Enobosarm

MIAMI, FL, Dec. 04, 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 multiple presentations at The Society on Sarcopenia, Cachexia, and Wasting Disorders (SCWD) 18th International Conference, and the SCWD’s Regulatory and Clinical Trials Update Regulatory Workshop, both in Rome, Italy. 18th International Conference of the Society on Sarcopenia, Cachexia, and Wasting Disorders Program Session P: Weight loss drugs and cardiovascular healthPresenter: Mitchell Steiner, Veru Inc.’s Chairman, President & CEOSession Date: December 12, 2025Presentation Number: P3Presentation Name: The Veru ExperiencePresentation Time: 4:30 pm – 4:45 pm Central European TimePresentation Location: Hall A, A. Roma Lifestyle Hotel, Rome, Italy Program Session U: THERAPEUTICS, Novel strategies to address sarcopenia while treating obesity - round table discussionPresenter: Mitchell Steiner, Veru Inc.’s Chairman, President & CEO Session Date: December 13, 2025Presentation Number: U3Presentation Name: EnobosarmPresentation Time: 10:00 am - 10:15 am Central European TimePresentation Location: Hall A, A. Roma Lifestyle Hotel, Rome, Italy Additional information on the meeting can be found on the following website: https://society-scwd.org/annual-conference/ SCWD Regulatory and Clinical Trials Update - Regulatory Workshop Presentation Name: Treatment Approaches to Address Muscle Wasting in the Context of Obesity Therapy & Regulatory IssuesTherapeutic approaches to prevent/counteract skeletal muscle loss during incretin therapy – drugs, trial designs, and endpoints. Comments from industry representatives: Lilly approachVeru approach: Mitchell Steiner, Veru Inc.’s Chairman, President & CEOActimed approachRegeneron approach Academic discussants Regulatory considerations: EMA+FDA representativesGeneral discussionSession Date: December 11, 2025Session Number: C2Session Time: 10:15 am - 11:15 am Central European TimeSession Location: A.Roma Lifestyle Hotel, Rome, Italy Presentation Name: Possible Endpoints for Regulatory Approval of Treatments Addressing Muscle Wasting in the Context of Obesity Therapy Reviewing possible endpointsIndustry viewpoint: Mitchell Steiner, Veru Inc.’s Chairman, President & CEORegulatory considerationsGeneral discussion Session Date: December 11, 2025Session Number: C3Session Time: 11:15 am - 11:55 am Central European TimeSession Location: A.Roma Lifestyle Hotel, Rome, Italy 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 leading to improved body composition and physical function with expected clinically meaningful incremental weight reduction versus GLP-1 RA monotherapy. Sabizabulin, a microtubule disruptor, is being developed for the treatment of inflammation in atherosclerotic cardiovascular disease. Enobosarm Obesity Program - Enobosarm is a next generation drug that makes weight reduction by GLP-1 RA more tissue selective for fat loss – Phase 2b QUALITY clinical studyThe Phase 2b QUALITY clinical study was a positive 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 (Wegovy®) for weight reduction. After completing the efficacy dose-finding portion of the Phase 2b QUALITY clinical trial ended at 16 weeks, participants continued into a Phase 2b maintenance extension study where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3mg, or enobosarm 6mg as monotherapy in a double-blind fashion for 12 weeks. The Phase 2b QUALITY and Maintenance Extension clinical trial was a positive study that demonstrated that preserving lean mass and physical function with enobosarm plus semaglutide led to greater fat loss during the 16 week active weight loss period. While weight loss was similar across treatment groups in this short 16 week study, we anticipate that preservation of lean mass and function will lead to increased energy expenditure, and this effect coupled with the direct effects of enobosarm on the additional selective reduction in fat mass will result in incremental weight reduction in a longer clinical study in patients who have obesity. Planned Phase 2b PLATEAU clinical studyVeru’s planned Phase 2b PLATEAU clinical study will evaluate the effect of enobosarm 3mg on total body weight, physical function, and safety in approximately 200 patients who have obesity (BMI ≥ 35) and are initiating 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 72 weeks. An interim analysis will be conducted at 36 weeks to assess the percent change from baseline in lean body mass and fat mass, as measured by DEXA scans. The key secondary endpoints are total fat mass, total lean mass, physical function (stair climb test), bone mineral density, and patient reported outcome questionnaires for physical function (SF-36 PF-10, and IWQOL-lite CT physical function). 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 72 weeks. The clinical study is expected to begin in calendar Q1 2026. 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 the planned design, enrollment, timing, commencement, interim and full data readout timing, scope and regulatory pathways for the continued development of enobosarm in patients with obesity, including the planned PLATEAU Phase 2b study; whether clinically meaningful incremental weight loss in the PLATEAU Phase 2b study will continue to be seen as an acceptable primary endpoint by the FDA to support potential approval; whether the FDA will continue to accept 3mg as an acceptable dosage for enobosarm in the planned PLATEAU Phase 2b study or in any other studies; whether the FDA will further evolve its position on the acceptable patient population for the PLATEAU Phase 2b study or any other future studies; whether the Company will be able to partner with any other company in the development of enobosarm; whether the results of the Phase 2b QUALITY study and the extension maintenance study of enobosarm, including weight loss, preservation of lean mass and function, will be replicated to the same or any degree in the planned PLATEAU Phase 2b study or in any future Phase 3 studies; whether patients treated with enobosarm in the planned PLATEAU Phase 2B study will exhibit increased energy and whether such effects will result in incremental weight reduction; the expected costs, timing, patient population, design, endpoints and results of the planned PLATEAU Phase 2b study or any future Phase 3 studies of enobosarm in patients with obesity; whether the Company will be able to raise sufficient capital, dilutive or otherwise, to fund the PLATEAU Phase 2b study of enobosarm in patients with obesity or any other studies; whether the Company will be able to recruit a sufficient number of patients in a timely manner for the PLATEAU Phase 2b study; whether the Company will be able to obtain sufficient GLP-1 RA drugs in a timely or cost-effective manner in the planned PLATEAU Phase 2b study or any future Phase 3 studies; whether the Company will be able to engage clinical research organizations and recruit patients for the PLATEAU Phase 2b program and in a timely or cost-effective manner; whether enobosarm will cause weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will cause weight loss in the planned PLATEAU Phase 2b study or any future Phase 3 studies or, if approved and commercialized, in clinical practice; whether patients treated with enobosarm for a longer period of time than in the Phase 2b QUALITY study will experience weight loss or have a greater loss of adiposity or greater weight loss than with GLP-1 RA drug alone; whether and when enobosarm will be approved by the FDA as a weight loss drug or a body composition drug or any other type of drug; and whether and when the Company will be able to further advance the development of sabizabulin in atherosclerotic disease. 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 2b program for enobosarm as a weight loss or body composition drug and the number of future 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, including as a result of a future shutdown of the U.S. government; any products of the Company, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing, including any partnership or collaboration agreements, 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 regulatory challenges, product liability claims, intellectual property, securities litigation and litigation with the purchaser of the Company’s FC2 business; 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. Wegovy® is a registered trademark of Novo Nordisk A/S. Investor and Media Contact:Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: veruinvestor@verupharma.com

MIAMI, FL, Oct. 30, 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, announced today the pricing of an underwritten public offering of (i) 1,400,000 shares of its common stock, (ii) pre-funded warrants to purchase up to 7,000,000 shares of its common stock, and (iii) accompanying Series A warrants to purchase up to 8,400,000 shares of common stock and accompanying Series B warrants to purchase up to 8,400,000 shares of common stock. The combined public offering price of each share of common stock, accompanying Series A warrant and accompanying Series B warrant is $3.00. For investors who elect to purchase pre-funded warrants in lieu of common stock, the combined public offering price for each pre-funded warrant, accompanying Series A warrant and accompanying Series B warrant is $2.999, which equals the combined price at which shares of common stock, accompanying Series A warrants and accompanying Series B warrants are being sold in the offering, minus $0.001, the per share exercise price of each pre-funded warrant. All of the securities being sold in the offering are being sold by Veru. The offering is expected to close on or about October 31, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds to Veru from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $25.2 million. If all of the warrants sold in this offering were to be exercised in cash at their exercise price, Veru would receive additional gross proceeds of approximately $50.4 million, before deducting expenses and fees. Veru intends to use the net proceeds from the proposed offering to fund the development of enobosarm, with a primary focus on Phase 2b PLATEAU clinical study activities. Some of the proceeds will also be used for working capital purposes, including existing vendor obligations, and for other general corporate purposes including working with potential development partners for enobosarm. Canaccord Genuity LLC and Oppenheimer & Co. Inc. are acting as joint book-running managers for the offering. The shares of common stock, pre-funded warrants and accompanying Series A warrants and Series B warrants, and shares of common stock issuable upon exercise of the pre-funded warrants, Series A warrants and Series B warrants, are being offered by Veru pursuant to a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC) on March 16, 2023 which was amended on April 11, 2023 and declared effective by the SEC on April 14, 2023. This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A final prospectus supplement related to the offering will be filed with the SEC, and will be available on the website of the SEC at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained when available by contacting Canaccord Genuity LLC, Attention: Syndication Department, One Post Office Square, Suite 3000, Boston, Massachusetts 02109, or by telephone at (617) 371-3900, or by email at prospectus@cgf.com; or Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, or by telephone at (212) 667-8055, or by email at EquityProspectus@opco.com. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction. About Veru Inc. Veru Inc. is a late clinical stage biopharmaceutical company focused on developing innovative medicines for the treatment of cardiometabolic and inflammatory diseases. Cautionary Statement on Forward Looking Statements This 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 Veru’s expectations regarding the timing of the proposed public offering, the size and expected gross proceeds from the offering and the anticipated use of proceeds from the proposed offering. 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 Veru Inc. (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 current 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, uncertainties related to market conditions and the satisfaction of customary closing conditions related to the proposed public offering and the Company’s expectations regarding the completion, timing and size of the proposed public offering and the use of proceeds therefrom. This list is not exhaustive and other risks are detailed in the Company’s periodic reports filed with the SEC, including the Company's Form 10-K for the year ended September 30, 2024 and subsequent Quarterly Reports on Form 10-Q. Investor and Media Contact:Samuel FischExecutive Director, Investor Relations and Corporate CommunicationsEmail: veruinvestor@verupharma.com