Company to Hold Earnings and Pipeline Update Conference Call at 4:30
p.m. EDT Today
SEATTLE, May 9, 2013 /PRNewswire/ - Oncothyreon Inc. (NASDAQ: ONTY) today
reported financial results for the first quarter ending March 31, 2013.
Loss from operations for the first quarter of 2013 was $8.0 million,
compared with $5.7 million for the first quarter of 2012. The increase
in loss from operations primarily resulted from an increase in research
and development expenses to $5.8 million from $4.3 million and an
increase in general and administrative expenses to $2.2 million from
$1.5 million. The increase in research and development expenses in the
first quarter of 2013 compared to the first quarter of 2012 was
primarily the result of increased development activity for
Oncothyreon's product candidates, PX-866 and ONT-10. The increase in
general and administrative expenses in the first quarter of 2013
compared to the first quarter of 2012 was primarily the result of a
non-cash expense in share-based compensation related to the change in
fair value of the restricted share unit liability, whose value was
affected by the change in our stock price. In addition, the increase
in general and administrative expenses was also the result of higher
salaries and benefits expense due to increased headcount partly offset
by lower legal expenses related to patents.
Net loss for the quarter ended March 31, 2013 was $8.3 million, or $0.14
loss per basic and diluted share, compared with net income of $9.7
million, or $0.22 earnings per basic share and $0.13 loss per diluted
share, for the quarter ended March 31, 2012. The net loss for the
quarter ended March 31, 2013 compared to the net income for the prior
year period was primarily attributable to a non-cash expense of $0.3
million as a result of the change in fair value of warrant liability
for the quarter ended March 31, 2013 compared to a non-cash income of
$15.6 million for the quarter ended March 31, 2012.
As of March 31, 2013, Oncothyreon's cash, cash equivalents and
investments were $76.8 million, compared to $83.8 million at December
31, 2012, a decrease of $7.0 million, or 8.4 percent. The decrease was
primarily attributable to $6.9 million cash used in operations during
the quarter ended March 31, 2013.
Oncothyreon believes the following financial guidance to be correct as
of the date provided. Oncothyreon is providing this guidance as a
convenience to investors and assumes no obligation to update it.
Expenses in 2013 are expected to be slightly higher compared to 2012,
primarily as a result of the continuing development of PX-866 and the
ongoing Phase 1 clinical trial of ONT-10. Oncothyreon currently expects
cash used in operations in 2013 to be approximately $30 to $33
million. As a result, Oncothyreon estimates that its existing cash,
cash equivalents and investments will be sufficient to fund operations
for at least the next 12 months.
PX-866 - PX-866 is Oncothyreon's small molecule compound designed to inhibit the
activity of phosphatidylinositol-3-kinase (PI-3K), a component of an
important cell survival signaling pathway. Oncothyreon is evaluating
PX-866 in five Phase 1/2 or Phase 2 trials in six different cancer
The first Phase 1/2 trial is evaluating PX-866 in combination with the
chemotherapeutic agent docetaxel (Taxotere®). The Phase 2 portion of the trial is an open-label, randomized
evaluation of the antitumor activity and safety of PX-866 administered
at the recommended daily dose in combination with docetaxel, versus
docetaxel alone, in two indications, patients with non-small cell lung
cancer (NSCLC) receiving second or third line treatment or patients
with locally advanced, recurrent or metastatic squamous cell carcinoma
of the head and neck (SCCHN) after failure of prior therapy. The two
groups were randomized and are being evaluated separately.
The Phase 2 portion of this trial in NSCLC enrolled 95 patients, 48 in
the PX-866 plus docetaxel group and 47 in the docetaxel alone group.
This portion of the trial is now concluded and did not demonstrate an
improvement in progression-free survival in the combination group when
compared to docetaxel alone, the primary endpoint of the trial. The
data are continuing to be analyzed and will be submitted for
presentation at a subsequent scientific meeting. The Phase 2 portion
of this trial in SCCHN completed enrollment of 81 patients earlier this
week, with primary efficacy data expected to be available late in 2013.
The second Phase 1/2 trial is evaluating PX-866 in combination with the
chimeric monoclonal antibody cetuximab (Erbitux®). The Phase 2 portion
is an open-label, randomized evaluation of the antitumor activity and
safety of PX-866 administered at the recommended daily dose in
combination with cetuximab, versus cetuximab alone, in two indications,
patients with metastatic colorectal cancer (CRC) who have a history of
progression or recurrence following prior treatment with irinotecan and
oxaliplatin containing regimens or who are intolerant of irinotecan, or
patients with incurable progressive, recurrent or metastatic SCCHN. The
two groups were randomized and are being evaluated separately.
The Phase 2 portion of this trial in CRC has enrolled 85 patients.
Primary efficacy data from this portion of the trial are expected later
this month. The Phase 2 portion of this trial in SCCHN has enrolled 83
patients, with primary efficacy data expected to be available late in
The third Phase 1/2 trial is evaluating PX-866 in combination with
vemurafenib (Zelboraf®) in patients with BRAF-mutant cancer, primarily
malignant melanoma. Patients are currently being enrolled in the Phase
1 dose escalation portion of this trial.
Two open label single-arm Phase 2 trials of PX-866 are being conducted
by the NCIC Clinical Trials Group (NCIC CTG), Queen's University in
Kingston, Canada. One NCIC trial is in patients with prostate cancer.
The initial part of this trial (Part A) enrolled 43 patients with
progressive castration-resistant prostate cancer who have received no
prior chemotherapy. Data from this part of the trial will be presented
at the upcoming American Society of Clinical Oncology (ASCO) meeting at
the end of this month. Part B will enroll up to 25 patients who
demonstrate disease progression while receiving abiraterone as
evidenced by a rising prostate specific antigen (PSA). PX-866 will be
administered in addition to continuing treatment with abiraterone and
prednisone. Currently, Part B is approximately fifty percent enrolled.
The NCIC CTG is also conducting an open-label single-arm Phase 2 trial
of PX-866 in patients with glioblastoma multiforme in first relapse
during or following primary therapy. Preliminary data from this trial
were presented at the ASCO meeting in 2012 and will be updated at the
upcoming ASCO meeting.
ONT-10 - ONT-10 is Oncothyreon's proprietary therapeutic vaccine targeting
MUC1, a tumor-associated antigen present on many types of human
malignant tumors. Oncothyreon is currently enrolling patients in a
Phase 1 trial designed to evaluate the safety and immunogenicity of
ONT-10 in patients with cancers which commonly express MUC1, including
breast, NSCLC, ovarian, colorectal, prostate, pancreatic, gastric and
other cancers. Patients are currently being enrolled in the final of
the pre-planned dose cohorts in this trial. Oncothyreon currently
expects to begin one or more Phase 2 trials of ONT-10 by early 2014.
Conference Call and Webcast
Oncothyreon will conduct a conference call today, May 9, 2013 at 4:30
p.m. Eastern time (1:30 p.m. Pacific time) to discuss its first quarter
2013 financial results and provide a review of its pipeline of products
in development. To participate in the call by telephone, please dial
(877) 280-7291 (United States) or (707) 287-9361 (International). In
addition, the call will be webcast live and can be accessed on the
"Events" page of the "News & Events" section of Oncothyreon's website
at www.oncothyreon.com. An archive of the webcast will be available after completion of the
discussion and will be posted on Oncothyreon's website.
Oncothyreon is a biotechnology company specializing in the development
of innovative therapeutic products for the treatment of cancer.
Oncothyreon's goal is to develop and commercialize novel synthetic
vaccines and targeted small molecules that have the potential to
improve the lives and outcomes of cancer patients. For more
information, visit www.oncothyreon.com.
In order to provide Oncothyreon's investors with an understanding of its
current results and future prospects, this release contains statements
that are forward-looking. Any statements contained in this press
release that are not statements of historical fact may be deemed to be
forward-looking statements. Words such as "believes," "anticipates,"
"plans," "expects," "will," "intends," "potential," "possible" and
similar expressions are intended to identify forward-looking
statements. These forward-looking statements include Oncothyreon's
expectations regarding future expenses, clinical development activities
and the use and adequacy of cash resources.
Forward-looking statements involve risks and uncertainties related to
Oncothyreon's business and the general economic environment, many of
which are beyond its control. These risks, uncertainties and other
factors could cause Oncothyreon's actual results to differ materially
from those projected in forward-looking statements, including the risks
associated with the costs and expenses of developing its product
candidates, the adequacy of financing and cash, cash equivalents and
investments, changes in general accounting policies, general economic
factors, achievement of the results it anticipates from its clinical
trials of its product candidates and its ability to adequately obtain
and protect its intellectual property rights. Although Oncothyreon
believes that the forward-looking statements contained herein are
reasonable, it can give no assurance that its expectations are correct.
All forward-looking statements are expressly qualified in their
entirety by this cautionary statement. For a detailed description of
Oncothyreon's risks and uncertainties, you are encouraged to review the
documents filed with the securities regulators in the United States on
EDGAR and in Canada on SEDAR. Oncothyreon does not undertake any
obligation to publicly update its forward-looking statements based on
events or circumstances after the date hereof.
Additional information relating to Oncothyreon can be found on EDGAR at www.sec.gov and on SEDAR at www.sedar.com.
Condensed Consolidated Statements of Operations
(In thousands except share and per share amounts)
| ||Three months ended|
| || ||2013|| || ||2012|
| || || || || || |
| || || || || || |
|Expenses|| || || || || |
Research and development
|| ||5,799|| || ||
General and administrative
|| ||2,192|| || ||
Total operating expenses
|| ||7,991|| || ||
Loss from operations
|| ||(7,991)|| || ||
|Other income (expense)|| || || || || |
Investment and other income (expense), net
|| ||28|| || ||
|| || || ||
Change in fair value of warrant liability
|| ||(325)|| || ||
Total other income (expense), net
|| ||(297)|| || ||
|Net income (loss)
|Net income (loss) per share - basic
|Net income (loss) per share - diluted
|Shares used to compute basic net income (loss) per share
|| ||57,216,237|| || ||
|Shares used to compute diluted net income (loss) per share
|| ||57,216,237|| || ||
Consolidated Balance Sheet Data
(In thousands except share amounts)
|| || ||March 31, 2013||
|| ||December 31, 2012|
Cash, cash equivalents and investments
| || || || || || || |
| || || || || || || |
Long term liabilities
| || || || || || || |
| || || || || || || |
Common shares outstanding
SOURCE Oncothyreon Inc.
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