Veru (VERU) investor relations material

Key clinical insights and study results

• Enobosarm, a selective androgen receptor modulator, is being combined with GLP-1 to address muscle loss and functional decline in older obese patients, aiming to preserve lean mass and improve outcomes beyond weight loss.

• Phase 2b quality study showed preservation of lean mass, increased fat loss, and prevention of rapid weight regain after GLP-1 discontinuation, with 100% of weight lost being adiposity.

• In patients with BMI >35, enobosarm led to incremental weight loss and higher rates of ≥5% weight loss, while maintaining 84% lean mass preservation.

• Enobosarm prevented significant physical decline in stair climb tests among older patients, addressing a key risk factor for falls and fractures.

• Drug demonstrated good safety and tolerability across multiple clinical trials, with regulatory discussions highlighting new endpoints for approval.

Regulatory and market landscape

• FDA now recognizes total hip bone mineral density (BMD) as a surrogate endpoint for osteoporosis drug development, opening new approval pathways.

• GLP-1s are associated with increased risk of bone loss and fractures, especially in older women, positioning enobosarm as a dual-action agent for muscle and bone health.

• The obesity market in older adults is substantial, with about 44 million Americans on Medicare Part D over age 65, half of whom could benefit from weight loss drugs.

• Regulatory flexibility allows for approval based on either incremental weight loss or clinically meaningful functional benefits, expanding potential indications.

• Multiple patient populations, including those with sarcopenic obesity and postmenopausal women with osteoporosis, are being targeted for future claims.

Upcoming studies and timelines

• The Phase 2b Plateau study will enroll obese, non-diabetic patients over 65 with BMI >35, randomizing to semaglutide alone or in combination with enobosarm, for 68 weeks.

• Primary endpoint is total body weight, with secondary endpoints including physical function, mobility, disability, body composition, and BMD.

• Enrollment is set to complete by Q3 2026, interim analysis in Q1 2027, and top-line data expected in Q4 2027.

• Study design and endpoints have been finalized, with no gating factors for enrollment; the program is on track.

• Multiple regulatory paths are available depending on study outcomes, including obesity, function, and osteoporosis endpoints.