357097--3/19/2007--ISOLAGEN

related topics

{product, candidate, development}

{stock, price, share}

{product, liability, claim}

{acquisition, growth, future}

{product, market, service}

{property, intellectual, protect}

{control, financial, internal}

{personnel, key, retain}

{stock, price, operating}

{operation, natural, condition}

{regulation, change, law}

{cost, operation, labor}

{interest, director, officer}

{provision, law, control}

{debt, indebtedness, cash}

{operation, international, foreign}

{financial, litigation, operation}

{cost, regulation, environmental}

Clinical trials may fail to demonstrate the safety or efficacy of our product candidates, which could prevent or significantly delay regulatory approval and/or prevent us from raising additional financing. Any delays in completion of our clinical trials could adversely affect our business. Our capital resources are not sufficient to fund us through commercialization. We may be unable to successfully commercialize any of our product candidates currently under development. We have not generated significant revenue from commercial sales of our products to date, and we do not know whether we will ever generate significant revenue. Obtaining FDA and other regulatory approvals is complex, time consuming and expensive, and the outcomes are uncertain. Our ability to effectively commercialize our product candidates depends on our ability to improve our manufacturing process and validate such future improvements. We may not be successful in our efforts to develop commercial-scale manufacturing technology and methods. Our product candidates utilize our Isolagen Therapy. If our Isolagen Therapy is found to be unsafe or ineffective, our business would be materially harmed. We are dependent on physicians to follow our established protocols both as to the administration and the handling of our product candidates in connection with our clinical trials, and we will continue to be dependent on physicians to follow such protocols if our product candidates are commercialized. If such protocols are not correctly followed, the efficacy and safety of our product candidates may be adversely affected. We currently operate a single manufacturing facility. Our business, which depends on one facility, is vulnerable to natural disasters, telecommunication and information systems failures, terrorism and similar problems, and we are not fully insured for losses caused by all of these incidents. Our outstanding indebtedness and any indebtedness that we may issue in the future may impact our financial condition and results of operations. We need to raise substantial additional capital to fund our operations in the future, and we do not have any commitments for that capital. As a result of our limited operating history, we may not be able to correctly estimate our future operating expenses, which could lead to cash shortfalls. Our operating results may fluctuate significantly in the future, which may cause our results to fall below the expectations of securities analysts, stockholders and investors. Losses may continue to increase from current levels and we will continue to experience significant negative cash flow as we expand our operations, which may limit or delay our ability to become profitable. We are party to securities and derivative litigation that distracts our management, is expensive to conduct and seeks a damage award against us. Our failure to comply with extensive governmental regulation may significantly affect our operating results. Legislative or regulatory reform of the healthcare system may affect our ability to sell our future products profitably. Agera currently conducts business in foreign markets, and our business strategy involves selling our product candidates in foreign markets. These operations are and will be subject to a variety of regulations in those foreign markets that could have a material adverse effect on our business in a particular market or in general. Our foreign operations and any foreign operations we may commence in the future are exposed to risks associated with exchange rate fluctuations, trade restrictions and political, economic and social instability. Any future products that we develop may not be commercially successful. Our competitors in the pharmaceutical, medical device and biotechnology industries may have superior products, manufacturing capabilities, financial resources or marketing position. Difficulties managing growth could adversely affect our business, operating results and financial condition. We are dependent on our key scientific and other management personnel, and the loss of any of these individuals could harm our business. We will need to attract, train and retain additional highly qualified senior executives and technical and managerial personnel in the future. If we are unable to effectively promote our brands and establish a leading position in the marketplace, our business may fail. Our ability to achieve commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of our technology and future products, as well as successfully defending these patents against third party challenges. If we are unable to obtain and maintain protection for our intellectual property and proprietary technology, the value of our technology and future products will be adversely affected, and we will not be able to protect our technology from unauthorized use by third parties. We have obtained some of our rights from third parties. If our agreements with these parties do not appear as we anticipate our business may be adversely affected. Our business may be harmed, and we may incur substantial costs as a result of litigation or other proceedings relating to patent and other intellectual property rights. We may be liable for product liability claims not covered by insurance. If we are unable to keep up with rapid technological changes, our future products may become obsolete or unmarketable. Our acquisitions of companies or technologies may result in disruptions in business and diversion of management attention. Our stock price has been volatile and could experience substantial declines. We have not declared any dividends on our common stock to date, and we have no intention of declaring dividends in the foreseeable future. Provisions in our charter documents could prevent or delay stockholders attempts to replace or remove current management. We have issued certain rights to our shareholders that may have anti-takeover effects. Provisions in our bylaws provide for indemnification of officers and directors, which could require us to direct funds away from our business and future products. Future sales of our common stock may depress our stock price. There is a limited public trading market for our common stock. As a public company, our business is subject to numerous requirements that are currently and continuously evolving and could substantially increase our operating expenses and divert management s attention from the operation of our business. Lack of effectiveness of internal controls over financial reporting could adversely affect the value of our securities.

Full 10-K form ▸

357097--3/19/2007--ISOLAGEN_INC