On May 7, 2024 Curis, Inc., 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, 2024 (Press release, Curis, MAY 7, 2024, View Source [SID1234642767]).
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Operational Highlights
The Company will release a topline update of clinical data from the ongoing TakeAim Leukemia study of emavusertib monotherapy in patients with relapsed or refractory (R/R) Acute Myeloid Leukemia (AML), including separate readouts for the FLT3 mutation (mFLT3) and Splicing Factor mutation (mSF) cohorts, on Tuesday, May 14, 2024, in connection with the publication of accepted abstracts for the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Conference.
"We are very pleased to have several opportunities to present additional patient data in R/R AML patients with a targeted mutation (mFLT3 or mSF), as well as progress updates for our R/R PCNSL and AML frontline triplet studies, at these prestigious oncology meetings," said James Dentzer, President and CEO of Curis.
Upcoming Presentations
At the upcoming ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) conferences, Curis will update its current dataset of 5 targeted patients with R/R AML (3 mFLT3, 3 mSF – including 1 patient with both a FLT3 and SF mutation who is included in both populations). The clinical update will include data for 25 new patients, bringing the total to 30 targeted patients with R/R AML treated with emavusertib as a monotherapy. The mutation status for the 30 patients is: 12 mFLT3, 20 mSF – including 2 patients with both a FLT3 and SF mutation who are included in both populations.
The following abstracts have been accepted for poster presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (May 31 – June 4):
TakeAim Leukemia
Preliminary safety, efficacy and molecular characterization of emavusertib (CA-4948) in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) with FLT3 mutation (FLT3m).
Predictive biomarkers of response to the IRAK4/FLT3 inhibitor emavusertib in hematological malignancies.
TakeAim Lymphoma
Emavusertib (CA-4948) in combination with ibrutinib in patients with relapsed/refractory primary central nervous system lymphoma (R/R PCNSL).
AML Triplet
A phase 1 single-arm, open-label study of emavusertib (CA-4948) in combination with azacitidine and venetoclax in patients (pts) with acute myeloid leukemia (AML) in complete response (CR) with measurable residual disease (MRD).
The following abstract has been accepted for poster presentation at the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Hybrid Conference in Madrid (June 13 – 16):
TakeAim Leukemia
Preliminary safety, efficacy and molecular characterization relapsed/refractory acute myeloid leukemia patients with a FLT3 mutation treated with single agent emavusertib (CA-4948).
Upcoming Milestones
TakeAim Leukemia – updated clinical data from the on-going combination study of emavusertib monotherapy in patients with R/R AML in mid-year 2024 (at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) later this quarter).
TakeAim Lymphoma – updated clinical data from the on-going combination study of emavusertib with ibrutinib in patients with R/R PCNSL in late 2024.
Initial safety data from the frontline triplet combination study of emavusertib with azacitidine and venetoclax in patients with AML in late 2024.
First Quarter 2024 Financial Results
For the first quarter of 2024, Curis reported a net loss of $11.9 million or $2.05 per share on both a basic and diluted basis as compared to $11.6 million or $2.39 per share on both a basic and diluted basis, for the same period in 2023.
Revenues for the first quarter of 2024 were $2.1 million as compared to $2.3 million for the same period in 2023. Revenues for both periods consist of royalty revenues from Genentech/Roche’s sales of Erivedge.
Research and development expenses were $9.6 million for the first quarter of 2024, as compared to $9.1 million for the same period in 2023. The increase was primarily attributable to higher employee-related costs.
General and administrative expenses were $4.9 million for the first quarter of 2024, as compared to $4.8 million for the same period in 2023.
Other income, net was $0.6 million for the first quarter of 2024, as compared to $0.1 million for the same period in 2023. The increase was primarily attributable to a decrease in the non-cash expense related to the sale of future royalties.
Curis’s cash, cash equivalents and investments totaled $40.7 million as of March 31, 2024, and the Company had approximately 5.9 million shares of common stock outstanding. Curis expects its existing cash, cash equivalents and investments will enable its planned operations into 2025.
Conference Call Information
Curis management will host a conference call today, May 7, 2024, at 8:30 a.m. ET, to discuss the business update and these financial results.
To access the live conference call, please dial 800-836-8184 from the United States or 1-646-357-8785 from other locations, or login to View Source shortly before 8:30 a.m. ET. The conference call can also be accessed on the Curis website in the ‘Investors’ section.