VERU 10-K & 10-Q changes, risk factors and insider trading

We have limited experience in obtaining regulatory approval or emergency use authorization for a drug.

We have only obtained regulatory approval for one drug, ENTADFI (tadalafil and finasteride) capsules, for oral use, which we sold to ONCO in April 2023. We have never obtained an EUA in the U.S. or in any other jurisdiction. It is possible that the FDA or other regulatory authorities may refuse to accept any or all of our planned NDAs for substantive review or may conclude, after review of our data, that our applications are insufficient to obtain regulatory authorization or approval of any of our drug candidates. The FDA may also require that we conduct additional clinical or manufacturing validation studies, which may be costly and time-consuming, and submit that data before it will reconsider our applications. Depending on the extent of these or any other FDA required studies, approval of any NDA or authorization of any EUA application that we submit may be significantly delayed, possibly for years, or may require us to expend more resources than we have available or can secure. Any delay or inability in obtaining regulatory approvals would delay or prevent us from commercializing our drug candidates, generating revenue from these proposed products and achieving and sustaining profitability. It is also possible that additional studies, if performed and completed, may not be considered sufficient by the FDA to approve any NDA or any EUA we submit. If any of these outcomes occur, we may be forced to abandon our planned NDAs or EUAs for one or more of our drug candidates, which would materially adversely affect our business.

Before we can obtain regulatory approval for the commercial sale of our drug candidates, we may be required to complete preclinical development with respect to such drug candidates and/or extensive clinical trials in humans to demonstrate the safety and efficacy of the drug candidates. To date, regulatory approval has not been obtained for any of our drug candidates.

We could experience delays or unanticipated costs in connection with our Phase 2bplanned clinical trialdevelopment program of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderlyolder patients receiving a GLP-1 RA.

Our future prospects are substantially dependent on our ability to successfully advance the development of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA. We arehave currently conductingconducted a Phase 2b multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness, withand have announced topline results from the firstPhase 2b clinical study as well as complete unblinded safety data and topline data from thea trialPhase expected2b inextension study. Although we have sought and received feedback from the secondFDA quarteron the design of calendar 2025. Any delays of or unanticipated changes to theour planned Phase 2b PLATEAU clinical trialstudy maythat increasewill ourevaluate costs,the sloweffect downof ourenobosarm product3mg developmenton total body weight, physical function, and approvalsafety processin approximately 200 patients who have obesity (BMI ≥ 35) and jeopardizeage our≥ ability to develop enobosarm for65 and ultimatelyare generate revenue from enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving ainitiating GLP-1 RA who are at-risktreatment for developingweight musclereduction, atrophythe and muscle weakness, whichFDA may causeultimately adisagree changewith inthe ourdesign developmentor strategy.conduct Additionalof costssuch trial. Delays or other issues may also result in the costs of our Phase 2b PLATEAU clinical study exceeding our expectations, and require usthat towe raise additional capital,capital to conduct this clinical study, which may not be available when needed or on terms acceptable to us.us As a result, we may be forced to abandon our development of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness.RA. There can be no assurances that the FDA will ultimately accept our Phase 2b trial design, that we will be able to cost-effectively continue development of enobosarm, or that enobosarm will receive FDA approval or be commercialized, for any application.

We may publicly disclose interim, preliminary or topline data from our preclinical studies and clinical trials.trials, such as our announcement on January 27, 2025, of topline results from our Phase 2b QUALITY clinical trial of enobosarm as a treatment to augment fat loss and to prevent muscle loss in obese or overweight elderly patients receiving a GLP-1 RA. These interim updates are based on preliminary analyses of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. For example, we may report responses in certain patients that are unconfirmed at the time and which do not ultimately result in confirmed responses to treatment after follow-up evaluations. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, preliminary or topline results that we report may differ from future results of the same studies or trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Interim, preliminary and topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the interim, preliminary or topline data we previously published. As a result, interim, preliminary and topline data should be viewed with caution until the final data are available. In addition, we may report interim analyses of only certain endpoints rather than all endpoints. Interim, preliminary and topline data from clinical trials are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Adverse changes between interim, preliminary or topline data and final data could significantly harm our business and prospects. Further, additional disclosure of interim, preliminary or topline data by us or by our competitors in the future could result in volatility in the price of our common stock.

We do not have the resources to independently conduct research and development activities. Therefore, we intend to and do rely on CROs to conduct research and development activities for our drug candidates and for the execution of our clinical studies. Although we will control only certain aspects of our CROs' activities, we will be responsible for ensuring that each of our studies is conducted in accordance with the applicable protocol and legal, regulatory and scientific standards, and our reliance on the CROs does not relieve us of our regulatory responsibilities. We cannot be sure that the CROs will conduct the research properly in a timely manner or on a cost-effective basis, or that the results will be reproducible. We and our CROs are required to comply with the FDA'sFDA’s cGCPs,current Good Clinical Practices (cGCPs), which are regulations and guidelines enforced by the FDA for all of our drug products in clinical development. The FDA enforces these cGCPs through periodic inspections of trial sponsors, principal investigators and clinical trial sites. If we or our CROs fail to comply with applicable cGCPs, the clinical data generated in our clinical trials may be deemed unreliable or invalid and the FDA may require us to perform additional clinical trials before approving our drug candidates. In addition, to evaluate the safety and effectiveness compared to placebo of our drug candidates to a statistically significant degree, our clinical trials will require an adequately large number of test subjects. Any clinical trial that a CRO conducts abroad on our behalf is subject to similar regulation. Accordingly, if our CROs fail to comply with these regulations or recruit a sufficient number of patients, we may be required to repeat clinical trials, which would delay the regulatory approval process.

In addition, regulatory requirements could pose barriers to the manufacture of our drug candidates. Third-party manufacturers are required to comply with the FDA’s cGMPs.current Good Manufacturing Practices (cGMPs). As a result, the facilities used by any manufacturers of our drug candidates must maintain a compliance status acceptable to the FDA. Holders of NDAs, or other forms of FDA approvals or clearances, or those distributing a regulated product under their own name, are responsible for manufacturing even though that manufacturing is conducted by a third-party contract manufacturing organization (CMO). Our third-party manufacturers will be required to produce our drug candidates under FDA cGMPs in order to meet acceptable standards. Our third-party manufacturers may not perform their obligations under their agreements with us or may discontinue their business before the time required by us to gain approval for or commercialize our drug candidates. In addition, our manufacturers will be subject to ongoing periodic unannounced inspections by the FDA and corresponding state and foreign agencies for compliance with cGMPs and similar regulatory requirements. Failure by any of our manufacturers to comply with applicable cGMPs could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspensions or withdrawals of approvals, operating restrictions, interruptions in supply, recalls, withdrawals, issuance of safety alerts and criminal prosecutions, any of which could have a material adverse effect on our business, financial condition, results of operations and prospects. Finally, we also could experience manufacturing delays if our CMOs give greater priority to the supply of other products over our products or otherwise do not satisfactorily perform according to the terms of their agreements with us.

The FDA has established regulations, guidelines and policies to govern the drug development and approval process, as have foreign regulatory authorities. Any change in regulatory requirements resulting from the adoption of new legislation, regulations or policies may require us to amend existing clinical trial protocols or add new clinical trials to comply with these changes. Such amendments to existing protocols or clinical trial applications or the need for new ones, may significantly and adversely affect the cost, timing and completion of the clinical trials for our drug candidates. In addition, the FDA’s policies may change and additional government regulations may be issued that could prevent, limit or delay regulatory approval of our drug candidates, or impose more stringent product labeling and post-marketing testing and other requirements. The political environment in the U.S. could result in significant changes in, and uncertainty with respect to, legislation, regulation and government policy that could significantly impact our business and the health care industry. While it is not possible to predict whether and when any such changes will occur, specific proposals that have been discussed or implemented which could have a material impact on us include, but are not limited to, potential changes to the ACA,Affordable recentlyCare issuedAct regulations offering employers religious and moral exemptions from the ACA’s requirement to provide insurance covering birth control,(ACA), and the enactment of the 21st Century Cures Act. If we are slow or unable to adapt to any such changes, our business, prospects and ability to achieve or sustain profitability would be adversely affected.

We cannot be sure that, if our clinical trials for any of our drug candidates are successfully completed, we will be able to submit an NDA to the FDA or that any NDA we submit will be approved by the FDA in a timely manner, if at all, or that the submission of any NDA is commercially feasible. Similar risks apply to EUA applications in the U.S. and other jurisdictions. After completing clinical trials for a drug candidate in humans, a drug dossier is prepared and submitted to the FDA as an NDA, and includes all preclinical studies and clinical trial data relevant to the safety and effectiveness of the product at the suggested dose and duration of use for the proposed indication as well as manufacturing information, in order to allow the FDA to review such drug dossier and to consider a drug candidate for approval for commercialization in the United States. If we are unable to submit an NDA with respect to any of our current drug candidates, if any NDA we submit is not approved by the FDA, or we elect not to file an NDA, or if we are unable to obtain any required state and local distribution licenses or similar authorizations, we will be unable to commercialize that product. The FDA can and does reject NDAs and require additional clinical trials, even when drug candidates achieve favorable results in Phase 3 clinical trials.

Our development and commercialization of sabizabulin as a treatment forto ARDSslow the progression of or promote regression of cardiovascular atherosclerotic disease will depend on our ability to secure significant funding through government grants, pharmaceutical company partnerships or similarother external sources.

We currently plan to prioritize the use of our internal cash and the net proceeds of any future financings to the development of enobosarm, with a primary near-term focus on funding aour PLATEAU Phase 2b clinical trial to evaluate theenobosarm 3mg versus placebo on total body weight, body composition, physical function and safety and efficacy of enobosarm initially as a treatment to augment fat loss and to prevent lean mass loss in sarcopenicapproximately obese or overweight elderly200 patients with obesity receiving atirzepatide GLP-1 RA who are at-risk(ZEPBOUND) for developingweight muscle atrophy and muscle weakness,reduction., and to seek external funding through government grants, pharmaceutical company partnerships or similar sources to advance sabizabulin as a treatment forto viral-inducedslow ARDS.the progression of or promote regression of cardiovascular atherosclerotic disease. Such funding may not be available on a timely basis or at all, which may cause a significant delay in or the suspension of our development of sabizabulin as a treatment forto viral-inducedslow ARDS.the progression of or promote regression of cardiovascular atherosclerotic disease. Government funding for private sector research and development activities can be difficult to obtain and may contain limitations on its use. For example, in October 2023, we were notified that we were not selected for participation in the planned Phase 2 ARDS clinical trial to be sponsored by BARDA. There are also uncertainties regarding our ability to obtain funding through partnerships with pharmaceutical companies, including significant competition in seeking appropriate partners and the possibility that potential partners may not view sabizabulin as having the requisite potential to demonstrate safety and efficacy or adequate intellectual property protection.

We are subject to extensive and costly governmental regulation, including healthcare reform measures that may negatively impact sales of FC2.regulation.

Our marketed product, FC2, and our drug candidates are subject to extensive and rigorous domestic government regulation, including regulation by the FDA, the FTC,Federal Trade Commission, the Centers for Medicare & Medicaid Services (CMS), other divisions of the U.S. Department of Health and Human Services, including its Office of Inspector General, the U.S. Department of Justice, the Departments of Defense and Veterans Affairs, to the extent our products arewill be paid for directly or indirectly by those departments, state and local governments and their respective foreign equivalents. The FDA regulates the research, development, preclinical and clinical testing, manufacture, safety, effectiveness, record keeping, reporting, labeling, storage, approval, advertising, promotion, sale, distribution, import and export of pharmaceutical products and medical devices under various regulatory provisions. The Office of Prescription Drug Promotion (OPDP) division of the FDA also regulates the advertising, marketing, and promotion of the Company’sdrug products. Many states and local governments require distribution licenses or similar authorizations to sell products in their jurisdictions. Any of our products that are tested or marketed outside the U.S. are also subject to extensive regulation by foreign governments, whether or not we have obtained FDA approval for a given product and its uses. Such foreign regulation may be equally or more demanding than corresponding U.S. regulation.

In addition, there has been a recent years, a numbertrend of states,increased including California, Minnesota, Oregon, Texasfederal and Washington,state regulation of payments made by drug manufacturers to health care practitioners. Some states mandate implementation of corporate compliance programs, while other state laws prohibit, or require tracking and reporting of, certain gifts, compensation and other remuneration to physicians and other health care practitioners. In addition, certain states have enacted laws requiring manufacturers to submit reports on drugs whose list price has increased by more than a certain percentage during a specified period and/or new drugs that are being launched at a price exceeding a specified amount. Among other things, the reports must explain the justifications for the price or price increase.

Market acceptance and sales for our marketed product, FC2, and drug candidates will depend on coverage and reimbursement policies and may be affected by health care reform measures. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which products they will pay for and establish reimbursement levels. We cannot be sure that coverage and reimbursement will be available for our drug candidates, if approved. We also cannot be sure that the amount of reimbursement available, if any, will not reduce the demand for, or the price of, our products. If reimbursement is not available or is available only at limited levels, we may not be able to successfully commercialize our drug candidates.

Physicians may not prescribe our drug candidates, if approved by the appropriate regulatory authorities for marketing and sale, which would prevent any such drug candidate from generating revenue. Market acceptance of our marketed product, FC2, and drug candidates by physicians, patients and payors, will depend on a number of factors, many of which are beyond our control, including the following:

We incurred a net loss of $22.7 million and $37.8 million during the yearyears ended September 30, 2024.2025 and 2024, respectively. Pharmaceutical product development is a speculative undertaking, involves a substantial degree of risk and is a capital-intensive business. We expect to incur significant expenses until we are able to obtain regulatory approval and subsequently sell one or more of our drug candidates under development in significant quantities, which may not happen. We expect to devote most of our financial resources to research and development, including our non-clinical development activities and clinical trials. Our drug candidates will require the completion of regulatory review, significant marketing efforts and substantial investment before they can provide us with any revenue. We are uncertain when or if we will be able to achieve or sustain profitability. If we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. Failure to become and remain profitable would impair our ability to sustain operations and adversely affect the price of our common stock and our ability to raise capital.

We will need to raise additional capital to fund our operations and development programs in the future. If we are unsuccessful in attracting new capital, we may not be able to continue operations or development or may be forced to sell assets to do so. Alternatively, capital may not be available to us on favorable terms, or if at all. If available, financing terms may lead to significant dilution of our stockholders’ equity.

We are not profitable and have had negative cash flow from operations. We will need large amounts of capital to support our development and commercialization efforts for our drug candidates, including the Phase 2b clinical trial to evaluate the efficacy and the safety of enobosarm in preventing significant muscle wasting in obese patients receiving a GLP-1 therapeutic to treat obesity.candidates. Our existing cash, cash equivalents, and restricted cash equivalents as of the date of this report may not be sufficient to fund our working capital needs and operating expenses. To obtain the capital necessary to fund our operations, we expect to finance our cash needs through public or private equity offerings, debt financing and/or other capital sources. Additional capital may not be available at such times or amounts as needed by us.

Even if capital is available, it might be available only on unfavorable terms. Any additional equity or convertible debt financing into which we enter could be dilutive to our existing stockholders. Any future debt financing into which we enter may impose covenants upon us that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our stock, make certain investments and engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. If we raise additional funds through collaboration and licensing arrangements with third parties, we may need to relinquish rights to our technologies or our products or grant licenses on terms that are not favorable to us. Our low stock price may make it more difficult to access equity capital markets and may increase the dilution to our shareholders if we raise capital through the sale of equity securities. If access to sufficient capital is not available as and when needed, our business will be materially impaired, and we may be required to cease operations, curtail one or more product development or commercialization programs, scale back or eliminate the development of business opportunities, or significantly reduce expenses, sell assets, seek a merger or joint venture partner, file for protection from creditors or liquidate all of our assets. Any of these factors could harm our operating results.

We may experience competition, especially for enobosarm as a treatment for metabolic diseases, if approved, and FC2.approved.

The Pill Club was one of ourthe largest customers,customers of the FC2 Business, accounting for 44% of our net revenues in fiscal 2022 and 43% of our net revenues in fiscal 2021. On February 7, 2023, the California Attorney General announced a settlement with The Pill Club over a number of alleged improper actions by The Pill Club, including alleged overbilling for FC2. Although we were not involved in the business practices that were the subject of the California Attorney General’s allegations, it is possible that the California Attorney General or another governmental authority may investigate or assert claims against us in connection with The Pill Club’s practices with respect to sales of FC2. Any such claims or investigations could have a material adverse effect on our reputation, business, results of operations and financial condition. Any such claims or investigations, regardless of the outcome, would be costly and time-consuming.

WeAlthough havewe asold concentrationthe ofFC2 Business, we retained our claims relating to accounts receivable atdue from The Pill Club, withwhich had a balance of $3.9 million of accounts receivable as of September 30, 2024.2025. On April 18, 2023, The Pill Club filed for Chapter 11 bankruptcy and its assets were sold in June 2023 to satisfy a secured creditor. Our claims against The Pill Club for these receivables have been filed with The Pill Club bankruptcy estate and weWe will continue to pursue payment for as much of the receivables as possible but based on the amount of the claims of other unsecured creditors and the limited assets remaining in The Pill Club bankruptcy estate it is unlikely that we will recover any of these receivables. We recorded in fiscal 2023 and maintain as of September 30, 20242025 an allowance for credit losses of $3.9 million due to The Pill Club’s Chapter 11 bankruptcy filing in April 2023.

We are a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology,cardiometabolic and viral-inducedinflammatory ARDS.diseases. Our drug development program includesconsists of two late-stage new chemical entities, enobosarm and sabizabulin. Enobosarm, aan oral selective androgen receptor modulator (“SARM”), is being developed inas twoa differentnext programs:generation (i)drug obesity-that enobosarmmakes inweight combinationreduction withby GLP-1 RA todrugs augmentmore tissue selective for loss of fat loss,and preservation of lean mass. This activity leads to preventimproved musclebody loss,composition and maintain physical function forwith higherexpected qualityclinically meaningful incremental weight lossreduction andversus (ii)GLP-1 breastRA cancer- enobosarm plus abemaciclib for the 2nd line treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer, subject to the availability of sufficient funding.monotherapy. Sabizabulin, a microtubule disruptor, is being developed for the treatment of hospitalizedinflammation patientsin withatherosclerotic viral-inducedcardiovascular ARDS.disease. WeOn doDecember not30, intend to undertake further development of sabizabulin for2024, the treatmentCompany ofsold viral-induced ARDS unless we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources. We also have anits FDA-approved commercial product, the FC2 Female Condom® (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections.infections (the “FC2 Business”).

Obesity Program - Enobosarm

In reported third-party clinical trials evaluating currentlyCurrently approved GLP-1 RA in obesepatients patients,with trial participantsobesity exhibited significant weight loss composed of reductions in both fat and lean (muscle and bone) mass. Of the total weight loss reported in certain ofthird these third-partyparty clinical trials, 20-50% of the total weight loss reported by patients was attributable to lean mass (muscle) loss. AccordingPatients to the CDC, 41.5% of older adults are obese and could benefit from weight loss medication. Up to 34.4% of people over the age of 60 with obesity in the United Stateswho have sarcopenic obesity. Sarcopenic obese patients are patients whoobesity have both obesity and low muscle mass at the same time and are potentially at the greatest risk for developing critically low muscle mass when taking a currently approved GLP-1 RA. We therefore believe there is an urgent unmet need for a drug that can ameliorateprevents the muscle wasting effectsloss of currently approved GLP-1 RA therapiesmuscle and alsoincreases allow for preferentialthe loss of fat massfor greater weight loss in at-risk sarcopenic obese and overweight elderly patients. While older adultspatients arereceiving atGLP-1 higher riskRA for sarcopeniaweight and sarcopenic obesity, in discussions with the FDA, Veru intends to ultimately seek an approval in the broadest population that could benefit in all ages rather than limiting the indication to patients over the age of 60 years as younger patients (including females of child-bearing potential) with obesity on GLP-1 receptor agonists could benefit from the potential muscle-preserving effects of enobosarm.reduction.

WeEnobosarm submittedis anbeing Investigationaldeveloped Newas Druga Applicationtreatment (IND)to preserve muscle/physical function and reduce fat to cause incremental weight loss in patients with obesity receiving a GLP-1 RA for enobosarmweight forreduction. a Phase 2b clinical study in January 2024. In February 2024, the Company received FDA clearance to initiate theA Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding QUALITY clinical trial designedwas conducted to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to augment fat loss and to prevent muscle loss in sarcopenic168 obesepatients orwith overweight olderobesity (>≥60 years of age) patients receiving semaglutide (Wegovy®). for weight reduction. The primary endpoint iswas the percent change from baseline in total lean body mass, and the key secondary endpoints arewere the percent change from baseline in total body fat mass, total body weight, and physical function as measured by stair climb test at 16 weeks. InAfter April 2024completing the Companyefficacy announceddose-assessment that it had enrolled its first patients in the Phase 2b QUALITY clinical study and in August 2024 the Company completed enrollment of 168 subjects in 14 clinical sites in the U.S. with the topline clinical results from the trial expected in January 2025. The purposeportion of the Phase 2b QUALITY clinical trial is to selecttrial, the optimalparticipants dosecontinued ofinto enobosarma inPhase combination2b extension maintenance trial where all patients stopped treatment with semaglutide (Wegovy®), thatbut bestcontinue preservestaking placebo, enobosarm 3mg, or enobosarm 6mg in a blinded fashion for 12 additional weeks. The Phase 2b extension clinical trial evaluated whether enobosarm can maintain muscle and reducesprevent the fat regain that generally occurs after 16 weeks of treatment to advance intodiscontinuing a PhaseGLP-1 3 obesity clinical trial.RA.

After completing the efficacy dose-finding and active weight reduction portion of the Phase 2b QUALITY clinical trial, the participants are expected to continuecontinued into a Phase 2b maintenance extension trialstudy where all patients will stop treatment withdiscontinued semaglutide (Wegovy®),treatment, but willcontinued continue takingreceiving placebo, 3mgenobosarm of enobosarm,3mg, or enobosarm 6mg ofas enobosarmmonotherapy in a blindeddouble-blind fashion for 12 weeks. TheOn June 24, 2025, we announced positive results from the Maintenance Extension portion of the Phase 2b extensionQUALITY clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight regain that generally occurs after discontinuing a GLP-1 RA. The topline results of the separate blinded Phase 2b extension clinical study are expected in the second quarter of calendar 2025.study.

Veru is also currently developing a novel, patentable, modified release oral formulation for enobosarmenobosarm. with multiple releases during a 24-hour dosing period. We anticipate theThe actual formulation, pharmacokinetic release profile(s), and method of manufacturing will be the subjectsubjects of future patents.patent Theapplications. purposeIf ofissued, the modification is to create a consistent release profile with a significantly reduced maximum exposure plus an extended-release profile to minimize any dose-related adverse events while facilitating full exposure of the patient to the drug product between dosesexpiry for the entirenew periodmodified ofrelease 24oral hours. Thisenobosarm formulation is currently in animal trials andpatent is anticipatedexpected to be available2045. forThe new enobosarm formulation has completed the initial Phase 1 bioavailability clinical trial duringin the first half ofJuly 2025. WeThe expectexpectation is that thethis oral enobosarmnovel modified release drugoral enobosarm formulation will be utilizedavailable for anythe Phase 3 obesity clinical studies.studies and for commercialization.

Under current SEC regulations, because our public float is less than $75 million, and for so long as our public float remains less than $75 million, the amount we can raise through primary public offerings of securities in any 12-month period using shelf registration statements is limited to an aggregate of one-third of our public float (referred to as the “baby shelf” rule). As of AprilJuly 7,2, 2026, the aggregate market value of our outstanding common shares held by non-affiliates, or public float, was approximately $38.5$65.5 million, which is calculated based on 14,480,29215,480,292 shares of our outstanding common stock held by non-affiliates and a price of $2.66$4.23 per share, the closing price of our common stock on FebruaryJune 26,4, 2026, which is the highest closing price of our common stock on the Nasdaq Capital Market within the prior 60 days of AprilJuly 7,2, 2026. IfOn July 2, 2026, we filed a prospectus supplement with the SEC relating to the offering and sale of up to $21.8 million of shares of the Company’s common stock pursuant to the Sales Agreement, which represented one-third of our public float of $65.5 million calculated as of July 2, 2026. Depending on the amount of common stock we sell pursuant to the Sales Agreement, our use of our shelf registration statement for other primary public offerings may be limited. In addition, if our public float decreases, the amount of securities we may sell under our shelf registration statement may also decrease.

Enobosarm is being developed for weight loss and as a treatment to preserve physical function as well as to augment fat loss resulting in incremental weight loss in older patients with obesity receiving a GLP-1 RA for weight reduction. A Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding Phase 2b QUALITY clinical trial was conducted to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo in 168 older patients with obesity (≥60 years of age) with obesity receiving semaglutide (Wegovy®) for weight reduction. The primary endpoint for the Phase 2b QUALITY clinical trial was the percent change from baseline in total lean body mass, and the key secondary endpoints were the percent change from baseline in total body fat mass, total body weight, and physical function as measured by stair climb test at 16 weeks. After completing the efficacy dose-assessment portion of the Phase 2b QUALITY clinical trial, the participants continued into a Phase 2b maintenance extension trial where all patients stopped treatment with semaglutide, but continuecontinued taking placebo, enobosarm 3mg, or enobosarm 6mg monotherapy in a blinded fashion for 12 additional weeks. The Phase 2b extension clinical trial evaluated whether enobosarm can maintain muscle and prevent the fat and weight regain that generally occurs after discontinuing a GLP-1 RA.

Currently Enrolling Phase 2b PLATEAU Clinical Study

On MarchJuly 9,27, 2026, the Company announced it had enrolledcompleted itsthe firstenrollment patientof patients in the Phase 2b PLATEAU clinical trial. Veru’s PLATEAU clinical trial design is a double-blind, placebo-controlled study to evaluate the effect of enobosarm 3mg on total body weight, fat mass, lean mass and physical function, bone mineral density and safety in approximately 200 older patients (age ≥ 65 yo) who have obesity (BMI ≥ 35) and are initiating semaglutide (Wegovy) GLP-1 RA treatment for weight reduction. The primary efficacy endpoint of the study is the percent change from baseline in total body weight at 68 weeks. An interim analysis will be conducted at 3632 weeks to assess the percent change from baseline in lean body mass, total fat mass, percentage body fat mass, percentage body lean mass, and total body mass, as measured by DXA scan. The key secondary endpoints for the overall study are total fat mass, total lean mass, physical function (stair climb test), mobility-disability assessment, bone mineral density,density (BMD), and patient reported outcome questionnaires for physical function (SF-36 PF-10, and IWQOL-lite CT physical function), HbA1c, and insulin resistance.

The Phase 2b PLATEAU clinical study is designed to assess the ability of enobosarm treatment to break through the weight loss plateau observed in patients with obesity receiving GLP-1 RA treatment to achieve clinically meaningful incremental weight reduction and preserve muscle mass and physical function by 68 weeks. AnThe interim analysis for the clinical studystudy, to assess the percent change from baseline in lean body mass, total fat mass, percentage body fat mass, percentage body lean mass, and total body mass, as measured by DXA scan, will be conducted after all patients are treated for 3632 weeks and is planned for the first quarter of calendar 2027.

Based on FDA regulatory feedback and qualification of BMD as an acceptable surrogate endpoint, results from the Phase 2b PLATEAU study may have three possible regulatory pathways to support efficacy for approval of enobosarm in combination with the GLP- 1 RA. If incremental weight loss is ≥ 5%, the Phase 3 study could be a study in patients with obesity with a primary endpoint of total body weight, and key secondary endpoints for prespecified subgroups of physical function in sarcopenic patients (age ≥ 65 yo) with mobility disability and another for BMD in postmenopausal women with osteoporosis. If the incremental weight loss is < 5%, the Phase 3 study could be a study in patients with obesity and mobility disability with a primary endpoint of physical function in sarcopenic obesity patients (age ≥ 65 yo) with mobility disability, and a key secondary endpoint could beof BMD in a prespecified group of postmenopausal women with osteoporosis. Alternatively, the Phase 3 study could be a study in patients with obesity and osteoporosis with a primary endpoint of BMD in postmenopausal women with osteoporosis, and a key secondary endpoint of physical function in sarcopenic patients (age ≥ 65 yo) with mobility disability.

Veru had a pre-IND meeting with the FDA Division of Cardiology and Nephrology Center for Drug Evaluation and Research on December 26, 2024. The indication for discussion was the use of sabizabulin to slow progression or promote regression of atherosclerotic disease in patients with a history of coronary artery disease. The FDA agreed that there remains an unmet medical need based on disease pathophysiology. Initially, we plan to evaluate sabizabulin in a small Phase 2 dose finding proof of concept study to assess whether sabizabulin reduces blood levels of high sensitivity C-reactive protein, aan important measurement of inflammation, in 45 patients with stable CAD following 3 months of treatment. Veru currently has sufficient drug substance to supply the proposed Phase 2 clinical study in patients with stable CAD to measure levels of high sensitivity C-reactive protein.

During the threenine months ended MarchJune 31,30, 2026, the Company recognized an additional gain on sale of the FC2 business of $351,000, which is for net proceeds received from the Purchaser in the settlement of a dispute related to a pre-closing tax receivable and liability.

The FC2 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 the FC2 business within loss from discontinued operations, net of tax, in the condensed consolidated statements of operations for the three and sixnine months ended MarchJune 31,30, 2025. We did not allocate any amounts for shared general and administrative operating support expense to discontinued operations. The assets and liabilities sold as part of the FC2 Business Sale were written off upon the closing of the FC2 Business Sale, and therefore there are no assets and liabilities of discontinued operations in our condensed consolidated balance sheet as of MarchJune 31,30, 2026 or September 30, 2025.

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 “ONCO Series D Preferred Stock”) and a warrant (the “ONCO Warrant”) to purchase 169,3953,216,344 shares of ONCO’s common stock (the “ONCO WarrantCommon Stock”) (such cash payment, shares of ONCO Series D Preferred Stock, and the ONCO Warrant, collectively, the “Settlement Amount”) in full satisfaction of all amounts due under the ONCO Promissory Notes, as amended by all preceding amendments, forbearance agreements, and waivers, in complete discharge of all obligations thereunder. The ONCO Promissory Notes and the Forbearance Agreement terminated upon payment of the Settlement Amounts.Amount. The Company received proceeds of $3.2$5.0 million from the sale of shares of ONCO’sONCO commonCommon stockStock acquired from the conversion of ONCO Series D Preferred Stock during the threenine months ended MarchJune 31, 2026 and $1.8 million from the sale of shares of ONCO’s common stock acquired from the conversion of ONCO Series D Preferred Stock subsequent to March 31,30, 2026, and after such sales the Company no longer holds any shares of ONCO Series D Preferred Stock. There can be no assurances as to whether and when the Company will be able to receive any cash proceeds from the shares of ONCO Warrant or any shares of ONCO’sONCO commonCommon stockStock that the Company might acquire upon exercise of the ONCO Warrant.

Operating Expenses. Conducting research and development is central to our drug development programs. The Company has several products under development and management routinely evaluates each product in its portfolio of products. Advancement is limited to available working capital and management’s understanding of the prospects for each product. If future prospects do not meet management’s strategic goals, advancement may be discontinued. We have invested and expect to continue to invest significant time and capital in our research and development operations. Our research and development expenses were $3.1$4.4 million and $3.9$3.0 million for the three months ended MarchJune 31,30, 2026 and 2025, respectively, and $4.5$8.8 million and $9.6$12.7 million for the six months ended MarchJune 31,30, 2026 and 2025, respectively. We expect to continue investing significant resources in research and development in the future due to advancement of our drug candidates.

THREE MONTHS ENDED MarchJune 31,30, 2026 COMPARED TO THREE MONTHS ENDED MarchJune 31,30, 2025 Research and development expenses decreasedincreased to $3.1$4.4 million in the three months ended MarchJune 31,30, 2026 from $3.9$3.0 million in the same period in fiscal 2025. The decreaseincrease in research and development expenses is primarily due to reducedincreased personnelexpenses costs,related drivento bythe lowerongoing share-basedPhase compensation2b expense.PLATEAU clinical study.

General and administrative expenses were $4.1$3.4 million in the three months ended MarchJune 31,30, 2026, which is a decrease from $5.2$5.0 million in the three months ended MarchJune 31,30, 2025. The decrease is due primarily to a reduction in corporate personnel costs, primarily due to reduced share-based compensation expense.expense, and a decrease in third-party consulting expenses.

The Company recorded a gain on sale of ENTADFI assets of $1.0$0.5 million in the three months ended MarchJune 31,30, 2025. The Company recognized a gain on sale of ENTADFI assets as nonrefundable consideration was received from the ONCO Promissory Notes. The ONCO Promissory Notes were settled in fiscal 2025 so no additional gain from additional consideration is expected in future periods. Refer to Note 15 to the financial statements included in this report for additional information.

The Company also recorded a gain from the increase in fair value of equity securities of $3.9$0.5 million in the three months ended MarchJune 31,30, 2026. The increase in fair value was driven by realized gain from the conversion of the ONCO Series D Preferred Stock and sale of the underlying ONCO commonCommon stockStock and a change in the fair value of the remaining outstanding ONCO Series D Preferred Stock and the ONCO Warrants, driven by favorable provisions triggered by ONCO’s reverse stock split onin March 25,May 2026.

SixNine MONTHS ENDED MarchJune 31,30, 2026 COMPARED TO SixNine MONTHS ENDED MarchJune 31,30, 2025 Research and development expenses decreased to $4.5$8.8 million in the sixnine months ended MarchJune 31,30, 2026 from $9.6$12.7 million in the same period in fiscal 2025. The decrease in research and development expenses is due primarily to the wind down of the Company’s Phase 2b QUALITY clinical study for enobosarm as a treatment to augment fat loss and to prevent muscle loss, which was completed during fiscal 2025. The Company initiated the Phase 2b PLATEAU clinical study during the three months endedin March 31, 2026. Personnel costs also decreased due primarily to reduced share-based compensation expense.

General and administrative expenses were $8.2$11.5 million in the sixnine months ended MarchJune 31,30, 2026, which is a decrease from $10.4$15.4 million in the sixnine months ended MarchJune 31,30, 2025. The decrease is due primarily to a reduction in corporate personnel costs, due to reduced share-based compensation expense.expense, and a decrease in third-party consulting expenses.

The Company recorded a gain on sale of ENTADFI assets of $1.7$2.2 million in the sixnine months ended MarchJune 31,30, 2025. The Company recognized a gain on sale of ENTADFI assets as nonrefundable consideration was received from the ONCO Promissory Notes. The ONCO Promissory Notes were settled in fiscal 2025 so no additional gain from additional consideration is expected in future periods. Refer to Note 15 to the financial statements included in this report for additional information.

Gain on extinguishment of debt of $8.6 million was recognized during the sixnine months ended MarchJune 31,30, 2025, related to the termination of the Residual Royalty Agreement, in connection with the FC2 Business Sale. The gain was the difference between the change of control payment of $4.2 million and the net carrying amount of the extinguished debt of $12.8 million, which included an embedded derivative for the change of control provision at fair value of $4.7 million.

During the sixnine months ended MarchJune 31,30, 2026, the Company also recorded a gain from the increase in fair value of equity securities of $3.8$4.4 million compared to a loss from a decrease in fair value of equity securities of $0.3 million during the sixnine months ended MarchJune 31,30, 2025. The increase in fair value in the fiscal 2026 period was driven by realized gain from the conversion of the ONCO Series D Preferred Stock and sale of the underlying ONCO commonCommon stockStock and a change in the fair value of the remaining outstanding ONCO Series D Preferred Stock and the ONCO Warrants, driven by favorable provisions triggered by ONCO’s reverse stock splitsplits onin March 25,2026 and May 2026.

Net income from discontinued operations, net of taxes, related to the FC2 business of $351,000$0.4 million for the sixnine months ended MarchJune 31,30, 2026, which is an additional gain on the sale of the FC2 business for net proceeds received from the Purchaser in the settlement of a dispute related to a pre-closing tax receivable and liability. The Company recorded a net loss from discontinued operations, net of taxes, related to the FC2 business of $7.2 million for the sixnine months ended MarchJune 31,30, 2025. The net loss from discontinued operations during the sixnine months ended MarchJune 31,30, 2025 is attributable to the operations of the FC2 business during that period and the recognition of the loss on sale of FC2, initially estimated as $4.2$4.3 million for the sixnine months ended MarchJune 31,30, 2025 and adjusted to $4.1 million in a subsequent quarter during fiscal 2025.

Our cash, cash equivalents, and restricted cash on hand at MarchJune 31,30, 2026 was $27.6$23.9 million, compared to $15.8 million at September 30, 2025. Restricted cash included in this balance is $0.1 million$54,000 at each of MarchJune 31,30, 2026 and September 30, 2025. At MarchJune 31,30, 2026, the Company had working capital of $28.0$21.1 million and stockholders’ equity of $34.8$28.4 million compared to working capital of $11.1 million and stockholders’ equity of $18.3 million as of September 30, 2025. The increase in working capital is primarily due to an increase in cash, cash equivalents, and restricted cash of $11.8$8.1 million, an increase in prepaid expenses of $2.0 million, a decrease in accrued compensation of $1.3 million,million and a decrease in accounts payable of $1.0$1.4 million.

Operating activities used cash of $15.1$20.6 million in the sixnine months ended MarchJune 31,30, 2026. Cash used in operating activities included net loss of $8.1$15.1 million, adjustments to reconcile net loss to net cash used in operating activities totaling a decrease of $2.7$2.5 million and changes in operating assets and liabilities resulting in a decrease of $4.3$3.0 million. Adjustments to net loss primarily consisted of $3.8$4.4 million for the gain from the change in fair value of equity securitiessecurities, andpartially $1.2offset by $1.7 million for share-based compensation. The decrease in cash from changes in operating assets and liabilities primarily included a decrease in accounts payable of $1.6$2.3 million, a decrease in accrued expenses and other liabilities of $1.4$0.3 million, and ana increasedecrease in prepaidoperating expenseslease and other assetsliabilities of $1.1$0.4 million.

Operating activities used cash of $19.1$24.6 million in the sixnine months ended MarchJune 31,30, 2025. Cash used in operating activities included net loss of $16.8$24.2 million, adjustments to reconcile net loss to net cash used in operating activities totaling an increase of $2.5$3.9 million and changes in operating assets and liabilities resulting in a decrease of $4.7$4.3 million. Adjustments to net loss primarily consisted of $4.9$6.6 million for share-based compensation, $4.2$4.3 million for the loss on sale of the FC2 business, $3.1 million for the change in fair value of derivative liabilities, partially offset by the gain on extinguishment of debt of $8.6 million and the gain on sale of ENTADFI assets of $1.7$2.2 million. The decrease in cash from changes in operating assets and liabilities primarily included a decrease in accrued expenses and other current liabilities of $2.6$1.9 million and a decrease in accounts payable of $1.7$1.9 million. The cash flows related to discontinued operations have not been segregated and are included in the consolidated statements of cash flows. Total operating cash flows of discontinued operations for the sixnine months ended MarchJune 31,30, 2025 are outflows of $0.3 million.

Net cash provided by investing activities was $3.5$5.3 million during the sixnine months ended MarchJune 31,30, 2026, and consisted of net proceeds from the sale of equity securities of $3.2$5.0 million and net proceeds of $0.4 million from the sale of the FC2 business for the settlement of a dispute related to a pre-closing tax receivable and liability.

Net cash provided by investing activities was $18.4$18.9 million during the sixnine months ended MarchJune 31,30, 2025, and consisted of net proceeds of $16.3 million from the sale of the FC2 business, proceeds of $1.7$2.2 million from the sale of ENTADFI assets, and proceeds of $0.4 million from the sale of equity securities.

The cash flows related to discontinued operations have not been segregated and are included in the consolidated statements of cash flows. Total investing cash flows of discontinued operations for the sixnine months ended MarchJune 31,30, 2026 and 2025 are inflows of $0.3$0.4 million and $16.2$16.3 million, respectively, which consist of net proceeds from the sale of the FC2 business.

Net cash provided by financing activities in the sixnine months ended MarchJune 31,30, 2026 was $23.4$23.3 million, which consisted primarily of proceeds from the sale of common stock and warrants in an underwritten public offering, net of commissions and costs, of $23.4 million.

Net cash used in financing activities in the sixnine months ended MarchJune 31,30, 2025 was $4.2 million, which represented a change of control payment of $4.2 million to SWK pursuant to the Residual Royalty Agreement, which terminated the Residual Royalty Agreement and extinguished the related debt.

Excluding the change of control payment, the Company made total payments under the Residual Royalty Agreement of $0.3 million during the three and sixnine months ended MarchJune 31,30, 2025. The Company is not required to make any additional payments under the Residual Royalty Agreement.

During the sixnine months ended MarchJune 31,30, 2026 and 2025, we did not sell any shares under the Lincoln Park Purchase Agreement. Since inception of the Lincoln Park Purchase Agreement through MarchJune 31,30, 2026, we sold 302,500 shares of common stock to Lincoln Park resulting in proceeds to the Company of $3.1 million.

The Company has investments in equity securities consisting of the ONCO Warrant as of June 30, 2026 and the ONCO Series D Preferred Stock and the ONCO Warrant as of March 31, 2026 and September 30, 2025. The ONCO Series D Preferred Stock and the ONCO Warrant were received on September 22, 2025 as a settlement of the ONCO Promissory Notes. See Note 15 to the financial statements included in this report for additional information. The Company has elected to measure the ONCO Series D Preferred Stock and the ONCO Warrant at fair value in accordance with ASC 825. The investments in the ONCO Series D Preferred Stock and the ONCO Warrant are classified within Level 3 of the fair value hierarchy because there is no market for these types of securities and the fair value is determined using significant unobservable inputs. The fair value of the ONCO Series D Preferred Stock and the ONCO Warrant have beenwere determined using a Monte Carlo simulation model. This valuation model incorporates the contractual terms of the instruments and assumptions including the stock price of ONCO Common Stock, expected volatility, and a selected discount rate. Additionally, the ONCO Series D Preferred Stock and the ONCO Warrant were issued by ONCO as part of a Securities Purchase Agreement, which included the sale of 16,099 shares of Series D convertible preferred stock and warrants to purchase 4,362,82787,256 shares of ONCO Common Stock to eleven institutional investors, for an aggregate purchase price of $12.9 million. The valuation of the ONCO Series D Preferred Stock and ONCO Warrant at issuance included a calibration discount to the proceeds of the original transaction, which was done at arms’ length. The calibration discount was reduced to zero as of March 31, 2026 aswhen the Company began to convert the ONCO Series D Preferred Stock during the threenine months ended MarchJune 31,30, 2026, which had the effect of increasing the fair value of the ONCO Series D Preferred Stock and the ONCO Warrant. The assumptions used in calculating the fair value of the financial instruments represent the Company’s best estimates, but these estimates involve inherent uncertainties and the application of management judgment. As a result, the use of different estimates or assumptions would result in a higher or lower fair value and different amounts being recorded in the Company’s financial statements. Material changes in any of these inputs could result in a significantly higher or lower fair value measurement at future reporting dates, which could have a material effect on our results of operations. See Note 4 to the financial statements included in this report for additional information.