SOUTH
SAN FRANCISCO, CALIFORNIA and VANCOUVER, CANADA, Dec. 13,
2022 /CNW/ - 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 year ended September
30, 2022. All references to "$" in this release refer to
United States dollars, unless
otherwise indicated.
"ESSA achieved major milestones in 2022 with the release of
Phase 1 monotherapy and combination data for our lead candidate
EPI-7386 from three clinical trials in patients with metastatic
castration-resistant prostate cancer ("mCRPC"), which demonstrated
initial anti-tumor activity in certain patients, and EPI-7386's
favorable safety profile as a single agent and in combination with
second-generation antiandrogens," stated David Parkinson, MD, President and CEO of ESSA.
"Early data from these clinical studies demonstrated notable PSA
reductions in the Phase 1 study of EPI-7386 and Astellas'
Xtandi® (enzalutamide) and in the Phase 1 study of
EPI-7386 and Janssen's antiandrogens Erleada®
(apalutamide) and Zytiga® (abiraterone acetate). In
addition, the Phase 1a dose escalation monotherapy results showed
tumor volume decreases and PSA declines in a subset of heavily
pretreated mCRPC patients who had progressed on standard-of-care
therapies."
Dr. Parkinson continued: "Looking ahead to 2023, we expect a
busy year as we advance clinical studies of EPI-7386 as a
monotherapy and in combination with approved antiandrogens in a
number of prostate cancer patient populations. Our cash runway is
strong and expected to fund our operations and clinical programs
through 2025, including the Phase 1b
monotherapy expansion and Window of Opportunity studies, a Phase 2
combination study with enzalutamide, additional cohorts in a Phase
1 study evaluating EPI-7386 with Janssen's antiandrogens, and an
investigator-sponsored study of EPI-7386 and darolutamide."
Clinical and Corporate Highlights for 2022 Fiscal
Year
EPI-7386 Combination Studies
- Updated clinical data from the first two cohorts of the Phase
1/2 study of EPI-7386 in combination with enzalutamide were
presented at the 2022 Prostate Cancer Foundation ("PCF") Scientific
Retreat. The data showed preliminary evidence of anti-tumor
activity, with five of six patients achieving PSA90 and four of six
patients achieving PSA90 within 90 days.
- In October 2022, the Company
announced that Janssen Research and Development is suspending
enrollment into the Phase 1 clinical study of EPI-7386 with
apalutamide or EPI-7386 with abiraterone acetate plus prednisone in
mCRPC patients as a result of operational recruitment challenges.
Before suspending enrollment, Janssen treated three mCRPC patients
(chemotherapy naive) for up to four months of therapy, with two of
the three patients achieving PSA90 within 90 days. ESSA anticipates
enrolling additional cohorts in the Phase 1 study in 2023 to
further assess the safety and tolerability of abiraterone acetate
plus prednisone or apalutamide (administered at the dose
recommended in their prescribing information) when administered in
combination with EPI-7386 and to establish recommended Phase 2
dosing for these combinations.
- Preclinical data for the Company's lead first generation
androgen receptor ANITen bAsed Chimera ("ANITAC"™) N-terminal
domain degrader were presented in a poster session at the 34th
EORTC-NCI-AACR Annual Symposium on Molecular Targets and Cancer
Therapeutics.
EPI-7386 Monotherapy
- In June 2022, the Company
presented a clinical update on EPI-7386 monotherapy and combination
therapy clinical development. Initial data from 33 heavily
pretreated mCRPC patients enrolled in the Phase 1a dose escalation
monotherapy study demonstrated that EPI-7386 was well-tolerated and
reached clinically relevant exposures at all dose levels tested.
Clinically important signals of anti-tumor activity were observed
in a subset of these patients (less than 3 lines of treatment for
mCRPC, lack of visceral disease, no prior chemotherapy and lack or
few non-AR mutations).
Corporate Updates
- In September 2022, the Company
announced the appointment of Philip
Kantoff, M.D., to its Board of Directors. Dr. Kantoff is a
renowned medical oncologist and leader in the clinical development
of new prostate cancer treatments.
Summary Financial Results
- Net Loss. ESSA recorded a net loss of $35.1 million for the year ended September 30, 2022, compared to a net loss of
$36.8 million for the year ended
September 30, 2021. For the year
ended September 30, 2022, this
included non-cash share-based payments of $7.9 million compared to $9.5 million for the prior year, recognized for
stock options granted and vesting. The net loss for the fourth
quarter ended September 30, 2022 was
$6.3 million compared to a net loss
of $8.5 million for the fourth
quarter ended September 30, 2021. The
decrease in the fourth quarter was primarily attributed to a
decrease in research and development expenditures.
- Research and Development ("R&D") expenditures.
R&D expenditures for the year ended September 30, 2022 were $24.4 million compared to $24.3 million for the year ended September 30, 2021 and include non-cash costs
related to share-based payments ($4.3
million for the year ended 2022 compared to $3.6 million for the year ended 2021). The
R&D expenditures for the year ended September 30, 2022 largely remained consistent
when compared to the year ended September
30, 2021, as the increased expense in preclinical and data
analysis was offset by the decreased expense in manufacturing costs
related to the Phase 1 clinical trial of EPI-7386. For the fourth
quarter ended September 30, 2022,
R&D expenditures were $4.4
million (net and gross), compared to $6.3 million (net and gross) for the fourth
quarter ended September 30, 2021. The
decrease in the fourth quarter was primarily attributed to a
decrease in non-cash share-based payments, manufacturing costs and
travel costs.
- General and administration ("G&A") expenditures.
G&A expenditures for the year ended September 30, 2022 were $12.5 million compared to $12.9 million for the year ended September 30, 2021 and include non-cash costs
related to share-based payments of $3.6
million for the year ended 2022 compared to $5.8 million for the year ended 2021. For the
fourth quarter ended September 30,
2022, G&A expenditures were $2.8
million, compared to $2.9
million for the fourth quarter ended September 30, 2021. The decrease in the full year
and fourth quarter is the result of decreased professional fees as
well as the decrease in non-cash share-based payments.
Liquidity and Outstanding Share Capital
At September 30, 2022, the Company
had available cash reserves and short-term investments of
$167.2 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 September 30, 2022, the
Company had 44,073,076 common shares issued and outstanding.
In addition, as of September 30,
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 7,902,061 common shares issuable upon the exercise of
outstanding stock options at a weighted-average exercise price of
$5.13 per common share.
About EPI-7386
EPI-7386 is an investigational,
highly-selective, oral, small molecule inhibitor of the N-terminal
domain of the androgen receptor. EPI-7386 is currently being
studied in a Phase 1 clinical trial (NCT04421222) in men with
castration-resistant prostate cancer ("CRPC") whose tumors have
progressed on standard-of-care therapies and a Window of
Opportunity study in patients with non-metastatic CRPC. The U.S.
FDA has granted Fast Track designation to EPI-7386 for the
treatment of adult male patients with mCRPC resistant to
standard-of-care treatment. ESSA is also conducting a Phase 1/2
clinical trial (NCT05075577) of EPI-7386 in combination with
enzalutamide in metastatic CRPC patients who have not yet been
treated with second-generation antiandrogen therapies. ESSA retains
all rights to EPI-7386 worldwide.
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.
About Prostate Cancer
Prostate cancer is estimated to
be the second-most commonly diagnosed cancer among men and the
fifth most common cause of male cancer death worldwide (Globocan,
2020). Adenocarcinoma of the prostate is dependent on androgen for
tumor progression, and depleting or blocking androgen action has
been a mainstay of hormonal treatment for over six decades.
Although tumors are often initially sensitive to medical or
surgical therapies that decrease levels of testosterone, disease
progression despite castrate levels of testosterone can lead to
mCRPC. The treatment of mCRPC patients has evolved rapidly over the
past ten years. Despite these advances, many patients with mCRPC
fail or develop resistance to existing treatments, leading to
continued disease progression and limited survival rates.
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 results of initial clinical data, including the
favorable pharmaceutical properties of EPI-7386, the planned
advancement and development of EPI-7386 as a monotherapy and in
combination with approved antiandrogens, the Phase 1b monotherapy expansion and Window of
Opportunity studies, the Phase 2 study and combination studies, the
planned study evaluating EPI-7386 with Janssen's antiandrogens, the
ESSA-sponsored study of EPI-7386 and darolutamide, 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.
CONSOLIDATED BALANCE SHEETS
Amounts in thousands of United
States dollars
|
September
30, 2022
|
September
30, 2021
|
|
|
|
Cash and cash
equivalents
|
$
57,076
|
$
137,825
|
Prepaids and other
current assets
|
112,429
|
60,341
|
|
|
|
Total assets
|
$
169,505
|
$
198,166
|
|
|
|
Current
liabilities
|
2,310
|
3,930
|
Operating lease
liabilities
|
76
|
210
|
Derivative
liabilities
|
-
|
20
|
Shareholders'
equity
|
167,118
|
194,006
|
|
|
|
Total liabilities and
shareholders' equity
|
$
169,505
|
$
198,166
|
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
ended
September 30,
2022
|
Three months
ended
September 30,
2021
|
Year ended
September 30,
2022
|
Year ended
September 30,
2021
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
Research and development
|
$
4,351
|
$
6,273
|
$
24,415
|
$
24,259
|
Financing costs
|
3
|
4
|
14
|
22
|
General and administration
|
2,770
|
2,942
|
12,545
|
12,885
|
|
|
|
|
|
Total operating
expenses
|
(7,124)
|
(9,219)
|
(36,974)
|
(37,166)
|
|
|
|
|
|
Gain
(loss) on derivative
liability
|
-
|
577
|
20
|
107
|
Other items
|
734
|
121
|
1,738
|
219
|
|
|
|
|
|
Net loss before
taxes
|
(6,390)
|
(8,521)
|
(35,215)
|
(36,840)
|
Income tax
recovery
|
66
|
-
|
112
|
34
|
|
|
|
|
|
Net loss for the
period
|
$
(6,324)
|
$
(8,521)
|
$
(35,103)
|
$
(36,805)
|
|
|
|
|
|
Basic and diluted loss
per common share
|
$
(0.14)
|
$
(0.20)
|
$
(0.80)
|
$
(0.96)
|
|
|
|
|
|
Weighted average number
of
common shares
outstanding
|
44,073,076
|
42,044,664
|
44,038,241
|
38,480,378
|
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SOURCE ESSA Pharma Inc