VANCOUVER and HOUSTON, Aug. 14,
2019 /CNW/ - ESSA Pharma Inc. ("ESSA", or the "Company")
(TSX-V: EPI, NASDAQ: EPIX), a 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,
2019. All references to "$" in this release refer to
United States dollars, unless
otherwise indicated.
"The last quarter marked another significant period in our
ongoing transformation process for Essa from both corporate and
clinical standpoints. During the quarter, we worked diligently on
the work required to complete the acquisition of Realm Therapeutics
with the transaction closing on July
31st. The acquisition of Realm and its cash
balance put Essa in a strong financial position to allow us to
commence the Phase 1 clinical study of EPI-7386," stated
David Parkinson, MD, President and
CEO of ESSA. "We are progressing with IND-enabling studies on
EPI-7386 and on track to file an IND with the FDA in the first
calendar quarter of 2020. We look forward to presenting further in
vitro and in vivo study results of EPI-7386 in the coming months at
medical conferences."
Recent Company Highlights
- On July 31, 2019, the Company
completed the acquisition of Realm Therapeutics plc ("Realm")
pursuant to a scheme of arrangement under Part 26 of the U.K.
Companies Act 2006 (the "Acquisition"). Under the terms of the
Acquisition, ESSA acquired all of the issued and outstanding shares
of Realm, and Realm shareholders received a total of 6,718,150
common shares of the Company.
- On May 4, 2019 at the 2019
American Urological Association Meeting, an oral poster
presentation presented a deeper preclinical characterization of
EPI-7386. The poster showed that pre-clinical studies demonstrate
that EPI-7386 (i) displays similar in vitro IC50 potency
compared to the lutamide class of antiandrogens in an in
vitro androgen receptor (AR) inhibition assay; (ii) shows in
vitro activity in several enzalutamide-resistant prostate
cancer cell models in which enzalutamide is resistant; (iii)
exhibits a favorable metabolic profile across three preclinical
animal species (which suggests that EPI-7386 will have high
exposure and a long half-life in humans) (iv) provides similar
antitumor activity to enzalutamide in the enzalutamide-sensitive
LNCaP prostate cancer xenograft model, and (v) provides superior
antitumor activity to enzalutamide, as a single agent or in
combination with enzalutamide, in the enzalutamide
emerging-resistant VCaP prostate cancer xenograft model,
specifically showing AR inhibition with both an N-terminal domain
inhibitor (EPI-7386) and a ligand binding domain inhibitor
(enzalutamide), induces deeper and more consistent anti-tumor
responses in the enzalutamide emerging-resistant VCaP xenograft
model.
- EPI-7386 was selected for a poster presentation at the European
Society for Medical Oncology ("ESMO") 2019 Congress to be held
September 27-October 1, 2019 in
Barcelona, Spain.
Summary Financial Results
- Net Income (Loss). ESSA recorded a net loss of
$3.3 million ($0.52 loss per common share based on 6,383,737
weighted average common shares outstanding) for the quarter ended
June 30, 2019, compared to a net loss
of $2.9 million ($0.50 loss per common share based on 5,776,098
weighted average common shares outstanding) for the quarter ended
June 30, 2018.
- Research and Development ("R&D") expenditures.
R&D expenditures for the quarter ended June 30, 2019 were $1.95
million compared to $0.99
million for the quarter ended June
30, 2018. The increase in R&D expenditures for the
quarter were primarily related to ESSA's efforts in preparing an
Investigational New Drug application for its recently-nominated
clinical candidate, EPI-7386. Costs in the comparative period
included preclinical research related to the Company's
next-generation aniten compounds.
- General and administration ("G&A") expenditures.
G&A expenditures for the quarter ended June 30, 2019 were $1.2
million compared to $1.6
million for the quarter ended June
30, 2018. The decrease is the result of a reduction in
professional fees, primarily due to Acquisition-related
professional fees being recorded as deferred costs for the period,
as well as decreases in rent expense and share-based payments.
Liquidity and Outstanding Share Capital
Cash on
hand at June 30, 2019, was
$4.9 million, with working capital of
$0.3 million, reflecting the
aggregate gross proceeds of the completed January 2018 financing, which totaled
$26 million, less operating expenses
in the intervening period.
As of June 30, 2019, the Company
had 7,963,628 common shares issued and outstanding.
In addition, as of June 30, 2019
there were 473,688 common shares issuable upon the exercise of
warrants and broker warrants at a weighted-average exercise price
of $34.36 per ESSA common share and
1,154,711 ESSA common shares issuable upon the exercise of
outstanding stock options at a weighted-average exercise price of
$4.58 per common share.
About ESSA Pharma Inc.
ESSA is a pharmaceutical
company focused on developing novel and proprietary therapies for
the treatment of castration-resistant prostate cancer ("CRPC") in
patients whose disease is progressing despite treatment with
current therapies. ESSA's proprietary "aniten" compounds bind to
the N-terminal domain of the androgen receptor ("AR"), inhibiting
AR driven transcription and the AR signaling pathway in a unique
manner which bypasses the drug resistance mechanisms associated
with current anti-androgens. The Company is currently progressing
IND-enabling studies and expects to file an IND with the FDA
forEPI-7386 in the first calendar quarter of 2020. For more
information, please visit www.essapharma.com or 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 generally represents a
transition to the lethal variant of the disease, metastatic CRPC
("mCRPC"), and most patients ultimately succumb to the illness. The
treatment of mCRPC patients has evolved rapidly over the past five
years. Despite these advances, additional treatment options are
needed to improve clinical outcomes in patients, particularly those
who fail existing treatments including abiraterone or enzalutamide,
or those who have contraindications to receive those drugs. Over
time, patients with mCRPC generally experience continued disease
progression, worsening pain, leading to substantial morbidity and
limited survival rates. In both in vitro and in vivo animal
studies, ESSA's novel approach to blocking the androgen pathway has
been shown to be effective in blocking tumor growth when current
therapies are no longer effective.
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 "look forward", "anticipate" and, "believe", and
statements that an action or event "is expected", "is predicted",
"should", "may" or "will" be taken or occur, or other similar
expressions and includes, but is not limited to, statements
regarding ESSA's poster presentation at the ESMO and other medical
conferences in respect of the in vitro and in vivo study results
for EPI-7386, the timing of filing an IND, the timing of any
related clinical trials, and the exercise of any outstanding
warrants, broker warrants or options.
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 20-F dated December 13, 2018 under the heading "Risk
Factors", a copy of which is available on ESSA's profile on the
SEDAR website at www.sedar.com or ESSA's profile on EDGAR at
www.sec.gov, and as otherwise disclosed from time to time on ESSA's
SEDAR and EDGAR 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 Canadian and United
States securities laws. Readers are cautioned against
attributing undue certainty to forwardlooking statements.
Neither the TSX Venture Exchange nor its Regulation Services
Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or
accuracy of this release.
ESSA PHARMA
INC. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(Unaudited) Amounts in thousands of United States
dollars
|
|
|
June 30,
2019
|
|
|
September
30, 2018
|
|
|
|
|
|
|
Cash
|
$
|
4,874
|
|
$
|
14,829
|
Prepaid and other
assets
|
|
2,198
|
|
|
1,188
|
|
|
|
|
|
|
Total
assets
|
$
|
7,072
|
|
$
|
16,017
|
|
|
|
|
|
|
Current
liabilities
|
|
5,040
|
|
|
3,344
|
Long-term
debt
|
|
1,405
|
|
|
3,501
|
Derivative
liability
|
|
8
|
|
|
20
|
Shareholders'
deficiency
|
|
619
|
|
|
9,152
|
|
|
|
|
|
|
Total liabilities and
shareholders' deficiency
|
$
|
7,072
|
|
$
|
16,017
|
ESSA PHARMA
INC. CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited) Amounts in thousands of United States
dollars, except share and per share data
|
|
Three months
ended
June 30,
2019
|
Three months
ended
June 30,
2018
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
Research and development
|
|
$
|
1,951
|
|
$
|
988
|
Financing costs
|
|
|
139
|
|
|
223
|
General and administration
|
|
|
1,213
|
|
|
1,579
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
(3,303)
|
|
|
(2,790)
|
|
|
|
|
|
|
|
Gain on derivative liability
|
|
|
15
|
|
|
32
|
Other items
|
|
|
3
|
|
|
(100)
|
|
|
|
|
|
|
|
Net loss before
taxes
|
|
|
(3,285)
|
|
|
(2,852)
|
Income tax
expense
|
|
|
(16)
|
|
|
(22)
|
|
|
|
|
|
|
|
Net loss for the
period
|
|
$
|
(3,301)
|
|
$
|
(2,880)
|
|
|
|
|
|
|
|
Basic and diluted
loss per common
share
|
$
|
|
(0.52)
|
$
|
|
(0.50)
|
|
|
|
|
|
|
|
Weighted average
number of
common shares
outstanding
|
|
|
6,383,737
|
|
|
5,776,098
|
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SOURCE ESSA Pharma Inc