Curis, Inc. (NASDAQ:CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today reported its financial results for the second quarter ended June 30, 2010.
"Although we were disappointed to announce during the second quarter of 2010 that the topline results from Genentech and Roche's Phase II clinical trial with the hedgehog pathway inhibitor GDC-0449 in metastatic colorectal cancer indicated that the trial did not meet its primary endpoint, we are encouraged that Genentech is testing GDC-0449 in two additional tumor types, which should provide more information on its potential in cancers where we believe the Hedgehog pathway acts via different mechanisms of action," said Dan Passeri, Curis' President and Chief Executive Officer. "We expect that results will be available from the Phase II advanced ovarian cancer trial in the very near term and that we will communicate the topline results within August. In addition, Roche has indicated that it expects results from the pivotal Phase II clinical trial in advanced basal cell carcinoma during the first half of 2011 and that it plans to initiate a Phase II clinical trial in operable basal cell carcinoma patients during the second half of 2010."
Mr. Passeri continued, "We also have continued to make progress with our other drug candidates, including CUDC-101, for which we recently completed our Phase I dose escalation study, initiated a Phase Ib expansion trial in patients with advanced, refractory head and neck, gastric, breast and liver cancers, and plan to begin a Phase I/II clinical trial in head and neck cancer. Also during the second quarter, our licensee Debiopharm initiated a Phase I clinical trial of Hsp90 inhibitor Debio 0932, and we earned $3 million in July upon Debiopharm's treatment of the fifth patient in this study. Lastly, we continue to progress our preclinical research efforts and anticipate that we will select a new development candidate during the second half of 2010."
For the second quarter of 2010, Curis reported a net loss of $2.1 million, or ($0.03) per share on both a basic and fully diluted share outstanding basis, as compared to a net loss of $4.2 million or ($0.07) per share on both a basic and fully diluted share outstanding basis for the same period in 2009.
Revenues for the second quarter of 2010 were $99,000 as compared to $63,000 for the same period in 2009.
Operating expenses for the second quarter of 2010 were $4.0 million as compared to $4.3 million for the same period in 2009.
- Research and development spending was $2.2 million for the second quarter of 2010 as compared to $2.3 million for the same period in 2009. The decrease is primarily attributable to lower spending on Debio 0932 as a result of licensing this program to Debiopharm in August 2009. All subsequent development costs have been assumed by Debiopharm. Offsetting this decrease, Curis increased spending on other targeted cancer programs.
- General and administrative spending was $1.8 million for the second quarter of 2010 as compared to $2.0 million for the same period in 2009. The decrease in general and administrative expenses was primarily due to non-recurring legal costs incurred during the second quarter of 2009 related to an arbitration proceeding that was settled during the first quarter of 2010.
Other income of $1.8 million for the second quarter of 2010 represents the change in the fair value of a warrant liability established in connection with Curis' January 2010 registered direct offering as a result of a decrease in Curis' stock price from March 31, 2010 to June 30, 2010.
For the six-month period ending June 30, 2010, Curis reported net income of $2.7 million, or $0.04 per basic share outstanding and $0.03 per fully diluted share outstanding, as compared to a net loss of $3.1 million or ($0.05) per share on both a basic and fully diluted share outstanding basis for the same period in 2009.
Revenues for the six months ended June 30, 2010, were $12.7 million as compared to $6.1 million for the same period in 2009.
Operating expenses were $10.9 million for the six months ended June 30, 2010, as compared to $9.3 million for the same period in 2009. Research and development expenses were $4.7 million for the six months ended June 30, 2010, as compared to $5.2 million for the same period in 2009. General and administrative expenses were $6.2 million for the six months ended June 30, 2010, as compared to $4.1 million for the same period in 2009.
Other income of $0.9 million for the six-month period ended June 30, 2010 as compared to $0.2 million for the same period in 2009.
As of June 30, 2010, Curis' cash, cash equivalents and marketable securities totaled $44.9 million, and there were 75.6 million shares of common stock outstanding.
Updated Financial Guidance
As a result of lower than anticipated expenses associated with CUDC-101 and other development candidates, Curis expects that research and development expenses will be between $10 and $13 million. The Company had previously estimated that these expenses would be between $13 and $17 million. As a result of lower than anticipated research and development expenses and a $3 million payment earned under the Company's license agreement with Debiopharm, Curis expects that its 2010 year end cash, cash equivalents and marketable securities will be between $38 to $40 million. The Company had previously estimated that its year end cash, cash equivalents and marketable securities would be between $30 and $35 million.
Recent Developments
CUDC-101 (HDAC/EGFR/Her2 Inhibitor)
-- Initiated expansion of Phase Ib expansion clinical trial