About Curis, Inc.Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new targeted small molecule drug candidates for cancer. Curis is building upon its previous experiences in targeting signaling pathways, including in the Hedgehog pathway, in its effort to develop proprietary targeted cancer programs. For more information, visit Curis' website at www.curis.com. Curis Cautionary Statement: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding the potential benefit of CUDC-101 in treating locally advanced head and neck cancers and other cancers, Curis’ plans and expectations for the continued development of CUDC-101, including with respect to future studies in head and neck cancer, and the potential of CUDC-101 to effectively and therapeutically attack and disrupt cancer pathway networks . Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates", "assumes", "will", "may," “could” or similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, uncertainties, assumptions and other important factors that may cause actual results to be materially different from those indicated by such forward-looking statements including, among other things:
- CUDC-101 is a novel compound whose potential benefit as a therapeutic cancer drug is heretofore unproven. Curis may experience adverse results, delays and/or failures in its ongoing and planned clinical trials of CUDC-101. Moreover, favorable results of preclinical studies and early clinical trials of CUDC-101 may not be predictive of results that may be obtained in later trials.
- Genentech and Roche may experience adverse results, delays and/or failures in their development program under collaboration with Curis. For example, Genentech and Roche may: experience adverse or inconclusive results in their clinical trials of vismodegib, fail to achieve any development and commercialization timelines that they publicly announce with respect to vismodegib; or otherwise fail to meet applicable regulatory standards for approval of vismodegib in one or more indications.
- Curis' collaborator Debiopharm may experience adverse results, delays and/or failures in its development program under collaboration with Curis. For example, Debiopharm may not be able to successfully advance Debio 0932 through its ongoing Phase I clinical trial as planned.
- Curis may experience difficulties or delays in obtaining or maintaining required regulatory approvals for products under development both internally and through its collaborations.
- Curis may not be able to obtain or maintain the intellectual property protection necessary for the development and commercialization of drug candidates based on its technologies.
- Curis may not be able to obtain the substantial additional funding required to conduct research and development of its drug candidates.
- Curis may experience unplanned cash requirements, and may not receive additional anticipated milestone payments under its collaborations, any of which could shorten the estimated period in which Curis will have cash to fund its operations and which could also adversely affect Curis' estimated operating expenses for 2011 and beyond.
- Curis faces risks relating to its ability to enter into and maintain collaborations for development candidates under its network-targeted cancer programs, its ability to maintain its current collaborations with Genentech/Roche and Debiopharm, and the risk that any such collaborators will not perform adequately or may terminate such collaborations on short notice and/or for circumstances outside of Curis’ control.
- Curis also faces other important risks with respect to its business, operations, financial condition and future prospects generally, that are discussed in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2011 and other filings that it periodically makes with the Securities and Exchange Commission.