ESSA Pharma Provides Corporate Update and Reports Financial Results for Fiscal First Quarter Ended December 31, 2023
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
-- Reported Phase 1 dose escalation data at multiple medical meetings from
the four cohorts of its ongoing Phase 1/2 study evaluating masofaniten
in combination with enzalutamide in patients with metastatic
castration-resistant prostate cancer ("mCRPC") naïve to
second-generation antiandrogens but may have been treated with
chemotherapy in the metastatic castration-sensitive setting. These data
were presented at the 2024 ASCO Genitourinary Cancers Symposium, the
2023 Prostate Cancer Foundation Scientific Retreat and at the European
Society for Medical Oncology 2023 Congress. As of the most recent data
presentation, the results demonstrated that the combination continues to
be well tolerated at the dose levels tested through up to 25 cycles of
dosing in some patients. Deep and durable reductions in PSA were
observed across evaluable patients for efficacy in all dosing cohorts
(n=16). Across all dosing cohorts, 88% of patients achieved PSA50, 81%
of patients achieved PSA90, 69% of patients achieved PSA90 in less than
90 days, and 63% of patients achieved PSA <0.2ng/mL. While the data for
time to PSA progression are still maturing with a current median follow
up of 11.1 months, the median time to PSA progression is 16.6 months.
ESSA expects to report updated data from the Phase 1 dose escalation
study during the second half of 2024.
-- Enrollment is underway in the Phase 2 portion of the Phase 1/2 study
evaluating the combination of masofaniten and enzalutamide compared to
enzalutamide monotherapy in patients with mCRPC naïve to
second-generation antiandrogens but who may have been treated with
chemotherapy in the metastatic castration-sensitive setting. The Phase 2
portion of the study is an open-label randomized study comparing 160 mg
once-daily of single agent enzalutamide to the combination of
masofaniten with enzalutamide, and is expected to enroll approximately
120 patients. The recommended Phase 2 combination dose was identified as
masofaniten 600 mg twice-daily combined with enzalutamide 160 mg once
daily. The study is currently enrolling at approximately 25 sites in the
USA, Canada and Australia. Expansion to European sites is in progress.
ESSA plans to provide guidance for timing of the public disclosure of
initial data once the Phase 2 portion has been underway for several
months.
-- Initiated two additional masofaniten combination arms as part of the
ongoing Phase 1 masofaniten study. One arm will evaluate masofaniten in
combination with abiraterone acetate and prednisone in patients with
either metastatic castration-sensitive prostate cancer or mCRPC while
the second arm will evaluate masofaniten in combination with apalutamide
in patients with non-metastatic castration-resistant prostate cancer
after 12 weeks of masofaniten single agent. ESSA expects to report
preliminary data from these Phase 1 arms during the second half of 2024.
-- An investigator-sponsored neoadjuvant study was also initiated
evaluating neoadjuvant use of the combination of masofaniten and
darolutamide compared to darolutamide monotherapy in high-risk patients
undergoing prostatectomy.
Masofaniten Monotherapy Study
-- On track to complete the Phase 1b masofaniten monotherapy study
evaluating masofaniten in patients with late-line mCRPC, which is
currently ongoing. The initial results from the study were reported at
the 2023 American Society of Clinical Oncology Genitourinary Cancers
Symposium, which demonstrated that masofaniten monotherapy was
well-tolerated, achieved clinically significant exposures, and showed
preliminary signals of anti-tumor activity in a subset of patients. ESSA
plans to present the complete Phase 1a and 1b monotherapy results in
2024 at a medical conference.
Summary Financial results
(Amounts expressed in U.S. dollars)
-- Net Loss. ESSA recorded a net loss of $6.0 million for the first quarter
ended December 31, 2023 compared to $6.7 million for the first quarter
ended December 31, 2022. The decrease in the first quarter was primarily
attributed to an increase in investment income over the prior period of
$0.5 million.
-- Research and Development ("R&D") expenditures. R&D expenditures for the
first quarter ended December 31, 2023 were $5.4 million compared to $5.3
million for the first quarter ended December 31, 2022, and include
non-cash costs related to share-based payments $526,241 for the first
quarter ended 2023 compared to $791,192 for the first quarter ended
2022. Reduced expenditure on manufacturing for the period was offset by
additional investment in the clinical trial work on masofaniten.
-- General and Administration ("G&A") expenditures. G&A expenditures for
the first quarter ended December 31, 2023 were $2.2 million compared to
$2.5 million for the first quarter ended December 31, 2022 and include
non-cash costs related to share-based payments of $277,177 for the first
quarter ended 2023 compared to $772,419 for the first quarter ended
2022. The overall expenditure is largely comparable to the Company's
additional spend on professional fees to update Company's documents for
its shelf prospectus and ATM program.
Liquidity and Outstanding Share Capital
-- As of December 31, 2023, the Company had available cash reserves and
short-term investments of $142.1 million. The Company's cash position is
expected to be sufficient to fund current and planned operations beyond
2025.
-- On November 6, 2023, the Company announced that it had entered into an
Open Market Sale Agreement(SM) (the "ATM Sales Agreement") with
Jefferies LLC, effective as of November 3, 2023. Under the ATM Sales
Agreement, ESSA may, within the period that the ATM Sales Agreement is
in effect, sell its common shares from time to time for up to $50.0
million in aggregate sales proceeds. No offers or sales of common shares
will be made in Canada, to anyone known by Jefferies LLC to be a
resident of Canada or on or through the facilities of any stock exchange
or trading markets in Canada.
-- As of December 31, 2023, the Company had 44,163,647 common shares issued
and outstanding.
-- In addition, as of December 31, 2023, 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 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,
2023 2023
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
ended ended
December 31, December 31,
2023 2022
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 o
ther 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
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