1125001--3/27/2008--IOMAI

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{provision, law, control}

{stock, price, operating}

{cost, contract, operation}

{cost, regulation, environmental}

{financial, litigation, operation}

{regulation, change, law}

{control, financial, internal}

{personnel, key, retain}

{stock, price, share}

{regulation, government, change}

{capital, credit, financial}

We will need additional funding, and we cannot guarantee that we will find adequate sources of capital in the future. We will need to demonstrate the safety and efficacy of our needle-free travelers diarrhea vaccine in one or more Phase 3 clinical trials in order to obtain approval by the FDA and other regulatory authorities, and there can be no assurance that our needle-free travelers diarrhea vaccine will achieve positive results in further clinical testing. The success of some programs may depend on licensing biologics from, and entering into collaboration arrangements with, third parties. We cannot be certain that our licensing or collaboration efforts will succeed or that we will realize any revenue from them. We may not be able to manufacture our product candidates in commercial quantities, which would prevent us from initiating Phase 3 trials and commercializing our product candidates. Our IS patch for pandemic flu program relies on government health organizations for funding clinical development and for ultimately procuring the product, if approved. U.S. government agencies have special contracting requirements, which create additional risks. Our technology is unproven and presents challenges for our product development efforts. We rely on third parties to conduct our clinical trials, and those third-parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such trials. We rely on third parties to provide us with materials necessary to manufacture our product candidates that may not be available on commercially reasonable terms, or at all, which may delay the development, regulatory approval and commercialization of our product candidates. We rely on a limited number of manufacturers for our skin preparation systems, and our business will be seriously harmed if these manufacturers are not able to satisfy our demand and alternative sources are not available. The skin preparation systems used in connection with our product candidates may make our products less attractive to consumers. As part of our product development efforts, we may make significant changes to our product candidates. These changes may not yield the benefits that we expect. We may be required to conduct clinical trials of our IS patch with flu vaccines developed by different manufacturers, which may lead to added cost and delay in approval and commercialization of our IS patch. None of our product candidates has been approved for commercial sale, and we may never receive such approval. Federal regulatory reforms may create additional burdens that would cause us to incur additional costs and may adversely affect our ability to commercialize our products. If physicians and patients do not accept our products, we may be unable to generate significant revenue. Our license to use TCI technology from The Walter Reed Army Institute of Research, or WRAIR, is critical to our success. Under some circumstances, WRAIR may modify or terminate our license or sublicense the TCI technology to third parties which could adversely affect our business. If we are unable to protect our intellectual property, we may not be able to operate our business profitably. If we are unable to protect the confidentiality of our proprietary information and know-how, the value of our technology and products could be adversely affected. If the use of our technology conflicts with the intellectual property rights of third parties, we may incur substantial liabilities, and we may be unable to commercialize products based on this technology in a profitable manner, if at all. We may be involved in lawsuits to protect or enforce our patents or the patents of our collaborators or licensors, which could be expensive and time consuming. We depend on our key personnel, the loss of whom may adversely affect our operations. If we fail to attract and retain the talent required for our business, our business will be materially harmed. Our competitors may have superior products, manufacturing capability or marketing expertise. Our ability to generate revenues will be diminished if we fail to obtain acceptable prices or an adequate level of reimbursement for our products. We have no experience in sales, marketing and distribution and will depend on the sales and marketing efforts of third parties. Our business exposes us to potential product liability claims. We deal with hazardous materials that may cause injury to others and are regulated by environmental laws that may impose significant costs and restrictions on our business. Until 2006, we operated as a private company and as a result, we have limited experience attempting to comply with public company obligations. Attempting to comply with these requirements will increase our costs and require additional management resources, and we still may fail to comply. If we fail to maintain an effective system of internal control over financial reporting, we may not be able to accurately report our financial results or prevent fraud. As a result, stockholders could lose confidence in our financial and other public reporting, which would harm our business and the trading price of our common stock. We expect that our stock price will fluctuate significantly, which may adversely affect holders of our stock and our ability to raise capital. If the price and volume of our common stock experience extreme fluctuations, then we could face costly litigation. Our directors and management exercise significant control over our company. We may not achieve our projected development goals in the time frames we announce and expect. Provisions of Delaware law or our charter documents could delay or prevent an acquisition of our company, even if the acquisition would be beneficial to our stockholders, and could make it more difficult for you to change management.

Full 10-K form ▸

1125001--3/27/2008--IOMAI_CORP