1412067--3/30/2009--Oncothyreon

related topics

{product, candidate, development}

{stock, price, share}

{product, liability, claim}

{control, financial, internal}

{cost, regulation, environmental}

{personnel, key, retain}

{property, intellectual, protect}

{acquisition, growth, future}

Our near-term success is highly dependent on the success of our lead product candidate, Stimuvax, and we cannot be certain that it will be successfully developed or receive regulatory approval or be successfully commercialized. Stimuvax and our other vaccine product candidates are based on novel technologies, which may raise new regulatory issues that could delay or make FDA approval more difficult. We have a history of net losses, we anticipate additional losses and we may never become profitable. There is no assurance that we will be granted regulatory approval for any of our product candidates. We are dependent upon our collaborative relationship with Merck KGaA to develop and commercialize our lead product candidate, Stimuvax. We currently rely on third party manufacturers to supply our product candidates, which could delay or prevent the clinical development and commercialization of our product candidates. Any failure or delay in commencing or completing clinical trials for our product candidates could severely harm our business. The failure to enroll patients for clinical trials may cause delays in developing our product candidates. Even if regulatory approval is received for our product candidates, the later discovery of previously unknown problems with a product, manufacturer or facility may result in restrictions, including withdrawal of the product from the market. Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing our products internationally. Our product candidates may never achieve market acceptance even if we obtain regulatory approvals. If we are unable to obtain, maintain and enforce our proprietary rights, we may not be able to compete effectively or operate profitably. If any products we develop become subject to unfavorable pricing regulations, third party reimbursement practices or healthcare reform initiatives, our ability to successfully commercialize our products will be impaired. Foreign governments often impose strict price controls, which may adversely affect our future profitability. We face potential product liability exposure, and if successful claims are brought against us, we may incur substantial liability for a product candidate and may have to limit its commercialization. We face substantial competition, which may result in others discovering, developing or commercializing products before, or more successfully, than we do. If we are unable to enter into collaborations with partners to perform sales and marketing functions, or build these functions ourselves, we will not be able to commercialize our product candidates. If we lose key personnel, or we are unable to attract and retain highly-qualified personnel on a cost-effective basis, it would be more difficult for us to manage our existing business operations and to identify and pursue new growth opportunities. Our business is subject to increasingly complex environmental legislation that has increased both our costs and the risk of noncompliance. If we fail to establish and maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired, which would adversely affect our consolidated operating results, our ability to operate our business, and our stock price. If we are required to redeem the shares of our Class UA preferred stock, our financial condition may be adversely affected. We may expand our business through the acquisition of companies or businesses or in-licensing product candidates that could disrupt our business and harm our financial condition. Risks Related to the Ownership of Our Common Stock Our common stock may become ineligible for listing on The NASDAQ Stock Market, which would materially adversely affect the liquidity and price of our common stock. The trading price of our common stock may be volatile. Because we do not expect to pay dividends on our common stock, stockholders will benefit from an investment in our common stock only if it appreciates in value.

Full 10-K form ▸

1412067--3/30/2009--Oncothyreon_Inc.