707511--3/28/2008--REGENERX_BIOPHARMACEUTICALS

related topics

{product, candidate, development}

{stock, price, share}

{property, intellectual, protect}

{product, liability, claim}

{personnel, key, retain}

{regulation, government, change}

{stock, price, operating}

{cost, regulation, environmental}

{control, financial, internal}

{condition, economic, financial}

{provision, law, control}

{operation, international, foreign}

{competitive, industry, competition}

{acquisition, growth, future}

Risks Related to Our Business We have incurred losses since inception and expect to incur significant losses in the foreseeable future and may never become profitable. We will need substantial additional capital to develop our and for our future operations. If we are unable to obtain such funds when needed, we may have to delay, scale back or terminate our product development efforts or our business. Our business prospects are difficult to evaluate because we are developing complex and novel medical We may not successfully establish and maintain development and testing relationships with third parties, which could adversely affect our ability to develop our product candidates. We are subject to intense government regulation and we may not receive regulatory approvals for our new drug candidates. We may not be able to enter into strategic relationships with third parties related to the development and commercialization of our product candidates Mauro Bove, a member of our Board, is also a director and officer of Sigma-Tau, our largest stockholder, which could give rise to a conflict of interest involving Mr. Bove. are heavily reliant on our license from the National Institutes of Health and may be unable to maintain our license. All of our drug candidates are based on a single compound that has yet to be proven effective. We have no manufacturing or formulation capabilities and are dependent upon third-party suppliers to provide us with our product candidates. If these suppliers do not manufacture our product candidates in sufficient quantities, at acceptable quality levels and at acceptable cost and if we are unable to identify suitable replacement suppliers, our clinical development efforts could be delayed, prevented or impaired. If any of our key executives discontinue their services with us, our efforts to develop our business may be delayed. We are subject to intense competition from companies with greater resources and more mature products. We face the risk of product liability claims, which could adversely affect our business and financial condition. Governmental and third-party payers may subject any we develop to sales and pharmaceutical pricing controls that could limit our product revenues and delay profitability. Clinical trials could be delayed or fail to show efficacy, resulting in additional cost or failure to commercialize our technology platform. We have no marketing experience, sales force or distribution capabilities. If our are approved, and we are unable to recruit key personnel to perform these functions, we may not be able to commercialize them successfully. Even if approved for marketing, our technologies and product candidates are relatively novel and unproven and they may fail to gain market acceptance. Our technologies and product candidates may have unacceptable side effects that could delay or prevent product approval. Our suppliers use hazardous and biological materials in our business. Any claims relating to improper handling, storage or disposal of these materials could be time consuming and costly , and we are not insured against such claims To the extent we enter markets outside the United States our business will be subject to political, economic, legal and social risks in those markets, which could adversely affect our business. We may not be able to obtain orphan drug exclusivity for our product candidates. If our competitors are able to obtain orphan drug exclusivity for a product that is competitive with one or more of our product candidates and we cannot show that our product candidate is clinically superior, we may not be able to have competing products approved by the applicable regulatory authority for a significant period of time. Risks Related To Our Intellectual Property If we are not able to maintain adequate patent protection for our and product candidates, we may be unable to prevent our competitors from using our technology or technology that we license. Changes to U.S. patent laws could materially reduce any value our patent portfolio may have. We may not have adequate protection for our unpatented proprietary information, which could adversely affect our competitive position. We may be subject to claims that we or our employees have wrongfully used or disclosed alleged trade secrets of former employers. Risks Related To Our Securities Our common stock price is volatile, our stock is highly illiquid, and any investment in our stock could decline substantially in value. We have never paid dividends on our common stock. Our principal stockholders have significant voting power and may take actions that may not be in the best interests of our other stockholders. A sale of a substantial number of shares of our common stock may cause the price of our common stock to decline. The exercise of options and warrants and other issuances of shares of common stock or securities convertible into common stock will dilute your interest. Our certificate of incorporation, our rights agreement and Delaware law contain provisions that could discourage a takeover, even if such a transaction would be in your best interests.

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707511--3/28/2008--REGENERX_BIOPHARMACEUTICALS_INC