Cell Cycle to Treat AML and MDS

Cell Cycle to Treat AML and MDS

BioCentury Newsmakers

in the Biotech Industry Conference

contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation

Reform Act of 1995 about financial results and estimates, business strategy, clinical trial plans and research and development

programs of Cyclacel Pharmaceuticals, Inc. By their nature, forward-looking statements and forecasts involve risks and uncertainties

because they relate to events and depend on circumstances that will occur in the future. 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

current filings that have been filed with the Securities and Exchange Commission and are available at www.sec.gov. The information

in this presentation is current as of this date. Cyclacel does not take any responsibility to update such information.

Cyclacel Pharmaceuticals, Inc. Released SEP 2014 2

in front-line AML in the elderly: SEAMLESS Phase 3

for elderly AML patients; minimal options today

analysis for futility expected late 2014/early 2015

enrollment 2014/15; top-line data 2H15

in high-risk MDS after HMA failure

Phase 2 survival data in 2nd/3rd Line MDS

RCT planned to start in 2015

position & earlier-stage pipeline

capital beyond SEAMLESS Phase 3 data readout

in solid tumors; CDK and PLK inhibitors

1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP

Sapacitabine for AML 1997-2014 Cyclacel Pharmaceuticals,

Inc. Released SEP 2014 4

14000 16000 18000 20000 6000

2009 2010 2011 2012 2013 2014

prevalence '13E 14,590 US incidence '13E

for Intensive Chemo (20%) Unfit/Refused Intensive Chemo (80%)

Relapsed/ Refractory

Clinical trial Clinical trial

disease: 50% 70 yrs.; median age: ~ 67. Source: American Cancer Society and Cyclacel-commissioned primary market

research. Sapacitabine data on file.

Cyclacel Pharmaceuticals, Inc. Released SEP 2014 5

70+ year old AML Patient

AML: multigenetic, heterogeneous disease

frailty and comorbid conditions

intensive chemotherapy regimen

agent(s) in a clinical trial

terminal care at home

median survival of 3 - 6 months

in first 2 months of ~ 20 - 36%

goal: overall survival (OS)

1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP

Elderly AML Benchmark

Most elderly patients

unable to sustain intensive chemotherapy Treatment mortality and survival with age over 60 years

Patients 4-week death rate 8-week death rate m OS (months)

Intensive Chemotherapy

70 yrs. 26% 36% ~ 5 *

Care 70 yrs. 17% 30% ~ 4

Low-intensity (LoDac

or decitabine) 60 yrs. 9% 20% ~ 5 - 8

Pilot Lead-in for SEAMLESS 70 yrs. 5% 13% ~ 8 @

et al, Blood , 2012 Harousseau, et al, Blood 2009. Cashen, et al,

JCO, 2010, Kantarjian,

et al, JCO, 2012. Est. from survival curves. @ Ravandi F, et al, American Soc. of Hematology Ann. Mtg. 2012, Abs. 2630.

Cyclacel Pharmaceuticals, Inc. Released SEP 2014 7

patients are very frail

leukemia cell growth but not worsen the patient's immunity & quality of life?

- Sapacitabine-based

Phase 3 "low-intensity" regimen

balances those needs,

resulting in ~ half the 60-day mortality vs. that reported with control regimen

tested in SEAMLESS Phase 3 study under SPA:

use of a sapacitabine-based less-intensive

2012. Kantarjian et al, JCO, 2012.

Cyclacel Pharmaceuticals, Inc. Released SEP 2014 8

front line; 70 years; n=485; p=0.05; HR=0.725)

consultation with FDA under SPA enrolling at U.S. and European centers

every 100 patients (n=119; n=212:"no safety or efficacy

analysis for futility after 212 events (50% of required events)

Cyclacel Pharmaceuticals, Inc. Released SEP 2014 9

SEAMLESS Milestones - DSMB review at ~ 300 patients: 2H14

- Interim analysis for futility: Late 2014/Early 2015 - Enrollment > 75%; completion: Late '14/Early '15

- Top-line data: 2H15 1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP 2014 10

WILL SEAMLESS PHASE 3 SUCCEED? REQUIRED REDUCTION IN RISK OF

DEATH: 27.5% MEDIAN OVERALL SURVIVAL (OS): Decitabine (DACO-016 , > 75 years, n=95): ~ 6 MOS. Sapacitabine/ Decitabine

(ASH '12, > 75y, n=33): ~ 9 MOS. * 60-DAY MORTALITY: Decitabine (DACO-016, > 65y, n=242): 20% Sapacitabine/

Decitabine (ASH '12, > 70y, n=46): 13% * * INTERIM DATA FROM PILOT, LEAD-IN STUDY OF ARM A IN SEAMLESS; SUBJECT TO CHANGE.

ASH 2012, ABS. 2630; 76% > 75 YEARS. CAVEAT: CROSS-STUDY COMPARISON. KANTARJIAN, ET AL, JCO, 2012. 1997-2014

Cyclacel Pharmaceuticals, Inc. Released SEP 2014

NDA ENABLING ACTIVITIES

- External consultant review of available NDA content - Planning a potential "rolling NDA" submission -

Biopharm section - CMC section - Clinical section would be last to be submitted - Core dossier also to be used

for MAA submission in EU 1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP 2014

MDS 1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP 2014

NEED TREATMENT LOW RISK HIGH RISK 1st line LENALIDOMIDE # AZACITIDINE# DECITABINE 2nd line CLINICAL TRIAL CLINICAL TRIAL SAPACITABINE

NCCN GUIDELINES FOR 1ST LINE HYPOMETHYLATING AGENTS: 4-6 CYCLES MEDIAN OS INT-2/HIGH-RISK MDS AFTER TREATMENT

FAILURE OF HM AGENTS: 4.3-5.6 MONTHS # REVLIMID , CELGENE. VIDAZA , CELGENE. & DACOGEN , OTSUKA. DACOGEN

& VIDAZA ARE HYPOMETHYLATING (HM) AGENTS. NCCN GUIDELINES MDS V.2.2011 P. 19. PREBET T, GORE S, ET AL, JCO

2011; JABBOUR E, GARCIA-MANERO G, ET AL, CANCER 2010. 1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP 2014

YEAR OLD HIGH-RISK MDS PATIENT HIGH RISK MDS AFTER FAILURE OF FRONT-LINE DRUGS - Already failed 1st line hypomethylating

agents (HMAs): azacitidine (Vidaza ) and/or decitabine (Dacogen ) - Higher risk from infections; transformation into

AML - Multigenetic, heterogeneous disease Options: - Investigational agent(s) in a clinical trial - Hospice or

terminal care at home - Expected median survival of 4.3 - 5.6 months SOURCE: PREBET T, GORE S, ET AL, JCO

2011; JABBOUR E, GARCIA-MANERO G, ET AL, CANCER 2010. 1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP 2014

2 MDS DESIGN: 682-06, PART 4 HIGH-RISK MDS: 2ND, 3RD OR 4TH LINE; 60 YEARS; N=63; ALL ARMS 28-DAY CYCLES x Intermed-2

or hi-risk IPSS after HMA failure; blasts 6% -19% x Primary Endpoint: 1-year survival G. SAPACITABINE 200MG BID X 7D (n=21)

H. SAPACITABINE 300MG QD X 7D (n=21) I. SAPACITABINE 100MG QD X 5D X 2W (n=21) SOURCE: GARCIA-MANERO ET AL, J. CLIN. ONCOL. 2012:30:ABS.

6520. HMA = HYPOMETHYLATING AGENTS. 1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP 2014