1010086--3/6/2009--SIGA_TECHNOLOGIES

related topics

{product, candidate, development}

{regulation, government, change}

{property, intellectual, protect}

{product, liability, claim}

{stock, price, share}

{acquisition, growth, future}

{provision, law, control}

{control, financial, internal}

{cost, regulation, environmental}

{competitive, industry, competition}

{cost, operation, labor}

Risks Related to Our Financial Position and Need for Additional Financing We have incurred operating losses since our inception and expect to incur net losses and negative cash flow for the foreseeable future. Our business will suffer if we are unable to raise additional equity funding. Risks Related to Our Common Stock Our stock price is, and we expect it to remain, volatile, which could limit investors ability to sell stock at a profit. The future issuance of preferred stock may adversely affect the rights of the holders of our common stock. Concentration of ownership of our capital stock could delay or prevent change of control. Risks Related to Our Dependence on U.S. Government Contracts and Grants Most of our immediately foreseeable future revenues are contingent upon grants and contracts from the United States government and collaborative and license agreements and we may not achieve sufficient revenues from these agreements to attain profitability. Risks Related to Product Development Our business depends significantly on our success in completing development of and commercializing drug candidates that are still under development. If we are unable to commercialize these drug candidates, or experience significant delays in doing so, our business will be materially harmed. We will not be able to commercialize our drug candidates if our preclinical development efforts are not successful, our clinical trials do not demonstrate safety or our clinical trials or animal studies do not demonstrate efficacy. We are in various stages of product development and there can be no assurance of successful commercialization. Because we must obtain regulatory clearance to test and market our products in the United States, we cannot predict whether or when we will be permitted to commercialize our products. The biopharmaceutical market in which we compete and will compete is highly competitive. Our potential products may not be acceptable in the market or eligible for third-party reimbursement resulting in a negative impact on our future financial results. If our products harm people, we may experience product liability claims that may not be covered by insurance. We may be required to perform additional clinical trials or change the labeling of our products if we or others identify side effects after our products are on the market, which could harm sales of the affected products. Healthcare reform and controls on healthcare spending may limit the price we charge for any products and the amounts thereof that we can sell. Risks Related to Manufacturing and Manufacturing Facilities Our drug candidates are complex to manufacture, especially on a large scale commercial basis, which could cause us to delay product launches or experience shortages of products. If third parties do not manufacture our drug candidates or products in sufficient quantities and at an acceptable cost or in compliance with regulatory requirements and specifications, the development and commercialization of our drug candidates could be delayed, prevented or impaired. Our activities involve hazardous materials and may subject us to environmental regulatory liabilities. Risks Related to Sales of Biodefense Products to the U.S. Government Our business could be adversely affected by a negative audit by the U.S. government. Laws and regulations affecting government contracts might make it more costly and difficult for us to successfully conduct our business. Risks Related to Regulatory Approvals If we are not able to obtain required regulatory approvals, we will not be able to commercialize our drug candidates, and our ability to generate revenue will be materially impaired. Failure to obtain regulatory approval in international jurisdictions could prevent us from marketing our products abroad. Risks Related to Our Dependence on Third Parties If third parties on whom we rely for clinical trials do not perform as contractually required or as we expect, we may not be able to obtain regulatory approval for or commercialize our drug candidates and our business may suffer. Risks Related to Our Intellectual Property Our ability to compete may decrease if we do not adequately protect our intellectual property rights. If our technologies or those of our collaborators are alleged or found to infringe the patents or proprietary rights of others, we may be sued or have to license those rights from others on unfavorable terms. We may have difficulty managing our growth.

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1010086--3/6/2009--SIGA_TECHNOLOGIES_INC