Cascadian Therapeutics
Mar 14, 2016

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, March 14, 2016 (GLOBE NEWSWIRE) -- 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:

Internal Research & Discovery Collaborations:

Leadership:

Full Year and Fourth Quarter 2015 Financial Highlights

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 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 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 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 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 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. 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

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,
 2015201420152014
     
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   

 

Investor Contact:

Julie Rathbun

Rathbun Communications

206-769-9219

ir@oncothyreon.com

Primary Logo

Source: Oncothyreon Inc.

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