Oncosec Medical Incorporated · OTC:ONCSQ
Oncosec Medical — Investor Presentation (December 2020)
40 slides from Oncosec Medical's investor presentation, December 2020
Slide 1: Powerful, Tumor-agnostic Immunotherapy Treatment
Powerful, Tumor-agnostic Immunotherapy Treatment ONCOSEC’S PLATFORM TO ATTACK VISCERAL, CUTANEOUS AND SUBCUTANEOUS TUMORS NASDAQ: ONCS DECEMBER 2020
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 12/11/20): ~$148M Stock Price (as of 12/11/20): $5.29 • Late-stage biotechnology company focused on intratumoral delivery of DNA-based immunotherapies as monotherapy and in combination regimes • Developing treatments for cancer indications
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™ is Capable of TAVO (plasmid-based interleukin-12) is administered locally at the tumor site using OncoSec’s electro gene Reversing Resistance transfer system. TAVO is designed to induce local expression of IL-12, to Checkpoint turning “cold” tumors “hot” and enabling checkpoint therapies to be
Slide 7: IL-12 Is a Key Mediator of Communication Between Immune 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: 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/IFN𝛾𝛾 Feed Forward tumor, followed by Loop a 3 sec. pulse of Tumors express IL-12 energy stimulating NK and T cells to make IFN-𝛾𝛾, Tumor cells take up which then…
Slide 9: Benefits of Gene Electro Transfer System
Benefits of Gene Electro Transfer System A non-invasive, Rapid Transfection Versatile non-chemical, More rapid than Wide array of molecules can traditional chemical or be transfected, and can be biologic cell transfection applied to a broad selection non-toxic techniques of cell types method that is
Slide 10: Seamless Delivery Of Plasmid IL-12
Seamless Generator Delivery Of • Fixed electrical field intensity • 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 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: KEYNOTE-695
Up To Number Of 30 Sites PATIENTS KEYNOTE-695 TO BE TREATED 100 Canada Italy United States Australia FAST TRACK AND U.S. ORPHAN DESIGNATED Dosing Schedule • Single-arm phase 2 registration enabled IL-12 EP IL-12 EP IL-12 EP • Stage III/IV melanoma • Rigorously confirmed anti-PD-1 non-responder P P P
Slide 14: 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 2020 14
Slide 15: 5 of 54 Evaluable Patients had 100% Tumor Reduction
Investigator-Assessed Response per Recist v1.1 5 of 54 Evaluable Patients had 100% Tumor Reduction Fernandez-Peñas, P. et al., SITC 2020 15
Slide 16: Treatment-Related Adverse Events (TRAE) 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 17: Treated and Untreated Lesions from Responding Patients
Treated and Untreated Lesions from 16 Responding Patients Fernandez-Peñas, P. et al., SITC 2020 17
Slide 18: 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 18 Fernandez-Peñas, P. et al., SITC 2020
Slide 19: 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 2020 19
Slide 20: 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 2020 20
Slide 21: 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 2020 21
Slide 22: US Market Opportunity: Focusing First on Metastatic Melanoma
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 23: Commercialization by 2022 Targeted
Commercialization by 2022 Targeted 2021 2022 Pre-BLA Meeting FDA Accelerated Approval of TAVO with FDA for Metastatic Melanoma Potential US TAVO is US Orphan Designated and Keynote-695 is fast Regulatory 2021 tracked. OncoSec will seek Timeline Submission of BLA for accelerated approval Accelerated
Slide 24: 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 25: 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 26: 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 27: 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 27
Slide 28: 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 29: The Power of TAVO for Visceral Lesions (liver, GI, lung)
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 30: 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 30
Slide 31: 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 32: 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 33: CORVax12 Vaccine for COVID-19
CORVax12 Vaccine for COVID-19 CORVax12 is a DNA vaccine The combination of IL-12 and Providence Cancer Institute is which combines OncoSec’s NIH’s spike protein is designed conducting a Phase I trial of TAVO / IL-12 immunotherapy IN to drive a coordinated vaccine CORVax12 with NIH’s “spike” protein
Slide 34: 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 35: Strong Financial Position to Drive TAVO Development Forward
Strong Financial Position to Drive TAVO™ Development Forward $24M 27,991,274 Cash & Equivalent as of Total Shares Outstanding 10/31/20 as of 12/11/20 None Debt 35 35
Slide 36: Key Developments in 1H 2020
Key Developments in 1H 2020 Closed on $30 million strategic financing and partnership with CGP/Sirtex Presented promising preclinical data on novel visceral lesion applicator Announced partnership with Providence Cancer Institute to investigate OncoSec’s CORVax-12 vaccine for COVID-19 Appointed reno
Slide 37: Anticipated Milestones
Anticipated Milestones Closed on $15 million financing Obtain IND for CORVax12, a vaccine for COVID-19 Provide interim data update at SITC 2020 for KEYNOTE-695 Complete enrollment in registration directed KEYNOTE-695 study First patient dosed CORVax12 Prepare to file TAVO™ for accelerated FDA approv
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 Daniel J. O’Connor, JD Robert W. Ashworth, Ph.D Herbert Kim Lyerly, M.D. President/Director/CEO Senior Vice President
Slide 39: OncoSec is Positioned for Success with TAVO
OncoSec is Positioned Positive tumor Well tolerated, natural shrinkage/response data being solution that may increase generated by our lead product the efficacy of checkpoint for Success with candidate, TAVO, across multiple solid tumor types therapies TAVO™ Expanding device Fast track status and de
Slide 40: Thank You
Thank You Keir Loiacono HEAD OF CORPORATE DEVELOPMENT 914.329.9071 [email protected] HEADQUARTERS SCIENTIFIC LAB & RESEARCH 24 NORTH MAIN STREET 3565 GENERAL ATOMICS CT. PENNINGTON, NJ SAN DIEGO, CA
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