921114--3/31/2009--TARGETED_GENETICS_CORP

related topics

{product, candidate, development}

{stock, price, share}

{product, liability, claim}

{property, intellectual, protect}

{product, market, service}

{stock, price, operating}

{personnel, key, retain}

{control, financial, internal}

{acquisition, growth, future}

{cost, operation, labor}

Risks Related to Our Business If we are unable to raise additional capital or secure additional sources of funding in the very near term, we will be unable to continue our operations. We expect to continue to operate at a loss and may never become profitable. All of our product candidates are in preclinical development or early-stage clinical trials, and if we and our partners are unable to successfully develop, commercialize and market our product candidates, we will be unable to generate sufficient capital to maintain our business. If our clinical trials are delayed, suspended or terminated, we may be unable to develop our product candidates on a timely basis, which could increase our development costs, delay the potential commercialization of our products, and make it difficult to raise additional capital. Litigation involving intellectual property, product liability or other claims and product recalls could strain our resources, subject us to significant liability, damage our reputation or result in the invalidation of our proprietary rights. If we lose our collaborative partners or we do not receive the funding we anticipate under our collaborative agreements or grants, we may be unable to develop our potential products. We may not be able to obtain and maintain the additional third-party relationships that are necessary to develop, commercialize and manufacture some or all of our product candidates or to expand our pipeline by adding new candidates. Failure to recruit subjects could delay or prevent clinical trials of our potential products, which could delay or prevent the development of potential products. Because our product candidates involve new and unproven technologies, the regulatory approval process may proceed more slowly compared to clinical trials involving new candidates in already proven drug classes. The regulatory approval process for our product candidates is costly, time-consuming and subject to unpredictable changes and delays, and our product candidates may never receive regulatory approval or be found safe and effective. If we are unable to obtain or maintain licenses for necessary third-party technology on acceptable terms or to develop alternative technology, we may be unable to develop and commercialize our product candidates. If we do not attract and retain qualified personnel, we may be unable to develop and commercialize some of our potential products. Our recent reductions in force may harm our business. If our partners or scientific consultants terminate, reduce or delay our relationships with them, we may be unable to develop our potential products. We rely on third parties to conduct our preclinical research and clinical trials. If these third parties do not perform as contractually required or otherwise expected, we may not be able to obtain regulatory approval for or commercialize our product candidates. Any success of our clinical trials and preclinical studies may not be indicative of results in a large number of subjects of either safety or efficacy. We may be unable to adequately protect our proprietary rights domestically or overseas, which may limit our ability to successfully market any product candidates. If we do not develop adequate development, manufacturing, sales, marketing and distribution capabilities, either alone or with our business partners, we will be unable to generate sufficient product revenue to maintain our business. Our product candidates may never achieve market acceptance even if we obtain regulatory approvals. Post-approval manufacturing or product problems or failure to satisfy applicable regulatory requirements could prevent or limit our ability to market our products. We rely on single third-party suppliers for some of our raw materials; if these third parties fail to supply these items, development of affected product candidates may be delayed or discontinued. Risks Related to Our Industry Adverse events in the field of gene therapy could damage public perception of our potential products and negatively affect governmental approval and regulation. Our use of hazardous materials exposes us to liability risks and regulatory limitations on their use, either of which could reduce our ability to generate product revenue. The intense competition and rapid technological change in our market may result in failure of our potential products to achieve market acceptance. Healthcare reform measures and the unwillingness of third-party payors to provide adequate reimbursement for the cost of our products could impair our ability to successfully commercialize our potential products and become profitable. Risks Related to Our Common Stock We expect that we will be unable to comply with the minimum requirements for quotation on the NASDAQ Capital Market and will be delisted from the NASDAQ Capital Market. As a result, we expect the liquidity and market price of our common stock to decline. If we sell additional shares, our stock price may decline as a result of the dilution that will occur to existing shareholders. Concentration of ownership of our common stock may give certain shareholders significant influence over our business and may result in certain decisions that are contrary to your interests. Market fluctuations or volatility could cause the market price of our common stock to decline and limit our ability to raise capital or cause impairment issues.

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921114--3/31/2009--TARGETED_GENETICS_CORP_/WA/