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Mar 31, 2024
Veru Q2 2024 Earnings Report
Reported second quarter fiscal year 2024 financial results and progress of its Enobosarm High Quality Weight Loss Clinical Program.
Key Takeaways
Veru Inc. reported a decrease in net revenues to $4.1 million from $6.6 million, a decrease in gross profit to $0.7 million from $4.1 million, and a decrease in operating loss to $9.9 million versus $34.4 million compared to the same quarter last year. Net loss was $10.0 million, or $0.07 per share, compared to $33.8 million, or $0.42 per share, as restated.
Phase 2b clinical study of enobosarm in combination with semaglutide (Wegovy®*) for high quality weight loss is actively enrolling.
Company assembles esteemed high quality weight loss Scientific Advisory Board – five MDs with significant relevant medical, clinical and scientific expertise.
Company to present this month at upcoming American Association of Clinical Endocrinology annual meeting and GLP-1 Based Therapeutics Summit.
Company to host conference call and webcast today at 8:00 a.m. ET.
Veru
Veru
Forward Guidance
The company is focused on the clinical development of enobosarm to preserve muscle while augmenting fat loss in patients receiving a GLP-1 RA for weight loss. Topline clinical results from the Phase 2b trial are expected by the end of calendar year 2024, and topline results from the Phase 2b extension clinical study are expected in calendar Q2 2025.
Positive Outlook
- Enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function.
- Enobosarm treatment leads to dose-dependent reductions in fat mass.
- Enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women, some of which included patients dosed for up to 3 years.
- Enobosarm was generally well tolerated with no increases in gastrointestinal side effects.
- The company expects that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while preserving muscle mass.
Challenges Ahead
- The development of the Company’s product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development.
- The ability to enroll sufficient numbers of subjects in clinical studies and the ability to enroll subjects in accordance with planned schedules.
- The ability to fund planned clinical development as well as other operations of the Company.
- The timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority.
- The Company’s existing product, FC2, and any future products, if approved, possibly not being commercially successful.