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Our business now consists
−Removed: of one early-clinical-stage therapeutic program (QN-302) and one preclinical therapeutic program (Pan-RAS).
+Added: of one early-clinical-stage therapeutic program (QN-302), one preclinical therapeutic program (Pan-RAS), and a co-development agreement
+Added: with Marizyme, Inc (“Marizyme”).
lead program, QN-302, is an investigational small molecule G-quadruplexes (G4)-selective transcription inhibitor with strong binding
affinity to G4s prevalent in cancer cells (such as pancreatic cancer).
−Removed: Such binding could, by stabilizing the G4s against DNA
−Removed: “unwinding,” help inhibit cancer cell proliferation.
−Removed: QN-302 is currently undergoing a Phase 1a clinical trial at START
−Removed: Midwest in Grand Rapids, Michigan, and HonorHealth in Scottsdale, Arizona.
+Added: Such binding could, by stabilizing the G4s against DNA “unwinding,”
+Added: help inhibit cancer cell proliferation.
Pan-RAS program, which is currently at the preclinical stage, consists of a family of RAS oncogene protein-protein interaction inhibitor
−Removed: small molecules believed to inhibit or block mutated RAS genes’ proteins from binding to their effector proteins thereby
−Removed: leaving the proteins from the mutated RAS unable to cause further harm.
+Added: small molecules believed to inhibit or block mutated RAS genes’ proteins from binding to their effector proteins thereby leaving
+Added: the proteins from the mutated RAS unable to cause further harm.
In theory, such mechanism of action may be effective in the treatment
of about one quarter of all cancers, including certain forms of pancreatic, colorectal, and lung cancers.
−Removed: The investigational compounds within our Pan-RAS portfolio are designed to suppress the interaction of endogenous RAS with c-RAF,
−Removed: upstream of the KRAS, HRAS and NRAS effector pathways.
−Removed: November 23, 2022, we effected a 1-for-10, reverse stock split of our outstanding shares of common stock (the “Reverse Stock Split”).
−Removed: The Reverse Stock Split reduced our shares of outstanding common stock, stock options, and warrants to purchase shares of our common
−Removed: Fractional shares of common stock that would have otherwise resulted from the Reverse Stock Split were rounded down to the nearest
−Removed: whole share and cash in lieu of fractional shares was paid to stockholders.
−Removed: All share and per share data for all periods presented in
−Removed: this Annual Report on Form 10-K have been adjusted retrospectively to reflect the Reverse Stock Split.
−Removed: The number of authorized shares
−Removed: of common stock and the par value per share remains unchanged.
+Added: The investigational compounds
+Added: within our Pan-RAS portfolio are designed to suppress the interaction of endogenous RAS with c-RAF, upstream of the KRAS, HRAS and NRAS
+Added: effector pathways.
+Added: April 11, 2024, the Company entered into a Co-Development Agreement (the “Co-Development Agreement”) with Marizyme.
+Added: the Co-Development Agreement (as amended), we agreed to pay Marizyme a Funding Payment of up to $1,750,000 and an Exclusivity Fee of
+Added: The Exclusivity Fee of $200,000 and a Funding Payment of $500,000 was paid to Marizyme on April 12, 2024.
+Added: The Exclusivity Fee
+Added: entitled us to an exclusivity period until May 31, 2024 for purposes of proposing and outlining a broader strategic relationship with
+Added: Marizyme with regard to Marizyme’s DuraGraft business.
+Added: The Funding Payment is designed to provide financial support for commercialization
+Added: of Marizyme’s DuraGraft™ vascular conduit solution, which is indicated for adult patients undergoing coronary artery bypass
+Added: grafting surgeries and is intended for the flushing and storage of the saphenous vein grafts used in coronary artery bypass grafting
+Added: In return for the Funding Payment, we will receive quarterly a 33% payment in the nature of royalties on any Net Sales (as defined
+Added: with a meaning tantamount to gross profit on net sales) of DuraGraft, capped at double the amount of the Funding Payment cash provided.
+Added: No such payments-in-the-nature-of-royalties would accrue until after DuraGraft has been launched in the United States and a cumulative
+Added: total of $500,000 of DuraGraft Net Sales have been made in the United States.
+Added: addition, during the year ended December 31, 2024, the Company advanced a total of $2,257,400 to Marizyme, against which Marizyme had
+Added: previously delivered demand promissory notes to the Company of like principal amounts (the “Marizyme Notes”).
+Added: Notes bear interest the rate of eighteen percent (18%) per annum.
+Added: Marizyme may pre-pay all or any part of the outstanding principal or
+Added: interest of the Marizyme Notes at any time and from time to time, in whole or in part, without premium or penalty.
+Added: November 5, 2024, the Company effected a 1-for-50, reverse stock split of our outstanding shares of common stock (the “Reverse
+Added: Stock Split”).
+Added: The Reverse Stock Split reduced our shares of outstanding common stock, stock options, and warrants to purchase
+Added: shares of our common stock.
+Added: Fractional shares of common stock that would have otherwise resulted from the Reverse Stock Split were rounded
+Added: down to the nearest whole share and cash in lieu of fractional shares was paid to stockholders.
+Added: All share and per share data for all
+Added: periods presented in this Annual Report on Form 10-K have been adjusted retrospectively to reflect the Reverse Stock Split.
+Added: of authorized shares of common stock and the par value per share remains unchanged.
do not expect to be profitable before products from our therapeutics pipeline are commercialized.
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products are still under development is, of course, typical for biotechnology companies.
−Removed: 1 Clinical Trial of QN-302
−Removed: August 1, 2023, we announced that the FDA has cleared our IND application for QN-302.
−Removed: Based on this clearance, we chose Translational Drug Development, LLC (“TD2”) to serve
−Removed: as our contract research organization to conduct a Phase 1 clinical trial in patients with advanced or metastatic solid tumors.
−Removed: Phase 1 trial (NCT06086522) is designed as a multicenter, open-label, dose escalation, safety, pharmacokinetic, and pharmacodynamic
−Removed: study with dose expansion to evaluate safety, tolerability, and antitumor activity of QN-302 in patients with advanced solid tumors
−Removed: that have not responded to or that have recurred following treatment with available therapies.
−Removed: On November 7, 2023, we announced
−Removed: that the first patient had been enrolled and dosed in the dose escalation (Phase 1a) portion of the study.
−Removed: Subject to available
−Removed: funding (which is, however, not all currently in hand), we anticipate that Phase 1a of the trial can be completed by the end of
−Removed: The exact number of patients to be enrolled in the trial will depend on the observed safety profile, which will
−Removed: determine the number of patients per dose level, as well as the number of dose escalations required to meet the Maximum Tolerated
−Removed: Dose (“MTD”).
−Removed: Once the MTD has been established in dose escalation, dose expansion will begin.
−Removed: of Diagnostics Business
−Removed: July 20, 2023, we sold all of the issued and outstanding shares of common stock of Qualigen, Inc., a wholly-owned subsidiary and the
−Removed: legal entity operating our FastPack™ diagnostic business, to Chembio Diagnostics, Inc.
−Removed: (“Chembio”), a subsidiary of
−Removed: Biosynex, S.A.
−Removed: As consideration for the shares of Qualigen, Inc., we received cash payments of approximately $4.9 million, which payment
−Removed: is subject to post-closing adjustments.
−Removed: An additional $450,000 was delivered by Chembio to an escrow account to satisfy our indemnification
−Removed: Any amounts remaining in the escrow account that have not been offset or reserved for claims will be released to us within
−Removed: five business days following January 20, 2025.
−Removed: Following the consummation of the transaction, Qualigen, Inc.
−Removed: became a wholly-owned subsidiary
−Removed: and Settlement Agreement with NanoSynex Ltd.
−Removed: July 20, 2023, we entered into and effectuated the NanoSynex Amendment, by which we agreed to, among other things, forfeit 281,000 Series
−Removed: B Preferred Shares of NanoSynex held by us, resulting in our ownership in NanoSynex being reduced from approximately 52.8% to approximately
−Removed: 49.97% of the voting equity of NanoSynex.
−Removed: In addition, we agreed to cancel approximately $3.0 million of promissory notes which NanoSynex
−Removed: had issued to us under the NanoSynex Funding Agreement, relieving NanoSynex of any repayment obligations to us with respect to such notes.
−Removed: The NanoSynex Amendment superseded any NanoSynex Funding Agreement obligations to provide funding to NanoSynex, except we agreed to provide
−Removed: future loans as follows:
−Removed: (i) $560,000 on or before November 30, 2023, and (ii) $670,000 on or before March 31, 2024.
−Removed: However, on November
−Removed: 22, 2023, in full settlement of any additional funding obligations to NanoSynex, we forfeited certain of our shares of Series A-1 Preferred
−Removed: Stock of NanoSynex in an amount that reduced our ownership in NanoSynex from approximately 49.97% to 39.90%.
−Removed: Accordingly, NanoSynex was
−Removed: deconsolidated from our financial statements as of July 20, 2023, and is reported as Discontinued Operations in this Annual Report.
−Removed: investment in NanoSynex will be accounted for in the future as an equity method investment.
+Added: Given our financial situation, the company slowed
+Added: the development of the aforementioned therapeutic products beginning in the second quarter 2024.
+Added: We have also implemented dramatic expense
+Added: controls in an effort to stem the rate of losses.
+Added: Management and the board are strategically reviewing plans on how to best advance our
+Added: therapeutics pipeline, and will ramp up development when properly funded through either the capital markets or strategic partnerships.
Accounting Policies and Estimates
−Removed: consolidated financial statements historically have not separated our diagnostics-related activities from our therapeutics-related
+Added: consolidated financial statements historically have not separated our diagnostics-related activities from our therapeutics-related activities.
All of our historically reported revenue was diagnostics-related.
−Removed: Before the third quarter of 2023, our reported
−Removed: expenses represented the total of our diagnostics-related and therapeutics-related expenses.
−Removed: In this Annual Report, all
−Removed: diagnostics-related revenues and expenses have been reclassified to discontinued operations (See Note 5 - Discontinued
+Added: Before the third quarter of 2023, our reported expenses represented
+Added: the total of our diagnostics-related and therapeutics-related expenses.
+Added: In this Annual Report, all diagnostics-related revenues and expenses
+Added: have been reclassified to discontinued operations (See Note 6 - Discontinued Operations).
discussion and analysis is based on our consolidated financial statements, which have been prepared in accordance with U.S.
−Removed: preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of
−Removed: assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our consolidated financial statements.
−Removed: On an ongoing basis, we evaluate our estimates and judgments, including those related to impairment of goodwill and other intangible
−Removed: assets, fair value of warrant liabilities, and stock-based compensation.
−Removed: We base our estimates on historical experience, known trends
−Removed: and events and various other factors we believe to be reasonable under the circumstances, the results of which form the basis for making
−Removed: judgments about the carrying values of assets and liabilities that are not readily apparent from other sources.
−Removed: Actual results may differ
−Removed: from these estimates under different assumptions or conditions.
+Added: The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported
+Added: amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our consolidated
+Added: financial statements.
+Added: On an ongoing basis, we evaluate our estimates and judgments, including those related to the determination of
+Added: the allowance for credit losses, fair value of derivative financial instruments and warrant liabilities, and stock-based
+Added: compensation.
+Added: We base our estimates on historical experience, known trends and events and various other factors we believe to be
+Added: reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and
+Added: liabilities that are not readily apparent from other sources.
+Added: Actual results may differ from these estimates under different
+Added: assumptions or conditions.
our significant accounting policies are more fully described in Note 1 to our consolidated financial statements appearing in “Item
1 unchanged sentence
you in fully understanding and evaluating our financial condition and results of operations:
−Removed: and development
−Removed: of long-lived assets
−Removed: financial instruments and warrant liabilities
−Removed: 2004, Qualigen, Inc.
−Removed: issued Series C preferred stock warrants to investors and brokers in connection with a private placement.
−Removed: warrants were subsequently extended and survived the May 2020 Ritter reverse recapitalization transaction and are now exercisable
−Removed: for Qualigen Therapeutics common stock.
−Removed: These warrants contain a provision that if the Company issues shares (except in certain
−Removed: defined scenarios) at a price below the warrants’ exercise price, the exercise price will be re-set to such new price and the
−Removed: number of shares underlying the warrants will be increased in the same proportion as the exercise price decrease.
−Removed: For accounting
−Removed: purposes, such warrants give rise to warrant liabilities.
−Removed: Accounting principles gene rally
−Removed: accepted in the United States of America (“U.S.
−Removed: GAAP”) require us to recognize the fair value of these warrants as
−Removed: warrant liabilities on our Consolidated Balance Sheets and to reflect period-to-period changes in the fair value of the warrant
−Removed: liabilities on our Consolidated Statements of Operations.
+Added: Research and Development
+Added: Discontinued Operations
+Added: Reverse Stock Splits
+Added: Derivative Financial Instruments and Warrant Liabilities
+Added: Stock-Based Compensation
+Added: time to time the Company has issued certain warrants with terms that give rise to warrant liabilities (see Note 8 – Warrant Liabilities).
+Added: Accounting principles generally accepted in the United States of America (“U.S.
+Added: GAAP”) require us to recognize the fair value
+Added: of these warrants as warrant liabilities on our Consolidated Balance Sheets and to reflect period-to-period changes in the fair value
+Added: of the warrant liabilities on our Consolidated Statements of Operations.
The estimated fair value of these warrant liabilities was approximately
$0.3 million, and $0.1 million at December 31, 2024 and 2023, respectively.
−Removed: There were 455,623 of these warrants outstanding at
−Removed: December 31, 2023 and 1,349,571 of these warrants outstanding at December 31, 2022.
−Removed: the fair value of the above liability classified warrants will be determined each quarter on a
−Removed: “mark-to-market” basis , significant variability in our future quarterly and annual Consolidated Statement of Operations
−Removed: and Consolidated Balance Sheets could occur based on changes in our public market common stock price.
+Added: There were liability classified warrants outstanding for
+Added: 68,712 shares with a weighted average price of $2.00 (of which 52,693 were exercisable with a weighted average price of $0.23) at December
+Added: 31, 2024 and liability classified warrants outstanding for 9,113 shares (of which all were exercisable) with a weighted average price
+Added: of $36.50 at December 31, 2023.
+Added: the fair value of the above liability classified warrants will be determined each quarter on a “mark-to-market” basis, significant
+Added: variability in our future quarterly and annual Consolidated Statement of Operations and Consolidated Balance Sheets could occur based
+Added: on changes in our public market common stock price.
Pursuant to U.S.
−Removed: GAAP, a quarter-to-quarter
−Removed: increase in our stock price would result in an increase in the fair value of the warrant liabilities and a quarter-to-quarter decrease
−Removed: in our stock price would result in a decrease in the fair value of the warrant liabilities.
−Removed: December 22, 2022, as part of the 2022 Debenture financing, we issued to Alpha a common stock warrant (exercisable from June 22, 2023
−Removed: through June 22, 2028) to purchase 2,500,000 shares of our common stock.
−Removed: The exercise price of the warrant was modified from $1.65 to
−Removed: $0.73 on December 5, 2023, and was further modified to $0.26 on February 27, 2024.
−Removed: The warrant may be exercised by Alpha, in whole or
−Removed: in part before June 22, 2028.
−Removed: The warrant was originally liability classified, but was modified on December 5, 2023 to allow for equity
−Removed: classification.
−Removed: The estimated fair value of this warrant upon reclassification from warrant liabilities to equity was approximately $1.6
−Removed: million and the estimated fair value of this warrant which was included in warrant liabilities-related party on December 31, 2022 was
−Removed: approximately $2.8 million.
+Added: GAAP, a quarter-to-quarter increase in our stock price would result
+Added: in an increase in the fair value of the warrant liabilities and a quarter-to-quarter decrease in our stock price would result in a decrease
+Added: in the fair value of warrant liabilities.
+Added: the year ended December 31, 2024, the Company issued liability classified warrants for 52,474 shares, at a weighted average price of
+Added: $8.64, reclassified warrants for 71,026 shares with a weighted average price of $2.14 from equity to liabilities, and warrants for 38,315
+Added: shares with a weighted average price of $6.50 from liabilities to equity.
+Added: Liability classified warrants for 25,586 shares expired with
+Added: a weighted average price of $13.00.
+Added: No liability classified warrants were exercised during the year ended December 31, 2024.
+Added: the year ended December 31, 2023, the Company issued liability classified warrants for 9,113 shares, at a weighted average price of
+Added: $36.50, reclassified warrants for 50,000 shares with a weighted average price of $82.50 from liabilities to equity.
+Added: classified warrants for 21,952 shares with a weighted average price of $66.00 expired, and liability classified warrants for 5,040
+Added: shares with a weighted average price of $66.00 were forfeited.
+Added: No liability classified warrants were exercised during the year ended
+Added: December 31, 2023.
+Added: Notes Receivable
+Added: the year ended December 31, 2024, the Company advanced to Marizyme, Inc., $2,257,400, against which Marizyme delivered demand promissory
+Added: notes to the Company of like principal amounts (the “Marizyme Notes”).
+Added: As of December 31, 2024, accrued interest related
+Added: to the Marizyme Notes was $113,292 and interest income of this amount was recognized in other income in the consolidated statement of
+Added: As of December 31, 2023 there were no amounts due to the Company under the Marizyme Notes.
+Added: Marizyme Notes bear at interest the rate of eighteen percent (18%) per annum.
+Added: Marizyme may pre-pay all or any part of the outstanding
+Added: principal or interest at any time and from time to time, in whole or in part, without premium or penalty.
+Added: ASC 326-20, known as the current expected credit loss (“CECL”) model, the Company was required to estimate credit losses
+Added: expected over the life of an exposure (or pool of exposures) based on historical information, current information, and reasonable and
+Added: supportable forecasts.
+Added: The Company is unable to use its historical data to estimate losses as it has no relevant loss history to
+Added: To determine the estimate of expected credit losses, the Company used a probability-weighted approach that incorporates multiple
+Added: settlement scenarios, including recovery of amounts due upon an acquisition of the debtor, and recovery in different liquidation scenarios,
+Added: and determines the expected recoverable amount of the loan in each scenario.
+Added: This model requires management to make certain assumptions
+Added: including the likelihood of each outcome, the estimated value of the debtor’s assets, and the Company’s expected claim and
+Added: recovery rate on the debtor’s assets in the event of an insolvency or a liquidation proceeding.
+Added: As of December 31, 2024, the estimate
+Added: for expected credit losses on the Marizyme Notes is $360,000.
+Added: Given the inherently uncertain nature of the debtor’s financial condition
+Added: and future outcomes, actual credit losses may differ materially from this estimate.
+Added: The Company will continue to monitor relevant events
+Added: and conditions and update its assumptions and allowance as necessary.
of Operations
3 unchanged sentences
Research and development
+Added: Credit loss expense - short-term note receivable
Total expenses
1 unchanged sentence
(11,304,857 )
−Removed: (14,760,720 )
OTHER EXPENSE (INCOME), NET
Gain on change in fair value of warrant liabilities
−Removed: Interest expense, net
−Removed: Loss on voluntary conversion of convertible debt
+Added: Gain on change in fair value of derivative liabilities
+Added: Interest income
+Added: Interest expense
+Added: Loss on issuance of convertible debt
+Added: (Gain) loss on voluntary conversion of convertible debt into common stock
Loss on debt extinguishment
+Added: Loss on monthly redemptions of convertible debt into common stock
+Added: Gain on settlements of accounts payable
Loss on fixed asset disposal
1 unchanged sentence
Total other expense (income), net
−Removed: LOSS BEFORE (BENEFIT) PROVISION FOR INCOME TAXES
−Removed: (12,479,803 )
+Added: LOSS BEFORE PROVISION FOR INCOME TAXES
(12,479,803 )
−Removed: (BENEFIT) PROVISION FOR INCOME TAXES
+Added: PROVISION (BENEFIT) FOR INCOME TAXES
NET LOSS FROM CONTINUING OPERATIONS
(12,475,010 )
−Removed: (13,894,462 )
DISCONTINUED OPERATIONS
3 unchanged sentences
(13,760,250 )
−Removed: (21,034,643 )
Net loss attributable to non-controlling interest from discontinued operations
+Added: Net loss available to Qualigen Therapeutics, Inc.
+Added: (13,417,212 )
+Added: Deemed dividend arising from warrant down-round provision
Net loss attributable to Qualigen Therapeutics, Inc.
3 unchanged sentences
Net loss per common share, basic and diluted - discontinued operations
+Added: Total net loss per common share, basic and diluted
Weighted—average number of shares outstanding, basic and diluted
5 unchanged sentences
(13,640,777 )
−Removed: (20,983,922 )
Comprehensive loss attributable to noncontrolling interest from discontinued operations
3 unchanged sentences
and Administrative Expenses
−Removed: and administrative expenses decreased from $10.3 million for the year ended December 31, 2022 to $6.1 million for the year ended
−Removed: December 31, 2023.
−Removed: This decrease was due to a $3.8 million decrease in stock-based compensation expense, a $0.4 million decrease in
−Removed: payroll related expenses, a $0.3 million decrease in insurance expenses, and a $0.2 million decrease in license fees, offset by an
−Removed: increase of $0.5 million in professional fees.
−Removed: (The foregoing comparison, and all other comparisons presented in this Item, exclude
−Removed: Qualigen, Inc.
−Removed: and NanoSynex, Ltd.
−Removed: results for both years.)
+Added: and administrative expenses decreased from $6.1 million for the year ended December 31, 2023 to $4.2 million for the year ended December
+Added: This decrease was primarily due to a $0.8 million decrease in stock-based compensation expense, a $0.9 million decrease in
+Added: payroll related expenses due to a reduction in force, and a $0.3 million decrease in insurance expenses, offset by an increase of $0.1 million in professional fees.
and Development Costs
−Removed: and development expenses increased from $4.5 million for the year ended December 31, 2022 to approximately $5.2 million for year ended December
−Removed: This increase in research and development expenses for the year ended December 31, 2023 compared to for the year ended December
−Removed: 31, 2022 was primarily due to a $2.1 million increase in pre-clinical and clinical research costs for QN-302, offset by a $1.0 million
−Removed: decrease in pre-clinical research costs for QN-247 a $0.3 million decrease in preclinical research costs for Pan-RAS, and a $0.1 million decrease in preclinical research costs for QN-165.
−Removed: Expense (Income)
−Removed: in Fair Value of Warrant Liabilities
−Removed: the year ended December 31, 2023 we experienced a $2.0 million gain in other income because of the change in fair value of the
−Removed: warrant liabilities arising from our liability classified warrants described above.
−Removed: The estimated fair value of these warrant
−Removed: liabilities decreased to $0.1 million as of December 31, 2023 from $3.6 million as of December 31, 2022 due to a reduction in fair
−Removed: value of the warrant liabilities resulting from an associated decrease in the market price of our common stock, and the
−Removed: reclassification at fair value of a liability classified warrant to equity of $1.6 million.
−Removed: For the year ended December 31, 2022,
−Removed: the gain on change in fair value of warrant liabilities was $0.9 million due to an associated decrease in the market price of our
−Removed: common stock.
−Removed: Typically, a decline in our stock price would result in a decline in the fair value of our warrant liabilities,
−Removed: generating a gain, while an increase in our stock price would result in an increase in the fair value of our warrant liabilities,
−Removed: generating a loss.
−Removed: remaining liability classified warrants expire on June 26, 2024.
−Removed: Because the fair value of the warrant liabilities will be determined
−Removed: each quarter on a “mark-to-market” basis, this item is likely to, until then, continue to result in variability in our future
−Removed: quarterly Consolidated Statements of Operations based on unpredictable changes in our public market common stock price and the number
−Removed: of warrants outstanding at the end of each quarter.
−Removed: (Income) Expense, Net
−Removed: was $1.5 million in net interest expense during the year ended December 31, 2023 compared to net interest income of $34,000 during the
−Removed: year ended December 31, 2022.
−Removed: The increase was due to the interest on the 2022 Debenture.
−Removed: on Voluntary Conversion of Convertible Debt
+Added: and development expenses decreased from $5.2 million for the year ended December 31, 2023 to $1.2 million for year ended December 31,
+Added: This decrease was primarily due to a $2.9 million decrease in preclinical, clinical research, and licensing costs for QN-302, a
+Added: $1.0 million decrease in preclinical research, and licensing costs for Pan-RAS, a $0.6 million decrease in payroll related expenses due
+Added: to a reduction in force, a $0.1 million decrease in stock-based compensation expense, and a $0.1 million decrease in professional fees,
+Added: offset by a $0.7 increase in expenses related to the Marizyme Co-Development Agreement.
+Added: Loss Expense - Short Term Notes Receivable
+Added: There was a $0.4 million loss in the current year due to a charge for the Company’s estimate for expected credit
+Added: losses on the Marizyme Notes Receivable during the year ended December 31, 2024.
+Added: There were no credit losses during the year ended December
+Added: Expense (Income), Net
+Added: on Change in Fair Value of Warrant Liabilities
+Added: the year ended December 31, 2024 we experienced a $0.4 million gain in other income due to the change in fair value of the warrant liabilities
+Added: described above.
+Added: The estimated fair value of warrant liabilities increased to $0.3 million as of December 31, 2024 from $0.1 million
+Added: as of December 31, 2023 due to the issuance of new liability classified warrants with an initial fair value of $0.6 million, the reclassification
+Added: at fair value of equity classified warrants to warrant liabilities of $0.3 million, offset by the reclassification at fair value to equity
+Added: of liability classified warrants of $0.2 million, and the $0.4 million gain on the change in fair value of the warrant liabilities due
+Added: to an associated decrease in the market price of our common stock and the expiration of liability classified warrants during the year.
+Added: the year ended December 31, 2023 we experienced a $2.0 million gain in other income because of the change in fair value of the warrant
+Added: The estimated fair value of warrant liabilities decreased to $0.1 million as of December 31, 2023 from $3.6 million as of
+Added: December 31, 2022 due to a reduction in fair value of the warrant liabilities resulting from an associated decrease in the market price
+Added: of our common stock, and the reclassification at fair value of a liability classified warrant to equity of $1.6 million.
+Added: a decline in our stock price would result in a decline in the fair value of our warrant liabilities, generating a gain, while an increase
+Added: in our stock price would result in an increase in the fair value of our warrant liabilities, generating a loss.
+Added: Because the fair value
+Added: of the warrant liabilities will be determined each quarter on a “mark-to-market” basis, this item is likely to continue to
+Added: result in variability in our future quarterly Consolidated Statements of Operations based on unpredictable changes in our public market
+Added: common stock price and the number of liability classified warrants outstanding at the end of each quarter.
+Added: on Change in Fair Value of Derivative Liabilities
+Added: the year ended December 31, 2024, we experienced a gain of approximately $0.2 million on change in fair value of derivative liabilities
+Added: due to the issuance and subsequent extinguishment of the 2024 Alpha Debenture and 2024 Chen Debenture during the year.
+Added: Derivative liabilities
+Added: at December 31, 2023 had no fair value.
+Added: was $0.1 million in interest income during the year ended December 31, 2024 compared to no interest income during the year ended December
+Added: The increase was due to interest accrued on the Marizyme Notes.
+Added: There were no Marizyme notes outstanding during the year ended
+Added: December 31, 2023.
+Added: was $0.9 million in net interest expense during the year ended December 31, 2024 compared to net interest expense of $1.5 million during
+Added: the year ended December 31, 2023.
+Added: The decrease was due to lower outstanding balances on convertible debt during the current year compared
+Added: to the prior year.
+Added: on Issuance of Convertible Debt
+Added: the year ended December 31, 2024 we experienced a loss of approximately $358,000 due to the issuance of new convertible debt.
+Added: was no loss on issuance of convertible debt during the year ended December 31, 2023.
+Added: Loss on Voluntary Conversion of Convertible Debt into Common Stock
+Added: the year ended December 31, 2024, we recognized a gain of approximately $56,000 on the voluntary conversion of convertible debt into
+Added: common stock, due to the issuance of 58,378 shares of common stock with a fair value of approximately $674,000 upon partial voluntary
+Added: conversion of the 2022 Alpha Debenture at a weighted average share price of $13.00, resulting in a gain of approximately $85,000, offset
+Added: by a loss of approximately $29,000 from the issuance of 7,842 shares of common stock with a fair value of approximately $61,000 upon
+Added: Alpha’s partial voluntary conversion of the 2024 Alpha Debenture at a weighted average share price of $6.50.
the year ended December 31, 2023 we issued 16,835 shares of common stock upon Alpha’s partial voluntary conversion of the 2022
Debenture at $66.00 per share for a total of $1,111,078 principal converted.
−Removed: Upon conversion, we recognized a loss on voluntary
−Removed: conversion of convertible debt of approximately $1.1 million.
+Added: Upon conversion, we recognized a loss on voluntary conversion
+Added: of convertible debt of approximately $1.1 million.
on Debt Extinguishment
−Removed: the year ended December 31, 2023, we issued 309,665 shares of common stock in lieu of cash for the October and December 2023 monthly
−Removed: redemptions, for a total of $220,000 principal redeemed, pursuant to the terms of the 2022 Debenture at a weighted average share
−Removed: price of $0.71.
+Added: the year ended December 31, 2024, we recognized a loss on debt extinguishment of approximately $57,000.
+Added: In connection with the closing
+Added: of the Company’s private placement transaction and issuance of Series A-2 Preferred Stock, we used approximately $531,000 of the
+Added: proceeds to repay the outstanding principal and accrued interest on the 2024 Alpha Debenture, in full settlement of the obligation, resulting
+Added: in a debt extinguishment loss of approximately $68,000.
+Added: This loss was offset by a debt extinguishment gain of approximately $13,000 from
+Added: the issuance of 1,154 shares of newly designated Series A-2 Preferred Stock, in full settlement of the obligation of $1,154,000 in outstanding
+Added: principal and interest on the 2024 Chen Debenture.
+Added: the year ended December 31, 2023, we issued 6,193 shares of common stock in lieu of cash for the October and December 2023 monthly redemptions,
+Added: for a total of $220,000 principal redeemed, pursuant to the terms of the 2022 Debenture at a weighted average share price of $35.52.
Upon redemption in shares, we recognized a loss on partial debt extinguishment of $34,315.
−Removed: The modification of the 2022 Debenture during the year ended December 31, 2023 met the criteria to be accounted for
−Removed: as a debt extinguishment in the amount of $591,338.
−Removed: Accordingly, we recognized an additional loss on partial debt extinguishment of that
+Added: The modification of the 2022 Debenture during
+Added: the year ended December 31, 2023 met the criteria to be accounted for as a debt extinguishment in the amount of $591,338.
+Added: we recognized an additional loss on partial debt extinguishment of that amount.
+Added: on Monthly Redemptions of Convertible Debt into Common Stock
+Added: the year ended December 31, 2024, we issued 45,496 shares of common stock with a fair value of approximately $903,000, in lieu of cash
+Added: for monthly redemptions of $660,000 principal and approximately $34,000 accrued interest redeemed, pursuant to the terms of the 2022
+Added: Alpha Debenture at a weighted average share price of $14.51.
+Added: Upon redemption in shares, we recognized a loss on monthly redemptions of
+Added: convertible debt into common stock of approximately $209,000.
+Added: on Settlements of Accounts Payable
+Added: the year ended December 31, 2024, we settled $395,000 of our outstanding accounts payable for a gain of approximately $348,000.
+Added: were no such settlements during the year ended December 31, 2023.
on Fixed Asset Disposal
−Removed: the year ended December 31, 2023, we incurred a $21,747 loss on fixed asset disposal due to disposal of research and development equipment
−Removed: previously used for QN-165.
+Added: the year ended December 31, 2024 there was no loss on fixed asset disposal.
+Added: During the year ended December 31, 2023, we incurred a $21,747
+Added: loss on fixed asset disposal due to disposal of research and development equipment previously used for QN-165.
+Added: income, net was immaterial during the years ended December 31, 2024 and 2023.
+Added: was no loss from discontinued operations during the year ended December 31, 2024, compared approximately $0.7 million during the year
+Added: ended December 31, 2023, which consisted of approximately $0.2 million from our former Qualigen, Inc.
+Added: subsidiary and approximately $0.5
+Added: million from NanoSynex.
+Added: Company recorded a loss of approximately $0.1 million on disposal of discontinued operations during the year ended December 31, 2024,
+Added: which was generated due to the early settlement of an escrow account from the sale of Qualigen, Inc.
+Added: During the year ended December 31,
+Added: 2023, the Company recorded a loss of approximately $0.6 million on disposal of discontinued operations, consisting of a loss of approximately
+Added: $4.5 million from the deconsolidation of NanoSynex, offset by a gain of approximately $3.9 million from the sale of our former Qualigen,
and Going Concern
9 unchanged sentences
FastPack® diagnostics products business in 2023.
−Removed: February 26, 2024, we entered into a Securities Purchase Agreement (“Agreement”) with Alpha.
−Removed: The transactions contemplated
−Removed: by the Agreement closed on February 27, 2024, at which time we delivered to Alpha a new Debenture and warrant, as described in this paragraph,
−Removed: and Alpha paid the Company a cash purchase price of $500,000 (less expenses).
−Removed: Pursuant to the Agreement, we issued to Alpha an 8% Convertible
−Removed: Debenture (the “2024 Debenture”) in the principal amount of $550,000.
−Removed: The 2024 Debenture has a maturity date of December
−Removed: 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,
−Removed: at $0.6111 per share, subject to adjustment as described in the 2024 Debenture.
−Removed: The 2024 Debenture accrues interest on its outstanding
−Removed: principal balance at the rate of 8% per annum, payable at maturity.
−Removed: Pursuant to the terms of the Agreement, we also issued to Alpha a
−Removed: 5-year common stock purchase warrant to purchase (at $0.26 per share) 900,016 shares of common stock of the Company.
−Removed: We also granted
−Removed: to Alpha an option, exercisable until July 1, 2024, to purchase from us additional 8% Convertible Debentures, of like tenor, with face
−Removed: amounts of up to an aggregate of $1,100,000 (and with a proportional number of accompanying common stock warrants of like tenor, up to
−Removed: a total of 1,800,032 additional warrants), which would (if and when Alpha exercises such option) provide us up to an additional $1.0
−Removed: million in cash proceeds (less expense reimbursement, and not including any possible cash proceeds from any future exercise of the additional warrants).
−Removed: currently expect our cash balances to fund operations only into the second quarter of 2024.
−Removed: We expect to continue to have net losses and negative cash flow from operations, which will challenge our liquidity.
−Removed: These factors raise substantial doubt regarding our ability to continue as a going concern for the one-year period following the date
−Removed: that the financial statements in this Annual Report were issued.
−Removed: is no assurance that we will ever achieve profitable operations, or, if achieved, could be sustained on a continuing basis.
−Removed: to fully execute our business plan, we will require significant additional financing for planned research and development activities,
−Removed: capital expenditures, QN-302 clinical trials, and preclinical development of Pan-RAS, as well as commercialization activities.
+Added: Our current liabilities at December 31, 2024 include approximately $1.6
+Added: million of accounts payable, $170,000 of accrued expenses and other current liabilities, and $269,000 in warrant liabilities.
+Added: currently expect our cash balances to fund operations only into the third quarter of 2025.
+Added: We expect to continue to have net
+Added: losses and negative cash flow from operations, which will challenge our liquidity.
+Added: These factors raise substantial doubt regarding our
+Added: ability to continue as a going concern for the one-year period following the date that the financial statements in this Annual Report
Historically,
−Removed: our principal sources of cash have, in addition to revenue from FastPack product sales and license revenues (see Note 5 - Discontinued
−Removed: Operations), included proceeds from the issuance of common and preferred equity and proceeds from the issuance of debt.
−Removed: In December 2022
−Removed: and February 2024 we raised approximately $3.0 million and $0.5 million, respectively from the sale of convertible debentures to Alpha.
−Removed: no assurance that further financing can be obtained on favorable terms, or at all.
−Removed: If we are unable to obtain funding, we could be required
−Removed: to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, and
−Removed: we could be unable to continue operations.
+Added: our principal sources of cash have, in addition to previous revenue from product sales and license revenues from the FastPack product
+Added: of line of Qualigen, Inc.
+Added: (which we divested in July 2023), included proceeds from the issuance of common and preferred equity and proceeds
+Added: from warrant exercises and the issuance of debt.
+Added: There can be no assurance that further financing can be obtained on favorable terms,
+Added: If we are unable to obtain funding, we could be required to delay, reduce or eliminate research and development programs,
+Added: product portfolio expansion or future commercialization efforts, and we could be unable to continue operations.
+Added: the year ended December 31, 2024 we raised approximately $8.0 million in new equity consisting of $4.6 million from the sale of Preferred
+Added: Series A-2 Preferred Stock, $3.0 million from the sale of common stock and prefunded warrants in a public offering, and $0.4 million
+Added: from warrant exercises.
+Added: We also raised $1.5 million in new convertible debt, and $2.0 million in short-term debt, of which $1.1 million
+Added: in convertible debt and accrued interest was exchanged for Preferred Series A-2 Preferred Stock, and $0.5 million was repaid in cash.
+Added: The $2.0 million in short-term
+Added: debt was also repaid in cash during the year.
+Added: These equity and debt capital raises resulted in approximately $9.0 million in cash provided
+Added: by financing activities during the year ended December 31, 2024, compared to no new equity or debt issued during the year ended December
the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interests of our
6 unchanged sentences
streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us.
−Removed: In addition, any future
−Removed: financing (depending on the terms and conditions) may be subject to the approval of Alpha under the terms of the Debentures and/or trigger
−Removed: certain adjustments to the Debentures or warrants held by Alpha.
−Removed: accompanying financial statements have been prepared assuming that the Company will continue as a going concern.
−Removed: The financial statements
−Removed: do not include any adjustments that would be necessary should the Company be unable to continue as a going concern, and therefore, be
−Removed: required to liquidate its assets and discharge its liabilities in other than the normal course of business and at amounts that may differ
−Removed: from those reflected in the accompanying financial statements.
−Removed: current liabilities at December 31, 2023 include $2.2 million of accounts payable, $0.6 million of accrued expenses and other current
−Removed: liabilities, $0.1 million in warrant liabilities, and $1.3 million of convertible debt to a related party.
+Added: of our common stock from Nasdaq would have a serious negative effect on any future financing efforts.
+Added: On April 24, 2025, the Company
+Added: received a notice from Nasdaq notifying the Company that, because the Company was delinquent in filing its 2024 Form 10-K, the Company
+Added: no longer complied with Nasdaq Listing Rule 5250(c), which requires companies with securities listed on Nasdaq to timely file all required
+Added: periodic reports with the SEC.
+Added: Therefore, in line with the Panel Monitor’s decision, the Company’s securities will be delisted
+Added: If the Company did not request an appeal of this decision by May 1, 2025, trading of the Company’s common stock would
+Added: have been suspended at the start of business on May 5, 2025.
+Added: The Company appealed this decision to Nasdaq on May 1, 2025 and has taken
+Added: the necessary steps to regain compliance with Nasdaq’s listing rules as soon as practicable.
+Added: Notwithstanding the foregoing, there
+Added: can be no assurance that the Panel will grant the Company further extensions for other late filings, or that the Company will ultimately
+Added: regain compliance with all applicable requirements for continued listing.
+Added: accompanying financial statements have been prepared assuming that we will continue as a going concern.
+Added: The financial statements do not
+Added: include any adjustments that would be necessary should we be unable to continue as a going concern, and therefore, be required to liquidate
+Added: its assets and discharge its liabilities in other than the normal course of business and at amounts that may differ from those reflected
+Added: in the accompanying financial statements.
Obligations and Commitments
2 unchanged sentences
and Sponsored Research Agreements
−Removed: have obligations under various license and sponsored research agreements to make future payments to third parties that become due and
−Removed: payable on the achievement of certain development, regulatory and commercial milestones (such as the start of a clinical trial, filing
−Removed: for product approval with the FDA or other regulatory agencies, product approval by the FDA or other regulatory agencies, product launch
−Removed: or product sales) or on the sublicense of our rights to another party.
−Removed: We have not included these commitments on our balance sheet because
−Removed: the achievement and timing of these events is not determinable.
−Removed: Certain milestones are in advance of receipt of revenue from the sale
−Removed: of products and, therefore, we may require additional debt or equity capital to make such payments.
−Removed: have multiple license and sponsored research agreements with ULRF.
−Removed: Under these agreements, we have taken over development, regulatory
−Removed: approval and commercialization of various drug compounds from ULRF and are responsible for maintenance of the related intellectual property
−Removed: We agreed to reimburse ULRF for sponsored research expenses of up to $2.7 million and prior patent costs of up to $112,000
−Removed: As of December 31, 2023, there were no remaining un-expensed amounts under this sponsored research agreement for Pan-RAS.
−Removed: Under the terms of these agreements, we are required to make patent maintenance payments and payments based upon development, regulatory
−Removed: and commercial milestones for any products covered by the in-licensed intellectual property.
−Removed: The maximum aggregate milestone payments
−Removed: we may be obligated to make per product are $5 million.
−Removed: We will also be required to pay a royalty on net sales of products covered by
−Removed: the in-licensed intellectual property in the low single digits.
−Removed: The royalty is subject to reduction for any third-party payments required
−Removed: to be made, with a minimum floor in the low single digits.
−Removed: We have the right to sublicense our rights under these agreements, but we
−Removed: will be required to pay ULRF a percentage of any sublicense income.
−Removed: previously had sponsored research agreements with ULRF for QN-247 and QN-165.
−Removed: As of December 31, 2023, there were no remaining un-expensed
−Removed: amounts under these sponsored research agreements and the agreements were terminated effective August 31, 2022, and November 30, 2021
−Removed: respectively.
−Removed: January 13, 2022, we entered into a License Agreement with UCL Business Limited to obtain an exclusive worldwide in-license of a
−Removed: genomic quadruplex (G4)-selective transcription inhibitor drug development program which had been developed at University College
−Removed: London, including lead and back-up compounds, preclinical data and a patent estate.
−Removed: (UCL Business Limited is the commercialization
−Removed: company for University College London.) We are further developing the program’s lead compound under the name QN-302.
−Removed: License Agreement requires (if and when applicable) tiered royalty payments in the low to mid-single digits,
−Removed: clinical/regulatory/sales milestone payments, and sharing of a percentage of any non-royalty sublicensing consideration paid to the
−Removed: In November 2023, we became obligated to pay $100,000 to UCL Business Limited upon the first patient dosing of QN-302,
−Removed: which is included in accounts payable in our consolidated balance sheet.
−Removed: Convertible Debt
−Removed: December 22, 2022, pursuant to the terms of a Securities Purchase Agreement, dated December 21, 2022 (the “Alpha Purchase Agreement”),
−Removed: we issued to Alpha, in exchange for $3,000,000 in cash (less $50,000 for expense reimbursement), the 2022 Debenture with an original
−Removed: face amount of $3,300,000 due on December 22, 2025, plus 2,500,000 common stock warrants exercisable (from June 22, 2023 through June
−Removed: 22, 2028) at $1.65 per share.
−Removed: 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
−Removed: of the 2022 Debenture, we must redeem $110,000 plus accrued but unpaid interest, liquidated damages and any amounts then owing under
−Removed: the 2022 Debenture.
−Removed: The Monthly Redemption Amount must be paid in cash;
−Removed: provided that after the first two monthly redemptions, we may
−Removed: (if the Equity Conditions, as defined in the 2022 Debenture, are then satisfied or have been waived) elect to pay all or a portion of
−Removed: a Monthly Redemption Amount in shares of our common stock, based on a conversion price equal to the lesser of (i) the then applicable
−Removed: conversion price of the 2022 Debenture and (ii) 85% of the average of the VWAPs (as defined in the 2022 Debenture) for the five consecutive
−Removed: trading days ending on the trading day that is immediately prior to the applicable Monthly Redemption Date.
−Removed: 2022 Debenture accrues interest at the rate of 8% per annum, which began accruing on December 1, 2023, and will be payable on a quarterly
−Removed: Interest may be paid in cash or shares of common stock or a combination thereof at our option;
−Removed: provided that the Equity Conditions
−Removed: have been satisfied.
−Removed: has waived the Equity Conditions for certain Monthly Redemption Amounts, but Alpha is not required to continue such waivers beyond May
−Removed: For the foreseeable future, we do not expect to be able to satisfy the Equity Conditions;
−Removed: as a result, where there is no waiver
−Removed: of the Equity Conditions we would not have the opportunity to make 2022 Debenture payments in the form of stock rather than in the form
−Removed: of cash, even for types of payments for which payment in the form of stock would have been allowed.
−Removed: 2022 Debenture is convertible into our common stock at any time at the holder’s option;
−Removed: the conversion price was originally $1.32
−Removed: but pursuant to a Securities Purchase Agreement amendment it was reduced to $0.73 on December 5, 2023 and then on February 27, 2024 it
−Removed: was adjusted downward to $0.26 per share by virtue of the operation of a “ratchet” antidilution provision.
−Removed: (The exercise
−Removed: price of the warrants issued with the 2022 Debenture was originally $1.65 but pursuant to the Securities Purchase Agreement amendment
−Removed: it was reduced to $0.73 on December 5, 2023 and then on February 27, 2024 it was adjusted downward to $0.26 per share by virtue of the
−Removed: operation of a “ratchet” antidilution provision.)
−Removed: the 2022 Debenture and the accompanying warrants provide for “ratchet” antidilution adjustments to their conversion price
−Removed: and exercise price.
−Removed: the 2022 Debenture and the accompanying warrants include a beneficial ownership blocker of 9.99%, which may only be waived by Alpha upon
−Removed: 61 days’ notice to the Company.
−Removed: granted Alpha resale registration rights for the common shares underlying the 2022 Debenture and the accompanying warrants.
−Removed: December 5, 2023, we entered into an Amendment No.
−Removed: 1 with regard to Securities Purchase Agreement, with Alpha, which, among other things,
−Removed: revised certain provisions of the 2,500,000 warrants to clarify the intention that such 2,500,000 warrants would not be liability-classified
−Removed: for GAAP purposes.
−Removed: the year ended December 31, 2023, we recognized an extinguishment loss on voluntary conversion of convertible debt of approximately
−Removed: $1.1 million, an extinguishment loss of $0.6 million upon October and December 2023 share redemptions and the modification of the
−Removed: 2022 Debenture in December 2023, and recorded accrued interest of approximately $1.5 million, in other expenses in the consolidated
−Removed: statements of operations.
−Removed: During the year ended December 31, 2023 we paid Monthly Redemption Amounts of $550,000 in cash and
−Removed: $220,000 in common stock, and as of December 31, 2023 the remaining 2022 Debenture principal balance was approximately $1.4 million,
−Removed: the remaining discount was approximately $0.1 million, and the fair value of the suite of bifurcated embedded derivative features
−Removed: is also made to the 2024 Debenture, which was issued to Alpha after the end of the 2023 fiscal year and is described above.
−Removed: Funding Agreement
−Removed: a condition to our acquisition of a majority voting equity interest in NanoSynex from Alpha and NanoSynex, we entered into a Master Agreement
−Removed: for the Operational and Technological Funding of NanoSynex (the “Funding Agreement”), on May 26, 2022, pursuant to which
−Removed: we agreed to fund NanoSynex up to an aggregate of approximately $10.4 million, subject to NanoSynex’s achievement of certain performance
−Removed: milestones specified in the Funding Agreement and the satisfaction of other terms and conditions described in the Funding Agreement.
−Removed: the year ended December 31, 2022, we funded a total of approximately $2.4 million and in February 2023 we funded an additional $0.5 million
−Removed: to NanoSynex under the Funding Agreement.
−Removed: July 20, 2023, we entered into the NanoSynex Amendment, which amended the Funding Agreement, pursuant to which the Company agreed to,
−Removed: among other things, forfeit 281,000 Series B Preferred Shares of NanoSynex held by the Company, resulting in our ownership in NanoSynex
−Removed: being reduced from approximately 52.8% to approximately 49.97% of the voting equity of NanoSynex.
−Removed: In addition, we agreed to cancel approximately
−Removed: $3.0 million of promissory notes which NanoSynex had issued to us under the NanoSynex Funding Agreement, relieving NanoSynex of any repayment
−Removed: obligations to us with respect to such notes.
−Removed: The surrender of shares reducing our interest in NanoSynex from approximately 52.8% to
−Removed: approximately 49.97% occurred on July 20, 2023.
−Removed: Accordingly, NanoSynex was deconsolidated from our financial statements as of July 20,
−Removed: 2023, and is reported as Discontinued Operations in this Annual Report.
−Removed: NanoSynex Amendment superseded any payment obligations contemplated by the original Funding Agreement and amended our obligations to
−Removed: provide funding to NanoSynex, except we agreed to provide future funding as follows:
−Removed: (i) $560,000 on or before November 30, 2023,
−Removed: and (ii) $670,000 on or before March 31, 2024, in each case issued in the form of a promissory note to the Company with a face value
−Removed: in the amount of such funding.
−Removed: However, on November 22, 2023, in full settlement of any additional funding obligations to NanoSynex,
−Removed: we forfeited certain of our shares of Series A-1 Preferred Stock of NanoSynex in an amount that reduced our ownership in NanoSynex
−Removed: from approximately 49.97% to 39.90%.
−Removed: Our investment in NanoSynex will be accounted as an equity method investment
−Removed: prospectively from the July 20, 2023 deconsolidation date.
+Added: have obligations under various license agreements to make future payments to third parties that become due and payable on the achievement
+Added: of certain development, regulatory and commercial milestones (such as the start of a clinical trial, filing for product approval with
+Added: the FDA or other regulatory agencies, product approval by the FDA or other regulatory agencies, product launch or product sales) or on
+Added: the sublicense of our rights to another party.
+Added: We have not included these commitments on our balance sheet because the achievement and
+Added: timing of these events is not determinable.
+Added: Certain milestones are in advance of receipt of revenue from the sale of products and, therefore,
+Added: we may require additional debt or equity capital to make such payments.
+Added: have multiple license and sponsored research agreements with University of Louisville Research Foundation ULRF.
+Added: agreements, we have taken over development, regulatory approval and commercialization of various drug compounds from ULRF and are
+Added: responsible for maintenance of the related intellectual property portfolio.
+Added: Under the terms of these agreements, we are required to
+Added: make patent maintenance payments and payments based upon development, regulatory and commercial milestones for any products covered
+Added: by the in-licensed intellectual property.
+Added: The maximum aggregate milestone payments we may be obligated to make per product are $5
+Added: We will also be required to pay a royalty on net sales of products covered by the in-licensed intellectual property in the
+Added: low single digits.
+Added: The royalty is subject to reduction for any third-party payments required to be made, with a minimum floor in the
+Added: low single digits.
+Added: We have the right to sublicense our rights under these agreements, but we will be required to pay ULRF a
+Added: percentage of any sublicense income.
+Added: January 13, 2022, we entered into a License Agreement with UCL Business Limited to obtain an exclusive worldwide in-license of a genomic
+Added: quadruplex (G4)-selective transcription inhibitor drug development program which had been developed at University College London, including
+Added: lead and back-up compounds, preclinical data and a patent estate.
+Added: (UCL Business Limited is the commercialization company for University
+Added: College London.) We are further developing the program’s lead compound under the name QN-302.
+Added: The License Agreement requires (if
+Added: and when applicable) tiered royalty payments in the low to mid-single digits, clinical/regulatory/sales milestone payments, and sharing
+Added: of a percentage of any non-royalty sublicensing consideration paid to the Company.
+Added: In November 2023, we became obligated to pay $100,000
+Added: to UCL Business Limited upon the first patient dosing of QN-302, which was paid in January 2024.
+Added: April 11, 2024, we entered into a Co-Development Agreement with Marizyme, Inc.
+Added: (“Marizyme”).
+Added: Under the Co-Development Agreement
+Added: (as amended on August 6, 2024), we agreed to pay Marizyme a Funding Payment of up to $1,750,000 and an Exclusivity Fee of $200,000.
+Added: Exclusivity Fee of $200,000 and a Funding Payment of $500,000 was paid to Marizyme on April 12, 2024.
+Added: The Exclusivity Fee entitled us
+Added: to an exclusivity period until May 31, 2024 for purposes of proposing and outlining a broader strategic relationship with Marizyme with
+Added: regard to Marizyme’s DuraGraft business.
+Added: The Funding Payment is designed to provide financial support for commercialization of
+Added: Marizyme’s DuraGraft™ vascular conduit solution, which is indicated for adult patients undergoing coronary artery bypass
+Added: grafting surgeries and is intended for the flushing and storage of the saphenous vein grafts used in coronary artery bypass grafting
+Added: In return for the Funding Payment we will receive quarterly a 33% payment in the nature of royalties on any Net Sales (as defined
+Added: with a meaning tantamount to gross profit on net sales) of DuraGraft, capped at double the amount of the Funding Payment cash provided.
+Added: No such payments-in-the-nature-of-royalties would accrue until after DuraGraft has been launched in the United States and a cumulative
+Added: total of $500,000 of DuraGraft Net Sales have been made in the United States.
+Added: the year ended December 31, 2024, the Company advanced to Marizyme $2,257,400, against which Marizyme delivered demand promissory notes
+Added: to the Company of like principal amounts (the “Marizyme Notes”).
+Added: As of December 31, 2024, accrued interest related to the
+Added: Marizyme Notes was $113,292 and interest income of this amount was recognized in other income in the consolidated statement of operations.
+Added: As of December 31, 2024, the estimate for expected credit losses on the
+Added: Marizyme Notes is $200,000, which was recognized in other income in the consolidated statement of operations.
+Added: As of December 31, 2024, the estimate for expected credit losses on the Marizyme Notes is $360,000, which was recognized in the consolidated statement of operations.
+Added: Marizyme Notes bear interest the rate of eighteen percent (18%) per annum.
+Added: Marizyme may pre-pay all or any part of the outstanding principal
+Added: or interest of the Marizyme Notes at any time and from time to time, in whole or in part, without premium or penalty.
+Added: From January through June 2025, an additional $1,518,500 was advanced to
+Added: Marizyme against which Marizyme delivered additional demand promissory notes.
Service Agreements
5 unchanged sentences
following table sets forth the significant sources and uses of cash for the periods set forth below:
−Removed: the Twelve Months Ended
−Removed: cash (used in) provided by:
−Removed: $ (10,304,263 )
+Added: For the Years Ended
+Added: Net cash (used in) provided by:
+Added: Operating activities
$ (6,327,503 )
−Removed: of exchange rate on cash
−Removed: decrease in cash and restricted cash
$ (10,304,263 )
+Added: Investing activities
+Added: Financing activities
+Added: Net increase (decrease) in cash and restricted cash
$ (6,638,320 )
Cash Used in Operating Activities
−Removed: the year ended December 31, 2023, operating activities used $10.3 million of cash, primarily resulting from a loss from continuing
−Removed: operations of $12.5 million.
−Removed: Cash flows from operating activities for the year ended December 31, 2023 were positively impacted by
−Removed: adjustments for a $1.1 million non cash loss on voluntary conversion of convertible debt, a $0.6 million non cash loss on
−Removed: convertible debt extinguishment, accretion of discount of $1.5 million on convertible debt, a $1.6 million increase in accounts
−Removed: payable, and $1.1 million in non cash stock-based compensation expense.
−Removed: Cash flows from operating activities for the year ended December 31, 2023 were negatively impacted by adjustments for a
−Removed: $2.0 million decrease in fair value of warrant liabilities, a $0.3 million increase in prepaid expenses and other assets, a $0.2
−Removed: million decrease in accrued expenses and other current liabilities, and cash used in discontinued operations of $1.2 million.
−Removed: the year ended December 31, 2022, operating activities used $13.2 million of cash, primarily resulting from a loss from continuing
−Removed: operations of $13.9 million.
−Removed: Cash flows from operating activities for the year ended December 31, 2022 were positively impacted by
−Removed: an adjustment for $4.8 million in non cash stock-based compensation expense.
−Removed: flows from operating activities for the year ended December 31, 2022 were negatively impacted by cash used in discontinued
−Removed: operations of $2.6 million, a $0.9 million decrease in fair value of warrant liabilities, a $0.5 million decrease in accrued
−Removed: expenses and other current liabilities, and a $0.1 million increase in prepaid expenses.
+Added: the year ended December 31, 2024, operating activities used $6.3 million of cash, primarily resulting from a net loss of $6.3 million.
+Added: Cash flows from operating activities for the year ended December 31, 2024 were positively impacted by adjustments for accretion
+Added: of discount on convertible debt of $0.6 million, a non-cash loss on issuance of convertible debt of approximately $0.4 million, a non-cash
+Added: loss on debt extinguishment of approximately $57,000, change in provision for non-cash credit losses on short-term notes receivable of
+Added: $0.4 million, a non-cash loss on monthly redemptions of convertible debt into common stock of $0.2 million, and non-cash stock based
+Added: compensation of $0.1 million.
+Added: Cash flows from operating activities for the year ended December 31, 2024 were negatively impacted
+Added: by adjustments for a non-cash gain on change in fair value of warrant liabilities of $0.4 million, a $0.3 million gain on settlement
+Added: of accounts payable, a $0.4 million decrease in accounts payable, a $0.2 million increase in prepaid expenses and other assets, a $0.2
+Added: million non-cash gain on change in fair value of derivative liabilities, a $0.1 million decrease in accrued expenses and other current
+Added: liabilities, accrued interest receivable on the Marizyme notes of $0.1 million, and a non-cash gain on voluntary conversion of convertible
+Added: debt of approximately $56,000.
+Added: the year ended December 31, 2023, operating activities used $10.3 million of cash, primarily resulting from a loss from continuing operations
+Added: of $12.5 million.
+Added: Cash flows from operating activities for the year ended December 31, 2023 were positively impacted by adjustments for
+Added: a $1.1 million non-cash loss on voluntary conversion of convertible debt, a $0.6 million non-cash loss on convertible debt extinguishment,
+Added: accretion of discount of $1.5 million on convertible debt, a $1.6 million increase in accounts payable, and $1.1 million in non-cash
+Added: stock-based compensation expense.
+Added: Cash flows from operating activities for the year ended December 31, 2023 were negatively impacted
+Added: by adjustments for a $2.0 million decrease in fair value of warrant liabilities, a $0.3 million increase in prepaid expenses and other
+Added: assets, a $0.2 million decrease in accrued expenses and other current liabilities, and cash used in discontinued operations of $1.2 million.
+Added: was no charge for provision for credit losses on short-term notes receivable during the year ended December 31, 2023.
Cash Provided By Investing Activities
+Added: the year ended December 31, 2024, net cash used by investing activities was approximately $1.9 million resulting from the
+Added: issuance of $2.3 million in notes receivable to Marizyme, offset by $0.4 million in proceeds from the disposal of discontinued operations,
+Added: due to the release of escrow from the sale of Qualigen, Inc.
the year ended December 31, 2023, net cash provided by investing activities was approximately $4.2 million resulting from discontinued
1 unchanged sentence
$0.2 million in purchases of property and equipment prior to deconsolidation.
−Removed: During the year ended December 31, 2022, net cash used in investing activities
−Removed: was approximately $0.2 million, due to capital expenditures offset by cash acquired in the NanoSynex acquisition.
+Added: Net Cash Provided by
+Added: (Used in) Financing Activities
+Added: Net cash provided
+Added: by financing activities for the year ended December 31, 2024, was approximately $9.0 million, resulting from $4.6 million in proceeds
+Added: from the sale of Series A-2 Preferred Stock, approximately $3.1 million in proceeds from the sale of common stock and prefunded warrants,
+Added: $2.0 million in proceeds from the issuance of short term debt, $1.5 million from the issuance of convertible debt, $0.4 million in proceeds
+Added: from warrant exercises, offset by $2.0 million in short term debt repayments, and $0.5 million in convertible debt repayments.
+Added: used in financing activities for the year ended December 31, 2023, was approximately $0.6 million, due to monthly redemption payments
+Added: on the 2022 Alpha Debenture.
Cash Provided by Financing Activities
+Added: cash provided by financing activities for the year ended December 31, 2024, was approximately $9.0 million, resulting from $4.6 million
+Added: in proceeds from the sale of Series A-2 Preferred Stock, $3.0 million in proceeds from the sale of common stock and prefunded warrants,
+Added: $2.0 million in proceeds from the issuance of short term debt, $1.5 million from the issuance of convertible debt, $0.4 million in proceeds
+Added: from warrant exercises, offset by $2.0 million in short term debt repayments, and $0.5 million in convertible debt repayments.
cash provided by financing activities for the year ended December 31, 2023, was approximately $0.6 million, due to monthly redemption
−Removed: payments which we made in the form of stock (rather than in the form of cash) on the 2022 Debenture.
−Removed: Net cash provided by financing activities for the year ended December 31,
−Removed: 2022, was approximately $2.9 million, due to the issuance of convertible debt to Alpha.
+Added: payments on the 2022 Alpha Debenture.
+Added: QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
+Added: a “smaller reporting company,” as defined by Rule 12b-2 of the Exchange Act, we are not required to provide the information
+Added: in this Item.
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.