Veru Inc. Q1 FY2026 earnings call

• Veru is a late clinical-stage biopharmaceutical focused on developing novel medicines for cardiometabolic and inflammatory diseases, with drug development programs for Novosarm and cabozantinib.
• Completed a positive Phase 2b quality clinical trial for Novosarm in combination with a GLP-1 receptor agonist, showing selective fat loss and preservation of lean mass.
• FDA provided regulatory clarity for Novosarm in combination with GLP-1 for obesity, with two possible approval pathways: incremental weight loss or preservation of physical function.
• FDA updated hip bone mineral density as a validated surrogate endpoint, relevant for Novosarm's obesity program as it preserves BMD.
• Planned Phase 2b PLATO clinical study to begin this quarter, evaluating weight loss, fat/lean mass, physical function, and BMD in older patients with obesity, with an interim analysis at 34 weeks in 2027.
• Financial highlights: $23.4M net proceeds from an underwritten public offering, research and development costs decreased, general and administrative expenses decreased, and net loss improved compared to the prior year quarter.

Veru Inc. is a late clinical-stage biopharmaceutical company with two drug development segments: Novosarm, a next-generation oral selective androgen receptor for obesity treatment, and cabozantinib, a microtubule disruptor for atherosclerotic cardiovascular disease. Financially, for the three months ended December 31, 2025, research and development costs decreased to $1,300,000 from $5,700,000 in the prior year period, primarily due to the wind-down of the Phase 2b quality clinical study for Novosarm. General and administrative expenses were $4,100,000 compared to $5,200,000 in the prior quarter, decreasing primarily due to a decrease in share-based compensation. The net loss for the three months ended December 31, 2025, was $5,300,000 or $0.26 per diluted common share, compared to a net loss of $8,900,000 or $0.61 per diluted common share in the prior year's quarter.

• Cash as of the issuance date of financial statements is expected to fund operations through the interim analysis in the Phase 2b PLATO clinical study.
• Phase 2b PLATO clinical study is expected to begin this quarter, with an interim analysis of lean body mass and fat mass measured by DEXA at 34 weeks anticipated in 2027.

• Forward-looking statements are subject to known and unknown risks detailed in SEC filings.
• GLP-1 receptor agonist users often hit weight loss plateaus, posing a clinical and therapeutic challenge.
• Regulatory approval for Novosarm depends on meeting specified endpoints, which is uncertain.

Q: Why use injectable semaglutide in the Phase 2b PLATO study instead of oral semaglutide?

A: To minimize potential differences from the Phase 2b quality study, as injectable semaglutide is better, and oral semaglutide could be bridged in future Phase 3 studies.

Q: Did Veru discuss with the FDA about the stair climb test for the physical function endpoint?

A: Yes, Veru spoke to the FDA about stair climb, which is sensitive and has been used in prior studies, and the FDA wanted duplicate runs and loaded/unloaded tests to be conducted.

Q: Were there pre-specified decision rules for the interim analysis in the Phase 2b PLATO study?

A: No, there is no futility analysis or sample size re-estimation associated with the interim analysis; it primarily looks at lean mass and fat mass to confirm the study is heading in the right direction.

Q: What is the basis for approval if less than 5% weight loss is observed but there is significant functional benefit?

A: If incremental weight loss is less than 5% but there is a statistically significant and clinically meaningful benefit in the preservation of physical function, this could be an acceptable basis for approval.