Financial Data and Key Metrics Changes - The company reported a net loss of $7.3 million or $0.50 per diluted common share for the three months ended June 30, 2025, compared to a net loss of $10.3 million or $0.71 per diluted common share in the prior year's quarter [24] - For the nine months ended June 30, 2025, the net loss from continuing operations was $17 million or $1.16 per diluted common share, compared to a net loss of $26.7 million or $2.04 per diluted common share in the prior period [26] - Research and development costs decreased to $3 million from $4.8 million in the prior quarter, primarily due to the wind down of the Phase 2b quality clinical study for Inovasaram [22] Business Line Data and Key Metrics Changes - The company initiated the Phase 2b quality clinical study for Inovasaram during the quarter ended June 30, 2024, and completed it during the quarter ended June 30, 2025 [22] - Selling, general and administrative expenses decreased to $5 million from $5.8 million in the prior quarter, mainly due to a decrease in share-based compensation [23] Market Data and Key Metrics Changes - The company has identified a significant market opportunity, with 47.4 million patients over the age of 60 enrolled in Medicare Part D, of which 41.5% could benefit from the drug for overweight or obesity [18] - Up to 34.4% of patients over the age of 60 with obesity in the United States have sarcopenic obesity, indicating a high-risk population for developing critically low muscle mass when taking currently approved GLP-1 receptor agonists [19] Company Strategy and Development Direction - The company is focusing exclusively on drug development following the sale of the FC2 Female Condom business, which represented a change in strategy [26] - The company plans to advance the modified release oral formulation of Inovasaram for chronic weight management into Phase III clinical studies, with a unique manufacturing process protected by global patents [15] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about receiving regulatory clarity for the GLP-1 receptor agonist and Inovasaram combination Phase III program, with an end of Phase II FDA meeting scheduled [16] - The management highlighted the importance of preserving lean mass and improving physical function in older patients, which aligns with the FDA's expectations for the drug's efficacy [17] Other Important Information - The company completed a one-for-ten reverse stock split on August 8, 2025, which did not change the total number of shares authorized or par value per share [20][21] - The cash balance as of June 30, 2025, was $15 million, down from $24.9 million as of September 30, 2024, indicating a need for additional capital to support drug development [28][29] Q&A Session Summary Question: Can you discuss the modified release formulation of Inovasaram and its potential for fixed dose combinations? - Management confirmed that the new formulation can allow for fixed dose combinations with oral GLP-1s and is actively discussing partnerships in this area [34][36] Question: What are the expectations for the end of Phase II meeting with the FDA? - Management anticipates clarity on endpoints and patient populations, with a focus on retaining muscle in the older population, which is at high risk [44][46] Question: Will the new formulation have a better side effect profile than the current formulation? - Management indicated that the new formulation is expected to have a better safety profile due to reduced Cmax and delayed Tmax, while maintaining similar efficacy [53][55] Question: What is the design of the Phase III trial? - The Phase III trial design includes a double-blind randomized placebo-controlled study with a focus on physical function as the primary endpoint, incorporating both short-term and long-term assessments [60][62] Question: How will the company communicate the outcome of the FDA meeting? - Management plans to communicate the feedback from the FDA around September, following the official written response [49][50]

Veru (VERU) Q2 2025 Earnings Call May 08, 2025 08:00 AM ET Company Participants Samuel Fisch - Executive Director of Investor Relations & Corporate CommunicationsMitchell Steiner - Chairman, President & CEOMichele Greco - CFO & Chief Administrative OfficerAnthea Li - Equity Research AssociateGary Nachman - Managing Director - Equity ResearchGary Barnette - Chief Scientific OfficerEduardo Martinez-Montes - Biotechnology Equity Research Associate Conference Call Participants William Wood - Equity Research Ana ...

Veru (VERU) Q2 2025 Earnings Call May 08, 2025 08:00 AM ET Speaker0 After this morning's discussion, there will be an opportunity to ask questions. Please note that this event is being recorded. I would now like to turn the conference call over to Mr. Sam Fish, Veru Inc. Executive Director, Investor Relations and Corporate Communications. Please go ahead, sir. Speaker1 Statements made on this conference call may be forward looking statements. Forward looking statements may include, but are not necessarily l ...