On August 8, 2023 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 a corporate update and reported financial results for the fiscal third quarter ended June 30, 2023 (Press release, ESSA, AUG 8, 2023, View Source [SID1234634011]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"Over the past months we have ramped up preparations to initiate the randomized Phase 2 combination study of EPI-7386 and Astellas and Pfizer’s antiandrogen Xtandi (enzalutamide), and we expect to complete the Phase 1 part of the study in the coming quarter," stated David Parkinson, MD, President and CEO of ESSA. "In the past quarter, we finalized our clinical collaboration with Janssen to evaluate EPI-7386 in combination with Janssen’s antiandrogens Erleada (apalutamide) and Zytiga (abiraterone acetate) in two Phase 1 cohorts, building on initial Phase 1 clinical data demonstrating promising prostate-specific antigen ("PSA") declines following combination treatment. ESSA is in a strong cash position as we advance our EPI-7386 studies, with our cash runway expected to fund operations and programs through 2025."

Clinical and Corporate Highlights for the Third Quarter Ended June 30, 2023
EPI-7386 Clinical Collaborations

The Company is preparing to initiate the open-label, randomized Phase 2 study of EPI-7386 and Astellas and Pfizer’s antiandrogen Xtandi (enzalutamide) in patients with metastatic castration-resistant prostate cancer ("mCRPC") naïve to second-generation antiandrogens. The Phase 2 study will assess the anti-tumor activity of EPI-7386 in combination with enzalutamide at the recommended Phase 2 doses versus single agent enzalutamide at the standard-of-care dose. The study is expected to enroll approximately 120 patients. The Company expects to complete the Phase 1 part of the study and establish the recommended Phase 2 combination doses (for both EPI-7386 and enzalutamide when used in combination) in the third calendar quarter of 2023, followed by initiation of the Phase 2 part of the study.

In April 2023, the Company entered into a clinical trial support agreement with Janssen Research & Development, LLC ("Janssen") under which Janssen will supply apalutamide and abiraterone acetate for a Phase 1 clinical study sponsored and conducted by ESSA evaluating EPI-7386 combination therapies in two cohorts. The two cohorts will be evaluated as additional cohorts in the Company’s ongoing Phase 1 study of EPI-7386 (Clinical Trials Identifier: NCT04421222). Cohort 1 will assess EPI-7386 in combination with abiraterone acetate plus prednisone in patients with mCRPC and high-risk metastatic castration-sensitive prostate cancer. Cohort 2 is a Window of Opportunity study in which patients with non-metastatic castration-resistant prostate cancer ("nmCRPC") will receive up to 12 weeks of single agent EPI-7386 before adding standard-of-care apalutamide. ESSA will retain all rights to EPI-7386. The Company expects enrollment to begin in the second half of calendar 2023.
EPI-7386 Monotherapy

The Phase 1b EPI-7386 monotherapy dose expansion study is ongoing and is evaluating two doses/schedules of single agent EPI-7386 in mCRPC patients with less than three prior lines of therapy, no visceral disease and no prior chemotherapy who have progressed on at least one second-generation antiandrogen. The Company is also enrolling nmCRPC patients in the Window of Opportunity cohort of the study, in which patients will receive 12 weeks of EPI-7386 monotherapy treatment before starting standard-of-care therapy.
Corporate Updates

In June 2023, the Company announced the appointment of Lauren Merendino, M.B.A., to its Board of Directors. Ms. Merendino is a leading biopharmaceutical executive who brings over 25 years of commercial experience spanning 20+ disease states, including 15 years of leadership for oncology-specific portfolios.
Summary Financial Results

Net Loss. ESSA recorded a comprehensive loss of $7.3 million for the third quarter ended June 30, 2023, compared to a comprehensive loss of $8.8 million for the third quarter ended June 30, 2022. For the third quarter ended June 30, 2023, this included non-cash share-based payments of $1.2 million compared to $1.6 million for the prior year, recognized for stock options granted and vesting. The decrease in the third quarter was primarily attributed to decreases in research and development expenditures and general and administration expenditures in addition to an increase of $1.2 in interest and other income.

Research and Development ("R&D") expenditures. R&D expenditures for the third quarter ended June 30, 2023 were $6.3 million compared to $6.4 million for the third quarter ended June 30, 2022 and include non-cash costs related to share-based payments ($599,621 for the third quarter ended 2023 compared to $872,531 for the third quarter ended 2022). The decrease in R&D expenditures for the year ended June 30, 2023 is the result of decreased non-cash share-based payments, legal patents and license fees and manufacturing costs related to the Phase 1 clinical trial of EPI-7386.

General and administration ("G&A") expenditures. G&A expenditures for the third quarter ended June 30, 2023 were $2.6 million compared to $2.9 million for the third quarter ended June 30, 2022 and include non-cash costs related to share-based payments of $561,452 for the third quarter ended 2023 compared to $718,469 for the third quarter ended 2022. The decrease in the third quarter is the result of decreased non-cash share-based payments, salaries and benefits and consulting and subcontractor fees.
Liquidity and Outstanding Share Capital
At June 30, 2023, the Company had available cash reserves and short-term investments of $152.5 million reflecting the gross proceeds of the February 2021 financing of approximately $150.0 million, less operating expenses in the intervening period. The Company’s cash position is expected to be sufficient to fund current and planned operations through 2025.

As of June 30, 2023, the Company had 44,092,374 common shares issued and outstanding.

In addition, as of June 30, 2023 there were 2,927,477 common shares issuable upon the exercise of warrants and broker warrants. This includes 2,920,000 prefunded warrants at an exercise price of $0.0001, and 7,477 warrants at a weighted average exercise price of $42.80. There were 8,150,274 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $5.05 per common share.