Item 7A. Quantitative and Qualitative Disclosures About Market Risk
Item
7A. Quantitative and Qualitative Disclosures about Market Risk.
We
are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information otherwise
required under this Item.
31
Item
8. Consolidated Financial Statements and Supplementary Data
INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID: 23 )
33
Consolidated Balance Sheets
35
Consolidated Statements of Operations and Comprehensive Loss
36
Consolidated Statements of Stockholders’ Equity
37
Consolidated Statements of Cash Flows
38
Notes to Consolidated Financial Statements
39
32
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To
the Board of Directors and Stockholders of Qualigen Therapeutics, Inc.
Opinion
on the Financial Statements
We
have audited the accompanying consolidated balance sheets of Qualigen Therapeutics, Inc. (the “Company”) as of December
31, 2023 and December 31, 2022, the related consolidated statements of operations and comprehensive loss, stockholders’ equity
(deficit) and cash flows for each of the two years in the period ended December 31, 2023, and the related notes (collectively
referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present
fairly, in all material respects, the financial position of the Company as of December 31, 2023 and December 31, 2022, and the
results of its operations and its cash flows for each of the two years in the period ended December 31, 2023, in conformity with
accounting principles generally accepted in the United States of America.
Going
Concern 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’s current liquidity position and projected cash needs raise substantial
doubt about its ability to continue as a going concern. Management’s plans regarding 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 audits. We are a public accounting firm registered with the Public
Company Accounting Oversight Board (United States) (“PCAOB”) and are required to be independent with respect to the Company
in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission
and the PCAOB.
We
conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the 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 audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing
an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our
audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether
due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence
regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles
used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements.
We believe that our audits provide a reasonable basis for our opinion.
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.
33
Accounting
for Financial Instruments – Modification of Convertible Debt with Warrants
Critical
Audit Matter Description
As described in Note 8 to the consolidated financial
statements, during the year ended December 31, 2023, the Company modified the conversion price and strike price of its convertible debenture
and common stock purchase warrants, respectively. Further, the Company modified certain terms of its stock warrant agreements that were
originally classified as liabilities enabling them to be classified as equity.
We identified the accounting for the modification
of this complex financial instrument as a critical audit matter. This includes both the evaluation of the various features as potential
embedded derivatives and the determination of the respective fair value of the instruments and the embedded features, as well as the determination
of the appropriate classification of warrants between equity and liabilities. The application of the accounting guidance applicable to
issuing and modifying a complex financial instrument requires significant judgment.
Determination of appropriate classification of warrants
requires management’s judgments relating to the interpretations of relevant accounting guidance based on specific provisions of
the warrant agreement. Accounting for the convertible notes and embedded conversion features requires management’s judgments related
to initial and subsequent recognition of the debt and related features, use of a valuation model, and key inputs used in the selected
valuation model.
How We Addressed the Matter in Our Audit
The
primary procedures we performed to address this critical audit matter included:
●
Inspecting the agreements associated with the transactions and evaluating management’s technical accounting analysis, including
the application of the relevant accounting literature.
●
Utilizing an auditor’s specialist to assist in assessing management’s analysis of the transaction, including (i) evaluating
the contracts to identify relevant terms that affect the recognition of the financial instruments, (ii) assessing the appropriateness
of conclusions reached by management, and (iii) reviewing the valuation model for derivatives, performing independent calculations, and
examining the significant assumptions utilized in the valuation model.
/s/
Baker Tilly US, LLP
We
have served as the Company’s auditor since 2018.
San
Diego, California
April
5, 2024
34
QUALIGEN
THERAPEUTICS, INC.
CONSOLIDATED
BALANCE SHEETS
December 31,
December 31,
2023
2022
ASSETS
Current assets
Cash
$ 401,803
$ 3,165,985
Prepaid expenses and other current assets
764,964
1,366,704
Current assets of discontinued operations
—
6,287,849
Total current assets
1,166,767
10,820,538
Property and equipment, net
—
26,242
Other assets
866,481
—
Non-current assets of discontinued operations
—
8,236,711
Total Assets
$ 2,033,248
$ 19,083,491
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities
Accounts payable
$ 2,222,983
$ 619,568
Accrued expenses and other current liabilities
560,006
864,559
Warrant liabilities
54,600
788,100
Warrant liabilities - related party
—
2,834,547
Convertible debt - related party
1,299,216
60,197
Current liabilities of discontinued operations
—
3,441,198
Total current liabilities
4,136,805
8,608,169
Non-current liabilities of discontinued operations
—
1,708,732
Total liabilities
4,136,805
10,316,901
Commitments and Contingencies (Note 10)
-
-
Stockholders’ equity (deficit)
Qualigen Therapeutics, Inc. stockholders’ equity (deficit):
Common stock, $ 0.001 par value; 225,000,000 shares authorized; 5,362,128 and 4,210,737 shares issued and outstanding as of December 31, 2023 and December 31, 2022, respectively
43,262
42,110
Additional paid-in capital
114,655,565
110,528,050
Accumulated other comprehensive income
—
50,721
Accumulated deficit
( 116,802,384 )
( 103,385,172 )
Total Qualigen Therapeutics, Inc. stockholders’ equity (deficit)
( 2,103,557 )
7,235,709
Noncontrolling interest
—
1,530,881
Total Stockholders’ Equity (deficit)
( 2,103,557 )
8,766,590
Total Liabilities & Stockholders’ Equity (Deficit)
$ 2,033,248
$ 19,083,491
The
accompanying notes are an integral part of these consolidated financial statements.
35
QUALIGEN
THERAPEUTICS, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
2023
2022
For the Years Ended
December 31,
2023
2022
EXPENSES
General and administrative
$ 6,095,607
10,274,600
Research and development
5,209,250
4,486,120
Total expenses
11,304,857
14,760,720
LOSS FROM OPERATIONS
( 11,304,857 )
( 14,760,720 )
OTHER EXPENSE (INCOME), NET
Gain on change in fair value of warrant liabilities
( 2,035,469 )
( 907,203 )
Interest expense, net
1,524,722
34,397
Loss on voluntary conversion of convertible debt
1,077,287
—
Loss on debt extinguishment
625,653
—
Loss on fixed asset disposal
21,747
—
Other income, net
( 38,994 )
—
Total other expense (income), net
1,174,946
( 872,806 )
LOSS BEFORE (BENEFIT) PROVISION FOR INCOME TAXES
( 12,479,803 )
( 13,887,914 )
(BENEFIT) PROVISION FOR INCOME TAXES
( 4,793 )
6,548
NET LOSS FROM CONTINUING OPERATIONS
( 12,475,010 )
( 13,894,462 )
DISCONTINUED OPERATIONS
Loss from discontinued operations, net of tax
( 683,008 )
( 7,140,181 )
Loss on disposal of discontinued operations, net of tax
( 602,232 )
—
LOSS FROM DISCONTINUED OPERATIONS
( 1,285,240 )
( 7,140,181 )
NET LOSS
( 13,760,250 )
( 21,034,643 )
Net loss attributable to non-controlling interest from discontinued operations
( 343,038 )
( 2,394,100 )
Net loss attributable to Qualigen Therapeutics, Inc.
$ ( 13,417,212 )
$ ( 18,640,543 )
Net loss per common share, basic and diluted - continuing operations
$ ( 2.46 )
$ ( 3.62 )
Net loss per common share, basic and diluted - discontinued operations
$ ( 0.19 )
$ ( 1.24 )
Weighted-average number of shares outstanding, basic and diluted
5,072,709
3,840,340
Other comprehensive loss, net of tax
Net loss
$ ( 13,760,250 )
$ ( 21,034,643 )
Foreign currency translation adjustment from discontinued operations
119,473
50,721
Other comprehensive loss
( 13,640,777 )
( 20,983,922 )
Comprehensive loss attributable to noncontrolling interest from discontinued operations
( 304,735 )
( 2,394,100 )
Comprehensive loss attributable to Qualigen Therapeutics, Inc.
$ ( 13,336,042 )
$ ( 18,589,822 )
The
accompanying notes are an integral part of these consolidated financial statements.
36
QUALIGEN
THERAPEUTICS, INC.
CONSOLIDATED
STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
Shares
Amount
Paid-In
Capital
Comprehensive
Income
Accumulated
Deficit
Equity
(Deficit)
Noncontrolling
Interest
Equity
(Deficit)
Common
Stock
Additional
Accumulated
Other Comprehensive
Total
Qualigen
Therapeutics,
Inc.
Stockholders’
Total
Stockholders’
Shares
Amount
Paid-In
Capital
Income (Deficit)
Accumulated
Deficit
Equity
(Deficit)
Noncontrolling
Interest
Equity
(Deficit)
Balance at December 31, 2022
4,210,737
$ 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
841,726
842
1,111,740
—
—
1,112,582
—
1,112,582
Redemptions of convertible
debt into common stock
309,665
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
5,362,128
$ 43,262
$ 114,655,565
$ —
$ ( 116,802,384 )
$ ( 2,103,557 )
$ —
$ ( 2,103,557 )
Common
Stock
Additional
Accumulated
Other
Total
Qualigen
Therapeutics,
Inc.
Total
Shares
Amount
Paid-In
Capital
Comprehensive
Income
Accumulated
Deficit
Stockholders’
Equity
Noncontrolling
Interest
Stockholders’
Equity
Balance at December 31, 2021
3,529,018
$ 35,290
$ 101,274,073
$ —
$ ( 84,744,629 )
$ 16,564,734
$ —
$ 16,564,734
Balance
3,529,018
$ 35,290
$ 101,274,073
$ —
$ ( 84,744,629 )
$ 16,564,734
$ —
$ 16,564,734
Stock issued upon exercise
of warrants
332,000
3,320
4,711
—
—
8,031
—
8,031
Stock-based compensation
—
—
5,484,044
—
—
5,484,044
—
5,484,044
Common stock and prefunded
warrants issued for business acquisition
350,000
3,500
3,740,417
—
—
3,743,917
3,882,225
7,626,142
Noncontrolling interest
adjustments relating to Stock-based compensation and other
—
—
( 42,756 )
—
—
( 42,756 )
42,756
—
Foreign currency translation
adjustment
—
—
—
50,721
—
50,721
—
50,721
Fair value of warrant modification
for professional services
—
—
67,370
—
—
67,370
—
67,370
Fair value of warrant modification
for business acquisition
—
—
696
—
—
696
—
696
Issuance of rounded shares
as a result of the reverse stock split
( 281 )
—
( 505 )
—
—
( 505 )
—
( 505 )
Net
loss
—
—
—
—
( 18,640,543 )
( 18,640,543 )
( 2,394,100 )
( 21,034,643 )
Balance at December 31,
2022
4,210,737
$ 42,110
$ 110,528,050
$ 50,721
$ ( 103,385,172 )
$ 7,235,709
$ 1,530,881
$ 8,766,590
Balance
4,210,737
$ 42,110
$ 110,528,050
$ 50,721
$ ( 103,385,172 )
$ 7,235,709
$ 1,530,881
$ 8,766,590
The
accompanying notes are an integral part of these consolidated financial statements.
37
QUALIGEN
THERAPEUTICS, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
2023
2022
For the Years Ended December 31,
2023
2022
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss
$ ( 13,760,250 )
$ ( 21,034,643 )
Loss from discontinued operations, net of tax
( 1,285,240 )
( 7,140,181 )
Loss from continuing operations
( 12,475,010 )
( 13,894,462 )
Adjustments to reconcile loss from continuing operations to net cash used in operating activities:
Depreciation and amortization
4,495
12,165
Stock-based compensation
1,098,533
4,765,276
Change in fair value of warrant liabilities
( 2,035,469 )
( 906,345 )
Loss on voluntary conversion of convertible debt
1,077,287
—
Accretion of discount on convertible debt
1,469,640
—
Loss on debt extinguishment
625,653
—
Loss on disposal of fixed assets
21,747
—
Fair value of warrant modification for professional services
7,945
67,370
Changes in operating assets and liabilities:
Prepaid expenses and other assets
( 264,741 )
( 126,985 )
Accounts payable
1,603,422
( 43,440 )
Accrued expenses and other current liabilities
( 227,101 )
( 472,441 )
Net cash used in operating activities - continuing operations
( 9,093,599 )
( 10,598,862 )
Net cash provided by (used in) operating activities - discontinued operations
( 1,210,664 )
( 2,648,679 )
Net cash used in operating activities
( 10,304,263 )
( 13,247,541 )
CASH FLOWS FROM INVESTING ACTIVITIES:
Net cash provided by (used in) investing activities -
discontinued operations
4,215,943
( 183,763 )
Net cash provided by (used in) investing activities
4,215,943
( 183,763 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from warrant exercises
—
7,173
Proceeds from issuance of convertible debt
—
2,903,847
Payments on convertible notes payable
( 550,000 )
—
Fractional share payments related to the reverse stock split
—
( 505 )
Net cash (used in)/provided by financing activities - continuing operations
( 550,000 )
2,910,515
Net cash used in financing activities - discontinued operations
—
—
Net cash (used in) provided by financing activities
( 550,000 )
2,910,515
Net change in cash and restricted cash
( 6,638,320 )
( 10,520,789 )
Effect of exchange rate changes on cash and restricted cash
—
22,639
Cash and restricted cash from continuing operations -
beginning of period
3,165,985
9,174,383
Cash and restricted cash from discontinued operations - beginning of period
3,874,138
8,363,890
Less: cash and restricted cash from discontinued operations - end of period
—
( 3,874,138
)
Cash from continuing operations - end of period
$ 401,803
$ 3,165,985
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION
Cash paid during the year for:
Interest
$ —
$ —
Taxes
$ 5,571
$ 5,571
NONCASH FINANCING AND INVESTING ACTIVITIES:
Net transfers to equipment held for lease from inventory
$ 83,281
$ —
Fair value of warrant liabilities on date of exercise
$ —
$ 858
Redemption of convertible debt into common stock
$ 254,316
$ —
Voluntary conversion of convertible debt into common stock
$ 1,112,582
$ —
Fair value of warrant modifications pursuant to Securities Purchase
Agreement
$ —
$ 9,439
Fair value of warrant modifications for business acquisition
$ —
$ 33,543
The
accompanying notes are an integral part of these consolidated financial statements.
38
QUALIGEN
THERAPEUTICS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
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 5 – 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 350,000 reverse split adjusted shares of the Company’s
common stock and a prefunded warrant to purchase 331,464 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 5 -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. 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 5 – 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.
39
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 5 - 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, 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 5 – 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 in-process research and development, goodwill, warrant
liabilities, and stock-based compensation. Actual results could vary from the estimates that were used.
Reverse
Stock Split
On
November 23, 2022, the Company effected a 1-for-10 reverse stock split of its outstanding shares of common stock (the “Reverse
Stock Split”). The 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 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 the Reverse Stock Split. 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 government money market mutual funds and 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.
In March 2023, Silicon Valley Bank and Signature Bank, and more recently in May 2023, First Republic Bank, were closed due to liquidity
concerns and taken over by the FDIC. While the Company did not have an account at any of these banks, in the event of failure of any
of the financial institutions where the Company maintains its cash and cash equivalents, there can be no assurance that the Company would
be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely
affect the Company’s business and financial position.
Impairment
of Long-Lived Assets
The
Company assesses potential impairments to its long-lived assets when there is evidence that events or changes in circumstances indicate
that assets may not be recoverable. An impairment loss would be recognized when the sum of the expected future undiscounted cash flows
is less than the carrying amount of the assets. The amount of impairment loss, if any, will generally be measured as the difference between
the net book value of the assets and their estimated fair values. During the years ended December 31, 2023 and 2022, no such impairment
losses have been recorded.
Segment
Reporting
Operating
segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation
by the chief operating decision-maker 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).
40
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
statement of operations.
Business
Combinations
The
Company accounts for business combinations using the acquisition method pursuant to Financial Accounting Standards Board’s (“FASB”)
ASC Topic 805. This method requires, among other things, that results of operations of acquired companies are included in the Company’s
financial results beginning on the respective acquisition date, and that assets acquired and liabilities assumed are recognized at fair
value as of the acquisition date. Intangible assets acquired in a business combination are recorded at fair value using a discounted
cash flow model. The discounted cash flow model requires assumptions about the timing and amount of future net cash flows, the cost of
capital and terminal values from the perspective of a market participant. Each of these factors can significantly affect the value of
the intangible asset. Any excess of the fair value of consideration transferred (the “purchase price”) over the fair values
of the net assets acquired is recognized as goodwill. The fair value of assets acquired and liabilities assumed in certain cases may
be subject to revision based on the final determination of fair value during a period of time not to exceed 12 months from the acquisition
date. Legal costs, due diligence costs, business valuation costs and all other acquisition-related costs are expensed when incurred.
Goodwill
Goodwill
represents the difference between the purchase price and the fair value of the identifiable tangible and intangible net assets acquired,
when accounted for using the purchase method of accounting. Goodwill has an indefinite useful life and is not amortized but is reviewed
for impairment annually and whenever events or changes in circumstances indicate that the carrying value of the goodwill may not be recoverable.
In testing for impairment, the fair value of the reporting unit is compared to the carrying value. If the net assets assigned to the
reporting unit exceed the fair value of the reporting unit, an impairment loss equal to the difference is recorded. As a result of the
annual goodwill impairment analysis, the Company recognized a $ 4,239,000 non-cash goodwill and fixed asset impairment charge in the valuation
of its business acquisition of NanoSynex for the year ended December 30, 2022.
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 7-Warrant Liabilities and Note 8- Convertible
Debt - Related Party).
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;
41
●
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,
accounts receivable, prepaids, accounts payable, and accrued liabilities are carried at cost, which management believes approximates
fair value due to the short-term nature of these instruments.
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.
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. For more information, refer to Note 14 - Income Taxes.
In
December 2023, the FASB issued Accounting Standards Update 2023-09, Improvements to Income Tax Disclosures, 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.
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 5 - Discontinued Operations).
Recent
Accounting Pronouncements
The
Company reviewed all other recently issued accounting pronouncements and concluded that they were either not applicable or not expected
to have a significant impact to the financial statements.
42
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. Popular 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 5 – Discontinued Operations).
Inflation
and Global Economic Conditions
During
the year ended 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 5 - Discontinued Operations).
Other
accounting standard updates are either not applicable to the Company or are not expected to have a material impact on the Company’s
consolidated financial statements.
NOTE
2 — LIQUIDITY AND GOING CONCERN
As
of December 31, 2023, the Company had approximately $ 0.4
million in cash and an accumulated deficit of $ 116.8
million. For the years ended December 31,
2023 and 2022, the Company used cash of $ 10.3
million and $ 13.2
million, respectively, in operations.
The
Company’s cash balances as of the date that these financial statements were issued along with the proceeds from the above sale
to Chembio, without additional financing, are expected to fund operations only into the second quarter of 2024. 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.
43
There
is no assurance that profitable operations will ever be achieved, or, if achieved, could be sustained on a continuing basis. In order
to fully execute its business plan, the Company will require significant additional financing for planned research and development activities,
capital expenditures, clinical testing for QN-302 and preclinical development of Pan-RAS, as well as commercialization activities.
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. In December 2022 the Company raised $ 3.0
million from the sale of an 8% Senior Convertible
Debenture (the “Debenture”) to Alpha (see Note 8 - Convertible Debt - Related Party). 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, 2023 and December 31, 2022:
SCHEDULE OF PREPAID EXPENSES AND OTHER CURRENT ASSETS
December 31,
December 31,
2023
2022
Prepaid insurance
$ 566,011
$ 1,329,034
Other prepaid expenses
25,053
37,670
Receivable from sale of Qualigen, Inc.
—
—
Prepaid research and development expenses
173,900
—
Prepaid expenses and
other current assets
$ 764,964
$ 1,366,704
Prepaid
expenses attributable to Qualigen, Inc. and NanoSynex were deemed disposed of as discontinued operations (see Note 5 - Discontinued Operations).
NOTE
4 — OTHER NON-CURRENT ASSETS
Other
non-current assets consisted of the following at December 31, 2023:
SCHEDULE
OF OTHER NON CURRENT ASSETS
December 31,
2023
Funds held in escrow
$ 450,000
Long-term research and development deposits
416,481
Other non-current assets
$ 866,481
44
NOTE
5 — DISCONTINUED OPERATIONS
The
summary of assets and liabilities classified in discontinued operations as of December 31, 2022 are as follows:
SCHEDULE
OF BALANCE SHEETS AND INCOME STATEMENT CLASSIFIED IN DISCONTINUED OPERATIONS
Qualigen, Inc.
NanoSynex
Total
Current assets of discontinued operations
$ 4,448,999
$ 1,838,850
$ 6,287,849
Non-current assets of discontinued operations
1,876,270
6,360,441
8,236,711
Total assets of discontinued operations
$ 6,325,269
$ 8,199,291
$ 14,524,560
Current liabilities of discontinued operations
$ 1,299,948
$ 2,141,250
$ 3,441,198
Non-current liabilities of discontinued operations
1,350,975
357,757
1,708,732
Total liabilities of discontinued operations
$ 2,650,923
$ 2,499,007
$ 5,149,930
The
summary of gain (loss) from discontinued operations, net of tax, as of December 31, 2023 and 2022 are as follows:
Year ended December 31, 2023
Year ended December 31, 2022
Qualigen, Inc.
NanoSynex
Total
Qualigen, Inc.
NanoSynex
Total
(Loss) from discontinued operations
$ ( 171,701 )
$ ( 511,307 )
$ ( 683,008 )
$ ( 2,142,763 )
$ ( 4,997,418 )
$ ( 7,140,181 )
Gain (loss) on disposal of discontinued operations
3,876,778
( 4,479,010 )
( 602,232 )
—
—
—
Total gain (loss) from discontinued operations
$ 3,705,077
$ ( 4,990,317 )
$ ( 1,285,240 )
$ ( 2,142,763 )
$ ( 4,997,418 )
$ ( 7,140,181 )
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
is being held in escrow until January 20, 2025 to satisfy certain Company indemnification obligations.
The
assets and liabilities classified in discontinued operations for Qualigen, Inc. as of December 31, 2022 are as follows:
ASSETS
AND LIABILITIES CLASSIFIED IN DISCONTINUED OPERATIONS
December 31,
2022
Cash
$ 2,246,482
Accounts receivable, net
512,088
Inventory, net
1,586,297
Prepaid expenses and other current assets
104,132
Total current assets of discontinued operations
4,448,999
Right-of-use assets
1,422,538
Property and equipment, net
289,696
Intangible assets, net
145,702
Other assets
18,334
Total non-current assets of discontinued operations
1,876,270
Total assets of discontinued operations of Qualigen, Inc.
$ 6,325,269
Accounts payable
$ 236,470
Accrued vacation
187,906
Accrued expenses and other current liabilities
518,766
Deferred revenue, current portion
116,161
Operating lease liability, current portion
240,645
Total current liabilities of discontinued operations
1,299,948
Operating lease liability, net of current portion
1,301,919
Deferred revenue, net of current portion
49,056
Total non-current liabilities of discontinued operations
1,350,975
Total liabilities of discontinued operations of Qualigen, Inc.
$ 2,650,923
45
The
Company reclassified the following statement of operations items to discontinued operations for the years ended December 31, 2023 and
2022, respectively:
2023
2022
For the Years Ended
December 31,
2023
2022
REVENUES
Net product sales
$ 3,661,121
$ 4,983,556
Total revenues
3,661,121
4,983,556
EXPENSES
Cost of product sales
2,551,114
4,302,755
General and administrative
610,559
561,047
Research and development
206,819
1,245,973
Sales and marketing
405,626
950,420
Goodwill and fixed asset impairment
—
75,000
Total expenses
3,774,118
7,135,195
OTHER EXPENSE (INCOME), NET
Loss on disposal of equipment held for lease
63,302
—
Interest (income) expense, net
—
( 7,751 )
Other expense (income), net
( 4,898 )
( 1,125 )
Loss on fixed asset disposal
300
—
Total other expense (income), net
58,704
( 8,876 )
INCOME (LOSS) FROM DISCONTINUED OPERATIONS BEFORE DISPOSAL
( 171,701 )
( 2,142,763 )
Gain on sale of Qualigen, Inc., net of tax
3,876,778
—
INCOME (LOSS) FROM DISCONTINUED OPERATIONS OF QUALIGEN, INC.
$ 3,705,077
$ ( 2,142,763 )
In
connection with this transaction, the Company recorded a gain on the sale of Qualigen, Inc. in its consolidated financial statements
for the years ended December 31, 2023:
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
In
the fourth quarter of 2023, the gain was adjusted upward by $ 17,000 upon final payment of transaction costs.
Amendment
and Settlement Agreement with NanoSynex Ltd.
On
July 20, 2023, the Company entered into and effectuated the NanoSynex Amendment, pursuant to which the Company agreed to, in exchange
for eliminating all future NanoSynex Funding Agreement obligations for the Company to invest further cash in NanoSynex (except for obligations
to lend NanoSynex $ 560,000 on or before November 30, 2023, and $ 670,000 on or before March 31, 2024), surrender 281,000 Series B Preferred
Shares of NanoSynex held by the Company, resulting in the Company’s ownership in NanoSynex being reduced from approximately 52.8 %
to approximately 49.97 % of the voting equity of NanoSynex; in addition, the Company agreed to surrender approximately $ 3.0 million of
promissory notes which NanoSynex had issued to the Company under the NanoSynex Funding Agreement. On November 22, 2023, the Company further
agreed to eliminate the Company’s obligations to lend NanoSynex $ 560,000 on or before November 30, 2023, and $ 670,000 on or before
March 31, 2024, by instead 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 %.
The
surrender of Series B Preferred Shares of NanoSynex was accounted for as a loss of control of a subsidiary that constitutes a business
under ASC 810. As a result, on July 20, 2023, the Company deconsolidated NanoSynex’s related assets, liabilities, accumulated other
comprehensive income, and the noncontrolling interest. Subsequently, the retained investment in NanoSynex is accounted for as an equity
method investment. On the date of deconsolidation, the Company recognized its retained investment at fair value, which during the preparation
of these financial statements 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. Future
equity method earnings, if any, will not be recognized until the amount exceeds the unrecognized net losses in prior periods.
46
Based
upon the magnitude of the disposition and because the Company is exiting certain research and development operations, 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.
The
assets and liabilities classified in discontinued operations for NanoSynex as of December 31, 2022 are as follows:
ASSETS
AND LIABILITIES CLASSIFIED IN DISCONTINUED OPERATIONS
December 31,
2022
Cash
$ 1,621,967
Accounts receivable, net
26,499
Prepaid expenses and other current assets
190,384
Total current assets of discontinued operations
1,838,850
Restricted cash
5,690
Property and equipment, net
29,149
Intangible assets, net
5,700,000
Goodwill
625,602
Total non-current assets of discontinued operations
6,360,441
Total assets of discontinued operations of NanoSynex
$ 8,199,291
Accounts payable
$ 1,273
Accrued vacation
115,002
Accrued expenses and other current liabilities
293,571
R&D grant liability
780,682
Short term debt-related party
950,722
Total current liabilities of discontinued operations
2,141,250
Deferred tax liability
357,757
Total non-current liabilities of discontinued operations
357,757
Total liabilities of discontinued operations of NanoSynex
$ 2,499,007
The
Company reclassified the following statement of operations items to discontinued operations for the years ended December 31, 2023 and
2022, respectively:
2023
2022
For the Years Ended
December 31,
2023
2022
EXPENSES
Research and development
$ 869,064
$ 1,105,040
Goodwill and fixed asset impairment
—
4,164,000
Total expenses
869,064
5,269,040
Loss on disposal of discontinued operations
4,479,010
—
(BENEFIT) PROVISION FOR INCOME TAXES
( 357,757 )
( 271,622 )
LOSS FROM DISCONTINUED OPERATIONS
( 4,990,317 )
( 4,997,418 )
Loss attributable to noncontrolling interest
( 343,038 )
( 2,394,100 )
NET LOSS ATTRIBUTABLE TO STOCKHOLDERS
$ ( 4,647,279 )
$ ( 2,603,318 )
47
In
connection with this transaction, the Company recorded a loss on deconsolidation of NanoSynex in its consolidated financial statements
for the years ended December 31, 2023:
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 from deconsolidation of NanoSynex
$ ( 4,479,010 )
NOTE
6 — ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
Accrued
expenses and other current liabilities consisted of the following at December 31, 2023 and December 31, 2022:
SCHEDULE OF ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES
December 31,
December 31,
2023
2022
Board compensation
$ 129,499
70,000
Interest (Convertible debt)
10,004
2,829
License fees
32,975
150,130
Payroll
1,215
1,247
Professional fees
121,775
136,203
Research and development
104,402
329,412
Vacation
151,286
165,040
Other
8,850
9,698
Accrued expenses and
other current liabilities
$ 560,006
$ 864,559
Other
accrued liabilities attributable to Qualigen Inc, and NanoSynex were deemed disposed of as discontinued operations (see Note 5 – Discontinued
Operations).
NOTE
7 – 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, at $ 7.195
per share, subject to adjustment. As of December 31, 2023, the Series C Warrants had a remaining term of 0.49
years. 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. On April 25, 2022, the Series C warrants were
repriced from $ 7.195
per share exercise price to $ 6.00
per share exercise price with 49,318
additional ratchet Warrants issued. On May 26, 2022, the Series C warrants were repriced from $ 6.00
per share exercise price to $ 5.136
per share exercise price with 49,952
additional ratchet Warrants issued. As a result of these repricings, 247,625
warrants were forfeited and 346,896
warrants were reissued. On December 22, 2022, the Series C Warrants were repriced again from $ 5.136
per share exercise price to $ 1.32
per share exercise price with 1,002,717
additional ratchet Warrants issued.
Additionally,
on December 22, 2022, in conjunction with the issuance of the Debenture to Alpha (see Note 8 – Convertible Debt – Related
Party), the Company issued to Alpha a warrant to purchase 2,500,000 shares of the Company’s common stock (the “Alpha Warrant”).
The exercise price of the Alpha Warrant was $ 1.65 (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, at any time before June 22, 2028, subject to certain terms and conditions described
in the Alpha Warrant. The fair value of this warrant was included in Warrant liabilities-related party on the Company’s consolidated
balance sheet as of December 31, 2022. On December 5, 2023, the Company entered into an Amendment No. 1 with regard to Securities Purchase
Agreement, with Alpha. This Amendment amended two instruments which the Company issued under the Securities Purchase Agreement dated
December 21, 2022: (a) the 8% Senior Convertible Debenture dated December 22, 2022 in favor of Alpha, and (b) the Common Stock Purchase
Warrant dated December 22, 2022 in favor of Alpha. The Amendment reduced the conversion price of the Debenture from $ 1.32 per share to
$ 0.73 per share (subject to possible future adjustment pursuant to the terms of the Debenture) and reduced the exercise price of the
Warrant from $ 1.65 per share to $ 0.73 per share (subject to possible future adjustment pursuant to the terms of the Warrant). The Amendment
also eliminated certain adjustment provisions of the Warrant. The Company determined the event resulted in equity classification for
the Warrant and, accordingly, the Company remeasured the warrant liabilities to fair value, and reclassified.
As
a result of the Alpha Warrant repricing, on December 5, 2023 the Series C Warrants were repriced again from $ 1.32 per share exercise
price to $ 0.73 per share exercise price with 203,652 additional ratchet Series C Warrants issued, resulting in 455,623 of these Series
C Warrants outstanding and exercisable as of December 31, 2023.
48
The
following table summarizes the activity in liability classified warrants for the year ended December 31, 2023:
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, 2022
3,849,571
$ 1.53
$ 1.32 - $ 1.65
3.9
Exercised
—
—
—
—
Forfeited
( 2,751,976 )
1.53
—
—
Expired
( 1,097,595 )
1.32
1.32
—
Granted
455,623
0.73
0.73
0.49
Total outstanding – December 31, 2023
455,623
$ 0.73
$ 0.73
0.49
Exercisable
455,623
$ 0.73
$ 0.73
0.49
The
following table summarizes the activity in the Common Stock Warrants received in exchange for the Series C Warrants for the year ended
December 31, 2022:
Common Stock Warrants
Shares
Weighted–
Average
Exercise
Price
Range
of
Exercise
Price
Weighted–Average
Remaining
Life (Years)
Total outstanding –December 31, 2021
248,162
$ 7.20
$ 7.20
2.00
Exercised
( 536 )
7.20
Forfeited
( 247,625 )
7.20
Expired
—
—
Granted
3,849,570
1.53
Total outstanding – December 31, 2022
3,849,571
$ 1.53
$ 1.32 - 1.65
3.9
Exercisable
1,349,571
$ 1.32
$ 1.32
1.00
The
following table presents the Company’s fair value hierarchy for its Common Stock Warrant liabilities measured at fair value on
a recurring basis as of December 31, 2023:
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, 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 a valuation received from an independent valuation firm determined using a Monte-Carlo
simulation. 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.
49
The
following are the assumptions used in, and 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, 2023 and December
31, 2022:
SCHEDULE
OF ASSUMPTIONS OF WARRANT LIABILITIES
December 31, 2023
December 31, 2022
Actual
Range
Weighted Average
Risk-free interest rate
5.13 %
3.906 % — 4.628 %
4.15 %
Expected volatility (peer group)
68.9 %
88 % — 103 %
98 %
Term of warrants (in years)
0.49
.90 — 5.48
3.9
Expected dividend yield
0.00 %
0.00 %
0.00 %
NOTE
8 — CONVERTIBLE DEBT- 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
for a purchase price of $ 3,000,000
(less expenses) pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022. The Debenture has a maturity date
of December
22, 2025 and was initially convertible, at any time, and from time to time, until the Debenture is no longer outstanding, at
Alpha’s option, into shares of common stock of the Company (the “Conversion Shares”), at a price equal to $ 1.32
per share, subject to adjustment as described in the Debenture (the “Conversion Price”) and other terms and conditions
described in the Debenture, including the necessary stockholder approvals, which the Company obtained at its 2023 annual meeting of
stockholders on July 13, 2023. As a part of the same transaction, on December 22, 2022, the Company issued to Alpha a
liability classified warrant (the “Alpha Warrant”) to purchase 2,500,000
shares of the Company’s common stock (see Note 7 - Warrant Liabilities). The exercise price of the Alpha Warrant was initially
$ 1.65
(equal to 125 %
of the Conversion Price of the Debenture on the closing date) subject to adjustment as described in the Alpha Warrant. The Alpha
Warrant may be exercised by Alpha, in whole or in part, at any time before June 22, 2028, subject to certain terms and
conditions described in the Alpha Warrant, including the necessary stockholder approvals, which the Company obtained at its 2023
annual meeting of stockholders on July 13, 2023.
The
proceeds from the transaction were used to advance the Company’s QN-302 Investigative New Drug candidate towards clinical trials
and other working capital purposes.
Commencing
June 1, 2023 and continuing on the first day of each month thereafter until the earlier of (i) December 22, 2025 and (ii) the full redemption
of the Debenture (each such date, a “Monthly Redemption Date”), the Company must redeem $ 110,000 plus accrued but unpaid
interest, liquidated damages and any amounts then owing under the Debenture (the “Monthly Redemption Amount”). The Monthly
Redemption Amount must be paid in cash; provided that after the first two monthly redemptions, the Company may elect to pay all or a
portion of a Monthly Redemption Amount in shares of common stock of the Company, based on a Conversion Price equal to the lesser of (i)
the then Conversion Price of the Debenture and (ii) 85 % of the average of the VWAPs (as defined in the Debenture) for the five consecutive
trading days ending on the trading day that is immediately prior to the applicable Monthly Redemption Date. The Company may also redeem
some or all of the then outstanding principal amount of the Debenture at any time for cash in an amount equal to 105 % of the then outstanding
principal amount of the Debenture being redeemed plus accrued but unpaid interest, liquidated damages and any amounts then owing under
the Debenture. The Company’s election to pay monthly redemptions in Conversion Shares or to effect an optional redemption is subject
to the satisfaction (or waiver) of the Equity Conditions (as defined in the Debenture), including the necessary stockholder approvals,
which the Company obtained at its 2023 annual meeting of stockholders on July 13, 2023.
The
Debenture accrues interest at the rate of 8 % per annum, which did not begin accruing until December 1, 2023. Interest may be paid in
cash or shares of common stock of the Company or a combination thereof at the option of the Company; provided that interest may only
be paid in shares if the Equity Conditions have been satisfied (or waived).
Both
the Debenture and the Alpha Warrant provide for adjustments to the Conversion Price and exercise price, respectively, in connection with
stock dividends and splits, subsequent equity sales and rights offerings, pro rata distributions, and certain fundamental transactions.
Both the Debenture and the Alpha Warrant include a beneficial ownership blocker of 9.99 %, which may only be waived by Alpha upon
61 days’ notice to the Company.
Pursuant
to resale registration rights granted by the Company to Alpha in such Securities Purchase Agreement, the Company filed a
resale registration statement on Form S-3 (File Number 333-269088) on December 30, 2022 registering the resale by Alpha of
up to 5,157,087
shares of common stock of the Company which could be issued to Alpha pursuant to the Debenture and the Alpha Warrant, which
registration statement was declared effective by the SEC on January 5, 2023 (the “Original Registration Statement”). The
Company later became ineligible to update the Original Registration Statement via incorporation by reference of its future SEC
periodic and current reports as a result of its failure to timely file its annual report on Form 10-K for the fiscal year ended
December 31, 2022. Therefore, the Company filed a Post-Effective Amendment No. 1 to Form S-3 on Form S-1 (No. 333-269088)(the
“Post-Effective Amendment No. 1”) on September 1, 2023 in order to maintain the registration of the resale by Alpha of up to 3,958,537
shares of common stock of the Company issuable under the Debenture and the Alpha Warrant., which Post-Effective Amendment No. 1 was
declared effective by the SEC on September 7, 2023.
50
The
Company evaluated the Debenture and the Alpha Warrant and determined that the Alpha Warrant is a freestanding financial instrument. Initially,
the Alpha 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 Alpha Warrant was classified
as a liability and recognized at fair value, with subsequent changes in fair value recognized in earnings.
The
proceeds from the Debenture were allocated to the initial fair value of the Alpha Warrant, with the residual balance allocated to the
initial carrying value of the Debenture. The Company has not elected the fair value option for the Debenture. The Debenture was recognized
as proceeds received after allocating the proceeds to the Alpha 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 determined to have no fair value.
The
original issue discount of $ 0.3 million, the initial fair value of the Alpha Warrant of $ 2.8 million, the initial fair value of the suite
of bifurcated embedded derivative features of $ 0 , and the fees and costs paid to Alpha and other third parties of $ 0.1 million
comprised the debt discount upon issuance. The debt discount is amortized to interest expense over the expected term of the Debenture
using the effective interest method, in accordance with ASC 835-30. The debt host instrument of the Debenture will subsequently be measured
at amortized cost using the effective interest method to accrete interest over its term to bring the Debenture’s initial carrying
value to the principal balance at maturity.
Between
January 9 and 12, 2023, the Company issued 841,726
shares of common stock upon Alpha’s partial conversion of the Debenture at $ 1.32
per share for a total of $ 1,111,078
principal. Upon conversion, the Company recognized a loss on conversion of convertible debt of approximately $ 1.1
million, recorded to other expenses in the consolidated statements of operations.
In October and December 2023, the Company issued 309,665
shares of common stock to Alpha in lieu of cash for monthly redemption payments on the Debenture at a weighted average price
of $ 0.71
per share. Upon redemption for shares, the Company recognized a loss on partial debt extinguishment of $ 34,315 .
On
September 22, 2023, the Company entered into a consent and waiver (the “Waiver”) with Alpha. Pursuant to the Waiver,
Alpha consented to the Company’s election to pay all of the Monthly Redemption Amount for October 2023 in Conversion Shares
(the “October Payment”) and waived the requirement of satisfaction of the Equity Conditions in relation to the October and
December Payment. On October 3, 2023 the Company issued 128,595 shares of common stock to Alpha in satisfaction of the October
Payment. On December 8, 2023 the Company issued 181,070 shares of common stock to Alpha in satisfaction of the December Payment.
On
December 5, 2023, the Company and Alpha executed Amendment No. 1 with regard to Securities Purchase Agreement (the “SPA
Amendment”), pursuant to which the Company and Alpha agreed to, among other things, reduce the Conversion Price of the
Debenture from $ 1.32
per share to $ 0.73
per share and reduce the exercise price of the Alpha Warrant from $ 1.65
per share to $ 0.73
per share, in each case subject to certain adjustments. In addition, the SPA Amendment revised certain provisions of the Alpha
Warrant to (i) limit the circumstances which would trigger a potential adjustment to the exercise price of the Alpha Warrant and
(ii) clarify the treatment of the Alpha Warrant upon a Fundamental Transaction. The purpose of these revisions was to remove the
terms that caused the Alpha Warrant to be liability-classified under U.S. GAAP. The Company performed an assessment and concluded
that all remaining adjustment features in the revised language meet the FASB’s definition of a down-round feature. In
addition, the Alpha Warrant was determined to meet all of the additional requirements for equity classification. Accordingly, as of
December 5, 2023, the Company remeasured the Alpha 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 Alpha Warrant modification of $ 0.09
million was included in the Company’s evaluation of the Debenture modification under ASC 470, discussed further below. The
Company then reclassified the Alpha 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 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 Debenture principal and its fair value on December 5, 2023
was recorded as a debt discount and will be 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 recognized a loss on voluntary conversion of convertible debt of
approximately $ 1.1
million, recognized an extinguishment loss of $ 0.6
million upon October and December 2023 share redemptions and December 2023 modification of the Debenture, and recorded
accrued interest of approximately $ 1.5
million, in other expenses in the consolidated statements of operations. During the year ended December 31, 2023 the Company paid
Monthly Redemption Amounts of $ 550,000
in cash and $ 220,000
in common stock, and as of December 31, 2023 the remaining Debenture principal balance was approximately $ 1.4
million, the remaining discount was approximately $ 0.1
million, and the fair value of the suite of bifurcated embedded derivative features was $ 0 .
51
The
senior convertible debt comprises the following:
SCHEDULE OF SENIOR SECURED CONVERTIBLE DEBT
December 31,
2023
December 31,
2022
Senior convertible debenture
$ 1,418,922
$ 3,300,000
Discount on convertible debenture
( 119,706 )
( 3,239,803 )
Total convertible debt-related party
$ 1,299,216
$ 60,197
As
of December 31, 2023, there were no unwaived events of default or violation of any covenants under the Company’s financing obligations.
NOTE
9 — EARNINGS (LOSS) PER SHARE
Basic
loss per share (“EPS”) is computed by dividing net loss by the weighted-average number of common shares outstanding. 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 convertible debt, stock options and warrants.
The
following potentially dilutive securities have been excluded from diluted net loss per share as of December 31, 2023 and 2022 because
their effect would be anti-dilutive:
SCHEDULE
OF DILUTIVE SECURITIES EXCLUDED FROM DILUTED NET LOSS PER SHARE
2023
2022
For the Years Ended
December 31,
2023
2022
Net loss used for basic earnings per share
$ ( 13,417,212 )
$ ( 18,640,543 )
Basic weighted-average common shares outstanding
5,072,709
3,840,340
Dilutive potential shares issuable from convertible debt, stock options and warrants
—
—
Diluted weighted-average common shares outstanding
5,072,709
3,840,340
NOTE
10 — COMMITMENTS AND CONTINGENCIES
Litigation
and Other Legal Proceedings
On
November 9, 2021, the Company was named as a defendant in an action brought by Mediant Communications Inc. (“Mediant”) in
the U.S. District Court for the Southern District of New York. The complaint alleged that Qualigen entered into an implied contract with
Mediant, whereby Qualigen retained Mediant to distribute proxy materials and subsequently conduct shareholder vote tabulations. The Company
filed a Motion to Dismiss with the District Court and on March 14, 2022 a hearing was held during which the presiding judge ruled in
favor of the Motion to Dismiss. The Company and Mediant settled the litigation on April 5, 2022 in the amount of $ 96,558 , at which time
the amount was paid.
NOTE
11 — 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.
52
For
the years ended December 31, 2023 and 2022 there were license costs of approximately $ 128,000 and $ 338,000 , 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 intends to enter into statements of work with TD2 for the performance
of specific services under this Master Clinical Research Services Agreement.
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 intends to 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 intends to 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. The project timeline started in July 2023 and is expected to continue until approximately
July 2026. The total amount to be paid under these work orders and statements of work is currently expected to be approximately $ 7.6
million over the term of the QN-302 Phase 1 study, subject to available funding.
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 set to expire
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 RAS agreements for the years ended December 31, 2023 and December 31, 2022 were approximately $ 743,000
and $ 758,000 , respectively, and are recorded in research and development expenses in the Consolidated Statements of Operations. License
costs related to these agreements for the years ended December 31, 2023 and December 31, 2022 were approximately $ 133,000 and $ 40,000 ,
respectively, and are included in research and development expenses in the Consolidated Statements of Operations.
53
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.
The
sponsored research agreement for QN-247 expired in August 2022. The sponsored research expenses related to these QN-247 agreements for
the years ended December 31, 2023 and December 31, 2022 were $ 0 and approximately $ 164,000 , respectively, and these amounts are recorded
in research and development expenses in the consolidated statements of operations and other comprehensive loss. License costs related
to these agreements were approximately $ 23,000 and $ 94,000 for the years ended December 31, 2023 and December 31, 2022, respectively,
and are included in research and development expenses in the consolidated statements of operations and other comprehensive loss.
In June 2020, the Company entered into an exclusive license agreement with ULRF for its intellectual property in the use of QN-165 as
a treatment for COVID-19. Under the agreement, the Company took over development, regulatory approval and commercialization of the compound
(for such use) from ULRF and is responsible for maintenance of the related intellectual property portfolio. In return, ULRF received
approximately $ 24,000 for an upfront license fee and reimbursement of prior patent costs. In addition, the Company was required to enter
into a separate sponsored research agreement with ULRF (for QN-165 as a treatment for COVID-19) for at least $ 250,000 . In November 2020,
the Company executed a sponsored research agreement with ULRF (for QN-165 as a treatment for COVID-19) supporting up to approximately
$ 430,000 in research which satisfied this requirement. This sponsored research agreement expired in November 2021 and the exclusive license
agreement was terminated on October 31, 2022. There were no sponsored research expenses or license costs related to these QN-165 agreements
for the years ended December 31, 2023 and 2022.
NOTE
12 — STOCKHOLDERS’ EQUITY
As
of December 31, 2023, and 2022 the Company had two classes of 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, 2023, the Company has reserved 5,781,161 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
755,715
Conversion of convertible debt
1,943,729
Exercise of stock warrants
3,081,717
Total
5,781,161
54
Preferred
Stock
At
December 31, 2023 and December 31, 2022, there were no shares of preferred stock outstanding.
Stock
Options and Equity Classified Warrants
Stock
Options
The
Company recognizes all compensatory stock-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 grant of incentive
or non-statutory common stock options, restricted stock, stock bonus awards, stock appreciation rights, restricted stock units and performance
awards to qualified employees, officers, directors, consultants and other service providers. At December 31, 2023 and December 31, 2022
there were 398,924 and 608,012 outstanding stock options, respectively, under the 2020 Plan and there were 356,778 and 147,690 Plan shares
available, 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, 2023, 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, 2022
608,012
$ 35.02
$ 5.14 - $ 51.30
8.09
Granted
—
—
—
—
Expired
—
—
—
—
Forfeited
( 209,088 )
34.71
5.14 - 51.30
—
Total outstanding – December 31, 2023
398,924
$ 35.21
$ 5.14 — $ 51.30
7.06
Exercisable (vested)
320,918
$ 41.97
$ 5.14 — $ 51.30
6.77
Non-Exercisable (non-vested)
78,006
$ 7.36
$ 5.14 - $ 32.90
8.36
The
following represents a summary of the options granted (under the 2020 Plan and otherwise) to employees and non-employee service providers
that were outstanding at December 31, 2022, 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, 2021
484,186
$ 60.70
$ 12.40 — $ 14,657.50
8.52
Granted
134,469
5.24
5.14 — 10.50
5.99
Expired
( 9,379 )
932.75
57.50 - 14,657.50
—
Forfeited
( 1,264 )
22.64
5.14 - 49.70
—
Total outstanding – December 31, 2022
608,012
$ 35.02
$ 5.14 — $ 51.30
8.09
Exercisable (vested)
288,704
$ 46.32
$ 12.40 — $ 51.30
7.59
Non-Exercisable (non-vested)
319,308
$ 24.80
$ 5.14 — $ 10.50
8.59
There
was approximately $ 1.1 million and $ 5.4 million of compensation costs related to outstanding options for the year ended December 31, 2023
and December 31, 2022, respectively. This cost is expected to be recognized over a weighted average period of 1.09 years.
No
stock options were granted or exercised during the year ended December 31, 2023 or 2022.
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 10-year
period.
55
There
were no options granted during the year ended December 31, 2023. The weighted average grant date fair value per share of the shares underlying
options granted during the year ended December 31, 2022 was $ 3.96 .
Fair
Value of Equity Awards
The
Company utilizes the Black-Scholes option pricing model to value awards under the 2020 Plan, and for equity classified compensatory warrants.
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.
●
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.
The
material factors incorporated in the Black-Scholes model in estimating the fair value of the options granted for the periods presented
were as follows:
SCHEDULE
OF ASSUMPTION USED IN BLACK-SCHOLES OPTION-PRICING METHOD
For
the Years Ended December 31,
2023
2022
Expected dividend yield
n/a
0.00 %
Expected stock-price volatility
n/a
103 %
Risk-free interest rate
n/a
1.58 % — 3.77 %
Expected average term of options (in years)
n/a
5.99
Stock price
n/a
5.14 - 10.50
The
Company recorded stock-based compensation expense and classified it in the Consolidated Statements of Operations as follows:
SCHEDULE
OF SHARE-BASED COMPENSATION EXPENSE
2023
2022
For the Years Ended December 31,
2023
2022
General and administrative
$ 939,228
$ 4,649,649
Research and development
159,305
834,395
Total
$ 1,098,533
$ 5,484,044
Equity
Classified Compensatory Warrants
In
connection with the $ 4.0 million equity capital raise as part of the May 2020 reverse recapitalization transaction, the Company issued
common stock warrants to an advisor and its designees for the purchase of 81,143 reverse split adjusted shares of the Company’s
common stock at a reverse split adjusted exercise price of $ 11.10 per share. The issuance cost of these warrants was charged to additional
paid-in capital, and did not result in expense in the Company’s consolidated statements of operations and comprehensive loss.
In
addition, various service providers hold equity classified compensatory warrants issued in 2017 and earlier (originally exercisable to
purchase Series C convertible preferred stock, and now instead exercisable to purchase common stock) for the purchase of 66,802 reverse
split adjusted shares of Company common stock at a weighted average exercise price of $ 23.40 per share. These are to be differentiated
from the Series C Warrants described in Note 7- Warrant Liabilities.
56
On
April 25, 2022, 60,000
warrants were repriced from $ 13.20
per share exercise price to a reverse split adjusted exercise price of $ 6.00
per share exercise price and extended from June
3, 2023 to September 14, 2023 . The increase in fair value of $ 67,370
for the modification of these warrants was charged to general and administrative expenses in the Company’s consolidated
statements of operations and comprehensive loss. These warrants expired on September 14, 2023 . On April 25, 2022 and May 26, 2022 an
additional 67,620
reverse split adjusted warrants were repriced from reverse split adjusted $ 11.10
per share exercise price to $ 5.136
per share exercise price. The increase in fair value of $ 31,010
for the modification of these warrants was charged to additional paid-in capital and did not result in expense on the
Company’s consolidated statements of operations and comprehensive loss. On December 22, 2022 67,620
warrants were repriced from $ 5.136
per share exercise price to $ 1.32
per share exercise price. The increase in fair value of $ 8,548
for the modification of these warrants was charged to additional paid-in capital and did not result in expense on the
Company’s consolidated statements of operations and comprehensive loss. On December 5, 2023, 67,620
warrants were repriced from $ 1.32
per share exercise price to $ 0.73
per share exercise price. The increase in fair value of $ 7,945
for the modification of these warrants was charged to general and administrative expenses in the Company’s consolidated
statements of operations and comprehensive loss.
No
new compensatory warrants were issued during the year ended December 31, 2023 or 2022.
The
following table summarizes the equity classified compensatory warrant activity for the year ended December 31, 2023:
SCHEDULE
OF WARRANT ACTIVITY
Common Stock
Shares
Weighted– Average
Exercise
Price
Range of
Exercise Price
Weighted–Average
Remaining
Life (Years)
Total outstanding – December 31, 2022
179,046
$ 9.12
$ 1.32 — $ 25.40
1.73
Granted to advisor and its designees
—
—
Exercised
—
—
Expired
( 60,000 )
6.00
6.00
Forfeited
—
—
Total outstanding – December 31, 2023
119,046
$ 10.69
$ 0.73 — $ 25.40
1.25
Exercisable
119,046
$ 10.69
$ 0.73 — $ 25.40
1.25
Non-Exercisable
—
$ —
$ —
—
The
following table summarizes the equity classified compensatory warrant activity for the year ended December 31, 2022:
Common Stock
Shares
Weighted– Average
Exercise
Price
Range of
Exercise Price
Weighted–Average Remaining
Life (Years)
Total outstanding – December 31, 2021
179,046
$ 15.20
$ 11.10 — $ 25.40
2.64
Granted to advisor and its designees
—
—
Exercised
—
—
Expired
—
—
Forfeited
—
—
Total outstanding – December 31, 2022
179,046
$ 9.12
$ 1.32 — $ 25.40
1.73
Exercisable
179,046
$ 9.12
$ 1.32 - $ 25.40
1.73
Non-Exercisable
—
$ —
$ —
—
There
was $ 7,945 in compensation costs related to outstanding warrants for the year ended December 31, 2023 and $ 67,370 for the year
ended December 31, 2022. As of December 31, 2023 and December 31, 2022, there was no unrecognized compensation cost related to nonvested
warrants.
57
Noncompensatory
Equity Classified Warrants
In
May 2020, as a commitment fee, the Company issued noncompensatory equity classified warrants to Alpha (a related party) for the
purchase of 27,048 reverse split adjusted shares of Company common stock at a reverse split adjusted exercise price of $ 11.10 per share
(of which warrants for 20,000 shares were subsequently exercised in December 2020). In July 2020 the Company issued noncompensatory equity
classified warrants to Alpha for the purchase of 78,019 reverse split adjusted shares of Company common stock at a reverse split
adjusted exercise price of $ 0.01 per share (which were subsequently exercised in July 2020), and 192,068 reverse split adjusted shares
of Company common stock at a reverse split adjusted exercise price of $ 52.50 per share. In August 2020, the Company issued noncompensatory
equity classified warrants to Alpha for the purchase of 128,783 reverse split adjusted shares of Company common stock at a reverse
split adjusted exercise price of $ 60.00 per share. In December 2020, the Company issued noncompensatory equity classified warrants to
Alpha for the purchase of 100,000 reverse split adjusted shares of Company common stock at a reverse split adjusted exercise
price of $ 0.10 per share (which were exercised in February 2021) and 219,101 reverse split adjusted shares of Company common stock at
a reverse split adjusted exercise price of $ 40.70 per share. In May 2022, the Company issued noncompensatory equity classified warrants
to Alpha for the purchase of 331,464 reverse split adjusted shares of Company common stock at a reverse split adjusted exercise
price of $ 0.01 per share.
On
November 29, 2021, with the exception of the warrants to purchase 27,048 reverse split adjusted shares of the Company’s common
stock at a reverse split adjusted exercise price of $ 11.10 per share, the exercise prices of all outstanding warrants to purchase a total
of 539,951 reverse split adjusted shares of the Company’s common stock were modified to a reverse split adjusted exercise price
of $ 20.00 per share and each of their remaining terms extended by six months. The fair value of the modification cost of these warrant
modifications of approximately $ 2.3 million was charged to additional paid-in capital and did not result in expense on the Company’s
consolidated statements of operations and comprehensive loss. In May 2022, pre-funded warrants to purchase 331,464 reverse split adjusted
shares of the Company’s common stock at a reverse split adjusted exercise price of $ 0.01 per share with no expiration date were
issued to Alpha. These warrants were subsequently exercised in 2022.
In
conjunction with the NanoSynex Acquisition, on April 25, 2022 the exercise price of 7,048
reverse split adjusted outstanding warrants at $ 11.10
was modified to a reverse split adjusted exercise price of $ 6.00 .
The increase in fair value of $ 2,533 ,
using a Monte Carlo pricing model for the modification of these warrants, was charged to additional paid-in capital and did not
result in expense on the Company’s consolidated statements of operations and comprehensive loss. On May 26, 2022, the reverse
split adjusted exercise price of these warrants was modified again to $ 5.136 ,
and the increase in fair value of $ 696 ,
using a Monte Carlo pricing model for the modification of these warrants, was included in consideration transferred in the NanoSynex
Acquisition. On December 22, 2022 the exercise price of these warrants was modified again to $ 1.32 .
The increase in fair value of $ 891 ,
using a Monte Carlo pricing model for the modification of those warrants, was charged to additional paid-in capital and did not
result in expense on the Company’s consolidated statements of operations and comprehensive loss.
On
December 5, 2023, the Company entered into an Amendment No. 1 with regard to Securities Purchase Agreement, with Alpha. This
Amendment amended two instruments which the Company issued under the Securities Purchase Agreement dated December 21, 2022: (a) the 8%
Senior Convertible Debenture dated December 22, 2022 in favor of Alpha, and (b) the Common Stock Purchase Warrant dated December
22, 2022 in favor of Alpha. The Amendment reduced the Conversion Price of the Debenture from $ 1.32 per share to $ 0.73
per share (subject to possible future adjustment pursuant to the terms of the Debenture) and reduced the Exercise Price of the Alpha
Warrant from $ 1.65 per share to $ 0.73 per share (subject to possible future adjustment pursuant to the terms of the Alpha Warrant). The
Amendment revised certain provisions of the Warrant which resulted in reclassification of the Warrant from liabilities to equity. For
more details see Note 7 - Warrant Liabilities.
The
following table summarizes the noncompensatory equity classified warrant activity for the year ended December 31, 2023:
SCHEDULE
OF WARRANT ACTIVITY
Common Stock
Shares
Weighted–Average
Exercise
Price
Range of
Exercise Price
Weighted– Average Remaining
Life (Years)
Total outstanding – December 31, 2022
547,003
$ 19.76
$ 1.32 - $ 20.00
0.33
Legacy Ritter warrants
—
—
Reclassification of Alpha Warrant from warrant liabilities to equity
2,500,000
0.73
0.73
Exercised
—
—
Expired
( 539,953 )
20.00
20.00
Forfeited
—
—
Total outstanding – December 31, 2023
2,507,050
$ 0.73
Exercisable
2,507,050
$ 0.73
0.73
4.47
Non-Exercisable
—
$ —
$ —
—
58
The
following table summarizes the noncompensatory equity classified warrant activity for the year ended December 31, 2022:
Common Stock
Shares
Weighted– Average Exercise
Price
Range of
Exercise
Price
Weighted– Average Remaining
Life (Years)
Total outstanding – December 31, 2021
554,914
$ 20.10
11.10 — 37.78
1.32
Legacy Ritter warrants
—
—
Granted
331,464
0.01
0.01
Exercised
( 331,464 )
0.01
0.01
Expired
( 7,911 )
37.78
37.78
Forfeited
—
—
0
Total outstanding – December 31, 2022
547,003
$ 19.76
1.32 - 20.00
0.33
Exercisable
547,003
$ 19.76
1.32 - 20.00
0.33
Non-Exercisable
—
$ —
$ —
—
NOTE
13 — RELATED PARTY TRANSACTIONS
Convertible
Debt
See
Note 8 – Convertible Debt – Related Party for additional information concerning convertible debt – related party
transactions. 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 Debenture had a
remaining principal balance of $ 1,418,922 ,
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
price equal to $ 0.73
per share, subject to adjustment as described in the Debenture and other terms and conditions described in the Debenture.
Warrants
Additionally,
on December 22, 2022, in conjunction with the issuance of the Debenture to Alpha, the Company issued to Alpha the Alpha
Warrant to purchase 2,500,000 shares of the Company’s common stock (the “Alpha Warrant”). As of December 31, 2023,
the exercise price of the Alpha Warrant was $ 0.73 . The Alpha Warrant may be exercised by Alpha, in whole or in part, at any time
before June 22, 2028, subject to certain terms and conditions described in the Alpha Warrant. The Alpha Warrant is included in equity
on the Company’s consolidated balance sheets (see Note 12 – Stockholders’ Equity).
NanoSynex
Pursuant
to a Share Purchase Agreement dated April 29, 2022, the Company acquired 2,232,861 shares of NanoSynex Series A-1 Preferred Stock from
Alpha in exchange for 350,000 reverse split adjusted shares of the Company’s common stock and a prefunded warrant to purchase
331,464 reverse split adjusted shares of the Company’s common stock at an exercise price of $ 0.001 per share.
NOTE
14 — 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,
2023
December 31,
2022
Domestic
$ ( 12,479,803 )
$ ( 13,887,914 )
Foreign
—
—
Loss before provision for income taxes
$ ( 12,479,803 )
$ ( 13,887,914 )
59
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, 2023
December 31, 2022
Statutory federal income tax rate
21.00 %
21.00 %
State taxes, net of federal tax benefit
1.76 %
7.50 %
Non-deductible expenses
- 0.64 %
- 2.09 %
NOL expiration
- 5.26 %
- 19.88 %
Tax credit
2.92 %
3.71 %
Goodwill impairment
0.00 %
0.00 %
Foreign rate differential
0.00 %
0.00 %
Change in fair value of warrant liability
3.35 %
0.00 %
Tax impact of convertible debenture
- 5.46 %
1.37 %
Tax impact of divestiture
- 229.26 %
4.01 %
True-up
- 10.65 %
2.24 %
Change in valuation allowance
222.28 %
- 17.91 %
Income taxes provision (benefit)
0.04 %
- 0.05 %
Income
tax expense for the year ended December 31, 2023 and 2022 consisted of the following:
SCHEDULE
OF PROVISION FOR INCOME TAXES
December 31, 2023
December 31, 2022
For the Years Ended
December 31, 2023
December 31, 2022
Current
U.S. Federal
$ ( 10,000 )
$ —
U.S. State
5,000
7,000
Total current provision
( 5,000 )
7,000
Deferred Benefit
U.S. Federal
23,128,000
( 236,000 )
U.S. State
4,697,000
( 2,252,000 )
Total deferred benefit
27,825,000
( 2,488,000 )
Change in valuation allowance
( 27,825,000 )
2,488,000
Total provision (benefit) for income taxes
$ ( 5,000 )
$ 7,000
The
components of deferred tax assets and liabilities are as follows:
SCHEDULE
OF DEFERRED TAX ASSETS AND LIABILITIES
December 31, 2023
December 31, 2022
Deferred tax assets:
Net operating loss
$ 8,644,000
$ 32,587,000
Research and development credits
4,970,000
7,857,000
Accrued expenses
68,000
1,020,000
Patent
—
—
Stock compensation
3,004,000
3,069,000
Research and development expenses
1,102,000
1,196,000
Fixed assets
—
280,000
Total deferred income tax assets
17,788,000
46,009,000
Deferred tax liabilities:
Intangible assets
—
( 13,000 )
Right-of-use asset
—
( 382,000 )
Total deferred income tax liabilities
—
( 395,000 )
Net deferred income tax assets
17,788,000
45,614,000
Valuation allowance
( 17,788,000 )
( 45,614,000 )
Deferred tax asset, net of allowance
$ —
$ —
60
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, 2023 and December 31, 2022.
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. However, there is no valuation allowance recorded against
the Company’s foreign net operating loss deferred tax assets, as the Company’s foreign IPR&D deferred tax liabilities
and foreign net operating loss deferred tax assets are both indefinite-lived and thus they may be netted to arrive at a net foreign deferred
tax liability.
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 2023 and
2022 consolidated financial statements, noting that the impact on the Company’s consolidated financial statements was immaterial.
At
December 31, 2023, the Company has U.S. federal and state net operating loss carryforwards of approximately $ 15,942,000 and $ 78,693,000 ,
respectively, which are available to offset future taxable income. U.S. federal and state net operating loss carryovers began to expire
in 2020. As a result of the May 2020 reverse recapitalization, an ownership change has occurred. The Company has not completed an Internal
Revenue Code Section 382 analysis. As a result, there could be substantial limitations on the Company’s ability to utilize its
pre-ownership change net operating loss and tax credit carryforwards. These substantial limitations may result in both a permanent loss
of certain tax benefits related to net operating loss carryforwards and federal research and development credits, and an annual utilization
limitation.
The
Company also has research and development credit carryforwards for federal and state tax purposes of approximately $ 3,560,000 and $ 1,410,000 ,
respectively. The research and development credit carryforwards began to expire in 2020 for federal tax purposes and have an indefinite
life for state tax purposes .
U.S.
income tax has not been recognized on the excess of the amount for financial reporting over the tax basis of investments in foreign subsidiaries
that is indefinitely reinvested outside the United States. This amount becomes taxable upon a repatriation of assets from the subsidiary
or a sale or liquidation of the subsidiary. Determination of the amount of any unrecognized deferred income tax liability on this temporary
difference is not practicable because of the complexities of the hypothetical calculation.
The
Company files income tax returns in the U.S. federal jurisdiction and in various states. 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.
The
Company did no t have any unrecognized tax benefits as of December 31, 2023 and December 31, 2022 and does not expect this to change significantly
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, 2023, the Company has not accrued any
interest or penalties related to uncertain tax positions.
NOTE
15 — SUBSEQUENT EVENTS
On
February 26, 2024, the Company entered into a Securities Purchase Agreement (“Agreement”) with Alpha. The transactions
contemplated by the Agreement closed on February 27, 2024, at which time the Company delivered to Alpha the 2024 Debenture and the
2024 Warrant, as described below, and Alpha paid the Company a cash purchase price of $ 500,000
(less $ 25,000
for expense reimbursement). Pursuant to the Agreement, the Company issued to Alpha an 8% Convertible Debenture (the “2024
Debenture”) in the principal amount of $ 550,000 .
The Debenture has a maturity date of December
31, 2024 and is convertible, at any time, and from time to time, at Alpha’s option, into shares of common stock of the
Company, at $ 0.6111
per share, subject to adjustment as described in the 2024 Debenture (the “Conversion Price”). The Debenture accrues
interest on its outstanding principal balance at the rate of 8 %
per annum. The 2024 Debenture does not call for scheduled payments of principal or interest before the scheduled maturity date of
December 31, 2024. Pursuant to the terms of the Agreement, the Company also issued to Alpha a 5-year common stock purchase warrant
(the “2024 Warrant”) to purchase (at $ 0.26
per share) 900,016
shares of common stock of the Company. Under the Agreement, Alpha also has an option, exercisable until July 1, 2024, to
purchase from the Company up to an additional $ 1,100,000
in principal amount of 2024 Debentures of like tenor, together with up to an additional 1,800,032
2024 Warrants of like tenor, which would (if and when Alpha exercises such option) provide us up to an additional $ 1.0
million in cash proceeds (less expense reimbursement, and not including any possible cash proceeds from any future exercise of the
additional 2024 Warrants). We granted Alpha “piggyback” registration rights for the common shares underlying the
2024 Debenture and the 2024 Warrant.
61
Item
9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure.
Not
applicable.