On January 6, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported a business update reviewing 2021 achievements and outlining the Company’s key business objectives for 2022 (Press release, Cyclacel, JAN 6, 2022, View Source [SID1234598356]).

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"This past year proved to be very productive for Cyclacel as we achieved our planned business objectives," said Spiro Rombotis, President and Chief Executive Officer. "First and foremost, we initiated two registration-directed, Phase 1/2 trials for our lead candidate fadraciclib, an oral CDK2/9 inhibitor. These studies are assessing fadraciclib activity across a range of solid tumors and hematological malignancies. In the solid tumor study we are enrolling patients at the third dose level using a schedule of twice daily dosing for five days, for 3 out of 4 weeks. In the leukemia study we are enrolling patients at the initial dosing level. We have also completed FDA review of an Investigational New Drug Application (IND) of CYC140, a differentiated oral PLK1 inhibitor, and received clearance to proceed with a registration-directed Phase 1/2 study in solid tumors. Finally, we strengthened our balance sheet in the year which provides a cash runway until early 2023."

"In early 2022 we expect to dose the first patient in our third, registration-directed, Phase 1/2 study, which will evaluate CYC140 across various solid tumors. We are currently planning our fourth registration-directed trial of CYC140 in hematological malignancies to follow soon thereafter. We also anticipate updates from collaborative, preclinical research studies providing valuable insights into which tumor histologies may be sensitive to CYC140’s mechanism of action. We anticipate reporting initial data for oral fadraciclib in solid tumors and lymphomas at a major medical meeting in the first half of 2022, which could be an exciting year for our company."

2021 Key Achievements

Seven patients with advanced solid tumors treated in the 065-101 study of oral fadraciclib
Three internationally recognized cancer treatment centers now enrolling in the 065-101 study selected for their expertise with tumor types of interest
First patient dosed in the 065-102 study of oral fadraciclib in patients with leukemia or myelodysplastic syndromes
Preclinical studies in progress to inform clinical development of fadraciclib
FDA clearance of our IND to proceed with 140-101, a streamlined, registration-directed, Phase 1/2 study of oral CYC140 in solid tumors
Preclinical studies in progress to support selection of histologies for CYC140 Phase 1/2 study
Raised $14.5 million in gross proceeds in a public offering in the first quarter of 2021
Key Business Objectives for 2022

First patient to be dosed with oral CYC140 in the 140-101 solid tumor study
Initial data from Phase 1 dose escalation of the 065-101 solid tumor study of oral fadraciclib
First patient to be dosed with oral CYC140 in the 140-102 leukemia study
Commence Phase 2 proof of concept stage in the 065-101 solid tumor study of oral fadraciclib
Initial data from Phase 1 dose-escalation of the 065-102 leukemia study of oral fadraciclib
Commence Phase 2 proof of concept stage of oral fadraciclib in the 065-102 leukemia study