1157601--3/20/2008--SYNTA_PHARMACEUTICALS_CORP

related topics
{product, candidate, development}
{property, intellectual, protect}
{product, liability, claim}
{stock, price, share}
{product, market, service}
{provision, law, control}
{control, financial, internal}
{cost, operation, labor}
{acquisition, growth, future}
{cost, contract, operation}
{system, service, information}
{cost, regulation, environmental}
{personnel, key, retain}
Risks Related to Our Financial Position and Need for Additional Capital We have incurred significant losses since our inception, and we expect to incur losses for the foreseeable future and may never reach profitability. Our operating history may make it difficult to evaluate the success of our business to date and to assess our future viability. If we fail to obtain the capital necessary to fund our operations, we will be unable to successfully develop and commercialize our lead drug candidates. Raising additional capital may cause dilution to existing stockholders, restrict our operations or require us to relinquish rights. Risks Related to the Development and Regulatory Approval of Our Drug Candidates Our success is largely dependent on the success of our lead drug candidate, elesclomol, as well as our other drug candidates, and we cannot be certain that we will be able to obtain regulatory approval for or successfully commercialize any of these drug candidates. If we do not obtain the required regulatory approval, we will be unable to market and sell our drug candidates. We will need to demonstrate the safety and efficacy of elesclomol in one or more Phase 3 clinical trials in order to obtain FDA approval for use in the treatment of metastatic melanoma, and there can be no assurance that elesclomol will achieve positive results in further clinical testing. Even if our SYMMETRY trial of elesclomol for the treatment of metastatic melanoma achieves the primary endpoint of increasing PFS, the FDA may not find the increase to be clinically meaningful or the FDA might still require us to establish an overall survival benefit prior to registration. If the FDA requires additional clinical data prior to registration, we may need to conduct more, larger or longer Phase 3 clinical trials than currently planned. If the current formulation and method of administering elesclomol is not commercially feasible, we may not be able to commercialize elesclomol without reformulation and conducting additional clinical trials. While we believe elesclomol may have applicability to a broad range of solid tumor cancers, including tumor types other than melanoma, our clinical trials of elesclomol in non-small cell lung cancer and soft tissue sarcoma have shown negative or inconclusive results. Because our drug candidates are in an early stage of development, there is a high risk of failure, and we may never succeed in developing marketable products or generating product revenue. If clinical trials for our drug candidates, including elesclomol and apilimod, are prolonged or delayed, we may be unable to commercialize our drug candidates on a timely basis, which would require us to incur additional costs and delay our receipt of any revenue from potential product sales. Failure to comply with foreign regulatory requirements governing human clinical trials and marketing approval for drugs could prevent us from selling our drug candidates in foreign markets, which may adversely affect our operating results and financial condition. Our drug candidates will remain subject to ongoing regulatory review even if they receive marketing approval, and if we fail to comply with continuing regulations, we could lose these approvals and the sale of any approved commercial products could be suspended. If side effects increase or are identified during the time our drug candidates are in development or after they are approved and on the market, we may be required to perform lengthy additional clinical trials, change the labeling of any such products, or withdraw any such products from the market, any of which would hinder or preclude our ability to generate revenues. While we choose to test our drug candidates in specific clinical indications based in part on our understanding of their mechanisms of action, our understanding may be incorrect or incomplete and, therefore, our drugs may not be effective against the diseases tested in our clinical trials. We deal with hazardous materials and must comply with environmental laws and regulations, which can be expensive and restrict how we do business. Risks Related to Our Dependence on Third Parties We have recently entered into an agreement with GSK relating to the development and commercialization of elesclomol. If this agreement is unsuccessful or terminated by GSK for any reason, our ability to commercialize elesclomol on a timely basis, or at all, could be affected and our business could be materially harmed. 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 clinical trials. We have no manufacturing capacity and depend on third-party manufacturers to produce our clinical trial drug supplies. We are using a single manufacturer for the supply of elesclomol powder-filled vials for the SYMMETRY trial, our global, pivotal Phase 3 clinical trial for the treatment of metastatic melanoma and potentially, for commercial supply, and the failure of this manufacturer to supply sufficient quantities of elesclomol powder-filled vials could have a material adverse effect on our business. We anticipate continued reliance on third-party manufacturers if we are successful in obtaining marketing approval from the FDA and other regulatory agencies for any of our drug candidates. If we do not establish additional collaborations, we may have to alter our development plans. If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our drug candidates, we may be unable to generate product revenue or co-commercialize elesclomol under our arrangement with GSK. Risks Related to Our Intellectual Property If our patent position does not adequately protect our drug candidates or any future products, others could compete against us more directly, which would harm our business. We may be unable to adequately prevent disclosure of trade secrets and other proprietary information. Litigation or other proceedings or third-party claims of intellectual property infringement would require us to spend time and money and could prevent us from developing or commercializing our drug candidates. We may be subject to claims that we have wrongfully hired an employee from a competitor or that we or our employees have wrongfully used or disclosed alleged confidential information or trade secrets of their former employers. Risks Related to the Commercialization of Our Drug Candidates If physicians and patients do not accept our future products or if the markets for indications for which any drug candidate is approved is smaller than expected, we may be unable to generate significant revenue, if any. If the government and third-party payors fail to provide adequate coverage and reimbursement rates for our future products, if any, our revenue and prospects for profitability will be harmed. If a successful product liability claim or series of claims is brought against us for uninsured liabilities or in excess of insured liabilities, we could be forced to pay substantial damage awards. If we inadvertently violate the guidelines pertaining to promotion and advertising of our clinical candidates or approved products, we may be subject to disciplinary action by the FDA's Division of Drug Marketing, Advertising, and Communications or other regulatory bodies. Risks Related to Our Industry We may not be able to keep up with the rapid technological change in the biotechnology and pharmaceutical industries, which could make any future approved products obsolete and reduce our revenue. Our market is subject to intense competition. If we are unable to compete effectively, our drug candidates may be rendered noncompetitive or obsolete. Risks Related to Employee Matters and Managing Growth Our future success depends on our ability to retain our chief executive officer and other key executives and to attract, retain, and motivate qualified personnel. We expect to expand our development, clinical research, and marketing capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations. If we make strategic acquisitions, we will incur a variety of costs and might never realize the anticipated benefits. Risks Related to Our Common Stock Our stock price has been and is likely to continue to be volatile and the market price of our common stock may drop. Insiders have substantial control over us which could delay or prevent a change in corporate control or result in the entrenchment of management and/or the board of directors. Provisions of our charter, bylaws, and Delaware law may make an acquisition of us or a change in our management more difficult. We do not anticipate paying cash dividends, and accordingly, our stockholders must rely on stock appreciation for any return on their investment.

Full 10-K form ▸

related documents
1157601--3/28/2007--SYNTA_PHARMACEUTICALS_CORP
1157601--3/26/2009--SYNTA_PHARMACEUTICALS_CORP
1142576--3/11/2010--OPTIMER_PHARMACEUTICALS_INC
1107332--2/22/2010--DENDREON_CORP
872589--2/26/2009--REGENERON_PHARMACEUTICALS_INC
1322505--12/21/2007--Biodel_Inc
884731--3/16/2006--ARIAD_PHARMACEUTICALS_INC
1340744--3/11/2008--Altus_Pharmaceuticals_Inc.
1001233--3/5/2010--SANGAMO_BIOSCIENCES_INC
1178711--3/17/2008--NOVACEA_INC
1128495--3/15/2007--ANADYS_PHARMACEUTICALS_INC
1208261--3/15/2010--EPICEPT_CORP
722104--3/2/2009--SAVIENT_PHARMACEUTICALS_INC
1180145--3/14/2008--REPLIDYNE_INC
1180145--3/27/2007--REPLIDYNE_INC
1178711--4/2/2007--NOVACEA_INC
1142576--3/12/2009--OPTIMER_PHARMACEUTICALS_INC
1340744--3/11/2009--Altus_Pharmaceuticals_Inc.
1322505--12/11/2008--Biodel_Inc
1310094--12/29/2006--ACCENTIA_BIOPHARMACEUTICALS_INC
1093649--3/4/2009--IDENIX_PHARMACEUTICALS_INC
874015--3/13/2008--ISIS_PHARMACEUTICALS_INC
1212235--3/17/2008--XTENT_INC
1340744--3/12/2007--Altus_Pharmaceuticals_Inc.
1093649--3/14/2008--IDENIX_PHARMACEUTICALS_INC
1333248--3/13/2008--CADENCE_PHARMACEUTICALS_INC
1107332--3/15/2006--DENDREON_CORP
1087432--3/15/2010--INTERMUNE_INC
899923--9/7/2006--MYRIAD_GENETICS_INC
1322505--12/14/2009--Biodel_Inc