OncoSec Medical Incorporated · OTC:ONCSQ
OncoSec Medical — Investor Presentation (May 2017)
31 slides from OncoSec Medical's investor presentation, May 2017
Slide 1: Taking the Fight Directly to the Tumor
Taking the Fight Directly to the Tumor OncoSec: May 2017
Slide 2: Cautionary Note Regarding Forward-Looking Statements
Cautionary Note Regarding Forward-Looking Statements To the extent statements contained in the following presentations are not descriptions of historical facts regarding OncoSec Medical Incorporated, they should be considered “forward-looking statements,” as described in the Private Securities Litig
Slide 3: Our Purpose
FDA Regulatory Plan Large Pharma Unmet Market 2017 Inflection Year with Registration directed study regulatory and commercial Our Purpose starting 1H17 for large unmet pathway for ImmunoPulse® IL-12 market opportunity in melanoma To pioneer new intratumoral immunotherapy Efficacy in Phase II studies
Slide 4: OncoSec's Roadmap to 2019
OncoSec’s Roadmap to 2019 Opportunity Melanoma Milestones Triple Negative Breast Cancer Renal Cell Carcinoma Finalize drug supply partnership for ImmunoPulse® IL-12 registration-directed trial Lung Carcinoma Head & Neck Initiation of "P.I.S.C.E.S.” registration-directed trial in stage Objective III/
Slide 5: The Next Great Challenge in Cancer Immunotherapy
The Next Great Challenge in Cancer Immunotherapy Anti-PD-1 / PD-L1 mAB Tumor Type Patient responses to Anti-PD-1 Non-Response therapies are effective and durable Melanoma ~60 – 80% Triple Negative Breast ~70 – 82% 1 The ma jority of patients in most solid tumors do not respond to Anti-PD-1 therapy R
Slide 6: How Do We Improve Patient Responses?
How Do We Improve Patient Responses? Patients who respond to anti- Combining different treatment modalities to improve PD-1 therapies will generally patient outcome has been an effective strategy have a “hot” or “inflamed” tumor, defined by key The rationale is to convert patient tumors from “cold”
Slide 7: What Happens when a Patient Fails Anti-PD-1 Therapy in Melanoma?
What Happens when a Patient Fails Anti-PD-1 Therapy in Melanoma? Stage III/IV Unresectable Metastatic Melanoma Targeted Small Most patients will progress Molecule Therapies within 9-12 months Immunotherapy 60-80% of patients (Anti-PD-1 / CTLA-4) will not respond Biggest Market Opportunity: No Availa
Slide 8: Core Technology: ImmunoPulse
Core Technology: ImmunoPulse® ImmunoPulse® IL-12 expresses IL-12 protein intratumorally and triggers a systemic immune response against tumor cells throughout the body Electroporation permits plasmid to enter cell for optimal gene expression Anti-tumor T-cell response is generated Low TIL tumors con
Slide 9: Lead Program: ImmunoPulse IL-12 for Melanoma
Lead Program: ImmunoPulse® IL-12 for Melanoma Interleukin-12 (IL-12) is a potent, well-characterized pro-inflammatory cytokine Intratumoral delivery of IL-12 stimulates a safe but powerful systemic immune response Remarkably low toxicity for immunotherapeutic drug 1 2 3 4 5 Injection of Intratumoral
Slide 10: ImmunoPulse IL-12 Development in Advanced Melanoma
ImmunoPulse® IL-12 Development in Advanced Melanoma Based on Positive Phase 1 and 2 Clinical Data 1 PHASE 01 Dose-Escalation: Acceptable safety profile and early efficacy results 2 PHASE 02 Repeat Dose: 31% ORR, 50% abscopal responses 3 PHASE 02 Retrospective Analysis: 64%-75% ORR from ImmunoPulse®
Slide 11: Complete Response, Distant Lesion Regression After 1 Cycle of Local Treatment (Phase I)
Complete Response, Distant Lesion Regression After 1 Cycle of Local Treatment (Phase I) Numbered lesions on Residual pigmentation the chest were treated in macrophages Chest No lesions on the Seborrheic back were injected Keratosis or electroporated Back Daud-A, et al, JCO 2008 Pre-treatment Day 256
Slide 12: Targeting Anti-PD-1 Non-Responders
Targeting Anti-PD-1 Non-Responders
Slide 13: Addressing the Unmet Need of Anti-PD-1/PD-L1 Non-Responders
Addressing the Unmet Need of Anti-PD-1/PD-L1 Non-Responders ImmunoPulse® IL-12 can enhance PD-1 PD-L1 PD-1 x PD-L1 immunogenicity and convert T cell-poor (low TIL, “cold”) tumors into T cell-inflamed (high TIL, Responder ImmunoPulse IL-12® “hot”) tumors An ongoing Phase II trial with OncoSec’s Immun
Slide 14: ImmunoPulse IL-12 is the Only IL-12-Based Therapeutic with Proven Safety AND Efficacy
ImmunoPulse® IL-12 is the Only IL-12-Based Therapeutic in Development That Yields Proven Safety AND Efficacy Company Drug Description Indication Phase Route OncoSec ImmunoPulse® IL-12 Intratumoral IL-12 Electroporation Melanoma II IT OncoSec ImmunoPulse® IL-12 Intratumoral IL-12 Electroporation CTCL
Slide 15: Strong Rationale for Combination with Anti-PD-1/PD-L1
Strong Rationale for Combination with Anti-PD-1/PD-L1 ImmunoPulse® has shown a good safety Safety and tolerability profile; no additive or new AE / SAE in combination trials Safety Efficacy ImmunoPulse® IL-12 has shown local and Efficacy systemic response in PD-I predicted non responders Improved An
Slide 16: ImmunoPulse IL-12 Can Increase TIL in Multiple Solid Tumor Types
ImmunoPulse® IL-12 Can Increase TIL in Multiple Solid Tumor Types High Power Image (Spectral Deconvolution) Metastatic Melanoma PD-L1 CD68 CD8 Foxp3 Sox-10 / CK20 Merkel Cell Carcinoma Pre-ImmunoPulse® IL-12 Post-ImmunoPulse® IL-12 Pre-ImmunoPulse® IL-12 Post-ImmunoPulse® IL-12 “Low TIL” “High TIL”
Slide 17: Targeting Predicted Anti-PD-1 Non-Responder Patients
Targeting Predicted Anti-PD-1 Non-Responder Patients Anti-PD-1 “Hot” Tumors “Cold” Tumors OMS-1102 ImmunoPulse® IL-12 + Anti-PD-1 Therapy 100% 0% 17 ONCOSEC™
Slide 18: OMS-1102 Interim Data
OMS-1102 Interim Data Durable Responses in Patients with Prior Checkpoint Inhibitor Therapy Non-Responders 20 Responders ORR at W2 = 43% BORR = 48% 10 0 Predicted ImmunoPulse® Pembro + Pembro Monotherapy Combination 18 ONCOSEC™
Slide 19: OMS-1102 Phase II Trial Design
OMS-1102 Phase II Trial Design ImmunoPulse® IL-12 in Combination with Pembrolizumab 3 week treatment cycles with 200 mg pembrolizumab Eligible patients using administered as a 30-minute IV infusion biomarker assay: < 25% CTLA4hiPD1hi TIL phenotype Patients treated with ImmunoPulse® IL-12 on days 1,
Slide 20: ImmunoPulse IL-12 Positioned to Capture the Anti-PD-1 Non-Responder Market in Melanoma
OncoSec Lead Program ImmunoPulse® IL-12 is Positioned to Capture the Anti-PD-1 Non-Responder Market in Melanoma Targeting Anti-PD-1 Fast Track Therapeutic Company Country Phase Non-Responders Designation Binimetinib Array BioPharma, Inc. United States NDA No No Abraxane Celgene Corporation United St
Slide 21: ImmunoPulse IL-12: Focused on Speed of Approval
ImmunoPulse® IL-12: Focused on Speed of Approval Traditional Approach Overall survivial – All-comers; 2:1 randomized trial (> 200 patient study) required endpoint; Phase 3 Clinical Trial projected 2022 – ImmunoPulse® IL-12 + anti-PD-1 vs. anti-PD-1 alone approval OncoSec Accelerated Approach Phase 2
Slide 22: P.I.S.C.E.S Trial Design
P.I.S.C.E.S Trial Design Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study Patients treated with IT-pIL12-EP and anti-PD-1 Stage III-IV Melanoma Simon 2 stage minimax design Eligible patients will have failed Overall response rate (ORR) by independent central or are failing Anti-PD-1 Th
Slide 23: From Supply Agreement to Commercial Partnership
From Supply Agreement to Commerical Partnership 23 ONCOSEC™
Slide 24: U.S. Melanoma Market Opportunity
U.S. Melanoma Market Opportunity 239K US Melanoma Patients Receiving Anti-PD-1 Therapy Prevalent Cases, 2019 Anti-PD-1 Therapy Responder Non-Responder 1 First Line: 9.9K 3.5K 6.4K 64k 64k 2 Second Line: 4.0K 1.4K 2.6K 67k 44k 3 Third Line: 1.8K 0.6K 1.2K ImmunoPulse® Stage I & II Stage III IL-12 Add
Slide 25: Differentiating ImmunoPulse IL-12 from the Competition
Differentiating ImmunoPulse IL-12 from the Competition Flexible platform using DNA Focused development plan with and electroporation with broad near-term commercialization applicability for multiple cancer opportunity indications First-ever data demonstrating Low development + production improved re
Slide 26: Creating a Fully Integrated Immuno-Oncology Platform
Creating a Fully Integrated Immuno-Oncology Platform In Vitro/In Vivo Biology Pipeline Momentum and Expansion Bioengineering Translational Research Biology Novel Electroporation Development (T.R.A.C.E.) Discovery of Novel Multi-Gene Plasmid Constructs Clinical Regulatory Development Affairs Building
Slide 27: Intellectual Property
Intellectual Property Freedom to Operate in Critical Areas Exploiting Existing Intellectual Property (via Asset Purchase and License Agreements) Electroporation-mediated Lifecycle Design ImmunoPulse® IL-12 intratumoral delivery of Improvements Management Patents immune stimulators Building a Broad N
Slide 28: Corporate Milestones for 2017
Corporate Milestones for 2017 Data announcement at key scientific Initiation of “PISCES” registration-directed meeting from ongoing clinical program trial in stage III/IV melanoma anti-PD-1 in predicted anti-PD-1 non-responder non-responder population population in advanced melanoma Announcement of
Slide 29: OncoSec Management Team
OncoSec Management Team Sharron Gargosky, P.h.D. Richard Slansky Chief Clinical & Regulatory Officer Punit Dhillon Chief Financial Officer Chief Executive Officer Our team has many years of combined experience at the following institutions: Tu Diep VP of Operations Robert H. Pierce, M.D. Sheela Moha
Slide 30: Financial Summary
Financial Summary Category $ Million Follow-on $10M offering of common stock and warrants completed May 24, 2016 Market Cap $23.7A Shares Outstanding = 19.6 million B Cash & Cash Equivalents $20.5B Series A Warrants = 5.5 million; Series exercisable at $1.69 per share Debt $00.0B Notes: (A) Share pr
Slide 31: Thank You
THANK YOU NASDAQ: ONCS Company Information 855-662-6732 [email protected] www.oncosec.com Social Media @OncoSec @OncoSecMedical 5820 Nancy Ridge Drive OncoSec Medical Inc. San Diego, CA | 92121