Slides
Page 1
T h e C i t i z e n s L i f e S c i e n c e s C o n f e r e n c e R e d e f i n i n g t h e F u t u r e o f I m m u n i z a t i o n s Steven Lo Chief Executive Officer James F. Cummings, M.D. Chief Medical Officer May 7, 2025
Page 2
2 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 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’sstrategy, 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’sability 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 trialsand 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’sexpectations with respect to the effectiveness of its products or product candidates, including Vaxart’spotential role in mitigating the impact of COVID-19 globally. Vaxartmay 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 eventscould 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 Vaxartmakes, 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’sproduct 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’sproduct candidates may not achieve broad market acceptance; that a Vaxartcollaborator may not attain development and commercial milestones; that Vaxartor its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart’sor 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 personnelor key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxartmay not be able to obtain, maintain and enforce necessary patent and other intellectual property protection; that Vaxart’scapital resources may be inadequate; Vaxart’sability 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’sQuarterly and Annual Reports filed with the SEC. Vaxartdoes not assume any obligation to update any forward-looking statements, except as required by law.
Page 3
3 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Who likes getting shots?
Page 4
4 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 What if you did not need a shot? What if you could take a pill instead?
Page 5
5 The Citizens Life Sciences Conference – New York City | 7 May 2025 Vaxart’s Oral Pill Vaccines Can Revolutionize How The Immune System Responds And The Way Vaccines Are Delivered We are working to create a new generation of immunizations that are easier to administer, more accessible, and designed to meet the global health challenges now and in the future. The Pill That Moves The NeedleTM
Page 6
6 The Citizens Life Sciences Conference – New York City | 7 May 2025 Immunizations Are Essential Public Health Infrastructure Immunizations are considered one of the top public health achievements of the 20th century by1, 2: ✓ Prevents illness and complications ✓ Prevents cancer ✓ Reduces hospitalizations and deaths ✓ Reduces healthcare costs ✓ Increases productivity 1. MMWR, April 2, 1999/Vol. 48/No. 12 Ten Great Public Health Achievements —United States, 1900–1999. https://www.cdc.gov/mmwr/preview/mmwrhtml/00056796.htm. 2. Rodrigues, C. M., & Plotkin, S. A. (2020). Impact of vaccines; Health, economic and Social Perspectives. Frontiers in Microbiology, 11. https://doi.org/10.3389/fmicb.2020.01526 . 3. IQVIA Institute for Human Data Science. Lifetime Trends in Biopharmaceutical Innovation: Recent Evidence and Implications. IQVIA, March 2024. Available at: https://www.iqvia.com/insights/the-iqvia-institute/reports-and- publications/reports/lifetime-trends-in-biopharmaceutical-innovation-recent-evidence-and-implications
Page 7
7 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Limitations of Injectable Vaccines Warrant a New Approach Cold Chain Complexity Provider Administered Access Challenges Injection Site Reactions Limited ProtectionNeedles Current system is limited by logistics, access and acceptanceCurrent State Self- administered Easily Deployable Simplified Logistics Improved Tolerability Broad, Durable Immunity No Medical Waste Ideal State
Page 8
8 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Not Just A Pill But A Paradigm Shift Vaxart’s Oral Pill Injectable Vaccine Needle-free ✓ 𝙓 Induces Mucosal and Systemic immunity ✓ 𝙓 Potential to Reduce Transmission ✓ 𝙓 Benign Safety & Tolerability profile ✓ 𝙓 Thermostable ✓ 𝙓 Self-administration ✓ 𝙓 Vaxart’s oral vaccine candidates have the potential to address many of the shortcomings of injectable vaccines
Page 9
9 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Vaxart at a Glance Biopharma veterans with deep vaccine experience In-house manufacturing at US-based facilities South San Francisco, CA Dr. Sean Tucker, globally recognized expert in mucosal immunity Proprietary modular oral recombinant pill vaccine platform Norovirus, COVID-19, Influenza, and HPV vaccine programs Team Manufacturing Location Founder Technology Pipeline
Page 10
10 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Vaxart’s Proprietary VAAST® Platform: Vector-Adjuvant- Antigen Standardized Technology Vaxart’s thermostable rAd5 pill vaccine is taken orally Our oral pill vaccines engage the immune system at the mucosal level — the first line of defense against invading pathogens Vaxart Has Developed A Unique Modular Vaccine Platform
Page 11
11 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Vaxart’s Proprietary VAAST® Platform: Vector-Adjuvant- Antigen Standardized Technology The tablet dissolves and the vaccine is delivered to the intestine, activating the immune system Vaxart Has Developed A Unique Modular Vaccine Platform Our oral pill vaccines engage the immune system at the mucosal level — the first line of defense against invading pathogens
Page 12
12 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Vaxart Has Developed A Unique Modular Vaccine Platform Vaxart’s Proprietary VAAST® Platform: Vector-Adjuvant- Antigen Standardized Technology Our oral pill vaccines engage the immune system at the mucosal level — the first line of defense against invading pathogens The Vaxart oral vaccine stimulates the immune system to produce IgA and IgG in the blood and at mucosal surfaces (nose, lung and intestines)
Page 13
13 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Vaxart Has Developed A Unique Modular Vaccine Platform Vaxart’s Proprietary VAAST® Platform: Vector-Adjuvant- Antigen Standardized Technology Our oral pill vaccines engage the immune system at the mucosal level — the first line of defense against invading pathogens Secreted IgA at mucosal surfaces protects against pathogen entry and prevents infection
Page 14
14 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Vaxart’s Oral Platform Drives Broader Immunity Through Mucosal IgA Responses Characteristics: • Major antibody isotype induced systemically • Major isotype produced by mRNA vaccines • Binding affinity is significantly reduced when challenged with variants • Has shown poor cross-reactivity with respect to known variants1,2 IgG IgA Characteristics: • Predominantly present in the mucosal tissues • Efficiently produced through VAAST platform • Minimal decrease in binding affinity when challenged with variants • Shown to have greater cross-reactivity against both SARS- CoV-21 and Influenza2 variants 1.Ejemel, et al, Nature, 2020 2.Muramatsu, et al, PLOS, 2014. ANTIBODY CROSS-REACTIVITY: IgG VS. IgA 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
Page 15
15 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Vaxart Has Multiple Promising Clinical-Stage Programs Based on our proprietary platform technology 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 (Second-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) 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
Page 16
16 The Citizens Life Sciences Conference – New York City | 7 May 2025 Norovirus Is A Leading Cause Of Acute Gastroenteritis (AGE) Worldwide1 2 4 1. Carlson, K.B., Dilley, A., O’Grady, T. et al. A narrative review of norovirus epidemiology, biology, and challenges to vaccine development. npj Vaccines 9, 94 (2024). https://doi.org/10.1038/s41541-024-00884-2. 2. Petracek, K. (2025, March 4). There have been 7 norovirus outbreaks on Florida cruises this year – two on the same ship . Health News Florida. 3. Li, David K. (2020, April 21). Chipotle agrees to pay $25 million penalty for 2015 -18 norovirus outbreaks. U.S. NBC News. 4. Evans, K. (2024, March 4). Oprah Winfrey hospitalized with stomach virus and dehydration. People. https://people.com/oprah-winfrey-hospitalized-with-stomach-virus-dehydration-8661869 Responsible for outbreaks in schools, cruise ships, restaurants, and healthcare settings 3
Page 17
17 The Citizens Life Sciences Conference – New York City | 7 May 2025 Norovirus Is Attributed To Nearly One Out Of Every Five Episodes Of Diarrheal Disease Globally1 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 200K Deaths (50K among children) 900 Deaths (mostly older adults) 100K Hospitalizations Economic Costs $60 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, K.B., Dilley, A., O’Grady, T. et al. A narrative review of norovirus epidemiology, biology, and challenges to vaccine development. npj Vaccines 9, 94 (2024). https://doi.org/10.1038/s41541-024-00884-2
Page 18
18 The Citizens Life Sciences Conference – New York City | 7 May 2025 Several Eligible Populations Based On Age Or Risk Creating An Attractive Market Opportunity Age Health Status Occupation Seniors (54M) ≥65 years old Care Facility Residents (2M) Long-term care, skilled nursing, assisted living Immunocompromised (6 – 13M) Due to conditions or treatment Military Personnel (10M) Active-duty members, National Guard and Reserve personnel, retirees, and their families Situation Healthcare (22M) Professionals with direct patient contact or non-direct patient care First Responders (5M) Career and volunteer firefighters, police, EMTs, and paramedics Food Handlers (20M) Professionals in the food industry subject to US food handling regulations Childcare Providers (2M) Preschool teachers and child daycare workers Travel (45 – 60M) Group or individuals travelling to a large event / confined setting (e.g. cruise ship, large holiday resort, festival) and professionals in the travel industry (cruise workers) Lactating Mothers (1M) Mothers who exclusively breastfeed their infant for 6 months Total potential market size in the US is $3 – 5 BN
Page 19
19 The Citizens Life Sciences Conference – New York City | 7 May 2025 An Ideal Norovirus Vaccine Would Have the Following Characteristics Provides Durable, Cross-reactive, and Mucosal Immunity Triggers both mucosal and systemic immune responses that are long-lasting and cross-reactive within genogroups, providing broad protection across age groups State-of-the-art Recombinant Technology Free from live, replicating virus or animal products, permitting use in a broad range of individuals, including immunocompromised populations Easy to Administer Convenient, oral self-administration, eliminating the need for needles and related tolerability issues Thermostable Stable for storage and transport without requiring complex cold chain logistics and ability maintain efficacy without the need for refrigeration Provide Global Accessibility An easy-to-administer dosage form that can significantly reduce healthcare costs, improve accessibility, and enhance distribution, particularly in remote or underserved areas Can be Developed Rapidly Modular, scalable, and standardized approach to vaccine development that supports the rapid development against established targets as well as against new and emerging pathogens
Page 20
20 The Citizens Life Sciences Conference – New York City | 7 May 2025 Vaxart’s Bivalent Norovirus Vaccine Candidate Is Designed To Address The Major Circulating Genotypes Vaxart’s vaccine candidate is composed of GI.I and GII.4 components GII.4 68% Other GII 17% GI 15% Distribution Of Norovirus Genotypes U.S., 2009 - 20151 GII.4 • Predominant cause of pediatric illness worldwide2, 3 • Overwhelmingly predominates as a cause of disease amongst the elderly in healthcare- associated outbreaks2, 3 • Results in more severe illness compared to other norovirus genotypes2, 3 1. Shah MP, Wikswo ME, Barclay L, et al. Near Real -Time Surveillance of U.S. Norovirus Outbreaks by the Norovirus Sentinel Testing and Tracking Ne twork — United States, August 2009–July 2015. MMWR Morb Mortal Wkly Rep 2017;66:185–189. DOI: http://dx.doi.org/10.15585/mmwr.mm6607a1 2. Lopman b, et. al. Global Burden of Norovirus and Prospects for Vaccine Development. Centers for Disease Control and Prevention. August 2015. 3. CDC – Norovirus Trends and Outbreaks – Burdern of Norovirus Illness in the US. https://www.cdc.gov/norovirus/trends-outbreaks/burden-US.html September 23, 2021.
Page 21
21 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Norovirus Clinical Program has Demonstrated Robust Results in 8 Complete Trials and the FDA has Provided Guidance Key Clinical Data Findings to Date ✓ Norovirus oral vaccination induces mucosal and systemic immune responses ✓ Norovirus oral vaccination reduces shedding and infection in a human challenge model ✓ Norovirus vaccination protection most tightly associates with making a functional antibody response to norovirus in the serum (NBAA) and norovirus specific fecal IgA antibodies1 ✓ Because of the strong induction of mucosal IgA due to the oral vaccination and potential read through into the serum, suggests that functional fecal IgA response is probably critical for protection against norovirus infection FDA Feedback Received in 2024 ✓ Received constructive feedback from the FDA on our data for potential correlates of protection and next steps for our norovirus program ✓ While we believe we have identified a functional antibody response that may be associated with protection for norovirus, FDA requested new clinical data before proceeding with further review of our potential correlate 1. Based on machine learning and evaluation of 13+ different immune parameters.
Page 22
22 The Citizens Life Sciences Conference – New York City | 7 May 2025 Second Generation Norovirus Constructs have Improved Immunogenicity Compared to First Generation Constructs in Preclinical Models Balb/c mice immunized D-1 and D28
Page 23
23 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Phase 1 Trial Evaluating Our Second-Generation Norovirus Vaccine Constructs Head-to-Head Against First-Generation Constructs Completed Enrollment Treatment Group Study Drug Dose (±0.5 log) No. of Doses No. of Subjects Cohort 1 Bivalent 2nd Generation Construct GI.1 @ 1x1010 I.U. 1 20 GII.4 @ 1x1010 I.U. Cohort 2 Bivalent 1st Generation Construct GI.1 @ 1x1011 I.U. 1 20 GII.4 @ 1x1011 I.U. Cohort 3 Bivalent 2nd Generation Construct GI.1 @ 1x1011 I.U. 1 20 GII.4 @ 1x1011 I.U. Total 60 • Objective: dose ranging and construct selection for pivotal Phase 2 and 3 studies • Active period: 4 weeks (Day 30) Screening Window (45 days) Active Period (30 Days) (Reactogenicity, Safety and Immunogenicity) Dose 1 (Day 1) Safety Follow-up Period (through Day 365) (Duration of Immune Response, SAEs, AESIs, NOCIs) End of Active Period (Day 30) End of Study (Day 365) The Phase 1 trial is an open label, dose ranging clinical study that will will measure safety and immune parameters that have correlated to protection in the completed norovirus challenge study
Page 24
24 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Vaxart Has Multiple Promising Clinical-Stage Programs Based on our proprietary platform technology 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 (Second-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) 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
Page 25
25 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Vaxart Received a BARDA1 Award to Conduct a Phase 2b Trial Evaluating our COVID-19 Vaccine Candidate H2H Against an Approved mRNA Comparator Source: https://medicalcountermeasures.gov/nextgen 1In collaboration with the National Institute of Allergy and Infectious Diseases (NIAID). 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-19 vaccine can potentially address most of Project NextGen’s desired attributes
Page 26
26 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 BARDA has Lifted Stop Work Order and Continues Funding for 10,000-participant Phase 2b Trial BARDA Award • Vaxart received a BARDA Project NextGen award of up to $460.7M • ~$240.1M is currently available for payment 400-participant Safety Lead-in Study • 200 Vaxart XBB vaccine compared to 200 XBB mRNA • Completed enrollment in November 2024 • 30-day safety data received a favorable review from an independent DSMB 10,000- participant Phase 2b Trial • Stop Work Order lifted April 24, 2025 • Reactivate field sites and screen participants for enrollment • Continue discussions with BARDA regarding dosing participants Vaxart is reactivating field sites to begin screening participants
Page 27
27 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 • 46% of participants that had increased IgA antibodies to SARS-CoV-2 S also had increased antibody responses to the S protein of other coronaviruses, including SARS-CoV-1, MERS, and endemic common cold viruses • Beneficial for maintaining immunization protection against current and future COVID-19 variants (Delta, Omicron, etc.) 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 VXA-CoV2-1 (Expresses S + N) Langel, et al, Sci Translational Med, 2022 IgA Cross-Reactivity to Other Coronaviruses Source: Langel, et al. Adenovirus type 5 SARS-CoV-2 vaccines delivered orally or intranasally reduced disease severity and transmission in a hamster mo del.
Page 28
28 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Vaxart Has Generated Promising COVID-19 Clinical Data To Date VXA-CoV2-1 (Expresses S + N): CompletedPhase 1 ✓ Highly immunogenic on eliciting T cells, to both Sand N ✓ T-cell responses to the S appear much higher thanthose of injectable mRNA vaccines in Phase 1 study1 ✓ Cross-reactive mucosal IgA ✓ Durable responses to 360 days ✓ Benign tolerability VXA-CoV2-1.1-S (Expresses only S):Completed Phase 2a ✓ 72% had an immune response post vaccination ✓ Better serum responses than S+N ✓ Ability to boost mRNA vaccines ✓ Cross-reactive mucosal IgA ✓ Benign tolerability
Page 29
29 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Vaxart Has Multiple Promising Clinical-Stage Programs Based on our proprietary platform technology 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 (Second-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) 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
Page 30
30 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 • A single dose administration of one of the following: – Arm 1: VXA-A1.1 oral vaccine + placebo IM injection (n=60+extra) – Arm 2: QIV (Fluzone) injection + oral placebo tablet (n=60+extra) – Arm 3: Placebo IM injection + oral placebo tablet (n=30+extra) • Participants with baseline HAI titers <10 • Challenge after day 90 (up to 120 days) – A wild-type influenza A/Ca/2009/pH1N1 strain was administered to participants in all treatment groups • Primary endpoint – Number and % of participants protected against infection and illness following influenza (A/CA/2009/pH1N1) challenge. VXA-A1.1 compared to placebo and QIV (Fluzone). Human Influenza Challenge Design Source: Liebowitz, et al, Lancet ID, 2020
Page 31
31 The Citizens Life Sciences Conference – New York City | 7 May 2025 Vaxart’s Oral Influenza Vaccine Candidate Reduced Shedding (Infection Rate) VAXART ORAL TABLET vs. FLUZONE Oral vaccine candidate protected against influenza infection as well as market leading injected vaccine after influenza challenge. 80% chance of improved protection. o Infection was measured by influenza virus shedding in participants o Shedding reductions are believed to typically translate to lower transmission 36% 44% 71% 0% 10% 20% 30% 40% 50% 60% 70% 80% Vaxart Tablet Vaccine Fluzone Placebo p = 0.001 p = 0.009 Infection rates Reduced Infection Rates Compared to Placebo - 49% - 38% Note: Infection defined as detectable viral shedding on any day after the first 36 hours from challenge. Source: Flitter, B.A. et al Drop the Needle; A Temperature Stable Oral Tablet Vaccine Is Protective against Respiratory Viral Patho gens. Vaccines 2022, 10, 593. https://doi.org/ 10.3390/vaccines10040593.
Page 32
32 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Expect to Achieve Multiple Key Milestones in 2025 Norovirus Vaccine ✓ Topline data from Phase 1 trial expected in mid-2025 COVID-19 Vaccine ✓ BARDA Project NextGen award up to $460.7M ($240.1M currently available) to prepare and execute an approximately 10,400 participant Phase 2b trial for COVID-19 evaluating our vaccine candidate head- to-head against an FDA approved mRNA vaccine comparator ✓ The Stop Work Order for Vaxart’s BARDA Project NextGen award has been lifted ✓ Proceeding with field site reactivation and dosing, pending BARDA approval ✓ Primary endpoint is relative efficacy of Vaxart’s COVID-19 vaccine candidate compared to an FDA approved mRNA comparator for the prevention of symptomatic disease (12 months post-vaccination) Influenza Vaccine ✓ Demonstrated protective activity in a Phase 2 study for influenza, similar to market-leading injectable ✓ Continuing development of our seasonal influenza vaccine candidate Exploring various cash runway extension strategies through business development partnerships and non-dilutive funding options
Page 33
33 The Citizens Life Sciences Conference – New York City | 7 May 2025 o Our vaccine platform is designed to generate substantial systemic and mucosal immunity as well as provide improved convenience for market disruptive potential o The platform supports a broad pipeline with programs in norovirus, influenza, and COVID-19 nearing key milestones o Clinical proof-of-concept demonstrated in challenge studies against both respiratory and GI viruses o All manufacturing in the United States EXECUTIVE SUMMARY Vaxart Is Pioneering A Transformative Approach To Immunization With Our Oral Mucosal Pill Vaccine Platform
Page 34
34 The Citizens Life Sciences Conference – New York City | 7 May 2025 vaxart.com
Page 35
35 The Citizens Life Sciences Conference – New York City | 7 May 2025 Appendix
Page 36
36 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 VAAST Platform Utilizes Mucosal Immunity to Generate IgA in Addition to IgG to Potentially Block Infection and Transmission
Page 37
37 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Will Evaluate Immune Parameters That Have Correlated to Protection in a Norovirus Challenge Study Safety • Frequency, duration, and severity of Solicited Symptoms of Reactogenicity (GI and systemic) for 1 week following each study drug dose • Frequency, duration, and severity of unsolicited adverse events (AEs) for 28 days following last study drug dose Immunogenicity • Serum – NBAA titers for both sets of GI.1 and GII.4 constructs (new and old) o Geometric mean titer (GMT) Day 1 and Day 29 o Geometric mean fold rise (GMFR) from Day 1 to Day 29 o Proportion of subjects with titer >59 on Day 29 • Fecal IgA normalized to GI.1 and GII.4 VP1 o AU/ml per total IgA concentration at Day 1 and Day 29 Immune parameters that correlated to protection in the norovirus challenge study
Page 38
38 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Phase 2 double-blinded placebo-controlled study • GI.1 vaccine candidate or placebo, given to healthy participants • Given norovirus infection 29+ days after vaccination • Determine infection and rate of acute gastroenteritis (AGE) in placebo and vaccinated participants • Measure immune parameters; determine which ones are important at predicting protection NVV-201 Study: Norovirus Challenge Study
Page 39
39 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 • No vaccine-related Serious Adverse Events (SAEs) • No vaccine-related solicited Grade-3 Adverse Events (AEs) • Solicited AEs reported in 58% of VXA-G1.1- NN group and 46% of placebo group overall • Most solicited AEs were mild (Grade 1) • Benign safety and tolerability data profile consistent with safety of the platform in previous studies Norovirus Challenge Study: No Significant Differences Between Vaccine and Placebo for Solicited Adverse Events VXA-G1.1-NN N (%) Placebo N (%) VACCINE PHASE, N=1651 N=86 N=79 Participants reporting ≥ 1 solicited symptoms through 7 days post vaccination 50 (58.1) 36 (45.6) Maximum severity mild 38 (44.2) 31 (39.2) Maximum severity moderate 12 (14.0) 5 (6.3) Maximum severity severe 0 (0.0) 0 (0.0) Malaise/Fatigue 25 (29.1) 20 (25.3) Myalgia 11 (12.8) 12 (15.2) Anorexia 10 (11.6) 6 (7.6) Headache 25 (29.1) 19 (24.1) Fever 0 (0.0) 0 (0.0) Diarrhoea 20 (23.3) 12 (15.2) Nausea 13 (15.1) 10 (12.7) Vomiting 0 (0.0) 1 (1.3) Abdominal Pain 14 (16.3) 8 (10.1)1. 165 participants were immunized. 141 of those were challenged.
Page 40
40 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Norovirus Challenge Study: Protection Against Infection and Illness Norovirus Infection p = 0.003 p = 0.149 58% 45% 82% 57% 29% relative reduction 21% relative reduction Vaccine (n=76) Placebo (n=65) Vaccine (n=76) Placebo (n=65) Full analysis (N=141) Norovirus AGE
Page 41
41 The Citizens Life Sciences Conference – New York City | 7 May 2025The Citizens Life Sciences Conference – New York City | 7 May 2025 Norovirus Challenge Study: 85% Reduction in Viral Shedding 0 1 2 3 4 5 6 7 8 0 20000 40000 60000 Time (days) Geomean Noro (GCx103/g) Viral Shedding Full Analysis Set - Stool Samples Placebo Vaccine LOD is 256 copies per reaction or 1.52x10e5 copies per mL 2 3 4 5 6 7 8 0 50000 100000 150000 200000 Time (Days) Area Under the Curve Running AUC Full Analysis Set - Stool Samples Total AUC-Vaccine Total AUC-Placebo 85% reduction in AUC
Page 42
42 The Citizens Life Sciences Conference – New York City | 7 May 2025 Vaxart’s Norovirus Data Appears Favorable Despite More Aggressive Challenge 1. Bernstein et. al, JID, 2015 2. Exact number was not disclosed. ~30% is an estimate based on the graphic in the publication. Cross-study comparison. Vaccines not studied head-to-head directly Vaxart Oral Tablet GI.1 Challenge Injectable Vaccine1 GII.4 Challenge Application Oral tablet Intramuscular injection Doses 1 2 Placebo Attack Rates • Norovirus infection • Noro-AGE 82% 57% 63% 33% Vaccine Protection • Reduction in infection • Reduction in Noro-AGE • Reduction in shedding 29% 21% 85% 14% 22% ~30%2
Page 43
43 The Citizens Life Sciences Conference – New York City | 7 May 2025 Reasons to Expect More Significant Real-World Protection From Our Norovirus Bivalent Vaccine Candidate Virus Vaccine Challenge study Field study Flu Fluzone 27% 49-66% Norovirus HIL-214 22% 34% Typhoid Vi-TT; Typbar- TCV 55% 82% RSV Multiple 10-60% 43-60% Real-world efficacy is 50-100% more than that seen in several challenge studies Challenge studies expose participants to an artificially high amount of virus – many orders of magnitude higher than typical in the real world