On May 4, 2023 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its business update and financial results for the first quarter ended March 31, 2023 (Press release, Curis, MAY 4, 2023, View Source [SID1234631026]).
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"I am pleased with our progress in the TakeAim leukemia study. We enrolled the additional patients requested by FDA ahead of schedule in the first quarter – which is indicative of both the clear unmet need in leukemia and the excitement among the clinical community for this novel agent. We are on track to collect data from these patients in the second quarter and discuss these data with the FDA in the third quarter of this year. I am also pleased to announce the expansion of the Curis Executive Team with the addition of Jonathan Zung, Ph.D. as our Chief Development Officer. Dr. Zung is a well-respected leader in the industry and brings a wealth of experience from senior roles across the industry, most recently at Evelo. We look forward to his contributions toward our mission at Curis," said James Dentzer, President and CEO of Curis.
"I am excited to be joining the Curis team during this critical time, as the company advances its first-in-class IRAK4 inhibitor, emavusertib. In biotech, it is rare to find a novel target with such broad therapeutic potential in that exciting period between the initial demonstration of clear single agent activity and the final stage of clinical development. I look forward to working with the Curis team on the clinical development of emavusertib and helping to establish it as a cornerstone therapy in hematologic malignancies," said Dr. Zung.
First Quarter 2023 and Recent Operational Highlights
Appointed new CDO
Dr. Zung was appointed as Chief Development Officer of Curis on May 1, 2023. Prior to joining Curis, he served as CDO of Evelo Biosciences, where he was responsible for the operational design and execution of Evelo’s clinical programs. Dr. Zung held previous leadership roles at WCG, Covance, UCB, Bristol Myers Squibb, and Pfizer. He also serves on the advisory board of Saama Technologies. He received his Ph.D. in analytical chemistry from Emory University.
Upcoming Milestones
Curis completed the enrollment of 9 additional patients at the 200mg BID dose level requested by FDA, is collecting data on those patients in the second quarter, and expects to discuss those data with FDA in the third quarter of 2023. Discussions with the FDA are expected to determine the recommended Phase 2 dose and resolution of the partial clinical hold on emavusertib development in leukemia.
First Quarter 2023 Financial Results
For the first quarter of 2023, Curis reported a net loss of $11.6 million or $0.12 per share on both a basic and diluted basis as compared to $16.1 million or $0.18 per share on both a basic and diluted basis, for the same period in 2022.
Revenues for the first quarter of 2023 were $2.3 million as compared to $2.1 million for the same period in 2022. Revenues for both periods consist of royalty revenues from Genentech’s and Roche’s sales of Erivedge.
Research and development expenses were $9.1 million for the first quarter of 2023, as compared to $11.4 million for the same period in 2022. The decrease is primarily attributable to the timing of manufacturing costs and lower employee related costs due to a reduction in headcount.
General and administrative expenses were $4.8 million for the first quarter of 2023, as compared to $5.7 million for the same period in 2022. The decrease was mainly attributable to lower employee related costs due to a reduction in headcount.
Other income, net was $0.1 million for the first quarter of 2023, as compared to other expense, net of $1.0 million for the same period in 2022. Other income (expense), net primarily consisted of interest income partially offset by expense related to future royalty payments.
As of March 31, 2023, Curis’s cash, cash equivalents and investments totaled $71.8 million, and the Company had approximately 96.6 million shares of common stock outstanding. Curis expects its existing cash, cash equivalents and investments should enable it to maintain its planned operations into 2025.
Conference Call Information
Curis management will host a conference call today, May 4, 2023, at 4:30 p.m. ET, to discuss the business update and these financial results.
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. ET. The conference call can also be accessed on the Curis website in the Investors section.