imuc investor presentation

8/8/2019 IMUC Investor Presentation

1/28

October 2010 1

Manish Singh,PhDPresidentandCEO

[email protected]

OTCBB:

IMUC.OB

www.imuc.com


2/28

October 2010 2

SEC Disclaimer Statement

Thispresentationcontainscertainforwardlookingstatements

(statementsas

to

matters

other

than

historical

facts)

as

defined

in

thePrivateSecuritiesLitigationReformActandinSection27AoftheSecuritiesActof1933andSection21EoftheSecuritiesExchangeActof1934. Suchstatementsinvolverisksanduncertaintiesthatcouldcauseactualeventsorresultstodiffermaterially

from

the

events,

projections

or

results

described

in

the

forwardlookingstatements.TheserisksanduncertaintiesaredescribedinIMUCs mostrecentlyfiledSECdocuments,suchasitsmostrecentannualreportonForm10K,allquarterlyreportson

Form10

Q

and

any

current

reports

on

Form

8K.


3/28

October 2010 3

Overview of ImmunoCellular Therapeutics

NextGenerationActiveImmunotherapyCompany

TargetingCancerStemCells

MultipleTumorAssociatedAntigens

Dendritic cell vaccine to elicit persistent and targeted T cell

immune response

1

st

active immunotherapy targeting CSCs to treat Glioblastoma with IMPROVED SURVIVAL data


4/28October 2010 4

Cancer Stem Cells: Good Guys Turned Bad

Normal

StemCell

mutations

Cancer

StemCell

MatureTissue

BulkTumor

Progenitorcells Cancersoriginateintissue

progenitoror

stem

cells

throughdysregulation oftheselfrenewalprocess.

ThroughouttumorigenesisCSCsdrivetumorgrowth.

WithoutkillingCSCs,itislikespraying

for

weeds

without

killingtheroots. Theweeds(tumors)comeback!


5/28October 2010 5

Recent M&A Transactions in Cancer Stem Cells

Macrogenics(undisclosed)

MonoclonalantibodiestargetingCSC(preclinical)

Raven

Roche$200MillionMonoclonalantibodiestargetingCSC(preclinical)

AriusResearch

GSK$1.4Billioninupfrontandmilestones

MonoclonalantibodiestargetingCSC

(preclinical)

Oncomed

M&A

Transaction

Product

Platform

Company

CancerStemCellsisahotsector!


6/28October 2010 6

Using Both Arms of Immune System

ACTIVEIMMUNOTHERAPIES

CellularVaccineWithSurvivalBenefit(ICT107)

Dendritic cellvaccinetoelicitpersistentandtargetedTcellimmuneresponseagainsttumorassociatedantigens/CSCantigens

PhaseItrialrecentlyshowedsurvivalbenefitforbraintumors

PhaseIIplannedin2H,2010

OfftheshelfCSCPeptide(plusadjuvant)Vaccine(ICT121)

Platform technology for cancer stem cells

Product applicable in glioblastoma, breast, ovarian, pancreatic, colon and othersolid tumors

ANTIBODYIMMUNOTHERAPIES

Antibodytherapeuticstargetingnovelcancerantigensandcancer stemcells

DIAAD: platformtechnologyforcancerantigens


7/28

October 2010 7

ICT-107 targets Cancer Stem Cells & GBM but

has broad potential

BraincancerIL13aR2

HighBreast,ovarian,

colon,

brainAIM

2

Melanoma,braincancerMAGE1

MediumBreast,ovariancancerHer2/neu

HighMelanomaandbraincancerTrp2

Melanoma,braincancergp100

CSC

Expression

TumorExpressionAntigens

FirstIndicationisBrainCancer,butbroadpotential


8/28

October 2010 8

Successful Phase I Trial of ICT-107

Design

PhaseIglioblastoma

trial

initiated

in

May

2007

Todeterminesafetyandimmuneresponse

Patientsreceived

three

vaccinations,

two

weeks

apart

19patients(16newlydiagnosedand3recurrentpatients)treated

Patientspecific

cell

manufacturing

(5

doses)

AllpatientstreatedatCedarsSinaiHospital(LosAngeles)


9/28

October 2010 99

Mature antigen-presenting

dendritic cells

Isolation of monocytes

from peripheral blood

Generation of immature

dendritic cells

Culture with

IL-4 + GM-CSF

Pulsing of DC with peptides

Vaccination of the patient

TARGETING CSC AND

TUMOR ANTIGENS

Dendritic Cell Therapy for GBM


10/28

October 2010 10

NEWLY DIAGNOSEDWEEKS FROM 1ST SURGERY

Pt # 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104 108 112 116 120 124 128 132 136 140 144 148 152 156 160 164 168 172 176 180 184 188

5

3

6

1

9

10

13

11

12

14

8

15

16

17

18

19

4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104 108 112 116 120 124 128 132 136 140 144 148 152 156 160 164 168 172 176 180 184 188

RECURRENT

Pt # 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104 108 112 116 120 124 128 132 136 140 144 148 152 156 160 164 168 172 176 180 184 188

7

4

2

4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 100 104 108 112 116 120 124 128 132 136 140 144 148 152 156 160 164 168 172 176 180 184 188

WEEKS FROM 1ST SURGERY

2nd Surgery 1st Chemo Progression Vaccine Death

10

Patient Treatment and Survival Timelines

June 2010 10

Historical Survival(Stupp)

Better Overall Survival than Historical Controls


11/28

October 2010 11

SignificantImprovementinProgressionFreeSurvival

(Comparedto

Historical

Controls

using

Standard

of

Care)

Radiation + Temozolomide* Radiation + Temozolomide +ICT-107

Stupp etal,Radiotherapyplusconcomitantandadjuvanttemozolomide forglioblastoma,

NewEngland

Journal

of

Medicine,

March

2005


12/28

October 2010 12

SignificantImprovement

in

Overall

Survival

Radiation + Temozolomide* Radiation + Temozolomide +ICT-107

Stupp etal,Radiotherapyplusconcomitantandadjuvanttemozolomide forglioblastoma,

NewEngland

Journal

of

Medicine,

March

2005


13/28

October 2010 13

ICT107

+SOC*

(n=16)SOC

(Stupp,

NEJM,

2005)

(n=287)

PFS(%) At6months 100(63.2 99.1)** 53.9(48.1 59.6)

At12

months 62.5

(34.8

81.1) 26.9

(21.8

32.1)

At18months 49.2(23.570.6) 18.4(13.922.9)

At24months 49.2(23.570.6) 10.7(7.014.3)

Median(months) 17.7

(11.1

39.3) 6.9

(5.8

8.2)

OS(%) At6months 100 86.3(82.390.3)

At12months 100 61.1(55.466.7)

At18months 93.7(63.299.1) 39.4(33.845.1)

At24months 81.2(52.493.5) 26.5(21.231.7)

Median(months) NR 14.6(13.216.8)

NR Notreached** value(95%CI)

SummaryPFSandOS NewlyDiagnosedPatients

* SOC=StandardofCare(XRT+TMZ)


14/28

October 2010 14

Progression Free Survival Better Than Competition

RT+TMZ

0 2 4 6 8 10 12 14 16 18 20

TMZ (Merck) EOTRC Trial

TMZ (Merck) UCLA ASCO2009

Avastin (Roche)

Cilengitide (Merck KGA)

Gliadel (Eisai)

CDX-110 (Celldex)

ICT-107 (IMUC)

Time (months)

RT+TMZ+ICT107

RT+TMZ+CDX110

RT+Gliadel

RT+TMZ+Cilengitide

RT+TMZ+Avastin

RT+TMZ

RecentUCLA

Data

PFSinNewlyDiagnosedGBM


15/28

October 2010 15

Centralized GMP manufacturing process for Phase

II clinical trials and commercialization

Outpatient

apheresis

Apheresisproduct

Ship

Outpatienttreatment

GMP manufacturing facility

Monocyte

enrichment

~20 doses from onedoses from oneapheresisapheresis

Culture with

cytokines

Wash, concentrate and freeze

Ship dose

Antigen

pulse

and

maturation


16/28

October 2010 1616

Manufacturing for longer dosing and low COGS

Single process for 20 doses

Better economics than Provenge which produces separate batch foreach dose

Cryopreservation technology to keep it for several

years

Plan in Phase II trial to add boost every 3-6 months toextend the benefit

4 years would be 16 doses

COGS should be 5-10%


17/28

October 2010 17

Phase II Trial Design

102patientsat15centersinUS/Canada

2:1randomization,

double

blind

Placebo:Unloadeddendritic cells

PrimaryEndPoints:OSandPFS

SecondaryEndPoints:

OS/PFSatvarioustimeintervals

ImmuneResponse

Safety

Interimanalysisafter17months(basedon50%events)


18/28

October 2010 18

ICT-107 Summary

TargetingCancerStemCellsviaTcellapproachdemonstrates

significantclinical

utility

ClinicalDatademonstratessignificantdelayindiseaseprogressionafterprimarysurgery(81%survivalafter2yearsisthebestresult

seen

in

GBM

trials

over

2

decades) MulticenteredPhaseIIclinicaltrialplannedtostartinQ4,2010

Potentialinadditionaltumortypes

Recurrentbrain

tumors,

Melanoma,

breast,

ovarian,

and

colon

cancers


19/28

October 2010 19

MarkerstoIdentifyandIsolateCancerStemCells

+++Leukemia

++-+MultipleMyeloma

++++Melanoma

+Liver

+Brain

++Lung

+++++Pancreatic

++Head&Neck

+++++Prostate

+++++Colon++++++Breast

CD20CD166CD34CD1386B1ESAALDH1CD133CD24CD44Cancer

StemCellMarker

From Boman et al, JCO 26:2795, 2008


20/28

October 2010 20

TargetofICT121upregulatedonCSCs andtumor

30,000180,000copiesofCD133onCSCs

Only4500

copies

on

hematopoietic

stem

cells

SelectivityincreasedbydifferencesinMHCclassIexpression

Ontumorcells,notnormalcells

NormalStem

Cells Cancer

Stem

Cells Cancer

Daughter

Cells

PE-HLA-D

R

FITC-HLA-A,B,C

CSCprimed

T

cells

dont

recognizenormalstemcellsCSC

primed

T

cells

recognizeCSCsCSC

primed

T

cells

recognize

Cancerdaughtercells(tumor)

Secondproduct:ICT121


21/28

October 2010 21

ICT121:OfftheshelfCancerStemCellVaccine

PeptidebasedvaccinetargetingCD133antigenpresentonCSCs

Applicableformultiplesolidtumors

INDtobefiledin1H,2011

Maybe

applicable

to

brain,

pancreatic,

lung,

colon,

renal,

melanoma,andbreastcancers

Onlycompanydevelopinganactiveimmunotherapy

platformtargeting

CSCs

PotentialBlockBusterProduct.


22/28


23/28

October 2010 23

StrongIP

Position

25+PatentsandPatentApplications.

7Issued

18+Pending

IssuedPatentscovercompositionofmatter,therapeutictreatmentsanddiagnosticsrelatedtomonoclonalantibodies


24/28

October 2010 24

ValueCreationinNext12Months

Clinical

InitiatePhaseIIclinicaltrialsforICT107(Q4)

PeerreviewedpublicationofphaseItrialinamajor

journal

InitiatePhaseIclinicaltrialforanofftheshelfvaccine

Business

Development PotentialpartneringofICT107vaccineoroneofthe

antibodycandidates


25/28

October 2010 25

ExperiencedManagement

Team

ManishSingh,PhD,PresidentandCEO

CaliforniaTechnologyVentures,CellGenesys,ChironViagene,GeneticTherapyInc(Novartis)

JohnYu,MD,ChairmanandCSO

Neurosurgeonat

Cedars

Sinai

Medical

Center,

Mass

General

Hospital,HarvardMedicalSchool

JimBender,PhD,MPH,VPofClinicalDevelopment

IDM

Pharma,

Baxter

Healthcare C.KirkPeacock,CPA,CFO

CytRx,DigitalMed,Ants.com


26/28

October 2010 26

KeyOpinion

Leaders

KeithBlack,MD,HeadofScientificAdvisoryBoard

HeadofNeurosurgery,CedarsSinaiMedicalCenter

GeorgePeoples,MD,MemberofScientificAdvisoryBoard

Directorof

Cancer

Vaccines,

US

Military

Cancer

Institute

RobertMartuza,MD,MemberBoardofDirectors

ProfessorofNeurosurgery,HarvardMedicalSchool,and

Chiefof

Neurosurgery,

Massachusetts

General

Hospital

SherieMorrison,PhD,MemberofScientificAdvisoryBoard

Chair,DeptofMicrobiology,ImmunologyandMolecular

Genetics,UCLA


27/28

October 2010 2727

StrongFinancial

Position

and

Capitalization

Cash: $7.7Million(June30th,2010)

Currentburnrate: $1.15M/quarter(Q2,2010)

Outstandingdebt: $0

Sharesoutstanding: 21.6

million

Currentshareprice: $1.00

Currentmarketcap: $22million

Warrantsoutstanding 3.4million

Optionsoutstanding: 11.3million;averageweightedaverageexercisepriceof$0.92


28/28

October 2010 28

ImmunoCellular Therapeutics AdvancingPromisingCancer

Stem

Cell

Therapeutics

BuildingNextGenerationVaccineTargetingCancer

Stem

Cells

to

prevent

recurrence Bestclinicaldataforglioblastoma outofall

publishedclinicaltrialsover30years

PhaseII

trial

to

start

in

Q4,

2010

Additionalclinicaltrialsinnext3yearsinrecurrent

brain

cancers,

pancreatic,

and

ovarian

cancers Experiencedmanagementteamwithprovendrug

developmentexperience

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