OncoGenex Pharmaceuticals, Inc. Provides Update on Clinical Development Program and Reports Financial Results for Fourth Quarter

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
        doublet regimen.

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
        2013.
    --  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
        coming months.

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
        research.
    --  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)

(unaudited)
                Three months ended     Year ended December 31,
                December 31,
                2012        2011       2012          2011

Collaboration $ 9,780 $ 1,236 $ 20,095 $ 5,496 revenue

Operating expenses:

Research and 15,645 7,477 39,948 21,553 development

General and 2,042 1,731 7,791 6,230 administrative

Restructuring (1,657) - (1,657) - gain

Total operating 16,030 9,208 46,082 27,783 expenses

Loss from 6,250 7,972 25,987 22,287 operations

Other income 2,147 (1,596) 4,889 7,614 (expense)

Loss for the period before (4,103) (9,568) (21,098) (14,673) income taxes

Income taxes - - - -

Net loss $ (4,103) $ (9,568) $ (21,098) $ (14,673)

Basic and diluted net $ (0.28) $ (0.98) $ (1.56) $ (1.51) loss per share

Weighted average number of basic and 14,656,793 9,748,639 13,522,723 9,729,340 diluted common shares

    Consolidated Balance Sheets

(In thousands)
                                       December 31,  December 31,
                                       2012          2011
                                       (unaudited)

Assets:

Cash, cash
equivalents,
short term                             $ 75,697      $ 65,304
investments
and restricted
cash

Interest                               327           363
receivable

Amounts                                714           449
receivable

Prepaid and
other current                          3,755         1,210
assets

Property,
equipment and                          1,523         689
other assets

Total assets                           $ 82,016      $ 68,015



Liabilities
and
stockholders'
equity:

Accounts
payable and                            $ 7,050       $ 3,217
accrued
liabilities

Deferred
collaboration                          -             18,271
revenue

Current
portion of                             1,084         1,417
long-term
obligations

Warrant                                3,422         7,881
liability

Long term                              4,253         6,339
liabilities

Stockholders'                          66,207        30,890
equity

Total
liabilities
and                                    $ 82,016      $ 68,015
stockholders'
equity

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, jwelch@oncogenex.com, +1-604-630-5403, or Investor Relations 
Contact: Susan Specht, sspecht@oncogenex.com, +1-425-686-1535

http://www.oncogenex.com

SOURCE: OncoGenex Pharmaceuticals, Inc.

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-0- Mar/07/2013 21:01 GMT