On May 12, 2020 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 first quarter ended March 31, 2020 (Press release, Curis, MAY 12, 2020, View Source [SID1234557594]).
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"The first quarter of 2020 was productive for Curis, as we advanced our ongoing study for CA-4948 and accomplished several key licensing and financial objectives to support future progress across our pipeline and business," said James Dentzer, President and Chief Executive Officer of Curis. "In response to the COVID-19 pandemic, we have implemented both clinical and operational measures to help protect patients, staff, study investigators and our community, and I am incredibly proud of the resiliency and dedication our team continues to demonstrate during this difficult period. We look forward to updating efficacy data from our CA-4948 study in patients with non-Hodgkin’s lymphoma (NHL) and remain on track to pursue clinical testing of CA-4948 in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS), two areas of critical unmet need."
First Quarter 2020 and Recent Operational Highlights
Precision oncology, CA-4948 (IRAK4 Inhibitor; Aurigene collaboration):
Curis is evaluating its IRAK4 inhibitor, CA-4948 in an ongoing Phase 1 dose escalation study for the treatment of patients with relapsed or refractory (R/R) NHL, including patients with diffuse large B-cell lymphoma (DLBCL), Waldenström’s macroglobulinemia (WM) and oncogenic MYD88 mutations. The Phase 1 study is on track and the Company expects to report updated efficacy data from the study and declare the recommended Phase 2 dose in 2020.
Due to the corona virus, certain sites for the Phase 1 study remain open for enrollment, while other sites have temporarily halted enrollment of new patients. Curis and its study investigators continue to monitor the COVID-19 pandemic and are focused on the safety and treatment of patients currently enrolled in the study.
Curis expects to initiate a separate Phase 1 trial of CA-4948 in patients with AML and MDS, including patients with spliceosome mutations that encode oncogenic IRAK4-L, in the second quarter of 2020.
Immuno-oncology, CI-8993 (anti-VISTA antibody; ImmuNext collaboration):
In January 2020, Curis announced it entered into an option and license agreement to acquire exclusive, worldwide rights from ImmuNext Inc. (ImmuNext) to develop and commercialize anti-VISTA antibodies for the treatment of cancer, including ImmuNext’s lead clinical-stage compound, CI-8993. Ongoing non-clinical studies are underway, and the initial clinical study will begin in the second half of 2020.
Precision oncology, fimepinostat (HDAC/PI3K inhibitor):
Fimepinostat has previously been shown to induce durable single-agent responses in difficult-to-treat lymphomas, including MYC-driven and double-hit disease. Curis is collaborating with DarwinHealth on ongoing analytical research to characterize biomarkers and tumor subtype alignments, which may help guide future clinical development opportunities with fimepinostat.
COVID-19 and Business Operations:
Curis has implemented several clinical and operational measures to support the safety of patients, staff, and study investigators and maintain rigorous clinical trial conduct. Curis currently believes there will be no disruption to the clinical supply of CA-4948 or CI-8993. The Company is in close contact with its partners and manufacturers, and all parties have established procedures to manage drug supply during the COVID-19 pandemic.
Consistent with guidelines from the Centers for Disease Control (CDC) and the Commonwealth of Massachusetts, Curis has implemented certain measures, such as ordering all employees to work remotely and restricting business travel, to help maintain the safety of its employees, families and community.
Upcoming 2020 Planned Milestones
Declare the recommended Phase 2 dose for CA-4948 in the ongoing lymphoma Phase 1 study and report updated efficacy data from the study.
Initiate a Phase 1 study of CA-4948 in patients with AML and MDS, including patients with spliceosome mutations that encode oncogenic IRAK4-L, in the second quarter of 2020.
Initiate a Phase 1a/1b dose escalation study of CI-8993 in in the second half of 2020.
First Quarter 2020 Financial Results
For the first quarter of 2020, Curis reported a net loss of $9.7 million, or $0.28 per share on both a basic and diluted basis, as compared to a net loss of $9.9 million, or $0.30 per share on both a basic and diluted basis for the same period in 2019.
Revenues for the first quarter of 2020 were $2.7 million, as compared to $1.8 million for the same period in 2019. Revenues for both periods comprise primarily royalty revenues recorded on Genentech and Roche’s net sales of Erivedge.
Operating expenses for the first quarter of 2020 were $11.2 million, as compared to $7.3 million for the same period in 2019, 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 $0.1 million for both the first quarter of 2020 and 2019.
Research and Development Expenses. Research and development expenses were $7.5 million for the first quarter of 2020, as compared to $4.1 million for the same period in 2019. The increase was primarily due to in-license expenses incurred from Curis’ option and license agreement with ImmuNext, and increased costs related to clinical activities including consulting, outside lab expenses, and Contract Research Organization (CRO) services.
General and Administrative Expenses. General and administrative expenses were $3.6 million for the first quarter of 2020, as compared to $3.1 million for the same period in 2019. The increase was driven primarily by higher legal services during the period.
Other expense, net. Net other expense was $1.2 for the first quarter of 2020, as compared to $4.3 million for the same period in 2019. Net other expense for the first quarter 2020 primarily consisted of imputed interest expense related to future royalty payments, whereas in 2019 the expense related to the extinguishment of debt.
As of March 31, 2020, Curis’ cash, cash equivalents, marketable securities and investments totaled $12.5 million and there were approximately 36.6 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 the second half of 2020.
Conference Call Information
Curis management will host a conference call today, May 12, 2020, 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.