COVID-19 Phase 2b study poised to initiate 10,000 participant portion of trial pending U.S. Food and Drug Administration (FDA) review of sentinel cohort 30-day safety data Norovirus program to proceed with Phase 1 study following scientific advisory board and FDA feedback; Trial to initiate the first half of 2025 with topline data expected as early as mid-2025 New avian influenza vaccine candidate being tested in preclinical studies SOUTH SAN FRANCISCO, Calif., Jan. 14, 2025 (GLOBE NEWSWIRE) -- Vaxart, Inc. ...

Independent Data Safety Monitoring Board (DSMB) recommends study to proceed without modifications based on initial safety assessment of 400 participant 30-day data Note Regarding Forward-Looking Statements This press release 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, receipt of funding from BARDA, results from precl ...

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 ...