On February 7, 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 first quarter ended December 31, 2022 (Press release, ESSA, FEB 7, 2023, View Source [SID1234626942]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"Building on our momentum and encouraging clinical results observed in 2022, we continue to advance our studies of EPI-7386, ESSA’s first-in-class N-terminal domain androgen receptor inhibitor, in patients with metastatic castration-resistant prostate cancer ("mCRPC")," stated David Parkinson, MD, President and CEO of ESSA. "In the first half of 2023, we expect to complete the Phase 1 EPI-7386 combination study with Xtandi (enzalutamide) in patients with mCRPC naïve to second generation anti-androgens and to initiate the Phase 2 randomized study in the same patient population shortly thereafter. In addition, our cash runway continues to be strong and is expected to fund our operations and clinical programs through 2025."

Clinical and Corporate Highlights for the First Quarter Ended December 31, 2022
EPI-7386 Combination Studies

The Company continues to enroll patients in the third cohort of the Phase 1/2 study of EPI-7386 in combination with enzalutamide in patients with mCRPC naïve to second generation antiandrogens. The Company expects to complete the Phase 1 portion of the study and establish the recommended Phase 2 combination doses (for both EPI-7386 and enzalutamide when used in combination) in the first half of 2023, followed by initiation of the Phase 2 study. The open-label, randomized Phase 2 study will assess the anti-tumor activity of EPI-7386 in combination with enzalutamide at the recommended phase 2 combination dose of EPI-7386 and enzalutamide versus single agent enzalutamide at the standard of care dose.
Initial results from the first two cohorts of the Phase 1/2 study of EPI-7386 in combination with enzalutamide were presented at the Prostate Cancer Foundation Scientific Retreat in October 2022. Further analysis of these data will be presented at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium ("ASCO GU"), taking place February 16-19, 2023, in San Francisco, CA and online.
The Company continues to anticipate that enrollment of additional combination regimens of EPI-7386 with other antiandrogens in different studies will begin in 2023 in different prostate cancer patient populations.
EPI-7386 Monotherapy

The Phase 1b dose expansion study is ongoing and 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 second-generation antiandrogens
The Company is continuing to seek to enroll patients in the Window of Opportunity study in non-metastatic CRPC patients. Patients will receive 12 weeks of EPI-7386 monotherapy treatment before starting standard of care therapy.
Summary Financial Results
Net Loss. ESSA recorded a comprehensive loss of $6.7 million for the first quarter ended December 31, 2022, compared to a comprehensive loss of $9.1 million for the first quarter ended December 31, 2021. For the first quarter ended December 31, 2022, this included non-cash share-based payments of $1.6 million compared to $2.5 million for the prior year, recognized for stock options granted and vesting. The decrease in the first quarter was primarily attributed to decreases in research and development expenditures and general and administration expenditures in addition to an increase of $1.1 million in interest income.

Research and Development ("R&D") expenditures. R&D expenditures for the first quarter ended December 31, 2022 were $5.3 million compared to $6.0 million for the first quarter ended December 31, 2021 and include non-cash costs related to share-based payments ($791,192 for the first quarter ended 2022 compared to $1.3 million for the first quarter ended 2021). The R&D expenditures for the year ended December 31, 2022 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 first quarter ended December 31, 2022 were $2.5 million compared to $3.1 million for the first quarter ended December 31, 2021 and include non-cash costs related to share-based payments of $772,419 for the first quarter ended 2022 compared to $1.2 million for the first quarter ended 2021. The decrease in the first quarter is the result of decreased non-cash share-based payments and professional fees.
Liquidity and Outstanding Share Capital

At December 31, 2022, the Company had available cash reserves and short-term investments of $163.1 million reflecting the gross proceeds of the February 2021 financing of approximately $150.0 million and July 2020 financing of $48.9 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 December 31, 2022, the Company had 44,092,374 common shares issued and outstanding.

In addition, as of December 31, 2022 there were 3,234,750 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 314,750 warrants at a weighted average exercise price of $49.69. There were 7,922,061 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $5.13 per common share.