Earnings release
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ESSA ESSA Pharma Provides Corporate Update and Reports Financial Results for Fiscal First Quarter Ended December 31 , 2020 Vancouver , Canada and Houston , Texas , February 11 , 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 first quarter ended December 31 , 2020. All references to " $ " in this release refer to United States dollars , unless otherwise indicated . " ESSA's series of accomplishments over the past calendar year have included raising $ 48.9 million in an over- subscribed public offering , the granting by the U.S. Food and Drug Administration ( the " FDA ” ) of Fast Track Designation to our lead product candidate EPI - 7386 , and the initiation of a Phase 1 trial with EPI - 7386 for patients with metastatic castration - resistant prostate cancer who have become resistant to current standard of care therapies , " stated David Parkinson , MD , President and CEO of ESSA . " We were also pleased to have recently announced a clinical collaboration with Janssen Research & Development , LLC ( " Janssen ” ) to evaluate EPI - 7386 in combination clinical trials with abiraterone acetate / prednisone or apalutamide , which we believe has potential to improve treatment options for patients with prostate cancer . 2021 looks to be another pivotal year for our company as we continue to advance EPI - 7386 in our clinical trials . " Recent Clinical and Corporate Highlights • On January 13 , 2021 , the Company announced a clinical collaboration with Janssen to evaluate EPI - 7386 in combination with abiraterone acetate / prednisone or apalutamide for patients with metastatic castration- resistant prostate cancer ( " mCRPC " ) . Under the terms of the agreement , Janssen may sponsor and conduct up to two Phase 1/2 studies evaluating the safety , tolerability and preliminary efficacy of the combination of EPI - 7386 and apalutamide as well as the combination of EPI - 7386 with abiraterone acetate plus prednisone in patients with mCRPC who have failed a current second - generation antiandrogen therapy . Janssen will assume all costs associated with these studies other than the manufacturing costs associated with the clinical drug supply of EPI - 7386 . The parties will form a joint oversight committee for the clinical studies , which are planned to start in 2021. ESSA will retain all rights to EPI - 7386 . • • On November 25 , 2020 , the Company filed a Registration Statement on Form S - 3 with the United States Securities and Exchange Commission ( the " SEC " ) to replace the existing Registration Statement on Form F - 3 , which will allow the Company to raise up to $ 200 million worth of the securities listed therein . On October 26 , 2020 , ESSA announced its strategic decision to voluntarily delist its Common Shares from the TSX Venture Exchange in Canada . Summary Financial Results • Net Loss . ESSA recorded a net loss of $ 6.5 million ( $ 0.20 loss per common share based on 33,343,48 weighted average common shares outstanding ) for the quarter ended December 31 , 2020 , compared to a net loss of $ 4.6 million ( $ 0.22 loss per common share based on 20,762,374 weighted average common shares outstanding ) for the quarter ended December 31 , 2019. For the period ended December 31 , 2020 , this included non - cash share - based payments of $ 1.2 million compared to $ 1.3 million for the prior year , recognized for stock options granted and vesting . Research and Development ( “ R & D ” ) expenditures . R & D expenditures for the quarter ended December 31 , 2020 were $ 4.5 million compared to $ 2.6 million for the quarter ended December 31 , 2019 and includes non - cash costs related to share - based payments ( $ 287,424 for period ended December 31,2020 compared to $ 152,406 for period ended December 31 , 2019 ) . The increase in R & D expenditures for the first quarter were primarily related to the increased expenditure on chemistry and manufacturing of the drug product , and clinical costs related to the Phase 1 clinical trial of EPI - 7386 , which commenced with the dosing of the first patient in July 2020 . General and administration ( " G & A ” ) expenditures . G & A expenditures for the quarter ended December 31 , 2020 were $ 2.2 million compared to $ 2.1 million for the quarter ended December 31 , 2019 and include