1 confidential oms electrooncology precision tumor destruction and dna based cancer immunotherapy...
TRANSCRIPT
CONFIDENTIAL1
OMS ElectroOncology
Precision Tumor Destruction andDNA Based Cancer Immunotherapy
OTCBB: ONCS
Punit DhillonPresident & 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 1 - 4 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:Anti-Cancer Agent OncoSec Medical System (OMS)
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
Electroporation dramatically enhances cellular uptake of a useful therapeutic agent
Cell poration; agent enters cells
Drug surroundscells
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
Boosting the immune system to fight cancer
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
How it worksIL-12 recruits cytotoxic T-cells and macrophages
TH1
IL-12
TH1
B-cell
IFN-
Phagocytosis
IFN-
Inhibits tumor
angiogenesis
Apoptosis
Macrophage
Antibodies
Safe and effective local and systemic immune response and therapeutic benefit
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
Group Dose ElectroporationObjective Response
Complete Response
Females Males Females Males
1 0.05 mg Saline No 0% 0% 0% 0%
2 0.005 mg IL-12 No 0% 0% 0% 0%
3 0.005 mg IL-12 Yes 20% 20% 20% 20%
4 0.05 mg IL-12 No 20% 0% 20% 0%
5 0.05 mg IL-12 Yes 100% 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)
BBA B C
D E F
Best in class Phase I study results support initiation of Phase II
study
Pre-Treatment Day 256 Day 637
Righ
t Fro
nt
Ches
t Wal
lRi
ght U
pper
Back
CONFIDENTIAL12
Phase II Study Design for OMS-I100 (Melanoma)
Summary of clinical trial designTitle: Phase II trial of intratumoral pIL-12 electroporation in advanced stage
cutaneous and in transit malignant melanomaDesign: Single arm, open-label study
Patient population: MelanomaNumber of Subjects: 25
Endpoints: Primary:• Objective response rate (local and distant) at 6 monthsSecondary:• 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 carcinomaNumber of Subjects: 15
Endpoints: 10 Endpoint: • IL-12 protein expression in tumor tissue at 3-4 weeks20 Endpoint:• Safety• Objective response rate (local and distant)• Overall survival• Time to relapse or progression• Immunologic effects of intratumoral pIL-12 injection with
electroporationFirst 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 LymphomaNumber of Subjects: Stage 1 = 10 pts; Stage 2 = 17 pts
Endpoints: 10 Endpoint: • Objective Response Rate (Local and Distant) at 6 months
20 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
Precision tumor ablation enhancing patient quality of life
CONFIDENTIAL16
Treatment of Head and Neck Cancer
Electroporationapplied with applicator
Cancer cellsdestroyedwhilepreservinghealthytissue
Tumor injectedwithbleomycin
No removalof healthy
tissue
CONFIDENTIAL17
Treatment of Skin Cancer
Surgery would have required cutting out portion of ear
OMS ElectroChemotherapy of basal cell cancer
30 DaysPost-treatment
120 DaysPost-Treatment
Pre-Treatment
90 DaysPost-Treatment
BCC of Earlobe Tumor cells turn black as they die
Natural wound healing No 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 Carcinoma 18 56 of 56(100%)
51 of 56(91.1%)
Melanoma 10 84 of 85(98.8%)
75 of 85(88.2%)
Squamous Cell Carcinoma
1 1 of 1 (100%)
0 of 1(0%)
Kaposi’s Sarcoma 1 4 of 4(100%)
4 of 4(100%)
Totals 30 145 of 146(99.3%)
130 of 146(89.0%)
(H.Lee Moffitt Cancer Center – University of Florida)
CONFIDENTIAL19
OncoSec Product Pipeline
Research and Development Preclinical Phase 1 Phase 2 Phase 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)
Completed Planned
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
Benefits all aspects of healthcare including the Patient
CONFIDENTIAL21
Board & Executive Management Team
Board of Directors Executive Management
Avtar Dhillon, M.D., ChairmanInovio Pharmaceuticals, MDS Capital (Lumira)
James DeMesa, M.D., DirectorStem Cell Therapeutics, Induce Biologics
Anthony E. Maida III, Ph.D., DirectorBioConsul Drug Development, Replicon Neurotherapeutics, Trellis Bioscience, CancerVax Corp.
Punit Dhillon, President & CEOInovio Pharmaceuticals, MDS Capital (Lumira)
Punit Dhillon, President & CEOInovio Pharmaceuticals, MDS Capital (Lumira)
Michael Cross, Ph.D., Chief Business OfficerMDS Capital, GrowthWorks, MDS Proteomics, Viventia Biotech
Veronica Vallejo, CPA, Vice President FinanceCBIZ MHM, Mayer Hoffman & McCann
Caryn Peterson, Ph.D., Vice President Regulatory AffairsFeRx, Amylin Pharmaceuticals, Hybertech
Paul Goldfarb, M.D., Medical DirectorScripps Health, University of California, San Diego
Brian McCluskey, B.Eng., Executive Director EngineeringTDI Instruments, Digirad Corp.
Ernest Kitt, Executive Director Clinical OperationsMedicinova, 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