On May 5, 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 first quarter ended March 31, 2022 and provided an update on recent operational highlights (Press release, Cyteir Therapeutics, MAY 5, 2022, View Source [SID1234613711]).
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"In the first quarter, we began enrollment in the Phase 2 expansion cohorts with CYT-0851 monotherapy and continued enrolling in the Phase 1 combination study. Our R&D Day in April highlighted the exceptional work of our discovery research team that has provided us with a greater understanding of the mechanism of action for CYT-0851, potentially expanding the opportunity of the drug into new tumor types," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "I am proud of the entire Cyteir team and look forward to delivering on key data reporting milestones in the second half of the year."
First Quarter 2022 Accomplishments
Advanced CYT-0851 Clinical Program
Progress continues to advance CYT-0851 in monotherapy and combination clinical studies. Enrollment is ongoing in six disease-specific Phase 2 expansion cohorts with monotherapy in hematologic malignancies and solid tumors. Completion of stage 1 of this study is expected before the end of 2022. Enrollment is also ongoing in a Phase 1 combination study of CYT-0851 with three standard-of-care regimens: (1) rituximab plus bendamustine; (2) gemcitabine; and (3) capecitabine, in both hematologic malignancies and solid tumors. Initial safety data from this combination study is expected before the end of 2022.
A poster with updated data from the Phase 1 dose-escalation portion of the first-in-human Phase 1/2 trial of CYT-0851 will be presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 5, 2022.
Continued to Advance Our Synthetically Lethal Preclinical Pipeline
Cyteir continues to advance two previously reported discovery projects focused on identifying inhibitors of DNA damage repair. The first of these undisclosed targets (Target 2) plays a key role in Non-Homologous End Joining (NHEJ) and the second (Target 3) in Microhomology-Mediated End Joining (MMEJ) DNA repair pathways. Both undisclosed target projects are currently in lead generation, and we anticipate reaching the drug candidate nomination stage in 2023.
Cyteir expects to complete IND-enabling studies for CYT-1853 in the first half of 2022, and if the data supports an overall risk-benefit improvement and differentiation from CYT-0851, Cyteir plans to file an IND application with the FDA before the end of 2022.
CYT-0851 Mechanism of Action Due to Inhibition of Monocarboxylate Transporters, Essential Proteins in Cancer Metabolism
Based on molecular, bioinformatic, and biochemical characterization research that has been done at Cyteir to elucidate the mechanism of action of CYT-0851, management believes that the observed effects of CYT-0851 on the viability of cancer cells are due to inhibition of monocarboxylate transporter (MCT) activity and the subsequent disruption of lactate transport. Monocarboxylate transporters are essential proteins in cancer metabolism making MCTs an attractive target for cancer therapy. Based on the newly identified mechanism of action, the patient selection biomarker discovery strategy has been modified while all aspects of the trial design remain appropriate and unchanged. This new 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. The initial results from the work on our biomarker were presented in a virtual R&D Day in April.
First Quarter 2022 Financial Results
Cash and cash equivalents: Cash and cash equivalents as of March 31, 2022 were $177.4 million, which are expected to fund planned operations into 2024.
Research and development (R&D) expenses: R&D expenses were $10.1 million for the first quarter of 2022 versus $5.6 million for the same period in 2021. The year-over-year increase in R&D spending in the comparative periods was due primarily to increased research activity, clinical trial expenses, and headcount, including the ongoing of Phase 1 and Phase 2 studies for CYT-0851.
General and administrative (G&A) expenses: G&A expenses were $4.0 million for the first quarter of 2022 compared to $1.7 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 $14.1 million, or $0.40 per share, in the first quarter of 2022 compared to $7.3 million, or $3.40 per share, for the same period in 2021.