On May 10, 2019 ESSA Pharma Inc. (TSX-V: EPI,NASDAQ: EPIX), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, reported financial results for the fiscal second quarter ended March 31, 2019 (Press release, ESSA, MAY 10, 2019, View Source [SID1234536180]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.
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"Last quarter was a transformative period for ESSA as we selected EPI-7386 as our lead clinical candidate for the treatment of metastatic castration-resistant prostate cancer ("mCRPC"), supported by the preclinical data we have accumulated to date. We are extremely excited about the potential of EPI-7386," stated David Parkinson, MD, President and CEO of ESSA. "We are progressing with IND-enabling studies and are on track to enter clinical studies with EPI-7386 in the first quarter of 2020."
Recent Company Highlights
Announced the nomination of EPI-7386 as the lead clinical candidate for the treatment of mCRPC. EPI-7386 is a novel drug candidate that inhibits the N-terminal domain of the androgen receptor. Through this novel mechanism of action, EPI-7386 displays activity in vitro in numerous prostate cancer models including models where current antiandrogen therapies are inactive. Preclinical data shows EPI-7386 is significantly more potent, metabolically stable and more effective than the prior clinical candidate, EPI-506. In addition, EPI-7386 has demonstrated a favorable tolerability profile in all animal studies of the compound conducted to date.
Presented posters at the 2019 Genitourinary Cancers Symposium (ASCO-GU) and also at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting supporting the choice to develop EPI-7386.
Selected for an oral moderated poster presentation at the 2019 American Urological Association (AUA) Annual Meeting on May 4, 2019 in Chicago, Illinois, which provided preclinical information on the class of next-generation anitens and expanded on the preclinical characterization of ESSA’s recently declared investigational new drug ("IND") candidate, EPI-7386.
Summary Financial Results
Net Income (Loss). ESSA recorded a net loss of $3.4 million ($0.54 loss per common share based on 6,311,098 weighted average common shares outstanding) for the quarter ended March 31, 2019, compared to a net loss of $4.4 million ($0.83 loss per common share based on 5,287,605 weighted average common shares outstanding) for the quarter ended March 31, 2018.
Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended March 31, 2019 were $1.5 million compared to $2.0 million for the quarter ended March 31, 2018. The decreases in R&D expenditures for the quarter were primarily related to ESSA’s continued focus on preclinical research related to the ESSA’s next-generation aniten compounds in the current period. Costs in the comparative period included termination costs in relation to ESSA’s conclusion of its Phase I clinical study of EPI-506 in September 2017.
General and administration ("G&A") expenditures. G&A expenditures for the quarter ended March 31, 2019 were $1.8 million compared to $2.2 million for the quarter ended March 31, 2018. The decreases in the quarter primarily reflected decreased corporate activity, resulting in decreased professional and regulatory fees.
Liquidity and Outstanding Share Capital
Cash on hand at March 31, 2019, was $8.6 million, with working capital of $5.4 million, reflecting the aggregate gross proceeds of the completed January 2018 financing, which totaled $26 million, less operating expenses in the intervening period.
As of March 31, 2019, the Company had 6,311,098 common shares issued and outstanding, and 1,654,000 common shares issuable on the exercise of prepaid warrants at a nominal exercise price of $0.002 per common share. If all prepaid warrants are exercised, there would be approximately 7,965,098 ESSA common shares outstanding.
In addition, as of March 31, 2019 there were 474,937 common shares issuable upon the exercise of warrants and broker warrants at a weighted-average exercise price of $34.35 per ESSA common share and 1,149,961 ESSA common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $4.59 per common share.
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