Slide 1: First Quarter 2024 Financial Results
First Quarter 2024 Financial Results May 13, 2024 :INO 1
Slide 2: 1st Quarter 2024 Financial Results & Recent Business Highlights
1st Quarter 2024 Financial Results & Recent Business Highlights Welcome and Overview • 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 Financial Update • Pete
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 & Overview
Welcome & Overview 4
Slide 5: Key Objectives for 2024
Key Objectives for 2024 • Initiate confirmatory trial – Believe we’re aligned with FDA on trial design and moving forward; Prepare for focused on delivering key competitive advantages in U.S. & ROW Commercialization • File BLA 2H24 – Anticipate requesting rolling submission & priority review of INO-
Slide 6: Regulatory & Medical Affairs Update
Regulatory & Medical Affairs Update 6
Slide 7: Recent Highlights for Lead Candidate INO-3107
Recent Highlights for Lead Candidate INO-3107 Potential Treatment for Recurrent Respiratory Papillomatosis (RRP) • BLA submission on track for 2H24 under accelerated approval program • Moving forward with proposed design of confirmatory trial based on FDA feedback ◦ Randomized, placebo-controlled, ~
Slide 8: Iatrogenic injury risk with repeated RRP surgeries
We stress, however, that even among patients who have had less than 5 surgeries…44% of these patients still incurred permanent iatrogenic injury…the cumulative risk for injury increases with every surgery, but ultimately it only takes 1 surgical misadventure to permanently damage the larynx.” - Fact
Slide 9: INO-3107: Addresses Key Aspects of RRP
INO-3107: Addresses Key Aspects of RRP RRP INO-3107 Rare disease characterized by papillomas in Generates cytotoxic CD8 T cells targeting both respiratory tract caused by HPV-6 and HPV-11 HPV-6 and HPV-11 • Teaches immune system to mount effective response Inability of patient’s immune system to pre
Slide 10: INO-3107: In Phase 1/2 trial 81.3% of participants had a decrease in surgeries
INO-3107: In Phase 1/2 trial 81.3% of participants had a decrease in surgeries Median decrease of 3 surgeries 10 Patients had a median range of 4 surgeries (2-8) in the year prior to dosing.
Slide 11: Future Development Plans for INO-3107
Future Development Plans for INO-3107 • Strength of DNA medicine technology Redosing • Investigating redosing strategies to optimize patient benefit – focus on maintaining and enhancing efficacy; planning to submit Phase 2 redosing trial to FDA in 3Q24 • Conversations with regulators in European Uni
Slide 12: INO-3112: Recent Progress
INO-3112: Recent Progress • Announced clinical collaboration and supply agreement with Coherus Biosciences – 1Q24 ◦ Investigate INO-3112 as potential treatment for HPV-related locoregionally advanced, high risk, HPV-16/HPV-18 positive, throat cancer when used in combination with LOQTORZITM ◦ LOQTORZ
Slide 13: 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** PRECL
Slide 14: Commercial Update
Commercial Update 14
Slide 15: Significant Unmet Need for RRP Patients
Significant Unmet Need for RRP Patients “It rules my life, and it has “I don’t know how to since I was young. I’ve manage it…you know, missed a lot of life events surgery every 3-4 months, because for many years I and it takes me longer now was travelling to get to the after 350 surgeries to get a r
Slide 16: Building Blocks for Successful Commercial Launch
Building Blocks for Successful Commercial Launch Market Access Distribution Physician Marketing • Payer market • 3PL partner Engagement • Ad agency research • Specialty distribution • Field Sales selection • CPT codes & specialty pharmacy Strategy • Brand name partners • MSLs/Trainers Identify key s
Slide 17: Desmoid Tumor Analog Demonstrates Need for Therapeutic Options
Desmoid Tumor Analog Demonstrates Need for Therapeutic Options for Recurring, Non-Cancerous Growths Impacting QoL INO-3107 Nirogacestat Target Indication • RRP: papilloma in respiratory • Desmoid tumors: non- tract cancerous growths in • Rarely malignant/fatal; can connective tissue progress to lung
Slide 18: Financial Update
Financial Update 18
Slide 19: Ongoing Commitment to Financial Discipline
Ongoing Commitment to Financial Discipline March 31, March 31, 2024 2023 % • Strengthened balance sheet in (unaudited) (unaudited) Change 2Q24 Revenue - $0.1 - - Common stock offering with Operating expense $31.5 $44.1 (29%) prefunded warrants Net loss ($30.5) ($40.6) (25%) - Net proceeds ~$33.2M Ne
Slide 20: Q&A
Q&A 20
Slide 21: 2024 Key Catalysts
2024 Key Catalysts ✓ Finalize trial design for INO-3112 in throat • INO-3107: cancer - Initiate confirmatory trial • Determine next steps for INO-5401 in GBM - Submit BLA • Finalize plans for INO-4201 Ebola booster - Publish immunology data based on FDA feedback, discuss with • First clinical data f
Slide 22: Thank you.
Thank you. 22