On March 24, 2016 Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP); "Cyclacel" or the "Company"), a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, reported its financial results and business highlights for the fourth quarter and full year ended December 31, 2015 (Press release, Cyclacel, MAR 24, 2016, View Source [SID:1234509935]).
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The Company’s net loss applicable to common shareholders for the fourth quarter ended December 31, 2015 was $3.4 million, or $0.10 per basic and diluted share, compared to net loss applicable to common shareholders of $4.8 million, or $0.21 per basic and diluted share for the fourth quarter ended December 31, 2014. As of December 31, 2015, cash and cash equivalents totaled $20.4 million.
"In SEAMLESS, our Phase 3 pivotal study in acute myeloid leukemia (AML), approximately 4% of required events remain to be observed before mature data become available, expected around the first half of 2016 or approximately 18 months after completion of enrollment," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "The primary endpoint of the study is overall survival. After top-line data readout, the mature data will be evaluated for submissibility to regulatory authorities. In parallel, we have been progressing our CDK inhibitor programs. We have reported encouraging interim data from the ongoing Phase 1/2 combination trial of seliciclib and sapacitabine in solid tumor patients, including durable partial responses and stable disease in patients with BRCA positive breast, ovarian and pancreatic cancers. In particular, two ongoing patients with BRCA positive breast cancer have achieved over 1 and 4.5 years of treatment, respectively. In light of these data and investigator interest, we have started an extension cohort in a BRCA-enriched population of breast cancer patients. Last fall we initiated a first-in-human, Phase 1 study of CYC065, our second-generation CDK2/9 inhibitor, in patients with solid tumors and lymphomas following extensive preclinical data in the literature suggesting broad activity of CYC065 in both liquid and solid tumor models. The Cyclacel team continues to pursue the vision of our founders, as appreciation of the importance of CDK inhibitors is increasing among the medical community."
Recent Business Highlights
SEAMLESS Study
Continued follow up of patients enrolled in SEAMLESS, a Phase 3 study of orally-administered sapacitabine alternating with intravenous decitabine compared to decitabine alone, as first-line treatment in patients aged 70 years or older with AML.
Approximately 4% of the pre-specified events remain to be observed until mature data become available for analysis.
Submitted to the European Medicines Agency (EMA) a Paediatric Investigation Plan application for sapacitabine.
Cyclin Dependent Kinase 2/9 (CDK2/9) Inhibitor Programs
Dosed first patients in an extension cohort of the Phase 1/2 combination study of seliciclib and sapacitabine in a population of BRCA-positive breast cancer patients. In the first part of the study, several patients with BRCA positive breast, ovarian and pancreatic cancers achieved durable partial responses and stable disease.
Continued patient recruitment in the first-in-human trial of CYC065, a second-generation CDK2/9 inhibitor, to evaluate the safety, tolerability and pharmacokinetic profile of CYC065 in patients with solid tumors and lymphomas.
Presented preclinical data on the molecular rationale and therapeutic potential in both hematologic and solid tumors of CYC065 at several medical conferences during the fourth quarter, including the Society of Hematologic Oncology (SOHO) 2015 Annual Meeting, the AACR (Free AACR Whitepaper)-NCI-EORTC International Conference, the San Antonio Breast Cancer Symposium (SABCS) and the Neuroblastoma UK Annual Meeting.
Cyclacel’s Key Milestones for 2016
Sapacitabine in SEAMLESS
Continue follow-up of patients until the requisite number of events occur, which is anticipated around the end of the first half of 2016.
Report top-line results.
Determine submissibility to regulatory authorities for marketing approval following analysis of the mature data set.
Progress a Paediatric Investigation Plan for sapacitabine with the EMA.
Sapacitabine in myelodysplastic syndromes (MDS):
Initiate a Phase 1/2 trial of sapacitabine in combination with other agents to determine safety and tolerability.
Plan a Phase 2 randomized controlled trial (RCT) of sapacitabine in combination with other agents following review of all relevant clinical data with mature follow-up.
CDK Inhibitor Programs
Progress the seliciclib and sapacitabine Phase 1/2 study in an extension cohort of breast cancer patients enriched for BRCA mutations.
Report updated Phase 1 seliciclib and sapacitabine combination data in approximately 60 patients with advanced solid tumors.
Report top-line results of the CYC065 Phase 1 trial in patients with solid tumors and lymphomas.
Present additional preclinical data on CYC065 at the upcoming AACR (Free AACR Whitepaper) conference in April.
Report data when available from on-going investigator sponsored trials (ISTs) evaluating seliciclib in patients with Cushing’s disease and rheumatoid arthritis. Seliciclib is also being evaluated in cystic fibrosis through a license and supply agreement with ManRos Therapeutics.
Fourth Quarter 2015 Financial Results
Grant Revenue
Revenue for the three months ended December 31, 2015 was $0.4 million compared to $0.2 million for the same period of the previous year. The revenue is related to previously awarded grants from the UK government being recognized over the period to progress CYC065 to IND and complete IND-directed preclinical development of CYC140, a novel, orally available, Polo-Like Kinase 1 (PLK 1) inhibitor.
Research and Development Expenses
Research and development expenses decreased to $2.6 million for the three months ended December 31, 2015 compared to $4.4 million for the same period in the previous year. The decrease was primarily due to reduced study and clinical supply costs associated with the SEAMLESS Phase 3 trial, which completed enrollment in December 2014, offset by increased expenditures primarily related to the first-in-human, Phase 1 study of CYC065 and grant supported research and development.
General and Administrative Expenses
General and administrative expenses for the three months ended December 31, 2015 increased to $1.7 million, compared to $1.6 million for the same period in 2014.
Based on current plans, the Company estimates that it has capital resources to reach beyond the final analysis of SEAMLESS and continue existing programs through the end of 2017.