Core Insights - Vaxart is advancing its oral pill vaccine platform with significant developments in its COVID-19 and norovirus programs, aiming for key clinical milestones in the near future [2][3] COVID-19 Program Developments - An independent Data and Safety Monitoring Board (DSMB) has recommended the continuation of the Phase 2b study after reviewing the 30-day safety data from the sentinel cohort [4] - The FDA is currently reviewing this safety data, and upon a favorable review, Vaxart plans to enroll approximately 10,000 participants for the next phase of the trial [5] - The primary efficacy analysis will occur 12 months post-vaccination for all participants [5] Norovirus Program Developments - Vaxart will initiate a Phase 1, open-label, dose-ranging clinical trial to evaluate its second-generation oral norovirus vaccine constructs against first-generation constructs, with topline data expected by mid-2025 [7][8] - If successful, a Phase 2 safety and immunogenicity study could begin as early as the second half of 2025, followed by a potential Phase 3 trial in 2026 [9] Influenza Program Developments - The company is advancing its avian influenza program, having created a new vaccine candidate to cover the latest clade 2.3.4.4b, with preclinical studies currently underway [10] Funding and Financial Outlook - Vaxart has received funding under Project NextGen, valued at up to $460.7 million, which will support its clinical and regulatory milestones into 2026 [6][11] - The company is exploring partnerships and non-dilutive funding options to extend its cash runway and maximize shareholder value [12] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines, including those for COVID-19, norovirus, and influenza, utilizing a proprietary delivery platform [13]

Core Insights - An independent Data Safety Monitoring Board (DSMB) has recommended that Vaxart's COVID-19 Phase 2b trial proceed without modifications based on a safety assessment of 30-day data from 400 participants [1][2] - The trial aims to enroll approximately 10,000 participants, pending favorable review from the FDA and approval from BARDA [1][2] - Vaxart's Phase 2b trial is designed to compare the efficacy, safety, and immunogenicity of its oral COVID-19 vaccine candidate against an approved mRNA vaccine [3] Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines using a proprietary delivery platform [6] - The company has received funding under Project NextGen, a $5 billion initiative aimed at accelerating the development of innovative COVID-19 vaccines and therapeutics, with Vaxart's project award valued at up to $460.7 million [4] - Vaxart is recognized as a pioneer in oral vaccines, being the first U.S. company to complete a Phase 2 clinical trial for an oral COVID-19 vaccine [5]

Clinical Trial Progress - Vaxart's Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study to evaluate the efficacy, safety, and immunogenicity of its oral pill COVID-19 vaccine candidate compared to an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 [1] - The company was the first U S company to complete a Phase 2 clinical trial of an oral vaccine for COVID-19 [2] - An independent Data Safety Monitoring Board (DSMB) recommended the study to proceed without modifications based on the initial safety assessment of 400 participants' 30-day data [3] - The company plans to enroll 10,000 participants in the trial, pending favorable review from the FDA and approval from BARDA [3][5] Funding and Support - Vaxart received funding under Project NextGen, a $5 billion initiative led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID) to accelerate the development of next-generation COVID-19 vaccines, therapeutics, and enablers [4] - The company's project award through the Rapid Response Partnership Vehicle (RRPV) is valued at up to $460 7 million, funded by federal funds from the U S Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), and BARDA [4] Company Overview - Vaxart is a clinical-stage biotechnology company developing oral recombinant vaccines using its proprietary delivery platform [6] - The company's vaccines are designed to be administered via pills that do not require refrigeration and eliminate the risk of needle-stick injuries [6] - Vaxart's development programs include oral vaccines for coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [6] - The company has filed broad domestic and international patent applications covering its proprietary technology for oral vaccination using adenovirus and TLR3 agonists [6] Next Steps - The FDA is reviewing the 30-day safety data from the sentinel cohort, and upon favorable review and BARDA approval, the study will progress to enroll approximately 10,000 participants [5] - The trial aims to enroll participants in line with U S demographics, including at least 25% of participants over the age of 65 [5]

SOUTH SAN FRANCISCO, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced completion of enrollment of the sentinel cohort of a Phase 2b clinical trial evaluating Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA vaccine comparator. The sentinel cohort comprised of 400 participants, with 200 receiving Vaxart’s COVID-19 vaccine candidate and 200 receiving an approved mRNA vaccine comparator. “We are pleased to complete the enrollment of the sentinel cohort ...

VAXART, INC. (VXRT) came out with a quarterly loss of $0.06 per share versus the Zacks Consensus Estimate of a loss of $0.10. This compares to loss of $0.11 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 40%. A quarter ago, it was expected that this company would post earnings of $0.03 per share when it actually produced a loss of $0.09, delivering a surprise of -400%.Over the last four quarters, the company has surpassed con ...

Vaxart, Inc. (NASDAQ:VXRT) Q3 2024 Earnings Conference Call November 13, 2024 4:30 PM ET Company Participants Edward Berg - Senior Vice President and General Counsel Steven Lo - Chief Executive Officer James Cummings - Chief Medical Officer Sean Tucker - Senior Vice President and Chief Scientific Officer Phillip Lee - Chief Financial Officer Conference Call Participants Cheng Li - Oppenheimer Mayank Mamtani - B. Riley Securities Liang Cheng - Jefferies Operator Greetings and welcome to the Vaxart Business U ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☑ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-35285 Vaxart, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 59-1212264 (State or o ...

Vaxart Provides Business Update and Reports Third Quarter 2024 Financial Results Exhibit 99.1 Expects to complete enrollment of the 400-participant sentinel cohort for the COVID-19 Phase 2b study in November 2024 Solid financial position enables Vaxart to attain multiple regulatory and clinical milestones Conference call today at 4:30 p.m. ET SOUTH SAN FRANCISCO, Calif., November 13, 2024 — Vaxart, Inc. (Nasdaq: VXRT) today announced its business update and financial results for the third quarter of 2024. " ...

Expects to complete enrollment of the 400-participant sentinel cohort for the COVID-19 Phase 2b study in November 2024 Solid financial position enables Vaxart to attain multiple regulatory and clinical milestones Conference call today at 4:30 p.m. ET SOUTH SAN FRANCISCO, Calif., Nov. 13, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced its business update and financial results for the third quarter of 2024. “Our successful initiation of sentinel cohort dosing is a testament to our rapid ...

— 400 subject sentinel portion of Phase 2b study will evaluate the safety, immunogenicity and efficacy of Vaxart's next generation oral pill COVID-19 vaccine compared to an approved mRNA vaccine comparator — — The sentinel cohort is being funded as part of the Phase 2b NextGen COVID-19 clinical trial, valued at up to $456 million through the Rapid Response Partnership Vehicle under the U.S. government's Project NextGen — SOUTH SAN FRANCISCO, Calif., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: V ...