1160308--3/18/2010--ADVENTRX_PHARMACEUTICALS

related topics

{product, candidate, development}

{stock, price, share}

{product, liability, claim}

{property, intellectual, protect}

{acquisition, growth, future}

{provision, law, control}

{operation, natural, condition}

{personnel, key, retain}

{control, financial, internal}

{customer, product, revenue}

{cost, operation, labor}

{tax, income, asset}

{stock, price, operating}

{product, market, service}

Our financial resources are limited, we will need to obtain additional funding to pursue our business strategy and we may not be able to obtain such funding on a timely basis or on commercially reasonable terms, if at all. Our ability to raise capital may be limited by applicable laws and regulations. Our ability to raise capital may be limited by contractual restrictions. Raising additional capital may cause dilution to our existing stockholders, require us to relinquish proprietary rights or restrict our operations. We will need to increase the size of our organization, and we may experience difficulties in attracting and retaining qualified personnel and managing growth. We may not be able to manage our business effectively if we are unable to retain key personnel. If we are unable to raise sufficient additional capital, we may be forced to reduce our current and/or planned development and commercialization activities, partner our product candidates or products at inopportune times or pursue less expensive but higher-risk development and commercialization paths, which we have done in the past. The use of our net operating loss carry forwards and research and development tax credits may be limited. If we fail to maintain an effective system of internal control over financial reporting and disclosure controls and procedures, we may not be able to accurately report our financial results. As a result, current and potential investors could lose confidence in our financial reporting, which could harm our business and have an adverse effect on our stock price. Our operations might be interrupted by the occurrence of a natural disaster or other catastrophic event. Risks Related to Drug Development and Commercialization Further testing and/or validation of our product candidates and related manufacturing processes may be required and regulatory approval may be delayed or denied, which would limit or prevent us from marketing our product candidates and significantly impair our ability to generate revenues. We may not achieve our projected development and commercialization goals in the time frames we announce. Delays in the commencement or completion of nonclinical testing, bioequivalence or clinical trials or manufacturing, regulatory or launch activities could result in increased costs to us and delay or limit our ability to generate revenues. Positive results in our nonclinical testing and/or bioequivalence trials do not ensure that future bioequivalence or clinical trials will be successful or that our product candidates will receive the regulatory approvals necessary for their commercialization. We currently have no sales or marketing capability and our failure to develop these and related capabilities internally or contract with third parties to perform these activities successfully could delay and/or limit our ability to generate revenues in the event one or more of our product candidates obtains regulatory approval. If any of our product candidates for which we receive regulatory approval do not achieve broad market acceptance (including as a result of our inability to differentiate our products from competitor products or promote any such differences or as a result of failing to obtain reimbursement rates for our products that make our products competitive from the healthcare provider s perspective), the revenues we generate from their sales will be limited and our business may not be profitable. We do not have manufacturing capabilities and are dependent on single source manufacturers and suppliers for certain of our product candidates and their component materials, and the loss of any of these manufacturers or suppliers, or their failure to provide us with an adequate supply of products or component materials on commercially acceptable terms, or at all, could harm our business. We rely significantly on third parties to conduct our nonclinical testing and bioequivalence and clinical studies and other aspects of our development programs and if those third parties do not satisfactorily perform their contractual obligations or meet anticipated deadlines, the development of our product candidates could be adversely affected. If we receive regulatory approval for one or more of our product candidates, we may face competition from generic products, which could exert downward pressure on the pricing and market share of our products and limit our ability to generate revenues. If we receive regulatory approval for one or more of our product candidates, we may face competition for our products from lower priced products from foreign countries that have placed price controls on pharmaceutical products. Even if we receive regulatory approval for one or more of our product candidates, they may still face future development and regulatory difficulties that could materially and adversely affect our business, financial condition and results of operations and cause our stock price to decline. Even if one or more of our product candidates receive regulatory approval in the U.S., we may never receive approval or commercialize our products outside of the U.S., which would limit our ability to realize the full market potential of our product candidates. Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval or commercialization. Risks Related to Our Intellectual Property Our success will depend on patents and other protection we obtain on our product candidates and proprietary technology. Exclusivity for our emulsion-formulation product candidates may be limited because of the nature of patent protection available for these candidates. If we are sued for infringing the proprietary rights of third parties, it will be costly and time consuming, and an unfavorable outcome would have an adverse effect on our business. RISKS RELATED TO OUR INDUSTRY We expect intense competition in the marketplace for each of our products, if any are approved. We are subject to uncertainty relating to healthcare reform measures and reimbursement policies that, if not favorable to our products, could hinder or prevent our products commercial success. We face potential product liability exposure and, if successful claims are brought against us, we may incur substantial liability for a product or product candidate and may have to limit its commercialization. In the future, we anticipate that we will need to obtain additional or increased product liability insurance coverage and it is uncertain that such increased or additional insurance coverage can be obtained on commercially reasonable terms. RISKS RELATED TO OUR COMMON STOCK We currently are not in compliance with NYSE Amex continued listing standards and are at risk of being delisted from the NYSE Amex equities market. If our common stock were delisted and determined to be a penny stock, a broker-dealer may find it more difficult to trade our common stock and an investor may find it more difficult to acquire or dispose of our common stock in the secondary market. The market price of our common stock historically has been and is likely to continue to be highly volatile. Sales of substantial amounts of our common stock or the perception that such sales may occur could cause the market price of our common stock to drop significantly, even if our business is performing well. Anti-takeover provisions in our charter documents and under Delaware law may make an acquisition of us, which may be beneficial to our stockholders, more difficult, which could depress our stock price. Alternatively, prohibitions on anti-takeover provisions in our charter documents may restrict us from acting in the best interests of our stockholders. Because we do not expect to pay dividends with respect to our common stock in the foreseeable future, you must rely on stock appreciation for any return on your investment.

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1160308--3/18/2010--ADVENTRX_PHARMACEUTICALS_INC