Enobosarm

--Company reported positive efficacy and safety data from Phase 2b QUALITY study showing enobosarm added to semaglutide led to preservation of muscle, greater fat loss, and fewer gastrointestinal side effects compared to semaglutide alone-- --Company reported positive efficacy and safety data from Phase 2b QUALITY Maintenance Extension study showing enobosarm significantly reduced body weight regain, prevented fat regain, and preserved lean mass after semaglutide discontinuation-- --Company has selected a novel modified release oral enobosarm formulation following pharmacokinetic clinical study-- --Company anticipates FDA feedback to clarify the regulatory pathway for enobosarm to preserve lean mass during chronic weight loss management-- --Company to host conference call and webcast today at 8:00 a.m. ET-- MIAMI, FL, Aug. 12, 2025 (GLOBE NEWSWIRE) -- Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases, today announced financial results for its fiscal 2025 third quarter and provided an update on progress of its clinical development programs. “We have now reported all the positive efficacy and safety topline results from our Phase 2b QUALITY and Maintenance Extension study, and are looking forward to FDA feedback on the regulatory pathway for enobosarm to be used as an adjunctive therapy with GLP-1 RA to preserve lean mass while burning more fat for chronic weight loss management,” said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. “The efficacy and safety of Veru’s oral agent enobosarm looks better than any of the injectable myostatin inhibitors now under development by our competitors. Unlike our competitors, enobosarm has positive physical function data measured by stair climb power. Furthermore, we have strengthened our intellectual property position with the selection of a novel modified release oral enobosarm formulation confirmed in a clinical pharmacokinetic study.” Enobosarm for Chronic Weight Loss Management Program Phase 2b QUALITY study- enobosarm is a next generation drug that makes GLP-1 RA weight loss more selective for fat loss while preserving lean mass and physical function In January 2025, the Company announced positive topline efficacy results from the Phase 2b QUALITY clinical study, which is a multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed 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 168 older patients (≥60 years of age) receiving semaglutide for chronic weight management. The 3mg enobosarm dose had the best profile to advance into Phase 3 program. Enobosarm 3mg + semaglutide group met the primary endpoint of study with a statistically significant 100% average preservation of total lean mass compared to placebo + semaglutide at 16 weeks (p<0.001). Enobosarm + semaglutide treatment resulted in dose dependent greater loss of fat mass compared to placebo + semaglutide with the enobosarm 6mg dose having a 42% greater relative loss of fat mass compared to placebo + semaglutide group at 16 weeks (p=0.017) and the enobosarm 3mg having a 12% greater fat loss. Even with having preserved lean mass, enobosarm + semaglutide treatment resulted in a similar mean body weight loss as semaglutide alone at 16 weeks. The tissue composition of the total body weight lost was 34% lean mass and 66% fat mass for the placebo + semaglutide group whereas it was 0% lean mass and 100% fat mass for the enobosarm 3mg + semaglutide group.Physical function was measured by the Stair Climb Test. A responder analysis was conducted using a greater than 10% decline in stair climb power as the cut off at 16 weeks which represents an approximate 7 to 8 year loss of stair climb power that naturally occurs with aging. Phase 2b QUALITY clinical trial is the first human study to demonstrate that older patients who are overweight or have obesity receiving semaglutide are at higher risk for accelerated loss of physical function as 44.8% of the placebo + semaglutide group had at least a 10% decline in stair climb power physical function at 16 weeks.Enobosarm treatment preserved lean mass which translated into a reduction in the proportion of patients that had a clinically significant stair climb physical function decline with 17% of the enobosarm 3mg + semaglutide group having at least a 10% decline in stair climb power physical function at 16 weeks which is a 59.8% relative reduction in the proportion of subjects that lost at least 10% stair climb power compared to placebo + semaglutide group (p=0.006).In May 2025, the Company announced that the enobosarm and semaglutide GLP-1 RA combination had a positive safety profile in the Phase 2b QUALITY clinical trial After trial participants completed the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial, 148 participants continued to the Phase 2b Maintenance Extension study, a double-blind study, where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3mg, or enobosarm 6mg as monotherapy for 12 weeks. In June 2025, the Company announced positive topline efficacy and safety results from the maintenance extension portion of the Phase 2b QUALITY clinical study that showed that enobosarm significantly reduced body weight regain, prevented fat regain, and preserved Lean mass after semaglutide discontinuation The 3mg enobosarm monotherapy significantly reduced the body weight regained by 46% after discontinuation of semaglutide. At the end of the Phase 2b QUALITY study active weight loss period of 16 weeks, body weight loss was similar across treatment groups with the semaglutide plus placebo group losing an average of 11.88 lbs.After the 12-week Maintenance Extension study period (Day 112 to Day 196) where all treatment groups discontinued semaglutide, the placebo monotherapy group regained 43% of body weight that was previously lost during the Phase 2b QUALITY for a mean percent change of 2.57% (5.06 lbs) in body weight, compared to 1.41% (2.73 lbs) for the 3mg enobosarm group (p=0.038) and 2.87% (5.29lbs) for the 6mg enobosarm group.The mean tissue composition of body weight regained was 28% fat and 72% lean mass in the placebo group, versus 0% fat and 100% lean mass in both the 3mg and the 6mg enobosarm groups. Enobosarm plus semaglutide followed by enobosarm monotherapy regimen was more effective in preserving lean mass and causing and maintaining greater loss of fat by the end of the study. Placebo plus semaglutide followed by placebo monotherapy group experienced a loss of lean mass, while both enobosarm plus semaglutide followed by enobosarm monotherapy groups (3 mg and 6 mg doses) significantly preserved more than 100% of lean mass (enobosarm 3mg p<0.001 and enobosarm 6mg p=0.004).The enobosarm plus semaglutide followed by enobosarm monotherapy patients had a 58% greater loss of fat with enobosarm 3mg (p=0.085) and a 93% greater loss of fat with enobosarm 6mg (p=0.008) compared to placebo plus semaglutide followed by placebo monotherapy. Adverse events (AEs) and adverse events of special Interest In the double-blind Phase 2b QUALITY Maintenance Extension clinical trial (Day 112-196), enobosarm monotherapy had a positive safety profile. After discontinuation of semaglutide, there were essentially no gastrointestinal side effects, no evidence of drug induced liver injury (by Hy’s law), and no increases in obstructive sleep apnea observed at any dose of enobosarm compared to placebo monotherapy. There were no AEs of increases in prostate specific antigen in men. There were no AEs related to masculinization in women. There were no reports of suicidal ideation observed (Columbia-Suicide Severity Rating Scale). The Phase 2b QUALITY and Maintenance Extension clinical trial confirms that preserving lean mass with enobosarm plus semaglutide led to greater fat loss during the active weight loss period, and after semaglutide was discontinued, enobosarm monotherapy significantly prevented the regain of both weight and fat mass during the maintenance period such that by end of study there was greater loss of fat mass while preserving lean mass for a higher quality weight reduction compared to the placebo group. Novel Modified Release Oral Enobosarm Formulation On August 11, 2025, the Company announced the selection of a novel modified release oral enobosarm formulation following a pharmacokinetic clinical study for chronic weight loss management. The single-dose, open label pilot study evaluated the plasma concentration versus time profile of a proprietary, patentable modified release formulation of enobosarm 3mg. The new formulation demonstrated the intended distinct target product release profile, which includes a reduction in maximum plasma concentration (Cmax), a delayed time to maximum plasma concentration (Tmax), a distinct secondary peak concentration, and similar extent of absorption (AUC) compared to historical values for enobosarm immediate-release capsules. The novel modified release oral enobosarm formulation is planned to be available for further clinical studies and for commercialization. The novel enobosarm oral formulation’s unique manufacturing process is protected by issued global patents with protection through 2037 and the new patents on the novel modified release oral enobosarm formulation have been filed and if issued, expiry is expected to be 2046. Third Quarter Financial Summary: Fiscal 2025 vs Fiscal 2024 Research and development expenses decreased to $3.0 million from $4.8 millionSelling, general and administrative expenses decreased to $5.0 million from $5.8 millionOperating loss from continuing operations decreased to $7.5 million from $10.5 millionNet loss from continuing operations decreased to $7.3 million, or $0.50 per share, compared to $10.3 million, or $0.71 per shareNet loss decreased to $7.3 million, or $0.50 per share, compared to $11.0 million, or $0.75 per share Year-to-Date Financial Summary: Fiscal 2025 vs Fiscal 2024 Research and development expenses increased to $12.7 million from $9.5 millionSelling, general and administrative expenses decreased to $15.4 million from $18.4 millionOperating loss from continuing operations decreased to $25.9 million from $26.8 millionNet loss from continuing operations decreased to $17.0 million, or $1.16 per share, compared to $26.7 million, or $2.04 per shareNet loss decreased to $24.2 million, or $1.65 per share, compared to $29.3 million, or $2.23 per share Balance Sheet InformationCash, cash equivalents, and restricted cash were $15.0 million as of June 30, 2025 versus $24.9 million as of September 30, 2024 Event DetailsThe audio webcast will be accessible under the Home page and Investors page of the Company’s website at www.verupharma.com. To join the conference call via telephone, please dial 1-800-341-1602 (domestic) or 1-412-902-6706 (international) and ask to join the Veru Inc. call. An archived version of the audio webcast will be available for replay on the Company’s website for approximately three months. A telephonic replay will be available at approximately 12:00 p.m. ET by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international), passcode 2184944, for one week. About Veru Inc.Veru is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. The Company’s drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin. Enobosarm, a selective androgen receptor modulator (SARM), is being developed as a next generation drug that makes weight reduction by GLP-1 RA drugs more tissue selective for loss of fat and preservation of lean mass thereby improving body composition and physical function. Sabizabulin, a microtubule disruptor, is being developed for the treatment of inflammation in atherosclerotic cardiovascular disease. Forward-Looking StatementsThis press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to whether and when the full data set, including safety data, from the Phase 2b QUALITY study and Maintenance Extension study of enobosarm discussed above will be made available and whether that data will align with disclosed topline results or change any of the conclusions drawn from the topline data; whether and when the Company will present the full data from the Phase 2b QUALITY study and Maintenance Extension study and in what forum; whether and when the Company will have an end-of-Phase-2 meeting with FDA and the results of any such meeting; whether the results of the Phase 2b QUALITY study and Maintenance Extension study of enobosarm will be replicated to the same or any degree in any future Phase 3 studies; the expected costs, timing, patient population, design, endpoints and results of the planned Phase 3 studies of enobosarm as a body composition drug or any other Phase 3 studies; whether the Company and FDA will align on the Phase 3 program for enobosarm as a body composition drug and whether any such program will be able to be funded by the Company; whether the modified-released formation of enobosarm will be developed successfully and whether such formulation will have the same effectiveness as the current formulation, and whether and when such modified-release formulation will be available for any planned or future clinical studies; whether and when any patents will actually issue regarding such modified-release formulation and what any expiration dates of any such patents might be; whether the Company will be able to obtain sufficient GLP-1 RA drugs in a timely or cost-effective manner in the planned Phase 3 study or other Phase 3 studies; whether FDA will require more than one Phase 3 study for enobosarm as a body composition drug; whether enobosarm will enhance weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will enhance weight loss in any planned or other Phase 3 studies or if approved, in clinical practice; whether patients treated with enobosarm for a longer period of time than in the Phase 2b QUALITY study and Maintenance Extension study will have a greater loss of adiposity or greater weight loss than with semaglutide alone; and whether and when enobosarm will be approved by the FDA as a body composition drug. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward-looking statements contained in this press release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company’s product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the Company’s ability to reach agreement with FDA on study design requirements for the Company’s planned clinical studies, including for the Phase 3 program for enobosarm as a body composition drug and the number of Phase 3 studies to be required and the cost thereof; potential delays in the timing of and results from clinical trials and studies, including as a result of an inability to enroll sufficient numbers of subjects in clinical studies or an inability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the potential for disruptions at the FDA or other government agencies to negatively affect our business; any products of the Company, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations and to enable us to continue as a going concern; demand for, market acceptance of, and competition against any of the Company’s products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; the Company’s ability to protect and enforce its intellectual property; costs and other effects of litigation, including product liability claims, securities litigation, and litigation and other disputes with the purchaser of the Company’s FC2 business; our ability to maintain compliance with the continued listing requirements of the Nasdaq Stock Market, including our ability to regain and subsequently maintain compliance with the Nasdaq minimum bid price requirement after our recently completed reverse stock split; the Company’s ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company’s ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company’s press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2024, and subsequent quarterly reports on Form 10-Q. These documents are available on the “SEC Filings” section of our website at www.verupharma.com/investors. FINANCIAL SCHEDULES FOLLOW Veru Inc.Condensed Consolidated Balance Sheets(unaudited) June 30, September 30, 2025 2024 Cash, cash equivalents, and restricted cash $15,010,154 $24,916,285 Prepaid expenses and other current assets 1,183,023 1,547,928 Current assets of discontinued operations — 8,759,011 Total current assets 16,193,177 35,223,224 Property and equipment, net 393,381 481,372 Operating lease right-of-use assets 2,875,672 3,250,623 Goodwill 6,878,932 6,878,932 Other assets 989,596 989,596 Long-term assets of discontinued operations — 13,595,025 Total assets $27,330,758 $60,418,772 Accounts payable $2,538,724 $2,259,668 Accrued compensation 2,780,570 4,494,278 Accrued expenses and other current liabilities 1,362,721 1,406,655 Residual royalty agreement liability, short-term portion — 1,025,837 Current liabilities of discontinued operations — 2,681,530 Total current liabilities 6,682,015 11,867,968 Residual royalty agreement liability, long-term portion — 8,850,792 Operating lease liability, long-term portion 2,500,736 2,905,309 Other liabilities 2,803,374 4,477,991 Total liabilities 11,986,125 28,102,060 Total stockholders' equity 15,344,633 32,316,712 Total liabilities and stockholders' equity $27,330,758 $60,418,772 Veru Inc.Condensed Consolidated Statements of Operations(unaudited) Three Months Ended Nine Months Ended June 30, June 30, 2025 2024 2025 2024 Operating expenses: Research and development $3,020,563 $4,846,156 $12,669,495 $9,489,848 Selling, general and administrative 5,010,528 5,809,325 15,402,074 18,364,622 Total operating expenses 8,031,091 10,655,481 28,071,569 27,854,470 Gain on sale of ENTADFI® assets 484,615 110,000 2,154,134 1,028,372 Operating loss (7,546,476) (10,545,481) (25,917,435) (26,826,098) Non-operating income: Gain on extinguishment of debt — — 8,624,778 — Other non-operating income, net 223,375 205,425 307,260 115,561 Total non-operating income 223,375 205,425 8,932,038 115,561 Net loss from continuing operations (7,323,101) (10,340,056) (16,985,397) (26,710,537)Net loss from discontinued operations, net of taxes (9,719) (628,818) (7,194,389) (2,560,266)Net loss $(7,332,820) $(10,968,874) $(24,179,786) $(29,270,803) Net loss from continuing operations per basic and diluted common shares outstanding $(0.50) $(0.71) $(1.16) $(2.04)Net loss from discontinued operations per basic and diluted common shares outstanding $(0.00) $(0.04) $(0.49) $(0.20)Net loss per basic and diluted common shares outstanding $(0.50) $(0.75) $(1.65) $(2.23) Basic and diluted weighted average common shares outstanding 14,657,777 14,638,317 14,644,927 13,101,071 Veru Inc.Condensed Consolidated Statements of Cash Flows(unaudited) Nine Months Ended June 30, 2025 2024 Net loss $(24,179,786) $(29,270,803) Adjustments to reconcile net loss to net cash used in operating activities 3,920,100 12,177,598 Changes in operating assets and liabilities (4,292,066) (223,034) Net cash used in operating activities (24,551,752) (17,316,239) Net cash provided by investing activities 18,867,232 14,714 Net cash (used in) provided by financing activities (4,221,611) 36,826,910 Net (decrease) increase in cash, cash equivalents, and restricted cash (9,906,131) 19,525,385 Cash, cash equivalents and restricted cash at beginning of period 24,916,285 9,625,494 Cash, cash equivalents and restricted cash at end of period $15,010,154 $29,150,879 Investor and Media Contact:Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: veruinvestor@verupharma.com

Many survey respondents reported taking steps that could help to mitigate muscle wasting due to GLP-1 usage. As Miami-based Veru continues development of its enobosarm to prevent muscle wasting in patients being treated for obesity, among other conditions, the biopharma has conducted a survey showing that the side effect looms large in the minds of GLP-1 users.The survey took place in May and comprised 1,000 adults in the U.S. taking GLP-1 receptor agonists (RAs).When asked about how concerned they were about various side effects of the medications, 36% rated their perceived risk of experiencing muscle loss or weakness as “moderate,” “high” or “very high.”Only 15% of respondents said they’d actually experienced muscle loss or weakness as a side effect of a GLP-1 as of the time of the survey, but Veru flagged two asterisks to that finding. For one, nearly one-third of respondents aged 60 and up said they’d experienced the side effect, more than double the overall group’s percentage. And the results remain significant even when looking at the full cohort, per the company, since more than 80% of those surveyed were under the age of 60, a group in whom muscle loss can take months or years before becoming noticeable.Many respondents reported taking steps that could help to mitigate muscle wasting due to GLP-1 usage. When asked about what dietary measures they’re taking to stay healthy, if any, 36% said they follow a high-protein diet, and more than half said they’ve upped their intake of lean proteins, along with other whole foods; as Veru noted, “protein is crucial for building and maintaining lean muscle mass.”Most of those surveyed also reported engaging in some sort of regular exercise to stay healthy, including just under 40% who do strength or resistance training, another proven tool for mitigating lean mass decline. With the survey respondents citing their doctors as the most popular resource for information about GLP-1s, Veru encouraged healthcare professionals to discuss muscle loss as a potential risk of starting GLP-1 treatment and educate patients about possible ways to mitigate that risk.“It is evident that patients are aware of the substantial risk that GLP-1 RAs pose to their muscle mass and physical function,” Veru CEO Mitchell Steiner, M.D., said in a statement. “While diet and exercise are instrumental in combating lean mass decline, there is a mounting need—especially among the senior population—for treatments that can address the muscle loss which accompanies GLP-1 RAs. It is imperative that patients are presented with all the measures at their disposal to protect their long-term well-being.”Veru is certainly hoping that, at some point down the line, its enobosarm will be included among those measures.The drug has previously been tested as a method for reducing muscle wasting in patients being treated for cancer and virus-induced acute respiratory distress syndrome. Its current focus, however, is in combination with approved GLP-1 meds.Phase 2b study results released earlier this year showed a statistically significant reduction in loss of lean mass in people who took the oral selective androgen receptor modulator alongside Novo Nordisk’s Wegovy: That group reported an average 1.2% reduction in lean mass after 16 weeks, compared to 4.1% in those taking only Wegovy. The drug was also linked to a greater reduction in total fat loss, a secondary endpoint of the study, with an average 10.9% reduction among the combo group versus 8.6% among the participants on placebo.Veru has requested a meeting with the FDA to plan out a phase 3 study for enobosarm. As of late June, the request has been granted, though the company didn’t specify the meeting’s date in that announcement, which also included results from a maintenance extension of the phase 2b study showing that the company’s drug “completely prevented fat regain and preserved lean mass in both enobosarm dose groups compared to placebo” 12 weeks after patients stopped taking Wegovy.