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]