1260990--3/3/2009--GTX_INC

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{stock, price, operating}

{personnel, key, retain}

{provision, law, control}

{control, financial, internal}

{acquisition, growth, future}

Risks Related to Our Financial Results and Need for Additional Financing We have incurred losses since inception and anticipate that we will incur continued losses for the foreseeable future. We will need substantial additional funding and may be unable to raise capital when needed, which would force us to delay, reduce or eliminate our product development programs or commercialization efforts. Risks Related to Development of Product Candidates We will not be able to commercialize our product candidates if our preclinical studies do not produce successful results or if our or our collaborators clinical trials do not demonstrate safety and efficacy in humans. If we or our collaborators observe serious or other adverse events during the time our product candidates are in development or after our products are approved and on the market, we or our collaborators may be required to perform lengthy additional clinical trials, may be denied regulatory approval of such products, may be forced to change the labeling of such products or may be required to withdraw any such products from the market, any of which would hinder or preclude our ability to generate revenues. Risks Related to Our Dependence on Third Parties If third parties do not manufacture our product candidates in sufficient quantities, in the required timeframe, and at an acceptable cost, clinical development and commercialization of our product candidates would be delayed. Use of third-party manufacturers may increase the risk that we will not have adequate supplies of our product candidates. We may not realize the anticipated benefits from our collaborative arrangements with Ipsen and Merck. If third parties on whom we rely do not perform as contractually required or expected, we may not be able to obtain regulatory approval for or to commercialize our product candidates. Risks Related to Our Intellectual Property Our license agreement with Orion excludes the use of toremifene in humans to treat breast cancer outside the United States and may limit our ability to market toremifene for human uses outside the United States. If some or all of our, or our licensors , patents expire or are invalidated or are found to be unenforceable, or if some or all of our patent applications do not result in issued patents or result in patents with narrow or unenforceable claims, or if we are prevented from asserting that the claims of an issued patent cover a product of a third party, we may be subject to competition from third parties with products with the same active pharmaceutical ingredients as our product candidates. If we lose our licenses from Orion and UTRF, we may be unable to continue our business. Off-label sale or use of toremifene products could decrease sales of toremifene 80 mg and toremifene 20 mg tablets if approved for commercial sale and could lead to pricing pressure if such products become available at competitive prices and in dosages that are appropriate for the indications for which we and Ipsen are developing toremifene. If we infringe intellectual property rights of third parties, it may increase our costs or prevent us from being able to commercialize our product candidates. Risks Related to Regulatory Approval of Our Product Candidates If we or our collaborators are not able to obtain required regulatory approvals, we or our collaborators will not be able to commercialize our product candidates, and our ability to generate revenue will be materially impaired. The commercial success of any products that we and/or our collaborators may develop, including our toremifene products, will depend upon the market and the degree of market acceptance among physicians, patients, healthcare payors and the medical community. Our only marketed product generating revenue is FARESTON , which is subject to a number of risks. These risks may cause sales of FARESTON If we are unable to expand our sales and marketing capabilities or establish and maintain agreements with third parties to market and sell our product candidates, we may be unable to generate product revenue from such candidates. If we or our collaborators are unable to obtain adequate coverage and reimbursement from third-party payors for products we sell at acceptable prices, our revenues and prospects for profitability will suffer. If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of any products that we may develop. If our competitors are better able to develop and market products than any products that we and/or our collaborators may develop, our commercial opportunity will be reduced or eliminated. Risks Related to Employees and Growth If we fail to attract and keep senior management and key scientific personnel, we may be unable to successfully develop or commercialize our product candidates. We will need to hire additional employees in order to continue our clinical trials and commercialize our product candidates. Any inability to manage future growth could harm our ability to commercialize our product candidates, increase our costs and adversely impact our ability to compete effectively. Risks Related to Our Common Stock Market volatility may cause our stock price and the value of your investment to decline. Our executive officers, directors and largest stockholders have the ability to control all matters submitted to stockholders for approval. Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.

Full 10-K form ▸

1260990--3/3/2009--GTX_INC_/DE/