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]

Financial Data and Key Metrics Changes - Research and development costs increased to $3.9 million from $3.0 million in the prior quarter, attributed to expenses related to the Innovus Arm Phase 2b quality clinical study [23] - Selling, general and administrative expenses decreased to $5.2 million from $5.9 million in the prior quarter, primarily due to a decrease in share-based compensation [24] - The net loss for continuing operations was $7.9 million or $0.05 per diluted common share, compared to a net loss of $8.7 million or $0.06 per diluted common share in the prior year's quarter [24] - Cash, cash equivalents, and restricted cash balance was $20 million as of March 31, 2025, down from $24.9 million as of September 30, 2024 [29] - The company reported a net loss from discontinued operations of $49,000 or $0.00 per diluted common share, compared to a net loss of $1.3 million or $0.01 per diluted common share in the prior quarter [25] Business Line Data and Key Metrics Changes - The company is focused on two clinical stage drug candidates: enobosarb and sebisibulin, with a particular emphasis on the obesity program [5][6] - The Phase 2b quality clinical study demonstrated a 71% preservation of total lean body mass in patients receiving enovasarm plus semaglutide versus placebo plus semaglutide [11] - Enovasarm treatment resulted in a dose-dependent greater loss of fat mass compared to placebo, with the six-milligram dose showing a 46% greater relative loss of fat mass [12] Market Data and Key Metrics Changes - Obesity prevalence is reported at 41.5% among 47.4 million patients enrolled in Medicare Part D plans, with 34.4% of patients over the age of 60 having obesity [22] - The company aims to target older patients who are at higher risk for muscle weakness and falls due to age-related loss of muscle [21] Company Strategy and Development Direction - The company plans to focus exclusively on drug development following the sale of the FC2 female condom business, allowing for a more concentrated effort on its clinical programs [28] - Upcoming catalysts include the unblinded safety data for the Phase 2b quality study and regulatory clarity from the FDA regarding the Phase 3 program [30][18] - The company is exploring non-dilutive funding options, including partnerships with larger pharmaceutical companies [37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in having sufficient cash to last into the fourth quarter of 2025, allowing time to navigate upcoming clinical data releases [35] - The management highlighted the importance of demonstrating the ability of enovasarm to preserve lean mass while promoting fat loss, which is seen as a potential game changer in the obesity treatment landscape [38] - The company is actively discussing partnerships with large pharmaceutical companies to secure funding for the Phase 3 program [37] Other Important Information - The company recognized a gain on the sale of NTAPI assets of $974,000, which was not present in the prior quarter [24] - The company is developing a novel modified release oral formulation of enovasarm, expected to enter Phase 1 bioavailability clinical trials in the first half of 2025 [21] Q&A Session Summary Question: Could you talk about your cash balance and runway options for funding the Phase 3? - Management confirmed that there is enough cash to last into the fourth quarter and is exploring non-dilutive funding options, including partnerships with large pharmaceutical companies [35][37] Question: What outcomes would be considered a success for the Phase 2b extension maintenance study? - Success would be defined by the ability to blunt fat regain and potentially cause additional fat loss while maintaining muscle mass [51] Question: What is the expected size of the Phase 3 study and concerns regarding tariffs? - The expectation is to have approximately 400 patients randomized for the Phase 3 study, with one dose being selected for the trial [60] - Concerns regarding tariffs are minimal as the cost of goods for enovasarm is relatively low [61]

Financial Data and Key Metrics Changes - Research and development costs increased to $3.9 million from $3.0 million in the prior quarter, attributed to expenses related to the Innovus Arm Phase 2b quality clinical study [23] - Selling, general and administrative expenses decreased to $5.2 million from $5.9 million in the prior quarter, primarily due to a decrease in share-based compensation [24] - The net loss for continuing operations was $7.9 million or $0.05 per diluted common share, compared to a net loss of $8.7 million or $0.06 per diluted common share in the prior year's quarter [24] - Cash, cash equivalents, and restricted cash balance was $20 million as of March 31, 2025, down from $24.9 million as of September 30, 2024 [29] - The company reported a net loss from discontinued operations of $49,000 or $0.00 per diluted common share, compared to a net loss of $1.3 million or $0.01 per diluted common share in the prior quarter [25] Business Line Data and Key Metrics Changes - The company is focusing on its obesity program, specifically the drug candidates enobosarb and sebisibulin, with a significant emphasis on the Phase 2b quality clinical study for enobosarb [5][16] - The Phase 2b clinical trial demonstrated a 71% preservation of total lean body mass in patients receiving enobosarb plus semaglutide versus placebo plus semaglutide [10] - Enobosarb treatment resulted in a 46% greater relative loss of fat mass compared to placebo plus semaglutide, indicating a shift towards more selective fat loss [11] Market Data and Key Metrics Changes - The prevalence of obesity is reported at 41.5% among 47.4 million patients enrolled in Medicare Part D plans, with 34.4% of patients over the age of 60 having obesity in the United States [22] - Sarcopenic obesity, characterized by obesity and low muscle mass, poses a significant risk for older patients, highlighting the market potential for the company's drug candidates [22] Company Strategy and Development Direction - The company plans to focus exclusively on drug development following the sale of the FC2 female condom business, allowing for a more concentrated effort on its clinical programs [28] - Upcoming catalysts include the unblinded safety data for the Phase 2b quality study and regulatory clarity from the FDA regarding the Phase 3 program [16][30] - The company aims to propose a Phase 3 clinical program that is similar to the positive Phase 2b quality trial, targeting older patients with obesity or overweight [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in having sufficient cash to last into the fourth quarter of the calendar year, allowing time to navigate upcoming clinical data releases and regulatory meetings [34] - The company is in active discussions for potential partnerships to secure non-dilutive funding for the Phase 3 program, emphasizing the unique value proposition of its drug candidates [37] - Management highlighted the importance of demonstrating the ability to maintain muscle mass while promoting fat loss, which is a key differentiator in the obesity treatment landscape [38] Other Important Information - The company recognized a gain on the sale of NTAPI assets of $974,000, contributing positively to its financial results [24] - The cash generated from the sale of the FC2 business was approximately $16.3 million, which will support ongoing operations and drug development efforts [30] Q&A Session Summary Question: Could you talk about your cash balance and runway options for funding the Phase 3? - Management indicated that there is enough cash to last into the fourth quarter and is exploring non-dilutive funding options, including partnerships with large pharmaceutical companies [34][37] Question: What outcomes would be considered a success for the Phase 2b extension maintenance study? - Success would be defined by the ability to blunt fat regain and potentially cause additional fat loss while maintaining muscle mass after stopping GLP-1 treatment [46][50] Question: What is the expected size of the Phase 3 study and concerns regarding tariffs? - The Phase 3 study is expected to involve approximately 400 patients, and management does not foresee significant tariff-related issues affecting the cost of goods for enobosarb [58][59]