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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 March 31, 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: 001-41097
Cardio Diagnostics Holdings, Inc.
(Exact name of registrant
as specified in its charter)
Delaware |
|
87-0925574 |
(State or other jurisdiction of
incorporation or organization) |
|
(I.R.S. Employer
Identification No.) |
311 West Superior Street, Suite 444
Chicago, Illinois |
|
60654 |
(Address of principal executive offices) |
|
(Zip Code) |
(855) 226-9991
(Registrant’s
telephone number, including area code)
(Former name or former address,
if changed since last report)
Securities registered pursuant
to Section 12(b) of the Act:
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on
which registered |
Common Stock, par value $0.00001 per share |
|
CDIO |
|
The NASDAQ Stock Market LLC |
Redeemable Warrants, each whole warrant exercisable for one share of Common Stock |
|
CDIOW |
|
The NASDAQ Stock Market LLC |
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒
No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No
☐
Indicate by check mark whether
the registrant is a large, accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging
growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting
company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer |
☐ |
Accelerated filer |
☐ |
|
|
|
|
Non-accelerated filer |
☒ |
Smaller reporting company |
☒ |
|
|
|
|
|
|
Emerging growth company |
☒ |
If
an emerging growth company, indicate by 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 May 15, 2024, there
were 22,685,589 shares of the registrant’s Common Stock, $0.00001 par value, issued and outstanding.
CARDIO DIAGNOSTICS HOLDINGS,
INC.
FORM 10-Q
For the Quarter Ended March
31, 2024
TABLE OF CONTENTS
INTRODUCTORY
NOTE
Unless the context dictates otherwise, references
in this Quarterly Report on Form 10-Q to the "Company,” "Cardio,” "we,” "us,” "our,”
and similar words are references to Cardio Diagnostics Holdings, Inc., a Delaware corporation, and its consolidated subsidiary. "Legacy
Cardio” refers to Cardio Diagnostics, Inc. prior to the October 2022 Business Combination, which became our wholly-owned subsidiary
as a result of that transaction.
Trade names and trademarks of Cardio referred
to herein, and their respective logos, are our property. This Quarterly Report on Form 10-Q may contain additional trade names and/or
trademarks of other companies, which are the property of their respective owners. We do not intend our use or display of other companies’
trade names and/or trademarks, if any, to imply an endorsement or sponsorship of us by such companies, or any relationship with any of
these companies.
SPECIAL
NOTE ABOUT FORWARD-LOOKING STATEMENTS
This
Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act
of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange
Act”). All statements other than statements of historical fact are “forward-looking statements” for purposes of federal
and state securities laws, including, but not limited to, changes in laws or regulations, any statements about our business (including
the impact of a re-emergence of COVID-19 variants or
any other pandemic, epidemic or infectious disease outbreak on
our business), financial condition, operating results, plans, objectives, expectations and intentions, any guidance on, or projections
of, earnings, revenue or other financial items, or otherwise, and our future liquidity, including cash flows; any statements of any plans,
strategies, and objectives of management for future operations, such as the material opportunities that we believe exist for our Company;
any statements concerning proposed products and services, developments, mergers or acquisitions; or strategic transactions; any statements
regarding management’s view of future expectations and prospects for us; any statements about prospective adoption of new accounting
standards or effects of changes in accounting standards; any statements regarding future economic conditions or performance; any statements
of belief; any statements of assumptions underlying any of the foregoing; and other statements that are not historical facts. Forward-looking
statements may be identified by the use of forward-looking terms such as “anticipate,” “could,” “can,”
“may,” “might,” “potential,” “predict,” “should,” “estimate,”
“expect,” “project,” “believe,” “think,” “plan,” “envision,” “intend,”
“continue,” “target,” “seek,” “contemplate,” “budgeted,” “will,”
“would,” and the negative of such terms, other variations on such terms or other similar or comparable words, phrases, or
terminology. These forward-looking statements present our estimates and assumptions only as of the date of this Quarterly Report on Form
10-Q and are subject to change.
Forward-looking
statements involve risks and uncertainties and are based on the current beliefs, expectations, and certain assumptions of management.
Some or all of such beliefs, expectations, and assumptions may not materialize or may vary significantly from actual results. Such statements
are qualified by important economic, competitive, governmental, and technological factors that could cause our business, strategy, or
actual results or events to differ materially from those in our forward-looking statements. Factors that might cause or contribute to
such differences include, but are not limited to, the risk factors discussed under the heading “Risk Factors” in Part I, Item
IA of our Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (“SEC”)
on April 1, 2024 (the “2023 Form 10-K”) and in Part II, Item 1A of this Form 10-Q. Although we believe that the expectations
reflected in our forward-looking statements are reasonable, actual results could differ materially from those projected or assumed in
any of our forward-looking statements. Our future financial condition and results of operations, as well as any forward-looking statements,
are subject to change, and significant risks and uncertainties that could cause actual conditions, outcomes, and results to differ materially
from those indicated by such statements. Consequently, all of the forward-looking statements made in this Form 10-Q are qualified by these
cautionary statements and there can be no assurance that the actual results or developments anticipated by the Company will be realized
or, even if substantially realized, that they will have the expected consequence to or effects on the Company or its business or operations.
The Company assumes no obligations to update any such forward-looking statements.
PART I: FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
CARDIO DIAGNOSTICS HOLDINGS,
INC.
CONSOLIDATED
BALANCE SHEETS
(unaudited)
| |
| | |
| |
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
ASSETS | |
| | |
| |
|
Current assets | |
| | | |
| | |
Cash | |
$ | 1,563,139 | | |
$ | 1,283,523 | |
Accounts receivable | |
| 18,988 | | |
| 4,960 | |
Prepaid expenses and other current assets | |
| 1,007,147 | | |
| 1,477,197 | |
| |
| | | |
| | |
Total current assets | |
| 2,589,274 | | |
| 2,765,680 | |
| |
| | | |
| | |
Long-term assets | |
| | | |
| | |
Property and equipment, net | |
| 588,271 | | |
| 571,873 | |
Right of use assets, net | |
| 555,270 | | |
| 575,227 | |
Intangible assets, net | |
| 17,333 | | |
| 21,333 | |
Deposits | |
| 12,850 | | |
| 12,850 | |
Patent costs, net | |
| 564,565 | | |
| 515,402 | |
| |
| | | |
| | |
Total assets | |
$ | 4,327,563 | | |
$ | 4,462,365 | |
| |
| | | |
| | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |
| | | |
| | |
| |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable and accrued expenses | |
$ | 224,719 | | |
$ | 243,213 | |
Lease liability - current | |
| 227,203 | | |
| 223,929 | |
Finance agreement payable | |
| 233,750 | | |
| 374,000 | |
| |
| | | |
| | |
Total current liabilities | |
| 685,672 | | |
| 841,142 | |
| |
| | | |
| | |
Long-term liabilities | |
| | | |
| | |
Lease liability – long term | |
| 605,090 | | |
| 663,099 | |
| |
| | | |
| | |
Total liabilities | |
| 1,290,762 | | |
| 1,504,241 | |
| |
| | | |
| | |
Stockholders' equity | |
| | | |
| | |
Preferred stock, $.00001 par value; authorized - 100,000,000 shares; 0 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | |
| — | | |
| — | |
Common stock, $.00001 par value; authorized - 300,000,000 shares; 21,628,974 and 20,540,409 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | |
| 216 | | |
| 205 | |
Additional paid-in capital | |
| 21,568,549 | | |
| 17,326,299 | |
Accumulated deficit | |
| (18,531,964 | ) | |
| (14,368,380 | ) |
| |
| | | |
| | |
Total stockholders' equity | |
| 3,036,801 | | |
| 2,958,124 | |
| |
| | | |
| | |
Total liabilities and stockholders' equity | |
$ | 4,327,563 | | |
$ | 4,462,365 | |
The accompanying notes
are an integral part of these unaudited financial statements.
CARDIO DIAGNOSTICS HOLDINGS,
INC.
CONSOLIDATED STATEMENTS
OF OPERATIONS
(unaudited)
| |
| | |
| |
| |
Three Months Ended | |
| |
March 31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Revenue | |
$ | 15,928 | | |
$ | — | |
| |
| | | |
| | |
Operating expenses | |
| | | |
| | |
Sales and marketing | |
| 34,402 | | |
| 49,551 | |
Research and development | |
| 10,840 | | |
| 86,665 | |
General and administrative expenses | |
| 4,123,941 | | |
| 1,562,128 | |
Amortization | |
| 4,793 | | |
| 4,785 | |
| |
| | | |
| | |
Total operating expenses | |
| 4,173,976 | | |
| 1,703,129 | |
| |
| | | |
| | |
Loss from operations | |
| (4,158,048 | ) | |
| (1,703,129 | ) |
| |
| | | |
| | |
Other income (expenses) | |
| | | |
| | |
Change in fair value of derivative liability | |
| — | | |
| 5,686,901 | |
Interest income | |
| 281 | | |
| 221 | |
Interest expense | |
| (5,817 | ) | |
| (5,016,611 | ) |
| |
| | | |
| | |
Total other income (expenses) | |
| (5,536 | ) | |
| 670,511 | |
| |
| | | |
| | |
| |
| | | |
| | |
| |
| | | |
| | |
Provision for income taxes | |
| — | | |
| — | |
| |
| | | |
| | |
Net loss | |
$ | (4,163,584 | ) | |
$ | (1,032,618 | ) |
| |
| | | |
| | |
Basic and fully diluted income (loss) per common share: | |
| | | |
| | |
Net loss per common share | |
$ | (.20 | ) | |
$ | (.11 | ) |
| |
| | | |
| | |
Weighted average common shares outstanding - basic and fully diluted | |
| 21,077,225 | | |
| 9,547,177 | |
The accompanying notes are
an integral part of these unaudited financial statements.
CARDIO DIAGNOSTICS HOLDINGS,
INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’
EQUITY
Three Months Ended March 31, 2024 and 2023
(unaudited)
| |
| | | |
| | | |
| | | |
| | | |
| | |
| |
| | |
| | |
Additional | | |
| | |
| |
| |
Common
stock | | |
Paid-in | | |
Accumulated | | |
| |
| |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Totals | |
| |
| | |
| | |
| | |
| | |
| |
Balances, December 31, 2023 | |
| 20,540,409 | | |
$ | 205 | | |
$ | 17,326,299 | | |
$ | (14,368,380 | ) | |
$ | 2,958,124 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Common
stock issued for cash | |
| 1,048,876 | | |
| 11 | | |
| 1,877,846 | | |
| — | | |
| 1,877,857 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Restricted
stock awards vested | |
| 39,689 | | |
| — | | |
| 58,000 | | |
| — | | |
| 58,000 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Placement
agent fee | |
| — | | |
| — | | |
| (155,000 | ) | |
| — | | |
| (155,000 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Compensation
for vested stock options | |
| — | | |
| — | | |
| 2,461,404 | | |
| — | | |
| 2,461,404 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (4,163,584 | ) | |
| (4,163,584 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balances, March 31, 2024 | |
| 21,628,974 | | |
$ | 216 | | |
$ | 21,568,549 | | |
$ | (18,531,964 | ) | |
$ | 3,036,801 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balances, December 31, 2022 | |
| 9,514,743 | | |
$ | 95 | | |
$ | 10,293,159 | | |
$ | (5,991,546 | ) | |
$ | 4,301,708 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Warrants
converted to common stock | |
| 100,000 | | |
| 1 | | |
| 389,999 | | |
| — | | |
| 390,000 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Restricted
stock awards vested | |
| 1,092 | | |
| — | | |
| 4,000 | | |
| — | | |
| 4,000 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Placement
agent fee | |
| — | | |
| — | | |
| (315,000 | ) | |
| — | | |
| (315,000 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Adjustment
to liabilities assumed in merger with Mana | |
| — | | |
| — | | |
| 74,025 | | |
| — | | |
| 74,025 | |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Net
loss | |
| — | | |
| — | | |
| — | | |
| (1,032,618 | ) | |
| (1,032,618 | ) |
| |
| | | |
| | | |
| | | |
| | | |
| | |
Balances, March 31, 2023 | |
| 9,615,835 | | |
$ | 96 | | |
$ | 10,446,183 | | |
$ | (7,024,164 | ) | |
$ | 3,422,115 | |
The accompanying notes are an integral part of
these unaudited financial statements.
CARDIO DIAGNOSTICS HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
| |
| | |
| |
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
CASH FLOWS FROM OPERATING ACTIVITIES: | |
| | | |
| | |
Net loss | |
$ | (4,163,584 | ) | |
$ | (1,032,618 | ) |
Adjustments to reconcile net loss to net cash used in operating activities | |
| | | |
| | |
Depreciation | |
| 3,587 | | |
| — | |
Amortization | |
| 24,750 | | |
| 4,785 | |
Stock-based compensation expense | |
| 2,519,404 | | |
| 4,000 | |
Non-cash interest expense | |
| — | | |
| 5,007,740 | |
Change in fair value of derivative liability | |
| — | | |
| (5,686,901 | ) |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| (14,028 | ) | |
| — | |
Prepaid expenses and other current assets | |
| 470,050 | | |
| 338,105 | |
Deposits | |
| — | | |
| (2,100 | ) |
Accounts payable and accrued expenses | |
| (18,494 | ) | |
| (282,078 | ) |
Lease liability | |
| (54,735 | ) | |
| — | |
| |
| | | |
| | |
NET CASH USED IN OPERATING ACTIVITIES | |
| (1,233,050 | ) | |
| (1,649,067 | ) |
| |
| | | |
| | |
CASH FLOWS FROM INVESTING ACTIVITIES: | |
| | | |
| | |
Purchases of property and equipment | |
| (19,985 | ) | |
| — | |
Patent costs incurred | |
| (49,956 | ) | |
| (52,674 | ) |
| |
| | | |
| | |
NET CASH USED IN INVESTING ACTIVITIES | |
| (69,941 | ) | |
| (52,674 | ) |
| |
| | | |
| | |
CASH FLOWS FROM FINANCING ACTIVITIES: | |
| | | |
| | |
Proceeds from convertible notes payable, net of original issue discount of $500,000 | |
| — | | |
| 4,500,000 | |
Proceeds from exercise of warrants | |
| — | | |
| 390,000 | |
Proceeds from sale of common stock | |
| 1,877,857 | | |
| — | |
Payments of finance agreement | |
| (140,250 | ) | |
| (283,010 | ) |
Payments of placement agent fee | |
| (155,000 | ) | |
| (315,000 | ) |
| |
| | | |
| | |
NET CASH PROVIDED BY FINANCING ACTIVITIES | |
| 1,582,607 | | |
| 4,291,990 | |
| |
| | | |
| | |
NET INCREASE IN CASH | |
| 279,616 | | |
| 2,590,249 | |
| |
| | | |
| | |
CASH - BEGINNING OF PERIOD | |
| 1,283,523 | | |
| 4,117,521 | |
| |
| | | |
| | |
CASH - END OF PERIOD | |
$ | 1,563,139 | | |
$ | 6,707,770 | |
| |
| | | |
| | |
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: | |
| | | |
| | |
Cash paid during the period for: | |
| | | |
| | |
Interest | |
$ | 5,817 | | |
$ | 8,871 | |
Income taxes | |
$ | — | | |
$ | — | |
| |
| | | |
| | |
Non-cash investing and financing activities: | |
| | | |
| | |
Debt discount related to derivative liability | |
$ | — | | |
$ | 9,192,672 | |
Adjustment to liabilities assumed in acquisition | |
$ | — | | |
$ | 74,025 | |
The accompanying notes are an integral part of
these unaudited financial statements.
CARDIO DIAGNOSTICS HOLDINGS, INC.
NOTES TO CONSOLIDATED
FINANCIAL STATEMENTS
(UNAUDITED)
Note 1 - Organization and Basis of Presentation
The consolidated financial statements
presented are those of Cardio Diagnostics Holdings, Inc., (the “Company”) and its wholly-owned subsidiary, Cardio Diagnostics,
Inc. (“Legacy Cardio”). The Company was incorporated as Mana Capital Acquisition Corp. (“Mana”) under the laws
of the state of Delaware on May 19, 2021, and Legacy Cardio was formed on January 16, 2017 as an Iowa limited liability company (Cardio
Diagnostics, LLC) and was subsequently incorporated as a Delaware C-Corp on September 6, 2019. The Company was formed to develop and commercialize
a patent-pending Artificial Intelligence (“AI”)-driven DNA biomarker testing technology (“Core Technology”) for
cardiovascular disease invented at the University of Iowa by the Founders, with the goal of becoming one of the leading medical technology
companies for enabling precision prevention, early detection and treatment of cardiovascular disease. The Company is transforming the
approach to cardiovascular disease from reactive to proactive. The Core Technology is being
incorporated into a series of products for major types of cardiovascular disease and associated co-morbidities, including coronary heart
disease (“CHD”), stroke, heart failure and diabetes.
Interim Financial Statements
The following (a)
consolidated balance sheet as of December 31, 2023, which has been derived from audited financial statements, and (b) the unaudited
consolidated interim financial statements of the Company as of and for the period ended March 31, 2024 have been prepared
in accordance with the instructions to Form 10-Q and Rule 8-03 of Regulation S-X. Accordingly, they do not include all of the
information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments
(consisting of normal recurring accruals) considered necessary for a fair presentation
have been included. Operating results for the three months ended March 31, 2024 are not necessarily indicative of results that may
be expected for the year ending December 31, 2024. These unaudited consolidated financial statements should be read in
conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2023 included in
the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (“SEC”) on April 1,
2024.
Business Combination
On
May 27, 2022, Mana, Mana Merger Sub, Inc. (“Merger Sub”), a wholly-owned direct subsidiary of Mana, Meeshanthini Dogan, the
Shareholders’ Representative, and Legacy Cardio entered into the Business Combination Agreement (the “Merger Agreement”). On
October 25, 2022, pursuant to the Merger Agreement, Legacy Cardio merged with and into Merger Sub, with Legacy Cardio surviving as the
wholly-owned subsidiary of Mana. Subsequent to the merger, Mana changed its name to Cardio Diagnostics Holdings, Inc.
Going Concern
The accompanying consolidated
financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of
liabilities in the normal course of business. The Company has generated only nominal revenue in the past two years. The Company had
a net loss of $4,163,584 for the three months ended March 31, 2024 and an accumulated deficit of $18,531,964 at March 31, 2024. These
factors, among others, raise substantial doubt about the ability of the Company to continue as a going concern for a reasonable period
of time. The Company’s continuation as a going concern is dependent upon its ability to obtain necessary equity financing and
ultimately from generating revenues to continue operations. The Company expects that working capital requirements will continue to
be funded through a combination of its existing funds and further issuances of securities. Working capital requirements are expected to
increase in line with the growth of the business. Existing working capital, further advances and debt instruments, and anticipated
cash flow are expected to be adequate to fund operations over the next twelve months. The Company has no lines of credit or other bank
financing arrangements. Additional issuances of equity or convertible debt securities will result in dilution to current stockholders.
Further, such securities might have rights, preferences or privileges senior to common stock. Additional financing may not be available
upon acceptable terms, or at all. If adequate funds are not available or are not available on acceptable terms, the Company may not be
able to take advantage of prospective new business endeavors or opportunities, which could significantly and materially restrict business
operations.
The consolidated financial
statements do not include any adjustments that might result from the outcome of this uncertainty relating to the 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 2 – Merger Agreement and Reverse Recapitalization
As
discussed in Note 1, on October 25, 2022, the Company (formerly known as Mana) and Legacy Cardio entered into the Merger Agreement, which
has been accounted for as a reverse recapitalization in accordance with GAAP. Pursuant to the Merger Agreement, the Company acquired
cash of $4,021 and assumed liabilities of $928,500 from Mana. The liabilities assumed of $928,500 were payable to two investment bankers
and due on October 25, 2023. The assumed liabilities decreased to $854,475, after net of an early payment discount of $74,025 issued
by one of the two investment bankers on March 22, 2023. On March 27, 2023, the Company accepted the early payment discount and paid
Ladenburg the net balance due and payable of $419,475. On October 24, 2023, the Company paid the remaining post-merger liabilities balance
of $435,000 to Benchmark.
Mana’s
common stock had a redemption right in connection with the business combination. Mana’s stockholders exercised their right to redeem
6,465,452 shares of common stock, which constituted approximately 99.5% of the shares with redemption rights, for cash at a redemption
price of approximately $10.10 per share, for an aggregate redemption amount of $65,310,892. In accounting for the reverse recapitalization,
the Company’s legacy issued and outstanding 1,976,749 shares of common stock were reversed and the Mana shares of common stock
totaling 9,514,743 were recorded, as described in Note 10. Transactions costs incurred in connection with the recapitalization totaled
$1,535,035 and were recorded as a reduction to additional paid in capital.
As additional consideration for the
transaction, Cardio may issue to each holder who was entitled to merger consideration at the Closing, its pro rata proportion of
up to 1,000,000 shares of our authorized but unissued common stock (the “Earnout Shares” or “Contingently Issuable
Common Stock”), if on or prior to the fourth anniversary of the Closing Date (the “Earnout Period”), the VWAP of the
Company’s Common Stock equals or exceeds four different price triggers for 30 of any 40 consecutive trading days, as follows: (i)
one-quarter of the Earnout Shares will be issued if the VWAP equals or exceeds $12.50 per share for the stated period; (ii) one-quarter
of the Earnout Shares will be issued if the VWAP equals or exceeds $15.00 per share for the stated period; (iii) one-quarter of the Earnout
Shares will be issued if the VWAP equals or exceeds $17.50 for the stated period; and (iv) one-quarter of the Earnout Shares will be issued
if the VWAP equals or exceeds $20.00 for the stated period.
In evaluating the accounting treatment
for the earnout, we have concluded that the earnout is not a liability under Accounting Standards Codification (“ASC”) 480,
Distinguishing Liabilities from Equity, is not subject to the accounting guidance under ASC 718, Compensation—Stock Compensation,
and is not subject to derivative accounting under ASC 815, Derivative and Hedging. As such, the earnout is recognized in equity at fair
value upon the closing of the Business Combination. As of the date of filing of this Quarterly
Report on Form 10-Q, the Company’s common stock did not trade at equal to or greater than $12.50 for a period of at least 30 trading
days out of 40 consecutive trading days and the Company has not issued any Earnout Shares.
Note 3 – Summary of Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements
include the accounts of the Company and its wholly-owned subsidiary, Legacy Cardio. All intercompany accounts and transactions
have been eliminated.
Use of Estimates in the Preparation of Financial Statements
The preparation of financial statements
in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements
and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates.
Fair Value Measurements
The
Company adopted the provisions of ASC Topic 820, Fair Value Measurements and Disclosures, which defines fair value as used in numerous
accounting pronouncements, establishes a framework for measuring fair value and expands disclosure of fair value measurements.
The
estimated fair value of certain financial instruments, including cash and cash equivalents, accounts payable and accrued expenses are
carried at historical cost basis, which approximates their fair values because of the short-term nature of these instruments. The carrying
amounts of our short- and long-term credit obligations approximate fair value because the effective yields on these obligations, which
include contractual interest rates taken together with other features such as concurrent issuances of warrants and/or embedded conversion
options, are comparable to rates of returns for instruments of similar credit risk.
ASC
820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the
principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement
date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize
the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:
Level 1 – quoted prices
in active markets for identical assets or liabilities
Level 2 – quoted prices
for similar assets and liabilities in active markets or inputs that are observable
Level 3 – inputs that
are unobservable (for example cash flow modeling inputs based on assumptions)
The
estimated fair value of the derivative liability was calculated using the Black-Scholes option pricing model. The Company uses Level 3
inputs to value its derivative liabilities. The following table provides a reconciliation of the beginning and ending balances for the
major classes of assets and liabilities measured at fair value using significant unobservable inputs (Level 3) and reflects gains and
losses for the three months ended March 31, 2024 and 2023.
Schedule of fair value measurements | |
| | | |
| | |
| |
2024 | | |
2023 | |
Liabilities: | |
| | |
| |
Balance of derivative liabilities - beginning of period | |
$ |
— | | |
$ |
— | |
Issued | |
| — | | |
| 9,192,672 | |
Converted | |
| — | | |
| — | |
Change in fair value recognized in operations | |
| — | | |
| (5,686,901 | ) |
Balance of derivative liabilities - end of period | |
$ | — | | |
$ | 3,505,771 | |
The following table represents
the Company’s derivative instruments that are measured at fair value on a recurring basis as of March 31, 2024, for each fair value
hierarchy level:
Schedule of fair value hierarchy level | |
| | | |
| | |
March 31, 2024 | |
| Derivative
Liabilities | | |
| Total |
Level I | |
$ | — | | |
$ | — | |
Level II | |
$ | — | | |
$ | — | |
Level III | |
$ | — | | |
$ | — | |
Convertible Instruments
The
Company evaluates and accounts for conversion options embedded in convertible instruments in accordance with ASC 815, Derivatives and
Hedging Activities.
Applicable
GAAP requires companies to bifurcate conversion options from their host instruments and account for them as free standing derivative financial
instruments according to certain criteria. The criteria include circumstances in which (a) the economic characteristics and risks of the
embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b)
the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under
other GAAP with changes in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded
derivative instrument would be considered a derivative instrument.
The
Company accounts for convertible instruments (when it has been determined that the embedded conversion options should not be bifurcated
from their host instruments) as follows: The Company records, when necessary, discounts to convertible notes for the intrinsic value of
conversion options embedded in debt instruments based upon the differences between the fair value of the underlying common stock at the
commitment date of the note transaction and the effective conversion price embedded in the note. Debt discounts under these arrangements
are amortized over the term of the related debt to their stated date of redemption.
The
Company accounts for the conversion of convertible debt when a conversion option has been bifurcated using the general extinguishment
standards. The debt and equity linked derivatives are removed at their carrying amounts and the shares issued are measured at their then-current
fair value, with any difference recorded as a gain or loss on extinguishment of the two separate accounting liabilities.
Revenue Recognition
The Company offers its
products, Epi+Gen CHD™ and PrecisionCHD™ via telemedicine providers, provider organizations such as concierge practices, longevity
clinics, and risk-bearing provider organizations, and employer organizations. The Company is continuing to expand its markets and payment
optionality, and therefore, other organization types not listed below may be added, and from time-to-time, there may be additional payment
options.
For telemedicine, the telemedicine
provider collects payments from patients upon completion of eligibility screening and test order. Patients then send their samples to
the lab for biomarker assessments. The Company performs all quality control, analytical assessments and report generation and shares test
reports with the ordering healthcare provider. Revenue is recognized upon invoicing the telemedicine providers. Telemedicine providers
are invoiced at the end of each month for all tests completed since prior invoicing.
For provider organizations, the
cost of each test is negotiated prior to testing commencing. Pricing is determined based largely on the provider organization type and
testing volume commitment. Upon ordering a test, a patient’s sample is sent to the lab for biomarker assessments. The Company performs
all quality control, analytical assessments and report generation and shares test reports with the ordering healthcare provider. Revenue
is recognized upon invoicing the provider organization. The provider organization is invoiced the agreed upon pricing at the end of each
month for all samples accepted or tests completed since prior invoicing.
For employer organizations, the
cost of each test is negotiated prior to testing commencing. Pricing is determined based largely on testing volume commitment. Patient
samples are sent to the lab for biomarker assessments. The Company performs all quality control, analytical assessments and report generation
and shares test reports with the ordering healthcare provider. Revenue is recognized upon invoicing the employer organization. The employer
organization is invoiced the agreed upon pricing once a heart disease fair is completed or all testing is completed.
The
Company accounts for revenue under Accounting Standards Update (“ASU”) 2014-09, “Revenue from Contracts with Customers
(Topic 606)”, using the modified retrospective method. The modified retrospective adoption used by the Company did not result in
a material cumulative effect adjustment to the opening balance of accumulated deficit.
The Company determines the measurement of revenue and the timing
of revenue recognition utilizing the following core principles:
1. Identifying the contract with a customer;
2. Identifying the performance obligations in the contract;
3. Determining the transaction price;
4. Allocating the transaction price to the performance obligations
in the contract; and
5. Recognizing revenue when (or as) the Company satisfies its
performance obligations.
Research and Development
Research
and development costs are expensed as incurred. Research and development costs charged to operations for the three months ended March
31, 2024 and 2023 were $10,840 and $86,665, respectively.
Advertising Costs
The Company
expenses advertising costs as incurred. Advertising costs of $34,402 and $49,551 were charged to operations for the three months ended
March 31, 2024 and 2023, respectively.
Cash and Cash Equivalents
Cash
and cash equivalents are comprised of cash and highly liquid investments with original maturities of 90 days or less at the date of purchase.
The Company does not have any cash equivalents as of March 31, 2024 and December 31, 2023. Cash is maintained at a major financial institution.
Accounts held at U.S. financial institutions are insured by the FDIC up to $250,000. The Company is exposed to credit risk in the event
of default by the financial institutions or the issuers of these investments to the extent the amounts on deposit or invested are in excess
of amounts that are insured.
Property and Equipment
and Depreciation
Property
and equipment are stated at cost. Maintenance and repairs are charged to expense when incurred. When property and equipment are
retired or otherwise disposed of, the related cost and accumulated depreciation are removed from the respective accounts and any gain
or loss is credited or charged to income. Depreciation for both financial reporting and income tax purposes is computed using combinations
of the straight line and accelerated methods over the estimated lives of the respective assets as follows:
Schedule of estimated lives |
|
Office and computer equipment |
5 years |
Furniture
and fixtures |
7 years |
Leasehold improvements |
7 years |
Intangible Assets
Intangible assets are acquired individually
or as part of a group of assets, and are initially recorded at cost. The cost of a group of assets acquired in a transaction is allocated
to the individual assets based on their relative fair values. Intangible assets are carried at cost less accumulated amortization and
any recorded impairment. Intangible assets with finite useful lives are amortized using a straight-line method over the period of estimated
useful life. The estimated useful life of the Company’s intangible assets (Know-how license) is 5 years. The Company evaluates intangible
assets for impairment whenever events or changes in circumstances indicate that the assets might be impaired.
Patent Costs
The Company accounts for patents
in accordance with ASC 350-30, General Intangibles Other than Goodwill. The Company capitalizes patent costs representing legal
fees associated with filing patent applications and amortize them on a straight-line basis. The Company evaluates its patents’
estimated useful life and begins amortizing the patents when they are brought to the market or otherwise commercialized.
Impairment of Long-Lived
Assets
In accordance with ASC 360-10-35,
the Company assesses the valuation of components of its long-lived assets whenever events or circumstances dictate that the carrying value
might not be recoverable. The Company bases its evaluation on indicators such as the nature of the assets, the future economic benefit
of the assets, any historical or future profitability measurements and other external market conditions or factors
that may be present. If such factors indicate that the carrying amount of an asset or asset group may not be recoverable, the Company
determines whether an impairment has occurred by analyzing an estimate of undiscounted future cash flows at the lowest level for which
identifiable cash flows exist. If the estimate of undiscounted cash flows during the estimated useful life of the asset is less than the
carrying value of the asset, the Company recognizes a loss for the difference between the carrying value of the asset and its estimated
fair value, generally measured by the present value of the estimated cash flows.
Leases
The Company accounts for leases under
ASC 842, “Leases”. The Company determines if an arrangement is a lease or contains a lease at inception of the arrangement.
Operating lease liabilities are recognized based on the present value of the remaining lease payments, discounted using the
discount rate for the lease at the commencement date. As the rate implicit in the lease is not readily determinable for the operating
lease, the Company generally uses an incremental borrowing rate based on information available at the commencement date to determine the
present value of future lease payments. Operating lease right-of-use assets (“ROU assets”) represent the Company’s right
to control the use of an identified asset for the lease term and lease liabilities represent the Company’s obligation to make lease
payments arising from the lease. ROU assets are generally recognized based on the amount of the initial measurement of the lease liability.
Lease expense is recognized on a straight-line basis over the lease term. The Company elected to keep leases with an initial term of 12
months or less off the balance sheet.
ROU assets are reviewed for impairment
when indicators of impairment are present. ROU assets from operating and finance leases are subject to the impairment guidance in ASC
360, Property, Plant, and Equipment, as ROU assets are long-lived nonfinancial assets. ROU assets are tested for impairment individually
or as part of an asset group if the cash flows related to the ROU assets are not independent from the cash flows of other assets
and liabilities. An asset group is the unit of accounting for long-lived assets to be held and used, which represents the lowest level
for which identifiable cash flows are largely independent of the cash flows of other groups of assets and liabilities.
Stock-Based Compensation
The Company accounts for its stock-based
awards granted under its employee compensation plan in accordance with ASC Topic No. 718-20, Awards Classified as Equity, which requires
the measurement of compensation expense for all share-based compensation granted to employees and non-employee directors at fair value
on the date of grant and recognition of compensation expense over the related service period for awards expected to vest. The Company
uses the Black-Scholes option pricing model to estimate the fair value of its stock options and warrants. The Black-Scholes option pricing
model requires the input of highly subjective assumptions including the expected stock price volatility of the Company’s common
stock, the risk free interest rate at the date of grant, the expected vesting term of the grant, expected dividends, and an assumption
related to forfeitures of such grants. Changes in these subjective input assumptions can materially affect the fair value estimate of
the Company’s stock options and warrants.
Income Taxes
The Company accounts for income taxes
using the asset and liability method in accordance with ASC Topic No. 740, Income Taxes. Under this method, deferred tax assets and liabilities
are determined based on differences between financial reporting and tax bases of assets and liabilities, and are measured using the enacted
tax rates and laws that are expected to be in effect when the differences are expected to reverse.
The Company applies
the provisions of ASC Topic No. 740 for the financial statement recognition, measurement and disclosure of uncertain tax positions recognized
in the Company’s financial statements. In accordance with this provision, tax positions must meet a more-likely-than-not recognition
threshold and measurement attribute for the financial statement recognition and measurement of a tax position.
Recent Accounting Pronouncements
We have reviewed other recent accounting
pronouncements and concluded they are either not applicable to the business, or no material effect is expected on the consolidated financial statements as a result of future adoption.
Note 4 – Property and
Equipment
Property and equipment
are carried at cost and consist of the following at March 31, 2024 and December 31, 2023:
Schedule of property and equipment | |
| | |
| |
| |
2024 | | |
2023 | |
| |
| | |
| |
Office and computer equipment | |
$ | 17,394 | | |
$ | 17,394 | |
Furniture and fixtures | |
| 76,099 | | |
| 76,099 | |
Leasehold improvements | |
| 502,155 | | |
| 482,170 | |
Less: Accumulated depreciation | |
| (7,377 | ) | |
| (3,790 | ) |
Total | |
$ | 588,271 | | |
$ | 571,873 | |
Leasehold improvements
of $502,155 represent costs of the buildout of the leased laboratory in Iowa City, Iowa that was completed in January 2024.
Depreciation expense of $3,587 and
$0 was charged to operations for the three months ended March 31, 2024 and 2023, respectively.
Note 5 – Intangible Assets
The following table provides
detail associated with the Company’s acquired identifiable intangible assets at March 31, 2024 and December 31, 2023:
Schedule of intangible assets | |
| | |
| |
| |
2024 | | |
2023 | |
| |
| | |
| |
Know-how license | |
$ | 80,000 | | |
$ | 80,000 | |
Less: Accumulated amortization | |
| (62,667 | ) | |
| (58,667 | ) |
Total | |
$ | 17,333 | | |
$ | 21,333 | |
Amortization expense charged
to operations was $4,000 for the three months ended March 31, 2024 and 2023, respectively.
Note 6 – Patent
Costs
As of March 31, 2024, in the
first family of patents and patent applications owned solely by UIRF and is exclusively licensed by Cardio, there are seven granted
patents (US of 2, EU, China, Australia, India and Hong Kong) and other pending patent applications. The Company has pending
patent applications in patent families two, three, four and five. Legal fees associated
with the patents totaled $564,565 and
$515,402, net of accumulated amortization
of $3,975
and $3,182
as of March 31, 2024 and December 31, 2023, respectively and are presented in the consolidated balance sheets as patent costs.
Amortization expense charged to operations was $793
and $785
for the three months ended March 31, 2024 and 2023, respectively.
Note 7 – Operating Leases
The Company determines if a contract
is, or contains, a lease at contract inception. Operating leases are included in operating lease right-of-use (“ROU”) assets,
current portion of operating lease liabilities and operating lease liabilities, net of current
portion in the Company’s consolidated balance sheets. Finance leases are included in property and equipment, current portion of
finance lease obligations and finance lease obligations, net of current portion in the Company’s consolidated balance sheets.
ROU assets represent the right to
use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease.
ROU assets and lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term.
In addition, ROU assets include initial direct costs incurred by the lessee as well as any
lease payments made at or before the commencement date and exclude lease incentives. The Company used the implicit rate in the lease in
determining the present value of lease payments. Lease terms include options to extend or terminate the lease when it is reasonably certain
that the Company will exercise that option. Leases with a term of one year or less are generally not included in ROU assets and corresponding
operating lease liabilities.
In 2023, the Company entered into
a lease agreement for office space in Chicago, Illinois, commencing on August 1, 2023 for a term of three years and four months and expiring
on November 30, 2026. The monthly rent for August to November 2023 was abated and the Company started to make monthly
rental installments from December 2023 of $12,847. The monthly rental payment increases by approximately 2% every August starting from
2024.
On
July 20, 2023, the Company entered into another lease agreement for laboratory facilities in Iowa City, Iowa, commencing on August 1,
2023 for a term of five years and four months and expiring on November 30, 2028. The monthly rent for August to November 2023 was abated
and the Company agreed to pay a monthly rent of $8,505 ($102,060 annually) commencing December 1, 2023. In addition, the landlord agreed
to provide the Company with a one-time Tenant Improvement Allowance (“TIA”) in the amount of up to, but not exceeding $50
per rentable square foot of the premises for a maximum allowance of $253,000.
Pursuant
to ASC Topic 842 Leases, the Company accounted for both leases as operating leases and accounted for the TIA as a lease incentive, which
was estimated to be payable on December 1, 2023. The Company received the TIA from landlord in maximum amount of $253,000 on January 16,
2024 and recorded a reimbursement receivable from landlord of $253,000 as of December 31, 2023, which was included in Prepaid expenses
and other current assets on the consolidated balance sheets.
During
the year ended December 31, 2023, the Company recorded ROU assets of $663,875 and operating lease liabilities of $642,523 at the lease
commencement date. The discount rate used to determine the present value is the incremental borrowing rate, estimated to be 4.57% for
the Chicago lease and 4.24% for the Iowa City lease, respectively, as the interest rate implicit in our lease is not readily determinable.
As
of March 31, 2024 and December 31,2023, operating lease ROU assets and operating lease liabilities are recorded on the consolidated
balance sheets as follows:
Schedule of operating lease ROU assets and operating lease liabilities | |
| |
|
|
|
| |
March 31, | |
|
December 31 |
| |
2024 | |
|
2023 |
Operating Lease: | |
| | |
|
|
|
Operating lease right-of-use assets, net | |
$ | 555,270 | |
|
$ |
575,227 |
Current portion of operating lease liabilities | |
$ | 227,203 | |
|
$ |
223,929 |
Operating lease liabilities, net of current portion | |
$ | 605,090 | |
|
$ |
663,099 |
As of March 31, 2024, the weighted-average
remaining lease terms of the two operating leases were 2.6
years and 4.6
years, respectively.
The
following table summarizes maturities of operating lease liabilities based on lease terms as of December 31:
Schedule of future minimum payments due | | |
| |
2024 (remaining period) | | |
$ | 193,452 | |
2025 | | |
| 260,611 | |
2026 | | |
| 250,152 | |
2027 | | |
| 102,060 | |
2028 | | |
| 93,555 | |
Total lease payments | | |
| 899,830 | |
Less: Imputed interest | | |
| 67,537 | |
Present value of lease liabilities | | |
$ | 832,293 | |
At March 31, 2024, the Company
had the following future minimum payments due under the non-cancelable lease:
| | |
| |
2024 (remaining period) | | |
$ | 193,452 | |
2025 | | |
| 260,611 | |
2026 | | |
| 250,152 | |
2027 | | |
| 102,060 | |
2028 | | |
| 93,555 | |
Total minimum lease payments | | |
$ | 899,830 | |
Consolidated rental expense for
all operating leases was $35,816 and $26,853 for the three months ended March 31, 2024 and 2023, respectively.
The
following table summarizes the cash paid and related right-of-use operating lease recognized for the three months ended March 31,
2024.
Schedule of cash paid and related right-of-use operating lease | |
| |
| |
Three Months Ended | |
| |
March
31, 2024 | |
Cash paid for amounts included in the measurement of lease liabilities: | |
| | |
Operating cash flows from operating leases | |
$ | 64,056 | |
Right-of-use lease assets obtained in the exchange for lease liabilities: | |
| | |
Operating leases | |
$ | 54,735 | |
Note 8 – Finance Agreement Payable
On October 25, 2023, the Company entered
into an agreement with a premium financing company to finance its Directors and Officers insurance premiums for 12-month policies effective
October 25, 2023. The amount financed of $467,500 is payable in 10 monthly installments plus interest at a rate of 8.95% through August
25, 2024. Finance agreement payable was $233,750 and $374,000 at March 31, 2024 and December 31, 2023, respectively. $449,041 has been
recorded in prepaid expenses and is being amortized over the life of the policy.
Note 9 - Earnings (Loss) Per Common
Share
The Company calculates net income
(loss) per common share in accordance with ASC 260 “Earnings Per Share” (“ASC 260”). Basic and diluted net earnings
(loss) per common share was determined by dividing net earnings (loss) applicable to common
stockholders by the weighted average number of common shares outstanding during the period. The Company’s potentially dilutive
shares, which include outstanding common stock options, common stock warrants, and convertible debt have not been included in the computation
of diluted net loss per share for the three months ended March 31, 2024 and 2023 as the result would be anti-dilutive.
Schedule of anti dilutive earning per share | |
| | |
| |
| |
Three Months
Ended | |
| |
March
31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Stock warrants | |
| 8,528,766 | | |
| 7,854,620 | |
Stock options | |
| 3,772,425 | | |
| 1,759,599 | |
Total shares excluded from calculation | |
| 12,301,191 | | |
| 9,614,219 | |
Note 10 – Stockholders’ Equity
Stock Transactions
Pursuant to the Business
Combination Agreement on October 25, 2022, the Company issued the following securities:
Holders
of conversion rights issued as a component of units in Mana’s initial public offering (the “Public Rights”) were issued
an aggregate of 928,571 shares of the Company’s common stock;
Holders
of existing shares of common stock of Legacy Cardio and the holder of equity rights of Legacy Cardio (together, the “Legacy Cardio
Stockholders”) received an aggregate of 6,883,306 shares of the Company’s Common Stock, calculated based on the exchange ratio
of 3.427259 pursuant to the Merger Agreement (the “Exchange Ratio”) for each share of Legacy Cardio Common Stock held or,
in the case of the equity rights holder, that number of shares of the Company’s Common Stock equal to 1% of the Aggregate Closing
Merger Consideration, as defined in the Merger Agreement;
The
Legacy Cardio Stockholders received, in addition, an aggregate of 43,334 shares of the Company’s Common Stock (“Conversion
Shares”) upon conversion of an aggregate of $433,334 in principal amount of promissory notes issued by Mana to Legacy Cardio in
connection with its loan of such amount in order to extend Mana’s duration through October 26, 2022 (the “Extension Notes”),
which Conversion Shares were distributed to the Legacy Cardio Stockholders in proportion to their respective interest in Legacy Cardio.
Mana
public stockholders (excluding Mana Capital, LLC, the SPAC sponsor (the “Sponsor”), and Mana’s former officers and directors)
own 34,548 shares of the Company’s Common Stock and the Sponsor, Mana’s former officers and directors and certain permitted
transferees own 1,625,000 shares of the Company’s Common Stock.
Immediately
after giving effect to the Business Combination, there were 9,514,743 issued and outstanding shares of the Company’s Common Stock.
On
October 25, 2022, in connection with the approval of the Business Combination, the Company’s stockholders approved the Cardio Diagnostics
Holdings, Inc. 2022 Equity Incentive Plan (the “2022 Plan”). The purpose of the 2022 Plan is to promote the interests of the
Company and its stockholders by providing eligible employees, officers, directors and consultants with additional incentives to remain
with the Company and its subsidiaries, to increase their efforts to make the Company more successful, to reward such persons by providing
an opportunity to acquire shares of Common Stock on favorable terms and to attract and retain the best available personnel to participate
in the ongoing business operations of the Company. The 2022 Plan permits the grant of Incentive Stock Options, Nonstatutory Stock Options,
Restricted Stock, Restricted Stock Units, Stock Appreciation Rights, Performance Units and Performance Shares.
The
2022 Plan, as approved, permits the issuance of up to 3,265,516 shares of Common Stock (the “Share Reserve”) upon exercise
or conversion of grants and awards made from time to time to officers, directors, employees and consultants, however that the Share Reserve
will increase on January 1st of each calendar year and ending on and including January 1, 2027 (each, an “Evergreen Date”),
in an amount equal to the lesser of (i) 7% of the total number of shares of Common Stock outstanding on the December 31st immediately
preceding the applicable Evergreen Date and (ii) such lesser number of shares of Common Stock as determined to be appropriate by the Compensation
Committee, which administers the 2022 Plan, in its sole discretion. There was no increase in the Share Reserve on January 1, 2023. In
January 2024, the Compensation Committee approved an annual increase in the Share Reserve of 1,060,458 shares.
Common Stock Issued
Private Placement
In connection with a private offering memorandum
that the Company issued through a placement agent on January 23, 2024, the Company completed entering into subscription agreements with
7 accredited investors (the “Subscription Agreements”), whereby the Company issued a total of 561,793 units (“Units”),
with each Unit consisting of (i) one share of the Company’s common stock, $0.00001 par value (the “Common Stock”),
and (ii) one six year Common Stock purchase warrant (the “Warrants”), having an exercise price of $1.78 per share
(the “Private Placement”). The Private Placement resulted in the issuance to investors of 561,793 shares of Common
Stock and 561,793 Warrants. The purchase price of the securities was $1.78 per Unit, resulting in gross proceeds to the
Company of $1,000,000 and paid a fee of $100,000, before deducting placement agent fees (10% or $100,000) and other
offering expenses. The Company intends to use the net proceeds from the Private Placement for working capital and general corporate purposes.
The Private Placement closed on February 2, 2024.
In connection with the Private Placement, the
Company entered into a Placement Agent Agreement with Altitude Capital Group, LLC, as placement agent (“Altitude Capital”
or the “Placement Agent”). Pursuant to the Placement Agent Agreement, at closing, Altitude Capital was paid a cash commission
equal to 10% of the gross proceeds received by the Company, plus 20% warrant coverage, providing Altitude Capital with the right to purchase 112,353 shares
of Common Stock at $1.78 per share through February 2, 2030 (the “Placement Agent Warrants”).
At-the-Market Issuance
In
connection with an At-the-Market Issuance Sales Agreement (the “Sales Agreement”) that the Company issued through a placement
agent on January 26, 2024, the Company sold 487,083
common shares at various amounts per share to investors for gross proceeds totaling
$877,857
before deducting sales commissions of $21,947 to placement agent, during the three
months ended March 31, 2024. The Company also paid the placement agent a fee of $55,000.
Other Common Stock Issuance
During
the three months ended March 31, 2024, the Company issued 4,477
common shares to two consultants for services pursuant to vesting of Restricted Stock Units granted, valued at $8,000.
On
March 31, 2024, the Company issued 35,212 common shares to the board of directors for services pursuant to vesting of Restricted Stock
Units granted, valued at $50,000.
On
March 2, 2023, a shareholder exercised warrants in exchange for 100,000 common shares for proceeds of $390,000.
During the three months ended March
31, 2023, the Company issued 1,092 common shares to consultants for services pursuant to vesting of Restricted Stock Units granted,
valued at $4,000.
Warrants
On October 1, 2019, the Company issued
warrants to a seed funding firm equivalent to 2% of the fully-diluted equity of the Company, or 22,500 common shares at the time of issuance.
The warrant is exercisable on the earlier of the closing date of the next Qualified Equity Financing occurring after the issuance of the
warrant, and immediately before a Change of Control. The exercise price is the price per share of the shares sold to investors in the
next Qualified Equity Financing, or if the warrant becomes exercisable in connection with
a Change in Control before the next Qualified Equity Financing, the greater of the quotient obtained by dividing $150,000 by the Pre-financing
Capitalization, and the price per share paid by investors in the then-most recent Qualified Equity Financing, if any. The warrant will
expire upon the earlier of the consummation of any Change of Control, or 15 years after the issuance of the warrant.
In April 2022, the Company issued
fully vested warrants to investors as part of private placement subscription agreements pursuant to which the Company issued common
stock. Each shareholder received warrants to purchase 50% of the common stock issued at an exercise price of $3.90 per share with an expiration
date of June 30, 2027.
As of May 23, 2022, the Company issued
fully vested warrants to investors as part of an additional private placement subscription agreements pursuant to which the Company issued
common stock. Each shareholder received warrants to purchase 50% of the common stock issued at an exercise price of $6.21 per
share with an expiration date of five years from the date of issue.
All of the warrants issued by Legacy
Cardio were exchanged in the Business Combination for warrants of the Company based on the merger exchange ratio.
During the three months ended March 31, 2024, in connection with the
Private Placement as described above, the Company issued an aggregate of 674,146 warrants.
Warrant activity during the three
months ended March 31, 2024 and 2023 was as follows:
Schedule of warrant activity | |
| | |
| | |
| |
| |
| | |
| | |
| |
| |
Warrants
Outstanding | | |
Weighted
Average Exercise Price | | |
Weighted
Average Remaining Contractual Life (Years) | |
Warrants outstanding at December 31, 2022 | |
| 7,954,620 | | |
$ | 9.63 | | |
| 4.46 | |
Warrants exercised | |
| (100,000 | ) | |
| 3.90 | | |
| | |
Warrants outstanding at March 31, 2023 | |
| 7,854,620 | | |
$ | 9.70 | | |
| 4.22 | |
Warrants outstanding at December 31, 2023 | |
| 7,854,620 | | |
$ | 9.70 | | |
| 3.72 | |
Warrants granted | |
| 674,146 | | |
| 1.78 | | |
| | |
Warrants outstanding at March 31, 2024 | |
| 8,528,766 | | |
$ | 9.08 | | |
| 3.66 | |
Options
On May 6, 2022, Legacy Cardio granted
513,413
stock options to the management and advisors pursuant to the Cardio Diagnostics, Inc. 2022 Equity Incentive Plan. All of the options
granted under this legacy plan were exchanged for options under the Company’s 2022 Plan adopted by the Company’s stockholders
on October 25, 2022, and based on the exchange ratio for the merger, resulted in a total of 1,759,599
options issued upon closing. Each exchanged option has an exercise price of $3.90
per share with an expiration date of May
6, 2032. The exchanged options fully vested upon closing of the merger.
On January 23, 2024, the Company
authorized an additional 1,060,458 shares
to the Equity Incentive Plan Reserve (the “2022 Plan”) and granted 1,187,826 options
to management and employees, 1,166,826 of
which vested immediately with the remaining 21,000 options subject to 50% vesting
on June 30, 2024 and 100% vesting on December 31, 2024. Each option has
an exercise price of $2.11 per share with an expiration date of January 23, 2034. The vested 1,166,826 stock options were
valued at $2,461,404 at grant date based on the Black-Scholes Option Pricing model. The following assumptions were utilized in the Black-Scholes
valuation of vested stock options during the three months ended March 31, 2024, risk free interest rate of 5.22%, volatility of 228%,
and an exercise price of $2.11.
Option
activity during the three months ended March 31, 2024 and 2023 was as follows:
Schedule of option activity | |
| | |
| | |
| |
| |
Options Outstanding | | |
Weighted Average
Exercise Price | | |
Weighted
Average Remaining Contractual Life (Years) | |
Options outstanding at December 31, 2022 | |
| 1,759,599 | | |
$ | 3.90 | | |
| 9.35 | |
No option activity | |
| — | | |
| — | | |
| | |
Options outstanding at March 31, 2023 | |
| 1,759,599 | | |
$ | 3.90 | | |
| 9.10 | |
Options outstanding at December 31, 2023 | |
| 2,584,599 | | |
$ | 3.06 | | |
| 8.71 | |
Options granted | |
| 1,187,826 | | |
| 2.11 | | |
| | |
Options outstanding at March 31, 2024 | |
| 3,772,425 | | |
$ | 2.76 | | |
| 8.89 | |
Options vested and exercisable at March 31, 2024 | |
| 3,751,425 | | |
$ | 2.76 | | |
| | |
Note 11 – Convertible Notes Payable
On
March 8, 2023, the Company entered into a securities purchase agreement (“Securities Purchase Agreement”) with YA II PN,
Ltd., an investment fund managed by Yorkville Advisors Global, LP (“Yorkville”) under which the Company agreed to sell and
issue to Yorkville convertible debentures (“Convertible Debentures”) in a gross aggregate principal amount of up to $11.2
million (“Subscription Amount”). The Convertible Debentures were convertible into shares of common stock of the Company and
were subject to various contingencies being satisfied as set forth in the Securities Purchase Agreement. The notes were convertible at
any time through the maturity date, which, in each case, was one year from the date of issuance. The conversion price would be determined
on the basis of 92% of the two lowest VWAP (Volume Weighted Average Prices) of the Common Stock during the prior seven trading day period,
initially with a floor conversion price of $0.55, but subsequently lowered by mutual agreement of the parties to $0.20.
On
March 8, 2023, the Company issued and sold to Yorkville a Convertible Debenture in the principal amount of $5.0 million, for which it
received $4.5 million, with a $500,000 original issue discount (“OID”). Interest on the outstanding principal balance accrued
at a rate of 0% and would increase to 15% upon an Event of Default for so long as it remained uncured.
The
Company recorded a debt discount related to identified embedded derivatives relating to the conversion features (see Note 12) based on
fair values as of the inception date of the Note. The calculated debt discount, including the OID equaled the face of the Note and is
being amortized over the term of the note.
Yorkville
fully converted the initial $5,000,000 Convertible Debenture into an aggregate of 10,622,119 common shares during the year ended December
31, 2023./
On
January 4, 2024, the Company and Yorkville terminated the Securities Purchase Agreement dated as of March 8, 2023, as amended, by the
mutual consent of the parties, effective as of January 4, 2024. The First Convertible Debenture has been fully converted, and as of January
4, 2024, the obligation of the Company to issue and sell, and Yorkville’s obligation to purchase, the Second Convertible Debenture
has been terminated. At the time of termination, there were no outstanding borrowings, advance notices or shares of Common Stock to be
issued under the Securities Purchase Agreement. In addition, there were no fees due by the Company or Yorkville in connection with the
termination of the Securities Purchase Agreement.
Note 12 – Derivative Liability
The
Company has determined that the conversion feature embedded in the convertible notes described in Note 11 contain a potential variable
conversion amount which constitutes a derivative which has been bifurcated from the note and recorded as a derivative liability at fair
value, with a corresponding discount recorded to the associated debt. The excess of the derivative value over the face amount of the note
is recorded immediately to interest expense at inception, which aggregated $4,692,672. The Company used the Binomial Black-Scholes Option
Pricing model to value the conversion features.
The
Company used Level 3 inputs for its valuation methodology for the conversion option liability in determining the fair value using a Black-Scholes
option-pricing model with the following assumption inputs:
Schedule of option liability | |
| |
| |
| Three
Months Ended March 31, 2023 | |
Annual dividend yield | |
| — | |
Expected life (years) | |
| 1.0 | |
Risk-free interest rate | |
| 4.89% - 5.28% | |
Expected volatility | |
| 164% - 169% | |
Exercise price | |
| $2.20 - $3.53 | |
Stock price | |
| $3.91 - $5.32 | |
Based upon ASC 840-15-25
(EITF Issue 00-19, paragraph 11) the Company has adopted a sequencing approach regarding the application of ASC 815-40 to its outstanding
convertible notes. Pursuant to the sequencing approach, the Company evaluates its contracts based upon earliest issuance date.
Note 13 – Commitments and Contingencies
Prior Relationship of Cardio with
Boustead Securities, LLC
At
the commencement of efforts to pursue what ultimately ended in a terminated business acquisition, Legacy Cardio entered into a Placement
Agent and Advisory Services Agreement (the “Placement Agent Agreement”), dated April 12, 2021, with Boustead Securities, LLC
("Boustead Securities”). This agreement was terminated in April 2022, when Legacy Cardio terminated the underlying agreement
and plan of merger and the accompanying escrow agreement relating to that proposed business acquisition after efforts to complete the
transaction failed, despite several extensions of the closing deadline.
Under
the terminated Placement Agent Agreement, Legacy Cardio agreed to certain future rights in favor of Boustead Securities, including (i)
a two-year tail period during which Boustead Securities would be entitled to compensation if Cardio were to close on a transaction (as
defined in the Placement Agent Agreement) with any party that was introduced to Legacy Cardio by Boustead Securities; and (ii) a right
of first refusal to act as the Company’s exclusive placement agent for 24-months from the end of the term of the Placement Agent
Agreement (the “right of first refusal”). Cardio has taken the position that due to Boustead Securities’ failure to
perform as contemplated by the Placement Agent Agreement, these provisions purporting to provide future rights are null and void.
Boustead
Securities responded to the termination of the Placement Agent Agreement by disputing Legacy Cardio’s contention that it had not
performed under the Placement Agent Agreement because, among other things, Boustead Securities had never sought out prospective investors.
In its response, Boustead Securities included a list of funds that they had supposedly contacted on Legacy Cardio’s behalf. While
Boustead Securities’ contention appears to contradict earlier communications from Boustead Securities in which they indicated that
they had not made any such contacts or introductions, Boustead Securities is currently contending that they are due success fees for two
years following the termination of the Placement Agent Agreement on any transaction with any person on the list of supposed contacts or
introductions. Legacy Cardio strongly disputes this position. Notwithstanding the foregoing, the Company has not consummated any transaction,
as defined, with any potential party that purportedly was a contact of Boustead Securities in connection with the Placement Agent Agreement
and has no plans to do so at any time during the tail period. No legal proceedings have been instigated by either party, and Cardio believes
that the final outcome will not have a material adverse impact on its financial condition.
The Benchmark Company, LLC Right
of First Refusal
As
noted in Note 1, the Company completed the business combination on October 25, 2022. In connection with the proposed business combination,
by agreement dated May 13, 2022, Mana engaged The Benchmark Company, LLC (“Benchmark”) as its M&A advisor. Upon closing
of the business combination, Legacy Cardio assumed the contractual engagement entered into by Mana. On November 14, 2022, the Company
and Benchmark entered into Amendment No. 1 Engagement Letter (the “Amendment Engagement”). Pursuant to the Amendment Engagement,
the parties agreed that the Company would pay Benchmark $230,000 at the closing of the business combination and an additional $435,000
on October 25, 2023. Both of those payments have been made in full. In addition, the Amendment Engagement provided that Benchmark has
been granted a right of first refusal to act as lead or joint-lead investment banker, lead or joint-lead book-runner and/or lead or joint-lead
placement agent for all future public and private equity and debt offerings through October 25, 2023. Based on the right of first refusal,
Benchmark alleges that it is owed damages because the Company entered into the Yorkville Convertible Debenture Transaction (see Note 11)
without first offering Benchmark the right to serve as the lead or joint-lead placement agent for the transaction. The Company is evaluating
the claim. No legal proceedings have been instigated.
Demand Letter and Potential Mootness
Fee Claim
On June
25, 2022, a plaintiffs’ securities law firm sent a demand letter to the Company alleging that the Company’s Registration Statement
on Form S-4 filed (the “S-4 Registration Statement”) with the Securities and Exchange Commission (“SEC”) on May
31, 2022 omitted material information with respect to the Business Combination and demanding that the Company and its Board of Directors
immediately provide corrective disclosures in an amendment or supplement to the Registration Statement. Subsequent thereto, the Company
filed amendments to the S-4 Registration Statement on July 27, 2022, August 23, 2022, September 15, 2022, October 4, 2022 and October
5, 2022 in which it responded to various comments of the SEC staff and otherwise updated its disclosure. In October 2022, the SEC completed
its review and declared the S-4 registration statement on October 6, 2022. On February 23, 2023 and February 27, 2023, plaintiffs’
securities law firm contacted the Company’s counsel asking who will be negotiating a mootness fee relating to the purported claims
set forth in the June 25, 2022 demand letter. The Company vigorously denies that the S-4 Registration Statement, as amended and declared
effective, is deficient in any respect and that no additional supplemental disclosures are material or required. The Company believes
that the claims asserted in the Demand Letter are without merit and that no further disclosure is required to supplement the S-4 Registration
Statement under applicable laws. As of the date of filing of this Annual Report on Form 10-K, no lawsuit has been filed against the Company
by that firm. The firm has indicated its willingness to litigate the matter if a mutually satisfactory resolution cannot be agreed upon;
however, Cardio believes that the final outcome will not have a material adverse impact on its financial condition.
Northland Securities, Inc.
In
January 2024, following the Company’s termination of its agreement with Yorkville and in connection with the Company’s recent
at the market offering and/or its February 2024 private placement, a managing director of Northland Securities, Inc. (“Northland”)
contacted the Company claiming the right to be paid a fee of approximately $150,000 pursuant to the agreement of March 1, 2023 between
the Company and Northland regarding the Yorkville financing. Subsequently, the Company has been advised by another representative of Northland
that Northland would not proceed with any such claim. The Company does not believe that it owes Northland any sum based on the termination
of the Yorkville Securities Purchase Agreement and the subsequent financing transactions.
The
Company cannot preclude the possibility that claims or lawsuits brought relating to any alleged securities law violations or breaches
of fiduciary duty could potentially require significant time and resources to defend and/or settle and distract its management and board
of directors from focusing on its business.
Note 14 – Subsequent Events
The Company
evaluated its March 31, 2024 consolidated financial statements for subsequent events through the date the consolidated financial
statements were issued.
Common Stock Issued
Subsequent
to March 31, 2024, the Company sold 1,056,615
common shares for gross proceeds totaling $895,941
under the At-the-Market Issuance Sales Agreement as of the date of this Report.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
As a result of the closing of the Business Combination, which
was accounted for as a reverse recapitalization in accordance with U.S. GAAP as discussed in Note 2 – Merger Agreement and Reverse
Recapitalization, the consolidated financial statements of Cardio Diagnostics, Inc., a Delaware corporation and our wholly owned subsidiary,
are now the financial statements of the Company.
The following discussion and analysis provide information that
Cardio’s management believes is relevant to an assessment and understanding of Cardio’s results of operations and financial
condition. You should read the following discussion and analysis of Cardio’s results of operations and financial condition together
with its unaudited consolidated financial statements and related notes to those statements included elsewhere in this Quarterly
Report on Form 10-Q, and its audited consolidated financial statements and related notes to those statements included in the Company’s
2023 Annual Report on Form 10-K that was filed on April 1, 2024 (the “2023 Form 10-K”). In addition to historical financial
information, this discussion contains forward-looking statements based upon Cardio’s current expectations that involve risks and
uncertainties, including those described in the section titled, “Special Note About Forward-Looking Statements,” above. Cardio’s
actual results could differ materially from such forward-looking statements as a result of various factors, including those set forth
under “Risk Factors” in the 2023 Form 10-K (Item 1A therein), as well as in Part II, Item 1A of this Quarterly Report on Form
10-Q. Our historical results are not necessarily indicative of the results that may be expected for any period in the future.
Unless the context
requires otherwise, references to “Cardio,” the “Company,” “we,” “us” and “our” refer
to Cardio Diagnostics Holdings, Inc., a Delaware corporation, together with its consolidated subsidiary.
Overview
Cardio was formed to further develop and commercialize a series
of products for major types of cardiovascular disease and associated co-morbidities, including coronary heart disease ("CHD”),
stroke, heart failure and diabetes, by leveraging our Artificial Intelligence ("AI”)-driven Integrated Genetic-Epigenetic Engine™.
As a company, we aspire to give every American adult insight into their unique risk for various cardiovascular diseases. Cardio aims to
become one of the leading medical technology companies for enabling improved prevention, early detection and treatment of cardiovascular
disease. Cardio is transforming the approach to cardiovascular disease from reactive to proactive and hope to accelerate the adoption
of Precision Medicine for all. We believe that incorporating Cardio’s solutions into routine practice in primary care and prevention
efforts can help alter the trajectory that nearly one in two Americans is expected to develop some form of cardiovascular disease by 2035.
Cardio believes that it is
the first company to develop and commercialize epigenetics-based clinical tests for cardiovascular disease that have clear value propositions
for multiple stakeholders including (1) patients, (2) clinicians, (3) hospitals/health systems, (4) employers and (5) payors. According
to the CDC, epigenetics is the study of how a person’s behaviors and environment can cause changes that affect the way a person’s
genes work. Unlike genetic changes, epigenetic changes are reversible and do not change one’s DNA sequence, but they can
change how a person’s body reads a DNA sequence.
Cardio launched its first clinical test, Epi+Gen CHD™, a three-year
symptomatic CHD risk assessment clinical blood test targeting CHD events, including heart attacks, in 2021 during the Covid-19 pandemic.
As a result, the initial strategy for commercialization involved launching the test via telemedicine and in smaller provider practices
such as concierge medicine practices. The volume of tests through these channels were minimal, and as the circumstances around Covid-19
pandemic improved, management re-vamped the Company’s go-to-market strategy to include other healthcare verticals and stakeholders
beyond patients and small providers, including larger provider organizations, group purchasing organizations, employers, payors and life
insurers. This new approach allowed Cardio to expand the reach of our solutions beyond the initial focus areas. Beyond the launch of Epi+Gen
CHD, in March 2023, we announced the launch of our second product, PrecisionCHD™, an integrated
epigenetic-genetic clinical blood test for the detection of coronary heart disease. The Epi+Gen CHD™ and PrecisionCHD™
tests are coupled to Actionable Clinical Intelligence (ACI), a platform that offers new epigenetic and genetic insights to clinicians
prescribing the to help improve chronic care management. In May 2023, we launched CardioInnovate360TM, a research-use-only
(RUO) solution to support the discovery, development and validation of novel biopharmaceuticals for the assessment and management of cardiovascular
diseases. In February 2024, we announce the launch of HeartRisk™, a cardiovascular risk intelligence platform. We believe that our
Epi+Gen CHD™ and PrecisionCHD™ tests are categorized as laboratory-developed tests, or “LDTs.” The new go-to-market
strategy is also being implemented for these products.
Despite long partnership and sales cycles, in some instance as long
as 14 months, Cardio in 2023 generated revenue from patient(s), small provider(s), larger provider(s) and employer(s) for the first time
and has developed a more robust sales and partnership pipeline. In addition to increased revenue, other key developments since the 2023
Form 10-K, include:
|
· |
Published a key peer-reviewed economics study on PrecisionCHD™ demonstrating a potential savings of over $113 million annually to payers in Advances in Therapy journal; |
|
· |
Our two Current Procedural Terminology (“CPT”) Proprietary Laboratory Analysis (“PLA”) codes from the American Medical Association, 0440U for PrecisionCHD™ and 0439U for Epi+Gen CHD™ went effective on April 1, 2024; and |
|
· |
Entered into a nationwide telehealth agreement with Navierre. |
Cardio expects that sales and partnership cycles
will continue to be long. Our ongoing strategy for expanding our business operations and increasing revenue generation include the following:
|
· |
Develop additional products, including clinical tests for stroke, congestive heart failure and diabetes; |
|
· |
Expand clinical and health economics evidence portfolio to continue to demonstrate value of products and increase reach; |
|
· |
Leverage our newly-awarded CPT PLA codes; |
|
· |
Expand the adoption of our products across key channels, including health systems and self-insured employers, including for HeartRisk, Cardio’s new SaaS product; |
|
· |
Scale our internal operations capabilities with a focus on improving efficiency and reducing our cost of goods sold; and |
|
· |
Pursue potential strategic partnership(s) and acquisition(s) of one or
more synergistic companies.
|
Recent Developments
At the Market Sales Agreement
On January 26, 2024, the
Company entered into an At-the-Market Issuance Sales Agreement (the "Sales Agreement”) with Craig-Hallum Capital
Group LLC ("Craig-Hallum”). Pursuant to the Sales Agreement, the Company may sell, at its option, up to an aggregate of $17 million
in shares of its Common Stock through Craig-Hallum, as sales agent. Sales of the Common Stock made pursuant to the Sales Agreement have
been or will be made under the Company’s Registration Statement on Form S-3 filed on January 26, 2024 (File No. 333-276725)
(the "Registration Statement”), which was declared effective by the Securities and Exchange Commission on February 1, 2024.
Subject to the terms and conditions of the Sales Agreement, Craig-Hallum may sell the shares, if any, only by methods deemed to be an
"at the market” offering as defined in Rule 415 promulgated under the Securities Act. The Company has agreed to
pay Craig-Hallum a sales commission of 2.5% of the gross proceeds for sales under the Sales Agreement and to provide Craig-Hallum with
customary indemnification and contribution rights, including for liabilities under the Securities Act. In addition, the Company is required
to reimburse Craig-Hallum for certain specified expenses in connection with entering into the Sales Agreement.
As of May 15, 2024, the Company
has sold 1,543,698 shares of its common stock under the Sales Agreement, resulting in proceeds to the Company of approximately $1,729,464,
net of offering costs. The Company has paid Craig-Hallum approximately $44,345 in sales commissions.
Food and Drug Administration Proposed Regulation
On May 6, 2024, FDA published
a final rule amending the definition of an in vitro diagnostic (IVD) device to include IVDs manufactured by a clinical laboratory. Pursuant
to the rule, laboratory developed tests (LDTs), i.e., tests designed, manufactured, and used within a single CLIA-certified high complexity
laboratory, are medical devices subject to FDA regulation under the Federal Food, Drug, and Cosmetic Act. The final rule also announced
FDA’s intention to apply its medical device requirements to LDTs. Under the final rule, all LDTs, unless subject to a specific exemption,
will be subject to premarket authorization requirements (510(k), de novo classification, or PMA) for each LDT performed by the laboratory,
and to postmarket registration and listing, medical device reporting, correction, removal, and recall, complaint handling, labeling, investigational
device, and quality system requirements. FDA intends to phase in these requirements beginning May 6, 2025. The final rule states that
certain categories of LDTs will be subject to enforcement discretion with respect to some or all of these requirements. For example, FDA
will apply enforcement discretion to currently marketed LDTs that were first offered prior to May 6, 2024, with respect to most quality
system requirements and the requirement for premarket authorization if they are not modified or modified in only limited ways. Laboratories
performing these tests are subject to other requirements, including the requirement to submit the labeling for the LDT to FDA for review.
FDA will similarly exercise enforcement discretion with respect to premarket authorization for LDTs approved by the New York State Clinical
Laboratory Evaluation Program (NYS-CLEP). Unless overturned by a court or Congress, the final rule will substantially increase costs and
regulatory burdens for many clinical laboratories in ways that may adversely affect their ability to develop, perform, and offer LDTs.
Results of Operations
The results of operations presented below should
be reviewed in conjunction with the consolidated financial statements and notes included elsewhere in this Quarterly Report
on Form 10-Q. The following table sets forth Cardio’s results of operations data for the periods presented:
Comparisons for the three months ended
March 31, 2024 and 2023:
The following table presents summary of
consolidated operating results for the three-month periods indicated:
| |
Three Months Ended March 31, | |
| |
2024 | | |
2023 | |
Revenue | |
| | |
| |
Revenue | |
$ | 15,928 | | |
$ | — | |
| |
| | | |
| | |
Operating Expenses | |
| | | |
| | |
Sales and marketing | |
| 34,402 | | |
| 49,551 | |
Research and development | |
| 10,840 | | |
| 86,665 | |
General and administrative expenses | |
| 4,123,941 | | |
| 1,562,128 | |
Amortization | |
| 4,793 | | |
| 4,785 | |
Total operating expenses | |
| (4,173,976 | ) | |
| (1,703,129 | ) |
Other (expense) income | |
| (5,536 | ) | |
| 670,511 | |
Net (loss) | |
$ | (4,163,584 | ) | |
$ | (1,032,618 | ) |
Net Loss
Cardio’s net loss
for the three months ended March 31, 2024 was $4,163,584 as compared to $1,032,618 for the three months ended March 31, 2023, an increase
of $3,130,966. The increase in net loss was primarily the result of an increase in General and Administrative expenses associated with
being a public company, stock compensation issued, increased personnel and increased rent.
Revenue
Cardio had $15,928 and $0
in revenue for the three months ended March 31, 2024 and 2023, respectively.
Sales and Marketing
Expenses related to sales
and marketing for the three months ended March 31, 2024 were $34,402 as compared to $49,551 for the three months ended March 31, 2023,
a decrease of $15,149. The overall decrease was due to a decrease in sales and marketing efforts in the first quarter of 2024 due to fewer
tradeshows in 2024.
Research and Development
Research and development expense
for the three months ended March 31, 2024 was $10,840 as compared to $86,665 for the three months ended March 31, 2023, a decrease of
$75,825. The decrease was attributable to the decrease in laboratory runs performed in the 2024 period on new product offerings in the
pipeline as compared to laboratory runs performed in the same period in 2023.
General and Administrative Expenses
General and administrative expenses for the three months ended March
31, 2024 were $4,123,941 as compared to $1,562,128 for the three months ended March 31, 2023, an increase of $2,561,813. The overall increase
is primarily due to stock compensation expenses of $2,519,404, an increase in rent, personnel, and office and software expenses related
to new offices and the new internal lab setup.
Amortization
Amortization expense for the three months ended March 31, 2024 was
$4,793 as compared to $4,785 for the three months ended March 31, 2023. The total amortization expense for the three months ended March
31, 2024 is for intangible assets of $4,000 and patent costs of $793, respectively.
Other income (expenses)
Total other expenses for the three months ended March 31, 2024,
was $(5,536) as compared to $670,511 total other income for the three months ended March 31, 2023. The total other expenses for the
three months ended March 31, 2024 consists of interest expense of $5,817 net of interest income of $281. The total other income for the
three months ended March 31, 2023 consists of change in fair value of derivative liability of $5,686,901 offset by interest expense of
$5,016,611 net of interest income of $221.
Liquidity and Capital Resources
Liquidity describes the ability of a company to generate sufficient
cash flows in the short- and long-term to meet the cash requirements of its business operations, including working capital needs, debt
service, acquisitions and investments, and other commitments and contractual obligations. We consider liquidity in terms of cash flows
from operations and other sources, and their sufficiency to fund our operating and investing activities.
Historically, our principal sources of liquidity have been proceeds
from the issuance of equity and warrant exercises. More recently, upon signing the YA Securities Purchase Agreement on March 8, 2023 (the
"Securities Purchase Agreement”), we issued and sold to YA II PN, Ltd. ("Yorkville”) a Convertible Debenture in
the principal amount of $5,000,000 for a purchase price of $4,500,000 to provide additional liquidity. Yorkville fully converted the $5,000,000
Convertible Debenture into an aggregate of 10,622,119 common shares during the year ended December 31, 2023. The Securities Purchase Agreement
contemplated the issuance of a second convertible debenture in the amount of $6,200,000. However, prior to the issuance of the second
convertible debenture, the Company and Yorkville terminated the Securities Purchase Agreement by the mutual consent of the parties, effective
as of January 4, 2024.
On February 2, 2024, we closed a private placement with seven accredited
investors, whereby we issued a total of 561,793 units ("Units”), with each Unit consisting of (i) one share of our Common Stock
and (ii) one six-year Common Stock purchase warrant having an exercise price of $1.78 per share, subject to adjustment (the "Private
Placement”). The Private Placement resulted in the issuance to investors of 561,793 shares of Common Stock and 561,793 warrants
in an unregistered offering of securities. The purchase price of the securities was $1.78 per Unit, resulting in gross proceeds to the
Company of $1,000,000, before deducting placement agent fees (10% or $100,000) and other offering expenses. We intend to use the net proceeds
from the Private Placement for working capital and general corporate purposes.
As noted in Recent Developments, above, we entered into an At-the
Market Sales Agreement with Craig-Hallum on January 26, 2024. As of May 15, 2024, we have received $1,773,809 in gross proceeds from the
ATM sales, and we have available up to $15,226,191 in future sales of our Common Stock that we may elect to make under the Sales
Agreement.
We expect that our primary cash needs in 2024 will be for day-to-day
operations, funding working capital requirements, funding our growth strategy, paying the setup expenses of our internal laboratory and
paying expenses incurred in connection with our ongoing FDA submission activities.
Our long-term future capital requirements will depend on many factors,
including revenue growth rate, the timing and the amount of cash received from customers, the expansion of sales and marketing activities,
the timing and extent of spending to support investments, including research and development efforts, and the continuing market adoption
of our products. In each fiscal year since our inception, we have incurred losses from operations and generated negative cash flows from
operating activities. We expect this trend to continue in future periods for the foreseeable future.
We continue to explore our
financing options, such as equity private placement transactions. However, given recent stock prices and the extreme volatility of our
stock, it continues to be challenging to balance cash that could be raised and the dilution that might be required to close a particular
transaction. We expect that for the remainder of 2024, we will rely on the ongoing ATM offering, provided that market conditions are favorable.
We have had, and expect that we will continue to have, an ongoing
need to raise additional cash from outside sources to fund our operations and expand our business. If we are unable to raise additional
capital when desired, our business, financial condition and results of operations would be harmed. Successful transition to attaining
profitable operations depends upon achieving a level of revenue adequate to support the post-merger company. There is no assurance
that we will be successful in reaching and sustaining profitability.
We expect that working capital requirements will continue to be
funded through a combination of existing funds and further issuances of securities. Working capital requirements are expected to increase
in line with the growth of the business.. We have no lines of credit or other bank financing arrangements. In connection with our
business plan, management anticipates additional increases in operating expenses and capital expenditures relating to: (i) developmental
expenses associated with a start-up business and (ii) marketing expenses. Cardio intends to finance these expenses with further issuances
of securities and debt issuances. Thereafter, we expect we will need to raise additional capital and generate revenues to meet long-term
operating requirements. If we raise additional funds through the issuance of equity or convertible debt securities, the percentage ownership
of our equity holders could be significantly diluted, particularly at current stock price levels, and these newly-issued securities may
have rights, preferences or privileges senior to those of existing equity holders. If we raise additional funds by obtaining loans from
third parties, the terms of those financing arrangements may include negative covenants or other restrictions on our business that could
impair our operating flexibility and also require us to incur interest expense.
The exercise prices of our currently outstanding warrants range
from a high of $11.50 to a low of $1.78 per share of Common Stock. We believe the likelihood that warrant holders will exercise their
Warrants and therefore the amount of cash proceeds that we might receive, is dependent upon the trading price of our Common Stock, the
last reported sales price for which was $0.8140 on May 14, 2024. If the trading price of our Common Stock is less than the respective
exercise prices of our outstanding Warrants, we believe holders of any of our Warrants will be unlikely to exercise their Warrants. There
is no guarantee that the Warrants will be in the money prior to their respective expiration dates, and as such, the Warrants may expire
worthless, and we may receive no proceeds from the exercise of Warrants. Given the current differential between the trading price of our
Common Stock and the Warrant exercise prices and the volatility of our stock price, we are not making strategic business decisions based
on an expectation that we will receive any cash from the exercise of Warrants. However, we will use any cash proceeds received from the
exercise of Warrants for general corporate and working capital purposes, which would increase our liquidity. We will continue to evaluate
the probability of Warrant exercises and the merit of including potential cash proceeds from the exercise of the Warrants in our future
liquidity projections.
Cash at March 31, 2024 totaled $1,563,139
as compared to $1,283,523 at December 31, 2023, an increase of $279,616. The following table shows
Cardio’s cash flows from operating activities, investing activities and financing activities for the stated periods:
| |
Three months ended March 31, | |
| |
2024 | | |
2023 | |
Net cash used in operating activities | |
$ | 1,233,050 | | |
$ | 1,649,067 | |
Net cash used in investing activities | |
| 69,941 | | |
| 52,674 | |
Net cash provided by financing activities | |
| 1,582,607 | | |
| 4,291,990 | |
Cash
Used in Operating Activities
Cash used in operating activities for the three months ended March
31, 2024 was $1,233,050 as compared to $1,649,067 for the three months ended March 31, 2023. The cash used in operations during the three
months ended March 31, 2024 is a function of net loss of $4,163,584 adjusted for the following non-cash operating items: depreciation
of $3,587, amortization of $24,750, $2,519,404 in stock-based compensation, an increase of $14,028 in accounts receivable, a decrease
of $470,050 in prepaid expenses and other current assets, a decrease of $18,494 in accounts payable and accrued expenses and a decrease
in lease liability of $54,735.
The cash used in operations during the three months ended March 31,
2023, is a function of net loss of $1,032,618 adjusted for the following non-cash operating items: amortization of $4,785, $4,000 in stock
based compensation, $5,007,740 in non-cash interest expense offset by $5,686,901 in change in fair value of derivative liability, a decrease
of $338,105 in prepaid expenses and other current assets, an increase in deposits of $2,100 and a decrease of $282,078 in accounts payable
and accrued expenses.
Cash Used in Investing Activities
Cash used in investing activities
for the three months ended March 31, 2024 was $69,941 compared to $52,674 for the three months ended March 31, 2023. The cash used in
investing activities for the three months ended March 31, 2024 was due to purchases of property and equipment and patent costs incurred.
The cash used in investing activities for the three months ended March 31, 2023
was due to patent costs incurred.
Cash Provided by Financing Activities
Cash provided by financing activities for the three months ended
March 31, 2024 was $1,582,607 as compared to $4,291,990 for the three months ended March 31, 2023. This change was due to $1,877,857 in
proceeds from the sale of common stock offset by $140,250 in payments pursuant to a finance agreement and $155,000 in payments of placement
agent fees and all of which occurred during the three months ended March 31, 2024. Cash provided by financing activities for the three
months ended March 31, 2023 was due to $4,500,000 in proceeds from convertible notes payable, net of original issue discount (“OID”)
of $500,000, $390,000 in proceeds from exercise of warrants, offset by $283,010 in payments of finance agreement and $315,000 in payments
of placement agent fees during the three months ended March 31, 2023.
Going Concern
The accompanying consolidated financial statements have been
prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course
of business. The Company has generated only nominal revenue in the past two years. The Company had a net loss of $4,163,584 for the three
months ended March 31, 2024 and an accumulated deficit of $18,531,964 at March 31, 2024. These factors, among others, raise substantial
doubt about the ability of the Company to continue as a going concern for a reasonable period of time. The Company’s continuation
as a going concern is dependent upon its ability to obtain necessary equity financing and ultimately from generating revenues to continue
operations. The Company expects that working capital requirements will continue to be funded through a combination of its existing funds
and further issuances of securities. Working capital requirements are expected to increase in line with the growth of the business. The
Company has no lines of credit or other bank financing arrangements. Additional issuances of equity or convertible debt securities will
result in dilution to current stockholders. Further, such securities might have rights, preferences or privileges senior to common stock.
Additional financing may not be available upon acceptable terms, or at all. If adequate funds are not available or are not available on
acceptable terms, the Company may not be able to take advantage of prospective new business endeavors or opportunities, which could significantly
and materially restrict business operations.
The consolidated financial statements do not include any adjustments
that might result from the outcome of this uncertainty relating to the 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.
Off-Balance Sheet Financing Arrangements
We did not have any off-balance sheet
arrangements as of March 31, 2024.
Contractual Obligations
As of March 31, 2024, we do not have any ongoing contractual obligations
that would have a negative impact on liquidity and cash flows. However, if one or more of the following potential claims that arise from
contracts we have entered into were pursued against us, there is the potential that we could see a negative impact on liquidity and cash
flows, depending on the outcome.
Prior Relationships of Cardio with Boustead Securities, LLC
At the commencement of efforts to pursue what ultimately ended in
the terminated business acquisition referred to above under "Deposit for Acquisition,” Legacy Cardio entered into a Placement
Agent and Advisory Services Agreement (the "Placement Agent Agreement”), dated April 12, 2021, with Boustead Securities, LLC
("Boustead Securities”). This agreement was terminated in April 2022, when Legacy Cardio terminated the underlying agreement
and plan of merger and the accompanying escrow agreement relating to that proposed business acquisition after efforts to complete the
transaction failed, despite several extensions of the closing deadline.
Under the terminated Placement Agent Agreement, Legacy Cardio agreed
to certain future rights in favor of Boustead Securities, including (i) a two-year tail period during which Boustead Securities would
be entitled to compensation if Cardio were to close on a transaction (as defined in the Placement Agent Agreement) with any party that
was introduced to Legacy Cardio by Boustead Securities; and (ii) a right of first refusal to act as the Company’s exclusive placement
agent for 24-months from the end of the term of the Placement Agent Agreement (the "right of first refusal”). Cardio has taken
the position that due to Boustead Securities’ failure to perform as contemplated by the Placement Agent Agreement, these provisions
purporting to provide future rights are null and void.
Boustead Securities responded to the termination of the Placement
Agent Agreement by disputing Legacy Cardio’s contention that it had not performed under the Placement Agent Agreement because, among
other things, Boustead Securities had never sought out prospective investors. In its response, Boustead Securities included a list of
funds that they had supposedly contacted on Legacy Cardio’s behalf. While Boustead Securities’ contention appears to contradict
earlier communications from Boustead Securities in which they indicated that they had not made any such contacts or introductions, Boustead
Securities is currently contending that they are due success fees for two years following the termination of the Placement Agent Agreement
on any transaction with any person on the list of supposed contacts or introductions. Legacy Cardio strongly disputes this position. Notwithstanding
the foregoing, the Company has not consummated any transaction, as defined, with any potential party that purportedly was a contact of
Boustead Securities in connection with the Placement Agent Agreement and has no plans to do so at any time during the tail period. No
legal proceedings have been instigated by either party, and Cardio believes that the final outcome will not have a material adverse impact
on its financial condition.
The Benchmark Company, LLC Right of First Refusal
As noted in Note 1, the Company completed a business combination
with Mana on October 25, 2022. In connection with the proposed business combination, by agreement dated May 13, 2022, Mana engaged The
Benchmark Company, LLC ("Benchmark”) as its M&A advisor. Upon closing of the business combination, Cardio assumed the contractual
engagement entered into by Mana. On November 14, 2022, Cardio and Benchmark entered into Amendment No. 1 Engagement Letter (the "Amendment
Engagement”). Pursuant to the Amendment Engagement, Benchmark has been granted a right of first refusal to act as lead or joint-lead
investment banker, lead or joint-lead book-runner and/or lead or joint-lead placement agent for all future public and private equity and
debt offerings through October 25, 2023. Based on the right of first refusal, Benchmark alleges that it is owed damages because the Company
entered into the Yorkville Convertible Debenture Transaction (see Note 11 to Notes to Consolidated Financial Statements) without first
offering Benchmark the right to serve as the lead or joint-lead placement agent for the transaction. The Company continues to evaluate
the claim. No legal proceedings have been instigated.
Demand Letter and Potential Mootness Fee Claim
On June 25, 2022, a plaintiffs’ securities law firm sent a
demand letter to the Company alleging that the Company’s Registration Statement on Form S-4 filed (the "S-4 Registration Statement”)
with the Securities and Exchange Commission ("SEC”) on May 31, 2022 omitted material information with respect to the Business
Combination and demanding that the Company and its Board of Directors immediately provide corrective disclosures in an amendment or supplement
to the Registration Statement. Subsequent thereto, the Company filed amendments to the S-4 Registration Statement on July 27, 2022, August
23, 2022, September 15, 2022, October 4, 2022 and October 5, 2022 in which it responded to various comments of the SEC staff and otherwise
updated its disclosure. In October 2022, the SEC completed its review and declared the S-4 registration statement effective on October
6, 2022. On February 23, 2023 and February 27, 2023, plaintiffs’ securities law firm contacted the Company’s counsel asking
who will be negotiating a mootness fee relating to the purported claims set forth in the June 25, 2022 demand letter. The Company vigorously
denies that the S-4 Registration Statement, as amended and declared effective, is
deficient in any respect and believes that no additional supplemental disclosures are material or required. The Company believes that
the claims asserted in the Demand Letter are without merit and that no further disclosure is required to supplement the S-4 Registration
Statement under applicable laws. As of the date of filing of this Annual Report on Form 10-K, no lawsuit has been filed against
the Company by that firm. The firm has indicated its willingness to litigate the matter if a mutually satisfactory resolution cannot be
agreed upon; however, Cardio believes that the final outcome will not have a material adverse impact on its financial condition.
Northland Securities, Inc.
In January 2024, following the Company’s termination of its
agreement with Yorkville and in connection with the Company’s recent at the market offering and/or its February 2024 private placement,
a managing director of Northland Securities, Inc. ("Northland”) contacted the Company claiming the right to be paid a fee of
approximately $150,000 pursuant to the agreement of March 1, 2023 between the Company and Northland regarding the Yorkville financing.
Subsequently, the Company has been advised by another representative of Northland that Northland would not proceed with any such claim.
The Company does not believe that it owes Northland any sum based on the termination of the Yorkville Securities Purchase Agreement and
the subsequent financing transactions.
The Company cannot preclude the possibility that claims or lawsuits
brought relating to any alleged securities law violations or breaches of fiduciary duty could potentially require significant time and
resources to defend and/or settle and distract its management and board of directors from focusing on its business.
Critical Accounting Policies and Significant Judgments and Estimates
Cardio’s consolidated financial statements are prepared in
accordance with GAAP in the United States. The preparation of its consolidated financial statements and related disclosures
requires it to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue, costs and expenses, and
the disclosure of contingent assets and liabilities in Cardio’s financial statements. Cardio bases its estimates on historical experience,
known trends and events and various other factors that it believes are reasonable under the circumstances, the results of which form the
basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Cardio
evaluates its estimates and assumptions on an ongoing basis. Cardio’s actual results may differ from these estimates under different
assumptions or conditions.
While Cardio’s significant accounting policies are described
in more detail in Note 2 to its consolidated financial statements, Cardio believes that the following accounting policies are
those most critical to the judgments and estimates used in the preparation of its consolidated financial statements.
Use of Estimates in the Preparation of Financial Statements
The preparation of financial statements in conformity with generally
accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities
and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts
of revenues and expenses during the period. Actual results could differ from those estimates.
Fair Value Measurements
The Company adopted the provisions of ASC Topic 820, Fair
Value Measurements and Disclosures, which defines fair value as used in numerous accounting pronouncements, establishes a framework
for measuring fair value and expands disclosure of fair value measurements.
The estimated fair value of certain financial instruments, including
cash and cash equivalents, accounts payable and accrued expenses are carried at historical cost basis, which approximates their fair values
because of the short-term nature of these instruments. The carrying amounts of our short- and long-term credit obligations approximate
fair value because the effective yields on these obligations, which include contractual interest rates taken together with other
features such as concurrent issuances of warrants and/or embedded conversion options, are comparable to rates of returns for instruments
of similar credit risk.
ASC 820 defines fair value as the exchange price that would be received
for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in
an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy, which requires
an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes
three levels of inputs that may be used to measure fair value:
Level 1 – quoted prices in active markets for
identical assets or liabilities
Level 2 – quoted prices for similar assets
and liabilities in active markets or inputs that are observable
Level 3 –
inputs that are unobservable (for example cash flow modeling inputs based on assumptions)
Stock-Based Compensation
Cardio accounts for its stock-based awards granted under its employee
compensation plan in accordance with ASC Topic No. 718-20, Awards Classified as Equity, which requires the measurement
of compensation expense for all share-based compensation granted to employees and non-employee directors at fair value on the
date of grant and recognition of compensation expense over the related service period for awards expected to vest. The Company uses
the Black-Scholes option pricing model to estimate the fair value of its stock options and warrants. The Black-Scholes option pricing
model requires the input of highly subjective assumptions including the expected stock price volatility of the Company’s common
stock, the risk-free interest rate at the date of grant, the expected vesting term of the grant, expected dividends, and an assumption
related to forfeitures of such grants. Changes in these subjective input assumptions can materially affect the fair value estimate of
the Company’s stock options and warrants.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET
RISK
Pursuant to Item 305(e) of Regulation S-K,
the Company is not required to provide the information required by this Item as it is a “smaller reporting company.”
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls
and Procedures
Under the supervision and with the
participation of our management, including our principal executive officer and principal financial and accounting officer, we conducted
an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e)
and 15d-15(e) under the Exchange Act, as of the end of the period covered by this Quarterly Report. Based on this evaluation, our principal
executive officer and principal financial and accounting officer have concluded that during the period covered by this Report, our disclosure
controls and procedures are not effective. As a result, we performed additional analysis as deemed necessary to ensure that our financial
statements were prepared in accordance with U.S. generally accepted accounting principles. Accordingly, management believes that the financial
statements included in this Form 10-Q present fairly in all material respects our financial position, results of operations
and cash flows for the period presented.
Disclosure controls and procedures are designed to ensure that information
required to be disclosed by us in our Exchange Act reports is recorded, processed, summarized, and reported within the time periods specified
in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal
executive officer and principal financial officer or persons performing similar functions, as appropriate to allow timely decisions regarding
required disclosure.
We do not expect that our disclosure controls and procedures will
prevent all errors and all instances of fraud. Disclosure controls and procedures, no matter how well conceived and operated, can provide
only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Further, the design of
disclosure controls and procedures must reflect the fact that there are resource constraints, and the benefits must be considered relative
to their costs. Because of the inherent limitations in all disclosure controls and procedures, no evaluation of disclosure controls and
procedures can provide absolute assurance that we have detected all our control deficiencies and instances of fraud, if any. The design
of disclosure controls and procedures also is based partly on certain assumptions about the likelihood of future events, and there can
be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.
Changes in Internal Control over Financial
Reporting
There has not been any change in our internal control over financial
reporting that occurred during the three months ended March 31, 2024 that has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
PART II. OTHER
INFORMATION
ITEM 1. LEGAL PROCEEDINGS
From time-to-time, the Company may be involved in various civil
actions as part of its normal course of business. The Company is not a party to any litigation that is material to ongoing operations
as defined in Item 103 of Regulation S-K as of the period ended March 31, 2024.
ITEM 1A. RISK FACTORS
There have
been no material changes to the risk factors previously described in Item 1A of Part I of our Annual Report on Form 10-K for the fiscal
year ended December 31, 2023 except as set forth below. These risk factors, collectively, describe
some of the assumptions, risks, uncertainties and other factors that could adversely affect our
business or that could otherwise result in changes that differ materially from our expectations. We may disclose changes to such risk
factors or disclose additional risk factors from time to time in our future filings with the SEC, including as set forth below. Additional
risks and uncertainties not currently known to us or that we currently deem to be immaterial also may materially adversely affect our
business, financial condition or future results.
There can be no assurance that we will be able to comply with
the continued listing standards of Nasdaq.
Our common stock is listed on The Nasdaq Capital Market ("Nasdaq”).
In order to maintain that listing, we must satisfy minimum financial and other requirements or be subject to delisting. In the second
half of 2023, we received deficiency notices from Nasdaq with respect to our failure to meet the minimum bid price and the minimum stockholders’
equity requirement necessary for continued listing on Nasdaq. In both instances, we were able to cure the deficiencies within the applicable
cure period, and our securities continued to trade on Nasdaq without interruption. As of May 14, 2024 we have failed to meet the minimum
bid price for 18 consecutive business days. Unless our stock price closes above $1.00 on or before May 31, 2024, we can expect to receive
a deficiency letter from Nasdaq, advising us that our securities will be delisted from Nasdaq unless the stock price closes above $1.00
for ten consecutive business days during the 180-day cure period. At our annual meeting held on December 18, 2023, our stockholders gave
our board of directors discretion to effect a reverse stock split in the range of 1-for-5 to 1-for-40 to address this potential deficiency,
which approval is effective through December 18, 2024. Accordingly, we believe that in the event we do receive a deficiency letter from
Nasdaq with regard to the minimum bid price requirement, we will be able to address the deficiency by effecting a reverse stock split.
However, there can be no assurance that we will be able to comply with the continued listing standards of Nasdaq at all times in the future.
If Nasdaq
delists our shares of Common Stock or Public Warrants for failure to meet the listing standards, we and our securityholders could
face significant material adverse consequences including:
· |
|
a limited availability of market quotations for our securities; |
· |
|
reduced liquidity for our securities; |
· |
|
a determination that our common stock is a “penny stock,” which will require brokers trading in our common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for shares of our common stock; |
· |
|
a limited amount of analyst coverage; and |
· |
|
a decreased ability to issue additional securities or obtain additional financing in the future. |
Although our financial statements have been prepared on a going
concern basis, we must raise additional capital to fund our operations in order to continue as a going concern.
Prager Metis, our independent registered public accounting firm
for the fiscal year ended December 31, 2013, has included an explanatory paragraph in their opinion that accompanies our audited consolidated
financial statements as of and for the year ended December 31, 2023, indicating that our current liquidity position raises substantial
doubt about our ability to continue as a going concern. If we are unable to improve our liquidity position, we may not be able to continue
as a going concern. The accompanying consolidated financial statements do not include any adjustments that might result if we are unable
to continue as a going concern and, therefore, be required to realize our assets and discharge our liabilities other than in the normal
course of business which could cause investors to suffer the loss of all or a substantial portion of their investment. We anticipate
that our principal sources of liquidity will only be sufficient to fund our activities over the next twelve (12) months. In order to have
sufficient cash to fund our operations beyond the next twelve (12) months, we will need to raise additional equity over the next twelve
(12) months in order to continue as a going concern and we cannot provide any assurance that we will be successful in doing so.
The U.S. Food and Drug Administration’s (“FDA’s”)
newly-issued rule for laboratory developed tests (“LDTs”), which will be phased in over a period of four years, will significantly
change the regulatory landscape for LDTs. Unless the rule is overturned by a court or Congress, our currently marketed LDTs and those
we develop in the future will be subject to new requirements which may include, for some tests, premarket clearance, de novo authorization
or premarket approval. We will incur substantial costs and delays associated with complying with the new rule.
We believe our Epi+Gen CHD™ and PrecisionCHD™ tests
are LDTs. The FDA generally considers an LDT to be a test that is designed, manufactured,
and used within a single laboratory that is certified under CLIA and meets the regulatory requirements under CLIA to perform high complexity
testing
The FDA has historically taken the position that it has the authority to
regulate LDTs as in-vitro diagnostics (“IVDs”) under the Federal Food, Drug, and Cosmetic Act (“FDC Act”), although
it has generally exercised enforcement discretion with regard to LDTs. This means that even though the FDA believes it can impose regulatory
requirements on LDTs, such as requirements to obtain premarket approval, de novo authorization or clearance of LDTs, it has generally
chosen not to enforce those requirements.
On May 6, 2024, the FDA published a final rule amending the definition
of an IVD device to include IVDs manufactured by a clinical laboratory. The final rule also announced the FDA’s intention to phase
out its general enforcement discretion policy. Unless the rule is overturned by a court or Congress, the medical device requirements for
most LDTs will be phased in beginning on May 6, 2025. These requirements include premarket clearance, de novo authorization or premarket
approval for each LDT performed by a laboratory, and postmarket registration and listing, medical device reporting, correction, removal,
and recall, complaint handling, labeling, investigational device, and quality system requirements. Certain categories of LDTs will be
subject to enforcement discretion with respect to some or all of these requirements. For example, FDA will apply enforcement discretion
to currently marketed LDTs that were first offered prior to May 6, 2024, with respect to most quality system requirements and the requirement
for premarket authorization if they are not modified or modified in only limited ways. Laboratories performing these tests are subject
to other requirements, including the requirement to submit the labeling for the LDT to FDA for review, which could be burdensome and expensive.
FDA will similarly exercise enforcement discretion with respect to premarket clearance, de novo classification, or premarket approval
requirements for LDTs approved by the New York State Clinical Laboratory Evaluation Program.
Compliance
with these additional regulatory requirements will be time-consuming and expensive. If we are required to obtain premarket notification,
de novo authorization or premarket approval for our existing tests, or for any future tests we may develop, we may be required to successfully
complete analytical, pre-clinical and/or clinical studies beyond the studies we have already performed or planned to perform for our LDTs.
These studies may be extensive and costly and may take a substantial period of time to complete. Any such studies may fail to generate
data that meet the FDA’s requirements. The studies may also not be conducted
in a manner that meets the FDA’s requirements, and therefore may not support the marketing application. There can be no assurance
that the submission of such an application will result in a timely response by the FDA or a favorable outcome that will allow the test
to be marketed. In addition, we may be forced to stop selling our tests or we may be required to modify claims for or make other changes
to our tests while we work to obtain FDA clearance, approval or de novo authorization. Our business may be adversely affected while such
review is ongoing and if we are ultimately unable to obtain premarket clearance. de novo authorization or premarket approval.
Various bills have been introduced in Congress seeking to substantially
revamp the regulation of both LDTs and IVDs, but no legislation has been enacted thus far.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF
PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
None.
ITEM 5. OTHER INFORMATION
None of the
Company’s directors or officers adopted, modified or terminated a Rule 10b-5 trading arrangement or a non-Rule 10b-5 trading arrangement
during the fiscal quarter ended March 31, 2024, as such terms are defined under Item 408(a) of Regulation S-K.
ITEM 6. EXHIBITS
The following exhibits are filed as part of, or
incorporated by reference into, this Quarterly Report on Form 10-Q.
| |
| |
Incorporation
by Reference |
Exhibit
Number | |
Description | |
Form | |
Exhibit | | |
Filing
Date |
| |
| |
| |
| | |
|
2.1 | |
Agreement
and Plan of Merger dated as of May 27, 2022 by and among Mana Capital Acquisition Corp., Mana Merger Sub, Inc., Cardio Diagnostics,
Inc., and Meeshanthini (Meesha) Dogan, as representatives of the shareholders (included as Annex A to the Proxy Statement/Prospectus) | |
8-K | |
| 2.1 | | |
5/31/2022 |
2.2 | |
Amendment
dated September 15, 2022 to Agreement and Plan of Merger dated as of May 27, 2022 by and among Mana Capital Acquisition Corp., Mana
Merger Sub, Inc., Cardio Diagnostics, Inc., and Meeshanthini (Meesha) Dogan, as representatives of the shareholders | |
8-K | |
| 2.1 | | |
9/15/22 |
2.3 | |
Waiver
Agreement dated as of October 25, 2022 with respect to Agreement and Plan of Merger dated as of May 27, 2022, as amended on September
15, 2022 | |
8-K | |
| 2.3 | | |
10/31/22 |
3.1 | |
Third
Amended and Restated Certificate of Incorporation of Cardio Diagnostics Holdings, Inc., dated May 30, 2023 | |
8-K | |
| 3.1 | | |
5/30/23 |
3.2 | |
By-laws | |
S-1 | |
| 3.3 | | |
10/19/21 |
4.1 | |
Specimen
Stock Certificate | |
S-1/A | |
| 4.2 | | |
11/10/21 |
4.2 | |
Specimen
Warrant Certificate (contained in Exhibit 4.3) | |
8-K | |
| 4.1 | | |
11/26/21 |
4.3 | |
Warrant
Agreement, dated November 22, 2021, by and between the Company and Continental Stock Transfer & Trust Company, as warrant agent | |
8-K | |
| 4.1 | | |
11/26/21 |
4.4 | |
Description
of Securities | |
10-K | |
| 4.5 | | |
4/1/24 |
10.1 | |
At
the Market Offering Agreement, dated January 26, 2024, between Cardio Diagnostics Holdings, Inc. and Craig-Hallum Capital Group,
LLC | |
S-3 | |
| 1.2 | | |
1/26/24 |
31.1* | |
Certification of Principal Executive Officer Pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
| |
| | | |
|
31.2* | |
Certification of Principal Financial Officer Pursuant to Exchange Act Rules 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
| |
| | | |
|
32.1+ | |
Certification of Principal Executive Officer pursuant to 18 U.S. C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
| |
| | | |
|
32.2+ | |
Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
| |
| | | |
|
101.INS* | |
Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document) |
101.SCH* | |
XBRL
Taxonomy Extension Schema Document. | |
| |
| | | |
|
101.CAL* | |
XBRL
Taxonomy Extension Calculation Linkbase Document | |
| |
| | | |
|
101.DEF* | |
XBRL
Taxonomy Extension Definition Linkbase Document | |
| |
| | | |
|
101.LAB* | |
XBRL
Taxonomy Extension Label Linkbase Document | |
| |
| | | |
|
101.PRE* | |
XBRL
Taxonomy Extension Presentation Linkbase Document | |
| |
| | | |
|
104* | |
Cover Page Interactive Date File (embedded with the Inline XBRL document) |
| |
| |
| |
| | | |
|
* |
Filed herewith. |
|
+ |
Furnished herewith. The certifications attached as Exhibit 32.1 and Exhibit 32.2 that accompany this Quarterly Report on Form 10-Q are deemed furnished and not filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Cardio Diagnostics Holdings, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.
|
|
SIGNATURES
Pursuant to the
requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned
thereunto duly authorized.
|
Cardio Diagnostics Holdings, Inc. |
|
|
|
Date: May 15, 2024 |
By: |
/s/ Elisa Luqman |
|
|
Elisa Luqman |
|
|
Chief Financial Officer |
EXHIBIT 31.1
CERTIFICATION
I, Meeshanthini V. Dogan, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q
of Cardio Diagnostics Holdings, Inc. for the quarter ended March 31, 2024;
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 such 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.
Dated: May
15, 2024 |
/s/ Meeshanthini V. Dogan |
|
|
Meeshanthini V. Dogan |
|
|
Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
|
|
EXHIBIT 31.2
CERTIFICATION
I, Elisa Luqman, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q
of Cardio Diagnostics Holdings, Inc. for the quarter ended March 31, 2024;
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 such 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.
Dated: May 15, 2024 |
/s/ Elisa Luqman |
|
|
Elisa Luqman |
|
|
Chief Financial Officer
(Principal Financial and Accounting Officer) |
|
|
|
|
|
|
|
EXHIBIT 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION
1350,
AS ADOPTED PURSUANT TO SECTION 906 OF
THE SARBANES-OXLEY ACT OF 2002
In connection with this Quarterly Report
on Form 10-Q, (the “Report”) of Cardio Diagnostics Holdings, Inc. (the “Company”) for the quarter ended March
31, 2024, the undersigned, Meeshanthini V. Dogan, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section
906 of the Sarbanes-Oxley Act of 2002, that, to the best of the undersigned’s knowledge and belief:
(1) |
|
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
|
(2) |
|
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
|
|
|
May 15, 2024 |
|
|
/s/ Meeshanthini V. Dogan |
|
Meeshanthini V. Dogan
Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
EXHIBIT 32.2
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION
1350,
AS ADOPTED PURSUANT TO SECTION 906 OF
THE SARBANES-OXLEY ACT OF 2002
In connection with this Quarterly Report
on Form 10-Q, (the “Report”) of Cardio Diagnostics Holdings, Inc. (the “Company”) for the quarter ended March
31, 2024, the undersigned, Elisa Luqman, hereby certifies pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002, that, to the best of the undersigned’s knowledge and belief:
(1) |
|
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
|
|
|
(2) |
|
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
|
|
|
May 15, 2024 |
|
|
/s/ Elisa Luqman |
|
Elisa Luqman
Chief Financial Officer
(Principal Financial and Accounting Officer) |
|
|
|
|
v3.24.1.1.u2
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Entity File Number |
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Entity Registrant Name |
Cardio Diagnostics Holdings, Inc.
|
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Entity Central Index Key |
0001870144
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Chicago
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Title of 12(b) Security |
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v3.24.1.1.u2
CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Current assets |
|
|
Cash |
$ 1,563,139
|
$ 1,283,523
|
Accounts receivable |
18,988
|
4,960
|
Prepaid expenses and other current assets |
1,007,147
|
1,477,197
|
Total current assets |
2,589,274
|
2,765,680
|
Long-term assets |
|
|
Property and equipment, net |
588,271
|
571,873
|
Right of use assets, net |
555,270
|
575,227
|
Intangible assets, net |
17,333
|
21,333
|
Deposits |
12,850
|
12,850
|
Patent costs, net |
564,565
|
515,402
|
Total assets |
4,327,563
|
4,462,365
|
Current liabilities |
|
|
Accounts payable and accrued expenses |
224,719
|
243,213
|
Lease liability - current |
227,203
|
223,929
|
Finance agreement payable |
233,750
|
374,000
|
Total current liabilities |
685,672
|
841,142
|
Long-term liabilities |
|
|
Lease liability – long term |
605,090
|
663,099
|
Total liabilities |
1,290,762
|
1,504,241
|
Stockholders' equity |
|
|
Preferred stock, $.00001 par value; authorized - 100,000,000 shares; 0 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively |
|
|
Common stock, $.00001 par value; authorized - 300,000,000 shares; 21,628,974 and 20,540,409 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively |
216
|
205
|
Additional paid-in capital |
21,568,549
|
17,326,299
|
Accumulated deficit |
(18,531,964)
|
(14,368,380)
|
Total stockholders' equity |
3,036,801
|
2,958,124
|
Total liabilities and stockholders' equity |
$ 4,327,563
|
$ 4,462,365
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v3.24.1.1.u2
CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Statement of Financial Position [Abstract] |
|
|
Preferred stock, par value |
$ 0.00001
|
$ 0.00001
|
Preferred stock, shares authorized |
100,000,000
|
100,000,000
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
X |
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v3.24.1.1.u2
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Income Statement [Abstract] |
|
|
Revenue |
$ 15,928
|
|
Operating expenses |
|
|
Sales and marketing |
34,402
|
49,551
|
Research and development |
10,840
|
86,665
|
General and administrative expenses |
4,123,941
|
1,562,128
|
Amortization |
4,793
|
4,785
|
Total operating expenses |
4,173,976
|
1,703,129
|
Loss from operations |
(4,158,048)
|
(1,703,129)
|
Other income (expenses) |
|
|
Change in fair value of derivative liability |
|
5,686,901
|
Interest income |
281
|
221
|
Interest expense |
(5,817)
|
(5,016,611)
|
Total other income (expenses) |
(5,536)
|
670,511
|
Loss before provision for income taxes |
(4,163,584)
|
(1,032,618)
|
Provision for income taxes |
|
|
Net loss |
$ (4,163,584)
|
$ (1,032,618)
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v3.24.1.1.u2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - $ / shares
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Income Statement [Abstract] |
|
|
Net loss per common share, basic |
$ (0.20)
|
$ (0.11)
|
Net loss per common share, fully diluted |
$ (0.20)
|
$ (0.11)
|
Weighted average common shares outstanding, basic |
21,077,225
|
9,547,177
|
Weighted average common shares outstanding, fully diluted |
21,077,225
|
9,547,177
|
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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v3.24.1.1.u2
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY (Unaudited) - USD ($)
|
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Beginning balance, value at Dec. 31, 2022 |
$ 95
|
$ 10,293,159
|
$ (5,991,546)
|
$ 4,301,708
|
Beginning balance, shares at Dec. 31, 2022 |
9,514,743
|
|
|
|
Warrants converted to common stock |
$ 1
|
389,999
|
|
390,000
|
Warrants converted to common stock, shares |
100,000
|
|
|
|
Restricted stock awards vested |
|
4,000
|
|
4,000
|
Restricted stock awards vested, shares |
1,092
|
|
|
|
Placement agent fee |
|
(315,000)
|
|
(315,000)
|
Adjustment to liabilities assumed in merger with Mana |
|
74,025
|
|
74,025
|
Net loss |
|
|
(1,032,618)
|
(1,032,618)
|
Ending balance, value at Mar. 31, 2023 |
$ 96
|
10,446,183
|
(7,024,164)
|
3,422,115
|
Ending balance, shares at Mar. 31, 2023 |
9,615,835
|
|
|
|
Beginning balance, value at Dec. 31, 2023 |
$ 205
|
17,326,299
|
(14,368,380)
|
2,958,124
|
Beginning balance, shares at Dec. 31, 2023 |
20,540,409
|
|
|
|
Common stock issued for cash |
$ 11
|
1,877,846
|
|
1,877,857
|
Common stock issued for cash, shares |
1,048,876
|
|
|
|
Restricted stock awards vested |
|
58,000
|
|
58,000
|
Restricted stock awards vested, shares |
39,689
|
|
|
|
Placement agent fee |
|
(155,000)
|
|
(155,000)
|
Compensation for vested stock options |
|
2,461,404
|
|
2,461,404
|
Net loss |
|
|
(4,163,584)
|
(4,163,584)
|
Ending balance, value at Mar. 31, 2024 |
$ 216
|
$ 21,568,549
|
$ (18,531,964)
|
$ 3,036,801
|
Ending balance, shares at Mar. 31, 2024 |
21,628,974
|
|
|
|
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v3.24.1.1.u2
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
Net loss |
$ (4,163,584)
|
$ (1,032,618)
|
Adjustments to reconcile net loss to net cash used in operating activities |
|
|
Depreciation |
3,587
|
0
|
Amortization |
24,750
|
4,785
|
Stock-based compensation expense |
2,519,404
|
4,000
|
Non-cash interest expense |
|
5,007,740
|
Change in fair value of derivative liability |
|
(5,686,901)
|
Changes in operating assets and liabilities: |
|
|
Accounts receivable |
(14,028)
|
|
Prepaid expenses and other current assets |
470,050
|
338,105
|
Deposits |
|
(2,100)
|
Accounts payable and accrued expenses |
(18,494)
|
(282,078)
|
Lease liability |
(54,735)
|
|
NET CASH USED IN OPERATING ACTIVITIES |
(1,233,050)
|
(1,649,067)
|
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
Purchases of property and equipment |
(19,985)
|
|
Patent costs incurred |
(49,956)
|
(52,674)
|
NET CASH USED IN INVESTING ACTIVITIES |
(69,941)
|
(52,674)
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
Proceeds from convertible notes payable, net of original issue discount of $500,000 |
|
4,500,000
|
Proceeds from exercise of warrants |
|
390,000
|
Proceeds from sale of common stock |
1,877,857
|
|
Payments of finance agreement |
(140,250)
|
(283,010)
|
Payments of placement agent fee |
(155,000)
|
(315,000)
|
NET CASH PROVIDED BY FINANCING ACTIVITIES |
1,582,607
|
4,291,990
|
NET INCREASE IN CASH |
279,616
|
2,590,249
|
CASH - BEGINNING OF PERIOD |
1,283,523
|
4,117,521
|
CASH - END OF PERIOD |
1,563,139
|
6,707,770
|
SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: |
|
|
Interest |
5,817
|
8,871
|
Income taxes |
|
|
Non-cash investing and financing activities: |
|
|
Debt discount related to derivative liability |
|
9,192,672
|
Adjustment to liabilities assumed in acquisition |
|
$ 74,025
|
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v3.24.1.1.u2
Organization and Basis of Presentation
|
3 Months Ended |
Mar. 31, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization and Basis of Presentation |
Note 1 - Organization and Basis of Presentation
The consolidated financial statements
presented are those of Cardio Diagnostics Holdings, Inc., (the “Company”) and its wholly-owned subsidiary, Cardio Diagnostics,
Inc. (“Legacy Cardio”). The Company was incorporated as Mana Capital Acquisition Corp. (“Mana”) under the laws
of the state of Delaware on May 19, 2021, and Legacy Cardio was formed on January 16, 2017 as an Iowa limited liability company (Cardio
Diagnostics, LLC) and was subsequently incorporated as a Delaware C-Corp on September 6, 2019. The Company was formed to develop and commercialize
a patent-pending Artificial Intelligence (“AI”)-driven DNA biomarker testing technology (“Core Technology”) for
cardiovascular disease invented at the University of Iowa by the Founders, with the goal of becoming one of the leading medical technology
companies for enabling precision prevention, early detection and treatment of cardiovascular disease. The Company is transforming the
approach to cardiovascular disease from reactive to proactive. The Core Technology is being
incorporated into a series of products for major types of cardiovascular disease and associated co-morbidities, including coronary heart
disease (“CHD”), stroke, heart failure and diabetes.
Interim Financial Statements
The following (a)
consolidated balance sheet as of December 31, 2023, which has been derived from audited financial statements, and (b) the unaudited
consolidated interim financial statements of the Company as of and for the period ended March 31, 2024 have been prepared
in accordance with the instructions to Form 10-Q and Rule 8-03 of Regulation S-X. Accordingly, they do not include all of the
information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments
(consisting of normal recurring accruals) considered necessary for a fair presentation
have been included. Operating results for the three months ended March 31, 2024 are not necessarily indicative of results that may
be expected for the year ending December 31, 2024. These unaudited consolidated financial statements should be read in
conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2023 included in
the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (“SEC”) on April 1,
2024.
Business Combination
On
May 27, 2022, Mana, Mana Merger Sub, Inc. (“Merger Sub”), a wholly-owned direct subsidiary of Mana, Meeshanthini Dogan, the
Shareholders’ Representative, and Legacy Cardio entered into the Business Combination Agreement (the “Merger Agreement”). On
October 25, 2022, pursuant to the Merger Agreement, Legacy Cardio merged with and into Merger Sub, with Legacy Cardio surviving as the
wholly-owned subsidiary of Mana. Subsequent to the merger, Mana changed its name to Cardio Diagnostics Holdings, Inc.
Going Concern
The accompanying consolidated
financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of
liabilities in the normal course of business. The Company has generated only nominal revenue in the past two years. The Company had
a net loss of $4,163,584 for the three months ended March 31, 2024 and an accumulated deficit of $18,531,964 at March 31, 2024. These
factors, among others, raise substantial doubt about the ability of the Company to continue as a going concern for a reasonable period
of time. The Company’s continuation as a going concern is dependent upon its ability to obtain necessary equity financing and
ultimately from generating revenues to continue operations. The Company expects that working capital requirements will continue to
be funded through a combination of its existing funds and further issuances of securities. Working capital requirements are expected to
increase in line with the growth of the business. Existing working capital, further advances and debt instruments, and anticipated
cash flow are expected to be adequate to fund operations over the next twelve months. The Company has no lines of credit or other bank
financing arrangements. Additional issuances of equity or convertible debt securities will result in dilution to current stockholders.
Further, such securities might have rights, preferences or privileges senior to common stock. Additional financing may not be available
upon acceptable terms, or at all. If adequate funds are not available or are not available on acceptable terms, the Company may not be
able to take advantage of prospective new business endeavors or opportunities, which could significantly and materially restrict business
operations.
The consolidated financial
statements do not include any adjustments that might result from the outcome of this uncertainty relating to the 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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v3.24.1.1.u2
Merger Agreement and Reverse Recapitalization
|
3 Months Ended |
Mar. 31, 2024 |
Merger Agreement And Reverse Recapitalization |
|
Merger Agreement and Reverse Recapitalization |
Note 2 – Merger Agreement and Reverse Recapitalization
As
discussed in Note 1, on October 25, 2022, the Company (formerly known as Mana) and Legacy Cardio entered into the Merger Agreement, which
has been accounted for as a reverse recapitalization in accordance with GAAP. Pursuant to the Merger Agreement, the Company acquired
cash of $4,021 and assumed liabilities of $928,500 from Mana. The liabilities assumed of $928,500 were payable to two investment bankers
and due on October 25, 2023. The assumed liabilities decreased to $854,475, after net of an early payment discount of $74,025 issued
by one of the two investment bankers on March 22, 2023. On March 27, 2023, the Company accepted the early payment discount and paid
Ladenburg the net balance due and payable of $419,475. On October 24, 2023, the Company paid the remaining post-merger liabilities balance
of $435,000 to Benchmark.
Mana’s
common stock had a redemption right in connection with the business combination. Mana’s stockholders exercised their right to redeem
6,465,452 shares of common stock, which constituted approximately 99.5% of the shares with redemption rights, for cash at a redemption
price of approximately $10.10 per share, for an aggregate redemption amount of $65,310,892. In accounting for the reverse recapitalization,
the Company’s legacy issued and outstanding 1,976,749 shares of common stock were reversed and the Mana shares of common stock
totaling 9,514,743 were recorded, as described in Note 10. Transactions costs incurred in connection with the recapitalization totaled
$1,535,035 and were recorded as a reduction to additional paid in capital.
As additional consideration for the
transaction, Cardio may issue to each holder who was entitled to merger consideration at the Closing, its pro rata proportion of
up to 1,000,000 shares of our authorized but unissued common stock (the “Earnout Shares” or “Contingently Issuable
Common Stock”), if on or prior to the fourth anniversary of the Closing Date (the “Earnout Period”), the VWAP of the
Company’s Common Stock equals or exceeds four different price triggers for 30 of any 40 consecutive trading days, as follows: (i)
one-quarter of the Earnout Shares will be issued if the VWAP equals or exceeds $12.50 per share for the stated period; (ii) one-quarter
of the Earnout Shares will be issued if the VWAP equals or exceeds $15.00 per share for the stated period; (iii) one-quarter of the Earnout
Shares will be issued if the VWAP equals or exceeds $17.50 for the stated period; and (iv) one-quarter of the Earnout Shares will be issued
if the VWAP equals or exceeds $20.00 for the stated period.
In evaluating the accounting treatment
for the earnout, we have concluded that the earnout is not a liability under Accounting Standards Codification (“ASC”) 480,
Distinguishing Liabilities from Equity, is not subject to the accounting guidance under ASC 718, Compensation—Stock Compensation,
and is not subject to derivative accounting under ASC 815, Derivative and Hedging. As such, the earnout is recognized in equity at fair
value upon the closing of the Business Combination. As of the date of filing of this Quarterly
Report on Form 10-Q, the Company’s common stock did not trade at equal to or greater than $12.50 for a period of at least 30 trading
days out of 40 consecutive trading days and the Company has not issued any Earnout Shares.
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v3.24.1.1.u2
Summary of Significant Accounting Policies
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies |
Note 3 – Summary of Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements
include the accounts of the Company and its wholly-owned subsidiary, Legacy Cardio. All intercompany accounts and transactions
have been eliminated.
Use of Estimates in the Preparation of Financial Statements
The preparation of financial statements
in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements
and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates.
Fair Value Measurements
The
Company adopted the provisions of ASC Topic 820, Fair Value Measurements and Disclosures, which defines fair value as used in numerous
accounting pronouncements, establishes a framework for measuring fair value and expands disclosure of fair value measurements.
The
estimated fair value of certain financial instruments, including cash and cash equivalents, accounts payable and accrued expenses are
carried at historical cost basis, which approximates their fair values because of the short-term nature of these instruments. The carrying
amounts of our short- and long-term credit obligations approximate fair value because the effective yields on these obligations, which
include contractual interest rates taken together with other features such as concurrent issuances of warrants and/or embedded conversion
options, are comparable to rates of returns for instruments of similar credit risk.
ASC
820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the
principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement
date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize
the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:
Level 1 – quoted prices
in active markets for identical assets or liabilities
Level 2 – quoted prices
for similar assets and liabilities in active markets or inputs that are observable
Level 3 – inputs that
are unobservable (for example cash flow modeling inputs based on assumptions)
The
estimated fair value of the derivative liability was calculated using the Black-Scholes option pricing model. The Company uses Level 3
inputs to value its derivative liabilities. The following table provides a reconciliation of the beginning and ending balances for the
major classes of assets and liabilities measured at fair value using significant unobservable inputs (Level 3) and reflects gains and
losses for the three months ended March 31, 2024 and 2023.
Schedule of fair value measurements | |
| | | |
| | |
| |
2024 | | |
2023 | |
Liabilities: | |
| | |
| |
Balance of derivative liabilities - beginning of period | |
$ |
— | | |
$ |
— | |
Issued | |
| — | | |
| 9,192,672 | |
Converted | |
| — | | |
| — | |
Change in fair value recognized in operations | |
| — | | |
| (5,686,901 | ) |
Balance of derivative liabilities - end of period | |
$ | — | | |
$ | 3,505,771 | |
The following table represents
the Company’s derivative instruments that are measured at fair value on a recurring basis as of March 31, 2024, for each fair value
hierarchy level:
Schedule of fair value hierarchy level | |
| | | |
| | |
March 31, 2024 | |
| Derivative
Liabilities | | |
| Total |
Level I | |
$ | — | | |
$ | — | |
Level II | |
$ | — | | |
$ | — | |
Level III | |
$ | — | | |
$ | — | |
Convertible Instruments
The
Company evaluates and accounts for conversion options embedded in convertible instruments in accordance with ASC 815, Derivatives and
Hedging Activities.
Applicable
GAAP requires companies to bifurcate conversion options from their host instruments and account for them as free standing derivative financial
instruments according to certain criteria. The criteria include circumstances in which (a) the economic characteristics and risks of the
embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b)
the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under
other GAAP with changes in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded
derivative instrument would be considered a derivative instrument.
The
Company accounts for convertible instruments (when it has been determined that the embedded conversion options should not be bifurcated
from their host instruments) as follows: The Company records, when necessary, discounts to convertible notes for the intrinsic value of
conversion options embedded in debt instruments based upon the differences between the fair value of the underlying common stock at the
commitment date of the note transaction and the effective conversion price embedded in the note. Debt discounts under these arrangements
are amortized over the term of the related debt to their stated date of redemption.
The
Company accounts for the conversion of convertible debt when a conversion option has been bifurcated using the general extinguishment
standards. The debt and equity linked derivatives are removed at their carrying amounts and the shares issued are measured at their then-current
fair value, with any difference recorded as a gain or loss on extinguishment of the two separate accounting liabilities.
Revenue Recognition
The Company offers its
products, Epi+Gen CHD™ and PrecisionCHD™ via telemedicine providers, provider organizations such as concierge practices, longevity
clinics, and risk-bearing provider organizations, and employer organizations. The Company is continuing to expand its markets and payment
optionality, and therefore, other organization types not listed below may be added, and from time-to-time, there may be additional payment
options.
For telemedicine, the telemedicine
provider collects payments from patients upon completion of eligibility screening and test order. Patients then send their samples to
the lab for biomarker assessments. The Company performs all quality control, analytical assessments and report generation and shares test
reports with the ordering healthcare provider. Revenue is recognized upon invoicing the telemedicine providers. Telemedicine providers
are invoiced at the end of each month for all tests completed since prior invoicing.
For provider organizations, the
cost of each test is negotiated prior to testing commencing. Pricing is determined based largely on the provider organization type and
testing volume commitment. Upon ordering a test, a patient’s sample is sent to the lab for biomarker assessments. The Company performs
all quality control, analytical assessments and report generation and shares test reports with the ordering healthcare provider. Revenue
is recognized upon invoicing the provider organization. The provider organization is invoiced the agreed upon pricing at the end of each
month for all samples accepted or tests completed since prior invoicing.
For employer organizations, the
cost of each test is negotiated prior to testing commencing. Pricing is determined based largely on testing volume commitment. Patient
samples are sent to the lab for biomarker assessments. The Company performs all quality control, analytical assessments and report generation
and shares test reports with the ordering healthcare provider. Revenue is recognized upon invoicing the employer organization. The employer
organization is invoiced the agreed upon pricing once a heart disease fair is completed or all testing is completed.
The
Company accounts for revenue under Accounting Standards Update (“ASU”) 2014-09, “Revenue from Contracts with Customers
(Topic 606)”, using the modified retrospective method. The modified retrospective adoption used by the Company did not result in
a material cumulative effect adjustment to the opening balance of accumulated deficit.
The Company determines the measurement of revenue and the timing
of revenue recognition utilizing the following core principles:
1. Identifying the contract with a customer;
2. Identifying the performance obligations in the contract;
3. Determining the transaction price;
4. Allocating the transaction price to the performance obligations
in the contract; and
5. Recognizing revenue when (or as) the Company satisfies its
performance obligations.
Research and Development
Research
and development costs are expensed as incurred. Research and development costs charged to operations for the three months ended March
31, 2024 and 2023 were $10,840 and $86,665, respectively.
Advertising Costs
The Company
expenses advertising costs as incurred. Advertising costs of $34,402 and $49,551 were charged to operations for the three months ended
March 31, 2024 and 2023, respectively.
Cash and Cash Equivalents
Cash
and cash equivalents are comprised of cash and highly liquid investments with original maturities of 90 days or less at the date of purchase.
The Company does not have any cash equivalents as of March 31, 2024 and December 31, 2023. Cash is maintained at a major financial institution.
Accounts held at U.S. financial institutions are insured by the FDIC up to $250,000. The Company is exposed to credit risk in the event
of default by the financial institutions or the issuers of these investments to the extent the amounts on deposit or invested are in excess
of amounts that are insured.
Property and Equipment
and Depreciation
Property
and equipment are stated at cost. Maintenance and repairs are charged to expense when incurred. When property and equipment are
retired or otherwise disposed of, the related cost and accumulated depreciation are removed from the respective accounts and any gain
or loss is credited or charged to income. Depreciation for both financial reporting and income tax purposes is computed using combinations
of the straight line and accelerated methods over the estimated lives of the respective assets as follows:
Schedule of estimated lives |
|
Office and computer equipment |
5 years |
Furniture
and fixtures |
7 years |
Leasehold improvements |
7 years |
Intangible Assets
Intangible assets are acquired individually
or as part of a group of assets, and are initially recorded at cost. The cost of a group of assets acquired in a transaction is allocated
to the individual assets based on their relative fair values. Intangible assets are carried at cost less accumulated amortization and
any recorded impairment. Intangible assets with finite useful lives are amortized using a straight-line method over the period of estimated
useful life. The estimated useful life of the Company’s intangible assets (Know-how license) is 5 years. The Company evaluates intangible
assets for impairment whenever events or changes in circumstances indicate that the assets might be impaired.
Patent Costs
The Company accounts for patents
in accordance with ASC 350-30, General Intangibles Other than Goodwill. The Company capitalizes patent costs representing legal
fees associated with filing patent applications and amortize them on a straight-line basis. The Company evaluates its patents’
estimated useful life and begins amortizing the patents when they are brought to the market or otherwise commercialized.
Impairment of Long-Lived
Assets
In accordance with ASC 360-10-35,
the Company assesses the valuation of components of its long-lived assets whenever events or circumstances dictate that the carrying value
might not be recoverable. The Company bases its evaluation on indicators such as the nature of the assets, the future economic benefit
of the assets, any historical or future profitability measurements and other external market conditions or factors
that may be present. If such factors indicate that the carrying amount of an asset or asset group may not be recoverable, the Company
determines whether an impairment has occurred by analyzing an estimate of undiscounted future cash flows at the lowest level for which
identifiable cash flows exist. If the estimate of undiscounted cash flows during the estimated useful life of the asset is less than the
carrying value of the asset, the Company recognizes a loss for the difference between the carrying value of the asset and its estimated
fair value, generally measured by the present value of the estimated cash flows.
Leases
The Company accounts for leases under
ASC 842, “Leases”. The Company determines if an arrangement is a lease or contains a lease at inception of the arrangement.
Operating lease liabilities are recognized based on the present value of the remaining lease payments, discounted using the
discount rate for the lease at the commencement date. As the rate implicit in the lease is not readily determinable for the operating
lease, the Company generally uses an incremental borrowing rate based on information available at the commencement date to determine the
present value of future lease payments. Operating lease right-of-use assets (“ROU assets”) represent the Company’s right
to control the use of an identified asset for the lease term and lease liabilities represent the Company’s obligation to make lease
payments arising from the lease. ROU assets are generally recognized based on the amount of the initial measurement of the lease liability.
Lease expense is recognized on a straight-line basis over the lease term. The Company elected to keep leases with an initial term of 12
months or less off the balance sheet.
ROU assets are reviewed for impairment
when indicators of impairment are present. ROU assets from operating and finance leases are subject to the impairment guidance in ASC
360, Property, Plant, and Equipment, as ROU assets are long-lived nonfinancial assets. ROU assets are tested for impairment individually
or as part of an asset group if the cash flows related to the ROU assets are not independent from the cash flows of other assets
and liabilities. An asset group is the unit of accounting for long-lived assets to be held and used, which represents the lowest level
for which identifiable cash flows are largely independent of the cash flows of other groups of assets and liabilities.
Stock-Based Compensation
The Company accounts for its stock-based
awards granted under its employee compensation plan in accordance with ASC Topic No. 718-20, Awards Classified as Equity, which requires
the measurement of compensation expense for all share-based compensation granted to employees and non-employee directors at fair value
on the date of grant and recognition of compensation expense over the related service period for awards expected to vest. The Company
uses the Black-Scholes option pricing model to estimate the fair value of its stock options and warrants. The Black-Scholes option pricing
model requires the input of highly subjective assumptions including the expected stock price volatility of the Company’s common
stock, the risk free interest rate at the date of grant, the expected vesting term of the grant, expected dividends, and an assumption
related to forfeitures of such grants. Changes in these subjective input assumptions can materially affect the fair value estimate of
the Company’s stock options and warrants.
Income Taxes
The Company accounts for income taxes
using the asset and liability method in accordance with ASC Topic No. 740, Income Taxes. Under this method, deferred tax assets and liabilities
are determined based on differences between financial reporting and tax bases of assets and liabilities, and are measured using the enacted
tax rates and laws that are expected to be in effect when the differences are expected to reverse.
The Company applies
the provisions of ASC Topic No. 740 for the financial statement recognition, measurement and disclosure of uncertain tax positions recognized
in the Company’s financial statements. In accordance with this provision, tax positions must meet a more-likely-than-not recognition
threshold and measurement attribute for the financial statement recognition and measurement of a tax position.
Recent Accounting Pronouncements
We have reviewed other recent accounting
pronouncements and concluded they are either not applicable to the business, or no material effect is expected on the consolidated financial statements as a result of future adoption.
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v3.24.1.1.u2
Property and Equipment
|
3 Months Ended |
Mar. 31, 2024 |
Property, Plant and Equipment [Abstract] |
|
Property and Equipment |
Note 4 – Property and
Equipment
Property and equipment
are carried at cost and consist of the following at March 31, 2024 and December 31, 2023:
Schedule of property and equipment | |
| | |
| |
| |
2024 | | |
2023 | |
| |
| | |
| |
Office and computer equipment | |
$ | 17,394 | | |
$ | 17,394 | |
Furniture and fixtures | |
| 76,099 | | |
| 76,099 | |
Leasehold improvements | |
| 502,155 | | |
| 482,170 | |
Less: Accumulated depreciation | |
| (7,377 | ) | |
| (3,790 | ) |
Total | |
$ | 588,271 | | |
$ | 571,873 | |
Leasehold improvements
of $502,155 represent costs of the buildout of the leased laboratory in Iowa City, Iowa that was completed in January 2024.
Depreciation expense of $3,587 and
$0 was charged to operations for the three months ended March 31, 2024 and 2023, respectively.
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- DefinitionThe entire disclosure for long-lived, physical asset used in normal conduct of business and not intended for resale. Includes, but is not limited to, work of art, historical treasure, and similar asset classified as collections.
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v3.24.1.1.u2
Intangible Assets
|
3 Months Ended |
Mar. 31, 2024 |
Goodwill and Intangible Assets Disclosure [Abstract] |
|
Intangible Assets |
Note 5 – Intangible Assets
The following table provides
detail associated with the Company’s acquired identifiable intangible assets at March 31, 2024 and December 31, 2023:
Schedule of intangible assets | |
| | |
| |
| |
2024 | | |
2023 | |
| |
| | |
| |
Know-how license | |
$ | 80,000 | | |
$ | 80,000 | |
Less: Accumulated amortization | |
| (62,667 | ) | |
| (58,667 | ) |
Total | |
$ | 17,333 | | |
$ | 21,333 | |
Amortization expense charged
to operations was $4,000 for the three months ended March 31, 2024 and 2023, respectively.
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v3.24.1.1.u2
Patent Costs
|
3 Months Ended |
Mar. 31, 2024 |
Patent Costs |
|
Patent Costs |
Note 6 – Patent
Costs
As of March 31, 2024, in the
first family of patents and patent applications owned solely by UIRF and is exclusively licensed by Cardio, there are seven granted
patents (US of 2, EU, China, Australia, India and Hong Kong) and other pending patent applications. The Company has pending
patent applications in patent families two, three, four and five. Legal fees associated
with the patents totaled $564,565 and
$515,402, net of accumulated amortization
of $3,975
and $3,182
as of March 31, 2024 and December 31, 2023, respectively and are presented in the consolidated balance sheets as patent costs.
Amortization expense charged to operations was $793
and $785
for the three months ended March 31, 2024 and 2023, respectively.
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v3.24.1.1.u2
Operating Leases
|
3 Months Ended |
Mar. 31, 2024 |
Operating Leases |
|
Operating Leases |
Note 7 – Operating Leases
The Company determines if a contract
is, or contains, a lease at contract inception. Operating leases are included in operating lease right-of-use (“ROU”) assets,
current portion of operating lease liabilities and operating lease liabilities, net of current
portion in the Company’s consolidated balance sheets. Finance leases are included in property and equipment, current portion of
finance lease obligations and finance lease obligations, net of current portion in the Company’s consolidated balance sheets.
ROU assets represent the right to
use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease.
ROU assets and lease liabilities are recognized at the commencement date based on the present value of lease payments over the lease term.
In addition, ROU assets include initial direct costs incurred by the lessee as well as any
lease payments made at or before the commencement date and exclude lease incentives. The Company used the implicit rate in the lease in
determining the present value of lease payments. Lease terms include options to extend or terminate the lease when it is reasonably certain
that the Company will exercise that option. Leases with a term of one year or less are generally not included in ROU assets and corresponding
operating lease liabilities.
In 2023, the Company entered into
a lease agreement for office space in Chicago, Illinois, commencing on August 1, 2023 for a term of three years and four months and expiring
on November 30, 2026. The monthly rent for August to November 2023 was abated and the Company started to make monthly
rental installments from December 2023 of $12,847. The monthly rental payment increases by approximately 2% every August starting from
2024.
On
July 20, 2023, the Company entered into another lease agreement for laboratory facilities in Iowa City, Iowa, commencing on August 1,
2023 for a term of five years and four months and expiring on November 30, 2028. The monthly rent for August to November 2023 was abated
and the Company agreed to pay a monthly rent of $8,505 ($102,060 annually) commencing December 1, 2023. In addition, the landlord agreed
to provide the Company with a one-time Tenant Improvement Allowance (“TIA”) in the amount of up to, but not exceeding $50
per rentable square foot of the premises for a maximum allowance of $253,000.
Pursuant
to ASC Topic 842 Leases, the Company accounted for both leases as operating leases and accounted for the TIA as a lease incentive, which
was estimated to be payable on December 1, 2023. The Company received the TIA from landlord in maximum amount of $253,000 on January 16,
2024 and recorded a reimbursement receivable from landlord of $253,000 as of December 31, 2023, which was included in Prepaid expenses
and other current assets on the consolidated balance sheets.
During
the year ended December 31, 2023, the Company recorded ROU assets of $663,875 and operating lease liabilities of $642,523 at the lease
commencement date. The discount rate used to determine the present value is the incremental borrowing rate, estimated to be 4.57% for
the Chicago lease and 4.24% for the Iowa City lease, respectively, as the interest rate implicit in our lease is not readily determinable.
As
of March 31, 2024 and December 31,2023, operating lease ROU assets and operating lease liabilities are recorded on the consolidated
balance sheets as follows:
Schedule of operating lease ROU assets and operating lease liabilities | |
| |
|
|
|
| |
March 31, | |
|
December 31 |
| |
2024 | |
|
2023 |
Operating Lease: | |
| | |
|
|
|
Operating lease right-of-use assets, net | |
$ | 555,270 | |
|
$ |
575,227 |
Current portion of operating lease liabilities | |
$ | 227,203 | |
|
$ |
223,929 |
Operating lease liabilities, net of current portion | |
$ | 605,090 | |
|
$ |
663,099 |
As of March 31, 2024, the weighted-average
remaining lease terms of the two operating leases were 2.6
years and 4.6
years, respectively.
The
following table summarizes maturities of operating lease liabilities based on lease terms as of December 31:
Schedule of future minimum payments due | | |
| |
2024 (remaining period) | | |
$ | 193,452 | |
2025 | | |
| 260,611 | |
2026 | | |
| 250,152 | |
2027 | | |
| 102,060 | |
2028 | | |
| 93,555 | |
Total lease payments | | |
| 899,830 | |
Less: Imputed interest | | |
| 67,537 | |
Present value of lease liabilities | | |
$ | 832,293 | |
At March 31, 2024, the Company
had the following future minimum payments due under the non-cancelable lease:
| | |
| |
2024 (remaining period) | | |
$ | 193,452 | |
2025 | | |
| 260,611 | |
2026 | | |
| 250,152 | |
2027 | | |
| 102,060 | |
2028 | | |
| 93,555 | |
Total minimum lease payments | | |
$ | 899,830 | |
Consolidated rental expense for
all operating leases was $35,816 and $26,853 for the three months ended March 31, 2024 and 2023, respectively.
The
following table summarizes the cash paid and related right-of-use operating lease recognized for the three months ended March 31,
2024.
Schedule of cash paid and related right-of-use operating lease | |
| |
| |
Three Months Ended | |
| |
March
31, 2024 | |
Cash paid for amounts included in the measurement of lease liabilities: | |
| | |
Operating cash flows from operating leases | |
$ | 64,056 | |
Right-of-use lease assets obtained in the exchange for lease liabilities: | |
| | |
Operating leases | |
$ | 54,735 | |
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v3.24.1.1.u2
Finance Agreement Payable
|
3 Months Ended |
Mar. 31, 2024 |
Finance Agreement Payable |
|
Finance Agreement Payable |
Note 8 – Finance Agreement Payable
On October 25, 2023, the Company entered
into an agreement with a premium financing company to finance its Directors and Officers insurance premiums for 12-month policies effective
October 25, 2023. The amount financed of $467,500 is payable in 10 monthly installments plus interest at a rate of 8.95% through August
25, 2024. Finance agreement payable was $233,750 and $374,000 at March 31, 2024 and December 31, 2023, respectively. $449,041 has been
recorded in prepaid expenses and is being amortized over the life of the policy.
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v3.24.1.1.u2
Earnings (Loss) Per Common Share
|
3 Months Ended |
Mar. 31, 2024 |
Basic and fully diluted income (loss) per common share: |
|
Earnings (Loss) Per Common Share |
Note 9 - Earnings (Loss) Per Common
Share
The Company calculates net income
(loss) per common share in accordance with ASC 260 “Earnings Per Share” (“ASC 260”). Basic and diluted net earnings
(loss) per common share was determined by dividing net earnings (loss) applicable to common
stockholders by the weighted average number of common shares outstanding during the period. The Company’s potentially dilutive
shares, which include outstanding common stock options, common stock warrants, and convertible debt have not been included in the computation
of diluted net loss per share for the three months ended March 31, 2024 and 2023 as the result would be anti-dilutive.
Schedule of anti dilutive earning per share | |
| | |
| |
| |
Three Months
Ended | |
| |
March
31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Stock warrants | |
| 8,528,766 | | |
| 7,854,620 | |
Stock options | |
| 3,772,425 | | |
| 1,759,599 | |
Total shares excluded from calculation | |
| 12,301,191 | | |
| 9,614,219 | |
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v3.24.1.1.u2
Stockholders’ Equity
|
3 Months Ended |
Mar. 31, 2024 |
Equity [Abstract] |
|
Stockholders’ Equity |
Note 10 – Stockholders’ Equity
Stock Transactions
Pursuant to the Business
Combination Agreement on October 25, 2022, the Company issued the following securities:
Holders
of conversion rights issued as a component of units in Mana’s initial public offering (the “Public Rights”) were issued
an aggregate of 928,571 shares of the Company’s common stock;
Holders
of existing shares of common stock of Legacy Cardio and the holder of equity rights of Legacy Cardio (together, the “Legacy Cardio
Stockholders”) received an aggregate of 6,883,306 shares of the Company’s Common Stock, calculated based on the exchange ratio
of 3.427259 pursuant to the Merger Agreement (the “Exchange Ratio”) for each share of Legacy Cardio Common Stock held or,
in the case of the equity rights holder, that number of shares of the Company’s Common Stock equal to 1% of the Aggregate Closing
Merger Consideration, as defined in the Merger Agreement;
The
Legacy Cardio Stockholders received, in addition, an aggregate of 43,334 shares of the Company’s Common Stock (“Conversion
Shares”) upon conversion of an aggregate of $433,334 in principal amount of promissory notes issued by Mana to Legacy Cardio in
connection with its loan of such amount in order to extend Mana’s duration through October 26, 2022 (the “Extension Notes”),
which Conversion Shares were distributed to the Legacy Cardio Stockholders in proportion to their respective interest in Legacy Cardio.
Mana
public stockholders (excluding Mana Capital, LLC, the SPAC sponsor (the “Sponsor”), and Mana’s former officers and directors)
own 34,548 shares of the Company’s Common Stock and the Sponsor, Mana’s former officers and directors and certain permitted
transferees own 1,625,000 shares of the Company’s Common Stock.
Immediately
after giving effect to the Business Combination, there were 9,514,743 issued and outstanding shares of the Company’s Common Stock.
On
October 25, 2022, in connection with the approval of the Business Combination, the Company’s stockholders approved the Cardio Diagnostics
Holdings, Inc. 2022 Equity Incentive Plan (the “2022 Plan”). The purpose of the 2022 Plan is to promote the interests of the
Company and its stockholders by providing eligible employees, officers, directors and consultants with additional incentives to remain
with the Company and its subsidiaries, to increase their efforts to make the Company more successful, to reward such persons by providing
an opportunity to acquire shares of Common Stock on favorable terms and to attract and retain the best available personnel to participate
in the ongoing business operations of the Company. The 2022 Plan permits the grant of Incentive Stock Options, Nonstatutory Stock Options,
Restricted Stock, Restricted Stock Units, Stock Appreciation Rights, Performance Units and Performance Shares.
The
2022 Plan, as approved, permits the issuance of up to 3,265,516 shares of Common Stock (the “Share Reserve”) upon exercise
or conversion of grants and awards made from time to time to officers, directors, employees and consultants, however that the Share Reserve
will increase on January 1st of each calendar year and ending on and including January 1, 2027 (each, an “Evergreen Date”),
in an amount equal to the lesser of (i) 7% of the total number of shares of Common Stock outstanding on the December 31st immediately
preceding the applicable Evergreen Date and (ii) such lesser number of shares of Common Stock as determined to be appropriate by the Compensation
Committee, which administers the 2022 Plan, in its sole discretion. There was no increase in the Share Reserve on January 1, 2023. In
January 2024, the Compensation Committee approved an annual increase in the Share Reserve of 1,060,458 shares.
Common Stock Issued
Private Placement
In connection with a private offering memorandum
that the Company issued through a placement agent on January 23, 2024, the Company completed entering into subscription agreements with
7 accredited investors (the “Subscription Agreements”), whereby the Company issued a total of 561,793 units (“Units”),
with each Unit consisting of (i) one share of the Company’s common stock, $0.00001 par value (the “Common Stock”),
and (ii) one six year Common Stock purchase warrant (the “Warrants”), having an exercise price of $1.78 per share
(the “Private Placement”). The Private Placement resulted in the issuance to investors of 561,793 shares of Common
Stock and 561,793 Warrants. The purchase price of the securities was $1.78 per Unit, resulting in gross proceeds to the
Company of $1,000,000 and paid a fee of $100,000, before deducting placement agent fees (10% or $100,000) and other
offering expenses. The Company intends to use the net proceeds from the Private Placement for working capital and general corporate purposes.
The Private Placement closed on February 2, 2024.
In connection with the Private Placement, the
Company entered into a Placement Agent Agreement with Altitude Capital Group, LLC, as placement agent (“Altitude Capital”
or the “Placement Agent”). Pursuant to the Placement Agent Agreement, at closing, Altitude Capital was paid a cash commission
equal to 10% of the gross proceeds received by the Company, plus 20% warrant coverage, providing Altitude Capital with the right to purchase 112,353 shares
of Common Stock at $1.78 per share through February 2, 2030 (the “Placement Agent Warrants”).
At-the-Market Issuance
In
connection with an At-the-Market Issuance Sales Agreement (the “Sales Agreement”) that the Company issued through a placement
agent on January 26, 2024, the Company sold 487,083
common shares at various amounts per share to investors for gross proceeds totaling
$877,857
before deducting sales commissions of $21,947 to placement agent, during the three
months ended March 31, 2024. The Company also paid the placement agent a fee of $55,000.
Other Common Stock Issuance
During
the three months ended March 31, 2024, the Company issued 4,477
common shares to two consultants for services pursuant to vesting of Restricted Stock Units granted, valued at $8,000.
On
March 31, 2024, the Company issued 35,212 common shares to the board of directors for services pursuant to vesting of Restricted Stock
Units granted, valued at $50,000.
On
March 2, 2023, a shareholder exercised warrants in exchange for 100,000 common shares for proceeds of $390,000.
During the three months ended March
31, 2023, the Company issued 1,092 common shares to consultants for services pursuant to vesting of Restricted Stock Units granted,
valued at $4,000.
Warrants
On October 1, 2019, the Company issued
warrants to a seed funding firm equivalent to 2% of the fully-diluted equity of the Company, or 22,500 common shares at the time of issuance.
The warrant is exercisable on the earlier of the closing date of the next Qualified Equity Financing occurring after the issuance of the
warrant, and immediately before a Change of Control. The exercise price is the price per share of the shares sold to investors in the
next Qualified Equity Financing, or if the warrant becomes exercisable in connection with
a Change in Control before the next Qualified Equity Financing, the greater of the quotient obtained by dividing $150,000 by the Pre-financing
Capitalization, and the price per share paid by investors in the then-most recent Qualified Equity Financing, if any. The warrant will
expire upon the earlier of the consummation of any Change of Control, or 15 years after the issuance of the warrant.
In April 2022, the Company issued
fully vested warrants to investors as part of private placement subscription agreements pursuant to which the Company issued common
stock. Each shareholder received warrants to purchase 50% of the common stock issued at an exercise price of $3.90 per share with an expiration
date of June 30, 2027.
As of May 23, 2022, the Company issued
fully vested warrants to investors as part of an additional private placement subscription agreements pursuant to which the Company issued
common stock. Each shareholder received warrants to purchase 50% of the common stock issued at an exercise price of $6.21 per
share with an expiration date of five years from the date of issue.
All of the warrants issued by Legacy
Cardio were exchanged in the Business Combination for warrants of the Company based on the merger exchange ratio.
During the three months ended March 31, 2024, in connection with the
Private Placement as described above, the Company issued an aggregate of 674,146 warrants.
Warrant activity during the three
months ended March 31, 2024 and 2023 was as follows:
Schedule of warrant activity | |
| | |
| | |
| |
| |
| | |
| | |
| |
| |
Warrants
Outstanding | | |
Weighted
Average Exercise Price | | |
Weighted
Average Remaining Contractual Life (Years) | |
Warrants outstanding at December 31, 2022 | |
| 7,954,620 | | |
$ | 9.63 | | |
| 4.46 | |
Warrants exercised | |
| (100,000 | ) | |
| 3.90 | | |
| | |
Warrants outstanding at March 31, 2023 | |
| 7,854,620 | | |
$ | 9.70 | | |
| 4.22 | |
Warrants outstanding at December 31, 2023 | |
| 7,854,620 | | |
$ | 9.70 | | |
| 3.72 | |
Warrants granted | |
| 674,146 | | |
| 1.78 | | |
| | |
Warrants outstanding at March 31, 2024 | |
| 8,528,766 | | |
$ | 9.08 | | |
| 3.66 | |
Options
On May 6, 2022, Legacy Cardio granted
513,413
stock options to the management and advisors pursuant to the Cardio Diagnostics, Inc. 2022 Equity Incentive Plan. All of the options
granted under this legacy plan were exchanged for options under the Company’s 2022 Plan adopted by the Company’s stockholders
on October 25, 2022, and based on the exchange ratio for the merger, resulted in a total of 1,759,599
options issued upon closing. Each exchanged option has an exercise price of $3.90
per share with an expiration date of May
6, 2032. The exchanged options fully vested upon closing of the merger.
On January 23, 2024, the Company
authorized an additional 1,060,458 shares
to the Equity Incentive Plan Reserve (the “2022 Plan”) and granted 1,187,826 options
to management and employees, 1,166,826 of
which vested immediately with the remaining 21,000 options subject to 50% vesting
on June 30, 2024 and 100% vesting on December 31, 2024. Each option has
an exercise price of $2.11 per share with an expiration date of January 23, 2034. The vested 1,166,826 stock options were
valued at $2,461,404 at grant date based on the Black-Scholes Option Pricing model. The following assumptions were utilized in the Black-Scholes
valuation of vested stock options during the three months ended March 31, 2024, risk free interest rate of 5.22%, volatility of 228%,
and an exercise price of $2.11.
Option
activity during the three months ended March 31, 2024 and 2023 was as follows:
Schedule of option activity | |
| | |
| | |
| |
| |
Options Outstanding | | |
Weighted Average
Exercise Price | | |
Weighted
Average Remaining Contractual Life (Years) | |
Options outstanding at December 31, 2022 | |
| 1,759,599 | | |
$ | 3.90 | | |
| 9.35 | |
No option activity | |
| — | | |
| — | | |
| | |
Options outstanding at March 31, 2023 | |
| 1,759,599 | | |
$ | 3.90 | | |
| 9.10 | |
Options outstanding at December 31, 2023 | |
| 2,584,599 | | |
$ | 3.06 | | |
| 8.71 | |
Options granted | |
| 1,187,826 | | |
| 2.11 | | |
| | |
Options outstanding at March 31, 2024 | |
| 3,772,425 | | |
$ | 2.76 | | |
| 8.89 | |
Options vested and exercisable at March 31, 2024 | |
| 3,751,425 | | |
$ | 2.76 | | |
| | |
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v3.24.1.1.u2
Convertible Notes Payable
|
3 Months Ended |
Mar. 31, 2024 |
Debt Disclosure [Abstract] |
|
Convertible Notes Payable |
Note 11 – Convertible Notes Payable
On
March 8, 2023, the Company entered into a securities purchase agreement (“Securities Purchase Agreement”) with YA II PN,
Ltd., an investment fund managed by Yorkville Advisors Global, LP (“Yorkville”) under which the Company agreed to sell and
issue to Yorkville convertible debentures (“Convertible Debentures”) in a gross aggregate principal amount of up to $11.2
million (“Subscription Amount”). The Convertible Debentures were convertible into shares of common stock of the Company and
were subject to various contingencies being satisfied as set forth in the Securities Purchase Agreement. The notes were convertible at
any time through the maturity date, which, in each case, was one year from the date of issuance. The conversion price would be determined
on the basis of 92% of the two lowest VWAP (Volume Weighted Average Prices) of the Common Stock during the prior seven trading day period,
initially with a floor conversion price of $0.55, but subsequently lowered by mutual agreement of the parties to $0.20.
On
March 8, 2023, the Company issued and sold to Yorkville a Convertible Debenture in the principal amount of $5.0 million, for which it
received $4.5 million, with a $500,000 original issue discount (“OID”). Interest on the outstanding principal balance accrued
at a rate of 0% and would increase to 15% upon an Event of Default for so long as it remained uncured.
The
Company recorded a debt discount related to identified embedded derivatives relating to the conversion features (see Note 12) based on
fair values as of the inception date of the Note. The calculated debt discount, including the OID equaled the face of the Note and is
being amortized over the term of the note.
Yorkville
fully converted the initial $5,000,000 Convertible Debenture into an aggregate of 10,622,119 common shares during the year ended December
31, 2023./
On
January 4, 2024, the Company and Yorkville terminated the Securities Purchase Agreement dated as of March 8, 2023, as amended, by the
mutual consent of the parties, effective as of January 4, 2024. The First Convertible Debenture has been fully converted, and as of January
4, 2024, the obligation of the Company to issue and sell, and Yorkville’s obligation to purchase, the Second Convertible Debenture
has been terminated. At the time of termination, there were no outstanding borrowings, advance notices or shares of Common Stock to be
issued under the Securities Purchase Agreement. In addition, there were no fees due by the Company or Yorkville in connection with the
termination of the Securities Purchase Agreement.
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v3.24.1.1.u2
Derivative Liability
|
3 Months Ended |
Mar. 31, 2024 |
Derivative Liability |
|
Derivative Liability |
Note 12 – Derivative Liability
The
Company has determined that the conversion feature embedded in the convertible notes described in Note 11 contain a potential variable
conversion amount which constitutes a derivative which has been bifurcated from the note and recorded as a derivative liability at fair
value, with a corresponding discount recorded to the associated debt. The excess of the derivative value over the face amount of the note
is recorded immediately to interest expense at inception, which aggregated $4,692,672. The Company used the Binomial Black-Scholes Option
Pricing model to value the conversion features.
The
Company used Level 3 inputs for its valuation methodology for the conversion option liability in determining the fair value using a Black-Scholes
option-pricing model with the following assumption inputs:
Schedule of option liability | |
| |
| |
| Three
Months Ended March 31, 2023 | |
Annual dividend yield | |
| — | |
Expected life (years) | |
| 1.0 | |
Risk-free interest rate | |
| 4.89% - 5.28% | |
Expected volatility | |
| 164% - 169% | |
Exercise price | |
| $2.20 - $3.53 | |
Stock price | |
| $3.91 - $5.32 | |
Based upon ASC 840-15-25
(EITF Issue 00-19, paragraph 11) the Company has adopted a sequencing approach regarding the application of ASC 815-40 to its outstanding
convertible notes. Pursuant to the sequencing approach, the Company evaluates its contracts based upon earliest issuance date.
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v3.24.1.1.u2
Commitments and Contingencies
|
3 Months Ended |
Mar. 31, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
Note 13 – Commitments and Contingencies
Prior Relationship of Cardio with
Boustead Securities, LLC
At
the commencement of efforts to pursue what ultimately ended in a terminated business acquisition, Legacy Cardio entered into a Placement
Agent and Advisory Services Agreement (the “Placement Agent Agreement”), dated April 12, 2021, with Boustead Securities, LLC
("Boustead Securities”). This agreement was terminated in April 2022, when Legacy Cardio terminated the underlying agreement
and plan of merger and the accompanying escrow agreement relating to that proposed business acquisition after efforts to complete the
transaction failed, despite several extensions of the closing deadline.
Under
the terminated Placement Agent Agreement, Legacy Cardio agreed to certain future rights in favor of Boustead Securities, including (i)
a two-year tail period during which Boustead Securities would be entitled to compensation if Cardio were to close on a transaction (as
defined in the Placement Agent Agreement) with any party that was introduced to Legacy Cardio by Boustead Securities; and (ii) a right
of first refusal to act as the Company’s exclusive placement agent for 24-months from the end of the term of the Placement Agent
Agreement (the “right of first refusal”). Cardio has taken the position that due to Boustead Securities’ failure to
perform as contemplated by the Placement Agent Agreement, these provisions purporting to provide future rights are null and void.
Boustead
Securities responded to the termination of the Placement Agent Agreement by disputing Legacy Cardio’s contention that it had not
performed under the Placement Agent Agreement because, among other things, Boustead Securities had never sought out prospective investors.
In its response, Boustead Securities included a list of funds that they had supposedly contacted on Legacy Cardio’s behalf. While
Boustead Securities’ contention appears to contradict earlier communications from Boustead Securities in which they indicated that
they had not made any such contacts or introductions, Boustead Securities is currently contending that they are due success fees for two
years following the termination of the Placement Agent Agreement on any transaction with any person on the list of supposed contacts or
introductions. Legacy Cardio strongly disputes this position. Notwithstanding the foregoing, the Company has not consummated any transaction,
as defined, with any potential party that purportedly was a contact of Boustead Securities in connection with the Placement Agent Agreement
and has no plans to do so at any time during the tail period. No legal proceedings have been instigated by either party, and Cardio believes
that the final outcome will not have a material adverse impact on its financial condition.
The Benchmark Company, LLC Right
of First Refusal
As
noted in Note 1, the Company completed the business combination on October 25, 2022. In connection with the proposed business combination,
by agreement dated May 13, 2022, Mana engaged The Benchmark Company, LLC (“Benchmark”) as its M&A advisor. Upon closing
of the business combination, Legacy Cardio assumed the contractual engagement entered into by Mana. On November 14, 2022, the Company
and Benchmark entered into Amendment No. 1 Engagement Letter (the “Amendment Engagement”). Pursuant to the Amendment Engagement,
the parties agreed that the Company would pay Benchmark $230,000 at the closing of the business combination and an additional $435,000
on October 25, 2023. Both of those payments have been made in full. In addition, the Amendment Engagement provided that Benchmark has
been granted a right of first refusal to act as lead or joint-lead investment banker, lead or joint-lead book-runner and/or lead or joint-lead
placement agent for all future public and private equity and debt offerings through October 25, 2023. Based on the right of first refusal,
Benchmark alleges that it is owed damages because the Company entered into the Yorkville Convertible Debenture Transaction (see Note 11)
without first offering Benchmark the right to serve as the lead or joint-lead placement agent for the transaction. The Company is evaluating
the claim. No legal proceedings have been instigated.
Demand Letter and Potential Mootness
Fee Claim
On June
25, 2022, a plaintiffs’ securities law firm sent a demand letter to the Company alleging that the Company’s Registration Statement
on Form S-4 filed (the “S-4 Registration Statement”) with the Securities and Exchange Commission (“SEC”) on May
31, 2022 omitted material information with respect to the Business Combination and demanding that the Company and its Board of Directors
immediately provide corrective disclosures in an amendment or supplement to the Registration Statement. Subsequent thereto, the Company
filed amendments to the S-4 Registration Statement on July 27, 2022, August 23, 2022, September 15, 2022, October 4, 2022 and October
5, 2022 in which it responded to various comments of the SEC staff and otherwise updated its disclosure. In October 2022, the SEC completed
its review and declared the S-4 registration statement on October 6, 2022. On February 23, 2023 and February 27, 2023, plaintiffs’
securities law firm contacted the Company’s counsel asking who will be negotiating a mootness fee relating to the purported claims
set forth in the June 25, 2022 demand letter. The Company vigorously denies that the S-4 Registration Statement, as amended and declared
effective, is deficient in any respect and that no additional supplemental disclosures are material or required. The Company believes
that the claims asserted in the Demand Letter are without merit and that no further disclosure is required to supplement the S-4 Registration
Statement under applicable laws. As of the date of filing of this Annual Report on Form 10-K, no lawsuit has been filed against the Company
by that firm. The firm has indicated its willingness to litigate the matter if a mutually satisfactory resolution cannot be agreed upon;
however, Cardio believes that the final outcome will not have a material adverse impact on its financial condition.
Northland Securities, Inc.
In
January 2024, following the Company’s termination of its agreement with Yorkville and in connection with the Company’s recent
at the market offering and/or its February 2024 private placement, a managing director of Northland Securities, Inc. (“Northland”)
contacted the Company claiming the right to be paid a fee of approximately $150,000 pursuant to the agreement of March 1, 2023 between
the Company and Northland regarding the Yorkville financing. Subsequently, the Company has been advised by another representative of Northland
that Northland would not proceed with any such claim. The Company does not believe that it owes Northland any sum based on the termination
of the Yorkville Securities Purchase Agreement and the subsequent financing transactions.
The
Company cannot preclude the possibility that claims or lawsuits brought relating to any alleged securities law violations or breaches
of fiduciary duty could potentially require significant time and resources to defend and/or settle and distract its management and board
of directors from focusing on its business.
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v3.24.1.1.u2
Subsequent Events
|
3 Months Ended |
Mar. 31, 2024 |
Subsequent Events |
|
Subsequent Events |
Note 14 – Subsequent Events
The Company
evaluated its March 31, 2024 consolidated financial statements for subsequent events through the date the consolidated financial
statements were issued.
Common Stock Issued
Subsequent
to March 31, 2024, the Company sold 1,056,615
common shares for gross proceeds totaling $895,941
under the At-the-Market Issuance Sales Agreement as of the date of this Report.
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v3.24.1.1.u2
Summary of Significant Accounting Policies (Policies)
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Principles of Consolidation |
Principles of Consolidation
The consolidated financial statements
include the accounts of the Company and its wholly-owned subsidiary, Legacy Cardio. All intercompany accounts and transactions
have been eliminated.
|
Use of Estimates in the Preparation of Financial Statements |
Use of Estimates in the Preparation of Financial Statements
The preparation of financial statements
in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements
and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates.
|
Fair Value Measurements |
Fair Value Measurements
The
Company adopted the provisions of ASC Topic 820, Fair Value Measurements and Disclosures, which defines fair value as used in numerous
accounting pronouncements, establishes a framework for measuring fair value and expands disclosure of fair value measurements.
The
estimated fair value of certain financial instruments, including cash and cash equivalents, accounts payable and accrued expenses are
carried at historical cost basis, which approximates their fair values because of the short-term nature of these instruments. The carrying
amounts of our short- and long-term credit obligations approximate fair value because the effective yields on these obligations, which
include contractual interest rates taken together with other features such as concurrent issuances of warrants and/or embedded conversion
options, are comparable to rates of returns for instruments of similar credit risk.
ASC
820 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the
principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement
date. ASC 820 also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize
the use of unobservable inputs when measuring fair value. ASC 820 describes three levels of inputs that may be used to measure fair value:
Level 1 – quoted prices
in active markets for identical assets or liabilities
Level 2 – quoted prices
for similar assets and liabilities in active markets or inputs that are observable
Level 3 – inputs that
are unobservable (for example cash flow modeling inputs based on assumptions)
The
estimated fair value of the derivative liability was calculated using the Black-Scholes option pricing model. The Company uses Level 3
inputs to value its derivative liabilities. The following table provides a reconciliation of the beginning and ending balances for the
major classes of assets and liabilities measured at fair value using significant unobservable inputs (Level 3) and reflects gains and
losses for the three months ended March 31, 2024 and 2023.
Schedule of fair value measurements | |
| | | |
| | |
| |
2024 | | |
2023 | |
Liabilities: | |
| | |
| |
Balance of derivative liabilities - beginning of period | |
$ |
— | | |
$ |
— | |
Issued | |
| — | | |
| 9,192,672 | |
Converted | |
| — | | |
| — | |
Change in fair value recognized in operations | |
| — | | |
| (5,686,901 | ) |
Balance of derivative liabilities - end of period | |
$ | — | | |
$ | 3,505,771 | |
The following table represents
the Company’s derivative instruments that are measured at fair value on a recurring basis as of March 31, 2024, for each fair value
hierarchy level:
Schedule of fair value hierarchy level | |
| | | |
| | |
March 31, 2024 | |
| Derivative
Liabilities | | |
| Total |
Level I | |
$ | — | | |
$ | — | |
Level II | |
$ | — | | |
$ | — | |
Level III | |
$ | — | | |
$ | — | |
|
Convertible Instruments |
Convertible Instruments
The
Company evaluates and accounts for conversion options embedded in convertible instruments in accordance with ASC 815, Derivatives and
Hedging Activities.
Applicable
GAAP requires companies to bifurcate conversion options from their host instruments and account for them as free standing derivative financial
instruments according to certain criteria. The criteria include circumstances in which (a) the economic characteristics and risks of the
embedded derivative instrument are not clearly and closely related to the economic characteristics and risks of the host contract, (b)
the hybrid instrument that embodies both the embedded derivative instrument and the host contract is not re-measured at fair value under
other GAAP with changes in fair value reported in earnings as they occur and (c) a separate instrument with the same terms as the embedded
derivative instrument would be considered a derivative instrument.
The
Company accounts for convertible instruments (when it has been determined that the embedded conversion options should not be bifurcated
from their host instruments) as follows: The Company records, when necessary, discounts to convertible notes for the intrinsic value of
conversion options embedded in debt instruments based upon the differences between the fair value of the underlying common stock at the
commitment date of the note transaction and the effective conversion price embedded in the note. Debt discounts under these arrangements
are amortized over the term of the related debt to their stated date of redemption.
The
Company accounts for the conversion of convertible debt when a conversion option has been bifurcated using the general extinguishment
standards. The debt and equity linked derivatives are removed at their carrying amounts and the shares issued are measured at their then-current
fair value, with any difference recorded as a gain or loss on extinguishment of the two separate accounting liabilities.
|
Revenue Recognition |
Revenue Recognition
The Company offers its
products, Epi+Gen CHD™ and PrecisionCHD™ via telemedicine providers, provider organizations such as concierge practices, longevity
clinics, and risk-bearing provider organizations, and employer organizations. The Company is continuing to expand its markets and payment
optionality, and therefore, other organization types not listed below may be added, and from time-to-time, there may be additional payment
options.
For telemedicine, the telemedicine
provider collects payments from patients upon completion of eligibility screening and test order. Patients then send their samples to
the lab for biomarker assessments. The Company performs all quality control, analytical assessments and report generation and shares test
reports with the ordering healthcare provider. Revenue is recognized upon invoicing the telemedicine providers. Telemedicine providers
are invoiced at the end of each month for all tests completed since prior invoicing.
For provider organizations, the
cost of each test is negotiated prior to testing commencing. Pricing is determined based largely on the provider organization type and
testing volume commitment. Upon ordering a test, a patient’s sample is sent to the lab for biomarker assessments. The Company performs
all quality control, analytical assessments and report generation and shares test reports with the ordering healthcare provider. Revenue
is recognized upon invoicing the provider organization. The provider organization is invoiced the agreed upon pricing at the end of each
month for all samples accepted or tests completed since prior invoicing.
For employer organizations, the
cost of each test is negotiated prior to testing commencing. Pricing is determined based largely on testing volume commitment. Patient
samples are sent to the lab for biomarker assessments. The Company performs all quality control, analytical assessments and report generation
and shares test reports with the ordering healthcare provider. Revenue is recognized upon invoicing the employer organization. The employer
organization is invoiced the agreed upon pricing once a heart disease fair is completed or all testing is completed.
The
Company accounts for revenue under Accounting Standards Update (“ASU”) 2014-09, “Revenue from Contracts with Customers
(Topic 606)”, using the modified retrospective method. The modified retrospective adoption used by the Company did not result in
a material cumulative effect adjustment to the opening balance of accumulated deficit.
The Company determines the measurement of revenue and the timing
of revenue recognition utilizing the following core principles:
1. Identifying the contract with a customer;
2. Identifying the performance obligations in the contract;
3. Determining the transaction price;
4. Allocating the transaction price to the performance obligations
in the contract; and
5. Recognizing revenue when (or as) the Company satisfies its
performance obligations.
|
Research and Development |
Research and Development
Research
and development costs are expensed as incurred. Research and development costs charged to operations for the three months ended March
31, 2024 and 2023 were $10,840 and $86,665, respectively.
|
Advertising Costs |
Advertising Costs
The Company
expenses advertising costs as incurred. Advertising costs of $34,402 and $49,551 were charged to operations for the three months ended
March 31, 2024 and 2023, respectively.
|
Cash and Cash Equivalents |
Cash and Cash Equivalents
Cash
and cash equivalents are comprised of cash and highly liquid investments with original maturities of 90 days or less at the date of purchase.
The Company does not have any cash equivalents as of March 31, 2024 and December 31, 2023. Cash is maintained at a major financial institution.
Accounts held at U.S. financial institutions are insured by the FDIC up to $250,000. The Company is exposed to credit risk in the event
of default by the financial institutions or the issuers of these investments to the extent the amounts on deposit or invested are in excess
of amounts that are insured.
|
Property and Equipment and Depreciation |
Property and Equipment
and Depreciation
Property
and equipment are stated at cost. Maintenance and repairs are charged to expense when incurred. When property and equipment are
retired or otherwise disposed of, the related cost and accumulated depreciation are removed from the respective accounts and any gain
or loss is credited or charged to income. Depreciation for both financial reporting and income tax purposes is computed using combinations
of the straight line and accelerated methods over the estimated lives of the respective assets as follows:
Schedule of estimated lives |
|
Office and computer equipment |
5 years |
Furniture
and fixtures |
7 years |
Leasehold improvements |
7 years |
|
Intangible Assets |
Intangible Assets
Intangible assets are acquired individually
or as part of a group of assets, and are initially recorded at cost. The cost of a group of assets acquired in a transaction is allocated
to the individual assets based on their relative fair values. Intangible assets are carried at cost less accumulated amortization and
any recorded impairment. Intangible assets with finite useful lives are amortized using a straight-line method over the period of estimated
useful life. The estimated useful life of the Company’s intangible assets (Know-how license) is 5 years. The Company evaluates intangible
assets for impairment whenever events or changes in circumstances indicate that the assets might be impaired.
|
Patent Costs |
Patent Costs
The Company accounts for patents
in accordance with ASC 350-30, General Intangibles Other than Goodwill. The Company capitalizes patent costs representing legal
fees associated with filing patent applications and amortize them on a straight-line basis. The Company evaluates its patents’
estimated useful life and begins amortizing the patents when they are brought to the market or otherwise commercialized.
|
Impairment of Long-Lived Assets |
Impairment of Long-Lived
Assets
In accordance with ASC 360-10-35,
the Company assesses the valuation of components of its long-lived assets whenever events or circumstances dictate that the carrying value
might not be recoverable. The Company bases its evaluation on indicators such as the nature of the assets, the future economic benefit
of the assets, any historical or future profitability measurements and other external market conditions or factors
that may be present. If such factors indicate that the carrying amount of an asset or asset group may not be recoverable, the Company
determines whether an impairment has occurred by analyzing an estimate of undiscounted future cash flows at the lowest level for which
identifiable cash flows exist. If the estimate of undiscounted cash flows during the estimated useful life of the asset is less than the
carrying value of the asset, the Company recognizes a loss for the difference between the carrying value of the asset and its estimated
fair value, generally measured by the present value of the estimated cash flows.
|
Leases |
Leases
The Company accounts for leases under
ASC 842, “Leases”. The Company determines if an arrangement is a lease or contains a lease at inception of the arrangement.
Operating lease liabilities are recognized based on the present value of the remaining lease payments, discounted using the
discount rate for the lease at the commencement date. As the rate implicit in the lease is not readily determinable for the operating
lease, the Company generally uses an incremental borrowing rate based on information available at the commencement date to determine the
present value of future lease payments. Operating lease right-of-use assets (“ROU assets”) represent the Company’s right
to control the use of an identified asset for the lease term and lease liabilities represent the Company’s obligation to make lease
payments arising from the lease. ROU assets are generally recognized based on the amount of the initial measurement of the lease liability.
Lease expense is recognized on a straight-line basis over the lease term. The Company elected to keep leases with an initial term of 12
months or less off the balance sheet.
ROU assets are reviewed for impairment
when indicators of impairment are present. ROU assets from operating and finance leases are subject to the impairment guidance in ASC
360, Property, Plant, and Equipment, as ROU assets are long-lived nonfinancial assets. ROU assets are tested for impairment individually
or as part of an asset group if the cash flows related to the ROU assets are not independent from the cash flows of other assets
and liabilities. An asset group is the unit of accounting for long-lived assets to be held and used, which represents the lowest level
for which identifiable cash flows are largely independent of the cash flows of other groups of assets and liabilities.
|
Stock-Based Compensation |
Stock-Based Compensation
The Company accounts for its stock-based
awards granted under its employee compensation plan in accordance with ASC Topic No. 718-20, Awards Classified as Equity, which requires
the measurement of compensation expense for all share-based compensation granted to employees and non-employee directors at fair value
on the date of grant and recognition of compensation expense over the related service period for awards expected to vest. The Company
uses the Black-Scholes option pricing model to estimate the fair value of its stock options and warrants. The Black-Scholes option pricing
model requires the input of highly subjective assumptions including the expected stock price volatility of the Company’s common
stock, the risk free interest rate at the date of grant, the expected vesting term of the grant, expected dividends, and an assumption
related to forfeitures of such grants. Changes in these subjective input assumptions can materially affect the fair value estimate of
the Company’s stock options and warrants.
|
Income Taxes |
Income Taxes
The Company accounts for income taxes
using the asset and liability method in accordance with ASC Topic No. 740, Income Taxes. Under this method, deferred tax assets and liabilities
are determined based on differences between financial reporting and tax bases of assets and liabilities, and are measured using the enacted
tax rates and laws that are expected to be in effect when the differences are expected to reverse.
The Company applies
the provisions of ASC Topic No. 740 for the financial statement recognition, measurement and disclosure of uncertain tax positions recognized
in the Company’s financial statements. In accordance with this provision, tax positions must meet a more-likely-than-not recognition
threshold and measurement attribute for the financial statement recognition and measurement of a tax position.
|
Recent Accounting Pronouncements |
Recent Accounting Pronouncements
We have reviewed other recent accounting
pronouncements and concluded they are either not applicable to the business, or no material effect is expected on the consolidated financial statements as a result of future adoption.
|
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v3.24.1.1.u2
Summary of Significant Accounting Policies (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Accounting Policies [Abstract] |
|
Schedule of fair value measurements |
Schedule of fair value measurements | |
| | | |
| | |
| |
2024 | | |
2023 | |
Liabilities: | |
| | |
| |
Balance of derivative liabilities - beginning of period | |
$ |
— | | |
$ |
— | |
Issued | |
| — | | |
| 9,192,672 | |
Converted | |
| — | | |
| — | |
Change in fair value recognized in operations | |
| — | | |
| (5,686,901 | ) |
Balance of derivative liabilities - end of period | |
$ | — | | |
$ | 3,505,771 | |
|
Schedule of fair value hierarchy level |
Schedule of fair value hierarchy level | |
| | | |
| | |
March 31, 2024 | |
| Derivative
Liabilities | | |
| Total |
Level I | |
$ | — | | |
$ | — | |
Level II | |
$ | — | | |
$ | — | |
Level III | |
$ | — | | |
$ | — | |
|
Schedule of estimated lives |
Schedule of estimated lives |
|
Office and computer equipment |
5 years |
Furniture
and fixtures |
7 years |
Leasehold improvements |
7 years |
|
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v3.24.1.1.u2
Property and Equipment (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Property, Plant and Equipment [Abstract] |
|
Schedule of property and equipment |
Schedule of property and equipment | |
| | |
| |
| |
2024 | | |
2023 | |
| |
| | |
| |
Office and computer equipment | |
$ | 17,394 | | |
$ | 17,394 | |
Furniture and fixtures | |
| 76,099 | | |
| 76,099 | |
Leasehold improvements | |
| 502,155 | | |
| 482,170 | |
Less: Accumulated depreciation | |
| (7,377 | ) | |
| (3,790 | ) |
Total | |
$ | 588,271 | | |
$ | 571,873 | |
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- DefinitionTabular disclosure of physical assets used in the normal conduct of business and not intended for resale. Includes, but is not limited to, balances by class of assets, depreciation and depletion expense and method used, including composite depreciation, and accumulated deprecation.
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v3.24.1.1.u2
Operating Leases (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Operating Leases |
|
Schedule of operating lease ROU assets and operating lease liabilities |
Schedule of operating lease ROU assets and operating lease liabilities | |
| |
|
|
|
| |
March 31, | |
|
December 31 |
| |
2024 | |
|
2023 |
Operating Lease: | |
| | |
|
|
|
Operating lease right-of-use assets, net | |
$ | 555,270 | |
|
$ |
575,227 |
Current portion of operating lease liabilities | |
$ | 227,203 | |
|
$ |
223,929 |
Operating lease liabilities, net of current portion | |
$ | 605,090 | |
|
$ |
663,099 |
|
Schedule of future minimum payments due |
Schedule of future minimum payments due | | |
| |
2024 (remaining period) | | |
$ | 193,452 | |
2025 | | |
| 260,611 | |
2026 | | |
| 250,152 | |
2027 | | |
| 102,060 | |
2028 | | |
| 93,555 | |
Total lease payments | | |
| 899,830 | |
Less: Imputed interest | | |
| 67,537 | |
Present value of lease liabilities | | |
$ | 832,293 | |
At March 31, 2024, the Company
had the following future minimum payments due under the non-cancelable lease:
| | |
| |
2024 (remaining period) | | |
$ | 193,452 | |
2025 | | |
| 260,611 | |
2026 | | |
| 250,152 | |
2027 | | |
| 102,060 | |
2028 | | |
| 93,555 | |
Total minimum lease payments | | |
$ | 899,830 | |
|
Schedule of cash paid and related right-of-use operating lease |
Schedule of cash paid and related right-of-use operating lease | |
| |
| |
Three Months Ended | |
| |
March
31, 2024 | |
Cash paid for amounts included in the measurement of lease liabilities: | |
| | |
Operating cash flows from operating leases | |
$ | 64,056 | |
Right-of-use lease assets obtained in the exchange for lease liabilities: | |
| | |
Operating leases | |
$ | 54,735 | |
|
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v3.24.1.1.u2
Earnings (Loss) Per Common Share (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Basic and fully diluted income (loss) per common share: |
|
Schedule of anti dilutive earning per share |
Schedule of anti dilutive earning per share | |
| | |
| |
| |
Three Months
Ended | |
| |
March
31, | |
| |
2024 | | |
2023 | |
| |
| | |
| |
Stock warrants | |
| 8,528,766 | | |
| 7,854,620 | |
Stock options | |
| 3,772,425 | | |
| 1,759,599 | |
Total shares excluded from calculation | |
| 12,301,191 | | |
| 9,614,219 | |
|
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v3.24.1.1.u2
Stockholders’ Equity (Tables)
|
3 Months Ended |
Mar. 31, 2024 |
Equity [Abstract] |
|
Schedule of warrant activity |
Schedule of warrant activity | |
| | |
| | |
| |
| |
| | |
| | |
| |
| |
Warrants
Outstanding | | |
Weighted
Average Exercise Price | | |
Weighted
Average Remaining Contractual Life (Years) | |
Warrants outstanding at December 31, 2022 | |
| 7,954,620 | | |
$ | 9.63 | | |
| 4.46 | |
Warrants exercised | |
| (100,000 | ) | |
| 3.90 | | |
| | |
Warrants outstanding at March 31, 2023 | |
| 7,854,620 | | |
$ | 9.70 | | |
| 4.22 | |
Warrants outstanding at December 31, 2023 | |
| 7,854,620 | | |
$ | 9.70 | | |
| 3.72 | |
Warrants granted | |
| 674,146 | | |
| 1.78 | | |
| | |
Warrants outstanding at March 31, 2024 | |
| 8,528,766 | | |
$ | 9.08 | | |
| 3.66 | |
|
Schedule of option activity |
Schedule of option activity | |
| | |
| | |
| |
| |
Options Outstanding | | |
Weighted Average
Exercise Price | | |
Weighted
Average Remaining Contractual Life (Years) | |
Options outstanding at December 31, 2022 | |
| 1,759,599 | | |
$ | 3.90 | | |
| 9.35 | |
No option activity | |
| — | | |
| — | | |
| | |
Options outstanding at March 31, 2023 | |
| 1,759,599 | | |
$ | 3.90 | | |
| 9.10 | |
Options outstanding at December 31, 2023 | |
| 2,584,599 | | |
$ | 3.06 | | |
| 8.71 | |
Options granted | |
| 1,187,826 | | |
| 2.11 | | |
| | |
Options outstanding at March 31, 2024 | |
| 3,772,425 | | |
$ | 2.76 | | |
| 8.89 | |
Options vested and exercisable at March 31, 2024 | |
| 3,751,425 | | |
$ | 2.76 | | |
| | |
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|
3 Months Ended |
Mar. 31, 2024 |
Derivative Liability |
|
Schedule of option liability |
Schedule of option liability | |
| |
| |
| Three
Months Ended March 31, 2023 | |
Annual dividend yield | |
| — | |
Expected life (years) | |
| 1.0 | |
Risk-free interest rate | |
| 4.89% - 5.28% | |
Expected volatility | |
| 164% - 169% | |
Exercise price | |
| $2.20 - $3.53 | |
Stock price | |
| $3.91 - $5.32 | |
|
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v3.24.1.1.u2
Organization and Basis of Presentation (Details Narrative) - USD ($)
|
3 Months Ended |
|
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
|
|
Net loss |
$ 4,163,584
|
$ 1,032,618
|
|
Accumulated deficit |
$ 18,531,964
|
|
$ 14,368,380
|
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v3.24.1.1.u2
Merger Agreement and Reverse Recapitalization (Details Narrative) - USD ($)
|
1 Months Ended |
3 Months Ended |
|
|
Mar. 22, 2023 |
Mar. 31, 2024 |
Oct. 24, 2023 |
Mar. 27, 2023 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Liabilities assumed |
$ 854,475
|
|
|
|
Early payment discount |
$ 74,025
|
|
|
|
Loans payable |
|
|
|
$ 419,475
|
Post-merger liabilities balance |
|
|
$ 435,000
|
|
Stock redeemed shares |
|
6,465,452
|
|
|
Redemption percentage |
|
99.50%
|
|
|
Redemption price per shre |
|
$ 10.10
|
|
|
Redemption amount |
|
$ 65,310,892
|
|
|
Reverse recapitalization shares |
|
1,976,749
|
|
|
Common shares reversed |
|
9,514,743
|
|
|
Recapitalization cost |
|
$ 1,535,035
|
|
|
Two Investment Bankers [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Liabilities assumed payable |
|
928,500
|
|
|
Merger Agreement [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Cash Acquired from Acquisition |
|
4,021
|
|
|
Liabilities assumed |
|
$ 928,500
|
|
|
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v3.24.1.1.u2
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|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Platform Operator, Crypto Asset [Line Items] |
|
|
Balance of derivative liabilities - beginning of period |
|
|
Issued |
|
9,192,672
|
Converted |
|
|
Change in fair value recognized in operations |
|
(5,686,901)
|
Balance of derivative liabilities - end of period |
|
$ 3,505,771
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|
Mar. 31, 2024
USD ($)
|
Fair Value, Inputs, Level 1 [Member] |
|
Platform Operator, Crypto Asset [Line Items] |
|
Derivative liabilities |
|
Fair Value, Inputs, Level 1 [Member] | Derivative Financial Instruments, Liabilities [Member] |
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Property and Equipment (Details) - USD ($)
|
Mar. 31, 2024 |
Dec. 31, 2023 |
Property, Plant and Equipment [Abstract] |
|
|
Office and computer equipment |
$ 17,394
|
$ 17,394
|
Furniture and fixtures |
76,099
|
76,099
|
Leasehold improvements |
502,155
|
482,170
|
Less: Accumulated depreciation |
(7,377)
|
(3,790)
|
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$ 588,271
|
$ 571,873
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v3.24.1.1.u2
Operating Leases (Details) - USD ($)
|
Dec. 31, 2024 |
Mar. 31, 2024 |
Dec. 31, 2023 |
Aug. 01, 2023 |
Operating Lease: |
|
|
|
|
Operating lease right-of-use assets, net |
$ 575,227
|
$ 555,270
|
$ 575,227
|
$ 663,875
|
Current portion of operating lease liabilities |
223,929
|
227,203
|
$ 223,929
|
|
Operating lease liabilities, net of current portion |
$ 663,099
|
$ 605,090
|
|
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v3.24.1.1.u2
Operating Leases (Details1) - USD ($)
|
Mar. 31, 2024 |
Aug. 01, 2023 |
Operating Leases |
|
|
2024 (remaining period) |
$ 193,452
|
|
2025 |
260,611
|
|
2026 |
250,152
|
|
2027 |
102,060
|
|
2028 |
93,555
|
|
Total minimum lease payments |
899,830
|
|
Less: Imputed interest |
67,537
|
|
Present value of lease liabilities |
$ 832,293
|
$ 642,523
|
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v3.24.1.1.u2
Operating Leases (Details Narrative) - USD ($)
|
3 Months Ended |
4 Months Ended |
|
|
|
|
Mar. 31, 2024 |
Mar. 31, 2023 |
Nov. 30, 2023 |
Dec. 31, 2024 |
Jan. 16, 2024 |
Dec. 31, 2023 |
Aug. 01, 2023 |
Monthly rent payment |
|
|
$ 8,505
|
|
|
|
|
Annually rent payment |
|
|
$ 102,060
|
|
|
|
|
Premises allowance |
$ 253,000
|
|
|
|
|
|
|
Amount receivable |
|
|
|
|
$ 253,000
|
|
|
Reimbursement receivable |
|
|
|
|
$ 253,000
|
|
|
ROU assets |
555,270
|
|
|
$ 575,227
|
|
$ 575,227
|
$ 663,875
|
Operating lease liabilities |
832,293
|
|
|
|
|
|
$ 642,523
|
Rental expense for operating leases |
$ 35,816
|
$ 26,853
|
|
|
|
|
|
Lease One [Member] |
|
|
|
|
|
|
|
Operating Lease, Weighted Average Remaining Lease Term |
2 years 7 months 6 days
|
|
|
|
|
|
|
Lease Two [Member] |
|
|
|
|
|
|
|
Operating Lease, Weighted Average Remaining Lease Term |
4 years 7 months 6 days
|
|
|
|
|
|
|
Chicago [Member] |
|
|
|
|
|
|
|
Borrowing rate |
4.57%
|
|
|
|
|
|
|
IOWA |
|
|
|
|
|
|
|
Borrowing rate |
4.24%
|
|
|
|
|
|
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v3.24.1.1.u2
Earnings (Loss) Per Common Share (Details) - shares
|
3 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive shares |
12,301,191
|
9,614,219
|
Stock Warrants [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive shares |
8,528,766
|
7,854,620
|
Stock Options [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Anti-dilutive shares |
3,772,425
|
1,759,599
|
X |
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v3.24.1.1.u2
Stockholders' Equity (Details) - Warrant [Member] - $ / shares
|
3 Months Ended |
12 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Accumulated Other Comprehensive Income (Loss) [Line Items] |
|
|
|
|
Warrants outstanding, beginning |
7,854,620
|
7,954,620
|
7,954,620
|
|
Weighted average exercise price outstanding, beginning |
$ 9.70
|
$ 9.63
|
$ 9.63
|
|
Weighted average remaining contractual life |
3 years 7 months 28 days
|
4 years 2 months 19 days
|
3 years 8 months 19 days
|
4 years 5 months 15 days
|
Warrants exercised |
|
(100,000)
|
|
|
Weighted average exercise price, exercised |
|
$ 3.90
|
|
|
Warrants granted |
674,146
|
|
|
|
Weighted average exercise price, granted |
$ 1.78
|
|
|
|
Warrants outstanding, ending |
8,528,766
|
7,854,620
|
7,854,620
|
7,954,620
|
Weighted average exercise price outstanding, ending |
$ 9.08
|
$ 9.70
|
$ 9.70
|
$ 9.63
|
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v3.24.1.1.u2
Stockholders' Equity (Details 1) - Stock Options [Member] - $ / shares
|
3 Months Ended |
12 Months Ended |
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Dec. 31, 2022 |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
|
|
|
Options outstanding, beginning |
2,584,599
|
1,759,599
|
1,759,599
|
|
Weighted average exercise price outstanding, beginning |
$ 3.06
|
$ 3.90
|
$ 3.90
|
|
Options granted |
1,187,826
|
|
|
|
Weighted average exercise price granted |
$ 2.11
|
|
|
|
Weighted average remaining contractual life |
8 years 10 months 20 days
|
9 years 1 month 6 days
|
8 years 8 months 15 days
|
9 years 4 months 6 days
|
Options outstanding, ending |
3,772,425
|
1,759,599
|
2,584,599
|
1,759,599
|
Weighted average exercise price outstanding, ending |
$ 2.76
|
$ 3.90
|
$ 3.06
|
$ 3.90
|
Options vested and exercisable |
3,751,425
|
|
|
|
Weighted average exercise price vested and exercisable |
$ 2.76
|
|
|
|
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v3.24.1.1.u2
Stockholders’ Equity (Details Narrative) - USD ($)
|
|
|
|
1 Months Ended |
3 Months Ended |
|
|
|
|
|
Mar. 02, 2023 |
Oct. 25, 2022 |
May 06, 2022 |
May 15, 2024 |
Jan. 23, 2024 |
Apr. 30, 2022 |
Mar. 31, 2024 |
Mar. 31, 2023 |
Dec. 31, 2023 |
Mar. 08, 2023 |
Dec. 31, 2022 |
May 23, 2022 |
Oct. 01, 2019 |
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Principal amount |
|
|
|
|
|
|
|
|
|
$ 11,200,000
|
|
|
|
Common stock issuance |
|
|
|
|
|
|
|
|
|
|
|
|
22,500
|
Warrant exercise price |
|
|
|
|
|
|
|
|
|
|
|
$ 6.21
|
|
Placement agent fees |
|
|
|
|
|
|
$ (155,000)
|
$ (315,000)
|
|
|
|
|
|
Conversion of shares, shares |
100,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of shares, Value |
$ 390,000
|
|
|
|
|
|
|
|
|
|
|
|
|
Expiration date |
|
|
|
|
|
Jun. 30, 2027
|
|
|
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|
|
|
|
Restricted Stock Units (RSUs) [Member] |
|
|
|
|
|
|
|
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|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued for services, shares |
|
|
|
|
|
|
4,477
|
1,092
|
|
|
|
|
|
Stock issued for services, amount |
|
|
|
|
|
|
$ 8,000
|
$ 4,000
|
|
|
|
|
|
Equity Option [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
|
|
|
$ 3.90
|
|
|
|
|
|
|
|
Stock Options [Member] |
|
|
|
|
|
|
|
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|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
$ 3.90
|
|
|
|
|
|
|
|
|
|
|
|
Expiration date |
|
May 06, 2032
|
|
|
|
|
|
|
|
|
|
|
|
Options granted |
|
|
513,413
|
|
|
|
|
|
|
|
|
|
|
Options issued |
|
1,759,599
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares granted |
|
|
|
|
|
|
1,187,826
|
|
|
|
|
|
|
Sales Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
1,056,615
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
|
$ 895,941
|
|
|
|
|
|
|
|
|
|
Common Stock [Member] |
|
|
|
|
|
|
|
|
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|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Placement agent fees |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant exercise price |
|
|
|
|
|
|
$ 9.08
|
$ 9.70
|
$ 9.70
|
|
$ 9.63
|
|
|
Seven Accredited Investors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
|
|
|
|
$ 1,000,000
|
|
|
|
|
|
|
Placement agent fees |
|
|
|
|
|
|
$ 100,000
|
|
|
|
|
|
|
Altitude Capital Group L L C [Member] | Placement Agent Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Placement agent agreement description |
|
|
|
|
|
|
the
Company entered into a Placement Agent Agreement with Altitude Capital Group, LLC, as placement agent (“Altitude Capital”
or the “Placement Agent”). Pursuant to the Placement Agent Agreement, at closing, Altitude Capital was paid a cash commission
equal to 10% of the gross proceeds received by the Company, plus 20% warrant coverage, providing Altitude Capital with the right to purchase 112,353 shares
of Common Stock at $1.78 per share through February 2, 2030 (the “Placement Agent Warrants”).
|
|
|
|
|
|
|
Craig Hallum Capital Group LLC [Member] | Sales Agreement [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
|
|
|
487,083
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
|
|
|
|
$ 877,857
|
|
|
|
|
|
|
Placement agent fees |
|
|
|
|
|
|
55,000
|
|
|
|
|
|
|
Sales commissions |
|
|
|
|
|
|
$ 21,947
|
|
|
|
|
|
|
Plan 2022 [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issuance |
|
|
|
|
|
|
3,265,516
|
|
|
|
|
|
|
2022 Plan [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares authorized |
|
|
|
|
1,060,458
|
|
|
|
|
|
|
|
|
Number of shares granted |
|
|
|
|
1,187,826
|
|
|
|
|
|
|
|
|
Number of shares vested |
|
|
|
|
1,166,826
|
|
|
|
|
|
|
|
|
Equity incentive plan description |
|
|
|
|
Each option has
an exercise price of $2.11 per share with an expiration date of January 23, 2034. The vested 1,166,826 stock options were
valued at $2,461,404 at grant date based on the Black-Scholes Option Pricing model. The following assumptions were utilized in the Black-Scholes
valuation of vested stock options during the three months ended March 31, 2024, risk free interest rate of 5.22%, volatility of 228%,
and an exercise price of $2.11.
|
|
|
|
|
|
|
|
|
Legacy Cardio [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of aggregate shares |
|
|
|
|
|
|
43,334
|
|
|
|
|
|
|
Principal amount |
|
|
|
|
|
|
$ 433,334
|
|
|
|
|
|
|
Manas Former Officers and Directors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares transferred |
|
|
|
|
|
|
1,625,000
|
|
|
|
|
|
|
Board Of Directors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock issued for services, shares |
|
|
|
|
|
|
35,212
|
|
|
|
|
|
|
Stock issued for services, amount |
|
|
|
|
|
|
$ 50,000
|
|
|
|
|
|
|
Legacy Cardio Stockholders [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares received |
|
|
|
|
|
|
$ 6,883,306
|
|
|
|
|
|
|
IPO [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
|
|
|
928,571
|
|
|
|
|
|
|
Private Placement [Member] | Seven Accredited Investors [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
|
|
|
561,793
|
|
|
|
|
|
|
Common stock , per value |
|
|
|
|
|
|
$ 0.00001
|
|
|
|
|
|
|
Warrant exercise price |
|
|
|
|
|
|
$ 1.78
|
|
|
|
|
|
|
Private Placement [Member] | Seven Accredited Investors [Member] | Common Stock [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
|
|
|
561,793
|
|
|
|
|
|
|
Private Placement [Member] | Seven Accredited Investors [Member] | Warrant [Member] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Subsidiary, Sale of Stock [Line Items] |
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares issued |
|
|
|
|
|
|
561,793
|
|
|
|
|
|
|
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Convertible Notes Payable (Details Narrative) - USD ($)
|
|
3 Months Ended |
Mar. 08, 2023 |
Mar. 31, 2024 |
Short-Term Debt [Line Items] |
|
|
Principal amount |
$ 11,200,000
|
|
Conversion price determined percentage |
92.00%
|
|
Floor conversion price |
$ 0.55
|
|
Decrease floor conversion price |
$ 0.20
|
|
Yorkville Convertible Debenture [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Conversion of convertible debt |
|
$ 5,000,000
|
Conversion of shares converted |
|
10,622,119
|
Yorkville Convertible Debenture [Member] |
|
|
Short-Term Debt [Line Items] |
|
|
Principal amount |
$ 5,000,000.0
|
|
Principal amount received |
4,500,000
|
|
Debt Instrument original issue discount |
$ 500,000
|
|
Interest outstanding principal balance accrues percentage |
0.00%
|
|
Interest outstanding principal balance remains uncured percentage |
15.00%
|
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