HOUSTON and VANCOUVER, Dec. 11,
2017 /PRNewswire/ - ESSA Pharma Inc. ("ESSA" or
the "Company") (TSX-V: EPI, NASDAQ: EPIX), a pharmaceutical company
focused on developing novel therapies for prostate cancer, today
reported financial results for the fourth quarter and year ended
September 30, 2017 and progress on
its preclinical development program.
2017 Year Financial Highlights
Amounts disclosed herein, unless specified otherwise, are
expressed in United States dollars
and in accordance with International Financial Reporting Standards
("IFRS"). References to "$" are to United
States dollars and references to "C$" are to Canadian
dollars.
- Term loan from Silicon Valley Bank. On November 18, 2016, the Company entered into a
$10.0 million term loan agreement
with Silicon Valley Bank ("SVB Term Loan"), pursuant to which the
Company has drawn down $8.0
million.
- Receipt of grant from the Cancer Prevention and Research
Institute of Texas ("CPRIT").
In January and March 2017, ESSA
received a total of $5.2 million from
CPRIT. Under ESSA's agreement with CPRIT, a total of $12.0 million of grant funding (repayable out of
potential product revenues) will be made available to the Company,
of which $6.6 million had previously
been received.
Summary Financial Results
- Net Income (Loss). ESSA recorded a net loss of
$4.5 million ($0.15 loss per common share) for the year ended
September 30, 2017, compared to a net
loss of $13.1 million ($0.49 loss per common share) for the year ended
September 30, 2016. The net loss for
the fourth quarter of 2017 was $1.9
million compared to a net loss of $4.2 million for the fourth quarter of 2016.
- Research and Development ("R&D") expenditures.
R&D expenditures for the year ended September 30, 2017 were $5.73 million net of grants ($10.92 million gross) compared to $13.6 million (net and gross), for the year ended
September 30, 2016. For the fourth
quarter ended September 30, 2017,
R&D expenditures were $1.2
million compared to $3.9
million for the fourth quarter ended September 30, 2016. Decreases in R&D
expenditures for the full year and fourth quarter were primarily
related to decreases in manufacturing and clinical trial costs as
the Company approached the completion of the Phase I clinical study
of EPI-506, compared to the full year and fourth quarter ended
September 30, 2016, as the Company
ramped up its clinical development of EPI-506, which commenced in
November 2015.
- General and administration ("G&A") expenditures.
G&A expenditures for the year ended September 30, 2017 were $5.1 million compared to $5.6 million for the year ended September 30, 2016. For the fourth quarter ended
September 30, 2017, G&A
expenditures were $1.1 million
compared to $1.2 million for the
fourth quarter ended September 30,
2016. The decreases in the full year and fourth quarter
primarily reflects the reduction in administrative costs, as well
as reduced share-based payments reflecting vesting of stock options
granted in previous years.
Liquidity and Outstanding Share Capital
Cash on hand as at September 30,
2017 was $3.98 million, with
working capital of $1.28 million,
reflecting the $2.0 current portion
of the SVB Term Loan, for which repayment obligations commence in
January 2018. Management continues to
consider sources of additional financing which would assure
continuation of the Company's operations and preclinical research
programs on its next generation aniten compounds and the filing of
an Investigational New Drug ("IND") filing with the U.S. Food and
Drug Administration, currently anticipated for calendar Q1 of
2019.
As of September 30, 2017, the
Company had 29,101,889 common shares issued and outstanding,
3,717,519 common shares issuable upon the exercise of outstanding
stock options at a weighted-average exercise price of C$2.78 per common share, and 6,992,710 common
shares issuable upon the exercise of outstanding warrants at a
weighted-average exercise price of $3.27 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 "anticipate", "believe", "plan", "estimate",
"expect", and "intend", "potential", "promising", "refocus",
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 about the Company's
capital and capital requirements, expectations regarding the
acceleration of ESSA's next-generation NTD-inhibitor aniten
compounds, the anticipated timing of the IND filing for the aniten
program, the anticipated sufficiency of the Company's financial
resources, and the implementation of the Company's business model
and strategic plans including the advancement of the Company's
development portfolio.
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 11, 2017 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.
ESSA PHARMA
INC.
|
|
|
|
|
CONSOLIDATED
STATEMENTS OF FINANCIAL POSITION
|
|
|
(Unaudited)
|
|
|
|
|
Amounts in
thousands of United States dollars
|
|
|
|
|
|
|
|
|
|
|
|
September
30, 2017
|
|
September
30, 2016
|
|
|
|
|
|
Cash
|
$
|
3,957
|
|
$
|
8,985
|
Prepaid and other
assets
|
|
1,650
|
|
1,417
|
|
|
|
|
|
Total
assets
|
$
|
5,607
|
|
$
|
10,402
|
|
|
|
|
|
Current
liabilities
|
|
3,777
|
|
3,630
|
Long-term
debt
|
|
5,933
|
|
-
|
Derivative
liability
|
|
171
|
|
7,309
|
Shareholders'
deficiency
|
|
(4,274)
|
|
(537)
|
|
|
|
|
|
Total liabilities and
shareholders' deficiency
|
$
|
5,607
|
|
$
|
10,402
|
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, 2017
|
|
Three months
ended
September
30, 2016
|
|
Year ended
September
30, 2017
|
|
Year ended
September
30, 2016
|
|
|
|
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
|
|
|
|
|
Research and
development
|
$
|
1,166
|
|
$
|
3,952
|
|
$
|
5,726
|
|
$
|
13,060
|
|
Financing
costs
|
223
|
|
-
|
|
785
|
|
938
|
|
General and
administration
|
1,105
|
|
1,237
|
|
5,141
|
|
5,644
|
|
|
|
|
|
|
|
|
|
Total operating
expenses
|
|
(2,494)
|
|
(5,189)
|
|
(11,652)
|
|
(19,642)
|
|
|
|
|
|
|
|
|
|
|
Gain on derivative
liability
|
599
|
|
1,041
|
|
7,306
|
|
6,574
|
|
Other
items
|
(28)
|
|
2
|
|
(37)
|
|
79
|
|
|
|
|
|
|
|
|
|
Net loss for the year
before taxes
|
|
(1,923)
|
|
(4,146)
|
|
(4,383)
|
|
(12,989)
|
|
Income tax
expense
|
(22)
|
|
(91)
|
|
(116)
|
|
(151)
|
Net loss for the
year
|
$
|
(1,945)
|
|
$
|
(4,237)
|
|
$
|
(4,499)
|
|
$
|
(13,140)
|
|
|
|
|
|
|
|
|
|
Basic and diluted
loss per
common share
|
$
|
(0.07)
|
|
$
|
(0.15)
|
|
$
|
(0.15)
|
|
$
|
(0.49)
|
|
|
|
|
|
|
|
|
|
Weighted average
number of common shares outstanding
|
|
29,101,889
|
|
26,903,834
|
|
29,098,725
|
|
26,903,834
|
SOURCE ESSA Pharma Inc