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
BOTHELL, Wash. and VANCOUVER, British Columbia, May 2, 2013 /PRNewswire/ --
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
oIn 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 year.
oThe 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.
oThe 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 200 patients.
oThe 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
oThe 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.
oThe 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
oThe 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.
oPatient 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
"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
oRevenue 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.
oTotal 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 activities.
oNet 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
oThe 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.
o2013 cash guidance:
oNet cash requirements are expected to be in the range of $40 million
to $50 million.
oYear-end cash, cash equivalents and investments are expected to be in
the range of $25 million to $35 million.
oBased 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.
oAt 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 $ $
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 $ $
Basic and diluted net loss per share $ $
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 $ $
investments and restricted cash 64,903 75,697
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 $ $
Liabilities and stockholders' equity:
Accounts payable and accrued $ $
liabilities 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' $ $
equity 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.
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.OncoGenexandTeva 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 theSecurities and Exchange Commissionfrom 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
SOURCE OncoGenex Pharmaceuticals, Inc.
Contact: Media Contact: Jaime Welch, firstname.lastname@example.org, 604-630-5403,
Investor Relations Contact: Susan Specht, email@example.com, 425-686-1535
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