Veru Inc.

What they do

Veru develops enobosarm, an oral selective androgen receptor modulator (SARM), as a combination therapy with GLP-1 receptor agonists to preserve lean mass and physical function while augmenting fat loss in older patients with obesity. It also develops sabizabulin, a microtubule disruptor, for inflammation in atherosclerotic cardiovascular disease. The company sold its FDA-approved FC2 Female Condom business on December 30, 2024, and now operates without commercial revenue, relying on clinical trial execution and external capital.

Revenue drivers

• FC2 Female Condom business (divested) — The company's only FDA-approved commercial product, sold on December 30, 2024; it previously generated reported revenue of $16.9M in 2024, $16.3M in 2023 and $39.4M in 2022.
• Enobosarm obesity program — Pre-commercial; being developed in combination with semaglutide for high quality weight loss. No product revenue to date; management states the company currently has no commercial revenue.
• Sabizabulin cardiovascular program — Pre-commercial; in development for chronic inflammation related to atherosclerotic cardiovascular disease. No product revenue to date.

Recent performance

For fiscal 2026 third quarter ended June 30, 2026, no revenue was reported, consistent with $0.00 quarterly revenue in the March 31, 2025 and June 30, 2025 periods shown. Annual revenue fell from $42.6M in 2020 and $61.3M in 2021 to $16.3M in 2023 and $16.9M in 2024, reflecting the contraction of the FC2 business. Net losses were $84.0M in 2022, $93.2M in 2023, $37.8M in 2024 and $22.7M in 2025, with operating cash use of $88.0M, $21.7M and $30.0M in 2023, 2024 and 2025 respectively. As of June 30, 2026, Veru reported total assets of $37.0M, total liabilities of $8.7M, shareholder equity of $28.4M and cash and equivalents of $23.9M. The company effected a 1-for-10 reverse stock split on August 8, 2025.

Strategy

Veru's strategy is to develop and commercialize novel medicines for metabolic diseases, principally enobosarm as a combination therapy with GLP-1 receptor agonists for tissue-selective weight reduction in older patients with obesity. The company fully enrolled 239 patients in the Phase 2b PLATEAU trial of enobosarm plus semaglutide, exceeding its targeted 200 patients, and stated an interim analysis is on track for calendar Q1 2027. Veru entered a clinical supply agreement with Novo Nordisk in June 2026 and announced in August 2026 a USPTO notice of allowance for a key U.S. patent covering enobosarm with semaglutide, which management says would provide U.S. patent protection until at least October 2044. Management has stated it will need substantial capital to support drug development and any commercialization efforts.

Risks

• No commercial revenue — Veru states it currently has no commercial revenue and may never generate revenue or become profitable after divesting the FC2 business.
• Clinical trial delays — The company warns it could experience delays or unanticipated costs in its enobosarm obesity program and in the sabizabulin cardiovascular program if the FDA does not accept its trial design.
• Data may change — Interim, preliminary and topline data the company announces may change as more data become available and are subject to audit and verification that could result in material changes.
• Third-party dependence — Veru relies on contract research organizations to conduct research and development and on third-party manufacturers for its drug candidates.

Outlook

Management said full enrollment of the 239-patient Phase 2b PLATEAU trial marks an important milestone and that it remains on track to report interim analysis results, assessing lean body mass and fat mass by DXA after 32 weeks, in the first quarter of calendar year 2027. Final topline clinical data from the 68-week study is expected in the fourth quarter of calendar year 2027. The primary endpoint is percent change from baseline in total body weight, with key secondary endpoints including total fat mass, total lean mass, stair climb physical function, mobility disability, bone mineral density and patient-reported outcomes.