Item 8. Financial Statements and Supplementary Data
Item
8. Financial Statements and Supplementary Data
INDEX
TO FINANCIAL STATEMENTS
Report of Independent Registered Public Accounting Firm - WithumSmith+Brown, PC (PCAOB ID: 100 )
32
Report of Independent Registered Public Accounting Firm - Baker Tilly US, LLP (PCAOB ID: 23 )
33
Audited Consolidated Balance Sheets at December 31, 2024 and 2023
34
Audited Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2024 and 2023
35
Audited Consolidated Statements of Shareholders’ Equity (Deficit) for the years ended December 31, 2024 and 2023
36
Audited Consolidated Statements of Cash Flow for the years ended December 31, 2024 and 2023
37
Notes to Audited Consolidated Financial Statements
38
31
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors and Stockholders
Qualigen
Therapeutics, Inc.
Opinion
on the Financial Statements
We
have audited the accompanying consolidated balance sheet of Qualigen Therapeutics, Inc. (the “Company”) as of December 31,
2024, the related consolidated statements of operations and comprehensive loss, changes in stockholders’ equity (deficit) and cash
flows for the year then ended, and the related notes (collectively referred to as the “consolidated financial statements”).
In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company
as of December 31, 2024, and the results of its operations and its cash flows for the year then ended in conformity with accounting principles
generally accepted in the United States of America.
Going
Concern Uncertainty
The
accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed
in Note 2 to the consolidated financial statements, the Company has an accumulated deficit at December 31, 2024 and continuing net losses
and negative cash flows from operations that raise substantial doubt about its ability to continue as a going concern. Management’s plans
in regard to these matters are also described in Note 2. The consolidated financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on the Company’s consolidated financial statements based on our audit. We are a public accounting firm registered with the Public
Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company
in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission
and the PCAOB.
We
conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part
of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing
an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due
to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audit also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audit provides a reasonable basis for our opinion.
Critical
Audit Matter
The
critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated
or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial
statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters
does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit
matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which it relates.
Current
Expected Credit Losses (CECL)
Critical
Audit Matter Description
As
described in Note 4 to the consolidated financial statements, the Company establishes a reserve for the short-term notes receivable that
reflects its estimate of current expected credit losses (CECL). The Company is unable to use its historical data to estimate losses as
it has no relevant loss history to date. To determine the estimate of current expected credit losses, the Company used a probability-weighted
approach that incorporates multiple settlement scenarios, including recovering of amounts due upon acquisition of the debtor, and recovery
in liquidation scenario. The model requires management to make certain assumptions including the likelihood of each outcome. As of December
31, 2024, the estimate for expected credit losses on the debtor is approximately $360,000.
Auditing
the Company’s CECL reserve is challenging due to the significant assumptions and judgment used by management involve a high degree
of auditor judgment.
How
We Addressed the Matter in Our Audit
The
primary procedures we performed to address this critical audit matter included:
● Obtaining
and understanding the promissory note agreement.
● Obtaining
and reviewing management’s prepared accounting memo.
● Evaluating
management’s assumptions used in the probability-weighted approach.
● Obtaining
available market data to corroborate management’s probability assumptions.
/s/
WithumSmith+Brown, PC
We
have served as the Company’s auditor since 2024.
San
Francisco, California
June
30, 2025
32
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the shareholders and the board of directors of Qualigen Therapeutics, Inc.
Opinion
on the Financial Statements
We
have audited the accompanying consolidated balance sheet of Qualigen Therapeutics, Inc. (the “Company”) as of December
31, 2023, the related consolidated statements of operations, stockholders’ deficit and cash flows for the year then ended, and
the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the
consolidated financial statements present fairly, in all material respects, the financial position of the Company as of
December 31, 2023, and the results of its operations and its cash flows for the year then ended, in conformity with accounting
principles generally accepted in the United States of America.
Basis
for Opinion
These
consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion
on the Company’s consolidated financial statements based on our audit. We are a public accounting firm registered with the Public
Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company
in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission
and the PCAOB.
We
conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud.
The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part
of our audit, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing
an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audit included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due
to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audit also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audit provides a reasonable basis for our opinion.
/s/
Baker Tilly US, LLP
We
have served as the Company’s auditor from 2018 to 2024.
San
Diego, California
April
5, 2024, except for Note 1 Segment Reporting, as to which the date is June 30, 2025
33
QUALIGEN
THERAPEUTICS, INC.
CONSOLIDATED
BALANCE SHEETS
December 31,
December 31,
2024
2023
ASSETS
Current assets
Cash and cash equivalents
$ 1,174,608
$ 401,803
Prepaid expenses and other current assets
1,499,219
764,964
Short-term notes receivable, net of allowance for credit losses of $ 360,000 at December 31, 2024 and $ - at December 31, 2023
2,010,692
—
Total current assets
4,684,519
1,166,767
Other assets
2,000
866,481
Total Assets
$ 4,686,519
$ 2,033,248
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities
Accounts payable
$ 1,568,065
$ 2,222,983
Accrued expenses and other current liabilities
170,243
560,006
Warrant liabilities
269,175
54,600
Convertible debt - related party
—
1,299,216
Total current liabilities
2,007,483
4,136,805
Commitments and Contingencies (Note 11)
-
-
Stockholders’ Equity (Deficit)
Preferred stock, $ 0.001 par value; 15,000,000 shares authorized; 6,256 and zero shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively
5,716,400
—
Common stock, $ 0.001 par value ; 225,000,000 shares authorized; 736,431 and 107,243 shares issued and outstanding as of December 31, 2024 and December 31, 2023, respectively
65,314
43,262
Additional paid-in capital
119,958,897
114,655,565
Accumulated deficit
( 123,061,575 )
( 116,802,384 )
Total Stockholders’ Equity (Deficit)
2,679,036
( 2,103,557 )
Total Liabilities & Stockholders’ Equity (Deficit)
$ 4,686,519
$ 2,033,248
The
accompanying notes are an integral part of these consolidated financial statements.
34
QUALIGEN
THERAPEUTICS, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
2024
2023
For The Years Ended December 31,
2024
2023
EXPENSES
General and administrative
$ 4,204,558
$ 6,095,607
Research and development
1,197,162
5,209,250
Credit loss expense - short-term note receivable
360,000
-
Total expenses
5,761,720
11,304,857
LOSS FROM OPERATIONS
( 5,761,720 )
( 11,304,857 )
OTHER EXPENSE (INCOME), NET
Gain on change in fair value of warrant liabilities
( 415,810 )
( 2,035,469 )
Gain on change in fair value of derivative liabilities
( 191,068 )
—
Interest income
( 128,795 )
Interest expense
908,943
1,524,722
Loss on issuance of convertible debt
358,279
—
(Gain) loss on voluntary conversion of convertible debt into common stock
( 56,010 )
1,077,287
Loss on debt extinguishment
56,997
625,653
Loss on monthly redemptions of convertible debt into common stock
208,852
—
Gain on settlements of accounts payable
( 348,305 )
—
Loss on fixed asset disposal
—
21,747
Other income, net
( 1,946 )
( 38,994 )
Total other expense, net
391,137
1,174,946
LOSS BEFORE PROVISION FOR INCOME TAXES
( 6,152,857 )
( 12,479,803 )
(BENEFIT) PROVISION FOR INCOME TAXES
6,334
( 4,793 )
NET LOSS FROM CONTINUING OPERATIONS
( 6,159,191 )
( 12,475,010 )
DISCONTINUED OPERATIONS
Loss from discontinued operations, net of tax
—
( 683,008 )
Loss on disposal of discontinued operations, net of tax
( 100,000 )
( 602,232 )
LOSS FROM DISCONTINUED OPERATIONS
( 100,000 )
( 1,285,240 )
NET LOSS
( 6,259,191 )
( 13,760,250 )
Net loss attributable to non-controlling interest from discontinued operations
—
( 343,038 )
Net loss available to Qualigen Therapeutics, Inc.
$ ( 6,259,191 )
$ ( 13,417,212 )
Deemed dividend arising from warrant down-round provision
$ ( 87,604 )
$ —
Net loss attributable to Qualigen Therapeutics, Inc.
$ ( 6,346,795 )
$ ( 13,417,212 )
Net loss per common share, basic and diluted - continuing operations
$ ( 17.27 )
$ ( 122.93 )
Net income (loss) per common share, basic and diluted - discontinued operations
$ ( 0.28 )
$ $
( 9.32 )
Total net loss per common share, basic and diluted
$ ( 17.55 )
$ ( 132.25 )
Weighted-average number of shares outstanding, basic and diluted
361,587
101,454
Other comprehensive loss, net of tax
Net loss
$ ( 6,259,191 )
$ ( 13,760,250 )
Foreign currency translation adjustment from discontinued operations
—
119,473
Other comprehensive loss
( 6,259,191 )
( 13,640,777 )
Comprehensive loss attributable to noncontrolling interest from discontinued operations
—
( 304,735 )
Comprehensive loss attributable to Qualigen Therapeutics, Inc.
$ ( 6,259,191 )
$ ( 13,336,042 )
The
accompanying notes are an integral part of these consolidated financial statements.
35
QUALIGEN
THERAPEUTICS, INC.
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
Shares
Amount
Shares
Amount
Capital
Deficit
(Deficit)
Series A-2
Total
Convertible
Additional
Stockholders’
Preferred
Stock
Common
Stock
Paid-In
Accumulated
Equity
Shares
Amount
Shares
Amount
Capital
Deficit
(Deficit)
Balance at December 31, 2023
—
$ —
107,243
$ 43,262
$ 114,655,565 -
$ ( 116,802,384 ) ( 2,103,557
-
$ ( 2,103,557 )
Issuance of common stock and prefunded warrants in public offering
—
—
482,737
14,724
3,038,625 -
— -
-
3,053,349
Issuance of Series A-2 preferred shares upon closing of private placement
5,102
4,562,400
—
—
—
—
4,562,400
Voluntary conversion of convertible debt into preferred stock
1,154
1,154,000
—
—
—
—
1,154,000
Voluntary conversion of convertible debt into common stock
—
—
66,222
3,311
731,772
—
735,083
Redemptions of convertible debt into common stock
—
—
45,497
2,275
901,054
—
903,329
Fair value of warrant modification for professional services
—
—
—
—
12,036
—
12,036
Fair value of warrants reclassified to liabilities from equity
—
—
—
—
( 262,259 )
—
( 262,259 )
Fair value of warrants reclassified to equity from liabilities
—
—
—
—
197,456
—
197,456
Stock issued upon partial exercise of warrants
—
—
31,998
1,600
414,380
—
415,980
Restricted share settlements issued to former board members
—
—
2,843
142
142,209
—
142,351
Issuance of rounded shares as a result of the reverse stock split
—
—
( 109 )
—
—
—
—
Stock-based compensation
—
—
—
—
128,059
—
128,059
Net loss
—
—
—
—
— -
( 6,259,191 ) -
-
( 6,259,191 )
Balance at December 31, 2024
6,256
$ 5,716,400
736,431
$ 65,314
$ 119,958,897 -
$ ( 123,061,575 ) -
-
$ 2,679,036
Shares
Amount
Capital
(Deficit)
Deficit
(Deficit)
Interest
(Deficit)
Total
Qualigen
Accumulated
Other
Therapeutics, Inc.
Total
Common
Stock
Additional
Paid-In
Comprehensive
Income
Accumulated
Stockholders’
Equity
Noncontrolling
Stockholders’
Equity
Shares
Amount
Capital
(Deficit)
Deficit
(Deficit)
Interest
(Deficit)
Balance at December 31, 2022
84,215
$ 42,110
$ 110,528,050
$ 50,721
$ ( 103,385,172 )
$ 7,235,709
$ 1,530,881
$ 8,766,590
Balance
84,215
$ 42,110
$ 110,528,050
$ 50,721
$ ( 103,385,172 )
$ 7,235,709
$ 1,530,881
$ 8,766,590
Voluntary conversion of convertible debt into common stock
16,835
842
1,111,740
—
—
1,112,582
—
1,112,582
Redemptions of convertible debt into common stock
6,193
310
254,006
—
—
254,316
—
254,316
Fair value of warrant modification for professional services
—
—
7,945
—
—
7,945
—
7,945
Fair value of warrant reclassified from liabilities to equity
—
—
1,626,694
—
—
1,626,694
—
1,626,694
Stock-based compensation
—
—
1,098,533
—
—
1,098,533
9,297
1,107,830
Foreign currency translation adjustment
—
—
28,597
81,170
—
109,767
38,303
148,070
Deconsolidation of discontinued operations
—
—
—
( 131,891 )
—
( 131,891 )
( 1,235,443 )
( 1,367,334 )
Net loss
—
—
—
—
( 13,417,212 )
( 13,417,212 )
( 343,038 )
( 13,760,250 )
Balance at December 31, 2023
107,243
$ 43,262
$ 114,655,565
$ —
$ ( 116,802,384 )
$ ( 2,103,557 )
$ —
$ ( 2,103,557 )
Balance
107,243
$ 43,262
$ 114,655,565
$ —
$ ( 116,802,384 )
$ ( 2,103,557 )
$ —
$ ( 2,103,557 )
The
accompanying notes are an integral part of these consolidated financial statements.
36
QUALIGEN
THERAPEUTICS, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
2024
2023
For the Years Ended December 31,
2024
2023
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$ ( 6,259,191 )
$ ( 13,760,250 )
Loss from discontinued operations, net of tax
( 100,000 )
( 1,285,240 )
Loss from continuing operations
( 6,159,191 )
( 12,475,010 )
Adjustments to reconcile loss from continuing operations to net cash used in operating activities:
Depreciation and amortization
—
4,495
Stock-based compensation
128,059
1,098,533
Change in fair value of warrant liabilities
( 415,810 )
( 2,035,469 )
Change in fair value of derivative liabilities
( 191,068 )
—
Change in provision for credit losses of short-term note receivable
360,000
—
Accrued interest on short-term note receivable
( 113,292 )
—
(Gain) loss on voluntary conversion of convertible debt
( 56,010 )
1,077,287
Loss on monthly redemptions of convertible debt into common stock
208,852
—
Accretion of discount on convertible debt
615,534
1,469,640
Loss on debt extinguishment
56,997
625,653
Loss on issuance of convertible debt
358,279
—
Gain on settlement of accounts
payable
( 348,305 )
—
Loss on disposal of fixed assets
—
21,747
Fair value of warrant modification for professional services
12,036
7,945
Changes in operating assets and liabilities:
Prepaid expenses and other assets
( 219,774 )
( 264,741 )
Accounts payable
( 445,141 )
1,603,422
Accrued expenses and other current liabilities
( 118,669 )
( 227,101 )
Net cash used in operating activities - continuing operations
( 6,327,503 )
( 9,093,599 )
Net cash used in operating activities - discontinued operations
—
( 1,210,664 )
Net cash used in operating activities
( 6,327,503 )
( 10,304,263 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Issuance of short-term note receivables
( 2,257,400 )
—
Net cash provided by investing activities - discontinued operations
350,000
4,215,943
Net cash provided by (used in) investing activities
( 1,907,400 )
4,215,943
CASH FLOWS FROM FINANCING ACTIVITIES:
Payments on convertible notes payable
—
( 550,000 )
Proceeds from the issuance of convertible notes payable
1,475,000
—
Proceeds from issuance of preferred shares in private placement
4,562,400
—
Proceeds from issuance of common shares and prefunded warrants in public offering
3,053,349
—
Proceeds from issuance of short term debt
2,000,000
—
Proceeds from warrant exercises
415,980
—
Payments on convertible notes payable
( 499,021 )
—
Payments on short term debt
( 2,000,000 )
—
Net cash provided by (used in) financing activities
9,007,708
( 550,000 )
Net change in cash and cash equivalents
772,805
( 6,638,320 )
Cash and cash equivalents from continuing operations- beginning of year
401,803
7,040,123
Cash and cash equivalents from continuing operations - end of year
$ 1,174,608
$ 401,803
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
Cash paid during the year for:
Interest
$ 92,838
$ —
Taxes
$ 5,522
$ 5,571
NONCASH FINANCING AND INVESTING ACTIVITIES:
Monthly redemptions of convertible debt into common stock
$ 903,329
$ 254,316
Voluntary conversion of convertible debt into preferred stock
$ 1,154,000
$ —
Voluntary conversion of convertible debt into common stock
$ 735,083
$ 1,112,582
Deemed dividend arising from warrant down-round provision
$ 87,604
$ —
Exchange of derivative liability for warrant and convertible debt
$ 675,625
$ —
Restricted share settlements issued to former board members
$ 142,351
$ —
Warrants reclassified to equity from liabilities
$ 197,456
$ —
Warrants reclassified to liabilities from equity
$ 262,259
$ —
Net transfers to equipment held for lease from inventory
$ —
$ 83,281
The
accompanying notes are an integral part of these consolidated financial statements.
37
QUALIGEN
THERAPEUTICS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2024
NOTE
1 — ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ESTIMATES
Organization
Ritter
Pharmaceuticals, Inc. (the Company ’ s predecessor) was formed as a Nevada limited liability company on March 29, 2004 under
the name Ritter Natural Sciences, LLC. In September 2008, this company converted into a Delaware corporation under the name Ritter Pharmaceuticals,
Inc. On May 22, 2020, upon completing a “reverse recapitalization” transaction with Qualigen, Inc., Ritter Pharmaceuticals,
Inc. was renamed Qualigen Therapeutics, Inc. (the “Company”). Qualisys Diagnostics, Inc. was formed as a Minnesota corporation
in 1996, reincorporated to become a Delaware corporation in 1999, and then changed its name to Qualigen, Inc. in 2000. Qualigen, Inc.
was a wholly-owned subsidiary of the Company. On July 20, 2023, the Company sold all of the issued and outstanding shares of common stock
of Qualigen, Inc. to Chembio Diagnostics, Inc. (“Chembio”), a wholly-owned subsidiary of Biosynex, S.A. (“Biosynex”).
Following the consummation of this transaction, Qualigen, Inc. became a wholly-owned subsidiary of Chembio (see Note 6 – Discontinued
Operations).
On
May 26, 2022, the Company acquired 2,232,861 shares of Series A-1 Preferred Stock of NanoSynex, Ltd. (“NanoSynex”) from Alpha
Capital Anstalt (“Alpha”), a related party, in exchange for 7,000 reverse split adjusted shares of the Company’s common
stock and a prefunded warrant to purchase 6,629 reverse split adjusted shares of the Company’s common stock at an exercise price
of $ 0.001 per share. These warrants were subsequently exercised on September 13, 2022. Concurrently with this transaction, the Company
also entered into a Master Funding Agreement for the Operational and Technology Funding of NanoSynex Ltd., dated May 26, 2022, with NanoSynex
(the “NanoSynex Funding Agreement”), to, among other things, provide for the further funding of NanoSynex, and purchased
381,786 shares of Series B preferred stock from NanoSynex for a total purchase price of $ 600,000 . The transactions resulted in the Company
acquiring a 52.8 % interest in NanoSynex (the “NanoSynex Acquisition”). NanoSynex is a nanotechnology diagnostics company
domiciled in Israel. On July 20, 2023, the Company entered into an Amendment and Settlement Agreement with NanoSynex (the “NanoSynex
Amendment”), which amended the NanoSynex Funding Agreement, to, among other things, eliminate most of the Company obligation for
the further funding of NanoSynex. Pursuant to the terms of the NanoSynex Amendment, the Company lost its controlling interest in NanoSynex
(see Note 6 – Discontinued Operations).
Basis
of Presentation
The
accompanying consolidated financial statements of the Company have been prepared in conformity with accounting principles generally accepted
in the United States of America (“U.S. GAAP”), Regulation S-X and rules and regulations of the Securities and Exchange Commission
(“SEC”).
Principles
of Consolidation
The
accompanying consolidated financial statements include the accounts of the Company and its former wholly-owned and majority owned subsidiaries.
All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance
is meant to refer to U.S. GAAP. The Company views its operations and manages its business in one operating segment . See the section
Segment Reporting below for more information. In general, the functional currency of the Company and its subsidiaries is the U.S. dollar.
For NanoSynex, the functional currency was the local currency, New Israeli Shekels (NIS). As such, assets and liabilities for NanoSynex
were translated into U.S. dollars with the effects of foreign currency translation adjustments reflected as a component of accumulated
other comprehensive loss within the Company’s consolidated statements of changes in stockholders’ equity (deficit).
As
of July 20, 2023, NanoSynex was deconsolidated from these financial statements as the transactions contemplated by the NanoSynex Amendment
resulted in a loss of control of a subsidiary that constitutes a business under ASC 810. The retained investment in NanoSynex is accounted
for prospectively as an equity method investment. See Note 6 – Discontinued Operations for further information.
Discontinued
Operations
On
July 20, 2023, the Company completed the sale of Qualigen, Inc. to Chembio Diagnostics, Inc. The sale of Qualigen Inc. constituted a
significant disposition and as such, the Company concluded that the disposition of ownership in Qualigen, Inc. represented a strategic
shift that had a major effect on its operations and financial results. Therefore, Qualigen, Inc. is classified as discontinued operations
for all periods presented herein.
38
On
July 20, 2023, the Company entered into the NanoSynex Amendment, which amended the Master Funding Agreement for the Operational and Technology
Funding of NanoSynex Ltd., dated May 26, 2022, by and between the Company and NanoSynex (the “NanoSynex Funding Agreement”),
a former majority owned subsidiary of the Company, to, among other things, forfeit 281,000 Series B Preferred Shares of NanoSynex held
by the Company, resulting in the deconsolidation of NanoSynex. The disposition represents a strategic shift that will have a material
effect on the Company’s operations and financial results. Accordingly, the business of NanoSynex is classified as discontinued
operations for all periods presented herein.
See
Note 6 - Discontinued Operations for further information.
Equity
Method Investments
Following
deconsolidation of NanoSynex on July 20, 2023, the Company accounts for its retained investment under the equity method of accounting
as it retained the ability to exercise significant influence over the operating and financial policies of the investee. Under the equity
method, the Company recognizes its proportionate share earnings or losses each reporting period with an adjustment to the carrying value
of the investment. As of December 31, 2024 and 2023, the carrying value of the retained investment was zero, and therefore the Company
has suspended application of the equity method as the Company is not liable for the obligations of the investee nor otherwise committed
to provide financial support. Future equity method earnings, if any, will not be recognized until the amount exceeds the unrecognized
net losses in prior periods. See Note 6 – Discontinued Operations for further information.
Accounting
Estimates
Management
uses estimates and assumptions in preparing its consolidated financial statements in accordance with U.S. GAAP. Those estimates and assumptions
affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities, and the reported revenues
and expenses. The most significant estimates relate to the estimated fair value of convertible notes, warrant liabilities, determination
of the allowance for credit losses, and stock-based compensation. Actual results could vary from the estimates that were used.
Reverse
Stock Splits
On
November 23, 2022, the Company effected a 1-for-10 reverse stock split of its outstanding shares of common stock (the “2022 Reverse
Stock Split”). The 2022 Reverse Stock Split reduced the Company’s shares of outstanding common stock, stock options, and
warrants to purchase shares of common stock. Fractional shares of common stock that would have otherwise resulted from the 2022 Reverse
Stock Split were rounded down to the nearest whole share and cash in lieu of fractional shares was paid to stockholders.
On
November 20, 2024, the Company effected a 1-for-50 reverse stock split of its outstanding shares of common stock (the “2024 Reverse
Stock Split”). The 2024 Reverse Stock Split reduced the Company’s shares of outstanding common stock, stock options, and
warrants to purchase shares of common stock. Fractional shares of common stock that would have otherwise resulted from the 2024 Reverse
Stock Split were rounded down to the nearest whole share and cash in lieu of fractional shares was paid to stockholders.
All
share and per share data for all periods presented in the accompanying financial statements and the related disclosures have been adjusted
retrospectively to reflect both reverse stock splits. The number of authorized shares of common stock and the par value per share remains
unchanged.
Cash
The
Company considers all highly liquid investments purchased with an initial maturity of 90 days or less and money market funds to be cash
equivalents.
The
Company maintains the majority of its cash in accounts at banking institutions in the U.S. that are of high quality. Cash held in these
accounts often exceed the Federal Deposit Insurance Corporation (FDIC) insurance limits. If such banking institutions were to fail, the
Company could lose all or a portion of amounts held in excess of such insurance limitations. As of December 31, 2024, the Company had
not experienced losses on these accounts, and management believes the Company is not exposed to significant risk on such accounts.
39
Segment
Reporting
The Company adopted Accounting Standard Update (“ASU”) 2023-07,
Segment Reporting (Topic 280) – Improvements to Reportable Segment Disclosures, as of January 1, 2024. See the section Recent Accounting
Pronouncements below for more information. Operating segments are identified as components of an enterprise about which separate discrete
financial information is regularly reviewed for evaluation by the chief operating decision-maker (“CODM”) in making decisions
regarding resource allocation and assessing performance. To date, the Company has viewed its operations and managed its business as one
segment operating primarily within the United States (and in Israel prior to the NanoSynex deconsolidation). The Company is an early stage
clinical therapeutics company focused on developing treatments for adult and pediatric cancer. The Company’s operations are organized
and reported as a single reportable segment, which includes all activities related to the discovery, development, and commercialization
of its products. The Company’s CODM, its chief executive officer, reviews operating results on an aggregate basis and manages the
operations as a single operating segment. The accounting policies of the Company’s single operating and reportable segment are the
same as those described in the summary of significant accounting policies. The measure of segment assets is reported on the consolidated
balance sheets as total assets. The CODM evaluates performance and allocates resources based on consolidated net income (loss) that also
is reported on the consolidated statements of operations as net loss, and consolidated cash used in operations. The significant expenses
regularly reviewed by the CODM are consistent with those reported on the Company’s consolidated statement of operations, and expenses
are not regularly provided to or reviewed on a more disaggregated basis for purposes of assessing segment performance and deciding how
to allocate resources.
Research
and Development
Except
for acquired in process research and development (IPR&D), the Company expenses research and development costs as incurred including
therapeutics license costs.
Patent
Costs
The
Company expenses all costs as incurred in connection with patent applications (including direct application fees, and the legal and consulting
expenses related to making such applications) and such costs are included in general and administrative expenses in the consolidated
statements of operations.
Derivative
Financial Instruments and Warrant Liabilities
The
Company does not use derivative instruments to hedge exposures to cash flow, market, or foreign currency risks. The Company evaluates
all of its financial instruments, including issued stock purchase warrants, to determine if such instruments are derivatives or contain
features that qualify as embedded derivatives. For derivative financial instruments that are accounted for as liabilities, the derivative
instrument is initially recorded at its fair value and is then re-valued at each reporting date, with changes in the fair value reported
in the consolidated statements of operations and comprehensive loss. Depending on the features of the derivative financial instrument,
the Company uses either the Black-Scholes option-pricing model or a Monte-Carlo simulation to value the derivative instruments at inception
and subsequent valuation dates. The classification of derivative instruments, including whether such instruments should be recorded as
liabilities or as equity, is re-assessed at the end of each reporting period (See Note 8 – Warrant Liabilities and Note 9 –
Convertible Debt).
40
Fair
Value Measurements
The
Company determines the fair value measurements of applicable assets and liabilities based on a three-tier fair value hierarchy established
by accounting guidance and prioritizes the inputs used in measuring fair value. The Company discloses and recognizes the fair value of
its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy
gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level
1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements).
The guidance establishes three levels of the fair value hierarchy as follows:
● Level
1 - Inputs that reflect unadjusted quoted prices in active markets for identical assets or
liabilities that the Company has the ability to access at the measurement date;
● Level
2 - Inputs other than quoted prices that are observable for the assets or liability either
directly or indirectly, including inputs in markets that are not considered to be active;
and
● Level
3 - Inputs that are unobservable.
Fair
Value of Financial Instruments
Cash, prepaid expenses, and accrued liabilities are carried at cost, which
management believes approximates fair value due to the short-term nature of these instruments. Short-term notes receivable are valued
subject to a current expected credit loss (“CECL”) model (see Note 4 - Short-Term Notes Receivable).
Comprehensive
Loss
Comprehensive
loss consists of net income and foreign currency translation adjustments related to the discontinued operations of NanoSynex. Comprehensive
gains (losses) have been reflected in the statements of operations and comprehensive loss and as a separate component in the statements
of stockholders’ equity (deficit) for all periods presented.
Stock-Based
Compensation
Stock-based
compensation cost for equity awards granted to employees and non-employees is measured at the grant date based on the calculated fair
value of the award using the Black-Scholes option-pricing model, and is recognized as an expense, under the straight-line method, over
the requisite service period (generally the vesting period of the equity grant). If the Company determines that other methods are more
reasonable, or other methods for calculating these assumptions are prescribed by regulators, the fair value calculated for the Company’s
stock options could change significantly. Higher volatility, lower risk-free interest rates, and longer expected lives would result in
an increase to stock-based compensation expense to employees and non-employees determined at the date of grant.
Income
Taxes
Deferred
income taxes are recognized for temporary differences in the basis of assets and liabilities for financial statement and income tax
reporting that arise due to net operating loss carry forwards, research and development credit carry forwards and from using
different methods and periods to calculate depreciation and amortization, allowance for doubtful accounts, accrued vacation,
research and development expenses, and state taxes. A provision has been made for income taxes due on taxable income and for the
deferred taxes on the temporary differences. The Company recognizes interest and penalties accrued on any unrecognized
tax benefits as a component of income tax expense.
Deferred
tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all
of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws
and rates on the date of enactment. Realization of the deferred income tax asset is dependent on generating sufficient taxable income
in future years. See Note 15 - Income Taxes for further information.
Foreign
Currency Translation
The
functional currency for the Company is the U.S. dollar. The functional currency for the discontinued operations of NanoSynex was the
New Israeli Shekel (NIS). The financial statements of NanoSynex were translated into U.S. dollars using exchange rates in effect at each
period end for assets and liabilities; using exchange rates in effect during the period for results of operations; and using historical
exchange rates for certain equity accounts. The adjustment resulting from translating the financial statements of NanoSynex was reflected
as a separate component of other comprehensive income (loss) (see Note 6 – Discontinued Operations).
41
Accounting
Standards Updates - Recently Adopted
In
November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standard Update (“ASU”) No. 2023-07, Segment
Reporting (Topic 280) – Improvements to Reportable Segment Disclosures (ASU 2023-07) , which is intended to improve reportable
segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses. Effective January 1, 2024,
the Company adopted the new standard on a retrospective basis for annual periods, and interim periods beginning for the first quarter
of 2025. The Company does not believe the impact of the new guidance and related codification improvements had a material impact to its
financial position, results of operations and cash flows.
Accounting
Standards Updates - Not Yet Adopted
In
December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures (Topic 740) , which requires more detailed income
tax disclosures. The guidance requires entities to disclose disaggregated information about their effective tax rate reconciliation as
well as expanded information on income taxes paid by jurisdiction. The disclosure requirements will be applied on a prospective basis,
with the option to apply them retrospectively. The standard is effective for fiscal years beginning after December 15, 2024, with early
adoption permitted. The Company is evaluating the disclosure requirements related to the new standard.
In
November 2024, the FASB issued ASU 2024-03 , Income Statement—Reporting Comprehensive Income (Subtopic 220-40): Expense
Disaggregation Disclosures . This update requires entities to disaggregate operating expenses into specific categories, such as salaries
and wages, depreciation, and amortization, to provide enhanced transparency into the nature and function of expenses. Accounting Standards
Update 2024-03 is effective for fiscal years beginning after December 15, 2026, with early adoption permitted. Accounting Standards Update
2024-03 may be applied retrospectively or prospectively. The Company is evaluating the disclosure requirements related to the new standard.
We
do not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact
on our consolidated financial statements or disclosures.
Global
Economic Conditions
Ongoing
Wars in Ukraine and Israel
In
February 2022, Russia invaded Ukraine. While the Company has no direct exposure in Russia and Ukraine, the Company continues to monitor
any broader impact to the global economy, including with respect to inflation, supply chains and fuel prices. The full impact of the
conflict on the Company’s business and financial results remains uncertain and will depend on the severity and duration of the
conflict and its impact on regional and global economic conditions.
In
October 2023, Hamas conducted terrorist attacks in Israel resulting in ongoing war. There continue to be hostilities between Israel and
Hezbollah in Lebanon and Hamas in the Gaza Strip, both of which have resulted in rockets being fired into Israel, causing casualties
and disruption of economic activities. In early 2023, there were a number of changes proposed to the political system in Israel by the
current government which, if implemented as planned, could lead to large-scale protests and additional uncertainty, negatively impacting
the operating environment in Israel. Populist uprisings in various countries in the Middle East over the last few years have also affected
the political stability of those countries and have led to a decline in the regional security situation. Such instability may also lead
to deterioration in the political and trade relationships that exist between Israel and these countries. Any armed conflicts, terrorist
activities or political instability involving Israel or other countries in the region could adversely affect the Company’s minority
interest in NanoSynex, its results of operations, financial condition, cash flows and prospects (see Note 6 – Discontinued Operations).
Inflation
and Global Economic Conditions
Beginning
in 2022 and continuing into the current fiscal year, global commodity and labor markets experienced significant inflationary pressures
attributable to government stimulus and recovery programs, government deficit spending and supply chain issues. The Company cannot provide
assurance that it will be successful in fully offsetting increased costs resulting from inflationary pressure. In addition, the global
economy suffers from slowing growth and rising interest rates, and some economists believe that there may be a global recession in the
near future. If the global economy slows, the Company’s business may be adversely affected.
Impact
of COVID-19 Pandemic
The
COVID-19 pandemic has had a dramatic impact on businesses globally and on the Company’s business as well. During the height of
the pandemic, sales of diagnostic products decreased significantly and the Company’s net loss increased significantly, as clinics
and small hospitals’ demand for Qualigen, Inc.’s FastPack™ diagnostic test kits was reduced sharply, largely due to
deferral of patients’ non-emergency visits to physician offices. In July 2023 the Company sold Qualigen, Inc., its wholly-owned
subsidiary, to Chembio (see Note 6 - Discontinued Operations).
42
NOTE
2 — LIQUIDITY AND GOING CONCERN
As
of December 31, 2024, the Company had approximately $ 1.2 million in cash and an accumulated deficit of $ 123.1 million. For the years
ended December 31, 2024 and 2023, the Company used cash of $ 6.3 million and $ 10.3 million, respectively, in operations.
The
Company’s cash balances as of the date that these financial statements were issued, without additional financing, are expected
to fund operations only into the third quarter of 2025. The Company expects to continue to have net losses and negative cash flow
from operations, which will challenge its liquidity. These factors raise substantial doubt about the Company’s ability to continue
as a going concern for the one-year period following the date that these financial statements were issued.
There
is no assurance that profitable operations will ever be achieved, or, if achieved, could be sustained on a continuing basis.
Historically,
the Company’s principal sources of cash have included proceeds from the issuance of common and preferred equity and proceeds
from the issuance of debt. During the year ended December 31, 2024 the Company raised approximately $ 1.5
million from the sale of Convertible Debentures (see Note 9 – Convertible Debt), and an additional $ 2.0
million from the sale of a nonconvertible 18% Senior Note, which was subsequently repaid in September 2024. The Company raised
additional net proceeds of approximately $ 3.1
million from the sale of common stock and prefunded warrants in a public offering, raised approximately $ 4.6
million from the sale of newly designated Series A-2 Convertible Preferred Stock in a private placement, and $ 0.4
million from warrant exercises. At the closing of the private placement, approximately $ 1.2
million in Convertible Debentures and accrued interest were exchanged for shares of Series A-2 Convertible Preferred stock, and the
remaining outstanding balance of $ 0.5
million in Convertible Debentures and accrued interest was repaid. From January to June 2025, we borrowed a total of $ 3,470,000
from eight investors as short-term borrowings, each due within six months after the date of borrowing. There can be no assurance
that further financing can be obtained on favorable terms, or at all. If the Company is unable to obtain funding, the Company could
be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization
efforts, which could adversely affect the Company’s business prospects.
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The financial statements
do not include any adjustments that would be necessary should the Company be unable to continue as a going concern, and therefore, be
required to liquidate its assets and discharge its liabilities in other than the normal course of business and at amounts that may differ
from those reflected in the accompanying financial statements.
NOTE
3 — PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets consisted of the following at December 31, 2024 and 2023:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
December 31,
December 31,
2024
2023
Prepaid consulting
$ 1,241,537
$ —
Prepaid insurance
226,482
566,011
Prepaid research and development expenses
—
173,900
Other current assets
31,200
25,053
Prepaid expenses and
other current assets
$ 1,499,219
$ 764,964
NOTE
4 — SHORT-TERM NOTES RECEIVABLE
Short
term notes receivable - consisted of the following at December 31, 2024 and 2023:
SCHEDULE
OF SHORT-TERM NOTE RECEIVABLE
December 31,
December 31,
2024
2023
Short-term notes receivable - Marizyme
$ 2,370,692
$ —
Less allowance for credit losses
( 360,000 )
Short-term notes receivable
$ 2,010,692
$ —
Allowance
for credit losses consisted of the following at December 31, 2024 and 2023:
SCHEDULE
OF ALLOWANCE FOR CREDIT LOSSES
December 31,
December 31,
2024
2023
Beginning Balance
$ —
$ —
Current period provision for expected credit
losses
( 360,000 )
—
Ending Balance
$ ( 360,000 )
$ —
During
the year ended December 31, 2024, the Company advanced to Marizyme, Inc., $ 2,257,400 , against which Marizyme delivered demand promissory
notes to the Company of like principal amounts (the “Marizyme Notes”). As of December 31, 2024, accrued interest related
to the Marizyme Notes was $ 113,292 and interest income of this amount was recognized in other income in the consolidated statement of
operations and is included in short-term notes receivable on the consolidated balance sheet. As of December 31, 2023 there were no amounts due to the Company under the Marizyme Notes.
The Marizyme Notes bear at interest the rate of eighteen percent ( 18 %) per annum. Marizyme may pre-pay all or any part of the
outstanding principal or interest at any time and from time to time, in whole or in part, without premium or penalty.
43
Under
ASC 326-20, known as the current expected credit loss (“CECL”) model, the Company was required to estimate credit losses
expected over the life of an exposure (or pool of exposures) based on historical information, current information, and reasonable and
supportable forecasts. The Company is unable to use its historical data to estimate losses as it has no relevant loss history to date.
To determine the estimate of expected credit losses, the Company used a probability-weighted approach that incorporates multiple settlement
scenarios, including recovery of amounts due upon an acquisition of the debtor, and recovery in different liquidation scenarios, and
determines the expected recoverable amount of the loan in each scenario. This model requires management to make certain assumptions including
the likelihood of each outcome, the estimated value of the debtor’s assets, and the Company’s expected claim and recovery
rate on the debtor’s assets in the event of an insolvency or a liquidation proceeding. As of December 31, 2024, the estimate for
expected credit losses on the Marizyme Notes is $ 360,000 . Given the inherently uncertain nature of the debtor’s
financial condition and future outcomes, actual credit losses may differ materially from this estimate. The Company will continue to
monitor relevant events and conditions and update its assumptions and allowance as necessary.
The
Company is also party to a Co-Development Agreement with Marizyme (see Note 12 - Research and License Agreements).
NOTE
5 — OTHER ASSETS
Other
non-current assets consisted of the following at December 31, 2024 and 2023:
SCHEDULE
OF OTHER NON CURRENT ASSETS
December 31,
December 31,
2024
2023
Funds held in escrow
$ —
$ 450,000
Long-term research and development deposits
—
416,481
Other
2,000
—
Other non-current assets
$ 2,000
$ 866,481
NOTE
6 — DISCONTINUED OPERATIONS
The
summary of gain (loss) from discontinued operations, net of tax, for the years ended December 31, 2024 and 2023 are as follows:
SCHEDULE
OF GAIN (LOSS) FROM DISCONTINUED OPERATIONS
Qualigen, Inc.
NanoSynex
Total
Qualigen, Inc.
NanoSynex
Total
Year Ended December 31, 2024
Year Ended December 31, 2023
Qualigen, Inc.
NanoSynex
Total
Qualigen, Inc.
NanoSynex
Total
Loss from discontinued operations, net of tax
$ —
$ —
$ —
$ ( 171,701 )
$ ( 511,307 )
$ ( 683,008 )
Gain (loss) on disposal of discontinued operations, net of tax
( 100,000 )
—
( 100,000 )
3,876,778
( 4,479,010 )
( 602,232 )
GAIN (LOSS) FROM DISCONTINUED OPERATIONS
$ ( 100,000 )
$ —
$ ( 100,000 )
$ 3,705,077
$ ( 4,990,317 )
$ ( 1,285,240 )
Sale
of Qualigen, Inc.
On
July 20, 2023, the Company completed the sale of Qualigen, Inc., its formerly wholly-owned subsidiary, to Chembio Diagnostics, Inc. for
net cash consideration of $ 5.4 million, of which $ 4.9 million was received during the year ended December 31, 2023, and $ 450,000 was
being held in escrow until January 20, 2025 to satisfy certain Company indemnification obligations. On June 4, 2024, the escrow account
was settled early by mutual agreement of the Company and the buyer resulting in cash proceeds to the Company of $ 350,000 and a loss on
disposal of discontinued operations of $ 100,000 for the year ended December 31, 2024. There was no other activity related to Qualigen,
Inc. during the year ended December 31, 2024.
There
were no assets and liabilities remaining related to Qualigen, Inc. as of December 31, 2024 or 2023.
44
The
Company reclassified the following statement of operations items to discontinued operations for the year ended December 31, 2023:
SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS
For the Year Ended
December 31,
2023
REVENUES
Net product sales
$ 3,661,121
Total revenues
3,661,121
EXPENSES
Cost of product sales
2,551,114
General and administrative
610,559
Research and development
206,819
Sales and marketing
405,626
Total expenses
3,774,118
OTHER EXPENSE, NET
Loss on disposal of equipment held for lease
63,302
Other income, net
( 4,898 )
Loss on fixed asset disposal
300
Total other expense, net
58,704
LOSS FROM DISCONTINUED OPERATIONS BEFORE DISPOSAL
( 171,701 )
Gain on sale of Qualigen, Inc., net of tax
3,876,778
INCOME FROM DISCONTINUED OPERATIONS OF QUALIGEN, INC.
$ 3,705,077
The
Company recorded a gain on the sale of Qualigen, Inc. in its consolidated financial statements for the years ended December 31, 2023
as follows:
Gain on sale of
Qualigen, Inc.
Fair value of consideration received
$ 5,489,337
Working capital adjustment
235,402
Total Assets of discontinued operations
( 4,225,562 )
Total Liabilities of discontinued operations
3,005,407
Transaction expenses
( 627,806 )
Gain on sale of Qualigen, Inc.
$ 3,876,778
Amendment
and Settlement Agreement with NanoSynex Ltd.
On
July 20, 2023, the Company entered into and effectuated the NanoSynex Amendment, reducing its ownership from approximately 52.8 % to approximately
49.97 % of the voting equity of NanoSynex, and deconsolidation of the subsidiary. On November 22, 2023, the Company further agreed to
eliminate the Company’s obligations to lend additional funds to NanoSynex by surrendering shares of Series A-1 Preferred Stock
of NanoSynex in an amount that reduced the Company’s ownership in NanoSynex voting equity from approximately 49.97 % to 39.90 %.
On
the date of deconsolidation, the Company recognized its retained investment at fair value, which was determined to be de minimis based
on various economic, industry, and other factors. As a result, the Company has discontinued recognition of its proportionate share
of equity method losses following the date of initial recognition. As of December 31, 2024 and 2023, the carrying value of the retained
investment was zero. Future equity method earnings, if any, will not be recognized until the amount exceeds the unrecognized net losses
in prior periods.
There
were no assets and liabilities recognized related to NanoSynex as of December 31, 2024 or 2023.
45
The
Company reclassified the following statement of operations items to discontinued operations for the year ended December 31, 2023:
SCHEDULE OF STATEMENT OF OPERATIONS ITEMS TO DISCONTINUED OPERATIONS
For the Year Ended
December 31,
2023
EXPENSES
Research and development
$ 869,064
Total expenses
869,064
Loss on disposal of discontinued operations
4,479,010
BENEFIT FOR INCOME TAXES
( 357,757 )
LOSS FROM DISCONTINUED OPERATIONS OF NANOSYNEX, LTD.
( 4,990,317 )
Loss attributable to noncontrolling interest
( 343,038 )
NET LOSS ATTRIBUTABLE TO STOCKHOLDERS
$ ( 4,647,279 )
The
Company recorded a loss on disposal of discontinued operations from the deconsolidation of NanoSynex in its consolidated financial statements
for the year ended December 31, 2023 as follows:
Loss on
deconsolidation of
NanoSynex
Fair value of NanoSynex interest retained
$ —
Net assets deconsolidated
( 2,768,403 )
Non-controlling interest share
1,235,443
Accumulated other comprehensive income attributable to NanoSynex
131,891
Forgiveness of debt
( 3,077,941 )
Loss on deconsolidation of NanoSynex
$ ( 4,479,010 )
NOTE
7 — ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accrued
expenses and other current liabilities consisted of the following at December 31, 2024 and 2023:
SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
December 31,
December 31,
2024
2023
Board compensation
$ —
$ 129,499
Interest (Convertible debt)
—
10,004
License fees
14,427
32,975
Payroll
—
1,215
Professional fees
109,324
121,775
Research and development
—
104,402
Vacation
46,492
151,286
Other
8,850
Accrued expenses and
other current liabilities
$ 170,243
$ 560,006
As
of December 31, 2023, accrued liabilities attributable to Qualigen Inc, and NanoSynex were deemed disposed of as discontinued operations
(see Note 6 – Discontinued Operations).
46
NOTE
8 – WARRANT LIABILITIES
In
2004, the Company issued warrants to various investors and brokers for the purchase of Series C preferred stock in connection with a
private placement (the “Series C Warrants”). The Series C Warrants were subsequently extended and, upon closing of the reverse
recapitalization transaction with Ritter, exchanged for warrants to purchase common stock of the Company. The Series C Warrants were
determined to be liability-classified pursuant to the guidance in ASC 480 and ASC 815-40, based on the inclusion of a leveraged ratchet
provision for subsequent dilutive issuances. As of December 31, 2022 there were 26,992 Series C Warrants outstanding with an exercise
price of $ 66.00 per share. On November 24, 2023, 21,952 Series C Warrants expired, and on December 5, 2023 the remaining Series C Warrants
were repriced from an exercise price of $ 66.00 per share to an exercise price of $ 36.50 per share, with 4,074 additional ratchet Series
C Warrants issued, resulting in 9,113 Series C Warrants outstanding and exercisable as of December 31, 2023.
On
February 27, 2024, these Series C Warrants were repriced again as a result of a down-round provision triggered by a Securities Purchase
Agreement with Alpha for the purchase of the February 2024 Debentures described below, from an exercise price of $ 36.50 per share to
an exercise price of $ 13.00 per share, with 16,473 additional ratchet Series C Warrants issued, resulting in 25,586 Series C Warrants,
which expired on June 26, 2024. During the year ended December 31, 2024, the Company recorded a gain on change in fair value of warrant
liabilities of $ 54,600 for the Series C Warrants.
In
December 2022, in conjunction with the issuance of a convertible debenture to Alpha (see Note 9 – Convertible Debt), the Company
issued to Alpha a warrant to purchase 50,000 shares of the Company’s common stock (the “Alpha Warrant”). The exercise
price of the Alpha Warrant was $ 82.50 (equal to 125 % of the conversion price of the Debenture on the closing date). The Alpha Warrant
may be exercised by Alpha, in whole or in part, on or after June 22, 2023 and at any time before June 22, 2028, subject to certain terms
and conditions described in the Alpha Warrant. On December 5, 2023, the Company entered into an Amendment No. 1 with regard to a Securities
Purchase Agreement with Alpha. This Amendment eliminated certain adjustment provisions of the Warrant. The Company determined that the
event resulted in equity classification for the Alpha Warrant and, accordingly, the Company remeasured the fair value on that date and
reclassified to noncompensatory equity classified warrants (see Note 13 – Stockholders Equity (Deficit)).
On
February 27, 2024, in connection with an 8 % Convertible Debenture (the “2024 Alpha Debenture”) in the principal amount of
$ 550,000 issued to Alpha (see Note 9 – Convertible Debt), the Company issued a noncompensatory equity classified warrant to Alpha
(the “2024 Alpha Warrant”) to purchase 18,001 shares of common stock, at an exercise price of $ 13.00 per share, which may
be exercised in whole or in part, at any time before February 27, 2029. On September 6, 2024 as a result of the down-round provision
triggered by shares sold in a public offering, the above warrants were repriced from $ 13.00 per share exercise price to $ 6.50 per share
exercise price. As a result of a partial voluntary conversion of the 2024 Alpha Debenture on September 9, 2024, the Company no longer
had sufficient shares to settle the 2024 Alpha Warrant in full until shareholder approval was obtained, and a portion ( 2,314 warrant
shares with a fair value of $ 14,997 ) was reclassified to liabilities. Shareholder approval was subsequently obtained on October 25, 2024,
and as of that date, the Company determined that shareholder approval resulted in equity classification for the warrant and, accordingly,
the Company remeasured the warrant liability to fair value, and reclassified to noncompensatory equity classified warrants (see Note
13 – Stockholders Equity (Deficit)). During the year ended December 31, 2024, the Company recorded a gain on change in fair value
of warrant liabilities of $ 3,072 for these warrants.
On
April 12, 2024 , in connection with an 8 % Convertible Debenture in the principal amount of $ 1,100,000 issued to Yi Hua Chen (“Chen”)
(see Note 9 – Convertible Debt), the Company issued a liability classified warrant to Chen to purchase 36,001 shares of common
stock, exercisable until February 27, 2029. On September 6, 2024 , as a result of a down-round provision triggered by shares sold
in a public offering, the warrant was repriced from an exercise price of $ 13.00 per share to an exercise price of $ 6.50 per share. The
warrant was initially liability classified due to an insufficient number of authorized shares to settle the warrant prior to the receipt
of shareholder approval, which was subsequently obtained on October 25, 2024. As of that date, the Company determined that shareholder
approval resulted in equity classification for the warrant and accordingly, the Company remeasured the warrant liability to fair value,
and reclassified to noncompensatory equity classified warrants (see Note 13 – Stockholders Equity (Deficit)). The fair value of
this warrant was $ 565,582 on the issuance date and $ 185,531 on the date of reclassification to equity. During the year ended December
31, 2024, the Company recorded a gain on change in fair value of warrant liabilities of $ 380,051 for this warrant.
On
November 20, 2024, the Company closed its private placement transaction resulting in the issuance of newly designated Series A-2 Preferred
Stock (see Note 13 – Stockholders Equity (Deficit)). As a result of the issuance of a new class of voting securities, the Company
evaluated its equity classified warrants’ respective terms, and concluded that warrants for 68,712 common shares with a weighted
average exercise price of $ 2.00 and a fair value of $ 247,262 were required to be reclassified to liabilities as of November 20, 2024.
During the year ended December 31, 2024 the Company recorded a loss on change in fair value of warrant liabilities of $ 21,913 for these
warrants.
47
The
following table summarizes the activity in liability classified warrants for the year ended December 31, 2024:
SCHEDULE OF WARRANTS ACTIVITY
Common Stock Warrants
Shares
Weighted– Average Exercise Price
Range of Exercise Price
Weighted– Average Remaining Life (Years)
Total outstanding – December 31, 2023
9,113
$ 36.50
$ 36.50 - $ 36.50
0.49
Granted
52,474
$ 8.54
$ 6.50 - $ 13.00
4.16
Exercised
—
—
—
—
Reclassified from equity
71,026
$ 2.14
$ 0.05 - $ 7.80
n/a
Reclassified to equity
( 38,315 )
$ 6.50
$ 6.50 - $ 6.50
4.16
Expired
( 25,586 )
$ 13.00
$ 13.00 - $ 13.00
—
Total outstanding – December 31, 2024
68,712
$ 2.00
$ 0.05 - $ 7.80
n/a
Exercisable
52,693
$ 0.23
$ 0.05 - $ 6.50
n/a
The
following table summarizes the activity in liability classified warrants for the year ended December 31, 2023:
Common Stock Warrants
Shares
Weighted– Average Exercise Price
Range of Exercise Price
Weighted– Average Remaining Life (Years)
Total outstanding – December 31, 2022
76,992
$ 76.72
$ 66.00 - $ 82.50
3.9
Granted
9,113
$ 36.50
$ 36.50 - $ 36.50
0.49
Exercised
—
—
—
—
Reclassified to equity
( 50,000 )
$ 82.50
$ 82.50 - $ 82.50
—
Forfeited
( 5,040 )
$ 66.00
$ 66.00 - $ 66.00
—
Expired
( 21,952 )
$ 66.00
$ 66.00 - $ 66.00
—
Total outstanding – December 31, 2023
9,113
$ 36.50
$ 36.50 - $ 36.50
0.49
Exercisable
9,113
$ 36.50
$ 36.50 - $ 36.50
0.49
The
following table presents the Company’s fair value hierarchy for its warrant liabilities measured at fair value on a recurring basis
as of December 31, 2024:
SCHEDULE OF FAIR VALUE HIERARCHY FOR WARRANT LIABILITIES
Quoted
Market
Significant
Prices for
Other
Significant
Identical
Observable
Unobservable
Assets
Inputs
Inputs
Common Stock Warrant liabilities
(Level 1)
(Level 2)
(Level 3)
Total
Balance as of December 31, 2023
$ —
$ —
$ 54,600
$ 54,600
Granted
—
—
565,582
565,582
Exercised
—
—
—
—
Fair value of warrants reclassified from equity
—
—
262,259
262,259
Fair value of warrants reclassified to equity
—
—
( 197,456 )
( 197,456 )
Gain on change in fair value of warrant liabilities
—
—
( 415,810 )
( 415,810 )
Balance as of December 31, 2024
$ —
$ —
$ 269,175
$ 269,175
During
the year ended December 31, 2024, warrants for 71,026 common shares with a weighted average exercise price of $ 2.14 and a fair value
of $ 262,259 were reclassified from equity to liabilities, and warrants for 38,315 common shares with a weighted average exercise price
of $ 6.50 and a fair value of $ 197,456 were reclassified from liabilities to equity. There were no transfers of financial assets or liabilities
between category levels for the year ended December 31, 2024.
48
The
following table presents the Company’s fair value hierarchy for its warrant liabilities measured at fair value on a recurring basis
as of December 31, 2023:
Quoted
Market
Significant
Prices for
Other
Significant
Identical
Observable
Unobservable
Assets
Inputs
Inputs
Common Stock Warrant liabilities
(Level 1)
(Level 2)
(Level 3)
Total
Balance as of December 31, 2022
$ —
$ —
$ 3,622,647
$ 3,622,647
Exercises
—
—
—
—
Fair value of warrant reclassified from liabilities to equity
—
—
( 1,626,694 )
( 1,626,694 )
Loss on debt extinguishment
—
—
94,116
94,116
Gain on change in fair value of warrant liabilities
—
—
( 2,035,469 )
( 2,035,469 )
Balance as of December 31, 2023
$ —
$ —
$ 54,600
$ 54,600
There
were no transfers of financial assets or liabilities between category levels for the year ended December 31, 2023.
The
value of the warrant liabilities was based on valuations received from an independent valuation firm determined using a Monte-Carlo simulation
and internally generated Black Scholes valuations. Due to the nominal exercise price of the 2024 Pre-Funded Warrants and indefinite term,
the Company calculated an implied value of the 2024 Pre-Funded Warrants based on the underlying common stock price on the valuation date,
less the exercise price. For volatility, the Company considers comparable public companies as a basis for its expected volatility to
calculate the fair value of common stock warrants and transitions to its own volatility as the Company develops sufficient appropriate
history as a public company. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected term
of the common stock warrant. The Company uses an expected dividend yield of zero based on the fact that the Company has never paid cash
dividends and does not expect to pay cash dividends in the foreseeable future. Any significant changes in the inputs may result in significantly
higher or lower fair value measurements.
The
following are the weighted average and the range of assumptions used in estimating the fair value of warrant liabilities (weighted
average calculated based on the number of outstanding warrants on each issuance) as of December 31, 2024 and 2023:
SCHEDULE
OF ASSUMPTIONS OF WARRANT LIABILITIES
December 31, 2024
December 31, 2023
Range
Weighted
Average
Actual
Risk-free interest rate
4.24 % — 4.38 %
4.37 %
5.13 %
Expected volatility (peer group)
117.5 % — 133.5 %
132.1 %
68.9 %
Term of warrants (in years)
0.4 — 4.7
4.32
0.49
Expected dividend yield
0.00 %
0.00 %
0.00 %
NOTE
9 — CONVERTIBLE DEBT
2022
Convertible Debenture (Related party)
On
December 22, 2022, the Company issued to Alpha an 8 % Senior Convertible Debenture in the aggregate principal amount of $ 3,300,000 (the
“2022 Debenture”) for a purchase price of $ 3,000,000 pursuant to the terms of a Securities Purchase Agreement, dated December
21, 2022 (the “2022 Securities Purchase Agreement”). The 2022 Debenture carried a maturity date of December 22, 2025 and
was convertible, at any time, at Alpha’s option, into shares of the Company’s common stock (the “Conversion Shares”),
at a price initially equal to $ 66.00 per share, subject to adjustment as described in the 2022 Debenture. On July 13, 2023, the Company
obtained stockholder approval, for purposes of complying with Nasdaq Listing Rule 5635(d), to allow for the issuance to Alpha of more
than 20 % of our issued and outstanding shares of common stock pursuant to the terms and conditions of the 2022 Debenture, and the common
stock purchase warrant dated December 22, 2022 (the “2022 Warrant”) issued by us to Alpha.
Commencing
June 1, 2023, the Company was required to redeem $ 110,000 monthly, plus accrued and unpaid interest in cash, or, subject to the Equity
Conditions (as defined in the 2022 Debenture) having been satisfied or waived, in shares of our common stock, based on a conversion price
equal to the lesser of (i) the then-effective conversion price of the 2022 Debenture and (ii) 85 % of the average of the VWAPs (as defined
in the 2022 Debenture) for the five consecutive trading days ending on the trading day immediately before the applicable monthly redemption
date. The 2022 Debenture accrued interest at the rate of 8 % per annum beginning on December 1, 2023, and was payable on a monthly or
quarterly basis in cash or, subject to the Equity Conditions having been satisfied or waived, shares or a combination thereof at our
option.
49
In
December 2022, pursuant to the terms of the 2022 Securities Purchase Agreement, we entered into a registration rights agreement with
Alpha (the “Registration Rights Agreement”), pursuant to which we agreed to file one or more registration statements, as
necessary, and to the extent permissible, to register under the Securities Act the resale of the remaining shares (underlying the 2022
Debenture and the 2022 Warrant) not otherwise registered under the Company’s registration statement on Form S-3 (File No. 333-266430).
We filed a resale registration statement on Form S-3 pursuant to the requirements of the Registration Rights Agreement on December 2022
(File Number 333-269088), which registration statement was declared effective by the SEC on January 5, 2023. On September 1, 2023, we
filed a Post-Effective Amendment No. 1 to Form S-3 on Form S-1 (File No. 333-269088), which Post-Effective Amendment was declared effective
by the SEC on September 7, 2023. On May 1, 2024, we filed a Post-Effective Amendment No. 2 to Form S-1 on Form S-3 (File No. 333-269088),
which Post-Effective Amendment was declared effective by the SEC on May 2, 2024.
The
Company evaluated the 2022 Debenture and the 2022 Warrant and determined that the 2022 Warrant is a freestanding financial instrument.
Initially, the 2022 Warrant is not considered indexed to the Company’s own stock, because the settlement amount would not equal
the difference between the fair value of a fixed number of the Company’s equity shares and a fixed strike price and all of the
adjustment features in Section 3(b) of the Alpha Warrant are not down round provisions, as defined in ASU 2017-11. Accordingly, the 2022
Warrant was classified as a liability and recognized at fair value, with subsequent changes in fair value recognized in earnings.
The
proceeds from the 2022 Debenture were allocated to the initial fair value of the 2022 Warrant, with the residual balance allocated to
the initial carrying value of the 2022 Debenture. The Company has not elected the fair value option for the 2022 Debenture. The 2022
Debenture was recognized as proceeds received after allocating the proceeds to the 2022 Warrant, and then allocating remaining proceeds
to a suite of bifurcated embedded derivative features (conversion option, contingent acceleration upon an Event of Default, and contingent
interest upon an Event of Default), with the resulting difference, if any, allocated to the loan host instrument. The suite of derivative
features was measured and initially determined to have no fair value.
On
December 5, 2023, the Company and Alpha executed Amendment No. 1 to the 2022 Securities Purchase Agreement (the “SPA Amendment”),
pursuant to which the Company and Alpha agreed to, among other things, reduce the Conversion Price of the 2022 Debenture from $ 66.00
per share to $ 36.50 per share and reduce the exercise price of the 2022 Warrant from $8 2.50 per share to $ 36.50 per share, in each case
subject to certain adjustments. In addition, the SPA Amendment revised certain provisions of the 2022 Warrant to (i) limit the circumstances
which would trigger a potential adjustment to the exercise price of the 2022 Warrant and (ii) clarify the treatment of the 2022 Warrant
upon a Fundamental Transaction. The purpose of these revisions was to remove the terms that caused the 2022 Warrant to be liability-classified
under U.S. GAAP. The Company performed an assessment and concluded that (i) all remaining adjustment features in the revised language
meet the FASB’s definition of a down-round feature, and (ii) the 2022 Warrant, as amended, met all of the additional requirements
for equity classification. Accordingly, as of December 5, 2023, the Company remeasured the 2022 Warrant to its fair value immediately
prior to the modification and recognized the change in fair value in earnings. The incremental fair value impact from the 2022 Warrant
modification of $ 0.09 million was included in the Company’s evaluation of the 2022 Debenture modification under ASC 470, discussed
further below. The Company then reclassified the 2022 Warrant liability to equity at its post-modification fair value of $ 1.6 million.
In
accordance with ASC 470-50, the Company determined that the modified terms of the 2022 Debenture were substantially different when compared
to the original terms that existed prior to the SPA Amendment, and thus the event was required to be accounted for as a debt extinguishment.
Accordingly, the Company derecognized the net carrying value of the original Debenture, and recorded the new debt instrument at its fair
value of $ 1.4 million, and recorded a $ 0.6 million loss on debt extinguishment. The difference between the remaining 2022 Debenture principal
and its fair value on December 5, 2023 was recorded as a debt discount, which was amortized to interest expense over the expected term
of the Debenture using the effective interest method, in accordance with ASC 835-30.
During
the year ended December 31, 2023, the Company issued a total of (i) 16,834 shares of our common stock upon Alpha’s partial voluntary
conversion of the 2022 Debenture at a conversion price of $ 66.00 per share, extinguishing a total of $ 1,111,078 principal, and (ii) 6,193
shares of common stock to Alpha in lieu of cash for monthly redemption payments totaling $ 220,000 due on the 2022 Debenture at a weighted
average conversion price of $ 35.52 per share. During the year ended December 31, 2023, the Company paid monthly redemption payments of
$ 550,000 in cash, and recorded accrued interest of approximately $ 1.5 million in other expenses in the consolidated statements of operations.
As of December 31, 2023, the fair value of the suite of bifurcated embedded derivative features was $ 0 .
During
the year ended December 31, 2023, the Company recognized an extinguishment loss on voluntary conversions of the 2022 Debenture of approximately
$ 1.1
million, and a loss on debt extinguishment totaling $ 0.6
million upon monthly redemptions of the 2022 Debenture and the December 2023 modification, which are presented in the expenses in the
consolidated statements of operations.
On
February 27, 2024, in connection with the issuance of an additional warrant to Alpha with an exercise price of $ 13.00 per share, and
pursuant to certain antidilution provisions in the 2022 Debenture, the Conversion Price of the 2022 Debenture was reduced from $ 36.50
per share to $ 13.00 per share.
During
the year ended December 31, 2024, the Company issued a total of 45,496 shares of common stock to Alpha in lieu of cash for monthly redemption
payments totaling $ 660,000 due on the 2022 Debenture at a weighted average conversion price of $ 14.51 per share, resulting in a net loss
on debt extinguishment of approximately $ 209,000 in other expenses on the consolidated statements of operations. No redemption payments
were paid in cash during the year ended December 31, 2024. Interest expense on the 2022 Debenture was approximately $ 162,000 for the
year ended December 31, 2024, of which approximately $ 120,000 was attributable to discount amortization), which is reported in other
expenses in the consolidated statement of operations.
50
In
June and July 2024, Alpha voluntarily converted the aggregate remaining principal of the 2022 Debenture of $ 758,922 , extinguishing the
Company’s obligations in full with respect to the 2022 Debenture and suite of bifurcated embedded derivative features. As a result
of such voluntary conversions, the Company issued a total of 58,378 shares of common stock at a weighted average conversion price of
$ 13.00 . The Company recorded a gain on voluntary conversions of approximately $ 85,000 during the year ended December 31, 2024. As of
December 31, 2024, there were no amounts outstanding under the 2022 Debenture.
2024
Alpha Debenture (Related party)
On
February 27, 2024, pursuant to a Securities Purchase Agreement executed with Alpha on February 27, 2024 (the “2024 Securities Purchase
Agreement”) we issued to Alpha an 8 % Convertible Debenture (the “2024 Alpha Debenture”) with a principal amount of
$ 550,000 , for a gross purchase price of $ 500,000 less expenses. The 2024 Alpha Debenture carried a maturity date of December 31, 2024
and was convertible, at any time, and from time to time, at Alpha’s option, into shares of common stock of the Company, at a conversion
price initially equal to $ 30.56 per share, subject to adjustment as described in the 2024 Alpha Debenture. Upon the closing of the public
offering on September 6, 2024 per the terms of the antidilution provisions in the 2022 Debenture, the conversion price of the 2024 Alpha
Debenture was reduced from $ 30.56 to $ 6.50 per share. The 2024 Alpha Debenture accrued interest on its outstanding principal balance
at the rate of 8 % per annum, payable at maturity. In connection with this issuance, we also issued to Alpha a noncompensatory equity
classified 5 -year common stock purchase warrant (the “2024 Alpha Warrant”) to purchase 18,001 shares of our common stock
at an exercise price initially equal to $ 13.00 per share (see Note 13 - Stockholders Equity (Deficit)).
Pursuant
to the 2024 Securities Purchase Agreement, we also granted to Alpha an option (the “Option”), exercisable until July 1, 2024,
to purchase from us an additional 8 % Convertible Debentures, of like tenor, with a face amount of up to $ 1.1 million (and with a proportional
number of accompanying common stock warrants of like tenor, up to a total of 36,001 additional warrants), for a purchase price of $ 1.0
million.
The
Company evaluated the terms of the 2024 Securities Purchase Agreement and determined that the 2024 Alpha Warrant and the Option issued
to Alpha are each considered freestanding financial instruments. The 2024 Alpha Warrant was further determined to initially (i) be indexed
to the Company’s own stock, and (ii) meet all of the additional criteria for permanent equity classification. As the Option required
the Company to issue convertible debt with multiple cash settlement alternatives, the Option was classified as a liability and recognized
at fair value, with subsequent changes in fair value recognized in earnings.
The
net proceeds from the issuance of the 2024 Alpha Debenture were allocated first to the liability-classified Option and the bifurcated
embedded features in the 2024 Alpha Debenture (conversion option, contingent acceleration upon an Event of Default, and contingent interest
upon an Event of Default), with the resulting difference, if any, allocated to the loan host instrument and the equity-classified warrant
on a relative fair value basis. The fair value of the Option was estimated to be $ 0.8 million at issuance, and the suite of bifurcated
embedded derivative features was $ 0.08 million. As the fair value of the liability-classified instruments and features exceeded the net
proceeds received, the Company recognized a loss on issuance of convertible debt of $ 0.4 million, presented in other expenses in the
consolidated statements of operations. As a result, the Company recorded a debt discount at the maximum amount equal to the principal
of $ 550,000 , which was amortized as additional interest expense over the expected term of the 2024 Alpha Debenture.
On
September 9, 2024 we issued 7,842 shares of common stock upon Alpha’s partial voluntary conversion of the 2024 Alpha Debenture
at a conversion price of $ 6.50 per share for a total of $ 50,979 in principal. The Company recognized a loss on partial voluntary conversion
of approximately $ 29,000 .
During
the year ended December 31, 2024, interest expense on the 2024 Alpha Debenture was approximately $ 486,000 , of which approximately $ 473,000
was attributable to discount amortization), which is reported in other expenses in the consolidated statements of operations.
On
November 20, 2024, in connection with the closing of the Company’s private placement transaction and issuance of Series A-2 Preferred
Stock, the Company used $ 530,839 of the proceeds to repay the outstanding principal and accrued interest on the Alpha Debenture, in full
settlement of the obligation. The Company recognized a debt extinguishment loss of $ 68,000 on the settlement date, representing the difference
between (i) the cash reacquisition price, and (ii) the net carrying value of the debt, inclusive of unamortized discounts and issuance
costs and the fair value of the associated suite of bifurcated derivative liabilities on the settlement date. As of December 31, 2024,
there were no amounts outstanding under the 2024 Alpha Debenture.
51
2024
Chen Debenture (Related party)
In
April 2024, Alpha assigned the Option to Yi Hua Chen (“Chen”) and Chen exercised the option in full, in exchange for $ 1,000,000 ,
less expenses, we issued to Chen an 8 % Convertible Debenture (the “2024 Chen Debenture”) with a principal amount of $ 1,100,000 .
The 2024 Chen Debenture carried a maturity date of December 31, 2024 and was convertible, at any time, and from time to time, at Chen’s
option, into shares of common stock of the Company at a conversion price initially equal to $ 30.56 per share, subject to adjustment as
described in the 2024 Chen Debenture. Upon the closing of the public offering on September 6, 2024 per the terms of the antidilution
provision, the conversion price of the 2024 Chen Debenture was reduced from $ 30.56 to $ 6.50 per share. The 2024 Chen Debenture accrues
interest on its outstanding principal balance at the rate of 8 % per annum, payable at maturity. In connection with this issuance, we
also issued to Chen a 5 -year liability classified common stock purchase warrant (the “2024 Chen Warrant”) to purchase 36,001
shares of our common stock at an exercise price initially equal to $ 13.00 per share (see Note 8 - Warrant Liabilities).
The
Company evaluated the terms of the 2024 Chen Debenture and the 2024 Chen Warrant and determined that the 2024 Chen Warrant was considered
a freestanding financial instrument. The 2024 Chen Warrant was further determined to be indexed to the Company’s own stock. However,
the 2024 Chen Warrant failed to meet the additional criteria for permanent equity classification due to a lack of authorized shares available
to settle the instrument, as the Company was required to obtain shareholder approval to issue all shares underlying the 2024 Securities
Purchase Agreement to comply with the rules of Nasdaq. The Company has adopted a sequencing approach under ASC 815-40, Derivatives
and Hedging - Contracts in Entity’s Own Equity to determine the classification of its contracts at issuance and at each subsequent
reporting date, whereby shares are allocated based on the earliest issuance date of potentially dilutive instruments, with the earliest
issuance date receiving the first allocation of shares. In the event of identical issuance dates, shares are then allocated beginning
with instruments with the latest maturity date first. Pursuant to this sequencing approach, as of April 27, 2024, we determined that
the authorized shares were sufficient to settle the 2024 Alpha Warrant and was therefore classified in equity. The Company determined
the remaining shares were not sufficient to settle the 2024 Chen Warrant and therefore classified as a liability at fair value,
with subsequent changes in fair value recognized in earnings, until such shareholder approval was obtained on October 25, 2024 (see Note
8 - Warrant Liabilities).
The
net proceeds from the issuance of the 2024 Chen Debenture, inclusive of the fair value of the settled Option on April 12, 2024 of $ 0.7
million, was first allocated to the liability-classified 2024 Chen Warrant and the bifurcated embedded features in the 2024 Chen Debenture,
with the resulting difference, if any, allocated to the loan host instrument. As a result, the fair value of the 2024 Chen Warrant at
issuance of $ 0.6 million at issuance and the suite of bifurcated embedded derivative features of $ 0.03 million comprised the initial
debt discount, which was amortized to interest expense over the expected term of the 2024 Chen Debenture using the effective interest
method, in accordance with ASC 835-30.
During
the year ended December 31, 2024, interest expense on the 2024 Chen Debenture was approximately $ 78,000 , of which approximately $ 23,000
was attributable to discount amortization), which is reported in other expenses in the consolidated statements of operations.
On
November 20, 2024, in connection with the closing of the Company’s private placement transaction and issuance of Series A-2 Preferred
Stock, on November 18, 2024, the Company and Chen executed an Exchange Agreement (the “Exchange Agreement”), agreeing to
convert all outstanding principal and accrued interest on the 2024 Chen Debenture as of November 20, 2024 (totaling approximately $ 1,154,000 ),
in exchange for 1,154 shares of newly designated Series A-2 Preferred Stock, in full settlement of the Company’s obligations with
respect to the Chen Debenture. The Company recognized a debt extinguishment gain of $ 13,000 upon conversion, representing the difference
between (i) the reacquisition price, consisting of the fair value of the preferred shares issued, and (ii) the net carrying value of
the debt, inclusive of unamortized discounts and issuance costs and the fair value of the associated suite of bifurcated derivative liabilities
on the settlement date. As of December 31, 2024, there were no amounts outstanding under the 2024 Chen Debenture.
Convertible
debt is comprised of the following as of December 31, 2024 and December 31, 2023:
SCHEDULE OF CONVERTIBLE DEBT
December 31, 2024
December 31, 2023
Convertible debt - related party
$ —
$ 1,418,922
Discount on convertible debt - related party
—
( 119,706 )
Total convertible debt - related party
$ —
$ 1,299,216
52
A
reconciliation of the beginning and ending balances for the derivative liabilities arising from the issuance of convertible debt is as
follows for the year ended December 31, 2024:
SCHEDULE OF DERIVATIVE LIABILITIES
Derivative Liabilities Arising From Issuance of Convertible Debt
Quoted
Market
Prices for
Identical
Assets
(Level 1)
Significant
Other
Observable
Inputs
(Level 2)
Significant
Unobservable
Inputs
(Level 3)
Total
Balance as of December 31, 2023
$ —
$ —
$ —
$ —
Granted
—
—
215,897
215,897
Net gain on change in fair value of derivative liabilities
—
—
( 191,068 )
( 191,068 )
Extinguished upon settlement of convertible debt
—
—
( 24,829 )
( 24,829 )
Balance as of December 31, 2024
$ —
$ —
$ —
$ —
The
value of the derivative liabilities was estimated based on valuations received from an independent valuation firm determined using a
Monte-Carlo simulation or a binomial lattice model. For volatility, the Company considers comparable public companies as a basis for
its expected volatility to calculate the fair value of derivative liabilities and transitions to its own volatility as the Company develops
sufficient appropriate history as a public company. The risk-free interest rate is based on U.S. Treasury notes with a term approximating
the expected term of the debt. The Company uses an expected dividend yield of zero based on the fact that the Company has never paid
cash dividends and does not expect to pay cash dividends in the foreseeable future. Any significant changes in the inputs may result
in significantly higher or lower fair value measurements.
As
of December 31, 2024, no derivative liabilities measured at fair value using significant unobservable inputs are outstanding.
53
NOTE
10 — EARNINGS (LOSS) PER SHARE
Basic
loss per share (“EPS”) is computed by dividing net loss including deemed dividends by the weighted-average number of common
shares outstanding plus unexercised pre-funded warrants. Diluted EPS is computed based on the sum of the weighted-average number of common
shares and potentially dilutive common shares outstanding during the period. Potentially dilutive common shares consist of shares issuable
from preferred stock, convertible debt, stock options and warrants.
These potentially dilutive securities have been excluded from diluted net loss per share as of December 31, 2024 and 2023 because
their effect would be anti-dilutive:
SCHEDULE
OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE
2024
2023
For the Years Ended
December 31,
2024
2023
Net loss used for basic earnings per share
$ ( 6,346,795 )
$ ( 13,417,212 )
Basic weighted-average common shares outstanding
361,587
101,454
Dilutive potential shares issuable from preferred stock, convertible debt, stock options and warrants
—
—
Diluted weighted-average common shares outstanding
361,587
101,454
The
following potentially dilutive securities have been excluded from diluted net loss per share as of December 31, 2024 and 2023 because
their effect would be anti-dilutive:
As of December 31,
2024
2023
Shares of common stock subject to outstanding options
1,870
7,978
Shares of common stock subject to outstanding warrants (excluding pre-funded warrants)
90,026
61,634
Shares of common stock subject to outstanding preferred stock
3,437,363
—
Shares of common stock subject to outstanding convertible debt
—
38,875
Total common stock equivalents
3,529,259
108,487
NOTE
11 — COMMITMENTS AND CONTINGENCIES
Litigation
and Other Legal Proceedings
On
January 29, 2025, the Company was named as a defendant in an action brought by LifeSci Capital LLC (“LifeSci”) in the U.S.
District Court for the Southern District of New York. The complaint alleges that the Company failed to pay $ 503,483 in connection with
offerings of the Company’s common stock that occurred during the tail period of the agreement, pursuant to an engagement under
which the Company retained LifeSci to serve as its placement agent and financial advisor.
The
Company filed its answer on March 17, 2025, denying the material allegations in the complaint and asserting various affirmative defenses.
As of May 29, 2025, the matter is in the discovery phase.
The
Company disputes that any amount is owed and is vigorously defending the lawsuit. Based on the current stage of the proceedings and the
information available at this time, the Company does not believe a loss is probable or reasonably estimable.
NOTE
12 — RESEARCH AND LICENSE AGREEMENTS
UCL
Business Limited
In
January 2022, the Company entered into a License Agreement with UCL Business Limited to obtain an exclusive worldwide in-license of a
genomic quadruplex (G4)-selective transcription inhibitor drug development program which had been developed at University College London,
including lead and back-up compounds, preclinical data and a patent estate. (UCL Business Limited is the commercialization company for
University College London.) The program’s lead compound is now being developed at the Company under the name QN-302 as a candidate
for treatment for pancreatic ductal adenocarcinoma, which represents the vast majority of pancreatic cancers. The License Agreement required
a $ 150,000 upfront payment, reimbursement of past patent prosecution expenses (approximately $ 160,000 ), and (if and when applicable)
tiered royalty payments in the low to mid-single digits, clinical/regulatory/sales milestone payments and a percentage of any non-royalty
sublicensing consideration paid to the Company.
For
the years ended December 31, 2024 and 2023 there were license costs of $ 2,000 and approximately $ 128,000 , respectively, related to this
agreement which are included in research and development expenses in the consolidated statements of operations and other comprehensive
loss.
QN-302
Phase 1 Study
In
June 2023, the Company entered into a Master Clinical Research Services Agreement with Translational Drug Development, LLC (“TD2”)
whereby TD2 agreed to perform certain clinical research and development services for the Company including but not limited to trial management,
side identification and selection, site monitoring/management, medical monitoring, project management, data collection, statistical programming
or analysis, quality assurance auditing, scientific and medical communications, regulatory affairs consulting and submissions, strategic
consulting, and/or other related services. From time to time, the Company may enter into statements of work with TD2 for the performance
of specific services under this Master Clinical Research Services Agreement.
54
In
June 2023, the Company entered into a Master Laboratory Services Agreement with MLM Medical Labs, LLC (“MLM”) whereby MLM
agreed to perform certain clinical research and development services for the Company including but not limited to laboratory, supply,
testing, validation, data management, and storage services. From time to time, the Company may enter into work orders with MLM for the
performance of specific services under this Master Laboratory Services Agreement.
In
June 2023, the Company entered into a Master Services Agreement with Clinigen Clinical Supplies Management, Inc. (“Clinigen”)
whereby Clinigen agreed to provide certain pharmaceutical products and/or services. From time to time, the Company may enter into statements
of work with Clinigen for the performance of specific services under this Master Services Agreement.
In
July 2023, pursuant to the above agreements, the Company entered into work orders and statements of work for clinical trial services
for the conduct of the QN-302 Phase 1 study. Given our financial situation, the company slowed the development
of the QN-302 Phase 1 Study beginning in the second quarter of 2024.
University
of Louisville Research Foundation
In
March 2019, the Company entered into a sponsored research agreement and an option for a license agreement with University of Louisville
Research Foundation, Inc. (“ULRF”) for development of several small-molecule RAS interaction inhibitor drug candidates. Under
the terms of this agreement, the Company agreed to reimburse ULRF for sponsored research expenses of initially up to $ 693,000 for this
program. This agreement was amended in February 2021, March 2022 and August 2023, with the current term of this agreement expired in
December 2023 and the aggregate amount that the Company would reimburse ULRF for sponsored research expenses increased to approximately
$ 2.9 million. In July 2020, the Company entered into an exclusive license agreement with ULRF for RAS interaction inhibitor drug candidates.
Under the agreement, the Company took over development, regulatory approval and commercialization of the candidates from ULRF and is
responsible for maintenance of the related intellectual property portfolio. In return, ULRF received approximately $112,000 for an upfront
license fee and reimbursement of prior patent costs. In addition, the Company has agreed to pay ULRF (i) royalties, on patent-covered
net sales associated with the commercialization, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net sales above a cumulative
$250,000,000), until expiration of the licensed patent, and 2.5% (on net sales for any sales not covered by Licensed Patents), (ii) 30%
to 50% of any non-royalty sublicensee income received (50% for sublicenses granted in the first two years of the ULRF license agreement,
40% for sublicenses granted in the third or fourth years of the ULRF license agreement, and 30% for sublicenses granted in the fifth
year of the ULRF license agreement or thereafter), (iii) reimbursements for ongoing costs associated with the preparation, filing, prosecution
and maintenance of licensed patents, incurred prior to July 2020, and (iv) payments ranging from $ 50,000 to $ 5,000,000 upon the achievement
of certain regulatory and commercial milestones. Milestone payments for the first therapeutic indication would be $ 50,000 for first dosing
in a Phase 1 clinical trial, $ 100,000 for first dosing in a Phase 2 clinical trial, $ 150,000 for first dosing in a Phase 3 clinical trial,
$300,000 for regulatory marketing approval and $ 5,000,000 upon achieving a cumulative $ 500,000,000 of Licensed Product sales. The Company
also must pay ULRF shortfall payments if the total amounts actually paid with respect to royalties and non-royalty sublicensee income
for any year is less than the applicable annual minimum (ranging from $ 20,000 to $ 100,000 ) for such year.
Sponsored
research expenses related to these agreements for the years ended December 31, 2024 and 2023 were $ 0 and $ 743,000 . License costs were
approximately $ 68,000 and $ 133,000 related to these agreements for the years ended December 31, 2024 and 2023, respectively, and are
included in research and development expenses in the consolidated statements of operations and other comprehensive loss.
Between
June 2018 and April 2022, the Company entered into license and sponsored research agreements with ULRF for QN-247, a novel aptamer-based
compound that has shown promise as an anticancer drug. Under the agreements, the Company took over development, regulatory approval and
commercialization of the compound from ULRF and is responsible for maintenance of the related intellectual property portfolio. In return,
ULRF received a $ 50,000 convertible promissory note in payment of an upfront license fee, which was subsequently converted into the Company’s
common stock, and the Company agreed to reimburse ULRF for sponsored research expenses of up to approximately $ 805,000 and prior patent
costs of up to $ 200,000 . In addition, the Company agreed to pay ULRF (i) royalties, on patent-covered net sales associated with the commercialization
of anti-nucleolin agent-conjugated nanoparticles, of 4% (on net sales up to a cumulative $250,000,000) or 5% (on net sales above a cumulative
$250,000,000), until expiration of the last to expire of the licensed patents, (ii) 30% to 50% of any non-royalty sublicensee income
received (50% for sublicenses granted in the first two years of the ULRF license agreement, 40% for sublicenses granted in the third
or fourth years of the ULRF license agreement, and 30% for sublicenses granted in the fifth year of the ULRF license agreement or thereafter),
(iii) reimbursements for ongoing costs associated with the preparation, filing, prosecution and maintenance of licensed patents, incurred
prior to June 2018, and (iv) payments ranging from $ 100,000 to $ 5,000,000 upon the achievement of certain regulatory and commercial milestones.
Milestone payments for the first therapeutic indication would be $ 100,000 for first dosing in a Phase 1 clinical trial, $ 200,000 for
first dosing in a Phase 2 clinical trial, $ 350,000 for first dosing in a Phase 3 clinical trial, $ 500,000 for regulatory marketing approval
and $ 5,000,000 upon achieving a cumulative $ 500,000,000 of Licensed Product sales. The Company also agreed to pay another $ 500,000 milestone
payment for any additional regulatory marketing approval for each additional therapeutic (or diagnostic) indication. The Company must
also pay ULRF shortfall payments if the total amounts actually paid with respect to royalties and non-royalty sublicensee income for
any year is less than the applicable annual minimum (ranging from $ 10,000 to $ 50,000 ) for such year.
55
The
sponsored research agreement for QN-247 expired in August 2022 and there were no sponsored research expenses related to these agreements
for the years ended December 31, 2024 and 2023. License costs related to these agreements for the years ended December 31, 2024 and 2023
were approximately $ 1,000 and $ 23,000 , respectively, and are included in research and development expenses in the consolidated statements
of operations and other comprehensive loss.
Marizyme
On
April 11, 2024, we entered into a Co-Development Agreement with Marizyme. Under the Co-Development Agreement (as amended), we agreed
to pay Marizyme Funding Payments and an Exclusivity Fee of $ 200,000 . The Exclusivity Fee of $ 200,000 and a Funding Payment of $ 500,000
was paid to Marizyme on April 12, 2024, and is included in research and development expenses in the consolidated statements of operations
and other comprehensive loss. The Exclusivity Fee entitled us to an exclusivity period until May 31, 2024 for purposes of proposing and
outlining a broader strategic relationship with Marizyme with regard to Marizyme’s DuraGraft business. The Funding Payments are
designed to provide financial support for commercialization of Marizyme’s DuraGraft™ vascular conduit solution, which is
indicated for adult patients undergoing coronary artery bypass grafting surgeries and is intended for the flushing and storage of the
saphenous vein grafts used in coronary artery bypass grafting surgery. In return for the Funding Payments we will receive quarterly a
33% payment in the nature of royalties on any Net Sales (as defined with a meaning tantamount to gross profit on net sales) of DuraGraft,
capped at double the amount of the Funding Payments provided. No such payments-in-the-nature-of-royalties would accrue until after DuraGraft
has been launched in the United States and a cumulative total of $ 500,000 of DuraGraft Net Sales have been made in the United States.
During the year ended December 31, 2024, the Company advanced $ 2,257,400 to Marizyme, against which Marizyme had previously
delivered demand promissory notes to the Company. Accrued interest related to the Marizyme Notes was $ 113,292 and interest income of
this amount was recognized, and a $ 360,000 loan loss reserve was recorded in other income in the consolidated statement of operations
(see Note 4 - Short Term Notes Receivable).
NOTE
13 — STOCKHOLDERS’ EQUITY (DEFICIT)
As
of December 31, 2024 and 2023, the Company had two classes of authorized capital stock: common stock and preferred stock.
Common
Stock
Holders
of common stock generally vote as a class with the holders of the preferred stock and are entitled to one vote for each share held. Subject
to the rights of the holders of the preferred stock to receive preferential dividends, the holders of common stock are entitled to receive
dividends when and if declared by the Board of Directors. Following payment of the liquidation preference of the preferred stock, any
remaining assets will be distributed ratably among the holders of the common stock and, on an as-if-converted basis, the holders of any
preferred stock upon liquidation, dissolution or winding up of the affairs of the Company. The holders of common stock have no preemptive,
subscription or conversion rights and there are no redemption or sinking fund provisions.
At
December 31, 2024, the Company has reserved 3,593,702 shares of authorized but unissued common stock for possible future issuance as
follows:
SCHEDULE OF RESERVED SHARES
Exercise of issued and future grants of stock options
15,114
Conversion of Series A-2 Preferred Stock
3,437,363
Exercise of stock warrants
141,225
Total
3,593,702
Preferred
Stock
There are a total of 15,000,000 shares of Preferred Stock authorized. On
November 18, 2024 a Certificate of Designation for 10,000 shares of Series A-2 Preferred Stock was filed.
On
November 20, 2024 in a private placement transaction, the Company sold and issued to certain institutional and accredited investors 5,102
shares of the newly designated Series A-2 Convertible Preferred Stock, par value $ 0.001
per share (the “Series A-2 Preferred Stock”), at a purchase price of $ 1,000
per share, for an aggregate purchase price of $ 5.1
million. The Company also entered into an Exchange Agreement with Yi Hua Chen on November 18, 2024, pursuant to which it issued 1,154
shares of Series A-2 Preferred Stock in full settlement of the outstanding balance of the 2024 Chen Debenture of approximately
$ 1.15
million. At December 31, 2024 the Company had 6,256
shares of Series A-2 preferred stock outstanding.
At
December 31, 2023, there were no shares of preferred stock outstanding.
56
The
shares of Series A-2 Preferred Stock have the rights, preferences, powers, restrictions and limitations as set forth below.
Conversion
Rights – Each share of Series A-2 Preferred Stock is convertible at any time, at the option of the holder, into a number of shares
of common stock equal to $ 1,000 (the “Stated Value”), divided by a conversion price initially equal to $ 3.64 , subject to
adjustment for any stock splits, stock dividends and similar events (the “Conversion Price”). The Conversion Price is also
subject to “ratchet” antidilution adjustments if the Company at any time while the Series A-2 Convertible Preferred Stock
is outstanding issues common stock or common stock equivalents at a lower effective price per share than the then-effective Conversion
Price, in all cases subject to a floor price of $ 1.82 . Conversion of the Series A-2 Convertible Preferred Stock will be prohibited if,
as a result of such conversion, the holder, together with its affiliates, would beneficially own more than 4.99% (or 9.99% at the option
of the holder) of the total number of shares of the Company’s common stock issued and outstanding. The Conversion Price at December
31, 2024 was $ 3.64 .
Liquidation
Preference – Upon any voluntary or involuntary liquidation, dissolution or winding-up of the Corporation, the holders shall be
entitled to an amount equal to the Stated Value for each share of Series A-2 Preferred Stock before any distribution or payment shall
be made to the holders of common stock.
Voting
Rights – The holders of Series A-2 Preferred Stock are entitled to vote, together as a single class with the common stock, on all
matters presented to the common stockholders for a vote. Each share of Series A-2 Preferred Stock is entitled to a number of votes equal
to the number of shares into which such share of Series A-2 Preferred Stock would be convertible, as of the record date for determination
of stockholders entitled to vote as to such matter, if the conversion price was equal to the “Minimum Price” (as defined
in Nasdaq Listing Rule 5635(d)) as of November 20, 2024, taking into account for such purposes the beneficial ownership limitation as
then in effect.
Dividends
– The holders of Series A-2 Preferred Stock are entitled to receive dividends, if and when such dividends are paid to holders of
common stock, in the same form and at the same time on an as-converted to common stock basis.
Protective
Provisions – At all times while the Series A-2 Preferred Stock are outstanding, without the consent of the holders of at least
67% of the Stated Value of the then-outstanding Series A-2 Preferred Stock, the Company is prohibited from amending its charter documents
in any manner that adversely affects the rights of the Series A-2 Preferred Stock, repurchase junior securities of the Company, pay cash
dividends or distributions on junior securities of the Company, or enter into a material transactions with an affiliate of the Company
(unless it is at arm’s length and expressly approved by a majority of the disinterested directors).
Stock
Options and Warrants
Stock
Options
The
Company recognizes all compensatory share-based payments as compensation expense over the service period, which is generally the vesting
period.
In
April 2020, the Company adopted the 2020 Stock Incentive Plan (the “2020 Plan”), which provides for the granting of incentive
or non-statutory common stock options and other types of awards to qualified employees, officers, directors, consultants and other service
providers. At December 31, 2024 and 2023, there were 1,870 and 7,978 outstanding stock options, respectively, under the 2020 Plan and
on such dates there were 13,244 and 7,136 shares reserved under the 2020 Plan, respectively, for future grant.
The
following represents a summary of the options granted to employees and non-employee service providers that were outstanding at December
31, 2024, and changes during the twelve-months then ended:
SCHEDULE OF STOCK OPTION ACTIVITY
Shares
Weighted– Average
Exercise
Price
Range of
Exercise
Price
Weighted– Average Remaining
Life (Years)
Total outstanding – December 31, 2023
7,978
$ 1,760.26
$ 256.80 - $ 2,565.00
7.06
Granted
—
—
—
—
Expired
—
—
—
—
Forfeited
( 6,108 )
1,703.64
$ 256.80 - $ 2,565.00
—
Total outstanding – December 31, 2024
1,870
$ 1,948.41
$ 256.80 - $ 2,565.00
5.93
Exercisable (vested)
1,714
$ 2,085.52
$ 256.80 - $ 2,565.00
5.81
Non-Exercisable (non-vested)
156
$ 442.02
$ 256.80 - $ 620.00
7.24
57
The
following represents a summary of the options granted to employees and non-employee service providers that were outstanding at December
31, 2023 , and changes during the twelve months then ended:
Shares
Weighted– Average Exercise Price
Range of Exercise Price
Weighted– Average Remaining Life (Years)
Total outstanding – December 31, 2022
12,160
$ 1,751.00
$ 256.80 — $ 2,565.00
8.09
Granted
—
—
—
—
Expired
—
—
—
—
Forfeited
( 4,182 )
1,735.50
$ 256.80 — $ 2,565.00
—
Total outstanding – December 31, 2023
7,978
$ 1,760.26
$ 256.80 — $ 2,565.00
7.06
Exercisable (vested)
6,418
$ 2,098.50
$ 256.80 — $ 2,565.00
6.77
Non-Exercisable (non-vested)
1,560
$ 368.00
$ 256.80 — $ 1,645.00
8.36
There
were approximately $ 128,000 and $ 1.1 million of compensation costs related to outstanding options for the years ended December 31, 2024
and 2023, respectively. As of December 31, 2024, there was approximately $ 5,000 of total unrecognized compensation cost related to unvested
stock-based compensation arrangements. This cost is expected to be recognized over a weighted average period of 0.58 years.
The
exercise price for an option issued under the 2020 Plan is determined by the Board of Directors, but will be (i) in the case of an incentive
stock option (A) granted to an employee who, at the time of grant of such option, is a 10% stockholder, no less than 110% of the fair
market value per share on the date of grant; or (B) granted to any other employee, no less than 100% of the fair market value per share
on the date of grant; and (ii) in the case of a non-statutory stock option, no less than 100% of the fair market value per share on the
date of grant. The options awarded under the 2020 Plan will vest as determined by the Board of Directors but will not exceed a ten-year
period. A forfeiture is recognized as incurred if the option holder does not exercise after 90 days following termination of service.
Fair
Value of Equity Awards
The
Company utilizes the Black-Scholes option pricing model to value awards under its equity plans. Key valuation assumptions include:
● Expected
dividend yield. The expected dividend is assumed to be zero, as the Company has never
paid dividends and has no current plans to pay any dividends on the Company’s common
stock.
● Expected
stock-price volatility. The Company’s expected volatility is derived from the average
historical volatilities of publicly traded companies within the Company’s industry
that the Company considers to be comparable to the Company’s business over a period
approximately equal to the expected term, because the Company does not have sufficient stock
price history over the expected term.
● Risk-free
interest rate. The risk-free interest rate is based on the U.S. Treasury yield in effect
at the time of grant for zero coupon U.S. Treasury notes with maturities approximately equal
to the expected term.
● Expected
term. The expected term represents the period that the stock-based awards are expected
to be outstanding. The Company’s historical share option exercise experience does not
provide a reasonable basis upon which to estimate an expected term because of a lack of sufficient
data. Therefore, the Company estimates the expected term by using the simplified method provided
by the SEC. The simplified method calculates the expected term as the average of the time-to-vesting
and the contractual life of the options.
58
There
were no options granted during the years ended December 31, 2024 and 2023.
The
Company recorded share-based compensation expense and classified it in the consolidated statements of operations as follows:
SCHEDULE OF SHARE-BASED COMPENSATION EXPENSE
2024
2023
For the Years Ended
December 31,
2024
2023
General and administrative
$ 103,378
$ 939,228
Research and development
24,681
159,305
Total
$ 128,059
$ 1,098,533
Equity
Classified Compensatory Warrants
As
part of the May 2020 reverse recapitalization transaction, the Company issued equity classified compensatory common stock warrants to
an advisor and its designees. In addition, various service providers hold equity classified compensatory common stock warrants issued
in 2017 and earlier (originally exercisable to purchase Series C convertible preferred stock, and now instead exercisable to purchase
common stock). These are to be differentiated from the Series C Warrants described in Note 8 – Warrant Liabilities.
On
February 27, 2024, as a result of a down-round provision triggered by a Securities Purchase Agreement with Alpha for the purchase of
the February 2024 Debenture, 1,353 warrants were repriced from $ 36.50 per share exercise price to $ 13.50 per share exercise price. The
increase in fair value of $ 9,737 for the modification of these warrants was charged to general and administrative expenses in the Company’s
consolidated statements of operations and comprehensive loss. On September 6, 2024 as a result of a down-round provision triggered by
shares sold in the public offering, these 1,353 warrants were repriced again from $ 13.50 per share exercise price to $ 6.50 per share
exercise price. The increase in fair value of $ 2,299 for the modification of these warrants was charged to general and administrative
expenses in the Company’s consolidated statements of operations and comprehensive loss.
On
November 20, 2024, the Company closed its private placement transaction resulting in the issuance of newly designated Series A-2 Preferred
Stock. As a result of the issuance of a new class of voting securities, the Company evaluated its equity classified compensatory warrants’
respective terms, and concluded that compensatory warrants to purchase 1,353 common shares with a weighted average exercise price of
$ 6.50 and a fair value of $ 904 were required to be reclassified to liabilities as of November 20, 2024.
No
new compensatory warrants were issued during the years ended December 31, 2024 or 2023.
The
following table summarizes the equity classified compensatory warrant activity for the year ended December 31, 2024:
SCHEDULE OF COMPENSATORY WARRANT ACTIVITY
Common Stock
Shares
Weighted–
Average
Exercise Price
Range of
Exercise Price
Weighted– Average Remaining
Life (Years)
Total outstanding – December 31, 2023
2,381
$ 534.44
$ 66.00 - $ 1,270.25
1.25
Granted
—
—
—
—
Exercised
—
—
—
—
Expired
( 519 )
$ 1,033.15
$ 1,033.15 - $ 1,033.15
—
Reclassified to liabilities
( 1,353 )
$ 6.50
$ 6.50 - $ 6.50
—
Forfeited
—
—
—
—
Total outstanding – December 31, 2024
509
$ 1,270.25
$ 1,270.25 -$ 1,270.25
0.69
Exercisable
509
$ 1,270.25
$ 1,270.25 - $ 1,270.25
0.69
Non-Exercisable
—
—
—
—
59
The
following table summarizes the equity classified compensatory warrant activity for the year ended December 31, 2023:
Common Stock
Shares
Weighted– Average
Exercise
Price
Range of
Exercise Price
Weighted– Average Remaining
Life (Years)
Total outstanding – December 31, 2022
3,581
$ 455.88
$ 66.00 - $ 1,270.25
1.73
Granted
—
—
—
—
Exercised
—
—
—
—
Expired
( 1,200 )
$ 300.00
$ 300.00 - $ 300.00
—
Forfeited
—
—
—
Total outstanding – December 31, 2023
2,381
$ 534.44
$ 66.00 - $ 1,270.25
1.25
Exercisable
2,381
$ 534.44
$ 66.00 - $ 1,270.25
1.25
Non-Exercisable
—
—
—
—
There
was $ 12,036 in compensation costs related to outstanding warrants for the year ended December 31, 2024 and $ 7,945 for the year ended
December 31, 2023. As of December 31, 2024 and 2023, there was no unrecognized compensation cost related to nonvested warrants.
Noncompensatory
Equity Classified Warrants
On
May 22, 2020, as a commitment fee, the Company issued noncompensatory equity classified warrants to Alpha for the purchase of common
stock, of which warrants for 141 common shares remain outstanding and exercisable as of December 31, 2024 and may be exercised in whole
or in part, at any time before May 22, 2025.
On
December 22, 2022, in conjunction with the issuance of a debenture to Alpha (see Note 9 – Convertible Debt), the Company issued
to Alpha a warrant to purchase 50,000 shares of the Company’s common stock. The exercise price of this warrant was initially $ 82.50 ,
and may be exercised in whole or in part, on or after June 22, 2023 and at any time before June 22, 2028. On December 5, 2023, the Company
entered into an Amendment No. 1 with regard to the related Securities Purchase Agreement, with Alpha. This Amendment reduced the Exercise
Price of the December 22, 2022 warrant from $ 82.50 per share to $ 36.50 per share. The Amendment also revised certain provisions of the
warrant which resulted in reclassification of the warrant from liabilities to equity during the year ended December 31, 2023.
On
February 27, 2024 the Company entered into a new Securities Purchase Agreement with Alpha for the purchase of the February 2024 Debenture
(see Note 9 – Convertible Debt). This Securities Purchase Agreement resulted in the reduction of the exercise price of the December
22, 2022 warrant and the May 2020 warrant from $ 36.50 per share to $ 13.00 per share. The company recognized a deemed dividend of $ 60,017 ,
which represents the incremental fair value of the outstanding warrants as a result of the down-round provision. As the Company has an
accumulated deficit, the deemed dividend was recorded as a reduction in additional paid-in capital, resulting in a net impact of zero
to additional paid-in capital in the consolidated statements of changes in stockholders’ equity. In addition, on February 27, 2024,
the Company issued to Alpha a warrant to purchase 18,001 shares of the Company’s common stock at an exercise price of $ 13.00 per
share, which may be exercised in whole or in part, at any time before February 27, 2029.
On
September 6, 2024 as a result of the down-round provision triggered by shares sold in a public offering, the above warrants were repriced
from $ 13.00 per share exercise price to $ 6.50 per share exercise price. The company recognized an additional deemed dividend of $ 27,587 ,
which represents the incremental fair value of the outstanding warrants as a result of the down-round provision. As the Company has an
accumulated deficit, the deemed dividend was recorded as a reduction in additional paid-in capital, resulting in a net impact of zero
to additional paid-in capital in the consolidated statements of changes in stockholders’ equity (deficit).
As
a result of a partial voluntary conversion of the 2024 Alpha Debenture on September 9, 2024, the Company no longer had sufficient shares
to settle the 2024 Alpha Warrant in full until shareholder approval was obtained, and a portion ( 2,314 warrant shares with a fair value
of $ 14,997 ) was reclassified to liabilities (see Note 8 – Warrant Liabilities). Shareholder approval was subsequently obtained
on October 25, 2024, and as of that date, the Company determined that shareholder approval resulted in equity classification for the
warrant again and, accordingly, the Company remeasured the warrant liability to fair value, and reclassified to noncompensatory equity
classified warrants.
60
On
September 6, 2024, upon the closing of a public offering, the Company issued pre-funded warrants to purchase 239,456 common shares at
a price of $ 6.45 per share with an exercise price of $ 0.05 per share (the “pre-funded warrants”). The pre-funded warrants
are exercisable upon issuance and will remain exercisable until all the pre-funded warrants are exercised in full. Pre-funded warrants
for 188,257 common shares were exercised during the year ended December 31, 2024. At December 31, 2024 pre-funded warrants for 51,199
common shares remained outstanding.
On
September 6, 2024, upon the closing of a public offering, 16,019 warrants were issued to the placement agent. These warrants were not
exercisable until March 5, 2025 and expire on September 6, 2029.
On
November 20, 2024, the Company closed its private placement transaction resulting in the issuance of newly designated Series A-2 Preferred
Stock. As a result of the issuance of a new class of voting securities, the Company evaluated its equity classified noncompensatory warrants’
respective terms, and concluded that non-compensatory warrants for 67,359 common shares with a weighted average exercise price of $ 1.91
and an aggregate fair value of $ 246,357 were required to be reclassified to liabilities as of November 20, 2024.
The
following table summarizes the noncompensatory equity classified warrant activity for the year ended December 31, 2024:
SCHEDULE OF NON COMPENSATORY WARRANT ACTIVITY
Common Stock
Shares
Weighted– Average
Exercise
Price
Range of
Exercise Price
Weighted– Average Remaining
Life (Years)
Total outstanding – December 31, 2023
50,141
$ 36.50
$ 36.50 - $ 36.50
4.47
Granted
34,019
7.11
$ 6.50 - $ 7.80
4.16
Exercised
( 31,998 )
13.00
$ 13.00 - $ 13.00
—
Pre-funded investor warrants issued
239,456
0.05
$ 0.05 - $ 0.05
n/a
Pre-funded investor warrants exercised
( 188,257 )
0.05
$ 0.05 - $ 0.05
n/a
Reclassified to liabilities
( 69,672 )
2.06
$ 0.05 - $ 7.80
—
Reclassified from liabilities
38,315
6.50
$ 6.50 - $ 6.50
—
Expired
—
—
—
—
Forfeited
—
—
—
—
Total outstanding – December 31, 2024
72,004
$ 6.50
$ 6.50 - $ 6.50
—
Exercisable
72,004
$ 6.50
$ 6.50 - $ 6.50
3.99
Non-Exercisable
—
—
—
—
The
following table summarizes the noncompensatory equity classified warrant activity for the year ended December 31, 2023:
Common Stock
Shares
Weighted–
Average
Exercise
Price
Range of
Exercise Price
Weighted– Average
Remaining
Life (Years)
Total outstanding – December 31, 2022
10,941
$ 987.97
$ 66.00 - $ 1,000.00
0.33
Granted
—
—
—
—
Exercised
—
—
—
—
Reclassification of Alpha Warrant from warrant liabilities to equity
50,000
36.50
$ 36.50 - $ 36.50
—
Expired
( 10,800 )
1,000.00
$ 1,000.00 -$ 1,000.00
—
Forfeited
—
—
—
—
Total outstanding – December 31, 2023
50,141
$ 36.50
$ 36.50 - $ 36.50
4.47
Exercisable
50,141
$ 36.50
$ 36.50 - $ 36.50
4.47
Non-Exercisable
—
—
—
—
61
NOTE
14 — RELATED PARTY TRANSACTIONS
Convertible
Debt
On
December 22, 2022, the Company issued to Alpha, an 8 % Senior Convertible Debenture in the aggregate principal amount of $ 3,300,000 for
a purchase price of $ 3,000,000 pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022. As of December 31,
2023, the remaining principal balance was $ 1,418,922 . During the year ended December 31, 2024, the remaining principal balance of this
Debenture was converted into 103,876 shares of common stock of the Company, at a weighted average price of $ 13.66 per share.
On
February 27, 2024, the Company issued to Alpha, an 8 % Convertible Debenture in the principal amount of $ 550,000 for a purchase price
of $ 500,000 less expenses pursuant to the terms of a Securities Purchase Agreement dated February 26, 2024. During the year ended December
31, 2024, a principal amount of $ 50,979 of this Debenture was converted into 7,846 shares of common stock of the Company, at a weighted
average price of $ 6.50 per share. On November 20, 2024 the Company paid to Alpha in cash the remaining principal amount of $ 499,021 plus
outstanding accrued interest of $ 31,818 .
On
April 12, 2024, the Company issued to Chen an 8 % Convertible Debenture with a principal amount of $ 1,100,000 for a purchase price of
$ 1,000,000 less expenses pursuant to the terms of a Securities Purchase Agreement dated February 26, 2024. The Company entered into an
Exchange Agreement with Yi Hua Chen on November 18, 2024, pursuant to which it issued 1,154 shares of Series A-2 Preferred Stock in full
settlement of the outstanding balance of the 2024 Chen Debenture of approximately $ 1.15 million (see Note 13 — Stockholders Equity
(Deficit)).
See
Note 9 – Convertible Debt for additional information concerning convertible debt – related party transactions.
Warrants
On
May 22, 2020, as a commitment fee, the Company issued warrants to Alpha for the purchase of common stock. As of December 31, 2024, 141
of these warrants remain outstanding and exercisable, and may be exercised in whole or in part, at any time before May 22, 2025. During
years ended December 31, 2024 and 2023 there were no exercises of this warrant. This warrant was equity classified as of December 31,
2023 and was reclassified to warrant liabilities during the year ended December 31, 2024 (see Note 8 - Warrant Liabilities).
On
December 22, 2022, in conjunction with the issuance of a debenture to Alpha, the Company issued to Alpha a warrant to purchase 50,000
shares of the Company’s common stock. This warrant may be exercised by Alpha, in whole or in part, on or after June 22, 2023 and
at any time before June 22, 2028, subject to certain terms and conditions described in the warrant. During the year ended December 31,
2024, Alpha partially exercised this warrant to purchase 31,998 shares respectively, of the Company’s common stock at a weighted
average exercise price of $ 13.00 , for total cumulative proceeds to the Company of $ 416,000 . During the year ended December 31, 2023,
there were no exercises of this warrant. This warrant is included in equity on the Company’s consolidated balance sheets (see Note
13 – Stockholders’ Equity (Deficit)).
On
February 27, 2024, in conjunction with the issuance of a debenture to Alpha, the Company issued to Alpha, a warrant to purchase 18,001
shares of the Company’s common stock, exercisable in whole or in part, until February 27, 2029, subject to certain terms and conditions
described in the warrant.
On September 6, 2024 as a result of the down-round provision triggered
by shares sold in a public offering, the above warrants were repriced from $ 13.00 per share exercise price to $ 6.50 per share exercise
price. The company recognized an additional deemed dividend of $ 27,587 , which represents the incremental fair value of the outstanding
warrants as a result of the down-round provision. As the Company has an accumulated deficit, the deemed dividend was recorded as a reduction
in additional paid-in capital, resulting in a net impact of zero to additional paid-in capital in the consolidated statements of changes
in stockholders’ equity (deficit).
As a result of a partial voluntary conversion of the 2024 Alpha Debenture
on September 9, 2024, the Company no longer had sufficient shares to settle the 2024 Alpha Warrant in full until shareholder approval
was obtained, and a portion ( 2,314 warrant shares with a fair value of $ 14,997 ) was reclassified to liabilities (see Note 8 – Warrant
Liabilities). Shareholder approval was subsequently obtained on October 25, 2024, and as of that date, the Company determined that shareholder
approval resulted in equity classification for the warrant again and, accordingly, the Company remeasured the warrant liability to fair
value, and reclassified to noncompensatory equity classified warrants.
During the year ended December 31, 2024, there were no exercises of this warrant. This warrant is included
in equity on the Company’s consolidated balance sheets (see Note 13 – Stockholders’ Equity (Deficit)).
As
of December 31, 2024, the exercise price of all of the above warrants issued to Alpha was $ 6.50 .
On
April 12, 2024, in connection with the issuance of a debenture to Chen (see Note 9 – Convertible Debt), the Company issued a liability
classified warrant to Chen to purchase 36,001 shares of common stock, exercisable until February 27, 2029. On September 6, 2024, as a
result of a down-round provision triggered by shares sold in a public offering, the warrant was repriced from an exercise price of $ 13.00
per share to an exercise price of $ 6.50 per share. The warrant was initially liability classified due to an insufficient number of authorized
shares to settle the warrant prior to the receipt of shareholder approval, which was subsequently obtained on October 25, 2024. As of
that date, the Company determined that shareholder approval resulted in equity classification for the warrant and accordingly, the Company
remeasured the warrant liability to fair value, and reclassified to noncompensatory equity classified warrants (see Note 13 – Stockholders
Equity (Deficit)). The fair value of this warrant was $ 565,582 on the issuance date and $ 185,531 on the date of reclassification to equity.
During the year ended December 31, 2024, the Company recorded a gain on change in fair value of warrant liabilities of $ 380,051 for this
warrant.
62
NOTE
15 — INCOME TAXES
The
following table presents domestic and foreign components of consolidated loss before income taxes from continuing operations for the
periods presented:
SCHEDULE OF DOMESTIC AND FOREIGN COMPONENTS
December 31, 2024
December 31, 2023
Domestic
$ ( 6,152,857 )
$ ( 12,479,803 )
Foreign
—
—
Loss before provision for income taxes
$ ( 6,152,857 )
$ ( 12,479,803 )
A
reconciliation of the statutory income tax rates and the Company’s effective tax rate is as follows:
SCHEDULE OF RECONCILIATIONS OF STATUTORY INCOME TAX RATE
December 31, 2024
December 31, 2023
Statutory federal income tax rate
21.00 %
21.00 %
State taxes, net of federal tax benefit
5.90 %
1.76 %
Non-deductible expenses
0.02 %
- 0.64 %
NOL expiration
0.00 %
- 5.26 %
Tax credit
- 3.87 %
2.92 %
Change in FV of warrant liability
1.42 %
3.35 %
Tax impact of convertible debenture
- 4.18 %
- 5.46 %
Tax impact of divestiture
0.00 %
- 229.26 %
Tax impact of section 382 attribute forfeiture
- 202.84 %
0.00 %
Stock compensation
- 53.37 %
0.00 %
True-up
- 2.87 %
- 10.65 %
Change in valuation allowance
238.69 %
222.28 %
Income taxes provision (benefit)
- 0.10 %
0.04 %
The
components of deferred tax assets and liabilities are as follows:
SCHEDULE
OF COMPONENTS OF DEFERRED TAX ASSETS AND LIABILITIES
December 31, 2024
December 31, 2023
Current
US Federal
$ —
$ ( 9,793 )
US State
6,334
5,000
US Foreign
—
—
Total current provision (benefit)
6,334
( 4,793 )
Deferred
US Federal
6,069,000
23,128,000
US State
8,617,000
4,697,000
US Foreign
—
—
Total deferred benefit
14,686,000
27,825,000
Change in valuation allowance
( 14,686,000 )
( 27,825,000 )
Total provision (benefit) for income taxes
$ 6,334
$ ( 4,793 )
63
During
2024 and 2023, the aggregate changes in our total gross amount of unrecognized tax benefits are summarized as follows:
SCHEDULE
OF UNRECOGNIZED TAX BENEFITS
December
31, 2024
December
31, 2023
Gross unrecognized tax benefits at the beginning
of the year
$ —
$ —
Increases related to current year
positions
8,285
—
Increases related to prior year positions
270,820
—
Expiration of unrecognized tax benefits
—
—
Gross unrecognized tax
benefits at the end of the year
$ 279,105
$ —
Based
on the available objective evidence, including the Company’s history of cumulative losses, management believes it is likely that
the Company’s U.S. federal and state net deferred tax assets will not be realizable. Accordingly, the Company provided for a full
valuation allowance against its U.S. federal and state net deferred tax assets at December 31, 2024, and December 31, 2023.
Due
to the full valuation allowance already in place on the Company’s U.S. federal and state net deferred tax assets, the Company does
not anticipate significant changes in the Company’s effective tax rate.
The
Tax Cuts and Jobs Act resulted in significant changes to the treatment of research or experimental (“R&E”) expenditures
under Section 174. For tax years beginning after December 31, 2021, taxpayers are required to capitalize and amortize all R&E expenditures
that are paid or incurred in connection with their trade or business which represent costs in the experimental or laboratory sense. Specifically,
costs for U.S. based R&E activities must be amortized over five years and costs for foreign R&E activities must be amortized
over 15 years; both using a midyear convention. The Company has incorporated the impact of this new tax legislation into its 2022, 2023,
and 2024 consolidated financial statements, noting that the impact on the Company’s consolidated financial statements was immaterial.
At
December 31, 2024, the Company has U.S. federal and state net operating loss carryforwards of approximately $ 5,946,000
and $ 5,403,000 ,
respectively, which are available to offset future taxable income. U.S. federal net operating loss carryforwards can be carried
forward indefinitely. State net operating loss carryovers begin to expire in 2043.
The
Company’s net operating loss and tax credit carryforwards may be subject to an annual limitation under sections 382 and 383 of
the Internal Revenue Code of 1986 (the “Code”), and similar state provisions if the Company experienced one or more ownership
changes, which would limit the amount of net operating loss and tax credit carryforwards that may be utilized to offset future taxable
income and tax, respectively. In general, an ownership change, as defined by section 382, results from equity shifts that increase ownership
of certain stockholders or public groups in the stock of the corporation of more than 50% over a three-year period. As a result of the
May 2020 reverse recapitalization transaction, a section 382 ownership change has occurred. Prior to the reverse recapitalization transaction,
the Ritter business was discontinued resulting in any pre-ownership change net operating loss and tax credit carryforwards becoming fully
limited under section 382. The pre-ownership change net operating losses and tax credit carryforward DTAs are considered worthless and
have been written-off the deferred tax table presented above. Subsequent ownership changes may have also occurred due to the Company’s
equity activity in recent years. The Company has not completed an Internal Revenue Code Section 382 analysis. As a result, there could
be additional limitations on the Company’s ability to utilize its net operating loss and tax credit carryforwards. These additional
limitations may result in both a permanent loss of certain tax benefits related to net operating loss and tax credit carryforwards, and
an annual utilization limitation.
The
Company also has research and development credit carryforwards for federal and state tax purposes of approximately $ 323,000 and $ 235,000 ,
respectively. The research and development credit carryforwards begin to expire in 2043 for federal tax purposes and have an indefinite
life for state tax purposes.
The
Company files income tax returns in the U.S. federal jurisdiction and in California. The Company’s U.S. federal income tax returns
remain subject to examination by the Internal Revenue Service. The Company’s California income tax returns remain subject to examination
by the California Franchise Tax Board. Due to net operating losses, research and development credits and other tax credit carryforwards
that may be utilized in future years, all U.S. federal and state tax years are open to examination.
Generally
accepted accounting principles clarify the accounting for uncertainty in income taxes recognized in the Company’s financial statements
and prescribe thresholds for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax
return, and also provide guidance on de-recognition and measurement of a tax position taken or expected to be taken in a tax return.
The Company adopted these provisions effective April 1, 2009.
64
The
Company had unrecognized tax benefits of $ 279,105
as of December 31, 2024. Due to the existence of the valuation allowance, future changes in unrecognized tax benefits would have no
effect on the Company’s effective tax rate. The Company does not foresee any material changes over the next 12 months. In
accordance with generally accepted accounting principles, the Company will recognize interest and penalties accrued on any
unrecognized tax benefits as a component of income tax expense. As of December 31, 2024, the Company has not accrued any interest or
penalties related to uncertain tax positions.
NOTE
16 — SUBSEQUENT EVENTS
From
January through April 2025, a total of 3,272.5 shares of Series A-2 Preferred Stock were converted into 899,044 shares of common stock
at a conversion price of $ 3.64 per share.
From
January through June 2025, we borrowed a total of $ 3,470,000 from eight investors as short-term borrowings, each due within six months after
the date of borrowing.
From
January through June 2025, an additional $ 1,518,500 was advanced to Marizyme against which Marizyme delivered demand promissory notes
to the Company of like principal amounts with terms similar to the Marizyme Notes described in Note 4 - Short Term Notes Receivable.
ITEM
9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.