1208261--3/13/2009--EPICEPT

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, share}

{stock, price, operating}

{property, intellectual, protect}

{control, financial, internal}

{product, market, service}

{competitive, industry, competition}

{acquisition, growth, future}

{debt, indebtedness, cash}

{provision, law, control}

{personnel, key, retain}

{regulation, change, law}

We may not be able to continue as a going concern. Credit market volatility may affect our ability to refinance our existing debt or incur additional debt. Our quarterly financial results are likely to fluctuate significantly, which could have an adverse effect on our stock price. We have had limited operating activities, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability. In 2009, we may be required to comply with of the Sarbanes-Oxley Act of 2002 and obtain an attestation of our internal controls and procedures, which, if a material weakness exists, could adversely impact our ability to report our consolidated financial results accurately and on a timely basis. Other than the marketing authorization for Ceplene in the European Union, we currently have no products approved for sale and we cannot guarantee you that we will ever obtain regulatory approval for such other product candidates, which could delay or prevent us from being able to generate revenue from product sales. We may not be able to obtain regulatory approval in the United States for Ceplene , our lead product candidate, which could delay or prevent us from being able to generate revenue from sales of Ceplene , and require additional expenditures. Clinical trial designs that were discussed with regulatory authorities prior to their commencement may subsequently be considered insufficient for approval at the time of application for regulatory approval. We may not be able to maintain European Union regulatory approval for Ceplene , our lead product candidate, which could delay or prevent us from being able to generate revenue from sales of Ceplene If we receive regulatory approval, our marketed products will also be subject to ongoing FDA and/or foreign regulatory agency obligations and continued regulatory review, and if we fail to comply with these regulations, we could lose approvals to market any products, and our business would be seriously harmed. Any regulatory approval we receive for our product candidates will be limited to those indications and conditions for which we are able to show clinical safety and efficacy. The results of our clinical trials are uncertain, which could substantially delay or prevent us from bringing our product candidates to market. The use of FDA-approved therapeutics in certain of our pain product candidates could require us to conduct additional preclinical studies and clinical trials, which could increase development costs and lengthen the regulatory approval process. In some instances, we rely on third parties, over which we have little or no control, to conduct clinical trials for our products and their failure to perform their obligations in a timely or competent manner may delay development and commercialization of our product candidates. We may not be able to successfully market and sell Ceplene or find a collaborative partner to help market and sell Ceplene may fail to achieve market acceptance, which could harm our business. We may be dependent upon collaborative arrangements for the further development and commercialization of Ceplene . These collaborative arrangements may place the development and commercialization of Ceplene outside of our control, may require us to relinquish important rights or may otherwise be on terms unfavorable to us. If we fail to enter into and maintain successful strategic alliances for our product candidates, we may have to reduce or delay our product commercialization or increase our expenditures. If the market does not accept and use our product candidates, we will not achieve sufficient product revenues and our business will suffer. Our product candidates could be rendered obsolete by technological change and medical advances, which would adversely affect the performance of our business. We have no manufacturing capacity and anticipate continued reliance on third parties for the manufacture of our product candidates. We may be the subject of costly product liability claims or product recalls, and we may be unable to obtain or maintain insurance adequate to cover potential liabilities. The coverage and reimbursement status of newly approved healthcare drugs is uncertain and failure to obtain adequate coverage and reimbursement could limit our ability to market our products. Foreign governments tend to impose strict price controls, which may adversely affect our future profitability. Risks Relating to Our Business and Industry Our failure to attract and retain skilled personnel could impair our product development and commercialization efforts. Our competitors may develop and market drugs that are less expensive, safer, or more effective, which may diminish or eliminate the commercial success of any of our product candidates. EpiCept GmbH, our German subsidiary, is subject to various risks associated with its international operations. Risks Relating to Intellectual Property If we are unable to protect our intellectual property, our competitors could develop and market products with features similar to our products and demand for our products may decline. If we are sued for infringing intellectual property rights of third parties, such litigation will be costly and time consuming, and an unfavorable outcome could increase our costs or have a negative impact on our business. We may be subject to damages resulting from claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers. Risks Relating to our Common Stock Our common stock may be delisted from The Nasdaq Capital Market or the OMX Nordic Exchange, which may make it more difficult for you to sell your shares. We expect that our stock price will fluctuate significantly due to external factors, which could cause the value of your investment to decline. If securities or industry analysts do not publish research or reports about us, if they change their recommendations regarding our stock adversely or if our operating results do not meet their expectations, our stock price and trading volume could decline. Future sales of common stock may cause our stock price to fall. Provisions of our charter documents or Delaware law could delay or prevent an acquisition of us, even if the acquisition would be beneficial to our stockholders, and could make it more difficult for you to change management. We have never paid dividends on our capital stock, and we do not anticipate paying any cash dividends in the foreseeable future. The requirements of being a public company may strain our resources and distract management.

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1208261--3/13/2009--EPICEPT_CORP