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 ...

Oppenheimer initiated coverage on Vaxart Inc. VXRT, an American biotechnology company focused on the discovery, development, and commercialization of oral recombinant vaccines. The analyst's bullish view is centered around optimism associated with attractive opportunities for Vaxart's 'differentiated' oral vaccine platform and key programs, such as the norovirus vaccine and COVID-19 vaccine. Oppenheimer initiated with an Outperform rating and a price target of $4, representing significant potential upside. ...

VAXART, INC. (VXRT) came out with a quarterly loss of $0.09 per share versus the Zacks Consensus Estimate of $0.03. This compares to loss of $0.16 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -400%. A quarter ago, it was expected that this company would post a loss of $0.16 per share when it actually produced a loss of $0.14, delivering a surprise of 12.50%. Over the last four quarters, the company has surpassed consensus ...

Conference call to begin at 4:30 p.m. ET SOUTH SAN FRANCISCO, Calif., Aug. 02, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT) today announced it will provide a business update and report financial results for the second quarter ended June 30, 2024 after the market close on Thursday, August 8, 2024. The Vaxart senior management team will host a conference call on the same day, beginning at 4:30 p.m. ET. The conference call can be accessed using the following information: Webcast: Click here Date: Thurs ...

Conference call to begin at 4:30 p.m. ET SOUTH SAN FRANCISCO, Calif., Aug. 02, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT) today announced it will provide a business update and report financial results for the second quarter ended June 30, 2024 after the market close on Thursday, August 8, 2024. The Vaxart senior management team will host a conference call on the same day, beginning at 4:30 p.m. ET. The conference call can be accessed using the following information: Webcast: Click here Date: Thurs ...

Vaxart, Inc. (NASDAQ:VXRT) Q1 2024 Earnings Conference Call May 13, 2024 4:30 PM ET Company Participants Ed Berg - Senior Vice President and General Counsel Steven Lo - Chief Executive Officer Sean Tucker - Founder and Chief Scientific Officer James Cummings - Chief Medical Officer Phil Lee - Chief Financial Officer Conference Call Participants Madison Britt Wynne El-Saadi - B. Riley Securities Aseah Khan - Cantor Fitzgerald Liang Cheng - Jefferies Operator Greetings, and welcome to the Vaxart Business Upda ...