Oncosec Medical Incorporated · OTC:ONCSQ
Oncosec Medical — SITC 2018
45 slides from Oncosec Medical's conference presentation, Nov 6, 2018
Slide 1: KEYNOTE 695: TAVO Phase 2b Melanoma Trial Preliminary Data for SITC 2018
oncosec IMMUNOTHERAPIES KEYNOTE 695: TAVO™ Phase 2b Melanoma Trial ! Preliminary Data for SITC 2018 November 6, 2018
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: KEYNOTE-695 Introduction
KEYNOTE-695 Introduction * Immune checkpoint inhibitors have become a mainstay in the treatment of melanoma? ° However, a high unmet medical need remains in metastatic melanoma - Most patients do not respond to immune checkpoint inhibition?? - Attempts to potentiate activity by combining ipilimumab
Slide 4: Patient eligibility criteria
* Pathologically documented unresectable melanoma, Stage III/IV, with histological or cytological confirmed diagnosis of unresectable melanoma with progressive locally advanced or metastatic disease ¢ All patients must be refractory to anti-PD-1 mAbs (pembrolizumab or nivolumab according to their ap
Slide 5: KEYNOTE-695 Preliminary Data
KEYNOTE-695 Preliminary Data * Interim data set as of September 1, 2018 - 21 enrolled, 19 patients treated ~ 9 patients evaluable for first scan, having completed 12 weeks of treatment © Preliminary responses (based on RECIST v1.1) - 2/9 PRs and 1/9 SD (22% BORR and 33% DCR) at initial tumor evaluat
Slide 6: KEYNOTE-695: TAVO for Stage III/IV Melanoma
KEYNOTE-695: TAVO for Stage III/IV Melanoma Anti-PD-1 !L-12 Stage III/IV Combination Electroporation Study * Single Arm Phase 2/3 study Orphan designation ° Primary outcome: BORR based on RECIST v1.1 Fast Track * Secondary outcomes: DOR, PFS and OS Breakthrough status ° iar patients: anti-PD-1 non-r
Slide 7: KEYNOTE-695—Response Rates for First Patients
KEYNOTE-695—Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate 61- 007-108) | 61-004-103 | erane or . SUMMARY OF RESPONSE iUPD; iSD 2PR (SD TL/ new NTL) 1SD 01- 009-101 iUPD; WDC 3iUPD ae / new NTL) 3PD 61-008-102 iUPD; WDC | 61-007-102 | PD | 61-006
Slide 8: Overview Patient 61-007-104
Overview Patient # 61-007-104 e Male 65yrs ° Stage at screening — Stage IVB e Metastatic disease in lymph nodes (distant), lung and subcutaneous ¢ Medical history — hip replacement, thumb infection, enlarged prostate, removal of BCC on the neck ¢ Prior surgery on lesion on abdominal wall, dissection
Slide 9: Medical History (61-007-104)
Medical History 65 year-old white male with Stage I1VB melanoma (61-007-104) Medical * Osteoarthritis with bilateral hip History: replacements * Benign prostatic hyperplasia * Basal cell carcinoma * Spontaneous pneumothorax Melanoma October 2017 History: * Distant recurrence: Excision February 2014
Slide 10: Measures and PI ORR Assessment
Measures and PI ORR Assessment Patient # 61-007-104 °@ Cycle 5 (2 TAVO treatments) ¢ Target Lesion PR °Non target lesion non CR / non PR ° No new lesions TL1 skin TL2 skin TL3 lymph (treated) (treated) (untreated) Baseline 16mm 25mm 28mm e Measures Cycle 5 (“12 wks) 4mm 27mm 6mm — 10
Slide 11: Clinical Trial Experience and 12-week Response
Clinical Trial Experience and 12-week Response Patient # 61-007-104 9 April 2018: 16 April 2018 - 9 July 2018 9 July 2018 (cycle 5, day 1): Screening Treatment as per protocol Cycle 1-5 Tumor response at 12 weeks * Melanoma, Stage IVB, * |T-tavo-EP: Days 1, 5, 8 every other cycle (each 6 weeks) * Ta
Slide 12: Baseline vs. Week 12 Assessment Lesions
, 7 of Baseline vs. 12 Week Assessment L Patient # 611-007-104 Baseline 12 weeks Lesion #1: No photo available due to the tumor being undetectable post treatment. oncosec 12
Slide 13: CT Images of Baseline vs. Week 12 Assessment Lesions
CT Images of Baseline vs. 12 Week Assessment Lesions Patient # 61-007-104 Pre-Treatment 12 Weeks TLA Pre-Treatment 12 Weeks TL2 The untreated lesion is a left hilar node, far away from the treated lesions. eo
Slide 14: KEYNOTE-695—Response Rates for First Patients
KEYNOTE-695—Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate 61- 007-104 PR 61-004-103 ES 2 A A =D SUMMARY OF RESPONSE 6 3 iUPD; iSD 2PR (SD TL/ new NTL) 1SD "nee oa ae / new NTL) 3PD 61-008-102 iUPD; WDC Po 61-006-102 PD 61-004-102 PD ONCOSEC on s
Slide 15: Overview Patient 61-004-103
Overview Patient # 61-004-103 ¢ Female 71yrs ° Stage at screening — Stage IVB e Metastatic disease in lymph nodes (distant), lung and subcutaneous ¢ Medical history — hypothyroidism, Vaginal prolapse, BCC, SCC ¢ Prior surgery on skin excisions, wide excisions. No radiotherapy. ¢ Prior Systemic thera
Slide 16: Medical History (61-004-103)
Medical History 71 Year-old White Female with Stage |1VB Melanoma (61-004-103) Medical * Hypothyroidism History: * Multiple basal cell carcinomas and squamous cell carcinomas * Vaginal prolapse * Constipation, insomnia, anxiety, and night sweats May 2017 Melanoma * Distant Recurrence: IVA History: O
Slide 17: Measures and PI ORR Assessment
Measures and PI ORR Assessment ! aI Patient # 61-004-103 | °@ Cycle 5 (2 TAVO treatments) ° Target Lesion PR ° Non target lesion non CR / non PR ¢ No new lesions * Measures SESE Baseline 32mm 24mm Cycle 5 (“12 wks) 22mm 17mm oncosec IMMUN JOTHERAPIES 7
Slide 18: Clinical Trial Experience and 12-week Response
Clinical Trial Experience and 12-week Response Patient # 61-004-103 10 May 2018: 24 May 2018 - 16 August 2018 16 August2018 (cycle 5, day 1): Screening Treatment as per protocol Cycle 1-5 Tumor response at 12 weeks * Melanoma, stage IVA, * |T-tavo-EP: Days 1, 5, 8 every other cycle (each 6 weeks) *
Slide 19: Baseline vs. Week 12 Assessment
Baseline vs. 12 Week Assessment Target and Non-Target Lesion Images (61-004-103) Baseline 12 weeks oncosec
Slide 20: Axial Images Baseline vs. Week 12 Assessment
Axial Images Baseline vs. 12 Week Assessment Target and Non-Target Lesion Images (61-004-103) (2 ra Baseline >» Axial images from patient c2D1 ) $ ’ #61-004-103 showing large exophytic scalp lesions. balan
Slide 21: Intratumoral Gene Expression
_ Intratumoral Gene Expression — Patient # 61-004-103 eee wo P 22) a soon wrt 5129) z 312 ba F pe i i i 2 2. z 2 2. 1 —sarten CHT Sie Chi 128) = tanan coe 123) 4 cme CXCLIB g a H a, ie i bP OSs emt Saban cmt Intratumoral gene expression in a PR demonstrates increased _ antigen presentation and T cel
Slide 22: Intratumoral Gene Expression
Intratumoral Gene Expression Patient # 61-004-103 128) sonon Lage 2048) 5 scmen RF 1024) 6. scmon 101 64) semen CTLA4 = cor “= c201 = ca = cor 2 2 ao 512 2 z £ 1024 z 3 3 3 256. 32 8 6 8 $ 3 H i B54 gs 3 1 i 8 3 E E E 64 te 2 2 256 3 32 32: 128- 8 Screen 201 ‘Screen 201 6 Screen C201 Screen C201 Int
Slide 23: KEYNOTE-695—Response Rates for First Patients
KEYNOTE-695—Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate 61-007-102 PD 61-006-102 PD 61-004-102 PD PR £1008-101 SUMMARY OF RESEONSE 6. 3 iUPD; iSD 2 PR (SD TL/ new NTL) 1SD 01- 009-101 iUPD; WDC 3iUPD ae / new NTL) 3PD 61-008-102 iUPD; WDC ONCO
Slide 24: Overview Patient 61-008-101
Overview Patient # 61-008-101 ° 57 year-old white male with stage IVA melanoma ° 10 cycles of pembro 200 mg ° Surgery arm for melanoma / axillary clearance / axillary SLNB ° No radiation therapy ° 16Jul2018 (cycle 5, day 1): — Target lesion: SD (0% decrease in sum of diameters) —Non target lesions:
Slide 25: Multispectral IHC
Multispectral IHC Patient # 61-008-101 25007 © Screen = C2D1 s 0.3 @B Screen oO ie - L 15004 a C2D1 is] a 7) re 0.2 8 = r=) Ww HN 2 04 8 é ise) Q Bd ic PD-1+/CD8+T cells © PD-L1+ Tumor FoxP3+ T cells * 0.0 Multispectral IHC: patient has an “immuno-active” lesion after oncosec a single cycle of treat
Slide 26: KEYNOTE-695—Response Rates for First Patients
KEYNOTE-695—Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment 61- 007-104 PR Patient Number Response Rate PR SUMMARY OF RESPONSE 61-008-101 SD 61-007-103 iUPD; iSD 2PR (SD TL/ new NTL) 1SD 01- 009-101 iUPD; WDC 3iUPD (PR TL/ new NTL) 3PD 61-008-102 iUPD; WDC (SD TL/ new NTL) 61
Slide 27: Overview Patient 61-007-103
Overview Patient 61-007-103 ° 70 year-old white male with stage IVB melanoma ° 4cycles of pembro 210 mg paccline ° Surgery Lymph node / heel ° No radiation therapy ° 16Mar2018 (cycle 5, day 1): — Target lesions: Stable Disease (13% decrease in sum of diameters) — Non target lesions: non CR / non PD
Slide 28: KEYNOTE-695—Response Rates for First Patients
KEYNOTE-695—Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate 61- 007-104 PR 61-004-103 PR 61-008-101 SD 61-007-103 iUPD; iSD (SD TL/ new NTL) 01- 009-101 iUPD; WDC (PR TL/ new NTL) 61-008-102 iUPD; WDC (SD TL/ new NTL) 61-007-102 PD 61-006-102 PD 6
Slide 29: Overview Patient 01-009-101
Overview Patient # 01-009-101 * 39 year-old white female with stage IVC melanoma * Prior treatments: — Temozolmide 4 cycles — Nivolumab 18 cycles — Ipi 3 cycles — Trametinib / IL-2 2 cycles — Epadacostst 4 cycles — Interferons / pembrolizumab 4 cycles — Ipi & nivo 4 cycles * Surgery intussusception
Slide 30: KEYNOTE-695—Response Rates for First Patients
KEYNOTE-695—Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment Patient Number Response Rate PR PR SUMMARY OF RESPONSE 61-008-101 SD 61-007-103 iUPD; iSD 2PR (SD TL/ new NTL) 1SD 01- 009-101 iUPD; WDC 3iUPD (PR TL/ new NTL) 3PD 61-008-102 iUPD; WDC (SD TL/ new NTL) 61-007-102 61-
Slide 31: Overview Patient 61-008-102
Overview Patient # 61-008-102 * 72 year-old white male with stage |VB melanoma * Prior treatments: — Encorafenib 2 cycles — Binimetinib 2 cycles — Dabrafenib 30 cycles — Trametinib 30 cycles — Pembrolizumab 18 cycles [200mg] * Surgery scalp * No radiation therapy ° Aug 2018 (cycle 5, day 1): — Targe
Slide 32: KEYNOTE-695—Response Rates for First 9 Patients
Patient Number Response Rate KEYNOTE-695—Response Rates for First 9 Patients Who Completed 12 Weeks of Treatment 61- 007-104 61-004-103 61-008-101 61-007-103 01-0 1 ba lin ona 61-008-102 61-007-102 61-004-102 PR PR sD iUPD; iSD (SD TL/ new NTL) iUPD; WDC (PR TL/ new NTL) iUPD; WDC (SD TL/ new NTL) S
Slide 33: Overview Patient 61-007-102
Overview Patient # 61-007-102 ° 74 year-old white female with stage IIIC melanoma ¢ Prior treatment: —Pembrolizumab 4 cycles — lpi & nivo 4 cycles ° Surgery TLS skin | TL2 TL3 (vaginal mass) ¢ No radiation therapy ° April 2018 (cycle 5, day 1): — Target lesions: PD Screening 15mm 69mm 22mm EOS 15mm
Slide 34: Overview Patient 61-006-102
Overview Patient # 61-006-102 ° 61 year-old white female with stage |VA melanoma ° Prior treatment: —Pembrolizumab 11 cycles —Ipi 4 cycles —Nivo 16 cycles ° Surgery / groin excision / subcut mets ¢ No radiation therapy ° Mar2018 (cycle 5, day 1): — Target lesions: SD TL1i5 — Non target lesions: non
Slide 35: ORR and Tumor Measures (61-004-102)
ORR and Tumor Measures 71 Year-old White Male with Stage IVA Melanoma (61-004-102) | Baseline Images Screening 31mm 7imm 24mm 33mm 39mm Cycle 5 35mm 47mm 1imm 41mm 42mm 176 oncosec TL, target lesion; NTL, non-target lesion; SD, stable disea 17Jul2018 (cycle 5, day 1): Tumor response at 12 weeks * Ta
Slide 36: Immunologic Impact via mIHC
Immunologic Impact via mIHC Patient # 61-004-102 a a a S ¢ 61-004-102 8 4 i Screen g = to 2 5 a 004-102 008-101 004-103 30004 ““"P<0.0001 “p<001 = @ Screen 61-004-102 A oe = capt c2D1 a = 2000 | fuse ous E 2 1000. Fos a 004-102 008-101 004-103 mlHC Demonstrates a Powerful Treatment-related Increase
Slide 37: Preliminary Safety
PRELIMINARY SAFETY eo
Slide 38: TAVO + Pembrolizumab Tolerability in Patients Who Completed 12 Weeks
KEYNOTE-695 — TAVO™ + Pembrolizumab Tolerability in Patients Who Completed 12 Weeks of Treatment TAVO™- Pembrolizumab-related | Total AEs/SAEs related to related AEs AEs study drugs Grade 1, n (%) 5/9 (55.6) 3/9 (33.3) 8/9 (88.9) Grade 3, n (%) 1/9 (11.1) 2/9 (22.2) 3/9 (33.3) TAVO"™-related AEs wer
Slide 39: Additional Preliminary Biomarker Data
ADDITIONAL PRELIMINARY BIOMARKER DATA IMMUNOTHERAPIES
Slide 40: Treatment-related upregulation of immune-based transcripts in tumor microenvironment
A treatment-related upregulation of immune-based transcripts in the tumor microenvironment was observed in 7 matched biopsies 1x10*4 Higher Pre-treatment Higher Post-treatment p96 ° j oe, E ° cuz ys 0.001 ° Orr © o Bb r s | ° © ° | 5 | ae ee eee eT Pee ro p.o--- adj. p-value <0.1_ > 0.014 oa S ° 3 ©
Slide 41: IHC: PR Has Increase in the Density of CD8+ TILs
IHC: PR Has Increase in the Density of CD8* TILs CD8 % Intratumoral 3 60 g PD PR & Pre-treatment 2 @™@ Post-Treatment oO 5 40 = o > a 8 20 a Ro PD SD [a0] Bo N v & ws a ro ae eS eS Zs RS 8 © © © oncosec
Slide 42: IHC: PR/SD Have Increased PD-L1+ Tumor Cells
IHC: PR/SD Have Increased PD-L1* Tumor Cells PD-L1 % Tumor Positive 254 g PR I Pre-treatment % 20+ @™@ Post-Treatment a 5 154 £ i] F 104 De PD PD sD = a 5 a 0 N oy N os we Ss aS SS S gS s s s s $ s 3 3 3 oncosec
Slide 43: gMDSC Reduced in PR/SD Patients
gMDSC Reduced in PR/SD Patients Partial Response (61-007-104) Comp-PerCP-Cy-6-A = CD15 Progressive Disea se (61-007-103) Screen Cc2D Comp-PercP.CyS-8-a:: CDI q 41 gwDsc 0.0 Screen c2D w © 1 8 ] 8 é Yoo | oy ¢ | A é 5 & é Comp-BUVa35-4: CD11» __ Camp-BUV35-A «: CD! Stable Disease (61-008-101) Screen
Slide 44: Decreased Monocytes/Macrophages in PR/SD
Decreased Monocytes/Macrophages in PR/SD Partial Response (61-007-104) Progressive Disease (61-007-103) Screen c2D1 Screen c2D1 Meroe mac Nonocytes, Macrophages Wonoses, acropnages Monaeyes, Macrophages ove 7 wr . a3 7 318 4 ‘ £ < g a r Fa e 5 E 5 aoa ta) ood 5 od Danip-auvass-x ona Compalvass-A: cO
Slide 45: Frequency of Peripheral CD8+ T Cell
Frequency of Peripheral CD8* T Cell Patients After 1 Cycle of Treatment PR (61-007-104) SD (61-008-101) PD (61-007-103 PD (61-007-102 cD4+ cD4+ cD4+ cD4+ 476 64.5 69.6 68.4 Comp-BUV395-A :: CD4 Comp-BUV395-A :: CD4 Comp-BUV395-A :: CD4 Comp-BUV395-A » CD4 ‘Comp-BUV496-A : CDB Comp-BUV496-A ": CD ‘Co