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Cyclacel Pharmaceuticals Reports Third Quarter 2015 Financial Results

The following excerpt is from the company's SEC filing.

BERKELEY HEIGHTS, N.J., Nov. 12, 2015 - 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, today reported its financial results and business highlights for the third quarter ended September 30, 2015.

The Company's net loss applicable to common shareholders for the third quarter ended September 30, 2015 was $2.8 million, or $0.08 per basic and diluted share, compared to a net loss applicable to common shareholders of $5.0 million, or $0.22 per basic and diluted share for the third quarter ended September 30, 2014. As of September 30, 2015, cash and cash equivalents totaled $22.7 million.

"SEAMLESS continues to progress towards final data read-out,” said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. “There are now approximately 8% of events remaining to occur and we anticipate reporting top-line data during the first half of 2016. Following unblinding and analysis of the data, we will review the results to determine their suitability for submission to regulators. Our CDK2/9 programs made significant progress over the quarter. The CYC065 Phase 1 trial in solid tumor and lymphoma patients has started and the mechanistic rationale for CDK2/9 inhibition in targeted solid tumors and hematological malignancies is supported by multiple presentations at scientific conferences. Seliciclib was administered to the first patients with Cushing’s disease in an investigator-sponsored trial. We and our investigators are excited about the prospects of CDK2/9 inhibitors and we look forward to keeping you apprised as to our progress."

Business Highlights

Sapacitabine in SEAMLESS, pivotal, Phase 3 study for first-line treatment in elderly patients with acute myeloid leukemia (AML):

Continued follow-up with 8% of events remaining before analyzing mature data and reporting top-line results. The SEAMLESS study is powered at 90% to detect a 27.5% improvement of survival between the experimental and control arms.

Cyclin Dependent Kinase (CDK) Inhibitor Programs

Presented the molecular rationale for clinical development of CYC065 for the treatment of solid tumors at the AACR-NCI-EORTC International Conference: Molecular Targets and Cancer Therapeutics

Dosed the first patient in a first-in-human, Phase 1 trial of CYC065, the Company’s second-generation CDK2/9 inhibitor, in solid tumor and lymphoma patients to evaluate the safety, tolerability and pharmacokinetic profile of CYC065

200 Connell Drive, Suite 1500, Berkeley Heights, NJ 07922 USA T: +1 (908) 517 7330 F: +1 (866) 271 3466

Dundee Technopole, James Lindsay Place, Dundee, DD1 5JJ, UK Tel +44 1382 206 062 Fax +44 1382 206 067

www.cyclacel.com

info@cyclacel.com

Presented the molecular rationale for clinical development of CYC065 for the treatment of leukemias and lymphomas at the Society of Hematologic Oncology (SOHO) 2015 Annual Meeting

Dosed the first patient in a Phase 2 investigator-sponsored trial (IST) evaluating seliciclib as a potential treatment for Cushing’s disease.

CYC065 data to be presented at the upcoming

2015 San Antonio Breast Cancer Symposium in Texas and at the

Neuroblastoma Symposium in Newcastle Upon Tyne, United Kingdom

Third Quarter 2015 Financial...


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