880643--3/17/2008--GENTA_INC

related topics

{product, candidate, development}

{stock, price, share}

{financial, litigation, operation}

{control, financial, internal}

{product, liability, claim}

{provision, law, control}

{customer, product, revenue}

{personnel, key, retain}

{property, intellectual, protect}

{cost, operation, labor}

{stock, price, operating}

We may be unsuccessful in our efforts to obtain approval from the FDA or EMEA and commercialize Genasense or our other pharmaceutical products. Recurring losses and negative cash flows from operations raise substantial doubt about our ability to continue as a going concern and we may not be able to continue as a going concern. Our business will suffer if we fail to obtain timely funding. We have relied on and continue to rely on our contractual collaborative arrangements with research institutions and corporate partners for development and commercialization of our products. Our business could suffer if we are not able to enter into suitable arrangements, maintain existing relationships, or if our collaborative arrangements are not successful in developing and commercializing products We anticipate that we will incur additional losses and we may never be profitable Our business depends heavily on a small number of products We may be unable to obtain or enforce patents, other proprietary rights and licenses to protect our business; we could become involved in litigation relating to our patents or licenses that could cause us to incur additional costs and delay or prevent our introduction of new drugs to market. Most of our products are in an early stage of development, and we may never receive regulatory approval for these products. We will not be able to commercialize our product candidates if our preclinical studies do not produce successful results or if our clinical trials do not demonstrate safety and efficacy in humans. Clinical trials are costly and time consuming and are subject to delays; our business would suffer if the development process relating to our products were subject to meaningful delays If we fail to obtain the necessary regulatory approvals, we cannot market and sell our products in the United States If the third party manufacturers upon which we rely fail to produce our products in the volumes that we require on a timely basis, or to comply with stringent regulations applicable to pharmaceutical drug manufacturers, we may face delays in the commercialization of, or be unable to meet demand for, our products and may lose potential revenues Even if we obtain regulatory approval, we will be subject to ongoing regulation, and any failure by us or our manufacturers to comply with such regulation could suspend or eliminate our ability to sell our prod The raw materials for our products are produced by a limited number of suppliers, and our business could suffer if we cannot obtain needed quantities at acceptable prices and qualities. If third-party payors do not provide coverage and reimbursement for use of our products, we may not be able to successfully commercialize our products. Our business exposes us to potential product liability that may have a negative effect on our financial performance and our business generally We may incur a variety of costs to engage in future acquisitions of companies, products or technologies, and the anticipated benefits of those acquisitions may never be realized. We face substantial competition from other companies and research institutions that are developing similar products, and we may not be able to compete successfully. We are dependent on our key executives and scientists, and the loss of key personnel or the failure to attract additional qualified personnel could harm our business. Risks Related to Outstanding Litigation The outcome of and costs relating to the pending shareholder class action and shareholder derivative actions are uncertain. Risks Related to Our Common Stock Provisions in our restated certificate of incorporation and bylaws and Delaware law may discourage a takeover and prevent our stockholders from receiving a premium for their shares We have not paid, and do not expect to pay in the future, cash dividends on our common stock Our stock price is volatile Our common stock may be delisted from the NASDAQ Global Market, or NASDAQ

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880643--3/17/2008--GENTA_INC_DE/