OncoGenex Pharmaceuticals, Inc. Reports Financial Results for Fourth Quarter
and Year End 2013
Conference call to be held on Tuesday, March 11, 2014 at 4:30 p.m. Eastern Time
BOTHELL, Wash. and VANCOUVER, British Columbia, March 11, 2014 /CNW/ -
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today provided a summary of
clinical developments and anticipated near-term milestones and announced
fourth quarter and year end 2013 financial results.
Clinical Developments and Anticipated Near-term Milestones
o The SYNERGY Phase 3 trial is designed to evaluate a survival
benefit for custirsen, in combination with first-line
docetaxel chemotherapy, in men with metastatic
castrate-resistant prostate cancer, or CRPC. OncoGenex
recently announced that the pre-specified number of events
required for final analysis of the Phase 3 SYNERGY trial were
reached. Overall survival results will remain blinded until
all study data have been thoroughly reviewed and prepared for
final analysis, and final results are expected by mid-year
o The AFFINITY Phase 3 trial is designed to evaluate a survival
benefit for custirsen in combination with cabazitaxel
treatment as second-line chemotherapy in patients with CRPC.
Enrollment of approximately 630 patients is ongoing and
expected to be completed by the end of 2014.
o The ENSPIRIT Phase 3 trial is evaluating a survival benefit
for custirsen in combination with docetaxel treatment as
second-line chemotherapy in patients with non-small cell lung
cancer (NSCLC). Enrollment of approximately 1,100 patients is
o OncoGenex and collaborating investigators are in the process
of conducting seven randomized Phase 2 clinical trials to
evaluate apatorsen's ability to inhibit heat shock protein 27
(Hsp27) and improve treatment outcomes in bladder, lung,
pancreatic and prostate cancer patients. Patient enrollment
in the Borealis-1™ Phase 2 trial of apatorsen in
combination with gemcitabine and cisplatin in patients with
metastatic bladder cancer was fully enrolled in July 2013 and
data are expected to be available in the second half of 2014.
Financial Update and Results
-- Revenue for the fourth quarter and year ended December 31, 2013
was $8.6 million and $29.9 million, respectively. This compares
with $9.8 million and $20.1 million, respectively, in the same
periods in 2012. Revenue earned in 2013 consists of
reimbursable clinical trial, manufacturing and preclinical
costs incurred by OncoGenex under the Amended Clinical
Development Plan with Teva.
-- The Company has fulfilled its obligation of funding $30.0
million towards the development of custirsen. Teva is required
to fund all additional expenses under the Amended Clinical
-- Total operating expenses for the fourth quarter and year ended
December 31, 2013 were $15.6 million and $65.2 million,
respectively, compared with $16.0 million and $46.1 million,
respectively, in the same periods in 2012. The increase in 2013
as compared to 2012 was predominantly the result of higher
clinical trial expenses associated with patient enrollment and
treatment in the AFFINITY and Borealis-1 trials, increased
costs related to our investigator-sponsored apatorsen trials,
toxicology expenses related to apatorsen and OGX-225 and
increased employee expenses, including stock-based
compensation, due to an increase in the average number of
employees to support our clinical development activities.
-- Net loss for the fourth quarter and year ended December 31,
2013 was $6.7 million, or $0.45 per diluted common share, and
$31.8 million, or $2.17 per diluted common share, respectively.
Comparatively, 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,
-- The company had $39.2 million in cash, cash equivalents and
short-term investments as of December 31, 2013, compared to
$75.4 million as of December 31, 2012.
-- Based on current expectations, the company believes its capital
resources as of December 31, 2013 will be sufficient to fund
its currently-planned operations beyond the first quarter of
2015, and through:
o the expected release of final survival results from the
SYNERGY trial by mid-2014;
o the expected release of final survival results from the
Borealis-1 trial in the second-half of 2014; and
o the completion of enrollment in the AFFINITY and Spruce
trials by the end of 2014.
-- At March 11, 2014, OncoGenex had 14,718,610 shares outstanding.
Consolidated Statements of Loss
(In thousands, except per share and share data)
Three months ended Twelve months ended December
December 31, 31,
2013 2012 2013 2012
Collaboration $ 8,604 $ 9,780 $ 29,882 $ 20,095
Research and 13,195 15,645 55,317 39,948
General and 2,446 2,042 9,892 7,791
Restructuring - (1,657) - (1,657)
operating 15,641 16,030 65,209 46,082
Loss from (7,037) (6,250) (35,327) (25,987)
Other income 359 2,147 3,478 4,889
Net loss $ (6,678) $ (4,103) $ (31,849) $ (21,098)
diluted net $ (0.45) $ (0.28) $ (2.17) $ (1.56)
loss per share
of basic and 14,707,558 14,656,793 14,683,389 13,522,723
Consolidated Balance Sheets
December 31, December 31,
short term $ 39,536 $ 75,697
Interest 218 327
Amounts 8,657 714
expenses and 5,770 3,755
equipment and 1,508 1,523
Total assets $ 55,689 $ 82,016
payable and $ 13,628 $ 7,050
portion of 1,092 1,084
Warrant 214 3,422
Long term 3,544 4,253
Stockholders' 37,211 66,207
and $ 55,689 $ 82,016
Conference Call Details OncoGenex will host a conference call at 4:30 p.m.
Eastern Time today, Tuesday, March 11, 2014, to provide a business update and
discuss the fourth quarter and year end 2013 results. A live event will be
available on the Investor Relations section of the OncoGenex website 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.
Apatorsen is currently being evaluated in seven randomized Phase 2 trials for
a variety of cancers and OGX-225 is currently in pre-clinical development.
More information is available at www.OncoGenex.com and at the company's
Twitter account: https://twitter.com/OncoGenex_IR.
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.
SOURCE OncoGenex Pharmaceuticals, Inc.
Media Contact: Jaime Welch, email@example.com, 604-630-5403; Investor
Relations Contact: Susan Specht, firstname.lastname@example.org, 425-686-1535
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