On February 24, 2022 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 fourth quarter ended December 31, 2021 (Press release, Curis, FEB 24, 2022, View Source [SID1234608959]).
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"2021 was a year marked by significant clinical progress across our pipeline of targeted cancer therapies, including our report of positive updated data from our ongoing Phase 1/2 TakeAim Leukemia study of emavusertib (CA-4948) demonstrating a favorable safety profile and encouraging anti-cancer activity, with expansion into multiple combination trials in R/R hematologic malignancies. We have also identified a potential registrational path for CA-4948 as a monotherapy in genetically-defined patient populations, and reported promising initial safety data highlighting the potential of CI-8993 to activate multiple anti-cancer immune mechanisms," said James Dentzer, President and Chief Executive Officer of Curis. "As we look ahead, we expect 2022 to be a year of meaningful clinical updates from across our ongoing clinical trials, as we plan on providing additional updates on expanded clinical data for emavusertib and an update on a potential rapid regulatory path to bring this novel therapy to a genetically-defined patient population in dire need. We will continue our dose-escalation study for CI-8993 to determine the recommended Phase 2 dose and to assess signs of anti-cancer activity. We also look forward to presenting data from both of our combination trials with emavusertib in AML/MDS and in B Cell Cancers this year.
"We are also pleased to have expanded our leadership with three new executives that will bring expertise to strengthen our internal capabilities. We are also delighted with the appointment of John Hohneker, M.D. to the Board of Directors as we continue to grow our team and build our capabilities to deliver a new class of therapies to our patients," added Mr. Dentzer.
Full Year 2021 and Recent Operational Highlights
Precision oncology, emavusertib (IRAK4 Inhibitor; Aurigene collaboration):
Today, Curis announced that it will be implementing the new name "emavusertib" for all future references of CA-4948, including in scientific publications and corporate materials. The Company also announced new branding of its existing clinical trials of emavusertib as TakeAim Leukemia and TakeAim Lymphoma to highlight the targeting mechanisms.
In January 2022, Curis presented an updated expanded data set supporting earlier preliminary efficacy data of emavusertib in R/R AML/MDS whose disease is characterized by spliceosome or FLT3 mutation, suggesting a favorable safety and anti-cancer activity profile compared to standard of care therapies for these patient populations. The safety profile observed showed emavusertib was well-tolerated across multiple dose levels, including at the Recommended Phase 2 Dose of 300 mg BID. Enrollment of the study is currently ongoing, and Curis expects to have discussions with the FDA in the first half of 2022 regarding the potential for a rapid registrational path for emavusertib as a monotherapy in genetically defined patient populations. Curis expects to provide additional data from the R/R AML/MDS study at a medical meeting in 2022.
In October 2021, Curis initiated dosing in the combination stage of the TakeAim Leukemia study of emavusertib plus azacitidine or venetoclax. The combination therapy portion includes two arms: emavusertib plus azacitidine, for patients naïve to HMA, and emavusertib plus venetoclax, for patients naïve to venetoclax.
In October 2021, Curis announced new preclinical data highlighting the potential of emavusertib in additional hematologic malignancies in two presentations at the AACR (Free AACR Whitepaper)-NCI-EORTC Virtual Conference on Molecular Targets and Cancer Therapeutics. The preclinical data concluded emavusertib is synergistic with small molecule therapies targeted BCR signaling and suggest it can overcome or reduce secondary resistance to the therapies in marginal zone lymphoma.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):
In January 2022, Curis announced that the ongoing Phase 1 dose escalation study of CI-8993 demonstrated a promising safety profile, with no dose-limiting toxicities observed, and encouraging PK/PD activity, suggesting the possibility that CI-8993 can activate multiple anti-cancer immune mechanisms, including mechanisms that are not addressed by currently approved checkpoint inhibitors. The initial safety data from this trial is based on 13 patients in the first two dose cohorts of 0.15mg/kg and 0.3mg/kg. Curis expects to report expanded safety and tolerability data, along with PK, PD, and anti-cancer data from the trial in the second half of 2022.
Corporate:
Curis expanded its executive leadership capabilities, adding Felix Geissler, M.D., Ph.D., as Vice President of Medical Affairs, Kimberly Steinmann, M.D., as Vice President of Clinical Development, and Dora Ferrari, as Vice President of Clinical Operations. Drs. Geissler and Steinmann, and Ms. Ferrari are reporting directly to Dr. Reinhard von Roemeling, Senior Vice President, Clinical Development.
Curis expanded its Board of Directors with the appointment of John Hohneker, M.D. to the Board of Directors.
Upcoming 2022 Planned Milestones
In the first half of 2022, discuss potential for rapid registrational path for emavusertib with FDA
In the first half of 2022, report initial data for emavusertib in combination with ibrutinib in NHL
In 2022, report updated data for emavusertib in AML/MDS monotherapy
In the second half of 2022, report initial efficacy data for CI-8993 (VISTA)
In the second half of 2022, report initial data for emavusertib in combination with azacitadine or venetoclax in AML/MDS
Full Year and Fourth Quarter 2021 Financial Results
For the year ended December 31, 2021, Curis reported a net loss of $45.4 million, or $0.50 per share on both a basic and diluted basis, as compared to a net loss of $29.9 million, or $0.61 per share on both a basic and diluted basis in 2020. For the fourth quarter of 2021, Curis reported a net loss of $13.6 million or $0.15 per share on both a basic and diluted basis as compared to a net loss of $7.5 million, or $0.11 per share on both a basic and diluted basis, for the same period in 2020.
Revenues for the year ended December 31, 2021, were $10.6 million as compared to $10.8 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. Revenues for the fourth quarters of 2021 and 2020 were $3.1 million and $3.0 million, respectively.
Operating expenses for the year ended December 31, 2021, were $52.7 million, as compared to $35.7 million for the same period in 2020. Operating expenses for the fourth quarter of 2021 were $15.7 million, as compared to $9.3 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 $0.5 million for the years ended December 31, 2021 and 2020. Cost of royalty revenues were $0.2 million for the fourth quarter of 2021 and 2020.
Research and Development Expenses. Research and development expenses were $34.9 million for the year ended December 31, 2021, as compared to $23.1 million for the same period in 2020. Research and development expenses were $10.8 million for the fourth quarter of 2021 as compared to $5.6 million for the same period in 2020. The increase was primarily attributable to increased clinical and manufacturing costs for our programs and higher personnel counts as a result of additional headcount.
General and Administrative Expenses. General and administrative expenses were $17.3 million for the year ended December 31, 2021, as compared to $12.1 million for the same period in 2020. General and administrative expenses were $4.8 million for the fourth quarter of 2021, as compared to $3.5 million for the same period in 2020. The increase in general administrative expense was driven primarily by higher costs for stock-based compensation, professional and consulting services, personnel, and insurance as compared to the prior year.
Other Expense, Net. Net other expense was $3.4 million for the year ended December 31, 2021, as compared to $5.0 million for the same period in 2020. For the fourth quarter of 2021 and 2020, net other expense was $1.1 million and $1.2 million, respectively. Net other expense primarily consisted of imputed interest expense related to royalty payments.
As of December 31, 2021, Curis’s cash, cash equivalents and investments totaled $139.8 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, February 24, 2022, 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.