Oncosec Medical Incorporated · OTC:ONCSQ
Oncosec Medical — Investor Presentation (August 2018)
39 slides from Oncosec Medical's investor presentation, August 2018
Slide 1: OncoSec Immunotherapies August 2018
oncosec IMMUNOTHERAPIES August 2018 | NASDAQ:ONCS
Slide 2: Forward-Looking Statements
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 Litigation Reform Act of 1995,
Slide 3: Converting cold tumors to hot tumors with TAVO
Converting “cold” tumors to immunologically “hot” tumors through the intratumoral administration of Tavokinogene Teleplasmid “TAVO” … The Right Way™
Slide 4: Making Good Drugs Great
MAKING GOOD DRUGS GREAT CHECKPOINT INHIBITORS (CPIs) INTRATUMORAL IL-12 • Specific immune cells called • IL-12 is a potent pro-inflammatory “Cytotoxic T Lymphocytes” (CTLs) cytokine that promotes activation of can destroy cancer cells CTLs • Tumors produce “immune The majority of patients • IL-12, w
Slide 5: The OncoSec Opportunity Is Massive
THE ONCOSEC OPPORTUNITY IS MASSIVE Checkpoint inhibitors dramatically increase survival Tumor Type % of Checkpoint in patients with HOT tumors but is largely ineffective Non-Responders in COLD tumors Melanoma ~60-80% Triple Negative Breast ~95%1 Potential for Checkpoint Inhibitors in Head and Neck ~
Slide 6: The Day of the Cytokine Has Dawned
THE DAY OF THE CYTOKINE HAS DAWNED • Potent, well-characterized pro-inflammatory cytokine • Shown to make the tumor microenvironment (TME) immunogenic • Locally targets innate cells allowing for productive Th1 adaptive immune responses • Safer, local delivery with “systemic” benefits • Local immune
Slide 7: Taking the Fight Right to the Tumor
TAKING THE FIGHT RIGHT TO THE TUMOR 1 2 3 4 5 Trillions of IL-12 coded DNA Intratumoral electroporation IL-12 transfected cells express IL-12 expression in the TME IL-12 expression in the TME plasmids to produce immune increases the permeability of and secrete IL-12 into the tumor enhances induces s
Slide 8: ImmunoPulse Platform
IMMUNOPULSE® PLATFORM GENPULSE TM PROCEDURE Step 1: TAVO Injection • IL-12 is injected into the tumor using a conventional needle and syringe Step 2: Applicator Insertion • The applicator’s tip needle array is inserted into the tumor, up to a depth of 15mm GENPULSE Applicator Step 3: Electroporation
Slide 9: OncoSec Pipeline
ONCOSEC PIPELINE Planning Phase 1 Phase 2 Phase 2b Phase 3 TAVO + pembrolizumab registration-enabled study in R/R melanoma in partnership OMS-103/PISCES/KEYNOTE-695 with Merck OMS-102 TAVO + pembrolizumab ImmunoPulse® IL-12 +in melanoma patients pembrolizumab with in melanoma patients with Melanoma
Slide 10: TAVO in Metastatic Melanoma
Date | Presenter TAVO in Metastatic Melanoma
Slide 11: TAVO Metastatic Melanoma Development Program
TAVO METASTATIC MELANOMA DEVELOPMENT PROGRAM Clinical Study Finding Phase 1 Dose-Escalation Metastatic Melanoma Strong safety profile with early efficacy results OMS-100 Phase 2 Repeat Dose Abscopal tumor response and continued safety Evidence of priming for anti-PD-1 response and continued OMS-100
Slide 12: Phase 2 Study (OMS-100) Monotherapy TAVO in Metastatic Melanoma
PHASE 2 STUDY (OMS-100) MONOTHERAPY TAVO IN METASTATIC MELANOMA 35% 19% 69% 50% Best Overall Complete Disease Complete Regression Response Response Control Rate in at Least One Lesion Multi-center Phase 2 trial of Monotherapy TAVO Demonstrated Single-Agent Activity with Complete Response and Strong
Slide 13: Phase 2 Study (OMS-102) of TAVO Combination with Pembro
PHASE 2 STUDY (OMS-102) OF TAVO COMBINATION WITH PEMBRO IN PATIENTS WITH “COLD” TUMORS • Open-label, Phase 2 Multicenter Study • Primary Endpoint: BORR based on RECIST v1.1 Patients Highly Unlikely to Respond • Secondary Endpoint: DOR, PFS, OS • Eligible patients using biomarker assay < 25% CTLA4hiP
Slide 14: OMS-102 Patient Selected Based on Anticipated Checkpoint Non-Response
OMS-102 PATIENT SELECTED BASED ON ANTICIPATED CHECKPOINT NON-RESPONSE 4 5 6 7 8 9 Low TIL Patients Enrolled in Study Unlikely to Respond to Anti-PD-1 14
Slide 15: OMS-102 TAVO + Pembro Delivers Durable Responses in 50% of Patients
OMS-102 TAVO + PEMBRO DELIVERS DURABLE RESPONSES IN 50% OF PATIENTS • Best overall response rate (BORR) of 50% (11/22) – 43% [9/21] achieved RECIST v1.1 BORR • Complete response (CR) rate of 41% (9/22) – 38% [8/21] achieved RECIST v1.1 durable CR • Disease control rate (DCR) of 59% (13/22) – 52% [11
Slide 16: Durable Responses in Patients with Cold Tumors
DURABLE RESPONSES IN PATIENTS WITH “COLD” TUMORS Clinical RECIST 0 0 1 -0 0 3 Best Overall Response Rate 11/22 (50%) 9/21 (43%) 0 0 1 -0 0 4 (BORR = CR + PR) 0 0 1 -0 0 9 0 0 1 -0 1 3 Disease Control Rate (DCR = 13/22 (59%) 12/21 (57%) 0 0 1 -0 2 0 CR + PR + SD) 0 0 1 -0 2 2 Complete Response (CR) 9
Slide 17: Case Example: Patient 001-004
CASE EXAMPLE: PATIENT 001-004 Pre-treatment Post-treatment Post-treatment Post-treatment (Week 12) – PD by RECIST (Week 48) – PR* (Week 60) – PR* Patient Previously Failed Ipilimumab, Nivolumab, and Pembrolizumb 17
Slide 18: Median PFS Not Yet Reached: 57% PFS at 18 Months
MEDIAN PFS NOT YET REACHED: 57% PFS AT 18 MONTHS Response Type N • Duration of response (DOR) of 100% (11/11) RECIST v 1.1 9 Progression then response 1 Non-measurable (<1 cm) 1 Source: Algazi SITC Presentation 2017 Most Patients Still Responding Beyond 18-24 Months 18
Slide 19: TAVO Converts Cold to Hot
TAVO Converts “Cold” to “Hot” Merkel Cell Carcinoma Head & Neck Cancer Pre-ImmunoPulse® IL-12 Post-ImmunoPulse® IL-12 Pre-ImmunoPulse® IL-12 Post-ImmunoPulse® IL-12 “LowTIL” “High” TIL “LowTIL” “High” TIL CD8 – Green Foxp3 –White FoxP3 – Green CD3 - Pink PD-L1 –Red Sox-10/CK20 – Blue PD-L1 –Red DAPI
Slide 20: PISCES/KEYNOTE-695
PISCES/KEYNOTE-695 A leading biotechnology Collaboration Highlights company developing DNA-based intratumoral • Built on the success of OMS-102, immunotherapies study represents second melanoma study in collaboration with Merck • Registration directed study could support commercialization • Joint De
Slide 21: PISCES/KEYNOTE-695: TAVO for Stage III/IV Melanoma
PISCES/KEYNOTE-695: TAVO for Stage III/IV Melanoma Anti-PD-1 IL-12 Stage III/IV Combination Electroporation Study • Single Arm Phase 2/3 study, Simon 2 stage minimax design - 4 responders out of 23 in the first stage additional 25 patients ✓Orphan designation • Primary outcome: BORR based on RECIS
Slide 22: Favorable PISCES Data Could Unlock ~10K Stage III/IV in the US
FAVORABLE PISCES DATA COULD UNLOCK ~10K STAGE III/IV IN THE US • Combo therapy with checkpoint 1st Line 2nd Line 3rd Line inhibitors rapidly becoming SOC in cancer • Checkpoint products becoming 9.9K 4.0K 1.8K backbone therapy for ~60% or more of all treatable cancers Anti-PD-1 Responders • Anti-PD-
Slide 23: TAVO in Triple Negative Breast Cancer (TNBC)
TAVO in Triple Negative Breast Cancer (TNBC)
Slide 24: Metastatic TNBC Summary
METASTATIC TNBC SUMMARY Patients are ineligible for HER2 and ER- Urgent need for additional targeted therapies therapeutic options in TNBC Disease progression is rapid, and chemotherapy Poor overall survival for responses are not durable metastatic patients Novel targeted therapies (e.g., PARP inhib
Slide 25: OMS-140 Study Design
OMS-140 STUDY DESIGN Pre-Sample TAVO TAVO TAVO TAVO Post-Sample OMS-140 Trial One cycle TAVO (Days 1, 5 &8) Therapy: 1 5 2 patients received off 8 protocol nivolumab as next immediate treatment One “Cycle” of TAVO (Days 1, 5 and 8) Patients: Patients with advanced or Sample = Pre and Post TAVO tissu
Slide 26: Case Study: 64-Year-Old TNBC Patient Previously Received Atezolizumab
CASE STUDY: 64-YEAR-OLD T2N0M0 TNBC July 2017: PATIENT PREVIOUSLY RECEIVED ATEZOLIZUMAB Clinical PD – enlarging right October 2015: breast nodule and May 2014: December 2015: CT shows multiple non-healing scalp Dx’d clinical stage IIA CT-guided lung spiculated pulmonary February 2017: metastases met
Slide 27: Case Study: Protocol and Post-Protocol Treatment
CASE STUDY: PROTOCOL AND POST-PROTOCOL TREATMENT August 14, 2017 – September 14, 2017: Cycle 1, Day 1 – Day 28 (post Bx) Patient received all 3 per-protocol injections • Left scalp skin mets (control)-UNTREATED August 14, 2017: • Right breast lesion-TREATED September 21, 2017: Off-protocol nivolumab
Slide 28: AACR 2018 Abstract
OMS-140: TAVO MONOTHERAPY IN METASTATIC TNBC PATIENTS January 18, 2018 ONCOSEC PROVIDES ENCOURAGING CLINICAL OBSERVATION RELATED TO TRIPLE NEGATIVE BREAST AACR 2018 CANCER STUDY March 15, 2018 Abstract OncoSec's Intratumoral IL-12 In Metastatic Triple Negative Breast Cancer (TNBC) Selected For Poste
Slide 29: Regulatory Avenues to Rapid Approval
REGULATORY AVENUES TO RAPID APPROVAL Benefits of expedited regulatory programs Frequent Guidance from FDA Approval Through Rolling Surrogate and Priority Endpoint Review Expedited regulatory programs may allow ImmunoPulse IL-12 to achieve rapid FDA approval 29
Slide 30: OMS-141/KEYNOTE-890
OMS-141/KEYNOTE-890 A leading biotechnology Collaboration Highlights company developing DNA-based intratumoral • Study represents expanding immunotherapies clinical relationship with Merck • Second tumor type combining TAVO and KEYTRUDA® • Joint Development Committee Global leader in provides access
Slide 31: OMS-141 Trial Design
OMS-141 TRIAL DESIGN • Endpoint - ORR by ICR based on RECIST v1.1 • Subjects with histologically confirmed diagnosis of inoperable locally advanced or metastatic TNBC and at least 1 prior line of approved systemic chemotherapy or immunotherapy. • 25 subjects (15 subjects in Stage 1 and, if appropria
Slide 32: TNBC Clinical Development Path
TNBC CLINICAL DEVELOPMENT PATH Initial Execution of the Expedited FDA Utilization in Clinical Data OMS-141 Trial Approval Late-Line TNBC Therapy: ImmunoPulse TAVO is likely to qualify for Following approval as a late- IL-12 with anti- expedited regulatory line therapy in TNBC, An PD-1 programs: util
Slide 33: Rationale for Special Regulatory Status in TNBC
RATIONALE FOR SPECIAL REGULATORY STATUS IN TNBC Requirements for special Relevant to IL-12 Supporting regulatory status plus checkpoint inhibition in TNBC? Information in TNBC Serious Overall survival for metastatic TNBC disease is 1 -2 years from diagnosis Unmet medical Current therapies result in
Slide 34: TAVO Has Strong Competitive Positioning
TAVO HAS STRONG COMPETITIVE POSITIONING Early Stage Late Stage Phase of Clinical Development Immune ADC PD-(L)1 PARPi PD-(L)1 PARP Agonists Combo Combo Combo Inhibitor PI3Ki / ADC Other AKTi Other PD-1 ADC OncoSec uniquely PI3K/AKT PARP PD-(L)1 Immuno- ADCs positioned relative to Inhibitors Inhibito
Slide 35: TAVO Summary
TAVO SUMMARY • Positioned for accelerated approval in Stage III/IV relapsed/refractory melanoma – Initial data 2018, seek FDA feedback on accelerated approval – Potential US file for approval in 2019 via accelerated pathway • TAVO converts checkpoint inhibitor non-responders to responders – 60-70% o
Slide 36: ONCS Financial Summary
ONCS FINANCIAL SUMMARY CASH SUMMARY EQUITY SUMMARY Cash on hand $33.3M Shares 51.9 M (as of 04/30/18) Outstanding (as of 04/30/18) NO DEBT 36
Slide 37: Investment Highlights
INVESTMENT HIGHLIGHTS Registration-Enabled Clinical Program • Ongoing global, multi-center Phase 2 PISCES/KEYNOTE-695 trial in combining with Near-Term Commercial patients with stage III/IV melanoma Opportunity in Advanced Melanoma • Preliminary Data anticipated 2018; anticipated US filing 2019 • Hi
Slide 38: OncoSec Anticipated Milestones
ONCOSEC ANTICIPATED MILESTONES PISCES/KEYNOTE-695: FPI Complete PISCES/KEYNOTE-695: Interim Data at AACR Complete PISCES/KEYNOTE-695: Complete Enrollment (Stage 1) 3Q 2018 Melanoma PISCES/KEYNOTE-695: Preliminary Data (Stage 1) YE 2018 BLA Filing 2019 OMS-104 - Neo-adjuvant + PD-1: FPI 2H 2018 ATMP
Slide 39: Thank You
Thank You Contact Will O’Connor, Stern Investor Relations 212.698.8694 will@sternir.com oncosec.com 39
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