VERU INC. Q3 FY2024 earnings call

• Veru is a late clinical stage biopharmaceutical company focused on weight loss, oncology, and acute respiratory distress syndrome. - Focused on Enobosarm in combination with GLP-1 receptor agonists for muscle preservation and fat loss in weight management. - Conducting Phase IIb quality clinical trial of Enobosarm in combination with Wegovy (semaglutide) for high-quality weight loss, with enrollment completed, top-line results expected in January 2025 and extension trial results in Q2 2025. - Financial highlights including net revenues, gross profit, operating expenses, net loss, and cash balance details. - Strategic decisions to focus drug development efforts on candidates with best long-term success potential, and reduction in certain expenses post EUA declination for sabizabulin.

For the third quarter ended June 30, 2024: Net revenues were $4 million. U.S. prescription business sales were $552,000 (vs. $863,000 prior year). Global Public Sector business net revenue was $3.4 million (vs. $2.5 million prior year). Gross profit was $1.3 million (34% of net revenues). Operating expenses were $12.4 million. Net loss was $11 million. For the 9 months ended June 30, 2024: Total net revenues were $10.2 million. U.S. prescription business net revenues were $1.8 million (vs. $5.2 million prior year, due to Pill Club bankruptcy). Global Public Sector business net revenue was $8.4 million (vs. $7.2 million prior year). Gross profit was $3.2 million (31% of net revenues). Operating loss was $28.7 million. Cash balance as of June 30, 2024 was $29.2 million.

• Phase IIb quality study of Enobosarm completed enrollment, top-line results expected in January 2025, extension trial results in Q2 2025. - Sufficient cash ($29.2M) on hand to complete both Phase IIb quality and extension trials. - Potential multibillion-dollar opportunity with Enobosarm-GLP-1 combination in the global obesity and overweight drug market.

• Risks related to clinical trial outcomes not meeting expectations. - Uncertainties regarding regulatory approvals for Enobosarm. - Competition in the biopharmaceutical space. - Financial uncertainties related to cash flow and funding for ongoing trials.

Q: Assuming positive results coming out of the Phase IIb quality study, how soon can you advance the candidate to the next step and whether you plan to find a partnership for a potential registration study?

A: If positive, top-line results in January 2025 will allow beginning discussions with FDA and potential partners. Expect to meet with FDA to understand Phase III program and start partnership discussions.

Q: Just a question actually on safety. In the trials that you referenced in the 5 studies that you referenced with the enobosarm, I think the high dose was 3 milligrams. I know you're testing up to 6 in the current quality study. Just wanted to ask kind of what gives you confidence that you'll be okay to expect to liver at 6? And are there any considerations with respect to the types of patients in the study, i.e., overlay obese, therefore, may have bad accumulation in the liver could that put them in for the risk of having tiering? And also, is there any provision for our alcohol cessation during the study, which also could be affected.

A: Database includes single ascending dose and multiple ascending dose studies at higher doses (up to 100mg) with no evidence of drug-induced liver injury. Monitor alcohol history but exclude patients with alcohol-associated liver conditions. Dr. Gary Barnette noted not excluding alcohol but monitoring intake.

Q: Can you just talk about how you're expecting the Phase IIb to progress now that you're fully enrolled? And if we should expect any incremental updates before you report top line in January? And on that safety question, are you pleased with everything you're seeing with the safety committee thus far in that current trial?

A: Last patient to complete 16-week portion in December, top-line results in January. No incremental updates before January. Pleased with safety so far but study still early as many patients just starting first month. No surprises in safety but continuing to follow.

Q: On Star claim Power, could you talk a little bit about what the MCID is for the measure and what would be a successful outcome in Phase II? And on the Phase III, you've spoken previously about moving forward in elderly patients only versus the broader obesity population. Can you just let us know your thinking there and how the Phase 2 informed that decision.

A: Success in Phase II is powering and informing Phase III design. MCID related to Steroclime test (FDA-accepted functional endpoint). Phase III intends to include all comers but subgroup power for elderly as at-risk population. Phase II in older patients informed by experience in previous studies showing benefit in physical function, guiding Phase III approach.