HOUSTON, Texas and VANCOUVER, Canada, Aug.
16, 2021 /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 third quarter ended June 30,
2021. All references to "$" in this release refer to
United States dollars, unless
otherwise indicated.
"During this quarter, the Company continued to focus on the
execution of the Phase 1a clinical program of EPI-7386 as a
monotherapy in patients with late-stage metastatic
castration-resistant prostate cancer ("mCRPC") whose tumors have
progressed on multiple current standard-of-care therapies,
including antiandrogens," said Dr. David R.
Parkinson, M.D., President and Chief Executive Officer of
ESSA Pharma Inc. "In this heavily pretreated cohort of
patients, EPI-7386 continues to be safe, well-tolerated, with
generally good drug exposures, and adverse-events typical of those
associated with antiandrogen therapy. Patients are currently
being dosed at 600 mg, 800 mg, and 1,000 mg QD, with each of these
dose levels being cleared as safe and tolerable. Given the
favorable tolerability of the drug and the wide therapeutic window
seen in preclinical studies, we plan to enroll additional higher
dose cohorts using a twice daily (BID) dosing schedule to further
enhance patient drug exposures. In addition, we are planning to
file a protocol amendment to focus further monotherapy development
in less heavily pretreated patients in whom we believe the androgen
receptor pathway continues to be the primary driver of tumor
growth. Our goal is to establish a recommended Phase 2 dose
("RP2D") for monotherapy during the first half of 2022 and
commence the expansion Phase 1b study
soon thereafter in earlier, less heavily pretreated and more
biologically characterized patients. We look forward to presenting
a clinical readout of the Phase 1a monotherapy trial in the first
half of 2022."
Dr. Parkinson continued, "In parallel, our development of
EPI-7386 in combination with current antiandrogens in mCRPC
patients remains on track. The ESSA-managed clinical trial
collaboration with Astellas (enzalutamide) will begin in the fourth
quarter of 2021. The EPI-7386 combination studies with other
antiandrogens that were announced earlier this year are on track
and are anticipated to begin in late 2021 or early
2022. Lastly, using nuclear magnetic resonance studies, we
have achieved our long-term preclinical goal of demonstrating
definitive evidence that EPI-7386 binds to the N-terminal domain of
the androgen receptor and look forward to presenting these results
at an upcoming scientific conference this year. As a result
of the successful financing earlier this year, our cash and
short-term investments of over $202
million provide us a cash runway into 2024 and fully fund
the current development programs."
Recent Clinical and Corporate Highlights
- On April 28, 2021, the
Company announced a clinical collaboration with Bayer to
evaluate EPI-7386 in combination with Bayer's androgen receptor
inhibitor darolutamide in patients with metastatic
castration-resistant prostate cancer ("mCRPC"). Under the terms of
the agreement, Bayer may sponsor and conduct a Phase 1/2 study to
evaluate the safety, pharmacokinetics and efficacy of the
combination of EPI-7386 and darolutamide in mCRPC patients. ESSA
will supply EPI-7386 for the trial and will retain all rights to
EPI-7386.
- On April 10, 2021, the Company
reported new preclinical data on EPI-7386 at the 2021 American
Association of Cancer Research (AACR) Annual Meeting demonstrating
that in vitro EPI-7386 can prevent the androgen receptor from
binding to genomic DNA and can inhibit AR related transcription in
prostate cancer cell lines expressing androgen receptor ("AR")
splice variants including the AR-v567es variant. The results also
demonstrate that combining EPI-7386 with enzalutamide in vitro
results in a broader and deeper inhibition of the AR pathway.
Summary Financial Results
- Net Loss. ESSA recorded 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, compared to a net loss of
$4.9 million ($0.24 loss per common share based on 20,824,568
weighted average common shares outstanding) for the quarter ended
June 30, 2020. For the period ended
June 30, 2021, this included non-cash
share-based payments of $2.8 million
compared to $1.5 million for the
prior year, recognized for stock options granted and vesting.
- Research and Development ("R&D")
expenditures. R&D expenditures for the quarter ended
June 30, 2021 were $6.2 million compared to $2.7 million for the quarter ended June 30, 2020 and includes non-cash costs related
to share-based payments ($1.2 million
for period ended June 30, 2021
compared to $382,941 for period ended
June 30, 2020). The increase in
R&D expenditures for the third quarter were primarily related
to preclinical research with work directed to the completion of the
IND filing in March 2020 and
chemistry and manufacturing costs in preparation for the Phase 1
study.
- General and administration ("G&A")
expenditures. G&A expenditures for the quarter ended
June 30, 2021 were $3.1 million compared to $2.2 million for the quarter ended June 30, 2020 and include non-cash costs related
to share-based payments of $1.5
million for the period ended June 30,
2021 compared to $1.1 million
for the period ended June 30, 2020.
The increase in the third quarter is the result of increased
share-based payments related to the expense recognized in relation
to the grant and vesting of these equity instruments.
Liquidity and Outstanding Share Capital
At June 30, 2021, the Company had
available cash reserves and short-term investments of $202,263,003 reflecting the gross proceeds of the
February 2021 financing of
$150.0 million and July 2020 financing of $48.9 million, less operating expenses in the
intervening period.
As of June 30, 2021, the Company
had 41,854,916 common shares issued and outstanding.
In addition, as of June 30, 2021
there were 5,359,750 common shares issuable upon the exercise of
warrants and broker warrants. This includes 5,045,000 prefunded
warrants at an exercise price of $0.0001, and 314,750 warrants at a weighted
average exercise price of $49.69.
There are 6,803,230 common shares issuable upon the exercise of
outstanding stock options at a weighted-average exercise price of
$5.20 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 mCRPC
whose tumors have progressed on current standard-of-care therapies.
The Phase I clinical trial of EPI-7386 began in calendar Q3 of 2020
following FDA allowance of our Investigational New Drug application
and Health Canada acceptance. 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.
About Prostate Cancer
Prostate cancer is the
second-most commonly diagnosed cancer among men and the fifth most
common cause of male cancer death worldwide (Globocan, 2018).
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 Company's clinical evaluation of EPI-7386, including
the advancement and development of EPI-7386 in the current Phase 1
study, expectations to explore additional higher dose cohorts, our
goal to establish a recommended Phase 2 dose for monotherapy by the
first-half of 2022 and the expectation of presenting a complete
clinical summary of the Phase 1a monotherapy trial in the first
half of 2022, results of preclinical data suggesting
that EPI-7386 can inhibit AR related transcription and EPI-7386 in
combination with enzalutamide may result in broader and deeper
inhibition of the AR pathway, statements regarding the sponsorship
of Phase 1/2 combination studies with Bayer and Astellas, and the
anticipated start date in 2021 of those studies.
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 16, 2021 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
|
June
30, 2021
|
|
September 30,
2020
|
|
|
|
|
Cash and cash
equivalents
|
$
|
145,194
|
|
$
|
56,321
|
Prepaids and other
assets
|
58,330
|
|
24,254
|
|
|
|
|
Total
assets
|
$
|
203,524
|
|
$
|
80,575
|
|
|
|
|
Current
liabilities
|
3,008
|
|
1,204
|
Long-term
liability
|
220
|
|
-
|
Derivative
liability
|
598
|
|
127
|
Shareholders'
deficiency
|
199,698
|
|
79,244
|
|
|
|
|
Total liabilities and
shareholders' equity
|
$
|
203,524
|
|
$
|
80,575
|
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,
2021
|
|
Three months
ended
June 30,
2020
|
|
Nine months
ended
June 30,
2021
|
|
Nine months
ended
June 30,
2020
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
Research and
development
|
$
|
6,232
|
|
$
|
2,704
|
|
$
|
17,986
|
|
$
|
9,909
|
Financing
costs
|
17
|
|
197
|
|
18
|
|
501
|
General and
administration
|
3,118
|
|
2,171
|
|
9,942
|
|
9,174
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
(9,367)
|
|
(5,072)
|
|
(27,946)
|
|
(19,584)
|
|
|
|
|
|
|
|
|
Gain (loss) on
derivative liability
|
(569)
|
|
(36)
|
|
(470)
|
|
(60)
|
Other items
|
46
|
|
183
|
|
136
|
|
478
|
|
|
|
|
|
|
|
|
Net loss before
taxes
|
(8,752)
|
|
(4,925)
|
|
(28,280)
|
|
(19,166)
|
Income tax
recovery
|
-
|
|
-
|
|
35
|
|
274
|
|
|
|
|
|
|
|
|
Net loss and
comprehensive loss for the period
|
$
|
(8,752)
|
|
$
|
(4,925)
|
|
$
|
(28,245)
|
|
$
|
(18,892)
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per common share
|
$
|
(0.21)
|
|
$
|
(0.24)
|
|
$
|
(0.76)
|
|
$
|
(0.91)
|
|
|
|
|
|
|
|
|
Weighted average
number of
common shares
outstanding
|
41,018,024
|
|
20,824,568
|
|
36,937,014
|
|
20,802,026
|
|
|
|
|
|
|
|
|
View original
content:https://www.prnewswire.com/news-releases/essa-pharma-provides-corporate-update-and-reports-financial-results-for-fiscal-third-quarter-ended-june-30-2021-301355521.html
SOURCE ESSA Pharma Inc