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Curis Reports Fourth Quarter And Year-End 2012 Financial Results

CUDC-427:

  • Principal investigators and Genentech to present full study results from its completed Phase I study in solid tumors or lymphoma at a medical meeting in mid-2013  
  • Curis to initiate clinical studies of CUDC-427 administered in combination with other anti-cancer agents and explore the therapeutic potential of single-agent CUDC-427 in selected population of cancer patients

CUDC-907:

  • Curis to continue enrollment and provide updates on ongoing Phase I study in patients with advanced or refractory lymphomas or multiple myeloma  
  • Curis to evaluate CUDC-907 administered in combination with other anti-cancer agents in solid tumor clinical study

Erivedge:

  • Regulatory approval decisions in advanced BCC in Europe and Australia in the first half of 2013 and decisions in other territories later in 2013  
  • Results of Phase II study in operable nodular BCC expected in first half of 2013  
  • Results from ongoing National Cancer Institute and investigator sponsored clinical studies

Debio 0932:

  • Debiopharm intends to plan the initiation of a Phase I/II clinical trial with Debio 0932 in combination with everolimus in renal cell carcinoma patients  
  • Debiopharm to present Phase Ib clinical study results at a medical meeting in 2013  
  • Debiopharm to continue enrollment in Phase I/II study of Debio 0932 in advanced non-small cell lung cancer

CUDC-101:

  • Curis to continue enrollment in Phase I study in locally advanced head and neck cancer patients  
  • Curis to pursue development of alternate oral formulations

Recent Operational Highlights

  • In February 2013, Curis hired Ali Fattaey, Ph.D. as its President and Chief Operating Officer.  
  • In January 2013, Curis treated the first patient in a Phase I clinical study of CUDC-907 in relapsed or refractory lymphoma or multiple myeloma cancer patients. During the fourth quarter of 2012 and early 2013, Curis received an aggregate of $1.1 million under its agreement with LLS.  
  • In December 2012, Curis closed a $30 million Erivedge royalty-secured debt transaction. The debt is secured with certain future royalties and other royalty-related payments from net sales of Erivedge.   
  • In December 2012, the U.S. Patent and Trademark Office issued a patent covering a genus of compounds that includes Debio 0932, an orally-administered Heat Shock Protein 90 (HSP90) inhibitor, which is being developed by Curis' licensee Debiopharm.  
  • In November 2012, Curis secured the exclusive global development and commercialization rights from Genentech to antagonist of IAP proteins, CUDC-427.  
  • In October 2012, Curis initiated a Phase I clinical study of an oral formulation of CUDC-101. This study was subsequently terminated as sufficient drug exposure was not achieved after dosing the first cohort of patients. Curis is currently pursuing the development of alternative formulations as well as backup candidates, which may be more amenable to oral dosing.

Upcoming Activities

Curis expects to present at the following investor conferences through April 2013:

  • Citi 2013 Global Healthcare Conference on February 25-27, 2013 in New York City  
  • 2013 RBC Capital Markets' Healthcare Conference on February 26-27, 2013 in New York City  
  • Cowen and Company 33rd Annual Health Care Conference on March 4-6, 2013 in Boston, Massachusetts  
  • Roth Capital Partners 25th Annual ROTH Growth Conference on March 18-20, 2013 in Dana Point, California  
  • BioCentury Future Leaders in the Biotech Industry on April 5, 2013 in New York City  
  • 12th Annual Needham Healthcare Conference on April 30 – May 1, 2013 in New York City

Conference Call Information

Daniel Passeri, Chief Executive Officer of Curis, will host a conference call today, February 20, 2013, at 9:00 a.m. EST, to discuss Curis' financial results for the quarter and year ended December 31, 2012, as well as corporate developments, plans and strategies.

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