Onconetix, Inc.
For the period ended Sep 30, 2025. Filed Nov 13, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 13, 2025
ONCO$6.95+26.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001213900-25-076032
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001213900-25-110142
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 141 previous paragraphs and 136 current paragraphs.
70 unchanged; 31 reworded; 34 added; 37 removed; 3 previous and 1 current paragraphs rearranged.
Tables are not compared: 26 previous and 19 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (34)
Current report
Termination of Business Combination Agreement:
Current report
Effective September 24, 2025, pursuant to Section 9.01(a) of the Merger Agreement, the Company and Ocuvex entered into a Termination and Release Agreement (the “Termination Agreement”) pursuant to which they agreed to terminate the Merger Agreement and the transactions contemplated thereby. The Termination Agreement also terminates and makes void the anciliary documents entered into in connection with the Merger Agreement. The Termination Agreement also provides for a mutual release of claims among Company and Ocuvex and their affiliates and in consideration of the foregoing, the Company agreed to pay to Ocuvex, an amount equal to**$**302,343.55 (the “Termination Payment”), which represents all amounts payable by the Company to Ocuvex pursuant to Section 6.02(f) of the Merger Agreement.
Current report
As of September 24, 2025, Ocuvex confirmed receipt of the Termination Payment, and as a result the Merger Agreement is of no further force and effect.
Current report
Series C PIPE Financing and ELOC
Current report
As of September 30, 2025, 7 shares of Series C Preferred Stock were outstanding, after the exchange of 203 shares of Series C Preferred Stock into 244 shares of Series D Preferred Stock (as defined below).
Current report
Series D PIPE Financing
Current report
On September 22, 2025, the Company entered into a securities purchase agreement (the “Series D Securities Purchase Agreement”) with eleven institutional investors, and sold or exchanged debt, to such investors (collectively, the “Series D PIPE Investors”) an aggregate of 16,099 shares of Series D convertible preferred stock, par value $0.00001 per share (“Series D Preferred Stock”), which includes an issuance of 500 shares of Series D Preferred Stock to the lead investor in consideration for the Series D PIPE Investors’ irrevocable commitment to purchase shares of the Series D Preferred Stock, and warrants (the “Series D Warrants”) to purchase 4,362,827 shares of Common Stock, for an aggregate purchase price of approximately $12.9 million and net cash proceeds of $9.3 million. The exercise price of the Series D Warrants is $3.6896, and the Series D Warrants are exercisable beginning on the issuance date and expire on the third anniversary of the issuance date.
Current report
Concurrently with entering into the Securities Purchase Agreement, the Company also entered into a registration rights agreement with the Series D PIPE Investors, pursuant to which it has agreed to provide the Series D PIPE Investors with certain registration rights related to the shares of Common Stock underlying the shares of Series D Preferred Stock and Series D Warrants.
Current report
Veru Settlement Agreement and Release
Current report
On April 19, 2023, the Company entered into an asset purchase agreement with Veru (the “Veru APA”). Pursuant to, and subject to the terms and conditions of, the Veru APA, the Company purchased substantially all of the assets related to Veru’s ENTADFI business, in a transaction that closed in April 2023. Pursuant to the terms of the Veru APA, the Company agreed to provide Veru with initial consideration totaling $20.0 million, including (i) $4.0 million in the form of a non-interest bearing note payable due on September 30, 2023, and (iii) $10.0 million in the form of two equal (i.e. each for $5.0 million) non-interest bearing notes payable, each due on April 19, 2024 (the “April Veru Note”) and September 30, 2024 (the “September Veru Note” and together with the April Veru Note, the “Veru Notes”).
Current report
As of September 22, 2025, approximately $8.8 million was payable to Veru under the Veru Notes and related amendments. On September 22, 2025, the Company and Veru entered into a Settlement Agreement and Release (the “Veru Settlement Agreement”), pursuant to which Veru agreed to accept a cash payment of approximately $6.3 million (including interest accrued through receipt of the Settlement Amounts (as defined herein), 3,125 shares of Series D Preferred Stock and 846,975 Series D Warrants (such cash payment, shares of Series D Preferred Stock and Series D Warrants, collectively, the “Settlement Amounts”) in full satisfaction of all amounts due under the Veru Notes, as amended by all preceding amendments, forbearance agreements, and waivers, and Veru agreed that such acceptance constituted complete discharge of all obligations thereunder. The Settlement Agreement contains customary release provisions that upon timely delivery of the Settlement Amounts, Veru shall release all claims or actions against the Company. As of September 24, 2025, Veru confirmed receipt of all Settlement Amounts in satisfaction of all outstanding amounts, and all Veru Notes and related amendments were deemed cancelled and terminated, respectively, and of no further force or effect.
Current report
As of September 24, 2025, Veru confirmed receipt of all Settlement Amounts in satisfaction of all outstanding amounts, and all Veru Notes and related amendments were deemed cancelled and terminated, respectively, and of no further force or effect. The extinguishment of the Veru Notes was accounted for as a debt extinguishment in accordance with ASC 405-20 and ASC 470-50. The Company derecognized the carrying amount of the Veru Notes and recognized a gain or loss on extinguishment equal to the difference between the reacquisition price—measured at the fair value of the cash and equity instruments transferred—and the net carrying value of the debt. The Company recognized a loss on extinguishment related to this transaction of $3,516,811 recorded within loss on extinguishment of notes payable in the accompanying condensed consolidated statement of operations and comprehensive loss for the three and nine months ended September 30, 2025.
Current report
On September 22 2025, Keystone Capital Partners, LLC and the Company agreed to exchange the principal owed under the May Keystone Note, the June Keystone Note, the August 6 Keystone Note and the August 28 Keystone Notes for Series D Preferred Stock of 3,125 shares and Warrants of 846,975 shares of common stock in connection with the Series D PIPE Financing. The February Keystone Note has a balance as of September 30, 2025 of $113,725 and matures on November 12, 2025. The transaction was accounted for as a debt extinguishment in accordance with ASC 405-20 and ASC 470-50. The Company derecognized the carrying amount of the Keystone Notes and recognized a gain or loss on extinguishment equal to the difference between the reacquisition price, measured at the fair value of the cash and equity instruments transferred, and the net carrying value of the debt. The Company recognized a loss on extinguishment related to this transaction of $1,867,908 recorded within loss on extinguishment of notes payable in the accompanying condensed consolidated statement of operations and comprehensive loss for the three and nine months ended September 30, 2025. The extinguishment of the May Keystone Note, the June Keystone Note, the August 6 Keystone Note and the August 28 Keystone Notes was accounted as a debt extinguishment in accordance with ASC 405-20 and ASC 470-50. The Company derecognized the carrying amount of the Veru Notes and recognized a gain or loss on extinguishment equal to the difference between the reacquisition price—measured at the fair value of the cash and equity instruments transferred—and the net carrying value of the debt. The Company recognized a loss on extinguishment related to this transaction of $3,516,811 recorded within loss on extinguishment of notes payable in the accompanying condensed consolidated statement of operations and comprehensive loss for the three and nine months ended September 30, 2025.
Current report
During the three and nine months ended September 30, 2025, the Company recorded approximately $0.3 million and $0.8 million of interest expense, respectively, which includes accrued interest and amortization of the debt discount. The unamortized debt discount as of September 30, 2025 and December 31, 2024 was $0 and $5,000, respectively. As of September 30, 2025 and December 31, 2024, the Company has recorded accrued interest of approximately $0 million and $0.1 million, respectively, which is included in accrued expenses in the accompanying condensed consolidated balance sheets.
Current report
Series E PIPE Financing
Current report
On October 1, 2025, the Company entered into a securities purchase agreement (the “Series E Securities Purchase Agreement”) with institutional investor(s) and sold to such institutional investors(s)(collectively, the “Series E PIPE Investors”), an aggregate of 7,813 shares of Series E convertible preferred stock, par value $0.00001 per share (“Series E Preferred Stock”), which are convertible into common stock of the Company, $0.00001 par value per share and warrants (the “Series E Warrants”) to purchase 2,025,223 shares of Common Stock, for an aggregate purchase price of approximately $6.25 million, which was also equal to the net cash proceeds. The exercise price of the Series E Warrants is $3.8576, and the Series E Warrants are exercisable beginning on the issuance date and expire on the third anniversary of the issuance date.
Current report
Concurrently with entering into the Series E Securities Purchase Agreement, the Company also entered into a registration rights agreement with the Series E PIPE Investors, pursuant to which it has agreed to provide the Series E PIPE Investors with certain registration rights related to the shares of Common Stock underlying the shares of Series E Preferred Stock and Series E Warrants.
Current report
Immunovia-Proteomedix Licensing Agreement
Current report
On September 17, 2025, Proteomedix entered into a licensing agreement (the “Immunovia Agreement”) with Immunovia, Inc. (“Immunovia”), a pancreatic cancer diagnostics company based in Lund, Sweden. Under the Agreement, Proteomedix will provide Immunovia with master cell lines required to produce antibodies for three of the five biomarkers used in the PancreaSure test, as well as a license to key intellectual property related to the manufacturing of associated reagents.
Current report
In return, Immunovia will make two payments of $300,000 each to Proteomedix, due on September 30, 2025, and March 31, 2026. Additionally, Immunovia will make a $100,000 payment for materials and pay a 3% royalty on net sales of PancreaSure and any other products incorporating the licensed intellectual property from January 1, 2026, through December 31, 2032.
Current report
Other expense during the three months ended September 30, 2025, increased by approximately $5.5 million compared to the same period in 2024. The increase was primarily attributable to a $5.4 million loss on extinguishment of notes payable and $2.5 million loss on issuance of preferred stock and warrants, partially offset by a $1.9 million gain on the change in fair value of Series D warrant liabilities.
Current report
Comparison of the Nine months Ended September 30, 2025 and 2024
Current report
For the nine months ended September 30, 2025, selling, general and administrative expenses decreased by approximately $3.1 million compared to the same period in 2024. The decrease primarily reflects a reduction of approximately $1.0 million in net periodic benefit cost due to the settlement of the defined benefit plan, a reduction of approximately $0.4 million in professional fees, a reduction of approximately $0.4 million in director and officers insurance fees, and a reduction of approximately $1.1 million in payroll related expenses, largely driven by cost containment efforts.
Current report
Income Tax Benefit
Current report
During the third quarter of 2025, the Company successfully closed a Series D financing, and in October 2025, it completed a Series E financing. These financings provided the Company with additional cash flow to support near-term operations. While these capital raises may enable the Company to sustain current operations and meet existing obligations, the Company continues to generate recurring net operating losses and has not yet established sustained positive cash flows to support its strategic growth initiatives, which includes the commercialization of Proclarix, and the development and commercialization of the Company’s future product candidates. These factors raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date of the issuance of these condensed consolidated financial statements.
Current report
Management’s plans for funding the Company’s operations include generating product revenue from sales of Proclarix, which is still subject to further successful development and commercialization activities within certain jurisdictions. Management also intends to pursue additional equity or debt financing to support operations and strategic initiatives. However, there are currently no committed sources of financing, and there is no assurance that additional funding will be available on favorable terms, if at all. This uncertainty raises significant concern about the Company’s ability to sustain operations and execute its strategic initiatives. If additional capital is not secured, the Company may need to curtail clinical trials, development, and commercialization efforts, and take further measures to reduce expenses to conserve cash.
Current report
Accounting for Series D PIPE Securities including Warrant and Derivative Liabilities
Current report
In connection with the Series D PIPE Financing, we issued Series D Preferred Stock and Series D Warrants certain institutional investors on September 22, 2025. The accounting determinations in connection with the Series D PIPE Securities have a significant effect on our reported financial position and results of operations.
Current report
We determine the accounting classification of the instruments by first assessing each instrument under ASC 480, Distinguishing Liabilities from Equity, then assessing each instrument under ASC 815, Derivatives and Hedging Activities. Under ASC 480, instruments are considered liability classified if they are mandatorily redeemable, obligate us to settle the warrants or the underlying shares by paying cash or other assets, and instruments that must or may require settlement by issuing variable number of shares. If instruments do not meet the liability classification under ASC 480-10, we assess the requirements under ASC 815-40, which states that contracts that require or may require the issuer to settle the contract for cash are liabilities recorded at fair value, irrespective of the likelihood of the transaction occurring that triggers the net cash settlement feature. If the financial instruments do not require liability classification under ASC 815-40, in order to conclude equity classification, we also assess whether the instruments are indexed to our Common Stock and whether the instruments are classified as equity under ASC 815-40 or other GAAP. After all such assessments, we conclude whether the instruments are classified as liability or equity.
Current report
In addition, ASC 815 requires companies to bifurcate certain features from their host instruments and account for them as free-standing derivative financial instruments should certain criteria be met. We evaluate our financial instruments to determine whether such instruments are derivatives or contain features that qualify as embedded derivatives. Embedded derivatives must be separately measured from the host contract if all the requirements for bifurcation are met. The assessment of the conditions surrounding the bifurcation of embedded derivatives depends on the nature of the host contract and the features of the derivatives. Bifurcated embedded derivatives are recognized at fair value, with changes in fair value recognized in the consolidated statements of operations each period. Bifurcated embedded derivatives are classified with the related host contract in our consolidated balance sheets. 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.
Current report
Liability classified instruments require fair value accounting at issuance and subsequent to initial issuance with all changes in fair value after the issuance date recorded in the consolidated statements of operations.
Current report
The Company concluded the Series D Preferred Stock was more akin to an equity-like host than a debt-like host and was classified as permanent equity as it was not redeemable in any manner that would require classification outside of permanent equity pursuant to ASC 480-10-S99. The Series D Warrants and certain embedded share-settled redemption features of the Series D Preferred Stock issued were determined to be liability-classified instruments pursuant to ASC 480 and ASC 815. The embedded features of the Series D Preferred Stock were bifurcated and accounted for separately as derivative liabilities.
Current report
Fair Value Measurements for Warrant and Derivative Liabilities
Current report
The Company measured its bifurcated embedded derivative and warrant liabilities as of September 30, 2025 and September 22, 2025, at fair value on a recurring basis using level 3 inputs. These financial instruments are measured using management’s best estimate of fair value, where the inputs into the determination of fair value require significant management judgment to estimation. The derivative and warrant liabilities were both measured using Monte Carlo valuation models. Valuations based on unobservable inputs are highly subjective and require significant judgments. Changes in such judgments could have a material impact on fair value estimates.
Removed paragraphs (37)
Previous report
Potential Business Combination:
Previous report
Upon the consummation of the Transactions (the “Closing”), each share of common stock, par value $0.0001 per share, of Ocuvex (the “Ocuvex Common Stock”) shall be exchanged into a number of shares of common stock, par value $0.00001 per share, of the Company (the “Company Common Stock”) equal to the Exchange Ratio (as defined below) (such shares, the “Merger Consideration”), subject to adjustment as described below and the reduction of the Escrow Shares (as defined below) in respect of the satisfaction of indemnification obligations.
Previous report
As a result of the Transactions, it is anticipated that immediately following the Closing, (i) the pre-Closing Ocuvex stockholders will own 90% of the issued and outstanding equity interests of the Company, on a fully diluted basis, and (ii) the pre-Closing Company stockholders will own 10% of the issued and outstanding equity interests of the Company, on a fully-diluted basis, subject to adjustment in respect of Permitted Financing.
Previous report
“Exchange Ratio” means a number equal to the quotient obtained by dividing (x) the product of (I) the fully diluted Company Common Stock less the aggregate number of shares of Company Common Stock issuable in connection with a Permitted Financing and (II) 9 by (y) the fully diluted Ocuvex Common Stock.
Previous report
“Permitted Financing” means an equity or debt financing transaction or series of equity or debt financing transactions entered into by Parent prior to Closing in connection with the Transactions, the proceeds of which Parent loans to the Company prior to the Effective Time.
Previous report
The Closing is subject to the satisfaction or waiver of customary conditions, including, among other things, (i) receipt of the required approval of the Company stockholders and the adoption of the Merger Agreement and the Transactions by the requisite vote of the Ocuvex stockholders; (ii) the accuracy of the representations and warranties of the parties made in the Merger Agreement, subject to customary materiality qualifiers; (iii) compliance by the parties with their respective covenants and agreements under the Merger Agreement; (iv) the approval for listing on Nasdaq of the Company Common Stock to be issued as the Merger Consideration; (v) the registration statement for the Merger having been declared effective and (v) the absence of a material adverse effect with respect to the other party.
Previous report
Ocuvex’s obligation to complete the Closing is subject to additional conditions, including (i) the restructuring of certain outstanding indebtedness of the Company and (ii) a condition that the Merger qualifies as a “reorganization” within the meaning of Section 368(a) of the Internal Revenue Code of 1986.
Previous report
The Company’s obligation to complete the Closing is subject to additional conditions, including (i) the satisfaction of certain other obligations of Ocuvex with respect to third-party consents under existing contracts and (ii) that certain lock-up agreements, the Escrow Agreement and the certain stockholder support agreements are in full force and effect.
Previous report
Onconetix and Ocuvex intend to file with the SEC a registration statement on Form S-4, which will include a preliminary proxy statement of Onconetix and a prospectus in connection with the proposed Merger between Onconetix and Ocuvex pursuant to the Merger Agreement.
Previous report
Veru Forbearance Agreements
Previous report
On September 19, 2024, the Company entered into an Amended and Restated Forbearance Agreement with Veru (the “Amended and Restated Forbearance Agreement” or “A&R Forbearance Agreement”), which amends and restates the Original Forbearance Agreement in its entirety. Pursuant to the A&R Forbearance Agreement, Veru will forbear from exercising its rights under both April Veru Note and the September Veru note, subject to the terms and conditions set forth below.
Previous report
The A&R Forbearance Agreement extends the due date for the April 2024 and September 2024 Veru Notes until the earlier to occur of (i) June 30, 2025 or (ii) the occurrence of any Event of Default. The Amended and Restated Forbearance Agreement also effected certain modifications to the payment terms in the Original Forbearance Agreement and amended certain terms of the September Veru Note as summarized below.
Previous report
Pursuant to the A&R Forbearance Agreement, the Company agreed to make the following required payments (the “Required Payments”) during the April 2024 Forbearance Period first to accrued and unpaid interest under the April Veru note and then any remainder to the outstanding principal amount of the April Veru Note:
Previous report
The Company and Veru also agreed to the following amendments to the September Veru Note in the A&R Forbearance Agreement:
Previous report
November Amended and Restated Forbearance Agreement with Veru
Previous report
On November 26, 2024, the Company entered into another Amended and Restated Forbearance Agreement with Veru (the “November Amended and Restated Forbearance Agreement” or “November A&R Forbearance Agreement”), which amends and restates certain terms of the A&R Forbearance Agreement. Pursuant to the November A&R Forbearance Agreement, Veru agreed to waive the due date for payment of applicable Cash Receipt Payments (as such term is defined in the A&R Forbearance Agreement) generated in October 2024 until the Company receives funds of at least $97,000 pursuant to its equity line of credit facility with Keystone Capital Partners LLC. In exchange, the Company agreed to increase its payments to be made to Veru out of future financing and strategic transactions through June 30, 2025, from 20% to 25% of net proceeds generated from such transactions. All other terms of the A&R Forbearance Agreement with Veru remain the same.
Previous report
March 2025 Amended and Restated Forbearance Agreement with Veru on April 2025
Previous report
On March 31, 2025, Veru and the Company entered into a waiver agreement, pursuant to which Veru agreed to waive and extend the date for payment of the April 2024 Promissory Note to April 14, 2025.
Previous report
April 2025 Amended and Restated Forbearance Agreement with Veru
Previous report
On April 23, 2025, Veru and the Company entered into a limited waiver agreement, pursuant to which Veru agreed to waive and extend the date for payment of the April 2024 Promissory Note to June 30, 2025.
Previous report
June 2025 Amended and Restated Forbearance Agreement with Veru
Previous report
On June 30, 2025, Veru and the Company entered into a waiver agreement, pursuant to which Veru agreed to waive and extend the date for payment of the April 2024 and September 2024 Promissory Notes to July 31, 2025.
Previous report
July 2025 Amended and Restated Forbearance Agreement with Veru
Previous report
On July 31, 2025, Veru and the Company entered into a waiver agreement, pursuant to which Veru agreed to waive and extend the date for payment of the April 2024 and September 2024 Promissory Notes to August 14, 2025.
Previous report
August 2025 Amendment and Restatement of September Veru Note
Previous report
PIPE Financing
Previous report
As of June 30, 2025, an aggregate of 2,130 Series C Preferred Stock was outstanding, after redemptions of 1,369 shares for an aggregate of $1.71 million. As a result of draws on the ELOC in April and June 2025, an additional 329 share of Series C preferred stock were to be redeemed for an aggregate amount of $409,510.
Previous report
On July 16, 2025, the Company exercised its right, pursuant to Section 8(g) of the Series C Certificate of Designation, to lower the conversion price of the Series C Preferred Stock (each, a “Conversion Price Reduction”) to $3.50 until July 31, 2025. On July 16, 2025, all holders of Series C Preferred Stock approved, by written consent, the Conversion Price Reduction.
Previous report
ELOC
Previous report
Other expense during the three months ended June 30, 2025, decreased by approximately $0.2 million compared to the same period in 2024. The decrease was primarily attributable to a $0.2 million reduction in related party interest expense.
Previous report
Income Tax Expense
Previous report
Comparison of the Six months Ended June 30, 2025 and 2024
Previous report
For the six months ended June 30, 2025, selling, general and administrative expenses decreased by $2.8 million compared to the same period in 2024.
Previous report
For the six months ended June 30, 2025, selling, general and administrative expenses decreased by approximately $2.8 million compared to the same period in 2024. The decrease primarily reflects a reduction of approximately $0.8 million in professional fees, including accounting, legal, and regulatory services, associated with the acquisition of Proteomedix in 2024. These costs were non-recurring and did not continue into 2025.
Previous report
Additionally, the Proteomedix entity experienced a further reduction in professional fees of approximately $0.5 million, primarily due to transaction-related activities that occurred in early 2024 and were not repeated in the current year. Payroll-related expenses declined by approximately $0.8 million, and miscellaneous selling, general and administrative expenses decreased by approximately $0.7 million, both largely driven by cost containment efforts and reduced liquidity during the current period.
Previous report
Impairments
Previous report
During the six months ended June 30, 2025, the Company used approximately $3.4 million in cash for operating activities. In addition, as of August 13, 2025, the Company’s cash balance was approximately $0.2 million. The Company’s current cash balance is not sufficient to fund its operations through twelve months after the date of these financials are issued. In December 2024, the Company began drawing on the Equity Financing Line of Credit (“ELOC”), which it entered into on October 2, 2024, referred herein as the ELOC Purchase Agreement. These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date of the issuance of these consolidated financial statements. The Company’s projections are also indicative that it is currently unable to meet its contractual commitments and obligations as they come due in the ordinary course of business. The Company will require significant additional capital in the short-term to fund its continuing operations, satisfy existing and future obligations and liabilities, including the remaining payments due for the acquisition of the ENTADFI assets, and funds needed to support the Company’s working capital needs and business activities. These business activities include the development and commercialization of Proclarix, and the development and commercialization of the Company’s future product candidates.
Reworded paragraphs (31)
Previous wording
On October 1, 2024, the Board authorized the Company to create a series of 10,000 shares of preferred stock designated as “Series C convertible Preferred Stock”, with a par value of $0.00001, pursuant to the certificate of designations. At any time after the initial issuance date of Series C convertible Preferred Stock, each Preferred Share shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock. The holders of Series C Preferred Stock are entitled to dividends, on an as-if converted basis, equal to and in the same form as dividends actually paid on shares of Common Stock, when and if actually paid. In addition, from and after the occurrence and during the continuance of any Triggering Event, dividends (“Default Dividends”) will accrue on the Stated Value of each Preferred Share at a rate of fifteen percent (15.0%) (the “Default Rate”) per annum. Each holder is entitled to convert any portion of the outstanding Preferred Shares held by such holder into validly issued, fully paid and non-assessable Conversion shares at the Conversion Rate, which can be determined by dividing (x) the Conversion Amount of such Preferred Share by (y) the Conversion Price, $4.5056, subject to adjustment as provided in the Certificate of Designations.
Current wording
On October 1, 2024, the Board authorized the Company to create a series of 10,000 shares of preferred stock designated as “Series C Convertible Preferred Stock”, with a par value of $0.00001, pursuant to the certificate of designations. At any time after the initial issuance date of Series C Preferred Stock, each Series C Preferred Stock shall be convertible into validly issued, fully paid and non-assessable shares of Common Stock. The holders of Series C Preferred Stock are entitled to dividends, on an as-if converted basis, equal to and in the same form as dividends actually paid on shares of Common Stock, when and if actually paid. In addition, from and after the occurrence and during the continuance of any Triggering Event, dividends (“Default Dividends”) will accrue on the Stated Value of each Series C Preferred Stock at a rate of fifteen percent (15.0%) (the “Default Rate”) per annum. Each holder is entitled to convert any portion of the outstanding Series C Preferred Stock held by such holder into validly issued, fully paid and non-assessable Conversion shares at the Conversion Rate, which can be determined by dividing (x) the Conversion Amount of such Series C Preferred Stock by (y) the Conversion Price, $4.5056, subject to adjustment as provided in the Certificate of Designations.
Previous wording
On October 2, 2024, the Company entered into, and sold, to six institutional investors (collectively, the “PIPE Investors”), pursuant to the securities purchase agreement an aggregate of 3,499 shares of Series C Preferred Stock which includes an issuance of 840 shares of Series C Preferred Stock to the lead investor in consideration for the PIPE Investors’ irrevocable commitment to purchase shares of the Series C Preferred Stock, and warrants to purchase 6,963 shares of Common Stock for aggregate net cash proceeds to the Company of $1.9 million. The exercise price of the warrants is $372.30, and the warrants are exercisable six months after the issuance date and expire on the third anniversary of the initial exercisability date.
Current wording
On October 2, 2024, the Company entered into, and sold, to six institutional investors (collectively, the “Series C PIPE Investors”), pursuant to the securities purchase agreement an aggregate of 3,499 shares of Series C Preferred Stock which includes an issuance of 840 shares of Series C Preferred Stock to the lead investor in consideration for the Series C PIPE Investors’ irrevocable commitment to purchase shares of the Series C Preferred Stock, and warrants to purchase 6,963 shares of Common Stock (“Series C Warrants”) for aggregate net cash proceeds to the Company of $1.9 million. The exercise price of the Series C Warrants is $372.30 on a post-reverse split basis, and the Series C Warrants are exercisable six months after the issuance date and expire on the third anniversary of the Initial Exercisability Date.
Previous wording
On October 2, 2024, the Company entered into a Common Stock ELOC Purchase Agreement relating to a Committed Equity Facility with an institutional investor (the “ELOC Purchaser”), whereby the Company may offer and sell, from time to time at its sole discretion, and whereby the ELOC Purchaser has committed to purchase, up to $25.0 million of the Company’s newly issued Common Stock, subject to certain limitations. Concurrently with entering into the ELOC Purchase Agreement, the Company also entered into a registration rights agreement with the ELOC Purchaser, pursuant to which it agreed to provide the ELOC Purchaser with certain registration rights related to the shares issued under the ELOC Purchase Agreement (the “ELOC Registration Rights Agreement”). In no event will the Company issue to the Purchaser under the ELOC Purchase Agreement more than 19,512 shares of Common Stock, representing 19.99% of the total number of shares of Common Stock outstanding immediately prior to the execution of the Common Stock Purchase Agreement (the “Exchange Cap”), unless (i) the Company obtains the approval of the issuance of such shares by its stockholders in accordance with the applicable stock exchange rules or (ii) sales of Common Stock are made at a price equal to or in excess of the lower of (A) the closing price immediately preceding the delivery of the applicable notice to the Purchaser and (B) the average of the closing prices of the Common Stock for the five business days immediately preceding the delivery of such notice, such that the sales of such Common Stock to the Purchaser would not count toward the Exchange Cap because they are “at market” under applicable stock exchange rules.
Current wording
On October 2, 2024, the Company also entered into the ELOC Purchase Agreement with an institutional investor (the “ELOC Purchaser”), whereby the Company may offer and sell, from time to time at its sole discretion, and whereby the ELOC Purchaser has committed to purchase, up to $25.0 million of the Company’s newly issued Common Stock, subject to the limitations described herein. Concurrently with entering into the ELOC Purchase Agreement, the Company also entered into a registration rights agreement with the ELOC Purchaser, pursuant to which it agreed to provide the ELOC Purchaser with certain registration rights related to the shares issued under the ELOC Purchase Agreement (the “ELOC Registration Rights Agreement”).
Previous wording
On July 16, 2025, the Company exercised its voluntary Series C adjustment right to lower the conversion price of the Series C preferred stock to $3.50, and holders of 2,130 Series C shares agreed to convert their shares into shares of common stock. As of August 13, 2025, 1,920 shares of Series C preferred stock had been converted to 547,051 shares of common stock for an aggregate conversion amount of approximately $1.9 million.
Current wording
On July 16, 2025, the Company exercised its voluntary Series C Preferred Stock adjustment right to lower the conversion price of the Series C Preferred Stock to $3.50, and holders of 1,920 Series C Preferred Stock shares agreed to convert their shares into shares of common stock.
Previous wording
After the Stockholder Approval Date, if a Triggering Event occurs and is continuing at any time after the earlier of the holders’ receipt of a Triggering Event Notice and such holder becoming aware of such Triggering Event (such earlier date, the “Alternate Conversion Right Commencement Date”) and ending on the twentieth (20 th) Trading Day after the later of (x) the date of such Triggering Event is cured and (y) such holder’s receipt of a Triggering Event Notice (such ending date, the “Alternate Conversion Right Expiration Date”), and each such period, an “Alternate Conversion Right Period”), such holder may, at such holder’s option, by delivery of a Conversion Notice to the Company (the date of any such Conversion Notice, each an “Alternate Conversion Date”), convert all, or any number of Preferred Shares held by such holder into shares of Common Stock at the Alternate Conversion Price (each, an “Alternate Conversion”). Alternate Conversion Price means, with respect to any Alternate Conversion that price will be the lowest of (i) the applicable Conversion Price as in effect on the applicable Conversion Date of the applicable Alternate Conversion, and (ii) the greater of (x) the Floor Price and (y) 80% of the lowest VWAP of the Common Stock during the five (5) consecutive Trading Day period ending and including the Trading Day immediately preceding the delivery or deemed delivery of the applicable Conversion Notice (such period, the “Alternate Conversion Measuring Period”).
Current wording
After the Stockholder Approval Date, if a Triggering Event occurs and is continuing at any time after the earlier of the holders’ receipt of a Triggering Event Notice and such holder becoming aware of such Triggering Event (such earlier date, the “Alternate Conversion Right Commencement Date”) and ending on the twentieth (20 th) Trading Day after the later of (x) the date of such Triggering Event is cured and (y) such holder’s receipt of a Triggering Event Notice (such ending date, the “Alternate Conversion Right Expiration Date”), and each such period, an “Alternate Conversion Right Period”), such holder may, at such holder’s option, by delivery of a Conversion Notice to the Company (the date of any such Conversion Notice, each an “Alternate Conversion Date”), convert all, or any number of Series C Preferred Shares held by such holder into shares of Common Stock at the Alternate Conversion Price (each, an “Alternate Conversion”).
Previous wording
At any time, the Company has the right to redeem in cash all or part of the Preferred Shares then outstanding at a price (the “Company Optional Redemption Price”) equal to 125% of the greater of (i) the Conversion Amount being redeemed and (ii) the product of (1) the Conversion Rate with respect to the Conversion Amount being redeemed multiplied by (2) the greatest closing sale price of the Company’s Common Stock on any Trading Day during the period commencing on the date immediately preceding the date the Company notifies the holders of its elections to redeem and the date the Company makes the entire payment required. Upon the occurrence of a Bankruptcy Triggering Event, the Company will immediately redeem, in cash, each of the Preferred Shares then outstanding at a redemption price equal to the greater of (i) the product of (A) the Conversion Amount to be redeemed multiplied by (B) 125% and (ii) the product of (X) the Conversion Rate with respect to the Conversion Amount in effect immediately following the date of initial public announcement of such Bankruptcy Triggering Event multiplied by (y) the product of (1) 125% multiplied by (2) the greatest closing sale price of the Common Stock on any Trading Day during the period commencing on the date immediately preceding such Bankruptcy Triggering Event and ending on the date the Company pays the entire payment required.
Current wording
At any time, the Company has the right to redeem in cash all or part of the Series C Preferred Stock then outstanding at a price (the “Company Optional Redemption Price”) equal to 125% of the greater of (i) the Conversion Amount being redeemed and (ii) the product of (1) the Conversion Rate with respect to the Conversion Amount being redeemed multiplied by (2) the greatest closing sale price of the Company’s Common Stock on any Trading Day during the period commencing on the date immediately preceding the date the Company notifies the holders of its elections to redeem and the date the Company makes the entire payment required. Upon the occurrence of a Bankruptcy Triggering Event, the Company will immediately redeem, in cash, each of the Series C Preferred Stock then outstanding at a redemption price equal to the greater of (i) the product of (A) the Conversion Amount to be redeemed multiplied by (B) 125% and (ii) the product of (X) the Conversion Rate with respect to the Conversion Amount in effect immediately following the date of initial public announcement of such Bankruptcy Triggering Event multiplied by (y) the product of (1) 125% multiplied by (2) the greatest closing sale price of the Common Stock on any Trading Day during the period commencing on the date immediately preceding such Bankruptcy Triggering Event and ending on the date the Company pays the entire payment required.
Previous wording
In no event may any Preferred Shares be converted (or Warrants be exercised) and shares of Common Stock be issued to any holder if after giving effect to the issuance of shares of Common Stock upon such conversion of the Preferred Shares (or exercise of the Warrants), the holder (together with its affiliates, if any) would beneficially own more than 4.99% of the outstanding shares of Common Stock, which we refer to herein as the “PIPE Blocker”. The PIPE Blocker may be raised or lowered to any percentage not in excess of 9.99% at the option of the applicable holder of the Preferred Shares (or Warrants), except that any raise will only be effective upon 61-days’ prior notice to the Company.
Current wording
In no event may any Series C Preferred Stock be converted (or Series C Warrants be exercised) and shares of Common Stock be issued to any holder if after giving effect to the issuance of shares of Common Stock upon such conversion of the Series C Preferred Stock (or exercise of the Series C Warrants), the holder (together with its affiliates, if any) would beneficially own more than 4.99% of the outstanding shares of Common Stock, which we refer to herein as the “Series C PIPE Blocker”. The Series C PIPE Blocker may be raised or lowered to any percentage not in excess of 9.99% at the option of the applicable holder of the Series C Preferred Stock (or Series C Warrants), except that any raise will only be effective upon 61-days’ prior notice to the Company.
Previous wording
On August 7, 2025, Veru and the Company agreed to amend and restate the September Veru Note (as amended and restated, the “A&R September Veru Note”). Pursuant to the A&R September Veru Note, the principal amount owed to Veru was increased by $100,000 to an aggregate principal amount of $5.1 million, and the maturity date was amended to August 14, 2025. All other terms of the September Veru Note remained the same.
Current wording
Subsequently, the Company and Veru modified and extended the payment terms under the Veru Notes on various occasions. On August 28, 2025, Veru and the Company agreed to amend and restate the September Veru Note (as amended and restated, the “Second A&R September Veru Note”). Pursuant to the Second A&R September Veru Note, the principal amount owed to Veru was increased by $100,000 to an aggregate principal amount of $5.2 million, and the maturity date was amended to September 19, 2025. All other terms of the September Veru Note remained the same. On August 28, 2025, Veru and the Company also entered into a waiver agreement (the “August 2025 Veru Waiver”) pursuant to which Veru agreed to waive and extend the date for payment of the April Veru Note to September 19, 2025.
Previous wording
During the six months ended June 30, 2025, the Company issued three subordinated promissory notes to Keystone Capital Partners, LLC, each with an original issue discount and payable upon the earlier of (i) receipt of sufficient proceeds from the Company’s Equity Line of Credit (“ELOC”) with the Investor or (ii) a specified maturity date. All notes are subordinated to the Company’s existing debt obligations to Veru Inc., do not initially bear interest, and are subject to a late charge of 15% per annum on any unpaid amounts past due.
Current wording
During the nine months ended September 30, 2025, the Company issued six subordinated promissory notes to Keystone Capital Partners, LLC, each with an original issue discount and payable upon the earlier of (i) receipt of sufficient proceeds from the Company’s Equity Line of Credit (“ELOC”) with the Investor or (ii) a specified maturity date. All notes are subordinated to the Company’s existing debt obligations to Veru, do not initially bear interest, and are subject to a late charge of 15% per annum on any unpaid amounts past due.
Previous wording
Selling, general and administrative expenses consist principally of commercialization activities, payroll, and personnel expenses, including salaries and bonuses, benefits and stock-based compensation expenses, professional fees for legal, consulting, accounting and tax services, information technology costs, costs incurred with respect to acquisitions and potential acquisitions, and other general operating expenses.
Current wording
Selling, general and administrative expenses consist principally of commercialization activities, payroll, and personnel expenses, including salaries and bonuses, benefits and stock-based compensation expenses, net periodic benefit costs, professional fees for legal, consulting, accounting and tax services, information technology costs, costs incurred with respect to acquisitions and potential acquisitions, and other general operating expenses.
Previous wording
We anticipate that our selling, general and administrative expenses related to Proteomedix will decrease when compared to historical levels due to cost reduction efforts including headcount reductions.
Current wording
We anticipate that our selling, general and administrative expenses related to Proteomedix will decrease when compared to historical levels due to cost reduction efforts, including headcount reductions, and the termination of the pension plan.
Previous wording
Other income (expense) is comprised of interest expense on notes payable, the change in fair value of financial instruments that are recorded as liabilities, which includes the related party subscription agreement liability and the contingent warrant liability, and other financing-related costs.
Current wording
Other income (expense) is comprised of interest expense on notes payable, loss on extinguishment of notes payables and preferred stock, loss on issuance of preferred stock and warrants, the change in fair value of financial instruments that are recorded as liabilities; which includes the related party subscription agreement liability, Series D warrant and derivative liabilities, and the contingent warrant liabilities; and other financing-related costs.
Previous wording
For the six months ended June 30, 2025, the Company had approximately $0.2 million of revenue, which was attributable to sale of products generated by Proteomedix. Cost of revenue of approximately $0.09 million was mostly attributable to costs incurred on Proteomedix revenue. For the six months ended June 30, 2024, the Company had approximately $1.4 million of revenue, which was attributable to sales and development services generated by Proteomedix. The cost of revenue of approximately $1.1 million is attributable to costs incurred on Proteomedix revenue including amortization of the product rights intangible asset of approximately $0.3 million, in addition to approximately $0.4 million related to the full impairment of ENTADFI inventory.
Current wording
For the three months ended September 30, 2025, the Company had approximately $0.3 million of revenue, which was attributable to other revenue including license revenue with Immunovia through an agreement that grant rights to use its intellectual property and proprietary materials generated by Proteomedix. Cost of revenue of approximately $0.03 million was mostly attributable to costs incurred on Proteomedix revenue. For the three months ended September 30, 2024, the Company had approximately $0.4 million of revenue, which was attributable to sales and development services generated by Proteomedix. The cost of revenue of approximately $0.3 million is attributable to costs incurred on Proteomedix revenue including amortization of the product rights intangible asset of approximately $0.2 million.
Previous wording
For the three months ended June 30, 2025, selling, general and administrative expenses decreased by approximately $0.7 million compared to the same period in 2024. This decrease was primarily driven by a reduction of approximately $0.5 million in payroll-related expenses, reflecting cost-saving measures implemented in response to reduced liquidity during the current quarter. Additionally, miscellaneous selling, general and administrative expenses declined by approximately $0.2 million over the same period.
Current wording
For the three months ended September 30, 2025, selling, general and administrative expenses decreased by approximately $0.3 million compared to the same period in 2024. This decrease was primarily driven by a reduction of approximately $0.4 million in net periodic benefit cost, due to the settlement of the defined benefit plan.
Previous wording
For the three months ended June 30, 2025 and 2024, there were no substantial research and development expenses. The lack of activity was primarily attributable to the Company’s decision to halt its vaccine programs and focus on commercialization activities, which occurred during the third quarter of 2023. This change in business strategy led to a halt in the Company’s clinical and other research activities.
Current wording
For the three months ended September 30, 2025 and 2024, there were no substantial research and development expenses. There has been no substantial R&D activity since the Company decided to halt its vaccine programs and focus on commercialization activities in the third quarter of 2023. This change in business strategy led to a halt in the Company’s clinical and other research activities.
Previous wording
The Company did not record any income tax benefit or expense during the three months ended June 30, 2025. For the same period in 2024, the Company recorded an income tax expense of approximately $0.05 million, related to foreign deferred income taxes recorded in connection with Proteomedix.
Current wording
The Company did not record any income tax benefit or expense during the three months ended September 30, 2025. For the same period in 2024, the Company recorded an income tax benefit of approximately $0.06 million, related to foreign deferred income taxes recorded in connection with Proteomedix.
Previous wording
For the three months ended June 30, 2025, the Company had approximately $0.1 million of revenue, which was attributable to sale of products generated by Proteomedix. Cost of revenue of approximately $0.04 million was mostly attributable to costs incurred on Proteomedix revenue. For the three months ended June 30, 2024, the Company had approximately $0.7 million of revenue, which was attributable to sales and development services generated by Proteomedix. The cost of revenue of approximately $0.6 million is attributable to costs incurred on Proteomedix revenue including amortization of the product rights intangible asset of approximately $0.2 million, in addition to approximately $0.4 million related to the full impairment of ENTADFI inventory.
Current wording
For the nine months ended September 30, 2025, the Company had approximately $0.5 million of revenue, which was attributable to other revenue including license revenue with Immunovia through an agreement that grant rights to use its intellectual property and proprietary materials generated by Proteomedix. Cost of revenue of approximately $0.1 million was mostly attributable to costs incurred on Proteomedix revenue. For the nine months ended September 30, 2024, the Company had approximately $1.8 million of revenue, which was attributable to sales and development services generated by Proteomedix. The cost of revenue of approximately $1.4 million is attributable to costs incurred on Proteomedix revenue including amortization of the product rights intangible asset of approximately $0.5 million, in addition to approximately $0.4 million related to the full impairment of ENTADFI inventory.
Previous wording
For the six months ended June 30, 2025 and 2024, there were no substantial research and development expenses. The lack of activity was primarily attributable to the Company’s decision to halt its vaccine programs and focus on commercialization activities, which occurred during the third quarter of 2023. This change in business strategy led to a halt in the Company’s clinical and other research activities.
Current wording
For the nine months ended September 30, 2025 and 2024, there were no substantial research and development expenses. There has been no substantial R&D activity since the Company decided to halt its vaccine programs in the third quarter of 2023. This change in business strategy led to a halt in the Company’s clinical and other research activities.
Previous wording
During the six months ended June 30, 2025, there was no impairment recorded related to the ENTADFI asset, as the asset had been fully impaired in the prior year. Specifically, an impairment charge of approximately $3.5 million was recognized during the same period in 2024, based on a valuation assessment conducted by an external specialist.
Current wording
During the nine months ended September 30, 2025, there was no impairment recorded related to the ENTADFI asset, as the asset had been fully impaired in the prior year. Specifically, an impairment charge of approximately $3.5 million was recognized during the same period in 2024, based on a valuation assessment conducted by an external specialist.
Previous wording
The Company recorded an impairment of goodwill related to the PMX acquisition during the six months ended June 30, 2025 totaling $11.5 million, as compared to an impairment of $15.5 million recognized for the same period last year in connection with the same acquisition.
Current wording
The Company recorded an impairment of goodwill related to the PMX acquisition during the nine months ended September 30, 2025 totaling $11.5 million, as compared to an impairment of $15.5 million recognized for the same period last year in connection with the same acquisition.
Previous wording
Other income (expense) incurred during the six months ended June 30, 2025, increased by approximately $4.4 million compared to the same period in 2024. The increase was primarily driven by a $3.2 million increase in the change in fair value of the subscription agreement liability – related party, a $0.9 million gain on forgiveness of accounts payable related to the settlement of IQVIA balances, and a $0.4 million reduction in related party interest expense.
Current wording
Other income (expense) incurred during the nine months ended September 30, 2025, increased by approximately $1.0 million compared to the same period in 2024. The increase was primarily attributable to a $5.4 million loss on extinguishment of notes payable and $2.5 million loss on issuance of preferred stock and warrants, partially offset by a $1.9 million gain on the change in fair value of Series D warrant liabilities, a $4.1 million increase in the change in fair value of the subscription agreement liability – related party and a $0.9 million gain on forgiveness of accounts payable related to the settlement of IQVIA balances.
Previous wording
The Company did not record any income tax benefit or expense during the six months ended June 30, 2025. For the same period in 2024, the Company recorded an income tax benefit of approximately $0.07 million, related to foreign deferred income taxes recorded in connection with Proteomedix.
Current wording
The Company did not record any income tax benefit or expense during the nine months ended September 30, 2025. For the same period in 2024, the Company recorded an income tax benefit of approximately $0.1 million, related to foreign deferred income taxes recorded in connection with Proteomedix.
Previous wording
The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of June 30, 2025, the Company had cash of approximately $0.3 million, a working capital deficit of approximately $11.8 million and an accumulated deficit of approximately $128.1 million.
Current wording
The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future. As of September 30, 2025, the Company had cash of approximately $0.8 million, a working capital deficit of approximately $15.0 million and an accumulated deficit of approximately $136.9 million. During the nine months ended September 30, 2025, the Company used approximately $6.6 million in cash for operating activities. In addition, as of November 10, 2025, the Company’s cash balance was approximately $6.1 million.
Previous wording
We will require significant amounts of additional capital in the short-term, to continue to fund our continuing operations, satisfy existing and future obligations and liabilities, including the remaining payments due under the Veru APA and other contracts entered into in support of the Company’s commercialization plans, in addition to funds needed to support our working capital needs and business activities, including the consummation of the Ocuvex transaction, development and commercialization of Proclarix, and the development and commercialization of our future product candidates. Until we can generate a sufficient amount of revenue from sales of Proclarix if at all, we expect to finance our future cash needs through public or private equity or debt financings, third-party funding and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches. The future sale of equity or convertible debt securities may result in dilution to our stockholders, and, in the case of preferred equity securities or convertible debt, those securities could provide for rights, preferences or privileges senior to those of our common stock. Debt financing may subject us to covenant limitations or restrictions on our ability to take specific actions, such as incurring additional debt, making capital expenditures, or declaring dividends. There can be no assurance that we will be successful in acquiring additional funding at levels sufficient to fund our operations or on terms favorable or acceptable to us. If we are unable to obtain adequate financing when needed or on terms favorable or acceptable to us, we may be forced to delay, reduce the scope of our business activities.
Current wording
We will require significant amounts of additional capital in the short-term, to continue to fund our continuing operations, satisfy existing and future obligations and liabilities contracts entered into in support of the Company’s commercialization plans, in addition to funds needed to support our working capital needs and business activities, including the development and commercialization of Proclarix, and the development and commercialization of our future product candidates. Until we can generate a sufficient amount of revenue from sales of Proclarix if at all, we expect to finance our future cash needs through public or private equity or debt financings, third-party funding and marketing and distribution arrangements, as well as other collaborations, strategic alliances and licensing arrangements, or any combination of these approaches. In December 2024, the Company began utilizing the ELOC entered into in October 2024 on an as-needed basis to fund current operating needs, subject to certain restrictions and beneficial ownership constraints. When the Company can again utilize the ELOC, it may be able to raise up to $17.9 million in gross proceeds remaining under the ELOC. However, given the terms of the ELOC and the uncertainty to drawdown fully from the ELOC, there are no assurances that the Company may not have funds to sustain operations for the next 12 months.
Previous wording
Management’s plans for funding the Company’s operations include generating product revenue from sales of Proclarix, which is still subject to further successful commercialization activities within certain jurisdictions. Management also intends to secure additional funding through equity or debt financings if available, and to utilize the ELOC entered into in October 2024 on an as-needed basis to assist with the paydown of the notes and to fund current operating needs, subject to certain restrictions and beneficial ownership constraints. However, based on the terms of the ELOC and the current maximum availability, management determined that the funds readily available under the ELOC will not be sufficient to sustain operations. In addition, there are currently no other commitments in place for further financing nor is there any assurance that such financing will be available to sustain its operations and expand commercialization of Proclarix. If the Company is unable to secure additional capital, it may be required to curtail any future clinical trials, development and/or commercialization of Proclarix and any future product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations, or, if it is required to, file for bankruptcy.
Current wording
In addition, there are currently no other commitments in place for further financing nor is there any assurance that such financing will be available to the Company on favorable terms, if at all. This creates significant uncertainty whether the Company will have the funds available to be able to sustain its operations and expand commercialization of Proclarix. If the Company is unable to secure additional capital, it may be required to curtail any future clinical trials, development and/or commercialization of future product candidates, and it may take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations, or, if it’s required to, file for bankruptcy.
Previous wording
Net cash used in operating activities for the six months ended June 30, 2025, was approximately $3.4 million, which primarily resulted from a net loss of approximately $10.9 million, a non-cash change in fair value of subscription liability of approximately $3.1 million, a gain on forgiveness of accounts payable of approximately $0.9 million, and net changes in our operating assets and liabilities of $0.1 million. These items were offset by several non-cash items, which primarily include impairment of goodwill of approximately $11.5 million.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2025, was approximately $6.6 million, which primarily resulted from a net loss of approximately $19.7 million, a non-cash change in fair value of subscription liability of approximately $3.1 million, a gain on forgiveness of accounts payable of approximately $0.9 million, a non-cash change in fair value of Series D warrant liability of approximately $1.9 million, and net changes in our operating assets and liabilities of $1.3 million. These items were offset by several non-cash items, which primarily include impairment of goodwill of approximately $11.5 million, loss on extinguishment of notes payable of approximately $5.4 million, and loss on issuance of Series D preferred stock of approximately $2.5 million.
Previous wording
Net cash used in operating activities for the six months ended June 30, 2024 was approximately $8.4 million, which primarily resulted from a net loss of approximately $25.4 million and a net change in our operating assets and liabilities of approximately $3.5 million, adjusted for the non-cash impairments of goodwill and ENTADFI of approximately $15.5 million and $3.5 million, respectively, depreciation and amortization expense of approximately $0.4 million, loss on impairment of ENTADFI inventory of approximately $0.4 million, in addition to noncash interest expense of approximately $0.8 million.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2024 was approximately $9.6 million, which primarily resulted from a net loss of approximately $29.3 million and a net change in our operating assets and liabilities of approximately $2.3 million and net change of deferred tax benefit by approximately $0.1 million. These items were offset by several non-cash items, which include: impairments of goodwill and ENTADFI of approximately $15.5 million and $3.5 million, respectively, depreciation and amortization expense of approximately $0.6 million, loss on impairment of ENTADFI inventory of approximately $0.4 million, noncash interest expense and amortization of debt discounts of approximately $1.1 million, and increase in the fair value of subscription liability of $1.0 million.
Previous wording
Net cash used in investing activities for the six months ended June 30, 2024 of approximately $22,000 resulted from purchases of property and equipment.
Current wording
Net cash used in investing activities for the nine months ended September 30, 2024 of approximately $25,000 resulted from purchases of property and equipment.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2025, was approximately $3.6 million, and resulted primarily from proceeds of approximately $6.4 million from the purchase of common stock in connection with the ELOC and $0.5 million from the issuance of notes payable. These proceeds were offset by payments on notes payable of approximately $1.5 million and a payment of approximately $1.7 million related to redemption of the Series C Preferred Stock.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2025, was approximately $7.9 million, and resulted primarily from proceeds of approximately $9.1 million from the issuance proceeds of Series D preferred stock and warrants, $6.4 million from the purchase of common stock in connection with the ELOC and $0.9 million from the issuance of notes payable. These proceeds were offset by payments on notes payable of approximately $6.9 million and a payment of approximately $1.7 million related to redemption of the Series C Preferred Stock.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2024 was approximately $4.9 million, and resulted primarily from the issuance of an aggregate of $5.7 million in notes payable, consisting of a $5.0 million debenture and $0.7 million for the financing for certain director and officer liability insurance policy premiums, offset by the payment of $0.4 million in financing costs and $0.4 million in payment on one of the notes payable.
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2024 was approximately $5.4 million, and resulted primarily from the issuance of an aggregate of approximately $5.9 million in notes payable, consisting of a $5.0 million debenture and approximately $0.9 million for the financing of director and officer liability insurance policy premiums and the proceeds received from the exercise of preferred investment options in connection with the warrant inducement transaction of approximately $0.9 million. These proceeds were offset by approximately $0.9 million in payments on the notes payable and $0.4 million in the payment of financing costs.
Previous wording
As of June 30, 2025, there have been no material changes to our critical accounting policies and estimates from those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates,” included in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on June 2, 2025.
Current wording
As of September 30, 2025, there have been changes to our critical accounting policies and estimates from those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Estimates,” included in our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on June 2, 2025. Please refer to “Critical Accounting Policies and Estimates – Accounting for Series D PIPE Securities including Warrant and Derivative Liabilities” below.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Net cash used in investing activities for the nine months ended September 30, 2025 was $0.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
The Company may not issue or sell any shares of Common Stock to the ELOC Purchaser under the Common Stock Purchase Agreement, if it would result in the ELOC Purchaser beneficially owning more than 4.99% of the outstanding shares of Common Stock (the “ELOC Blocker”). The ELOC Blocker may be raised or lowered to any other percentage not in excess of 9.99% at the option of the ELOC Purchaser, except that any raise will only be effective upon 61 days’ prior notice to the Company.
Previous report — wording carried elsewhere
During the three months ended June 30, 2025, there was no impairment recorded related to the ENTADFI asset, as the asset had been fully impaired in the prior year. Specifically, an impairment charge of approximately $1.2 million was recognized during the same period in 2024, based on a valuation assessment conducted by an external specialist.
Previous report — wording carried elsewhere
The Company recorded an impairment of goodwill related to the PMX acquisition during the three months ended June 30, 2025 totaling $0.6 million, as compared to an impairment of $10.3 million recognized for the same period last year in connection with the same acquisition.