On August 3, 2023 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 inhibitor for the treatment of hematologic malignancies, reported its business update and financial results for the second quarter ended June 30, 2023 (Press release, Curis, AUG 3, 2023, View Source [SID1234633742]).

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"We are very pleased with our progress this quarter, as we were able to work with the FDA to remove the partial clinical hold on the TakeAim Leukemia study a quarter ahead of schedule. In that process, we also gained alignment with FDA in confirming 300 mg BID as the RP2D for monotherapy, which we believe is the optimal monotherapy dose. We appreciate the strong support of our clinical investigators during our discussions with FDA and we are excited to expand patient enrollment in the TakeAim Leukemia study at the RP2D," said James Dentzer, President and CEO of Curis.

Second Quarter 2023 and Recent Operational Highlights

Precision Oncology, Emavusertib (IRAK4 Inhibitor)

TakeAim Leukemia

In July, the Company announced that the U.S. Food and Drug Administration (FDA) removed the partial clinical hold on the TakeAim Leukemia Phase 1/2 study of emavusertib. Further, the recommended phase 2 dose (RP2D) for emavusertib as a monotherapy has been confirmed at 300 mg BID in patients with Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndromes (MDS).
The Company is currently enrolling relapsed or refractory (R/R) AML patients with FLT3 mutation or a spliceosome mutation (U2AF1 or SF3B1 mutation) who have received ≤ 2 prior lines of treatment in the monotherapy study.
The Company is also planning a combination study of emavusertib with azacitidine and venetoclax to treat AML patients in the front-line setting.
TakeAim Lymphoma

The Company is focusing its lymphoma clinical development efforts on Primary CNS lymphoma (PCNSL), a rare form of extranodal non-Hodgkin lymphoma for which there are limited treatment options. The Company is currently enrolling pCNSL patients in its TakeAim Lymphoma study in which patients are being treated with a combination of emavusertib and ibrutinib.
Upcoming Milestones

We expect updated clinical data in both the monotherapy and combination studies in 2024.
Corporate

In July 2023, the Company completed a registered direct offering with net proceeds of approximately $13.8 million.

First Quarter 2023 Financial Results

For the second quarter of 2023, Curis reported a net loss of $12.0 million or $0.12 per share on both a basic and diluted basis as compared to $15.9 million or $0.17 per share on both a basic and diluted basis, for the same period in 2022. Curis reported a net loss of $23.5 million or $0.24 per share on both a basic and diluted basis, for the six months ended June 30, 2023 as compared to a net loss of $32.0 million or $0.35 per share on both a basic and diluted basis for the same period in 2022.

Revenues for the first quarter of 2023 were $2.2 million as compared to $2.4 million for the same period in 2022. Revenues for both periods consist of royalty revenues from Genentech’s and Roche’s sales of Erivedge. Revenues for the six months ended June 30, 2023 and 2022 were both $4.5 million.

Research and development expenses were $10.0 million for the second quarter of 2023, as compared to $12.3 million for the same period in 2022. The decrease was primarily attributable to lower employee related costs due to a reduction in headcount. Research and development expenses were $19.2 million for the six months ended June 30, 2023, as compared to $23.8 million for the same period in 2022.

General and administrative expenses were $4.2 million for the second quarter of 2023, as compared to $5.1 million for the same period in 2022. The decrease was mainly attributable to lower employee related costs due to a reduction in headcount. General and administrative expenses were $9.0 million for the six months ended June 30, 2023, as compared to $10.8 million for the same period in 2022.

Other income, net was $0.2 million for the second quarter of 2023, as compared to other expense, net of $0.9 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. Other income, net was $0.2 million for the six months ended June 30, 2023 compared to other expense, net $1.9 million for the same period in 2022.

Including the impact of the July Registered Direct offering, Curis’s cash, cash equivalents and investments totaled $77.4 million, and the Company had approximately 117.7 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, August 3, 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.