Inovio Pharmaceuticals, Inc. · NASDAQ:INO
Inovio Pharmaceuticals — Investor Presentation (December 2018)
49 slides from Inovio Pharmaceuticals's investor presentation, December 2018
Slide 1: J. Joseph Kim, Ph.D. – President & CEO, December 2018
J. Joseph Kim, Ph.D. – President & CEO December 2018 1
Slide 2: Forward Looking Statement
Forward Looking Statement Our commentary and responses to your questions may contain forward-looking statements, including comments concerning clinical trials and product development programs, evaluation of potential opportunities, the level of corporate expenditures, the assessment of Inovio’s tech
Slide 3: Inovio Immunotherapy Technology Platform
Inovio Immunotherapy Technology Platform Inovio’s technology platform is designed to work in vivo to activate an individual’s immune system, generating robust T cell and antibody responses to fight cancer and infectious disease. SynCon®: Synthetic consensus full-length DNA plasmid • Select appropria
Slide 4: Advantages of Inovio’s Platform
Advantages of Inovio’s Platform Refrigerated (2-8°C) Storage >3 years Robust Immune Responses (T cell and B cell) Room Temp (25°C) Storage >1 year; 37°C > 2 months CELLECTRA® SynCon® Rapid Rapid & Scalable SynCon® Design Manufacture Multi-antigen No Anti-Vector Response Immunotherapy in (effective b
Slide 5: Inovio’s T cell Immunotherapy Strategy
Inovio’s T cell Immunotherapy Strategy Human papilloma virus (HPV) Immunotherapeutic HPV is a viral infection that can cause cancer Inovio’s MOA and platform Infectious Diseases developed to target diverse Immuno-Oncology tumor types and pathogens Applying the same MOA, From pre-cancer into
Slide 6: Inovio Product Pipeline
Inovio Product Pipeline Product Indication Preclinical Phase 1 Phase 2 Phase 3 Status Ongoing Phase 3; BLA Cervical Dysplasia target submission 2021 VGX-3100 Vulvar/Anal Dysplasia Interim efficacy data 2019 Dosed first subject Aug 2018; Bladder Cancer interim readouts 2019 INO-5401 Glioblastoma Dose
Slide 7: HPV-Associated Diseases
HPV-Associated Diseases INEVIO
Slide 8: HPV-Related Cancers: Rates & Global Threat
HPV-Related Cancers: Rates & Global Threat CDC reported 43,371 new cases Cancers linked to the HPV rose dramatically in a of HPV-associated cancers 15-year period within the U.S., within the U.S. in 2015 1 despite an increase in vaccination rates 44% spike since 1999 Cervical cancer is the most comm
Slide 9: Unmet Treatment Needs of HPV-Related Precancers
Unmet Treatment Needs of HPV-Related Precancers • VGX-3100 in Phase 3 study for the treatment Annual Incidence (HPV 16/18+ Precancers) of the following precancerous diseases caused by HPV types 16 and 18: US: 195,000 Cervical • High-grade Cervical Dysplasia EU: 233,000 • High-grade Vulvar Dysplasia
Slide 10: HPV Caused Precancers: Limitations of Surgery
HPV Caused Precancers: Limitations of Surgery Loss Loss Loss ofofof 1Massad LS, et al. Obstet Gynecol. 2013;121:829846. 2Nobbenhuis MA, et al. Lancet. 2001;358:1782–1783. Reproductive Reproductive Reproductive Health Health Health 3Xi LF, et al. J Infect Dis. 2007;195:1340–1344. 4Nobbenhuis MA, et a
Slide 11: Phase 2b Achieves All Primary and Secondary Endpoints
Phase 2b Achieves All Primary and Secondary Endpoints Ph3 Primary Endpoint: T Cell Responses Measured in Blood Cervical HSIL regression to low or normal 800 VGX-3100 VGX-3100 Specific T Cells1 AND HPV clearance Placebo 600 VGX-3100 40.2% 400 * * * * 200 Control 14.3% 0 0 5 10 15 20 Study Week 25 30
Slide 12: Phase 3 Program: HPV-Related Cervical HSIL
Phase 3 Program: HPV-Related Cervical HSIL VGX-3100 has the potential to be: 1) the first treatment for HPV infection of the cervix and; 2) the first non-surgical treatment for precancerous cervical lesions Primary Endpoint • VGX-3100: Targets HPV 16/18 subtypes; E6/E7 oncogenes Regression of HSIL (
Slide 13: Immuno-Oncology Programs
Immuno-Oncology Programs 13
Slide 14: Rationale for Checkpoint Combinations with Inovio Products
Rationale for Checkpoint Combinations with Inovio Products Preclinical mouse model Checkpoint Inhibitor Therapies Combined with Inovio Cancer Products • Potential to improve response rates, without adding toxicity • Tumor infiltration of antigen-specific, functional CD8+ T cells may prime patients f
Slide 15: Immuno-Oncology Studies with Efficacy Endpoints
Immuno-Oncology Studies with Efficacy Endpoints MEDI0457 INO-5401 INO-5401 (licensed out to MedImmune) (combination of 3 tumor-associated (combination of 3 tumor-associated antigens: hTERT, PSMA, WT1) antigens: hTERT, PSMA, WT1) • Metastatic HPV-related squamous • Advanced unresectable or cell carci
Slide 16: MEDI0457: Turning “Cold” Tumors to “Hot” Tumors in Phase 1
MEDI0457: Turning “Cold” Tumors to “Hot” Tumors in Phase 1 CD8+ T Cells in H&N Tumor Phase 1 study of MEDI0457 in 22 HPV+ H&N Cancer Patients Before “Cold” • Increase in CD8+ killer T cell observed in 20 of 22 patients treatment with • One patient developed progressive disease at 11 months MEDI0457
Slide 17: CT and PET Scan of HNSCC Patient with Complete Remission
CT and PET Scan of HNSCC Patient with Complete Remission • Patient with HNSCC, treated with MEDI0457 A (INO-3112) with progressive disease with dermal and lymph node metastases; treatment with nivolumab resulted in radiographic complete response over time. • At 6 weeks post-nivolumab, there was inte
Slide 18: Platform Development Programs
Platform Development Programs 18
Slide 19: Positive Clinical Data & Partnering Opportunities
Positive Clinical Data & Partnering Opportunities Data Reported Next Product Indication (to date) Partner/s Milestone • Phase 1: 93% (71 of 76) evaluable vaccinated participants showed a CD4+ or CD8+ cellular immune Expect results from PENNVAX-GP HIV response to at least one of the vaccine antigens
Slide 20: Highlights & Upcoming Milestones
Highlights & Upcoming Milestones 20
Slide 21: Company Highlights
Company Highlights Collaborations & Partnerships Initiation of the Phase 2 Entered into Entered into Entered into Closed license Signed R&D agreement portion of the SSCHN supply agreement; supply agreement; collaboration agreement; for MERS and Lassa; trial; $7.0 million INO-5401 + cemiplimab INO-54
Slide 22: 2018-2019 Upcoming Milestones
2018-2019 Upcoming Milestones 4Q18: Collaborative partner MedImmune/AstraZeneca to expand Phase 2 study with MD Anderson (trigger milestone to Inovio) 4Q18/1Q19: Complete Zika vaccine Puerto Rico study/publish data 1Q19: Finish REVEAL 1 Enrollment, VGX-3100 Phase 3 study; begin enrollment for
Slide 23: Financials and Management
Click to edit Master title style Financials and Management 23
Slide 24: Financial Information
Financial Information Recent share price 1 $5.06 Shares outstanding 2 94.5 M Market cap 1 $478.2 M Cash & short-term investments 2 $85.5 M Debt 2 0M 1 November 1, 2018 2 September 30, 2018 24
Slide 25: Senior Management
Senior Management J. Joseph Kim, PhD Peter Kies Niranjan Y. Sardesai, PhD Mark L. Bagarazzi, MD Laurent Humeau, PhD President & CEO CFO COO CMO CSO • Decades of • Ernst & Young • Extensive biotech • Clinical research • Extensive R&D leadership biotechnology/pharma • Experience with management and pr
Slide 26: Board of Directors
Board of Directors Avtar Dhillon, MD Simon X. Benito Angel Cabrera, PhD Morton Collins, PhD Chairman, BOD • Former Senior Vice President, • President, George Mason University • General Partner, DSV • Seasoned venture capitalist Merck Vaccine Division Ventures, Battelle Ventures and biotech entrepren
Slide 27: Scientific Advisory Board
Scientific Advisory Board David B. Weiner, PhD Anthony W. Ford-Hutchinson, PhD Stanley A. Plotkin, MD Rafi Ahmed, PhD Chairman • Former SVP, Vaccines R&D, Merck • Developed rubella and rabies vaccines • Professor, Department of • “Father of DNA vaccines” • Oversaw development: Singulair®, • Oversaw
Slide 28: Investment Thesis
Investment Thesis Bringing IMMUNO-INGENUITY to life Powerful T cell-activating Transforming treatment immunotherapy platform, of HPV-associated with multiple cancer and Diseases infectious disease targets INO: NASDAQ Checkpoint inhibitor Validation: Partnerships, combination programs Publishing, Gra
Slide 29: Appendix
Appendix 29
Slide 30: Inovio’s Key Differentiators
Inovio’s Key Differentiators Potent, in vivo generation of • First and only entity to demonstrate clinical efficacy of an enhanced antigen-specific CD8+ killer T cells delivery DNA vaccine • Favorable safety profile – 6,000+ administrations across 1,600+ patients • Zero anti-vector response – allows
Slide 31: A Proven Technology Platform
A Proven Technology Platform SynCon® antigen genetic code enables precise targeting of cancer or pathogen • Designed to break tolerance and cover mutating strains • Versatility to target a broad range of diseases, with multiple antigens that direct a specific and potent immune response to disease ta
Slide 32: Technology Platform – Steps to Activating Potent Immune Responses
Inovio Immunotherapy Technology Platform – Steps to Activating Potent Antigen Specific Immune Responses Inovio immunotherapies induce a patient’s immune system to produce functional antibodies and killer T cells to fight cancer and infectious disease Antigen Y Sequence 1 EMEKIVLLFAIV…SL Sequence 2 A
Slide 33: SynCon plus CELLECTRA Delivery Technology
SynCon® plus CELLECTRA ® Delivery Technology Inovio’s therapeutic immunotherapy induces a patient’s immune system to produce functional antibodies and killer T cells 33
Slide 34: Enhanced Cellular Delivery: Key Enabler of SynCon Immunotherapies
Enhanced Cellular Delivery: Key Enabler of SynCon® Immunotherapies • DNA plasmids must get through protective membrane into a cell to work • DNA plasmids delivered with controlled, milli-second electrical pulses which create reversible pores in cell membrane, allowing significantly greater uptake of
Slide 35: CELLECTRA 5PSP Delivery Device
CELLECTRA® 5PSP Delivery Device 35
Slide 36: Innovation in the Delivery of SynCon Immunotherapy
Innovation in the Delivery of SynCon® Immunotherapy Surface EP (SEP) CELLECTRA®-5PSP CELLECTRA®-3P • Surface • Intra muscular • Intradermal – Minimally invasive • Noninvasive • 4x4 electrode array • 13, 19, 25mm electrodes • 3 mm electrodes • Specifically targets epidermis • In clinical use • In cli
Slide 37: Design + Delivery = Improved Immune Responses
Design + Delivery = Improved Immune Responses T Cell Responses By ELISpot Assay 5000 4000 1 x 10-6 spleenocytes 3000 2000 1000 0 Display of GFP gene expression after CELLECTRA® delivery into rabbit muscle Immunized 3x with 15ug pNP 37 responses @2 wk post Imm
Slide 38: Clinical Confirmation of Inovio’s MOA Response
Clinical Confirmation of Inovio’s MOA Response HIV Antigen Response 90 • CD4 and CD8 intracellular cytokine Four doses with EP staining (IFN-γ, IL-2) response 80 associated with IL-12 and EP administration (2 clinical studies) with HIV gag, pol, env antigens/plasmids 70 • Dosing at 0, 4, 12 weeks 60
Slide 39: Inovio and ApolloBio Transaction: VGX-3100
Inovio and ApolloBio Transaction: VGX-3100 • On December 28, 2017, Inovio entered into an amended and restated Collaboration and License Agreement with ApolloBio Corporation • ApolloBio to receive exclusive rights to VGX-3100 within Greater China (China, Hong King, Macao, Taiwan) • Potential inclusi
Slide 40: First Partnership to Initiate Immuno-Oncology Strategy
First Partnership to Initiate Immuno-Oncology Strategy AstraZeneca/MedImmune (deal signed August 2015) MEDI0457 (previously INO-3112) Products HPV-driven cancer immunotherapy + 2 new R&D products Upfront Payment $27.5 million Development Costs All development costs Milestone Payments $700 million Up
Slide 41: MEDI0457 Drives Antigen Specific CD8+ T Cells with Lytic Phenotype
MEDI0457 Drives Antigen Specific CD8+ T Cells with Lytic Phenotype in Patient with HPV16/18 Head & Neck Cancer Granzyme A Granzyme B Granulysin Perforin • Lytic phenotype: patient PBMCs stimulated 120 hours in vitro with antigen. No co-stimulation; no cytokine added at any time. • Activation markers
Slide 42: Induction of CD8+ Activation, Lytic Protein Synthesis, and Humoral Responses
Induction of CD8+ Activation, Lytic Protein Synthesis, and Humoral Immune Responses to HPV 16 and 18 in MEDI0457 Treated HNSCC Patient MEDI0457 IN O - 3 1 1 2 % C D 8 /C D 3 8 & C D 6 9 & C D 1 3 7 1 .0 0 .8 HPV 16/18 Specific CD8+ T 0 .6 Cell Activation 0 .4 0 .2 0 .0 BBefore e fo re AAfter fte r I
Slide 43: Rationale for Checkpoint Combinations with Inovio Products
Rationale for Checkpoint Combinations with Inovio Products 43
Slide 44: MEDI0457: Turning “Cold” Tumors to “Hot” Tumors in Phase 1
MEDI0457: Turning “Cold” Tumors to “Hot” Tumors in Phase 1 Control: FoxP3 CD8 “Cold” Before treatment with MEDI0457 After treatment with MEDI0457 “Hot” 44
Slide 45: Emerging Infectious Disease Vaccine Opportunities
Emerging Infectious Disease Vaccine Opportunities Rapid response technology platform desired by health authorities to fight emerging infectious diseases • Inovio DNA vaccine platform demonstrates rapid design, manufacturing, and clinical development of products for emerging diseases • Commercializat
Slide 46: Platform Development Programs: Global Health Vaccines
Platform Development Programs: Global Health Vaccines • Concept to 1st patient dosed in ~6 months. • Only vaccine with clinical data – 100% antibody response rates • Current Puerto Rico study is ongoing 46
Slide 47: dMAb Products: Multiple Immune Mechanisms & Products
dMAb™ Products: Multiple Immune Mechanisms & Products Inovio’s DNA-based monoclonal antibody products target: Cancers Infectious Diseases • Checkpoint Inhibitors • Influenza A & B (published) (CI) • Pseudomonas (published) • PD-1 • MRSA/Staph • PD-L1 • Ebola (published) • CTLA4 • MERS • Additional C
Slide 48: Promising Preclinical dMAb Data
Promising Preclinical dMAb Data Cancer dMAb Dengue dMAb Prostate cancer model in mice (Nature Scientific Reports 2015) (Unpublished data) 100% 100% 100% 80% Protection in Challenge 80% with Dengue Virus (%) Tumor Clearance (%) 60% 70% 60% 40% 40% 20% 20% 0% 0% 0% 0% dMAb (7 of 10) Control (0 of 10)
Slide 49: Fully Integrated Capabilities for Immunotherapy R&D and Manufacturing
Inovio: Fully Integrated Capabilities for Immunotherapy R&D and Manufacturing Philadelphia Corporate and San Diego Device Engineering San Diego Research Center Operations Site and Manufacturing Facility • Corporate, Clinical, Regulatory, • Molecular biology, cell biology, and • Electroporation deliv
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