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Dec 31, 2024
Veru Q1 2025 Earnings Report
Announced fiscal 2025 first quarter financial results and progress in clinical programs.
Key Takeaways
Veru reported a net loss of $8.9 million, or $0.06 per share, for the first quarter of fiscal 2025. The company sold its FC2 Female Condom business for $18 million and announced positive Phase 2b QUALITY study topline results for enobosarm + semaglutide.
Reported positive Phase 2b QUALITY study topline results for enobosarm + semaglutide (Wegovy®).
The Independent Data Monitoring Committee recommended to continue the QUALITY extension study as designed.
Topline results of the Phase 2b extension maintenance study to reduce fat regain following discontinuation of GLP-1 RA are expected in the second quarter of calendar 2025.
Announced new cardiometabolic indication for sabizabulin to treat inflammation in atherosclerotic coronary artery disease.
Veru
Veru
Forward Guidance
Veru is focused on developing innovative medicines for cardiometabolic and inflammatory diseases, with key programs advancing in clinical trials and new indications being explored.
Positive Outlook
- The ongoing Phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat regain that generally occurs after discontinuing a GLP-1 RA.
- The Company plans to present the full clinical efficacy and safety data set for the Phase 2b QUALITY clinical study in future scientific conferences and publications after the Phase 2b extension portion of the study is completed and unblinded.
- As the Phase 2b QUALITY study has positive topline clinical results, we plan to move forward to request an end of Phase 2 meeting with the FDA.
- The oral enobosarm modified release drug formulation will be utilized for the Phase 3 clinical studies and for commercialization.
- Veru currently has sufficient drug substance to supply the proposed Phase 2 clinical study.
Challenges Ahead
- Safety data for the Phase 2b QUALITY study remains blinded as the Phase 2b extension clinical study portion is ongoing.
- The FDA also requested that the Company conduct chronic nonclinical toxicology animal studies to support the chronic use of sabizabulin for this indication.
- If the Company decides to pursue the Phase 2 clinical study, the Company plans to partner with the Colorado Prevention Center, Aurora, Colorado and Lundquist Institute, Torrence, California.
- The chronic nonclinical toxicology studies are expected to be completed and a new IND for the proposed indication is planned to be submitted by the first half calendar 2026.
- The Company’s failure to timely file certain reports in February 2024 may impair its ability to raise capital under the Company’s current effective shelf registration statement on Form S-3 or under a new registration statement