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OncoGenex Pharmaceuticals, Inc. Provides Clinical Development Program Overview and Reports Financial Results for First Quarter


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
        year.
        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
          200 patients.
        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
        activities.
    --  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)

(unaudited)
                                          Three months ended March 31,
                                          2013         2012
    Collaboration revenue                     $ 5,076      $ 1,316



Operating expenses:

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

(In thousands)
                                          March 31,    December 31,
                                          2013         2012
                                          (unaudited)

Assets:

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
liabilities

Current portion of long-term              1,088        1,084
obligations

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
equity

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, jwelch@oncogenex.com, 604-630-5403, Investor 
Relations Contact: Susan Specht, sspecht@oncogenex.com, 425-686-1535

http://www.OncoGenex.com

SOURCE: OncoGenex Pharmaceuticals, Inc.

To view this news release in HTML formatting, please use the following URL: 
http://www.newswire.ca/en/releases/archive/May2013/02/c3104.html

CO: OncoGenex Pharmaceuticals, Inc.
ST: British Columbia
NI: HEA MTC BTC ERN CONF 

-0- May/02/2013 20:01 GMT

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