1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO.

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Presentation transcript:

1 CONFIDENTIAL OMS ElectroOncology Precision Tumor Destruction and DNA Based Cancer Immunotherapy OTCBB: ONCS Punit Dhillon President & CEO

CONFIDENTIAL2 Forward Looking Statement Our commentary and responses to your questions may contain forward- looking statements, including comments concerning clinical trials and product development programs, evaluation of potential opportunities, the level of corporate expenditures, the assessment of OncoSec’s technology by potential corporate partners, capital market conditions, timing of events, cash consumption and other subjects. Information concerning factors that could cause actual results to differ materially from those set forth in our regulatory filings from time to time.

CONFIDENTIAL3 Investment Overview Cancer Therapy with OMS ElectroChemotherapy and OMS ElectroImmunotherapy Ablation platform selectively destroys cancer cells while leaving healthy tissue intact, dramatically improving patient quality of life Immunotherapy platform allows activation of both innate and adaptive immunity to kill cancer cells Drug-device combination using low dose bleomycin or DNA based cytokines Locally delivered with electroporation into targeted tumors/tissue Selective killing of cancer cells, preserving healthy tissue Extensive human clinical experience showing efficacy and strong safety profile in Phase clinical trials of 400+ patients: cutaneous (BCC, SCC, melanoma), head & neck, breast, prostate, pancreatic tumors Near-term commercial potential, recurring sales model

CONFIDENTIAL4 OncoSec Solution = OMS ElectroOncology OncoSec’s treatment platform has two components: Chemotherapeutic Agent (Bleomycin) Cytokine Plasmid DNA Construct (e.g. IL-12) or Drug-device combination Razor-razor blade marketing strategy with revenue from single use disposable; potential profit from proprietary biologics Patent estate Electric pulse generators and applicators Electroporation conditions and methods of use

CONFIDENTIAL5 Electroporation Enhances Therapeutic Potency Anti-cancer agent injected directly into tissue Tissue electroporation enhances cellular uptake Cell poration; agent enters cells Drug surrounds cells Electroporation: millisecond pulses increase cell permeability Cells reseal, allowing agent to perform its function

CONFIDENTIAL6 OMS ElectrOncology Cancer Targets OncoSec’s ElectroOncology has successfully treated a range of solid tumor cancers in humans Skin (Melanoma and Non-Melanoma) Head & Neck Breast Prostate Pancreatic

CONFIDENTIAL7 OMS ElectoImmunotherapy DNA plasmids encoding for cytokines (e.g. IL-12) to stimulate the body’s immune system to kill cancer cells DNA plasmid encoding for cytokines in combination with OMS  increased cellular uptake of DNA immunotherapeutic  subsequent production/expression of IL-12 Induces innate and adaptive anti-tumor immune responses No unwanted immune responses and immunogenic effects associated with protein IL-12 administered directly into the body No unwanted immune responses and immunogenic effects often attributed to viral vectors Lead drug candidate is a DNA plasmid construct coding for interleukin-12 (IL-12) Phase II clinical pipeline for several cancer indications based on positive Phase I clinical data

CONFIDENTIAL8 OncoSec’s Lead Candidate: IL-12 1.DNA IL-12 uptake into tumor cells enhanced by electroporation 2.Cells produce and secrete IL-12 3.IL-12 recruits macrophages and cytotoxic T-cells and activates other pro- inflammatory responses – innate immune respone 4.Cancer cells and tumors at local treatment site destroyed 5.Selective systemic adaptive immune effect on remote, untreated cancer lesions IL-12 recruits cytotoxic T-cells and macrophages TH1TH1 IL-12 TH1TH1 B-cell IFN-  Phagocytosis IFN-  Inhibits tumor angiogenesis Apoptosis Macrophage Antibodies

CONFIDENTIAL9 IL-12 Plasmid in Melanoma Mouse Model - I Intratumoral delivery of IL-12 by electroporation demonstrated: Cytokine expression within the tumor Potential anti-angiogenic effect (prevents growth of blood vessels that feed tumor) Tumor control in all treated animals Long-term survival and resistance to challenge in melanoma model Lucas et al., 2002, IL-12 plasmid delivery by in Vivo electroporation for the successful treatment of established subcutaneous B16.F10 melanoma, Molecular Therapy

CONFIDENTIAL10 IL-12 Plasmid in Melanoma Mouse Model - II GroupDoseElectroporation Objective Response Complete Response FemalesMalesFemalesMales mg SalineNo0% mg IL-12No0% mg IL-12Yes20% mg IL-12No20%0%20%0% mg IL-12Yes100%80%100%80% Tumor response at day 30 post-treatment Electroporation increased desired immune response and potency of DNA IL-12 Higher dose achieved significantly higher partial tumor response rates including complete responses in one study cohort Study also showed no significant toxicity associated with DNA IL-12 N = 50 animals; 10 animals per group; 5 females, 5 males per group. Heller et al., 2006, Evaluation of toxicity following electrically mediated IL-12 gene delivery in a B16 mouse melanoma model, Clin Can Res

CONFIDENTIAL11 US Phase I Melanoma Trial Results Dose escalation clinical study in patients with metastatic melanoma Treatment with OMS and IL-12 completed in 24 patients at University of Southern Florida, Moffitt Cancer Center US Phase I results reported in Journal of Clinical Oncology (Daud et al, 2008): Study established efficacy, safety and tolerability Evidence of systemic response (objective response) in 53% of patients with distal (remote) metastases that were untreated 15% of patients demonstrated 100% clearance of distal, non-treated tumors; only 0.25% could be expected to spontaneously regress based on historic clinical data Greater then 90% of locally treated lesions showed evidence of necrosis (histological biopsy) B B A B C D EF Pre-TreatmentDay 256Day 637 Right Front Chest Wall Right Upper Back

CONFIDENTIAL12 Phase II Study Design for OMS-I100 (Melanoma) Summary of clinical trial design Title:Phase II trial of intratumoral pIL-12 electroporation in advanced stage cutaneous and in transit malignant melanoma Design:Single arm, open-label study Patient population:Melanoma Number of Subjects:25 Endpoints:Primary: Objective response rate (local and distant) at 6 months Secondary: Local response rate Progression free survival Overall survival Duration of distant response Time to objective response Safety of intratumoral IL-12 in vivo electroporation First patient first visit:Q3 2011

CONFIDENTIAL13 Phase II Study Design for OMS-I110 (MCC) Summary of Clinical Trial Design: Title:A Phase II Study of Intratumoral Injection of Interleukin-12 Plasmid and in vivo Electroporation in Patients with Merkel Cell Carcinoma Design:Single arm, open-label study Patient Population:Merkel cell carcinoma Number of Subjects:15 Endpoints:1 0 Endpoint: IL-12 protein expression in tumor tissue at 3-4 weeks 2 0 Endpoint: Safety Objective response rate (local and distant) Overall survival Time to relapse or progression Immunologic effects of intratumoral pIL-12 injection with electroporation First Patient First Visit:Q3 2011

CONFIDENTIAL14 Phase II Study Design for OMS-I120 (CTCL) Summary of Clinical Trial Design: Title:Phase II Trial of Intratumoral IL-12 Plasmid Electroporation In Cutaneous Lymphoma Design:Open-label study; Simon’s 2-stage mini-max design Patient Population:Cutaneous T-Cell Lymphoma Number of Subjects:Stage 1 = 10 pts; Stage 2 = 17 pts Endpoints:1 0 Endpoint: Objective Response Rate (Local and Distant) at 6 months 2 0 Endpoint: Safety Progression free survival First Patient First Visit:Q3 2011

CONFIDENTIAL15 OMS ElectroChemotherapy Chemotherapeutic agent (bleomycin) delivered intracellularly with electroporation Chemical based ablation, unlike surgery, radio frequency ablation and cryotherapy that has the ability to selectively kill cancer Clinical and physician experience in late stage head & neck and skin cancer studies demonstrated therapy to be a safe, tissue sparing, easy to use, economical and highly effective alternative to surgery OncoSec’s new clinical development plan is to maximize the likelihood of clinical and regulatory success

CONFIDENTIAL16 Treatment of Head and Neck Cancer Electroporation applied with applicator Cancer cells destroyed while preserving healthy tissue Tumor injectedwith bleomycin No removal of healthy tissue

CONFIDENTIAL17 Treatment of Skin Cancer OMS ElectroChemotherapy of basal cell cancer 30 Days Post-treatment 120 Days Post-Treatment Pre-Treatment 90 Days Post-Treatment BCC of EarlobeTumor cells turn black as they die Natural wound healingNo further evidence of tumor

CONFIDENTIAL18 Cutaneous Cancer Therapy Clinical Data Complete response (CR) + partial response (PR) Heller et al., Cancer Vol. 83 (1), July 1, 1998 Complete response is similar to treatment by surgery, without removal of healthy tissue Type# of Patients Objective Response *Complete Response Basal Cell Carcinoma18 56 of 56 (100%) 51 of 56 (91.1%) Melanoma10 84 of 85 (98.8%) 75 of 85 (88.2%) Squamous Cell Carcinoma 1 1 of 1 (100%) 0 of 1 (0%) Kaposi’s Sarcoma1 4 of 4 (100%) 4 of 4 (100%) Totals of 146 (99.3%) 130 of 146 (89.0%) (H.Lee Moffitt Cancer Center – University of Florida)

CONFIDENTIAL19 OncoSec Product Pipeline Research and Development PreclinicalPhase 1Phase 2Phase 3 Registration Trial ElectroImmunotherapy Program Malignant Melanoma Cutaneous T-Cell Lymphoma Merkel Cell Carcinoma ElectroChemotherapy Program Head & Neck Cancer (Europe) Skin Cancer (Europe) Skin Cancer (United States) CompletedPlanned

CONFIDENTIAL20 OncoSec Competitive Advantages Compelling stakeholder benefits and promise of market pull Improved cosmetic, functional and pain outcomes→ patient preference Minimal tissue removal = simple post-op care→ physician & payer preference Transcends tumor types & locations → physician preference Adjuvant therapy = easier adoption → physician preference Ease of use and higher income → physician preference Minimal upfront investment → institutional acceptance Fast procedure = operating room cost savings → payer preference

CONFIDENTIAL21 Board & Executive Management Team Board of Directors Executive Management Avtar Dhillon, M.D., Chairman Inovio Pharmaceuticals, MDS Capital (Lumira) James DeMesa, M.D., Director Stem Cell Therapeutics, Induce Biologics Anthony E. Maida III, Ph.D., Director BioConsul Drug Development, Replicon Neurotherapeutics, Trellis Bioscience, CancerVax Corp. Punit Dhillon, President & CEO Inovio Pharmaceuticals, MDS Capital (Lumira) Michael Cross, Ph.D., Chief Business Officer MDS Capital, GrowthWorks, MDS Proteomics, Viventia Biotech Veronica Vallejo, CPA, Vice President Finance CBIZ MHM, Mayer Hoffman & McCann Caryn Peterson, Ph.D., Vice President Regulatory Affairs FeRx, Amylin Pharmaceuticals, Hybertech Paul Goldfarb, M.D., Medical Director Scripps Health, University of California, San Diego Brian McCluskey, B.Eng., Executive Director Engineering TDI Instruments, Digirad Corp. Ernest Kitt, Executive Director Clinical Operations Medicinova, Vical Corp.

CONFIDENTIAL22 Financial Information Shares Issued & Outstanding:56,856,000 Warrants:13,456,000 Stock Option Pool:75,512,000 Management & Affiliates Ownership:51% Formation Capital:$4.1M

CONFIDENTIAL23 Commercialization Milestones Based on leveraging large historical patient database Initiate multiple OMS ElectroImmunotherapy trials for skin cancers Initiate US pivotal OMS ElectroChemotherapy trials for skin cancer Extend EU pre-marketing studies demonstrating pharmacoeconomic, reimbursement, and QoL benefits Develop OMS ElectroImmunotherapy combination Phase II program for skin cancers Near-term commercialization strategy: initiate pivotal and pre-marketing clinical trials, secure early market adoption, expand physician use base: Obtain marketing approvals and reimbursement coding Sales and marketing through partnerships Drive adoption via key opinion leaders, physician loyalty and advocacy groups Partner/co-develop in emerging countries: large and rapidly growing markets with both push and pull dynamics (device improvements)

CONFIDENTIAL24 Business Opportunity Summary $1B market for locally effective, tissue sparing tumor treatment Cancer therapy using biologics and small molecules: diversified Market exclusivity through potential orphan indications Market ready with favorable pharmacoeconomics & quality of life benefits Centers of Excellence/key opinion leaders to drive adoption Management team with extensive drug, device, clinical, commercial and capital markets expertise