Successful Phase IIb Clinical Trial for Enobosarm
The enobosarm 3-milligram plus semaglutide group met the primary endpoint with 100% average preservation of total lean mass compared to placebo, with a 12% greater fat loss at 16 weeks.
Positive Safety Profile
The combination of enobosarm and semaglutide showed a positive safety profile with no added gastrointestinal adverse events compared to semaglutide alone.
Regulatory Clarity and Path Forward
FDA provided guidance with two potential regulatory pathways for enobosarm development in combination with GLP-1 receptor agonists, focusing on incremental weight loss or preservation of physical function.
Strong Financial Position for Future Trials
The company ended the fiscal year with $15.8 million in cash and cash equivalents and raised an additional $23.4 million through a public offering.