Veru Participates in a Virtual Investor KOL Connect Segment
-- Moderated discussion with preeminent obesity expert, Louis J. Aronne, MD, FACP and Mitchell Steiner, M.D., F.A.C.S, President, CEO, and Founder, of Veru --
MIAMI, FL, May 08, 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 the release of a Virtual Investor KOL segment featuring Louis J. Aronne, MD, FACP.
As part of the segment, Mitchell Steiner, M.D., F.A.C.S, President, CEO, and Founder, of Veru and Dr. Aronne discussed obesity and GLP-1s, the current treatment landscape and areas of unmet need, highlighting Veru's lead program, the Enobosarm Phase 2b QUALITY study, and the topline clinical data released by Veru to date.
The Virtual Investor KOL Segment featuring Veru is now available here.
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 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 whether and when the unblinded safety data from the Phase 2b QUALITY study of enobosarm and the topline efficacy and safety data from the Phase 2b extension maintenance study will be made available and whether that data will align with previously disclosed topline results or change any of the conclusions drawn from previously disclosed topline data; whether and when Veru will present the full data from the Phase 2b QUALITY study or the Phase 2b extension maintenance study and in what forum; whether the Phase 2b extension study will successfully meet any of its endpoints, including whether such study will show that enobosarm may help prevent fat regain; whether and when Veru 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 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 Veru 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 Veru; whether the modified-released formation of enobosarm will be developed successfully, whether and when the Phase 1 study of formulation will begin, 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, including any Phase 3 program for enobosarm; whether Veru 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 will have a greater loss of adiposity or greater weight loss than with semaglutide alone; whether and when enobosarm will be approved by the FDA as a body composition drug; whether and when sabizabulin will be developed for an atherosclerotic coronary artery disease indication ("CAD"), and whether sabizabulin would provide a safer, effective alternative to colchicine; whether prior data regarding sabizabulin's anti-inflammatory effects would be repeated in any such future CAD indication; the timing of the completion of tox studies and the submission of an IND for sabizabulin in a CAD indication; 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 and reflect Veru's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. Veru 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 Veru's product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; Veru's ability to reach agreement with FDA on study design requirements for Veru'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 Veru; 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 Veru, if approved, possibly not being commercially successful; the ability of Veru to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of Veru'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; Veru's ability to protect and enforce its intellectual property; costs and other effects of litigation, including product liability claims and securities litigation; Veru's ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; Veru's ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in Veru's press releases, shareholder communications and Securities and Exchange Commission filings, including Veru'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 Fisch
Executive Director, Investor Relations and Corporate Communications
Email: [email protected]
