On March 23, 2023 Cyteir Therapeutics, Inc. ("Cyteir") (Nasdaq: CYT), a clinical stage oncology company, reported financial results for the fourth quarter and full year ended December 31, 2022 and provided an update on recent operational highlights (Press release, Cyteir Therapeutics, MAR 23, 2023, View Source [SID1234629239]).
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"We continue to be encouraged by the early clinical activity of CYT-0851 in ovarian cancer and are committed to bringing CYT-0851 to patients," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "Our significant cash runway gives us the resources to focus our development on CYT-0851 and into a potentially registrational trial as early as the second half of 2024."
Recent Updates to the CYT-0851 Clinical Program
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In January, Cyteir reported encouraging preliminary clinical activity in the Phase 1 dose escalation cohorts with CYT-0851, an investigational oral monocarboxylate transporter inhibitor, in combination with capecitabine for the treatment of advanced ovarian cancer. Cyteir announced the prioritization of development of CYT-0851 in combination with capecitabine in advanced ovarian cancer and deferred development of additional indications with this combination. Cyteir plans to enroll up to an additional nine patients with advanced ovarian cancer in the capecitabine combination at the 400 mg CYT-0851 dose level. If supported by the data and regulatory feedback, Cyteir intends to pursue development and potential registration of CYT-0851 in combination with capecitabine as an all-oral treatment for platinum resistant ovarian cancer. Preliminary data on the combination with capecitabine are expected to be disclosed in mid-2023.
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Enrollment in the Phase 1 dose escalation cohorts of CYT-0851 in combination with gemcitabine in solid tumors continues. This combination is currently being evaluated at 300 mg of CYT-0851 in combination with gemcitabine, and if deemed tolerable, will advance to 400 mg of CYT-0851 in combination with gemcitabine. Preliminary data from the Phase 1 dose escalation cohorts of CYT-0851 in combination with gemcitabine are expected to be disclosed in mid-2023.
Recent Business Updates
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In conjunction with the prioritization of the clinical plan for CYT-0851, Cyteir also ceased all discovery projects focused on identifying inhibitors of DNA damage repair. Cyteir is pursuing out licensing of its preclinical pipeline
Fourth Quarter and Full Year 2022 Financial Results
Cash and cash equivalents: Cash and cash equivalents as of December 31, 2022 were $147.1 million, which are expected to fund planned operations into 2026.
Research and development (R&D) expenses: R&D expenses were $7.5 million for the fourth quarter of 2022 versus $8.3 million for the same period in 2021 and $34.6 million for the full year 2022 versus $31.0 million for full year 2021. The year-over-year increase in R&D spending was due primarily to increased headcount and research activity. The decrease in fourth quarter 2022 R&D spending versus 2021 was due to lower clinical trial costs.
General and administrative (G&A) expenses: G&A expenses were $2.6 million for the fourth quarter of 2022 compared to $3.6 million for the same period in 2021 and $13.5 million for the full year 2022 compared to $11.3 million for full year 2021. The year-over-year increase in full year 2022 G&A expenses was primarily due to employee-related costs, as well as other administrative expenses associated with company growth and operating as a public company. The decrease in fourth quarter 2022 G&A spending versus 2021 was due to lower employee-related costs and other administrative expenses.
Net loss: Net loss was $8.8 million, or $0.25 per share, in the fourth quarter of 2022 compared to $11.8 million, or $0.34 per share, for the same period in 2021. For the full year 2022, net loss was $46.1 million, or $1.31 per share compared to $42.1 million, or $2.16 per share for full year 2021.