Veru Inc. Q3 FY2025 earnings call

• Drug Development: Inovasaram showed in Phase 2b studies preservation of lean mass and greater fat loss when combined with semaglutide. The maintenance extension study showed Inovasaram prevented weight and fat regain after semaglutide discontinuation. - Formulation: Selected a novel modified release oral formulation for Inovasaram with positive PK profile, planned for Phase III and commercialization. - Regulatory: Scheduled end-of-Phase III/Phase II FDA meeting this quarter; discussed FDA comments on clinical program design, including physical function as a key endpoint and focus on older adult patient population.

Veru is a late clinical-stage biopharmaceutical company focused on chronic weight loss management with drug candidates Inovasaram and sebisibulin. For the three months ended 06/30/2025, research and development costs decreased to $3,000,000 from $4,800,000 prior quarter; selling, general and administrative expenses were $5,000,000 vs $5,800,000; net loss from continuing operations was $7,300,000. For the nine months ended 06/30/2025, research and development costs increased to $12,700,000 from $9,500,000; selling, general and administrative expenses were $15,400,000 vs $18,400,000; net loss from continuing operations was $17,000,000. The company focuses on its chronic weight loss program with key results from Phase 2b studies.

• Expect regulatory clarity from the end-of-Phase III/Phase II FDA meeting this quarter. - Phase III clinical program focused on older population at high risk for muscle weakness and falls. - Targeting obesity week for abstract submissions with additional data.

• Uncertainties in regulatory approval processes. - Potential challenges in maintaining patent protection and defending against generic competition. - Risks associated with drug development, including safety and efficacy concerns in clinical trials.

Q: On modified release formulation of Inovasaram and partnering updates A: Modified release allows fixed dose combinations with oral GLP-1s, ongoing partnership discussions with potential partners in big pharma and others working on GLP-1s.

Q: FDA meeting expectations and Phase III design A: FDA likely expects physical function as a key endpoint, potential expansion to younger patients; Phase III design includes dechallenge and rescue portions to assess efficacy and safety.

Q: New formulation patent defensibility A: Novel formulation with composition of matter patents, method of use patents, and formulation patents, considered highly defensible against generics.

Q: Phase III trial patient population and comorbidities A: Focus on older population over 60, with consideration of sarcopenia, osteoporosis, and bone health; patient population selected for informative muscle and bone loss assessment.

Q: Capital needs for Phase III A: Need to wait for FDA feedback to determine exact capital needs, but estimated around $40M for 18 months based on Phase 2b effect size.