HOUSTON, Texas and VANCOUVER, Canada, Feb.
3, 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 first quarter ended December
31, 2021. All references to "$" in this release refer to
United States dollars, unless
otherwise indicated.
"In the last quarter ESSA continued to execute on all aspects of
the development program of EPI-7386, our highly-selective, oral,
small molecule inhibitor of the N-terminal domain of the androgen
receptor for the treatment of patients with metastatic
castration-resistant prostate cancer ("mCRPC")," stated
David Parkinson, M.D., President and
CEO of ESSA. "We are currently dosing patients in the Phase 1a dose
escalation study evaluating EPI-7386 as a monotherapy at 800 mg
administered as 400 mg BID. We look forward to presenting a
clinical update of the monotherapy trial in the first half of 2022.
We expect to establish a recommended Phase 2 dose ("RP2D") for
EPI-7386 monotherapy during the first half of 2022 and commence the
Phase 1b expansion study soon
thereafter. In addition, we are dosing patients in our first cohort
of patients in the Company-sponsored combination Phase 1/2 study of
EPI-7386 with Astellas Pharma Inc.'s ("Astellas") and Pfizer Inc.'s
ligand-binding domain androgen receptor inhibitor, enzalutamide, in
patients with mCRPC. Additional Phase 1/2 combination studies
we announced last year with Janssen Research and Development LLC
("Janssen") and Bayer, which will evaluate EPI-7386 in combination
with the companies' respective antiandrogen therapies in earlier
line mCRPC patients, remain on track to begin in 2022. The full
EPI-7386 clinical development program, including a Phase 2 study
and preparatory work for a Phase 3 confirmatory study, is supported
by our cash runway into 2024."
Clinical and Corporate Highlights
- On January 19, 2022, the Company
announced the first patient dosed in the Company-sponsored Phase
1/2 study to evaluate the safety, tolerability, and preliminary
efficacy of ESSA's lead product candidate, EPI-7386, a
first-in-class N-terminal domain androgen receptor inhibitor, in
combination with Astellas and Pfizer Inc.'s ligand-binding domain
androgen receptor inhibitor, enzalutamide, in patients with
mCRPC.
- At the 2021 American Association for Cancer Research, National
Cancer Institute, and European Organisation for Research and
Treatment of Cancer Virtual International Conference on Molecular
Targets and Cancer Therapeutics, the Company presented preclinical
data characterizing the mechanism of action of EPI-7386, including
the results of NMR studies which confirm the binding of the
compound to the N-terminal domain of the androgen receptor ("AR"),
a region not currently targeted by other antiandrogen therapies.
The data also demonstrate that the combination of EPI-7386 with
enzalutamide results in complete inhibition of genome-wide
androgen-induced AR binding, supporting the rationale for Phase 1/2
combination trials of EPI-7386 with approved antiandrogens in
patients with mCRPC.
Summary Financial Results
- Net Loss. ESSA recorded a net loss of $9.1 million ($0.21
loss per common share based on 43,989,773 weighted average common
shares outstanding) for the quarter ended December 31, 2021, compared to a net loss of
$6.5 million ($0.20 loss per common share based on 33,343,488
weighted average common shares outstanding) for the quarter ended
December 31, 2020. For the quarter
ended December 31, 2021, this
included non-cash share-based payments of $2.5 million compared to $1.2 million for the comparable period in 2020,
recognized for stock options granted and vesting.
- Research and Development ("R&D") expenditures.
R&D expenditures for the quarter ended December 31, 2021 were $6.0 million compared to $4.5 million for the quarter ended December 31, 2020 and includes non-cash costs
related to share-based payments ($1.3
million for the quarter ended December 31,2021 compared to $287,424 for the quarter ended December 31, 2020). The increase in R&D
expenditures for the first fiscal quarter ended December 31, 2021 were primarily related to
clinical data analysis associated with the Phase 1a clinical study,
as well as increased expenses related to intellectual property and
salaries, as well as the non-cash share-based expenses.
- General and administration ("G&A") expenditures.
G&A expenditures for the quarter ended December 31, 2021 were $3.1 million compared to $2.2 million for the quarter ended December 31, 2020 and include non-cash costs
related to share-based payments of $1.2
million for the quarter ended December 31, 2021 compared to $917,561 for the comparable period in 2020. The
increased expenditure is the result of increased professional fees
related to transitioning to be a large accelerated filer, higher
salaries and benefits, as well as the non-cash share-based
payments.
Liquidity and Outstanding Share Capital
At
December 31, 2021, the Company had
available cash reserves and short-term investments of $189.2 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.
As of December 31, 2021, the
Company had 44,015,870 common shares issued and outstanding.
In addition, as of December 31,
2021 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 $4.84.
There were 6,789,566 common shares issuable upon the exercise of
outstanding stock options at a weighted-average exercise price of
$5.30 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. EPI-7386 is also being studied in
earlier line mCRPC patients in a Phase 1/2 trial in combination
with enzalutamide. 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 RP2D 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 regarding EPI-7386, the
start date and sponsorship of Phase 1/2 combination studies with
Janssen, Bayer and Astellas, 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 February 3, 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
|
|
|
|
December 31,
2021
|
September 30,
2021
|
|
|
|
Cash and cash
equivalents
|
$
|
121,058
|
$
|
137,825
|
Prepaids and other
assets
|
70,428
|
60,341
|
|
|
|
Total
assets
|
$
|
191,486
|
$
|
198,166
|
|
|
|
Current
liabilities
|
3,658
|
3,930
|
Long-term
debt
|
169
|
210
|
Derivative
liability
|
120
|
20
|
Shareholders'
deficiency
|
187,539
|
194,006
|
|
|
|
Total liabilities and
shareholders' equity
|
$
|
191,486
|
$
|
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 December 31,
2021
|
|
Three months
ended December 31,
2020
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
Research and
development
|
|
|
$
|
6,020
|
|
$
|
4,486
|
Financing
costs
|
|
|
4
|
|
1
|
General and
administration
|
|
|
3,062
|
|
2,209
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
(9,086)
|
|
(6,696)
|
|
|
|
|
|
|
Gain (loss) on
derivative liability
|
|
|
(99)
|
|
89
|
Other items
|
|
|
87
|
|
43
|
|
|
|
|
|
|
Net loss before
taxes
|
|
|
(9,098)
|
|
(6,564)
|
Income tax
recovery
|
|
|
1
|
|
35
|
|
|
|
|
|
|
Net loss and
comprehensive loss
for the period
|
|
|
$
|
(9,097)
|
|
$
|
(6,529)
|
|
|
|
|
|
|
Basic and diluted
loss per common
share
|
|
|
$
|
(0.21)
|
|
$
|
(0.20)
|
|
|
|
|
|
|
Weighted average
number of common shares
outstanding
|
|
|
43,989,773
|
|
33,343,488
|
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SOURCE ESSA Pharma Inc