Slides
Page 1
Corporate Presentation H.C. Wainwright 27th Annual Global Investment Conference September 8, 2025 The Pill That Moves The Needle®
Page 2
2 Vaxart Corporate Presentation | Sept 2025 Forward Looking Statement 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 preclinical and clinical trials, commercialization agreements and licenses, beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as “should,” “believe,” “could,” “potential,” “will,” “expected,” “plan” and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart’s ability to develop (including enrolling a sufficient number of participants and manufacturing sufficient quantities of its product candidates) and commercialize its COVID-19 vaccine candidate and preclinical or clinical results and trial data (including plans with respect to the COVID-19 vaccine product candidates); expectations regarding the timing and nature of future announcements including, those related to clinical trials and results of preclinical studies; Vaxart’s expectations with respect to the important advantages it believes its oral vaccine platform can offer over injectable alternatives, particularly for coronaviruses; the potential applicability of results seen in our preclinical trials to those that may be seen in human studies or clinical trials; the expected role of mucosal immunity in blocking transmission of COVID-19; and Vaxart’s expectations with respect to the effectiveness of its products or product candidates, including Vaxart’s potential role in mitigating the impact of COVID-19 globally. Vaxart may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials or preclinical studies, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial and preclinical study data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart’s product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart’s product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart’s or its partners’ control, including the recent outbreak of COVID-19; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain and enforce necessary patent and other intellectual property protection; that Vaxart’s capital resources may be inadequate; Vaxart’s ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the “Risk Factors” sections of Vaxart’s Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.
Page 3
3 Vaxart Corporate Presentation | Sept 2025 o Platform designed to generate both systemic and mucosal immunity o Broad pipeline with programs in norovirus, COVID-19 and influenza • Phase 2 norovirus challenge study demonstrated potential to reduce rates of infection, illness, and shedding • Next-generation norovirus candidate showed statistically significant increases in GI.1 and GII.4 norovirus blocking antibodies in head-to-head (H2H) study • BARDA-funded COVID-19 study to provide platform validating H2H evidence of efficacy and safety vs. FDA approved mRNA vaccine • Influenza program demonstrated potential superiority to market leader using the first-generation constructs o Thermostable oral pill format has potential to revolutionize distribution and administration of vaccines o Manufacturing fully based in the United States EXECUTIVE SUMMARY Pioneering a Transformative Approach with Our Oral Pill Vaccine Platform
Page 4
4 Vaxart Corporate Presentation | Sept 2025 Vaxart Differentiation and Scientific Overview
Page 5
5 Vaxart Corporate Presentation | Sept 2025 Injectable Vaccines Vaxart’s Oral Pill Vaccine Vaxart’s Oral Pill Vaccines Can Revolutionize How the Immune System Responds and the Way Vaccines are Delivered Mechanism of Protective Immunity Safety Administration Distribution Systemic immunity only Injection site reactions Medical professional in clinic or at pharmacy Cold chain requirement makes for access challenges Systemic and mucosal immunity Benign safety & tolerability to date* Self administration at home Thermo stable, hence simplified access and logistics * 1,179 participants dosed-to-date with Vaxart’s oral vaccine, excluding the ongoing COVID-19 study in partnership with BARDA
Page 6
6 Vaxart Corporate Presentation | Sept 2025 HPV Influenza SARS-CoV-2 Vaxart has Developed a Unique Modular Vaccine Platform Which Provides Both a Systemic and Mucosal Response Vaxart’s thermostable rAd5 pill vaccine is taken orally Oral pill dissolves and the vaccine is delivered to the intestine, activating the immune system Vaxart’s oral pill vaccine dissolves in the intestine and elicits an immune response against protein antigen target rAd5 Delivery Vehicle Pathogen Specific Protein Antigen Molecular Adjuvant Norovirus Vaxart’s VAAST® Platform: Vector-Adjuvant-Antigen Standardized Technology
Page 7
7 Vaxart Corporate Presentation | Sept 2025 Induction of Systemic IgG and Mucosal IgA Enables Broader Protection Unlike injectable vaccines that only induce systemic IgG, Vaxart’s platform generates both mucosal and systemic responses—offering greater cross-reactivity and potential for high variant coverage Injectable mRNA vaccines induce predominantly systemic IgG response 1.Ejemel, et al, Nature, 2020 2.Muramatsu, et al, PLOS, 2014. • Binding affinity is significantly reduced when challenged with variants • Poor cross-reactivity with respect to known variants1,2 Vaxart’s oral pill vaccines induce systemic IgG response + mucosal IgA response • IgA response efficiently produced through VAAST platform • IgA antibodies show minimal decrease in binding affinity when challenged with variants • IgA antibodies show greater cross-reactivity
Page 8
8 Vaxart Corporate Presentation | Sept 2025 Clinical Pipeline
Page 9
9 Vaxart Corporate Presentation | Sept 2025 PRECLINICAL PHASE 1 PHASE 2 E N T E R I C V A C C I N E S Norovirus Bivalent (First-Generation) Bivalent (Next-Generation) R E S P I R A T O R Y V A C C I N E S COVID-19 S Protein Influenza Monovalent (H1) Seasonal (Trivalent) Pandemic (H5), Clade 2.1 Pandemic (H5), Clade 2.3.4.4b T H E R A P E U T I C V A C C I N E S HPV HPV, cervical dysplasia and/or cancer Multiple Promising Clinical-Stage Programs Based on our proprietary platform technology
Page 10
10 Vaxart Corporate Presentation | Sept 2025 Next Generation Vaccine Builds on Compelling Data In Challenge Model with Enhanced Efficacy Potential 1. Norovirus 2. COVID-19 3. Influenza Highlights: • Norovirus responsible for up to $10bn+ annual U.S. economic burden1 • First in class potential – no approved vaccines available • Potential to reduce rates of norovirus infection, illness, and shedding demonstrated in Phase 2 challenge study of our first-generation vaccine candidate • Bivalent vaccine provides protection against dominant GI.1 and GII.4 norovirus strains • Potential for improved protection against norovirus infection with our next-generation vaccine candidate 1 2 3 1.Bartsch, et. al., JID, 2020.
Page 11
11 Vaxart Corporate Presentation | Sept 2025 Norovirus a Leading Cause of Acute Gastroenteritis (AGE) Worldwide1 At least 1 episode by age 5 3 – 8 episodes of norovirus Individual Life-Time Risk1 Disease Burden1 Worldwide (per year) US (per year) Infections 685 M 20 M Deaths and Hospitalizations 220K Deaths (50K among children) 900 Deaths (mostly older adults) 100K Hospitalizations Economic Costs $62 BN $10 BN Norovirus AGE causes significant morbidity and mortality in countries of all income levels, particularly among young children and older adults1 1. Carlson, et. al., npj Vaccines, 2024
Page 12
12 Vaxart Corporate Presentation | Sept 2025 Norovirus GI.1 Challenge Study1 Demonstrated Protection Against Infection and a Reduction in Viral Shedding Vaxart‘s candidate met 5 of 6 primary endpoints including on infection. Norovirus is rapidly spread, and several important secondary and exploratory endpoints were met showing that the vaccine candidate provided a possible reduction in transmission potential INFECTION SECONDARY 58% 82% 0% 20% 40% 60% 80% 100% Vaccine N=71 Placebo N=65 30% relative reduction, p=0.003 45% 57% 0% 20% 40% 60% 80% 100% 21% relative reduction, p=0.149 NOROVIRUS AGE CORRELATES Functional antibodies (NBAA) and fecal IgA identified as clear correlates of protection using machine learning. 1.Flitter, et. al., STM, 2025 Vaccine N=71 Placebo N=65 KEY PRIMARY ENDPOINYS Potential reduction in transmission potential with observed reductions in: • Virus in stool • Emesis incidence • Virus in emesis NEXT STEPS: These correlates are being used to guide next-generation vaccine candidate development
Page 13
13 Vaxart Corporate Presentation | Sept 2025 Enhanced Antigen Expression and Improved Immune Responses With Our Next-Generation Norovirus Vaccine NVV-109 study was designed to evaluate whether the new optimized next-generation vaccine candidate generated stronger immune responses in humans compared to the first generation • Open label, 3-arm study, enrolled sequentially • Immunological endpoints1 – Serum NBAA2 titers (Primary) – Fecal IgA against VP1 (Exploratory) • The trial design was not powered to determine statistical significance – NBAA results to inform the selection of the better vaccine candidate and dose based on trends – Fecal IgA to confirm improved mucosal responses Treatment Arm Study Drug Dose (±0.5 log)4 No. of Participants Arm 1 Bivalent3 Next Generation 1x1010 I.U. 20 Arm 2 Bivalent First Generation 1x1011 I.U. 20 Arm 3 Bivalent Next Generation 1x1011 I.U. 20 1 Both endpoints correlated with protection from norovirus infection in a completed Phase 2 challenge study 2 NBAA = Norovirus Blocking Antibody Assay. 3 Stimulating an immune response against two different norovirus strains – GI.1 and GII.4 4 For each strain in the bivalent vaccine candidate
Page 14
14 Vaxart Corporate Presentation | Sept 2025 Significant improvement in geometric fold rise of NBAA in both GI.1 and GII.4 following next-generation high-dose vaccine at the same dose level as the first-generation vaccine GMFR = Geometric mean fold rise One-way ANOVA, Tukey post-test Significant Increases In GI.1 (141%) and GII.4 (94%) Neutralizing Antibodies With Our Next-Generation Norovirus Vaccine Candidate 0 1 2 3 4 5 6 7 8 9 10 Next Gen Low Dose First Gen High Dose Next Gen High Dose +141% GI.1 NBAA GMFR 95% CI GI.1 ns P<0.05 5.10 5.37 2.23 0 1 2 3 4 5 6 7 8 9 10 Next Gen Low Dose First Gen High Dose Next Gen High Dose +94% GII.4 NBAA GMFR 95% CI GII.4 ns P<0.05 3.54 3.73 1.92 N=20 N=19 N=20 N=20 N=19 N=20
Page 15
15 Vaxart Corporate Presentation | Sept 2025 Start of Phase 2b and 3 contingent on partnership or other funding Development timelines contingent on partnership or other funding. Vaxart expects to conduct a Phase 2b safety and immunogenicity study that could potentially begin as early as the second half of 2025 followed by an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA). A Phase 3 trial could then begin as early as 2026. Next-Generation Norovirus Vaccine to Progress to Phase 2b for Additional Insights into Safety and Immunogenicity 2025 2026 Phase 1 head-to-head study first generation vs. next-generation Phase 2b ~600 subjects Phase 2b ~600 subjects Safety and immunogenicity study End of Phase2 Phase 3 10-25,000 subjects Phase 3 10-25,000 subjects Efficacy study
Page 16
16 Vaxart Corporate Presentation | Sept 2025 Conducting a Head-to-Head Study against Approved mRNA Injectable Currently ~5,000 Subjects Enrolled 1. Norovirus 2. COVID-19 3. Influenza Highlights: • Conducting BARDA funded Phase 2b clinical trial • Up to 10,000 subjects • Enrollment at ~5,000 subjects currently due to U.S. Government Stop Work Order • Study will establish safety and tolerability in this indication, and potentially support the safety profile for the platform • Study uses our next-generation vaccine construct • 12-months relative efficacy endpoint expected to read out in H2 2026 1 2 3
Page 17
17 Vaxart Corporate Presentation | Sept 2025 Head-to-Head Study of Vaxart’s Oral Pill vs. mRNA Injectable 2024 2026 Phase 2b - 400 participant sentinel cohort 200 Vaxart XBB oral vaccine, 200 XBB mRNA Phase 2b - up to 10,000 participant main cohort up to 5,000 Vaxart KP .2 oral vaccine, up to 5,000 KP .2 mRNA 2025 12-mo Observation Period 12-mo Observation Period Contract awarded 12-mo data readout • Phase 2b trial evaluating our oral pill COVID-19 vaccine candidate against an mRNA vaccine comparator approved by the U.S. FDA (enrollment at ~5000 subjects currently due to U.S. Government Stop Work Order ) • Primary endpoint is relative efficacy of the two vaccines for 12 months post vaccination, while the trial will also measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and adverse events • Vaxart received a BARDA Project NextGen award of up to $460.7M to fund this trial 12-mo data readout ~5,000 enrolled, Stop Work Order in place
Page 18
18 Vaxart Corporate Presentation | Sept 2025 Promising Phase 2 Data Comparing Vaxart’s Oral Pill Influenza Vaccine to an Approved Injectable Vaccine 1. Norovirus 2. COVID-19 3. Influenza Highlights: • Demonstrated to be at least as protective as an approved market-leading injectable vaccine in a Phase 2 challenge trial • Differentiated mechanism of action: protection from both mucosal and serum antibodies • Reduced shedding may reduce disease transmission • Favorable safety data • H5N1 program demonstrated strong survival benefit in animal model 1 2 3
Page 19
19 Vaxart Corporate Presentation | Sept 2025 Head-to-Head Challenge Study Shows At Least Comparable Protection for Vaxart’s Oral Vaccine vs. Injected Vaccine 36% 44% 71% 0% 10% 20% 30% 40% 50% 60% 70% 80% Vaxart Tablet Vaccine Fluzone Placebo p = 0.001 p = 0.009 Influenza Infection rates Human Influenza Challenge Study Design • A single dose administration of one of the following: o VXA-A1.1 oral vaccine + placebo IM injection (n=60) o QIV (Fluzone) injection + oral placebo pill (n=60) o Placebo IM injection + oral placebo pill (n=30) • Influenza challenge after 90-120 days o A wild-type influenza A/Ca/2009/pH1N1 strain • Primary endpoint o Number and % of participants protected against infection and illness following influenza challenge Vaxart’s first-generation oral vaccine candidate protected as well as market leading injected vaccine against influenza infection* and had an 80% probability of improved protection * Infection defined as detectable viral shedding on any day after the first 36 hours from challenge. Flitter, et. al., Vaccines, 2022. - 49% - 38%
Page 20
20 Vaxart Corporate Presentation | Sept 2025 H5N1 Challenge Study | LS17 Vaccinated Ferrets had 100% Survival and Reduced Viral Load Avian flu challenge in animals vaccinated with old H5 (ND1.1) vs. new H5 (LS17) vaccines • Two-dose (D0, D28) oral endoscopic administration of one of the following: o ND1.1 vaccine (n=8) o LS17 vaccine (n=8) o Placebo (n=8) • Intranasal H5N1 challenge at D56 o challenged with 1 x 105 TCID50 of Clade 2.3.4.4b HPAI, Genotype B (A/dairy cow/Texas/24-008749-002-v/2024) • 100% survival in LS17-immunized ferrets vs. 0% survival for ferrets on placebo • >2-log reduction in nasal wash viral load in LS17-immunized ferrets by Day 3 *Preliminary results % survival
Page 21
21 Vaxart Corporate Presentation | Sept 2025 Upcoming Milestones and Cash Runway
Page 22
22 Vaxart Corporate Presentation | Sept 2025 Multiple Value Creating Milestones and Cash Runway into 1Q 2026 Norovirus Vaccine • Phase 2b safety and immunogenicity study could potentially begin as early as the second half of 2025 COVID-19 Vaccine • Conducting head-to-head study, enrollment to be completed in 3Q/4Q 2025 and 12-month data in late 2026 • Continuing to monitor the 400 participants for up to 12 months post-vaccination to assess safety, immunogenicity, and efficacy for the sentinel cohort, with data anticipated in 1Q2026 Influenza Vaccine • Continuing development of our seasonal and avian influenza programs Complete Enrollment 400 Subject Data 1 Year Data 2025 20272026 Ph2b Start* FDA EoPh2* Ph3 Start* COVID NORO * Timing of next steps in norovirus clinical development contingent on partnership or other funding
Page 23
23 Vaxart Corporate Presentation | Sept 2025 Leadership Has Deep Experience in Vaccines and Biopharma Jeroen Grasman Chief Financial Officer Steven Lo Chief Executive Officer Sean Tucker, Ph.D. Chief Scientific Officer Published in: James Cummings, M.D. Chief Medical Officer Ray Stapleton, Ph.D. Chief Technology Officer Edward Berg SVP, General Counsel Laurie Hastings SVP, Human Resources Founder
Page 24
24 Vaxart Corporate Presentation | Sept 2025 o Platform designed to generate both systemic and mucosal immunity o Broad pipeline with programs in norovirus, COVID-19 and influenza • Phase 2 norovirus challenge study demonstrated potential to reduce rates of infection, illness, and shedding • Next-generation norovirus candidate showed statistically significant increases in GI.1 and GII.4 norovirus blocking antibodies in head-to-head (H2H) study • BARDA-funded COVID-19 study to provide platform validating H2H evidence of efficacy and safety vs. FDA approved mRNA vaccine • Influenza program demonstrated potential superiority to market leader using the first-generation constructs o Thermostable oral pill format has potential to revolutionize distribution and administration of vaccines o Manufacturing fully based in the United States EXECUTIVE SUMMARY Pioneering a Transformative Approach with Our Oral Pill Vaccine Platform
Page 25
25 Vaxart Corporate Presentation | Sept 2025 vaxart.com