818033--3/15/2010--AP_PHARMA_INC

related topics

{product, candidate, development}

{product, liability, claim}

{stock, price, operating}

{control, financial, internal}

{property, intellectual, protect}

{stock, price, share}

{provision, law, control}

{acquisition, growth, future}

{personnel, key, retain}

{regulation, change, law}

{condition, economic, financial}

{tax, income, asset}

{cost, regulation, environmental}

{competitive, industry, competition}

{customer, product, revenue}

Risks Related To Our Business We have a history of losses, we expect to generate losses in the near future, and we may never achieve or maintain profitability. We are substantially dependent upon the success of our APF530 product candidate. Clinical trial results and the NDA for this product may not lead to regulatory approval. We may not obtain regulatory approval for APF530 or any of our product candidates. Regulatory approval may also be delayed or cancelled or may entail limitations on the indicated uses of a proposed product. Additional capital will be needed to enable us to implement our business plan, and we may be unable to raise capital when needed, which would force us to limit or cease our operations and related product development programs. Raising such capital may have to be accomplished on unfavorable terms, possibly causing dilution to our existing stockholders. The general economic environment in which we operate is experiencing unprecedented weakness and volatility. We depend on our collaborators as a source of capital and to help us complete the process of developing and testing our products. Suspension of our pipeline development program will delay potential realization of value from new products. Clinical trials are expensive and may not result in commercially viable products. Delays in clinical testing could increase our costs and delay our ability to obtain regulatory approval and commercialize our product candidates. We rely on third parties to conduct our clinical trials, and their failure to perform their obligations in a timely and competent manner may delay development and commercialization of our product candidates. We have yet to demonstrate the full commercial viability of our delivery technology, and we cannot be certain that attainment of such a goal can be accomplished. If any products that we or our collaborators may develop do not attain adequate market acceptance by healthcare professionals and patients, our business prospects and results of operations will suffer. We depend on contract manufacturers and collaborators for manufacturing our products; if they do not perform as expected, our revenue and customer relations will suffer. If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any products we may develop, we may be unable to generate product revenue. If we fail to comply with continuing federal, state and foreign regulations, we could lose our approvals to market drugs and our business would be seriously harmed. If we are unable to recruit and retain skilled employees, we may not be able to achieve our objectives. We face intense competition from other companies. Because we, or our collaborators must obtain regulatory approval to market our products in the United States and foreign jurisdictions, we cannot predict whether or when we will be permitted to commercialize our products. If we cannot establish pricing of our product candidates acceptable to the United States or foreign governments, insurance companies, managed care organizations and other payors, or arrange for favorable reimbursement policies, any product sales will be severely hindered. Our business strategy includes the entry into additional collaborative agreements. We may not be able to enter into additional collaborative agreements or may not be able to negotiate commercially acceptable terms for these agreements. If we or our collaborators cannot arrange for adequate third-party reimbursement for our products, our future revenue will suffer. Our inability to obtain specialized materials could slow down our product development process. If we are unable to adequately protect or enforce our intellectual property rights or secure rights to third-party patents, we may lose valuable assets, experience reduced market share or incur costly litigation to protect our rights or our third-party collaborators may choose to terminate their agreements with us. We may infringe on the intellectual property rights of others, and any litigation could force us to stop developing or selling potential products and could be costly, divert management attention and harm our business. We are exposed to risks and increased expenses as a result of laws requiring smaller reporting company filers to evaluate internal controls over financial reporting. Legislative actions, potential new accounting pronouncements and higher insurance costs are likely to impact our future financial position or results of operations. We could be exposed to significant product liability claims that could be time consuming and costly to defend, divert management attention and adversely impact our ability to obtain and maintain insurance coverage. Our use of hazardous materials could subject us to liabilities, fines and sanctions. Earthquake damage to our facilities could delay our research and development efforts and adversely affect our business. 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 price of our common stock has been and may continue to be 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. Further concentration in shareholder ownership could influence strategic actions. Future sales of our common stock may cause our stock price to decline. Future utilization of net operating loss carryforwards may be impaired due to recent changes in ownership.

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818033--3/15/2010--AP_PHARMA_INC_/DE/