On August 3, 2017 Curis, Inc. (NASDAQ:CRIS), a biotechnology company focused on the development and commercialization of innovative and effective drug candidates for the treatment of human cancers, reported its financial results for the second quarter ended June 30, 2017 (Press release, Curis, AUG 3, 2017, View Source [SID1234520025]). Schedule your 30 min Free 1stOncology Demo! Curis also reported today data from the interim analysis of the Phase 2 trial of CUDC-907 in patients with MYC-altered DLBCL. Of the 36 evaluable patients with MYC-altered DLBCL in the interim analysis, 7 patients experienced confirmed durable objective responses (19.4% ORR), including 3 with complete responses. In addition, and consistent with the original hypothesis, all 7 responders in the Phase 2 study had MYC-altered disease, while no objective responses were observed in 12 patients with MYC-negative disease status.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"The ability of CUDC-907 treatment to result in durable complete responses, and the continued correlation of this benefit selectively in patients with MYC-altered disease, is encouraging for the continued development of CUDC-907," said Ali Fattaey, President and CEO. "While we believe the results from this Phase 2 trial are insufficient to serve as the basis of a request for accelerated approval of CUDC-907, we are evaluating alternative designs for a separate registration-enabling trial to demonstrate CUDC-907’s benefit for patients with MYC-altered DLBCL."
"The reported response rate is impressive, especially in this population of patients with relapsed/refractory MYC-altered lymphomas who rarely respond to salvage therapies," said Dr. Daniel J. Landsburg, Assistant Professor of Clinical Medicine at the Abramson Cancer Center at the Hospital of the University of Pennsylvania. "I believe this agent warrants continued investigation."
Second Quarter 2017 Financial Results
Curis reported a net loss of $14.1 million, or $0.10 per share, on both a basic and diluted basis for the second quarter of 2017, as compared to a net loss of $11.3 million, or $0.09 per share, on both a basic and diluted basis for the same period in 2016. Curis reported a net loss of $29.8 million, or $0.21 per share, on both a basic and diluted basis for the six months ended June 30, 2017, as compared to a net loss of $20.7 million, or $0.16 per share on both a basic and diluted basis for the same period in 2016.
Revenues for the second quarter of 2017 were $2.1 million, as compared to $1.7 million for the same period in 2016. Revenues for the six months ended June 30, 2017 were $4.2 million, as compared to $3.4 million for the same period in 2016. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.
Operating expenses were $15.2 million for the second quarter of 2017, as compared to $12.4 million for the same period in 2016. Operating expenses for the six months ended June 30, 2017 were $32.4 million, as compared to $22.9 million for the same period in 2016, and comprised the following:
Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.1 million for both the second quarter of 2017 and 2016. Cost of royalty revenues for the six months ended June 30, 2017 and 2016 were $0.2 million for both periods.
Research and Development Expenses. Research and development expenses were $11.3 million for the second quarter of 2017, as compared to $8.8 million for the same period in 2016. The increase was primarily due to increased direct spending related to clinical activities of CUDC-907 and CA-170 and increased employee-related expenses primarily due to additional headcount to support the multiple programs. Research and development expenses were $24.8 million for the six months ended June 30, 2017 as compared to $15.7 million for the same period in 2016.
General and Administrative Expenses. General and administrative expenses were $3.8 million for the second quarter of 2017 as compared to $3.4 million for the same period in 2016. The increase in general and administrative expenses was driven primarily by higher personnel costs and stock-based compensation expense due to increased headcount. General and administrative expenses were $7.4 million for the six months ended June 30, 2017, as compared to $7.1 million for the same period in prior 2016.
Other expense, net was $1.0 million for the second quarter of 2017, as compared to $0.6 million for the same period in 2016. Other expense, net primarily consisted of interest expense related to Curis Royalty’s (a wholly owned subsidiary of Curis) debt obligations. Other expense, net was $1.7 million and $1.2 million for the six months ended June 30, 2017 and 2016, respectively.
As of June 30, 2017, Curis’s cash, cash equivalents, marketable securities and investments totaled $51.0 million and there were approximately 143.9 million shares of common stock outstanding. On a fully-diluted basis, which includes 18.6 million options, there were 162.5 million shares outstanding.
Recent Operational Highlights
Precision oncology (CUDC-907: HDAC / PI3K inhibitor program):
The following summarizes the CUDC-907 Phase 1 trial results and Phase 2 interim analysis:
View Source
Immuno-oncology (CA-170: PD-L1 / VISTA antagonist program; Aurigene collaboration):
In May 2017, Curis presented the CA-170 Phase 1 trials-in-progress poster at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.
Upcoming Activities
Curis expects that it will make presentations at the following conferences through September 2017:
CA-170 poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Conference (Sept. 8-12, 2017) in Madrid.