On May 14, 2019 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2019 (Press release, Curis, MAY 14, 2019, View Source [SID1234536294]).
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"2019 has been a transformational year for Curis as we demonstrate the results of our heightened focus on clinical execution. We are currently on track or ahead of schedule in the execution of all three of our clinical trials," said James Dentzer, President and Chief Executive Officer of Curis. "We look forward to discussing clinical data from all three trials later this year: this summer for CA-4948 and later in the second half for fimepinostat and CA-170."
"Furthermore, with this quarter’s agreement with Oberland Capital, for $65 million upfront and up to $70.7 million in additional milestones, we secured the financial flexibility needed to ensure we can continue to move forward aggressively in our clinical execution of all three programs," he concluded.
First Quarter 2019 Financial Results
Curis reported a net loss of $9.9 million, or $0.30 per share on both a basic and diluted basis for the first quarter of 2019, as compared to a net loss of $10.7 million, or $0.33 per share on both a basic and diluted basis for the same period in 2018.
Revenues for the first quarter of 2019 were $1.8 million, as compared to $2.5 million for the same period in 2018. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.
Operating expenses were $7.3 million for the first quarter of 2019, as compared to $12.4 million for the same period in 2018, 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 2019 and 2018.
Research and Development Expenses. Research and development expenses were $4.1 million for the first quarter of 2019 as compared to $8.3 million for the same period in 2018. The decrease was primarily due to decreased costs related to ongoing clinical and manufacturing activities for fimepinostat and CA-170. Employee-related expenses decreased from the prior quarter primarily due to a reduction in headcount that occurred in the fourth quarter of 2018. These changes reflect our shift in focus toward clinical development, while down-sizing the in-house discovery research organization. We have also focused the CA-170 program toward the VISTA-expressing mesothelioma indication, which allowed substantial reduction in the number of sites and regions required.
General and Administrative Expenses. General and administrative expenses were $3.1 million for the first quarter of 2019 as compared to $4.0 million for the same period in 2018. The decrease in general and administrative expenses was driven primarily by lower personnel, legal, and stock-based compensation for the period.
Other expense, net was $4.3 million for the first quarter of 2019, as compared to $0.8 million for the same period in 2018. Other expense, net primarily consisted of the loss on extinguishment of $3.5 million and interest expense of $0.8 million related to Curis Royalty’s (a wholly owned subsidiary of Curis) debt obligations.
As of March 31, 2019, Curis’s cash, cash equivalents and investments totaled $42.8 million and there were approximately 33.2 million shares of common stock outstanding.
Recent Operational Highlights
Precision oncology, fimepinostat (HDAC/PI3K inhibitor):
Curis is initiating a study of fimepinostat (a MYC suppressor) with venetoclax (a BCL-2 inhibitor) combination regimen in diffuse large B-cell lymphoma (DLBCL), including patients with Double-Hit/Double-Expressor Lymphoma. In preclinical models, fimepinostat administered in combination with venetoclax resulted in an enhanced benefit relative to each agent alone.
Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):
In April 2019, Curis advanced to the 200mg BID cohort in the CA-4948 study for treatment of patients with non-Hodgkin lymphoma, including those with MYD88 alterations.
Immuno-oncology, CA-170 (VISTA / PDL1 antagonist; Aurigene collaboration):
In January 2019, Curis dosed the first mesothelioma patient in its ongoing Phase 1 CA-170 trial following evidence supporting high levels of VISTA expression in mesothelioma tumor samples. Recent publications have identified VISTA as a possible resistance mechanism to treatment with anti-PD1 antibodies in several cancer indications.
In May 2019, Curis announced completion of its target enrollment of mesothelioma patients in the ongoing Phase 1 CA-170 trial.
First Quarter 2019 and Recent Corporate Highlights
In March 2019, Curis announced that it sold a portion of its Erivedge royalties to Oberland Capital for up to $135.7 million, including $65 million upfront.
2019 Data Catalysts
For the remainder of the year, Curis expects to:
Report initial data on the combination of fimepinostat and venetoclax regimen in patients with R/R DLBCL, including patients with DH/DE Lymphoma, in the second half of 2019.
Report initial efficacy data from its CA-4948 dose escalation study in patients with NHL in mid-year 2019.
Report initial efficacy data from its CA-170 Phase 1 trial in patients with mesothelioma (high VISTA expressors) in the second half of 2019.
Conference Call Information
Curis management will host a conference call today, May 14, 2019, at 4:30 p.m. EDT, to discuss these financial results, as well as provide a corporate update.
To access the live conference call, please dial 1-888-346-6389 from the United States or 1-412 317-5252 from other locations, shortly before 4:30 p.m. EDT. The conference call can also be accessed on the Curis website at www.curis.com in the Investors section.