On February 13, 2020 ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX, TSX-V: EPI), a 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, 2019 (Press release, ESSA, FEB 13, 2020, View Source [SID1234554317]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This past calendar year was a transformative year for ESSA, and we are excited to continue the momentum into 2020. Preparations for an IND filing are nearly complete and we remain on track to file the IND in the first quarter of 2020 with an initiation of the Phase 1 study of EPI-7386 expected shortly thereafter," stated David Parkinson, MD, President and CEO of ESSA. Dr. Parkinson continued, "From our successful acquisition of Realm Therapeutics and fundraising efforts in 2019, ESSA ended the year with $45.9M in cash. Our current cash balance allows us to complete the Phase 1 monotherapy dose-escalation study and an expansion phase to that study. We expect to enroll approximately 18 patients at multiple well-known US and Canadian medical institutions in a standard 3+3 trial design with an approximate 10 additional patients enrolled in the dose expansion cohort. In addition, we believe the Company is sufficiently funded to also conduct a combination study of EPI-7386 with currently utilized antiandrogens in prostate cancer patients with earlier stages of the disease. We look forward to presenting additional preclinical data at upcoming conferences in the first half of 2020".

Recent Corporate Highlights

Abstracts were accepted for presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Special Conference on Advances in Prostate Cancer Research on March 14, 2020 and the 2020 American Urological Association Annual Meeting on May 18, 2020.
On February 13, 2020, a poster abstract of EPI-7386 was presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) GU highlighting preclinical data including new data showing EPI-7386 activity in an enzalutamide-resistant patient-derived xenograft model and favorable safety results from our IND-enabling studies.
In October 2019, the Company paid off the balance of its $3.6M debt facility, leaving the Company with no outstanding debt.
Summary Financial Results

Net Income (Loss). ESSA recorded 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, compared to a net loss of $2.7 million ($0.43 loss per common share based on 6,305,283 weighted average common shares outstanding) for the quarter ended December 31, 2018.
Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended December 31, 2019 were $2.6 million compared to $1.3 million for the quarter ended December 31, 2018. The increase in R&D expenditures for the quarter were primarily related to ESSA’s efforts in preparing an Investigational New Drug ("IND") application for its recently nominated clinical candidate, EPI-7386. Costs in the comparative period included preclinical research related to the Company’s next-generation aniten compounds.
General and administration ("G&A") expenditures. G&A expenditures for the quarter ended December 31, 2019 were $2.1 million compared to $1.2 million for the quarter ended December 31, 2018. The decrease in the quarter is primarily due to share-based payments made as a result of stock options issued in the period.
Liquidity and Outstanding Share Capital

Cash on hand at December 31, 2019 was $45.9 million, with working capital of $45.5 million, reflecting the aggregate gross proceeds of the August 2019 financing of $36 million and the acquisition of Realm Therapeutics plc which provided the Company with $22.2 million in cash, less operating expenses in the intervening period.

As of December 31, 2019, the Company had 20,762,374 common shares issued and outstanding.

In addition, as of December 31, 2019 there were 12,393,092 common shares issuable upon the exercise of warrants and broker warrants. This includes 11,919,404 prefunded warrants at an exercise price of $0.0001, and 473,688 other warrants at a weighted average exercise price of $34.36. There are 5,311,500 common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $3.43 per common share.