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Vaxart(VXRT) - 2023 Q4 - Annual Report
2024-03-14 20:46
FORM 10-K Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☑ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 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 | | | ...
Vaxart(VXRT) - 2023 Q4 - Annual Results
2024-03-14 20:05
Exhibit 99.1 Vaxart Provides Business Update and Reports Full Year 2023 Financial Results Significant progress made in preparing for a Phase 2b study evaluating Vaxart's oral pill XBB COVID-19 vaccine against an approved mRNA vaccine comparator Topline data from Phase 1 norovirus study in lactating mothers expected in mid-2024 Steven Lo appointed President, Chief Executive Of icer and Board Member Conference call today at 4:30 p.m. ET SOUTH SAN FRANCISCO, Calif., March 14, 2024 — Vaxart, Inc. (Nasdaq: VXRT) ...
Vaxart(VXRT) - 2023 Q3 - Earnings Call Transcript
2023-11-02 23:37
Vaxart, Inc. (NASDAQ:VXRT) Q3 2023 Earnings Conference Call November 2, 2023 4:30 PM ET Company Participants Andrei Floroiu - President and CEO James Cummings - Chief Medical Officer Phil Lee - CFO Brant Biehn - SVP and Business Operations Edward Berg - Senior Vice President and General Counsel Conference Call Participants Mayank Mamtani - B. Riley Securities Liang Cheng - Jefferies Operator Greetings, and welcome to the Vaxart Business Update and Third Quarter 2023 Financial Results Conference Call. A ques ...
Vaxart(VXRT) - 2023 Q3 - Quarterly Report
2023-11-02 20:16
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, 2023 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 | | - ...
Vaxart(VXRT) - 2023 Q2 - Earnings Call Transcript
2023-08-03 23:40
Start Time: 16:30 January 1, 0000 5:01 PM ET Vaxart, Inc. (NASDAQ:VXRT) Q2 2023 Earnings Conference Call August 03, 2023, 16:30 PM ET Company Participants Andrei Floroiu - President and CEO James Cummings - Chief Medical Officer Sean Tucker - SVP and Chief Scientific Officer Phil Lee - CFO Brant Biehn - SVP and Business Operations Conference Call Participants Charles Duncan - Cantor Fitzgerald Mayank Mamtani - B. Riley Securities Operator Greetings, and welcome to the Vaxart Business Update and Second Quart ...
Vaxart(VXRT) - 2023 Q2 - Quarterly Report
2023-08-03 20:30
Table of Contents Commission file number: 001-35285 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 June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to If an emerging growth company, indicate by check mark if the registrant has elected not to use the exten ...
Vaxart(VXRT) - 2023 Q1 - Earnings Call Transcript
2023-05-04 22:10
Vaxart, Inc. (NASDAQ:VXRT) Q1 2023 Earnings Conference Call May 4, 2023 4:30 PM ET Company Participants Edward Berg - Senior Vice President and General Counsel Andrei Floroiu - Chief Executive Officer James Cummings - Chief Medical Officer Sean Tucker - Founder & Chief Scientific Officer Phil Lee - Chief Financial Officer Conference Call Participants Mayank Mamtani - B. Riley Securities Roger Song - Jefferies Operator Greetings and welcome to Vaxart Business Update and First Quarter 2023 Financial Results C ...
Vaxart(VXRT) - 2023 Q1 - Quarterly Report
2023-05-04 20:05
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 March 31, 2023 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 | | --- | ...
Vaxart(VXRT) - 2022 Q4 - Earnings Call Transcript
2023-03-16 00:51
Vaxart, Inc. (NASDAQ:VXRT) Q4 2022 Earnings Conference Call March 15, 2023 4:30 PM ET Company Participants Brant Biehn - Senior Vice President, Business Operations Andrei Floroiu - Chief Executive Officer James Cummings - Chief Medical Officer Sean Tucker - Founder & Chief Scientific Officer Phil Lee - Chief Financial Officer Conference Call Participants Charles Duncan - Cantor Fitzgerald Mayank Mamtani - B. Riley Securities Operator Greetings. Welcome to Vaxart Business Update and Full Year 2022 Financial ...
Vaxart(VXRT) - 2022 Q4 - Annual Report
2023-03-15 20:01
Financial Performance and Capital Needs - The company has incurred significant losses since inception, with an accumulated deficit of $327.1 million as of December 31, 2022[323]. - The company generated limited product revenue and expects to continue incurring substantial and increasing losses for the foreseeable future[322]. - The company has $95.7 million in cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2022, which is expected to fund operations for at least one year[331]. - The company may require additional capital to fund operations and complete the development and commercialization of its tablet vaccine candidates[330]. - The company expects significant additional capital will be needed in the future to continue planned operations, financing cash needs through equity offerings, royalties, debt financings, and strategic alliances[334]. - If the company raises additional funds through collaborations or licensing arrangements, it may have to relinquish valuable rights to technologies or future revenue streams[335]. - Significant additional capital will be needed for future operations, with potential financing through equity offerings, which may dilute existing stockholders' ownership[510]. Research and Development Challenges - The company anticipates significant increases in research and development expenses for its tablet vaccines, including those for norovirus, SARS-CoV-2, influenza, and RSV[323]. - The company is heavily dependent on the success of its tablet vaccine candidates for norovirus and coronavirus, which are still in early-stage clinical development[324]. - The company is in early stages of clinical development for tablet vaccine candidates for norovirus and seasonal influenza, requiring extensive additional clinical testing before submitting a Biologics License Application (BLA)[365]. - The company estimates that clinical trials necessary for BLA submissions will take several years to complete, with significant costs and risks associated with potential failures at any stage[365]. - The company acknowledges that success in preclinical testing does not guarantee success in later clinical trials, which may involve larger subject populations and different strains of viruses[366]. - The company may face delays in clinical trials due to various factors, including regulatory requirements, participant enrollment challenges, and potential negative trial results[368]. - The company anticipates significant delays in clinical trials due to factors such as difficulties in enrolling subjects and potential interruptions caused by the pandemic[377]. - Regulatory challenges, including potential delays in clinical trials and approvals, may hinder the development of product candidates[449]. Regulatory and Competitive Landscape - The regulatory pathway for the company's vaccine candidates is evolving, and unexpected challenges may arise due to the emergence of new variants[317]. - The company faces significant competition from other biotechnology and pharmaceutical companies in the vaccine development space[317]. - The company faces intense competition from larger pharmaceutical and biotechnology companies, which may have more resources and experience in obtaining regulatory approvals[381]. - There is currently no approved norovirus vaccine globally, but competitors like HilleVax, Inc. and Anhui Zhifei Longcom Biopharmaceutical Co. Ltd. are developing their own candidates[391]. - The COVID-19 vaccine market is highly competitive, with established products from Pfizer-BioNTech and Moderna dominating the market[392]. - The company may face challenges in obtaining marketing approvals due to potential adverse effects of its tablet vaccine candidates, which could delay or prevent commercialization[393]. - Regulatory approval processes are expensive and time-consuming, with no guarantee of success, and can vary significantly by jurisdiction[396]. - The company must navigate varying regulatory requirements across countries, which could delay or prevent the introduction of its tablet vaccine candidates in international markets[397]. Operational Risks and Challenges - The company relies on third-party contract manufacturers for certain portions of its manufacturing process, which could lead to delays or increased expenses if they do not perform as expected[317]. - The company has not yet produced a commercially viable vaccine and may never be able to do so[317]. - The company may experience difficulties in managing growth, which could disrupt operations and impact financial performance[353]. - The company faces challenges in attracting and retaining high-quality personnel due to competition from larger pharmaceutical firms with greater resources and career advancement opportunities[354]. - The company is currently involved in legal proceedings that may result in substantial costs and divert management's attention, potentially impacting financial condition and operational results[355]. - The company lacks infrastructure for sales, marketing, and distribution of its tablet vaccine candidates, which may hinder commercialization efforts[416]. - The company may face significant penalties and operational curtailments if it fails to comply with healthcare regulatory laws[404]. - The company is subject to stringent FDA regulations regarding post-approval marketing and promotion, which could impact its ability to market its products effectively[399]. Intellectual Property and Legal Risks - The success of the company heavily relies on obtaining and maintaining patent protection for its oral vaccine platform technology[485]. - There is a risk that patent applications may not result in issued patents, which could limit the company's ability to commercialize product candidates[486]. - The company may encounter challenges in patent validity and enforceability, which could impact its competitive position[491]. - Legal proceedings related to intellectual property could be costly and time-consuming, potentially harming the company's business[492]. - The company may need to obtain licenses for third-party patents, which may not be available on acceptable terms, affecting product development[497]. - Changes in U.S. patent law could diminish the value of patents, impacting the company's ability to protect its product candidates[501]. - The company may not be able to protect its intellectual property rights globally, allowing competitors to develop similar products in unprotected jurisdictions[502]. - The company may face claims regarding the wrongful use or disclosure of confidential information by employees, which could lead to litigation and potential loss of intellectual property rights[503]. Market and Revenue Considerations - The company anticipates that sales from its tablet vaccine candidates for coronavirus and norovirus, if approved, will generate substantially all of its revenues for the foreseeable future[403]. - The company earns royalty revenue from Inavir, which is subject to seasonal fluctuations, with low revenues typically occurring in the second and third fiscal quarters[428]. - The last patent related to Inavir will expire in December 2029, while the patent for the laninamivir octanoate compound expires in 2024, potentially leading to generic competition and decreased royalty income[429]. - The company faces significant competition from new products, including Xofluza, which has gained market share from Inavir in Japan, adversely affecting royalty payments[429]. - The company may experience fluctuations in royalty revenues due to the seasonal nature of influenza, which could impact operating results significantly[427]. - Changes in government reimbursement policies could negatively impact revenue and profitability[450]. - Market acceptance of product candidates is uncertain, and failure to gain acceptance could result in limited revenue generation[453].