946644--3/17/2008--HEMISPHERX_BIOPHARMA

related topics

{product, candidate, development}

{stock, price, share}

{product, liability, claim}

{property, intellectual, protect}

{product, market, service}

{acquisition, growth, future}

{cost, regulation, environmental}

{interest, director, officer}

{system, service, information}

{financial, litigation, operation}

{control, financial, internal}

{provision, law, control}

Risks Associated With Our Business No assurance of successful product development Our drug and related technologies are investigational and subject to regulatory approval. If we are unable to obtain regulatory approval, our operations will be significantly affected. Although preliminary in vitro testing indicates that Ampligen enhances the effectiveness of different drug combinations on avian influenza, preliminary testing in the laboratory is not necessarily predictive of successful results in clinical testing or human treatment. We may continue to incur substantial losses and our future profitability is uncertain. We may require additional financing which may not be available. We may not be profitable unless we can protect our patents and/or receive approval for additional pending patents. The patent position of biotechnology and pharmaceutical firms is highly uncertain and involves complex legal and factual questions. There can be no assurance that we will be able to obtain necessary licenses if we cannot enforce patent rights we may hold. In addition, the failure of third parties from whom we currently license certain proprietary information or from whom we may be required to obtain such licenses in the future, to adequately enforce their rights to such proprietary information, could adversely affect the value of such licenses to us. We have limited marketing and sales capability. If we are unable to obtain additional distributors and our current and future distributors do not market our products successfully, we may not generate significant revenues or become profitable. There are no long-term agreements with suppliers of required materials. If we are unable to obtain the required raw materials, we may be required to scale back our operations or stop manufacturing Alferon N Injection and/or Ampligen . There is no assurance that successful manufacture of a drug on a limited scale basis for investigational use will lead to a successful transition to commercial, large-scale production. We have limited manufacturing experience and capacity. We may not be profitable unless we can produce Ampligen or other products in commercial quantities at costs acceptable to us. Rapid technological change may render our products obsolete or non-competitive. Our products may be subject to substantial competition. Possible side effects from the use of Ampligen or Alferon N Injection could adversely affect potential revenues and physician/patient acceptability of our product. We may be subject to product liability claims from the use of Ampligen , Alferon N Injection , or other of our products which could negatively affect our future operations. The loss of services of key personnel including Dr. William A. Carter could hurt our chances for success. Uncertainty of health care reimbursement for our products. There are risks of liabilities associated with handling and disposing of hazardous materials. Risks Associated With an Investment in Our Common Stock The market price of our stock may be adversely affected by market volatility. Our stock price may be adversely affected if a significant amount of shares are sold in the public market. The sale of our common stock to Fusion Capital may cause dilution and the sale of the shares of common stock acquired by Fusion Capital and other shares registered for selling stockholders could cause the price of our common stock to decline. Provisions of our Certificate of Incorporation and Delaware law could defer a change of our management which could discourage or delay offers to acquire us. Special Note Regarding Forward Looking Statements

Full 10-K form ▸

946644--3/17/2008--HEMISPHERX_BIOPHARMA_INC