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): November 6, 2014

 

 

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

(Registrant’s 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 November 6, 2014, Oncothyreon Inc. (the “Company”) issued a press release and will hold a conference call regarding the Company’s financial results for the quarter ended September 30, 2014. A copy of the Company’s 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

(d) Exhibits.

 

Exhibit
Number

  

Description

99.1    Press Release issued by Oncothyreon Inc. on November 6, 2014.

 

2


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/ Robert L. Kirkman

  Robert L. Kirkman
  President & Chief Executive Officer

Date: November 6, 2014

 

3


EXHIBIT INDEX

 

Exhibit
Number

  

Description

99.1    Press Release issued by Oncothyreon Inc. dated November 6, 2014.

 

4



Exhibit 99.1

 

 

LOGO

Oncothyreon Reports Third Quarter 2014

Financial Results

Company to Hold Conference Call at 4:30 p.m. EST Today

SEATTLE, WASHINGTON, Nov 6, 2014/PRNewswire/ - Oncothyreon Inc. (NASDAQ: ONTY) today reported financial results for the third quarter ended September 30, 2014.

Loss from operations increased to $8.0 million for the three months ended September 30, 2014 compared with $7.6 million for the comparable period in 2013 due to slight increases in general and administrative expenses and research and development expenses. Loss from operations decreased to $23.0 million for the nine months ended September 30, 2014 compared with $33.6 million for the comparable period in 2013. The decrease was due to lower research and development expenses primarily attributable to a $10.0 million upfront payment to Array BioPharma Inc. (Array) in June 2013. The decrease was partly offset by an increase in general and administrative expenses.

Net loss for the three months ended September 30, 2014 was $6.7 million, or $0.09 per basic and diluted share, compared with a net loss of $7.7 million, or $0.12 per basic and diluted share, for the comparable period in 2013. The decrease in net loss for the three months ended September 30, 2014 compared to the prior year period was primarily due to $1.3 million in non-cash income from the change in the fair value of warrant liability during the three months ended September 30, 2014 compared to $0.2 million in non-cash expense from the change in the fair value of warrant liability during the three months ended September 30, 2013, which was partially offset by slight increases in general and administrative expenses and research and development expenses. Net loss for the nine months ended September 30, 2014 was $22.4 million, or $0.31 per basic and diluted share, compared with a net loss of $32.4 million, or $0.54 per basic and diluted share, for the comparable period in 2013. The decrease in net loss for the nine months ended September 30, 2014 compared to the prior year period was due to lower research and development expenses primarily attributable to the upfront payment of $10.0 million to Array in June 2013, partially offset by an increase in general and administrative expenses and lower non-cash income from the change in fair value of warrant liability, which was $0.5 million for the nine months ended September 30, 2014 compared to $1.1 million for the nine months ended September 30, 2013.


As of September 30, 2014, Oncothyreon’s cash, cash equivalents and investments were $91.2 million, compared to $72.6 million at December 31, 2013, an increase of $18.6 million, or 25.6 percent. The increase was primarily attributable to the net proceeds of $40.2 million from the closing of concurrent but separate underwritten offerings of 11,500,000 shares of Oncothyreon common stock and 10,000 shares of Oncothyreon Series A convertible preferred stock in September 2014, which resulted in net proceeds of $21.6 million and $18.6 million, respectively. This increase was offset in part by $21.0 million of cash used in operations during the nine months ended September 30, 2014.

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 2014 to be lower than in 2013, which included the one-time upfront payment to Array. Oncothyreon currently expects cash used in operations in 2014 to be approximately $30 million, including expenses associated with the acquisition of Alpine Biosciences, Inc. 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.

Conference Call and Webcast

Oncothyreon will conduct a conference call today, November 6, 2014 at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss its third quarter 2014 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.

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 discover, develop and commercialize compounds 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 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 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. 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 and Media Relations 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.

Condensed Consolidated Statements of Operations

(In thousands except share and per share amounts)

(Unaudited)

 

     Three months ended
September 30,
    Nine months ended
September 30,
 
     2014     2013     2014     2013  

Operating Expenses

    

Research and development

   $ 5,663      $ 5,517      $ 15,876      $ 27,374   

General and administrative

     2,357        2,085        7,101        6,266   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     8,020        7,602        22,977        33,640   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (8,020     (7,602     (22,977     (33,640
  

 

 

   

 

 

   

 

 

   

 

 

 

Other income (expense)

    

Investment and other income (expense), net

     11        66        52        118   

Change in fair value of warrant liability

     1,273        (174     541        1,126   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total other income (expense), net

     1,284        (108     593        1,244   
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (6,736   $ (7,710   $ (22,384   $ (32,396
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share – basic and diluted

   $ (0.09   $ (0.12   $ (0.31   $ (0.54

Shares used to compute basic and diluted net loss per share

     77,237,246        63,886,874        72,919,829        59,962,328   
  

 

 

   

 

 

   

 

 

   

 

 

 

 


ONCOTHYREON INC.

Consolidated Balance Sheet Data

(In thousands except share amounts)

(Unaudited)

 

     As of  
     September 30, 2014      December 31, 2013  

Cash, cash equivalents and investments

   $ 91,245       $ 72,562   

Total assets

   $ 130,946       $ 77,746   

Long term liabilities

   $ 7,841       $ 1,536   

Stockholders’ equity

   $ 118,396       $ 71,550   

Common shares outstanding

     91,555,975         70,673,143   
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