921114--3/29/2007--TARGETED_GENETICS_CORP

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, share}

{property, intellectual, protect}

{product, market, service}

{stock, price, operating}

{control, financial, internal}

{interest, director, officer}

{personnel, key, retain}

Risks Related to Our Business The audit report prepared by our independent registered public accounting firm includes an explanatory paragraph expressing the substantial doubt about our ability to continue as a going concern. If we are unable to raise additional capital when needed, we will be unable to conduct our operations and develop our potential products. We expect to continue to operate at a loss and may never become profitable. All of our product candidates are in early-stage clinical trials or preclinical development, and if we are unable to successfully develop and commercialize our product candidates we will be unable to generate sufficient capital to maintain our business. Failure to recruit subjects could delay or prevent clinical trials of our potential products, which could delay or prevent the development of potential products. 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. 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. 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, we may be unable to develop our potential products. If we do not attract and retain qualified personnel, we may be unable to develop and commercialize some of our potential products. If our partners or scientific consultants terminate, reduce or delay our relationships with them, we may be unable to develop our potential products. The 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. Post-approval manufacturing or product problems or failure to satisfy applicable regulatory requirements could prevent or limit our ability to market our products. 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 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. Market fluctuations or volatility could cause the market price of our common stock to decline and limit our ability to raise capital.

Full 10-K form ▸

921114--3/29/2007--TARGETED_GENETICS_CORP_/WA/