On March 16, 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 fourth quarter and full year ended December 31, 2021 and provided an update on recent operational highlights (Press release, Cyteir Therapeutics, MAR 16, 2022, View Source [SID1234610169]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"In 2021, we made significant progress towards our goal of advancing our lead program CYT-0851 in the clinic with the completion of a dose escalation study and identification of the recommended Phase 2 dose. Our interim analysis demonstrated anti-tumor effects with disease control and responses in heavily pretreated and progressing lymphoma and solid tumor patients, with a safety profile consisting primarily of mild adverse events," said Markus Renschler, MD, President and Chief Executive Officer of Cyteir. "We are now dosing patients in the Phase 2 monotherapy expansion cohorts and have begun Phase 1 combination therapy cohorts. We expect interim safety and efficacy data read-outs from these cohorts this year that may allow us to design one or more potentially registrational trials. We continue to invest in our pipeline and are advancing two new targets from our synthetic lethality DNA damage response platform toward the clinic."
Fourth Quarter and Full Year 2021 Accomplishments
Advanced CYT-0851 Clinical Program
Cyteir completed the dose-escalation portion of the first-in-human Phase 1/2 trial of CYT-0851 up to the maximum feasible daily dose of 1200 mg and determined the maximum tolerated dose of 600 mg per day. The recommended Phase 2 dose was identified as 400 mg per day. An interim analysis of the Phase 1 portion was presented in an oral session at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting. In a heavily pretreated and progressing patient group typical of Phase 1 studies, we demonstrated disease control in 20 of 46 response evaluable patients, including three responses in non-Hodgkin lymphoma and soft tissue sarcoma. No patient at or below the recommended Phase 2 dose discontinued treatment for treatment-related adverse events. The three most common treatment-related adverse events were fatigue (21% of patients), hyperuricemia (11%), and nausea (11%). There was no clinically significant myelosuppression.
We began enrolling patients in six disease-specific Phase 2 expansion cohorts with monotherapy in hematologic malignancies and solid tumors. In January 2022, the first patient was dosed. Completion of stage 1 of this study is expected before the end of 2022.
Simultaneously, we initiated 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. In January 2022, we dosed the first patient in the study, and we are currently enrolling additional patients. Initial safety data from this combination study is expected before the end of 2022.
In total for our CYT-0851 Phase 1/2 trial, we are now actively enrolling nine patient cohorts in both monotherapy and combination therapy with interim safety results expected in 2022.
Advanced DNA Damage Response (DDR) Platform
In 2021, we initiated two additional drug 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. For both targeted drug discovery projects, we have identified subsets of cancers that, we believe, uniquely depend on the target of interest for their survival and we are working to identify patient selection biomarkers to identify these cancer subsets for use in drug candidate development. Both undisclosed target projects are currently in lead generation, and we anticipate reaching the drug candidate nomination stage in 2023.
We expect 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, we plan to file an IND application with the FDA before the end of 2022.
Efficient execution of research and clinical strategy with cash runway into 2024
Ended 2021 with approximately $190 million in cash and cash equivalents with cash runway expected to extend into 2024
Continued investment in our clinical and preclinical portfolio
Progress achieved in key clinical milestones, including advancing CYT-0851 monotherapy to Phase 2 and initiating Phase 1 combination therapy study
Continuing to build management and research teams while maintaining low employee turnover
2022 Key Milestones Completed
Dose first patient in the Phase 1 CYT-0851 combination therapy cohorts
Dose first patient in the Phase 2 CYT-0851 monotherapy expansion cohorts
2022 Expected Key Milestones Completed
Present data from Phase 1 CYT-0851 monotherapy dose escalation study
Announce top line safety data from Phase 1 CYT-0851 combination therapy study
Announce top line interim results from stage 1 of CYT-0851 Phase 2 monotherapy study
Design potential registrational trial for one or more indications with CYT-0851
File IND for CYT-1853
Continue to elucidate CYT-0851’s molecular target and mechanism of action
Lead optimization of NHEJ inhibitor leading to potential target nomination in 2023
Lead optimization of MMEJ inhibitor leading to potential target nomination in 2023
Fourth Quarter and Full Year 2021 Financial Results
Cash and cash equivalents: Cash and cash equivalents as of December 31, 2021 were $189.7 million, which are expected to fund planned operations into 2024.
Research and development (R&D) expenses: R&D expenses were $8.3 million for the fourth quarter of 2021 versus $3.9 million for the same period in 2020 and $31.0 million for the full year 2021 versus $16.8 million for full year 2020. 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 initiation of Phase 1 and Phase 2 studies for our product CYT-0851.
General and administrative (G&A) expenses: G&A expenses were $3.6 million for the fourth quarter of 2021 compared to $1.5 million for the same period in 2020 and $11.3 million for the full year 2021 compared to $4.2 million for full year 2020. 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 $11.8 million, or $0.34 per share, in the fourth quarter of 2021 compared to $5.4 million, or $2.92 per share, for the same period in 2020. For the full year 2021, net loss was $42.1 million, or $2.16 per share compared to $20.8 million, or $13.60 per share for full year 2020.
Fourth Quarter and Full year 2021 Conference Call and Webcast Information
Cyteir will host a conference call to discuss the fourth quarter and full year of 2021 financial and operational results on Wednesday, March 16, 2022, at 4:30 p.m. ET. The conference call will be available by webcast on the Investor Relations page at www.cyteir.com. An audio replay of the call will be available on the website after 9:00 p.m. ET the same day.