Veru to Announce Q3 2024 Financial Results on August 8, 2024

Veru Inc., a clinical-stage biopharmaceutical company, announced it will host a conference call and audio webcast on August 8, 2024, at 8:00 a.m. ET. During this session, Veru will discuss its financial results for the third quarter of fiscal year 2024 and provide a business update. The webcast will be accessible through the Investors page on the company's website, while a telephonic replay will be available shortly after the call.

Veru Inc. is focusing on a Phase 2b clinical trial to evaluate the safety and efficacy of enobosarm, a selective androgen receptor modulator (SARM), in preserving muscle and augmenting fat loss. The trial aims to assess three different doses: 3mg and 6mg of enobosarm, and a placebo, in about 150 elderly patients with sarcopenic obesity or those who are overweight and receiving semaglutide (Wegovy®). The primary endpoint is total lean body mass, while secondary endpoints include total body fat mass and physical function as measured by a stair climb test over 16 weeks. The trial is currently recruiting participants from up to 15 clinical sites in the United States, with topline results expected by the end of 2024.

Following the Phase 2b trial, participants will proceed into a blinded extension study where they will discontinue the GLP-1 RA treatment but continue with either placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. This phase aims to evaluate whether enobosarm can maintain muscle mass and prevent weight gain after stopping GLP-1 RA therapy. The results from this extension study are expected in the second quarter of 2025.

Sarcopenic obesity, a condition characterized by age-related muscle loss and obesity, affects a significant portion of the elderly population in the United States. According to the CDC, 41.5% of older adults are obese, and up to 34.4% of these obese patients over 60 have sarcopenic obesity. Patients with this condition who take GLP-1 RA drugs for weight loss may experience further muscle loss, leading to severe health issues like poor balance, decreased mobility, and increased mortality.

Enobosarm has been previously studied in five clinical trials involving 968 older men and postmenopausal women, as well as patients with cancer-induced muscle wasting. These studies have shown that enobosarm leads to dose-dependent increases in muscle mass and improvements in physical function, along with significant reductions in fat mass. The data from these trials provide a strong rationale for using enobosarm in combination with GLP-1 RA to potentially augment weight loss while preserving muscle mass.

The safety of enobosarm has been demonstrated in 27 clinical trials involving 1581 men and women, with some patients being dosed for up to three years. The drug was generally well-tolerated and did not increase gastrointestinal side effects, which are significant concerns with GLP-1 RA treatments alone.

Veru Inc. is dedicated to developing novel medicines for metabolic diseases, oncology, and acute respiratory distress syndrome (ARDS). Their pipeline includes two late-stage small molecules, enobosarm and sabizabulin. Enobosarm is being developed for two indications: preventing muscle loss in sarcopenic obese patients receiving GLP-1 RA therapy, and treating metastatic breast cancer. Sabizabulin is being developed for hospitalized patients with viral-induced ARDS, although further development is contingent on securing additional funding.

The company also has an FDA-approved product, the FC2 Female Condom, for dual protection against unplanned pregnancy and sexually transmitted infections.

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