Exhibit 99.1
OncoGenex Reports Second Quarter Financial Results
Conference Call on Thursday, August 5, 2010 at 4:30 p.m. Eastern Time
BOTHELL, WA, and VANCOUVER, August 5, 2010 OncoGenex Pharmaceuticals, Inc. (OncoGenex or the
Company) (NASDAQ: OGXI) today reported unaudited financial results for the three and six months
ended June 30, 2010 and reviewed the Companys highlights for the second quarter of 2010.
The Company reported net income of $0.2 million for the quarter ended June 30, 2010. Net loss
before income taxes for the quarter ended June 30, 2010 was $2.8 million. As of June 30, 2010, cash
and investment securities totalled $47.3 million, a decrease of $0.3 million from the March 31,
2010 balance of $47.6 million. Management believes existing cash and investment securities will
provide adequate resources to fund the Companys currently planned operations into mid-2012.
At OncoGenex we are committed to developing new cancer therapies, such as OGX-011/TV-1011
(custirsen) and OGX-427, which we believe have the potential to reduce treatment resistance and
thereby increase the efficacy of various therapeutic agents used in numerous cancer indications,
said Scott Cormack, president and chief executive officer of OncoGenex. Despite the number of new
treatment options for patients with advanced prostate cancer, many patients will eventually develop
treatment resistance and their disease will progress.
Cormack added, Our partnership with Teva Pharmaceuticals has financed a robust clinical trial
program for custirsen and provided us with the cash to fund operations into mid-2012, while
retaining royalty rates which we estimate at the higher tiers could approach economics seen in
profit-sharing arrangements. Were now focusing on advancing OGX-427 to more fully realize its
diverse potential. We are currently evaluating various alternatives, including partnering, which
would allow us to expand the OGX-427 development plan beyond the ongoing Phase 1 bladder cancer
trial and the randomized Phase 2 prostate cancer trial planned to initiate later this year.
Recent Accomplishments and Anticipated Milestones
Custirsen
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In partnership with Teva, we initiated the international Phase 3 Prostate Cancer SATURN
trial evaluating custirsen with docetaxel retreatment as second-line therapy in
castrate-resistant prostate cancer (CRPC). The SATURN trial will be conducted in
approximately 50 cancer centers and will enroll approximately 300 men who have previously
responded to first-line docetaxel therapy, but subsequently have disease progression that
involves prostate cancer-related pain despite opioid usage. |
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Two additional Phase 3 trials will be initiated evaluating custirsen in first-line
treatment of metastatic CRPC and first-line treatment of advanced, unresectable non-small
cell lung cancer (NSCLC). Both trials will be in combination with chemotherapy and will
assess overall survival as the primary endpoint. |
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OGX-427
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Final results from a Phase 1 trial of OGX-427 were announced at the ASCO 2010 Annual
Meeting. OGX-427 is designed to reduce levels of Hsp27, a heat shock protein that is
over-produced in response to many cancer treatments including hormone ablation therapy,
chemotherapy, and radiation therapy. Results demonstrated that OGX-427 was safe and well
tolerated as monotherapy, as well as in combination with docetaxel. In addition, when
OGX-427 was used as a single agent there were declines in circulating tumor cells in
patients at all doses and in all diseases evaluated, as well as evidence of reduction in
tumor markers in prostate and ovarian cancer. |
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Partnering discussions and assessment of other opportunities to expand the development
plan into additional randomized Phase 2 trials will continue. |
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A Phase 1 trial in bladder cancer is currently underway. |
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A randomized Phase 2 trial in CRPC is expected to initiate later this year. |
Financial Results
Under our Collaboration Agreement with Teva relating to our contribution to the custirsen Phase 3
development plan, we earned Collaboration Revenues of $1.7 million and $6.4 million, respectively,
for the three and six months ended June 30, 2010, compared to no revenues in the corresponding
periods of 2009. Of the revenues in the second quarter, $362 thousand is reimbursable from Teva on
a cash basis and is included on the Companys balance sheet as amounts receivable at June 30, 2010.
As of June 30, 2010, $24.1 million of the upfront payment received from Teva was included on the
Companys balance sheet as deferred collaboration revenue which we are amortizing over the expected
performance period of our deliverables under our agreement. We currently expect this performance
period to end in the fourth quarter of 2012.
Research and development expenses for the three and six months ended June 30, 2010 were $3.1
million and $9.5 million, respectively, compared to $3.6 million and $5.3 million, respectively, in
the corresponding periods of 2009. The increased research and development expenses recorded in the
six months ended June 30, 2010 are the result of increased expenses relating to OncoGenexs
contribution to the custirsen Phase 3 clinical trials. The lower research and development expenses
in the second quarter of 2010 as compared with the second quarter of 2009 are the result of a $0.5
million non-cash expense included in research and development expenses in the second quarter of
2009.
General and administrative expenses for the three and six months ended June 30, 2010 were $1.5
million and $2.8 million, respectively, compared to $1.0 million and $1.8 million, respectively, in
the corresponding periods of 2009. The increases in 2010 were due mainly to higher employee
expenses including severance charges, professional fees for legal and accounting services, employee
recruitment costs and stock based compensation expense.
An income tax recovery of $3.0 million was recorded in the second quarter of 2010, as the Company
received approval from the Israel Tax Authority (ITA) for its request for a withholdings tax
exemption on amounts received from Teva in relation to the Collaboration Agreement. In the fourth
quarter of 2009, the Company had recorded a $3.0 million liability recognizing this amount as an uncertain tax position. Following this
approval from the ITA, this liability was released.
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The net income for the second quarter was $0.2 million compared to a $4.6 million net loss in the
same period 2009. For the six months ended June 30, 2010 the net loss decreased to $2.9 million
from $7.0 million in 2009.
The Company had $47.3 million in cash and investment securities as of June 30, 2010, compared to
$64.6 million at December 31, 2009. The decrease in cash and investment securities is primarily due
to costs incurred relating to the custirsen development plan, and the $10 million payment made to
Isis in the first quarter of 2010. For 2010, we anticipate ending the year with cash, cash
equivalents, short-term investments, and amounts receivable of between $32 million and $34 million.
The Company had 6,444,273 shares outstanding as of August 5, 2010.
Conference Call Today at 4:30 p.m. ET
OncoGenex management will host a conference call at 4:30 p.m. Eastern Time today to provide a
business update and discuss the second quarter results. A live webcast will be available through
the Events and Presentations Web page found in the Investor Relations section of the OncoGenex Web
site at www.ir.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 at the same Web location for 90 days.
About OncoGenex
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 deep
oncology pipeline, with each product candidate having a distinct mechanism of action and
representing a unique opportunity for cancer drug development. OncoGenex and Teva Pharmaceuticals
have entered a global collaboration and license agreement to develop and commercialize OncoGenex
lead drug candidate, OGX-011/TV-1011 (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 1 clinical development; SN2310 has
completed a Phase 1 clinical trial; and CSP-9222 and OGX-225 are currently in pre-clinical
development. More information is available at www.OncoGenex.com.
OncoGenexs 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, the timing and costs of these
activities, the potential benefits of our product candidates, our key 2010 objectives, expectations
regarding accrual of clinical trials and timing of release of results of studies, and our
anticipated future expenses, revenues,
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reimbursements, 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 our product candidates will not obtain the requisite regulatory approvals to
commercialize or that the future sales of our product candidates may be less than expected, and the
risk factors set forth in the Companys filings with the Securities and Exchange Commission,
including the Companys Annual Report on Form 10-K for fiscal year 2009. 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.
# # #
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands)
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Three months |
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Six months |
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Ended June 30, |
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Ended June 30, |
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2010 |
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2009 |
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2010 |
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2009 |
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Collaboration revenue |
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$ |
1,701 |
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$ |
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$ |
6,401 |
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$ |
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Operating expenses |
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Research and development |
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3,079 |
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3,588 |
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9,459 |
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5,282 |
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General and administrative |
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1,475 |
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1,003 |
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2,825 |
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1,785 |
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Total operating expenses |
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4,554 |
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4,591 |
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12,284 |
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7,067 |
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Other income (expense) |
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7 |
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34 |
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(7 |
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91 |
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Loss for the period before taxes |
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2,846 |
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4,557 |
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5,890 |
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6,976 |
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Income tax expense
(recovery) |
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(3,000 |
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6 |
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(3,000 |
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(4 |
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Net income (loss) |
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$ |
154 |
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($4,563 |
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($2,890 |
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($6,972 |
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Condensed Consolidated Balance Sheets
(in thousands)
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June 30, |
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December 31, |
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2010 |
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2009 |
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(unaudited) |
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Assets: |
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Cash, cash equivalents and short
term investments |
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$ |
47,304 |
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$ |
64,568 |
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Restricted cash |
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502 |
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Amounts receivable |
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413 |
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3,109 |
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Prepaid and other current assets |
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2,341 |
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722 |
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Property, equipment and other assets |
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582 |
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581 |
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Total assets |
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51,142 |
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$ |
68,980 |
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Liabilities and stockholders equity: |
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Accounts payable and accrued expenses |
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1,667 |
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$ |
14,453 |
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Deferred collaboration revenue |
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24,135 |
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26,528 |
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Other current liabilities |
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1,278 |
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1,328 |
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Long term liabilities |
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3,163 |
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3,712 |
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Stockholders equity |
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20,899 |
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22,959 |
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Total liabilities and stockholders equity |
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51,142 |
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$ |
68,980 |
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OncoGenex Contact:
Scott Cormack
President & CEO
(604) 736-3678
scormack@oncogenex.com
Media and Investor Contact:
Jason Spark
Canale Communications
(619) 849-6005
Jason@canalecomm.com
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