918112--9/13/2007--NEUROBIOLOGICAL_TECHNOLOGIES_INC

related topics

{product, candidate, development}

{product, liability, claim}

{control, financial, internal}

{acquisition, growth, future}

{stock, price, share}

{stock, price, operating}

{provision, law, control}

{competitive, industry, competition}

{cost, regulation, environmental}

{customer, product, revenue}

{interest, director, officer}

{personnel, key, retain}

{property, intellectual, protect}

{condition, economic, financial}

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. If we succeed in raising additional capital through a financing transaction, it may adversely affect our stock price. If we are unable to raise additional capital, we may be forced to curtail operations. Risks Related to Our Business Viprinex has failed in one of two Phase 3 clinical trials conducted by Knoll for the treatment of acute ischemic stroke, and it may not prove to be safe and effective in our current Phase 3 trials. Because Viprinex is our only product candidate, any negative or inconclusive results in the ongoing trials would significantly harm our prospects and depress our stock price. If our clinical trials for Viprinex are delayed because of patient enrollment or other problems, we would incur additional cost and experience delays in the potential receipt of revenues. The approval of Viprinex or any future product candidate by the FDA or other regulatory authorities is uncertain and will involve the commitment of substantial time and resources. Regulatory authorities may not approve Viprinex or any of our product candidates even if the product candidates meet safety and efficacy endpoints in clinical trials, or the approvals may be too limited for us to earn sufficient revenues. Even if we are granted FDA approval for any of our product candidates, we may not be able to maintain that approval, which would reduce our revenues. We do not have our own manufacturing facilities and are dependent on contract manufacturers and suppliers for the development and production of Viprinex. We have relied, and will continue to 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 delay development and commercialization of our product candidates. 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. We have only limited rights under our license and cooperation agreement with Merz and CMCC, and either of our partners can terminate the agreement upon six months notice, which would result in the loss of our memantine royalty revenues. We have limited control over the development and commercialization of XERECEPT, the rights to 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. Acquisitions of new product candidates could result in operating difficulties and harm our results of operations. 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. The offering contemplated by our registration statement on Form S-1 filed with the SEC on August 13, 2007 may result in a significant reduction in our available net operating loss carryforwards and tax research credits. Risks Related to Our Common Stock Our common stock may be delisted from The NASDAQ Capital Market, which could negatively impact the price of our common stock and our ability to access the capital markets. The market price of our common stock has been, and is likely to continue to be, highly volatile. 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 management.

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918112--9/13/2007--NEUROBIOLOGICAL_TECHNOLOGIES_INC_/CA/