886744--2/27/2009--GERON

related topics

{product, candidate, development}

{property, intellectual, protect}

{product, liability, claim}

{control, financial, internal}

{stock, price, share}

{provision, law, control}

{cost, regulation, environmental}

{stock, price, operating}

{acquisition, growth, future}

{personnel, key, retain}

RISKS RELATED TO OUR BUSINESS Our business is at an early stage of development. Restrictions on the use of human embryonic stem cells, political commentary and the ethical and social implications of research involving human embryonic stem cells could prevent us from developing or gaining acceptance for commercially viable products based upon such stem cells and adversely affect the market price of our common stock. RISKS RELATED TO OUR FINANCIAL POSITION AND NEED FOR ADDITIONAL FINANCING We have a history of losses and anticipate future losses, and continued losses could impair our ability to sustain operations. We will need additional capital to conduct our operations and develop our product candidates, and our ability to obtain the necessary funding is uncertain. RISKS RELATED TO CLINICAL AND COMMERCIALIZATION ACTIVITIES Delays in the commencement of clinical testing of our current and potential product candidates could result in increased costs to us and delay our ability to generate revenues. We do not have experience as a company conducting large-scale clinical trials, or in other areas required for the successful commercialization and marketing of our product candidates. Obtaining regulatory approvals to market our product candidates in the United States and other countries is a costly and lengthy process and we cannot predict whether or when we will be permitted to commercialize our product candidates. Failure to achieve continued compliance with government regulation over approved products could delay or halt commercialization of our products. RISKS RELATED TO PROTECTING OUR INTELLECTUAL PROPERTY Impairment of our intellectual property rights may adversely affect the value of our technologies and product candidates and limit our ability to pursue their development. Challenges to our patent rights can result in costly and time-consuming legal proceedings that may prevent or limit development of our product candidates. If we fail to meet our obligations under license agreements, we may lose our rights to key technologies on which our business depends. We may be subject to litigation that will be costly to defend or pursue and uncertain in its outcome. We may be subject to infringement claims that are costly to defend, and which may limit our ability to use disputed technologies and prevent us from pursuing research and development or commercialization of potential products. Much of the information and know-how that is critical to our business is not patentable and we may not be able to prevent others from obtaining this information and establishing competitive enterprises. RISKS RELATED TO OUR RELATIONSHIPS WITH THIRD PARTIES We depend on other parties to help us develop, manufacture and test our product candidates, and our ability to develop and commercialize potential products may be impaired or delayed if collaborations are unsuccessful. Our reliance on the activities of our non-employee consultants, research institutions, and scientific contractors, whose activities are not wholly within our control, may lead to delays in development of our product candidates. RISKS RELATED TO COMPETITIVE FACTORS The loss of key personnel could slow our ability to conduct research and develop product candidates. Our products are likely to be expensive to manufacture, and they may not be profitable if we are unable to significantly reduce the costs to manufacture them. Some of our competitors may develop technologies that are superior to or more cost-effective than ours, which may impact the commercial viability of our technologies and which may significantly damage our ability to sustain operations. To be successful, our product candidates must be accepted by the health care community, which can be very slow to adopt or unreceptive to new technologies and products. If we fail to obtain acceptable prices or adequate reimbursement for our product candidates, the use of our potential products could be severely limited. RISKS RELATED TO ENVIRONMENTAL AND PRODUCT LIABILITY Our activities involve hazardous materials, and improper handling of these materials by our employees or agents could expose us to significant legal and financial penalties. We may not be able to obtain or maintain sufficient insurance on commercially reasonable terms or with adequate coverage against potential liabilities in order to protect ourselves against product liability claims. RISKS RELATED TO OUR COMMON STOCK AND FINANCIAL REPORTING Our stock price has historically been very volatile. The sale of a substantial number of shares may adversely affect the market price for our common stock. Our undesignated preferred stock may inhibit potential acquisition bids; this may adversely affect the market price for our common stock and the voting rights of holders of our common stock. Provisions in our share purchase rights plan, charter and bylaws, and provisions of Delaware law, may inhibit potential acquisition bids for us, which may prevent holders of our common stock from benefiting from what they believe may be the positive aspects of acquisitions and takeovers. We do not intend to pay cash dividends on our common stock in the foreseeable future. Failure to achieve and maintain effective internal controls in accordance with Section 404 of the Sarbanes-Oxley Act of 2002 could have a material adverse effect on our business and stock price.

Full 10-K form ▸

886744--2/27/2009--GERON_CORP