On August 14, 2019 ESSA Pharma Inc. ("ESSA", or the "Company") (TSX-V: EPI,NASDAQ: EPIX), a pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, provided a corporate update and reported financial results for the fiscal third quarter ended June 30, 2019 (Press release, ESSA, AUG 14, 2019, View Source [SID1234538749]). All references to "$" in this release refer to United States dollars, unless otherwise indicated.

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"The last quarter marked another significant period in our ongoing transformation process for Essa from both corporate and clinical standpoints. During the quarter, we worked diligently on the work required to complete the acquisition of Realm Therapeutics with the transaction closing on July 31st. The acquisition of Realm and its cash balance put Essa in a strong financial position to allow us to commence the Phase 1 clinical study of EPI-7386," stated David Parkinson, MD, President and CEO of ESSA. "We are progressing with IND-enabling studies on EPI-7386 and on track to file an IND with the FDA in the first calendar quarter of 2020. We look forward to presenting further in vitro and in vivo study results of EPI-7386 in the coming months at medical conferences."

Recent Company Highlights

On July 31, 2019, the Company completed the acquisition of Realm Therapeutics plc ("Realm") pursuant to a scheme of arrangement under Part 26 of the U.K. Companies Act 2006 (the "Acquisition"). Under the terms of the Acquisition, ESSA acquired all of the issued and outstanding shares of Realm, and Realm shareholders received a total of 6,718,150 common shares of the Company.
On May 4, 2019 at the 2019 American Urological Association Meeting, an oral poster presentation presented a deeper preclinical characterization of EPI-7386. The poster showed that pre-clinical studies demonstrate that EPI-7386 (i) displays similar in vitro IC50 potency compared to the lutamide class of antiandrogens in an in vitro androgen receptor (AR) inhibition assay; (ii) shows in vitro activity in several enzalutamide-resistant prostate cancer cell models in which enzalutamide is resistant; (iii) exhibits a favorable metabolic profile across three preclinical animal species (which suggests that EPI-7386 will have high exposure and a long half-life in humans) (iv) provides similar antitumor activity to enzalutamide in the enzalutamide-sensitive LNCaP prostate cancer xenograft model, and (v) provides superior antitumor activity to enzalutamide, as a single agent or in combination with enzalutamide, in the enzalutamide emerging-resistant VCaP prostate cancer xenograft model, specifically showing AR inhibition with both an N-terminal domain inhibitor (EPI-7386) and a ligand binding domain inhibitor (enzalutamide), induces deeper and more consistent anti-tumor responses in the enzalutamide emerging-resistant VCaP xenograft model.
EPI-7386 was selected for a poster presentation at the European Society for Medical Oncology ("ESMO") 2019 Congress to be held September 27-October 1, 2019 in Barcelona, Spain.
Summary Financial Results

Net Income (Loss). ESSA recorded a net loss of $3.3 million ($0.52 loss per common share based on 6,383,737 weighted average common shares outstanding) for the quarter ended June 30, 2019, compared to a net loss of $2.9 million ($0.50 loss per common share based on 5,776,098 weighted average common shares outstanding) for the quarter ended June 30, 2018.

Research and Development ("R&D") expenditures. R&D expenditures for the quarter ended June 30, 2019 were $1.95 million compared to $0.99 million for the quarter ended June 30, 2018. The increase in R&D expenditures for the quarter were primarily related to ESSA’s efforts in preparing an Investigational New Drug 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 June 30, 2019 were $1.2 million compared to $1.6 million for the quarter ended June 30, 2018. The decrease is the result of a reduction in professional fees, primarily due to Acquisition-related professional fees being recorded as deferred costs for the period, as well as decreases in rent expense and share-based payments.
Liquidity and Outstanding Share Capital
Cash on hand at June 30, 2019, was $4.9 million, with working capital of $0.3 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 June 30, 2019, the Company had 7,963,628 common shares issued and outstanding.

In addition, as of June 30, 2019 there were 473,688 common shares issuable upon the exercise of warrants and broker warrants at a weighted-average exercise price of $34.36 per ESSA common share and 1,154,711 ESSA common shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $4.58 per common share.