Oncosec Medical Incorporated · OTC:ONCSQ
Oncosec Medical — Investor Presentation (February 2019)
53 slides from Oncosec Medical's investor presentation, Feb 1, 2019
Slide 1: OncoSec Immunotherapies February 2019
v ZS S i> i oncosec IMMUNOTHERAPIES February 2019] 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: Investment Highlights
IL-12 REVERSES PD-1 RESISTANCE & DELIVERS WHOLE-BODY ANTI-CANCER KEYNOTE-695 DATA INDICATES VIABLE ACCELERATED APPROVAL OPPORTUNITY SECOND REGISTRATION- ENABLED STUDY IN CERVICAL CANCER UNDERWAY TAVO + PEMBRO DATA IN TNBC EFFECT IN 2H 2019 NEW PRODUCT AND APPLICATOR TO ATTACK VISCERAL LESIONS oncose
Slide 4: Interleukin (IL-12) Is a Powerful Immunoregulatory Cytokine
INTERLEUKIN 12 (IL-12) IS A POWERFUL IMMUNOREGULATORY CYTOKINE POTENT, WELL-CHARACTERIZED, PRO-INFLAMMATORY * Potent, well-characterized, pro- inflammatory cytokine * Shown to make the tumor microenvironment (TME) immunogenic * Targets innate cells allowing for productive Thi adaptive immune respons
Slide 5: TAVO Capable of Reversing Resistance to CPIs
TAVO CAPABLE OF REVERSING RESISTANCE TO CPI’S IMPROVING CHECKPOINT RESPONSES BY CONVERTING “COLD” TUMORS TO “HOT” TUMORS CHECKPOINT INHIBITORS (CPIs) « “Checkpoint inhibitors” or “CPIs” block the suppression of CTLs Specific immune cells called “Cytotoxic T Lymphocytes” (CTLs) can destroy cancer cel
Slide 6: TAVO's Opportunity Is Significant
TAVO’S OPPORTUNITY IS SIGNIFICANT 60-90% OF PATIENTS HAVE NO ANTI-PD-1 RESPONSE IL-12 + CPI’S Elicits a Highly Potent Attack Against A Wide Array of Solid Tumors 90% Of all cancer cases are solid tumors Poteriial [u Checkpsint (uhibitersin TAVO cabi ‘et A 6 M | New cases of checkpoint ~¢g@lid tumors
Slide 7: Intratumoral Delivery of TAVO
INTRATUMORAL DELIVERY OF TAVO COST EFFECTIVE & AVOIDS SYSTEMIC TOXICITIE PROCEDURE Step 1: TAVO Injection Trillions of IL-12 coded DNA plasmids to produce immune modulatory proteins are injected directly into the tumor using a conventional needle and syringe GENPULSE ™ Generator Applicator P g Step
Slide 8: Clinical Development Pipeline
Phase 2 Registration-Enabled Phase 3 Phase 1 Phase 2 Melanoma LUCE BIE Dose-escalation of Metastatic Melanoma HB actively enrolling [Completed underway IOSG IC TAVO monotherapy in metastatic melanoma patients = TAVO + pembrolizumab in melanoma patients with aaszeog immunologically cold tumors TAVO +
Slide 9: TAVO Opportunity in Metastatic Melanoma in the U.S.
TAVO OPPORTUNITY IN METASTATIC MELANOMA IN THE U.S. CPI FAILURE IN METASTATIC MELANOMA IS A HIGH UNMET NEED Diagnoses in U.S. 91K & Deaths in U.S. each year) 9K each year) * Response rates of re- treatment in a post-anti- PD-1 setting do not exist « 5% among ALL patients is a reasonable approximatio
Slide 10: TAVO in Metastatic Melanoma - Traditional Development
TAVO IN METASTATIC MELANOMA - TRADITIONAL DEVELOPMENT PROOF OF CONCEPT IN LATE STAGE MELANOMA LEADS TO KEYNOTE-695 COMBINATION WITH KEYTRUDA & PURSUIT OF ACCELERATED APPROVAL Clinical Study Finding Phase i Ep Strong safety profile with early efficacy results a Phase 2 Ey Abscopal tumor response Keyn
Slide 11: Completed: Multi-Center Phase 2 Monotherapy
COMPLETED: MULTI-CENTER PHASE 1 & PHASE 2 MONOTHERAPY TAVO IN METASTATIC MELANOMA STUDIES SINGLE-AGENT ACTIVITY WITH CR’S AND STRONG ABSCOPAL EFFECT OMS-100 PHASE 2 RR DATA (n=26) Regression of at Least ORR ‘One Non- Treated Lesion cR 30% 21% 46% TAVO MONOTHERAPY demonstrated anti-tumor efficacy aft
Slide 12: Completed: Phase 2 Study of TAVO + Pembro (OMS-102)
* Open-label, Phase 2 Multicenter Study © Primary Endpoint: BORR based on RECIST v1.1 * Secondary Endpoint: DOR, PFS, OS * Eligible patients using biomarker assay < 25% CTLA4PD1' TIL phenotype 22C3 MEL IHC assay MEL Score Total ae 20 30 40 50 60 70 80 90 100 ORR (%) Daud, ef al. Journal of Clinical
Slide 13: TAVO + Pembro Delivers Durable Responses in 50% of Patients
TAVO + PEMBRO DELIVERS DURABLE RESPONSES IN 50% OF PATIENTS (OMS-102) HEAVILY PRE-TREATED PATIENT POPULATION DURABLE RESPONSES 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 C
Slide 14: KEYNOTE-695: Currently No Durable Responses in Checkpoint Refractory Melanoma
KEYNOTE-695: CURRENTLY NO DURABLE RESPONSES IN CHECKPOINT REFRACTORY MELANOMA THERE IS NO APPROVED THERAPY IN THIS “SALVAGE” SETTING v Immune checkpoint inhibitors have become a mainstay in the treatment of melanoma! however, response rates of re-treatment in a post-anti-PD-1 setting do not exist (5
Slide 15: KEYNOTE-695: Reversing Resistance to PD-1 with TAVO + Keytruda
KEYNOTE-695: REVERSING RESISTANCE TO PD-1 WITH TAVO + KEYTRUDA COMPLETE ENROLLMENT IN 2019 / POTENTIAL U.S. FILING FOR ACCELERATED APPROVAL IN 2020 ALL PATIENTS ARE DEFINITIVE PD-1 FAILURES TO ENABLE REGULATORY FILING UNDER ACCELERATED APPROVAL © Pathologically documented unresectable melanoma, Stag
Slide 16: KEYNOTE-695: Preliminary Response Rate Data
KEYNOTE-695: PRELIMINARY RESPONSE RATE DATA AS OF DECEMBER 15, 2018 FOR FIRST 21 PATIENTS 1 CR/4PR/5 SD =IMPORTANT, FIRST OF ITS KIND DATA 4 PRs and 1 CR out of 21 evaluated patients Assessments by blinded independent review or {~24% ORR) investigator at either Cycle 5 (~3 months) or Cycle 9 (~6 mon
Slide 17: KEYNOTE-695: Patient A
KEYNOTE-695: PATIENT A WHITE FEMALE WITH STAGE IVA MELANOMA DURABLE COMPLETE RESPONSE: BASELINE VS. 12 AND 24 WEEKS Baseline 12 Weeks 24 Weeks IMAGES OF BASELINE VS. 12 AND 24 WEEKS * Patient no longer treated with TAVO as there are no accessible lesions « Patient continues maintenance pembrolizumab
Slide 18: KEYNOTE-695: Patient E
KEYNOTE-695: PATIENT E WHITE MALE WITH STAGE IVB MELANOMA DEEP, DURABLE PARTIAL RESPONSE IMAGES OF BASELINE VS. 12 WEEKS AND 24 WEEKS TUMOR FLARE, NECROSIS, AND RESPONSE Baseline Regression of mediastinal node and parenchymal lung metastases 12 weeks + Patient no longer treated with TAVO : as there
Slide 19: KEYNOTE-695: Near Term Regulatory Approvals in US and EU
KEYNOTE-695: NEAR TERM REGULATORY APPROVALS IN US AND EU POTENTIALLY FILF FORACCELERATED APPROVAL IN US IN 2020 & IN EUIN Potential US Regulatory Timeline Potential EU Regulatory Timeline ; Early 2019 Obtain Advanced Therapy Medicinal Late 2019 Pre-BLA Meeting at FDA y Product (ATMP) Designation Ear
Slide 20: TAVO Potential in Cervical Cancer: A High Unmet Medical Need
TAVO POTENTIAL IN CERVICAL CANCER: A HIGH UNMET MEDICAL NEED OMS-150: REGISTRATION-ENABLED PHASE 2 TAVO + KEYTRUDA qq canosnonoe OMS-150 Single-arm Phase 2b study Primary endpoint - ORR by BIRC based on RECIST v1.1 511K New Cases WW 247K Deaths WW each year) each year()) REGULATORY Orphan designatio
Slide 21: TAVO in Metastatic TNBC: High Unmet Medical Need
TAVO IN METASTATIC TNBC: HIGH UNMET MEDICAL NEED COMPLETED: OMS-140 TAVO AS A MONOTHERAPY, SINGLE-CYCLE ONGOING: KEYNOTE-890: TAVO + KEYTRUDA REGULATORY Orphan designation OMS-140: COMPLETED & PRESENTED AT SAN KEYNOTE-890 Roe ia ANTONIO BREAST CANCER CONFERENCE ‘18 ONGOING: Single arm Phase 2 study
Slide 22: Financial Summary & Anticipated Milestones
FINANCIAL SUMMARY & ANTICIPATED MILESTONES FINANCIAL SUMMARY ANTICIPATED MILESTONES TAVO Receive ATMP Classification | 1H 2019 ° $33.3M cash as of Dec. 6, 2018 Melanoma initiate European Sites 2019 * 64.5M shares of common stock eels complete Enrollment 2Hi2018 outstanding as of Dec. 14, 2018 Accele
Slide 23: Leadership and Board of Directors
LEADERSHIP AND BOARD OF DIRECTORS ESTABLISHED BIOTECH LEADERS WITH TRACK RECORDS OF oncosec HERAPIES Daniel J. O’Connor, JD President, Director & Chief Executive Officer Sara Bonstein, MBA Chief Financial Officer & Chief Operating Officer Christopher G. Twitty, PhD Chief Scientific Officer Kellie Ma
Slide 24: Thank You
THANK YOU © East Coast West Coast 24 North Main Street 3565 General Atomics Court Pennington, NJ San Diego, CA Will O’Connor oncosec Stern Investor Relations IMMUNOTHERAPIES 212.698.8694 —" , will@sternir.com
Slide 25: Supplemental Slides
Slide 26: Medical History: Patient A
MEDICAL HISTORY: PATIENT A WHITE FEMALE WITH STAGE IVA MELANOMA DURABLE COMPLETE RESPONSE Medical History © Fi le 71 , 3 ae a as emeleeests © Prior surgery on skin excisions, wide excisions © Stage IVA, multiple basal cell carcinomas & squamous cell * — Horadictherepy carcinomas =m 7 2 * Ci stipati
Slide 27: KEYNOTE-695 History: Patient A
KEYNOTE-695 HISTORY: PATIENT A 24 MAY 2018 —- 26 NOVEMBER 2018 Treatment as per protocol cycle 1-9 © [T-tavo-EP: Days 1, 5, 8 every other cycle (each 6 weeks) * Pembrolizumab (200 mg IV): Day 1 of each 3-week cycle 10 May 2018: Screening * Melanoma, stage IVA, with skin lesions * ECOG PS: 0 14 Augus
Slide 28: Patient A
PATIENT A IMAGES OF BASELINE VS. 12 AND 24 WEEKS Baseline 12 weeks 24 weeks oncosec
Slide 29: Patient A
PATIENT A CT IMAGES OF BASELINE VS. 12 AND 24 WEEKS Baseline oncosec
Slide 30: Oral Gene Expression
i _ ae ORAL GENE EXPRESSION AFFICKING Liza ‘ibe HLADR 2043) ¢ saen auTA 2804 r TABI Normalized Counts e 8 + 8 Normalized Count + 8 Nermatized Counts z 8 + qf Normalized Counts 2. § + 8 \ Normatzed Counts ge 8 rT br 8 8 g Screen eat Seen eat saben a] Bowen Cm orean abt cacy zAP70 Bias ssc cxeig exe a
Slide 31: Patient A Intratumoral Gene Expression
PATIENT A INTRATUMORAL GENE EXPRESSION TREATMENT-RELATED INCREASE IN ADAPTIVE RESISTANCE 128) < senon AS 2048) -«- scron RFA 1Do1 6a cTLAa Sco S cer ~ |B ee = er 512 ‘a 256- 2 3 128: 3 3 64 § 16 2 32. Nomulized Counts Normalized Counts a 3 28 Nomalized Counts 32: 128. 16 . a ‘Screen 201 Screen C201
Slide 32: Medical History: Patient B
MEDICAL HISTORY: PATIENT B WHITE MALE WITH STAGE IVB MELANOMA © Male 65yrs / Stage IV Medical History © Metastatic disease in LNs (distant), lung, and subcutaneous © Osteoarthritis with bilateral hip replacements, benign prostatic hyperplasia, basal cell carcinoma removal on neck, pontaneous pneumot
Slide 33: KEYNOTE-695 History: Patient B
KEYNOTE-695 HISTORY: PATIENT B 16 APRIL 2018 — 18 OCTOBER 2018 Treatment as per protocol cycle 1-9 (27 weeks) ¢ [T-tavo-EP: Days 1,5, 8 every other cycle (each 6 weeks) * Pembrolizumab (200 mg IV}: Day 1 of each 3-week cycle 9 April 2018: Screening * Melanoma, Stage IVB, with subcutaneous lesions, l
Slide 34: Patient B
PATIENT B CT IMAGES OF BASELINE VS. 12 WEEKS Baseline 12 weeks Baseline 12 weeks Regression of distant, untreated hilar node lesion Response confirmed at 24 weeks oo 7 TL, target lesion.
Slide 35: Medical History: Patient C
MEDICAL HISTORY: PATIENT C WHITE MALE WITH STAGE IVA MELANOMA SIGNIFICANT PARTIAL RESPONSE Medical History ° Male 71 yrs / Stage IVA © Left thigh excision, left groin dissection, wide local excision of left groin. © Metastatic disease in LNs (distant) and No radiotherapy skin © Constipation Melanoma
Slide 36: KEYNOTE-695 History: Patient C
KEYNOTE-695 HISTORY: PATIENT C 26 APRIL 2018 — 30 OCTOBER 2018 Treatment as per protocol cycle 1-9 (27 weeks) ¢ |T-tavo-EP: Days 1, 5, 8 every other cycle (each 6 weeks) * Pembrolizumab (200 mg IV}: Day 1 of each 3-week cycle 12 April 2018: Screening ¢ Melanoma, stage IVA, with subcutaneous lesions
Slide 37: Patient C
PATIENT C CT IMAGES OF BASELINE VS. 24 WEEKS
Slide 38: Patient C
PATIENT C TUMOR FLARE, NECROSIS, AND RESPONSE oncosec
Slide 39: Patient C
PATIENT C IMMUNOLOGIC IMPACT VIA MIHC A POWERFUL TREATMENT-RELATED INCREASE IN TIL DENSITY WITH 1 CYCLE OF TAVO + PEMBRO IN AN IMMUNOLOGICALLY COLD LESION ar) a a i 61-004-102 = Screen 8 = ™ a o 004-102 008-101 004-103 30005 ““P<0.00c1_“*p<C.04 LJ ® Screen = cant 61-004-102 c2D1 2000. } { 41000. Tum
Slide 40: Medical History: Patient D
MEDICAL HISTORY: PATIENT D WHITE FEMALE WITH STAGE IVA MELANOMA Medical History * Female 52 years / Stage IVA * Metastatic disease in LNs {local/regional) * Decreased hearing, memory loss, back/joint pain, lymphedema, anemia, fatigue, night sweats, obstructive sleep apnea, nerve damage on the back,
Slide 41: KEYNOTE-695 History: Patient D
KEYNOTE-695 HISTORY: PATIENT D 16 JULY 2018 —- 5 OCTOBER 2018 Treatment as per protocol cycle 1-5 (12 weeks) 25 June 2018: ¢ |T-tavo-EP: Days 1, 5, 8 every other cycle (each 6 weeks) 5 October (cycle 5, day 1): © Pembrolizumab (200 mg IV}: Day 1 of each 3-week cycle Screening Tumor response at 12 we
Slide 42: 25% of Lesions Were Treated: Global Response
OF 160 (25%) LESIONS WERE TREATED > GLOBAL RESPONSE $$ $a Baseline . 9 a oncosec ONLY 25% OF 160 (~40 LESIONS) LESIONS WERE TREATED > GLOBAL RESPONSE
Slide 43: Patient D
PATIENT D CT IMAGES OF BASELINE VS. 24 WEEKS Baseline oncosec Net radiographic response
Slide 44: Medical History: Patient E
MEDICAL HISTORY: PATIENT E WHITE MALE WITH STAGE IVB MELANOMA * Male 81 years / Stage IVB Medical History ° Metastatic disease in lung and LNs (distant) * BCC, SCC, keratoses, hiatal hernia, hypertriglyceridemia, knee replacement, back pain, artery surgery, thyroid nodule, GERD, type II DM, sinus br
Slide 45: KEYNOTE-695 History: Patient E
KEYNOTE-695 HISTORY: PATIENT E 27 JUNE 2018 —- 19 DECEMBER 2018 Treatment as per protocol cycle 1-5 (12 weeks) ¢ [T-tavo-EP: Days 1,5, 8 every other cycle (each 6 weeks) Pembrolizumab (200 mg IV}: Day 1 of each 3-week cycle 20 June 2018: Screening * Melanoma, stage IVB, with 12 December (cycle 9, da
Slide 46: Patient E
PATIENT E IMAGES OF BASELINE VS. 12 AND 24 WEEKS Baseline Regression of mediastinal node and parenchymal lung metastases 24 weeks oncosec
Slide 47: OMS-140 TNBC Patient
OMS-140 TNBC PATIENT 1 MEDICAL HISTORY June 2014: Dx’d (6 months post- partum) inflammatory right IDC with oligometastases to left contralateral ALN Dose-dense ACT J October 2014: Right Mastectomy/ALND: +LVI, residual disease (0.4 cm), 4/19 LN+ oncosec MMUNOTHERAPIES January 2015: Right chest wall a
Slide 48: OMS-140 TNBC Patient
OMS-140 TNBC PATIENT 1 PROTOCOL AND POST-PROTOCOL TREATMENT April 4, 2016 - May 2, 2016: Cycle 1, Day. 1-Day 28 (post Bx} May 5, 2016: May 5, 2016: Off-protocol (compassionate use} Nivolumab IV q 2 weeks Rapid clinical response Completed 10 cycles October, 2016: Disease progression (PD) in mediastin
Slide 49: OMS-140 TNBC Patient
OMS-140 TNBC PATIENT 1 REPRESENTATIVE POST-TREATMENT IMAGES Representative post-treatment images of a patient with primary refractory inflammatory right breast TNBC r ol Treated right chest wall disease Treated left Untreated breast disease exophytic left axillary skin nodule ONCOSEC nix triple nega
Slide 50: OMS-140 TNBC Patient (T2N0M0)
OMS-140 TNBC PATIENT 2 (T2NOMO) MEDICAL HISTORY PATIENT PREVIOUSLY RECEIVED ATEZOLIZUMAB July 2017: Clinical PD — enlarging right breast nodule and October 2015: D ber 2015: May 2014: s Seem ee non-healing scalp Cm CT shows multiple CT-guided lung Dx’d clinical stage IIA cule Bl | Feb 2017: metastas
Slide 51: OMS-140 TNBC Patient
OMS-140 TNBC PATIENT 2 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 * Right breast lesion-TREATED August 14, 2017: September 21, 2017: Off-protoco
Slide 52: TAVO Monotherapy Followed by PD-1 Checkpoint
TAVO MONOTHERAPY FOLLOWED BY PD-1 CHECKPOINT January 18, 2018 oncosec ONCOSEC PROVIDES ENCOURAGING CLINICAL ~ OBSERVATION RELATED TO TRIPLE NEGATIVE BREAST CANCER STUDY March 15, 2018 oncosec OncoSec's Intratumoral IL-12 In Metastatic Triple Negative Breast Cancer (TNBC) Selected For Poster Presenta
Slide 53: Accessible Lesions US Only Market Opportunity
ACCESSIBLE LESIONS US ONLY MARKET OPPORTUNITY $1,785M Patients Having Accessible Lesions $748M Treatment Refractory Patients $416M PD-1/PD-L1 Refractory Patients oncosec TAVO used in combination with PD-1/PD-L1 treatments, the US market opportunity is $748 million As a monotherapy in PD-1/PD-L1 refr
OncoSec Medical — Investor Presentation (February 2019) on 6ix