VERU INC.
For the period ended Jun 30, 2026. Filed Aug 10, 2026.
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Jun 30, 2026 · Filed Aug 10, 2026
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Notes to Unaudited Condensed Consolidated Financial Statements
Note1 – Basis of Presentation and Significant Accounting Policies
The accompanying unaudited interim condensed consolidated financial statements for Veru Inc. (“we,” “our,” “us,” “Veru” or the “Company”) have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting of interim financial information. Pursuant to these rules and regulations, certain information and footnote disclosures normally included in annual financial statements prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) have been condensed or omitted, although the Company believes that the disclosures made are adequate to make the informationnot misleading. Accordingly, these statements donot include all the disclosures normally required by U.S. GAAP for annual financial statements and should be read in conjunction with Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in this report and the audited financial statements and notes thereto included in our Annual Report on Form10-K for the fiscal year ended* September 30, 2025*. The accompanying condensed consolidated balance sheet as of* September 30, 2025* has been derived from our audited financial statements. The unaudited condensed consolidated statements of operations and cash flows for thethree andnine months ended* June 30, 2026* arenot necessarily indicative of the results to be expected for any future period or for the fiscal year ending* September 30, 2026*.
The preparation of our unaudited interim condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Actual results could differ from those estimates.
In the opinion of management, the accompanying unaudited interim condensed consolidated financial statements contain all adjustments (consisting of only normally recurring adjustments) necessary to present fairly the financial position and results of operations as of the dates and for the periods presented.
Principles of consolidation and nature of operations: Veru Inc. is referred to in these notes collectively with its subsidiaries as “we,” “our,” “us,” “Veru” or the “Company.” The consolidated financial statements include the accounts of Veru and its wholly owned subsidiaries, Aspen Park Pharmaceuticals, Inc. (APP) and PCHC Limited (formerly known as The Female Health Company Limited). PCHC Limited sold the stock of its wholly owned subsidiary, The Female Health Company (UK) plc effective* December 30, 2024,as part of theFC2* Business Sale (see Note3 for additional information). The Female Health Company (UK) plc and The Female Health Company (UK) plc’s wholly owned subsidiary, The Female Health Company (M) SDN.BHD (the “Malaysia subsidiary”) were included in the consolidated financial statements through* December 30, 2024.Veru International Holdco Inc. was a wholly owned subsidiary of the Company and was dissolved in December 2025.Veru International Holdco Inc. didnot* have any impact on the Company’s operations during the quarter ended* December 31, 2025.Veru International Holdco Inc.’s wholly owned subsidiaries, Veru Biopharma Netherlands B.V., Veru Biopharma UK Limited, and Veru Biopharma Europe Limited were dissolved during fiscal2024* and were included in the consolidated financial statements through the date of dissolution. All significant intercompany transactions and accounts have been eliminated in consolidation. The Company is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. Our drug development program includes enobosarm, an oral selective androgen receptor modulator, which is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass, and sabizabulin, a microtubule disruptor, which is being developed for the treatment of inflammation in atherosclerotic cardiovascular disease. On* December 30, 2024,the Company sold substantially all of the assets relating to its FDA-approved commercial product, theFC2* Female Condom® (Internal Condom). See Note3 for additional information. The Company also had ENTADFI® (finasteride and tadalafil) capsules for oral use (ENTADFI), a new treatment for benign prostatic hyperplasia that was approved by the FDA in* December 2021.We sold substantially all of the assets related to ENTADFI on April**19,* 2023. See Note15 for additional information. All of the Company’s net revenues during thethree andnine months ended* June 30, 2025* were derived from sales ofFC2 and are included within discontinued operations. The Company hadno net revenues during thenine months ended* June 30, 2026*.
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Reverse stock split: As described more fully in Note9, effective* August 8, 2025,the Company effected a1*-for-10 reverse stock split for all of its issued and outstanding shares of common stock. All share and per share amounts presented in these consolidated financial statements and accompanying notes and elsewhere in this Quarterly Report on Form10-Q, including butnot limited to shares issued and outstanding, loss per share, and stock options and stock appreciation rights, as well as the dollar amounts of common stock and paid-in-capital, have been retroactively adjusted for all periods presented. There wasno change to the total number of shares authorized or par value per share as a result of this reverse stock split.
Other comprehensive loss: Accounting principles generally require that recognized revenue, expenses, gains and losses be included in net loss. Although certain changes in assets and liabilities, such as foreign currency translation adjustments, are reported as a separate component of the equity section of the accompanying unaudited condensed consolidated balance sheets, these items, along with net loss, are components of other comprehensive loss. For thethree andnine months ended* June 30, 2026and2025*, comprehensive loss is equivalent to the reported net loss.
Recent accounting pronouncementsnot yet adopted: In* December 2023,the FASB issued ASU2023*-09, Income Taxes (Topic740): Improvements to Income Tax Disclosures, which includes amendments that further enhance income tax disclosures, primarily through standardization and disaggregation of rate reconciliation categories and income taxes paid by jurisdiction. ASU2023-09 is effective for the Company’s annual periods beginning with the fiscal year ending* September**30,* 2026, with early adoption permitted, and should be applied either prospectively or retrospectively. The Company is currently evaluating the impact of adopting ASU2023-09 on its disclosures.
In* November 2024,the FASB issued ASU2024*-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic220-40): Disaggregation of Income Statement Expenses, which requires more detailed disclosures about specified categories of expenses (including employee compensation, depreciation, and selling expenses) included in certain expense captions presented on the face of the statement of operations. In* January 2025,the FASB issued ASU2025*-01 to clarify the effective date of ASU2024-03. ASU2024-03 is effective for the Company's annual reporting periods beginning with the fiscal year ending* September 30, 2028,and subsequent interim periods, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU2024*-03 on its consolidated financial statements and disclosures.
In* December 2025,the FASB issued ASU2025*-11, Interim Reporting (Topic270): Narrow-Scope Improvements, which improves the guidance in Topic270 by improving the navigability of the required interim disclosures and clarifying when that guidance is applicable. The amendments also provide additional guidance on what disclosures should be provided in interim reporting periods and adds to Topic270 a principle that requires entities to disclose events since the end of the last annual reporting period that have a material impact on the entity. ASU2025-11 is effective for interim reporting periods within the Company’s fiscal year ending* September 30, 2029,with early adoption permitted. The Company is currently evaluating the impact of adopting ASU2025*-11 on its disclosures.
We have reviewed all other recently issued accounting pronouncements and have determined that such standards that arenot yet effective willnot have a material impact on our financial statements or donot otherwise apply to our operations.
Note2 – Going Concern
The Company isnot profitable and has had negative cash flow from operations. We will need substantial capital to support our drug development and any related commercialization efforts for our drug candidates. Based upon the Company’s current operating plan, it estimates that its cash and cash equivalents as of the issuance date of these financial statements are insufficient for the Company to fund operating, investing and financing cash flow needs for thetwelve months subsequent to the issuance date of these financial statements. To obtain the capital necessary to fund our operations, we expect to finance our cash needs through public or private equity offerings, debt financing transactions and/or other capital sources. Additional capital* may**not* be available at such times and in such amounts as needed by us to fund our activities on a timely basis.
These uncertainties raise substantial doubt regarding our ability to continue as a going concern for a period oftwelve months subsequent to the issuance date of these financial statements. Certain elements of our operating plan to alleviate the conditions that raise substantial doubt, including butnot limited to our ability to secure equity financing or other financing alternatives, are outside of our control and cannot be included in management’s evaluation under the requirement of ASC205-40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern. Accordingly, we have concluded that substantial doubt exists about our ability to continue as a going concern for a period of at leasttwelve months subsequent to the issuance date of these financial statements.
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Note3 – Discontinued Operations
On* December 30, 2024,the Company and PCHC Limited (collectively, the “Sellers”) entered into a Stock and Asset Purchase Agreement (the “Purchase Agreement”) with Clear Future, Inc. (the “Purchaser”). Pursuant to, and subject to the terms and conditions of, the Purchase Agreement, the Purchaser purchased substantially all of the assets (the“FC2* Business Sale”) related to the Company’sFC2 business, including the stock of The Female Health Company (UK) plc and the Malaysia subsidiary. The Purchaser assumed certain liabilities relating to theFC2 business that are specified in the Purchase Agreement. The transaction closed on* December 30, 2024.The Sellers and the Purchaser made customary representations and warranties, and agreed to certain customary covenants, in the Purchase Agreement. Subject to certain exceptions and limitations, each party agreed to indemnify the other for breaches of representations, warranties and covenants and for certain other matters. The Purchase Agreement also specifies that, subject to a $54,000 retention amount, a representations and warranties insurance policy issued to the Purchaser would be the sole and exclusive remedy for breach of representations and warranties (other than certain specified representations and warranties) by the Sellers except in the case of fraud. Pursuant to an Escrow Agreement entered into under the terms of the Purchase Agreement, the $54,000 retention amount is being held in escrow as of June 30, 2026* and is classified as restricted cash, included within cash, cash equivalents, and restricted cash on the accompanying condensed consolidated balance sheet.
The purchase price for theFC2 Business Sale was $18.0 million in cash, subject to adjustment as set forth in the Purchase Agreement, which included a customary working capital adjustment subsequent to closing based on the amount by which certain working capital items at closing are greater or less than a target set forth in the Purchase Agreement. Net proceeds from theFC2 Business Sale were $16.5 million, which is the $18.0 million purchase price per the Purchase Agreement, net of costs incurred of $1.4 million, and amounts allocated to the related transition services agreement of $150,000 but excluding the change of control payment pursuant to the Residual Royalty Agreement of $4.2 million (see Note8 for additional information). The loss on sale of theFC2 business was $4.1 million, which is the difference between net proceeds of $16.5 million and the total carrying value of theFC2 business of $20.6 million. The carrying value of theFC2 business at* December 30, 2024*primarily included deferred income tax assets of $12.3 million, accounts receivable of $4.6 million, and inventory of $3.4 million, partially offset by accrued expenses and other current liabilities of $1.5 million.
The Purchase Agreement contains a provision for an adjustment to the purchase price, including an adjustment based on the working capital of theFC2 business as of the closing date. The Purchaser was required to deliver its purchase price adjustment calculation within90 days after the closing date. The Purchaser delivered its calculation in* April 2025and we disputed the calculation. This dispute was submitted to an accounting firm for binding resolution, and in September 2025*the accounting firm delivered its final determination, resolving all disputed matters in favor of the Company. As a result of the final determination, the Purchaser paid additional purchase price of approximately $150,000 to us and approximately $300,000 was released from escrow.
During thenine months ended* June 30, 2026,the Company recognized an additional gain on sale of theFC2* business of$351,000, which is for net proceeds received from the Purchaser in the settlement of a dispute related to a pre-closing tax receivable and liability.
TheFC2 Business Sale represented a strategic shift, which had a major effect on our operations and financial results. We classified all direct revenues, costs and expenses related to theFC2 business within loss from discontinued operations, net of tax, in the condensed consolidated statements of operations for thenine months ended* June 30, 2025*. We didnot allocate any amounts for shared general and administrative operating support expense to discontinued operations. We didnot have any discontinued operations during thethree andnine months ended* June 30, 2026*. The assets and liabilities sold as part of theFC2 Business Sale were written off upon the closing of theFC2 Business Sale, and therefore there areno assets and liabilities of discontinued operations in our condensed consolidated balance sheets as of* June 30, 2026* or* September 30, 2025*.
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The following table presents results of discontinued operations for thethree andnine months ended* June 30, 2026and2025*:
| Three Months Ended · Nine Months Ended | |||||
|---|---|---|---|---|---|
| June 30, · June 30, | |||||
| 2026 · 2025 · 2026 · 2025 | |||||
| Net revenues | $— | $— | $— | $4,484,591 | |
| Cost of sales | — | — | — | 2,900,514 | |
| Gross profit | — | — | — | 1,584,077 | |
| Operating expenses | — | 565 | — | 1,111,962 | |
| Gain (loss) on sale of FC2 business | — | (9,154) | 351,418 | (4,253,405) | |
| Operating income (loss) | — | (9,719) | 351,418 | (3,781,290) | |
| Non-operating expenses: | |||||
| Interest expense | — | — | — | (164,270) | |
| Change in fair value of derivative liabilities | — | — | — | (3,138,316) | |
| Other expense, net | — | — | — | (31,960) | |
| Total non-operating expenses | — | — | — | (3,334,546) | |
| Income (loss) before income taxes | — | (9,719) | 351,418 | (7,115,836) | |
| Income tax expense | — | — | — | 78,553 | |
| Net (loss) income from discontinued operations, net of taxes | $ | - | $(9,719) | $351,418 | $(7,194,389) |
The cash flows related to discontinued operations havenot been segregated and are included in the consolidated statements of cash flows. Total operating and investing cash flows, which includes net proceeds from the sale ofFC2, from discontinued operations for thenine months ended* June 30, 2026and2025* are comprised of the following:
| Nine Months Ended | ||
|---|---|---|
| June 30, | ||
| 2026 | 2025 | |
| Total net cash used in operating activities from discontinued operations | $— | $(335,429) |
| Total net cash provided by investing activities from discontinued operations | $351,418 | $16,319,881 |
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Note4 – Fair Value Measurements
ASC820 specifies a hierarchy of valuation techniques based on whether the inputs to those valuation techniques are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level1 measurement) and the lowest priority to unobservable inputs (Level3 measurement).
Thethree levels of the fair value hierarchy are as follows:
Level1 – Quoted prices for identical instruments in active markets.
Level2 – Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that arenot active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable.
Level3 – Instruments with primarily unobservable value drivers.
As of* June 30, 2026*, the Company has investments in equity securities consisting of a warrant (the “ONCO Warrant”) to purchase 3,216,344 shares of common stock (the “ONCO Common Stock”) of Onconetix, Inc. (“ONCO”). ONCO effected a1-for-10 reverse stock split for all of the issued and outstanding shares of ONCO Common Stock in* May 2026,which resulted in an adjustment to the number of shares under the ONCO Warrant. All ONCO Common Stock amounts presented have been retroactively adjusted for all periods presented. As of September 30, 2025,the Company had investments in equity securities consisting of 3,125 shares of Series D Convertible Preferred Stock (the “ONCO Series D Preferred Stock”) of ONCO and the ONCO Warrant. The ONCO Series D Preferred Stock and the ONCO Warrant were received on September 22, 2025as a settlement of the ONCO Promissory Notes. See Note15* for additional information. The Company elected to measure the ONCO Series D Preferred Stock and the ONCO Warrant at fair value in accordance with ASC825. The investments in the ONCO Series D Preferred Stock and the ONCO Warrant are classified within Level3 of the fair value hierarchy because there isno market for these types of securities and the fair value is determined using significant unobservable inputs. The fair value of the ONCO Series D Preferred Stock and the ONCO Warrant were determined using a Monte Carlo simulation model. This valuation model incorporates the contractual terms of the instruments and assumptions including the stock price of ONCO Common Stock, expected volatility, and a selected discount rate. Additionally, the ONCO Series D Preferred Stock and the ONCO Warrant were issued by ONCO as part of a Securities Purchase Agreement, which included the sale of 16,099 shares of ONCO Series D Preferred Stock and warrants to purchase 87,256 shares of ONCO Common Stock toeleven institutional investors, for an aggregate purchase price of $12.9 million. The valuation of the ONCO Series D Preferred Stock and ONCO Warrant at issuance included a calibration discount to the proceeds of the original transaction, which was done at arms’ length. The calibration discount was reduced tozero when the Company began to convert the ONCO Series D Preferred Stock during thethree months ended* March 31, 2026,which had the effect of increasing the fair value of the ONCO Series D Preferred Stock and the ONCO Warrant. The assumptions used in calculating the fair value of the financial instruments represent the Company’s best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, the use of different estimates or assumptions would result in a higher or lower fair value and different amounts being recorded in the Company’s financial statements. Material changes in any of these inputs could result in a significantly higher or lower fair value measurement at future reporting dates, which could have a material effect on our results of operations. The following table summarizes the significant unobservable inputs used in the Monte Carlo Simulations as of June 30, 2026* and* September 30, 2025*:
| Significant Unobservable Input | June 30, 2026 | September 30, 2025 |
|---|---|---|
| ONCO Series D Preferred Stock | ||
| Simulation Term (Years) | — | 1.5 |
| Expected Volatility | — | 72.5% |
| Discount Rate | — | 25.0% |
| Calibration Discount | — | 48.6% |
| ONCO Warrant | ||
| Simulation Term (Years) | 2.2 | 3.0 |
| Equity Volatility | 74.5% | 68.6% |
| Calibration Discount | 0.0% | 48.6% |
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The following table provides a reconciliation of the beginning and ending balance associated with the ONCO Series D Preferred Stock and the ONCO Warrant measured at fair value for thenine months ended* June 30, 2026and2025*, which are presented as investments in equity securities on the accompanying consolidated balance sheet:
| Nine Months Ended | ||
|---|---|---|
| June 30, | ||
| 2026 | 2025 | |
| ONCO Series D Preferred Stock | ||
| Beginning balance | $1,764,318 | $— |
| Change in fair value of equity securities | 3,255,908 | — |
| Converted into ONCO Common Stock | (5,020,226) | — |
| Ending balance | $— | $— |
| ONCO Warrant | ||
| Beginning balance | $760,987 | $— |
| Change in fair value of equity securities | 1,150,399 | — |
| Ending balance | $1,911,386 | $— |
During thethree months ended* June 30, 2026,the Company converted the remaining outstanding 1,196 shares of ONCO Series D Preferred Stock into 104,174 shares of ONCO Common Stock and sold 104,206 shares of ONCO Common Stock for net proceeds of $1.8 million. During thenine* months ended* June 30, 2026,*the Company converted 3,125 shares of the ONCO Series D Preferred Stock into 181,283 shares of ONCO Common Stock and sold the shares of ONCO Common Stock for net proceeds of $5.0 million.
The Company also had an investment in equity securities consisting of 2,854 shares of ONCO Common Stock, which were sold during thenine months ended* June 30, 2025* for net proceeds of $0.4 million. The Company recognized a loss from the change in fair value of equity securities related to the ONCO Common Stock of $0.3 million during thenine months ended* June 30, 2025*.
The following is a summary of unrealized and realized gains and losses on equity securities recognized during thethree andnine months ended* June 30, 2026and2025*:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| June 30, | June 30, | |||
| 2026 | 2025 | 2026 | 2025 | |
| Net gains (losses) recognized during the period on equity securities | $546,129 | $— | $4,357,467 | $(349,078) |
| Less: net gains (losses) recognized during the period on equity securities sold during the period | 437,389 | — | 3,207,068 | (349,078) |
| Unrealized gains (losses) recognized during the reporting period on equity securities still held at the reporting date | $108,740 | $— | $1,150,399 | $— |
Note5 – Accounts Receivable
All of the Company's accounts receivables were included in the assets sold as part of theFC2 Business Sale, except for the Company's accounts receivables due from The Pill Club. The Company has an allowance for credit losses of $3.9 million related to the total amount of receivables due from The Pill Club due to The Pill Club’s Chapter11 bankruptcy, filed on* April**18,* 2023. The Company has an open claim with The Pill Club bankruptcy estate for these receivables but the timing and amount of recovery, if any, are unknown at this time.
Note6 – Fixed Assets
We record equipment, furniture and fixtures, and leasehold improvements at historical cost. Expenditures for maintenance and repairs are recorded to expense. Depreciation and amortization are primarily computed using the straight-line method. Depreciation and amortization are computed over the estimated useful lives of the respective assets. Leasehold improvements are depreciated on a straight-line basis over the lesser of the remaining lease term or the estimated useful lives of the improvements.
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Property and equipment consisted of the following at* June 30, 2026* and* September 30, 2025*:
| Estimated | June 30, | September 30, | |
|---|---|---|---|
| Useful Life (in years) | 2026 | 2025 | |
| Property and equipment: | |||
| Office equipment, furniture and fixtures | 3 - 7 | $765,911 | $765,911 |
| Leasehold improvements | 8 | 199,532 | 199,532 |
| Total property and equipment | 965,443 | 965,443 | |
| Less: accumulated depreciation and amortization | (685,216) | (600,635) | |
| Property and equipment, net | $280,227 | $364,808 | |
Depreciation expense was approximately $28,000 and $29,000 for thethree months ended* June 30, 2026and2025*, respectively, and approximately $85,000 and $88,000 for thenine months ended* June 30, 2026and2025,* respectively.
Note7 – Goodwill
The carrying amount of goodwill at* June 30, 2026* and* September 30, 2025* was $6.9 million. There wasno change in the balance during thenine months ended* June 30, 2026and2025*.
Note8 – Debt
SWK Residual Royalty Agreement
On* March5,* 2018, the Company entered into a Credit Agreement (as amended, the “Credit Agreement”) with the financial institutions party thereto from time to time (the “Lenders”) and SWK Funding LLC, as agent for the Lenders (the “Agent”), for a synthetic royalty financing transaction. On and subject to the terms of the Credit Agreement, the Lenders provided the Company with a term loan of $10.0 million, which was advanced to the Company on the date of the Credit Agreement. The Company repaid the loan and return premium specified in the Credit Agreement in* August2021,* and as a result hasno further obligations under the Credit Agreement. The Agent has released its security interest in Company collateral previously pledged to secure its obligations under the Credit Agreement.
In connection with the Credit Agreement, the Company and the Agent also entered into a Residual Royalty Agreement, dated as of* March**5,* 2018 (as amended, the “Residual Royalty Agreement”), which provides for an ongoing royalty payment of 5% of product revenue from net sales ofFC2. The Residual Royalty Agreement will terminate upon (i) a change of control or sale of theFC2 business and the payment by the Company of the amount due in connection therewith pursuant to the Residual Royalty Agreement, or (ii) mutual agreement of the parties. If a change of control or sale of theFC2 business occurs, the Agent will receive a payment that is the greater of (A) $2.0 million or (B) the product of (x)5% of the product revenue from net sales ofFC2 for the most recently completed12-month period multiplied by (y) five.
In connection with the closing of theFC2 Business Sale, on* December 30, 2024,*the Company made a change of control payment of $4.2 million to SWK pursuant to the Residual Royalty Agreement, and upon such payment, the Residual Royalty Agreement terminated in accordance with its terms. The Company recognized a gain on extinguishment of debt of $8.6 million for the difference between the change of control payment of $4.2 million and the net carrying amount of the extinguished debt, which included an embedded derivative for the change of control provision at fair value.
For accounting purposes, the $10.0 million advance under the Credit Agreement was allocated between the Credit Agreement and the Residual Royalty Agreement on a relative fair value basis. A portion of the amount allocated to the Residual Royalty Agreement, equal to the fair value of the respective change of control provisions, was allocated to the embedded derivative liability. The derivative liability was adjusted to fair market value at each reporting period. The loss associated with the change in fair value of the embedded derivatives was included within net loss from discontinued operations on the accompanying consolidated statement of operations for thethree months ended* December 31, 2024.It was included in discontinued operations because the related debt was required to be repaid as a result of theFC2* Business Sale.
At* June 30, 2026* and* September 30, 2025*, there wereno balances remaining related to the Residual Royalty Agreement liability.
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Note9 – Stockholders’** Equity**
Preferred Stock
The Company has 5,000,000 authorized shares designated as Class A Preferred Stock with a par value of $0.01 per share. There are 1,040,000 shares of Class A Preferred Stock – Series1 authorized;1,500,000 shares of Class A Preferred Stock – Series2 authorized;700,000 shares of Class A Preferred Stock – Series3 authorized; and 548,000 shares of Class A Preferred Stock – Series4 (the “Series4 Preferred Stock”) authorized. There wereno shares of Class A Preferred Stock of any series issued and outstanding at* June 30, 2026* and* September 30, 2025*. The Company has 15,000 authorized shares designated as Class B Preferred Stock with a par value of $0.50 per share. There wereno shares of Class B Preferred Stock issued and outstanding at* June 30, 2026* and* September 30, 2025*, and there wasno activity during thethree andnine months ended* June 30, 2026and2025*.
Reverse Stock Split
On* August 8, 2025,the Company effected a1*-for-10 reverse stock split of its issued and outstanding common stock. As a result of the reverse split, each10 shares of issued and outstanding common stock were automatically converted intoone share of common stock. The reverse stock split didnot change the total number of shares authorized or par value per share. The reverse stock split was approved by the Company’s shareholders on* July 25, 2025.*
All share and per share amounts presented in these consolidated financial statements and accompanying notes and elsewhere in this Quarterly Report on Form10-Q, including butnot limited to shares issued and outstanding, loss per share, and stock options and stock appreciation rights, as well as the dollar amounts of common stock and paid-in-capital, have been retroactively adjusted for all periods presented.No fractional shares were issued in connection with the reverse stock split. Shareholders who would have otherwise been entitled to receive fractional shares as a result of the reverse stock split received a cash payment in lieu thereof, based on the closing price of the Company’s common stock on* August 7, 2025.*
Shelf Registration Statements
In* March2023,* the Company filed a shelf registration statement on Form S-3 (FileNo. 333-270606) with a capacity of $200 million, which was declared effective by the SEC on* April14,* 2023. That shelf registration statement expired on* April 14, 2026.In April 2026,the Company filed a new shelf registration statement on Form S-3 (FileNo.* 333-294911) with a capacity of $200 million, which was declared effective by the SEC on* April 15, 2026.This new shelf registration statement expires on April 15, 2029.Under current SEC regulations, because the aggregate market value of the Company’s common stock held by non-affiliates (“public float”) is less than$75* million, and for so long as the Company’s public float remains less than*$75* million, the amount it can raise through primary public offerings of securities in any12-month period using shelf registration statements is limited to an aggregate ofone-third of the Company’s public float.
Public Offering
On* October 31, 2025,we completed an underwritten public offering of (i)1,400,000 shares of our common stock, (ii) pre-funded warrants to purchase up to 7,000,000 shares of our common stock, each representing the right to purchaseone share of common stock at an exercise price of $0.001, in lieu of common stock, (iii) accompanying Series A warrants to purchase up to 8,400,000 shares of our common stock at an exercise price of $3.00, and (iv) accompanying Series B warrants to purchase up to 8,400,000 shares of our common stock at an exercise price of $3.00, at a combined public offering price of $3.00 per share of common stock, accompanying Series A warrant and accompanying Series B warrant. Net proceeds to the Company from this offering were approximately $23.4 million, after deducting the underwriting discounts and commissions of $1.5 million and costs payable by the Company of $0.3 million. All of the securities in the offering were sold by the Company. The offering was made pursuant to the Company’s shelf registration statement on Form S-3 (FileNo.* 333-270606) in effect at that time. The relative fair value allocated to the common stock, pre-funded warrants, accompanying Series A warrants and accompanying Series B warrants were $1.7 million, $8.4 million, $8.5 million, and $6.7 million, respectively.
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Pre-Funded Warrants
The following table summarizes the Company’s pre-funded warrant activity for thenine months ended* June 30, 2026*:
| Weighted | ||
|---|---|---|
| Pre-Funded | Average | |
| Warrants | Exercise Price | |
| Outstanding at September 30, 2025 | — | $— |
| Issued | 7,000,000 | $0.001 |
| Exercised | (1,000,000) | $0.001 |
| Canceled/Expired | — | $— |
| Outstanding at June 30, 2026 | 6,000,000 | $0.001 |
Warrants
The following table summarizes the Company’s warrant activity, excluding pre-funded warrants, for thenine months ended* June 30, 2026*:
| Weighted | ||
|---|---|---|
| Average | ||
| Warrants | Exercise Price | |
| Outstanding at September 30, 2025 | — | $— |
| Issued | 16,800,000 | $3.00 |
| Exercised | — | $— |
| Canceled/Expired | — | $— |
| Outstanding at June 30, 2026 | 16,800,000 | $3.00 |
Lincoln Park Capital Fund LLC Purchase Agreement
On* May2,* 2023, the Company entered into a purchase agreement (as amended, the “Lincoln Park Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“Lincoln Park”), which provides that, upon the terms and subject to the conditions and limitations set forth therein, the Company* maysell to Lincoln Park up to $100.0 million of shares (the “Purchase Shares”) of the Company’s common stock over the 36 month term of the Lincoln Park Purchase Agreement. The Lincoln Park Purchase Agreement maybe terminated by the Company at any time, at its sole discretion, without any cost or penalty, by givingone* business day notice to Lincoln Park. Lincoln Park has covenantednot to in any manner whatsoever enter into or effect, directly or indirectly, any short selling or hedging of the Company’s common stock. On* December13,* 2023, the Company entered into an amendment (the “Lincoln Park Amendment”) with Lincoln Park to reduce the amount of shares of common stock subject to the registration from $100.0 million to $50.0 million until the Company has sold at least $50.0 million of shares of common stock under the Lincoln Park Purchase Agreement. The issuance of shares of common stock pursuant to the Lincoln Park Purchase Agreement up to $50.0 million were registered pursuant to the Company’s shelf registration statement on Form S-3 (FileNo. 333-270606), and a related prospectus supplement that was filed with the SEC on* May3,* 2023, as further supplemented on* December13,* 2023 to reflect the Lincoln Park Amendment. The shelf registration statement on Form S-3 (FileNo. 333-270606) expired on* April 14, 2026,and after that date the Company was unable to sell any common stock pursuant to the Lincoln Park Purchase Agreement because such sales wouldno* longer be covered by an effective registration statement. The Company didnot have plans to utilize the remaining capacity under the Lincoln Park Purchase Agreement and terminated the agreement effective* May 12, 2026.*
During thenine months ended* June 30, 2026and2025*, we didnot sell any shares under the Lincoln Park Purchase Agreement. Since inception of the Lincoln Park Purchase Agreement through its termination on* May 12, 2026,*we sold 302,500 shares of common stock to Lincoln Park resulting in proceeds to the Company of $3.1 million.
17
In consideration for entering into the Lincoln Park Purchase Agreement, concurrently with the execution of the Lincoln Park Purchase Agreement, the Company issued 80,000 shares of the Company’s common stock to Lincoln Park. The shares of common stock issued as consideration were valued at $1.0 million, based on the closing price per share of the Company’s common stock on the date the shares were issued. This amount and related expenses of $57,000, which total approximately $1.1 million, were recorded as deferred costs. During thenine months ended* June 30, 2026,associated with the termination of the Lincoln Park Purchase Agreement, the total remaining unamortized deferred costs of $870,000 were written off and are included in general and administrative expenses on the accompanying unaudited condensed consolidated statements of operations for thenine* months ended* June 30, 2026.The unamortized deferred costs related to the Lincoln Park Purchase Agreement of$870,000 as of September 30, 2025* are included in other assets on the accompanying unaudited condensed consolidated balance sheets.
Note10 – Share-based Compensation
We allocate share-based compensation expense to general and administrative expense and research and development expense based on the award holder’s employment function. For thethree andnine months ended* June 30, 2026and2025*, we recorded share-based compensation expenses as follows:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| June 30, | June 30, | |||
| 2026 | 2025 | 2026 | 2025 | |
| General and administrative | $451,788 | $1,290,912 | $1,356,846 | $4,914,586 |
| Research and development | 126,181 | 378,516 | 381,440 | 1,662,839 |
| Discontinued operations | — | — | — | (10,049) |
| Share-based compensation | $577,969 | $1,669,428 | $1,738,286 | $6,567,376 |
We have issued share-based awards to employees and non-executive directors under the Company’s approved equity plans. Upon the exercise of share-based awards, new shares are issued from authorized common stock.
Equity Plans
In* June 2022,the Company’s board of directors adopted the Company’s2022* Employment Inducement Equity Incentive Plan (the “Inducement Plan”). The Inducement Plan is a non-shareholder approved stock plan adopted pursuant to the “inducement exception” provided under Nasdaq listing rules. The Inducement Plan is used exclusively for the issuance of equity awards to certain new hires who satisfied the requirements to be granted inducement grants under Nasdaq rules as an inducement material to the individual’s entry into employment with the Company. The Company reserved 400,000 shares of common stock under the Inducement Plan and as of* June 30, 2026*,400,000 shares are available for issuance under the Inducement Plan.
In* March 2018,the Company’s stockholders approved the Company's2018* Equity Incentive Plan (as amended, the*“2018* Plan”). On* March**12,* 2026, the Company’s stockholders approved an increase in the number of shares that* maybe issued under the2018* Plan to 5.85 million. As of* June 30, 2026*,1,582,260 shares remain available for issuance under the2018 Plan.
In* July 2017,the Company’s stockholders approved the Company's2017* Equity Incentive Plan (the*“2017* Plan”). A total of 470,000 shares are authorized for issuance under the2017 Plan. As of* June 30, 2026*,1,312 shares remain available for issuance under the2017 Plan. The2017 Plan replaced the Company's2008 Stock Incentive Plan (the*“2008* Plan”), andno further awards will be made under the2008 Plan.
In* May 2026,the Company’s board of directors adopted the Company’s2026* Special Performance Stock Option Plan (the “Special Performance Plan”). The Company reserved 2,955,000 shares of common stock under the Special Performance Plan. On* May 4, 2026,the Compensation Committee of the Company’s board of directors approved the grant of options to purchase an aggregate of 2,955,000 shares of common stock pursuant to the Special Performance Plan, which options mayonly be exercised if both of the following conditions are satisfied: (i) achievement of a milestone event relating to the execution and public announcement of a clinical supply agreement in connection with our Phase2b* PLATEAU clinical trial, which condition was satisfied on* June 2, 2026,and (ii) subsequent approval of the plan by our shareholders by November 4, 2027.By definition, the grant date cannot occur before all necessary approvals have been obtained, including shareholder approval for the share-based compensation plan. Therefore, these stock options arenot* included in stock options outstanding as of* June 30, 2026*, as shareholder approval is required and hasnot been obtained.
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Stock Options
Each option grants the holder the right to purchase from usone share of our common stock at a specified price, which is generally the closing price per share of our common stock on the date the option is issued. Options generally vest on a pro-rata basis on each anniversary of the issuance date within three years of the date the option is issued. Options* maybe exercised after they have vested and prior to the specified expiry date provided applicable exercise conditions are met, if any. The expiry date can be for periods of up toten years from the date the option is issued. The fair value of each option is estimated on the date of grant using the Black-Scholes option pricing model based on the assumptions established at that time. The Company accounts for forfeitures as they occur and doesnot* estimate forfeitures as of the option grant date. There wasno reduction in share-based compensation expense for forfeitures during thethree months ended* June 30, 2026.The Company recognized a reduction in share-based compensation expense for stock options forfeited of $36,000 during thethree* months ended* June 30, 2025and a reduction of $44,000 and $0.5 million during thenine* months ended* June 30, 2026and2025,* respectively.
The following table outlines the weighted average assumptions for options granted during thethree andnine months ended* June 30, 2026and2025*:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| June 30, | June 30, | |||
| 2026 | 2025 | 2026 | 2025 | |
| Weighted Average Assumptions: | ||||
| Expected volatility | 114.7% | 115.3% | 115.0% | 114.6% |
| Expected dividend yield | 0.0% | 0.0% | 0.0% | 0.0% |
| Risk-free interest rate | 4.2% | 4.0% | 4.1% | 4.0% |
| Expected term (in years) | 6.0 | 6.0 | 6.0 | 6.0 |
| Fair value of options granted | $1.93 | $4.32 | $1.97 | $4.59 |
During thethree andnine months ended* June 30, 2026and2025*, the Company used historical volatility of our common stock over a period equal to the expected life of the options to estimate their fair value. The dividend yield assumption is based on the Company’s recent history and expectation of future dividend payouts on the common stock. The risk-free interest rate is based on the implied yield available on U.S. treasuryzero-coupon issues with an equivalent remaining term.
The following table summarizes the stock options outstanding and exercisable at* June 30, 2026*:
| Weighted Average | ||||
|---|---|---|---|---|
| Remaining · Aggregate | ||||
| Number of | Exercise Price | Contractual Term | Intrinsic | |
| Shares | Per Share | (years) | Value | |
| Outstanding at September 30, 2025 | 1,911,020 | $42.18 | ||
| Granted | 2,715,100 | $2.29 | ||
| Exercised | — | $— | ||
| Forfeited and expired | (185,693) | $41.15 | ||
| Outstanding at June 30, 2026 | 4,440,427 | $17.83 | 7.85 | $2,294,880 |
| Exercisable at June 30, 2026 | 1,554,278 | $46.04 | 4.40 | $— |
The aggregate intrinsic values in the table above are before income taxes and represent the number of in-the-money options outstanding or exercisable multiplied by the closing price per share of the Company’s common stock on the last trading day of the quarter ended* June 30, 2026* of $3.13, less the respective weighted average exercise price per share at period end.
As of* June 30, 2026*, the Company had unrecognized compensation expense of approximately $5.9 million related to unvested stock options. This expense is expected to be recognized over a weighted average period of 2.7 years.
19
Stock Appreciation Rights
In connection with the closing of our acquisition of Aspen Park Pharmaceuticals, Inc. on* October31,* 2016 (the “APP Acquisition”), the Company issued stock appreciation rights based on 5,000 and 14,000 shares of the Company’s common stock to an employee and an outside director, respectively, that vested on* October31,* 2018. The stock appreciation rights have aten-year term and an exercise price per share of $9.50, which was the closing price per share of the Company’s common stock as quoted on Nasdaq on the trading day immediately preceding the date of the completion of the APP Acquisition. Upon exercise, the stock appreciation rights will be settled in common stock issued under the2017 Plan. As of* June 30, 2026*, vested stock appreciation rights based on 5,000 shares of common stock remain outstanding.
Note11 – Leases
The Company has operating leases for its office and office equipment. The Company’s leases have remaining lease terms of less thantwo years to less than five years. Certain of our lease agreements include variable lease payments for common area maintenance, real estate taxes, and insurance or based on usage for certain equipment leases. The Company doesnot have any leases that havenot yet commenced as of* June 30, 2026*.
The components of the Company’s lease costs were as follows for thethree andnine months ended* June 30, 2026and2025*:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| June 30, | June 30, | |||
| 2026 | 2025 | 2026 | 2025 | |
| Operating lease cost | $186,233 | $186,233 | $558,698 | $558,699 |
| Short-term lease cost | 2,541 | 2,541 | 7,623 | 7,623 |
| Variable lease cost | 17,909 | 5,440 | 69,591 | 54,009 |
| Total lease cost | $206,683 | $194,214 | $635,912 | $620,331 |
The Company paid cash of $589,000 and $572,000 for amounts included in the measurement of operating lease liabilities during thenine months ended* June 30, 2026and2025*, respectively.
The Company’s operating lease right-of-use assets and the related lease liabilities are presented as separate line items on the accompanying unaudited condensed consolidated balance sheets as of* June 30, 2026* and* September 30, 2025*.
Other information related to the Company’s leases as of* June 30, 2026* and* September 30, 2025* was as follows:
| June 30, | September 30, | |
|---|---|---|
| 2026 | 2025 | |
| Operating Leases | ||
| Weighted-average remaining lease term (years) | 3.7 | 4.4 |
| Weighted-average discount rate | 7.1% | 7.1% |
The Company’s lease agreements donot provide a readily determinable implicit rate. Therefore, the Company estimates its incremental borrowing rate based on information available at lease commencement in order to discount lease payments to present value.
Note12 – Contingent Liabilities and Third Party Agreements
The testing, manufacturing and marketing of consumer products by the Company and the clinical testing of our product candidates entail an inherent risk that product liability claims will be asserted against the Company. The Company has tail product liability insurance coverage for claims arising from the use of products it previously sold. The coverage amount is $10.0 million.
20
Legal Proceedings
On* December 5, 2022,a putative class action complaint was filed in federal district court for the Southern District of Florida (Ewing v. Veru Inc., et al., CaseNo.* 1:22-cv-23960) against the Company and Mitchell Steiner, its Chairman, CEO and President, and Michele Greco, its CFO (the “Ewing Lawsuit”). The First Amended Class Action Complaint, filed on* September 15, 2023by purported stockholders Dr. Myo Thant and Karen Brounstein, alleges that certain public statements about sabizabulin as a treatment for COVID-19 between March 1, 2021and March 2, 2023violated Sections10*(b) and20(a) of the Securities Exchange Act of1934 and Rule10b-5 promulgated thereunder, and seeks monetary damages.
On* July 7, 2023,Anthony Maglia, a purported stockholder, filed a derivative action in the Circuit Court for the Eleventh Judicial Circuit, Miami-Dade County, Florida (Maglia v. Steiner et al., CaseNo.* 2023-019406-CA-01), against the Company as a nominal defendant, and Company officers and directors Mitchell S. Steiner, Michele Greco, Harry Fisch, Mario Eisenberger, Grace S. Hyun, Lucy Lu and Michael L. Rankowitz (the “Maglia Lawsuit”). The Maglia lawsuit asserts claims for breach of fiduciary duty, waste of corporate assets, and unjust enrichment primarily in connection with the issues and claims asserted in the Ewing Lawsuit. The Maglia Lawsuit seeks to direct the Company to improve its corporate governance and internal procedures, and also seeks monetary damages, injunctive relief, restitution, and an award of reasonable fees and expenses.
On* September1,* 2023, Anthony Franchi, a purported stockholder, filed a derivative action in the United States District Court for the Eastern District of Wisconsin (Franchi v. Steiner et al., CaseNo. 2:23-CV-01164), against the Company as a nominal defendant, and Company officers and directors Mitchell S. Steiner, Mario Eisenberger, Harry Fisch, Michael L. Rankowitz, Grace Hyun, Lucy Lu, and Michele Greco (the “Franchi Lawsuit”). The Franchi lawsuit asserts claims for breach of fiduciary duty and unjust enrichment primarily in connection with the issues and claims asserted in the Ewing Lawsuit. The Franchi Lawsuit seeks to direct the Company to improve its corporate governance and internal procedures, and also seeks monetary damages, restitution, and an award of reasonable fees and expenses. On* November8,* 2023, this action was consolidated with the Renbarger action, discussed below.
On* September**28,* 2023, Philip Renbarger, a purported stockholder, filed a derivative action in the United States District Court for the Eastern District of Wisconsin (Renbarger v. Steiner et al., CaseNo. 2:23-CV-01291), against the Company as a nominal defendant, and Company officers and directors Mitchell Steiner, Mario Eisenberger, Harry Fisch, Michael L. Rankowitz, Grace S. Hyun, Lucy Lu, and Michele Greco (the “Renbarger Lawsuit”). The Renbarger lawsuit asserts claims for breach of fiduciary duty, aiding and abetting, gross mismanagement, waste of corporate assets, and unjust enrichment primarily in connection with the issues and claims asserted in the Ewing Lawsuit. The Renbarger Lawsuit seeks to direct the Company to improve its corporate governance and internal procedures, and also seeks monetary damages and an award of reasonable fees and expenses. On* November 8, 2023,*the Renbarger Lawsuit was consolidated with the Franchi Lawsuit, discussed above.
On* October**9,* 2023, Mohamed Alshourbagy, a purported stockholder, filed a derivative action in the United States District Court for the Southern District of Florida (Alshourbagy v. Steiner et al., CaseNo. 1:23-cv-23846), against the Company as a nominal defendant, and Company officers and directors Mitchell S. Steiner, Mario A. Eisenberger, Harry D. Fisch, Michael L. Rankowitz, Grace S. Hyun, Lucy Lu, and Michele Greco (the “Alshourbagy Lawsuit”). The Alshourbagy lawsuit asserts claims for breach of fiduciary duty and contribution primarily in connection with the issues and claims asserted in the Ewing Lawsuit. The Alshourbagy Lawsuit seeks to direct the Company to improve its corporate governance and internal procedures, and also seeks monetary damages, injunctive relief, restitution, and an award of reasonable fees and expenses.
On* September 30, 2024,** June*Ovadias, a purported stockholder, filed a derivative action in the United States District Court for the Western District of Wisconsin (Ovadias v. Steiner et al., CaseNo. 3:24-cv-00676), against the Company as a nominal defendant, and Company officers and directors Mitchell S. Steiner, Michele Greco, Mario A. Eisenberger, Harry D. Fisch, Grace S. Hyun, Lucy Lu, and Michael L. Rankowitz (the “Ovadias Lawsuit”). The Ovadias lawsuit asserts claims for breach of fiduciary duty, unjust enrichment, abuse of control, gross mismanagement, waste of corporate assets, and contribution primarily in connection with the issues and claims asserted in the Ewing Lawsuit. The Ovadias Lawsuit seeks to direct the Company to improve its corporate governance and internal procedures, and also seeks monetary damages, restitution, and an award of reasonable fees and expenses
The Ewing Lawsuit, Maglia Lawsuit, Franchi Lawsuit, Renbarger Lawsuit, Alshourbagy Lawsuit and the Ovadias Lawsuit are collectively referred to as the “Shareholder Litigation.” At this time, the Company is unable to estimate potential losses, if any, related to the Shareholder Litigation.
21
On* August 5, 2025,the Purchaser filed a complaint in the Superior Court of the State of Delaware (Clear Future, Inc. v. Veru Inc., CaseNo.* N25C-08-066 EMD) against the Company (the “Clear Future Lawsuit”), and on* October 2, 2025,the Purchaser filed an amended complaint in the Clear Future Lawsuit. The amended complaint alleges that the Company breached certain representations and warranties in the Purchase Agreement for theFC2* Business Sale and otherwise made false representations relating to a customer relationship. The amended complaint makes claims for fraud, breach of representations and warranties, and a declaratory judgment for indemnification. During thethree months ended* March 31, 2026,*the parties settled the Purchaser’s claim that the Company is responsible to indemnify the Purchaser for a pre-closing tax liability. At this time, the Company is unable to estimate potential losses, if any, related to the Clear Future Lawsuit.
License and Purchase Agreements
From time to time, we license or purchase rights to technology or intellectual property fromthird parties. These licenses and purchase agreements require us to pay upfront payments as well as development or other payments upon successful completion of preclinical, clinical, regulatory or revenue milestones. In addition, these agreements* mayrequire us to pay royalties on sales of products arising from the licensed or acquired technology or intellectual property. Because the achievement of future milestones isnot* reasonably estimable, we havenot recorded a liability on the accompanying unaudited condensed consolidated financial statements for any of these contingencies.
Clinical Supply Agreement
On* June 2, 2026,the Company entered into a clinical supply agreement (the “Supply Agreement”) with Novo Nordisk A/S (“Novo Nordisk”) in conjunction with the Company’s Phase2b* PLATEAU clinical study. The objective of the Phase2b PLATEAU clinical study is to evaluate the combination of enobosarm, the Company’s oral,first-in-class, novel small molecule, selective androgen receptor modulator, with Novo Nordisk’s Wegovy® (semaglutide for injection), a GLP-1 RA, in older adults with obesity who are receiving Wegovy® therapy for weight reduction. Under the terms of the Supply Agreement, the Company is solely responsible for conducting and sponsoring the Phase2b PLATEAU clinical study while Novo Nordisk will supply Wegovy® to the Company atno charge and as required for the conduct of the Phase2b PLATEAU study. Novo Nordisk provides Wegovy® solely for use within the study under a clinical supply agreement. In return, the Company will provide Novo Nordisk with insights into obesity and weight management trial design, methodology, and clinical conduct, including regular clinical study updates, protocol changes, and safety updates. While the Company maintains full global development and commercialization rights to enobosarm, the Company has granted Novo Nordisk a right offirst negotiation in the Supply Agreement if the Company in the future intends to develop, commercialize, or license enobosarm intellectual property in combination with any Novo Nordisk GLP-1 product, including Wegovy®, for any indication.
The terms of the Novo Nordisk Agreement meet the criteria under ASC Topic845, Nonmonetary Transactions (“ASC845”). The value of the drug supply received from Novo Nordisk will be offset against the drug supply cost, which is expensed as incurred under ASC730 as the product hasno alternative future use to the Company, resulting in netzero effect to research and development expense.
Resolution of Commercial Dispute
A supplier claimed that we owed approximately $10 million for products and services relating to our efforts to commercialize sabizabulin under an emergency use authorization. We disputed the amount owed and on* February29,* 2024, we entered into an agreement with the supplier, which resolves the dispute by modifying the payment terms under the original agreement. The Company agreed to pay $8.3 million, with $2.3 million payable upon execution of the agreement, $3.5 million payable in equal monthly installments over 48 months, and $2.5 million payable (the “Balance”) on or prior to* December31,* 2025 out of the proceeds of certain payments that* maybe received by the Company from ONCO on promissory notes due in April 2024and September 2024.The portion of the Balance that remained unpaid as of December**31,* 2025 is being paid in equal monthly installments over 24 months, commencing in* January 2026.$1.0 million and $2.6 million is included in accounts payable and $0.6 million and $1.4 million is included in other liabilities related to this agreement as of June 30, 2026* and* September 30, 2025*, respectively, on the accompanying condensed consolidated balance sheets.
22
Note13 – Income Taxes
The Company accounts for income taxes using the liability method, which requires the recognition of deferred tax assets or liabilities for the tax-effected temporary differences between the financial reporting and tax bases of its assets and liabilities, and for net operating loss (NOL) and tax credit carryforwards.
A reconciliation of income tax expense, which iszero as a result of the Company’s full valuation allowance for deferred tax assets, and the amount computed by applying the U.S. statutory rate of 21% to loss from continuing operations is as follows:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| June 30, | June 30, | |||
| 2026 | 2025 | 2026 | 2025 | |
| Income tax benefit at U.S. federal statutory rates | $(1,467,554) | $(1,537,851) | $(3,236,830) | $(3,566,933) |
| State income tax benefit, net of federal benefit | (230,616) | (403,409) | (508,645) | (560,518) |
| Non-deductible expenses | 52,054 | 58,150 | 72,650 | 78,763 |
| U.S. research and development tax credit | (704,711) | 6,722 | (959,164) | (421,986) |
| Effect of change in effective tax rate | — | 554,430 | — | 554,430 |
| Change in estimated unrecognized tax benefit | 703,833 | — | 717,240 | — |
| Change in valuation allowance | 1,646,994 | 1,321,958 | 3,914,749 | 3,916,244 |
| Income tax expense | $— | $— | $— | $— |
Note14 – Net Loss Per Share
Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares and pre-funded warrants outstanding for the period. Diluted net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period after giving effect to all dilutive potential common shares that were outstanding during the period. Dilutive potential common shares consist of the incremental common shares issuable upon the exercise of outstanding warrants, stock options and stock appreciation rights. Due to our net loss for the periods presented, all potentially dilutive instruments were excluded because their inclusion would have been anti-dilutive. See Notes9 and10 for a discussion of our potentially dilutive common shares.
Note15 – Sale of ENTADFI Assets
On* April 19, 2023,the Company entered into an asset purchase agreement (the “Asset Purchase Agreement”) to sell substantially all of the assets related to ENTADFI® (finasteride and tadalafil) capsules for oral use, a new treatment for benign prostatic hyperplasia that was approved by the FDA in December 2021,with ONCO. The transaction closed on April19,* 2023. The purchase price for the transaction was $20.0 million, consisting of $6.0 million paid at closing, $4.0 million payable pursuant to a promissory note due on* September 30, 2023,$5.0 million payable pursuant to a promissory note due on April19,* 2024 (the* “April 2024Promissory Note”), and $5.0 million payable pursuant to a promissory note due on September 30, 2024 (the “September 2024Promissory Note” and, together with the April 2024Promissory Note, the “ONCO Promissory Notes”), plus up to $80.0 million based on ONCO’s net revenues from ENTADFI after closing (the “Milestone Payments”). The Company believes the probability of receiving any Milestone Payments is remote. On April 24, 2024,the Company entered into a Forbearance Agreement with ONCO, which was amended and restated as of September 19, 2024 (*as amended and restated, the “Forbearance Agreement”), relating to certain defaults under the ONCO Promissory Notes.
23
As of* September 22, 2025,an aggregate of $8.8 million was payable to the Company under the ONCO Promissory Notes and related amendments. On September 22, 2025,the Company and ONCO entered into a Settlement Agreement and Release (the “Settlement Agreement”), whereby the Company agreed to accept a cash payment of $6.3 million,3,125 shares of ONCO Series D Preferred Stock and the ONCO Warrant to purchase 3,216,344 shares of ONCO’s common stock (such cash payment, shares of ONCO Series D Preferred Stock, and the ONCO Warrant, collectively, the “Settlement Amount”) in full satisfaction of all amounts due under the ONCO Promissory Notes, as amended by all preceding amendments, forbearance agreements, and waivers, in complete discharge of all obligations thereunder. The ONCO Promissory Notes and the Forbearance Agreement terminated upon payment of the Settlement Amounts. The Company received proceeds of $5.0 million from the sale of shares of ONCO Common Stock acquired from the conversion of ONCO Series D Preferred Stock during thenine* months ended* June 30, 2026,and after such sales the Companyno* longer holds any shares of ONCO Series D Preferred Stock. There can beno assurances as to whether and when the Company will be able to receive any cash proceeds from the shares of ONCO Warrant or any shares of ONCO Common Stock that the Company might acquire upon exercise of the ONCO Warrant.
The Company determined that it wasnot probable, at the time of the transaction and until the Settlement Agreement was executed, that substantially all of the consideration promised under the Asset Purchase Agreement would be collected. Therefore, the Company recognized the difference between the nonrefundable consideration received and the carrying amount of the assets as a gain. The Company recorded a gain on sale of ENTADFI assets of $2.2 million during thenine months ended* June 30, 2025*, for the nonrefundable consideration received during that period. The ONCO Promissory Notes are now settled sono additional gain from additional consideration is expected in future periods.
Note16 - Segments
Operating segments are identified as components of an entity about which separate discrete financial information is available for evaluation by the CODM, or decision-making group, in making decisions on how to allocate resources and assess performance. The Company’s CODM is Mitchell S. Steiner, M.D., our Chairman, President and Chief Executive Officer, who views the Company’s operations asone operating segment, which is focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company doesnot have revenue, incurs expenses primarily in the U.S., and manages the business activities on a consolidated basis.
The accounting policies of the drug development segment are the same as those described in the summary of significant accounting policies.
The CODM assesses performance for the drug development segment and decides how to allocate resources based on net loss that is also reported on the income statement as consolidated net loss. The measure of segment assets is reported on the balance sheet as cash, cash equivalents, and restricted cash.
The Company hasnot generated any product revenue from continuing operations in the current period and expects to continue to incur significant expenses and operating losses for the foreseeable future as the Company advances its product candidates through all stages of development and clinical trials. As such, the CODM uses cash forecast models in deciding how to invest into the drug development segment. Such cash forecast models are reviewed to assess the entity-wide operating results and performance. Net loss is used to monitor budget versus actual results. Monitoring budgeted versus actual results, net cash used in operating activities for the period and cash on hand are used in assessing performance of the segment.
24
The table below summarizes the significant expense categories regularly reviewed by the CODM for thenine months ended* June 30, 2026and2025*:
| Three Months Ended · Nine Months Ended | ||||
|---|---|---|---|---|
| June 30, | June 30, | |||
| 2026 | 2025 | 2026 | 2025 | |
| Operating expenses: | ||||
| Research and development | $4,352,668 | $3,020,563 | $8,842,633 | $12,669,495 |
| General and administrative | 3,361,013 | 5,010,528 | 11,514,031 | 15,402,074 |
| Total operating expenses | 7,713,681 | 8,031,091 | 20,356,664 | 28,071,569 |
| Other segment items: | ||||
| Gain on sale of ENTADFI® assets | — | 484,615 | — | 2,154,134 |
| Gain on extinguishment of debt | — | — | — | 8,624,778 |
| Change in fair value of equity securities | 546,129 | — | 4,357,467 | (349,078) |
| Other income, net | 179,202 | 223,375 | 585,718 | 656,338 |
| Net (loss) income from discontinued operations, net of taxes | — | (9,719) | 351,418 | (7,194,389) |
| Net loss | $(6,988,350) | $(7,332,820) | $(15,062,061) | $(24,179,786) |
The Company is a single operating segment and therefore the measure of segment net loss is the same as consolidated net loss and doesnot require reconciliation.
For thenine months ended* June 30, 2026and2025*, net cash used in operating activities was $20.6 million and $24.6 million, respectively. The table below summarizes the significant asset categories regularly reviewed by the CODM as of* June 30, 2026* and* September 30, 2025*:
| 2026 | 2025 | |
|---|---|---|
| Cash, cash equivalents and restricted cash | $23,880,142 | $15,794,562 |
Note17 - Subsequent Event
On* July 2, 2026,the Company entered into a Sales Agreement (the “Sales Agreement”), with Oppenheimer & Co. Inc. and Canaccord Genuity LLC (each, an “Sales Agent” and, collectively the “Sales Agents”), as sales agents, pursuant to which the Company mayissue and sell, from time to time, to or through the applicable Sales Agent (the “Designated Sales Agent”), shares of the Company’s common stock. The offering and sale of up to $21.8 million of shares of the Company’s common stock pursuant to the Sales Agreement are registered pursuant to the Company’s Registration Statement on Form S-3 (FileNo.* 333-294911), which became effective on* April**15,* 2026, which includes a base prospectus and a related prospectus supplement that was filed with Securities and Exchange Commission on* July 2, 2026.*
The Company isnot obligated to sell any shares of common stock under the Sales Agreement. Subject to the terms and conditions of the Sales Agreement, each Sales Agent will use commercially reasonable efforts consistent with its normal trading and sales practices, to sell shares of common stock from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. Upon delivery of a placement notice, and subject to the Company’s instructions in that notice, and the terms and conditions of the Sales Agreement generally, the Designated Sales Agent* maysell the common stock by any method permitted by law deemed to be an "at the market offering" as defined by Rule415*(a)(4) promulgated under the Securities Act of1933, as amended (the "Securities Act"). The Sales Agents’ obligations to sell shares under the Sales Agreement are subject to satisfaction of certain conditions set forth in the Sales Agreement. The Company will pay the Designated Sales Agent a commission of 3.0% of the aggregate gross proceeds from each sale of the common stock and has agreed to provide the Sales Agents with customary indemnification and contribution rights, including liabilities under the Securities Act and the Securities Exchange Act of1934, as amended. The Company has also agreed to reimburse the Sales Agents for certain specified expenses.
The Company incurred issuance costs of $237,000 during thethree months ended* June 30, 2026,which were deferred and are included in other assets on the accompanying unaudited condensed consolidated balance sheet as of June 30, 2026.*
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