1099215--7/31/2007--PROTALEX

related topics

{product, candidate, development}

{stock, price, share}

{property, intellectual, protect}

{stock, price, operating}

{product, liability, claim}

{competitive, industry, competition}

{product, market, service}

{control, financial, internal}

{personnel, key, retain}

{financial, litigation, operation}

Risks Related to Our Business We have a history of significant losses, and we may never achieve or sustain profitability. If we fail to obtain regulatory approvals for PRTX-100 or any other drug we develop, we will not be able to generate revenues from the commercialization or sale of those drugs. If we are unable to enroll enough patients to complete our clinical trials, regulatory agencies may delay their review of, or reject our applications, which may result in increased costs and harm our ability to develop products. Our products, if approved, may fail to achieve market acceptance. If we cannot raise additional capital on acceptable terms, we will be unable to complete planned clinical trials, obtain regulatory approvals or commercialize our product candidate. If we are unable to obtain, protect, and maintain our proprietary rights in intellectual property, we may not be able to compete effectively or operate profitably. If other companies claim that we infringe their proprietary technology, we may incur liability for damages or be forced to stop our development and commercialization efforts. We may become involved in lawsuits to protect or enforce our patents that would be expensive and time consuming. If third-party manufacturers of our products fail to devote sufficient time and resources to our concerns, or if their performance is substandard, our clinical trials and product introductions may be delayed and our costs may rise. We may not be able to manufacture our products in commercial quantities, which would prevent us from marketing our products. We have no experience selling, marketing or distributing our products and no internal capability to do so. Competition in the pharmaceutical industry is intense; if we fail to compete effectively, our financial results will suffer. If we are unable to retain key personnel and hire additional qualified scientific, sales and marketing, and other personnel, we may not be able to achieve our goals. Risks Relating to Our Industry Even if we obtain marketing approval, PRTX-100 will be subject to ongoing regulatory review. Market acceptance of PRTX-100 will be limited if users are unable to obtain adequate reimbursement from third-party payors. We may be required to defend lawsuits or pay damages in connection with the alleged or actual harm caused by our products. Rapid technological change could make our products obsolete Risks Related to Our Common Stock Our common stock has experienced in the past, and may experience in the future, significant price volatility, which substantially increases the risk of loss to persons owning our common stock. We may be the subject of securities class action litigation due to future stock price volatility. Future sales of common stock by our existing stockholders may cause our stock price to fall. We have never paid dividends on our capital stock, and we do not anticipate paying any cash dividends in the foreseeable future. Our common stock is quoted on the OTC Bulletin Board which may have an unfavorable impact on our stock price and liquidity

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1099215--7/31/2007--PROTALEX_INC