UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 14, 2016
ONCOTHYREON INC.
(Exact
name of registrant as specified in its charter)
|
|
|
|
|
Delaware |
|
001-33882 |
|
26-0868560 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File Number) |
|
(IRS Employer
Identification No.) |
2601 Fourth Avenue, Suite 500
Seattle, Washington 98121
(Address of principal executive offices, including zip code)
(206) 801-2100
(Registrants telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 Results of Operations and Financial Condition
On March 14, 2016, Oncothyreon Inc. (the Company) issued a press release regarding the Companys financial results for
the fourth quarter and full year ended December 31, 2015. A copy of the Companys press release is attached hereto as Exhibit 99.1.
The information furnished with this report, including Exhibit 99.1, shall not be deemed filed for purposes of Section 18 of
the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Exchange Act or under the
Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and
Exhibits
|
|
|
Exhibit Number |
|
Description |
|
|
99.1 |
|
Press Release issued by Oncothyreon Inc. dated March 14, 2016. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
|
|
ONCOTHYREON INC. |
|
|
By: |
|
/s/ Julia M. Eastland |
|
|
Julia M. Eastland |
|
|
Chief Financial Officer |
Date: March 14, 2016
EXHIBIT INDEX
|
|
|
Exhibit Number |
|
Description |
|
|
99.1 |
|
Press Release issued by Oncothyreon Inc. dated March 14, 2016. |
Exhibit 99.1
Oncothyreon Reports Full Year and Fourth Quarter 2015
Financial Results & Provides Corporate Update
Initiated Phase 2 ONT-380 Trial Based on Encouraging Combination Data
$56M in Cash and Investments at December 31, 2015
SEATTLE, WASHINGTON, March 14, 2016 Oncothyreon Inc. (NASDAQ: ONTY), a clinical-stage biopharmaceutical company dedicated to the
development of therapeutic products that can improve the lives and outcomes of patients with cancer, today provided a corporate update and reported financial results for the year and quarter ended December 31, 2015.
2015 was a significant year for Oncothyreon, with the company reporting encouraging data from two combination trials of ONT-380 demonstrating that this
product candidate may be impactful on HER2-positive breast cancer patients, including those with brain metastases a patient population in desperate need of new treatment options, said Christopher S. Henney, Chairman and interim CEO of
Oncothyreon. We believe our clinical results to date provided a strong foundation for us to advance ONT-380 into our recently initiated randomized, double-blind, placebo-controlled Phase 2 trial in combination with Herceptin and Xeloda,
which includes enrolling patients with progressing central nervous system disease.
Corporate Update & Recent Highlights
Clinical Development:
|
|
|
ONT-380 Phase 2 Combination Trial Underway in Patients with HER2-Positive Breast Cancer. The randomized, double-blind, placebo control trial is evaluating ONT-380 in combination with Herceptin® (trastuzumab) and Xeloda® (capecitabine). ONT-380 is an oral, HER2-selective, central nervous system (CNS)-active tyrosine kinase
inhibitor. The trial is targeted to enroll approximately 180 heavily pretreated patients with advanced HER2-positive breast cancer who present with or without brain metastases. Building on encouraging Phase 1b results, the primary and secondary
endpoint objectives are designed to measure ONT-380s contribution on both systemic and CNS disease, an area of unmet need for patients. |
|
|
|
Data from Ongoing ONT-380 Phase 1b Combination Trials Show Objective, Durable Responses and Favorable Tolerability Profile. During 2015, data from two ongoing trials of ONT-380 were presented at the American
Society of Clinical Oncology (ASCO) and the San Antonio Breast Cancer Symposium (SABCS). |
|
|
|
ONT-380 in combination with Xeloda and/or Herceptin: |
|
|
|
This Phase 1b trial enrolled patients with metastatic HER2-positive breast cancer with progression following prior treatment with Herceptin and Kadcyla®
(ado-trastuzumab emtansine or T-DM1). In addition to patients without a prior history of CNS disease, patients with untreated, asymptomatic CNS disease and patients with progressing CNS disease after prior local therapy were allowed to enroll in the
trial and were followed for responses both systemically and in the CNS. Overall, ONT-380 in combination with Xeloda, Herceptin or both Xeloda and Herceptin has been well tolerated. As reported at ASCO 2015, in a total of 32 patients treated with
these combinations, the majority of adverse events were Grade 1 or 2 in severity, with no reported Grade 3 diarrhea. As reported at SABCS 2015, the objective response rate across treatment groups was 42 percent and the CNS response rate
was 33 percent, providing encouraging data to support moving forward with a follow-on Phase 2 study of ONT-380 in combination with Xeloda and Herceptin. |
|
|
|
ONT-380 in combination with Kadcyla: |
|
|
|
This Phase 1b trial enrolled patients with metastatic HER2-positive breast cancer with progression following prior treatment with Herceptin and a taxane. Patients may have received prior treatment with Perjeta® (pertuzumab) and Tykerb® (lapatinib). Patients with or without brain metastases were eligible. This trial has completed enrollment, but is
ongoing with patients continuing to receive treatment. Clinical data from this trial were presented at SABCS 2014 and 2015, and at ASCO 2015. Overall, the combination of ONT-380 and Kadcyla was clinically well tolerated in 50 patients treated at the
maximum tolerated dose of ONT-380, with the majority of adverse events either Grade 1 or Grade 2 in severity. Grade 3 diarrhea was reported in 4 percent of patients. Durable (>6 months) systemic and CNS responses and disease
stabilization were seen, with an objective response rate of 41 percent and a CNS response rate of 33 percent. |
Internal Research & Discovery Collaborations:
|
|
|
Research Collaboration Moving Chk1 Inhibitors Forward. During 2015, Oncothyreon continued preclinical activities to develop a small molecule against the checkpoint kinase 1 (Chk1) target in collaboration
with Sentinel Oncology. IND-enabling studies are expected to begin in 2017. |
|
|
|
Protocell Research Program Progressing. During 2015, Oncothyreon continued research on protocells, a novel nanoparticle platform technology that may enable the targeted delivery of a variety of therapeutic
agents. |
Leadership:
|
|
|
Expanded Leadership Team, CEO Search Underway. In January 2016, Oncothyreon announced the appointment of Christopher S. Henney, the companys chairman, as interim CEO. The companys comprehensive
search for a new CEO is actively ongoing. Additionally, Oncothyreon appointed three new members to its Board of Directors: Steven P. James in March 2015 and Mark Lampert and Gwen Fyfe, M.D. in January 2016. |
Full Year and Fourth Quarter 2015 Financial Highlights
|
|
|
Cash, cash equivalents and investments totaled $56.4 million as of December 31, 2015, compared to $63.7 million at December 31, 2014, a decrease of $7.3 million, or 11.5%. The decrease was primarily
attributable to $28.9 million of cash used in operations during the year ended December 31, 2015, partially offset by the net proceeds of $22.4 million from the closing of concurrent but separate underwritten offerings of common stock
and Series B convertible preferred stock in February 2015. |
|
|
|
Research and development expenses for the fourth quarter of 2015 decreased by $19.1 million to $6.9 million from $26.0 million in the fourth quarter of 2014. Full year research and development expenses
decreased by $18.4 million to $23.5 million in 2015 from $41.9 million in 2014. The fourth quarter and full year decrease in expense was primarily the result of the one-time upfront payment made to Array Biopharma in December 2014.
|
|
|
|
General and administrative expenses for the fourth quarter of 2015 increased by $0.4 million to $2.3 million, from $1.9 million in the fourth quarter of 2014. Full year 2015 general and administrative expenses
were $9.3 million, an increase of $0.3 million from $9.0 million in 2014. This increase was primarily due to patent expenses related to our product candidates. |
|
|
|
Net loss for the year ended December 31, 2015 was $32.6 million, or $0.34 per basic and diluted share, compared with a net loss of
$50.0 million, or $0.64 per basic and diluted share, for the comparable period in 2014. Net loss for the three months ended December 31, 2015 was $9.1 million, or $0.10 per basic and diluted share, compared with a net loss of
$27.6 million, or $0.30 per basic and diluted share, for the comparable |
|
period in 2014. The decrease in net loss for the year and quarter was primarily attributable to a $20.0 million upfront payment Oncothyreon made to Array BioPharma upon entering into an
exclusive license agreement in December 2014. The decrease in net loss was partly offset by slightly higher general and administrative expenses and lower non-cash income from the change in the fair value of our warrant liability.
|
Financial Guidance
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.
Oncothyreon currently expects operating expenses in 2016 to be higher than in 2015. This increase will primarily be related to expenditures associated with
the Phase 2 trial of ONT-380. Oncothyreon currently expects cash used in operations in 2016 to be approximately $38.0 million to $40.0 million. With cash, cash equivalents and investments of $56.4 million as of December 31,
2015, Oncothyreon estimates that its cash, cash-equivalents and investments will be sufficient to fund operations for at least the next 12 months.
About Oncothyreon
Oncothyreon is a clinical-stage
biopharmaceutical company specializing in the development of innovative therapeutic products for the treatment of cancer. Our goal is to discover, develop and commercialize novel compounds that have the potential to improve the lives and outcomes of
cancer patients. Our most advanced product candidate is ONT-380, an orally active and selective small molecule HER2 inhibitor. We are developing preclinical product candidates in oncology and immune-oncology using our protocell technology. For more
information, visit www.oncothyreon.com.
Forward-Looking Statements
In order to provide Oncothyreons 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 Oncothyreons
expectations regarding clinical and preclinical development activities, potential benefits of its current and future product candidates, future expenses and the use and adequacy of cash resources.
Forward-looking statements involve risks and uncertainties related to Oncothyreons business and the general economic environment, many of which are
beyond its control. These risks, uncertainties and other factors could cause Oncothyreons 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 preclinical development and 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 Oncothyreons 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. Except as required by law, Oncothyreon does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.
Additional Information
Additional information relating
to Oncothyreon can be found on EDGAR at www.sec.gov and on SEDAR at www.sedar.com.
Investor Contact:
Julie Rathbun
Rathbun Communications
206-769-9219
ir@oncothyreon.com
ONCOTHYREON INC. 2601 Fourth Avenue, Suite 500, Seattle, WA 98121
Tel: (206) 801-2100 Fax: (206) 801-2101
http://www.oncothyreon.com
ONCOTHYREON INC.
Consolidated Statements of Operations
(In thousands except share and per share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended December 31, |
|
|
Year ended December 31, |
|
|
|
2015 |
|
|
2014 |
|
|
2015 |
|
|
2014 |
|
Operating Expenses |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
6,887 |
|
|
$ |
26,008 |
|
|
$ |
23,468 |
|
|
$ |
41,884 |
|
General and administrative |
|
|
2,264 |
|
|
|
1,850 |
|
|
|
9,321 |
|
|
|
8,951 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
9,151 |
|
|
|
27,858 |
|
|
|
32,789 |
|
|
|
50,835 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(9,151 |
) |
|
|
(27,858 |
) |
|
|
(32,789 |
) |
|
|
(50,835 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
Investment and other income (expense), net |
|
|
20 |
|
|
|
24 |
|
|
|
80 |
|
|
|
76 |
|
Change in fair value of warrant liability |
|
|
|
|
|
|
255 |
|
|
|
128 |
|
|
|
796 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense), net |
|
|
20 |
|
|
|
279 |
|
|
|
208 |
|
|
|
872 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(9,131 |
) |
|
$ |
(27,579 |
) |
|
$ |
(32,581 |
) |
|
$ |
(49,963 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share basic and diluted |
|
$ |
(0.10 |
) |
|
$ |
(0.30 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.64 |
) |
Shares used to compute basic and diluted net loss per share |
|
|
94,934,417 |
|
|
|
91,566,479 |
|
|
|
96,617,119 |
|
|
|
77,619,807 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ONCOTHYREON INC.
Consolidated Balance Sheet Data
(In thousands except share amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
As of |
|
|
|
December 31, 2015 |
|
|
December 31, 2014 |
|
Cash, cash equivalents and investments |
|
$ |
56,360 |
|
|
$ |
63,714 |
|
Total assets |
|
$ |
96,574 |
|
|
$ |
103,103 |
|
Long term liabilities |
|
$ |
8,044 |
|
|
$ |
7,430 |
|
Stockholders equity |
|
$ |
83,735 |
|
|
$ |
91,266 |
|
Common shares outstanding |
|
|
94,961,859 |
|
|
|
91,601,352 |
|
Cascadian Therapeutics, Inc. (NASDAQ:CASC)
Historical Stock Chart
From Aug 2024 to Sep 2024
Cascadian Therapeutics, Inc. (NASDAQ:CASC)
Historical Stock Chart
From Sep 2023 to Sep 2024