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Cyclacel Pharmaceuticals, Inc. CYCLACEL PHARMACEUTICALS REPORTS FIRST QUARTER 2016 FINANCIAL RESULTS - Conference Call Scheduled

Key Takeaway: CYCLACEL PHARMACEUTICALS REPORTS FIRST QUARTER 2016 FINANCIAL RESULTS - Conference Call Scheduled May 11, 2016 at 4:30 p.m. EDT - Berkeley Heights, NJ, May 11, 2016 - Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutic

Full Press Release Details

CYCLACEL PHARMACEUTICALS REPORTS FIRST
QUARTER 2016 FINANCIAL RESULTS
- Conference Call Scheduled
May 11, 2016 at 4:30 p.m. EDT -
Berkeley Heights, NJ, May 11, 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 first quarter ended March 31, 2016.
The Company's net loss applicable
to common shareholders for the first quarter ended March 31, 2016 was $3.1 million, or $0.09 per basic and diluted share, compared
to net loss applicable to common shareholders of $5.0 million, or $0.19 per basic and diluted share for the first quarter ended
March 31, 2015. As of March 31, 2016, cash and cash equivalents totaled $17.1 million.
our Phase 3 pivotal study in acute myeloid leukemia (AML), approximately 2.6% of required events remain to be observed before
mature data become available," 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 tumors, including durable partial responses
and stable disease in patients with BRCA positive breast, ovarian and pancreatic cancers. Updated data from this combination
study will be reported in an oral presentation at the 2016 ASCO Annual Meeting. In light of these data and investigator interest,
we started enrollment of an extension cohort in a BRCA-enriched population of breast cancer patients. We continue to enroll patients
in a first-in-human, Phase 1 study of CYC065, our second-generation CDK2/9 inhibitor, in patients with solid tumors and lymphomas.
Data presented at the AACR Annual Meeting 2016 highlighted CYC065's potential as an agent to treat hematological malignancies,
such as B-cell lymphoma. 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
Dependent Kinase (CDK) 2/9 Inhibitor Programs
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
Cyclacel's Key Milestones for
Sapacitabine in myelodysplastic
CDK Inhibitor Programs
2016 Financial Results
Revenue for the three months ended March
31, 2016 was $0.1 million compared to $0.5 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 $2.5 million for the three months ended March 31, 2016 compared to $4.3 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 March 31, 2016 decreased to $1.4 million compared to $1.5 million for the same period in 2015.
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 May 11, 2016 at 4:30 p.m. EDT to review the quarterly results. Conference call and webcast details are as follows:
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 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 1/2 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.
STATEMENTS OF OPERATIONS
(In $000s, except share and per share amounts)
Three Months Ended March 31,
2015 2016
Revenues:
Grant revenue $ 512 $ 139
Total revenues 512 139
Operating expenses:
Research and development 4,342 2,499
General and administrative 1,468 1,384
Total operating expenses 5,810 3,883
Operating loss (5,298 ) (3,744 )
Other income (expense):
Change in valuation of financial instruments associated with stock purchase agreement (20 ) -
Foreign exchange gains (losses) (378 ) 180
Interest income 1 10
Other income, net 20 20
Total other income (expense) (377 ) 210
Loss from continuing operations before taxes (5,675 ) (3,534 )
Income tax benefit 763 493
Net loss (4,912 ) (3,041 )
Dividend on convertible exchangeable preferred shares (50 ) (50 )
Net loss applicable to common stockholders $ (4,962 ) $ (3,091 )
Basic and diluted earnings per common share:
Net loss per share - basic and diluted $ (0.19 ) $ (0.09 )
Weighted average common shares outstanding 26,067,078 35,582,492
CYCLACEL PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
(In $000s, except share, per share,
Last updated: May 11, 2016