Oncothyreon reports third quarter 2009 financial results & provides product
pipeline update
Oncothyreon reported a loss from operations of
Operating expenses for the three and nine months ended
Total revenue was
Oncothyreon reported a net loss of
As of
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.
Cash outflow in 2009 is expected to be substantially less than in 2008, primarily as a result of transferring manufacturing and process development activities for Stimuvax to Merck KGaA and of the previously announced plan to restrict development activities to PX-478 and PX-866. Oncothyreon currently expects cash used for operating and capital expenditures in 2009 to be approximately
Oncothyreon Pipeline Update
The following provides an update on Oncothyreon's product development candidates:
Stimuvax - Stimuvax is an investigational therapeutic cancer vaccine designed to induce an immune response to cancer cells that express MUC1, a glycoprotein antigen widely expressed on common cancers, including lung cancer, breast cancer, prostate cancer and colorectal cancer. Oncothyreon's partner for the development of Stimuvax, Merck KGaA, is actively enrolling patients in two global Phase 3 trials. Initiated in
In
BGLP40 - BGLP40 is a completely synthetic MUC1-based liposomal glycolipopeptide cancer vaccine for potential use in several cancer indications. The antigen incorporated in BGLP40 combines carbohydrate and peptide determinates in a multi-epitopic vaccine that evokes both cell- and antibody-mediated immune responses against major cancer-associated targets expressed on adenocarcinomas. The vaccine also includes the fully synthetic PET-lipid A adjuvant which is proprietary to Oncothyreon.
Oncothyreon currently intends to substantially complete the pre-clinical development of BGLP40 in 2010, with the goal of initiating clinical development in 2011. Merck KGaA has a right of first negotiation with respect to the development or marketing of BGLP40.
PX-866 - PX-866 is a small molecule inhibitor of the PI-3-kinase/PTEN/AKT pathway, an important survival signaling pathway that is activated in many types of human cancer. Oncothyreon is currently conducting a Phase 1 trial of PX-866 in patients with advanced metastatic cancer. The trial includes both an intermittent and a continuous dosing arm. The maximally-tolerated dose has been identified in the intermittent dosing arm, and patient entry has begun in the continuous dosing arm of the study.
Based upon the results seen in this trial to date, including the preliminary data presented at the American Society of Oncology meeting earlier this year, Oncothyreon has made the decision to move PX-866 into Phase 2 clinical development in the first half of 2010. The Phase 2 development program is currently expected to include two or more trials of PX-866 in combination with chemotherapy or other targeted agents and as a single agent.
PX-478 - PX-478 is a novel small molecule compound that inhibits the activity of hypoxia inducible factor (HIF)-1 alpha, a component of the transcription factor HIF-1 that controls the expression of a number of genes important for growth and survival of cancer cells. Oncothyreon currently expects to complete patient enrollment in its Phase 1 trial of PX-478 in the fourth quarter of 2009. In addition, pre-clinical data concerning the activity of PX-478 in diffuse large B-cell lymphoma cells will be presented at the American Society of Hematology meeting in early
Conference Call and Webcast
Oncothyreon's management will discuss the Company's third quarter 2009 financial results and provide a business update during a conference call beginning at
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, but are not limited to, the following: our expectations regarding future expenses; clinical and pre-clinical development activities, including our plans to substantially complete the pre-clinical development of BGLP40 in 2010, our goal to initiate clinical development of BGLP40 in 2011, our decision to move PX-866 into Phase 2 clinical development in the first half of 2010 and our expectations regarding completion of patient enrollment in our Phase 1 trial of PX-478 in the fourth quarter of 2009;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 pre-clinical development of our product candidates 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
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.
Consolidated Statements of Operations and Other Comprehensive Loss Data
(in thousands except per share amounts)
(unaudited)
Three Months Ended Nine Months Ended
September 30 September 30
------------------ ------------------
2009 2008 2009 2008
-------- -------- -------- --------
Revenue
Contract manufacturing......... $ - $ 426 $ - $ 2,946
Licensing revenue from
collaborative agreements...... 4 376 12 1,028
Licensing, royalties and
other revenue................. - - 27 -
-------- -------- -------- --------
4 802 39 3,974
-------- -------- -------- --------
Expenses
Research and development....... 1,320 1,704 3,995 6,395
Manufacturing.................. - 422 - 3,148
General and administrative..... 1,377 2,120 4,873 7,827
Amortization................... 67 111 199 317
-------- -------- -------- --------
2,764 4,357 9,067 17,687
-------- -------- -------- --------
Loss from Operations (2,760) (3,555) (9,028) (13,713)
-------- -------- -------- --------
Other (Income) Expenses
Investment and other income.... (16) 14 17 (114)
Change in fair value of
warrant liability............. 3,201 - 5,703 -
-------- -------- -------- --------
3,185 14 5,720 (114)
-------- -------- -------- --------
Net loss......................... (5,945) (3,569) (14,748) (13,599)
Other comprehensive income....... - 31 - -
-------- -------- -------- --------
Comprehensive net loss........... $ (5,945) $ (3,538) $(14,748) $(13,599)
-------- -------- -------- --------
-------- -------- -------- --------
Basic and diluted loss per
share........................... $ (0.24) $ (0.18) $ (0.68) $ (0.70)
-------- -------- -------- --------
-------- -------- -------- --------
Weighted average number of
common shares outstanding....... 24,714 19,492 21,749 19,490
-------- -------- -------- --------
-------- -------- -------- --------
Oncothyreon Inc.
Consolidated Balance Sheets Data
(in thousands)
(unaudited)
September, 2009 December 31, 2008
Cash, cash equivalents..................... $ 34,980 $ 19,166
Total assets............................... $ 39,625 $ 24,971
Total long-term liabilities................ $ 10,303 $ 393
Stockholders' equity....................... $ 26,936 $ 20,717
Common shares outstanding.................. 25,662 19,492
For further information: Investor and Media Relations Contact: Julie Rathbun, Rathbun Communications, (206) 769-9219, [email protected]
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