Veru to Participate in Fireside Chat at the Jones Healthcare and Technology Innovation Conference - Seite 2

As for secondary clinical endpoints, enobosarm + semaglutide treatment resulted in dose dependent greater loss of fat mass compared to placebo + semaglutide, with the enobosarm 6mg dose + semaglutide group having a 46% greater relative loss of fat mass compared to the placebo + semaglutide group at 16 weeks (p=0.014). Although enobosarm + semaglutide significantly preserved lean mass, the additional loss of fat mass caused by enobosarm treatment was able to replace the lean mass preserved to allow a similar net mean weight loss with semaglutide at 16 weeks. Accordingly, the tissue composition of the total weight loss shifted to greater and selective loss of fat with enobosarm treatment. The median percentage of total body weight loss in the placebo + semaglutide group that was due to lean mass was 32% and estimated fat loss was 68%. In contrast, in the all enobosarm + semaglutide group, the median total weight loss due to lean mass was 9.4% vs estimated fat loss of 90.6% meaning the all enobosarm + semaglutide group experienced approximately 33.2% more fat loss relative to the placebo + semaglutide group, and for the enobosarm 3mg + semaglutide group, it was 0.9% lean mass vs 99.1% estimated fat loss, meaning the enobosarm 3mg + semaglutide group experienced approximately 45.7% more fat loss relative to the placebo + semaglutide group. Therefore, enobosarm + semaglutide improved changes in body composition resulting in more selective and greater loss of adiposity than in subjects receiving placebo + semaglutide.

Physical function was measured by the Stair Climb Test. Climbing stairs is an activity of daily living, and the Stair Climb Test measures functional muscle strength, balance and agility. Declines in performance measured by Stair Climb Test predicts higher risk for mobility disabilities, gait difficulties, hospitalizations, falls, and bone fractures in older patients. As a point of reference, stair climb power declines by -1.38% annually with aging.

• A responder analysis was conducted using a ≥10% decline in stair climb power as the cut off at 16 weeks which represents 7 to8 year loss of stair climb power function due to aging. In our study, the loss of lean mass mattered as 42.6% of patients on placebo + semaglutide group had at least a 10% decline in stair climb power physical function at 16 weeks. This is the first human study to demonstrate that older patients who are overweight or have obesity receiving semaglutide GLP-1 RA are at higher risk for accelerated loss of lean mass with physical function decline.

• The all enobosarm + semaglutide group had a statistically significant and clinically meaningfully 54.4% mean relative reduction in the proportion of subjects that lost ≥10% stair climb power compared to placebo + semaglutide group (p=0.0049). Therefore, 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.