets for
at least one indication or medical device approval is at least reasonably expected. Further, as the diagnostic asset may be used as an
in vitro technology, it could be classified as a medical device, and therefore toxicity studies would not be a contingency to be resolved
before reasonably establishing future value assumptions. In addition, there is perceived value in the CD38 assets, based on publicly disclosed
current business deals in cell therapies, the developing market for these innovative technologies, and current interest from third parties
in these technologies. The Company may sell or license its right to another party, with the written consent of Vy-Gen, which cannot be
unreasonably withheld. Furthermore, the Company believes that any negative results from ongoing development of a single therapy or use,
would not result in abandoning the project. Given these considerations, The Company has determined that these options have alternative
future use and should be recorded as assets pursuant to ASC 730-10-25-2, Research and Development.
Related to the joint development, the Company,
under the direction of the joint steering committee, is assessing market opportunities, intellectual property protection, and potential
regulatory strategies for the CD38 Assets. Vy-Gen is responsible for development activities conducted and overseen by the scientists at
Karolinska Institute. The agreement does not currently require additional payments for research and development costs by the Company and
no additional payments are required upon development or regulatory milestones.
NOTE 4 – DEBT
In September 2021, as part of a termination of
a license agreement with Purple (see Note 3), the Company issued a convertible note in the principal amount of $1,500,000 that was payable
on or before the maturity date in February 2023, bearing interest of 5% per annum and convertible in whole or in part at any time by Purple
into shares of common stock of the Company. The conversion price is $5 per share of common stock, subject to certain adjustments under
such terms and conditions as agreed between the parties. The Company may prepay the principal amount of the note plus accrued and unpaid
interest at any time prior to the maturity date. Inventory, which has been fully written-off on the Company’s balance sheet, was
transferred back to Purple at Purple’s cost. On July 14, 2023, the Company and Purple executed an amendment to revise the note’s
payment schedule, extending the maturity date to March 31, 2024. On June 19, 2024, the Company and Purple executed another amendment to
extend the maturity date to August 31, 2024. The outstanding principal balance due under the convertible note at June 30, 2024 and December
31, 2023 was $218,750 and $625,000, respectively.
In October 2022, as a result of the Merger, the
Company entered into a convertible promissory note agreement with an unrelated third party in the principal amount of $350,000 with no
accruing interest and was due on October 28, 2023 for legal services rendered to the Company. The noteholder may elect, in its sole discretion
upon written notice to the Company, at any time prior to, as of or following the maturity date, to require that all or any portion of
the principal amount not then repaid be converted, without any further action on the part of the noteholder, into shares of common stock,
par value $0.0001 per share, of the Company’s common stock. The conversion price as set forth by the note is equal to $10.00 per
share, provided that the conversion price shall be subject to a one-time adjustment on January 3, 2023, with the conversion price adjustable
to a price equal to the thirty-day volume weighted average price of the stock as traded on the Nasdaq. However, the conversion price following
such adjustment shall not be lower than a floor of $5.00 per share nor greater than $10.00 per share. Upon full conversion of the remaining
principal amount due, the note will, for all purposes be deemed cancelled and all obligations shall be deemed paid in full. On October
27, 2023, a $200,000 payment was made, and on December 15, 2023, another $50,000 payment was made. On June 25, 2024, the Company and the
unrelated third party signed an amendment to the note that extended the maturity date to July 31, 2024. The outstanding balance due under
the convertible note at June 30, 2024 and December 31, 2023 was $100,000 and $100,000, respectively.
In May 2023, the Company entered into an unsecured
note agreement with an unrelated party in the principal amount of $200,000, together with interest at 4.5%, which was due on June 15,
2023. On October 27, 2023, a $100,000 payment was made. On October 31, 2023, the Company and the unrelated party signed an amendment to
the note that extended the maturity date to March 31, 2024. In March of 2024, a $100,000 payment was made, along with an interest payment
of $5,967, which satisfied the note in full.
In June 2023, the Company entered into an unsecured
note agreement with an unrelated party in the principal amount of $150,000. In August 2023, this Note was converted into shares of the
Company’s common stock.
In September 2023, the Company entered into an
unsecured convertible note agreement in the principal amount of $150,000. Shortly thereafter, prior to September 30, 2023, this Note was
converted into shares of the Company’s common stock.
In December 2023, the Company entered into an
unsecured convertible promissory note with an unrelated party in the principal amount of $150,000 together with interest at 5% and a maturity
date of June 30, 2024. On April 24, 2024, the Company converted the note into shares of common stock, which satisfied the note in full.
On January 3, 2024, the Company entered into an
unsecured note agreement with an unrelated third party in the principal amount of $1,500,000, which was issued with a 10% original issue
discount. The original principal amount, together with interest of 8%, was payable by the Company on March 15, 2024, and was extended
to July 31, 2024. The note had an outstanding principal balance of $1,235,178 with $150,000 of the debt discount fully amortized to interest
expense as of June 30, 2024.
On April 17, 2024, the Company entered into an
unsecured note agreement with a related party in the principal amount of $500,000 together with interest at 10%, with a maturity date
of September 30, 2024. The agreement is between the Company and an investment fund where the manager is a member of the Company’s
board of directors. On June 3, 2024, the Company and the related party agreed to convert the note agreement in full, both principal and
interest, to equity in connection with the Company’s Series A Preferred Stock offering. See Note 5, Capital Structure, for more
information on the Series A Preferred Stock offering.
Loans under the CARES Act -- On July 8,
2020, the Company received a loan of $150,000 from the United States Small Business Administration (the “SBA”) under its Economic
Injury Disaster Loan (“EIDL”) assistance program in light of the impact of the COVID-19 pandemic on the Company’s business.
Proceeds are intended to be used for working capital purposes. Interest on the EIDL loan accrues at the rate of 3.75% per annum and installment
payments, including principal and interest, are due monthly in the amount of $731. Each payment will be applied first to interest accrued
to the date of receipt of each payment, and the balance, if any, will be applied to principal. Installment payments have been deferred
by the SBA until January 2023. The balance of principal and interest is payable thirty years from the date of the promissory note. The
balance of the loan is $150,000, as of June 30, 2024 and December 31, 2023.
Maturities of notes payable are as follows for the years ending December
31,
| Schedule of maturities for notes payable |
|
|
|
| 2024 |
|
$ |
1,553,929 |
|
| 2025 |
|
|
– |
|
| 2026 |
|
|
– |
|
| 2027 |
|
|
1,687 |
|
| 2028 |
|
|
3,266 |
|
| Thereafter |
|
|
145,047 |
|
| Total notes payable |
|
$ |
1,703,929 |
|
Derivative Liability Warrants -
At June 30, 2024 and December 31, 2023, there
were (i) 7,500,000 public warrants (the “Public Warrants”) outstanding that were issued as part of Bull Horn’s
November 2020 initial public offering, which warrants are exercisable in the aggregate to acquire 3,750,000 shares of our common stock
at an exercise price of $11.50 per share, (ii) 3,750,000 private warrants (the “Private Placement Warrants”) outstanding that
were issued to our sponsor Bull Horn Holdings Sponsor LC and the underwriters in Bull Horn’s initial public offering in November
2020, which warrants are exercisable in the aggregate to acquire 3,750,000 shares of our common stock at an exercise price of $11.50 per
share, The Private Placement Warrants became exercisable on the consummation of our Business Combination in October 2022. No Public Warrants
will be exercisable for cash unless the Company has an effective and current registration statement covering the ordinary shares issuable
upon exercise of the Public Warrants and a current prospectus relating to such shares of common stock. With respect to the shares of common
stock issuable upon the exercise of the Public Warrants, the class A warrants and the class B warrants during any period when the Company
shall have failed to maintain an effective registration statement related to the issuance of such shares underlying the applicable warrants,
the holder of any applicable warrants may exercise its warrant on a cashless basis pursuant to an available exemption from registration
under the Securities Act. If an exemption from registration is not available, holders will not be able to exercise their Public Warrants
on a cashless basis. The Public Warrants will expire five years from the consummation of a Business Combination or earlier upon
redemption or liquidation.
The Company may call the Public Warrants for redemption,
in whole and not in part, at a price of $0.01 per warrant:
| |
· |
at any time while the Public Warrants are exercisable, |
| |
|
|
| |
· |
upon not less than 30 days’ prior written notice of redemption to each Public Warrant holder, |
| |
|
|
| |
· |
if, and only if, the reported last sale price of the ordinary shares equals or exceeds $16.50 per share, for any 20 trading days within a 30-trading day period ending on the third trading day prior to the notice of redemption to Public Warrant holders, and |
| |
|
|
| |
· |
if, and only if, there is a current registration statement in effect with respect to the ordinary shares underlying such warrants at the time of redemption and for the entire 30-day trading period referred to above and continuing each day thereafter until the date of redemption. |
If the Company calls the Public Warrants for redemption,
management will have the option to require all holders that wish to exercise the Public Warrants to do so on a “cashless basis,”
as described in the warrant agreement. The exercise price and number of ordinary shares issuable upon exercise of the warrants may be
adjusted in certain circumstances including in the event of a share dividend, extraordinary dividend or recapitalization, reorganization,
merger or consolidation. However, except as described above, the warrants will not be adjusted for issuances of ordinary shares at a price
below its exercise price. Additionally, in no event will the Company be required to net cash settle the warrants. If the Company is unable
to complete a Business Combination within the Combination Period and the Company liquidates the funds held in the Trust Account, holders
of warrants will not receive any of such funds with respect to their warrants, nor will they receive any distribution from the Company’s
assets held outside of the Trust Account with respect to such warrants. Accordingly, the warrants may expire worthless.
The Private Placement Warrants are identical to
the Public Warrants, except that the Private Placement Warrants only allow the holder thereof to one ordinary share. Additionally, the
Private Placement Warrants will be exercisable on a cashless basis and be non-redeemable so long as they are held by the initial purchasers
or their permitted transferees. If the Private Placement Warrants are held by someone other than the initial purchasers or their permitted
transferees, the Private Placement Warrants will be redeemable by the Company and exercisable by such holders on the same basis as the
Public Warrants.
Within ASC 815, Derivative and Hedging,
Section 815-40-15 addresses equity versus liability treatment and classification of equity-linked financial instruments, including warrants,
and states that a warrant may be classified as a component of equity only if, among other things, the warrant is indexed to the issuer’s
ordinary share. Under ASC Section 815-40-15, a warrant is not indexed to the issuer’s ordinary share if the terms of the warrant
require an adjustment to the exercise price upon a specified event and that event is not an input to the fair value of the warrant. Based
on management’s evaluation, the Company’s audit committee, in consultation with management, concluded that the Company’s
Private Placement Warrants and Public Warrants are not indexed to the Company’s ordinary share in the manner contemplated by ASC
Section 815-40-15 because the holder of the instrument is not an input into the pricing of a fixed-for-fixed option on equity shares.
In addition, based on management’s evaluation, the Company’s audit committee, in consultation with management, concluded that
certain warrant provisions preclude equity treatment as by ASC Section 815-10-15.
The Company accounts for its Public Warrants and
Private Placement Warrants as liabilities as set forth in ASC 815-40-15-7D and 7F. See below for details over the methodology and valuation
of the Warrants.
The Company follows the guidance in ASC Topic
820, Fair Value Measurement for its financial assets and liabilities that are re-measured and reported at fair value at each reporting
period, and non-financial assets and liabilities that are re-measured and reported at fair value at least annually.
The fair value of the Company’s financial
assets and liabilities reflects management’s estimate of amounts that the Company would have received in connection with the sale
of the assets or paid in connection with the transfer of the liabilities in an orderly transaction between market participants at the
measurement date. In connection with measuring the fair value of its assets and liabilities, the Company seeks to maximize the use of
observable inputs (market data obtained from independent sources) and to minimize the use of unobservable inputs (internal assumptions
about how market participants would price assets and liabilities). The following fair value hierarchy is used to classify assets and liabilities
based on the observable inputs and unobservable inputs used in order to value the assets and liabilities:
| |
Level 1: |
Quoted prices in active markets for identical assets or liabilities. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis. |
| |
Level 2: |
Observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active. |
| |
Level 3: |
Unobservable inputs based on our assessment of the assumptions that market participants would use in pricing the asset or liability. |
The following table presents information about
the Company’s assets that are measured at fair value on a recurring basis at June 30, 2024 and December 31, 2023, and indicates
the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value:
| Schedule of fair value hierarchy | |
| | |
| | |
| |
| Description | |
Level | | |
June 30,
2024 | | |
December 31,
2023 | |
| Warrant Liability – Public Warrants | |
| 1 | | |
$ | 225,000 | | |
$ | 232,500 | |
| Warrant Liability – Private Placement Warrants | |
| 3 | | |
$ | 446,625 | | |
$ | 324,750 | |
The Warrants are accounted for as liabilities
in accordance with ASC 815-40 and are presented within warrant liabilities in the accompanying condensed consolidated balance sheets.
The warrant liabilities are measured at fair value at inception and on a recurring basis, with changes in fair value presented in the
condensed consolidated statements of operations.
The Warrants were valued using a binomial lattice
model, which is considered to be a Level 3 fair value measurement. The binomial lattice model’s primary unobservable input utilized
in determining the fair value of the Warrants is the expected volatility of the ordinary shares. The expected volatility as of the Initial
Public Offering date was derived from observable public warrant pricing on comparable ‘blank-check’ companies without an identified
target. For periods subsequent to the detachment of the Public Warrants from the Units, the close price of the Public Warrant price will
be used as the fair value as of each relevant date.
The following table provides quantitative information
regarding Level 3 fair value measurements:
| Schedule of fair value assumptions | |
| | |
| |
| | |
June 30,
2024 | | |
December 31,
2023 | |
| Risk-free interest rate | |
| 4.37% | | |
| 3.84% | |
| Expected volatility | |
| 152.06% | | |
| 82.12% | |
| Exercise price | |
$ | 11.50 | | |
$ | 11.50 | |
| Stock Price | |
$ | 0.29 | | |
$ | 0.78 | |
The following table presents the changes in the
fair value of warrant liabilities:
| Schedule of changes in fair value of warrant liabilities | |
| | |
| | |
| |
| | |
Private Placement | | |
Public | | |
Warrant Liabilities | |
| Fair value as of December 31, 2023 | |
$ | 324,750 | | |
$ | 232,500 | | |
$ | 557,250 | |
| Change in valuation inputs | |
| 6,375 | | |
| (41,250 | ) | |
| (34,875 | ) |
| Fair value as of March 31, 2024 | |
| 331,125 | | |
| 191,250 | | |
| 522,375 | |
| Change in valuation inputs | |
| 115,500 | | |
| 33,750 | | |
| 149,250 | |
| Fair value as of June 30, 2024 | |
$ | 446,625 | | |
$ | 225,000 | | |
$ | 671,625 | |
There were no transfers in or out of Level 3 from
other levels in the fair value hierarchy during the three and six months ended June 30, 2024 and December 31, 2023.
NOTE 5 – CAPITAL STRUCTURE
The total number of shares of stock which the
corporation shall have authority to issue is 160,000,000 shares, of which 150,000,000 shares of $0.0001 par value shall be designated
as Common Stock and 10,000,000 shares of $0.0001 shall be designated as Preferred Stock. The Preferred Stock authorized by the Company’s
Articles of Incorporation may be issued in one or more series. The Board of Directors of the Corporation is authorized to determine or
alter the rights, preferences, privileges, and restrictions granted or imposed upon any wholly unissued series of Preferred Stock, and
within the limitations or restrictions stated in any resolution or resolutions of the Board of Directors originally fixing the number
of shares constituting any series, to increase or decrease (but not below the number of shares of any such series then outstanding) the
number of shares of any such series subsequent to the issue of shares of that series, to determine the designation and par value of any
series and to fix the numbers of shares of any series.
Common Stock – As of June 30, 2024
the Company had 39,718,593 shares of its common stock issued and outstanding, and on December 31, 2023, the Company had 35,331,036 shares
of its common stock issued and outstanding.
During the three and six months ended June 30,
2024 and 2023, there were no capital distributions.
On June 16, 2023, the Company completed a public
offering issuing 2,150,000 shares of our common stock, 1,350,000 pre-funded warrants, 3,062,500 Series A Warrants and 3,062,500 Series
B Warrants, for net proceeds of approximately $3.0 million, after offering costs. The pre-funded warrants are immediately exercisable,
at a price of $0.0001 per share, with no expiration date. As of June 30, 2024, all of the pre-funded warrants had been exercised for a
total of 3,500,000 shares of common stock issued as a result of the public offering. The Series A Warrants and the Series B Warrants are
referred to herein together as the “Series Warrants.” The shares of common stock and Series Warrants were purchased together
and then immediately separable and were issued separately. Each Series Warrant to purchase one share of common stock has an exercise price
of $1.65 per share, and is initially exercisable commencing six months from the date of the offering. The Series Warrants are exercisable
for a term of five years following the initial exercise date.
On October 26, 2023, the Company completed a private
placement of 777,000 shares of our common stock, pre-funded warrants exercisable to acquire up to 1,223,000 shares of our common stock,
Series A Warrants exercisable to acquire up to 2,000,000 shares of our common stock and Series B Warrants exercisable to acquire up to
2,000,000 shares of our common stock, for net proceeds of approximately $1.8 million, after offering costs. The pre-funded warrants are
immediately exercisable, at a price of $0.001 per share, with no expiration date. In December 2023, a pre-funded warrants were exercised.
The Series A Warrants and the Series B Warrants are referred to herein together as the “Series Warrants.” The shares of common
stock and Series Warrants were purchased together and then immediately separable and were issued separately. The Series A Warrants and
Series B Warrants are exercisable on or after the earlier of (i) the date on which the Company’s stockholders approve the issuance
of the shares issuable upon exercise of the Series Warrants or (ii) April 26, 2024 at an exercise price of $1.36 per share. The Series
A Warrants have a term of exercise equal to eighteen (18) months and the Series B Warrants have a term of exercise equal to five and one-half
(5.5) years. This private placement was conducted with the same underwriter as the June public offering, and as a result, each Series
Warrant issued in connection with the June offering was repriced from an exercise price of $1.65 per share to $1.36 per share. In connection
with the private placement the Company also issued to the exclusive placement agent warrants exercisable to acquire up to 120,000 shares
of our common stock at an exercise price of $1.40 per share, warrant holders 22, 23, and 24.
On December 28, 2023, the Company granted pre-funded
warrants exercisable to acquire up to 1,200,000 shares of our common stock for net proceeds of $1,200,000. The pre-funded common stock
purchase warrants can be exercised at a price of $0.0001 per share, with no expiration date. During the first quarter of 2024, the Company
and the third-party borrower agreed to amend the note as a result of the decline in the publicly traded common stock price. The amount
of pre-funded warrants exercisable to acquire up to 1,200,000 shares of common stock was amended to 2,000,000 shares of common stock,
and the total principal balance of the note agreement was increased from $1,000,000 to $1,100,000. The aggregate exercise price of this
Warrant was partially pre-funded in connection with $100,000 and a $1,100,000 note receivable at a 6% per annum interest rate due on November
29, 2024. The $1,100,000 outstanding receivable balance is recorded as subscription receivable, a contra equity account within stockholders’
equity (deficit) at June 30, 2024.
On February 8, 2024, the Company granted pre-funded
warrants exercisable to acquire up to 4,000,000
shares of our common stock for net proceeds of $2,400,000. The pre-funded common stock purchase warrants can be exercised at a
price of $0.0001 per share, with no expiration date. The aggregate exercise price of this Warrant was partially pre-funded in connection
with $500,000
and a $1,900,000
note receivable at a 6% per annum interest rate due on December 31, 2024. The $1,900,000 outstanding receivable balance is recorded
as subscription receivable, a contra equity account within stockholders’ equity (deficit) at June 30, 2024.
Treasury Stock – As part of the Merger
in February of 2021, Coeptis Therapeutics, Inc., our wholly-owned subsidiary, repurchased 110,762 shares of its common stock previously
held by shareholders of Vinings Holdings Inc. (the former name of Coeptis Therapeutics, Inc.). The stock was recorded at the cost paid
for it, of $247,165 and held as treasury stock for the duration of 2021. Subsequent to year end, the Company retired the 110,762 shares
of treasury stock, as of February 18, 2022. There was no treasury stock at June 30, 2024 and December 31, 2023.
Preferred Stock – As of June 30,
2024, the Company had 4,300 shares of preferred stock issued and outstanding. As of December 31, 2021, Coeptis Therapeutics, Inc., our
wholly-owned subsidiary, had 8,000 shares of its Series B preferred stock issued and outstanding. The Series B preferred stock was converted
into common equity immediately prior to the consummation of the Business Combination, and the shares of common stock received in such
conversion were exchanged for shares of common stock in the Company at the closing of the Business Combination.
On June 14, 2024, the Company performed an initial
closing and raised $4.3 million in a sale to accredited investors (collectively, the “Series A Investors”) of 4,300 shares
of the Company’s series A preferred stock (the “Series A Preferred Stock”), at a purchase price of $1,000 per share,
in a financing led by CJC Investment Trust, an entity controlled by board member Christopher Calise, in a combination of cash and short-term
collateralized promissory notes. The Series A Investors also received in the aggregate a 6.45% non-voting equity ownership interest in
two of the Company’s newly formed subsidiaries, SNAP Biosciences Inc. and GEAR Therapeutics Inc. The Company anticipates holding the final closing in or around the
month of August 2024. The key terms of the Series A Preferred Stock are as
follows:
Conversion. Each share of Series A Preferred
Stock is convertible at the option of the holder, subject to the beneficial ownership and, if applicable, the primary market limitations
described below, into such number of shares of the Company’s common stock as is equal to the number of shares of Series A Preferred
Stock to be converted, multiplied by the stated value of $1,000 (the “Stated Value”), divided by the then conversion price.
The initial conversion price is $0.40 per share of common stock, subject to adjustment in the event of stock splits, stock dividends,
and similar transactions. In addition, the Series A Preferred Stock will automatically convert into shares of the Company’s common
stock, subject to the beneficial ownership and, if applicable, the primary market limitations described below upon the consummation of
a fundraising transaction in which the Company raises gross proceeds of at least $20 million.
Rank. The Series A Preferred Stock will
be senior to the Company’s common stock and any other class of the Company’s capital stock that is not by its terms senior
to or pari passu with the Series A Preferred Stock.
Dividends. The holders of Series A Preferred
Stock will be entitled to dividends equal, on an as-if-converted to shares of the Company’s common stock basis (in each case after
applying the beneficial ownership and, if applicable, the primary market limitations described below), to and in the same form as dividends
actually paid on shares of the Company’s common stock when, as, and if such dividends are paid on shares of the Company’s
common stock.
Liquidation. In the event of any voluntary
or involuntary liquidation, dissolution or winding up of the Company, the holders of shares of Series A Preferred Stock then outstanding
will be entitled to be paid out of the assets of the Company available for distribution to its stockholders, before any payment shall
be made to the holders of the Company’s common stock by reason of their ownership thereof, an amount per share equal to the greater
of (i) the Stated Value, plus any dividends accrued but unpaid thereon, or (ii) such amount per share as would have been payable had all
shares of Series A Preferred Stock been converted (in each case after applying the beneficial ownership and, if applicable, the primary
market limitations described below) into the Company’s common stock immediately prior to such event.
Voting. On any matter to be acted upon
or considered by the stockholders of the Company, each holder of Series A Preferred Stock shall be entitled to vote on an “as converted”
basis (after applying the beneficial ownership and primary market limitations described below).
Beneficial Ownership Limitation. The Company
will not affect any conversion of the Series A Preferred Stock, and a holder will not have the right to receive dividends or convert any
portion of its Series A Preferred Stock, to the extent that prior to the conversion such holder (together with such holder’s affiliates,
and any persons acting as a group together with such holder or any of the holder’s affiliates) beneficially owns less than 20% of
the Company’s outstanding common stock and, after giving effect to the receipt of dividends or the conversion, the holder (together
with such holder’s affiliates, and any persons acting as a group together with such holder or any of the holder’s affiliates)
would beneficially own 20% or more of the Company’s outstanding common stock.
Exchange Limitation. Unless the approval
of the Company’s stockholders is not required by the applicable rules of Nasdaq for issuances of the Company’s common stock
in excess of 19.99% of the outstanding common stock as of June 14, 2024 (the “Market Limit”), or unless the Company has obtained
such approval, the Company shall not affect any conversion of the Series A Preferred Stock, including, without limitation, any automatic
conversion, and a holder shall not have the right to receive dividends on or convert any portion of the Series A Preferred Stock, to the
extent that, after giving effect to the receipt of the Company’s common stock in connection with such dividends or conversion, the
holder would have received in excess of its pro rata share of the Market Limit.
Stock Based Compensation –
A summary of the Company’s stock option activity is as follows:
| Schedule of stock option activity | |
| | |
| | |
| | |
| |
| | |
Shares Underlying Options | | |
Weighted Average Exercise Price | | |
Weighted Average Contractual Life (Years) | | |
Intrinsic Value | |
| Outstanding at December 31, 2023 | |
| 1,757,500 | | |
$ | 2.01 | | |
| 7.97 | | |
$ | – | |
| Granted | |
| 2,400,000 | | |
| 0.31 | | |
| 10.00 | | |
| | |
| Forfeited | |
| (100,000 | ) | |
| 10.00 | | |
| | | |
| | |
| Exercised | |
| – | | |
| – | | |
| | | |
| | |
| Outstanding at June 30, 2024 | |
| 4,057,500 | | |
$ | 0.81 | | |
| 9.58 | | |
$ | – | |
For the three months ended June 30, 2024 and 2023,
the Company recorded $611,570 and $113,391, respectively, for stock-based compensation expense related to stock options. For the
six months ended June 30, 2024 and 2023, the Company recorded $708,459 and $235,692, respectively, for stock-based compensation expense
related to stock options. As of June 30, 2024, unamortized stock-based compensation for stock options was $1,029,725 to be recognized
through December 31, 2027.
The options granted during the six months ended
June 30, 2024 and 2023 were valued using the Black-Scholes option pricing model using the following weighted average assumptions:
| Schedule of options assumptions | |
| | | |
| | |
| | |
For the six months ended June 30, | |
| | |
2024 | | |
2023 | |
| Expected term, in years | |
| 5.0 | | |
| 5.38 | |
| Expected volatility | |
| 85.84% | | |
| 79.35% | |
| Risk-free interest rate | |
| 4.24% | | |
| 3.66% | |
| Dividend yield | |
| – | | |
| – | |
Options/Stock Awards – On June 13,
2024, the Compensation Committee (the “Compensation Committee”) of the Company’s Board of Directors, and the Board of
Directors, approved the grant to David Mehalick, the Company’s CEO, under the Company’s 2022 equity incentive plan, of options
exercisable to acquire up to 2,400,000 shares of the Company’s common stock at an exercise price $0.31 per share. The options are
fully vested and carry a 10-year term. On January 27, 2023, the Company granted options to purchase an aggregate of 1,357,500 shares of
our common stock under the 2022 Equity Incentive Plan, to various officers, directors, employees and consultants, at an average exercise
price of $1.63 per share. The Company had also granted a stand-alone option to a former employee to purchase up to 100,000 shares of our
common stock at an exercise price of $10 per share, however, the stand-alone option expired by its terms on January 31, 2024. On October
2, 2023, the Company granted additional options to purchase an aggregate of 300,000 shares of our common stock to two employees at an
average price of $1.07.
Common Stock Warrants –
As a result of the Merger on October 28, 2022,
all surviving warrants from Coeptis Therapeutics, Inc. were converted using a 2.9685:1 ratio, and became exercisable to acquire shares
of the Company’s common stock.
On November 23, 2020, Coeptis Therapeutics, Inc.
(under its prior name Vinings Holdings Inc.) issued a class A and a class B warrant to Coral Investment Partners, LP (“CIP”),
with each warrant granting CIP the right to purchase 500,000 shares of common stock at a price of $2 for Class A or $5 for Class B. The
warrants expired on November 30, 2023.
Warrant Holder 1 - On May 28, 2021, Coeptis
Therapeutics, Inc. issued a warrant to a third party in exchange for professional services, granting the warrant holder the right to purchase
500,000 shares of common stock at a price of $1 per share, 500,000 shares at $2 per share, and 500,000 shares at $5 per share. The warrants
expire on June 1, 2026. As part of the call, 2,500 warrants at $1 per share were exercised on July 28, 2022. As of June 30, 2024, the
remaining warrants outstanding are exercisable to acquire 504,460 shares of the Company’s common stock on an as converted basis
resulting from the consummation of the Business Combination in October 2022.
Warrant Holder 2 - On July 30, 2021, Coeptis
Therapeutics, Inc. issued a warrant to a third party in exchange for professional services, granting the warrant holder the right to purchase
200,000 shares of common stock at a price of $1 per share, 100,000 shares at $2 per share, and 100,000 shares at $5 per share. The warrants
expire on July 26, 2026. As part of the call, 5,000 warrants at $1 per share were exercised on March 1, 2022, and 195,000 warrants at
$1 per share and 75,000 warrants at $2 per share were exercised on June 27, 2022. 25,000 warrants at $2 per share expired on September
13, 2022 as a result of the call. As of June 30, 2024, the remaining warrants outstanding are exercisable to acquire 33,687 shares of
the Company’s common stock on an as converted basis resulting from the consummation of the Business Combination in October 2022.
On September 22, 2021, Coeptis Therapeutics, Inc.
issued a warrant in conjunction with the termination of the license right (see Note 3) with Purple, granting Purple the right to purchase
300,000 shares of common stock at $5 per share, subject to certain adjustments. During 2021, the Company recorded $1,897,585 as general
and administrative expense in the condensed consolidated statement of operations upon immediate vesting of the warrant. The warrant was
valued using the Black-Scholes option pricing model using the following assumptions: 1) exercise price of $5.00 per share, 2) fair value
of $6.50 per share, 3) discount rate of 0.48%, 3) dividend rate of 0%, and 4) a term of 3 years. As of June 30, 2024, all warrants remain
outstanding and are exercisable to acquire 101,061 shares of the Company’s common stock on an as converted basis resulting from
the consummation of the Business Combination in October 2022.
Warrant Holder 3 – On December 20,
2021, Coeptis Therapeutics, Inc. issued a warrant to a third party in exchange for services to be provided, granting the warrant holder
the right to purchase 600,000 shares of common stock at a price of $1 per share. The warrants expire on December 20, 2026. As part of
the call, 300,000 of the warrants were transferred to Warrant Holder 4, and 175,000 of the warrants were transferred to Warrant Holder
5. The remaining 115,000 warrants at $1 per share were exercised on August 19, 2022, and 10,000 warrants at $1 per share expired on September
13, 2022 as a result of the call. As of June 30, 2024, none of these warrants were outstanding.
Warrant Holder 4 – On July 13, 2022,
Warrant Holder 3 transferred 300,000 warrants to Warrant Holder 4 with the same terms. As part of a call, 300,000 warrants at $1 per share
were exercised on August 19, 2022. As of June 30, 2024, none of these warrants were outstanding.
Warrant Holder 5 – On September 6,
2022, Warrant Holder 3 transferred 175,000 warrants to Warrant Holder 5 with the same terms, and Warrant Holder 9 transferred 200,000
to Warrant Holder 5 with the same terms. On January 31, 2024, 67,374 warrants at $4.45 per share expired, and as of June 30, 2024, 58,952
warrants remain outstanding on an as converted basis resulting from the consummation of the Business Combination in October 2022.
Warrant Holder 6 – On January 28,
2022, Coeptis Therapeutics, Inc. issued a warrant to a third party in exchange for contemplation of a debt extension, granting the warrant
holder the right to purchase 250,000 shares of common stock at a price of $1.50 per share with an expiration date of January 31, 2024.
The warrants were expensed immediately as a loss on extinguishment of debt. Subsequently, on April 14, 2022, an agreement was executed
with the debt holder extending the maturity of the debt to July 31, 2022 in recognition of the warrants issued on January 28, 2022. This
amendment was treated as a debt modification. On January 31, 2024, 84,217 warrants at $4.45 per share expired, and as of June 30, 2024,
none of these warrants were outstanding.
Warrant Holder 7 - On January 28, 2022,
Coeptis Therapeutics, Inc. issued a warrant to a third party in exchange for contemplation of a debt extension, granting the warrant holder
the right to purchase 400,000 shares of common stock at a price of $1.50 per share with an expiration date of January 31, 2024. The warrants
were expensed immediately as a loss on extinguishment of debt. Subsequently, on April 14, 2022, an agreement was executed with the debt
holder extending the maturity of the debt to July 31, 2022 in recognition of the warrants issued on January 28, 2022. This amendment was
treated as a debt modification. On January 31, 2024, 134,747 warrants at $4.45 per share expired, and as of June 30, 2024, none of these
warrants were outstanding.
Warrant Holder 8 – On January 28,
2022, Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the warrant holder
the right to purchase 775,000 shares of common stock at a price of $1.50 per share with an expiration date of January 31, 2024. As part
of the call, 775,000 warrants at $1.50 per share were exercised on September 14, 2022. As of June 30, 2024, none of these warrants were
outstanding.
Warrant Holder 9 - On January 28, 2022,
Coeptis Therapeutics, Inc. issued a warrant to a third party in exchange for professional services, granting the warrant holder the right
to purchase 200,000 shares of common stock at a price of $1.50 per share with an expiration date of January 31, 2024. As part of the call,
all 200,000 warrants at $1.50 per share were transferred to Warrant Holder 5. As of June 30, 2024, none of these warrants were outstanding.
Warrant Holder 10 - On January 28, 2022,
Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the warrant holder the right
to purchase 350,000 shares of common stock at a price of $1.50 per share with an expiration date of January 31, 2024. As part of the call,
53,334 warrants at $1.50 per share were exercised on March 1, 2022, 50,000 warrants at $1.50 per share were exercised on August 19, 2022
and 246,666 warrants at $1.50 per share were exercised on September 14, 2022. As of June 30, 2024, none of these warrants were outstanding.
Warrant Holder 11 - On January 28, 2022,
Coeptis Therapeutics, Inc. issued a warrant to a third party in exchange for professional services, granting the warrant holder the right
to purchase 150,000 shares of common stock at a price of $1 per share and 150,000 shares at $2 per share, with an expiration date of January
31, 2024. On April 14, 2022, the Company issued an additional warrant in exchange for professional services, granting the warrant holder
the right to purchase an additional 170,000 shares of common stock at a price of $1.50 per share with an expiration date of January 31,
2024. On January 31, 2024, 50,530 warrants at $2.97 per share, 50,530 warrants at $5.94 per share, and 57,268 warrants at $4.45 per share
expired. As of June 30, 2024, none of these warrants were outstanding.
Warrant Holder 12 - On January 28, 2022,
Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the warrant holder the right
to purchase 1,018,050 shares of common stock at a price of $1.50 per share with an expiration date of January 31, 2024. As part of the
call, 100,000 warrants at $1.50 per share were exercised on August 19, 2022, and 918,050 warrants at $1.50 per share were exercised on
September 14, 2022. As of June 30, 2024, none of these warrants were outstanding.
Warrant Holder 13 - On January 28, 2022,
Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the warrant holder the right
to purchase 225,000 shares of common stock at a price of $1.50 per share with an expiration date of January 31, 2024. As part of the call,
15,000 warrants at $1.50 per share were exercised on March 1, 2022, and 210,000 warrants at $1.50 per share were exercised on September
14, 2022. As of June 30, 2024, none of these warrants were outstanding.
Warrant Holder 14 - On January 28, 2022,
Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the warrant holder the right
to purchase 100,000 shares of common stock at a price of $1 per share with an expiration date of January 31, 2024. As part of the call,
100,000 warrants at $1 per share were exercised on August 19, 2022. As of June 30, 2024, none of these warrants were outstanding.
Warrant Holder 15 - On January 28, 2022,
Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the warrant holder the right
to purchase 100,000 shares of common stock at a price of $1.50 per share with an expiration date of January 31, 2024. As part of the call,
100,000 warrants at $1.50 per share were exercised on September 14, 2022. As of June 30, 2024, none of these warrants were outstanding.
Warrant Holder 16 - On January 28, 2022,
Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the warrant holder the right
to purchase 100,000 shares of common stock at a price of $1.50 per share with an expiration date of January 31, 2024. As part of the call,
25,000 warrants at $1.50 per share were exercised on June 27, 2022, and 75,000 warrants at $1.50 per share were exercised on September
14, 2022. As of June 30, 2024, none of these warrants were outstanding.
Warrant Holder 17 - On January 28, 2022,
Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the warrant holder the right
to purchase 52,050 shares of common stock at a price of $1.50 per share with an expiration date of January 31, 2024. As part of the call,
52,050 warrants at $1.50 per share were exercised on September 14, 2022. As of June 30, 2024, none of these warrants were outstanding.
Warrant Holder 18 - On March 30, 2022,
Coeptis Therapeutics, Inc., issued a warrant to a third party in conjunction with an investment, granting the warrant holder the right
to purchase 250,000 shares of common stock at a price of $3 per share. On March 30, 2024, 84,217 warrants at $8.91 per share expired.
As of June 30, 2024, none of these warrants were outstanding.
Warrant Holder 19 - On March 30, 2022,
Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the warrant holder the right
to purchase 300,000 shares of common stock at a price of $1.50 per share. The warrants expire on April 1, 2027. As part of the call, 300,000
warrants at $1.50 per share were exercised on September 14, 2022. As of June 30, 2024, none of these warrants were outstanding.
Warrant Holder 20 - On January 3, 2023,
Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the warrant holder the right
to purchase 100,000 shares of common stock at a price of $2.50 per share. The warrants expire on January 2, 2027. As of June 30, 2024,
all warrants remain outstanding.
Warrant Holder 21 - On January 3, 2023,
Coeptis Therapeutics, Inc., issued a warrant to a third party in exchange for professional services, granting the warrant holder the right
to purchase 250,000 shares of common stock at a price of $1.90 per share. The warrants expire on January 19, 2027. As of June 30, 2024,
all warrants remain outstanding.
Warrant Holder 22 – On June 16, 2023,
Coeptis Therapeutics, Inc., issued a warrant to a third party in conjunction with an investment, granting the warrant holder the right
to purchase 126,000 shares of common stock at a price of $1.25 per share. The warrants expire on December 16, 2028. On October 23, 2023,
the Company issued an additional warrant in conjunction with an investment, granting the warrant holder the right to purchase an additional
66,000 shares of common stock at a price of $1.40 per share. The warrants expire on April 26, 2029. As of June 30, 2024, all warrants
remain outstanding.
Warrant Holder 23 – On June 16, 2023,
Coeptis Therapeutics, Inc., issued a warrant to a third party in conjunction with an investment, granting the warrant holder the right
to purchase 84,000 shares of common stock at a price of $1.25 per share. The warrants expire on December 16, 2028. On October 23, 2023,
the Company issued an additional warrant in conjunction with an investment, granting the warrant holder the right to purchase an additional
48,000 shares of common stock at a price of $1.40 per share. The warrants expire on April 26, 2029. As of June 30, 2024, all warrants
remain outstanding.
Warrant Holder 24 – On October 23,
2023, Coeptis Therapeutics, Inc., issued a warrant to a third party in conjunction with an investment, granting the warrant holder the
right to purchase 6,000 shares of common stock at a price of $1.40 per share. The warrants expire on April 26, 2029. As of June 30, 2024,
all warrants remain outstanding.
On April 19, 2022, Coeptis Therapeutics, Inc.
initiated a warrant conversion call for certain warrants and on April 20, 2022, for additional warrants. The original expiration for the
warrant conversions was set as May 19, 2022, and May 20, 2022. The expiration date was extended and moved to June 30, 2022. A second extension
moved the expiration to July 15, 2022, and the third extension moved the expiration date for the warrant conversions to August 1, 2022.
The final extension was extended and moved to September 13, 2022. Warrants that were part of the call and not exercised by this date have
expired.
The warrants listed above and issued since May
28, 2021 and as of June 30, 2024 were valued using the Black-Scholes option pricing model using the following assumptions: 1) exercise
price ranging from $1.40 to $14.84 per share, 2) fair value ranging from $1.36 to $6.00 per share, 3) discount rate ranging from 1.15%
to 4.81%, 3) dividend rate of 0%, and 4) a term ranging from 2 to 5 years. The warrants listed below were not valued using the Black-Scholes
option pricing model.
As above, on June 16, 2023, the Company completed
a public offering issuing 1,350,000 pre-funded warrants, 3,062,500 Series A Warrants and 3,062,500 Series B Warrants. The pre-funded warrants
are immediately exercisable, at a price of $0.0001 per share, with no expiration date. As of June 30, 2024, all of the of the pre-funded
warrants had been exercised for a total of 3,500,000 shares of common stock issued as a result of the public offering. The Series A Warrants
and the Series B Warrants are referred to herein together as the “Series Warrants.” The shares of common stock and Series
Warrants were purchased together and then immediately separable and were issued separately. Each Series Warrant to purchase one share
of common stock has an exercise price of $1.65 per share, and is initially exercisable commencing six months from the date of the offering.
The Series Warrants are exercisable for a term of five years following the initial exercise date.
As above, on October 26, 2023, the Company completed
a private placement of pre-funded warrants exercisable to acquire up to 1,223,000 shares of our common stock, Series A Warrants exercisable
to acquire up to 2,000,000 shares of our common stock and Series B Warrants exercisable to acquire up to 2,000,000 shares of our common
stock. The Pre-funded warrants are immediately exercisable, at a price of $0.001 per share, with no expiration date. As of June 30, 2024,
all of the of the pre-funded warrants had been exercised for a total of 2,000,000 shares of common stock issued as a result of the private
placement. The Series A Warrants and the Series B Warrants are referred to herein together as the “Series Warrants.” The shares
of common stock and Series Warrants were purchased together and then immediately separable and were issued separately. The Series A Warrants
and Series B Warrants are exercisable on or after the earlier of (i) the date on which the Company’s stockholders approve the issuance
of the shares issuable upon exercise of the Series Warrants or (ii) April 26, 2024 at an exercise price of $1.36 per share. The Series
A Warrants have a term of exercise equal to eighteen (18) months and the Series B Warrants have a term of exercise equal to 5 and one-half
(5.5) years. This private placement was conducted with the same underwriter as the June public offering, and as a result, each Series
Warrant issued in connection with the June offering was repriced from an exercise price of $1.65 per share to $1.36 per share. In connection
with the private placement the Company also issued to the exclusive placement agent warrants exercisable to acquire up to 120,000 shares
of our common stock at an exercise price of $1.40 per share.
As discussed above, on December 28, 2023, the
Company granted pre-funded warrants exercisable to acquire up to 1,200,000 shares of our common stock for net proceeds of $1,200,000.
During the first quarter of 2024, the Company and the third-party borrower agreed to amend the note as a result of the decline in the
publicly traded common stock price. The amount of pre-funded warrants exercisable to acquire up to 1,200,000 shares of common stock was
amended to 2,000,000 shares of common stock, and the total principal balance of the note agreement was increased from $1,000,000 to $1,100,000.
As discussed above, On February 8, 2024, the
Company granted pre-funded warrants exercisable to acquire up to 4,000,000
shares of our common stock for net proceeds of $2,400,000.
All warrants outstanding, regardless of valuation
method are listed below:
| Schedule of warrants outstanding | |
| |
| | |
| | |
| | |
| |
| | |
| |
| | | |
| | | |
| Outstanding at | |
| Reference | |
Date Issued | |
| Exercise price | | |
| Expiration | | |
| June 30, 2024 | | |
| December 31, 2023 | |
| Warrant Holder 1 | |
5/28/2021 | |
$ | 2.97 | | |
| 5/13/2026 | | |
| 167,592 | | |
| 167,592 | |
| Warrant Holder 1 | |
5/28/2021 | |
$ | 5.94 | | |
| 5/13/2026 | | |
| 168,434 | | |
| 168,434 | |
| Warrant Holder 1 | |
5/28/2021 | |
$ | 14.84 | | |
| 5/13/2026 | | |
| 168,434 | | |
| 168,434 | |
| Warrant Holder 2 | |
7/30/2021 | |
$ | 2.97 | | |
| 7/30/2026 | | |
| 8,422 | | |
| 8,422 | |
| Warrant Holder 2 | |
7/30/2021 | |
$ | 14.84 | | |
| 6/1/2026 | | |
| 25,265 | | |
| 25,265 | |
| Kitov/Purple Biotech | |
9/23/2021 | |
$ | 14.84 | | |
| 9/21/2024 | | |
| 101,061 | | |
| 101,061 | |
| Warrant Holder 5 | |
12/20/2021 | |
$ | 2.97 | | |
| 12/20/2026 | | |
| 58,952 | | |
| 58,952 | |
| Warrant Holder 5 | |
1/28/2022 | |
$ | 4.45 | | |
| 1/31/2024 | | |
| – | | |
| 67,374 | |
| Warrant Holder 6 | |
1/28/2022 | |
$ | 4.45 | | |
| 1/31/2024 | | |
| – | | |
| 84,217 | |
| Warrant Holder 7 | |
1/28/2022 | |
$ | 4.45 | | |
| 1/31/2024 | | |
| – | | |
| 134,747 | |
| Warrant Holder 11 | |
1/28/2022 | |
$ | 2.97 | | |
| 1/31/2024 | | |
| – | | |
| 50,530 | |
| Warrant Holder 11 | |
1/28/2022 | |
$ | 5.94 | | |
| 1/31/2024 | | |
| – | | |
| 50,530 | |
| Warrant Holder 11 | |
4/14/2022 | |
$ | 4.45 | | |
| 1/31/2024 | | |
| – | | |
| 57,268 | |
| Warrant Holder 18 | |
3/30/2022 | |
$ | 8.91 | | |
| 3/30/2024 | | |
| – | | |
| 84,217 | |
| Warrant Holder 20 | |
1/3/2023 | |
$ | 2.50 | | |
| 1/2/2027 | | |
| 100,000 | | |
| 100,000 | |
| Warrant Holder 21 | |
1/20/2023 | |
$ | 1.90 | | |
| 1/19/2027 | | |
| 250,000 | | |
| 250,000 | |
| Series A & B Warrants | |
6/16/2023 | |
$ | 1.36 | | |
| 12/16/2028 | | |
| 6,125,000 | | |
| 6,125,000 | |
| Series A Warrants | |
10/26/2023 | |
$ | 1.36 | | |
| 4/26/2025 | | |
| 2,000,000 | | |
| 2,000,000 | |
| Series B Warrants | |
10/26/2023 | |
$ | 1.36 | | |
| 4/26/2029 | | |
| 2,000,000 | | |
| 2,000,000 | |
| Warrant Holder 22 | |
6/16/2023 | |
$ | 1.25 | | |
| 12/16/2028 | | |
| 126,000 | | |
| 126,000 | |
| Warrant Holder 22 | |
10/26/2023 | |
$ | 1.40 | | |
| 4/26/2029 | | |
| 66,000 | | |
| 66,000 | |
| Warrant Holder 23 | |
6/16/2023 | |
$ | 1.25 | | |
| 12/16/2028 | | |
| 84,000 | | |
| 84,000 | |
| Warrant Holder 23 | |
10/26/2023 | |
$ | 1.40 | | |
| 4/26/2029 | | |
| 48,000 | | |
| 48,000 | |
| Warrant Holder 24 | |
10/26/2023 | |
$ | 1.40 | | |
| 4/26/2029 | | |
| 6,000 | | |
| 6,000 | |
| Pre-Funded Warrants 2 | |
12/28/2023 | |
$ | 0.0001 | | |
| – | * | |
| 1,200,000 | | |
| 1,200,000 | |
| Pre-Funded Warrants 3 | |
2/8/2024 | |
$ | 0.0001 | | |
| – | * | |
| 4,000,000 | | |
| – | |
| | |
Total Warrants outstanding | | |
| | | |
| 16,703,160 | | |
| 13,232,043 | |
Subscription receivable - In September
2023, the Company agreed to issue 500,000 shares of common stock to the borrower for a principal sum amount of $500,000. The $500,000
outstanding receivable balance is recorded as subscription receivable, a contra equity account within stockholders’ equity (deficit)
at June 30, 2024. See Note 11 for further detail.
In September 2023, the Company agreed to issue
2,000,000 shares of common stock to the borrower for a principal sum amount of $2,000,000. The $2,000,000 outstanding receivable balance
is recorded as subscription receivable, a contra equity account within stockholders’ equity (deficit) at June 30, 2024.
As discussed above, in December 2023, the Company
agreed to grant pre-funded warrants exercisable to acquire up to 1,200,000 shares of common stock to the borrower for a principal sum
amount of $1,000,000. During the first quarter of 2024, the Company and the third-party borrower agreed to amend the note as a result
of the decline in the publicly traded common stock price. The amount of pre-funded warrants exercisable to acquire up to 1,200,000 shares
of common stock was amended to 2,000,000 shares of common stock, and the total principal balance of the note agreement was increased from
$1,000,000 to $1,100,000. The $1,100,000 outstanding receivable balance is recorded as subscription receivable, a contra equity account
within stockholders’ equity (deficit) at June 30, 2024.
As discussed above, in February 2024, the Company
agreed to grant pre-funded warrants exercisable to acquire up to 4,000,000
shares of common stock to the borrower for a principal sum amount of $1,900,000.
The $1,900,000
outstanding receivable balance is recorded as subscription receivable, a contra equity account within stockholders’ equity (deficit)
at June 30, 2024.
NOTE 6 – NON-CONTROLLING INTEREST
As a result of the series A preferred stock offering discussed in Note
5, Capital Structure, the Company has consolidated the two newly formed subsidiaries, SNAP Biosciences Inc. and GEAR Therapeutics Inc.,
because we have a controlling interest in both. Therefore, the entities’ financial statements are consolidated in our condensed
consolidated financial statements and the entities’ other equity is recorded as a non-controlling interest. As part of the initial
closing, the Series A Investors received in the aggregate a 6.45% non-voting equity ownership in both of the newly formed subsidiaries.
The Company contributed the co-development options to GEAR Therapeutics Inc. and recorded $132,494 of non-controlling interest at June
30, 2024. The remainder was recorded as additional paid in capital. No assets have been contributed to SNAP Biosciences Inc. as of June 30,
2024.
NOTE 7 – COMMITMENTS AND CONTINGENCIES
Leases - The Company leases office space
under an operating lease that commenced December 1, 2017 through November 30, 2019 and a first lease extension commencing December 1,
2019 through May 31, 2020. The second lease extension extended the lease for twenty-four months, beginning on June 1, 2020 and ended on
May 31, 2022. The third lease extension extended the lease for twenty-four months, beginning on June 1, 2022 and ended on May 31, 2024.
The fourth lease extension, signed on January 30, 2024, extends the lease for twenty-four months, beginning June 1, 2024 and ending on
May 31, 2026. The monthly rent is $3,805 for the first year of the extension and increasing to $3,860 for the second year of the extension.
On January 1, 2019, the Company adopted ASC Topic
842, Leases, requiring this lease to be recorded as an asset and corresponding liability on its condensed consolidated balance
sheet. The Company records rent expense associated with this lease on the straight-line basis in conjunction with the terms of the underlying
lease. During the three and six months ended June 30, 2024, rents paid totaled $11,250 and $22,555, respectively.
Future minimum rental payments required under
the lease are as follows:
| Schedule of future minimum rental payments |
|
|
|
| 2024 |
|
$ |
22,830 |
|
| 2025 |
|
|
46,101 |
|
| 2026 |
|
|
19,301 |
|
| Total minimum lease payments: |
|
|
88,232 |
|
| Less amount representing interest |
|
|
(7,493 |
) |
| Present value of minimum lease payments: |
|
$ |
80,739 |
|
As of June 30, 2024, the Company had recorded
a right of use asset of $79,104, and current and non-current lease liabilities of $19,560 and $61,179, respectively.
Legal Matters – The Company is currently
not a defendant in any litigation or threatened litigation that could have a material effect on the Company’s condensed consolidated
financial statements.
University of Pittsburgh Option Agreement
- On April 29, 2022, the Company entered into an exclusive option agreement with University of Pittsburgh for rights to three chimeric
antigen receptor T cell (“CAR T”) technologies that offer the potential to address a range of hematologic and solid tumors.
Among the initial cancer indications under development are pre-clinical programs targeting breast cancer and ovarian cancer. The exclusive
option agreement involves the intellectual property rights to three technologies jointly developed in the laboratories of Jason Lohmueller,
Ph.D., Assistant Professor of Immunology; Alexander Deiters, Ph.D., Professor of Chemistry; and Olivera Finn, Ph.D., Professor of Immunology:
1) mSA2 affinity-enhanced biotin-binding CAR, 2) universal self-labeling SynNotch and CARs for programable antigen-targeting, and 3) conditional
control of universal CAR T-cells through stimulus-reactive adaptors. Per the option agreement, the Company paid the University of Pittsburgh a
non-refundable fee of $5,000 for the exclusive option to license the patent rights to each of the three technologies. On October 16, 2023,
the Company terminated the remaining portion of the option agreement with the University of Pittsburgh.
CAR T License - On August 31, 2022, the
Company entered into an exclusive license agreement with the University of Pittsburgh for certain intellectual property rights related
to the universal self-labeling SynNotch and CARs for programable antigen-targeting technology platform. The Company paid the University
of Pittsburgh a non-refundable fee in the amount of $75,000 for the exclusive patent rights to the licensed technology. Under the terms
of the agreement, the Company has been assigned the worldwide development and commercialization rights to the licensed technology in the
field of human treatment of cancer with antibody or antibody fragments using SNAP-CAR T-cell technology, along with (i) an intellectual
property portfolio consisting of issued and pending patents and (ii) options regarding future add-on technologies and developments. In
consideration of these rights, the Company paid an initial license fee of $75,000, and will have annual maintenance fees ranging between
$15,000 and $25,000, as well as developmental milestone payments (as defined in the agreement) and royalties equal to 3.5% of net sales.
On January 25, 2023, the Company entered into a corporate research agreement with the University of Pittsburgh for the pre-clinical development
of SNAP-CAR T-cells targeting HER2. The Company agreed to pay $716,714 for performance-based milestones over a two-year term, and no payments
have been made as of June 30, 2024.
In September 2023, the Company expanded its exclusive
license agreement with the University of Pittsburgh to include SNAP-CAR technology platform in natural killer (NK) cells. The Company
agreed to pay $2,000 to amend the agreement.
Deverra Therapeutics, Inc. – On August
16, 2023, the Company entered into an exclusive licensing arrangement (the “License Agreement”) with Deverra Therapeutics
Inc. (“Deverra”), pursuant to which the Company completed the exclusive license of key patent families and related intellectual
property related to a proprietary allogeneic stem cell expansion and directed differentiation platform for the generation of multiple
distinct immune effector cell types, including natural killer (NK) and monocyte/macrophages. The License Agreement provides the Company
with exclusive rights to use the license patents and related intellectual property in connection with development and commercialization
efforts in the defined field of use (the “Field”) of (a) use of unmodified NK cells as anti-viral therapeutic for viral infections,
and/or as a therapeutic approach for treatment of relapsed/refractory AML and high-risk MDS; (b) use of Deverra’s cell therapy platform
to generate NK cells for the purpose of engineering with Coeptis SNAP-CARs and/or Coeptis GEAR Technology; and (c) use of Deverra’s
cell therapy platform to generate myeloid cells for the purpose of engineering with the Company’s current SNAP-CAR and GEAR technologies.
In support of the exclusive license, the Company also entered into with Deverra (i) an asset purchase agreement (the “APA”)
pursuant to which the Company purchased certain assets from Deverra, including but not limited to two Investigational New Drug (IND) applications
and two Phase 1 clinical trial stage programs (NCT04901416, NCT04900454) investigating infusion of DVX201, an unmodified natural killer
(NK) cell therapy generated from pooled donor CD34+ cells, in hematologic malignancies and viral infections and (ii) a non-exclusive sublicense
agreement (the “Sublicense Agreement”), in support of the assets obtained by the exclusive license, pursuant to which the
Company sublicensed from Deverra certain assets which Deverra has rights to pursuant a license agreement (“FHCRC Agreement”)
by and between Deverra and The Fred Hutchinson Cancer Research Center (“FHCRC”).
As consideration for the transactions described
above, the Company paid Deverra approximately $570,000 in cash, issued to Deverra 4,000,000 shares of the Company’s common stock
and assumed certain liabilities related to the ongoing clinical trials. Total consideration paid was $4,937,609, which was fully expensed
in accordance with ASC 730, and is reflected within research and development in the accompanying consolidated statement of operations
for the year ended December 31, 2023. In addition, in accordance with the terms of the Sublicense Agreement, the Company agreed to pay
FHCRC certain specified contingent running royalty payments and milestone payments under the FHCRC Agreement, in each case to the extent
such payments are triggered by the Company’s development activities.
On October 26, 2023, the Company entered into
a Shared Services Agreement (“SSA”) with Deverra, in accordance with requirements set forth in the APA. Under the terms of
the SSA, Coeptis and Deverra will share resources and collaborate to further the development of Coeptis’ GEAR and SNAP-CAR platforms,
as well as the purchased and licensed assets under the License Agreement and APA. The SSA expires on October 26, 2024.
Registration Rights
Pursuant to a registration rights agreement entered
into on October 29, 2020, the holders of the founder shares, the Private Placement Warrants and underlying securities, and any securities
issued upon conversion of Working Capital Loans (and underlying securities) would be entitled to registration rights pursuant to a registration
rights agreement. The holders of at least a majority in interest of the then-outstanding number of these securities were entitled to make
up to three demands, excluding short form demands, that the Company register such securities. In addition, the holders have certain “piggy-back”
registration rights with respect to registration statements filed subsequent to the consummation of a Business Combination. Notwithstanding
the foregoing, Imperial, I-Bankers and Northland did not exercise their demand and “piggyback” registration rights after five
(5) and seven (7) years after the effective date of the registration statement and did not exercise its demand rights on more than one
occasion. The registration rights agreement did not contain liquidating damages or other cash settlement provisions resulting from delays
in registering the Company’s securities. The Company would bear the expenses incurred in connection with the filing of any such
registration statements.
NOTE 8 - 401(k) PROFIT-SHARING PLAN
The Company sponsors a qualified profit-sharing
plan with a 401(k) feature that covers all eligible employees. Participation in the 401(k) feature of the plan is voluntary. Participating
employees may defer up to 100% of their compensation up to the maximum prescribed by the Internal Revenue Code. The plan permits for employee
elective deferrals but has no contribution requirements for the Company. During the three and six month periods ended June 30, 2024 and
2023, no employer contributions were made.
NOTE 9 – INCOME TAXES
For the three and six months ended June 30, 2024 and 2023, respectively, no income tax expense
or benefit was recognized. The Company’s deferred tax assets are comprised primarily of net operating loss carryforwards. The Company
maintains a full valuation allowance on its deferred tax assets since it has not yet achieved sustained profitable operations. As a result,
the Company has not recorded any income tax benefit since its inception.
NOTE 10 – NOTES RECEIVABLE
On July 19, 2023 the Company (“Lender”)
entered into a Senior Secured Note agreement with Deverra (“Borrower”). The Company agreed to make advances of principal to
the Borrower of up to an aggregate amount equal to $572,000. Any advances are at the sole discretion of the Company. The outstanding unpaid
principal balance of the note bears interest at 3% per annum and is due and payable on the maturity date, September 30, 2023.
In the event that a certain business transaction
between the Lender and Borrower as contemplated by that certain binding term sheet dated April 13, 2023, and referenced in Note 7, is
consummated prior to the maturity date, the full amounts due under this note shall be applied against the cash portion of any closing
payment due from the Lender in connection with such transaction and any excess amounts under this note shall be treated as additional
purchase price in connection with the transaction.
As of September 30, 2023, and in relation to the
Deverra asset purchase referenced in Note 7, $567,609 of principal and $2,892 of interest were applied against the cash portion of the
closing payment with the Company in connection with such transaction. The note is considered paid in full.
NOTE 11 – RELATED PARTY TRANSACTION
In September 2023, the Company entered
into a transaction with AG Bio Life Capital I LP (“AG”), a Delaware limited partnership, where an employee of the Company
is the general partner. The Company agreed to issue 600,000 shares of common stock of the Company (“AG Shares”) to AG, in
exchange for $600,000, $100,000 payable in cash and the balance payable under a promissory note (“AG Note”). The principal
amount including all interest under the AG Note is due and payable by AG no later than August 30, 2024 (the “AG Maturity Date”).
The outstanding unpaid principal balance of the AG Note bears interest commencing as of the Company’s next registration statement
at the rate of six (6%) percent per annum, which interest rate will increase to eighteen (18%) percent per annum in the event an event
of default occurs under the AG Note, computed on the basis of the actual number of days elapsed and a year of 365 days. AG has the option
of repaying the obligations under the AG Note in advance of the AG Maturity Date, in whole or in part, at any time upon at least thirty
(30) days prior written notice delivered to the Company. AG has certain obligations to contribute the proceeds of the sale of its AG Shares
to the Company, in the event that any AG Shares are sold prior to the AG Maturity Date.
NOTE 12 – SUBSEQUENT EVENTS
Management has performed a review of all events
and transactions occurring after June 30, 2024 for items that would require adjustment to or disclosure in the accompanying condensed
consolidated financial statements, noting no such items or transactions other than the following.
On July 31, 2024, the Company performed a second
closing as part of its series A preferred stock offering and raised $1.3 million, at a purchase price of $1,000 per share. The Series
A Investors currently have an aggregate 8.40% non-voting equity ownership interest in the Company’s two newly formed subsidiaries,
SNAP Biosciences Inc. and GEAR Therapeutics Inc. See Note 5, Capital Structure, for further information regarding the series A preferred
stock offering.
On August 12, 2024, the Company satisfied $5.7
million of subscription receivables in the form of shares of common stock in two privately held companies. The shares of common stock
will be carried as an investment on the Company’s balance sheet.
| Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
As discussed elsewhere
in this Quarterly Report on Form 10-Q, pursuant to the Merger, we acquired our primary operating subsidiary Coeptis Therapeutics, Inc.
The Merger was accounted for as a “reverse merger,” and Coeptis Therapeutics, Inc. was deemed to be the accounting acquirer
in the Merger. Consequently, the financial condition, results of operations and cash flows discussed in this Management’s Discussion
and Analysis of Financial Condition and Results of Operations discussed below are those of Coeptis Therapeutics, Inc. and its consolidated
subsidiaries. When we use words in this section like “we,” “us”, “our,” the “Company”
and words of the like, unless otherwise indicated, we are referring to the operations of our wholly-owned subsidiaries, including Coeptis
Therapeutics, Inc.
Forward-Looking Statements
This Report contains certain forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and Section 12E of the Securities Exchange Act of 1934, including
or related to our future results, certain projections and business trends. Assumptions relating to forward-looking statements involve
judgments with respect to, among other things, future economic, competitive and market conditions and future business decisions, all of
which are difficult or impossible to predict accurately and many of which are beyond our control. When used in this Report, the words
“estimate,” “project,” “intend,” “believe,” “expect” and similar expressions
are intended to identify forward-looking statements. Although we believe that assumptions underlying the forward-looking statements are
reasonable, any of the assumptions could prove inaccurate, and we may not realize the results contemplated by the forward-looking statement.
Management decisions are subjective in many respects and susceptible to interpretations and periodic revisions based on actual experience
and business developments, the impact of which may cause us to alter our business strategy or capital expenditure plans that may, in turn,
affect our results of operations. In light of the significant uncertainties inherent in the forward-looking information included in this
Report, you should not regard the inclusion of such information as our representation that we will achieve any strategy, objective or
other plans. The forward-looking statements contained in this Report speak only as of the date of this Report as stated on the front cover,
and we have no obligation to update publicly or revise any of these forward-looking statements. These and other statements which are not
historical facts are based largely on management’s current expectations and assumptions and are subject to a number of risks and
uncertainties that could cause actual results to differ materially from those contemplated by such forward-looking statements. These risks
and uncertainties include, among others, the failure to successfully develop a profitable business, delays in identifying customers, and
the inability to retain a significant number of customers, as well as the risks and uncertainties described in “Risk Factors”
section to our Annual Report for the fiscal year ended December 31, 2023.
When we use words like “we,” “us”,
“our,” the “Company” and words of the like, unless otherwise indicated, we are referring to the operations of
us and our wholly-owned subsidiaries Coeptis Therapeutics, Inc. and Coeptis Pharmaceuticals, Inc. (“Coeptis”).
Objective
The objective of our Management’s Discussion
and Analysis of Financial Condition and Results of Operations (“MD&A”) is to provide users of our condensed consolidated
financial statements with the following:
| |
· |
A narrative explanation from the perspective of management of our financial condition, results of operations, cash flows, liquidity and certain other factors that may affect future results; |
| |
|
|
| |
· |
Useful context to the condensed consolidated financial
statements; and |
| |
|
|
| |
· |
Information that allows assessment of the likelihood that past performance is indicative of future performance. |
Our MD&A is provided as a supplement to, and should be read together
with, our unaudited condensed consolidated financial statements for the three and six months ended June 30, 2024 and 2023, included in
Part I, Item 1 of this Form 10-Q.
Company History
General. The Company was originally
incorporated in the British Virgin Islands on November 27, 2018 under the name Bull Horn Holdings Corp. On October 27, 2022, Bull Horn
Holdings Corp. domesticated from the British Virgin Islands to the State of Delaware. On October 28, 2022, in connection with the closing
of the Merger, the Company changed its corporate name from Bull Horn Holdings Corp. to “Coeptis Therapeutics Holdings, Inc.”
The Merger Transaction. On October
28, 2022, a wholly-owned subsidiary of Bull Horn Holdings Corp., merged with and into Coeptis Therapeutics, Inc., with Coeptis Therapeutics,
Inc. as the surviving corporation of the Merger. As a result of the Merger, the Company acquired the business of Coeptis Therapeutics,
Inc., which now continues its existing business operations as the Company’s wholly-owned subsidiary.
About the Company’s Subsidiaries.
The Company now operates through its direct and indirect wholly-owned subsidiaries Coeptis Therapeutics, Inc., Coeptis Pharmaceuticals,
Inc. and Coeptis Pharmaceuticals, LLC.
Issuance under Merger Transaction. Simultaneously
with the closing of the Merger, all of the issued and outstanding shares of Coeptis Therapeutics, Inc. common stock (including the shares
of common stock underlying Coeptis’ series B preferred stock) converted, on a 2.96851721 for 1 basis, into shares of our Common
Stock. As of the Merger, there were no Coeptis options outstanding, and there were warrants outstanding to purchase an aggregate of 4,642,500
shares of Coeptis common stock at an average exercise price of $2.67 per share, which warrants converted on the closing of the Merger
into warrants to purchase an aggregate of 1,563,912 shares of our Common Stock at an average exercise price of $7.93 per share.
On the closing of the Merger, the former Coeptis
common stock was exchanged for the right to receive 17,270,079 shares of our Common Stock (including 2,694,948 shares of Common Stock
issued in exchange for the Coeptis series B preferred stock issued and outstanding). Our common stockholders before the Merger retained
2,246,760 shares of our Common Stock. As a result, immediately following the closing of the Merger, Coeptis’ former stockholders
and our then existing stockholders held approximately 88% and 12%, respectively, of the total combined voting power of all classes of
our stock entitled to vote.
The Merger was treated as a recapitalization of
the Company, and was accounted for as a “reverse merger,” and Coeptis was deemed to be the acquirer in the reverse merger.
Consequently, the assets and liabilities and the historical operations reflected in the condensed consolidated financial statements prior
to the Merger are those of Coeptis, and the condensed consolidated financial statements after completion of the Merger include the assets
and liabilities of Coeptis, historical operations of Coeptis and operations of Coeptis from the closing of the Merger.
Company History of Coeptis Therapeutics, Inc.
Coeptis Pharmaceuticals, LLC was formed on July
12, 2017 as a Pennsylvania multi-member limited liability company. On December 1, 2018, the members of LLC contributed their interest
to a newly formed corporation, Coeptis Pharmaceuticals, Inc. As of December 1, 2018, the LLC became a disregarded single-member limited
liability company which is wholly owned by the newly formed corporation. On February 12, 2021, Vinings Holdings, Inc., a Delaware corporation
(“Vinings”), merged (the “Merger”) with and into Coeptis Pharmaceuticals, Inc. On July 12, 2021, the company legally
changed its name from Vinings Holdings, Inc. to Coeptis Therapeutics, Inc. Coeptis was the surviving corporation of that Merger. As a
result of the Merger, Vinings acquired the business of Coeptis and will continue the existing business operations of Coeptis as a wholly
owned subsidiary. The Merger was treated as a recapitalization of the Company for financial accounting purposes. The historical financial
statements of Vinings before the Merger were replaced with the historical financial statements of Coeptis before the Merger in all future
filings with the Securities and Exchange Commission (the “SEC”).
Overview and Outlook
We are a biopharmaceutical company which owns,
acquires, and develops cell therapy technologies for cancer and other diseases. Our products and technologies are intended to be commercialized
in the US and other major markets throughout the world. Since our inception in 2017, we have acquired and commercialized two drug products
for the US market, which were approved as 505b2 applications. These anti-hypertension products were launched into the US market during
2020 through a marketing partner. At launch, the sales and promotional efforts were significantly impeded by the limitation of the global
pandemic and as such, we have since abandoned all activities and ownership pertaining to both products. We also began the development
of several ANDA products which we divested in 2019 to a larger generic pharmaceutical drug manufacturer, and have moved away from focusing
on the commercialization of generic products. In early 2021, we entered into strategic partnerships to co-develop improved therapies for
the auto-immune and oncology markets. Following the reverse merger transaction, we continue to focus on identifying and investing resources
into innovative products and technologies which we believe will significantly transform our current products and therapies.
During 2020 and continuing through 2021, we faced
several operational challenges related to the COVID-19 global pandemic, which we continue to work to overcome. The launch of both 5050b2
products was impacted because of various COVID-19 limitations, most notably field sales personnel were not able to make healthcare provider
visits in person; thereby limiting the awareness of the availability of these products. We explored and implemented several non-personal
promotion efforts, but given the global limitations and dynamics, it was challenging to achieve expected sales. We have since abandoned
all activities and ownership pertaining to both products.
Vy-Gen Bio, Inc.
In May 2021, we entered into two exclusive option
agreements (the “CD38 Agreements”) relating to separate technologies designed to improve the treatment of CD38-related cancers
(e.g., multiple myeloma, chronic lymphocytic leukemia, and acute myeloid leukemia) with Vy-Gen Bio, Inc. (“Vy-Gen”), a majority-owned
subsidiary of Vycellix, Inc., a Tampa, Florida-based private, immuno-centric discovery life science company focused on the development
of transformational platform technologies to enhance and optimize next-generation cell and gene-based therapies, including T-cell and
Natural Killer (“NK”) cell-based cancer therapies.
The CD38 Agreements relate to two separate Vy-Gen drug product candidates,
as follows:
CD38-GEAR-NK. This Vy-Gen drug product
candidate is designed to protect CD38+ NK cells from destruction by anti-CD38 monoclonal antibodies, or mAbs. CD38-GEAR-NK is an autologous,
NK cell-based therapeutic that is derived from a patient’s own cells and gene-edited to enable combination therapy with anti-CD38
mAbs. We believe CD38-GEAR-NK possesses the potential to minimize the risks and side effects from CD38-positive NK cell fratricide.
Market Opportunity. We believe CD38-GEAR-NK
could potentially revolutionize how CD38-related cancers are treated, by protecting CD38+ NK cells from destruction by anti-CD38 mAbs,
thereby promoting the opportunity to improve the treatment of CD38-related cancers, including multiple myeloma, chronic lymphocytic leukemia,
and acute myeloid leukemia.
Multiple myeloma is expected to be the first cancer
indication targeted with CD38-GEAR-NK. The global multiple myeloma market was $19.48B in 2018 and is expected to reach $31B by 2026 [Source:
Fortune Business Reports].
CD38-Diagnostic. This Vy-Gen product
candidate is an in vitro diagnostic tool to analyze if cancer patients might be appropriate candidates for anti-CD38 mAb therapy. CD38-Diagnostic
is an in vitro screening tool that provides the ability to pre-determine which cancer patients are most likely to benefit from targeted
anti-CD38 mAb therapies, either as monotherapy or in combination with CD38-GEAR-NK. CD38-Diagnostic also has the potential to develop
as a platform technology beyond CD38, to identify patients likely to benefit for broad range of mAb therapies across myriad indications.
Market Opportunity. We believe CD38-Diagnostic
provides opportunity to make more cost-effective medical decisions for the treatment of B cell malignancies with high CD38 expression,
including multiple myeloma, which may help to avoid unnecessary administration of anti-CD38 therapies. CD38-Diagnostic could prevent patients
from being subjected to ineffective therapy and enable significant savings to healthcare systems.
CD38-Diagnostic could be offered as an in-vitro
diagnostic for determining patient suitability and likelihood of positive treatment outcomes for CD38-GEAR-NK and/or CD38 monoclonal antibody
therapies.
On September 28, 2023, we received FDA’s
response to our 513(g) request for information submission pertaining to the classification of the CD38-Diagnostic. The CD38-Diagnostic
has been designated a Class II type device. The confirmation of this classification is beneficial as we’re now better able to plan
for and execute future development activities.
GEAR-NK Product Overview. GEAR-NK
is an autologous, gene-edited, natural killer cell-based therapeutic development platform that allows for modified NK cells to be co-administered
with targeted mAbs, which, in the absence of the GEAR-NK, would otherwise be neutralized by mAb therapy.
In May 2021, we made initial payments totaling
$750,000 under the CD38 Agreements, to acquire the exclusive options to acquire co-development rights with respect to CD38-GEAR-NK and
CD38-Diagnostic. On August 15, 2021, we entered into amendments to each of the CD038 Agreements. In connection with the two amendments,
we delivered to Vy-Gen promissory notes aggregating $3,250,000 with maturity dates of December 31, 2021, and made a cash payment of $1,000,000,
upon which cash payment we exercised the two definitive option purchase agreements. In December 2021, we completed our payment obligations
to secure the 50% ownership interest in the CD38-Diagnostic, and subsequently in November 2022 we completed our purchase of the 50% ownership
interest for the CD38-GEAR-NK product candidate. Details of the two August amendments and the December amendment are summarized in the
amendments attached at Exhibits 4.1 and 4.2 to our Current Report on Form 8-K dated August 19, 2021 and Exhibits 4.2 to the our Current
Report on Form 8-K dated December 27, 2021.
In connection with the Vy-Gen relationship and
the Company’s ownership in the two product candidates described above, in December 2021 the Company and Vy-Gen entered into a co-development
and steering committee agreement. The co-development and steering committee agreement provides for the governance and economic agreements
between the Company and Vy-Gen related of the development of the two Vy-Gen drug product candidates and the revenue sharing related thereto,
including each company having a 50% representation on the steering committee and each company receiving 50% of the net revenues related
to the Vy-Gen product candidates. Details of the co-development and steering committee agreement are summarized in our Current Report
on Form 8-K dated December 27, 2021, including Exhibits 4.1 and 4.2 thereto.
Deverra Therapeutics, Inc.
On August 16, 2023, the Company entered into an
exclusive licensing arrangement (the “License Agreement”) with Deverra Therapeutics Inc. (“Deverra”), pursuant
to which the Company completed the exclusive license of key patent families and related intellectual property related to a proprietary
allogeneic stem cell expansion and directed differentiation platform for the generation of multiple distinct immune effector cell types,
including natural killer (NK) and monocyte/macrophages. The License Agreement provides the Company with exclusive rights to use the license
patents and related intellectual property in connection with development and commercialization efforts in the defined field of use (the
“Field”) of (a) use of unmodified NK cells as anti-viral therapeutic for viral infections, and/or as a therapeutic approach
for treatment of relapsed/refractory AML and high-risk MDS; (b) use of Deverra’s cell therapy platform to generate NK cells for
the purpose of engineering with Coeptis SNAPCARs and/or Coeptis GEAR Technology; and (c) use of Deverra’s cell therapy platform
to generate myeloid cells for the purpose of engineering with the Company’s current SNAP CAR and GEAR technologies. In support of
the exclusive license, the Company also entered into with Deverra (i) an asset purchase agreement (the “APA”) pursuant to
which the Company purchased certain assets from Deverra, including but not limited to two Investigational New Drug (IND) applications
and two Phase 1 clinical trial stage programs (NCT04901416, NCT04900454) investigating infusion of DVX201, an unmodified natural killer
(NK) cell therapy generated from pooled donor CD34+ cells, in hematologic malignancies and viral infections and (ii) a non-exclusive sublicense
agreement (the “Sublicense Agreement”), in support of the assets obtained by the exclusive license, pursuant to which the
Company sublicensed from Deverra certain assets which Deverra has rights to pursuant a license agreement (“FHCRC Agreement”)
by and between Deverra and The Fred Hutchinson Cancer Research Center (“FHCRC”).
As consideration for the transactions described
above, the Company paid Deverra approximately $570,000 in cash, issued to Deverra 4,000,000 shares of the Company’s common stock
and assumed certain liabilities related to the ongoing clinical trials. Total consideration paid was $4,937,609, which was fully expensed
in accordance with ASC 730, and is reflected within research and development in the accompanying condensed consolidated statement of operations
for the year ended December 31, 2023. In addition, in accordance with the terms of the Sublicense Agreement, the Company agreed to pay
FHCRC certain specified contingent running royalty payments and milestone payments under the FHCRC Agreement, in each case to the extent
such payments are triggered by the Company’s development activities.
On October 26, 2023, the Company entered into
a Shared Services Agreement (“SSA”) with Deverra, in accordance with requirements set forth in the APA. Under the terms of
the SSA, Coeptis and Deverra will share resources and collaborate to further the development of Coeptis’ GEAR and SNAP-CAR platforms,
as well as the purchased and licensed assets under the License Agreement and APA. The term of the SSA is six months from the effective
date.
Vici Health Sciences, LLC.
In 2019, we entered into a co-development agreement
with Vici Health Sciences, LLC (“Vici”). Through this partnership, we would co develop, seek FDA approval and share ownership
rights with Vici to CPT60621, a novel, ready to use, easy to swallow, oral liquid version of an already approved drug used for the treatment
of Parkinson’s Disease (PD). As we continue to direct its operational focus towards the Vy-Gen opportunities previously described,
we have recently stopped allocating priority resources to the development of CPT60621. We are currently in negotiations in which Vici
intends to buy-out most or all of our remaining ownership rights. In partnership with Vici Health Sciences, LLC (“Vici”),
we are co-developing a drug product, CPT60621 – a focus on Parkinson’s Disease. Through this partnership, we would co-develop
with Vici and, seek FDA approval and share ownership rights to CPT60621.
Our Results of Operations
Revenues. To date, we have generated
minimal revenue mostly from consulting arrangements and product sales. Due to the COVID-19 global pandemic and the resulting market dynamics,
it is uncertain if the current marketed products can generate sufficient sales to cover expenses.
Operating Expenses. General and
administrative expenses consist primarily of warrant expense related to strategic financing costs, salaries and related costs for personnel
and professional fees for consulting services related to regulatory, pharmacovigilance, quality, legal, and business development. We expect
that our general and administrative expenses will increase in the future as we increase our headcount to support the business growth.
We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance, insurance, and investor relation expenses
associated with operating as a public company.
Research and Development Costs.
Research and development costs will continue to be dependent on the strategic business collaborations and agreements we are anticipating
in the future. We expect development costs to increase to support new strategic initiatives.
Comparison of the three months ended June
30, 2024 and June 30, 2023
Revenues. Revenues recorded in the
three months ended June 30, 2024 and 2023 respectively, continue to be minimal. The Company’s activities primarily include product
development, raising capital, and building infrastructure. Management does not expect the Company to generate any significant revenue
for at least the next two years, during which time drug development will continue toward the goal of commercializing, through a partnership
or otherwise, one or more of the Company’s target products or technologies.
Operating Expenses
Overview. Operating expenses decreased
from $3,684,984 in the three months ended June 30, 2023 to $2,828,102 in the three months ended June 30, 2024. The decrease is mainly
due to lower professional services expense related to equity transactions.
General and Administrative Expenses. For
the three months ended June 30, 2024 and 2023, general and administrative expenses are included in operating expenses. All costs incurred
can be attributed to the planned principal operations of product development, raising capital, and building infrastructure.
Interest Expense. Interest expense
was $42,636 for the three months ended June 30, 2023 and was $66,056 for the three months ended June 30, 2024. Interest was related to
notes payable, which are discussed in detail in the notes to the condensed consolidated financial statements, incorporated by reference
herein.
Comparison of the six months ended June
30, 2024 and June 30, 2023
Revenues. Revenues recorded in the
six months ended June 30, 2024 and 2023 respectively, continue to be minimal. The Company’s activities primarily include product
development, raising capital, and building infrastructure. Management does not expect the Company to generate any significant revenue
for at least the next two years, during which time drug development will continue toward the goal of commercializing, through a partnership
or otherwise, one or more of the Company’s target products or technologies.
Operating Expenses
Overview. Operating expenses decreased
from $10,223,936 in the six months ended June 30, 2023 to $5,750,485 in the six months ended June 30, 2024. The decrease is mainly due
to lower professional services expense related to equity transactions.
General and Administrative Expenses. For
the six months ended June 30, 2024 and 2023, general and administrative expenses are included in operating expenses. All costs incurred
can be attributed to the planned principal operations of product development, raising capital, and building infrastructure.
Interest Expense. Interest expense
was $74,053 for the six months ended June 30, 2023 and was $266,561 for the six months ended June 30, 2024. Interest was related to notes
payable, which are discussed in detail in the notes to the condensed consolidated financial statements, incorporated by reference herein.
Financial Resources and Liquidity. The
Company had limited financial resources during the year ended December 31, 2023 with cash and cash equivalents of $1,469,134. For the
six months ended June 30, 2024, cash and cash equivalents increased to $1,555,075. During both these time periods, the Company continues
to operate a minimal infrastructure in order to maintain its ability to fund operations, keep full focus on all product development targets
and to stay current with all of the Company’s scientist consultants, legal counsel, and accountants. During 2024, the Company believes
that the ability to raise capital through equity transactions will increase liquidity and enable the execution of management’s
operating strategy.
| Item 3. |
Quantitative and Qualitative Disclosures about Market Risk |
The Company is a smaller reporting company as
defined by Rule 12b-2 of the Exchange Act and is not required to provide the information under this Item.
| Item 4. |
Controls and Procedures |
Disclosure controls and procedures as defined
in Rules 13a-15(e) and 15d-15(e) under the Exchange Act are controls and other procedures that are designed to ensure that information
required to be disclosed in our reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported, within
the time periods specified in the Securities and Exchange Commission’s rules and forms. Disclosure controls and procedures include,
without limitation, controls and procedures designed to ensure that information required to be disclosed in our reports filed or submitted
under the Exchange Act is accumulated and communicated to management, including our principal executive and principal financial officers,
or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
Our management, with the participation of our
chief executive officer (our principal executive officer) and our chief financial officer (our principal financial officer) evaluated
the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Report on Form 10-Q. Based upon
that evaluation, and as a result of the self-identified material weaknesses described below, our principal executive officer and principal
financial officer concluded that, as of June 30, 2024, our disclosure controls and procedures were not operating effectively. Management
anticipates that such disclosure controls and procedures will not be effective until the material weaknesses are remediated.
Our Annual Report on Form 10-K contains information
regarding self-identified material weakness in our internal control over financial reporting as of December 31, 2023. For example,
the Company’s system of internal controls, as designed and implemented, were not operating effectively. Additionally, the Company’s
financial statement close process and disclosure controls and procedures were not operating effectively.
In an effort to address the Company’s internal
accounting personnel deficiencies, in May 2023 we appointed a new Chief Financial Officer. Accordingly, the Company believes, based on
its knowledge, that: (i) this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances under which they were made, not misleading with respect to the period
covered by this report; and (ii) the condensed consolidated financial statements, and other financial information included in this quarterly
report, fairly present in all material respects our financial condition, results of operations and cash flows as of and for the periods
presented in this quarterly report.
PART II — OTHER INFORMATION
| Item 1. |
Legal Proceedings |
None.
In addition to the other information set forth
in this report, you should carefully consider the risk factors discussed in Part I, “Item 1A. Risk Factors” in our Annual
Report on Form 10-K for the year ended December 31, 2023, which could materially affect our business, financial condition or
future results. The risks described in our Annual Report on Form 10-K are not the only risks facing our company. Additional risks
and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our business,
financial condition and/or operating results.
| Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
All prior sales of unregistered securities have been properly disclosed
in prior SEC filings.
| Item 3. |
Defaults Upon Senior Securities |
Not applicable.
| Item 4. |
Mine Safety Disclosures |
Not applicable.
| Item 5. |
Other Information |
During the three months ended June 30,
2024, no director or officer of the Company adopted or terminated a “Rule 10b5-1 trading arrangement” or “non-Rule 10b5-1
trading arrangement,” as each term is defined in Item 408(a) of Regulation S-K.
The following exhibits are attached hereto or
incorporated by reference herein (numbered to correspond to Item 601(a) of Regulation S-K, as promulgated by the Securities and Exchange
Commission) and are filed as part of this Form 10-Q:
| 31.1 |
Rule 13a-14(a)/15(d)-14(a) Certification of Chief Executive Officer, Principal Executive Officer. Filed herewith. |
| 31.2 |
Rule 13a-14(a)/15(d)-14(a) Certification
of President, Principal Financial Officer. Filed herewith. |
| 32.1 |
Section 1350
Certification of Principal Executive Officer. Filed herewith. |
| 32.2 |
Section 1350 Certification of Principal Financial Officer. Filed herewith. |
| 101.INS |
Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document) |
| 101.SCH |
Inline XBRL Taxonomy Extension Schema Document |
| 101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
| 101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document |
| 101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase Document |
| 101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
| 104 |
Cover Page Interactive Data File (formatted in iXBRL, and included in exhibit 101). |
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.
| |
COEPTIS THERAPEUTICS HOLDINGS, INC. |
| |
Registrant |
| |
| Date: August 16, 2024 |
By: |
/s/ David Mehalick |
| |
David Mehalick |
| |
Chief Executive Officer, Principal Executive Officer |
| |
|
| |
|
| |
| Date: August 16, 2024 |
By: |
/s/ Brian Cogley |
| |
Brian Cogley |
| |
Chief Financial Officer, Principal Financial and Accounting Officer |
Coeptis Therapeutics (NASDAQ:COEP)
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