8-K: Veru Inc. Announces Positive Phase 2b Clinical Trial Results and First Quarter Fiscal 2025 Financial Results

Veru Inc. reports positive topline results from its Phase 2b QUALITY study of enobosarm + semaglutide, demonstrating preservation of lean mass, greater fat loss, and improved physical function, while also announcing the sale of its FC2 Female Condom business and providing a financial update for the first quarter of fiscal year 2025.

Summary

• Veru Inc. announced positive topline results from the Phase 2b QUALITY clinical study evaluating enobosarm in combination with semaglutide (Wegovy) for sarcopenic obese or overweight older patients.
• The study met its primary endpoint, showing a statistically significant preservation of lean body mass in patients receiving enobosarm + semaglutide compared to placebo + semaglutide at 16 weeks (71% relative reduction in lean mass loss, p=0.002).
• The enobosarm 3mg + semaglutide dose showed the best results with a >99% mean relative reduction in loss of lean mass (p <0.001).
• Enobosarm + semaglutide treatment also 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 study also demonstrated a 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).
• 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.
• Veru is exploring sabizabulin for the treatment of inflammation in atherosclerotic coronary artery disease, with a pre-IND meeting held with the FDA in December 2024.
• The company sold its FC2 Female Condom business for $18 million, with estimated net proceeds of $12.3 million after adjustments.
• For the first quarter of fiscal 2025, research and development expenses increased to $5.7 million from $1.7 million, while selling, general, and administrative expenses decreased to $5.2 million from $6.7 million.
• The operating loss from continuing operations increased to $10.2 million from $7.4 million, and the net loss from continuing operations decreased to $1.8 million, or $0.01 per share, compared to $7.7 million, or $0.08 per share.
• Cash, cash equivalents, and restricted cash were $26.6 million as of December 31, 2024, compared to $24.9 million as of September 30, 2024.

Sentiment

Score: 7

Explanation: The document presents positive clinical trial results and a strategic asset sale, but also acknowledges increased operating losses and R&D expenses. The overall tone is cautiously optimistic.

Positives

• Positive topline results from the Phase 2b QUALITY clinical study indicate potential for enobosarm to improve body composition and physical function in older patients receiving semaglutide.
• The sale of the FC2 Female Condom business provides an influx of $12.3 million in net proceeds.
• The company is exploring a new cardiometabolic indication for sabizabulin, potentially expanding its market opportunity.
• Net loss from continuing operations decreased to $1.8 million, or $0.01 per share, compared to $7.7 million, or $0.08 per share.

Negatives

• The operating loss from continuing operations increased to $10.2 million from $7.4 million.
• Net loss increased to $8.9 million, or $0.06 per share, compared to $8.3 million, or $0.08 per share.
• Research and development expenses increased to $5.7 million from $1.7 million.

Risks

• The Phase 2b QUALITY study safety data remains blinded until the extension study is completed.
• The development of sabizabulin for atherosclerotic coronary artery disease is still in early stages and requires further clinical studies.
• The company's ability to fund planned clinical development is subject to risks and uncertainties.
• The company's failure to timely file certain reports in February 2024 may impair its ability to raise capital.

Future Outlook

The company plans to present full clinical efficacy and safety data for the Phase 2b QUALITY study, request an end-of-Phase-2 meeting with the FDA, and move forward with Phase 3 studies for enobosarm. They also plan to submit a new IND for sabizabulin in a CAD indication by the first half of calendar 2026.

Management Comments

• Mitchell Steiner, M.D., Chairman, President, and Chief Executive Officer of Veru, stated that the Phase 2b QUALITY study provides proof of concept that you can retain lean mass and improve physical function and lose enough fat mass to make up for the lean mass retained to have the same weight loss as semaglutide alone at 16 weeks.
• Dr. Steiner added that they are excited to explore advancing sabizabulin as a better option to colchicine to treat inflammation responsible for the progression of atherosclerotic coronary artery disease.

Industry Context

The announcement highlights the growing interest in treatments that improve body composition, particularly in older adults taking GLP-1 RA drugs for weight loss. The company is positioning enobosarm as a way to mitigate the loss of lean mass associated with these drugs. Additionally, the exploration of sabizabulin for atherosclerotic coronary artery disease reflects the increasing focus on inflammation as a key factor in cardiovascular disease.

Comparison to Industry Standards

• The study references Van Roie E. PLOS ONE 14:e0210653, 2019, which indicates that stair climb power declines by -1.38% annually with aging.
• The document mentions that recent randomized controlled trials assessing the role of low-dose colchicine to treat inflammation to reduce major adverse cardiovascular events had promising results demonstrating significant cardiovascular risk reduction.
• The document notes that colchicine lowered major adverse cardiovascular events by 31% among those with stable CAD and by 23% in patients following a recent myocardial infarction.
• The document states that the magnitude of benefit of colchicine is greater than what has been observed in contemporary trials of lipid lowering medications including those with proprotein convertase subtilisin/kexin type 9 (PCSK-9) inhibitors.
• The document references the SELECT cardiovascular outcomes clinical trial for Wegovy, which now highlights a 400% increase in pelvic and hip fractures that was observed in patients greater than 75 years of age receiving Wegovy compared to placebo (2.4% versus 0.6%).

Stakeholder Impact

• Shareholders may react positively to the clinical trial results and asset sale.
• Employees may be affected by the sale of the FC2 Female Condom business.
• Patients may benefit from the potential development of new treatments for sarcopenic obesity and atherosclerotic coronary artery disease.

Next Steps

• Present the full clinical efficacy and safety data set for the Phase 2b QUALITY clinical study in future scientific conferences and publications.
• Request an end of Phase 2 meeting with the FDA.
• Run a similar study as a Phase 3 study for enobosarm.
• Complete chronic nonclinical toxicology animal studies to support the chronic use of sabizabulin for the atherosclerotic coronary artery disease indication.
• Submit a new IND for the proposed sabizabulin indication by the first half of calendar 2026.

Key Dates

Keywords

enobosarm, sabizabulin, QUALITY study, semaglutide, atherosclerotic coronary artery disease, FC2 Female Condom, clinical trial, Veru Inc., financial results, cardiometabolic, inflammation, obesity