On November 12, 2021 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a company focused on the discovery and development of next-generation synthetically lethal therapies for cancer, reported financial results for the third quarter ended September 30, 2021 and provided an update on recent business highlights (Press release, Cyteir Therapeutics, NOV 12, 2021, View Source [SID1234595389]).
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"We continue to make significant progress in advancing the Phase 1/2 study of our lead program, CYT-0851, as we reached an important milestone with the identification of the Phase 2 dose," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "The Cyteir team is excited to continue with the next steps of CYT-0851 clinical development as we advance the drug into the Phase 2 expansion cohorts as a monotherapy and as we initiate Phase 1 combination therapy with standard chemotherapy, with the ultimate goal of bringing the drug to patients in need."
Third Quarter and Recent Developments Business Review and Operational Updates
CYT-0851
Cyteir completed the dose-escalation portion of its Phase 1/2 study of CYT-0851 up to the maximum feasible daily dose of 1200 mg and declared the maximum tolerated dose of 600mg per day. Dose limiting toxicities of fatigue, vomiting, dehydration, dry skin, stomatitis, myalgia, and acidosis were observed at daily doses of 600mg and above. All were grade 3 events and reversible with dose interruption.
With the dose escalation portion of the study complete, the Phase 2 dose has been identified as 400 mg per day. We continue to enroll patients at the 400mg per day dose and below, to obtain additional safety, pharmacokinetic, and biomarker data. Simultaneously, we are initiating Phase 2 expansion study into disease-specific cohorts and expect to begin enrolling patients in the first quarter of 2022. We are also initiating a Phase 1 combination study of CYT-0851 with three standard-of-care regimens: rituximab plus bendamustine, gemcitabine and capecitabine, in both hematologic malignancies and solid tumors.
Pipeline
Investigational New Drug (IND)-enabling studies with CYT-1853 are ongoing and the Company expects to submit an IND application for CYT-1853 in 2022. Cyteir is also advancing preclinical studies on additional targets to nominate the next target from the Company’s DNA damage response platform.
Third Quarter Financial Results
Cash and cash equivalents: Cash and cash equivalents for the quarter ended September 30, 2021, were $199.8 million. The cash and cash equivalents total for the third quarter includes the $14.5 million in net proceeds raised from the partial exercise of the option to purchase additional shares of common stock by the underwriters of our IPO.
Research and development (R&D) expenses: R&D expenses were $8.2 million for the third quarter of 2021 versus $4.2 million for the same period in 2020. The year-over-year increase in R&D spending in the comparative periods was due primarily to increased R&D and clinical activity and increased headcount.
General and administrative (G&A) expenses: G&A expenses were $3.5 million for the third quarter of 2021 compared to $0.8 million for the same period in 2020. The year-over-year increase in G&A expenses in the comparative periods was primarily due to increased headcount, as well as increased professional fees and other administrative expenses associated with company growth and operating as a public company.
Net loss: Net loss was $11.7 million, or $0.33 per share in the third quarter of 2021 compared to $5.0 million, or $3.44 per share in the third quarter of 2020.