Pipeline

Breast Cancer

Enobosarm, a selective androgen receptor modulator (SARM), is the Company’s lead product candidate and is being developed as a targeted treatment for two advanced breast cancer indications: estrogen receptor positive (ER+) and androgen receptor positive (AR+) breast cancer, and AR+ triple negative breast cancer (TNBC). Preliminary data from the first stage of both Phase 2 clinical trials are expected by the end of 2016, which will allow us to determine whether we will enroll additional patients in the second stage of each clinical trial.

The Company has an ongoing open-label, Phase 2 clinical trial of enobosarm to assess clinical benefit in women with metastatic or locally advanced, ER+/AR+ breast cancer. The study is designed to enroll up to 118 patients to obtain data from 88 evaluable patients to assess the primary efficacy objective of clinical benefit following 24 weeks of treatment.

The Company has an ongoing open-label, proof-of-concept Phase 2 clinical trial of enobosarm in women with advanced AR+ TNBC. The study is designed to enroll up to 55 patients to obtain data from 41 evaluable patients to assess the primary efficacy objective of clinical benefit following 16 weeks of treatment.

More information about our clinical trials may be found on clinicaltrials.gov.

More information on Breast Cancer may be found here.

More information concerning expanded access for enobosarm may be found here.