On May 3, 2018 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2018 (Press release, Curis, MAY 3, 2018, View Source [SID1234526008]).
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"Curis continues to advance our clinical pipeline, developing therapeutics in precision oncology and applying a small-molecule approach for immune checkpoint inhibition," said Ali Fattaey, Ph.D., Chief Executive Officer of Curis. "We continue to prepare for a pivotal study of fimepinostat, formerly CUDC-907, to bring a much-needed treatment option to patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) with MYC alterations. Our Phase 1 study of CA-4948, currently the only IRAK4 kinase inhibitor in clinical development for cancer, continues to enroll patients with lymphoma. We are also continuing to enroll patients in escalating doses in the Phase 1 clinical study of CA-170, a small-molecule dual inhibitor of PDL1 and VISTA immune checkpoints. Our collaborator, Aurigene, is also enrolling patients at sites in India in a Phase 2 trial of CA-170. We are proud of the depth of our pipeline and encouraged by the potential for the novel treatment mechanisms of our candidate therapeutics to make an impact on patient care in oncology."
First Quarter 2018 Financial Results
Curis reported a net loss of $10.7 million, or $0.07 per share on both a basic and diluted basis for the first quarter of 2018, as compared to a net loss of $15.7 million, or $0.11 per share on both a basic and diluted basis for the same period in 2017.
Revenues for the first quarter of 2018 were $2.5 million, as compared to $2.1 million for the same period in 2017. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.
Operating expenses were $12.4 million for the first quarter of 2018, as compared to $17.2 million for the same period in 2017, 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 first quarter of 2018 and 2017.
Research and Development Expenses. Research and development expenses were $8.3 million for the first quarter of 2018, as compared to $13.5 million for the same period in 2017. The decrease was primarily due to a payment to Aurigene of $3.8 million for an exclusivity option in January 2017, as well as decreased costs related to ongoing clinical activities for CUDC-907 and CA-170.
General and Administrative Expenses. General and administrative expenses were $4.0 million for the first quarter of 2018 as compared to $3.5 million for the same period in 2017. The increase in general and administrative expenses was driven primarily by higher legal, professional and consulting services for the period.
Other expense, net was $0.8 million for the first quarter of 2018, as compared to $0.7 million for the same period in 2017. Other expense, net primarily consisted of interest expense related to Curis Royalty’s (a wholly owned subsidiary of Curis) debt obligations.
As of March 31, 2018, Curis’s cash, cash equivalents, marketable securities and investments totaled $48.5 million and there were approximately 165.6 million shares of common stock outstanding.
Recent Operational Highlights
Precision oncology, fimepinostat (formerly CUDC-907):
Engaged with a companion diagnostic partner to enable selection of DLBCL patients with MYC-alterations
Engaged with commercial API and product manufacturers
Precision oncology, CA-4948 (IRAK4 Kinase Inhibitor; Aurigene collaboration):
Initiated enrollment in a Phase 1 trial of CA-4948 for treatment of patients with lymphoma
Immuno-oncology, CA-170 (PDL1 / VISTA antagonist; Aurigene collaboration):
Initiated twice-daily dosing at increasing doses in the Phase 1 trial of CA-170 in patients with advanced solid tumors or lymphomas
Curis collaborator Aurigene continued enrollment of patients in a Phase 2 clinical study of CA-170 at trial sites in India
Immuno-oncology, CA-327 (PDL1 / TIM3 antagonist; Aurigene collaboration):
Completing IND-enabling studies in preparation for a regulatory filing
Conference Call Information
Curis management will host a conference call today, May 3, 2018, at 8:30 a.m. EDT, to discuss these financial results, as well as provide a corporate update.
To access the live conference call, please dial (877) 870-4263 from the United States or (412) 317-0790 from other locations, shortly before 8:30 a.m. EDT. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.