Entered into clinical trial support agreement with Janssen to
supply Erleada® (apalutamide) and Zytiga®
(abiraterone acetate) for an ESSA-sponsored Phase 1 study of
EPI-7386 combination therapies; enrollment expected to begin
2H2023
Continue to enroll patients into the fourth cohort of the
Phase 1 EPI-7386 combination study with
Xtandi® (enzalutamide); Phase 1
completion expected in 3Q2023 followed by initiation of the
randomized Phase 2 part of the study
Phase 1b EPI-7386 monotherapy
expansion study in mCRPC patients ongoing
SOUTH
SAN FRANCISCO, California and VANCOUVER, Canada, May 9, 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 second quarter ended March
31, 2023. All references to "$" in this release refer to
United States dollars, unless
otherwise indicated.
"ESSA is in a strong cash position as we execute our clinical
strategy to advance our lead candidate, EPI-7386, with our cash
runway expected to fund operations and programs through 2025,"
stated David Parkinson, MD,
President and CEO of ESSA. "This quarter, we continued to enroll
patients into our Phase 1 study of EPI-7386 in combination with
Xtandi® (enzalutamide), and we are working with clinical
sites to prepare for initiation of the randomized Phase 2 portion
of the study as soon we complete Phase 1 and select a recommended
Phase 2 dose. Our Phase 1 EPI-7386 monotherapy expansion study is
progressing as planned with two doses of EPI-7386 currently being
tested in advanced metastatic castration-resistant prostate cancer
("mCRPC") patients. We also advanced an additional EPI-7386
combination therapy program through an agreement with Janssen,
under which Janssen will supply Erleada® (apalutamide)
and Zytiga® (abiraterone acetate) for an ESSA-sponsored
and conducted Phase 1 clinical study in multiple prostate cancer
patient populations including metastatic hormone-sensitive prostate
cancer patients and non-metastatic castration-sensitive prostate
cancer patients. We plan to begin testing these new antiandrogen
combinations with EPI-7386 in the second half of 2023."
Clinical and Corporate Highlights for the Second Quarter
Ended March 31, 2023
EPI-7386 Clinical Collaborations
- The Company continues to enroll patients into the fourth 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 third
quarter of 2023, followed by initiation of the Phase 2 part of the
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 doses versus single agent enzalutamide at
the standard of care dose. The Phase 2 study is expected to enroll
approximately 120 patients.
- In April 2023, the Company
entered into a clinical trial support agreement with Janssen
Research & Development, LLC ("Janssen") under which Janssen
will supply apalutamide and abiraterone acetate for a Phase 1
clinical study sponsored and conducted by ESSA evaluating EPI-7386
combination therapies in two cohorts. The two cohorts will be
evaluated as additional cohorts in the Company's ongoing Phase 1
study of EPI-7386 (Clinical Trials Identifier: NCT04421222). Cohort
A will assess EPI-7386 in combination with abiraterone acetate plus
prednisone in patients with mCRPC and high-risk metastatic
castration-sensitive prostate cancer. Cohort B is a Window of
Opportunity study in which patients with non-metastatic
castration-resistant prostate cancer ("nmCRPC") will receive up to
12 weeks of single agent EPI-7386 before adding standard-of-care
apalutamide. ESSA will retain all rights to EPI-7386. The Company
expects enrollment to begin in the second half of 2023.
EPI-7386 Monotherapy
- The Phase 1b EPI-7386 monotherapy
dose expansion study is ongoing and is 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 at least one
second-generation antiandrogen. The Company is also enrolling
nmCRPC patients in the Window of Opportunity cohort of this study,
in which 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
$7.1 million for the first quarter
ended March 31, 2023, compared to a
comprehensive loss of $10.9 million
for the second quarter ended March 31,
2022. For the second quarter ended March 31, 2023, this included non-cash
share-based payments of $1.4 million
compared to $1.9 million for the
prior year, recognized for stock options granted and vesting. The
decrease in the second quarter was primarily attributed to
decreases in research and development expenditures and general and
administration expenditures in addition to an increase of
$852,347 in interest income.
- Research and Development ("R&D") expenditures.
R&D expenditures for the second quarter ended March 31, 2023 were $4.5
million compared to $7.6
million for the second quarter ended March 31, 2022 and include non-cash costs related
to share-based payments ($750,159 for
the second quarter ended 2023 compared to $1.1 million for the second quarter ended 2022).
The decrease in R&D expenditures for the year ended
March 31, 2023 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 second quarter ended March 31, 2023 were $3.7
million compared to $3.8
million for the second quarter ended March 31, 2022 and include non-cash costs related
to share-based payments of $686,932
for the second quarter ended 2023 compared to $741,494 for the second quarter ended 2022. The
decrease in the second quarter is the result of decreased non-cash
share-based payments and professional fees.
Liquidity and Outstanding Share Capital
At March 31, 2023, the Company had
available cash reserves and short-term investments of
$157 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 March 31, 2023, the Company
had 44,092,374 common shares issued and outstanding.
In addition, as of March 31, 2023
there were 2,927,477 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 7,477 warrants at a weighted average
exercise price of $42.80. There were
8,045,274 common shares issuable upon the exercise of outstanding
stock options at a weighted-average exercise price of $5.08 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 clinical trial support agreement, the supply of
apalutamide and abiraterone acetate, the rights to EPI-7386, the
testing of new antiandrogen combinations with EPI-7386, the
treatments under Cohort A and Cohort B of the Phase 1 clinical
trial 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
|
March 31,
2023
|
|
September 30,
2022
|
|
|
|
|
Cash and cash
equivalents
|
$
44,301
|
|
$
57,076
|
Prepaids and other
assets
|
114,203
|
|
112,429
|
|
|
|
|
Total assets
|
$
158,504
|
|
$
169,505
|
|
|
|
|
Current
liabilities
|
2,146
|
|
2,310
|
Long-term
debt
|
20
|
|
76
|
Shareholders'
deficiency
|
156,338
|
|
167,119
|
|
|
|
|
Total liabilities and
shareholders' equity
|
$
158,504
|
|
$
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
March 31,
2023
|
|
Three months
ended
March 31,
2022
|
|
Six months
ended
March 31,
2023
|
|
Six months
ended
March 31,
2022
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
Research and development
|
$
4,481
|
|
$
7,649
|
|
$
9,825
|
|
$
13,669
|
Financing costs
|
2
|
|
4
|
|
4
|
|
8
|
General and administration
|
3,731
|
|
3,817
|
|
6,250
|
|
6,880
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
(8,214)
|
|
(11,470)
|
|
(16,079)
|
|
(20,557)
|
|
|
|
|
|
|
|
|
Gain on derivative
liability
|
-
|
|
118
|
|
-
|
|
18
|
Interest and other
items
|
1,155
|
|
498
|
|
2,279
|
|
586
|
|
|
|
|
|
|
|
|
Net loss before
taxes
|
(7,059)
|
|
(10,854)
|
|
(13,800)
|
|
(19,953)
|
Income tax expense
(recovery)
|
(2)
|
|
-
|
|
(2)
|
|
1
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive
loss for the period
|
$
(7,061)
|
|
$
(10,854)
|
|
$
(13,802)
|
|
$
(19,952)
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per
common share
|
$
(0.16)
|
|
$
(0.25)
|
|
$
(0.31)
|
|
$
(0.45)
|
|
|
|
|
|
|
|
|
Weighted average number
of
common shares
outstanding
|
44,092,374
|
|
44,030,480
|
|
44,082,725
|
|
44,009,903
|
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SOURCE ESSA Pharma Inc