Cyclacel Pharmaceuticals, Inc. PRESS RELEASE CYCLACEL PHARMACEUTICALS REPORTS THIRD QUARTER 2011 FINANCIAL RESULTS SEAMLESS Phase 3 trial design simplified; FDA confirmed that SPA remains valid Conference Call Scheduled

CYCLACEL PHARMACEUTICALS REPORTS THIRD QUARTER 2011 FINANCIAL RESULTS

SEAMLESS Phase 3 trial design simplified; FDA confirmed that SPA remains valid

Conference Call Scheduled November 14, 2011 at 4:30 p.m. Eastern Time

Berkeley Heights, NJ, November 14, 2011 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ:

CYCCP; Cyclacel or the Company), announced today its financial results and business highlights for

the third quarter of 2011. The Company s net loss applicable to common shareholders for the third

quarter of 2011 was $3.6 million, or $0.07 per basic and diluted share, compared to a net loss

applicable to common shareholders of $4.0 million or $0.11 per basic and diluted share, for the

third quarter of 2010. For the nine months ended September 30, 2011, the Company reported a net

loss applicable to common shareholders of $12.1 million, or $0.25 per basic and diluted share,

compared to a net loss of $16.3 million, or $0.47 per basic and diluted share, for the nine months

ended September 30, 2010.

The Company also announced that it has implemented a simplification in the design of the on-going

SEAMLESS Phase 3 study of sapacitabine as front-line treatment in elderly patients with Acute

Myeloid Leukemia (AML) converting it into a 2-arm from the original 3-arm design, following the

recent recommendation by the SEAMLESS Data Safety Monitoring Board, or DSMB, to continue SEAMLESS.

The 2-arm design compares sapacitabine dosed sequentially with decitabine versus decitabine alone.

Cyclacel has received written confirmation from the US Food and Drug Administration (FDA) that,

following the modification in the trial design, the previously agreed Special Protocol Assessment

(SPA) agreement remains valid.

The original 3-arm design of SEAMLESS was based on the information available at that time, said

Spiro Rombotis, President and Chief Executive Officer of Cyclacel. Since then the safety and

efficacy data from the pilot Phase 1/2 study have encouraged us to amend the protocol into a 2-arm

design, comparing the regimen of sapacitabine dosed sequentially with decitabine versus decitabine

alone. The objective of the amendment is to increase the chance of detecting an improvement in

survival while staying within our existing budget and forecasted time frame. We have been

encouraged by the pace of early enrollment of patients and investigator interest in SEAMLESS. We

are looking forward to achieving our patient enrollment targets in SEAMLESS as our highest

Design Details of SEAMLESS Phase 3 study in AML

SEAMLESS is a registration-directed Phase 3 study of sapacitabine as front-line treatment in

patients with newly diagnosed AML de novo or AML preceded by antecedent hematological disorder who

were not treated with hypomethylating agents, aged 70 years or older, who are not candidates for or

have refused intensive induction chemotherapy. The study will enroll approximately 485 patients who

will be randomized 1:1 or about 243 patients into each of two arms: sapacitabine dosed sequentially

with decitabine versus decitabine alone. A prespecified interim analysis for futility will be

performed and reviewed by the DSMB when 212 deaths have occurred. The primary objective is to

detect with 90% power an improvement in overall survival at a statistical significance level of

p-value equal to or less than 0.05. The original 3-arm design required a statistical significance

level of p-value equal to or less than 0.025 for each of two pairwise comparisons. The secondary

objectives are to compare the response rates in terms of complete remission (CR), complete

remission with incomplete platelet recovery (CRp), partial response (PR), hematologic improvement

(HI), stable disease (SD) and their corresponding durations, transfusion requirements, number of

days in hospital, one-year survival and safety.

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Cyclacel s product revenues were comprised of sales of Xclair Cream for radiation dermatitis and

Numoisyn Liquid and Numoisyn Lozenges for xerostomia. Product revenues for the quarter and nine

months ended September 30, 2011 were $0.2 million and $0.5 million, respectively, compared to

approximately $0.2 million and $0.4 million, respectively, for the same periods in 2010.

Total operating expenses remained the same at $4.2 million for the each of the three months ended

September 30, 2011 and 2010. For the nine months ended September 30, 2011, total operating

expenses were $13.2 million, which included a $1.6 million milestone payment to Daiichi-Sankyo, as

compared to $13.4 million for the same period in 2010.

Research and Development Expenses

Research and development expenses for the third quarter of 2011 increased to $2.1 million as

compared to $1.5 million for the same period in 2010. For the nine months ended September 30, 2011,

research and development expenses were $7.0 million as compared to $5.0 million for the same period

in 2010. The increase was primarily due to a $1.6 million milestone payment in the first quarter

payable to Daiichi-Sankyo as part of our contractual obligation resulting from sapacitabine s entry

into Phase 3 trials and clinical trial costs related to SEAMLESS.

Selling, General and Administrative Expenses

Total selling, general and administrative expenses decreased by approximately $0.5 million from

$2.6 million for the third quarter of 2010 to $2.1 million for the third quarter of 2011. For the

nine months ended September 30, 2011 total selling, general and administrative expenses were $5.9

million as compared to $8.1 million for the same period in 2010. The decrease of $2.2 million in

expenses was primarily attributable to a net decrease in

professional and consultancy costs, the elimination of costs related to a facility lease that

expired in December 2010 and a decrease in compensation-related costs.

Cash and Cash Equivalents

As of September 30, 2011, Cyclacel s cash and cash equivalents were $27.7 million compared to $29.5

million as of December 31, 2010.

Received notification from NASDAQ that the Company failed to comply with the minimum $1 bid price

requirement for continued listing set forth in Marketplace Rule 5450(a)(1).

Conference call and Webcast Information:

Cyclacel will conduct a conference call on November 14, 2011 at 4:30 p.m., Eastern Time, to review

the third quarter and nine months ended September 30, 2011 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 call is 25156473.

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

Analyst Institutional Investor Meeting

The Company will hold an Analyst and Institutional Investor meeting on December 7, 2011 in New York

City. The meeting will include a discussion of treatment alternatives for elderly patients with

acute myeloid leukemia by an expert hematologist, the design of the SEAMLESS Phase 3 trial and a

discussion of the potential utility of sapacitabine in non-small cell lung cancer (NSCLC) by a

thoracic oncology expert. Details of the event will be provided in a forthcoming announcement.

About Acute Myeloid Leukemia (AML)

AML is a cancer of blood cells that progresses rapidly and if not treated, could be fatal in a few

months. AML is generally a disease of older people and is uncommon before the age of 40. The

average age of a patient with

AML is about 67 years. There are more than 12,300 new cases of AML, of which about half are

elderly, and nearly 9,000 deaths caused by this cancer each year in the United States. A recently

published review of The University of Texas MD Anderson Cancer Center s historical experience with

front-line intensive induction chemotherapy for elderly AML patients aged 70 years or older

demonstrated that while 45% of patients achieved a complete remission, median overall survival was

only 4.6 months and 36% of patients died within the first 8 weeks of treatment, underscoring the

unmet need in this patient setting. Currently there are no therapies approved for use in elderly