On November 9, 2022 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 third quarter ended September 30, 2022 (Press release, Curis, NOV 9, 2022, View Source [SID1234623543]).

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The Company plans to release updated data from its TakeAim Leukemia Phase 1/2 trial of emavusertib in relapsed or refractory (R/R) acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (hrMDS) during the upcoming 64th annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in New Orleans on December 10-13, 2022. The release includes data for 11 additional evaluable AML/hrMDS patients treated with monotherapy (total to date 24) in targeted populations (patients with U2AF1, SF3B1 or FLT3 mutations), as well as 5 AML/hrMDS patients treated with the combination of emavusertib and venetoclax.

To further advance the development of emavusertib based on these data, the Company is concentrating its resources to focus on and accelerate emavusertib. Resources will be reallocated to the emavusertib programs and resources dedicated to all other pipeline programs will be reduced. Deprioritization of other programs will enable a reduction of approximately 30% of the Company’s workforce and is expected to extend the Company’s cash runway into 2025.

"We believe emavusertib’s potential to address an area of high unmet need in R/R AML and R/R hrMDS sets it apart. To that end, we are dedicating the resources of the company to prioritize the acceleration of its regulatory path," said James Dentzer, President and Chief Executive Officer of Curis. "While we continue to believe in our entire pipeline, we recognize the unique potential of emavusertib and are fortunate that our existing cash will allow us to extend our runway into 2025 to advance its development," continued Mr. Dentzer.

Third Quarter 2022 and Recent Operational Highlights

Precision Oncology, Emavusertib (IRAK4 Inhibitor)

The Company announced in August that, after review of the comprehensive data packages submitted by the Company, the FDA has allowed enrollment to resume in the TakeAim Lymphoma study and in the monotherapy dose finding phase (Phase 1a) of the TakeAim Leukemia study.

Curis held the first annual IRAK4 in Cancer symposium virtually on October 7, 2022 where leaders from academia and industry gathered to present their cutting edge research on IRAK4, its biology and the role it could play as a target for therapeutic intervention.
Upcoming Milestones

The Company plans to report monotherapy and combination data from the TakeAim Leukemia studies during ASH (Free ASH Whitepaper) 2022.
Third Quarter 2022 Financial Results

For the third quarter of 2022, Curis reported a net loss of $13.3 million or $0.14 per share on both a basic and diluted basis, as compared to a net loss of $11.1 million, or $0.12 per share on both a basic and diluted basis for the same period in 2021. Curis reported a net loss of $45.3 million or $0.49 per share on both a basic and diluted basis, for the nine months ended September 30, 2022 as compared to a net loss of $31.8 million, or $0.35 per share on both a basic and diluted basis for the same period in 2021.

Revenues, net for the third quarter of 2022 and 2021 were $2.8 million and $3.0 million, respectively. Revenues, net for the nine months ended September 30, 2022 were $7.3 million as compared to $7.5 million for the same period in 2021. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.

Operating expenses for the third quarter of 2022 were $15.4 million, as compared to $13.1 million for the same period in 2021. Operating expenses for the nine months ended September 30, 2022 were $50.1 million, as compared to $37.0 million for the same period in 2021, and comprised the following:

Cost of Royalty Revenues. Cost of royalty revenues, which represents amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.1 million for the third quarter of 2022 and $0.2 million for the same period in 2021. Cost of royalty revenues for the nine months ended September 30, 2022 were $0.2 million, as compared to $0.4 million for the same period in 2021.

Research and Development Expenses. Research and development expenses were $10.8 million for the third quarter of 2022 as compared to $8.6 million for the same period in 2021. The increase in research and development expenses for the quarter is primarily attributable to increased personnel and consulting costs, partially offset by decreased manufacturing and clinical development costs. Research and development expenses were $34.6 million for the nine months ended September 30, 2022 as compared to $24.1 million for the same period in 2021.

General and Administrative Expenses. General and administrative expenses were $4.6 million for the third quarter of 2022, as compared to $4.3 million for the same period in 2021. The increase in general and administrative expenses was driven primarily by the timing of costs. General and administrative expenses were $15.3 million for the nine months ended September 30, 2022, as compared to $12.5 million for the same period in 2021.

Other Expense. For the third quarter of 2022 and 2021, total other expense was $0.7 million and $1.0 million, respectively. Other expense primarily consisted of imputed interest expense related to future royalty payments partially offset by interest income. Other expense was $2.5 million for the nine months ended September 30, 2022, as compared to $2.3 million for the same period in 2021.

As of September 30, 2022, Curis’s cash, cash equivalents and investments totaled $98.7 million, and the Company had approximately 96.4 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, November 9, 2022, 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 at in the Investors section.