Vaxart, Inc. · OTC:VXRT
Vaxart — Investor Presentation (August 2024)
33 slides from Vaxart's investor presentation, August 2024
Slide 1: Investor Presentation August 2024
INVESTOR PRESENTATION August 2024
Slide 2: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart’s strategy, prospects, plans and objectives, results from prec
Slide 3: Executive Summary
EXECUTIVE SUMMARY o Oral tablet vaccine platform designed to provide improved convenience as well as generate substantial systemic and mucosal immunity o Clinical proof-of-concept demonstrated in two challenge studies against both respiratory and GI viruses o Three pipeline programs in norovirus, in
Slide 4: Vaxart Has Multiple Promising Clinical-Stage Programs
Vaxart Has Multiple Promising Clinical-Stage Programs Preclinical Phase 1 Phase 2 E N T E R I C V A C C I N E S Norovirus Bivalent R E S P I R AT O R Y V A C C I N E S S Protein (Wuhan) COVID-19 S + N Protein (Wuhan) S Protein (XBB)1 Monovalent Influenza Seasonal (Trivalent) Universal T H E R A P E
Slide 5: Oral Vaccine Candidates Could Address Shortcomings of Injectable Vaccines
Vaxart’s Oral Vaccine Candidates Have the Potential to Address Many of the Shortcomings of Injectable Vaccines Cross-reactivity & Broad Long Duration of Protection and Immune Responses Immune Responses • Broad immune responses in • Long-lasting protection demonstrated preclinical & clinical COVID-19
Slide 6: Vaxart's Proprietary VAAST Platform is Unique
Vaxart’s Proprietary VAAST® Platform is Unique Proprietary Oral Vaccine Platform: VAAST Room-temperature (25⁰C) stable enteric- coated tablets VAAST: Vector-Adjuvant-Antigen Standardized Technology August 2024 6
Slide 7: VAAST Utilizes Mucosal Immunity to Generate IgA in Addition to IgG
VAAST Platform Utilizes Mucosal Immunity to Generate IgA in Addition to IgG to Potentially Block Infection and Transmission August 2024 7
Slide 8: IgA Mucosal Responses Have Greater Cross-Reactivity Than IgG
Vaxart Has Shown IgA Mucosal Responses Have Greater Cross-Reactivity Compared to IgG Systemic Responses ANTIBODY CROSS-REACTIVITY: IgG VS. IgA IgG IgA Characteristics: Characteristics: • Major antibody isotype induced systemically • Predominantly present in the mucosal tissues • Major isotype produc
Slide 9: Norovirus Program: Multi-Billion Dollar Opportunity, No Vaccine Approved
Norovirus Program Has Generated Compelling Data for a Multi-Billion Dollar Opportunity, No Vaccine Approved Highlights: 1. 1 Norovirus • $10bn+ annual U.S. economic burden • Norovirus human phase 2 challenge study 2 results indicate potential of our vaccine 2. Influenza candidate to reduce rates of
Slide 10: Norovirus has a $10 Billion+ Annual Economic Burden in the U.S.
Norovirus has a $10 Billion+ Annual Economic Burden in the U.S. Economic Burden $10.6 billion $60.3 billion Norovirus Annual Burden in the U.S. U.S. economic burden annually1 Global economic burden annually2 Risk Groups 19-21 Million Elderly 5x Total Norovirus Illnesses Adults ≥65 years old are at h
Slide 11: Norovirus Clinical Program Demonstrated Immunogenicity, Efficacy, and Safety
Norovirus Clinical Program Has Demonstrated Robust Immunogenicity, Promising Efficacy, and Benign Safety/Tolerability Profile Trial ID Phase N Vaccine Top line data Completed Phase 1 Placebo NVV-101 60 • Safety/dose escalation (GI.1) ✓ double blinded GI.1 Phase 1 60 • Safety/dose ranging and effecti
Slide 12: NVV-201 Study: Norovirus Challenge Study
NVV-201 Study: Norovirus Challenge Study • Phase 2 double-blinded placebo controlled study o GI.1 vaccine candidate or placebo, given to healthy participants o Given norovirus infection 29+ days after vaccination o Determine infection and rate of acute gastroenteritis (AGE) in placebo and vaccinated
Slide 13: Norovirus Challenge Study: Topline Safety
Norovirus Challenge Study: Topline Safety • No vaccine-related Serious Adverse Events (SAEs) • No vaccine-related solicited Grade-3 Adverse Events (AEs) • Benign safety and tolerability data profile consistent with safety of the platform in previous studies August 2024 13
Slide 14: Norovirus Challenge Study: Protection Against Infection and Illness
Norovirus Challenge Study: Protection Against Infection and Illness Full analysis (N=141) Norovirus Infection Norovirus AGE 29% relative reduction 21% relative reduction 82% 58% 57% 45% Vaccine Placebo Vaccine Placebo (n=76) (n=65) (n=76) (n=65) p = 0.003 p = 0.149 August 2024 14
Slide 15: Norovirus Challenge Study: 85% Reduction in Viral Shedding
Norovirus Challenge Study: 85% Reduction in Viral Shedding Viral Shedding Running AUC Full Analysis Set - Stool Samples Full Analysis Set - Stool Samples 60000 200000 Geomean Noro (GCx103/g) Placebo Area Under the Curve Total AUC-Placebo Vaccine 150000 Total AUC-Vaccine 40000 85% reduction 100000 in
Slide 16: Norovirus Data Appears Favorable Despite More Aggressive Challenge
Vaxart’s Norovirus Data Appears Favorable Despite More Aggressive Challenge Vaxart Oral Tablet Injectable Vaccine1 GI.1 Challenge GII.4 Challenge Application Oral tablet Intramuscular injection Doses 1 2 Placebo Attack Rates • Norovirus infection 82% 63% • Noro-AGE 57% 33% Vaccine Protection • Reduc
Slide 17: Reasons to Expect More Significant Real-World Protection
Reasons to Expect More Significant Real-World Protection From Our Norovirus Bivalent Vaccine Candidate Real-world efficacy is 50-100% more than that seen in several challenge studies Challenge studies expose participants to an artificially high Flu Fluzone 27% 49-66% amount of virus – many orders of
Slide 18: Additional FDA Feedback Will Clarify Next Steps For Norovirus
Additional FDA Feedback Will Clarify Next Steps For the Norovirus Program Adults and Elderly FDA feedback1 End of Phase 2 meeting Further analysis (including identifying Phase 2b Phase 3 potential correlates) G2.4 Challenge study Infants and Mothers Phase 1 trial ongoing Potential transmission (top-
Slide 19: Influenza Program Has Shown Promising Phase 2 Data
Vaxart’s Influenza Program Has Shown Promising Phase 2 Data Compared to an Approved Injectable Vaccine Highlights: 1. 1 Norovirus • Demonstrated to be at least as protective as an approved injectable vaccine in a phase 2 challenge trial 2. 2 Influenza • Very different mechanism of action: mucosal ra
Slide 20: Human Influenza Challenge Design
Human Influenza Challenge Design • A single dose administration of one of the following: o Arm 1: VXA-A1.1 oral vaccine + placebo IM injection (n=60+extra) o Arm 2: QIV (Fluzone) injection + oral placebo tablet (n=60+extra) o Arm 3: Placebo IM injection + oral placebo tablet (n=30+extra) • Participa
Slide 21: Oral Influenza Vaccine Candidate Reduced Shedding
Vaxart’s Oral Influenza Vaccine Candidate Reduced Shedding (Infection Rate) VAXART ORAL TABLET vs. FLUZONE Oral vaccine candidate protected Reduced Infection Rates Compared to Placebo against influenza infection as well as market leading injected vaccine after 80% influenza challenge. 80% chance of
Slide 22: COVID-19 Data and Preparing to Initiate Phase 2b Trial
Vaxart Has Demonstrated Exciting Clinical COVID-19 Data and is Preparing to Initiate a Phase P2b Trial Testing its Vaccine Candidate H2H Against mRNA Highlights: • BARDA funding to prepare and conduct a 1. 1 Norovirus 10,000 participant Phase 2b clinical trial • Vaccine constructs tested to date tri
Slide 23: Approach to COVID Vaccines Could Provide Multi-strain Coverage
Vaxart’s Approach to COVID Vaccines Could Provide Multi-strain Coverage in a Rapidly-distributed Tablet Rapid Emergence of New Vaxart Alternative COVID Approach SARS-CoV-2 Strains ▪ Tablets rather than injections ▪ Cross-reactive mucosal immune responses ▪ Reduce community transmission IgA Distribut
Slide 24: BARDA Supporting Next Generation COVID-19 Vaccines with Project NextGen
BARDA is Supporting the Development of Next Generation COVID-19 Vaccines with Project NextGen, a $5B Initiative Project NextGen Areas of Focus • Project NextGen is focused on developing innovative vaccines and therapeutics providing broader and more durable protection for COVID-19 • Vaxart’s COVID-1
Slide 25: BARDA Project NextGen Awards Cover Preparation and Execution of P2b
Vaxart’s BARDA Project NextGen Awards Covers the Preparation and Execution of the P2b Study • In Jan 2024, Vaxart received a BARDA Project NextGen award of $9.27M to prepare for a 10,000 participant Phase 2b clinical trial evaluating our XBB COVID-19 vaccine candidate • In Jun 2024, Vaxart received
Slide 26: 10,000 Participant COVID-19 P2b Trial Design
10,000 Participant COVID-19 P2b Trial Design1 • Double-blind, multi-center, randomized, comparator-controlled study Phase 2b trial comparing our oral tablet COVID-19 vaccine candidate (S protein expressing, XBB strain) to an FDA approved mRNA vaccine head-to-head o Enroll 10,000 healthy adults 18 ye
Slide 27: Vaxart Has Generated Promising COVID-19 Clinical Data
Vaxart Has Generated Promising COVID-19 Clinical Data VAXART’S TECHNOLOGY ALLOWS IT TO PRODUCE CROSS-PROTECTIVE VACCINES Trial Data Observed to Date: VXA-CoV2-1 (Expresses S + N): Completed Phase 1 • Highly immunogenic on eliciting T cells, to both S and N • T-cell responses to the S appear much hig
Slide 28: VXA-CoV2-1 Shown Cross-reactive Nasal IgA Response
In a Phase 1 Trial, Vaxart’s COVID-19 Vaccine Candidate VXA-CoV2-1 Has Shown Cross-reactive Nasal IgA Response to all Coronaviruses Tested • 46% of participants that had increased IgA antibodies to SARS-CoV-2 S also had VXA-CoV2-1 (Expresses S + N) increased antibody responses to the S IgA Cross-Rea
Slide 29: VXA-CoV2-1.1-S Increased Seroprotection Against Omicron 4/5
Vaxart’s COVID-19 Oral Vaccine Candidate VXA-CoV2-1.1-S Increased Seroprotection1 Against Omicron 4/5 Omicron d1 Omicron d1 Omicron d1 Omicron d57 Omicron d57 Omicron d57 Gained omicron seroprotection Previously seroprotected (>68%) Previously seroprotected (>68%) n seroprotection Previously seropro
Slide 30: Corporate Update
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Slide 31: Cash Runway Into 2026, Funding Key Clinical and Regulatory Milestones
Estimate Current Cash Runway Into 2026, Funding Through Multiple Key Clinical and Regulatory Milestones Norovirus Vaccine • Additional FDA feedback regarding correlates of protection • New constructs (if pursuing)1: Potential Phase 1 study COVID-19 Vaccine (XBB) • Initiate 10,000 participant head-to
Slide 32: Executive Summary
EXECUTIVE SUMMARY o Oral tablet vaccine platform designed to provide improved convenience as well as generate substantial systemic and mucosal immunity o Clinical proof-of-concept demonstrated in two challenge studies against both respiratory and GI viruses o Three pipeline programs in norovirus, in
Slide 33: vaxart.com
vaxart.com 33