VERU INC.

Note1 – Nature of Business and Significant Accounting Policies

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 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”) are included in the consolidated financial statements through* December 30, 2024.Veru International Holdco Inc.’s wholly owned subsidiaries, Veru Biopharma Netherlands B.V., Veru Biopharma UK Limited, and Veru Biopharma Europe Limited were dissolved in November 2024,** July 2025,and September 2025,*respectively. These entities are included in the consolidated financial statements through the respective 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 novel medicines for the treatment of cardiometabolic and inflammatory diseases. Our drug development program includes enobosarm, a selective androgen receptor modulator, being developed as a next generation drug that makes weight reduction by glucagon-like peptide-1 receptor agonist drugs more tissue selective for loss of fat and preservation of lean muscle mass, and sabizabulin, a microtubule disruptor, which is being developed for the treatment of inflammation in 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 Note14* for additional information. Most of the Company’s net revenues during fiscal2025 and2024 were derived from sales ofFC2 and are included within discontinued operations.

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.

Use of estimates: The preparation of financial statements in conformity with accounting principles generally accepted in the United States (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.

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 Annual Report on Form10-K, 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.

Segments: We regularly review our operating segments and the approach used by management to evaluate performance and allocate resources. The Company operates as a single operating segment. Our determination that we operate as a single segment is consistent with the financial information regularly reviewed by the chief operating decision maker (CODM) for purposes of evaluating performance, allocating resources, setting incentive compensation targets, and planning and forecasting for future periods. Our CODM allocates resources and assesses financial performance on a consolidated basis.

Cash, cash equivalents, and restricted cash and concentration: Cash, cash equivalents, and restricted cash, which primarily consist of cash on deposit with financial institutions and highly liquid money market funds, are recorded in the consolidated balance sheets at cost, which approximates fair value. The Company treats short-term, highly liquid funds that are readily convertible to known amounts of cash and have original maturities ofthree months or less as cash equivalents. The Company’s cash is maintained primarily inone financial institution, located in Chicago, Illinois.

F-7

Investments in equity securities: Investments in equity securities consisted of 3,125 shares of Series D Convertible Preferred Stock (the “Series D Preferred Stock”) of Onconetix, Inc. (“ONCO”) and a warrant to purchase 846,975 shares of common stock of ONCO (the “ONCO Warrant”) as of* September 30, 2025.Investments in equity securities consisted of 142,749 shares of common stock (“ONCO Common Stock”) of ONCO as of September 30, 2024.The Company elected to measure the Series D Preferred Stock, the ONCO Warrant, and the ONCO Common Stock using the fair value option, as provided for by FASB Accounting Standards Codification (ASC)825, Financial Instruments, which allows entities to make an irrevocable election of fair value as the initial and subsequent measurement attribute for certain eligible financial assets and liabilities. Under the fair value option, related gains and losses on the financial instrument will be reflected in non-operating income (expenses) in the Company’s statements of operations. The decision to elect the fair value option is determined on an instrument-by-instrument basis and must be applied to an entire instrument and is irrevocable once elected. Pursuant to this guidance, the carrying value will be adjusted to estimated fair value at the end of each quarter. The value of the Series D Preferred Stock and the ONCO Warrant was $2.5 million as of September 30, 2025.The value of the ONCO Common Stock was $0.7 million as of September 30, 2024.See Note4* for additional discussion.

Accounts receivable and concentration of credit risk: Accounts receivable are carried at original invoice amount less an estimate made for returns, discounts, and credit losses based on a review of all outstanding amounts on a periodic basis.

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, over the estimated useful lives of the 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 assets.

Leases: Leases are classified as either operating or finance leases at inception. A right-of-use (ROU) asset and corresponding lease liability are established at an amount equal to the present value of fixed lease payments over the lease term at the commencement date. The ROU asset includes any initial direct costs incurred and lease payments made at or before the commencement date and is reduced by lease incentive payments. The Company has electednot to separate the lease and nonlease components for all classes of underlying assets. The Company uses its incremental borrowing rate as the discount rate to determine the present value of the lease payments for leases that donot have a readily determinable implicit discount rate. The incremental borrowing rate is the rate of interest that the Company would be charged to borrow on a collateralized basis over a similar term and amount in a similar economic environment. The Company determines the incremental borrowing rates for its leases by adjusting the risk-free interest rate with a credit risk premium corresponding to the Company’s credit rating.

Operating lease costs are recognized for fixed lease payments on a straight-line basis over the term of the lease. Finance lease costs are a combination of the amortization expense for the ROU asset and interest expense for the outstanding lease liability using the applicable discount rate. Variable lease payments are recognized when incurred based on occurrence or usage. Short-term leases with an initial term of12 months or less arenot recorded on the balance sheet; we recognize lease expense for short-term leases on a straight-line basis over the lease term.

Patents and trademarks: The costs for patents and trademarks are expensed when incurred.

Goodwill: The Company’s goodwill arose from the acquisition of APP (the “APP Acquisition”) on* October 31, 2016.Goodwill isnot* amortized and is subject to an impairment review annually, in thefourth quarter of each fiscal year, and more frequently when indicators of impairment exist. An impairment of goodwill could occur if the carrying amount of a reporting unit exceeded the fair value of that reporting unit.

Goodwill consists of the cost of an acquired business in excess of the fair value of the net assets acquired. The Company’s goodwill is assigned to the reporting unit that is expected to benefit from the synergies of a business combination. The Company has identified a single reporting unit, consistent with its single operating segment. The Company tests goodwill for impairment byfirst assessing qualitative factors to determine whether it is more likely thannot that the fair value is less than its carrying amount. If the Company concludes it is more likely thannot that the fair value is less than its carrying amount, a quantitative impairment test is performed. For its quantitative impairment tests, the Company uses an estimated future cash flow approach that requires significant judgment with respect to future volume, revenue and expense growth rates, changes in working capital use, the selection of an appropriate discount rate, asset groupings and other assumptions and estimates. The estimates and assumptions used are consistent with the Company’s business plans and a market participant’s views. The use of alternative estimates and assumptions could increase or decrease the estimated fair value of the assets and potentially result in different impacts to the Company’s results of operations. Actual results* may*differ from the Company's estimates. The fair value of the reporting unit is compared with its carrying amount and an impairment charge would be recognized for the amount by which the carrying value exceeds the reporting unit’s fair value.

F-8

Regarding goodwill, the estimated fair value of a reporting unit is highly sensitive to changes in projections and assumptions; therefore, in some instances changes in these assumptions could potentially lead to impairment. We perform sensitivity analyses around our assumptions in order to assess the reasonableness of the assumptions and the results of our testing. Changes in these assumptions* mayimpact the estimated fair value of a reporting unit and cause the fair value of the reporting unit to be below its carrying value. We believe that our estimates are consistent with assumptions that marketplace participants would use in their estimates of fair value; however, if actual results arenot* consistent with our estimates and assumptions, we* may*be exposed to an impairment charge that could be material.

Deferred financing costs: Costs incurred in connection with the common stock purchase agreements and the at-the-market sale agreement discussed in Note9 have been included in other assets on the accompanying consolidated balance sheets at* September 30, 2025and2024*. When shares of the Company’s common stock are sold under the common stock purchase agreement or at-the market sale agreement, a pro-rata portion of the deferred costs is recorded to additional paid-in-capital.

Fair value measurements: Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Topic820 –* Fair Value Measurements and Disclosures,* defines fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB ASC Topic820 requires disclosures about the fair value of all financial instruments, whether ornot recognized, for financial statement purposes. Disclosures about the fair value of financial instruments are based on pertinent information available to us as of the reporting dates. Accordingly, the estimates presented in the accompanying consolidated financial statements arenot necessarily indicative of the amounts that could be realized on disposition of the financial instruments. See Note4 for a discussion of fair value measurements.

The carrying amounts reported in the accompanying consolidated balance sheets for cash, accounts payable and other accrued liabilities approximate their fair value based on the short-term nature of these instruments. The carrying value of the residual royalty agreement liabilities, taking into consideration the related derivative instruments, is estimated to approximate fair value.

Derivative instruments: The Company doesnot use derivative instruments to hedge exposures to cash flow, market or foreign currency risks. The Company reviews the terms of debt instruments it enters into to determine whether there are embedded derivative instruments, which are required to be bifurcated and accounted for separately as derivative financial instruments. Embedded derivatives that arenot clearly and closely related to the host contract are bifurcated and are recognized at fair value with changes in fair value recognized as either a gain or loss in earnings. Liabilities incurred in connection with an embedded derivative are discussed in Note4.

Research and development costs: Research and development costs are expensed as they are incurred and include salaries and benefits, costs to conduct clinical trials, and contract services. Nonrefundable advance payments made for goods or services to be used in research and development activities are deferred and capitalized until the goods have been delivered or the related services have been performed. If the goods areno longer expected to be delivered or the services areno longer expected to be performed, the Company would be required to expense the related capitalized advance payments. The Company didnot have any material capitalized nonrefundable advance payments as of* September 30, 2025* or2024.

The Company records estimated costs of research and development activities conducted bythird-party service providers, which include the conduct of preclinical studies and clinical trials and contract manufacturing activities. These costs are a significant component of the Company’s research and development expenses. The Company accrues for these costs based on factors such as estimates of the work completed and in accordance with agreements established with itsthird-party service providers under the service agreements. The Company makes significant judgments and estimates in determining the accrued liabilities balance in each reporting period. As actual costs become known, the Company adjusts its accrued liabilities. The Company hasnot experienced any material differences between accrued costs and actual costs incurred. However, the status and timing of actual services performed, number of patients enrolled and the rate of patient enrollments* may*vary from the Company’s estimates, resulting in adjustments to expense in future periods. Changes in these estimates that result in material changes to the Company’s accruals could materially affect the Company’s results of operations.

Share-based compensation: The Company recognizes share-based compensation expense in connection with its share-based awards, based on the estimated fair value of the awards on the date of grant, on a straight-line basis over the vesting period. Calculating share-based compensation expense requires the input of highly subjective judgment and assumptions, including estimates of the expected life of the share-based award, stock price volatility and risk-free interest rate.

Advertising: The Company’s policy is to expense advertising costs as incurred. The Company didnot incur significant advertising costs during the years ended* September 30, 2025and2024*.

F-9

Income taxes: FASB ASC Topic740 requires recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial statements and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Deferred tax assets are also provided for carryforwards for income tax purposes. In addition, the amount of any future tax benefits is reduced by a valuation allowance to the extent such benefits arenot expected to be realized.

Foreign currency translation and operations: Effective* October**1,* 2009, the Company determined that there were significant changes in facts and circumstances, triggering an evaluation of its subsidiaries’ functional currency, resulting in the adoption of the U.S. dollar as the functional currency for all foreign subsidiaries. The consistent use of the U.S. dollar as the functional currency across the Company reduces its foreign currency risk and stabilizes its operating results. The cumulative foreign currency translation loss included in accumulated other comprehensive loss was $0.6 million as of* September 30, 2024.As a result of theFC2* Business Sale, the cumulative foreign currency translation loss was reclassified and included in the calculation of the loss on the sale of theFC2 business. There wasno cumulative foreign currency translation loss included in accumulated other comprehensive loss as of* September 30, 2025*. Assets located outside of the U.S. were zero and $9.2 million at* September 30, 2025and September 30, 2024*, respectively.

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 consolidated balance sheets, these items, along with net loss, are components of other comprehensive loss. In fiscal2025 and2024, comprehensive income (loss) is equivalent to the reported net income (loss).

Recently adopted accounting pronouncements: In* November2023,* 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 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. ASU2023-07 is effective for the Company’s Annual Report on Form10-K for the fiscal year ending* September30,* 2025, and subsequent interim periods, with early adoption permitted. Accordingly, the Company adopted this new standard for the fiscal year ended* September 30, 2025.The adoption of this standard didnot* have a material impact on the Company’s consolidated financial results, but resulted in enhanced disclosures. See Note17 for segment disclosures.

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. ASU2024-03 is effective for the Company’s annual reporting periods beginning 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.

F-10

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, cash equivalents, and restricted cash 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.

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.

The purchase price for theFC2 Business Sale was $18.0 million in cash, including adjustments to the purchase price 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 is $4.1 million, which is the difference between estimated 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 been 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.

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 $150,000 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, which was recognized by the Company over asix month period.

F-11

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) $300,000, 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) $54,000 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. In* September 2025,$300,000 was released upon final determination of the purchase price adjustment pursuant to the Purchase Agreement. The remaining amount held in escrow of $54,000 as of September 30, 2025*is classified as restricted cash and included within cash, cash equivalents, and restricted cash on the accompanying 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 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 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 consolidated balance sheet as of* September 30, 2025.*

The following table presents results of discontinued operations for the years ended* September 30, 2025and2024*:

F-12

The following table presents the carrying amounts of assets and liabilities of discontinued operations as of* September 30, 2024:*

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 the years ended* September 30, 2025and2024* are comprised of the following:

Note4 – Fair Value Measurements

FASB ASC Topic820 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.

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.

There wereno transfers between Level1, Level2 and Level3 during fiscal2025 and2024.

F-13

As of* September 30, 2025and2024*, the Company’s financial liabilities measured at fair value on a recurring basis, which consisted of embedded derivatives, are also classified within Level3 of the fair value hierarchy.

The Company determines the fair value of hybrid instruments based on available market data using appropriate valuation models, considering all of the rights and obligations of each instrument. The Company estimates the fair value of hybrid instruments using various techniques (and combinations thereof) that are considered to be consistent with the objective of measuring fair value. In selecting the appropriate technique, the Company considers, among other factors, the nature of the instrument, the market risks that it embodies and the expected means of settlement. Estimating the fair value of derivative financial instruments requires the development of significant and subjective estimates that* may,*and are likely to, change over the duration of the instrument with related changes in internal and external market factors. Increases in fair value during a given financial quarter result in the recognition of non-cash derivative expense. Conversely, decreases in fair value during a given financial quarter would result in the recognition of non-cash derivative income.

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) for the years ended* September 30, 2025and2024*:

The loss associated with the change in fair value of the embedded derivatives is included within net loss from discontinued operations on the accompanying 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.

The liabilities associated with embedded derivatives represented the fair value of the change of control provisions in the Residual Royalty Agreement. See Note8 for additional information. 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. Material changes in any of these inputs would have resulted in a significantly higher or lower fair value measurement at future reporting dates, which could have had a material effect on our results of operations. 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 table presents 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:*

F-14

The Company also has investments in equity securities consisting of the Series D Preferred Stock and the ONCO Warrant as of* September 30, 2025and the ONCO Common Stock as of September 30, 2024.The Series D Preferred Stock and the ONCO Warrant were received on September 22, 2025as a settlement of the ONCO Promissory Notes. See Note14* for additional information. The Company has elected to measure the Series D Preferred Stock and the ONCO Warrant at fair value in accordance with ASC825. The investments in the 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 Series D Preferred Stock and the ONCO Warrant have been 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 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 Series D convertible preferred stock and warrants to purchase 4,362,827 shares of ONCO Common Stock toeleven institutional investors, for an aggregate purchase price of $12.9 million. The valuation of the Series D Preferred Stock and ONCO Warrant includes a calibration discount to the proceeds of the original transaction, which was done at arms’ length. 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* September 22, 2025 (the date the Series D Preferred Stock and the ONCO Warrant were received and initially recognized) and as of September 30, 2025:*

The following table provides a reconciliation of the beginning and ending balance associated with the Series D Preferred Stock and the ONCO Warrant measured at fair value of the year ended* September 30, 2025,*which are presented as investments in equity securities on the accompanying consolidated balance sheet:

The Company had an investment in equity securities consisting of the ONCO Common Stock, which were sold during the year ended* September 30, 2025for net proceeds of $0.4 million. The value of the ONCO Common Stock was $0.7 million as of September 30, 2024.*

F-15

The Company received 3,000 shares of Series A Convertible Preferred Stock (the “ONCO Series A 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 Note14 for additional information. The Company elected to measure the ONCO Series A Preferred Stock at fair value in accordance with ASC825. The investment in the ONCO Series A 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 Series A Preferred Stock it held into the ONCO Common Stock. Following this conversion, 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.

The Company recognized a loss from the change in fair value of equity securities of $0.3 million and $0.2 million during the years ended* September 30, 2025and2024*, respectively.

Note5 – Accounts Receivable and Concentration of Credit Risk

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 – Property and Equipment

Property and equipment consisted of the following at* September 30, 2025and2024*:

Depreciation expense for the years ended* September 30, 2025and2024* was approximately $0.1 million and $0.1 million, respectively.

**Note7 **–Goodwill

The carrying amount of goodwill at* September 30, 2025and2024* was $6.9 million. There wasno change in the balance during the years ended* September 30, 2025and2024*.

F-16

Note8 – Debt

SWK Residual Royalty Agreement

On* March5,* 2018, the Company entered into a Credit Agreement (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 change of control provision, was allocated to an embedded derivative liability. The derivative liability is adjusted to fair market value at each reporting period.

At* September 30, 2025and2024*, the Residual Royalty Agreement liability consisted of the following:

Premium Finance Agreement

On* November1,* 2022, the Company entered into an agreement to finance $1.4 million of its directors and officers liability insurance premium at an annual percentage rate of 6.3%. The financing agreement was payable ineleven monthly installments of principal and interest, which began on* December1,* 2022. The last payment of $0.1 million was made in* October 2023and there wasno balance outstanding as of September 30, 2025and September 30, 2024.*

Note9 – Stockholders’** Equity**

Preferred Stock

The Company has 5,000,000 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 authorized. There wereno shares of Class A Preferred Stock of any series issued and outstanding at* September 30, 2025and September 30, 2024*. The Company has 15,000 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* September 30, 2025and September 30, 2024*.

Common Stock

We are authorized to issue up to 308,000,000 shares of common stock, $0.01 par value per share. Holders are entitled toone vote for each share of common stock.

In fiscal2025, the Company issued 12,000 shares of common stock to athird party consultant for services to be provided totaling $59,000.

On* December**18,* 2023, we completed an underwritten public offering of 5,270,833 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 $7.20 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).

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 Annual Report on Form10-K, 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 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* September 30, 2025,$109.0 million remained available under that shelf registration statement. The shelf registration statement expires on April 14, 2026.*

F-18

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.

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 is above the Floor Price, as defined in the Lincoln Park Purchase Agreement, to require Lincoln Park to purchase up to 22,500 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 25,000 shares, if the closing sale price of the Company’s common stock on the applicable Purchase Date isnot below $60.00 and to 27,500 shares, if the closing sale price of the Company’s common stock on the applicable Purchase Date isnot below $80.00. Lincoln Park’s committed obligation under each Regular Purchase shallnot exceed $2,500,000 or 200,000 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 (3) 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 1,767,850 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 $12.60 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).

F-19

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. We are obligated to issue $1.0 million of shares of the Company’s common stock at the time Lincoln Park’s purchases cumulatively reach an aggregate amount of $50.0 million of Purchase Shares.

The Company didnot sell any shares under the Lincoln Park Purchase Agreement during fiscal2025. We sold 180,000 shares of common stock to Lincoln Park under the Lincoln Park Purchase Agreement during fiscal2024, resulting in proceeds to the Company of $1.7 million. As a result of these sales, we recorded approximately $0.2 million of deferred costs to additional paid-in capital. The unamortized amount of deferred costs related to the Lincoln Park Purchase Agreement is $0.9 million at each of* September 30, 2025and2024* and is included in other assets on the accompanying consolidated balance sheets.

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 mayissue 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 3,960,907 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.Pursuant to the terms of the Jefferies Sales Agreement, the Company could issue and sell, from time to time through or to Jefferies, shares of its common stock as set forth in the Jefferies Sales Agreement with an aggregate value of up to $75 million. 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.

We didnot sell any shares of common stock under the Jefferies Sales Agreement during fiscal2025. We sold 9,016 shares of common stock under the Jefferies Sales Agreement during fiscal2024, resulting in net proceeds to the Company of $0.1 million. The Company incurred issuance costs related to the Jefferies Sales Agreement of $0.2 million, which were recorded as deferred costs. The unamortized amount of deferred costs remaining when the agreement terminated was $0.2 million and was expensed at the time of termination. It is included in selling, general and administrative expenses on the accompanying consolidated statement of operations for the year ended* September**30,* 2024.

Note10 – Share-based Compensation

We allocate share-based compensation expense to cost of sales, selling, general and administrative expense and research and development expense based on the award holder’s employment function. We recorded income tax benefits for share-based compensation expense of approximately $2.0 million and $3.1 million during the years ended* September 30, 2025and2024*, respectively. During the years ended* September 30, 2025and2024* we recorded share-based compensation expenses as follows:

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.

F-20

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 new hires who satisfy the requirements to be granted inducement grants under Nasdaq listing rules as an inducement material to the individual’s entry into employment with the Company. The terms of the Inducement Plan are substantially similar to the terms of our2018 Plan. The Company has reserved 400,000 shares of common stock under the Inducement Plan and as of* September 30, 2025*,400,000 shares remain available for issuance.

In* March 2018,the Company’s stockholders approved the Company’s2018* Equity Incentive Plan (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 2.6 million. As of* September 30, 2025*,847,183 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* September 30, 2025*,17,546 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.

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 of $0.5 million and $1.9 million during the years ended* September 30, 2025and2024*, respectively.

The following table outlines the weighted average assumptions for options granted during fiscal2025 and2024:

During the years ended* September 30, 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.

F-21

The following table summarizes the stock options outstanding and exercisable at* September 30, 2025*:

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 year ended* September 30, 2025* of $3.80, less the respective weighted average exercise price per share at period end.

The Company didnot have a significant number of options exercised during fiscal2025 or2024 and thus, the total intrinsic value of options exercised and cash received from options exercised were immaterial.

As of* September 30, 2025*, the Company had unrecognized compensation expense of approximately $2.5 million related to unvested stock options. This expense is expected to be recognized over a weighted average period of 1.7 years.

Stock Appreciation Rights

In fiscal2017, the Company issued stock appreciation rights based on 5,000 shares of the Company’s common stock to an employee that vested on* October**31,* 2018. The stock appreciation rights have aten-year term and an exercise price per share of $9.50. Upon exercise, the stock appreciation rights will be settled in common stock issued under the2017 Plan. As of* September 30, 2025and2024*, 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.

Corporate Headquarters

In* June2021,* the Company executed a lease for its new corporate headquarters in Miami, Florida. The Company is leasing approximately 12,000 square feet of office space for aneight year term, which commenced on* March1,* 2022. Annual base rent payments are $58.00 per square foot and are subject to a 3% annual escalation. Based on the terms of the lease agreement, the Company paid a security deposit of approximately $117,000, which was partially refunded during fiscal2025.

F-22

Chicago Lease

The Company leased approximately 6,600 square feet of office space located in Chicago, Illinois. The Company executed the lease for this office in* May 2016,for aseven-year period commencing on November1,* 2016 and ending on* October31,* 2023. The lease granted the Company aseven-month lease holiday beginning* November1,* 2016, afive-month lease abatement beginning* June1,* 2017, and provided a tenant improvement allowance. Annual base rent payments were $14.00 per square foot in yearone and increase on an annual basis to $17 per square foot in the final year of the lease. The lease also required payment of related expenses, including real estate taxes, common area maintenance, utilities and insurance expenses from* June1,* 2017 to* October31,* 2023. Based on the terms of the lease agreement, the Company paid a security deposit of $55,000. Effective* September 1, 2017,the Company entered into a sublease for this office space through October 31, 2023.Monthly sublease payments of approximately $15,200 commenced in January 2018and ended August 2023.The monthly sublease payment was subject to annual increases in Septemberof each year and increased to approximately $17,300 per month in the final year of the sublease. Sublease income was recognized as a reduction to operating lease costs as the sublease was outside of the Company’s normal business operations. This is consistent with the Company’s recognition of sublease income prior to the adoption of FASB ASC Topic842.* The tenant under the sublease provided a security deposit of $30,000 to the Company. The Company continued to be responsible for performance under the lease until it expired on* October**31,* 2023.

Certain of our lease agreements include variable lease payments for common area maintenance, real estate taxes, and insurance or based on usage for the office equipment leases. The components of the Company’s lease cost were as follows for the years ended* September 30, 2025and2024*:

The Company paid cash of $0.8 million for amounts included in the measurement of operating lease liabilities during each of the years ended* September 30, 2025and2024*. The Company’s operating lease ROU assets and related lease liabilities are presented as separate line items on the accompanying consolidated balance sheet as of* September 30, 2025and2024*.

Other information related to the Company’s leases as of* September 30, 2025and2024* was as follows:

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.

F-23

As of* September 30, 2025*, maturities of lease liabilities were as follows:

The Company doesnot have any leases that havenot yet commenced as of* September 30, 2025*.

The lease liabilities presented above donot include variable lease payments for common area maintenance, real estate taxes, and insurance or based on usage for the office equipment leases. These amounts arenot fixed and can fluctuate from year to year.

Note12 – Contingent Liabilities

The testing, manufacturing and marketing of consumer products by the Company 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 currently $10.0 million.

Litigation

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.

F-24

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.

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. The amended complaint also alleges 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 in the accompanying consolidated financial statements for any of these contingencies.

F-25

Collaborative Arrangements

On* January 31, 2022,the Company entered into a Clinical Trial Collaboration and Supply Agreement (the “Lilly Agreement”) with Eli Lilly and Company (“Lilly”). The Company was sponsoring a clinical trial in which both the Company’s enobosarm compound and Lilly’s compound were being dosed in combination. Under the Lilly agreement, the Company conducts the research at its own cost and Lilly contributes its compound towards the study atno* cost to the Company. The parties continue to hold exclusive rights to all intellectual property relating solely to their own respective compounds. The Company would provide to Lilly copies of clinical data relating to the clinical trial and certain rights to use the clinical data. Veru maintains full exclusive, global commercialization rights to the enobosarm compound. As the ENABLAR-2 clinical trial is currently suspended, on* August 22, 2024*Lilly sent Veru a notice of expiration effectively terminating the Lilly Agreement.

The terms of the Lilly Agreement met the criteria under ASC Topic808, Collaborative Arrangements (“ASC808”), as both parties were active participants in the activity and were exposed to the risks and rewards dependent on the commercial success of the activity. ASC808 doesnot provide guidance on how to account for the activities under the collaboration, and the Company determined that Lilly didnot meet the definition of a customer under ASC606, Revenue from Contracts with Customers. The Company has concluded that ASC730, Research and Development, should be applied by analogy. There isno financial statement impact for the Lilly Agreement as the value of the drug supply received from Lilly would be offset against the drug supply cost within 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 the ONCO Promissory Notes. 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.The agreement resulted in a reduction in research and development expense for the year ended September 30, 2024of $0.6 million. $2.6 million and $0.9 million is included in accounts payable and $1.4 million and $4.5 million is included in other liabilities related to this agreement (in aggregate, the “Settlement Liablities”) as of September 30, 2025* and2024, respectively, on the accompanying consolidated balance sheets. Subsequent to* September 30, 2025,the Company made a payment of $1.6 million after receipt of a cash payment from ONCO related to the settlement of the ONCO Promissory Notes (see Note14* for additional information). As of* September 30, 2025*, maturities of the Settlement Liabilities were as follows:

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.

Within the calculation of the Company’s annual effective tax rate the Company has used assumptions and estimates that* maychange as a result of future guidance, interpretations, and rule-making from the Internal Revenue Service, the SEC, the FASB and/or various other taxing jurisdictions. For example, the Company anticipates that state jurisdictions will continue to determine and announce their conformity to the Tax Cuts and Jobs Act of2017* (the “TCJA”) which would have an impact on the annual effective tax rate. The Company’s calculations are based on the information available, prepared or analyzed (including computations) in reasonable detail.

On* July 4, 2025,the One Big Beautiful Bill Act (the “OBBBA”) was enacted in the U.S. The OBBBA includes significant provisions, such as the permanent extension of certain expiring provisions of the TCJA, allowing for accelerated tax deductions for qualified property and research expenditures, and the restoration of favorable tax treatment for certain business provisions. The legislation has multiple effective dates, with certain provisions effective in fiscal year2026* and others implemented through fiscal year2028.

F-26

The Company completes a detailed analysis of its deferred income tax valuation allowances on an annual basis or more frequently if information comes to its attention that would indicate that a revision to its estimates is necessary. In evaluating the Company’s ability to realize its deferred tax assets, management considers all available positive and negative evidence on a country-by-country basis, including past operating results, forecasts of future taxable income, and the potential Section382 limitation on the NOL carryforwards due to a change in control. In determining future taxable income, management makes assumptions to forecast U.S. federal and state operating income, the reversal of temporary differences, and the implementation of any feasible and prudent tax planning strategies. These assumptions require significant judgment regarding the forecasts of the future taxable income in each tax jurisdiction and are consistent with the forecasts used to manage the Company’s business. The Company had a cumulative pretax loss in the U.S. for fiscal2025 and thetwo preceding fiscal years. Forming a conclusion that a valuation allowance isnot needed is difficult when there is significant negative evidence such as cumulative losses in recent years. Management has projected future pretax losses in the U.S. driven by the investment in research and development and based on our analysis, concluded that a full valuation allowance should be recorded related to federal and state NOL carryforwards as of* September 30, 2025*. The valuation allowance against U.S. deferred tax assets was increased by $6.5 million during the year ended* September 30, 2025*. As of* September 30, 2025and2024* respectively, the Company has recorded a valuation allowance of $75.5 million and $69.0 million against U.S. deferred tax assets. In addition, the Company’s U.K. holding company for the non-U.S. operating companies, PCHC Limited, continues to have a full valuation allowance of $3.2 million as of* September 30, 2025and2024*. Veru Biopharma UK Limited, which was dissolved during fiscal2025, had a full valuation allowance of $0.4 million as of* September 30, 2024.*

As of* September 30, 2025*, the Company had U.S. federal and state NOL carryforwards of approximately $161.8 million and $92.8 million, respectively, for income tax purposes with $28.1 million and $49.5 million, respectively, expiring in fiscal years2026 to2044 and $133.7 million and $43.3 million, respectively, which can be carried forward indefinitely. The Company also has U.S. federal research and development tax credit carryforwards of $8.2 million, expiring in fiscal years2038 to2045.

Loss from continuing operations was taxed by the following jurisdictions for the years ended* September 30, 2025and2024*:

A reconciliation between the effective tax rate and the U.S. statutory rate and the related income tax expense for continuing operations is as follows:

F-27

Significant components of the Company’s deferred tax assets and liabilities are as follows:

ASC Topic740 prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC Topic740 developed atwo-step process to evaluate a tax position and also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosure, and transition. The Company hasnot recorded a reserve for any tax positions for which the ultimate deductibility is highly certain but for which there is uncertainty about the timing of such deductibility.

The Company files tax returns in all appropriate jurisdictions, including foreign, U.S. federal and state tax returns. For the U.S., a tax return* maybe audited any time within3* years from filing date or3 years after an NOL is utilized. The U.S. open tax years are for fiscal 2006 through2007, fiscal2015 through fiscal2019, and fiscal2022 through fiscal2024, for which the Company is carrying forward NOLs, which expire in years2026 through2038 or are being carried forward indefinitely withno expiration. The fiscal2025 tax returns havenot been filed as of the date of this filing. As of* September 30, 2025and2024*, the Company hasno recorded liability for unrecognized tax benefits.

The Company recognizes interest and penalties related to uncertain tax positions as income tax expense as incurred. No material expense for interest and penalties was recognized for the years ended* September 30, 2025and2024*.

Note14 – Sale of ENTADFI

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.

F-28

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’s common stock, subject to certain shareholder approval limitations. ONCO agreed in the Amendment to use commercially reasonable efforts to obtain such shareholder approval by* December 31, 2023.Shareholder approval was obtained on September 5, 2024.Effective September 24, 2024,ONCO effected a reverse stock split of all the outstanding shares of its issued and outstanding common stock at a ratio ofone-for-forty (1:40). Proportional adjustments were made to the number of shares of common stock issuable upon conversion of the ONCO Preferred Stock, such that the ONCO Preferred Stock was convertible into 142,749 shares of ONCO’s common stock. On September 24, 2024,*the Company converted all of the ONCO Preferred Stock into 142,749 shares of ONCO Common Stock.

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 “Forbearance 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 Forbearance 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 Forbearance Period towards the remaining principal balance of the* April 2024*Promissory 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 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.

Pursuant to the Amended Forbearance Agreement, the forbearance period relating to the Company’s agreement to forbear from exercising its rights and remedies on account of the failure by the Borrower to pay the amounts due under the* April 2024Promissory Note on the due date of April19,* 2024 continues 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) (such period, the* “April 2024Forbearance Period”). The Amended Forbearance Agreement extends the due date for the SeptemberPromissory Note until the earlier to occur of: (i) June**30,* 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.

F-29

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:

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:

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;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 and ONCO entered into a Limited Waiver, dated June 30, 2025,to extend the maturity dates of the April 2024Promissory Note and the September 2024Promissory Note to July 31, 2025;and the Company and ONCO entered into a Limited Waiver, dated July 31, 2025,to extend the maturity dates of the April 2024Promissory Note and the September 2024Promissory Note to August 14, 2025.During August 2025,the Company and ONCO entered into an Amended and Restated Promissory Note increasing the principal amount due under the September 2024*Promissory Note to $5.2 million from $5.0 million, after the Company advanced an additional $0.2 million to ONCO.

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’s Series D Convertible Preferred Stock (the “Series D Preferred Stock”) and a warrant to purchase 846,975 shares of ONCO’s common stock (the “Warrant”) (such cash payment, shares of Series D Preferred Stock, and the 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 had previously determined that it wasnot probable that substantially all of the consideration promised under the Asset Purchase Agreement would be collected. Therefore, the Company recognized a gain from the sale of ENTADFI assets as nonrefundable consideration was received. The Company recognized a gain on sale of $10.8 million and $1.2 million during years ended* September 30, 2025and2024*, respectively, based on the cash and the fair market value of equity instruments received from ONCO during each period. The ONCO Promissory Notes are now settled sono additional gain from additional consideration is expected in future periods.

Note15 – 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 income 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 as determined under the treasury stock method. 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.

Note16 – Employee Benefit Plans

Effective* January 1, 2018,the Company established a401*(k) plan in which substantially all U.S. employees are eligible to participate. Contributions made by employees are limited to the maximum allowable for U.S. federal income tax purposes. The Company matched employee contributions at a rate of 100% of applicable contributions up to 6% of included compensation. Effective* January 1, 2024,the Company paused matching contributions for U.S. employees and effective January 1, 2025,matching contributions for U.S. employees was reinstated at up to 4% of included compensation. Company contributions to the401*(k) plan were approximately $172,000 and $42,000 for the years ended* September 30, 2025and2024*, respectively.

Note17 - 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 novel 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.

F-31

The table below summarizes the significant expense categories regularly reviewed by the CODM for the years ended* September 30, 2025and2024*:

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 the years ended* September 30, 2025and2024*, net cash used in operating activities was$30.0 million and $21.7 million, respectively. The table below summarizes the significant asset categories regularly reviewed by the CODM for the years ended* September 30, 2025and2024*:

Note18 - Subsequent Events

Equity 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 and estimated costs payable by the Company. 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).