BOTHELL, Wash. and VANCOUVER, British Columbia, Aug. 4, 2016 /CNW/ -- OncoGenex Pharmaceuticals,
Inc. (NASDAQ: OGXI) today announced its second quarter 2016
financial results and provided a summary of anticipated
milestones.
Financial Results and Anticipated Near-term
Milestones
As of June 30, 2016, the company's
cash, cash equivalents, and short-term investments were
$39.7 million compared with
$55.2 million as of December 31, 2015.
Based on current expectations, OncoGenex believes that its cash,
cash equivalents, and short-term investments will be sufficient to
fund its currently planned operations into the third quarter of
2017. Depending on timing of enrollment or event-driven final
analyses, the expected key milestones and activities are as
follows:
- Custirsen
- Announcing results from the AFFINITY trial, the phase 3 trial
evaluating a survival benefit for custirsen in combination with
cabazitaxel as second-line chemotherapy in approximately 630
patients with castrate-resistant prostate cancer. The final
analysis for the intent-to-treat population is expected in the
third quarter of 2016.
- Announcing results from the ENSPIRIT trial, the phase 3 trial
evaluating a survival benefit for custirsen in combination with
docetaxel as second-line chemotherapy in approximately 700 patients
with non-small cell lung cancer. The final survival analysis is
expected by the first half of 2017.
- Apatorsen
- Announcing results from the Borealis-2™ trial, an
investigator-sponsored, randomized phase 2 trial evaluating
apatorsen in combination with docetaxel treatment compared to
docetaxel treatment alone in patients with advanced or metastatic
bladder cancer. Final results are expected in the fourth quarter of
2016.
- Completing a submission-ready investigational new drug
application regarding apatorsen via intravesical administration in
combination with Bacillus Calmette-Guerin (BCG) treatment in
patients with non-muscle invasive bladder cancer.
Revenue for the three and six months ended
June 30, 2016 was $2.1 million and $5.1
million, respectively, compared to $4.0 million and $5.4
million for the three and six months ended June 30, 2015, respectively. Revenue consists of
recognition of deferred collaboration revenue representing our
efforts in the development of custirsen. As of June 30, 2016, the full amount of the deferred
collaboration revenue has been fully recognized.
Total operating expenses for the three and six months ended
June 30, 2016 were $8.5 million and $15.9
million, respectively, compared to $9.6 million and $16.0
million for the three and six months ended June 30, 2015, respectively. Net loss for the
three and six months ended June 30,
2016 was $6.9 million and
$10.6 million, respectively, compared
to $6.0 million and $10.5 million for the three and six months ended
June 30, 2015, respectively.
As of Aug. 4, 2016 OncoGenex had
30,009,730 shares outstanding.
Conference Call Details
OncoGenex will host a
conference call at 4:30 p.m. Eastern
Time today, Thursday, Aug. 4,
2016, to provide a business update and discuss the second
quarter 2016 financial results. A live event will be available on
the Investor Relations section of the OncoGenex website at
www.OncoGenex.com. Alternatively, the live conference call may be
accessed 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
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. 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 in Phase 2 clinical development 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
regarding the company's anticipated product development activities,
such as expected clinical trial enrollment, completion and design,
statements regarding the potential benefits and potential
development of its product candidates and statements regarding its
expected financial results, use and adequacy of cash reserves and
expected future 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 the company's expected clinical trials may result in
delays or may not demonstrate a clinical benefit for its
product candidates, the risk that its product
candidates may not receive regulatory approval or be successfully
commercialized, the risk in the company's ability to
complete required regulatory filings and requirements and/or future
clinical trials, the risk of delayed future contractual payments
and product revenue, the risk that new data from its product
candidates or new developments in the rapidly evolving cancer
therapy landscape require changes in its clinical trial plans or
limit the potential benefits of its products, the risk that its
products' market acceptance and potential size may
differ materially from those projected, the risk that its
cash resources are insufficient to fund its planned activities for
the time period expected and the other factors described in the
company's risk factors set forth in its 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.
Borealis-2™ is a registered trademark of OncoGenex
Pharmaceuticals, Inc.
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Consolidated
Statements of Loss
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(In thousands,
except per share and share data)
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(unaudited)
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Three months ended
June 30,
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Six months ended
June 30,
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2016
|
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2015
|
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2016
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2015
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|
|
|
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|
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Collaboration
revenue
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$
|
2,122
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$
|
4,025
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$
|
5,062
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$
|
5,399
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|
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|
|
|
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Operating
expenses:
|
|
|
|
|
|
|
|
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Research and
development
|
4,662
|
|
6,545
|
|
9,304
|
|
10,217
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|
General and
administrative
|
2,475
|
|
3,067
|
|
4,774
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|
5,765
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|
Restructuring costs
(recovery)
|
(8)
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|
-
|
|
423
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|
-
|
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Litigation settlement
loss
|
1,375
|
|
-
|
|
1,375
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|
-
|
|
Total operating
expenses
|
8,504
|
|
9,612
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|
15,876
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|
15,982
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|
Loss from
operations
|
(6,382)
|
|
(5,587)
|
|
(10,814)
|
|
(10,583)
|
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Other income
(expense)
|
(507)
|
|
(423)
|
|
218
|
|
56
|
|
Net loss
|
$
|
(6,889)
|
|
$
|
(6,010)
|
|
$
|
(10,596)
|
|
$
|
(10,527)
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|
|
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|
|
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Basic and diluted net
loss per share
|
$
|
(0.23)
|
|
$
|
(0.26)
|
|
$
|
(0.35)
|
|
$
|
(0.46)
|
|
|
|
|
|
|
|
|
|
|
Weighted average
number of basic and diluted common shares
|
29,932,930
|
|
23,484,944
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|
29,880,377
|
|
23,072,773
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|
|
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|
|
|
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|
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Consolidated
Balance Sheets
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(In
thousands)
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|
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June
30,
|
|
December
31,
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2016
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2015
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(unaudited)
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Assets:
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Cash, cash
equivalents, short term investments and restricted cash
|
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|
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$
40,000
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$
55,458
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Interest
receivable
|
|
|
|
|
47
|
|
111
|
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Amounts
receivable
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|
|
|
|
-
|
|
-
|
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Prepaid
expenses and other current assets
|
|
|
|
|
1,605
|
|
2,001
|
|
Property,
equipment and other assets
|
|
|
|
|
546
|
|
639
|
|
Total
assets
|
|
|
|
|
$
42,198
|
|
$
58,209
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|
|
|
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|
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|
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Liabilities and
stockholders' equity:
|
|
|
|
|
|
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|
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Accounts
payable and accrued liabilities
|
|
|
|
|
$
10,212
|
|
$
13,217
|
|
Current
portion of long-tem obligations
|
|
|
|
|
57
|
|
52
|
|
Warrant
liability
|
|
|
|
|
971
|
|
1,105
|
|
Lease
termination liability
|
|
|
|
|
1,250
|
|
1,250
|
|
Litigation
settlement accrual
|
|
|
|
|
1,375
|
|
-
|
|
Deferred
collaboration revenue
|
|
|
|
|
-
|
|
5,040
|
|
Long term
liabilities
|
|
|
|
|
84
|
|
105
|
|
Stockholders'
equity
|
|
|
|
|
28,249
|
|
37,440
|
|
Total liabilities and
stockholders' equity
|
|
|
|
|
$
42,198
|
|
$
58,209
|
|
|
|
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To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/oncogenex-pharmaceuticals-inc-reports-financial-results-for-second-quarter-2016-300309298.html
SOURCE OncoGenex Pharmaceuticals, Inc.