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Cyclacel Pharmaceuticals, Inc. 2016 Annual Report

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Cyclacel Pharmaceuticals, Inc. 2016 Annual Report CDK inhibitors: a state-of-the-art class of www.cyclacel.com anticancer medicines CYCLACEL PHARMACEUTICALS, INC. INC. PHARMACEUTICALS, CYCLACEL Cell cycle pioneers: Improving patient lives with orally-available | innovative medicines REPORT ANNUAL 2016 Cyclacel Pharmaceuticals, Inc. | 2016 Annual Report Key Programs: Program Indication Preclinical Phase 1 Phase 2 Phase 3 Marketed Dear Fellow Stockholders, benefit of selective CDK inhibition and has led to great 2016 was a milestone year for our Company as we interest in further development of this class of drugs. completed follow-up in the Phase 3 SEAMLESS study Transcriptional Regulation Cyclacel’s founding scientist, Professor Sir David Lane, in elderly patients with acute myeloid leukemia, or AML. is a globally recognized authority in cell cycle biology SEAMLESS is one of the largest trials conducted in AML. who discovered p53, a key tumor suppressor gene that CYC065 Solid Tumor, We are grateful to the clinical investigators, the patients Phase 1 study malfunctions in about two-thirds of human cancers. Under CDK Inhibitor Blood Cancers and their families for their contributions to completing his guidance, Cyclacel’s drug discovery and development the study. As announced recently, the trial did not reach programs concentrated on the CDK2/9 isoforms, which statistically significant improvement in the primary operate as key components of the p53 pathway. DNA Damage Response endpoint of overall survival for the experimental arm versus an active control arm. However, an improvement Our efforts resulted in bringing two molecules in complete remission rate was observed. In the stratified Sapacitabine Solid Tumors into clinical trials: seliciclib, a first-generation, and and Seliciclib Phase 1/2 study subgroup of patients with low baseline peripheral white CYC065, a second-generation CDK inhibitor. Regimen BRCA mutation blood cell count, comprising approximately two-thirds of the study’s population, an improvement in overall CYC065, which is mechanistically similar but has survival was observed for the experimental arm. Cyclacel much higher dose potency, in vitro and in vivo, and Sapacitabine in Hematology plans to discuss the SEAMLESS data with regulatory improved metabolic stability than seliciclib, is in an authorities after completing ongoing analyses. ongoing, first-in-human, Phase 1 trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics Sapacitabine, Elderly AML SEAMLESS Phase 3 registration study BeBeyondyond SEAMLESEAMLESS,SS, CyclacelCyclacel is looking ahead with a CYC682 in patients with advanced solid tumors. In addition clearahead vision with aand clear stra visiontegy. and strategy. to determining safety and recommended dosing for Phase 2 trials, the study aims to investigate CYC065’s In our clinical development strategy, we are concentrating effects on the Mcl-1 biomarker, which is implicated our resources and efforts on two programs: 1) Progressing Sapacitabine, in the evolution of resistance in cancer. Evidence of MDS Phase 2 randomized study our CYC065 CDK inhibitor in our transcriptional CYC682 target engagement with prolonged Mcl-1 suppression in regulation program; 2) Progressing our sapacitabine peripheral blood cells was observed in patient samples and CDK inhibitor regimen in BRCA positive patients from the study, as well as decreases in kinase substrate with various cancers in our DNA damage response phosphorylation and increases in PARP cleavage, which Other program. These programs include our area of historical were consistent with the Company’s preclinical data. expertise in CDK inhibitors, and target biomarker- IND-directed selected patients, such as those with BRCA mutations CYC140 Esophageal, CYC065 was the subject of a number of presentations development PLK Inhibitor AML or patients experiencing resistance to existing cancer at scientific conferences during the year which completed therapies. We are encouraged by the continued demonstrated its molecular rationale and therapeutic support received from various stakeholders, the recent potential in both hematological and solid tumors. success of commercial stage CDK inhibitors and early Investigator Sponsored Trials Similarly to palbociclib and ribociclib, CYC065 may clinical data from our own CDK inhibitor trials. be most useful in combination with other anticancer agents, including Bcl-2 antagonists, such as venetoclax, Cushing’s During the year, we also strengthened our balance Seliciclib, disease and Phase 2 in Cushing’s disease and or HER2 inhibitors, such as trastuzumab. Subject to the CYC202 rheumatoid sheet with financing activities, raising approximately rheumatoid arthritis results of the ongoing Phase 1 study in patients with solid arthritis $6.8 million in aggregate net proceeds. As of this tumors, we also plan to evaluate CYC065 in patients writing, we estimate capital resources to be sufficient with hematological malignancies in light of profound to fund operations through the end of 2018. Licensing & Collaboration signals of activity observed in preclinical studies. Transcriptional Regulation Program: Cyclin DNA Damage Response DDR Program Dependent Kinase (CDK) Inhibitors Seliciclib, We continue to follow up patients with solid tumors in our Cystic fibrosis Phase 2 in Cystic fibrosis Recent Food and Drug Administration (FDA) approvals of CYC202 Phase 1/2 combination study of sapacitabine, dosed two CDK4/6 inhibitors, palbociclib and ribociclib for a type sequentially in part 1 or concomitantly in part 2 with of breast cancer, demonstrated the substantial clinical seliciclib, our first-generation CDK2/9 inhibitor. Interim AML = acute myeloid leukemia IND = investigational new drug MDS = myelodysplastic syndromes 01 Key Programs: Program Indication Preclinical Phase 1 Phase 2 Phase 3 Marketed Dear Fellow Stockholders, benefit of selective CDK inhibition and has led to great 2016 was a milestone year for our Company as we interest in further development of this class of drugs. completed follow-up in the Phase 3 SEAMLESS study Transcriptional Regulation Cyclacel’s founding scientist, Professor Sir David Lane, in elderly patients with acute myeloid leukemia, or AML. is a globally recognized authority in cell cycle biology SEAMLESS is one of the largest trials conducted in AML. who discovered p53, a key tumor suppressor gene that CYC065 Solid Tumor, We are grateful to the clinical investigators, the patients Phase 1 study malfunctions in about two-thirds of human cancers. Under CDK Inhibitor Blood Cancers and their families for their contributions to completing his guidance, Cyclacel’s drug discovery and development the study. As announced recently, the trial did not reach programs concentrated on the CDK2/9 isoforms, which statistically significant improvement in the primary operate as key components of the p53 pathway. DNA Damage Response endpoint of overall survival for the experimental arm versus an active control arm. However, an improvement Our efforts resulted in bringing two molecules in complete remission rate was observed. In the stratified Sapacitabine Solid Tumors into clinical trials: seliciclib, a first-generation, and and Seliciclib Phase 1/2 study subgroup of patients with low baseline peripheral white CYC065, a second-generation CDK inhibitor. Regimen BRCA mutation blood cell count, comprising approximately two-thirds of the study’s population, an improvement in overall CYC065, which is mechanistically similar but has survival was observed for the experimental arm. Cyclacel much higher dose potency, in vitro and in vivo, and Sapacitabine in Hematology plans to discuss the SEAMLESS data with regulatory improved metabolic stability than seliciclib, is in an authorities after completing ongoing analyses. ongoing, first-in-human, Phase 1 trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics Sapacitabine, Elderly AML SEAMLESS Phase 3 registration study BeBeyondyond SEAMLESEAMLESS,SS, CyclacelCyclacel is looking ahead with a CYC682 in patients with advanced solid tumors. In addition clearahead vision with aand clear stra visiontegy. and strategy. to determining safety and recommended dosing for Phase 2 trials, the study aims to investigate CYC065’s In our clinical development strategy, we are concentrating effects on the Mcl-1 biomarker, which is implicated our resources and efforts on two programs: 1) Progressing Sapacitabine, in the evolution of resistance in cancer. Evidence of MDS Phase 2 randomized study our CYC065 CDK inhibitor in our transcriptional CYC682 target engagement with prolonged Mcl-1 suppression in regulation program; 2) Progressing our sapacitabine peripheral blood cells was observed in patient samples and CDK inhibitor regimen in BRCA positive patients from the study, as well as decreases in kinase substrate with various cancers in our DNA damage response phosphorylation and increases in PARP cleavage, which Other program. These programs include our area of historical were consistent with the Company’s preclinical data. expertise in CDK inhibitors, and target biomarker- IND-directed selected patients, such as those with BRCA mutations CYC140 Esophageal, CYC065 was the subject of a number of presentations development PLK Inhibitor AML or patients experiencing resistance to existing cancer at scientific conferences during the year which completed therapies. We are encouraged by the continued demonstrated its molecular rationale and therapeutic support received from various stakeholders, the recent potential in both
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