877902--3/10/2008--NEOSE_TECHNOLOGIES

related topics

{product, candidate, development}

{property, intellectual, protect}

{product, liability, claim}

{cost, regulation, environmental}

{operation, international, foreign}

{control, financial, internal}

{stock, price, share}

{loss, insurance, financial}

{personnel, key, retain}

{acquisition, growth, future}

{stock, price, operating}

We require additional capital to fund our operations. Any additional financing could result in equity dilution. We have a history of losses, and we may incur continued losses for some time. We have not yet commercialized any products or technologies, and we may never become profitable. If the estimates we make and the assumptions on which we rely in preparing our financial statements prove inaccurate, our actual results may vary significantly. Risks Related to Development of Products and Technologies We may be unable to develop next-generation therapeutic proteins. Our long-term success depends upon our ability to develop, receive regulatory approval for and commercialize drug product candidates. Our ability to enter into new collaborations and to achieve success under existing collaborations is uncertain. We depend on our partners and other third parties to conduct our clinical trials. Non-clinical and clinical trial results for our products may not be favorable. Our and our partners' clinical trials may be delayed. We have no commercial manufacturing capability and rely on third parties to manufacture our product candidates and the materials used to make them. The manufacture of our product candidates is a complex and highly-regulated process. If any of our CMOs encounters problems manufacturing materials for us, our business could suffer. Proteins are uniquely susceptible to neutralizing antibodies that could result in diminished efficacy of our products. Developments in our product categories may adversely affect our ability to commercialize our product candidates. We may be exposed to product liability and related risks. Risks Related to Intellectual Property Blocking patents or claims of infringement may stop or delay the development of our proprietary products. The failure to obtain, maintain or protect patents and other intellectual property could impact our ability to compete effectively. We may have to develop or license alternative technologies if we are unable to maintain or obtain key technology from third parties. Our competitors may develop better or more successful products. We may be unable to retain key employees or recruit additional qualified personnel. Risks Related to Government Regulation We are subject to extensive government regulation, and we or our collaborators may not obtain necessary regulatory approvals or may encounter long delays and large expenditures in obtaining such approvals. Third-party reimbursement for our collaborators' or our future product candidates may not be adequate. Risk Related to Stock Market and Foreign Exchange Rates We currently fail to meet one of Nasdaq's listing requirements and if our common stock is delisted it could negatively impact the price of our common stock and our ability to access the capital markets. Our stock price may continue to experience fluctuations. Changes in foreign currency exchange rates could result in increased costs. Risks Related to Facilities, Business Interruption, and the Environment The use of hazardous materials in our operations may subject us to environmental claims or liability. Destructive actions by activists or terrorists could damage our facilities, interfere with our research activities, and cause ecological harm.

Full 10-K form ▸

877902--3/10/2008--NEOSE_TECHNOLOGIES_INC