Full Press Release Details
CYCLACEL PHARMACEUTICALS REPORTS FOURTH
QUARTER AND FULL YEAR 2016 FINANCIAL RESULTS
Call Scheduled March 28, 2017 at 4:30 p.m. EDT -
Berkeley Heights, NJ, March 28,
2017 - 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 fourth quarter and full year ended December 31,
2016. The Company's net loss applicable to common shareholders for the three months and year ended December 31, 2016 was $2.9 million
and $12.0 million, respectively. As of December 31, 2016, cash and cash equivalents totaled $16.5 million.
"Following the outcome of the
SEAMLESS study and a review of our clinical development pipeline we will concentrate our resources on our transcriptional regulation
and DNA damage response clinical stage programs," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel.
"While we will discuss the SEAMLESS data with regulators after completing ongoing analyses, we are looking ahead with a clear
strategy. We are dedicating our efforts and resources to progressing our CYC065 CDK inhibitor program and the promise in our BRCA
positive stratified, sapacitabine and CDK inhibitor study. We are encouraged by the support received from various stakeholders,
the recent success of commercial stage CDK inhibitors and early clinical data from our own CDK inhibitor trials."
Fourth Quarter and Full Year Highlights
Transcriptional Regulation Program
-Cyclin Dependent Kinase (CDK) inhibitors
DNA Damage Response (DDR) program
200 Connell Drive, Suite 1500, Berkeley Heights, NJ 07922,
USA Tel +1 908 517 7330 Fax +1 866 271 3466
1 James Lindsay Place, Dundee, DD1 5JJ, UK Tel +44 1382
206 062 Fax +44 1382 206 067
SEAMLESS Study in Elderly Patients
with Acute Myeloid Leukemia (AML)
Poster Presentation on the PLK Inhibitor CYC140 at the
Today, Cyclacel also announced a poster presentation at
the American Association for Cancer Research 2017 Annual Meeting to be held April 1-5 in Washington, D.C. The poster is
titled "The novel PLK1 inhibitor, CYC140: Identification of pharmacodynamic markers, sensitive target indications
and potential combinations" (Poster Board 1, Abstract number 4178, Convention Center, Halls A-C, Poster Section 7).
The poster details Cyclacel's preclinical study to identify target indications including acute leukemia and esophageal
cancer. The results will be presented in a session titled "Targeting Protein Kinases and DNA Repair" on Tuesday
Apr 4, 2017 1:00 PM - 5:00 PM Eastern Time.
Data presented in December 2016 at
the 28th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium, demonstrated anti-tumor activity of CYC140
in preclinical xenograft models of acute leukemia and solid tumors, including esophageal cancer, with tumor growth delay, tumor
regression and cures being observed. Several pharmacodynamic markers were identified and activity was demonstrated in a majority
of malignant cell lines derived from AML, acute lymphoblastic leukemia (ALL) and esophageal cancer.
Financial Highlights
As of December 31, 2016, cash and
cash equivalents totaled $16.5 million, compared to $20.4 million as of December 31, 2015. The decrease of $3.9 million was primarily
due to $10.1 million of net cash used in operating activities, partially offset by net proceeds of $6.8 million from the sale of
common stock through the ATM sales agreement with FBR Capital Markets & Co.
Revenue for the three months and year
ended December 31, 2016 were $0.3 million and $0.8 million respectively, compared to $0.4 million and $1.9 million for the same
periods of the previous year. The revenue is primarily related to previously awarded grants from the UK government being recognized
over the period to progress CYC065 to IND, which was completed in 2015, and IND-directed preclinical development of CYC140, a novel,
orally available, Polo-Like Kinase 1 (PLK 1) inhibitor, completed in November 2016.
Research and development expenses
were $1.9 million and $9.5 million for the three months and year ended December 31, 2016 respectively, compared to $2.6 million
and $12.4 million for the same periods of the previous year. The decrease was primarily due to reduced study and clinical supply
costs associated with the completion of the SEAMLESS study.
General and administrative expenses
for the three months and year ended December 31, 2016 were $1.5 million and $5.5 million respectively, compared to $1.7 million
and $5.7 million for the same periods of the previous year.
Other income (expense), net for the
three months and year ended December 31, 2016 were $(0.1) million and $0.4 million, compared to nil and $(0.3) million for the
same period of the previous year. The increase in other income (expense) is primarily related to foreign exchange movements.
United Kingdom research & tax
credits were $0.4 million and $2.0 million for the three months and year ended December 31, 2016 respectively, compared to $0.5
million and $2.1 million for the same periods of the previous year. The cash receipt for the 2016 tax credit of $2.0 million is
expected to be received in the second quarter of 2017, which results in proforma cash and cash equivalents of $18.5 million as
of December 31, 2016.
Net loss for the three months and
year ended December 31, 2016 was $2.8 million and $11.8 million respectively, compared to $3.4 million and $14.3 million for the
same periods of the previous year.
Conference call information:
US/Canada call: (877) 493-9121 / international
call: (973) 582-2750
US/Canada archive: (800) 585-8367
/ international archive: (404) 537-3406
Code for live and archived conference
For the live and archived webcast,
please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90
days and the audio replay for 7 days.
About Cyclacel Pharmaceuticals,
Cyclacel Pharmaceuticals is a clinical-stage
biopharmaceutical company using cell cycle, transcriptional regulation and DNA damage response biology to develop innovative,
targeted medicines for cancer and other proliferative diseases. The transcriptional regulation program is evaluating CYC065, a
CDK inhibitor, in patients with advanced cancers. The DNA damage response program is evaluating a sequential regimen of sapacitabine
and seliciclib, a CDK inhibitor, in patients with BRCA positive, advanced solid cancers. Cyclacel is analyzing stratified and
exploratory subgroups from a Phase 3 study of sapacitabine in elderly patients with AML. Cyclacel's strategy is to build a diversified
biopharmaceutical business focused in hematology and oncology based on a pipeline of novel drug candidates. For additional information,
please visit www.cyclacel.com.
Forward-looking Statements
This news release contains certain
forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from
historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements
include statements regarding, among other things, the efficacy, safety and intended utilization of Cyclacel's product candidates,
the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and
plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product
candidates that appeared promising in early
research and clinical trials do not
demonstrate safety and/or efficacy in larger-scale or later clinical trials, trials may have difficulty enrolling, Cyclacel may
not obtain approval to market its product candidates, the risks associated with reliance on outside financing to meet capital
requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization
of product candidates. You are urged to consider statements that include the words "may," "will," "would,"
"could," "should," "believes," "estimates," "projects," "potential,"