Inovio Pharmaceuticals, Inc. · NASDAQ:INO
Inovio Pharmaceuticals — Q3 2023 Earnings Presentation
28 slides from Inovio Pharmaceuticals's earnings presentation, Nov 9, 2023
Slide 1: Third Quarter 2023 Financial Results
Third Quarter 2023 Financial Results November 9, 2023 :INO 1
Slide 2: Third Quarter 2023 Financial Results & Clinical Updates
Third Quarter 2023 Financial Results & Clinical Updates Welcome, Third Quarter Highlights & Pipeline Review • Jacqueline Shea, PhD., President and CEO Regulatory & Medical Affairs Update • Michael Sumner, MBBS, MBA, Chief Medical Officer Commercial Update • Mark Twyman, MBA, Chief Commercial Officer
Slide 3: Forward-Looking Statements
Forward-Looking Statements This presentation includes statements that are, or may be deemed, “forward-looking statements,”” within the meaning of Section 27A of the Securities Act of 1933, as amended. All statements, other than statements of historical facts, included in this presentation regarding
Slide 4: Welcome & Third Quarter Overview
Welcome & Third Quarter Overview 4
Slide 5: Welcome & Third Quarter Overview
Welcome & Third Quarter Overview 5
Slide 6: Significant progress with INO-3107 for RRP
Significant progress with INO-3107 for RRP • Breakthrough Therapy Designation granted 3Q23 • Potential to submit BLA under Accelerated Approval Program ◦ FDA feedback indicated data from completed Phase 1/2 trial could be used to support submission ◦ No requirement to complete a Phase 3 trial prior
Slide 7: Accelerating Commercial Strategy
Accelerating Commercial Strategy • Experienced commercial team ◦ Prior experience bringing products to market, including for rare diseases • Critical pathways for commercial success ◦ Building value proposition d ◦ Optimizing distribution model ◦ Developing payor, specialty pharmacy, PBM strategies
Slide 8: Regulatory & Medical Affairs Update
Regulatory & Medical Affairs Update 8
Slide 9: INO-3107: Development Timeline
INO-3107: Development Timeline • Positive Ph 1/2 trial results – both cohorts • Orphan designation – EU • Orphan designation – US • Positive Ph 1/2 trial • Breakthrough Therapy designation • First patient dosed in Ph 1/2 trial results - 1st cohort • Pursuing BLA under Accelerated Approval Program 20
Slide 10: Accelerated Approval Program: INO-3107 Qualifications
Accelerated Approval Program: INO-3107 Qualifications • Addresses a serious or life-threatening condition - RRP ◦ Debilitating and rare disease caused by HPV-6 and/or HPV-11 ◦ Characterized by small, wart-like growths (papillomas) in upper respiratory tract d ◦ Can cause life-threatening airway obst
Slide 11: INO-3107: Phase 1/2 Trial Results
INO-3107: Phase 1/2 Trial Results • Trial results show meaningful advantage over other available therapies • 81.3% patients experienced reduction in surgery • 9 patients with no surgeries in 12 months after treatment • Induced antigen-specific cellular responses against HPV-6/11 d • Both CD4+ and CD
Slide 12: Fold Induction of INO-3107 Specific Immune Response
Immune Response – Patient in Phase 1/2 Trial Prior to INO-3107 CD8+ Killer T Cells GrzA+GrzB+Prf+ 10 9.2 8 INO-3107 Specific Fold Induction of 7.5 Killer T Cells 6 4.2 4 2 One Year Following INO-3107 1.4 0 Activation Marker: CD38+ CD69+ Ki67+ CD38+ CD69+ Ki67+ (Vocal cord images. RRP is a highly ind
Slide 13: Regulatory Objectives
Regulatory Objectives • Type B Meeting requested 4Q2023 • Utilize BTD status to quickly resolve outstanding questions • Plan to utilize other FDA acceleration mechanisms: ◦ Rolling Review – Submit completed sections of BLA for review over 3- d month window ◦ Priority Review – Action on application w
Slide 14: Cross-Functional Approach: Optimize Potential for Success
Cross-Functional Approach: Optimize Potential for Success • Experienced leaders spanning from research through commercial ◦ Preclinical ◦ Clinical & Immunology ◦ Medical Affairs and Regulatory d ◦ CMC/Pharmacovigilance/Quality/Device • Building foundational medical strategy for potential launch of I
Slide 15: Commercial Update
Commercial Update 15
Slide 16: 5 Key Areas for Orphan Drug Launches
5 Key Areas for Orphan Drug Launches Create a long-term commercial strategy Demonstrate value to stakeholders Ensure patient advocacy Take active role in disease education Get supply chain up to speed early 16 Source: BCG Analysis
Slide 17: Commercial Plans for INO-3107
Commercial Plans for INO-3107 • Engaging external partners and service providers • Implementing plans for: ◦ Product distribution and logistics ◦ Payor engagement and reimbursement ◦ Specialty pharmacy identification d ◦ Patient and provider awareness and education ◦ Customer service programs ◦ Othe
Slide 18: Snapshot: About RRP
Snapshot: About RRP • Rare disease caused by HPV-6/11, impacting both children and adults • Standard of care: repeated surgeries • Annual U.S. prevalence/incidence: ◦ ~14K active cases ◦ ~1.8 per 100,000 new cases in adults • Average 4 surgeries per year Image Source: National Institute on Deafness
Slide 19: Laryngologists: Primary healthcare providers for RRP
Laryngologists: Primary healthcare providers for RRP • 300-400 laryngologists in U.S. conduct majority of RRP surgeries • ~One-half of all laryngologists practice in academic institutions • Comfortable administering drugs, utilizing new tools and devices 19
Slide 20: Pipeline Update
Pipeline Update 20
Slide 21: Key Features of INO-3107
Key Features of INO-3107 Induces antigen-specific T cell responses No anti-vector response; against HPV 6 &11 ability to readminister and boost Response in patients across spectrum of No frozen storage or disease severity shipping required Well-tolerated, favorable safety profile Packaged in a singl
Slide 22: Value Creation: A 3-Step Process
Value Creation: A 3-Step Process Potential to unlock the promise of DNA Medicines Lead Program Diversified Clinical Pipeline NextGen DNA Medicines INO-3107 • Potential treatment for RRP • 8 additional clinical-stage • dMAbs: targeting infectious • FDA Breakthrough Therapy candidates disease Designat
Slide 23: INOVIO Pipeline
INOVIO Pipeline PRECLINICAL PHASE 1 PHASE 2 PHASE 3 REGISTRATION dMAb INO-5401 VGX-3100 INO-3107* Influenza BRCA1/2 Mutation Anal Dysplasia RRP dLNPs INO-4201 INO-3112 Various targets Ebola Booster Head & Neck Cancer INO-6172 INO-5401 HIV Glioblastoma INO-6160 HIV dMAbs COVID-19 OUT-LICENSED* PRECLI
Slide 24: Financial Update
Financial Update 24
Slide 25: Commitment to Financial Discipline Key to Strategy
Commitment to Financial Discipline Key to Strategy Total Operating Expense Financial Strengths Third Quarter Nine Months 2022 vs. 2023 2022 vs. 2023 • $167.5M in cash, $44.9M $221.8M cash equivalents, short-term -20% investments as of 09/30/23 $35.9M -47% • Cash runway into second quarter 2025 $117.
Slide 26: Q&A
Q&A 26
Slide 27: INOVIO: Drivers for Success
INOVIO: Drivers for Success Diversified Pipeline Unique Technology Power of Partnerships Experienced Leadership Advancing candidates Growing body of History of collaboration Extensive experience with scientific and research and late- in industry, academia bringing products to clinical promise, stage
Slide 28: Thank you
Thank you 28
Inovio Pharmaceuticals — Q3 2023 Earnings Presentation on 6ix