On August 04, 2016 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, 2016 (Press release, Curis, AUG 4, 2016, View Source [SID:1234514237]).

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"We are pleased that dosing of patients has started in the Phase 1 trial of CA-170, the first oral, small molecule immune checkpoint inhibitor targeting PD-L1 and VISTA pathways from our collaboration with Aurigene," said Ali Fattaey, Ph.D., Curis’s President and CEO. "Additionally, the second immuno-oncology program in our Aurigene collaboration that is focused on oral small molecules that target PD-1 and TIM3 pathways continues to progress well, further supporting our strategy to address inhibitory immune checkpoints with oral small molecules."

Dr. Fattaey continued, "We continue to enroll patients in the Phase 2 trial of CUDC-907 in patients with relapsed/refractory diffuse large B cell lymphoma or DLBCL, to assess its efficacy specifically in patients with MYC—altered DLBCL and remain on track for data in 2017."

Second Quarter 2016 Financial Results

Curis reported a net loss of $11.3 million, or ($0.09) per share on both a basic and diluted basis for the second quarter of 2016, as compared to a net loss of $8.1 million, or ($0.06) per share on both a basic and diluted basis for the same period in 2015. Curis reported a net loss of $20.7 million or ($0.16) per share on both basic and diluted basis for the six months ended June 30, 2016, as compared to a net loss of $40.0 million, or ($0.34) per share on both basic and diluted basis for the same period in 2015. The net loss for the six months ended June 30, 2015 includes a non-cash in-process research and development charge of $24.3 million related to Curis’s license agreement with Aurigene.

Revenues for the second quarter of 2016 were $1.7 million, as compared to $2.1 million for the same period in 2015. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge. Revenues for the six months ended June 30, 2016 were $3.4 million, as compared to $3.7 million for the same period in 2015.

Operating expenses were $12.4 million for the second quarter of 2016, as compared to $9.5 million for the same period in 2015.

Operating expenses for the six months ended June 30, 2016 were $22.9 million, as compared to $42.1 million for the same period in 2015, 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 2016 and 2015. Cost of royalty revenues for the six months ended June 30, 2016 and 2015 were $0.2 million for both periods.

In-Process Research and Development Expense. No in-process research and development expenses were recorded for the six months ended June 30, 2016 as compared to $24.3 million recorded during the same period in 2015 associated with the issuance of 17,120,131 shares of Curis common stock to Aurigene as partial consideration for the rights granted under the terms of the January 2015 collaboration agreement.

Research and Development Expenses. Research and development expenses were $8.8 million for the second quarter of 2016, as compared to $5.9 million for the same period in 2015. The increase was primarily due to increased direct spending related to clinical activities of CUDC-907 and programs under the Aurigene collaboration over the prior year period, including a $3.0 million milestone payment to Aurigene upon the U.S. Food and Drug Administration (FDA) acceptance of the CA-170 IND. Employee-related expenses increased over the prior year period primarily due to additional headcount to support the multiple programs. Research and development expenses were $15.7 million for the six months ended June 30, 2016 as compared to $10.7 million for the same period in 2015.

General and Administrative Expenses. General and administrative expenses remained unchanged at $3.4 million for the second quarter of 2016 as compared the second quarter of 2015. General and administrative expenses were $7.1 million for the six months ended June 30, 2016, as compared to $6.9 million for the same period in prior 2015.

Other expense, net was $0.6 million for the second quarter of 2016, as compared to $0.8 million for the same period in 2015. Other expense, net primarily consisted of $0.7 million and $0.8 million in interest expense for the quarters ended June 30, 2016 and 2015, respectively, related to the loan made by BioPharma-II (an investment fund managed by Pharmakon Advisors) to Curis Royalty (a wholly owned subsidiary of Curis). Other expense, net was $1.2 million and $1.6 million for the six months ended June 30, 2016 and 2015, respectively.

As of June 30, 2016, Curis’s cash, cash equivalents, marketable securities and investments totaled $61.7 million and there were approximately 129.5 million shares of common stock outstanding.

Second Quarter Operational Highlights

Precision oncology (CUDC-907: HDAC / PI3K inhibitor program):

In June 2016, updated data from the Phase 1 trial of CUDC-907 in 75 patients with relapsed/refractory lymphoma or multiple myeloma were presented at the European Hematology Association (EHA) (Free EHA Whitepaper)’s Annual Meeting. The updated assessment from a total of 31 of these patients with relapsed refractory DLBCL showed that among 21 response-evaluable patients with DLBCL, objective responses were reported in 9 patients, including 3 patients with complete responses. Additionally, a retrospective post-hoc analysis showed that among 6 response-evaluable DLBCL patients whose tumors were characterized with MYC alterations, 5 experienced objective responses, including 3 patients with complete responses. All 5 patients with MYC altered disease who experienced objective responses also had alterations in BCL-2, including 2 patients with BCL-2 gene translocations.

In June 2016, Curis presented the CUDC-907 Phase 2 trials-in-progress poster at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The presentation included the Phase 2 study’s design for investigating CUDC-907’s efficacy in patients with relapsed/refractory DLBCL with MYC alterations.
Immuno-oncology (CA-170: PD-L1 / VISTA antagonist program; Aurigene collaboration):

In June 2016, the Company filed an Investigational New Drug (IND) application with the U.S. FDA to initiate the Phase 1 trial of CA-170 for once-daily oral treatment of patients with advanced solid tumors or lymphoma. The FDA accepted the Company’s IND filing during the same month.

In June 2016, the Company initiated dosing of the first patient in the Phase 1 trial of CA-170.
Erivedge (partner: Roche/ Genentech):

In June 2016, Roche presented data from two trials of Erivedge at the ASCO (Free ASCO Whitepaper) Annual Meeting, highlighting that (1) the safety profile of Erivedge continues to be consistent with the previously reported safety profiles, and (2) intermittent dosing schedules may be an option for patients with multiple basal cell carcinomas to derive long term benefit from Erivedge treatment.
Upcoming Activities

Curis expects that it will make presentations at the following conferences through September 2016:

Baird’s Global Healthcare Conference on Sept 8-9, 2016 in New York City