november 2012 immunocellular therapeutics industry-leading, next-generation, cancer immunotherapy

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November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

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Page 1: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

November 2012

ImmunoCellular TherapeuticsIndustry-leading, next-generation, cancer immunotherapy

Page 2: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

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Disclaimer

This presentation contains certain “forward-looking statements” (statements as to matters other than historical facts) as defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual events or results to differ materially from the events and include statements about our plans, objectives, expectations and intentions with respect to the potential for success of our scientific approach to cancer immunotherapy, clinical development efforts, operations, financial condition and other statements that are not historical in nature, particularly those that use terms such as “will,” “potential”, “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “projects,” “estimates” or similar language.

Important factors known to us that could cause actual results to differ materially from those expressed in such forward-looking statements include those set forth in our most recent annual report on Form 10-K, quarterly reports on Form 10-Q and other reports filed with the SEC.

You may obtain these documents for free by visiting EDGAR on the SEC website at www.sec.gov. The information in this presentation speaks only as of the date hereof, and except as required by law, we disclaim any obligation to update or revise any forward-looking statement.

Page 3: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

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Disruptive Validated Technology

Cancer Stem Cell Targeting Potent Immunotherapy

= Effective Cancer Eradication

+

Page 4: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

Why Cancer Vaccines Previously Failed?

Problem• Late-stage disease

• Immune compromised patients

• Weak immune response

Solution• Minimal residual disease

• Immune competent patients at diagnosis

• Dendritic cells with persistent T-cell immune response

4

• Target multiple antigens• Overall survival endpoint• Target cancer stem cells

• Tumor mutation/escape• Flawed trial endpoints• Targeted tumor bulk

Page 5: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

Without killing CSCs, it is like spraying for weeds without killing the roots. The weeds (tumors) come back.

Page 6: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

Immunotherapy Has Advantages in Targeting Cancer Stem Cells

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Cancer cell Cytotoxic T-cell

Cytotoxic T-cells target CSC antigens cancer presented by MHCs

Antigen

MHC

Immunotherapy can elicit T-cell mediated rejection of tumors• T cells are the way the body kills cancer cells• Improves specificity• Targets intracellular & surface antigens• Better safety profile• Differentiates between CSCs and normal stem cells

Antibodies only target CSC antigens on the surface of cancer cells

Cancer cell

Antibody

Antigen

Page 7: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

Product Pipeline OverviewMultiple therapies in different cancer indications

Active immunotherapies ICT-107

F̶ Dendritic cell vaccine targeting glioblastoma antigens and CSCsF̶ Phase I trial showed compelling clinical outcomesF̶ Phase II study results anticipated late 2013

ICT-140F̶ Dendritic cell vaccine targeting ovarian cancer antigens and CSCsF̶ IND filing Q4/2012

ICT-121F̶ Dendritic cell vaccine targeting CD133 (CSC marker)F̶ IND approved; plan enrollment Q4/2012

Antibody immunotherapies Licensed to Caerus Molecular Discovery, funded by BioWa

7

Page 8: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

ICT-107 Preparation & ManufacturingMultiple doses from only one apheresis procedure

GMP Manufacturing Facility

Apheresis

Patient

Apheresisproduct

Ship back to physician

ICT-107 ICT-107~30 doses

Peripheral blood mononuclear cells

Activated dendritic cells

Culture with cytokines

Intradermal injection

Pulse w/ tumor-associated

antigens

Aliquot & freeze

Ship overnight

8

Page 9: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

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ICT-107 targets both tumor cells and CSCs

Page 10: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

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ICT-107 Targets Antigens Overexpressed on Glioblastoma Cancer Stem Cells

gp100 MAGE-1

IL-13Rα2

HER2/neu AIM2 TRP-2 EGFRv

IIIHSP Ags

Tumor Lys

ICT-107(IMUC)

CDX-110(Celldex)

DC Vax(Northwest Bio)

Prophage(Agenus)

ICT-107 targets six tumor antigens (nine amino acid epitopes that elicit an immune response in HLA-A1/A2 patients)

Page 11: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

Expression of Tumor Antigens in GBM by RT-PCRAll GBM patients express three or more antigens75% expressed all six

11

Pt # Pt ID AIM gp100 MAGE TRP-2 Her-2 IL-13R1630 ++ ++ wk +++ ++++ ++++ wk <1E51636 +++ + wk +++ +++ ++++ + >1E51639 ++ + wk +++ +++ ++++ ++ >1E41640 +++ ++ wk +++ ++++ neg +++ >1E31597 ++++ ++ + +++ ++++ +++++ ++++ >1E21587 ++ wk wk ++ ++ ++++ +++++ >1E11544 ++ ++ wk ++ +++ ++1576 + wk neg ++ +++ ++1577 ++ + wk ++ ++ ++1551 +++ + + +++ +++ ++1552 ++ wk wk ++ +++ ++1562 ++++ + + +++ +++ ++1564 ++ wk wk ++ +++ +++1540 ++ + +++ +++ +++ ++++1542 +++ ++ wk ++ +++ ++++1519 ++++ wk ++ ++ +++ +1522 +++++ + + ++++ ++++ ++++1523 ++++ + + +++ +++ ++++1525 +++ wk wk ++ ++++ ++++1412 +++ + + ++++ ++++ +++++1466 ++ + wk +++ ++++ +++

2 1526 ++++ + + ++ +++ ++5 1351 +++ + wk +++ +++ ++++6 1431 ++++ + + +++ ++++ +++++7 1508 +++++ neg + ++ ++++ ++++8 1468 ++++ ++ neg ++++ neg +++++9 1498 + ++ wk ++ ++++ ++++

11 1539 +++ + wk ++ +++ +12 1561 ++ wk wk +++ +++ +++13 1550 ++ ++ neg +++ ++++ ++++14 1547 ++++ neg + ++ +++ ++++15 1594 ++ + wk ++ +++ +++16 1560 +++ neg wk neg +++ neg17 1578 +++ wk wk ++ ++ ++18 1585 ++ ++ wk +++ ++++ ++++19 1614 + + wk ++ +++ ++++

Patients from ICT-107 Phase I clinical trial

Page 12: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

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Phase I Trial with ICT-107

Nonrandomized, single-center study at Cedars-Sinai 19 GBM patients 16 newly diagnosed, 3 recurrent ~75% fully resected

Patients received standard of care (surgery and chemo-radiation) followed by three vaccinations of ICT-107 every two weeks.

Page 13: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

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Pre- and Post-Operative MRI Scans of Four GBM Patients on ICT-107

Page 14: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

B-17

B-09

B-12

B-11

B-02

B-16

B-18

B-13

B-20

B-19

B-15

B-14

B-10

B-07

B-04

B-06

0 10 20 30 40 50 60 70

Months from Surgery

ICT-107 Phase I ResultsNewly diagnosed GBM patients (efficacy and safety)

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= Death

Historical Fully-resected

RT/Chemo Vaccine Progressive disease

ICT-107

Six patients without recurrence for over 4 years (3 of them over 5 years)

No Grade 3 or 4 toxicities.Adverse events (Grade 1 or 2) include diarrhea, fatigue, flushing, pruritis, rash, vomiting

Stupp et al. N Engl J Med. 2005 Mar 10;352(10):987-96 & Stupp et al. Lancet Oncol. 2009 May;10(5):459-66.

Page 15: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

ICT-107 Improves Survival in GBM

*Surgery followed by radiation and temozolomide (TMZ). Stupp et al. N Engl J Med. 2005 Mar 10;352(10):987-96.

Historical standard of care

ICT-107

Significant increase in median PFS 16.9 months for ICT-107 6.9 months for historical SoC*

Progression Free Survival (PFS)

Significant increase in median OS 38.4 months for ICT-107 14.6 months for historical SoC*

Historical standard of care

ICT-107

Overall Survival (OS)

15

Page 16: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

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Correlation of PFS and OS with Antigen Expression

Page 17: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

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CD133 Expression (CSC Biomarker)Primary & recurrent tumor samples from the same patient

A B C D E

19.1

6.65.3

3.52.5

Chemotherapy

Patient

Rela

tive

Incr

ease

in C

D13

3 Ex

pres

sion

F G H I J

12.3

2.1

7.6

0

12.3

0.60 0 0

1.4

0.2

ICT-107Before After After2

Patient

CD13

3 Ex

pres

sion

Phuphanich et al. Cancer Immunol Immunother. 2012 Jul 31.

Page 18: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

ICT-107 Phase II Trial DesignRandomized, placebo-controlled, double-blind trial

Newly Diagnosed

GBM Patients (n=123)

ICT-107 +TMZ

PlaceboUnloaded DCs + TMZ

2:1

rand

omiza

tion

• 123 patients treated at 25 centers HLA-A1/A2 50-75% of US population

• 278 patients enrolled • Primary endpoint: OS • Secondary endpoints:

PFS OS/PFS at various time intervals Immune response (T-cells) Safety

• Interim analysis (based on 50% events) in Q1/2013• Final results in 2H2013• Derisked by improving DC function, timing, frequency

7 weeks 6 weeks 4 weeks 4 weeks 4 weeks 4 weeks

TMZRadiation

4 weeks

Surgery Apheresis Vaccinations

18

Page 19: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

ICT-107 Phase II Trial Enrollment25 clinical trial sites – 278 patients enrolled

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Johns Hopkins UniversityNew York UniversityUniversity of Texas at Houston Northwestern University Arizona Cancer Center New Jersey Neuroscience InstituteUC San DiegoMoffitt Cancer CenterPenn StateUniversity of PennsylvaniaUniversity of VirginiaWake ForestCornell PresbyterianMassachusetts GeneralKentuckiana Cancer Institute Cedars-Sinai Medical CenterUniversity Hospital Case Medical Center Rush UniversityOverlook Hospital Baylor University Cleveland ClinicUniversity of AlabamaThomas JeffersonLong Island Brain Center

JAN

FEB

MAR

APRM

AYJU

N JUL

AUG SEP

OCTNOV

DECJA

NFE

BM

ARAPR

MAY

JUN JU

LAUG

0

50

100

150

200

250

300

Planned Actual

Page 20: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

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FDA ApprovalsNewly Diagnosed GBM

Gliadel Approval in 2003 Double-blind, placebo-controlled, randomized Phase III trial showing

13.8 vs. 11.6 month survival

Temozolomide Approval in 2005 Double-blind, placebo-controlled, randomized Phase III trial showing

14.6 vs. 12.1 month survival

Page 21: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

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Projected Costs: ICT-107 vs. ProvengeLower cost of goods, better logistics

ICT-107 Provenge% DCs/APC 60%-90% 15%-20%

Interleukin-12 Yes No

Target antigens Six One

Doses/apheresis ~30 1

Storage Liquid nitrogen N/A

Administration Intradermal injection IV infusion

Cost of Goods 5%-10% 70%

Source: Quarterly earnings transcripts and public filings.

Page 22: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

Other Immunotherapy Candidates

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Page 23: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

ICT-140: Ovarian Cancer Vaccine

Ovarian cancer is similar to GBM Minimal residual disease after surgery Immuno-responsive

Dendritic cell vaccine targeting CSCs Seven antigens over-expressed in ovarian cancer, including three

antigens used in ICT-107̶F HER2/neu, IL-13Rα2, MAGE1, mesothelin, EphA2, & two more antigens

File IND by Q4/2012

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Page 24: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

ICT-121: CSC-targeted Universal Vaccine• Dendritic cell vaccine loaded with two CD133 peptides• CD133 is highly expressed on CSCs• CD133 is expressed on most solid tumors, including brain,

colon, non-small cell lung, melanoma, pancreatic, and breast cancer

• Initial indication in recurrent GBM• PI-sponsored Phase I trial at Cedars-Sinai Medical Center

20 patients IND approved; plan enrollment Q4/2012

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Page 25: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

Inverse Correlation between CD133 Expression with Survival on Gliomas

Source: Rebetz et al. PLoS ONE. 2008.

CD133 expression correlates inversely with grade II to IV glioma patient survival time. The survival time calculated from the day of operation was plotted against the percentage of CD133+ cells in the CD45-cell fraction from the specimens of each patient. UD: undetectable CD133 expression. Bold black bars indicate the median survival time for patients in groups with CD133+ cells either lower or higher than 30% of total CD45-cells.

Page 26: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

Strong IP Position

28+ patents and patent applications 10 patents issued or allowed 18+ patents pending

Vaccine patents and applications include Method of use for six antigen vaccine (ICT-107) Manufacturing process for production of ICT-107 Use of dendritic cells with chemotherapy for neural cancers Immunotherapy targeting IL-13Rα2 Immunotherapy targeting CD133

Issued patents on monoclonal antibodies cover composition of matter, therapeutic treatments and diagnostics

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Page 27: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

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Experienced Management Team

John Yu, MD, Chairman & CSO, Interim CEO Neurosurgeon at Cedars-Sinai, Mass General Hospital, Harvard Medical School

Elma Hawkins, PhD, Head of Clinical Development Antigenics, Genzyme, Warner Lambert/Parke Davis

Jim Bender, PhD, MPH, VP of Manufacturing & Product Development IDM Pharma, Baxter Healthcare

David Fractor, CPA, CFO HemaCare, Andwin, Deloitte & Touche

Peter Ho, PhD, Director of Business Development Grey Healthcare Group, Prudential Equity Group, Allergan, D.E. Shaw

Experience in developing over 20 products in cell & gene therapy and vaccines

Page 28: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

Product Pipeline

28

2011

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

2012

Q1 Q2 Q3 Q4

2013

Q1 Q2 Q3 Q4

2014

ICT-107New GBM Phase II trial

Phase I/II trial

Phase I trial

Preclinical

Preclinical

ICT-140Ovarian

ICT-121Recurrent GBM

Interim analysis Final results

IND

IND

Page 29: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

Recent & Upcoming Milestones

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July 2012ICT-121 IND

October 2012SITC abstract

November 2012SNO abstract

August 2012ICT-107 Ph 2 enrollment

Q1 2013ICT-107 Ph 2 interimICT-140 IND

2H 2013ICT-107 Ph 2 final

Q3 2013ICT-140 Ph 1/2

October 2013SITC abstract

November 2013SNO abstract

May 2012NYSE MKT listing

June 2013ASCO abstract

December 2012ICT-121 Ph 1

Page 30: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

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Strong Financial Position & Capitalization

Cash (as of 9/30/2012) $10 million (A)Burn rate $3 million per quarter

Outstanding debt NoneShares outstanding (as of

9/30/12) 41.1 million (A)

Market capitalization (as of 11/6/2012) $98 million

Warrants outstanding (as of 9/30/12) 8.9 million (A)

Options outstanding 10.4 million (average weighted exercise price of $1.15)

(A) In October 2012, we raised $19.3 million from the issuance of 10 million shares of common stock and 4.5 million warrants.

Page 31: November 2012 ImmunoCellular Therapeutics Industry-leading, next-generation, cancer immunotherapy

November 2012

ImmunoCellular TherapeuticsIndustry-leading, next-generation, cancer immunotherapy