Get Cash Back and $0 Commissions
+ The Power of TradeStation
PRNewswire 13-Feb-2024 7:00 AM
Combination of masofaniten plus enzalutamide continues to be well tolerated with deep and durable reductions in PSA in Phase 1 dose escalation in patients with mCRPC, including 81% of patients achieving PSA90, 69% of patients achieving PSA90 in less than 90 days, and 63% of patients achieving PSA <0.2ng/mL
Phase 2 masofaniten plus enzalutamide combination dose expansion study ongoing
Cash runway sufficient to fund operations beyond 2025
SOUTH SAN FRANCISCO, California and VANCOUVER, Canada, Feb. 13, 2024 /PRNewswire/ - 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, 2023.
"As we enter 2024, we are focused on advancing the investigation of masofaniten in combination with second-generation antiandrogen agents, with the goal of improving clinical outcomes for patients battling prostate cancer," said David Parkinson, MD, President and CEO of ESSA. "We are extremely pleased with the data reported to date from the Phase 1 dose escalation study evaluating masofaniten combined with enzalutamide in patients with mCRPC naïve to second generation anti-androgens where we continue to observe compelling, deep and durable reductions in prostate-specific antigen ("PSA"), along with an encouraging 16.6 month median time to PSA progression. We look forward to reporting updated Phase 1 dose escalation data during 2024. In addition, we continue to advance enrollment in both Phase 1 arms evaluating masofaniten in combination with apalutamide or abiraterone acetate, respectively, and look forward to reporting preliminary data during the second half of 2024."
"On the financial front, we are bolstered by our strong cash position that we expect will provide sufficient runway to fund our planned operations through several data readouts and beyond 2025. We are excited to execute on our key 2024 objectives which we believe will meaningfully advance the investigation of masofaniten and look forward to providing updates on our progress throughout the year," concluded Dr. Parkinson.
First 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, sales of common shares pursuant to the ATM Sales Agreement 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
dwood@essapharma.com
Investors and Media:
Argot Partners
212.600.1902
essa@argotpartners.com
ESSA PHARMA INC.
CONSOLIDATED BALANCE SHEETS
Amounts in thousands of United States dollars
December 31, | September 30, | ||||
Cash and cash equivalents | $ | 35,345 | $ | 33,702 | |
Prepaids and other assets | 109,144 | 115,420 | |||
Total assets | $ | 144,489 | $ | 149,122 | |
Current liabilities | 3,531 | 3,495 | |||
Long-term debt | 275 | - | |||
Shareholders' equity | 140,683 | 145,627 | |||
Total liabilities and shareholders' equity | $ | 144,489 | $ | 149,122 |
ESSA PHARMA INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
Amounts in thousands of United States dollars, except share and per share data
Three months | Three months | ||||
OPERATING EXPENSES | |||||
Research and development | $ | 5,377 | $ | 5,344 | |
Financing costs | - | 3 | |||
General and administration | 2,218 | 2,519 | |||
Total operating expenses | (7,595) | (7,866) | |||
Investment income and other items | 1,631 | 1,124 | |||
Net loss for the period | $ | (5,964) | $ | (6,742) | |
OTHER COMPREHENSIVE LOSS | |||||
Unrealized gain on short-term investments | 20 | 30 | |||
Loss and comprehensive loss for the period | $ | (5,944) | $ | (6,712) | |
Basic and diluted loss per common shares | $ | (0.14) | $ | (0.15) | |
Weighted average number of common shares outstanding | 44,129,491 | 44,073,286 |
View original content:https://www.prnewswire.com/news-releases/essa-pharma-provides-corporate-update-and-reports-financial-results-for-fiscal-first-quarter-ended-december-31-2023-302060209.html
SOURCE ESSA Pharma Inc