HOUSTON, TX and VANCOUVER,
Dec. 13, 2018 /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 fourth quarter and
year ended September 30, 2018. All
references to "$" in this release refer to United States dollars, unless otherwise
indicated.
"We have narrowed our selection of an IND candidate to a small
number of compounds with high potency, metabolic stability and,
therefore, predicted long half-lives, as well as superior
pharmaceutical properties," stated David
Parkinson, MD, President and CEO of ESSA. "We will make a
final IND candidate selection following full compound selectivity
characterization and in vivo animal model results, which are
expected in the first calendar quarter of 2019. We look forward to
preparing our lead candidate efficiently in order to enter the
clinic as expeditiously as possible after our IND submission."
2018 Year Highlights
- Achieved significant progress in advancing the Company's
next-generation aniten program toward identifying a lead clinical
product candidate and submitting an Investigational New Drug
Application to the U.S. Food and Drug Administration
-
- Lead compounds are at least fifteen times more potent and five
times more stable in vitro compared to the first-generation
aniten N-terminal domain inhibitor compound, EPI-506.
- Two poster abstracts accepted for presentation at the American
Society of Clinical Oncology Genitourinary Symposium (ASCO-GU) in
February 2019, which will be the
first public presentation of preclinical data from ESSA's new
aniten compounds.
- Closed equity financings totaling $26
million in January 2018,
issuing a total of 4,321,000 common shares and 2,189,000 prepaid
warrants exercisable at a nominal price of $0.002.
- Strengthened the Company's preclinical development
capabilities.
Summary Financial Results
Effective
April 25, 2018, the Company
consolidated its issued and outstanding common shares on the basis
of one post-consolidation share for every 20 pre-consolidation
shares. The consolidation applied uniformly to all ESSA common
shares, incentive stock options, prepaid warrants, and other
securities convertible into or exercisable for common shares.
Unless otherwise stated, all ESSA common share and per share
amounts have been restated retrospectively to reflect this share
consolidation.
- Net Income (Loss). ESSA recorded a net loss of
$11.6 million ($2.55 loss per common share based on 4,566,519
weighted average common shares outstanding) for the year ended
September 30, 2018, compared to a net
loss of $4.5 million ($3.09 loss per common share based on 1,454,936
weighted average common shares outstanding) for the year ended
September 30, 2017, which included a
gain on derivative liability of $7.3
million. The net loss for the fourth quarter ended
September 30, 2018 was $2.3 million compared to a net loss of
$1.9 million for the fourth quarter
ended September 30, 2017.
- Research and Development ("R&D") expenditures.
R&D expenditures for the year ended September 30, 2018 were $4.9 million net of grants ($5.1 million gross) compared to $5.7 million net of grants ($10.9 million gross) for the year ended
September 30, 2017. For the fourth
quarter ended September 30, 2018,
R&D expenditures were $0.9
million net of grants ($1.2
million gross), as compared to $1.2
million (net and gross) for the fourth quarter ended
September 30, 2017. The decreases in
R&D expenditures for the full year and fourth quarter were
primarily related to decreases in manufacturing and clinical trial
costs as ESSA focused its R&D resources on preclinical research
related to the Company's next-generation aniten compounds in the
current year. ESSA concluded its Phase I clinical study of EPI-506
in September 2017.
- General and administration ("G&A") expenditures.
G&A expenditures for the year ended September 30, 2018 were $5.9 million compared to $5.1 million for the year ended September 30, 2017. For the fourth quarter ended
September 30, 2018, G&A
expenditures were $1.2 million,
compared to $1.1 million for the
fourth quarter ended September 30,
2017. The increases in the full year and fourth quarter
primarily reflected increased corporate activity, such as the 1:20
share consolidation, filing of the base shelf prospectus, as well
as compensation expenses and increased share-based payments
reflecting the vesting of stock options.
Liquidity and Outstanding Share Capital
Cash on
hand at September 30, 2018, was
$14.8 million, with working capital
of $12.3 million, reflecting the
aggregate gross proceeds of the completed January 2018 financing, which totaled
$26 million.
As of September 30, 2018, the
Company had 5,776,098 common shares issued and outstanding, and
2,189,000 common shares issuable on the exercise of prepaid
warrants at a nominal exercise price of $0.002 per common share. If all prepaid warrants
are exercised, there would be approximately 7,965,098 ESSA common
shares outstanding.
In addition, there were 474,937 common shares issuable upon the
exercise of warrants and broker warrants at a weighted-average
exercise price of $34.35 per ESSA
common share and 888,709 ESSA common shares issuable upon the
exercise of outstanding stock options at a weighted-average
exercise price of $4.81 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 believes that its proprietary compounds can
significantly expand the interval of time in which patients
suffering from CRPC can benefit from hormone-based therapies, by
disrupting the androgen receptor ("AR") signaling pathway that
drives prostate cancer growth and by preventing AR transcriptional
activity by binding selectively to the N-terminal domain ("NTD") of
the AR. A functional NTD is essential for transactivation of the
AR. In preclinical studies, blocking the NTD has demonstrated the
capability to overcome the known AR-dependent mechanisms of CRPC.
ESSA was founded in 2009.
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, 2012).
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 CPRC
("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", "should", or "will" be taken or
occur, or other similar expressions and includes, but is not
limited to, statements regarding timing of identifying the
next-generation aniten product candidate, the anticipated timing of
submitting an Investigational New Drug Application to the US Food
and Drug Administration and beliefs as to ESSA's proprietary
compounds can significantly expand the interval of time in which
patients suffering from CRPC can benefit from hormone-based
therapies.
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, ESSA's profile on EDGAR at
www.sec.gov, and as otherwise disclosed from time to time on ESSA's
SEDAR profile. 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 forward-looking statements. Neither
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
|
|
|
|
|
|
|
|
|
|
September
30, 2018
|
|
|
September
30, 2017
|
|
|
|
|
|
|
Cash
|
$
|
14,829
|
|
$
|
3,957
|
Prepaid and other
assets
|
|
1,188
|
|
|
1,650
|
|
|
|
|
|
|
Total
assets
|
$
|
16,017
|
|
$
|
5,607
|
|
|
|
|
|
|
Current
liabilities
|
|
3,344
|
|
|
3,777
|
Long-term
debt
|
|
3,501
|
|
|
5,933
|
Derivative
liability
|
|
20
|
|
|
171
|
Shareholders'
deficiency
|
|
9,152
|
|
|
(4,274)
|
|
|
|
|
|
|
Total liabilities and
shareholders' deficiency
|
$
|
16,017
|
|
$
|
5,607
|
ESSA PHARMA
INC. CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited) Amounts in thousands of United States
dollars, except share and per share data
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
months
ended
September
30, 2018
|
|
|
Three
months
ended
September
30, 2017
|
|
|
Year ended
September
30, 2018
|
|
|
Year ended
September
30, 2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
927
|
|
$
|
1,166
|
|
$
|
4,873
|
|
$
|
5,726
|
Financing costs
|
|
|
207
|
|
|
223
|
|
|
912
|
|
|
785
|
General and administration
|
|
|
1,211
|
|
|
1,105
|
|
|
5,929
|
|
|
5,141
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
|
(2,345)
|
|
|
(2,494)
|
|
|
(11,714)
|
|
|
(11,652)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) on derivative liability
|
|
|
21
|
|
|
600
|
|
|
151
|
|
|
7,306
|
Other items
|
|
|
53
|
|
|
(28)
|
|
|
(40)
|
|
|
(36)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
before taxes
|
|
|
(2,271)
|
|
|
(1,922)
|
|
|
(11,603)
|
|
|
(4,382)
|
Income tax
expense
|
|
|
(5)
|
|
|
(22)
|
|
|
(27)
|
|
|
(116)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) for
the period
|
|
$
|
(2,276)
|
|
$
|
(1,944)
|
|
$
|
(11,630)
|
|
$
|
(4,498)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
earnings (loss)
per common share
|
|
$
|
(0.39)
|
|
$
|
(1.34)
|
|
$
|
(2.55)
|
|
$
|
(3.09)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of
common shares
outstanding
|
|
|
5,776,098
|
|
|
1,455,094
|
|
|
4,566,519
|
|
|
1,454,936
|
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