VANCOUVER, Canada and HOUSTON, Texas, Nov.
18, 2021 /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 year ended
September 30, 2021. All references to
"$" in this release refer to United
States dollars, unless otherwise indicated.
"2021 has been a year of meaningful execution on all aspects of
the development program of EPI-7386, our highly-selective, oral,
small molecule inhibitor that uniquely targets the N-terminal
domain of the androgen receptor for the treatment of patients with
metastatic castration-resistant prostate cancer ("mCRPC")," stated
David Parkinson, MD, President and
CEO of ESSA. "During the year, we presented initial clinical data
at a scientific conference that suggest a favorable pharmacological
profile and provide clinical proof of concept for EPI-7386. In
addition, we demonstrated through nuclear magnetic resonance
("NMR") studies that EPI-7386 binds to the N-terminal domain of the
androgen receptor—the primary driver of prostate cancer growth. We
were pleased to announce this year clinical collaborations with
Janssen Research and Development LLC ("Janssen"), Astellas Pharma
Inc. ("Astellas"), and Bayer, three leading companies with approved
antiandrogen treatments for prostate cancer. These Phase 1/2
studies, anticipated to begin in late 2021 or early 2022, will
evaluate EPI-7386 in combination with the companies' respective
antiandrogen therapies in earlier line mCRPC patients."
Dr. Parkinson continued: "As a result of the successful
financing earlier this year, our cash and short-term investments of
$195 million are expected to provide
us a cash runway into 2024 and fully fund the current development
programs, including the Phase 1a/1b
monotherapy studies, Phase 2, preparatory work for a Phase 3
confirmatory study as well as commitments around the four Phase 1/2
combination studies with approved antiandrogens. In the Phase 1
monotherapy dose escalation study, we are currently dosing patients
with EPI-7386 at 800 mg administered as 400 mg BID, and our goal
remains to establish a recommended Phase 2 dose ("RP2D") for
monotherapy during the first half of 2022, while commencing the
expansion Phase 1b study soon
thereafter. We look forward to presenting a clinical readout of the
Phase 1a monotherapy trial in the first half of 2022."
Clinical and Corporate Highlights for 2021 Fiscal
Year
- On October 7, 2021, at the 2021
American Association for Cancer Research ("AACR"), National Cancer
Institute ("NCI"), and European Organisation for Research and
Treatment of Cancer ("EORTC") 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 ("NTD") 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.
- 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 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 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 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.
- On February 25, 2021, the Company
announced a clinical collaboration with Astellas Pharma Inc. to
evaluate the combination of EPI-7386 and Astellas/Pfizer's androgen
receptor inhibitor enzalutamide for patients with mCRPC. Under the
terms of the agreement, ESSA will sponsor and conduct a Phase 1/2
study to evaluate the safety, tolerability and preliminary efficacy
of the combination of EPI-7386 and enzalutamide in mCRPC patients
who have not yet been treated with second-generation antiandrogen
therapies. Astellas will supply enzalutamide for the trial. ESSA
will retain all rights to EPI-7386.
- On February 22, 2021, the Company
completed an underwritten public offering for aggregate gross
proceeds of $149,999,985, issuing a
total of 5,555,555 common shares, at a public offering price of
$27.00 per share.
- On February 11, 2021, the Company
presented favorable initial Phase 1 clinical pharmacology data of
EPI-7386 for advanced forms of prostate cancer at the 2021 ASCO
Genitourinary Cancers Symposium.
- On January 13, 2021, the Company
announced a clinical collaboration with Janssen to evaluate
EPI-7386 in combination with abiraterone acetate/prednisone or
apalutamide for patients with mCRPC. Under the terms of the
agreement, Janssen may sponsor and conduct up to two Phase 1/2
studies evaluating the safety, tolerability and preliminary
efficacy of the combination of EPI-7386 and apalutamide as well as
the combination of EPI-7386 with abiraterone acetate plus
prednisone in patients with mCRPC. Janssen will assume all costs
associated with these studies other than the manufacturing costs
associated with the clinical drug supply of EPI-7386. The parties
will form a joint oversight committee for the clinical studies.
ESSA will retain all rights to EPI-7386.
Summary Financial Results
- Net Loss. ESSA recorded a net loss of $36.8 million ($0.96 loss per common share based on 38,480,378
weighted average common shares outstanding) for the year ended
September 30, 2021, compared to a net
loss of $23.4 million ($1.04 loss per common share based on 22,443,893
weighted average common shares outstanding) for the year ended
September 30, 2020. For the year
ended September 30, 2021, this
included non-cash share-based payments of $9.5 million compared to $7.5 million for the prior year, recognized for
stock options granted and vesting. The net loss for the fourth
quarter ended September 30, 2021 was
$8.5 million compared to a net loss
of $4.6 million for the fourth
quarter ended September 30, 2020.
- Research and Development ("R&D") expenditures.
R&D expenditures for the year ended September 30, 2021 were $24.3 million compared to $12.1 million for the year ended September 30, 2020 and includes non-cash costs
related to share-based payments ($3.6M for year ended 2021 compared to
$1.9M for year ended 2020). For the
fourth quarter ended September 30,
2021, R&D expenditures were $6.3
million (net and gross), as compared to $2.2 million (net and gross) for the fourth
quarter ended September 30, 2020. The
increase in R&D expenditures for the full year and fourth
quarter were primarily related to preclinical work leading to the
filing of the IND for EPI-7386 in March
2020, the increased expenditure on chemistry and
manufacturing of drug product, and clinical costs related to the
Phase 1 clinical trial of EPI-7386 which commenced with the dosing
of the first patient in July
2020.
- General and administration ("G&A") expenditures.
G&A expenditures for the year ended September 30, 2021 were $12.9 million compared to $11.4 million for the year ended September 30, 2020 and include non-cash costs
related to share-based payments of $5.8M for the year ended 2021 compared to
$5.6M for the year ended 2020. For
the fourth quarter ended September 30,
2021, G&A expenditures were $2.9
million, compared to $2.2
million for the fourth quarter ended September 30, 2020. The increase in the full year
and fourth quarter is the result of increased professional fees
related to transitioning to be a domestic filer, higher salaries
and benefits, as well as the non-cash share-based payments.
Liquidity and Outstanding Share Capital
At September 30, 2021, the Company
had available cash reserves and short-term investments of
$194.9 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 September 30, 2021, the
Company had 43,984,346 common shares issued and outstanding.
In addition, as of September 30,
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 6,803,230 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 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 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 and the Company's expected cash runway into
2024.
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 November 18, 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.
CONSOLIDATED BALANCE SHEETS
Amounts in thousands of United
States dollars
|
|
|
|
September
30, 2021
|
September
30, 2020
|
|
|
|
Cash
|
$
|
137,825
|
$
|
56,321
|
Prepaids and other
assets
|
60,341
|
|
24,254
|
|
|
|
Total
assets
|
$
|
198,166
|
$
|
80,575
|
|
|
|
Current
liabilities
|
3,930
|
1,204
|
Long-term
debt
|
210
|
-
|
Derivative
liability
|
20
|
127
|
Shareholders'
deficiency
|
194,006
|
|
79,244
|
|
|
|
Total liabilities and
shareholders' equity
|
$
|
198,166
|
$
|
80,575
|
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,
2021
|
Three months
ended
September 30,
2020
|
Year ended
September 30,
2021
|
Year ended
September 30,
2020
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
Research and development
|
$
|
6,273
|
$
|
2,237
|
$
|
24,259
|
$
|
12,146
|
Financing costs
|
4
|
117
|
22
|
618
|
General and administration
|
|
2,942
|
|
2,200
|
|
12,885
|
|
11,374
|
|
|
|
|
|
Total operating
expenses
|
|
(9,219)
|
|
(4,554)
|
|
(37,166)
|
|
(24,138)
|
|
|
|
|
|
Gain (loss) on derivative
|
577
|
(51)
|
107
|
(111)
|
liability
|
Other
items
|
|
121
|
|
37
|
|
219
|
|
515
|
|
|
|
|
|
Net loss before
taxes
|
(8,521)
|
(4,568)
|
(36,840)
|
(23,734)
|
Income tax
expense
|
-
|
|
15
|
|
35
|
|
(289)
|
|
|
|
|
|
Net loss for the
period
|
$
|
(8,521)
|
$
|
(4,553)
|
$
|
(36,805)
|
$
|
(23,445)
|
|
|
|
|
|
Basic and diluted
loss per
common share
|
$
|
(0.20)
|
$
|
(0.17)
|
$
|
(0.96)
|
$
|
(1.04)
|
|
|
|
|
|
Weighted average
number of
common shares
outstanding
|
42,044,664
|
27,333,800
|
38,480,378
|
22,443,893
|
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SOURCE ESSA Pharma Inc