On March 28, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported its financial results and business highlights for the fourth quarter and full year ended December 31, 2021 (Press release, Cyclacel, MAR 28, 2022, View Source [SID1234611051]).
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"2021 was a year of solid execution, as the clinical and corporate objectives achieved by the Cyclacel team have positioned us to reach important milestones in 2022. These include initial data from the dose escalation stage of the ongoing Phase 1/2 study of fadraciclib, our CDK2/9 inhibitor, in advanced solid tumors", said Spiro Rombotis, President and Chief Executive Officer. "Enrollment has gone well with three new patients treated at dose level 4 at our two U.S. sites and two internationally recognized, cancer centers in Asia and Western Europe who recently joined the study. In 2022 we plan to report new clinical and preclinical evidence supporting the unique properties and therapeutic potential of fadraciclib. We believe that fadraciclib is emerging as the only transcriptional CDK inhibitor in development to have demonstrated single-agent activity and tolerable daily dosing by mouth in patients with solid tumors. If confirmed with additional data, fadraciclib may emerge as an important alternative for the treatment of advanced solid tumors in patients failing available therapies.
In addition, we expect imminent dosing of the first patient with oral CYC140, our novel, PLK1 inhibitor, in a Phase 1/2 study in advanced solid tumors. We are also enrolling patients with hematological malignancies in the dose escalation stage of a Phase 1/2 study of oral fadraciclib. We look forward to providing updates and further clinical and preclinical data from our ongoing programs as they become available."
Key Highlights
·12 patients with advanced solid tumors treated in four dose levels of 065-101 study of oral fadraciclib. Dose level 4 is 100mg given twice a day for 5 days for 3 weeks in a 4-week cycle. The proof-of-concept stage of this Phase 1/2 registration-directed study includes 7 histologically defined cohorts thought to be sensitive to the drug’s mechanism: breast, colorectal (including KRAS mutant), endometrial/ uterine, hepatobiliary, ovarian cancers and lymphomas. The study also includes a basket cohort which will enroll patients regardless of histology with biomarkers relevant to the drug’s mechanism, including MCL1, MYC and/or cyclin E amplified.
·Seoul National University Hospital, Seoul, South Korea and Vall d’Hebron University Hospital, Barcelona, Spain were added to the 065-101 oral fadraciclib study selected for their expertise with tumor types of interest.
·Two patients dosed in the 065-102 study of oral fadraciclib in patients with leukemia or myelodysplastic syndromes.
·Opened 140-101, a registration-directed, Phase 1/2 study of CYC140 in solid tumors, now recruiting. This Phase 1/2 registration-directed trial uses a streamlined design and will determine in dose escalation the recommended Phase 2 dose (RP2D) for single-agent oral CYC140. Once RP2D has been established, the trial will immediately enter into proof-of-concept, cohort stage, using a Simon 2-stage design. In this stage CYC140 will be administered to patients in up to seven mechanistically relevant cohorts plus a basket cohort which will enroll patients with biomarkers relevant to the drug’s mechanism.
·Preclinical studies are in progress to inform clinical development of fadraciclib and support selection of histologies for 140-101.
More information on our clinical trials can be found here.
Key Business Objectives for 2022
1H 2022
·Dose first patient with oral CYC140 in the 140-101 advanced solid tumor study
·Initial data from Phase 1 dose escalation of the 065-101 solid tumor study of oral fadraciclib
2H 2022
·Enter Phase 2 proof of concept stage in the 065-101 solid tumor study of oral fadraciclib in 8 cohorts (7 by histology and a basket cohort)
·Initial data from Phase 1 dose-escalation of the 065-102 leukemia study of oral fadraciclib
Financial Highlights
As of December 31, 2021, cash and cash equivalents totaled $36.6 million, compared to $33.4 million as of December 31, 2020. The increase of $3.2 million was primarily due to $21.7 million cash provided by financing activities, offset by $18.5 million net cash used in operating activities. The Company estimates that available cash resources will fund currently planned programs through mid-2023.
Research and development (R&D) expenses were $4.6 million and $15.5 million for the three months and year ended December 31, 2021, as compared to $1.4 million and $4.8 million for the same periods in 2020. R&D expenses relating to fadraciclib were $3.4 million and $11.1 million for the three months and year ended December 31, 2021, as compared to $1.1 million and $3.7 million for the same periods in 2020 due to clinical trial expenses for the evaluation of fadraciclib in Phase 1/2 studies and clinical supply manufacturing. Additionally, R&D expenses related to CYC140 were $1.1 million and $3.6 million for the three months and year ended December 31, 2021, as compared to $0.2 million and $0.6 million for the same periods in 2020 as preclinical evaluation and clinical trial supply manufacturing of CYC140 progressed.
General and administrative (G&A) expenses for the three months and year ended December 31, 2021, were $1.9 million and $7.5 million, compared to $1.8 million and $5.9 million for the same periods of the previous year due to increased legal and professional and personnel costs and a lease assignment. G&A expenses included non-cash stock compensation costs of $0.1 million and $0.8 million for the three months and full year ended December 31, 2021, compared to $0.1 million and $0.3 million for the same periods in 2020. United Kingdom research & development tax credits were $1.2 million and $3.8 million for the three months and year ended December 31, 2021, as compared to $0.4 million and $1.2 million for the same period in 2020 due to the increase in eligible R&D expenditure.
Net loss for the three months and year ended December 31, 2021, was $5.3 million and $18.9 million, compared to $2.8 million and $8.4 million for the same periods in 2020.
For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.