In This Article:
Release Date: May 08, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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Veru Inc (NASDAQ:VERU) reported positive topline results from its Phase 2B clinical study, demonstrating that its drug candidate, Novosarm, significantly preserves lean body mass while promoting fat loss.
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The company has sufficient cash to fund operations into the fourth quarter of the calendar year, allowing it to reach several upcoming catalysts.
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Veru Inc (NASDAQ:VERU) is actively pursuing non-dilutive funding options, including potential partnerships with large pharmaceutical companies.
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The company is developing a novel modified release oral formulation of Novosarm, which is expected to be available for Phase 3 clinical studies and commercialization.
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Veru Inc (NASDAQ:VERU) plans to focus its Phase 3 clinical program on older patients, a large market population with a high prevalence of obesity and sarcopenic obesity.
Negative Points
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Veru Inc (NASDAQ:VERU) reported a net loss of $7.9 million for the quarter, indicating ongoing financial challenges.
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The company acknowledged that its current cash reserves are not sufficient to fund operations for the next 12 months, highlighting the need for additional capital.
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Research and development costs increased significantly due to expenses related to the Novosarm Phase 2B clinical study.
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The sale of the FC2 female condom business resulted in a loss of approximately $4.2 million, impacting the company's financial position.
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Veru Inc (NASDAQ:VERU) faces uncertainties regarding the regulatory path forward for its drug candidates, pending further discussions with the FDA.
Q & A Highlights
Q: Could you talk a little bit more about how you're thinking about your cash balance and runway, specifically what options are exploring to fund the phase 3, and is there potential to partner out the program? A: We have enough cash to last into the fourth quarter, which gives us time to get through upcoming catalysts. We're considering non-dilutive funding options, such as partnerships with large pharmaceutical companies, as we have promising phase 2B data. The future of weight loss and chronic weight management is likely to involve oral drugs, and we are in active discussions with potential partners.
Q: For the phase 2B extension maintenance study, what outcomes would be considered a success in terms of weight loss and muscle mass? Does it need to be statistically significant or just show a positive trend? A: The extension study is more descriptive, focusing on the hypothesis that muscle is important. Success would be indicated by blunting fat regain and potentially causing additional fat loss. The timing for data release is expected shortly after the safety data for the phase 2B quality study.