“The third quarter of 2009 was significant for Curis, as we entered into a license agreement with Debiopharm for our novel Hsp90 technologies and announced the publication of highly encouraging Phase I clinical data on GDC-0449, a Hedgehog pathway inhibitor under collaboration with Genentech, in the New England Journal of Medicine,” said
For the third quarter of 2009, Curis reported a net loss of
Revenues for the third quarter of 2009 were
Operating expenses were
- Research and development spending was
$2.3 million for the third quarter of 2009 as compared to$3.0 million for the same period in 2008. The decrease is primarily attributable to lower spending on Curis’ CUDC-305 program as a result of licensing this program to Debiopharm onAugust 5, 2009 , which resulted in all subsequent development costs being assumed by Debiopharm. Offsetting this decrease, Curis increased spending on other preclinical targeted cancer programs as the Company continued to seek to select additional preclinical candidates for future development. - General and administrative spending was
$2.6 million for the third quarter of 2009 as compared to$1.9 million for the same period in 2008. The increase in general and administrative expenses was primarily due to business development efforts to support the Curis’ Heat Shock Protein, or Hsp90, inhibitor technology licensing efforts and legal services associated with various corporate matters. In addition, personnel costs increased for the quarter endedSeptember 30, 2009 as compared to the prior year.
For the nine-month period ending
Revenues for the nine months ended
Operating expenses were
As of
Third Quarter Highlights
-- Exclusive License Agreement with Debiopharm Covering Hsp90 Inhibitor CUDC-305
In
-- Publication of GDC-0449 Phase I Clinical Data in
In
The first article reported data on 33 advanced basal cell carcinoma patients that were treated in the Phase I clinical trial. Of these patients, 18, or 55%, responded to GDC-0449, including 2 complete responses and 16 partial responses. Of the remaining 15 patients, 11 patients had stable disease as a best response and 4 patients had progressive disease. At the time of the data cut-off for the paper, the median time on study and the median duration of response for these patients was 9.8 and 8.8 months, respectively, with 19 patients still on study. The article also summarized safety, pharmacokinetic and pharmacodynamic data for this patient population.
The second paper discussed symptomatic improvement and rapid but transient tumor regression observed in an adult medulloblastoma patient treated with GDC-0449.
Updated 2009 Financial Guidance
Curis expects to end 2009 with cash, cash equivalents and marketable securities of
Curis expects that 2009 research and development expenses will be
Curis has decreased its estimated 2009 research and development expense primarily due to lower than expected costs associated with CUDC-101 in its ongoing Phase I clinical trial and the inclusion in its original projections of Hsp90-related development expenses for all of 2009. Debiopharm assumed all Hsp90 costs subsequent to
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About
Curis is a drug development company that is committed to leveraging its innovative signaling pathway drug technologies to seek to create new medicines for cancer. In expanding its drug development efforts in the field of cancer through its targeted cancer programs, Curis is building upon its previous experiences in targeting signaling pathways for the development of next generation targeted cancer therapies. 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 the Company's statements regarding: the estimated period in which Curis will have cash to meet its operating requirements and its assumptions about factors that may positively affect such period; expectations regarding the Company’s year-end 2009 cash position and 2009 research and development and general and administrative expenses. Forward-looking statements used in this press release may contain the words "believes", "expects", "anticipates", "plans", "seeks", "estimates", "will", "may" 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 the actual results to be materially different from those indicated by such forward-looking statements including, among other things:
- Curis may experience adverse results, delays and/or failures in its internal drug development programs, including with respect to its Phase I clinical trial of CUDC-101, and with respect to its ongoing preclinical studies of its other targeted cancer programs.
- Genentech and Debiopharm may experience adverse results, delays and/or failures in their respective development programs under collaboration with Curis. For example, Genentech may not be able to replicate in later trials any favorable outcomes from earlier trials of GDC-0449, and Debiopharm may not be able to successfully advance Debio 0932 into clinical trials 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 received additional anticipated 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 2009 and beyond.
- Curis faces risks relating to its ability to enter into and maintain planned collaborations for development candidates under its targeted cancer programs, its ability to maintain its current collaborations with Genentech and Debiopharm, and the risk that any such collaborators will not perform adequately.
- Curis also faces other risk factors identified in its Annual Report on Form 10-K for the year ended
December 31, 2008 , its Quarterly Report for the Quarter endedJune 30, 2009 and other filings that it periodically makes with theSecurities and Exchange Commission .
In addition, any forward-looking statements represent the views only as of today and should not be relied upon as representing Curis' views as of any subsequent date. Curis disclaims any intention or obligation to update any of the forward-looking statements after the date of this press release whether as a result of new information, future events or otherwise.
Source:
Curis, Inc.
Michael P. Gray, 617-503-6632
Chief Operating and Chief Financial Officer
mgray@curis.com