On August 8, 2022 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 second quarter ended June 30, 2022 and provided an update on recent operational highlights (Press release, Cyteir Therapeutics, AUG 8, 2022, View Source [SID1234617782]).
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"We are encouraged by the enrollment of patients in the CYT-0851 Phase 2 monotherapy cohorts and Phase 1 combination therapy cohorts, with initial data expected on the solid tumor cohorts in the fourth quarter this year, and on the lymphoma cohorts in the first half of 2023," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "We have made the strategic decision to postpone the CYT-1853 IND, thereby extending our cash runway to focus on CYT-0851 clinical development and our synthetic lethality discovery research."
Second Quarter 2022 Business Update
Updates to the CYT-0851 Clinical Program
Progress continues with enrollment of both the monotherapy and combination cohorts. Initial data from the monotherapy solid tumor cohorts are expected beginning in the fourth quarter of 2022, with initial data from the hematologic malignancy cohorts expected in the first half of 2023. Dose-escalation in combination cohorts with capecitabine and gemcitabine in solid tumors is progressing and expected to be completed in the first half of 2023.
A Phase 2 cohort with CYT-0851 monotherapy in triple negative breast cancer has been opened. Data from this cohort are expected in the first half of 2023. Cyteir has made a strategic decision to halt further enrollment in the Phase 2 multiple myeloma monotherapy cohort and the dose-escalation combination cohort with rituximab plus bendamustine. This decision was based on the evolving treatment landscapes in multiple myeloma and diffuse large B-cell lymphoma, and the feasibility of development given the emerging competition.
We continue to perform metabolomic, genomic, and transcriptomic analyses on patient samples to identify potential patient selection biomarkers. Our understanding of the mechanism of action of CYT-0851 could potentially accelerate development of a biomarker and allow for expansion into additional opportunities in other tumor types. Progress on this work is expected to be updated by year-end 2022.
Update on Progress with CYT-1853
The development of CYT-1853 is paused and the filing of an Investigational New Drug (IND) application is postponed while Cyteir continues to evaluate the clinical results of the ongoing studies with CYT-0851. Accordingly, Cyteir will prioritize its resources on advancing CYT-0851 in the clinic and on its discovery research efforts to expand the company’s synthetically lethal preclinical pipeline.
Second Quarter 2022 Financial Results
Cash and cash equivalents: Cash and cash equivalents as of June 30, 2022 were $166.4 million. As a result of updates from the CYT-0851 program review and postponing CYT-1853 development, cash and cash equivalents are now expected to fund planned operations into the second half of 2024, which is longer than we previously forecasted.
Research and development (R&D) expenses: R&D expenses were $8.8 million for the second quarter of 2022 versus $8.9 million for the same period in 2021. The year-over-year decrease in R&D spending in the comparative periods was due primarily to decreased costs in external research activity offset by increased clinical trial expenses for the ongoing Phase 1/2 study of CYT-0851 and headcount.
General and administrative (G&A) expenses: G&A expenses were $3.4 million for the second quarter of 2022 compared to $2.4 million for the same period in 2021. The year-over-year increase in G&A expenses in the comparative periods was primarily due to employee-related costs, as well as other administrative expenses associated with company growth and operating as a public company.
Net loss: Net loss was $12.1 million, or $0.34 per share, in the second quarter of 2022 compared to $11.3 million, or $4.83 per share, for the same period in 2021.