Core Viewpoint - Vaxart, Inc. has appointed Kevin Finney to its Board of Directors, bringing extensive healthcare industry experience to support the company's strategic goals and milestones [1][3]. Group 1: Appointment Details - Kevin Finney's appointment is effective immediately, and he will serve on the Audit and Nominating and Governance Committees of the Board [2]. - The CEO of Vaxart, Steven Lo, expressed confidence that Finney's expertise will be a significant asset as the company advances its oral vaccine platform technology [3]. Group 2: Background of Kevin Finney - Finney has 35 years of leadership experience in the healthcare sector, currently serving as President and CEO of Autobahn Therapeutics since 2019 [1][5]. - His previous roles include President and COO of Abide Therapeutics, and he has held executive positions at Allergan, Prometheus Laboratories, and Amylin Pharmaceuticals [6][7]. Group 3: Company Overview - Vaxart is a clinical-stage biotechnology company focused on developing oral recombinant vaccines that can be stored and shipped without refrigeration [9]. - The company's current development programs include vaccines targeting coronavirus, norovirus, influenza, and a therapeutic vaccine for human papillomavirus (HPV) [9].

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 ...

Financial Data and Key Metrics Changes - Revenue for Q3 2024 was $4.9 million, compared to $2.1 million in Q3 2023, primarily from government contracts related to BARDA [37] - Cash, cash equivalents, and investments at the end of Q3 2024 totaled $58.7 million, with a cash runway anticipated into 2026 [38] Business Line Data and Key Metrics Changes - The COVID program has seen strong interest, with enrollment in the Phase 2b study progressing well, aiming to compare an oral pill vaccine candidate against an approved mRNA vaccine [9][20] - The Norovirus program is advancing with constructive feedback from the FDA, focusing on identifying correlates of protection and planning for future clinical development [13][25] - The HPV program has shown promising preclinical data, indicating potential for a non-invasive approach to prevent cervical cancer [16][35] Market Data and Key Metrics Changes - Approximately 35 million people are expected to receive a COVID vaccine dose in the US this season, comparable to last year's 40 million doses, indicating robust demand for COVID vaccines [11] - Norovirus is a significant public health concern, causing acute gastroenteritis in approximately 21 million people in the US annually, highlighting the market potential for an oral vaccine [15] Company Strategy and Development Direction - The company aims to advance its oral pill vaccine platform, focusing on mucosal immunity to improve public health and address the limitations of injectable vaccines [7][8] - There is a commitment to exploring additional indications while carefully investing in other programs, including HPV and Norovirus [16][34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential of their oral vaccine platform and its ability to meet public health needs more effectively than current methods [12][68] - The company is focused on building a compelling data package for FDA review and is committed to progressing its vaccine programs thoughtfully [63] Other Important Information - The company has received one of the largest BARDA-Funded Project NextGen Awards, valued at up to $456 million, to support its COVID program [10] - The Phase 2b study will measure various immune responses and safety, with a primary endpoint focused on the relative efficacy of the oral vaccine compared to an mRNA vaccine [23] Q&A Session Summary Question: Interest level from investigators and enrollment progress in the COVID-19 Phase 2 study - Management reported strong interest and no issues with enrollment, expecting to reach 400 participants soon [42] Question: Feedback from the FDA on the Norovirus program - The FDA provided clarity on requirements for moving forward, but specific details were not disclosed [46][57] Question: DSMB 30-day safety analysis expectations - The expectation is for no safety concerns, allowing continued enrollment [50] Question: Interim analysis plans for the COVID study - An interim analysis is being considered once 255 cases are accrued, but the focus remains on completing the full study [51] Question: Data requested by the FDA for the Norovirus program - Specific requests were not disclosed, but management feels they have a clear path forward [57] Question: Timing for IND filing for next-generation Norovirus constructs - No specific guidance was provided on the IND filing timeline [53]

Vaccine Development - The Phase 2 GI.1 norovirus challenge study achieved a statistically significant 29% relative reduction in the rate of norovirus infection between the vaccinated and placebo arms [143]. - The bivalent norovirus vaccine candidate showed an 85% relative decrease in viral shedding in the vaccine arm compared to placebo [143]. - The Phase 2b clinical study for the COVID-19 vaccine candidate is funded with up to $456.1 million to involve 10,000 patients [153]. - The COVID-19 vaccine candidate boosted serum neutralizing antibody responses from a geometric mean of 481 to 778, a fold rise of 1.6 [150]. - The HPV therapeutic vaccine candidate targets HPV 16 and HPV 18, responsible for 70% of cervical cancers [162]. - The H1N1 flu vaccine candidate reduced clinical disease by 39% relative to placebo, outperforming the market-leading injectable vaccine [158]. - The company received constructive feedback from the FDA regarding the norovirus program, requesting new clinical data before further review [145]. - The Phase 1 study funded by the Bill and Melinda Gates Foundation showed a 5.6-fold increase in serum antibodies to norovirus in lactating mothers [146]. - The company is developing additional norovirus constructs that may be more potent than those currently in clinical trials [147]. - The company intends to work with governments to create pandemic monovalent influenza vaccines for emergency use or stockpiling [161]. Financial Performance - Revenue for the three months ended September 30, 2024, was $4.9 million, a 134% increase from $2.1 million in the same period of 2023 [181]. - Revenue for the nine months ended September 30, 2024, was $13.5 million, up from $4.1 million in the same period of 2023, representing a significant increase [181]. - Operating expenses for the three months ended September 30, 2024, were $19.4 million, a slight decrease of 3% from $19.9 million in the same period of 2023 [181]. - Operating loss for the three months ended September 30, 2024, was $(14.5) million, a 19% improvement compared to $(17.8) million in the same period of 2023 [181]. - Net loss for the three months ended September 30, 2024, was $(14.1) million, a 19% decrease from $(17.4) million in the same period of 2023 [181]. - The company was awarded the 2024 ASPR-BARDA Contract with a total value of $9.3 million to support clinical trial planning activities [171]. - The 2024 ATI-RRPV Contract provides funding of up to $456.1 million for a Phase 2b comparative study of a COVID-19 vaccine candidate [172]. - Research and development expenses for the three months ended September 30, 2024, totaled $15.1 million, slightly up from $15.0 million in the same period of 2023 [178]. - Total external research and development costs for the nine months ended September 30, 2024, were $12.2 million, down from $13.5 million in the same period of 2023 [178]. - Total revenue for the three months ended September 30, 2024, was $4.9 million, a significant increase from zero in the same period of 2023, while total revenue for the nine months was $12.9 million compared to zero in 2023 [184]. - Revenue from government contracts for the three months ended September 30, 2024, was $4.9 million, with $0.9 million from the ASPR-BARDA Contract and $4.0 million from the ATI-RRPV Contract [184]. Cash Flow and Investments - As of September 30, 2024, the company had approximately $58.7 million in cash, cash equivalents, and short-term investments, sufficient to fund operations for at least one year [201]. - The company entered into the 2024 ATI-RRPV Contract, which provides funding of up to $456.1 million for a Phase 2b study and vaccine manufacturing, with $65.4 million received as of September 30, 2024 [196]. - The company terminated the September 2021 ATM, having raised $9.1 million in gross proceeds from the sale of shares, resulting in net proceeds of $8.8 million [195]. - For the nine months ended September 30, 2024, the net cash used in operating activities was $37.4 million, a decrease from $56.9 million in the same period of 2023 [207]. - The company experienced a net cash decrease of $12.7 million in the nine months ended September 30, 2024, compared to a decrease of $12.8 million in 2023 [206]. - In the nine months ended September 30, 2024, the company provided net cash of $56.4 million from financing activities, significantly up from $15.3 million in 2023 [206]. - The company recorded a net loss of $55.0 million for the nine months ended September 30, 2024, compared to a net loss of $65.1 million in the same period of 2023 [207]. - The company has contractual obligations totaling $52.7 million as of September 30, 2024, with long-term debt obligations of $21.6 million [211]. - The company used $31.2 million of cash for investments in the nine months ended September 30, 2024, compared to receiving $30.7 million from maturities of marketable securities in 2023 [209]. Stock and Compensation - The unrecognized stock-based compensation cost related to outstanding unvested stock options and RSUs was $15.9 million, expected to be recognized over an estimated weighted average period of 2.3 years [214]. - The company’s royalty revenue is sensitive to exchange rate fluctuations, with a 1% increase in the U.S. dollar against the Japanese yen leading to a 1% reduction in royalty revenue [229]. - The company is obligated to pay HCRP a total of $3.0 million in royalties during the first royalty interest period, which runs until March 31, 2025 [211]. Internal Controls - No material change in internal control over financial reporting during the quarter ended September 30, 2024 [232]. - Management does not expect disclosure controls and internal controls to prevent all errors and fraud [233].

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 ...