1098972--3/16/2009--ANTIGENICS_INC

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, share}

{property, intellectual, protect}

{provision, law, control}

{financial, litigation, operation}

{cost, contract, operation}

{regulation, change, law}

{cost, regulation, environmental}

{operation, international, foreign}

{debt, indebtedness, cash}

{acquisition, growth, future}

Risks Related to our Business If we incur operating losses for longer than we expect, or we are not able to raise additional capital, we may be unable to continue our operations, or we may become insolvent. We have significant long-term debt, and we may not be able to make interest or principal payments when due. Several factors could delay or prevent the successful commercial launch of Oncophage in Russia. In addition, we do not expect to generate significant revenue from sales of Oncophage in Russia for several months, if ever. Our approval to market Oncophage in Russia is limited to the treatment of kidney cancer patients at intermediate risk for disease recurrence, and is subject to regulatory requirements. If we fail to comply with these regulatory requirements in Russia or elsewhere, if these regulatory requirements change, or if we experience unanticipated regulatory problems, our commercial launch of Oncophage could be prevented or delayed, or Oncophage could be subjected to restrictions, or be withdrawn from the market, or some other action may be taken that may be adverse to our business. We face a risk of government enforcement actions in connection with our business and marketing activities. We may not be able to obtain approval to market Oncophage in countries other than Russia. Because we expect additional Phase 3 clinical trials of Oncophage may be required prior to submitting a BLA to the FDA for any indication, we likely will not commercialize Oncophage in the United States for several years, if ever. We may face similar hurdles in other territories where we may seek marketing approval. Risks associated with doing business internationally could negatively affect our business. Regulatory reforms may create additional burdens that would cause us to incur additional costs and may adversely affect our ability to commercialize our products. If we fail to obtain adequate levels of reimbursement for Oncophage, there may be no commercially viable market for Oncophage, or the commercial potential of Oncophage or our product candidates may be significantly limited. Our commercial operations experience and resources are limited and need to be developed or acquired. If we fail to do so, our revenues may be limited or nonexistent. In addition, we may be required to incur significant costs and devote significant efforts to augment our existing capabilities. Our competitors in the biotechnology and pharmaceutical industries may have superior products, manufacturing capability, and/or selling and marketing expertise. Manufacturing problems may cause product launch delays, unanticipated costs, or loss of revenue streams. The drug development and approval process is uncertain, time-consuming, and expensive. Challenges in identifying sufficient numbers of patients that meet our eligibility criteria, enrolling patients in our studies, or retaining patients in our studies after they have enrolled, will slow or prevent completion of clinical trials. New data from our research and development activities could modify our strategy and result in the need to adjust our projections of timelines and costs of programs. Failure to enter into significant collaboration agreements may hinder our efforts to develop and commercialize our product candidates and will increase our need to rely on other financing mechanisms, such as sales of securities, to fund our operations. Because we rely on collaborators and licensees for the development and commercialization of some of our product candidate programs, these programs may not prove successful, and/or we may not receive significant payments from such parties. If we are unable to purify heat shock proteins from some cancer types, we may have difficulty successfully initiating clinical trials in new indications or completing our clinical trials, and, even if we do successfully complete our clinical trials, the size of our potential market could decrease. If we fail to sustain and further build our intellectual property rights, competitors will be able to take advantage of our research and development efforts to develop competing products. We may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights, and we may be unable to protect our rights to, or use, our technology. We may become involved in expensive patent litigation or other proceedings, which could result in our incurring substantial costs and expenses or substantial liability for damages, or require us to stop development and commercialization efforts. Our patent protection for any compound or product that we seek to develop may be limited to a particular method of use or indication such that, if a third party were to obtain approval of the compound or product for use in another indication, we could be subject to competition arising from off-label use. If we fail to comply with our obligations in our intellectual property licenses with third parties, we could lose license rights that are important to our business. If we fail to retain the services of, and/or maintain positive relations with, key individuals and our employees, we may be unable to successfully develop our product candidates, conduct clinical trials, and obtain financing. We may face litigation that could result in substantial damages and may divert management s time and attention from our business. Product liability and other claims against us may reduce demand for our products and/or result in substantial damages. If we do not comply with environmental laws and regulations, we may incur significant costs and potential disruption to our business. Risks Related to our Common Stock Our officers and directors may be able to block proposals for a change in control. The unaffiliated holders of certain convertible securities have the right to convert such securities into a substantial percentage of our outstanding common stock. Provisions in our organizational documents could prevent or frustrate attempts by stockholders to replace our current management. Our stock has generally had low trading volume, and its public trading price has been volatile. The sale of a significant number of shares could cause the market price of our stock to decline. Our stock may be delisted from The NASDAQ Global Market, which could affect its market price and liquidity. Because we are a relatively small public company, we believe we have been disproportionately negatively impacted by the Sarbanes-Oxley Act of 2002 and related regulations, which have increased our costs and required additional management resources.

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