Full Press Release Details
ESSA Pharma Provides Corporate Update
and Reports Financial Results for
Fiscal First Quarter Ended December
Vancouver, Canada and Houston, Texas,
February 11, 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, today provided a corporate update and reported
financial results for the fiscal first quarter ended December 31, 2020. All references to "$" in this release refer
to United States dollars, unless otherwise indicated.
"ESSA's series of accomplishments
over the past calendar year have included raising $48.9 million in an over-subscribed public offering, the granting by the U.S.
Food and Drug Administration (the "FDA") of Fast Track Designation to our lead product candidate EPI-7386, and the
initiation of a Phase 1 trial with EPI-7386 for patients with metastatic castration-resistant prostate cancer who have become resistant
to current standard of care therapies," stated David Parkinson, MD, President and CEO of ESSA. "We were also pleased
to have recently announced a clinical collaboration with Janssen Research & Development, LLC ("Janssen") to evaluate
EPI-7386 in combination clinical trials with abiraterone acetate/prednisone or apalutamide, which we believe has potential to improve
treatment options for patients with prostate cancer. 2021 looks to be another pivotal year for our company as we continue to advance
EPI-7386 in our clinical trials."
Recent Clinical and Corporate Highlights
| On January 13, 2021, the Company announced a clinical collaboration with Janssen to evaluate EPI-7386 in combination with abiraterone acetate/prednisone or apalutamide for patients with metastatic castration-resistant prostate cancer ("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 current 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. | ||
| On November 25, 2020, the Company filed a Registration Statement on Form S-3 with the United States Securities and Exchange Commission (the "SEC") to replace the existing Registration Statement on Form F-3, which will allow the Company to raise up to $200 million worth of the securities listed therein. | ||
| On October 26, 2020, ESSA announced its strategic decision to voluntarily delist its Common Shares from the TSX Venture Exchange in Canada. |
Liquidity and Outstanding Share Capital
At December 31, 2020,
the Company had available cash reserves and short-term investments of $74,500,856 reflecting the gross proceeds of the July 2020
financing of $48.9 million, less operating expenses in the intervening period.
As of December 31, 2020, the Company had
33,605,383 common shares issued and outstanding.
In addition, as of December 31, 2020 there
were 7,779,473 common shares issuable upon the exercise of warrants and broker warrants. This includes 7,370,000 prefunded warrants
at an exercise price of $0.0001, and 409,473 warrants at a weighted average exercise price of $39.12. There are 6,750,023 common
shares issuable upon the exercise of outstanding stock options at a weighted-average exercise price of $4.24 per common share.
Principal Independent Accountant
Fees and Services Disclosure
The Company also wishes to provide the
following clarification with respect to the audit and non-audit fees paid by the Company to its auditors for the financial year
ended September 30, 2020, as disclosed in its proxy statement dated January 26, 2021 (the "Proxy Statement"). ESSA
disclosed in the Proxy Statement that it had incurred in 2020 and 2019: (i) audit fees of $35,476 and 32,253 respectively, (ii)
audit-related fees of $Nil, (iii) tax fees of $Nil and (iv) $36,003 and 21,946 respectively in fees in respect of professional
services with respect to filing a prospectus. This fourth category of fees included $15,278 and $18,218 incurred in 2020 and 2019
respectively, in connection with quarterly unaudited interim review of the financial statements which shall be reclassified as
"audit-related" on the basis that the fees are reasonably related to the performance of the audit or review of the
Company's financial statements provided by the Company's auditor.
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
About ESSA Pharma Inc.
ESSA is a clinical-stage pharmaceutical company focused on developing
novel and proprietary therapies for the treatment of patients suffering from prostate cancer. For more information, please visit
About Prostate Cancer
Prostate cancer is the second-most commonly diagnosed cancer
among men and the fifth most common cause of male cancer death worldwide (Globocan, 2018). Adenocarcinoma of the prostate is dependent
on androgen for tumor progression and depleting or blocking androgen action has been a mainstay of hormonal treatment for over
six decades. Although tumors are often initially sensitive to medical or surgical therapies that decrease levels of testosterone,
disease progression despite castrate levels of testosterone can lead to mCRPC. The treatment of mCRPC patients has evolved rapidly
over the past ten years. Despite these advances, many patients with mCRPC fail or develop resistance to existing treatments, leading
to continued disease progression and limited survival rates.
Forward-Looking Statement Disclaimer
This release contains certain information which, as presented,
constitutes "forward-looking information" within the meaning of the Private Securities Litigation Reform Act of 1995
and/or applicable Canadian securities laws. Forward-looking information involves statements that relate to future events and often
addresses expected future business and financial performance, containing words such as "anticipate", "believe",
"plan", "estimate", "expect", and "intend", statements that an action or event "may",
"might", "could", "should", or "will" be taken or occur, or other similar expressions and
includes, but is not limited to, statements regarding the Company's clinical evaluation of EPI-7386, including the advancement
and development of EPI-7386 in the current Phase 1 study, the potential of our clinical collaboration with Janssen to improve treatment
options for patients with prostate cancer, the initiation of one or more combination studies with approved anti-androgen treatments
and expectations as to enrollment and trial design.
Forward-looking statements and information are subject to various
known and unknown risks and uncertainties, many of which are beyond the ability of ESSA to control or predict, and which may cause
ESSA's actual results, performance or achievements to be materially different from those expressed or implied thereby. Such
statements reflect ESSA's current views with respect to future events, are subject to risks and uncertainties and are necessarily
based upon a number of estimates and assumptions that, while considered reasonable by ESSA as of the date of such statements, are
inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and
contingencies. In making forward looking statements, ESSA may make various material assumptions, including but not limited to (i)
the accuracy of ESSA's financial projections; (ii) obtaining positive results of clinical trials; (iii) obtaining necessary
regulatory approvals; and (iv) general business, market and economic conditions.
Forward-looking information is developed based on assumptions
about such risks, uncertainties and other factors set out herein and in ESSA's Quarterly Report on Form 10-Q dated February
9, 2021 under the heading "Risk Factors", a copy of which is available on ESSA's profile on EDGAR at www.sec.gov.com
and on the SEDAR website at www.sedar.com, and as otherwise disclosed from time to time on
ESSA's EDGAR and SEDAR profiles. Forward-looking statements are made based on management's beliefs, estimates and opinions
on the date that statements are made and ESSA undertakes no obligation to update forward-looking statements if these beliefs, estimates
and opinions or other circumstances should change, except as may be required by applicable United States and Canadian securities
laws. Readers are cautioned against attributing undue certainty to forward-looking statements.
CONDENSED CONSOLIDATED INTERIM BALANCE
Amounts in thousands of United States
| December 31, 2020 | September 30, 2020 | |||||||
| Cash and cash equivalents | $ | 52,485 | $ | 56,321 | ||||
| Prepaids and other assets | 23,690 | 24,254 | ||||||
| Total assets | $ | 76,175 | $ | 80,575 | ||||
| Current liabilities | 2,036 | 1,204 | ||||||
| Derivative liability | 38 | 127 | ||||||
| Shareholders' deficiency | 74,101 | 79,244 | ||||||
| Total liabilities and shareholders' equity | $ | 76,175 | $ | 80,575 |
CONDENSED CONSOLIDATED INTERIM STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS
Amounts in thousands of United States
dollars, except share and per share data
| Three months ended December 31, 2020 | Three months ended December 31, 2019 | |||||||
| OPERATING EXPENSES | ||||||||
| Research and development | $ | 4,486 | $ | 2,587 | ||||
| Financing costs | 1 | 216 | ||||||
| General and administration | 2,209 | 2,139 | ||||||
| Total operating expenses | (6,696 | ) | (4,942 | ) | ||||
| Gain (loss) on derivative liability | 89 | (57 | ) | |||||
| Other items | 43 | 108 | ||||||
| Net loss before taxes | (6,564 | ) | (4,891 | ) | ||||
| Income tax recovery | 35 | 278 | ||||||
| Net loss and comprehensive loss for the period | $ | (6,529 | ) | $ | (4,613 | ) | ||
| Basic and diluted loss per common share | $ | (0.20 | ) | $ | (0.22 | ) | ||
| Weighted average number of common shares outstanding | 33,343,488 | 20,762,374 |