On May 6, 2025 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule IRAK4 inhibitor, reported its business update and financial results for the first quarter ended March 31, 2025 (Press release, Curis, MAY 6, 2025, View Source [SID1234652571]).

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"I am pleased to announce the expansion of the Curis Executive Team with the addition of Dr. Ahmed Hamdy as our Chief Medical Officer. Dr. Hamdy is a well-known and respected leader in the industry and brings a wealth of experience as CMO of Pharmacyclics, CMO and CEO of Acerta, and CEO of Vincerx. We look forward to his contributions to Curis."

"Also, as we announced at the end of March, we have made exciting progress with both the FDA and EMA on the potential for accelerated approval of emavusertib in R/R PCNSL. We are currently enrolling patients in the TakeAim Lymphoma study to enable accelerated approval filings in both the EU and US. We expect to provide additional data for both BTK-naïve and BTK-experienced patients from the TakeAim Lymphoma study at ASH (Free ASH Whitepaper) later this year," said James Dentzer, President and CEO of Curis.

"Curis has made great progress developing IRAK4 as a novel oncology target and emavusertib as the first-in-class IRAK4 inhibitor. I am excited to be joining the Curis team at this critical time of advancement toward regulatory filing in PCNSL in the US and EU and expansion beyond PCNSL into additional indications in NHL, AML, and solid tumors. Given my experience developing both ibrutinib and acalabrutinib, I have a special appreciation for the potential of emavusertib in combination with BTK inhibition in NHL, and the importance of targeting IRAK4 and the toll-like receptor pathway in NHL, AML and solid tumors. I look forward to working with the Curis Team to bring this novel therapy to patients," said Dr. Hamdy.

Operational Highlights

TakeAim Lymphoma

Successfully concluded meetings with both the U.S. Food and Drug Administration (FDA) and the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) on the suitability of using the ongoing TakeAim Lymphoma study (NCT 03328078) to support a potential accelerated approval path in PCNSL.
Announced emavusertib had been granted Orphan Drug Designation for PCNSL in both the U.S. and Europe.
Provided data update for 27 patients enrolled in the ongoing TakeAim Lymphoma study in relapsed/refractory (R/R) PCNSL, 20 BTK-experienced patients and 7 BTK-naïve patients.
Ema-Ven-Aza Triplet Study in Frontline AML

Announced successful completion of the first dosing cohort and the commencement of dosing in the second cohort. Enrollment is currently ongoing.
Corporate

Completed a registered direct offering and concurrent private placement with net proceeds of approximately $8.8 million.
First Quarter 2025 Financial Results

For the first quarter of 2025, Curis reported a net loss of $10.6 million or $1.25 per share on both a basic and diluted basis as compared to $11.9 million or $2.05 per share on both a basic and diluted basis for the same period in 2024.

Revenues for the first quarter of 2025 were $2.4 million, as compared to $2.1 million for the same period in 2024. Revenues for both periods consist of royalty revenues from Genentech/Roche’s sales of Erivedge.

Research and development expenses were $8.5 million for the first quarter of 2025, as compared to $9.6 million for the same period in 2024. The decrease was primarily attributable to lower employee related costs.

General and administrative expenses were $4.0 million for the first quarter of 2025, as compared to $4.9 million for the same period in 2024. The decrease was primarily attributable to lower employee related and professional, legal and consulting costs.

Other expense, net was $0.5 million for the first quarter of 2025, as compared to other income, net of $0.6 million for the same period in 2024. The decrease was primarily attributable to an increase in the expense related to the sale of future royalties and a decrease in interest income.

Curis’s cash and cash equivalents totaled $20.3 million as of March 31, 2025, and the Company had approximately 10.5 million shares of common stock outstanding. Curis expects its existing cash and cash equivalents will enable its planned operations into the fourth quarter of 2025.

Conference Call Information

Curis management will host a conference call today, May 6, 2025, at 8:30 a.m. ET, to discuss the business update and these financial results.

To access the live conference call, please dial 1-800-836-8184 from the United States or 1-646-357-8785 from other locations, or login here shortly before 8:30 a.m. ET. The conference call can also be accessed on the Curis website at the Events and Presentations section of the Investors page.