VERU INC. Q1 FY2025 earnings call

• Veru has evolved into a late clinical stage biopharmaceutical company focused on cardiometabolic and inflammatory diseases, with drug programs enobosarm and sabizabulin.
• Phase 2b QUALITY clinical study of enobosarm showed positive top line results, meeting primary endpoint of preserving total lean body mass, with 71% relative reduction in lean mass loss at 16 weeks.
• Plan to move forward to request an end of Phase 2b meeting with FDA and run a Phase III study for enobosarm.
• Novel enobosarm modified release oral formulation in animal trials, expected for Phase I bioavailability trial in H1 2025.
• Exploring atherosclerosis inflammation program with sabizabulin, leveraging its anti-inflammatory activity and safer profile vs Colchicine.
• Sold FC2 female condom business on December 30, 2024, to focus on biopharmaceutical development.

Veru Inc. reported financials for Q1 Fiscal Year 2025. Research and development costs increased to $5.7 million from $1.7 million in the prior quarter. Selling, general and administrative expenses were $5.2 million compared to $6.7 million in the prior quarter. A gain on the sale of AntiFE assets was $695,000. A gain on extinguishment of debt of $8.6 million was recorded. The bottom line result for continuing operations was a net loss of $1.8 million or $0.01 per diluted common share. Net loss from discontinued operations net of taxes related to the FC2 business was $7.1 million or $0.05 per diluted common share.

• Phase 2b extension trial results of QUALITY study expected in Q2 2025.
• Plan to run a Phase III study for enobosarm with 52-week treatment duration.
• Oral enobosarm modified release drug formulation anticipated for Phase I bioavailability trial in H1 2025 and for Phase III studies/commercialization.
• Sabizabulin Phase II study planned, with new IND expected to be submitted by H1 2026.

• Dropout rates in studies due to GI side effects associated with GLP-1 RAs.
• Regulatory uncertainties in drug development and approval.
• Potential drug-drug interactions and safety concerns with existing anti-inflammatory drugs like Colchicine.
• Unmet medical needs in treating inflammation in atherosclerotic cardiovascular disease.

Q: What is the dropout rate in the Phase 2b QUALITY study and the reason for dropout?

A: Dropout rate is about 13%, most common reason is GI side effects associated with GLP-1 RAs.

Q: What are the expectations for the extension trial data in terms of weight regain?

A: Expect weight gain, specifically fat gain in placebo group, and enobosarm to minimize fat regain while maintaining lean mass.

Q: Can enobosarm be combined with oral GLP-1s as a fixed-dose combo?

A: Yes, enobosarm is an oral product and can be combined with oral GLP-1s, potentially making a fixed combination attractive.

Q: Will the extension data report full safety observations?

A: Yes, when the study is unblinded, the full safety data set will be reported.