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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended September 30, 2024
☐ |
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 001-41952
Telomir
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
Florida |
|
87-2606031 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(I.R.S.
Employer
Identification
No.) |
|
|
|
100
SE 2nd St.
Ste 2000 #1009
Miami,
Florida |
|
33131 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number (including area code):
(813)
864-2558
Not
Applicable
(Former
name, former address and former fiscal year, if changed since last report)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class: |
|
Trading
symbol |
|
Name
of each exchange on which registered |
Common
Stock, no par value |
|
TELO |
|
The
Nasdaq Capital Market |
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, or a non-accelerated filer or a smaller reporting
company. See definition 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 12b-2 of the Exchange Act). Yes ☐ No ☒
As
of November 12, 2024, there were 29,609,814 shares of company common stock issued and outstanding.
TELOMIR
PHARMACEUTICALS, INC.
Quarterly
Report on Form 10-Q
TABLE
OF CONTENTS
TELOMIR
PHARMACEUTICALS, INC.
CONDENSED
BALANCE SHEETS
AS
OF SEPTEMBER 30, 2024 AND DECEMBER 31, 2023
| |
September
30, | | |
December
31, | |
| |
2024 | | |
2023 | |
| |
(unaudited) | | |
| |
ASSETS | |
| | | |
| | |
Current
assets: | |
| | | |
| | |
Cash | |
$ | 834,638 | | |
$ | 1,231 | |
Deferred
offering costs | |
| - | | |
| 303,281 | |
Prepaid
expenses | |
| 77,347 | | |
| 713 | |
Due
from related parties | |
| 130,000 | | |
| 130,000 | |
Total
current assets | |
| 1,041,985 | | |
| 435,225 | |
| |
| | | |
| | |
Deferred
financing costs | |
| - | | |
| 4,338,543 | |
| |
| | | |
| | |
Total
assets | |
$ | 1,041,985 | | |
$ | 4,773,768 | |
| |
| | | |
| | |
LIABILITIES
AND STOCKHOLDERS’ EQUITY | |
| | | |
| | |
Current
liabilities: | |
| | | |
| | |
Trade
accounts payable and accrued liabilities | |
$ | 506,479 | | |
$ | 707,187 | |
Due
to related parties | |
| 93,432 | | |
| 527,377 | |
Related
party line of credit | |
| - | | |
| 101,000 | |
Total
current liabilities | |
| 599,911 | | |
| 1,335,564 | |
| |
| | | |
| | |
Total
liabilities | |
| 599,911 | | |
| 1,335,564 | |
| |
| | | |
| | |
Stockholders’
equity | |
| | | |
| | |
Preferred
Stock, no par value, 100,000,000 shares authorized and none issued or outstanding. | |
| - | | |
| - | |
Common
Stock, no par value; 300,000,000 shares authorized, 29,609,814 and 28,609,814 shares issued and outstanding at September 30, 2024
and December 31, 2023, respectively. | |
| - | | |
| - | |
Additional
paid-in capital | |
| 28,140,559 | | |
| 17,502,346 | |
Accumulated
deficit | |
| (27,698,485 | ) | |
| (14,064,142 | ) |
Total
stockholders’ equity | |
| 442,074 | | |
| 3,438,204 | |
Total
liabilities and stockholders’ equity | |
$ | 1,041,985 | | |
$ | 4,773,768 | |
See
notes to condensed financial statements.
TELOMIR
PHARMACEUTICALS, INC.
CONDENSED
STATEMENTS OF OPERATIONS
FOR
THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023
(Unaudited)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three
Months Ended September 30, | | |
Nine
Months Ended September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenues | |
$ | - | | |
$ | - | | |
$ | - | | |
$ | - | |
| |
| | | |
| | | |
| | | |
| | |
Operating
costs: | |
| | | |
| | | |
| | | |
| | |
General
and administrative expenses | |
| 5,378,744 | | |
| 102,191 | | |
| 6,999,981 | | |
| 204,902 | |
Related
party travel costs | |
| - | | |
| 589,400 | | |
| 370,500 | | |
| 1,288,000 | |
Research
and development expenses | |
| 627,434 | | |
| 262,562 | | |
| 1,966,258 | | |
| 1,370,522 | |
Total
operating costs | |
| 6,006,178 | | |
| 954,153 | | |
| 9,336,739 | | |
| 2,863,424 | |
| |
| | | |
| | | |
| | | |
| | |
Other
income (expense): | |
| | | |
| | | |
| | | |
| | |
Interest
income | |
| 15,445 | | |
| - | | |
| 40,939 | | |
| - | |
Interest
expense | |
| - | | |
| (757,173 | ) | |
| (4,338,543 | ) | |
| (881,225 | ) |
Total
other income (expense) | |
| 15,445 | | |
| (757,173 | ) | |
| (4,297,604 | ) | |
| (881,225 | ) |
Net
loss | |
$ | (5,990,733 | ) | |
$ | (1,711,326 | ) | |
$ | (13,634,343 | ) | |
$ | (3,744,649 | ) |
Basic
and diluted loss per share | |
$ | (0.20 | ) | |
$ | (0.06 | ) | |
$ | (0.46 | ) | |
$ | (0.14 | ) |
Weighted
average common stock shares outstanding | |
| 29,609,814 | | |
| 27,097,294 | | |
| 29,498,703 | | |
| 27,373,844 | |
See
notes to condensed financial statements.
TELOMIR
PHARMACEUTICALS, INC.
CONDENSED
STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
FOR
THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2024 AND SEPTEMBER 30, 2023
(Unaudited)
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
| |
Common
Stock | | |
Additional
Paid-In | | |
Accumulated | | |
Total
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balances,
June 30, 2024 | |
| 29,609,814 | | |
$ | - | | |
$ | 23,335,319 | | |
$ | (21,707,752 | ) | |
$ | 1,627,567 | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| (5,990,733 | ) | |
| (5,990,733 | ) |
Stock
compensation | |
| - | | |
| - | | |
| 4,805,240 | | |
| - | | |
| 4,805,240 | |
Balances,
September 30, 2024 | |
| 29,609,814 | | |
$ | - | | |
$ | 28,140,559 | | |
$ | (27,698,485 | ) | |
$ | 442,074 | |
| |
Common
Stock | | |
Additional
Paid-In | | |
Accumulated | | |
Total
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balances,
June 30, 2023 | |
| 27,097,294 | | |
$ | - | | |
$ | 6,915,000 | | |
$ | (3,025,600 | ) | |
$ | 3,889,400 | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| (1,711,326 | ) | |
| (1,711,326 | ) |
Balances,
September 30, 2023 | |
| 27,097,294 | | |
$ | - | | |
$ | 6,915,000 | | |
$ | (4,736,926 | ) | |
$ | 2,178,074 | |
| |
Common
Stock | | |
Additional
Paid-In | | |
Accumulated | | |
Total
Stockholders’ | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balances,
January 1, 2024 | |
| 28,609,814 | | |
$ | - | | |
$ | 17,502,346 | | |
$ | (14,064,142 | ) | |
$ | 3,438,204 | |
Issuance
of common stock at IPO, net | |
| 1,000,000 | | |
| - | | |
| 5,832,973 | | |
| - | | |
| 5,832,973 | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| (13,634,343 | ) | |
| (13,634,343 | ) |
Stock
compensation | |
| - | | |
| - | | |
| 4,805,240 | | |
| - | | |
| 4,805,240 | |
Balances,
September 30, 2024 | |
| 29,609,814 | | |
$ | - | | |
$ | 28,140,559 | | |
$ | (27,698,485 | ) | |
$ | 442,074 | |
| |
Common
Stock | | |
Additional
Paid-In | | |
Accumulated | | |
Total
Stockholders’
(Deficit) | |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balances,
January 1, 2023 | |
| 26,829,269 | | |
$ | - | | |
$ | 55,000 | | |
$ | (992,277 | ) | |
$ | (937,278 | ) |
Balances | |
| 26,829,269 | | |
$ | - | | |
$ | 55,000 | | |
$ | (992,277 | ) | |
$ | (937,278 | ) |
Issuance
of common stock, net | |
| 268,025 | | |
| - | | |
| 910,000 | | |
| - | | |
| 910,000 | |
Issuance
of Warrants | |
| - | | |
| - | | |
| 5,950,000 | | |
| - | | |
| 5,950,000 | |
Net
loss | |
| - | | |
| - | | |
| - | | |
| (3,744,649 | ) | |
| (3,744,649 | ) |
Balances,
September 30, 2023 | |
| 27,097,294 | | |
$ | - | | |
$ | 6,915,000 | | |
$ | (4,736,926 | ) | |
$ | 2,178,074 | |
Balances | |
| 27,097,294 | | |
$ | - | | |
$ | 6,915,000 | | |
$ | (4,736,926 | ) | |
$ | 2,178,074 | |
See
notes to condensed financial statements.
TELOMIR
PHARMACEUTICALS, INC.
CONDENSED
STATEMENTS OF CASH FLOWS
FOR
THE NINE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023
(Unaudited)
| |
2024 | | |
2023 | |
| |
Nine
Months Ended September 30, | |
| |
2024 | | |
2023 | |
Cash
flows from Operating activities | |
| | | |
| | |
Net
loss | |
$ | (13,634,343 | ) | |
$ | (3,744,649 | ) |
Adjustments
to reconcile net loss to net cash from operations | |
| | | |
| | |
Non-cash
interest expense | |
| - | | |
| 13,517 | |
Stock-based
compensation expense | |
| 4,805,240 | | |
| - | |
Amortization
of debt issuance costs | |
| 4,338,543 | | |
| 867,708 | |
Change
in operating assets and liabilities: | |
| | | |
| | |
Trade
accounts payable and accrued liabilities | |
| 102,574 | | |
| 91,806 | |
Prepaid
expenses | |
| (76,634 | ) | |
| (963 | ) |
Net
cash flows from operating activities | |
$ | (4,464,620 | ) | |
$ | (2,772,581 | ) |
| |
| | | |
| | |
Financing
activities: | |
| | | |
| | |
Payment
of deferred offering costs | |
| - | | |
| (55,583 | ) |
Payments
under related party line of credit | |
| (101,000 | ) | |
| (130,000 | ) |
Proceeds
from (payments to) due to/from related party | |
| (433,946 | ) | |
| 711,283 | |
Borrowings
under related party line of credit | |
| - | | |
| 1,337,914 | |
Proceeds
from sale of common stock | |
| 5,832,973 | | |
| 910,000 | |
Net
cash flows from financing activities | |
| 5,298,027 | | |
| 2,773,614 | |
| |
| | | |
| | |
Net
change in cash | |
| 833,407 | | |
| 1,033 | |
Cash,
beginning of period | |
| 1,231 | | |
| 1,419 | |
Cash,
end of period | |
$ | 834,638 | | |
$ | 2,452 | |
Cash
paid for interest | |
| - | | |
| - | |
Supplemental
schedule of non-cash financing activities: | |
| | | |
| | |
Accrued
offering expense | |
$ | - | | |
$ | 124,126 | |
Issuance
of warrants on related party line of credit | |
| - | | |
| 5,950,000 | |
See
notes to condensed financial statements.
TELOMIR
PHARMACEUTICALS, INC.
NOTES
TO CONDENSED FINANCIAL STATEMENTS
FOR
THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2024 AND 2023
(Unaudited)
Note
1. Description of business and summary of significant accounting policies:
Overview
Telomir
Pharmaceuticals, Inc. (“Telomir” or the “Company”) was formed in August 2021 and is a Florida incorporated early
pre-clinical stage biopharmaceutical company that is developing its licensed product candidate, TELOMIR-1, the first novel small molecule
designed to lengthen the DNA’s protective telomere caps, thereby promoting longevity in humans and canine animals by treating age-related
conditions. Telomeres, the protective end caps of chromosomes composed of DNA sequences and proteins, naturally shorten as humans age.
This shortening is accelerated by metal reactivity, which increases the risk of degenerative and age-related diseases.
As
such, TELOMIR-1 is undergoing studies to provide a therapeutic intervention against contracting a number of degenerative and age-related
diseases. Telomir’s goal is to develop and commercialize TELOMIR-1, proposed to be dosed orally, with the broader aim of promoting
longevity and enhancing overall quality of life.
Substantive
operations began in late 2022 and the Company’s initial Investigative New Drug (“IND”) application is anticipated
to be filed with the U.S. Food and Drug Administration (“FDA”) in the second half of 2025. National phase filings are
expected to be made during the third quarter 2025.
As
used herein, the Company’s common stock, no par value per share, is referred to as the “Common Stock” and the Company’s
preferred stock, no par value per share, is referred to as the “Preferred Stock”.
Basis
of Accounting
The
accounting and reporting policies of the Company conform to accounting principles generally accepted in the United States of America
(“GAAP”). In the opinion of management, all adjustments considered necessary for the fair presentation of the financial statements
for the periods presented have been included. The results of operations for the nine months ended September 30, 2024 are not necessarily
indicative of the results to be expected for future periods.
Initial
Public Offering
On
February 13, 2024, the Company closed its initial public offering (the “IPO”) consisting of 1,000,000 shares of Common Stock
at a price of $7.00 per share for approximately $7.0 million in gross proceeds. After deducting the underwriting commission and other
offering expenses totaling $1.2 million, the net proceeds to the Company were $5.8 million. The Common Stock began trading on The Nasdaq
Capital Market on February 9, 2024 under the symbol “TELO”.
Significant
Accounting Policies
There
have been no material changes in the Company’s significant accounting policies from those previously disclosed in the
Company’s 2023 Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which was filed with the Securities and
Exchange Commission (“SEC” or the “Commission”) on March 29, 2024, with the exception of stock compensation as
discussed below.
Stock-based
Compensation
The
Company accounts for stock-based compensation under the provisions of FASB ASC 718, “Compensation - Stock Compensation”,
which requires the measurement and recognition of compensation expense for all stock-based awards made to employees, directors and consultants
based on estimated fair values on the grant date. The Company estimates the fair value of stock-based awards on the date of grant using
the Black-Scholes model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the
requisite service periods using the straight-line method. The Company has elected to account for forfeiture of stock-based awards as
they occur.
Note
2. Liquidity and capital resources
As
of September 30, 2024, the Company had cash of approximately $0.8 million. The Company used approximately $4.5 million of cash in operations
during the nine months ended September 30, 2024.
Historically,
the Company has been primarily engaged in developing TELOMIR-1. During these activities, the Company has sustained substantial
losses. The Company’s ability to fund ongoing operations and future clinical trials required for FDA approval is dependent on
the Company’s ability to obtain significant additional external funding in the near and also over the long term. Since
inception, the Company has financed its operations through an initial public offering, related party financings and a private
financing. During the nine months ended September 30, 2024, the Company secured a $5
million line of credit from the Starwood Trust, a trust related to the Company’s majority shareholder (see Note 4). Although
additional sources of financing may be sought by the Company, there can be no assurance that any fundraising will be achieved on
commercially reasonable terms, if at all.
As
of the date of filing, the Company will continue to generate losses and have insufficient cash and cash equivalents on hand to support
its operations for at least the 12 months following the date the financial statements are issued. These conditions raise substantial
doubt about the Company’s ability to continue as a going concern through 12 months after the date the financial statements are
issued.
The
accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction
of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of
recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue
as a going concern
Note
3. License agreement, related party:
The
Company licenses the U.S. patent rights for the use of TELOMIR-1 in human applications from MIRALOGX, LLC (“MIRALOGX”),
a related party intellectual property development and holding company owned by the Bay Shore Trust, a trust established by the
Company’s founder for the benefit of the founder’s family, which such trust is also currently the majority shareholder
of the Company (“Bay Shore Trust”).
On
August 11, 2023, (the “Effective Date”), the Company and MIRALOGX entered into an Amended and Restated Exclusive License
Agreement (the “Initial MIRALOGX License Agreement”), under which the Company has the exclusive perpetual right and
license to TELOMIR-1 patent rights to make, have made, use, and sell “Licensed Products” (as defined in the Initial
MIRALOGX License Agreement) in the U.S. for human uses and preclinical studies and activities of any kind conducted in furtherance
of obtaining regulatory approval or commercialization for human uses.
On
November 10, 2023, the Company and MIRALOGX entered into the Amendment No. 1 to the Initial MIRALOGX License Agreement, pursuant to which
the field of use relating to the license was amended to include therapeutic treatments and other medical or health uses in animals, in
addition to humans, and related preclinical studies and activities conducted in furtherance of obtaining regulatory approval for and
commercialization of veterinary, in addition to human, therapeutic treatments and uses (such amendment, together with the Initial MIRALOGX
License Agreement, the “MIRALOGX License Agreement”). The Company has the right to grant corresponding sublicenses under
the licensed patent rights. The MIRALOGX License Agreement provides for the payment to MIRALOGX of an 8% royalty (payable quarterly)
on the Company’s net sales of Licensed Products, as defined, by the Company or its sublicensees and on non-royalty bearing milestone
revenue. There are no up-front, execution, or milestone payments in the MIRALOGX License Agreement. Further, no payments have been made
to date under the agreement.
The
term of the MIRALOGX License Agreement will continue through the date of the expiration of the last-to-expire licensed patent or, if
later, the date of the expiration of the last strategic partnership/sublicensing agreement covering the licensed products. The patent
rights are expected to extend through 2043, assuming patents are issued by the U.S Patent and Trademark Office, and additional patent
terms may be awarded, including additional patent terms based on the time taken for regulatory review of drug products.
The
MIRALOGX License Agreement also provides that the Company may bring suit in its own name to enforce patent rights. However, MIRALOGX
will control the prosecution of the patent applications for TELOMIR-1. The Company is required to be kept informed by MIRALOGX of patent
prosecution activities and may select identified countries for patent protection. The Company is to reimburse MIRALOGX for patent prosecution
and maintenance costs.
Note
4. Related party transactions:
Due
from related parties-
Amounts
due from related parties as of both September 30, 2024 and December 31, 2023 totaled $0.13 million. These advances are due on demand
and are non-interest bearing.
Due
to related parties-
During
the periods ended September 30, 2024 and December 31, 2023, the Company received working capital advances from companies under
common control. These advances are due on demand and are non-interest bearing. During the fiscal year ended December 31, 2023,
advances in the amount of $1.7
million were converted into 837,841
shares of Common Stock at a conversion rate of $2.05
per share resulting in a loss on the conversion of debt of $4.1 million.
As of September 30, 2024 and December 31, 2023, $0.1
million and $0.5
million, respectively, advances remained outstanding.
Shared
management-
Historically,
the Company has shared management with related parties on an as-needed basis, to collaborate and pool resources efficiently. For the
nine months ended September 30, 2024, the Company incurred $0.04 million in costs related to this arrangement which is recorded in general
and administrative expenses. As of September 30, 2024, the Company no longer expects to share management with related parties on an as-needed
basis.
Bay
Shore Trust Line of Credit-
On
June 15, 2023, the Company entered into a Promissory Note and Loan Agreement (the “Bay Shore Note”) with Bay Shore Trust.
Under the Bay Shore Note, the Company had the right to borrow up to an aggregate of $5 million from the Bay Shore Trust at any time up
to the second anniversary of the issuance of the Bay Shore Note or, if earlier, upon the completion of the IPO. The Company’s right
to borrow funds under the Bay Shore Note was subject to the absence of a material adverse change in its assets, operations, or prospects.
The Bay Shore Note, together with accrued interest, was to become due and payable on the second anniversary of the issuance of the note,
and allowed prepayment of the note at any time without penalty. The Bay Shore Note accrued interest at a rate equal 7% per annum, simple interest, during
the first year that the note was outstanding and 10% per annum, simple interest, thereafter. The Bay Shore Note was unsecured.
In
consideration of the Bay Shore Note, the Company issued to the Bay Shore Trust a Common Stock purchase warrant on June 15, 2023 giving the Bay
Shore Trust the right to purchase up to 2,439,025 shares of Common Stock at an exercise price of $3.73 per share, and such warrant will
expire five years after the date of grant. Pursuant to a registration rights agreement, the Company has granted to Bay Shore Trust the
right to require the Company, at any time after one year following the IPO, to register for resale the shares issuable upon the exercise
of the warrant, with such registration rights being in the form of demand and “piggyback” registration rights that are subject
to customary limitations and restrictions. As of September 30, 2024, these shares have been registered for resale. Upon issuance, the
warrant met the criteria to be classified as equity based on an analysis under Accounting Standards Codification (480) ASC 480, “Distinguishing
Liabilities from Equity” and was measured at fair value, resulting in an initial fair value of approximately $5.95 million upon
issuance of the warrant, using Black-Scholes valuation techniques.
The
borrowings from Bay Shore Trust were paid in full during the three months ended March 31, 2024, and the Company has fully amortized the
relating financing costs and future borrowings are no longer available due to the terms of the agreement, specifically the closing of
the IPO, which occurred on February 13, 2024.
Starwood
Trust Line of Credit-
On
September 24, 2024 the Company entered into an unsecured Promissory Note and Loan Agreement (“the Starwood Note”) with the
Starwood Trust, a separate related party trust established by the Company’s founder for the benefit of the founder’s family.
Under the Starwood Note, the Company has the right to borrow up to an aggregate of $5 million from the Starwood Trust at any time up
until the second anniversary of the note. The Company’s right to borrow funds under the Starwood Note is subject to the absence
of a material adverse change in its assets, operations, or prospects. The Starwood Note, together with accrued interest, is to become
due and payable on the second anniversary of the issuance of the note, provides for prepayment at any time without penalty, and accrues simple
interest at a rate equal 7% per annum. As of September 30, 2024, the Company has not borrowed any amounts under the Starwood Note.
Related
Party Travel Costs-
On
April 1, 2023 the Company entered into an Agreement For Shared Lease Costs (the “Shared Agreement”) with MIRALOGX, a related
party. Under the Shared Agreement, the Company agrees to make monthly contributions or payments in accordance with its use of shared
aircraft toward rent payments. During the nine months ended September 30, 2024 and September 30, 2023, the Company incurred $0.4 million
and $1.2 million, respectively, for travel-related expenses to MIRALOGX for rental charges and airplane-related expenses. The Company
will not participate in the use of the MIRALOGX airplane after March of 2024 and, pursuant to the terms of the Shared Agreement, has
no further obligation under the Shared Agreement.
MIRALOGX
License Agreement – (See Note 3).
Related
Party Rental Agreement- (See Note 5).
Note
5. Leases:
The
Company’s former corporate headquarters was located in Baltimore, Maryland, which included a lease for office space. This lease
began in November 2022 and expired in April 2024. The lease was not renewed.
The
Company moved all corporate related activities in April 2024 to the shared space in Tampa, Florida referenced below with variable lease
costs. In September 2024, the Company decided to no longer utilize the shared space and moved to a virtual office model and does not
have a physical office space.
Variable
lease costs
Variable
lease costs primarily include utilities, property taxes, and other operating costs that are passed on from the lessor. Variable lease
costs related to the aircraft include usage expenses, which includes pilot expenses, jet fuel and general flight expenses.
Beginning
August 1, 2023, the Company’s accounting and administrative staff began sharing office space with a related party. During the nine
months ended September 30, 2024, this variable lease cost related to the Tampa, Florida space totaled $0.02 million and included in general
and administrative expenses.
Schedule
of Components of Lease Expenses
| |
2024 | | |
2023 | |
| |
Nine
Months ended September
30, | |
| |
2024 | | |
2023 | |
Lease
Costs | |
| | | |
| | |
Operating
lease | |
$ | 55,667 | | |
$ | 7,416 | |
Variable
lease costs | |
| 337,111 | | |
| 1,292,545 | |
Total
lease cost | |
$ | 392,778 | | |
$ | 1,299,961 | |
Note
6. Stockholders’ equity:
Capital
stock
The
Company has the authority to issue 400,000,000 shares of capital stock, consisting of 300,000,000 shares of Common Stock and 100,000,000
shares of undesignated Preferred Stock, whose rights and privileges will be defined by the Board of Directors when a series of Preferred
Stock is designated.
Warrants
The
Company has granted warrants to purchase shares of Common Stock. Warrants may be granted to affiliates in connection with certain agreements.
As
of September 30, 2024, a cumulative total of 2,824,057 warrants, with exercise prices ranging from $3.73 to $15.42 remain exercisable
and outstanding. There were no warrants exercised during the nine months ended September 30,2024.
Underwriter
warrants
In
connection with the IPO, the Company issued 50,000 warrants to purchase Common Stock to the IPO underwriter (or its designees) at an
exercise price of $7.00 which expire after a four-and-a-half-year period commencing six months after the commencement of sales in the
IPO. The warrants will be exercisable at any time and from time to time, in whole or in part, during the four-and-a-half-year period
commencing six months after the commencement of sales in the IPO.
Stock-based
compensation
The
fair value of each option award is estimated on the grant date using the Black-Scholes valuation model that uses assumptions for expected
volatility, expected dividends, expected term, and the risk-free interest rate. Expected price volatility is based on the historical
volatilities of a peer group as the Company does not have a multi-year trading history for its shares. Industry peers consist of several
public companies in the biotech industry similar to the Company in size, stage of life cycle and product indications. The Company intends
to continue to consistently apply this process using the same or similar public companies until a sufficient amount of historical information
regarding the volatility of the Company’s own stock price becomes available, or unless circumstances change such that the identified
companies are no longer similar to the Company, in which case, more suitable companies whose share prices are publicly available would
be utilized in the calculation.
Expected
term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of
the vesting term plus contract term. The risk-free rate is based on the 5-year U.S. Treasury yield curve in effect at the time of grant.
The Company recognizes forfeitures as they occur.
During
the nine months ended September 30, 2024, a total of 2,370,170 options to purchase Common Stock, with an aggregate fair market value
of approximately $9.1 million were granted to the members of the Company’s Board of Directors, executive officers, employees and
consultants of the Company. The options have an exercise price of $5.02, a term of 10 years from the grant date, and vest over various
terms ranging from immediate vesting upon grant to the second anniversary of the grant date.
The
following is option activity during the nine months ended September 30, 2024.
Schedule
of option activity
| |
Number
of shares | | |
Weighted average
exercise
price per
share | | |
Aggregate intrinsic
value |
|
Outstanding
as January 1, 2024 | |
| - | | |
$ | - | | |
$ | - |
|
Options
granted | |
| 2,370,170 | | |
| 5.02 | | |
| - |
|
Forfeitures | |
| - | | |
| - | | |
| - |
|
Outstanding
as September 30, 2024 | |
| 2,370,170 | | |
$ | 5.02 | | |
$ | - |
|
As
of September 30, 2024, options exercisable totaled 1,046,335. There are approximately $4.3 million of unrecognized compensation costs
related to non-vested share-based compensation awards, which will be expensed through 2026.
Key
assumptions used to value stock options during the nine months ended September 30, 2024, are as follows:
Schedule
of key assumptions used to value stock options
Expected
volatility | |
| 88.8%-90.1 | % |
Risk-free
interest rate | |
| 3.7 | % |
Exercise
price | |
$ | 5.02 | |
Expected
term (in years) | |
| 5.1
to 6.2 years | |
Dividend
yield | |
| - | |
Earnings
Per Share
During
the three and nine months ended September 30, 2024 and 2023, outstanding stock options and warrants of 5,194,227 and 2,774,057, respectively,
were not included in the computation of diluted earnings per share, because to do so would have had an antidilutive effect.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion and analysis should be read in conjunction with the Condensed Financial Statements and Notes thereto included elsewhere
in this Quarterly Report. This discussion contains certain forward-looking statements that involve risks and uncertainties. The Company’s
actual results and the timing of certain events could differ materially from those discussed in these forward-looking statements as a
result of certain factors, including, but not limited to, those set forth herein and elsewhere in this Quarterly Report and in the Company’s
other filings with the SEC. See “Cautionary Note Regarding Forward Looking Statements” below.
As
used in this Management’s Discussion and Analysis of Financial Condition and Results of Operations, unless otherwise indicated,
the terms “the Company”, “we”, “us”, “our” and similar terminology refer to Telomir Pharmaceuticals,
Inc.
Background
of the Company
We
are a pre-clinical-stage pharmaceutical company focused on the development and commercialization of TELOMIR-1, a novel small molecule
being developed to lengthen the DNA’s protective telomere caps, potentially promoting longevity in humans and canine animals by
treating age-related conditions. Telomeres, the protective end caps of chromosomes composed of DNA sequences and proteins, naturally
shorten as humans age. This shortening is accelerated by metal reactivity, which increases the risk of degenerative and age-related diseases.
Our
goal is to advance the clinical development of TELOMIR-1 in the United States for the treatment of age-related inflammatory conditions
and commercialize Telomir-1, proposed to be dosed orally, with the broader aim of promoting longevity and enhancing overall quality of
life.
To
date, we have not generated any revenue nor do we expect to generate revenue unless and until we successfully complete preclinical and
clinical development of, receive regulatory approval for, and commercialize a program and we do not know when, or if at all, that will
occur. We expect our expenses to increase substantially in connection with our ongoing activities, particularly as we advance the preclinical
activities and studies and initiate clinical trials. In addition, if we obtain regulatory approval for any programs, we expect to incur
significant expenses related to production of sales, marketing, and distribution to the extent that such sales, marketing and distribution
are not the responsibility of potential collaborators. We expect to incur additional costs associated with operating as a public company.
Our
operating expenses have historically been the costs associated with our initial investment in pre-clinical research and development activities.
We expect research and development expenses will increase in the future as we advance TELOMIR-1 into and through clinical trials and
pursue regulatory approvals, which will require a significant investment in costs of clinical trials, regulatory support, and contract
manufacturing. In addition, we will evaluate opportunities to acquire or in-license additional product candidates and technologies, which
may result in higher research and development expenses due to license fee and/or milestone payments, as well as added clinical development
costs.
We
had net losses of $13.6 million and $3.7 million for the nine months ended September 30, 2024 and 2023, respectively.
Components
of Our Results of Operations
Research
and development expenses represent costs incurred to conduct research and development of our product candidate. We recognize all research
and development costs as they are incurred. Research and development expenses consist primarily of the following:
|
● |
contracted
research and manufacturing; |
|
● |
consulting
arrangements; and |
|
● |
other
expenses incurred to advance the Company’s research and development activities. |
Our
operating expenses have historically been the costs associated with our initial investment in pre-clinical research and development activities.
We expect research and development expenses will increase in the future as we advance TELOMIR-1 into and through clinical trials and
pursue regulatory approvals, which will require a significant investment in costs of clinical trials, regulatory support, and contract
manufacturing. In addition, we will evaluate opportunities to acquire or in-license additional product candidates and technologies, which
may result in higher research and development expenses due to license fee and/or milestone payments, as well as added clinical development
costs.
The
process of conducting clinical trials necessary to obtain regulatory approval is costly and time-consuming. We may never succeed in timely
development and achieving regulatory approval for our product candidates. The probability of success of our product candidates may be
affected by numerous factors, including clinical data, competition, manufacturing capability and commercial viability. As a result, we
are unable to determine the duration and completion costs of our development projects or when and to what extent we will generate revenue
from the commercialization and sale of our product candidates.
Critical
Accounting Policies
See
Note 1 of the Notes to Condensed Financial Statements included in Item 1 of this Quarterly Report for a summary of significant accounting
policies and information on recently issued accounting pronouncements.
Results
of Operations
For
the nine months ended September 30, 2024 compared to the nine months ended September 30, 2023
Research
and Development Expenses. During the nine months ended September 30, 2024, we incurred $1.9 million in research and development expenses,
which were primarily related to toxicology studies, pre-clinical research projects and related manufacturing for pre-clinical research
projects. We incurred $1.4 million in research and development expenses during the nine months ended September 30, 2023, relating to
initial payments for toxicology studies and consulting arrangements. Research and development expenses represent costs incurred to conduct
research and development of our product candidate and consist primarily of contracted pre-clinical research and manufacturing, toxicology,
consulting arrangements and other expenses incurred to advance the Company’s research and development activities.
General
and Administrative Expenses. We incurred $7.0 million and $0.2 million in general and administrative expenses during the nine months
ended September 30, 2024 and September 30, 2023, respectively. The increase is primarily due to payroll costs for management and consultants
that began after the IPO and were not incurred during the nine months ended September 30, 2023. Additionally, the Company granted stock options
in August 2024 to employees totaling approximately $4.8 million. General and administrative expenses consist of expenses paid in connection
with administrative functions, as well as fees paid for legal, consulting fees and facilities costs not otherwise included in research
and development expenses. Legal costs include general corporate legal fees and license costs.
Related
Party Travel Costs. We incurred $0.4 million and $1.3 million in related party travel costs during the nine months ended September
30, 2024 and September 30, 2023, respectively. Related party travel costs consisted of a lease and use of an airplane with MIRALOGX,
an entity under common control with us. We will not participate in the use of the MIRALOGX airplane after March of 2024 and, pursuant
to the terms of our agreement with MIRALOGX related to this matter, will not have any further obligation under the agreement.
Interest
expense, net. We incurred $4.3 and $0.9 million in interest expense, net during the nine months ended September 30, 2024 and September
30, 2023, respectively. The 2024 interest expense consists of the amortization of the deferred financing costs on warrants issued in
connection with the related party line of credit as disclosed in Note 5 to the accompanying condensed financial statements.
For
the three months ended September 30, 2024 compared to the three months ended September 30, 2023
Research
and Development Expenses. During the three months ended September 30, 2024, we incurred $0.6 million in research and development
expenses, which were primarily related to toxicology studies, pre-clinical research projects and related manufacturing for pre-clinical
research projects. We incurred $0.3 million in research and development expenses during the three months ended September 30, 2023, relating
to initial payments for toxicology studies and consulting arrangements. Research and development expenses represent costs incurred to
conduct research and development of our product candidate and consist primarily of contracted pre-clinical research and manufacturing,
toxicology, consulting arrangements and other expenses incurred to advance the Company’s research and development activities.
General
and Administrative Expenses. We incurred $5.3 million and $0.1 million in general and administrative expenses during the three
months ended September 30, 2024 and September 30, 2023, respectively. The increase is primarily due to payroll costs for management
and consultants that began upon the IPO and were not incurred during the three months ended September 30, 2023. Additionally, the
Company granted stock options in August 2024 to employees totaling approximately $4.8 million. General and administrative expenses
consist of administrative functions, as well as fees paid for legal and consulting fees and facilities costs not otherwise included
in research and development expenses. Legal costs include general corporate legal fees and license costs. We expect to incur
additional expenses as a result of becoming a public company, including expenses related to compliance with the rules and
regulations of the SEC and Nasdaq, additional insurance, investor relations and other administrative expenses and professional
services.
Related
Party Travel Costs. We incurred $0.6 million in related party travel costs during the three months ended September 30, 2023. There
was no such expense incurred during the same period ended September 30, 2024. Related party travel costs consisted of a lease and use
of an airplane with MIRALOGX, an entity under common control with us. We will not participate in
the use of the MIRALOGX airplane after March of 2024 and, pursuant to the terms of our agreement with MIRALOGX related to this matter,
will not have any further obligation under the agreement.
Interest
income (expense). We earned $0.02 million in interest income during the three months ended September 30, 2024 and incurred $0.8 million
in interest expense during the three months ended September 30, 2023. The interest income in the three months ended September 30, 2024
is primarily related to interest earned from money market account.
Liquidity
and Capital Resources
As
of September 30, 2024, we had cash of approximately $0.8 million. We used approximately $4.5 million of cash in operations during the
nine months ended September 30, 2024.
Historically,
we have been primarily engaged in developing TELOMIR-1. During these activities, we have sustained substantial losses. We have incurred
net losses of $13.6 million for the nine months ended September 30, 2024, of which $7 million was attributable to general and administrative
expenses, Since inception, we have financed its operations through an initial public offering, related party financings and a private
financing. During the nine months ended September 30, 2024, we secured $5 million in additional funding pursuant to the Starwood Note
(see Note 4 to the accompanying financial statements). Based on current projections, we do not have sufficient cash and cash equivalents
as of the date of this report to support our operations for at least the 12 months following the date that the financial statements are
issued. Accordingly, substantial doubt exists with respect to our ability to continue as a going concern within one year after the date
that the financial statements are issued.
Our
ability to fund ongoing operations and future clinical trials required for FDA approval is dependent on our ability to obtain significant
additional external funding in the near term. Although, additional sources of financing may be sought by us, there can be no assurance
that any fundraising will be achieved on commercially reasonable terms, if at all. The failure to obtain sufficient capital on acceptable
terms when needed would have a material adverse effect on our business, results of operations and financial condition. Accordingly, we
have concluded that substantial doubt exists with respect to our ability to continue as a going concern within one year after the date
that the financial statements are issued.
Sources
of Liquidity
Since
our inception in August 2021, we have financed our operations primarily through proceeds from our initial public offering that occurred
in February of 2024, an unsecured line of credit with the Bay Shore Trust, our majority shareholder, and through a $1.0 million private
placement of shares of our Common Stock that occurred during the first quarter 2023 at $3.73 per share (after giving effect to our 1-for-2.05
reverse stock split that occurred on December 11, 2023). We intend to finance our clinical development programs and working capital needs
from existing cash and potential new sources of debt and equity financing. Further, we plan to conduct a raise of capital in the near
future to assist in financing working capital needs.
On
September 24, 2024 we entered into an unsecured Promissory Note and Loan Agreement with the Starwood Trust, a separate trust which was
established by our founder for the benefit of his family. Under this Promissory Note and Loan Agreement (the “Starwood Note”),
we have the right to borrow up to an aggregate of $5 million from the Starwood Trust at any time up until the second anniversary of the
note. Our right to borrow funds under the Starwood Note is subject to the absence of a material adverse change in its assets, operations,
or prospects. The Starwood Note, together with accrued interest, is to become due and payable on the second anniversary of the issuance
of the note, and provides for prepayment at any time without penalty. The Starwood Note accrues interest at a rate equal of 7% per annum, simple
interest.
We
have incurred significant losses and negative cash flows from operations since inception and expect to incur additional losses until
such time that we can generate significant revenue and profit, which we do not expect to occur in the near future. We had negative cash
flow from operations of approximately $4.5 million for the nine months ended September 30, 2024. As of September 30, 2024, we had cash
and cash equivalents of approximately $0.8 million and an accumulated deficit of approximately $27.7 million.
We
currently expect that our cash and cash equivalents, when taking into account the net proceeds of $5.8 million from our initial public
offering and potential advances from the Starwood Note, will not be sufficient to fund our operations, development plans, and capital
expenditures through the third quarter of 2025 without additional financing. As such, there is substantial doubt about the Company’s
ability to continue as a going concern.
Cash
Flows
The
following table provides information regarding our cash flows for the periods presented:
| |
Nine
Months Ended September 30, | |
| |
2024 | | |
2023 | |
Net
cash flows from: | |
| | | |
| | |
Operating
activities | |
$ | (4,464,620 | ) | |
$ | (2,772,581 | ) |
Financing
activities | |
| 5,298,027 | | |
| 2,773,614 | |
Net
change in cash | |
$ | 833,407 | | |
$ | 1,033 | |
Net
Cash Flows from Operating Activities
The
cash used in operating activities resulted primarily from our net losses, amortization of debt issuance costs, stock compensation expense
and changes in components of accounts payable and prepaid expenses.
For
the nine months ended September 30, 2024, operating activities used $4.5 million of cash, primarily due to a net loss of $13.6 million,
offset by amortization of debt issuance costs of $4.3 million, stock compensation expense of $4.8 million and a $0.01 million change
in accounts payable, accrued and prepaid expenses. Accounts payable, accrued and prepaid expenses was primarily composed of research
and development payables, consultant costs, insurance costs, legal and accounting expenses.
For
the nine months ended September 30, 2023, operating activities used $2.7 million of cash, primarily due to a net loss of $3.7 million,
offset by amortization of debt issuance costs of $0.9 million and $0.1 million increase in accounts payable and accrued expenses. Accounts
payable and accrued expenses was primarily composed of research and development expenses and consultant costs.
Net
Cash Flows from Financing Activities
For
the nine months ended September 30, 2024, financing activities provided $5.3 million of cash, resulting primarily from $5.8 million in
proceeds from sale of Common Stock, net of offering costs, offset by $0.4 million payments to related parties, and $0.1 million of repayments
under the related party line of credit.
For
the nine months ended September 30, 2023, financing activities provided $2.8 million of cash, resulting primarily from $1 million in
proceeds from sale of Common Stock, $1.3 million in borrowing from related party line of credit, and $0.7 million in borrowings from
related parties, offset by $0.2 million net in related party borrowings and payments.
Item
3. Quantitative and Qualitative Disclosures About Market Risk
We
are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act, and therefore are not required to provide the information
under this item per Item 305(e) of Regulation S-K.
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
Our
management, our Chief Executive Officer (our principal executive officer) and our Chief Financial Officer (our principal financial
officer) (the “Certifying Officers”), has evaluated the effectiveness of our disclosure controls and procedures (as
defined in Rules 13a-15(e) or 15d-15(e) under the Exchange Act) as of September 30, 2024. The term “disclosure controls and
procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a
company that are designed to ensure that information required to be disclosed by the company in the reports that it files or submits
under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules
and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that
information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and
communicated to the company’s management, including its principal executive and principal accounting officers, or persons
performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that
any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their
objectives and our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and
procedures. The Certifying Officers have concluded, based on their evaluation as of the end of the period covered by this Report,
that our disclosure controls and procedures were not effective to provide reasonable assurance that the objectives of our disclosure
control system were met. Management is in the process of implementing plans to remediate the ineffectiveness of its disclosure
controls and procedures through enhancements to its internal control environment as more fully described below.
Changes
in Internal Control over Financial Reporting
During
2024, we designed and implemented new and enhanced controls to strengthen our internal controls over financial reporting, including hiring
additional experienced accounting personnel, among other enhancements. Management believes these enhancements will be sufficient to remediate
previously identified material weaknesses. However, the new and enhanced controls have not operated for a sufficient amount of time to
conclude that the Company’s disclosure controls and procedures were effective.
Other
than as described above, there were no additional changes in our internal control over financial reporting (as defined in Rule 13(a)-15(f)
of the Exchange Act) that occurred during the period covered by this quarterly report that have materially affected, or are reasonably
likely to materially affect, our internal control over financial reporting.
CAUTIONARY
NOTE ON FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q contains 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. In particular, statements about the markets in which we operate, including growth of our various markets, and our
expectations, beliefs, plans, strategies, objectives, prospects, assumptions, or future events or performance contained in this quarterly
report under the headings “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results
of Operations” and “Business” are forward-looking statements. We have based these forward-looking statements on our
current expectations, assumptions, estimates and projections. While we believe these expectations, assumptions, estimates, and projections
are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which
are beyond our control. These and other important factors, including those discussed in this quarterly report under the headings “Risk
Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business,”
may cause our actual results, performance, or achievements to differ materially from any future results, performance or achievements
expressed or implied by these forward-looking statements, or could affect our share price. Important factors that could cause actual
results or events to differ materially from those expressed in forward-looking statements include, but are not limited to, the following:
●
our use of the net proceeds from our initial public offering and other financings;
●
our ability to obtain and maintain regulatory approval of our product candidates;
●
our ability to successfully commercialize and market our product candidates, if approved;
●
our ability to contract with third-party suppliers, manufacturers and other service providers and their ability to perform adequately
under such contract;
●
the potential market size, opportunity, and growth potential for our product candidates, if approved;
●
our ability to obtain additional funding for our operations and development activities;
●
the accuracy of our estimates regarding expenses, capital requirements and needs for additional financing;
●
the initiation, timing, progress and results of our pre-clinical studies and clinical trials, and our research and development programs;
●
the timing of anticipated regulatory filings;
●
the timing of availability of data from our clinical trials;
●
our future expenses, capital requirements, need for additional financing, and the period over which we believe that the net proceeds
from our initial public offering, together with our existing cash and cash equivalents, will be sufficient to fund our operating expenses
and capital expenditure requirements;
●
our ability to retain the continued service of our key professionals and to identify, hire and retain additional qualified professionals;
●our
ability to advance product candidates into, and successfully complete, clinical trials;
●
our ability to recruit and enroll suitable patients in our clinical trials;
●
the timing or likelihood of the accomplishment of various scientific, clinical, regulatory, and other product development objectives;
●
the pricing and reimbursement of our product candidates, if approved;
●
the rate and degree of market acceptance of our product candidates, if approved;
●
the implementation of our business model and strategic plans for our business, product candidates, and technology;
●
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and technology;
●
developments relating to our competitors and our industry; and
●
other risks and factors listed under “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December
31, 2023.
Given
the risks and uncertainties set forth in this quarterly report, you are cautioned not to place undue reliance on such forward-looking
statements. The forward-looking statements contained in this quarterly report are not guarantees of future performance and our actual
results of operations, financial condition, and liquidity, and the development of the industry in which we operate, may differ materially
from the forward-looking statements contained in this quarterly report. In addition, even if our results of operations, financial condition
and liquidity, and events in the industry in which we operate, are consistent with the forward-looking statements contained in this quarterly
report, they may not be predictive of results or developments in future periods.
Any
forward-looking statement that we make in this quarterly report speaks only as of the date of such statement. Except as required by federal
securities laws, we do not undertake any obligation to update or revise, or to publicly announce any update or revision to, any of the
forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this quarterly report.
PART
II. OTHER INFORMATION
Item
1. Legal Proceedings
From
time to time, we may be named in claims arising in the ordinary course of business. Currently, no legal proceedings, government actions,
administrative actions, investigations, or claims are pending against us or involve us that, in the opinion of our management, could
reasonably be expected to have a material adverse effect on our business and financial condition.
Item
1A. Risk Factors.
Our
business, financial condition, results of operations and cash flows are subject to, and could be materially adversely affected by, various
risks and uncertainties. These risks are more fully disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31,
2023, any one of which could cause our actual results to vary materially from recent results or our anticipated future results, and also
include the following risks.
We
expect to rely on third parties to conduct our pre-clinical trials and those third parties may not perform satisfactorily, including
failing to meet deadlines for the completion of such trials or failing to comply with regulatory requirements or our pre-clinical protocols.
We
currently rely on third-party contract research organizations (“CROs”) to conduct our pre-clinical trials, as we currently
do not plan to independently conduct pre-clinical trials of any of our product candidates. Our agreements with these CROs, and other
third parties might terminate for a variety of reasons, including a failure to perform by the third parties to such agreements. If we
were ever to need to enter into alternative arrangements or if we were to need to change a CRO for an ongoing pre-clinical trial, we
might experience delays in our pre-clinical development activities.
Geopolitical
events and global economic conditions, such as the Israel-Hamas war may impact the third parties that we engage to supply materials or
manufacture any products for our preclinical tests and clinical trials, which increases the risk of potential delay of development efforts,
as applicable.
If
the third parties that we engage to supply any materials or manufacture any products for our preclinical tests and clinical trials should
cease to continue to do so for any reason, including due to the effects of global economic conditions, including the Hamas-Israel war,
we likely would experience delays in advancing these tests and trials while we identify and qualify replacement suppliers or manufacturers,
as applicable, and we may be unable to obtain replacement supplies on terms that are favorable to us. In addition, if we are not able
to obtain adequate supplies of our product, or the substances used to manufacture them, it will be more difficult for us to develop our
product, and compete effectively.
Our
current and anticipated dependence upon third-party suppliers may adversely affect our ability to develop our product and product candidates,
and could delay our clinical trials and development programs as well as affect our marketing and commercialization efforts. In addition,
such dependence may increase our costs and expenses, and may otherwise harm our operations and financial condition.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
On
February 13, 2024, the Company closed its IPO consisting of 1,000,000 shares at a price of $7.00 per share for approximately $7.0 million
in gross proceeds. After deducting the underwriting commission and other offering expenses totaling $1.2 million, the net proceeds to
the Company was $5.8 million. None of the underwriting discounts and commissions or other offering expenses were incurred or paid, directly
or indirectly, to any of our directors or officers or their associates or to persons owning 10% or more of our Common Stock or to any
of our affiliates.
The
shares were offered and sold pursuant to the Company’s Registration Statement on Form S-1, as amended (File No. 333-275534), originally
filed with the SEC on November 14, 2023 (the “Registration Statement”)
and the final quarterly report filed with the Commission pursuant to Rule 424(b)(4) of the Securities Act of 1933, as amended. The Registration
Statement was declared effective by the Commission on February 8, 2024. The Common Stock began trading on The Nasdaq Capital Market on
February 9, 2024 under the symbol “TELO”. The closing of the IPO occurred on February 13, 2024.
Item
3. Defaults upon Senior Securities.
None.
Item
4. Mine Safety Disclosures.
Not
applicable.
Item
5. Other Information.
None.
Item
6. Exhibits.
* |
Furnished
herewith |
|
|
+ |
Denotes
management contract or compensatory plan or arrangement. |
SIGNATURES
Pursuant
to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
TELOMIR
PHARMACEUTICALS, INC. |
|
|
|
Date:
November 12, 2024 |
By: |
/s/
Erez Aminov |
|
|
Erez
Aminov |
|
|
Chief
Executive Officer |
|
|
(Principal
Executive Officer) |
|
|
|
Date:
November 12, 2024 |
By: |
/s/
Michelle Yanez |
|
|
Michelle
Yanez |
|
|
Chief
Financial Officer, Treasurer and Secretary |
|
|
(Principal
Financial Officer) |
Exhibit
31.1
SECTION
302 CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
I,
Erez Aminov, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of Telomir Pharmaceuticals, Inc.; |
|
|
2. |
Based
on my knowledge, this 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 such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a. |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
Designed
each internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d. |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
a. |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b. |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
|
/s/
Erez Aminov |
Date:
November 12, 2024 |
Erez
Aminov |
|
Principal
Executive Officer |
Exhibit
31.2
SECTION
302 CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
I,
Michelle Yanez, certify that:
1. |
I
have reviewed this Quarterly Report on Form 10-Q of Telomir Pharmaceuticals, Inc.; |
|
|
2. |
Based
on my knowledge, this 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 such statements were made, not misleading with respect to
the period covered by this report; |
|
|
3. |
Based
on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material
respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in
this report; |
|
|
4. |
The
registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures
(as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange
Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
a. |
Designed
such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision,
to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others
within those entities, particularly during the period in which this report is being prepared; |
|
|
|
|
b. |
Designed
each internal control over financial reporting, or caused such internal control over financial reporting to be designed under our
supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements
for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c. |
Evaluated
the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about
the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation;
and |
|
|
|
|
d. |
Disclosed
in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s
most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected,
or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
5. |
The
registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial
reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing
the equivalent functions): |
|
a. |
All
significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are
reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information;
and |
|
|
|
|
b. |
Any
fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s
internal control over financial reporting. |
|
/s/
Michelle Yanez |
Date:
November 12, 2024 |
Michelle
Yanez |
|
Principal
Financial Officer |
Exhibit
32.1
CERTIFICATION
OF PRINCIPAL EXECUTIVE OFFICER
AND
PRINCIPAL FINANCIAL OFFICER
PURSUANT
TO
18
U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
Pursuant
to 18 U.S.C. § 1350, the undersigned officers of Trio Petroleum Corp. (the “Company”) hereby certify that the Company’s
Quarterly Report on Form 10-Q for the period ended September 30, 2024 (the “Report”) fully complies with the requirements of Section
13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934 and that the information contained in the Report fairly presents,
in all material respects, the financial condition and results of operations of the Company.
|
/s/
Erez Aminov |
Date:
November 12, 2024 |
Erez
Aminov |
|
Principal
Executive Officer |
|
|
|
/s/
Michelle Yanez |
|
Michelle
Yanez |
|
Principal
Financial Officer |
The
foregoing certification is being furnished solely pursuant to 18 U.S.C. § 1350 and is not being filed as part of the Report or as
a separate disclosure document.
v3.24.3
Cover - shares
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Nov. 12, 2024 |
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v3.24.3
Condensed Balance Sheets - USD ($)
|
Sep. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash |
$ 834,638
|
$ 1,231
|
Deferred offering costs |
|
303,281
|
Prepaid expenses |
77,347
|
713
|
Due from related parties |
130,000
|
130,000
|
Total current assets |
1,041,985
|
435,225
|
Deferred financing costs |
|
4,338,543
|
Total assets |
1,041,985
|
4,773,768
|
Current liabilities: |
|
|
Trade accounts payable and accrued liabilities |
506,479
|
707,187
|
Due to related parties |
93,432
|
527,377
|
Related party line of credit |
|
101,000
|
Total current liabilities |
599,911
|
1,335,564
|
Total liabilities |
599,911
|
1,335,564
|
Stockholders’ equity |
|
|
Preferred Stock, no par value, 100,000,000 shares authorized and none issued or outstanding. |
|
|
Common Stock, no par value; 300,000,000 shares authorized, 29,609,814 and 28,609,814 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively. |
|
|
Additional paid-in capital |
28,140,559
|
17,502,346
|
Accumulated deficit |
(27,698,485)
|
(14,064,142)
|
Total stockholders’ equity |
442,074
|
3,438,204
|
Total liabilities and stockholders’ equity |
$ 1,041,985
|
$ 4,773,768
|
X |
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v3.24.3
Condensed Balance Sheets (Parenthetical) - $ / shares
|
Sep. 30, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value |
$ 0
|
$ 0
|
Preferred stock, shares authorized |
100,000,000
|
100,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
Common stock, par value |
$ 0
|
$ 0
|
Common stock, shares authorized |
300,000,000
|
300,000,000
|
Common stock, shares issued |
29,609,814
|
28,609,814
|
Common stock, shares outstanding |
29,609,814
|
28,609,814
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.3
Condensed Statements of Operations (Unaudited) - USD ($)
|
3 Months Ended |
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Revenues |
|
|
|
|
Operating costs: |
|
|
|
|
General and administrative expenses |
5,378,744
|
102,191
|
6,999,981
|
204,902
|
Related party travel costs |
|
589,400
|
370,500
|
1,288,000
|
Research and development expenses |
627,434
|
262,562
|
1,966,258
|
1,370,522
|
Total operating costs |
6,006,178
|
954,153
|
9,336,739
|
2,863,424
|
Other income (expense): |
|
|
|
|
Interest income |
15,445
|
|
40,939
|
|
Interest expense |
|
(757,173)
|
(4,338,543)
|
(881,225)
|
Total other income (expense) |
15,445
|
(757,173)
|
(4,297,604)
|
(881,225)
|
Net loss |
$ (5,990,733)
|
$ (1,711,326)
|
$ (13,634,343)
|
$ (3,744,649)
|
Basic loss per share |
$ (0.20)
|
$ (0.06)
|
$ (0.46)
|
$ (0.14)
|
Diluted loss per share |
$ (0.20)
|
$ (0.06)
|
$ (0.46)
|
$ (0.14)
|
Weighted average common stock shares outstanding - basic |
29,609,814
|
27,097,294
|
29,498,703
|
27,373,844
|
Weighted average common stock shares outstanding - diluted |
29,609,814
|
27,097,294
|
29,498,703
|
27,373,844
|
X |
- DefinitionThe amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.
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v3.24.3
Condensed Statements of Stockholders' Equity (Deficit) (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balances at Dec. 31, 2022 |
|
$ 55,000
|
$ (992,277)
|
$ (937,278)
|
Balance, shares at Dec. 31, 2022 |
26,829,269
|
|
|
|
Net loss |
|
|
(3,744,649)
|
(3,744,649)
|
Issuance of common stock, net |
|
910,000
|
|
910,000
|
Issuance of common stock, net, shares |
268,025
|
|
|
|
Issuance of Warrants |
|
5,950,000
|
|
5,950,000
|
Balances at Sep. 30, 2023 |
|
6,915,000
|
(4,736,926)
|
2,178,074
|
Balance, shares at Sep. 30, 2023 |
27,097,294
|
|
|
|
Balances at Jun. 30, 2023 |
|
6,915,000
|
(3,025,600)
|
3,889,400
|
Balance, shares at Jun. 30, 2023 |
27,097,294
|
|
|
|
Net loss |
|
|
(1,711,326)
|
(1,711,326)
|
Balances at Sep. 30, 2023 |
|
6,915,000
|
(4,736,926)
|
2,178,074
|
Balance, shares at Sep. 30, 2023 |
27,097,294
|
|
|
|
Balances at Dec. 31, 2023 |
|
17,502,346
|
(14,064,142)
|
3,438,204
|
Balance, shares at Dec. 31, 2023 |
28,609,814
|
|
|
|
Net loss |
|
|
(13,634,343)
|
(13,634,343)
|
Stock compensation |
|
4,805,240
|
|
4,805,240
|
Issuance of common stock, net |
|
5,832,973
|
|
5,832,973
|
Issuance of common stock, net, shares |
1,000,000
|
|
|
|
Balances at Sep. 30, 2024 |
|
28,140,559
|
(27,698,485)
|
442,074
|
Balance, shares at Sep. 30, 2024 |
29,609,814
|
|
|
|
Balances at Jun. 30, 2024 |
|
23,335,319
|
(21,707,752)
|
1,627,567
|
Balance, shares at Jun. 30, 2024 |
29,609,814
|
|
|
|
Net loss |
|
|
(5,990,733)
|
(5,990,733)
|
Stock compensation |
|
4,805,240
|
|
4,805,240
|
Balances at Sep. 30, 2024 |
|
$ 28,140,559
|
$ (27,698,485)
|
$ 442,074
|
Balance, shares at Sep. 30, 2024 |
29,609,814
|
|
|
|
X |
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v3.24.3
Condensed Statements of Cash Flows (Unaudited) - USD ($)
|
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Cash flows from Operating activities |
|
|
Net loss |
$ (13,634,343)
|
$ (3,744,649)
|
Adjustments to reconcile net loss to net cash from operations |
|
|
Non-cash interest expense |
|
13,517
|
Stock-based compensation expense |
4,805,240
|
|
Amortization of debt issuance costs |
4,338,543
|
867,708
|
Change in operating assets and liabilities: |
|
|
Trade accounts payable and accrued liabilities |
102,574
|
91,806
|
Prepaid expenses |
(76,634)
|
(963)
|
Net cash flows from operating activities |
(4,464,620)
|
(2,772,581)
|
Financing activities: |
|
|
Payment of deferred offering costs |
|
(55,583)
|
Payments under related party line of credit |
(101,000)
|
(130,000)
|
Proceeds from (payments to) due to/from related party |
(433,946)
|
711,283
|
Borrowings under related party line of credit |
|
1,337,914
|
Proceeds from sale of common stock |
5,832,973
|
910,000
|
Net cash flows from financing activities |
5,298,027
|
2,773,614
|
Net change in cash |
833,407
|
1,033
|
Cash, beginning of period |
1,231
|
1,419
|
Cash, end of period |
834,638
|
2,452
|
Cash paid for interest |
|
|
Supplemental schedule of non-cash financing activities: |
|
|
Accrued offering expense |
|
124,126
|
Issuance of warrants on related party line of credit |
|
$ 5,950,000
|
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v3.24.3
Description of business and summary of significant accounting policies
|
9 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
Description of business and summary of significant accounting policies |
Note
1. Description of business and summary of significant accounting policies:
Overview
Telomir
Pharmaceuticals, Inc. (“Telomir” or the “Company”) was formed in August 2021 and is a Florida incorporated early
pre-clinical stage biopharmaceutical company that is developing its licensed product candidate, TELOMIR-1, the first novel small molecule
designed to lengthen the DNA’s protective telomere caps, thereby promoting longevity in humans and canine animals by treating age-related
conditions. Telomeres, the protective end caps of chromosomes composed of DNA sequences and proteins, naturally shorten as humans age.
This shortening is accelerated by metal reactivity, which increases the risk of degenerative and age-related diseases.
As
such, TELOMIR-1 is undergoing studies to provide a therapeutic intervention against contracting a number of degenerative and age-related
diseases. Telomir’s goal is to develop and commercialize TELOMIR-1, proposed to be dosed orally, with the broader aim of promoting
longevity and enhancing overall quality of life.
Substantive
operations began in late 2022 and the Company’s initial Investigative New Drug (“IND”) application is anticipated
to be filed with the U.S. Food and Drug Administration (“FDA”) in the second half of 2025. National phase filings are
expected to be made during the third quarter 2025.
As
used herein, the Company’s common stock, no par value per share, is referred to as the “Common Stock” and the Company’s
preferred stock, no par value per share, is referred to as the “Preferred Stock”.
Basis
of Accounting
The
accounting and reporting policies of the Company conform to accounting principles generally accepted in the United States of America
(“GAAP”). In the opinion of management, all adjustments considered necessary for the fair presentation of the financial statements
for the periods presented have been included. The results of operations for the nine months ended September 30, 2024 are not necessarily
indicative of the results to be expected for future periods.
Initial
Public Offering
On
February 13, 2024, the Company closed its initial public offering (the “IPO”) consisting of 1,000,000 shares of Common Stock
at a price of $7.00 per share for approximately $7.0 million in gross proceeds. After deducting the underwriting commission and other
offering expenses totaling $1.2 million, the net proceeds to the Company were $5.8 million. The Common Stock began trading on The Nasdaq
Capital Market on February 9, 2024 under the symbol “TELO”.
Significant
Accounting Policies
There
have been no material changes in the Company’s significant accounting policies from those previously disclosed in the
Company’s 2023 Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which was filed with the Securities and
Exchange Commission (“SEC” or the “Commission”) on March 29, 2024, with the exception of stock compensation as
discussed below.
Stock-based
Compensation
The
Company accounts for stock-based compensation under the provisions of FASB ASC 718, “Compensation - Stock Compensation”,
which requires the measurement and recognition of compensation expense for all stock-based awards made to employees, directors and consultants
based on estimated fair values on the grant date. The Company estimates the fair value of stock-based awards on the date of grant using
the Black-Scholes model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the
requisite service periods using the straight-line method. The Company has elected to account for forfeiture of stock-based awards as
they occur.
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v3.24.3
Liquidity and capital resources
|
9 Months Ended |
Sep. 30, 2024 |
Liquidity And Capital Resources |
|
Liquidity and capital resources |
Note
2. Liquidity and capital resources
As
of September 30, 2024, the Company had cash of approximately $0.8 million. The Company used approximately $4.5 million of cash in operations
during the nine months ended September 30, 2024.
Historically,
the Company has been primarily engaged in developing TELOMIR-1. During these activities, the Company has sustained substantial
losses. The Company’s ability to fund ongoing operations and future clinical trials required for FDA approval is dependent on
the Company’s ability to obtain significant additional external funding in the near and also over the long term. Since
inception, the Company has financed its operations through an initial public offering, related party financings and a private
financing. During the nine months ended September 30, 2024, the Company secured a $5
million line of credit from the Starwood Trust, a trust related to the Company’s majority shareholder (see Note 4). Although
additional sources of financing may be sought by the Company, there can be no assurance that any fundraising will be achieved on
commercially reasonable terms, if at all.
As
of the date of filing, the Company will continue to generate losses and have insufficient cash and cash equivalents on hand to support
its operations for at least the 12 months following the date the financial statements are issued. These conditions raise substantial
doubt about the Company’s ability to continue as a going concern through 12 months after the date the financial statements are
issued.
The
accompanying financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction
of liabilities in the normal course of business, and do not include any adjustments relating to recoverability and classification of
recorded asset amounts or the amounts and classification of liabilities that might be necessary should the Company be unable to continue
as a going concern
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v3.24.3
License agreement, related party:
|
9 Months Ended |
Sep. 30, 2024 |
License Agreement Related Party |
|
License agreement, related party: |
Note
3. License agreement, related party:
The
Company licenses the U.S. patent rights for the use of TELOMIR-1 in human applications from MIRALOGX, LLC (“MIRALOGX”),
a related party intellectual property development and holding company owned by the Bay Shore Trust, a trust established by the
Company’s founder for the benefit of the founder’s family, which such trust is also currently the majority shareholder
of the Company (“Bay Shore Trust”).
On
August 11, 2023, (the “Effective Date”), the Company and MIRALOGX entered into an Amended and Restated Exclusive License
Agreement (the “Initial MIRALOGX License Agreement”), under which the Company has the exclusive perpetual right and
license to TELOMIR-1 patent rights to make, have made, use, and sell “Licensed Products” (as defined in the Initial
MIRALOGX License Agreement) in the U.S. for human uses and preclinical studies and activities of any kind conducted in furtherance
of obtaining regulatory approval or commercialization for human uses.
On
November 10, 2023, the Company and MIRALOGX entered into the Amendment No. 1 to the Initial MIRALOGX License Agreement, pursuant to which
the field of use relating to the license was amended to include therapeutic treatments and other medical or health uses in animals, in
addition to humans, and related preclinical studies and activities conducted in furtherance of obtaining regulatory approval for and
commercialization of veterinary, in addition to human, therapeutic treatments and uses (such amendment, together with the Initial MIRALOGX
License Agreement, the “MIRALOGX License Agreement”). The Company has the right to grant corresponding sublicenses under
the licensed patent rights. The MIRALOGX License Agreement provides for the payment to MIRALOGX of an 8% royalty (payable quarterly)
on the Company’s net sales of Licensed Products, as defined, by the Company or its sublicensees and on non-royalty bearing milestone
revenue. There are no up-front, execution, or milestone payments in the MIRALOGX License Agreement. Further, no payments have been made
to date under the agreement.
The
term of the MIRALOGX License Agreement will continue through the date of the expiration of the last-to-expire licensed patent or, if
later, the date of the expiration of the last strategic partnership/sublicensing agreement covering the licensed products. The patent
rights are expected to extend through 2043, assuming patents are issued by the U.S Patent and Trademark Office, and additional patent
terms may be awarded, including additional patent terms based on the time taken for regulatory review of drug products.
The
MIRALOGX License Agreement also provides that the Company may bring suit in its own name to enforce patent rights. However, MIRALOGX
will control the prosecution of the patent applications for TELOMIR-1. The Company is required to be kept informed by MIRALOGX of patent
prosecution activities and may select identified countries for patent protection. The Company is to reimburse MIRALOGX for patent prosecution
and maintenance costs.
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v3.24.3
Related party transactions:
|
9 Months Ended |
Sep. 30, 2024 |
Related Party Transactions [Abstract] |
|
Related party transactions: |
Note
4. Related party transactions:
Due
from related parties-
Amounts
due from related parties as of both September 30, 2024 and December 31, 2023 totaled $0.13 million. These advances are due on demand
and are non-interest bearing.
Due
to related parties-
During
the periods ended September 30, 2024 and December 31, 2023, the Company received working capital advances from companies under
common control. These advances are due on demand and are non-interest bearing. During the fiscal year ended December 31, 2023,
advances in the amount of $1.7
million were converted into 837,841
shares of Common Stock at a conversion rate of $2.05
per share resulting in a loss on the conversion of debt of $4.1 million.
As of September 30, 2024 and December 31, 2023, $0.1
million and $0.5
million, respectively, advances remained outstanding.
Shared
management-
Historically,
the Company has shared management with related parties on an as-needed basis, to collaborate and pool resources efficiently. For the
nine months ended September 30, 2024, the Company incurred $0.04 million in costs related to this arrangement which is recorded in general
and administrative expenses. As of September 30, 2024, the Company no longer expects to share management with related parties on an as-needed
basis.
Bay
Shore Trust Line of Credit-
On
June 15, 2023, the Company entered into a Promissory Note and Loan Agreement (the “Bay Shore Note”) with Bay Shore Trust.
Under the Bay Shore Note, the Company had the right to borrow up to an aggregate of $5 million from the Bay Shore Trust at any time up
to the second anniversary of the issuance of the Bay Shore Note or, if earlier, upon the completion of the IPO. The Company’s right
to borrow funds under the Bay Shore Note was subject to the absence of a material adverse change in its assets, operations, or prospects.
The Bay Shore Note, together with accrued interest, was to become due and payable on the second anniversary of the issuance of the note,
and allowed prepayment of the note at any time without penalty. The Bay Shore Note accrued interest at a rate equal 7% per annum, simple interest, during
the first year that the note was outstanding and 10% per annum, simple interest, thereafter. The Bay Shore Note was unsecured.
In
consideration of the Bay Shore Note, the Company issued to the Bay Shore Trust a Common Stock purchase warrant on June 15, 2023 giving the Bay
Shore Trust the right to purchase up to 2,439,025 shares of Common Stock at an exercise price of $3.73 per share, and such warrant will
expire five years after the date of grant. Pursuant to a registration rights agreement, the Company has granted to Bay Shore Trust the
right to require the Company, at any time after one year following the IPO, to register for resale the shares issuable upon the exercise
of the warrant, with such registration rights being in the form of demand and “piggyback” registration rights that are subject
to customary limitations and restrictions. As of September 30, 2024, these shares have been registered for resale. Upon issuance, the
warrant met the criteria to be classified as equity based on an analysis under Accounting Standards Codification (480) ASC 480, “Distinguishing
Liabilities from Equity” and was measured at fair value, resulting in an initial fair value of approximately $5.95 million upon
issuance of the warrant, using Black-Scholes valuation techniques.
The
borrowings from Bay Shore Trust were paid in full during the three months ended March 31, 2024, and the Company has fully amortized the
relating financing costs and future borrowings are no longer available due to the terms of the agreement, specifically the closing of
the IPO, which occurred on February 13, 2024.
Starwood
Trust Line of Credit-
On
September 24, 2024 the Company entered into an unsecured Promissory Note and Loan Agreement (“the Starwood Note”) with the
Starwood Trust, a separate related party trust established by the Company’s founder for the benefit of the founder’s family.
Under the Starwood Note, the Company has the right to borrow up to an aggregate of $5 million from the Starwood Trust at any time up
until the second anniversary of the note. The Company’s right to borrow funds under the Starwood Note is subject to the absence
of a material adverse change in its assets, operations, or prospects. The Starwood Note, together with accrued interest, is to become
due and payable on the second anniversary of the issuance of the note, provides for prepayment at any time without penalty, and accrues simple
interest at a rate equal 7% per annum. As of September 30, 2024, the Company has not borrowed any amounts under the Starwood Note.
Related
Party Travel Costs-
On
April 1, 2023 the Company entered into an Agreement For Shared Lease Costs (the “Shared Agreement”) with MIRALOGX, a related
party. Under the Shared Agreement, the Company agrees to make monthly contributions or payments in accordance with its use of shared
aircraft toward rent payments. During the nine months ended September 30, 2024 and September 30, 2023, the Company incurred $0.4 million
and $1.2 million, respectively, for travel-related expenses to MIRALOGX for rental charges and airplane-related expenses. The Company
will not participate in the use of the MIRALOGX airplane after March of 2024 and, pursuant to the terms of the Shared Agreement, has
no further obligation under the Shared Agreement.
MIRALOGX
License Agreement – (See Note 3).
Related
Party Rental Agreement- (See Note 5).
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v3.24.3
Leases:
|
9 Months Ended |
Sep. 30, 2024 |
Leases |
|
Leases: |
Note
5. Leases:
The
Company’s former corporate headquarters was located in Baltimore, Maryland, which included a lease for office space. This lease
began in November 2022 and expired in April 2024. The lease was not renewed.
The
Company moved all corporate related activities in April 2024 to the shared space in Tampa, Florida referenced below with variable lease
costs. In September 2024, the Company decided to no longer utilize the shared space and moved to a virtual office model and does not
have a physical office space.
Variable
lease costs
Variable
lease costs primarily include utilities, property taxes, and other operating costs that are passed on from the lessor. Variable lease
costs related to the aircraft include usage expenses, which includes pilot expenses, jet fuel and general flight expenses.
Beginning
August 1, 2023, the Company’s accounting and administrative staff began sharing office space with a related party. During the nine
months ended September 30, 2024, this variable lease cost related to the Tampa, Florida space totaled $0.02 million and included in general
and administrative expenses.
Schedule
of Components of Lease Expenses
| |
2024 | | |
2023 | |
| |
Nine
Months ended September
30, | |
| |
2024 | | |
2023 | |
Lease
Costs | |
| | | |
| | |
Operating
lease | |
$ | 55,667 | | |
$ | 7,416 | |
Variable
lease costs | |
| 337,111 | | |
| 1,292,545 | |
Total
lease cost | |
$ | 392,778 | | |
$ | 1,299,961 | |
|
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v3.24.3
Stockholders’ equity:
|
9 Months Ended |
Sep. 30, 2024 |
Equity [Abstract] |
|
Stockholders’ equity: |
Note
6. Stockholders’ equity:
Capital
stock
The
Company has the authority to issue 400,000,000 shares of capital stock, consisting of 300,000,000 shares of Common Stock and 100,000,000
shares of undesignated Preferred Stock, whose rights and privileges will be defined by the Board of Directors when a series of Preferred
Stock is designated.
Warrants
The
Company has granted warrants to purchase shares of Common Stock. Warrants may be granted to affiliates in connection with certain agreements.
As
of September 30, 2024, a cumulative total of 2,824,057 warrants, with exercise prices ranging from $3.73 to $15.42 remain exercisable
and outstanding. There were no warrants exercised during the nine months ended September 30,2024.
Underwriter
warrants
In
connection with the IPO, the Company issued 50,000 warrants to purchase Common Stock to the IPO underwriter (or its designees) at an
exercise price of $7.00 which expire after a four-and-a-half-year period commencing six months after the commencement of sales in the
IPO. The warrants will be exercisable at any time and from time to time, in whole or in part, during the four-and-a-half-year period
commencing six months after the commencement of sales in the IPO.
Stock-based
compensation
The
fair value of each option award is estimated on the grant date using the Black-Scholes valuation model that uses assumptions for expected
volatility, expected dividends, expected term, and the risk-free interest rate. Expected price volatility is based on the historical
volatilities of a peer group as the Company does not have a multi-year trading history for its shares. Industry peers consist of several
public companies in the biotech industry similar to the Company in size, stage of life cycle and product indications. The Company intends
to continue to consistently apply this process using the same or similar public companies until a sufficient amount of historical information
regarding the volatility of the Company’s own stock price becomes available, or unless circumstances change such that the identified
companies are no longer similar to the Company, in which case, more suitable companies whose share prices are publicly available would
be utilized in the calculation.
Expected
term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of
the vesting term plus contract term. The risk-free rate is based on the 5-year U.S. Treasury yield curve in effect at the time of grant.
The Company recognizes forfeitures as they occur.
During
the nine months ended September 30, 2024, a total of 2,370,170 options to purchase Common Stock, with an aggregate fair market value
of approximately $9.1 million were granted to the members of the Company’s Board of Directors, executive officers, employees and
consultants of the Company. The options have an exercise price of $5.02, a term of 10 years from the grant date, and vest over various
terms ranging from immediate vesting upon grant to the second anniversary of the grant date.
The
following is option activity during the nine months ended September 30, 2024.
Schedule
of option activity
| |
Number
of shares | | |
Weighted average
exercise
price per
share | | |
Aggregate intrinsic
value |
|
Outstanding
as January 1, 2024 | |
| - | | |
$ | - | | |
$ | - |
|
Options
granted | |
| 2,370,170 | | |
| 5.02 | | |
| - |
|
Forfeitures | |
| - | | |
| - | | |
| - |
|
Outstanding
as September 30, 2024 | |
| 2,370,170 | | |
$ | 5.02 | | |
$ | - |
|
As
of September 30, 2024, options exercisable totaled 1,046,335. There are approximately $4.3 million of unrecognized compensation costs
related to non-vested share-based compensation awards, which will be expensed through 2026.
Key
assumptions used to value stock options during the nine months ended September 30, 2024, are as follows:
Schedule
of key assumptions used to value stock options
Expected
volatility | |
| 88.8%-90.1 | % |
Risk-free
interest rate | |
| 3.7 | % |
Exercise
price | |
$ | 5.02 | |
Expected
term (in years) | |
| 5.1
to 6.2 years | |
Dividend
yield | |
| - | |
Earnings
Per Share
During
the three and nine months ended September 30, 2024 and 2023, outstanding stock options and warrants of 5,194,227 and 2,774,057, respectively,
were not included in the computation of diluted earnings per share, because to do so would have had an antidilutive effect.
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v3.24.3
Description of business and summary of significant accounting policies (Policies)
|
9 Months Ended |
Sep. 30, 2024 |
Accounting Policies [Abstract] |
|
Basis of Accounting |
Basis
of Accounting
The
accounting and reporting policies of the Company conform to accounting principles generally accepted in the United States of America
(“GAAP”). In the opinion of management, all adjustments considered necessary for the fair presentation of the financial statements
for the periods presented have been included. The results of operations for the nine months ended September 30, 2024 are not necessarily
indicative of the results to be expected for future periods.
|
Initial Public Offering |
Initial
Public Offering
On
February 13, 2024, the Company closed its initial public offering (the “IPO”) consisting of 1,000,000 shares of Common Stock
at a price of $7.00 per share for approximately $7.0 million in gross proceeds. After deducting the underwriting commission and other
offering expenses totaling $1.2 million, the net proceeds to the Company were $5.8 million. The Common Stock began trading on The Nasdaq
Capital Market on February 9, 2024 under the symbol “TELO”.
|
Significant Accounting Policies |
Significant
Accounting Policies
There
have been no material changes in the Company’s significant accounting policies from those previously disclosed in the
Company’s 2023 Annual Report on Form 10-K for the fiscal year ended December 31, 2023, which was filed with the Securities and
Exchange Commission (“SEC” or the “Commission”) on March 29, 2024, with the exception of stock compensation as
discussed below.
|
Stock-based Compensation |
Stock-based
Compensation
The
Company accounts for stock-based compensation under the provisions of FASB ASC 718, “Compensation - Stock Compensation”,
which requires the measurement and recognition of compensation expense for all stock-based awards made to employees, directors and consultants
based on estimated fair values on the grant date. The Company estimates the fair value of stock-based awards on the date of grant using
the Black-Scholes model. The value of the portion of the award that is ultimately expected to vest is recognized as expense over the
requisite service periods using the straight-line method. The Company has elected to account for forfeiture of stock-based awards as
they occur.
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v3.24.3
Leases: (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Leases |
|
Schedule of Components of Lease Expenses |
Schedule
of Components of Lease Expenses
| |
2024 | | |
2023 | |
| |
Nine
Months ended September
30, | |
| |
2024 | | |
2023 | |
Lease
Costs | |
| | | |
| | |
Operating
lease | |
$ | 55,667 | | |
$ | 7,416 | |
Variable
lease costs | |
| 337,111 | | |
| 1,292,545 | |
Total
lease cost | |
$ | 392,778 | | |
$ | 1,299,961 | |
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v3.24.3
Stockholders’ equity: (Tables)
|
9 Months Ended |
Sep. 30, 2024 |
Equity [Abstract] |
|
Schedule of option activity |
The
following is option activity during the nine months ended September 30, 2024.
Schedule
of option activity
| |
Number
of shares | | |
Weighted average
exercise
price per
share | | |
Aggregate intrinsic
value |
|
Outstanding
as January 1, 2024 | |
| - | | |
$ | - | | |
$ | - |
|
Options
granted | |
| 2,370,170 | | |
| 5.02 | | |
| - |
|
Forfeitures | |
| - | | |
| - | | |
| - |
|
Outstanding
as September 30, 2024 | |
| 2,370,170 | | |
$ | 5.02 | | |
$ | - |
|
|
Schedule of key assumptions used to value stock options |
Key
assumptions used to value stock options during the nine months ended September 30, 2024, are as follows:
Schedule
of key assumptions used to value stock options
Expected
volatility | |
| 88.8%-90.1 | % |
Risk-free
interest rate | |
| 3.7 | % |
Exercise
price | |
$ | 5.02 | |
Expected
term (in years) | |
| 5.1
to 6.2 years | |
Dividend
yield | |
| - | |
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v3.24.3
Liquidity and capital resources (Details Narrative) - USD ($)
|
9 Months Ended |
|
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Liquidity And Capital Resources |
|
|
|
Cash |
$ 834,638
|
|
$ 1,231
|
Cash in operations |
4,464,620
|
$ 2,772,581
|
|
Cash |
$ 5,000,000
|
|
|
X |
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v3.24.3
Related party transactions: (Details Narrative) - USD ($)
|
|
3 Months Ended |
9 Months Ended |
12 Months Ended |
|
Jun. 15, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
Sep. 24, 2024 |
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Amounts due from related parties |
|
$ 130,000
|
|
$ 130,000
|
|
$ 130,000
|
|
Unused line of credit |
|
100,000
|
|
100,000
|
|
500,000
|
|
General and administrative expense |
|
5,378,744
|
$ 102,191
|
6,999,981
|
$ 204,902
|
|
|
Travel related expense |
|
|
$ 589,400
|
370,500
|
1,288,000
|
|
|
Miralogx LLC [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Advances in the amount |
|
|
|
|
|
$ 1,700,000
|
|
Converted of shares |
|
|
|
|
|
837,841
|
|
Conversion rate per share |
|
|
|
|
|
$ 2.05
|
|
Debt instrument conversion shares |
|
|
|
|
|
$ 4,100,000
|
|
Bay Shore Trust [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Unused line of credit |
$ 5,000,000
|
|
|
|
|
|
|
Accrue interest at a rate |
7.00%
|
|
|
|
|
|
|
Outstanding simple interest |
10.00%
|
|
|
|
|
|
|
Shares of common stock |
2,439,025
|
|
|
|
|
|
|
Exercise price |
$ 3.73
|
|
|
|
|
|
|
Fair value |
$ 5,950,000
|
|
|
|
|
|
|
Starwood Trust [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Unused line of credit |
|
|
|
|
|
|
$ 5,000,000
|
Accrue interest at a rate |
|
|
|
|
|
|
7.00%
|
MIRALOGX [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Travel related expense |
|
|
|
400,000
|
$ 1,200,000
|
|
|
Related Party [Member] |
|
|
|
|
|
|
|
Related Party Transaction [Line Items] |
|
|
|
|
|
|
|
Amounts due from related parties |
|
$ 130,000
|
|
130,000
|
|
$ 130,000
|
|
General and administrative expense |
|
|
|
$ 40,000.00
|
|
|
|
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v3.24.3
Schedule of Components of Lease Expenses (Details) - USD ($)
|
9 Months Ended |
Sep. 30, 2024 |
Sep. 30, 2023 |
Leases |
|
|
Operating lease |
$ 55,667
|
$ 7,416
|
Variable lease costs |
337,111
|
1,292,545
|
Total lease cost |
$ 392,778
|
$ 1,299,961
|
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v3.24.3
Schedule of option activity (Details)
|
9 Months Ended |
Sep. 30, 2024
USD ($)
$ / shares
shares
|
Equity [Abstract] |
|
Number of options, outstanding | shares |
|
Weighted average exercise price, outstanding | $ / shares |
|
Number of options, granted | shares |
2,370,170
|
Weighted average exercise price, granted | $ / shares |
$ 5.02
|
Number of options, forfeitures | shares |
|
Weighted average exercise price, forfeitures | $ / shares |
|
Number of options, outstanding | shares |
2,370,170
|
Weighted average exercise price, outstanding | $ / shares |
$ 5.02
|
Outstanding aggregate intrinsic value | $ |
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v3.24.3
Stockholders’ equity: (Details Narrative) - USD ($) $ / shares in Units, $ in Millions |
3 Months Ended |
9 Months Ended |
|
|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Feb. 13, 2024 |
Dec. 31, 2023 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
Issue of shares of capital stock |
400,000,000
|
|
400,000,000
|
|
|
|
Common stock, shares authorized |
300,000,000
|
|
300,000,000
|
|
|
300,000,000
|
Preferred stock, shares authorized |
100,000,000
|
|
100,000,000
|
|
|
100,000,000
|
Number of options, outstanding |
2,370,170
|
|
2,370,170
|
|
|
|
Weighted average exercise price, outstanding |
$ 5.02
|
|
$ 5.02
|
|
|
|
Share based compensation term of years |
|
|
10 years
|
|
|
|
Number of options, exercisable |
|
|
1,046,335
|
|
|
|
Unrecognized compensation costs |
$ 4.3
|
|
$ 4.3
|
|
|
|
Antidilutive securities excluded from computation of earnings per share, amount |
5,194,227
|
2,774,057
|
5,194,227
|
2,774,057
|
|
|
Minimum [Member] |
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
Share based compensation term of years |
|
|
5 years 1 month 6 days
|
|
|
|
Maximum [Member] |
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
Share based compensation term of years |
|
|
6 years 2 months 12 days
|
|
|
|
Warrant [Member] |
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
Total cumulative warrants |
2,824,057
|
|
2,824,057
|
|
|
|
Warrant [Member] | IPO [Member] |
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
Exercise price |
$ 7.00
|
|
$ 7.00
|
|
|
|
Warrants to purchase common stock |
|
|
|
|
50,000
|
|
Warrant [Member] | Minimum [Member] |
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
Exercise price |
3.73
|
|
3.73
|
|
|
|
Warrant [Member] | Maximum [Member] |
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
Exercise price |
$ 15.42
|
|
$ 15.42
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
|
|
Share based compensation fair market value |
|
|
$ 9.1
|
|
|
|
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Telomir Pharmaceuticals (NASDAQ:TELO)
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