Veru Stock Earnings Reports

Key points for investors: Veru is focused on two clinical-stage small molecules, with investor attention today on Novosarm (an oral selective androgen receptor modulator) being developed to augment GLP-1 receptor agonist–induced weight loss by selectively promoting fat loss while preserving lean mass, physical function and bone mineral density. A positive Phase 2b quality study (168 older patients) provided proof-of-concept. In a September 2025 FDA meeting, regulators outlined two potential approval pathways for Novosarm when added to a GLP-1: (1) ≥5% placebo-corrected incremental weight loss at 52 weeks, or (2) if incremental weight loss is <5%, demonstration of a clinically meaningful and statistically significant preservation/improvement in physical function could support approval. FDA confirmed 3 mg as an acceptable Novosarm dose. The company also notes a relevant FDA decision that hip BMD (DEXA) can serve as a validated surrogate endpoint in postmenopausal osteoporosis, which could create an alternative regulatory pathway for Novosarm focused on bone mineral density in at-risk women on GLP-1 therapy. Veru plans to initiate the randomized, double-blind Phase 2b PLATO trial (~200 patients ≥65 years with BMI ≥35) combining Novosarm 3 mg with semaglutide; primary endpoint is percent change in total body weight at 68 weeks, with an interim DEXA-based analysis of lean mass and fat mass at 34 weeks. Semaglutide (injectable) was chosen to align with prior data; oral semaglutide remains an option for later bridging. There is no futility or sample-size re-estimation tied to the interim analysis. Financials: Veru completed a $23.4M net underwritten offering in October 2025; cash and equivalents were $33.0M as of Dec 31, 2025, with net working capital ~$29.7M. Q1 FY2026 results: R&D costs declined (wind-down of prior Phase 2b trial), G&A modestly down, net loss $5.3M ($0.26/share) vs. $8.9M prior-year quarter. Management states current cash is expected to fund operations through the planned interim DEXA analysis in PLATO. Key risks remain typical for clinical-stage biopharma, including execution of PLATO, regulatory outcomes, and future financing needs.