Veru Inc. announced additional clinical results from the Phase 2 study demonstrating that the anticancer benefits of enobosarm, a selective androgen receptor (AR) targeting agent, were related to the presence and amount of AR expression in breast cancer tissue in subjects with AR+ER+ HER2- metastatic breast cancer, will be presented at the American Society of Clinical Oncology (ASCO) 2021 Annual Meeting being held June 4-8, 2021. In preclinical studies, AR has been established as a tumor suppressor in breast cancer. Clinically, AR is expressed in up to 90% of breast cancers and targeting AR with enobosarm, an oral selective AR agonist, would be a major new endocrine therapy for metastatic breast cancer. The positive G200802 Phase 2 clinical study in 136 heavily pretreated women with AR+ER+HER2- metastatic breast cancer who progressed following CDK4/6 inhibitor and/or estrogen blocking agent treatment confirmed that the AR is commonly expressed in breast cancer tissue (86.5-94%) and when activated by enobosarm is acting in these patients as a tumor suppressor. In the overall Phase 2 study, the presence and the amount of AR receptor expression in breast cancer tissue correlated with a beneficial antitumor response. The best overall target lesion reduction of >30% occurred only in subjects who were AR+. In a post-hoc analysis of 84 women who had AR+ER+HER2- metastatic breast cancer, measurable disease, and centrally confirmed AR status at study entry, an AR positivity threshold of = 40% in breast cancer tissue distinguished patients that responded to enobosarm in both dose arms (9 and 18 mg). AR positivity = 40% was common as 52% of subjects in study met this threshold. Focusing on the 9mg cohort, the dose selected for the Phase 3 ARTEST study, the best objective tumor response rate (complete + partial responses) was 48% for = 40% AR positivity versus 0% for <40% AR positivity (p<0.0001). Similarly, the clinical benefit rate was 79% for = 40% AR positivity versus 18% for <40% AR positivity (p<0.0001). The median radiographic progression free survival was 5.5 month for = 40% AR positivity versus 2.75 months for <40% AR positivity (p<0.001). Enobosarm was very well tolerated without masculinizing side effects, increases in hematocrit, or liver toxicity. Enobosarm Clinical Development Program: Enobosarm is an oral, first-in-class, new chemical entity, selective androgen receptor targeting agonist that activates the androgen receptor, a tumor suppressor, in AR+ER+HER2- metastatic breast cancer. The enobosarm clinical development program is initially focusing on two indications: (1) Phase 3 ARTEST clinical study of enobosarm in the 3rd line metastatic setting for AR+ER+HER2- metastatic breast cancer patients (= 40% AR positivity) whose disease has progressed after treatment with a nonsteroidal aromatase inhibitor, fulvestrant, and a CDK4/6 inhibitor which is expected to begin enrollment calendar third quarter 2021; (2) Phase 2 clinical study of enobosarm + CDK4/6 inhibitor, abemaciclib, in the 2nd line metastatic setting for AR+ER+HER2- metastatic breast cancer patients (= 40% AR positivity) whose disease has progressed after treatment with a 1st line CDK 4/6 inhibitor, palbociclib, in combination with either a nonsteroidal aromatase inhibitor or fulvestrant which is expected to begin enrollment during the third quarter of calendar 2021.