Veru Stock Earnings Reports

Key points for investors:

- Positive Phase 2b results (Enobosarm + GLP-1): The trial met its primary endpoint showing a statistically significant and clinically meaningful preservation of lean mass versus GLP-1 alone. Enobosarm (3 mg) was highlighted as the best dose for preserving lean mass while shifting total weight loss composition strongly toward fat loss. Functional benefit was also observed (Stair Climb test) with substantial relative reductions in patients experiencing clinically meaningful decline in function.

- Efficacy details: Company reported a 71% preservation of total lean body mass (all enobosarm doses combined vs placebo; p=0.002). The 3 mg dose showed the strongest lean preservation (reported near 99% relative reduction in lean loss). Enobosarm demonstrated dose-dependent greater fat mass loss (6 mg showed a 46% greater relative fat loss vs placebo; p=0.014).

- Safety and monitoring: Aggregate blinded safety data have shown no unexpected signals compared to prior enobosarm studies and expectations for GLP-1s; the independent data monitoring committee recommended continuing the study. Unblinded safety data for the Phase 2b study and efficacy/safety results from the Phase 2b extension maintenance study are expected this quarter.

- Upcoming catalysts and regulatory path: Anticipated near-term catalysts include unblinded safety data, extension study top-line results, and Phase 1 bioavailability data for a modified-release oral enobosarm formulation. An end-of-Phase 2 meeting with FDA is planned for Q3 2025 to obtain regulatory clarity for a Phase 3 program; proposed Phase 3 would target patients ≥60, use Stair Climb as primary endpoint at 24 weeks, and likely include GLP-1s semaglutide and/or tirzepatide.

- Product differentiation and IP: Enobosarm is an oral SARM designed to preserve lean mass while increasing fat loss when added to GLP-1 therapy. Company is developing a novel modified-release oral formulation with potential patent protection into ~2045.

- Financials and runway: Cash, cash equivalents and restricted cash were $20.0M as of March 31, 2025; net R&D spend increased due to the Phase 2b program. Management states cash runway into the fourth calendar quarter but not sufficient to fund operations for the next 12 months under current plan, so additional capital (likely partnerships or other financing) will be required to support Phase 3.

- Strategic outlook and risks: Management is pursuing non-dilutive funding/partnership discussions with larger pharma given the clinical data and commercial potential. Key risks: need to raise funds, FDA discussions may alter Phase 3 size/cost, competition in obesity space (many programs underway), and regulatory acceptance of body-composition/functional endpoints.