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CYCLACEL PHARMACEUTICALS REPORTS FOURTH

Key Takeaway: CYCLACEL PHARMACEUTICALS REPORTS FOURTH QUARTER AND FULL YEAR 2015 FINANCIAL RESULTS - Conference Call Scheduled March 24, 2016 at 4:30 p.m. EDT - Berkeley Heights, NJ, March 24, 2016 - Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company")

Full Press Release Details

CYCLACEL PHARMACEUTICALS REPORTS FOURTH
QUARTER AND FULL YEAR 2015 FINANCIAL RESULTS
- Conference Call Scheduled
March 24, 2016 at 4:30 p.m. EDT -
Berkeley Heights, NJ, 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, today reported its financial results and business highlights for the fourth quarter and full year ended December 31,
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.
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
200 Connell Drive, Suite 1500, Berkeley Heights, New Jersey 07922, USA Tel +1 (908) 517 7330 Fax +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
Dependent Kinase 2/9 (CDK2/9) Inhibitor Programs
Cyclacel's Key Milestones for
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.
2015 Financial Results
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
enrolment 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
Conference call and Webcast Information
Cyclacel will conduct a conference call
on March 24, 2016 at 4:30 p.m. EDT to review the fourth quarter and full year 2015 results. Conference call and webcast details
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 and Events 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, Inc.
a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of
cancer and other serious diseases. Sapacitabine, Cyclacel's most advanced product candidate, is the subject of SEAMLESS, a Phase
3 trial, which has completed enrollment and is being conducted under an SPA with the U.S. Food and Drug Administration (FDA) as
front-line treatment for acute myeloid leukemia (AML) in the elderly, and other indications, including myelodysplastic syndromes
(MDS). Cyclacel's pipeline includes an oral regimen of seliciclib in combination with sapacitabine in a Phase 1 study of patients
with solid tumors, including BRCA positive cancers, and CYC065, a novel CDK2/9 inhibitor, in a Phase 1 study of patients with
solid tumors and lymphomas with potential utility in both hematological malignancies and solid tumors. Cyclacel's strategy is
to build a diversified biopharmaceutical business focused in hematology and oncology based on a development pipeline of novel
drug candidates. Please visit www.cyclacel.com for more information.
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," "expects," "plans," "anticipates,"
"intends," "continues," "forecast," "designed," "goal," or the negative of those
words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties
the Company faces, please refer to our most recent Annual Report on Form 10-K and other periodic and other filings we file with
the Securities and Exchange Commission and are available at www.sec.gov. Such forward-looking statements are current only
as of the date they are made, and we assume no obligation to update any forward-looking statements, whether as a result of new
information, future events or otherwise.
Contacts for Cyclacel Pharmaceuticals,
Company: Paul McBarron, (908) 517-7330,
Investor Relations: Russo Partners LLC,
Robert Flamm, (212) 845-4226, robert.flamm@russopartnersllc.com
Pharmaceuticals, Inc.
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(In $000s, except share and per share amounts)
Three Months Ended December 31, Years Ended December 31,
2014 2015 2014 2015
(Unaudited) (Unaudited)
Revenues:
Grant revenue $ 247 $ 424 $ 1,734 $ 1,694
Collaboration and research and development revenue - - - 250
Total revenues 247 424 1,734 1,944
Operating expenses:
Research and development 4,416 2,559 18,277 12,382
General and administrative 1,613 1,726 5,894 5,752
Total operating expenses 6,029 4,285 24,171 18,114
Operating loss (5,782 ) (3,861 ) (22,437 ) (16,170 )
Other income (expense):
Change in valuation of financial instruments associated with stock purchase agreement (227 ) - (342 ) (51 )
Change in valuation of liabilities measured at fair value - - 20 -
Foreign exchange gains 13 (14 ) (10 ) (368 )
Interest income 1 4 6 9
Other income, net 88 (1 ) 114 94
Total other income (expense), net (125 ) (11 ) (212 ) (316 )
Loss from continuing operations before taxes (5,907 ) (3,872 ) (22,649 ) (16,486 )
Income tax benefit 1,108 498 3,243 2,144
Net loss from continuing operations (4,799 ) (3,374 ) (19,406 ) (14,342 )
Discontinued operations:
Income from discontinued operations - - 29 -
Income tax on discontinued operations - - (10 ) -
Net income from discontinued operations - - 19 -
Net loss (4,799 ) (3,374 ) (19,387 ) (14,342 )
Deemed dividend on convertible exchangeable preferred shares - - - -
Dividend on convertible exchangeable preferred shares (50 ) (51 ) (200 ) (201 )
Net loss applicable to common shareholders $ (4,849 ) $ (3,425 ) $ (19,587 ) $ (14,543 )
Net loss per share, continuing operations - basic and diluted $ (0.21 ) $ (0.10 ) $ (0.89 ) $ (0.45 )
Net (loss) income per share, discontinued operations - basic and diluted $ 0.00 $ 0.00 $ 0.00 $ 0.00
Net loss per share - basic and diluted $ (0.21 ) $ (0.10 ) $ (0.89 ) $ (0.45 )
Weighted average common shares outstanding 22,986,528 34,976,268 21,955,381 32,557,146
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(In $000s, except share, per share,
Last updated: Mar 24, 2016