On 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, reported financial results for the fiscal second quarter ended March 31, 2021 (Press release, ESSA, MAY 6, 2021, View Source [SID1234579416]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"This quarter was a very productive period for ESSA. We continue to advance our lead product candidate, EPI-7386, in an ongoing Phase 1 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) (Free AACR Whitepaper) 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.

On January 13, 2021, the Company announced a clinical collaboration with Janssen Research & Development, LLC ("Janssen") to evaluate EPI-7386 in combination with abiraterone acetate/prednisone or apalutamide for patients with 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 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.
Summary Financial Results

Net Loss. ESSA recorded a net loss of $13.0 million ($0.36 loss per common share based on 36,484,041 weighted average common shares outstanding) for the quarter ended March 31, 2021, compared to a net loss of $9.4 million ($0.45 loss per common share based on 20,821,956 weighted average common shares outstanding) for the quarter ended March 31, 2020. For the period ended March 31, 2021, this included non-cash share-based payments of $2.7 million compared to $3.6 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 March 31, 2021 were $7.3 million compared to $4.6 million for the quarter ended March 31, 2020 and includes non-cash costs related to share-based payments ($791,969 for period ended March 31, 2021 compared to $1.0 million for period ended March 31, 2020). The increase in R&D expenditures for the second 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 March 31, 2021 were $4.6 million compared to $4.9 million for the quarter ended March 31, 2020 and include non-cash costs related to share-based payments of $1.9 million for the period ended March 31, 2021 compared to $2.6 million for the period ended March 31, 2020. The increase in the second quarter is the result of increased share-based payments related the expense recognized in relation to the grant and vesting of these equity instruments.
Liquidity and Outstanding Share Capital
At March 31, 2021, the Company had available cash reserves and short-term investments of $208,597,224 reflecting the gross proceeds of the February 2021 financing of $150.0 million and July 2020 financing of $48.9 million, less operating expenses in the intervening period.

As of March 31, 2021, the Company had 40,417,857 common shares issued and outstanding.

In addition, as of March 31, 2021 there were 6,728,398 common shares issuable upon the exercise of warrants and broker warrants. This includes 6,370,000 prefunded warrants at an exercise price of $0.0001, and 358,398 warrants at a weighted average exercise price of $44.13. There are 6,726,642 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $4.53 per common share.

About EPI-7386
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 mCRPC whose tumors have progressed on current standard-of-care therapies. The Phase I clinical trial of EPI-7386 began in calendar Q3 of 2020 following FDA allowance of our Investigational New Drug application and Health Canada acceptance. 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 retains all rights to EPI-7386 worldwide.