8-K: Veru Inc. Announces Fiscal 2025 Second Quarter Financial Results and Clinical Program Progress

Veru Inc. reports positive topline results from its Phase 2b QUALITY clinical study and provides updates on its clinical development programs, along with its fiscal 2025 second quarter financial results.

Summary

• Veru Inc. announced its fiscal 2025 second quarter financial results and provided an update on its clinical development programs.
• The company is focused on developing innovative medicines for cardiometabolic and inflammatory diseases.
• Topline efficacy data from the enobosarm Phase 2b QUALITY study was previously disclosed.
• Unblinded safety data from the enobosarm Phase 2b QUALITY study is expected in the second quarter of calendar 2025.
• Topline efficacy and safety data for the Phase 2b extension maintenance study is also expected in the second quarter of calendar 2025.
• Veru plans to request an End of Phase 2 meeting with the FDA to discuss the Phase 3 clinical program, anticipated to occur in the third quarter of calendar 2025.
• The Phase 2b QUALITY study met its primary endpoint, showing a statistically significant benefit in lean mass preservation with enobosarm + semaglutide versus placebo + semaglutide (71% relative reduction in lean mass loss, p=0.002).
• The enobosarm 3mg + semaglutide dose showed a >99% mean relative reduction in loss of lean mass (p <0.001).
• Enobosarm + semaglutide treatment resulted in dose-dependent greater loss of fat mass compared to placebo + semaglutide, with the enobosarm 6mg dose having a 46% greater relative loss of fat mass (p=0.014).
• The all enobosarm + semaglutide group had a statistically significant 54.4% mean relative reduction in the proportion of subjects that lost at least 10% stair climb power compared to placebo + semaglutide group (p=0.0049).
• Research and development expenses increased to $3.9 million from $3.0 million for the quarter.
• Selling, general and administrative expenses decreased to $5.2 million from $5.9 million for the quarter.
• The operating loss from continuing operations decreased to $8.1 million from $8.9 million for the quarter.
• Net loss from continuing operations decreased to $7.9 million, or $0.05 per share, compared to $8.7 million, or $0.06 per share for the quarter.
• Cash, cash equivalents, and restricted cash were $20.0 million as of March 31, 2025, versus $24.9 million as of September 30, 2024.
• Veru is also exploring sabizabulin for the treatment of inflammation in atherosclerotic cardiovascular disease and plans to submit a new IND by the first half of calendar 2026.

Sentiment

Score: 7

Explanation: The document presents positive clinical trial results and strategic initiatives, but also acknowledges financial losses and cash decreases, resulting in a moderately positive sentiment.

Positives

• The Phase 2b QUALITY study met its primary endpoint, showing a statistically significant benefit in lean mass preservation with enobosarm + semaglutide versus placebo + semaglutide.
• Enobosarm + semaglutide treatment resulted in dose-dependent greater loss of fat mass compared to placebo + semaglutide.
• Enobosarm treatment preserved lean mass (muscle) which translated into a reduction in the proportion of patients that had a clinically significant stair climb physical function decline versus subjects receiving semaglutide alone.
• Veru is developing a novel modified release oral formulation for enobosarm, with patent expiry expected in 2045.
• Veru is exploring sabizabulin for the treatment of inflammation in atherosclerotic cardiovascular disease.
• Selling, general and administrative expenses decreased for both the quarter and year-to-date periods.

Negatives

• The company experienced an operating loss from continuing operations of $8.1 million for the quarter and $18.4 million year-to-date.
• Cash, cash equivalents, and restricted cash decreased to $20.0 million as of March 31, 2025, from $24.9 million as of September 30, 2024.

Risks

• The success of the planned Phase 3 studies of enobosarm is uncertain.
• The company's ability to reach an agreement with the FDA on the Phase 3 program for enobosarm is not guaranteed.
• The development of the modified-release formulation of enobosarm may not be successful.
• The company's ability to obtain sufficient GLP-1 RA drugs for the planned Phase 3 study is not guaranteed.
• The development of sabizabulin for atherosclerotic coronary artery disease is subject to regulatory approval and clinical trial success.
• The company's ability to fund planned clinical development and other operations is subject to financing risks.

Future Outlook

The company anticipates near-term catalysts including unblinded safety data from the enobosarm Phase 2b QUALITY study and topline efficacy and safety data from the Phase 2b extension maintenance study, and plans to request an End of Phase 2 meeting with the FDA to discuss the Phase 3 clinical program. Veru is also exploring sabizabulin for the treatment of inflammation in atherosclerotic cardiovascular disease and plans to submit a new IND by the first half of calendar 2026.

Management Comments

• The treatment objective is for patients to have a healthier option for choosing to stop GLP-1s without the fear of fat regain, said Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru.

Industry Context

The announcement highlights Veru's focus on cardiometabolic and inflammatory diseases, aligning with the growing interest in treatments for obesity and cardiovascular disease. The company's approach of combining enobosarm with GLP-1 receptor agonists addresses the issue of lean mass loss associated with weight loss drugs like semaglutide (Wegovy) and tirzepatide (Zepbound). The exploration of sabizabulin for atherosclerotic cardiovascular disease reflects the increasing recognition of inflammation as a key driver of cardiovascular events.

Comparison to Industry Standards

• The Phase 2b QUALITY study results are promising compared to existing GLP-1 RA therapies, which often lead to significant lean mass loss during weight reduction.
• The data suggests that enobosarm could offer a more selective weight loss profile, preserving muscle mass while reducing fat.
• The development of sabizabulin as an anti-inflammatory agent for cardiovascular disease is notable, especially considering the limitations of colchicine, the first FDA-approved drug in this category.
• Colchicine lowered major adverse cardiovascular events by 31% among those with stable CAD and by 23% in patients following a recent myocardial infarction.
• The company is aiming to provide a safer alternative to colchicine, which has significant drug-drug interactions.

Stakeholder Impact

• Shareholders may be positively impacted by the promising clinical trial results and the potential for new drug approvals.
• Employees are likely to be impacted by the company's ongoing clinical development programs and strategic initiatives.
• Patients may benefit from the development of new treatments for obesity and cardiovascular disease.
• The company's financial performance and strategic decisions may impact suppliers and creditors.

Next Steps

• The company expects unblinded safety data from the Phase 2b QUALITY study and topline efficacy and safety data for the Phase 2b extension maintenance study in the second quarter of calendar 2025.
• Veru plans to request an End of Phase 2 meeting with the FDA to discuss the Phase 3 clinical program, anticipated to occur in the third quarter of calendar 2025.
• The company plans to submit a new IND for sabizabulin for atherosclerotic cardiovascular disease by the first half of calendar 2026.
• The company will continue to develop a novel modified release oral formulation for enobosarm.

Key Dates

Keywords

enobosarm, semaglutide, QUALITY study, clinical trial, Phase 2b, Phase 3, FDA, weight loss, lean mass, fat mass, sabizabulin, atherosclerosis, cardiovascular disease, financial results, Veru Inc.