Earnings release
Page 1
ESSA ESSA Pharma Provides Corporate Update and Reports Financial Results for Fiscal Second Quarter Ended March 31 , 2021 Presented promising preliminary pharmacokinetic and clinical data on EPI - 7386 in metastatic castration- resistant prostate cancer at 2021 AACR Raised approximately $ 150 million in a public offering - Houston , Texas and Vancouver , Canada , May 6 , 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 second quarter ended March 31 , 2021. All references to " $ " in this release refer to United States dollars , unless otherwise indicated . " This quarter was a very productive period for ESSA . We continue to advance our lead product candidate , EPI - 7386 , in an ongoing Phase trial in patients with metastatic castration - resistant prostate cancer who are resistant to standard - of - care treatments . We recently reported promising preliminary pharmacokinetic and clinical data from the study and expect to provide a clinical update in the fourth quarter of this calendar year , " said Dr. David R. Parkinson , M.D. , President and Chief Executive Officer of ESSA Pharma . “ During the quarter , we also announced clinical collaborations with Janssen and Astellas , and recently on April 28th entered into a partnership with Bayer , all focused on evaluating EPI - 7386 in Phase 1/2 clinical studies in combination with their respective anti - androgen therapies . " Dr. David R. Parkinson added , “ With the completion of a successful public offering in which we raised approximately $ 150 million , we are well - positioned to fund our monotherapy and collaboration studies of EPI - 7386 in prostate cancer . In addition , the funding will expand and accelerate our discovery and preclinical research and development efforts to continue to build value across our overall pipeline . " 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. The clinical study is expected to start in the second half of calendar 2021 . On April 10 , 2021 , the Company reported updated preclinical data on EPI - 7386 at the 2021 American Association of Cancer Research ( AACR ) Annual Meeting demonstrating that the product candidate can inhibit in vitro androgen receptor ( " AR " ) splice variants including AR - v567es . The results also suggest that EPI - 7386 can inhibit AR related transcription and EPI - 7386 in combination with enzalutamide may result in broader and deeper inhibition of the AR pathway . • On February 25 , 2021 , the Company announced a clinical collaboration with Astellas Pharma Inc. ( " Astellas " ) to evaluate the combination of EPI - 7386 and Astellas / Pfizer's androgen receptor inhibitor , enzalutamide , for patients with mCRPC . Under the terms of the agreement , ESSA will sponsor and conduct a Phase 1/2 study to evaluate the safety , tolerability and preliminary efficacy of the combination of EPI - 7386 and enzalutamide in mCRPC patients who have not yet been treated with second - generation antiandrogen therapies . Astellas will supply enzalutamide for the trial . ESSA will retain all rights to EPI - 7386 . The clinical study remains on track to start in the second half of calendar 2021 . • On February 22 , 2021 , the Company completed an underwritten public offering for aggregate gross proceeds of $ 149,999,985 . The Company issued a total of 5,555,555 common shares of the Company at a public offering price of $ 27.00 per share , including the underwriters ' fully exercised option to purchase an additional 724,637 shares .