OncoGenex Pharmaceuticals, Inc. Provides Clinical Development Program Overview
and Reports Financial Results for First Quarter 2013
Conference call to be held on Thursday, May 2 at 4:30pm Eastern Time
BOTHELL, Wash. and VANCOUVER, British Columbia, May 2, 2013 /CNW/ - OncoGenex
Pharmaceuticals, Inc. (NASDAQ: OGXI) today provided an overview of clinical
development activities for its two product candidates, custirsen and OGX-427,
and announced first quarter 2013 financial results.
OGX-427 Program Update
-- In January 2013, the Company initiated the ORCA™ (Ongoing
Studies Evaluating Treatment Resistance in CAncer) program,
encompassing clinical trials of its unpartnered product
candidate, OGX-427, across multiple cancer indications. Trials
evaluating the addition of OGX-427 to commonly used anticancer
therapies in patients with advanced bladder, lung, pancreatic
and prostate cancers have been announced, with additional
updates to the ORCA program expected to be provided later this
o The Borealis-1™ Trial is a company-sponsored,
randomized, placebo-controlled Phase 2 trial of OGX-427 in
combination with first-line gemcitabine and cisplatin in
patients with metastatic bladder cancer. This global trial
aims to enroll approximately 180 patients and is expected to
complete patient accrual in the second half of 2013.
o The Borealis-2™ Trial is an investigator-sponsored,
randomized Phase 2 trial evaluating OGX-427 in combination
with docetaxel in patients with advanced or metastatic
bladder cancer who have disease progression following
first-line platinum-based chemotherapy. Borealis-2 was
initiated in April of 2013 and aims to enroll approximately
o The Spruce™ Trial is an investigator-sponsored,
randomized, placebo-controlled Phase 2 trial evaluating
OGX-427 in combination with carboplatin and pemetrexed in
patients with previously untreated, advanced, non-squamous,
non-small cell lung cancer (NSCLC). Plans for Spruce were
announced in April of 2013 and patient enrollment of
approximately 155 patients is expected to begin in mid-2013.
o The Rainier™ Trial is an investigator-sponsored,
randomized, placebo-controlled Phase 2 trial evaluating
OGX-427 in combination with ABRAXANE® (paclitaxel
protein-bound particles for injectable suspension)
(albumin-bound) and gemcitabine in approximately 130 patients
with previously untreated metastatic pancreatic cancer. Plans
for Rainier were announced in May of 2013 and patient
enrollment is expected to begin in mid-2013.
o The Pacific™ Trial is an investigator-sponsored,
randomized Phase 2 trial evaluating OGX-427 in approximately
80 men with metastatic castrate-resistant prostate cancer
(CRPC) who are experiencing rising prostate-specific antigen
(PSA) while receiving Zytiga® (abiraterone acetate). The
trial was initiated in December of 2012, and is currently
enrolling at sites in the United States and Canada.
Custirsen Program Update
-- The primary registration Phase 3 SYNERGY trial, designed to
evaluate a survival benefit for custirsen in combination with
first-line docetaxel chemotherapy in men with metastatic CRPC,
completed enrollment in 2012. The SYNERGY trial is continuing
as planned per the recommendation of an independent Data
Monitoring Committee (DMC), who have completed the second and
last futility analyses per protocol. The planned efficacy
interim analysis has not yet occurred. The expected timing of
final 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 continues in the additional Phase 3
custirsen trials, AFFINITY and ENSPIRIT. The AFFINITY trial
will evaluate the potential survival benefit of custirsen in
combination with Jevtana® (cabazitaxel) as second-line
chemotherapy in men with metastatic CRPC, and ENSPIRIT will
evaluate the potential survival benefit of combining custirsen
with docetaxel as second-line chemotherapy in patients with
advanced or metastatic NSCLC.
"The initiation of multiple investigator-sponsored Phase 2 trials, across
tumor types, represents a significant inflection point in the creation of
value for OGX-427 for which we currently retain all commercialization rights,"
said Scott Cormack, President and Chief Executive Officer, OncoGenex
Pharmaceuticals, Inc. "Considered alongside the three Phase 3 trials of
custirsen, and a strong cash position that will sustain us into 2015, well
past the SYNERGY data read-out, we believe the company is well situated to
continue to execute against our development goals."
First Quarter 2013 Financial Update and Results
-- Revenue for the first quarter of 2013 increased to $5.1 million
from $1.3 million for the first quarter of 2012. The increase
was due to higher revenue earned through the Company's
strategic collaboration with Teva, resulting from clinical
development activities associated with the AFFINITY trial which
was initiated in August 2012.
-- Total operating expenses for the first quarter of 2013
increased to $13.4 million from $6.8 million for the first
quarter of 2012. The increase was due primarily to higher
clinical trial expenses associated with patient enrollment in
the AFFINITY and Borealis-1 trials, increased costs directly
associated with efforts to increase patient enrollment and
higher employee expenses, including stock based compensation
expenses. These increases were partially offset by lower
manufacturing expenses due to timing of OGX-427 manufacturing
-- Net loss for the first quarter of 2013 was $6.7 million, or
$0.46 per diluted common share compared with a net loss of $6.9
million, or $0.67 per diluted common share for the first
quarter of 2012. The net loss for the first quarter of 2013
included a non-cash gain on revaluation of the Company's
warrant liability of $1.4 million compared with a $1.4 million
non-cash loss on revaluation of the warrant liability in the
same period in 2012.
-- The Company had $64.6 million in cash, cash equivalents and
short-term investments as of March 31, 2013, compared with
$75.4 million as of December 31, 2012.
-- 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 current expectations, the Company believes its capital
resources as of March 31, 2013 will be sufficient to fund its
currently planned operations into 2015.
-- At May 2, 2013, the Company had 14,670,395 shares outstanding.
Consolidated Statements of Loss
(In thousands, except per share and share data)
Three months ended March 31,
Collaboration revenue $ 5,076 $ 1,316
Research and development 10,855 5,082
General and administrative 2,500 1,737
Total operating expenses 13,355 6,819
Loss from operations (8,279) (5,503)
Other income (expense) 1,582 (1,357)
Net loss $ (6,697) $ (6,860)
Basic and diluted net loss per share $ (0.46) $ (0.67)
Weighted average number of basic and 14,660,643 10,235,237
diluted common shares
Consolidated Balance Sheets
March 31, December 31,
Cash, cash equivalents, short term $ 64,903 $ 75,697
investments and restricted cash
Interest receivable 321 327
Amounts receivable 5,156 714
Prepaid and other assets 4,537 4,907
Property, equipment and other assets 437 371
Total assets $ 75,354 $ 82,016
Liabilities and stockholders' equity:
Accounts payable and accrued $ 7,925 $ 7,050
Current portion of long-term 1,088 1,084
Warrant liability 1,988 3,422
Long term liabilities 4,088 4,253
Stockholders' equity 60,265 66,207
Total liabilities and stockholders' $ 75,354 $ 82,016
Conference Call Details
OncoGenex will host a conference call at 4:30 p.m. Eastern Time today,
Thursday, May 2, 2013, to provide a business update and discuss the first
quarter 2013 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 and
statements regarding the potential benefits and potential development of our
product candidates. 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, 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 candidates
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.
ORCA™, Borealis-1™, Borealis-2™, Spruce™, Rainier™ and Pacific™,
are registered trademarks of OncoGenex Pharmaceuticals, Inc. ABRAXANE® is a
registered trademark of Celgene Corporation JEVTANA® is a registered
trademark of sanofi-aventis Zytiga® is a registered trademark of the Johnson
& Johnson Corporation
Media Contact: Jaime Welch, firstname.lastname@example.org, 604-630-5403, Investor
Relations Contact: Susan Specht, email@example.com, 425-686-1535
SOURCE: OncoGenex Pharmaceuticals, Inc.
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