Completion of Phase 1 EPI-7386 combination
study with enzalutamide expected in 1H2023 followed by initiation
of the randomized Phase 2 study
Phase 1b
EPI-7386 monotherapy expansion study in mCRPC patients
ongoing
SOUTH
SAN FRANCISCO, CALIFORNIA and VANCOUVER, Canada, Feb. 7, 2023
/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, 2022. All references to "$" in this release refer to
United States dollars, unless
otherwise indicated.
"Building on our momentum and encouraging clinical results
observed in 2022, we continue to advance our studies of EPI-7386,
ESSA's first-in-class N-terminal domain androgen receptor
inhibitor, in patients with metastatic castration-resistant
prostate cancer ("mCRPC")," stated David
Parkinson, MD, President and CEO of ESSA. "In the first half
of 2023, we expect to complete the Phase 1 EPI-7386 combination
study with Xtandi® (enzalutamide) in patients with mCRPC naïve to
second generation anti-androgens and to initiate the Phase 2
randomized study in the same patient population shortly thereafter.
In addition, our cash runway continues to be strong and is expected
to fund our operations and clinical programs through 2025."
Clinical and Corporate
Highlights for the First Quarter Ended December 31, 2022
EPI-7386 Combination Studies
- The Company continues to enroll patients in the third cohort of
the Phase 1/2 study of EPI-7386 in combination with enzalutamide in
patients with mCRPC naïve to second generation antiandrogens. The
Company expects to complete the Phase 1 portion of the study and
establish the recommended Phase 2 combination doses (for both
EPI-7386 and enzalutamide when used in combination) in the first
half of 2023, followed by initiation of the Phase 2 study. The
open-label, randomized Phase 2 study will assess the anti-tumor
activity of EPI-7386 in combination with enzalutamide at the
recommended phase 2 combination dose of EPI-7386 and enzalutamide
versus single agent enzalutamide at the standard of care dose.
- Initial results from the first two cohorts of the Phase 1/2
study of EPI-7386 in combination with enzalutamide were presented
at the Prostate Cancer Foundation Scientific Retreat in
October 2022. Further analysis of
these data will be presented at the 2023 American Society of
Clinical Oncology Genitourinary Cancers Symposium ("ASCO GU"),
taking place February 16-19, 2023, in
San Francisco, CA and online.
- The Company continues to anticipate that enrollment of
additional combination regimens of EPI-7386 with other
antiandrogens in different studies will begin in 2023 in different
prostate cancer patient populations.
EPI-7386 Monotherapy
- The Phase 1b dose expansion study
is ongoing and evaluating two doses/schedules of single agent
EPI-7386 in mCRPC patients with less than three prior lines of
therapy, no visceral disease and no prior chemotherapy who have
progressed on second-generation antiandrogens
- The Company is continuing to seek to enroll patients in the
Window of Opportunity study in non-metastatic CRPC patients.
Patients will receive 12 weeks of EPI-7386 monotherapy treatment
before starting standard of care therapy.
Summary Financial
Results
- Net Loss. ESSA recorded a comprehensive loss of
$6.7 million for the first quarter
ended December 31, 2022, compared to
a comprehensive loss of $9.1 million
for the first quarter ended December 31,
2021. For the first quarter ended December 31, 2022, this included non-cash
share-based payments of $1.6 million
compared to $2.5 million for the
prior year, recognized for stock options granted and vesting. The
decrease in the first quarter was primarily attributed to decreases
in research and development expenditures and general and
administration expenditures in addition to an increase of
$1.1 million in interest income.
- Research and Development ("R&D") expenditures.
R&D expenditures for the first quarter ended December 31, 2022 were $5.3 million compared to $6.0 million for the first quarter ended
December 31, 2021 and include
non-cash costs related to share-based payments ($791,192 for the first quarter ended 2022
compared to $1.3 million for the
first quarter ended 2021). The R&D expenditures for the year
ended December 31, 2022 is the result
of decreased non-cash share-based payments, legal patents and
license fees and manufacturing costs related to the Phase 1
clinical trial of EPI-7386.
- General and administration ("G&A") expenditures.
G&A expenditures for the first quarter ended December 31, 2022 were $2.5 million compared to $3.1 million for the first quarter ended
December 31, 2021 and include
non-cash costs related to share-based payments of $772,419 for the first quarter ended 2022
compared to $1.2 million for the
first quarter ended 2021. The decrease in the first quarter is the
result of decreased non-cash share-based payments and professional
fees.
Liquidity and Outstanding Share Capital
At December 31, 2022, the Company
had available cash reserves and short-term investments of
$163.1 million reflecting the gross
proceeds of the February 2021
financing of approximately $150.0
million and July 2020
financing of $48.9 million, less
operating expenses in the intervening period. The Company's
cash position is expected to be sufficient to fund current and
planned operations through 2025.
As of December 31, 2022, the
Company had 44,092,374 common shares issued and outstanding.
In addition, as of December 31,
2022 there were 3,234,750 common shares issuable upon the
exercise of warrants and broker warrants. This includes 2,920,000
prefunded warrants at an exercise price of $0.0001, and 314,750 warrants at a weighted
average exercise price of $49.69.
There were 7,922,061 common shares issuable upon the exercise of
outstanding stock options at a weighted-average exercise price of
$5.13 per common share.
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 under
@ESSAPharma.
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 completion of the Phase 1 EPI-7386 monotherapy study
and the Phase 1/2 combination study, enrollment in the
monotherapy and combination studies, treatments under the Phase
1b dose expansion study, the Phase
1b Window of Opportunity study and
the Phase 1/2 combination study evaluating EPI-7386 with
enzalutamide, the initiation of the Phase 2 study, the assessment
of anti-tumor activity in the monotherapy and combination studies,
the presentation of initial results in the monotherapy and
combination studies, and the Company's expected cash runway into
2025.
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 13, 2022 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.
ESSA PHARMA INC.
CONDENSED CONSOLIDATED INTERIM
BALANCE SHEETS
(Unaudited)
Amounts in thousands of United States dollars
|
December 31,
2022
|
September 30,
2022
|
|
|
|
Cash and cash
equivalents
|
$
51,221
|
$
57,076
|
Prepaids and other
assets
|
113,782
|
112,429
|
|
|
|
Total assets
|
$
165,003
|
$
169,505
|
|
|
|
Current
liabilities
|
2,935
|
2,310
|
Long-term
debt
|
48
|
76
|
Shareholders'
deficiency
|
162,020
|
167,119
|
|
|
|
Total liabilities and
shareholders' equity
|
$
165,003
|
$
169,505
|
ESSA PHARMA INC.
CONDENSED CONSOLIDATED INTERIM STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
Amounts in thousands of United States dollars, except share and per
share data
|
|
|
Three months
ended
December 31,
2022
|
Three months
ended
December 31,
2021
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
Research and development
|
|
|
$
5,344
|
$
6,020
|
Financing costs
|
|
|
2
|
4
|
General and administration
|
|
|
2,519
|
3,062
|
|
|
|
|
|
Total operating
expenses
|
|
|
(7,865)
|
(9,086)
|
|
|
|
|
|
Loss
on derivative liability
|
|
|
-
|
(99)
|
Other items
|
|
|
1,124
|
87
|
|
|
|
|
|
Net loss before
taxes
|
|
|
(6,741)
|
(9,098)
|
Income tax
recovery
|
|
|
-
|
1
|
|
|
|
|
|
Net loss and
comprehensive loss
for the period
|
|
|
$
(6,738)
|
$
(9,097)
|
|
|
|
|
|
Basic and diluted loss
per common
share
|
|
|
$
(0.15)
|
$
(0.21)
|
|
|
|
|
|
Weighted average number
of
common shares
outstanding
|
|
|
44,073,286
|
43,989,773
|
|
|
|
|
|
|
|
|
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SOURCE ESSA Pharma Inc