OncoSec Medical Incorporated · OTC:ONCSQ
OncoSec Medical — Investor Presentation (March 2021)
40 slides from OncoSec Medical's investor presentation, March 2021
Slide 1: Powerful, Tumor-agnostic Immunotherapy Treatment
Powerful, Tumor-agnostic Immunotherapy Treatment ONCOSEC’S PLATFORM TO ATTACK VISCERAL, CUTANEOUS AND SUBCUTANEOUS TUMORS NASDAQ: ONCS MARCH 2021
Slide 2: Forward Looking Statements
FORWARD LOOKING STATEMENTS To the extent statements contained in the following retain key scientific or management personnel; (viii) presentations are not descriptions of historical facts the anticipated timing of clinical data availability; (ix) regarding OncoSec Medical Incorporated, they should t
Slide 3: Investment Highlights
Ticker: NASDAQ: ONCS Investment Highlights Market Cap (as of 3/22/21): ~$211M Stock Price (as of 3/22/21): $5.69 • Biotechnology company focused on intratumoral (IT) delivery of DNA-based immunotherapies as monotherapy and in combination regimes • Developing treatments for solid tumor cancer indicat
Slide 4: The Promise of Immunotherapy Has Yet to Be Fully Realized
How Checkpoint Inhibitors Work The Promise of Molecular switches known as Immunotherapy Has Yet 1 checkpoints normally prevent T- cells from attacking healthy tissue to Be Fully Realized When these checkpoints, such as 2 PD-1 and PD-L1, are hijacked by cancer cells, the immune system’s T-cell respon
Slide 5: Checkpoint Non-response in 60-90%
Checkpoint Powerful drugs (like KEYTRUDA®) have been highly Non-response successful for some patients, but not the majority in 60-90% 90% of cancers are solid tumors. Of these: of Cases % OF CHECKPOINT TUMOR TYPE NON-RESPONDERS MELANOMA ˜60-80% ~30% ~70% Hot Tumors Cold Tumors TRIPLE NEGATIVE BREAST
Slide 6: TAVO is Capable of Reversing Resistance to Checkpoint Therapies
TAVO (plasmid-based interleukin-12) is administered locally at the tumor site using OncoSec’s electroporation gene TAVO™ is Capable of delivery system. TAVO is designed to induce local expression of IL-12, turning “cold” tumors “hot” and Reversing Resistance enabling checkpoint therapies to be effec
Slide 7: IL-12 Is a Key Mediator of Communication Between Innate and Adaptive Cells
IL-12 IS A KEY MEDIATOR OF COMMUNICATION BETWEEN DC/MACROPHAGES (INNATE) & EFFECTOR T CELLS AND NK CELLS (ADAPTIVE) Lasek W, et al, Cancer Immunol Immunother 2014
Slide 8: Benefits of Electro Gene Transfer System
Benefits of Electro Gene Transfer System A non-invasive, Rapid Transfection Versatile non-chemical, non- More rapid than Wide array of molecules can traditional chemical or be transfected, and can be toxic method that biologic cell transfection applied to a broad selection techniques of cell types i
Slide 9: Seamless Delivery of Plasmid IL-12
Seamless Generator • Fixed electrical field intensity Delivery Of • Momentary electrical pulses (100 µsec duration and 300 Plasmid IL-12 millisecond interval) • Pulses activated by foot switch + Energy • 16 lbs. 12.5” w x 5.5” h x 13” d Step 3: Electroporation Electrical pulses, activated by a foot
Slide 10: Gene Electro Transfer of Immunotherapy: An Intratumoral IL-12 Factory
Gene Electro Transfer of Immunotherapy: An Intratumoral IL-12 Factory The IL-12 Factory DNA plasmid IL-12 is injected into the IL-12/IFN𝛾 Feed Forward Loop tumor, followed by Tumors express IL-12 a 3 sec. pulse of stimulating NK and T energy cells to make IFN-𝛾, which then feeds Tumor cells take…
Slide 11: TAVO: A Tumor Agnostic Platform with Single Agent Activity
5 TAVO: A Tumor Agnostic CLINICAL/ IMMUNOLOGICAL SIGNAL IN FIVE TUMOR TYPES Platform with Single Agent Activity TAVO + PEMBRO COMBINATION TAVO SINGLE AGENT SPONSORED TRIALS INVESTIGATOR-SPONSORED TRIALS Metastatic Melanoma Metastatic TNBC U.S. Orphan Accelerated Approval Metastatic Metastatic Fast T
Slide 12: Clinical Pipeline is Well Diversified with Multiple Growth Opportunities
Clinical Pipeline is Well Diversified with Multiple Growth Opportunities REGIMEN TRIAL INDICATION N PARTNER PHASE 1 PHASE 2 PIVOTAL TAVO + Checkpoint Resistant KEYNOTE-695 ~100 pembrolizumab Metastatic Melanoma TAVO + Triple Negative Breast KEYNOTE-890 ~65 pembrolizumab Cancer (TNBC) TAVO + TAVO™ CO
Slide 13: FDA Fast Track KEYNOTE-695
FDA Fast Track KEYNOTE-695 Ongoing pivotal trial in PD-1 checkpoint resistant metastatic melanoma provides a pathway towards accelerated approval GRANTED FAST TRACK AND ORPHAN DRUG DESIGNATIONS Fast-track makes Program for patients Must meet TAVO™ eligible for with no FDA RECIST (tumor accelerated a
Slide 14: KEYNOTE-695 Trial Design and Eligibility
Up To Number Of 30 Sites PATIENTS TO BE TREATED 100 Canada Italy United States Australia DEFINITIVE CLINICAL PROGRESSION ON FULL COURSE ANTI-PD-1 Stage 3/4 Received at Progressive Documented No intervening Eligible Melanoma therapies permitted patient/definitive least 12 weeks + disease + disease +
Slide 15: Patient Demographics and Disease Characteristics
Patient Demographics and Disease Characteristics ‡Based on maximum value prior to dosing; #2 patients with ≥ 2X ULN Fernandez-Peñas, P. et al., SITC Annual Meeting 2020, data as of September, 2020 15
Slide 16: 5 of 54 Evaluable Patients had 100% Tumor Reduction
Investigator-Assessed Response per Recist v1.1 – Preliminary Data 5 of 54 Evaluable Patients had 100% Tumor Reduction Fernandez-Peñas, P. et al., SITC Annual Meeting 2020 data as of September, 2020 16
Slide 17: Treatment-Related Adverse Events in ≥ 5% of Patients
Treatment–Related Adverse Events (TRAE) in ≥ 5% of Patients All Grades n(%) (N=56) Grade 1/2 Grade 3 Grade 4 Grade 5 Patients with at least one TEAE 43 (76.8%) 40 (71.4%) 3 (5.4%) - - Fatigue 15 (26.8%) 15 (26.8%) - - - Procedural pain 13 (23.2%) 13 (23.2%) - - - Diarrhea 11 (19.6%) 11 (19.6%) - - -
Slide 18: Treated and Untreated Lesions from Responding Patients
Treated and Untreated Lesions from 16 Responding Patients Fernandez-Peñas, P. et al., SITC Annual Meeting 2020, data as of September, 2020 18
Slide 19: Actively Progressing Patients & Short Interval Between Last Anti-PD-1 Dose and Study Treatment
Actively Progressing Patients & Short Interval Between the Last Dose of Anti-PD-1 and Study Treatment Fernandez-Peñas, P. et al., SITC Annual Meeting 2020, 19 Data as of September, 2020
Slide 20: Actively Growing Lesions Significantly Reduced in Size after pIL-12 + Pembrolizumab
Actively Growing Lesions Significantly Reduced in Size after pIL-12 + Pembrolizumab Treatment Fernandez-Peñas, P. et al., SITC Annual Meeting 2020, data as of September, 2020 20
Slide 21: Pseudo Progression in Target Lesion followed by Tumor Response
Pseudo Progression in Target Lesion followed by tumor Response [Stage IVB; PR (-93%)] Fernandez-Peñas, P. et al., SITC Annual Meeting 2020, data as of September, 2020 21
Slide 22: Progression on Ipi/Nivo Followed by Tumor Response
Progression on Ipi/Nivo Followed by Tumor Response[Stage IVC; PR (-53%)] Fernandez-Peñas, P. et al., SITC Annual Meeting 2020, data as of September, 2020 22
Slide 23: US Market Opportunity
US Market Focusing First on Metastatic Melanoma Opportunity in the United States 91,000 diagnosis 9,000 deaths each year each year 90% of all cancer cases are solid tumors Incidence of melanoma US melanoma market on the projected to almost 1.6M new cases of solid tumors in the US rise (1.4% yearly f
Slide 24: Commercialization by 2022 Targeted
Commercialization by 2022 Targeted 2021 2022 Pre-BLA Meeting Projected FDA Accelerated with FDA Approval of TAVO for Metastatic Melanoma Potential US TAVO is US Orphan Designated 2021/22 and Keynote-695 is fast Regulatory Planned submission of tracked. OncoSec will seek Timeline BLA for Accelerated
Slide 25: Expanding KEYNOTE-890 into First-Line mTNBC
Expanding KEYNOTE-890 into First-Line mTNBC Primary Endpoint: ORR by blinded independent central PHASE 2 COHORT 1 COHORT 2 review (BICR) based Multi-cohort, open-label study TAVO and KEYTRUDA on RECIST v1.1 TAVO and KEYTRUDA plus of TAVO in combination with in patients with heavily Chemotherapy in p
Slide 26: Case #1: TNBC BOR: CR (-100.0%)
CASE #1: TNBC BOR: CR (-100.0%) Total # Baseline Max tumor Age Sex Metastasis Prior Rx EOT of priors SLD (mm) reduction 35 F Liver, skin, LN 3 Paclitaxel; dox + cyclopho + goserelin; capecitabine 84.5 -100 Ongoing LDH at 1 non target skin nodule was treated with PD-L1 IL-12 EP. Three liver target le
Slide 27: Case #2: TNBC BOR: PR (-67.0%)
CASE #2: TNBC BOR: PR (-67.0%) Total # Baseline Max Tumor Age Sex Metastasis Prior Rx EOT of priors SLD (mm) reduction Breast, lung, lymph Paclitaxel: capecitabine: eribulin; 46 F 5 116 -67 Ongoing node cyclo + dox: carbo + gem LDH at PD-L1 Baseline Baseline C9D1 251 Negative Partial response 25 Com
Slide 28: Recent Peer Reviewed Publications
Recent Peer Reviewed Publications *Click thumbnails to access full articles TAVO + PEMBRO IN ANTICIPATED TAVO SINGLE AGENT ABSCOPAL EFFECT ANTI-PD-1 CHECKPOINT FAILURES 28
Slide 29: Future Opportunities: TAVO is Tumor Agnostic
FUTURE OPPORTUNITIES TAVO™ is Tumor Agnostic Renal Cell Ovarian Head/Neck Carcinoma Triple Negative Bladder Colorectal Giving life to the promise of Pancreatic Breast immunotherapies across cancer types HI Few cancers are highly infiltrated or “HOT” - most LYMPHOCYTES fall on a spectrum from warm (c
Slide 30: The Power of TAVO for Visceral Lesions
The Power of TAVO™ INTRODUCING THE for Visceral Lesions VLA: Visceral Lesion Applicator (liver, GI, lung) Pioneering technology Flexible catheter- Rigid trocar-based designed to target and based applicator applicator treat tumors located deep inside the body Lower voltage Apollo generator to be used
Slide 31: VLA Highlights
VLA Highlights 1 Rigid and catheter models: Used with bronchoscope, cystoscope, and trocar 2 Prototype successfully tested in large animal model: bone, pancreas, liver, lung, & bladder NEEDLE/ELECTRODES EXPANDED ENTERS THE ORGAN DRUG DELIVERY GENE ELECTROTRANSFER 1 2 3 31
Slide 32: OncoSec Catheter VLA
ONCOSEC CATHETER VLA VISCERAL LESION APPLICATOR A P P L I C A B L E I N D I C AT I O N S Lung Bladder GI Tract BRONCHOSCOPE CYSTOSCOPE ENDOSCOPE A P P L I C ATO R M E A S U R E M E N T S Electrode Width Electrode Length Injection Needle 4.5mm (+/- 0.5mm) 8mm (+/- 0.5mm) 4mm (+/- 1mm) May reduce leng
Slide 33: OncoSec Rigid VLA
ONCOSEC RIGID VLA A P P L I C A B L E I N D I C AT I O N S VISCERAL LESION APPLICATOR Liver Bone Pancreas A P P L I C ATO R M E A S U R E M E N T S Electrode Width Electrode Length Injection Needle 4.5mm (+/- 0.5mm) 8mm (+/- 0.5mm) 4mm (+/- 1mm) May reduce length depending on application 4.5mm LIVER
Slide 34: CORVax12 Vaccine for COVID-19
CORVax12 Vaccine for COVID-19 CORVax12 is a DNA vaccine The combination of IL-12 and Providence Cancer Institute which combines OncoSec’s NIH’s spike protein is designed Phase I trial of CORVax12 TAVO / IL-12 immunotherapy IN to drive a coordinated vaccine with NIH’s “spike” protein response, capabl
Slide 35: Leveraging World Class Strategic Partnerships to Enhance Pipeline Value
Leveraging World Class Strategic Partnerships to Enhance Pipeline Value We are partnering with Merck Emerge collaboration provides Our partnership with CGP gives Through our partnership with on several KEYNOTE clinical Australian metastatic us the ability to develop and Sirtex, we have access to top
Slide 36: Strong Financial Position to Drive TAVO Development Forward
Strong Financial Position to Drive TAVO™ Development Forward ~$60M ~36M Cash & Equivalent as of Total Shares Outstanding 1/31/21 as of Feb 2021 ~$42M Debt Financing Completed None Jan 2021 36 36
Slide 37: Important Milestones Planned for 2021 and 2022
Important Milestones Planned for 2021 and 2022 • Filing of new IND for second product candidate combining IL-12 with CXCL9 • FDA clearance GenPulse, the planned go-to-market generator • Commencing Phase 3 clinical trial of TAVO + pembro in metastatic melanoma • KEYNOTE-890 data update presented at a
Slide 38: Established Biotech Leaders
Established Biotech Leaders BOARD OF DIRECTORS WITH A TRACK RECORD OF SUCCESS Daniel J. O’Connor, JD Chief Executive Officer & Director MANAGEMENT Margaret R. Dalesandro, Ph.D. Chair Robert W. Ashworth, Kim Jaffe, Ph.D Herbert Kim Lyerly, M.D. Daniel J. O’Connor President/Director/CEO Ph.D Assistant
Slide 39: OncoSec is Positioned for Success with TAVO
OncoSec is Positive tumor Well tolerated, natural Positioned shrinkage/response data being generated by our lead product solution that may increase the efficacy of checkpoint for Success with candidate, TAVO, across multiple solid tumor types therapies TAVO™ Expanding device Fast Track and US Orphan
Slide 40: Thank You
Brian Leuthner Thank You CHIEF OPRERATING OFFICER 908.531.4566 [email protected] HEADQUARTERS LAB & RESEARCH 24 NORTH MAIN STREET 3565 GENERAL ATOMICS CT. PENNINGTON, NJ SAN DIEGO, CA