SOUTH
SAN FRANCISCO, California and VANCOUVER, Canada, Aug. 4, 2022
/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 third quarter ended June 30,
2022. All references to "$" in this release refer to
United States dollars, unless
otherwise indicated.
"It is a busy and important time for ESSA as we advance our lead
candidate for the treatment of prostate cancer, EPI-7386, into the
dose expansion phase of the single agent trial, dose the second
cohort of patients in the Company-sponsored combination trial with
enzalutamide, and plan to initiate additional trials of EPI-7386 in
earlier-line patients," stated David
Parkinson, M.D., President and CEO of ESSA. "During this
past quarter, we were pleased to report clinical results from the
Phase 1a dose escalation study demonstrating that EPI-7386 was safe
and well-tolerated at all dose levels tested and that tumor volume
decreases were observed in a subgroup of patients with
measurable disease who were on therapy for more than 12 weeks. We
also shared preliminary results from the first cohort of patients
in our Phase 1/2 combination trial with enzalutamide."
Clinical Highlights
EPI-7386 Monotherapy
- In June 2022, ESSA reported
clinical results from the Phase 1a dose escalation study of
EPI-7386 in patients with metastatic castration-resistant prostate
cancer ("mCRPC") resistant to current standard-of-care therapies.
The initial data demonstrate that EPI-7386 was well-tolerated,
exhibited a favorable pharmacokinetic profile, and demonstrated
initial anti-tumor activity in heavily pretreated patients.
EPI-7386 was safe and well-tolerated at all dose levels and
schedules tested, with no dose-limiting toxicities.
- The Phase 1b expansion study is
expected to begin in the third quarter of calendar 2022; the trial
is expected to enroll two dose cohorts as well as an additional
cohort of patients with non-metastatic castration-resistant
prostate cancer ("nmCRPC") who have not yet been treated with a
second-generation antiandrogen in a 12-week window of opportunity
study.
EPI-7386 Clinical Collaborations
- The Company has completed dosing of the first cohort of
patients and is currently enrolling the second cohort of patients
in the Company-sponsored Phase 1/2 study of EPI-7386 in combination
with Astellas Pharma Inc.'s and Pfizer Inc.'s enzalutamide in
patients with mCRPC who have not been treated with
second-generation antiandrogens. In June
2022, the Company reported preliminary results from the
first cohort suggesting that the drugs can be combined safely and
result in active drug levels of both EPI-7386 and enzalutamide.
- Janssen Research and Development LLC continues to enroll
patients in the Phase 1/2 trial of EPI-7386 in combination with
apalutamide or abiraterone acetate plus prednisone in earlier line
mCRPC patients.
- The Bayer-led Phase 1/2 trial will evaluate EPI-7386 in
combination with darolutamide in earlier line mCRPC patients.
- The Company expects to initiate a Phase 2
investigator-sponsored neoadjuvant study to evaluate darolutamide
compared to EPI-7386 + darolutamide in patients undergoing
prostatectomy for high-risk localized prostate cancer by
year-end.
Summary Financial Results
- Net Loss. ESSA recorded a net loss of $8.8 million ($0.20
loss per common share based on 44,059,700 weighted average common
shares outstanding) for the quarter ended June 30, 2022, compared to a net loss of
$8.8 million ($0.21 loss per common share based on 41,018,024
weighted average common shares outstanding) for the quarter ended
June 30, 2021. For the quarter ended
June 30, 2022, this included non-cash
share-based payments of $1.6 million
compared to $2.8 million for the
comparable period in 2021, recognized for stock options granted and
vesting.
- Research and Development ("R&D") expenditures.
R&D expenditures for the quarter ended June 30, 2022 were $6.4
million compared to $6.2
million for the quarter ended June
30, 2021 and included non-cash costs related to share-based
payments ($872,531 for the quarter
ended June 30, 2022 compared to
$1.2 million for the quarter ended
June 30, 2021). The increase in
R&D expenditures for the fiscal quarter ended June 30, 2022 was primarily related to
preclinical and clinical data analysis associated with the Phase 1a
clinical study.
- General and administration ("G&A") expenditures.
G&A expenditures for the quarter ended June 30, 2022 were $2.9
million compared to $3.1
million for the quarter ended June
30, 2021 and included non-cash costs related to share-based
payments of $718,469 for the quarter
ended June 30, 2022 compared to
$1.5 million for the comparable
period in 2021. The decreased expenditure is the result of
decreased professional fees from collaboration contracts in the
prior period and decreased non-cash share-based payments.
Liquidity and Outstanding Share Capital
At June 30, 2022, the Company had
available cash reserves and short-term investments of $174.6 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
2024.
As of June 30, 2022, the Company
had 44,073,076 common shares issued and outstanding.
In addition, as of June 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 7,852,061 common shares issuable upon the exercise of
outstanding stock options at a weighted-average exercise price of
$5.15 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 CRPC and mCRPC whose tumors have
progressed on current standard-of-care therapies. The Phase 1
clinical trial of EPI-7386 began in calendar Q3 of 2020 following
FDA allowance of ESSA's Investigational New Drug application and
Health Canada acceptance. The Phase 1b component of the study comprises two cohorts
enrolling in parallel. Cohort A - a dose expansion study of
EPI-7386 to evaluate the safety, tolerability, pharmacokinetic, and
preliminary anti-tumor activity and Cohort B – a window of
opportunity study with clinical endpoints to assess the anti-tumor
activity in nmCRPC patients unperturbed by previous second
generation anti-androgen therapies or chemotherapy. EPI-7386 is
also being studied in earlier line mCRPC patients in Phase 1/2
trials in combination with enzalutamide, apalutamide and
abiraterone acetate with prednisone. 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
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.
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 the initial clinical data, including the
favorable pharmaceutical properties of EPI-7386, the expected
commencement and timing of the Phase 1b study, the nature of the Phase 1/2 trial, the
potential clinical benefit of EPI-7386 in combination with approved
second-generation antiandrogens 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 Quarterly Report on Form 10-Q dated August 4, 2022 under the heading "Risk Factors",
a copy of which is available on ESSA's profile on EDGAR at
www.sec.gov 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
|
June 30,
2022
|
September 30,
2021
|
|
|
|
Cash and cash
equivalents
|
$
67,868
|
$
137,825
|
Prepaids and other
assets
|
107,793
|
60,341
|
|
|
|
Total assets
|
$
175,661
|
$
198,166
|
|
|
|
Current
liabilities
|
4,034
|
3,930
|
Long-term
debt
|
111
|
210
|
Derivative
liability
|
-
|
20
|
Shareholders'
deficiency
|
171,516
|
194,006
|
|
|
|
Total liabilities and
shareholders' equity
|
$
175,661
|
$
198,166
|
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
June 30,
2022
|
Three months
ended
June 30,
2021
|
Nine months
ended
June 30,
2022
|
Nine months
ended
June 30,
2021
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
Research and development
|
$
|
6,395
|
$
6,232
|
$
20,064
|
$
17,986
|
Financing costs
|
|
3
|
17
|
11
|
18
|
General and administration
|
|
2,896
|
3,118
|
9,775
|
9,942
|
|
|
|
|
|
|
Total operating
expenses
|
|
(9,294)
|
(9,367)
|
(29,850)
|
(27,946)
|
|
|
|
|
|
|
Gain (loss) on
derivative
liability
|
|
2
|
569
|
20
|
(470)
|
Other items
|
|
419
|
46
|
1,005
|
136
|
|
|
|
|
|
|
Net loss before
taxes
|
|
(8,873)
|
(8,752)
|
(28,825)
|
(28,280)
|
Income tax
recovery
|
|
46
|
-
|
46
|
34
|
|
|
|
|
|
|
Net loss and
comprehensive
loss for the period
|
$
|
(8,827)
|
$
(8,752)
|
$
(28,779)
|
$
(28,246)
|
|
|
|
|
|
|
Basic and diluted
loss per
common share
|
$
|
(0.20)
|
$
(0.21)
|
$
(0.65)
|
$
(0.76)
|
|
|
|
|
|
|
Weighted average number
of
common shares
outstanding
|
|
44,059,700
|
41,018,024
|
44,026,502
|
36,937,014
|
|
|
|
|
|
|
|
|
|
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SOURCE ESSA Pharma Inc