On March 13, 2023 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 fourth quarter ended December 31, 2022 (Press release, Curis, MAR 13, 2023, View Source [SID1234628584]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

As announced in November, the Company has concentrated its resources to focus on the development of emavusertib. As a result of these efforts, the Company has completed the re-opening of its clinical sites and completed enrollment of the 9 additional patients at the 200mg BID dose level requested by FDA in discussions related to the resolution of the partial clinical hold on the Company’s TakeAim Leukemia study. The Company expects to collect data from these patients in Q2 and request a Q3 meeting to discuss these data with FDA.

"We are pleased to announce that we have completed enrollment of the 9 additional patients requested by FDA ahead of schedule. This is an important step towards resolving the partial clinical hold in the TakeAim Leukemia study. We also look forward to discussions with FDA on the determination of the Recommended Phase 2 Dose (RP2D), as we work with our clinical investigators to develop potential pivotal study designs for emavusertib," said James Dentzer, President and Chief Executive Officer of Curis.

Fourth Quarter 2022 and Recent Operational Highlights

Precision Oncology, Emavusertib (IRAK4 Inhibitor)

In December at the 64th Annual ASH (Free ASH Whitepaper) Meeting and Exposition, the Company presented positive updated clinical data from the ongoing open label Phase 1a dose escalation study of emavusertib (CA-4948), a novel, small molecule IRAK-4 inhibitor, as a monotherapy in patients with relapsed or refractory (R/R) acute myeloid leukemia (AML) or high-risk myelodysplastic syndromes (hrMDS) in both targeted and non-targeted populations. Key findings in the data in targeted AML and hrMDS patient monotherapy populations included:
AML Patients with a FLT3 mutation had a CR rate of 29% (2 of 7 patients);
AML Patients with a spliceosome mutation had a CR/CRh rate of 22% (2 of 9 patients);
MDS Patients with a spliceosome mutation had an ORR of 45% (5 of 11 patients), with all 5 responses achieving a marrow Complete Remission (mCR).
CR: Complete Remission
CRh: Complete Remission with Partial Hematologic Recovery
ORR: Objective Response Rate
Upcoming Milestones

The Company expects to include data from the 9 additional patients in discussions with FDA in Q3 that it hopes will facilitate the determination of RP2D and resolution of the partial clinical hold.
Fourth Quarter 2022 Financial Results

For the year ended December 31, 2022, Curis reported a net loss of $56.7 million, or $0.61 per share on both a basic and diluted basis, as compared to a net loss of $45.4 million, or $0.50 per share on both a basic and diluted basis in 2021. For the fourth quarter of 2022, Curis reported a net loss of $11.3 million or $0.12 per share on both a basic and diluted basis as compared to a net loss of $13.6 million or $0.15 per share on both a basic and diluted basis, for the same period in 2021.

Revenues, net for the year ended December 31, 2022, were $10.2 million as compared to $10.6 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. Revenues for the fourth quarters of 2022 and 2021 were $2.9 million and $3.1 million, respectively.

Costs of royalties which relate to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, for the year ended December 31, 2022, were $0.3 million compared to $0.5 million for the same period in 2021. Cost of royalties for the fourth quarters of 2022 and 2021 were $0.1 million and $0.2 million, respectively.

Research and development expenses were $43.3 million for the year ended December 31, 2022, as compared to $34.9 million for the same period in 2020. The increase is mainly a result of increased employee-related costs of $7.4 million due to an increase in headcount. Research and development expenses were $8.7 million and $10.8 million for the fourth quarters of 2022 and 2021, respectively.

General and administrative expenses were $19.6 million for the year ended December 31, 2022, as compared to $17.3 million for the same period in 2021. The increase is mainly a result of increased employee-related costs of $1.4 million due to an increase in headcount and facility related costs of $0.8 million. General and administrative expenses were $4.3 million and $4.8 million for the fourth quarters of 2022 and 2021, respectively.

Other expense, net was $3.7 million for the year ended December 31, 2022, as compared to $3.4 million for the same period in 2021. Other expense, net was $1.1 million for the fourth quarters of 2022 and 2021, respectively. Other expense, net for the year ended December 31, 2022 primarily consisted of expense related to future royalty payments partially offset by interest income. Other expense, net for the year ended December 31, 2021 primarily consisted of imputed interest expense related to future royalty payments partially offset by a gain recognized upon the forgiveness of a PPP loan.

As of December 31, 2022, Curis’s cash, cash equivalents and investments totaled $85.6 million, and the Company had approximately 96.6 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, March 13, 2023, at 8:30 a.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 8:30 a.m. ET. The conference call can also be accessed on the Curis website in the Investors section.