OncoGenex Pharmaceuticals, Inc. Provides Update on Clinical Development
Program and Reports Financial Results for Fourth Quarter and Year End 2012
Conference call to be held on Thursday, March 7, 2013 at 4:30 p.m. Eastern Time
BOTHELL, Wash. and VANCOUVER, British Columbia, March 7, 2013 /CNW/ -
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today highlighted key clinical
development activities for its two product candidates, custirsen and OGX-427,
and announced its fourth quarter and year end 2012 financial results.
Custirsen Clinical Development Highlights
-- The Company announced completion of patient enrollment of more
than 1,000 men in the primary registration Phase 3 SYNERGY
study in the fourth quarter of 2012. The SYNERGY study is
designed to evaluate a survival benefit for custirsen, in
combination with first-line docetaxel chemotherapy, in men with
metastatic castrate-resistant prostate cancer (CRPC). The
expected timing of results is based on a pre-specified number
of death events that is projected to occur in the fourth
quarter of 2013, with data results expected to be announced in
the first half of 2014.
-- Patient enrollment began in the third quarter of 2012 in the
Phase 3 AFFINITY study, evaluating a survival benefit for
custirsen in combination with Jevtana® (cabazitaxel) as
second-line chemotherapy. AFFINITY aims to enroll approximately
630 men with CRPC and is being conducted at sites throughout
North America, Europe and Australia.
-- Patient enrollment began in the third quarter of 2012 in the
Phase 3 ENSPIRIT trial, a randomized Phase 3 study in
approximately 1,100 patients with advanced or metastatic
non-small cell lung cancer (NSCLC). ENSPIRIT will evaluate the
potential survival benefit of combining custirsen with
docetaxel as second-line chemotherapy. Custirsen has also
recently received Fast Track designation from the FDA for the
second-line treatment of advanced NSCLC when combined with
docetaxel in patients with disease progression following
treatment with a first-line, platinum-based chemotherapy
OGX-427 Clinical Development Highlights
-- In December 2012, the Company announced the initiation of the
Pacific trial, an investigator-sponsored, randomized Phase 2
study evaluating OGX-427 in approximately 80 men with CRPC who
are experiencing a rising prostate-specific antigen (PSA) while
receiving Zytiga® (abiraterone acetate). The study is currently
enrolling at sites in the United States and Canada.
-- The company-sponsored, randomized Phase 2 clinical trial of
OGX-427 in combination with gemcitabine and cisplatin in
patients with metastatic bladder cancer, Borealis-1, continues
to enroll patients throughout the United States, Canada and
Europe. The study aims to enroll approximately 180 patients and
is expected to complete patient accrual in the second half of
-- The Company also recently announced plans for the initiation of
an investigator-sponsored, randomized Phase 2 study evaluating
OGX-427 in patients with advanced or metastatic bladder cancer
who have disease progression following initial platinum-based
chemotherapy. The trial, Borealis-2, will seek to enroll
approximately 200 patients to receive either OGX-427 plus
docetaxel treatment or docetaxel treatment alone and is
expected to begin in the first half of 2013.
-- Pacific, Borealis-1 and Borealis-2 are part of the "ORCA"
(On-going studies evaluating treatment Resistance in CAncer)
program that encompasses clinical studies of OGX-427 across
multiple cancer indications. Plans to initiate additional
studies as part of the ORCA program will be announced in the
Financial Update and Results
-- Revenue for the fourth quarter and year ended December 31, 2012
increased to $9.8 million and $20.1 million, respectively. This
compares with $1.2 million and $5.5 million, respectively, in
the same periods in 2011. The increase in 2012 compared to 2011
was due to an increase in revenue earned through the Company's
strategic collaboration with Teva, as a result of the clinical
development activities associated with the AFFINITY trial which
was initiated in August 2012. Revenue for 2012 included
recognition of $18.3 million from the $30.0 million upfront
payment, as well as $1.8 million earned through collaborative
-- At December 31, 2012, the $30.0 million advanced reimbursement
received from Teva in December 2009 was fully expended
resulting in a Current Deferred Collaboration Revenue balance
of zero. Teva is required to fund all additional expenses under
the Amended Clinical Development Plan.
-- Total operating expenses for the fourth quarter and year ended
December 31, 2012 increased to $16.0 million and $46.0 million,
respectively, compared with $9.2 million and $27.8 million,
respectively, in the same periods in 2011. The increase in 2012
as compared to 2011 was due primarily to higher clinical study
expenses associated with the start-up of the AFFINITY trial,
increased patient enrollment in the Borealis-1 trial, OGX-427
manufacturing costs and increased employee expenses, including
stock-based compensation expense. These increases were
partially offset by lower preclinical expenses. Included in
operating expenses for the fourth quarter and year ended
December 31, 2012 was a $1.7 million restructuring gain related
to revised assumptions used to estimate the value of the
Company's excess lease liability.
-- Net loss for the fourth quarter and year ended December 31,
2012 was $4.1 million, or $0.28 per diluted common share, and
$21.1 million, or $1.56 per diluted common share, respectively.
Net loss for the fourth quarter and year ended December 31,
2011 was $9.6 million, or $0.98 per diluted common share, and
$14.7 million, or $1.51 per diluted common share, respectively.
The net loss in the years ended December 31, 2012 and 2011
included a non-cash gain on revaluation of our warrant
liability of $4.5 million and $7.4 million, respectively.
-- We had $75.4 million in cash, cash equivalents and short-term
investments as of December 31, 2012, compared to $64.9 million
as of December 31, 2011.
-- 2013 cash guidance:
o Net cash requirements are expected to be in the range of $40
million to $50 million.
o Year-end cash, cash equivalents and investments are expected
to be in the range of $25 million to $35 million.
-- Based on our current expectations, we believe our capital
resources as of December 31, 2012 will be sufficient to fund
our currently planned operations into 2015.
-- At March 7, 2013, we had 14,658,766 shares outstanding.
Consolidated Statements of Loss
(In thousands, except per share and share data)
Three months ended Year ended December 31,
2012 2011 2012 2011
Collaboration $ 9,780 $ 1,236 $ 20,095 $ 5,496
Research and 15,645 7,477 39,948 21,553
General and 2,042 1,731 7,791 6,230
Restructuring (1,657) - (1,657) -
operating 16,030 9,208 46,082 27,783
Loss from 6,250 7,972 25,987 22,287
Other income 2,147 (1,596) 4,889 7,614
Loss for the
period before (4,103) (9,568) (21,098) (14,673)
Income taxes - - - -
Net loss $ (4,103) $ (9,568) $ (21,098) $ (14,673)
diluted net $ (0.28) $ (0.98) $ (1.56) $ (1.51)
loss per share
of basic and 14,656,793 9,748,639 13,522,723 9,729,340
Consolidated Balance Sheets
December 31, December 31,
short term $ 75,697 $ 65,304
Interest 327 363
Amounts 714 449
other current 3,755 1,210
equipment and 1,523 689
Total assets $ 82,016 $ 68,015
payable and $ 7,050 $ 3,217
collaboration - 18,271
portion of 1,084 1,417
Warrant 3,422 7,881
Long term 4,253 6,339
Stockholders' 66,207 30,890
and $ 82,016 $ 68,015
Conference Call Details
OncoGenex will host a conference call at 4:30 p.m. Eastern Time today,
Thursday, March 7, 2013, to provide a business update and discuss the fourth
quarter and year end 2012 results.
A live event will be available on the Investor Relations section of the
OncoGenex Web site at www.OncoGenex.com. Alternatively, you may access the
live conference call by dialing 877-606-1416 (U.S. & Canada) or 707-287-9313
(International). A replay of the webcast will be available approximately two
hours after the call and will be archived for 90 days.
ABOUT ONCOGENEX OncoGenex is a biopharmaceutical company committed to the
development and commercialization of new therapies that address treatment
resistance in cancer patients. OncoGenex has a diverse oncology pipeline, with
each product candidate having a distinct mechanism of action and representing
a unique opportunity for cancer drug development. OncoGenex and Teva
Pharmaceutical Industries Ltd. (NYSE: TEVA) have entered a global
collaboration and license agreement to develop and commercialize OncoGenex'
lead drug candidate, custirsen. Custirsen is currently in Phase 3 clinical
development as a treatment in men with metastatic castrate-resistant prostate
cancer and in patients with advanced, unresectable non-small cell lung cancer.
OGX-427 is in Phase 2 clinical development and OGX-225 is currently in
pre-clinical development. More information is available at www.OncoGenex.com.
OncoGenex' Forward Looking Statements This press release contains
forward-looking statements within the meaning of the "safe harbor" provisions
of the Private Securities Litigation Reform Act of 1995, including, but not
limited to, statements concerning our anticipated product development
activities, such as expected clinical trial completion and design, statements
regarding the potential benefits and potential development of our product
candidates and statements regarding our expected financial results and
expected cash requirements. All statements other than statements of historical
fact are statements that could be deemed forward-looking statements. These
statements are based on management's current expectations and beliefs and are
subject to a number of risks, uncertainties and assumptions that could cause
actual results to differ materially from those described in the
forward-looking statements. Such forward-looking statements are subject to
risks and uncertainties, including, among others, the risk that our product
candidates will not demonstrate the hypothesized or expected benefits, the
risk of delays in our expected clinical trials, the risk that new developments
in the rapidly evolving cancer therapy landscape require changes in our
clinical trial plans or limit the potential benefits of our product, the risk
that our cash resources are insufficient to fund our planned activities for
the time period expected and the other factors described in our risk factors
set forth in our filings with the Securities and Exchange Commission from time
to time, including the Company's Annual Report on Form 10-K and Quarterly
Reports on Form 10-Q. The Company undertakes no obligation to update the
forward-looking statements contained herein or to reflect events or
circumstances occurring after the date hereof, other than as may be required
by applicable law.
JEVTANA® is a registered trademark of sanofi-aventis Zytiga® is a registered
trademark of the Johnson & Johnson Corporation
Jaime Welch, firstname.lastname@example.org, +1-604-630-5403, or Investor Relations
Contact: Susan Specht, email@example.com, +1-425-686-1535
SOURCE: OncoGenex Pharmaceuticals, Inc.
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