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ESSA ESSA Pharma Provides Corporate Update and Reports Financial Results for Fiscal Third Quarter Ended June 30 , 2021 - Houston , Texas and Vancouver , Canada , August 16 , 2021 ESSA Pharma Inc. ( " ESSA " or the " Company " ) ( NASDAQ : EPIX ) , a clinical - stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer , today provided a corporate update and reported financial results for the fiscal third quarter ended June 30 , 2021. All references to " $ " in this release refer to United States dollars , unless otherwise indicated . " During this quarter , the Company continued to focus on the execution of the Phase 1a clinical program of EPI - 7386 as a monotherapy in patients with late - stage metastatic castration - resistant prostate cancer ( " mCRPC " ) whose tumors have progressed on multiple current standard - of - care therapies , including antiandrogens , " said Dr. David R. Parkinson , M.D. , President and Chief Executive Officer of ESSA Pharma Inc. " In this heavily pretreated cohort of patients , EPI - 7386 continues to be safe , well - tolerated , with generally good drug exposures , and adverse - events typical of those associated with antiandrogen therapy . Patients are currently being dosed at 600 mg , 800 mg , and 1,000 mg QD , with each of these dose levels being cleared as safe and tolerable . Given the favorable tolerability of the drug and the wide therapeutic window seen in preclinical studies , we plan to enroll additional higher dose cohorts using a twice daily ( BID ) dosing schedule to further enhance patient drug exposures . In addition , we are planning to file a protocol amendment to focus further monotherapy development in less heavily pretreated patients in whom we believe the androgen receptor pathway continues to be the primary driver of tumor growth . Our goal is to establish a recommended Phase 2 dose ( " RP2D " ) for monotherapy during the first half of 2022 and commence the expansion Phase 1b study soon thereafter in earlier , less heavily pretreated and more biologically characterized patients . We look forward to presenting a clinical readout of the Phase 1a monotherapy trial in the first half of 2022. " Dr. Parkinson continued , " In parallel , our development of EPI - 7386 in combination with current antiandrogens in mCRPC patients remains on track . The ESSA - managed clinical trial collaboration with Astellas ( enzalutamide ) will begin in the fourth quarter of 2021. The EPI - 7386 combination studies with other antiandrogens that were announced earlier this year are on track and are anticipated to begin in late 2021 or early 2022. Lastly , using nuclear magnetic resonance studies , we have achieved our long - term preclinical goal of demonstrating definitive evidence that EPI- 7386 binds to the N - terminal domain of the androgen receptor and look forward to presenting these results at an upcoming scientific conference this year . As a result of the successful financing earlier this year , our cash and short- term investments of over $ 202 million provide us a cash runway into 2024 and fully fund the current development programs . " Recent Clinical and Corporate Highlights • • On April 28 , 2021 , the Company announced a clinical collaboration with Bayer to evaluate EPI - 7386 in combination with Bayer's androgen receptor inhibitor darolutamide in patients with metastatic castration- resistant prostate cancer ( " mCRPC " ) . Under the terms of the agreement , Bayer may sponsor and conduct a Phase 1/2 study to evaluate the safety , pharmacokinetics and efficacy of the combination of EPI - 7386 and darolutamide in mCRPC patients . ESSA will supply EPI - 7386 for the trial and will retain all rights to EPI- 7386 . On April 10 , 2021 , the Company reported new preclinical data on EPI - 7386 at the 2021 American Association of Cancer Research ( AACR ) Annual Meeting demonstrating that in vitro EPI - 7386 can prevent the androgen receptor from binding to genomic DNA and can inhibit AR related transcription in prostate cancer cell lines expressing androgen receptor ( " AR " ) splice variants including the AR - v567es variant . The results also demonstrate that combining EPI - 7386 with enzalutamide in vitro results in a broader and deeper inhibition of the AR pathway .