ONCOTHYREON REPORTS FULL YEAR AND FOURTH QUARTER 2010 FINANCIAL RESULTS

Mar 10, 2011, 07:00 ET from Oncothyreon Inc.

COMPANY TO HOLD CONFERENCE CALL AT 8:00 EST TODAY

SEATTLE, WA, March 10 /PRNewswire-FirstCall/ - Oncothyreon Inc. (NASDAQ: ONTY) (the "Company") today reported financial results for the year and quarter ending December 31, 2010. 

Net loss for the year ended December 31, 2010 was $15.6 million, or $0.58 per basic and diluted share, compared with net loss of $17.2 million, or $0.76 per basic and diluted share for the year ended December 31, 2009.  The decrease in net loss was the result of $3.0 million non-cash income from the change in fair value of warrant liability for the year ended December 31, 2010 versus a $6.2 million non-cash expense for the year ended December 31, 2009, partially offset by an increase in operating expenses to $19.5 million in 2010 from $12.9 million in 2009 and a decrease in revenue to $18,000 for the year ended December 31, 2010 from $2.1 million for the year ended December 31, 2009.

The decrease in revenue in 2010 compared to 2009 is primarily attributable to the absence of contract manufacturing or licensing revenue in 2010, compared with $2.1 million in 2009.  Licensing revenue in 2009 included a $2.0 million milestone payment from Merck KGaA in the fourth quarter related to the license for Stimuvax®.

The increase in operating expenses to $19.5 million in 2010 from $12.9 million in 2009 is due to a $5.2 million increase in research and development expenses and a $1.2 million increase in general and administrative expenses.   Research and development expenses increased due to the more advanced clinical development of PX-866 and preclinical activities associated with ONT-10.  General and administrative expenses increased to $7.8 million in 2010 from $6.6 million in 2009, primarily as the result of legal, accounting and consulting expenses related to regulatory compliance in the first half of 2010.

Net loss for the quarter ended December 31, 2010 was $6.2 million, or $0.20 per basic and diluted share, compared with net loss of $2.5 million or $0.10 per basic and diluted share for the comparable period in 2009. There was $5,000 of revenue for the fourth quarter of 2010, compared with $2.0 million for the fourth quarter of 2009. Operating expenses for the quarter ended December 31, 2010 were $5.0 million compared with $3.9 million for the quarter ended December 31, 2009 due to the more advanced clinical development of PX-866 and preclinical activities associated with ONT-10. 

As of December 31, 2010, Oncothyreon's cash, cash equivalents and short-term investments were $28.9 million, compared to $33.2 million at the end of 2009, a decrease of $4.3 million, or 13.0 percent. Major contributors to the net change included net proceeds of approximately $13.7 million from the sale of shares of the Company's common stock and warrants to purchase shares of the Company's common stock in 2010, offset by $18.0 million used for operating and capital expenditures.

Financial Guidance

The Company believes the following financial guidance to be correct as of the date provided.  The Company is providing this guidance as a convenience to investors and assumes no obligation to update it.

Expenses in 2011 are expected to be higher when compared to 2010, primarily as a result of the more advanced clinical development of PX-866 and IND-enabling preclinical development activities for ONT-10. The Company currently expects cash used in operations in 2011 to be approximately $23.0 million.  As a result, the Company estimates that its existing cash, cash-equivalents and short-term investments will be sufficient to fund operations for at least the next 12 months.

Conference Call and Webcast

Management will discuss the Company's 2010 financial results during a conference call beginning at 5:00 a.m. PT/ 8:00 a.m. ET today, March 10, 2011. 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 the Company's website at www.oncothyreon.com.  An archive of the webcast will be available after completion of the discussion and will be posted on the Company's website.

About Oncothyreon

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.

Forward-Looking Statements

In order to provide Oncothyreon's investors with an understanding of our current results and future prospects, this release may contain 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 our expectations regarding future expenses, clinical development activities and the use and adequacy of cash resources.

Forward-looking statements involve risks and uncertainties related to our business and the general economic environment, many beyond our control. These risks, uncertainties and other factors could cause our actual results to differ materially from those projected in forward-looking statements, including the risks associated with the costs and expenses of developing our product candidates, the adequacy of financing and cash reserves on hand, changes in general accounting policies, general economic factors, achievement of the results we anticipate from our clinical trials with our products and our ability to adequately obtain and protect our intellectual property rights. Although we believe that the forward-looking statements contained herein are reasonable, we can give no assurance that our expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For a detailed description of our risks and uncertainties, you are encouraged to review the official corporate documents filed with the securities regulators in the United States on U.S. 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

Additional information relating to Oncothyreon can be found on U.S. EDGAR at www.sec.gov and on SEDAR at www.sedar.com.

ONCOTHYREON INC. Condensed Consolidated Statement of Operations Data (in thousands except share and per share amounts) (Unaudited)
                     
                     
        Three months   Year
        Ended December 31,   Ended December 31,
        2010   2009   2010   2009
                     
Revenue                
                   
  Licensing revenue from collaborative & license agreements   $                 5                      
$           2,039
  $            18         2,051
  Licensing, royalties, and other revenue         27
        5                 2,039               18                           2,078
Expenses                
  Research and development   3,365                 2,086   11,241   6,081
  General and administrative   1,520                 1,716   7,799   6,589
  Depreciation   112                       70   462   269
                     
  Operating expenses     4,997                 3,872             19,502                         12,939
  Income (loss) from operations   (4,992)               (1,833)           (19,484)           (10,861)
                     
  Investment and other (income) expense   (536)                     (11)   (636)   8
  Change in fair value of warrant liability   1,698                    448   (3,030)   6,150
  Income Tax                        200                  (200)                  200
Net Loss   $(6,154)              $(2,470)           $(15,618)                 $(17,219)
                     
Basic and diluted loss per share   $(0.20)   $(0.10)                               $(0.58)                     $(0.76)
Weighted average number of common shares outstanding  - basic 30,062,101   24,713,794   26,888,588   22,739,138
Weighted average number of common shares outstanding  - diluted 30,062,101   24,713,794   26,888,588   22,739,138
                     
                     
                     
                     
                     
Consolidated Balance Sheet data  
(in thousands)  
(unaudited)  
                     
        As of December 31,        
        2010   2009        
  Cash, cash equivalents and short term investments   $    28,877   $    33,218        
  Total assets       34,445       38,225        
  Long term liabilities       13,727       10,732        
  Stockholder's equity       18,857       25,418        
  Common shares outstanding     30,089     25,753        
                     

SOURCE Oncothyreon Inc.