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ImmunoCellular Therapeutics

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Presentation on theme: "ImmunoCellular Therapeutics"— Presentation transcript:

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

2 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 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 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.

3 Disruptive Validated Technology
Cancer Stem Cell Targeting Potent Immunotherapy + = Effective Cancer Eradication

4 Why Cancer Vaccines Previously Failed?
Problem Solution Late-stage disease Immune compromised patients Weak immune response Minimal residual disease Immune competent patients at diagnosis Dendritic cells with persistent T-cell immune response Tumor mutation/escape Flawed trial endpoints Targeted tumor bulk Target multiple antigens Overall survival endpoint Target cancer stem cells

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

6 Immunotherapy Has Advantages in Targeting Cancer Stem Cells
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 Cancer cell Cytotoxic T-cell Cytotoxic T-cells target CSC antigens cancer presented by MHCs Antigen MHC Antibodies only target CSC antigens on the surface of cancer cells Cancer cell Antibody Antigen

7 Product Pipeline Overview Multiple therapies in different cancer indications
Active immunotherapies ICT-107 Dendritic cell vaccine targeting glioblastoma antigens and CSCs Phase I trial showed compelling clinical outcomes Phase II study results anticipated late 2013 ICT-140 Dendritic cell vaccine targeting ovarian cancer antigens and CSCs IND filing Q4/2012 ICT-121 Dendritic cell vaccine targeting CD133 (CSC marker) IND approved; plan enrollment Q4/2012 Antibody immunotherapies Licensed to Caerus Molecular Discovery, funded by BioWa

8 GMP Manufacturing Facility
ICT-107 Preparation & Manufacturing Multiple doses from only one apheresis procedure GMP Manufacturing Facility Ship overnight Culture with cytokines Apheresis Apheresis product Peripheral blood mononuclear cells Activated dendritic cells Pulse w/ tumor-associated antigens Patient Intradermal injection Ship back to physician Aliquot & freeze ~30 doses ICT-107 ICT-107

9 ICT-107 targets both tumor cells and CSCs

10 ICT-107 Targets Antigens Overexpressed on Glioblastoma Cancer Stem Cells
gp100 MAGE-1 IL-13Rα2 HER2/neu AIM2 TRP-2 EGFRvIII HSP 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)

11 Expression of Tumor Antigens in GBM by RT-PCR
All GBM patients express three or more antigens 75% expressed all six Pt # Pt ID AIM gp100 MAGE TRP-2 Her-2 IL-13R 1630 ++ wk +++ ++++ <1E5 1636 + >1E5 1639 >1E4 1640 neg >1E3 1597 +++++ >1E2 1587 >1E1 1544 1576 1577 1551 1552 1562 1564 1540 1542 1519 1522 1523 1525 1412 1466 2 1526 5 1351 6 1431 7 1508 8 1468 9 1498 11 1539 12 1561 13 1550 14 1547 15 1594 16 1560 17 1578 18 1585 19 1614 Patients from ICT-107 Phase I clinical trial

12 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.

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

14 ICT-107 Phase I Results Newly diagnosed GBM patients (efficacy and safety)
RT/Chemo Vaccine Progressive disease = Death Historical Fully-resected 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 14.6 historical, 18 fully-resected, 38.4 ICT-107 Stupp et al. N Engl J Med Mar 10;352(10): & Stupp et al. Lancet Oncol May;10(5):

15 ICT-107 Improves Survival in GBM
Progression Free Survival (PFS) Overall Survival (OS) ICT-107 ICT-107 Historical standard of care Historical standard of care Significant increase in median PFS 16.9 months for ICT-107 6.9 months for historical SoC* Significant increase in median OS 38.4 months for ICT-107 14.6 months for historical SoC* *Surgery followed by radiation and temozolomide (TMZ). Stupp et al. N Engl J Med Mar 10;352(10):

16 Correlation of PFS and OS with Antigen Expression

17 CD133 Expression (CSC Biomarker) Primary & recurrent tumor samples from the same patient
To determine the impact of ICT-107 on CSCs, we looked at CD133 expression from patient samples before and after treatment. CD133 (CSC marker) expression by RT-PCR in primary tumor and samples from subsequent surgeries from newly diagnosed and recurrent patients. Expression is calculated relative to GADPH. The sample for Patient H was negative for tumor. Phuphanich et al. Cancer Immunol Immunother Jul 31.

18 Newly Diagnosed GBM Patients (n=123)
ICT-107 Phase II Trial Design Randomized, placebo-controlled, double-blind trial 123 patients treated at 25 centers HLA-A1/A % 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 ICT-107 + TMZ Newly Diagnosed GBM Patients (n=123) 2:1 randomization Placebo Unloaded DCs + TMZ 7 weeks 6 weeks 4 weeks TMZ Radiation Surgery Apheresis Vaccinations

19 ICT-107 Phase II Trial Enrollment 25 clinical trial sites – 278 patients enrolled
Johns Hopkins University New York University University of Texas at Houston Northwestern University Arizona Cancer Center New Jersey Neuroscience Institute UC San Diego Moffitt Cancer Center Penn State University of Pennsylvania University of Virginia Wake Forest Cornell Presbyterian Massachusetts General Kentuckiana Cancer Institute Cedars-Sinai Medical Center University Hospital Case Medical Center Rush University Overlook Hospital Baylor University Cleveland Clinic University of Alabama Thomas Jefferson Long Island Brain Center

20 FDA Approvals Newly Diagnosed GBM
Gliadel Approval in 2003 Double-blind, placebo-controlled, randomized Phase III trial showing 13.8 vs month survival Temozolomide Approval in 2005 Double-blind, placebo-controlled, randomized Phase III trial showing 14.6 vs month survival

21 Intradermal injection
Projected Costs: ICT-107 vs. Provenge Lower 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. 21

22 Other Immunotherapy Candidates

23 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-107 HER2/neu, IL-13Rα2, MAGE1, mesothelin, EphA2, & two more antigens File IND by Q4/2012

24 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

25 Inverse Correlation between CD133 Expression with Survival on Gliomas
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. Source: Rebetz et al. PLoS ONE

26 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

27 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

28 Product Pipeline 2011 Q1 Q2 Q3 Q4 2012 2013 2014 Phase II trial
ICT-107 New GBM Interim analysis Final results Preclinical Phase I/II trial ICT-140 Ovarian IND Preclinical Phase I trial ICT-121 Recurrent GBM IND

29 Recent & Upcoming Milestones
May 2012 NYSE MKT listing July 2012 ICT-121 IND October 2013 SITC abstract October 2012 SITC abstract December 2012 ICT-121 Ph 1 Q3 2013 ICT-140 Ph 1/2 2H 2013 ICT-107 Ph 2 final June 2013 ASCO abstract November 2013 SNO abstract Q1 2013 ICT-107 Ph 2 interim ICT-140 IND Continue to have discussions with potential global and regional partners. November 2012 SNO abstract August 2012 ICT-107 Ph 2 enrollment

30 Strong Financial Position & Capitalization
Cash (as of 9/30/2012) $10 million (A) Burn rate $3 million per quarter Outstanding debt None Shares 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.

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

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