SEC Filing | Cyclacel Pharmaceuticals, Inc.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 26, 2014

CYCLACEL PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

Delaware	0-50626	91-1707622
(State or other jurisdiction	(Commission File Number)	(IRS Employer
of incorporation)		Identification No.)

200 Connell Drive, Suite 1500
Berkeley Heights, NJ 07922
(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (908) 517-7330

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing

obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

o	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01 Regulation FD Disclosure.

Attached hereto as Exhibit 99.1 and incorporated by reference herein is an investor presentation of Cyclacel Pharmaceuticals, Inc.

The information set forth under this “Item 7.01. Regulation FD Disclosure,” including the exhibit attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number		Description

99.1		Investor Presentation of Cyclacel Pharmaceuticals, Inc., dated September 26, 2014.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	CYCLACEL PHARMACEUTICALS, INC.

	By:	/s/ Paul McBarron
	Name:	Paul McBarron
	Title:	Executive Vice President—Finance,
		Chief Financial Officer and Chief Operating Officer

Date: September 26, 2014

EXHIBIT INDEX

Exhibit No.		Description

99.1		Investor Presentation of Cyclacel Pharmaceuticals, Inc., dated September 26, 2014.

Exhibit 99.1

Disrupting the Cell Cycle to Treat AML and MDS

BioCentury Newsmakers in the Biotech Industry Conference

September 2014

Disclaimer

This presentation 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 Highlights

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

– Oral agent for elderly AML patients; minimal options today

– Interim analysis for futility expected late 2014/early 2015

– Complete enrollment 2014/15; top-line data 2H15

Sapacitabine in high-risk MDS after HMA failure

– “Impressive” Phase 2 survival data in 2nd/3rd Line MDS

– Phase 2b RCT planned to start in 2015

Strong financial position & earlier-stage pipeline

– Sufficient capital beyond SEAMLESS Phase 3 data readout

– Sapacitabine in solid tumors; CDK and PLK inhibitors

AML Unmet Medical Need since 1969*

8000 10000 12000 14000 16000 18000 20000 6000

2005 2006 2007 2008 2009 2010 2011 2012 2013 2014

Incidence Deaths

16,000 US prevalence ’13E 14,590 US incidence ’13E

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

Front line 7 + 3 Clinical trial

Relapsed/ Refractory Clinical trial Clinical trial

* AML: elderly disease: 50% ≥ 70 yrs.; median age: ~ 67. Source: American Cancer Society and Cyclacel-commissioned primary market research. Sapacitabine data on file.

Predicament of 70+ year old AML Patient

• Newly diagnosed AML: multigenetic, heterogeneous disease

• Old age, frailty and comorbid conditions

Options:

• 45-year old intensive chemotherapy regimen

• Investigational agent(s) in a clinical trial

• Hospice or terminal care at home

• Expected median survival of 3 - 6 months

• Mortality in first 2 months of ~ 20 - 36%

• Drug development goal: overall survival (OS)

Elderly AML Benchmark Data

Most elderly patients unable to sustain intensive chemotherapy Treatment mortality ↑ and survival ↓ with age over 60 years

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

Intensive Chemotherapy ≥70 yrs. 26% 36% ~ 5 *

Best Supportive Care ≥70 yrs. 17% 30% ~ 4 ◊

Low-intensity (LoDac or decitabine) ≥60 yrs. 9% 20% ~ 5 - 8 † ‡

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

* Kantarjian, 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.

Rationale for Sapacitabine in AML

• Elderly AML patients are very frail

• How to control 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

• Hypothesis tested in SEAMLESS Phase 3 study under SPA:

– Can the use of a sapacitabine-based less-intensive

* Source: ASH 2012. Kantarjian et al, JCO, 2012.

“SEAMLESS” Phase 3 Design

(Untreated AML: front line; ≥ 70 years; n=485; p=0.05; HR=0.725)

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

ü DSMB every 100 patients (n=119; n=212:“no safety or efficacy concerns”)

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

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 UNMET MEDICAL 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

PREDICAMENT OF 60+ 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

SAPACITABINE PHASE 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

MDS HMA FAILURES: KEY BENCHMARKS MDS INT-2 & HIGH-RISK IPSS EXPERIMENTAL STANDARD OF CARE AFTER FRONTLINE FAILURE TREATMENT M OS 1 YEAR SURVIVAL Azacitidine 2nd line ~ 6 months † - † Decitabine 2nd line ~ 4 months † - † Best Supportive Care ~ 4 months † 17% † SAPACITABINE: Phase 2 study 2nd, 3rd, 4th line ~ 9 months@ 38% @ † PREBET T, GORE S, ET AL, JCO 2011 (95% CI, 14% TO 26% ON BEST SUPPORTIVE CARE; 29% ON INVESTIGATIONAL AGENTS). @ GARCIA- MANERO G ET AL, AMERICAN SOCIETY OF HEMATOLOGY ANNUAL MEETING DEC. 2013, ABSTRACT #2752 (ARM G 1-YEAR SURVIVAL). © 1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP 2014

SAPACITABINE PHASE 2 MDS DATA (HIGH RISK MDS: 2ND, 3RD OR 4TH LINE; AGED ≥ 60 YEARS; N=63) * TOTAL (63) ARM G (21) ARM H (21) ARM I (21) Prior Azacitidine 30 9 10 11 Prior Decitabine 15 4 3 8 Prior Aza + Decitabine 18 8 8 2 MEDIAN OS (DAYS) 260 291 290 227 ≥ 10% BLASTS IN B.M. 291 266 307 153 60-day deaths 8 3 2 3 Responders 32 11 11 10 * GARCIA-MANERO G ET AL, AMERICAN SOCIETY OF HEMATOLOGY ANNUAL MEETING DEC. 2013, ABSTRACT #2752. RESPONSE = CR/CRP, MAJOR HI, STABLE DISEASE OVER 16 WEEKS. © 1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP 2014

SAPACITABINE MDS PHASE 2B RCT STUDY OBJECTIVES » Prolong overall survival » Convenient outpatient treatment ACTIVE CONTROL OPTIONS 1. Low dose cytarabine (LoDAC) ‒ Differentiated mechanism ‒ Outpatient convenience ‒ Activity in 1st line setting * 2. OTHER HMA ‒ PATIENTS FAILED/PROGRESSED 1ST LINE HMA ‒ IV ADMINISTRATION ‒ HMA CROSS-TREATMENT DATA INCONCLUSIVE © 1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP 2014 * ZWIERZINA H ET AL, LEUKEMIA, 2005

RATIONALE FOR RANDOMIZED PHASE 2B RCT • Limited knowledge • Genetic heterogeneity & treatment complexity • Sapacitabine Phase 2 clinical data encouraging • Cyclacel approach — Review recent MDS trials — Confer with MDS KOLs — Conduct feasibility assessment • Goal: determine path that may — Add to understanding of sapacitabine’s role in the indication — If RCT data exceptional, discuss with regulators © 1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP 2014

PHASE 2B MDS RCT DESIGN (INT-2 OR HIGH RISK MDS AFTER HMA FAILURE: AGED ≥ 60 YEARS; N~250) A. ALTERNATING SAPACITABINE & LODAC (n~125) PRIMARY ENDPOINT: OVERALL SURVIVAL (OS) B. LODAC* (n~125) x Feasibility in over 100 US & EU sites x Est. enrollment ~15 months , excl. lead-in stage x Interim safety reviews at 100 & 200 patients * LODAC=LOW-DOSE CYTARABINE © 1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP 2014

SAPACITABINE OVERVIEW Interferes with cancer cell repair via HR pathway Therapeutic strategy: QOL maintenance vs. toxic cure attempt – Oral administration; well-tolerated; administered over multiple cycles Significant market opportunity beyond AML and MDS – Solid tumor activity in HR-deficient patients incl. gBRCA +ve Exclusivity: IP to 2027-30; Orphan Drug Status for AML & MDS © 1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP 2014

CYCLACEL EARLY-STAGE PIPELINE CANDIDATE MOA USE PRECLINICAL PHASE 1 PHASE 2 PHASE 3 SAPACITABINE + SELICICLIB DNA synthesis inhibitor + CDK2,7,9 inhibitor HR repairdeficient solid tumors CYC065 CDK2,5,9 inhibitor Blood (incl. MLLr) & solid tumors* CYC140 PLK1 inhibitor Blood & solid tumors* *BOTH MAINLY FUNDED BY GOVERNMENT GRANTS. © 1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP 2014

FINANCIAL POSITION & CAPITALIZATION CASH RUNWAY BEYOND SEAMLESS PHASE 3 DATA – ~$34 m cash & cash equivalents 1 – Complete SEAMLESS ~ end of 2014; data read-out ~ 2H 2015 (costs to data readout ~ $12 m) – Other R&D costs and G&A: ~ $8-9 m annually 2 FULLY DILUTED SHARES: ~ 25.3 MILLION 1, 3 NO DEBT 1. COMPANY 10-Q JUNE 30, 2014. COMMON STOCK OUTSTANDING: 22.7 MILLION. 2. EXCLUDES COST OF MDS PH 2B RCT. 3. INCLUDES 1.1 MILLION WARRANTS AND OPTIONS WITH AN EXERCISE PRICE > $10 PER SHARE. © 1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP 2014

KEY MILESTONES SAPACITABINE – SEAMLESS: 300-patient DSMB review – SEAMLESS: interim analysis for futility – SEAMLESS: complete enrollment – MDS: open enrollment of Phase 2b after HMA failure – Sapacitabine & seliciclib in patients with solid tumors: update Phase 1 data OTHER – Advance early-stage pipeline © 1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP 2014

SUMMARY • SAPACITABINE OPPORTUNITY IN FRONT LINE AML: SEAMLESS APPROACHING COMPLETION • SAPACITABINE IN MDS: PHASE 2 DATA, HIGH-REWARD • STRONG FINANCIAL POSITION: SUFFICIENT CAPITAL BEYOND SEAMLESS DATA READ-OUT • EARLY-STAGE PIPELINE ADDRESSING HIGH-INTEREST TARGETS & MECHANISMS OF ACTION © 1997-2014 Cyclacel Pharmaceuticals, Inc. Released SEP 2014