On November 9, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported its financial results for the third quarter ended September 30, 2021 and provided business updates (Press release, Curis, NOV 9, 2021, View Source [SID1234594917]).
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!
"During the third quarter of 2021, we continued to advance our clinical trials of CA-4948, our first-in-class, small molecule IRAK4 inhibitor in nine distinct patient populations across AML, MDS and B cell cancers, including the recent initiation of our Phase 1 combination study in AML/MDS. At the AACR (Free AACR Whitepaper)-NCI-EORTC Conference in October, we shared exciting preclinical data highlighting potential applications for CA-4948 across different hematologic malignancies, including pCNS lymphoma, an aggressive lymphoma with severe unmet need for patients, further highlighting the potential broad applicability of CA-4948," said James Dentzer, President and Chief Executive Officer of Curis.
"As we look ahead, we plan to provide a clinical data update in January from our ongoing clinical studies, including safety data from our Phase 1 study of CI-8993 and the latest safety and efficacy data from our CA-4948 study in AML/MDS patients with spliceosome or FLT3 mutations."
"In our ongoing monotherapy AML/MDS study, we expect to achieve our enrollment target of having 10-20 total patients with a spliceosome mutation by year-end. We believe data from these patients may provide for an opportunity to explore discussions with the FDA on a registrational path forward in the first half of 2022," concluded Mr. Dentzer.
Third Quarter 2021 and Recent Operational Highlights
Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):
Enrollment remains on track in nine distinct patient populations across AML, MDS and B cell cancers.
In November 2021, Curis initiated dosing in the combination stage of the Phase 1/2 study of CA-4948 plus azacitidine and CA-4948 plus venetoclax.
The combination therapy portion includes two arms: CA-4948 plus azacitidine, for patients naïve to HMA, and CA-4948 plus venetoclax, for patients naïve to venetoclax.
When combined with azacitidine, CA-4948 will be dosed at 200 mg twice daily for 21 days of a 28-day cycle, followed by a 300 mg dose cohort if tolerability allows. Azacitidine will be given in 7 consecutive doses or split doses starting at 75 mg/m2.
When combined with venetoclax, the starting dose level for CA-4948 will be 200 mg twice daily for 21 days of a 28-day cycle, followed by a 300 mg dose cohort if tolerability allows. Venetoclax will be administered at 100 mg orally with a ramp up over 3 days to 400 mg for 21 days of a 28-day cycle.
In October 2021, Curis announced new preclinical data highlighting the potential of CA-4948 in additional hematologic malignancies in two presentations at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual Conference on Molecular Targets and Cancer Therapeutics.
Preclinical data concluded CA-4948 is synergistic with small molecule BTKi therapies that target BCR signaling and suggest the combination can overcome or reduce secondary resistance to BTKi therapies in marginal zone lymphoma.
CA-4948 is able to cross the blood-brain barrier in a preclinical murine model of CNS lymphoma, producing significant and dose-dependent anti-tumor activity and survival advantage.
Curis expects to have 10-20 patients in AML/MDS patients with SF3B1 or U2AF1 spliceosome mutation enrolled by year-end 2021.
Curis plans to provide an update on efficacy and safety from these patients in January. Data may not be fully matured or complete at this time.
Curis expects to present additional data from the 10-20 patients with spliceosome mutations in more detail in the first half of 2022. Data from these patients may provide for an opportunity to explore discussions with the FDA on a registrational path forward in the first half of 2022.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):
Enrollment remains on track in the ongoing Phase 1 dose escalation study of CI-8993, Curis’s first-in-class monoclonal anti-VISTA antibody for the treatment of R/R solid tumors.
Curis expects to report initial safety data from this trial in January.
Curis will hold a poster presentation with new preclinical data on CI-8993 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 36th Annual Meeting being held from November 12-14, 2021.
Title: Preclinical evaluation of anti-VISTA antibody CI-8993 in a syngeneic huVISTA-KI model
Presenting Author: Andrew M. Scott, MD Olivia Newton-John Cancer Research Institute, Tumour Targeting Laboratory, Melbourne, VIC, Australia
Abstract Number: 324
Abstracts were made available Tuesday, November 9, 2021, at 8:00 a.m.
Virtual ePoster presentations will be available Friday, November 12, 2021, at 7:00 a.m.
Upcoming Planned Milestones for 2022
In January, provide a clinical data update on our ongoing studies, including initial safety data from the ongoing Phase 1 monotherapy study of CI-8993 for the treatment of R/R solid tumors and the latest safety and efficacy data from the Phase 1/2 monotherapy study of CA-4948 in AML/MDS patients with spliceosome mutations that result in aberrant splicing of oncogenic IRAK4-L and patients with FLT3 mutations.
In the first half of the year, provide additional data from the ongoing Phase 1/2 monotherapy study of CA-4948 in patients with R/R AML/MDS at a medical meeting.
In the first half of the year, report initial data at a medical meeting from the ongoing Phase 1/2 combination study of CA-4948 plus ibrutinib in patients with B cell cancers.
Third Quarter 2021 Financial Results
For the third quarter of 2021, Curis reported a net loss of $11.1 million or $0.12 per share on both a basic and diluted basis, as compared to a net loss of $6.0 million, or $0.11 per share on both a basic and diluted basis for the same period in 2020. Curis reported a net loss of $31.8 million or $0.35 per share on both a basic and diluted basis, for the nine months ended September 30, 2021, as compared to a net loss of $22.4 million, or $0.52 per share on both a basic and diluted basis, for the same period in 2020.
Revenues for the third quarter of 2021 and 2020 were $3.0 million and $2.7 million, respectively. Revenues for the nine months ended September 30, 2021 were $7.5 million, as compared to $7.8 million for the same period in 2020. 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 2021 were $13.1 million, as compared to $7.5 million for the same period in 2020. Operating expenses for the nine months ended September 30, 2021 were $37.0 million, as compared to $26.4 million for the same period in 2020, and comprised the following:
Costs of Royalty Revenues. Costs of royalty revenues, primarily amounts due to third-party university patent licensors in connection with Genentech and Roche’s Erivedge net sales, were $0.2 million for the third quarter of 2021, as compared to $0.1 million for the same period in 2020. Cost of royalty revenues for the nine months ended September 30, 2021 were $0.4 million, as compared to $0.4 million for the same period in 2020.
Research and Development Expenses. Research and development expenses were $8.6 million for the third quarter of 2021 as compared to $4.7 million for the same period in 2020. The increase in direct research and development expenses for the quarter is primarily attributable to increased clinical and manufacturing costs for our programs. Additionally, employee related costs increased by $2.3 million, primarily attributable to increased stock compensation and personnel costs as a result of additional headcount. Research and development expenses were $24.1 million for the nine months ended September 30, 2021 as compared to $17.5 million for the same period in 2020.
General and Administrative Expenses. General and administrative expenses were $4.3 million for the third quarter of 2021, as compared to $2.6 million for the same period in 2020. The increase in general administrative expense was driven primarily by higher costs for stock-based compensation, personnel, and professional and consulting services. General and administrative expenses were $12.5 million for the nine months ended September 30, 2021, as compared to $8.6 million for the same period in 2020.
Other Expense, Net. For the third quarter of 2021 and 2020, net other expense was $1.0 million and $1.3 million, respectively. Net other expense primarily consisted of imputed interest expense related to future royalty payments. Net other expense was $2.3 million for the nine months ended September 30, 2021, as compared to $3.8 million for the same period in 2020.
As of September 30, 2021, Curis’s cash, cash equivalents and investments totaled $149.8 million, and there were approximately 91.6 million shares of common stock outstanding. Curis expects that its existing cash, cash equivalents and investments should enable it to maintain its planned operations into 2024.
Conference Call Information
Curis management will host a conference call today, November 9, 2021, at 4:30 p.m. ET, to discuss these financial results, as well as provide a corporate update.
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 www.curis.com in the Investors section.