SOUTH SAN FRANCISCO, Calif. and VANCOUVER, Canada, May 14, 2024 /CNW/ - 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 second quarter ended March 31, 2024.
"The year is off to a strong start with the presentation of updated Phase 1 masofaniten dose escalation data at the 2024 ASCO Genitourinary Cancers Symposium ("ASCO-GU"), which demonstrated that masofaniten combined with enzalutamide continues to be well tolerated with deep and durable reductions in prostate-specific antigen ("PSA") in patients with metastatic castration-resistant prostate cancer ("mCRPC") naïve to second-generation antiandrogens," said David Parkinson, MD, President and CEO of ESSA. "Looking ahead, we have multiple critical milestones we are working toward, including reporting more updated data from the Phase 1 dose escalation study evaluating masofaniten combined with enzalutamide in this patient population during the second half of 2024, and completing enrollment in the Phase 2 dose expansion study evaluating masofaniten in combination with enzalutamide during the first quarter of 2025, with preliminary data expected to follow in mid-2025."
Second Quarter Fiscal 2024 and Recent Highlights
Masofaniten Combination Studies
Masofaniten Monotherapy Study
Summary Financial results
(Amounts expressed in U.S. dollars)
Liquidity and Outstanding Share Capital
About ESSA Pharma Inc.
ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer. For more information, please visit www.essapharma.com, and follow us on Twitter and LinkedIn.
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 plans to report updated data from its studies, the Company's advancement and evaluation of masofaniten, the timing of the Company's studies, enrollment in the Company's studies, the presentation of Phase 1a and 1b monotherapy results and the Company's expected cash runway.
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 Annual Report on Form 10-K dated December 12, 2023, under the heading "Risk Factors", a copy of which is available on ESSA's profile on EDGAR at www.sec.gov and on SEDAR+ at www.sedarplus.ca, 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.
Contacts
ESSA Pharma, Inc.
David Wood, Chief Financial Officer
778.331.0962
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Investors and Media:
Argot Partners
212.600.1902
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ESSA PHARMA INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
Amounts in thousands of United States dollars
March 31, 2024 | September 30, | |
Cash | $ 91,683 | $ 33,702 |
Prepaids and other assets | 46,213 | 115,420 |
Total assets | $ 137,896 | $ 149,122 |
Current liabilities | 4,174 | 3,495 |
Long-term debt | 253 | - |
Shareholders' equity | 133,469 | 145,627 |
Total liabilities and shareholders' equity | $ 137,896 | $ 149,122 |
ESSA PHARMA INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
Amounts in thousands of United States dollars, except share and per share data
Three months March 31, 2024 | Three months March 31, 2023 | Six months March 31, 2024 | Six months ended March 31, 2023 | |
OPERATING EXPENSES | ||||
Research and development | $ 6,178 | $ 4,481 | $ 11,555 | $ 9,825 |
Financing costs | - | 2 | - | 4 |
General and administration | 4,316 | 3,731 | 6,533 | 6,250 |
Total operating expenses | (10,494) | (8,214) | (18,088) | (16,079) |
Interest and other items | 1,504 | 1,155 | 3,134 | 2,279 |
Net loss before taxes | (8,990) | (7,059) | (14,954) | (13,800) |
Income tax expense (recovery) | - | (2) | - | (2) |
Net loss and comprehensive |
$ (8,990) |
$ (7,061) |
$ (14,954) |
$ (13,802) |
Basic and diluted loss per | $ (0.20) | $ (0.16) | $ (0.34) | $ (0.31) |
Weighted average number of common shares outstanding |
44,237,124 |
44,092,374 |
44,183,013 |
44,082,725 |
Last Trade: | US$1.40 |
Daily Change: | -3.88 -73.48 |
Daily Volume: | 33,248,762 |
Market Cap: | US$62.120M |
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