VERU INC.
For the period ended Mar 31, 2025. Filed May 8, 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.
Mar 31, 2025 · Filed May 8, 2025
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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, 2024*. The accompanying condensed consolidated balance sheet as of* September 30, 2024* has been derived from our audited financial statements. The unaudited condensed consolidated statements of operations and cash flows for thethree andsix months ended* March 31, 2025* arenot necessarily indicative of the results to be expected for any future period or for the fiscal year ending* September 30, 2025*.
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, Veru International Holdco Inc., Aspen Park Pharmaceuticals, Inc. (APP) and The Female Health Company Limited; and Veru International Holdco Inc.’s wholly owned subsidiaries, Veru Biopharma UK Limited and Veru Biopharma Europe Limited. The Female Health Company 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”) are included in the consolidated financial statements through* December 30, 2024.Veru International Holdco Inc.’s wholly owned subsidiary, Veru Biopharma Netherlands B.V. was dissolved during the quarter ended December 31, 2024and is included in the consolidated financial statements through the date of dissolution. Veru Biopharma Netherlands B.V. didnot* have a material impact on the consolidated financial statements. All significant intercompany transactions and accounts have been eliminated in consolidation. The Company is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of cardiometabolic and inflammatory diseases. Our drug development program includes enobosarm, a selective androgen receptor modulator, to improve body composition by augmenting fat loss and preventing muscle loss and physical function decline, in older patients receiving weight reduction drugs, and sabizabulin, a microtubule disruptor, which is being developed as a broad anti-inflammatory agent to reduce inflammation to slow the progression or promote the regression of atherosclerotic cardiovascular disease. The Company had theFC2 FemaleCondom/FC2 Internal Condom® (FC2), an FDA-approved commercial product for the dual protection against unplanned pregnancy and sexually transmitted infections. The Company sold theFC2 business on* December 30, 2024.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. Most of the Company’s net revenues during thesix months ended* March 31, 2025* and thethree andsix months ended* March 31, 2024* were derived from sales ofFC2 and are included within discontinued operations. The Company hadno net revenues during thethree months ended* March 31, 2025*.
Reclassifications: Certain prior period amounts in the accompanying consolidated financial statements have been reclassified to conform with the current period presentation. The reclassifications hadno effect on the results of operations or financial position for any period presented.
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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 andsix months ended* March 31, 2025and2024*, comprehensive loss is equivalent to the reported net loss.
Recent accounting pronouncementsnot yet adopted: In* November 2023,the FASB issued Accounting Standards Update (ASU)2023-07, Segment Reporting (Topic280*): Improvements to Reportable Segment Disclosures. The ASU expands public entities’ segment disclosures by requiring disclosure of significant segment expenses that are regularly reviewed by the chief operating decision maker (CODM) and included within each reported measure of segment profit or loss, an amount and description of its composition for other segment items, and interim disclosures of a reportable segment’s profit or loss and assets. The ASU also allows, in addition to the measure that is most consistent with U.S. GAAP, the disclosure of additional measures of segment profit or loss that are used by the CODM in assessing segment performance and deciding how to allocate resources. All disclosure requirements under ASU2023-07 are also required for public entities with a single reportable segment. The ASU is effective for the Company’s annual periods for the fiscal year ending* September 30, 2025,*and subsequent interim periods, with early adoption permitted. The Company is currently evaluating the impact of adopting this ASU on its disclosures.
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 this ASU 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, deprecation, 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.
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 The Female Health Company 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.
The purchase price for theFC2 Business Sale was $18.0 million in cash, subject to adjustment as set forth in the Purchase Agreement. The adjustments to the purchase price in the Purchase Agreement include a customary working capital adjustment in90 days from 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 are expected to be $16.3 million, which is the $18.0 million purchase price per the Purchase Agreement, net of costs incurred of $1.4 million, estimated purchase price adjustments of $0.1 million, and amounts allocated to the related transition services agreement of $0.2 million but excluding the change of control payment pursuant to the Residual Royalty Agreement of $4.2 million (see Note8 for additional information). These net proceeds are subject to adjustment as set forth in the Purchase Agreement. The loss on sale of theFC2 business is $4.2 million, which is the difference between estimated net proceeds of $16.3 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.
In connection with theFC2 Business Sale, the Company and the Purchaser entered into a transition services agreement (the “TSA”). Under the terms of the TSA, the Company will provide to the Purchaser, on a transitional basis, certain services or functions, including information technology services, facilitating the transition of assignable and non-assignable contracts, and other corporate and administrative matters. Generally, these services will be provided withinsix months, with certain services related to the transition of IT and technology systems extending up to12 months and certain services related to the transition of contracts extending up to 32 months. The transition services will be provided atno fees but the TSA provides for the reimbursement of certain out-of-pocket costs. The Company allocated $0.2 million of the purchase price per the Purchase Agreement to the transition services per the TSA, based on an estimate of the fair value of the services to be provided, to be recognized by the Company over asix month period. The Company estimates that any transition services extending beyondsix months have a de minimis value.
Pursuant to the terms of the Purchase Agreement, the Company, the Purchaser, and an escrow agent entered into an Escrow Agreement at closing, pursuant to which the Purchaser deposited $0.4 million of the aggregate purchase price of theFC2 Business Sale into an escrow account established with the escrow agent for the following purposes: (1) $0.3 million, from which any adjustment amount requiring payment from the Company to the Purchaser* maybe recovered upon final determination of such adjustments pursuant to the Purchase Agreement and (2) $0.1 million for certain indemnity obligations, if any, that arise under the Purchase Agreement, to be held for 18 months from the closing date to the extentnot* subject to a pending indemnity claim. The amounts held in escrow of $0.4 million as of* March 31, 2025* are classified as restricted cash and included within cash, cash equivalents, and restricted cash on the accompanying condensed consolidated balance sheet.
TheFC2 Business Sale represented a strategic shift, which had a major effect on our operations and financial results. We have 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 all periods presented. We havenot allocated any amounts for shared general and administrative operating support expense to discontinued operations. Additionally, the related assets and liabilities have been reported as assets and liabilities of discontinued operations in our condensed consolidated balance sheet as of* September 30, 2024.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 sheet as of* March 31, 2025*.
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The following table presents results of discontinued operations for thethree andsix months ended* March 31, 2025and2024*. Amounts included in discontinued operations during thethree months ended* March 31, 2025* represent changes in estimates.
| Three Months Ended · Six Months Ended | ||||
|---|---|---|---|---|
| March 31, | March 31, | |||
| 2025 | 2024 | 2025 | 2024 | |
| Net revenues | $— | $4,135,301 | $4,484,591 | $6,276,027 |
| Cost of sales | — | 3,457,002 | 2,900,514 | 4,447,276 |
| Gross profit | — | 678,299 | 1,584,077 | 1,828,751 |
| Operating expenses: | ||||
| Selling, general and administrative | 9,410 | 1,678,340 | 1,111,397 | 3,319,623 |
| Total operating expenses | 9,410 | 1,678,340 | 1,111,397 | 3,319,623 |
| Loss on sale of FC2 business | (39,816) | — | (4,244,251) | — |
| Operating loss | (49,226) | (1,000,041) | (3,771,571) | (1,490,872) |
| Non-operating expenses: | ||||
| Interest expense | — | (145,310) | (164,270) | (310,267) |
| Change in fair value of derivative liabilities | — | 21,000 | (3,138,316) | 19,000 |
| Other expense, net | — | (16,496) | (31,960) | (39,746) |
| Total non-operating expenses | — | (140,806) | (3,334,546) | (331,013) |
| Loss before income taxes | (49,226) | (1,140,847) | (7,106,117) | (1,821,885) |
| Income tax expense | — | 182,002 | 78,553 | 109,563 |
| Net loss from discontinued operations, net of taxes | $(49,226) | $(1,322,849) | $(7,184,670) | $(1,931,448) |
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The following table presents the carrying amounts of assets and liabilities of discontinued operations as of* September 30, 2024:*
| September 30, | |
|---|---|
| Current assets: | |
| Accounts receivable, net | $3,960,305 |
| Inventories, net | 4,144,179 |
| Prepaid expenses and other current assets | 654,527 |
| Total current assets of discontinued operations | $8,759,011 |
| Long-term assets: | |
| Plant and equipment, net | $803,282 |
| Operating lease right-of-use asset | 311,150 |
| Deferred income taxes | 12,340,237 |
| Other assets | 140,356 |
| Total long-term assets of discontinued operations | $13,595,025 |
| Current liabilities: | |
| Accounts payable | $777,173 |
| Accrued compensation | 185,418 |
| Accrued expenses and other current liabilities | 1,390,412 |
| Operating lease liability, short-term portion | 328,527 |
| Total current liabilities of discontinued operations | $2,681,530 |
| Long-term liabilities: | |
| Operating lease liability, long-term portion | $16,071 |
| Long-term liabilities of discontinued operations | $16,071 |
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 thesix months ended* March 31, 2025and2024* are comprised of the following:
| Six Months Ended | ||
|---|---|---|
| March 31, | ||
| 2025 | 2024 | |
| Total net cash (used in) provided by operating activities from discontinued operations | $(334,864) | $2,822,563 |
| Total net cash provided by investing activities from discontinued operations | $16,330,432 | $(41,272) |
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.
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As* September 30, 2024*, the Company’s financial liability measured at fair value on a recurring basis, which consisted of an embedded derivative, was classified within Level3 of the fair value hierarchy. The liability associated with embedded derivatives represented the fair value of the change of control provision in the Residual Royalty Agreement. During thesix months ended* March 31, 2025*, the Residual Royalty Agreement was terminated and the embedded derivative was extinguished together with the debt. See Note8 for additional information.
The following table provides a reconciliation of the beginning and ending liability balance associated with embedded derivatives measured at fair value using significant unobservable inputs (Level3) as of* March 31, 2025and2024*:
| Six Months Ended | ||
|---|---|---|
| March 31, | ||
| 2025 | 2024 | |
| Beginning balance | $1,570,000 | $1,331,000 |
| Change in fair value of derivative liabilities | 3,138,316 | (19,000) |
| Extinguishments | (4,708,316) | — |
| Ending balance | $— | $1,312,000 |
The gain or loss associated with the change in fair value of the embedded derivatives is included within net loss from discontinued operations on the accompanying unaudited condensed consolidated statements of operations. It is included in discontinued operations because the related debt was required to be repaid as a result of theFC2 Business Sale.
There isno current observable market for these types of derivatives. The Company estimated the fair value of the embedded derivative within the Residual Royalty Agreement by using a scenario-based method, whereby different scenarios were valued and probability weighted. The scenario-based valuation model incorporated transaction details such as the contractual terms of the instrument and assumptions including projectedFC2 revenues, expected cash outflows, probability and estimated dates of a change of control, risk-free interest rates and applicable credit risk. A significant increase in projectedFC2 revenues or a significant increase in the probability or acceleration of the timing of a change of control event, in isolation, would have resulted in a significantly higher fair value measurement of the liability associated with the embedded derivative. On* December 30, 2024,upon theFC2* Business Sale, the Company adjusted the fair value of the embedded derivative to the estimated fair value on that date and included the fair value of the embedded derivative in the carrying amount of debt, used to determine the gain on extinguishment of debt.
The following tables present quantitative information about the inputs and valuation methodologies used to determine the fair value of the embedded derivatives classified in Level3 of the fair value hierarchy as of* December 30, 2024,the date the Residual Royalty Agreement was terminated, and September 30, 2024*:
| Valuation Methodology · Significant Unobservable Input · December 30, 2024 · September 30, 2024 | ||
|---|---|---|
| Scenario-Based · Estimated change of control dates · December 2024 · March 2025 to March 2027 | ||
| Discount rate | N/A | 12.1% to 12.3% |
| Probability of change of control | 100% | 60% to 90% |
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The Company also had an investment in equity securities consisting of 142,749 shares of common stock of ONCO (the “ONCO Common Stock”), which were sold during the quarter ended* December 31, 2024for net proceeds of $0.4 million. The value of the ONCO Common Stock was $0.7 million as of September 30, 2024,which was included in prepaid expenses and other current assets on the accompanying unaudited condensed consolidated balance sheet. The Company recognized a loss from the change in fair value of equity securities of $0.3 million during thesix* months ended* March 31, 2025* and recognized losses from the change in fair value of equity securities of $0.2 million and $0.6 million during thethree andsix months ended* March 31, 2024*, respectively.
The Company received 3,000 shares of Series A Convertible Preferred Stock (the “ONCO Preferred Stock”) of ONCO on* October3,* 2023 as part of a settlement of the receivable due on* September30,* 2023 related to the sale of ENTADFI. See Note15 for additional information. The Company elected to measure the ONCO Preferred Stock at fair value in accordance with ASC825. The investment in the ONCO Preferred Stock was classified within Level3 of the fair value hierarchy because there isno market for the ONCO Preferred Stock and the fair value was determined using significant unobservable inputs. The fair value of the ONCO Preferred Stock was determined on the date received using a probability-weighted bond plus call option model, which incorporated the stock price of ONCO on the valuation date, expected volatility of 79%, expected term of 3 years, and a discount rate of 35%. The Company also applied a 15% discount for lack of marketability due to the fact that there isno market for the preferred stock and a 60% probability of dissolution. The valuation was determined to be $0.9 million at* October 3, 2023.On September 24, 2024,the Company converted all of the shares of ONCO Preferred Stock it held into 142,749 shares of ONCO Common Stock. As of September 30, 2024,the ONCO Common Stock was classified within Level1* of the fair value hierarchy and the valuation was determined based on the closing price of the ONCO Common Stock.
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.
Property and equipment consisted of the following at* March 31, 2025* and* September 30, 2024*:
| Estimated | March 31, | September 30, | |
|---|---|---|---|
| Useful Life (in years) | 2025 | 2024 | |
| 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 | (542,731) | (484,071) | |
| Property and equipment, net | $422,712 | $481,372 | |
Depreciation expense was approximately $29,000 and $32,000 for thethree months ended* March 31, 2025and2024*, respectively, and approximately $59,000 and $64,000 for thesix months ended* March 31, 2025and2024*, respectively.
Note7 – Goodwill
The carrying amount of goodwill at* March 31, 2025* and* September 30, 2024* was $6.9 million. There wasno change in the balance during thesix months ended* March 31, 2025and2024*.
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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. See Note4* for additional information.
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.
At* March 31, 2025* and* September 30, 2024*, the Residual Royalty Agreement liability consisted of the following:
| March 31, | September 30, | |
|---|---|---|
| 2025 | 2024 | |
| Residual royalty agreement liability, fair value at inception | $346,000 | $346,000 |
| Add: accretion of liability using effective interest rate | 13,149,689 | 12,985,419 |
| Less: cumulative payments | (5,357,616) | (5,024,790) |
| Less: extinguishments | (8,138,073) | — |
| Residual royalty agreement liability, excluding embedded derivative liability | — | 8,306,629 |
| Add: embedded derivative liability at fair value (see Note 4) | — | 1,570,000 |
| Total residual royalty agreement liability | — | 9,876,629 |
| Residual royalty agreement liability, short-term portion | — | (1,025,837) |
| Residual royalty agreement liability, long-term portion | $— | $8,850,792 |
Premium Finance Agreement
On* November 1, 2022,the Company entered into a Premium Finance Agreement to finance $1.4 million of its directors and officers liability insurance premium at an annual percentage rate of 6.3%. The financing is payable ineleven* monthly installments of principal and interest, beginning on* December**1,* 2022. The balance of the insurance premium liability was $0.1 million as of* September 30, 2023.The last payment was made in October 2023and there isno balance outstanding as of March 31, 2025* or* September 30, 2024.*
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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* March 31, 2025* and* September 30, 2024*. 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* March 31, 2025* and* September 30, 2024*, and there wasno activity during thethree andsix months ended* March 31, 2025and2024*.
Shelf Registration Statement
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. As of* March 31, 2025*, $109.0 million remains available under that shelf registration statement.
Common Stock
In* March 2025,the Company issued 200,000 shares of common stock to athird* party consultant for services to be provided over asix month period totaling $98,000.
On* December**18,* 2023, we completed an underwritten public offering of 52,708,332 shares of our common stock, which included the exercise in full of the underwriters’ option to purchase additional shares, at a public offering price of $0.72 per share. Net proceeds to the Company from this offering were approximately $35.2 million after deducting underwriting discounts and commissions and costs incurred by the Company. All of the shares sold in the offering were by the Company. The offering was made pursuant to the Company’s shelf registration statement on Form S-3 (FileNo. 333-270606).
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 have been registered pursuant to the Company’s effective 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.
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Under the Lincoln Park Purchase Agreement, the Company has the right, butnot the obligation, on any business day selected by the Company (the “Purchase Date”), provided that on such day the closing sale price per share of the Company’s common stock isnot below $0.25 per share (subject to adjustment for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction as provided in the Lincoln Park Purchase Agreement), to require Lincoln Park to purchase up to 225,000 shares of the Company’s common stock (the “Regular Purchase Amount”) at the Purchase Price (as defined below) per purchase notice (each such purchase, a “Regular Purchase”) provided, however, that (1) the limit on the Regular Purchase Amount will be increased to 250,000 shares, if the closing sale price of the Company’s common stock on the applicable Purchase Date isnot below $6.00 and to 275,000 shares, if the closing sale price of the Company’s common stock on the applicable Purchase Date isnot below $8.00. Lincoln Park’s committed obligation under each Regular Purchase shallnot exceed $2,500,000 or 2,000,000 Purchase Shares per each Regular Purchase. The purchase price for Regular Purchases (the “Purchase Price”) shall be equal to the lesser of: (i) the lowest sale price of the Company’s common stock during the Purchase Date, or (ii) the average of thethree lowest closing sale prices of the Company’s common stock on the10 consecutive business days ending on the business day immediately preceding such Purchase Date. The Company shall have the right to submit a Regular Purchase notice to Lincoln Park as often as every business day. A Regular Purchase notice is delivered to Lincoln Park after the market has closed (i.e., after4:00 P.M. Eastern Time) so that the Purchase Price is always fixed and known at the time the Company elects to sell shares to Lincoln Park.
In addition to Regular Purchases and provided that the Company has directed a Regular Purchase in full, the Company in its sole discretion* mayrequire Lincoln Park on each Purchase Date to purchase on the following business day (“Accelerated Purchase Date”) up to the lesser of (i)three times the number of shares purchased pursuant to such Regular Purchase or (ii)30% of the trading volume on the Accelerated Purchase Date (the “Accelerated Purchase”) at a purchase price equal to the lesser of 97% of (i) the closing sale price on the Accelerated Purchase Date, or (ii) the Accelerated Purchase Date’s volume weighted average price (the “Accelerated Purchase Price”). The Company may*also direct Lincoln Park, on any business day on which an Accelerated Purchase has been completed and all of the shares to be purchased thereunder have been properly delivered to Lincoln Park in accordance with the Lincoln Park Purchase Agreement, to make additional purchases upon the same terms as an Accelerated Purchase (an “Additional Accelerated Purchase”).
The purchase price of Regular Purchases, Accelerated Purchases and Additional Accelerated Purchases and the minimum closing sale price for a Regular Purchase will be adjusted for any reorganization, recapitalization, non-cash dividend, stock split or other similar transaction occurring during the business days used to compute the purchase price. The aggregate number of shares that the Company can sell to Lincoln Park under the Lincoln Park Purchase Agreement* mayinno* case exceed 17,678,502 shares (subject to adjustment as described above) of the Company’s common stock (which is equal to approximately 19.99% of the shares of the Company’s common stock outstanding immediately prior to the execution of the Lincoln Park Purchase Agreement) (the “Exchange Cap”), unless (i) shareholder approval is obtained to issue Purchase Shares above the Exchange Cap, in which case the Exchange Cap willno longer apply, or (ii) the average price of all applicable sales of the Company’s common stock to Lincoln Park under the Lincoln Park Purchase Agreement equals or exceeds $1.26 per share (subject to adjustment as described above) (which represents the Minimum Price, as defined under Nasdaq Listing Rule5635(d), on the Nasdaq Capital Market immediately preceding the signing of the Lincoln Park Purchase Agreement, such that the transactions contemplated by the Lincoln Park Purchase Agreement are exempt from the Exchange Cap limitation under applicable Nasdaq rules).
During thesix months ended* March 31, 2025*, we didnot sell any shares under the Lincoln Park Purchase Agreement. During thesix months ended* March 31, 2024*, we sold 1,800,000 shares of common stock to Lincoln Park resulting in proceeds to the Company of $1.7 million. As a result of these sales, we recorded approximately $164,000 of deferred costs to additional paid-in capital. Since inception of the Lincoln Park Purchase Agreement through* March 31, 2025*, we have sold 3,025,000 shares of common stock to Lincoln Park resulting in proceeds to the Company of $3.1 million.
In consideration for entering into the Lincoln Park Purchase Agreement, concurrently with the execution of the Lincoln Park Purchase Agreement, the Company issued 800,000 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. The unamortized deferred costs related to the Lincoln Park Purchase Agreement of $870,000 as of* March 31, 2025* and* September 30, 2024* are included in other assets on the accompanying unaudited condensed consolidated balance sheets.
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At-the-Market Sale Agreement
On* May 12, 2023,the Company entered into an Open Market Sale Agreement℠ (the “Jefferies Sales Agreement”) with Jefferies LLC (“Jefferies”), as sales agent, pursuant to which the Company could issue and sell, from time to time, through Jefferies, shares of the Company’s common stock, with an aggregate value of up to $75 million (not to exceed the lesser of 39,609,072 shares of common stock or the number of authorized, unissued and available shares of common stock at any time). Shares of common stock offered and sold pursuant to the Jefferies Sale Agreement have been registered pursuant to the Company’s effective shelf registration statement on Form S-3 (FileNo.* 333-270606), and a related prospectus supplement that was filed with the SEC on* May 12, 2023.On August 19, 2024,the Company delivered notice to Jefferies to terminate the Jefferies Sales Agreement, which was effective on September 3, 2024.As a result of the termination of the Jefferies Sales Agreement, the Company willnot* issue or sell any additional shares of common stock under the Jefferies Sales Agreement.
During thesix months ended* March 31, 2024*, we sold 90,156 shares of common stock under the Jefferies Sales Agreement resulting in net proceeds to the Company of $67,000.
Note10 – Share-based Compensation
We allocate share-based compensation expense to selling, general and administrative expense and research and development expense based on the award holder’s employment function. For thethree andsix months ended* March 31, 2025and2024*, we recorded share-based compensation expenses as follows:
| Three Months Ended · Six Months Ended | ||||
|---|---|---|---|---|
| March 31, | March 31, | |||
| 2025 | 2024 | 2025 | 2024 | |
| Selling, general and administrative | $1,618,958 | $2,294,427 | $3,623,674 | $4,694,851 |
| Research and development | 604,885 | 835,324 | 1,284,323 | 1,318,703 |
| Discontinued operations | — | 504,420 | (10,049) | 1,027,566 |
| Share-based compensation | $2,223,843 | $3,634,171 | $4,897,948 | $7,041,120 |
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 4.0 million shares of common stock under the Inducement Plan and as of* March 31, 2025*,4,000,000 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**13,* 2025, the Company’s stockholders approved an increase in the number of shares that* maybe issued under the2018* Plan to 26 million. As of* March 31, 2025*,9,519,955 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 4.7 million shares are authorized for issuance under the2017 Plan. As of* March 31, 2025*,198,948 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.
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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. The Company recognized a reduction in share-based compensation expense for stock options forfeited during the period of $0.1 million and $0.3 million during thethree months ended* March 31, 2025and2024*, respectively, and a reduction of $0.4 million and $1.4 million during thesix months ended* March 31, 2025and2024*, respectively.
The following table outlines the weighted average assumptions for options granted during thethree andsix months ended* March 31, 2025and2024*:
| Three Months Ended · Six Months Ended | ||||
|---|---|---|---|---|
| March 31, | March 31, | |||
| 2025 | 2024 | 2025 | 2024 | |
| Weighted Average Assumptions: | ||||
| Expected volatility | 115.5% | 109.1% | 110.2% | 105.6% |
| Expected dividend yield | 0.0% | 0.0% | 0.0% | 0.0% |
| Risk-free interest rate | 4.1% | 4.2% | 3.6% | 4.6% |
| Expected term (in years) | 6.0 | 5.6 | 6.0 | 5.9 |
| Fair value of options granted | $0.39 | $0.44 | $0.63 | $0.55 |
During thethree andsix months ended* March 31, 2025and2024*, 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* March 31, 2025*:
| Weighted Average | ||||
|---|---|---|---|---|
| Remaining · Aggregate | ||||
| Number of | Exercise Price | Contractual Term | Intrinsic | |
| Shares | Per Share | (years) | Value | |
| Outstanding at September 30, 2024 | 18,462,428 | $4.59 | ||
| Granted | 255,000 | $0.75 | ||
| Exercised | — | $— | ||
| Forfeited and expired | (678,576) | $5.23 | ||
| Outstanding at March 31, 2025 | 18,038,852 | $4.51 | 5.39 | $585 |
| Exercisable at March 31, 2025 | 14,295,539 | $4.72 | 4.59 | $— |
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* March 31, 2025* of $0.49, less the respective weighted average exercise price per share at period end.
As of* March 31, 2025*, the Company had unrecognized compensation expense of approximately $5.2 million related to unvested stock options. This expense is expected to be recognized over a weighted average period of 1.5 years.
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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 50,000 and 140,000 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 $0.95, 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* March 31, 2025*, vested stock appreciation rights based on 50,000 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 than three years to less thansix 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. Forone of our office space leases, the Company entered into a sublease, for which it received sublease income. Sublease income was recognized as a reduction to operating lease costs as the sublease is outside of the Company’s normal business operations. This lease, and the related sublease, terminated on* October**31,* 2023. The Company doesnot have any leases that havenot yet commenced as of* March 31, 2025*.
The components of the Company’s lease costs were as follows for thethree andsix months ended* March 31, 2025and2024*:
| Three Months Ended · Six Months Ended | ||||
|---|---|---|---|---|
| March 31, | March 31, | |||
| 2025 | 2024 | 2025 | 2024 | |
| Operating lease cost | $186,233 | $186,233 | $372,466 | $374,456 |
| Short-term lease cost | 2,541 | 2,541 | 5,082 | 5,082 |
| Variable lease cost | 47,251 | 2,980 | 48,569 | 16,946 |
| Sublease income | — | — | — | (15,148) |
| Total lease cost | $236,025 | $191,754 | $426,117 | $381,336 |
The Company paid cash of $378,000 and $376,000 for amounts included in the measurement of operating lease liabilities during thesix months ended* March 31, 2025and2024*, 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* March 31, 2025* and* September 30, 2024*.
Other information related to the Company’s leases as of* March 31, 2025* and* September 30, 2024* was as follows:
| March 31, | September 30, | |
|---|---|---|
| 2025 | 2024 | |
| Operating Leases | ||
| Weighted-average remaining lease term (years) | 4.9 | 5.4 |
| 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
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 maintains product liability insurance coverage for claims arising from the use of its products. The coverage amount is currently $10.0 million.
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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.
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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.
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.If all or any portion of the Balance remains unpaid as of December**31,* 2025, the Company shall pay the amount of the unpaid Balance in equal monthly installments over 24 months, commencing in* January 2026.$1.2 million is included in accounts payable and $3.4 million is included in other liabilities related to this agreement as of March 31, 2025* on the accompanying condensed consolidated balance sheet.
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 · Six Months Ended | ||||
|---|---|---|---|---|
| March 31, | March 31, | |||
| 2025 | 2024 | 2025 | 2024 | |
| Income tax benefit at U.S. federal statutory rates | $(1,649,002) | $(1,827,651) | $(2,029,082) | $(3,437,801) |
| State income tax benefit, net of federal benefit | (127,680) | (141,512) | (157,109) | (266,184) |
| Non-deductible expenses | 19,874 | 596 | 20,613 | 708 |
| U.S. research and development tax credit | (197,911) | (247,000) | (428,708) | (417,000) |
| Change in valuation allowance | 1,954,719 | 2,215,567 | 2,594,286 | 4,120,277 |
| 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 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 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 Note10 for a discussion of our potentially dilutive common shares.
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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 2024*Promissory 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* September 29, 2023,the Company entered into an Amendment to the Asset Purchase Agreement (the “Amendment”) providing that the promissory note for the $4.0 million installment of the purchase price due September 30, 2023would be deemed paid and fully satisfied upon (1) the payment to the Company of the sum of $1.0 million in immediately available funds on September 29, 2023and (2) the issuance to the Company by October3,* 2023 of 3,000 shares of ONCO Preferred Stock. The Company received payment of $1.0 million on* September 29, 2023and the ONCO Preferred Stock on October3,* 2023, which the Company determined had a fair value as of* October**3,* 2023 of $0.9 million. The ONCO Preferred Stock was convertible by the Company at any time and from time to time from and afterone year from the date of issuance of the ONCO Preferred Stock into that number of shares of the Purchaser’s common stock determined by dividing the stated value of $1,000 per share by the Conversion Price of $0.5254 per share. The ONCO Preferred Stock issued to the Company was initially convertible into an aggregate of approximately 5,709,935 shares of ONCO Common Stock, subject to certain shareholder approval limitations. Shareholder approval was obtained on* September 5, 2024.Effective September 24, 2024,ONCO effected a reverse stock split of all the outstanding shares of ONCO Common Stock at a ratio ofone-for-forty (1:40). Proportional adjustments were made to the number of shares of ONCO Common Stock issuable upon conversion of the ONCO Preferred Stock, such that the ONCO Preferred Stock was convertible into 142,749 shares of ONCO Common Stock. On September 24, 2024,the Company converted all of its ONCO Preferred Stock into 142,749 shares of ONCO Common Stock and during thesix* months ended* March 31, 2025*, the Company sold all 142,749 shares of ONCO Common Stock for net proceeds of $0.4 million.
On* April24,* 2024, the Company entered into a Forbearance Agreement (the "Forbearance Agreement") with ONCO, relating to certain defaults under the ONCO Promissory Notes. Pursuant to the Forbearance Agreement, (a) ONCO agreed to make a payment of $50,000 of the principal payable under the* April 2024Promissory Notenot* later than* April29,* 2024, which was paid on* April**25,* 2024, and (b) the Company agreed, subject to the terms and conditions set forth in the Forbearance Agreement, to forbear from exercising its rights and remedies on account of the failure by ONCO to pay the amounts due under the* April 2024Promissory Note on the due date of April 19, 2024,and on account of any failure by ONCO to make any mandatory repayment under the ONCO Promissory Notes that mayhave become due or maybecome due in connection with certain transactions relating to ONCO’s acquisition of Proteomedix AG, in each case for a period (the “April 2024Forbearance Period”) commencing on April 24, 2024and ending on the earlier of (a) March 31, 2025and (b) the occurrence of an Event of Default (as defined in the Forbearance Agreement). The Company also agreed that during the April 2024Forbearance Period the default provision in the ONCO Promissory Notes relating to insolvency of ONCO willnot* apply.
ONCO agreed in the Forbearance Agreement to make the following required payments during the* April 2024Forbearance Period towards the remaining principal balance of the April 2024Promissory Note: (1) monthly payments equal to 15% of cash receipts of ONCO or its subsidiaries from certain sale or licensing revenues or payments; and (2) payment of 10% of the net proceeds from certain financing or other transactions outside the ordinary course of business completed by ONCO or any of its subsidiaries during the April 2024*Forbearance Period.
On* September**19,* 2024, the Company entered into an Amended and Restated Forbearance Agreement and Amendment to* September 2024*Note (the “Amended Forbearance Agreement”) with ONCO. The Amended Forbearance Agreement amends and restates the entirety of the Forbearance Agreement.
24
Pursuant to the Amended Forbearance Agreement, the* April 2024Forbearance Period continued to end on the earlier of (a) March31,* 2025 and (b) the occurrence of an Event of Default (as defined in the Amended Forbearance Agreement). The Amended Forbearance Agreement extends the due date for the* SeptemberPromissory Note until the earlier to occur of: (i) June30,* 2025 or (ii) the occurrence of any Event of Default under the Amended Forbearance Agreement. The Amended Forbearance Agreement also effected certain modifications to the payment terms in the Forbearance Agreement and amended certain terms of the* September 2024*Promissory Note as summarized below.
The Borrower agreed in the Amended Forbearance Agreement to make the following required payments (the “Required Payments”) during the* April 2024Forbearance Periodfirst* to accrued and unpaid interest under the* April 2024Promissory Note and then any remainder to the outstanding principal amount of the April 2024*Promissory Note:
| ● | monthly payments equal to 25% (increased from 15% in the Original Forbearance Agreement) of cash receipts of the Borrower or its subsidiaries from certain sale or licensing revenues or payments, which increased amount shall begin on October 20, 2024 for cash receipts in September 2024; and |
| ● | payment of 20% (increased from 10% in the Original Forbearance Agreement) of the net proceeds from certain financing or other transactions outside the ordinary course of business completed by the Borrower or any of its subsidiaries during the April 2024 Forbearance Period, which increased amount will begin for any net proceeds received after September 19, 2024. |
The remaining balance of the* April 2024Promissory Note will be due at the end of the April 2024*Forbearance Period.
The Borrower and the Company also agreed to the following amendments to the* September 2024*Promissory Note in the Amended Forbearance Agreement:
| ● | As noted above, an extension of the maturity date to June 30, 2025. |
| ● | The accrual of interest at the rate of 10% per annum on any unpaid principal balance of the September 2024 Promissory Note commencing on October 1, 2024 through the date that the outstanding principal balance under the September 2024 Promissory Note is paid in full. |
| ● | Any amounts owed on the September 2024 Promissory Note, including but not limited to unpaid principal and accrued interest, will be paid in cash or, upon the mutual written consent of the Borrower and the Company, in shares of the Borrower’s common stock or a combination of cash and the Borrower’s common stock. |
| ● | Following full repayment of all principal and interest under the April 2024 Promissory Note, the Borrower will make the Required Payments first towards accrued and unpaid interest under the September 2024 Promissory Note and then towards the remaining principal balance payable under the September 2024 Promissory Note. |
| ● | If the aggregate unpaid principal outstanding under the April 2024 Promissory Note and the September 2024 Promissory Note and all accrued and unpaid interest thereon is repaid in cash on or before December 31, 2024, then the total principal balance under the September 2024 Promissory Note that will be payable by the Borrower in satisfaction of its obligations under the September 2024 Promissory Note will be reduced from $5,000,000 to $3,500,000. |
The Company and ONCO entered into a Waiver and AmendmentNo. 1 to the Forbearance Agreement, dated* November 26, 2024,that (x) extended the time for the payment by ONCO of the monthly payment of a percentage of its cash receipts referenced above and conditioned the payment of those amounts upon ONCO being able to raise capital of at least $97,000 and (y) increased the percentage of the net proceeds from certain financings payable to the Company from 20% to 25%. The Company and ONCO entered into a Limited Waiver, dated March 31, 2025,to extend the maturity date of the April 2024Promissory Note to April 14, 2025,and the Company and ONCO entered into a Limited Waiver, dated April 23, 2025,to extend the maturity date of the April 2024Promissory Note to June 30, 2025.*
The Company determined that it wasnot probable, at the time of the transaction and at* March 31, 2025*, 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 $1.0 million during thethree months ended* March 31, 2025* and $1.7 million and $0.9 million during thesix months ended* March 31, 2025and2024*, respectively, for the nonrefundable consideration received during each period. Additional gain could be recognized in future periods if additional consideration is received or when it is deemed probable that substantially all of the consideration promised will be collected. The Company will continue to evaluate the collectability of the ONCO Promissory Notes for future installments of the purchase price.
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