Veru Reports Fiscal Year 2025 Financial Results and Clinical Program Progress (Form 8-K)

Veru Reports Fiscal Year 2025 Financial Results and Clinical Program Progress

- Following positive efficacy and safety results from Phase 2b QUALITY study, company received FDA regulatory clarity for enobosarm in combination with GLP-1 RA -

- Incremental weight loss is an acceptable approvable primary endpoint with key secondary endpoints on physical function and body composition improvements -

- Company plans to initiate Phase 2 PLATEAU clinical study in calendar Q1 2026 -

- Post fiscal year end, company completed public offering for net proceeds of approximately $23.4 million -

-Company to host conference call and webcast today at 8:00 a.m. ET--

MIAMI, FL - December 17, 2025 - 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 year 2025 ended September 30, 2025 and provided an update on the clinical progress of its obesity program.

"The current FDA regulatory guidance for muscle preservation drugs in combination with GLP-1 RA drugs in the treatment of obesity seems particularly well aligned for enobosarm," said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru. "The FDA defines obesity as a disease of excess body fat, and as such, the medical objective to treat obesity should be to reduce excess body fat, NOT to reduce lean mass. Although GLP-1 RAs have demonstrated profound weight loss results, the strategy for the next generation of obesity drugs should be a combination therapy with GLP-1 RAs for patients to ONLY lose fat, while preserving lean mass and physical function for a quality weight reduction. The completed positive Phase 2b QUALITY clinical trial provided the proof of concept that enobosarm could be that next generation drug in combination with a GLP-1 receptor agonist to make the weight loss journey more selective for only fat while preserving lean mass and physical function in older patients who have obesity lessening the potential risk of loss of balance, and fractures."

Dr. Steiner added: "An emerging, common, and serious clinical and therapeutic challenge with GLP-1 RA monotherapy is that 88% of patients with obesity after one year on drug hit a weight loss plateau where they stop losing additional weight while on a GLP-1 RA. Unfortunately, 62.6% of these patients still had clinical obesity at the time they reached the weight loss plateau based on the SURMOUNT-1 study. Loss of muscle may stimulate these patients to consume more calories and may be an important reason why patients hit the weight loss plateau. The Phase 2b PLATEAU clinical trial is designed to address this problem, especially in older patients, by testing a novel combination of enobosarm and a GLP-1 RA. Enobosarm has been shown to directly burn fat and preserve muscle to increase physical function and burn more calories which could help to break through the weight loss plateau leading to incremental weight reduction. With our public offering now completed, the Phase 2b PLATEAU clinical trial is expected to start Q1 calendar year 2026 with interim analysis results anticipated Q1 calendar year 2027."

Enobosarm for chronic weight reduction 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 was a multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial designed to evaluate the safety and efficacy of enobosarm 3 mg, enobosarm 6 mg, or placebo as a treatment to increase fat loss and to prevent the loss of muscle in 168 older patients (≥60 years of age) receiving a GLP-1 RA (semaglutide) for chronic weight loss.

Highlights from the Phase 2b QUALITY clinical trial focusing on 3 mg enobosarm dose that has been selected by the Company and agreed upon by FDA for the PLATEAU clinical trial

Efficacy

The results for the 16 week active weight loss period of treatment with enobosarm 3 mg or placebo in combination with semaglutide:

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Results for the Maintenance Extension portion of the study, where all patients discontinued semaglutide treatment, but continued receiving placebo, enobosarm 3 mg as monotherapy for 12 weeks:

Safety

At the end of the 16 week active weight loss period, enobosarm and semaglutide combination had a positive safety profile and enobosarm did not have any added gastrointestinal (GI) adverse events compared to semaglutide alone. For the Maintenance Extension clinical trial, where semaglutide was stopped for 12 weeks, enobosarm monotherapy also had a positive safety profile. After discontinuation of semaglutide, there were essentially no GI side effects, no evidence of drug induced liver injury, and no increases in obstructive sleep apnea observed at any dose of enobosarm compared to placebo monotherapy. There were no AEs related to masculinization in women. There were no AEs of increases in prostate specific antigen in men.

Summary

The Phase 2b QUALITY 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 such that by the end of the 28 week study there was greater loss of fat mass while preserving lean mass for a higher quality weight reduction compared to the placebo group.

FDA Regulatory Feedback

In September 2025, the Company announced a successful FDA meeting providing regulatory clarity for enobosarm in combination with GLP-1 RA for greater weight loss in the treatment of obesity

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Highlights from September 2025 FDA meeting

Incremental weight loss: According to FDA feedback on Veru's clinical development program for enobosarm, FDA has guided us that there are at least 2 possible regulatory pathways forward for the development of enobosarm in combination with a GLP-1 RA and are based on incremental weight loss. First, incremental weight loss with at least a 5% placebo-corrected weight loss difference at 52 weeks of maintenance treatment with enobosarm in combination with a GLP-1 RA treatment compared to the GLP-1 RA treatment alone is an acceptable primary endpoint to support efficacy for approval. Second, if incremental weight loss difference of <5% (including similar weight loss) is observed at 52 weeks of maintenance treatment with a clinically significant positive benefit, such as clinically beneficial preservation in physical function, enobosarm in combination with GLP-1 RA may also be acceptable to support efficacy for approval.

Enobosarm dose - FDA confirmed that enobosarm 3 mg is an acceptable dosage for future Veru clinical development.

Planned Phase 2b PLATEAU clinical study

The planned Phase 2b PLATEAU clinical trial will measure incremental weight loss in this enriched patient population that has more weight to lose (BMI ≥ 35) and more at risk for physical decline and functional limitations (age ≥ 65) to better inform the design of the Phase 3 development program. For the planned Phase 2b PLATEAU clinical trial, we will evaluate the effect of enobosarm 3 mg on total body weight, physical function, and safety in approximately 200 patients who have obesity (BMI ≥ 35) and are older (age ≥ 65) and are initiating GLP-1 RA treatment for weight reduction. The primary efficacy endpoint of the study will be 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 scan. Since we want to continue to evaluate enobosarm as a muscle preserving and body composition drug, the key secondary endpoints will be function endpoints, physical function (stair climb test), mobility disability status (functional limitations), and patient reported outcome questionnaires for physical function (SF-36 PF-10, and IWQOL-lite CT physical function) as well as body composition endpoints, total fat mass, total lean mass, and bone mineral density.

Building on the Phase 2 QUALITY study and with greater FDA regulatory clarity, we have designed the Phase 2b PLATEAU clinical study to assess the ability of enobosarm treatment to break through the weight loss plateau in older patients (age ≥ 65) with obesity (BMI ≥ 35) receiving GLP-1 RA treatment with the expectation that patients will achieve clinically meaningful incremental weight reduction and preserve muscle mass and physical function at 52 weeks of GLP-1 weight reduction maintenance dose.

Full Year Financial Summary: Fiscal 2025 vs Fiscal 2024

Balance Sheet Information

Event Details

The 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 1-855-669-9658 (domestic) or 1-412-317-0088 (international), passcode 2225332, for one week.

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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 in combination with GLP-1 RA results in higher quality weight reduction

The 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 3 mg, enobosarm 6 mg, 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 3 mg, or enobosarm 6 mg 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.