Exhibit 99.1
OncoGenex Pharmaceuticals, Inc. Reports Financial Results for First Quarter 2011 and Provides
Update on Plans for the Phase 3 Prostate Cancer SATURN Clinical Trial
BOTHELL, WA., and VANCOUVER, British Columbia, May. 9, 2011 OncoGenex Pharmaceuticals, Inc.
(NASDAQ: OGXI) today announced its first quarter financial results and provided an update on
current events and activities.
Key OncoGenex Activities
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Currently enrolling the Phase 3 clinical trial referred to as SYNERGY, to be
conducted in approximately 123 cancer centers to evaluate a survival benefit for custirsen
in combination with first-line docetaxel treatment in approximately 800 patients with CRPC. |
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Enrollment continues for the Phase 3 Prostate Cancer SATURN trial to evaluate a durable
pain palliation benefit for custirsen in combination with docetaxel retreatment as
second-line chemotherapy. The study will enroll approximately 300 patients with
castration-resistant prostate cancer (CRPC). |
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OncoGenex has submitted to the FDA a revision to the approved Special
Protocol Assessment (SPA), to expand the inclusion criteria for the SATURN trial.
The proposed revision would permit participants to receive either docetaxel
re-treatment or cabazitaxel as chemotherapy in the clinical study. The study design
would remain the same in that all patients would be randomized to receive custirsen
or placebo in conjunction with chemotherapy. In addition, the pain palliation
endpoints remain unchanged. |
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Recent and upcoming data presentations at scientific meetings such as the American
Association of Cancer Research, the Society of Urologic Oncology and the American
Urological Association, provide new pre-clinical evidence and enhance the understanding of
OncoGenex product candidates, custirsen and OGX-427. |
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Two additional trials scheduled to commence this year; a Phase 3 clinical trial to
evaluate a survival benefit for custirsen in combination with first-line chemotherapy in
patients with non-small cell lung cancer (NSCLC) and a Phase 2 clinical trial of OGX-427 in
approximately 180 patients with metastatic bladder cancer. |
We recognize the prostate cancer landscape is evolving rapidly and the approval of new treatments
is encouraging news for patients, said Scott Cormack, president and CEO of OncoGenex. The
proposed revision to the SATURN trial will help ensure custirsen remains aligned with currently
approved chemotherapy.
Financial Results
Revenue for the first quarter of 2011 decreased to $1.2 million, compared with $4.7 million for the
first quarter of 2010. This decrease was due to lower reimbursement revenue earned through our
strategic collaboration with Teva resulting from manufacturing costs now being paid directly by
Teva, as well as lower costs associated with clinical trials.
At March 31, 2011, $21.0 million of the $30.0 million upfront payment received from Teva in
December 2009 was included in our Balance Sheet as Deferred Collaboration Revenue, which we are
amortizing over the expected performance period of our deliverables under the agreement. We
currently expect this performance period to end in the fourth quarter of 2012.
Total operating expenses for the first quarter of 2011 decreased to $6.4 million, compared with
$7.7 million for the first quarter of 2010. The decrease in operating expenses was primarily due to
lower custirsen manufacturing costs, as these costs are now being paid directly by Teva, and lower
clinical trial costs associated with the custirsen phase 3 clinical trials, offset by higher
manufacturing and clinical trial costs for OGX-427 in 2011.
Loss from operations for the first quarter of 2011 increased to $5.2 million, compared to $3.0
million for the first quarter of 2010. The increased loss from operations was primarily due to
lower revenue earned through our strategic collaboration with Teva and higher manufacturing and
clinical trial costs for OGX-427.
Net loss for the first quarter of 2011 was $3.0 million, or $0.31 per diluted common share,
compared to $3.0 million, or $0.48 per diluted common share, for the first quarter of 2010. The
lower net loss as compared to loss from operations was due to a $2.1 million non-cash gain on the
revaluation of our warrant liability as at March 31, 2011 which was included in other income. These
warrants were issued as part of the public offering completed in October of 2010, and there was no
comparable gain or loss in the first quarter of 2010.
We had $81.1 million in cash, cash equivalents and short-term investments as of March 31, 2011,
compared to $85.1 million as of December 31, 2010. As at May 9, 2011, we had 9,718,251 shares
outstanding.
Conference Call Details
OncoGenex will host a conference call at 4:30 p.m. Eastern Time today, Monday, May 9, 2011, to
provide a business update and discuss the first quarter financial results. A live event will be
available through the Events and Presentations Web page found in 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 webcast replay will be
available approximately two hours after the call and will be archived on www.oncogenex.com for 90
days.
About OncoGenex Pharmaceuticals
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new
cancer 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. (NASDAQ: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. The
companies plan to begin Phase 3 development of custirsen in first-line treatment of advanced,
unresectable non-small cell lung cancer in 2011. OGX-427 is in Phase 2 clinical development;and
CSP-9222 and OGX-225 are currently in pre-clinical development.
More information about OncoGenex 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, including proposed amendments
to our ongoing clinical trial design, the timing and costs of these activities, the potential
benefits of our product candidates, our key 2011 objectives, and our anticipated future expenses,
capital and sufficiency of capital. All statements other than statements of historical fact are
statements that could be deemed forward-looking statements. These statements are based on
managements 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, uncertainties regarding our future operating results, the risk that the
FDA does not approve our proposed amendment to the Saturn trial design, the risk that our product
candidates will not obtain the requisite regulatory approvals to commercialize, the risk that new
developments in the rapidly evolving prostate cancer therapy landscape require additional changes
in our clinical trial design or limit the potential benefits of our product candidates, the risk
that future sales of our product candidates may be less than 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 Companys Annual Report on Form 10-K for fiscal year 2010. 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.
OncoGenex Contact:
Jaime Welch
(604) 630-5403
jwelch@oncogenex.com
Condensed Consolidated Statements of Operations
(in thousands)
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Three months |
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Ended March 31, |
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2011 |
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2010 |
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(unaudited) |
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(unaudited) |
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Collaboration revenue |
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$ |
1,199 |
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$ |
4,700 |
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Operating expenses |
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Research and development |
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4,853 |
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6,380 |
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General and administrative |
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1,571 |
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1,350 |
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Total operating expenses |
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6,424 |
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7,730 |
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Loss from operations |
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5,225 |
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3,030 |
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Other income (expense) |
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2,180 |
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(14 |
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Loss for the period before taxes |
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3,045 |
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3,044 |
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Income tax expense (recovery) |
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Net loss |
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$ |
3,045 |
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$ |
3,044 |
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Basic and diluted loss per common share |
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0.31 |
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0.48 |
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Weighted average number of common shares |
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9,713,413 |
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6,333,272 |
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Condensed Consolidated Balance Sheets
(in thousands)
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March 31, |
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December 31, |
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2011 |
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2010 |
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(unaudited) |
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Assets: |
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Cash, cash equivalents and short term
investments |
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$ |
81,098 |
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$ |
85,107 |
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Amounts receivable |
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1,348 |
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1,224 |
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Prepaid and other current assets |
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1,470 |
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2,987 |
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Property, equipment and other assets |
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681 |
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600 |
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Total assets |
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84,597 |
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$ |
89,918 |
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Liabilities and stockholders equity: |
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Accounts payable and accrued expenses |
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1,166 |
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$ |
893 |
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Current deferred collaboration revenue |
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10,000 |
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10,000 |
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Warrant liability |
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13,141 |
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15,269 |
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Other current liabilities |
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1,305 |
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1,314 |
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Long term liabilities |
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17,487 |
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18,317 |
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Stockholders equity (deficiency) |
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41,498 |
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44,125 |
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Total liabilities and stockholders equity (deficiency) |
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84,597 |
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$ |
89,918 |
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