ESSA Pharma Inc. announced that the Company has entered into a clinical trial support agreement (the "Agreement") with Janssen Research & Development, LLC ("Janssen") to enable evaluation of ESSA's first-in-class N-terminal domain androgen receptor inhibitor, EPI-7386, in combination with apalutamide as well as the combination of EPI-7386 with abiraterone acetate plus prednisone in patients with prostate cancer. Under the terms of the Agreement, ESSA will sponsor and conduct a Phase 1 clinical trial evaluating the safety, pharmacokinetics, drug-drug interactions, and preliminary anti-tumor activity of EPI-7386 when administered in combination with either apalutamide or abiraterone acetateplus prednisone. Janssen will supply apalutamide and abiraterone acetate.

ESSA will retain all rights to EPI-7386. Cohort A of the Phase 1 clinical trial will assess EPI-7386 in combination with abiraterone acetated plus prednisone in patients With metastatic castration-resistant prostate cancer ("mCRPC") and high-risk metastatic castration-sensitive prostate cancer ("mCSPC"). Cohort B is a Window of Opportunity study in which patients with non-metastatic CRPC will receive up to 12 weeks of single agent EPI-7386 before adding standard-of-care apalutamide.

EPI-7386 is an investigational, highly-selective, oral, small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is currently being studied in a Phase 1 clinical trial (NCT04421222) in men with castration-resistant prostate cancer ("CRPC") whose tumors have progressed on standard-of- care therapies. The U.S. FDA has granted Fast Track designation to EPI-7386 for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment.

ESSA is also conducting a Phase 1/2 clinical trial (NCT05075577) of EPI-7386 in combination with enzalutamide in metastatic CRPC patients who have not yet been treated with second-generation antiandrogen therapies. ESSA retains all rights to EPI-7386 worldwide.