On November 14, 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 financial results and business highlights for the third quarter ended September 30, 2016 (Press release, Cyclacel, NOV 14, 2016, View Source [SID1234516611]).

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The Company’s net loss applicable to common shareholders for the third quarter ended September 30, 2016 was $3.0 million, or $0.86 per basic and diluted share, compared to net loss applicable to common shareholders of $2.8 million, or $0.95 per basic and diluted share for the third quarter ended September 30, 2015. As of September 30, 2016, cash and cash equivalents totaled $18.0 million.

"SEAMLESS, a Phase 3 study of oral sapacitabine capsules, represents one of the largest clinical trials conducted in elderly patients with AML who are unfit for or refused intensive chemotherapy. Following completion of follow-up at the beginning of the quarter, we have been conducting data validation operations," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "We are pleased to report that this process is nearing completion following which the database will be locked and transferred to our statistical analysis vendor. We anticipate reporting top line results late in the fourth quarter of 2016 or in early 2017."

"The collection and processing of SEAMLESS Phase 3 data represent many years of effort in our search to offer a new treatment regimen for this older patient population. We will soon analyze the data and determine whether the results warrant regulatory submissions," said Dr. Judy Chiao, VP, Clinical Development and Regulatory Affairs. "We are grateful to the patients, their families, the investigators and their teams for their valuable contributions to this study."

"During the quarter data presented at a pediatric cancer meeting demonstrated that CYC065, our second generation Cyclin Dependent Kinase (CDK) inhibitor, prolonged survival in MYCN-addicted neuroblastoma models. The data further validate the mechanism of CYC065 and provide a rationale for clinical investigation in neuroblastoma with MYCN amplification, a major oncogenic driver of this childhood cancer. MYC family proteins are important therapeutic targets in other oncology indications, including certain solid tumors, leukemias and lymphomas. Early clinical and preclinical data from our DNA damage response program suggest that our transcriptional CDK inhibitors may have a synergistic effect with other anticancer agents, including sapacitabine. We look forward to reporting new data from our ongoing clinical studies of sapacitabine and seliciclib in BRCA positive patients and of CYC065 in patients with solid tumors," continued Mr. Rombotis.

BUSINESS HIGHLIGHTS

SEAMLESS study

Phase 3 study of oral sapacitabine capsules alternating with intravenous decitabine compared to decitabine alone, as first-line treatment in patients aged 70 years or older with AML who are unfit for or refused intensive chemotherapy; cleaned and validated dataset being finalized and database lock imminent.
DNA damage response program

The Phase 1 combination of sapacitabine and seliciclib is continuing enrollment in an extension study in an enriched population of BRCA positive patients with advanced breast cancer.
Cyclin dependent kinase (CDK) inhibitor program

Continued recruitment in Phase 1, first-in-human trial of CYC065, a CDK2/9 inhibitor, to evaluate safety, tolerability and pharmacokinetics in patients with solid tumors. The sixth dose escalation level has been reached.

Preclinical data presented at the Childhood Cancer Meeting 2016 demonstrated effectiveness of CYC065 against neuroblastoma models with an overexpression and amplification of MYCN, a driver of neuroblastoma.
KEY UPCOMING MILESTONES

SEAMLESS study

Report top-line data and determination of submissibility to regulatory authorities, anticipated late fourth quarter 2016 or early 2017.
Progress the Paediatric Investigation Plan for sapacitabine with the European Medicines Agency.
DNA damage response program

Progress Phase 1 sapacitabine and seliciclib extension cohort in a breast cancer patient population enriched for BRCA mutations.
Initiate Phase 1 part 3, to include BRCA mutation positive, pancreatic and ovarian cancer patients.
CDK Inhibitor Program

Report top-line results of the CYC065 Phase 1 trial in patients with solid tumors.
Report data when available from ongoing investigator sponsored trials (ISTs) evaluating seliciclib in patients with Cushing’s disease and rheumatoid arthritis. Additionally, seliciclib is being evaluated in cystic fibrosis though a license and supply agreement with ManRos Therapeutics.
Sapacitabine in myelodysplastic syndromes (MDS)

Plan 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.
THIRD QUARTER 2016 FINANCIAL RESULTS

Cash and cash equivalents totaled $18.0 million as of September 30, 2016 compared to $20.4 million at December 31, 2015. Approximately $5.2 million was raised from the sale of common stock through the Company’s at-the-market facility with FBR Capital Markets. A further $1.5 million was received in October 2016 through this facility, resulting in a proforma cash balance as of September 30, 2016 of $19.5 million. Based on current plans, the Company estimates that it has capital resources to fund operations through the second quarter of 2018.

Revenue for the three months ended September 30, 2016 was $0.2 million, compared to $0.7 million for the same period of the previous year, with the decrease primarily related to grant revenue related to CYC065, for which the grant ended in December 2015.

Research and development expenses were $2.4 million for the three months ended September 30, 2016 and $2.9 million for the three months ended September 30, 2015.

General and administrative expenses were $1.3 million for the three months ended September 30, 2016 and $1.2 million for the three months ended September 30, 2015.