Veru (VERU) 8 Aug 24 2024 Q3 Earnings call transcript

In Veru Inc.'s recent earnings call, the company provided an update on their focus and progress, particularly with their novel oral selective androgen receptor modulator (SARM), Enobosarm. The drug is being developed in combination with semaglutide, a GLP-1 receptor agonist, to preserve muscle and augment fat loss for high-quality weight loss. This combination approach aims to address the issue of muscle loss caused by GLP-1 receptor agonists, which can lead to poor physical function and decreased independence in older adults.

Key Themes and Trends

The call highlighted several key themes and trends, including the company's focus on developing innovative medicines for high-quality weight loss, oncology, and acute respiratory distress syndrome. Enobosarm is a late-stage drug in Veru's pipeline, with two late-stage novel oral small molecules currently in development. The company's drug development strategy is to focus on those candidates with the best opportunity for long-term success and shareholder value creation, aligning with their financial resources.

Financial Highlights

The financial highlights for the third quarter of fiscal year 2024 showed a net loss of $11 million, down from a net loss of $12.5 million in the prior year. This decrease is primarily due to the reduction in operating expenses, particularly in research and development costs and selling, general, and administrative expenses. The company's cash balance at the end of June 2024 was $29.2 million, providing sufficient financial resources to complete and provide results on both the Phase IIb quality clinical trial and the Phase IIb extension clinical trial.

Looking Ahead

Veru is currently conducting a Phase IIb quality clinical trial of Qualtiname, which is a multicenter, double-blind, placebo-controlled, randomized dose-finding study to evaluate the safety and efficacy of Enobosarm in combination with semaglutide. The primary endpoint of this study is to select the optimal dose of Enobosarm that best preserves muscle and augments a reduction in fat mass for a better body composition at 16 weeks of treatment. Top line results are expected in January 2025, with top line results from the separate blinded Phase IIb extension clinical study expected in the second calendar quarter of 2025.

Conclusion

Veru Inc.'s earnings call underscored the company's commitment to developing innovative medicines, particularly in the area of high-quality weight loss, oncology, and acute respiratory distress syndrome. The focus on muscle preservation and fat loss using Enobosarm in combination with semaglutide presents an opportunity to address a significant unmet medical need, particularly in older adults who are overweight or obese. The financial highlights, including the reduction in operating expenses and the cash balance, position the company well to complete ongoing clinical trials and potentially seek partnerships for future development. Overall, Veru Inc.'s strategic focus and progress in developing Enobosarm bode well for the company's future prospects.