ESSA Pharma Provides Corporate Update and Reports Financial Results for Fiscal Fourth Quarter and Year Ended September 30, 2024
Company has initiated a process to explore and review strategic options focused on maximizing shareholder value
SOUTH SAN FRANCISCO, California and VANCOUVER, Canada, Dec. 17, 2024 /PRNewswire/ - ESSA Pharma Inc. ("ESSA," or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company that, prior to the discontinuation of its clinical trials and preclinical and other development programs, has been focused on developing novel therapies for the treatment of prostate cancer, today provided a corporate update and reported financial results for the fourth quarter and fiscal year ended September 30, 2024.
"We recently made the difficult decision to terminate the clinical development of masofaniten, and withdraw the related IND and CTAs, based on an interim analysis of the data from the Phase 2 combination study, concluding that masofaniten combined with enzalutamide was unlikely to meet its primary endpoint," said David Parkinson, MD, President and CEO of ESSA. "We are currently evaluating and reviewing our strategic options focused on maximizing shareholder value and look forward to providing further updates in the near future."
Fourth Quarter Fiscal 2024 and Recent Updates
-- In October 2024, ESSA made the decision to terminate all clinical trials
evaluating masofaniten and to withdraw the related IND and CTAs. The
decision was based on the outcome of a futility analysis conducted as
part of a protocol-specified interim review of the Phase 2 clinical
trial evaluating masofaniten combined with enzalutamide versus
enzalutamide monotherapy in patients with metastatic
castration-resistant prostate cancer ("mCRPC") naïve to
second-generation antiandrogens.
-- The interim analysis, which reviewed the Phase 2 safety, PK and
efficacy data, showed that the study enzalutamide monotherapy
control arm (which is the standard of care for this patient
population) had a much higher rate of PSA90 response than was
expected based upon historical data. In addition, there was no clear
efficacy benefit seen with the combination of masofaniten plus
enzalutamide compared to enzalutamide single agent. A futility
analysis determined a low likelihood of meeting the prespecified
primary endpoint of the study. It was therefore concluded that the
study was unlikely to achieve its primary endpoint.
-- The combination of masofaniten plus enzalutamide was well-tolerated
with no new safety signals and a safety profile similar to that seen
in Phase 1 monotherapy and combination studies.
-- ESSA has initiated a comprehensive process to explore and review a range
of strategic options focused on maximizing shareholder value, which may
include, but are not limited to a merger, amalgamation, take-over,
business combination, asset sale or acquisition, shareholder
distribution, wind-up, liquidation and dissolution, seek new products
for development, or other strategic direction. The process is expected
to involve headcount and other cost reductions.
-- On December 12, 2024, ESSA provided a notice of termination of the
License Agreement to the Licensors, notifying the Licensors that it
terminated the License Agreement in accordance with its terms, effective
as of December 12, 2024.
Summary Financial Results
(Amounts expressed in U.S. dollars)
-- Net Loss. ESSA recorded a net loss of $28.5 million for the year ended
September 30, 2024 compared to a net loss of $26.6 million for the year
ended September 30, 2023. For the year ended September 30, 2024, this
included non-cash share-based payments of $6.5 million compared to $5.3
million for the prior year, recognized for stock options granted and
vesting. Net loss for the fourth quarter ended September 30, 2024 was
$6.4 million compared to a net loss of $5.5 million for the fourth
quarter ended September 30, 2023.
-- Research and Development ("R&D") expenditures. R&D expenditures for the
year ended September 30, 2024 were $21.2 million compared to $21.3
million for the year ended September 30, 2023, and include non-cash
costs related to share-based payments ($1.8 million for the year ended
2024 compared to $2.7 million for the year ended 2023). R&D expenditures
for the fourth quarter ended September 30, 2024 were $4.2 million
compared to $5.2 million for the fourth quarter ended September 30, 2023
due to lower expenditures on preclinical and manufacturing.
-- General and Administration ("G&A") expenditures. G&A expenditures for
the year ended September 30, 2024 were $13.2 million compared to $10.8
million for the year ended September 30, 2023, and include non-cash
costs related to share-based payments of $4.7 million for the year ended
2024 compared to $2.6 million for the year ended 2023. G&A expenditures
for the fourth quarter ended September 30, 2024 were $3.5 million
compared to $1.9 million for the fourth quarter ended September 30,
2023. The increase for the fourth quarter was primarily due to increased
share-based payments and higher salary figures.
Liquidity and Outstanding Share Capital
-- As of September 30, 2024, the Company had available cash reserves and
short-term investments of $126.8 million and net working capital of
$124.3 million. The Company has no long-term debt facilities.
-- As of September 30, 2024, the Company had 44,388,550 common shares
issued and outstanding, and there were 2,920,000 common shares issuable
upon the exercise of prefunded warrants at an exercise price of $0.0001.
About ESSA Pharma Inc.
ESSA is a clinical-stage pharmaceutical company that was previously focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer. For more information, please visit www.essapharma.com.
Forward-Looking Statement Disclaimer
This release contains certain information which, as presented, constitutes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and "forward-looking information" within the meaning of applicable Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements include, but are not limited to, 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 termination of the Company's clinical studies of masofaniten, the Company's financial resources, the evaluation of the Company's strategic alternatives, the primary and PSA-related endpoints of the Phase 2 study and other statements surrounding the Company's evaluation of masofaniten.
Forward-looking statements 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; (iv) that one or more strategic options may be available to the Company at reasonably acceptable terms; and (v) general business, market and economic conditions.
Forward-looking statements are 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 [10], 2024, 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
September September
30, 30,
2024 2023
Cash $103,710 $33,702
Prepaids and other assets 24,402 115,420
Total assets $128,112 $149,122
Current liabilities 3,301 3,495
Long-term lease liability 205
Shareholders' deficiency 124,606 145,627
Total liabilities and shareholders' equity $128,112 $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 Year ended Year ended
ended ended
September 30, September 30,
September
30, September 30, 2024 2023
2024 2023
OPERATING EXPENSES
Research and development $4,188 $5,226 $21,207 $21,323
Financing costs 1 7
General and administration 3,507 1,922 13,214 10,812
Total operating expenses (7,695) (7,149) (34,421) (32,142)
Interest and other items 1,339 1,668 5,878 5,560
Net loss before taxes (6,356) (5,481) (28,543) (26,582)
Income tax expense (recovery) (2)
Net loss for the period $(6,356) $(5,483) $(28,543) $(26,584)
OTHER COMPREHENSIVE LOSS
Unrealized gain (loss) on short- 37 2 57 15
term investments
Loss and comprehensive loss for $(6,319) $(5,479) $(28,486) $(26,569)
the period
Basic and diluted loss per $(0.14) $(0.12) $(0.64) $(0.60)
common share
Weighted average number of 44,366,126 44,092,374 44,277,050 44,089,557
common shares outstanding
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