1160308--3/15/2007--ADVENTRX_PHARMACEUTICALS_INC

related topics
{product, candidate, development}
{property, intellectual, protect}
{stock, price, operating}
{product, liability, claim}
{stock, price, share}
{provision, law, control}
{regulation, change, law}
{acquisition, growth, future}
{cost, operation, labor}
{personnel, key, retain}
{capital, credit, financial}
{product, market, service}
Further testing of our product candidates will be required and there is no assurance of FDA approval. Our product candidates may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval or commercialization. Even if our product candidates receive regulatory approval, they may still face future development and regulatory difficulties. Even if our product candidates receive regulatory approval in the United States, we may never receive approval or commercialize our products outside of the United States. Positive results in our preclinical testing and clinical trials do not ensure that future clinical trials will be successful or that our product candidates will receive the regulatory approvals necessary for their commercialization. We expect intense competition in the marketplace for CoFactor and in the target markets for our other product candidates. If any of our product candidates for which we receive regulatory approval do not achieve broad market acceptance, the revenues we generate from their sales will be limited. 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 may not achieve our projected development goals in the time frames we announce. Delays in the commencement or completion of preclinical testing or clinical trials could result in increased costs to us and delay or limit our ability to generate revenues. We rely in part on third parties to conduct our clinical trials and other aspects of our research and development programs. We do not have manufacturing capabilities and may not be able to effectively develop manufacturing capabilities or contract for such services from third parties on commercially acceptable terms, or at all. Our success will depend on patents and other protection we and our licensors obtain on our product candidates and proprietary technology. Our market opportunity for CoFactor may be limited by the lack of composition-of-matter patents in territories outside the United States and Canada. We have licensed several of our product candidates from third parties and, if we default on any of our obligations, we could lose rights to our product candidates. The United States government and the University of Southern California retain certain rights in the technologies we have licensed from the University of Southern California. 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. We currently have no sales capability, and limited marketing capability. We will need to increase the size of our organization, and we may experience difficulties in managing growth. We have engaged in and may continue to engage in opportunistic acquisitions of companies and intellectual property, which could negatively affect our business and operations. We may be unable to retain skilled personnel and maintain key relationships. 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. If a trademark infringement action is commenced against us regarding the use of our corporate name, we could be required to pay monetary damages and/or change our name. Changes in laws and regulations that affect the governance of public companies have increased our operating expenses and may continue to do so. Risks Related to Our Common Stock The market price of our common stock 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. Concentration of ownership of our common stock among our existing executive officers, directors and principal stockholders may prevent new investors from influencing significant corporate decisions.

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