918112--9/16/2008--NEUROBIOLOGICAL_TECHNOLOGIES_INC

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, share}

{control, financial, internal}

{provision, law, control}

{acquisition, growth, future}

{competitive, industry, competition}

{loan, real, estate}

{stock, price, operating}

{personnel, key, retain}

{property, intellectual, protect}

{condition, economic, financial}

If our clinical trials for Viprinex are delayed because of patient enrollment or other problems, we would incur additional costs and experience delays in the potential receipt of revenues The approval of Viprinex by the FDA or other regulatory authorities is uncertain and regulatory authorities may not approve it even if it meets the safety and efficacy endpoints in our clinical trials. We rely on third parties to conduct our clinical trials for Viprinex, and their failure to perform their obligations in a timely or competent manner may prevent or delay development and commercialization of our lead drug candidate. We do not have our own manufacturing facilities and are dependent on contract manufacturers and suppliers for the development and production of Viprinex. Risks Related to Our Financial Condition We have a history of losses, we expect to generate losses in the near future, and we may never achieve or maintain profitability. We will need to raise additional capital to reach profitability and to complete the clinical trial work that is likely to be necessary to apply for approval of Viprinex. If we succeed in raising additional capital through a debt or equity financing transaction, it may adversely affect our stock price. If we are unable to raise additional capital, we may be forced to curtail operations. The auction rate securities we hold in our portfolio are currently not actively trading, and we may have to sell all or some of these securities at a loss to fund our operations Risks Related to Our Business The approval of any future product candidate by the FDA or other regulatory authorities is uncertain and will involve the commitment of substantial time and resources. Even if Viprinex is approved for commercialization, it may not be successfully commercialized or generate meaningful product revenues for us. If Viprinex does not attain adequate market acceptance by health care professionals and patients, our business prospects and results of operations will suffer. If government and third party payors fail to provide coverage and adequate payment rates for Viprinex, if approved, our revenues and prospects for profitability will suffer. Even if we are granted approval for our product candidates, we may not be able to maintain that approval, which would reduce our revenues. The royalty rate we receive for memantine product sales will decrease. We only have very limited control over the development and commercialization of XERECEPT, which we have sold to Celtic, and as a result, we may not realize a significant portion of the potential value of this product candidate. We face intense competition from other companies. If we do not continue to attract and retain key employees, our product development efforts and our operations will be impaired. Clinical trials or marketing of any of our potential products may expose us to liability claims from the use of such products, which our insurance may not cover. Our success will depend, in large part, on our ability to obtain or license patents, protect trade secrets and operate without infringing upon the proprietary rights of others. We have previously concluded that we have material weaknesses in our internal controls over accounting for certain complex transactions and other items, and we have restated financial statements from prior periods as a result of material weaknesses in our internal controls over accounting for highly complex issues and transactions. Risks Related to Our Common Stock The market price of our common stock has been, and is likely to continue to be, highly volatile. We may not continue to meet the listing standards of the NASDAQ Capital Market, which could result in our delisting and negatively impact the price of our common stock and our ability to access the capital markets. Our certificate of incorporation, our bylaws, Delaware law and our stockholder rights plan contain provisions that could discourage another company from acquiring us and may prevent attempts by our stockholders to replace or remove our current board and/or management. There may be issuances of shares of preferred stock in the future.

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918112--9/16/2008--NEUROBIOLOGICAL_TECHNOLOGIES_INC_/CA/