Curis Reports Q2 2024 Financial and Operational Update

Curis, Inc., a biotech firm focused on developing emavusertib, an oral, small molecule IRAK4 inhibitor, has announced its financial and operational results for the second quarter ending June 30, 2024.

One of the notable achievements in the quarter was the European Commission's (EC) Orphan Drug Designation (ODD) for emavusertib to treat primary central nervous system lymphoma (PCNSL). This designation is granted to medications intended for severe or chronic conditions affecting fewer than 5 in 10,000 people in the EU. Jonathan Zung, Chief Development Officer, highlighted the significance of this designation, emphasizing the high unmet need in the PCNSL patient population.

Curis continues to advance the clinical development of emavusertib. They anticipate initial data for 15-20 patients with relapsed/refractory (R/R) PCNSL by the end of 2024. James Dentzer, President and CEO, expressed optimism about the progress of the TakeAim Lymphoma study and noted forthcoming data presentations at the ASH conference in December. The company is also in discussions with health authorities to establish a registrational development path for emavusertib in PCNSL.

In the TakeAim Leukemia program, Curis released data in May 2024 for 25 new patients with R/R FLT3 mutation (FLT3m) and U2AF1/SF3B1 Splicing Factor mutation (SFm) who had received fewer than three prior therapies. These patients were treated with emavusertib monotherapy at the Recommended Phase 2 Dose (RP2D) of 300 mg BID. Among the 12 patients with FLT3m, six of the eleven response-evaluable patients showed objective responses, including three complete remissions (CR). Four patients were still undergoing treatment at the data cutoff point. In the SFm cohort of 20 patients, four of eighteen response-evaluable patients exhibited objective responses. Eight patients were ongoing at the data cutoff.

Curis is also set to host the 3rd Annual Symposium on IRAK-4 in cancer on September 26, 2024. The symposium, led by Dr. Eric S. Winer and Dr. Grzegorz S. Nowakowski, will explore the potential of IRAK-4 inhibition in treating hematologic malignancies and solid tumors.

Curis has several upcoming milestones. For the TakeAim Lymphoma study, updated clinical data from the ongoing combination study with ibrutinib is expected by late 2024. In the TakeAim Leukemia study, updated monotherapy data for patients with R/R AML and FLT3 or SFm mutations is also anticipated by late 2024. Additionally, initial safety data from a frontline triplet combination study involving emavusertib with azacitidine and venetoclax in AML patients is projected for late 2024.

Financially, Curis reported a net loss of $11.8 million, or $2.03 per share, for Q2 2024, compared to a net loss of $12.0 million, or $2.47 per share, in the same period in 2023. The net loss for the first half of 2024 was $23.7 million, slightly up from $23.5 million in the same period in 2023. Revenues for Q2 2024 were $2.5 million, an increase from $2.2 million in Q2 2023. For the first half of 2024, revenues were $4.6 million, compared to $4.5 million in the same period in 2023. The revenues primarily stem from royalties on sales of Erivedge® by Genentech/Roche.

Research and development expenses rose to $10.3 million in Q2 2024 from $10.0 million in Q2 2023, due to higher employee-related costs. For the first half, these expenses increased to $19.9 million from $19.2 million. General and administrative expenses were $4.8 million in Q2 2024, up from $4.2 million in Q2 2023, again due to higher employee-related costs. These expenses for the first half of 2024 were $9.7 million, slightly up from $9.0 million in 2023.

Curis had other income of $0.7 million in Q2 2024, primarily from reduced non-cash expenses related to the sale of future royalties, compared to $0.2 million in Q2 2023. Other income for the first half of 2024 was $1.3 million, up from $0.2 million in 2023.

As of June 30, 2024, Curis's cash, cash equivalents, and investments totaled $28.4 million, and the company had approximately 5.9 million shares of common stock outstanding. The existing funds are expected to support operations into the first quarter of 2025.

Curis is a biotechnology company focused on developing emavusertib, which is currently in various clinical trials for treating PCNSL, AML, and high-risk MDS. Emavusertib has received ODD from both the U.S. FDA and the European Commission.

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