Conference call to be held on Tuesday,
March 11, 2014 at 4:30 p.m. Eastern
Time
BOTHELL,
Wash. and VANCOUVER, British Columbia,
March 11,
2014 /CNW/ - OncoGenex Pharmaceuticals, Inc. (NASDAQ:
OGXI) today provided a summary of clinical developments and
anticipated near-term milestones and announced fourth quarter and
year end 2013 financial results.
Clinical Developments and Anticipated Near-term
Milestones
- Custirsen
- The SYNERGY Phase 3 trial is designed to evaluate a survival
benefit for custirsen, in combination with first-line docetaxel
chemotherapy, in men with metastatic castrate-resistant prostate
cancer, or CRPC. OncoGenex recently announced that the
pre-specified number of events required for final analysis of the
Phase 3 SYNERGY trial were reached. Overall survival results will
remain blinded until all study data have been thoroughly reviewed
and prepared for final analysis, and final results are expected by
mid-year 2014.
- The AFFINITY Phase 3 trial is designed to evaluate a survival
benefit for custirsen in combination with cabazitaxel treatment as
second-line chemotherapy in patients with CRPC. Enrollment of
approximately 630 patients is ongoing and expected to be completed
by the end of 2014.
- The ENSPIRIT Phase 3 trial is evaluating a survival benefit for
custirsen in combination with docetaxel treatment as second-line
chemotherapy in patients with non-small cell lung cancer (NSCLC).
Enrollment of approximately 1,100 patients is ongoing.
- Apatorsen
- OncoGenex and collaborating investigators are in the process of
conducting seven randomized Phase 2 clinical trials to evaluate
apatorsen's ability to inhibit heat shock protein 27 (Hsp27) and
improve treatment outcomes in bladder, lung, pancreatic and
prostate cancer patients. Patient enrollment in the Borealis-1™
Phase 2 trial of apatorsen in combination with gemcitabine and
cisplatin in patients with metastatic bladder cancer was fully
enrolled in July
2013 and data are expected to be available in the
second half of 2014.
Financial Update and Results
- Revenue for the fourth quarter and year ended December 31, 2013
was $8.6
million and $29.9 million, respectively. This compares
with $9.8
million and $20.1 million, respectively, in the same
periods in 2012. Revenue earned in 2013 consists of reimbursable
clinical trial, manufacturing and preclinical costs incurred by
OncoGenex under the Amended Clinical Development Plan with
Teva.
- The Company has fulfilled its obligation of funding
$30.0
million towards the development of custirsen. 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,
2013 were $15.6 million and $65.2 million,
respectively, compared with $16.0 million and $46.1 million,
respectively, in the same periods in 2012. The increase in 2013 as
compared to 2012 was predominantly the result of higher clinical
trial expenses associated with patient enrollment and treatment in
the AFFINITY and Borealis-1 trials, increased costs related to our
investigator-sponsored apatorsen trials, toxicology expenses
related to apatorsen and OGX-225 and increased employee expenses,
including stock-based compensation, due to an increase in the
average number of employees to support our clinical development
activities.
- Net loss for the fourth quarter and year ended December 31, 2013
was $6.7
million, or $0.45 per diluted common share, and
$31.8
million, or $2.17 per diluted common share,
respectively. Comparatively, 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.
- The company had $39.2 million in cash, cash equivalents
and short-term investments as of December 31, 2013,
compared to $75.4
million as of December 31, 2012.
- Based on current expectations, the company believes its capital
resources as of December 31, 2013 will be sufficient to
fund its currently-planned operations beyond the first quarter of
2015, and through:
- the expected release of final survival results from the SYNERGY
trial by mid-2014;
- the expected release of final survival results from the
Borealis-1 trial in the second-half of 2014; and
- the completion of enrollment in the AFFINITY and Spruce trials
by the end of 2014.
- At March 11,
2014, OncoGenex had 14,718,610 shares
outstanding.
Consolidated
Statements of Loss
|
(In thousands,
except per share and share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Three months ended
December 31,
|
|
Twelve months
ended December 31,
|
|
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
revenue
|
|
|
$ 8,604
|
|
$ 9,780
|
|
$ 29,882
|
|
$ 20,095
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research and
development
|
|
|
13,195
|
|
15,645
|
|
55,317
|
|
39,948
|
General and
administrative
|
|
|
2,446
|
|
2,042
|
|
9,892
|
|
7,791
|
Restructuring
gain
|
|
|
-
|
|
(1,657)
|
|
-
|
|
(1,657)
|
Total operating
expenses
|
|
|
15,641
|
|
16,030
|
|
65,209
|
|
46,082
|
Loss from
operations
|
|
|
(7,037)
|
|
(6,250)
|
|
(35,327)
|
|
(25,987)
|
Other
income
|
|
|
359
|
|
2,147
|
|
3,478
|
|
4,889
|
Net loss
|
|
|
$ (6,678)
|
|
$ (4,103)
|
|
$ (31,849)
|
|
$ (21,098)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
|
|
$ (0.45)
|
|
$ (0.28)
|
|
$ (2.17)
|
|
$ (1.56)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of basic and diluted common shares
|
|
|
14,707,558
|
|
14,656,793
|
|
14,683,389
|
|
13,522,723
|
|
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|
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Consolidated
Balance Sheets
|
(In
thousands)
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|
|
December
31,
|
|
December
31,
|
|
|
|
|
|
|
|
2013
|
|
2012
|
|
|
|
|
|
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
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Cash, cash
equivalents, short term investments and restricted cash
|
|
|
|
|
|
|
$ 39,536
|
|
$ 75,697
|
Interest
receivable
|
|
|
|
|
|
|
218
|
|
327
|
Amounts
receivable
|
|
|
|
|
|
|
8,657
|
|
714
|
Prepaid expenses and
other current assets
|
|
|
|
|
|
|
5,770
|
|
3,755
|
Property, equipment
and other assets
|
|
|
|
|
|
|
1,508
|
|
1,523
|
Total
assets
|
|
|
|
|
|
|
$ 55,689
|
|
$ 82,016
|
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity:
|
|
|
|
|
|
|
|
|
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Accounts payable and
accrued liabilities
|
|
|
|
|
|
|
$ 13,628
|
|
$ 7,050
|
Current portion of
long-term obligations
|
|
|
|
|
|
|
1,092
|
|
1,084
|
Warrant
liability
|
|
|
|
|
|
|
214
|
|
3,422
|
Long term
liabilities
|
|
|
|
|
|
|
3,544
|
|
4,253
|
Stockholders'
equity
|
|
|
|
|
|
|
37,211
|
|
66,207
|
Total liabilities and
stockholders' equity
|
|
|
|
|
|
|
$ 55,689
|
|
$ 82,016
|
Conference Call Details
OncoGenex will host a
conference call at 4:30 p.m. Eastern Time today, Tuesday, March 11,
2014, to provide a business update and discuss the
fourth quarter and year end 2013 results. A live event will be
available on the Investor Relations section of the OncoGenex
website 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. Apatorsen is
currently being evaluated in seven randomized Phase 2 trials for a
variety of cancers and OGX-225 is currently in pre-clinical
development. More information is available at www.OncoGenex.com and
at the company's Twitter account:
https://twitter.com/OncoGenex_IR.
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.
SOURCE OncoGenex Pharmaceuticals, Inc.