Tillkännagivande • Jul 07
Vaxart Reports Topline 12-Month Safety Data from the 400-Participant Sentinel Safety Cohort of the Phase 2B Clinical Trial of Its Oral Pill Covid-19 Vaccine Vaxart reported topline data from the approximately 400-participant sentinel safety cohort of its Phase 2b clinical trial evaluating the Company’s oral pill COVID-19 vaccine candidate against an approved mRNA vaccine comparator. Participants in this safety cohort received Vaxart’s oral pill vaccine (201 participants dosed) or an approved mRNA vaccine (199 participants dosed) targeting the XBB strain of SARS-CoV-2, the virus that causes COVID-19. No vaccine-related serious adverse events (SAEs) or sustained Grade 3 or higher adverse events (AEs) were reported in either arm of the study. Data from the complete study, comprising the 400 dosed participants in the sentinel safety cohort and approximately 5,000 dosed participants in the main cohort, are currently anticipated in 2027. Participants in the main cohort received vaccines targeting the KP.2 viral strain prevalent at the time cohort dosing was initiated. Key topline 12-month results from the 400-participant sentinel safety cohort (201 oral vaccinees and 199 mRNA vaccinees) include: No vaccine-related serious adverse events (SAEs) or sustained Grade 3 or higher AEs were reported in either the oral pill vaccine or mRNA arms of the trial. The most common AEs in participants receiving the oral pill vaccine were malaise/fatigue (20.9%), headache (18.9%) and anorexia (10.0%). Fewer than 10% of participants experienced any other AE. The most common AEs in participants receiving the mRNA vaccine were injection site pain (60.3%), injection site tenderness (40.2%), malaise/fatigue (35.2%), myalgia/muscle pain (33.2%), and headache (28.6%). Arthralgia, chills, anorexia, nausea, diarrhea, and induration/swelling at the injection site were experienced by between 10-15% of participants. Fewer than 10% of participants experienced any other AE. With respect to the efficacy measure of symptomatic COVID, 33 participants in Vaxart’s oral pill vaccine arm and 30 participants in the injectable mRNA vaccine arm had symptomatic disease. Asymptomatic COVID cases were reported in 12 participants in the Vaxart oral pill arm and 12 in the mRNA vaccine arm. It should be noted that this 400-participant sentinel safety cohort was not powered to determine comparative efficacy between the two arms. Topline data from the complete study, comprising the 400 participants in the sentinel safety cohort and approximately 5,000 participants in the main cohort, are anticipated in 2027. The main cohort is designed and powered to support the planned statistical comparison of safety and relative efficacy outcomes between the two arms. Funding for this award was received under Project NextGen, an initiative by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), and the National Institute of Allergy and Infectious Diseases (NIAID) to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers. Vaxart’s project award through the Rapid Response Partnership Vehicle (RRPV) Consortium is valued at up to $344.8 million. This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50123D00005. Live-nyheter • Jul 03
Vaxart Settles Proxy Contest and Reshapes Board With New Governance Initiatives Vaxart has settled a proxy contest by signing a cooperation agreement with a stockholder group, which will withdraw its director nominations while the company appoints a mutually agreed independent director and introduces new board committees and refreshed governance policies ahead of its 2026 annual meeting.
The company is adding Stockholder Engagement and Clinical and Regulatory Affairs Committees, updating director stock ownership and resignation policies, and rotating committee leadership, which collectively reshape how Vaxart’s board oversees its vaccine pipeline and interacts with investors.
Vaxart shares trade at about $0.64, with the stock up 75.6% year to date, reflecting a period of pronounced volatility and shifting sentiment around the company.
This governance reset reduces the distraction of a contentious proxy fight and puts more formal focus on investor dialogue and clinical oversight, but it also raises the bar on execution as the new structures and director begin influencing pipeline priorities and capital decisions. Tillkännagivande • Jul 02
Vaxart, Inc. Announces Board and Committee Changes Vaxart, Inc. announced a resolution to the proxy contest in connection with the Company's 2026 Annual Meeting of Stockholders. Vaxart, Inc. initiated a search for an additional independent director to be conducted within 90 days of the conclusion of the 2026 Annual Meeting. Pursuant to a cooperation agreement between the Company and stockholders Daniel P. Houle, Mark Silverberg, DDS, MD, Matthew M. Wallace, MD, Patrice Raffy, Marc Eustace Pereira and Third Quarter Nominees Pty Ltd., the Company will work with the Stockholder Group to identify a mutually agreeable candidate to be appointed to the Board. The Stockholder Group agreed under the cooperation agreement to withdraw the director nominations of Mr. Houle, Dr. Silverberg and Dr. Wallace in connection with the 2026 Annual Meeting. The cooperation agreement additionally provided for the formation of a Stockholder Engagement Committee and a Clinical and Regulatory Affairs Committee, Board committee refreshment, including the selection of new chairs for the Nominating and Governance and Compensation Committees, the adoption of director stock ownership and resignation policies, as well as certain customary standstill, voting, engagement and other provisions. Tillkännagivande • Jun 26
Vaxart Provides Update to Barda Funding Award for Covid-19 Oral Pill Vaccine Trial Vaxart entered into a contract modification that releases additional funding from BARDA, through a contract with Advanced Technology International, to support continuation of the Company’s ongoing Phase 2b COVID-19 oral pill vaccine candidate and advance the next phase of data analysis. Overall funding available for the trial is now approximately $345 million, a decrease of approximately $116 million from its prior modification, following an approximately 50% reduction in participants enrolled in the trial as the result of a BARDA partial termination ordered on August 5, 2025. Per the Company’s contract with Advanced Technology International, the total funding amount available to Vaxart represents an estimate of the costs that will be incurred in the study as it is currently contemplated. The latest modification allows for the release of approximately $29 million for completion of the trial and exploratory analyses to further evaluate safety and efficacy, enabling Vaxart to conduct deeper analytics from the trial data set. Vaxart intends to report 12-month data from the 400-participant Sentinel Cohort in the coming weeks and 12-month data from the 5,085-participant main cohort in the first half of 2027. Funding for this award was received under Project NextGen, an initiative led by BARDA and the National Institute of Allergy and Infectious Diseases to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers. This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Other Transaction Number: 75A50123D00005. Vaxart’s development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus. Tillkännagivande • Jun 23
Daniel P. Houle Issues an Investor Presentation On June 22, 2026, Daniel P. Houle issued an investor presentation titled “A Case for Change at Vaxart”, and urged the shareholders of Vaxart, Inc to vote for his nominees; Daniel P. Houle, Mark Silverberg, and Matthew M. Wallace. Tillkännagivande • Jun 10
Daniel Houle Issues Letter to Shareholders of Vaxart On June 10, 2026, Daniel P. Houle issued letter to shareholders of Vaxart, Inc., seeking support to vote FOR accountability, transparency, and stockholder value by electing Daniel P. Houle, Mark Silverberg, and Matthew M. Wallace. In addition, Daniel P. Houle stating that the stockholders believe the Company possesses a unique technology platform, but stockholder value has remained compromised due to disappointing performance, declining market value, and insufficient engagement, and they call for restoring confidence, increasing transparency, improving communication, and ensuring stockholder interests are central to decision-making. Further, Daniel P. Houle stating that the nominees bring governance, healthcare, clinical, and operational expertise to strengthen oversight and accountability while supporting strategic partnerships, improved communication of the VAAST platform, rebuilding trust, and establishing committees to enhance regulatory oversight and stockholder relations. Furthermore, Daniel P. Houle in the letter concludes that the campaign is about improvement, accountability, and maximizing stockholder value, urging stockholders to vote for transparency, accountability, and stockholder representation. Tillkännagivande • Jun 09
Daniel P. Houle Provides Information to Shareholders of Vaxart On June 6, 2026, Daniel P. Houle posted a message on Stocktwits. Daniel P. Houle reposted the message on Stocktwits on June 7, 2026, and he anticipates reposting it daily on Stocktwits through the date of Vaxart, Inc.’s annual meeting. Tillkännagivande • May 21
Vaxart, Inc., Annual General Meeting, Jul 16, 2026 Vaxart, Inc., Annual General Meeting, Jul 16, 2026. Tillkännagivande • May 02
Vaxart, Inc. to Report Q1, 2026 Results on May 07, 2026 Vaxart, Inc. announced that they will report Q1, 2026 results After-Market on May 07, 2026 Tillkännagivande • Apr 25
Vaxart, Inc. Appoints James Breitmeyer, M.D., Ph.D., to Board of Directors Vaxart, Inc. announced the appointment of James Breitmeyer, M.D., Ph.D., to its Board of Directors. Dr. Breitmeyer brings more than 35 years of biopharmaceutical experience, having led clinical development programs resulting in eight FDA product approvals and numerous regulatory successes across the United States, Europe, and Japan. In February 2026, he joined Altay Therapeutics as CEO and Board Director, directing the advancement of the company’s pipeline of oral transcription factor therapies. He most recently served as the President and CEO of Oncternal Therapeutics, Inc., where he oversaw the clinical development of a diverse pipeline of first-in-class oncology assets. He also brings vaccine development expertise from his previous role as President of Bavarian Nordic, Inc., where he oversaw the development of cancer, infectious disease, and bioterrorism vaccines. Additionally, Dr. Breitmeyer held senior clinical leadership roles at Eli Lilly and Company and Cadence Pharmaceuticals, where he managed the transition of multiple candidates through the clinical and regulatory process toward successful commercial launch. His board experience includes previous director roles at Zogenix, Inc. and Otonomy, Inc., where he served on Audit and Compensation Committees. Previously, he held the position of President at Bavarian Nordic, Inc. and served as Executive Vice President and Chief Medical Officer at Cadence Pharmaceuticals. Dr. Breitmeyer also served as Vice President of Biotechnology at Eli Lilly and Company, where he was responsible for the corporate biotechnology pipeline. Earlier in his career, he held senior leadership roles at Applied Molecular Evolution and Serono Laboratories, where he led the development of therapies resulting in FDA approvals for Rebif® and Serostim®. Dr. Breitmeyer earned his M.D. and Ph.D. from Washington University School of Medicine. He completed postdoctoral fellowships at Harvard Medical School and the Dana-Farber Cancer Institute, where he also served as a clinical instructor. Tillkännagivande • Apr 18
Vaxart, Inc. announced that it expects to receive $25 million in funding from Lincoln Park Capital, LLC Vaxart, Inc. announces that it has entered into a purchase agreement with Lincoln Park Capital Fund, LLC to issue common stock for gross proceeds of $25,000,000 on April 16, 2026. The Commitment Shares were issued and the Purchase Shares will be issued and sold by the Company to Lincoln Park in reliance upon the exemptions from the registration requirements of the Securities Act afforded by Section 4(a)(2) of the Securities Act and/ or Rule 506(b) of Regulation D thereunder. Tillkännagivande • Jan 15
Vaxart, Inc. Publishes Positive Data for Its Oral Bivalent Norovirus Candidate in Lactating Women and Their Infants Vaxart, Inc. announced the publication in npj Vaccines of data from a double-blind, placebo-controlled Phase 1 trial evaluating a single-dose, oral bivalent vaccine candidate in post-partum, breast feeding women (NCT07254728). Topline safety and immunogenicity results in lactating women were initially reported in April 2024; the newly published study additionally shows vaccine-induced functional norovirus-specific antibodies in breastmilk and serum from vaccinated women, and norovirus-specific IgA in the stool of their breastfed infants. A positive correlation between levels of breast milk IgA and infant stool IgA was observed. There is no approved vaccine against norovirus, which sickens approximately 21 million people in the United States each year, including the 15% of children under age 5 who contract norovirus annually. As previously reported, the vaccine was safe and well tolerated, and reports of mild or moderate adverse events (AEs) were similar between the placebo group and each of the vaccine groups; no AEs beyond grade 2 were reported. Pending a partnership or other funding, Vaxart expects to initiate the next clinical trial of its norovirus oral vaccine candidate in 2026. Tillkännagivande • Nov 07
Vaxart, Inc. to Report Q3, 2025 Results on Nov 13, 2025 Vaxart, Inc. announced that they will report Q3, 2025 results After-Market on Nov 13, 2025 Tillkännagivande • Nov 06
Vaxart, Inc. has filed a Follow-on Equity Offering in the amount of $5 million. Vaxart, Inc. has filed a Follow-on Equity Offering in the amount of $5 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 11,111,111
Price\Range: $0.45
Transaction Features: Registered Direct Offering Tillkännagivande • Sep 20
Vaxart Receives a Letter from the Office of the General Counsel of Nasdaq As previously reported by Vaxart, Inc., on August 27, 2025, the Nasdaq Hearings Panel of The Nasdaq Stock Market LLC granted the Company’s request to continue its listing on Nasdaq subject to the Company’s (i) receipt of shareholder approval for a reverse stock split on or before September 5, 2025, (ii) completion of such reverse stock split on or before October 6, 2025, and (iii) demonstration of compliance with Nasdaq’s minimum bid price requirement (the “Panel’s Conditions”). On September 18, 2025, the Company withdrew its proposal to effect a reverse stock split of the Company’s common stock ahead of its adjourned special meeting of stockholders. On September 19, 2025, the Company received a letter from the Office of the General Counsel of Nasdaq, stating that the Company’s securities will be delisted from Nasdaq as a result of the Company’s noncompliance with the Panel’s Conditions. Trading in the Company’s common stock on Nasdaq was suspended at the open of trading on July 8, 2025. The Company’s common stock is currently quoted on the OTCQX® Best Market under the symbol “VXRT”. Tillkännagivande • Sep 12
Vaxart, Inc. Reports Additional Phase 1 Data Supporting the Potential Efficacy of Its Second-Generation Norovirus Oral Vaccine Candidate Vaxart, Inc. reported additional positive data from the Phase 1 clinical trial evaluating its second-generation oral pill norovirus vaccine constructs head-to-head against its first-generation constructs. Dr. Sean Tucker, Vaxart's Founder and Chief Scientific Officer, presented the data at the 9thInternational Calicivirus Conference, which is taking place in Banff, Canada, September 7-11, 2025. Further, Dr. Becca Flitter presented data on Vaxart's norovirus challenge study at the same conference. The data show a 25-fold increase in the GII.4 fecal IgA response and a 10-fold increase in the GI.I fecal IgA response over baseline with the high dose of the second-generation vaccine candidates after a single tablet administration for each strain. Norovirus blocking antibodies also correlated with protection against infection in the Phase 2b challenge study. Assuming a partnership or other funding, Vaxart plans to conduct a Phase 2b safety and immunogenicity study that could potentially begin before the end of 2025 followed by an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA). Tillkännagivande • Sep 10
Richard John Burgess Files an Exempt Solicitation Statement with Vaxart On September 10, 2025, Richard John Burgess, Daniel P. Houle, Michael Patrick Kelley, Marc Eustace Pereira, Patrice Raffy, Benjamin Sauv, Matthew M. Wallace, MD and David Whitney announced that they have filed an exempt solicitation statement with Vaxart Inc, to condemn Company board’s decision to adjourn reverse stock split vote at Special Meeting, where the vote was scheduled for September 5, 2025, but the Board adjourned the meeting to September 19, 2025, without disclosing voting results, despite a valid quorum. Richard John Burgess stated that the Company had received a compliance extension from Nasdaq with three conditions 1) Approval of the reverse split by September 5, 2025, 2) Completion of the split by October 6, 2025, 3) Regaining $1.00 minimum bid price by October 17, 2025, where the 1st condition was not met, raising concerns about the company’s compliance status, and it is the 2nd time the Board has delayed a vote on the reverse split, the Company board cited vague reasons for the adjournment, such as recent changes in Board composition and potential disclosures, but provided no specifics. In addition, Richard John Burgess requested for immediate release of voting results, clarification on Nasdaq compliance, details on governance changes. Tillkännagivande • Sep 03
Vaxart, Inc. Announces Retirement of Michael J. Finney from the Board of Directors and Science and Technology Committee, Effective September 30, 2025 Vaxart, Inc. announced that its Chairman, Michael J. Finney, Ph.D., has announced his retirement from the Company's Board of Directors and Science and Technology Committee after a distinguished tenure of service. His retirement will be effective September 30, 2025. The Board of Directors will meet this month to discuss Board leadership, Board composition and other governance issues, taking into account stockholder feedback, with the goal of continuing to advance the Company’s scientific progress. Tillkännagivande • Sep 02
Richard John Burgess Urges Vaxart’s Shareholders to Vote Against Reverse Stock Split On September 2, 2025, Richard John Burgess, Daniel P. Houle, Michael Patrick Kelley, Marc Eustace Pereira, Patrice Raffy, Benjamin Sauv, Matthew M. Wallace, MD and David Whitney announced that they have urged the Vaxart, Inc shareholders to vote against the Company’s proposed reverse stock split at the upcoming special meeting of stockholders scheduled to be held on September 5, 2025. In addition, Richard John Burgess stated that Company’s shareholders have repeatedly expressed a lack of confidence in the Board, and the Board continues to act unilaterally, ignore the will of the Company’s investors and insists on pursuing what we view as a value-destructive course of action, and concerned that a reverse stock split at this time would only reduce liquidity, increase volatility and potentially mask deeper structural issues, and mentioned that the proposal is not in the best interest of long-term stockholders. Tillkännagivande • Aug 22
Richard John Burgess Oppose Vaxart’s Latest Reverse Stock Split On August 21, 2025, Richard John Burgess, Daniel P. Houle, Michael Patrick Kelley, Marc Eustace Pereira, Patrice Raffy, Benjamin Sauv, Matthew M. Wallace, MD and David Whitney (collectively, the “Concerned Vaxart Stockholders”) announced that they have joined forces to demand accountability from Vaxart, Inc.’s board of directors and oppose the Company’s proposed reverse stock split at the Company’s special meeting of stockholders scheduled to be held on September 5, 2025. The Concerned Vaxart Stockholders added that they are deeply concerned that the Board has repeatedly disregarded the will of stockholders and refused to respect the outcome of stockholder votes. For instance, at the Company’s 2025 annual meeting of stockholders 4 out of 6 directors failed to receive a majority of votes cast in favor of their re-election and stockholders overwhelmingly opposed the reverse stock split and “say on pay” proposals. Instead of taking remedial actions to address this widespread stockholder discontent, all 6 directors continue to serve on the Board, and the Board is yet again seeking approval for a reverse stock split, this time at the Special Meeting, which is being held less than three months after the conclusion of the 2025 Annual Meeting where stockholders emphatically voted down a reverse stock split proposal. The Concerned Vaxart Stockholders urged all stockholders to vote against the reverse stock split at the Special Meeting. Tillkännagivande • Aug 07
Vaxart, Inc. to Report Q2, 2025 Results on Aug 13, 2025 Vaxart, Inc. announced that they will report Q2, 2025 results After-Market on Aug 13, 2025 Tillkännagivande • Jul 08
Vaxart, Inc.(NasdaqCM:VXRT) dropped from NASDAQ Composite Index Vaxart, Inc. has been dropped from the NASDAQ Composite Index . Tillkännagivande • Jul 02
Nasdaq Determines to Delist Vaxart Common Stock, Suspends Trading Effective July 08 As previously reported, on July 2, 2024, Vaxart, Inc. received a written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC notifying the Company that because the closing bid price for the Company’s common stock had fallen below $1.00 per share for 30 consecutive business days, it no longer complied with the minimum bid price requirement for continued listing under Nasdaq Listing Rule 5550(a)(2) on The Nasdaq Capital Market. The Company was provided until December 30, 2024, to regain compliance with the Minimum Bid Price Requirement. Also as previously reported, on December 31, 2024, the Company received an additional notification from the Staff that while the Company had not regained compliance with the Minimum Bid Price Requirement, it was eligible for an additional 180-day compliance period, or until June 30, 2025, to regain compliance with the Minimum Bid Price Requirement. On July 1, 2025, the Company received a written notification (the “Delisting Notice”) from the Staff of its determination to delist the Company’s common stock as a result of the Company’s ongoing failure to comply with the Minimum Bid Price Requirement. The Delisting Notice also stated that trading in the Company’s common stock will be suspended at the open of trading on July 8, 2025. If the Company fails to timely request a hearing by July 8, 2025, then the Hearings Department will take action to follow procedures to delist the Company’s common stock. The Company plans to timely request a hearing before a Nasdaq Hearings Panel (the “Panel”) pursuant to the procedures set forth in the Nasdaq Listing Rule 5800 Series and is considering all options with regard to its stock listing, including efforts to regain compliance with the Minimum Bid Price Requirement. However, pursuant to Nasdaq Listing Rule 5815(a)(1)(B)(ii)(d), a timely request for a hearing will stay delisting but will not stay the trading suspension of the Company’s common stock and the Company's securities will remain suspended unless the Panel Decision issued after the hearing ultimately determines to reinstate trading of the securities on Nasdaq. The Company expects that its common stock will begin trading publicly on the over-the-counter market on July 8, 2025, under its existing symbol “VXRT.” The Company has applied to be traded on the OTCQX tier of the OTC Market. However, there can be no assurance that the Company will be approved for trading on the OTCQX. Tillkännagivande • Jun 11
Vaxart, Inc. Reports Positive Clinical Data Demonstrating that its Second-Generation Vaccine Technology Produces Much Stronger Antibody Responses than its First-Generation Technology Vaxart, Inc. reported positive topline results from the Phase 1 clinical trial evaluating its second-generation oral pill norovirus vaccine constructs head-to-head against its first-generation constructs. The open-label, Phase 1 trial was conducted in 60 healthy volunteers who were randomized to receive the first-generation constructs, an equivalent dose of the second-generation GI.1 and GII.4 constructs, or a lower dose of the second-generation constructs (n=20 for each group). The primary immunological endpoint was norovirus blocking antibody assay (NBAA) titer at Day 0 and Day 28. In a Phase 2 challenge trial of the first-generation vaccine constructs, these functional NBAA titers correlated with protection against norovirus infection. Although the study was not powered to determine superiority by statistical methods, the increase in NBAA titers with the second-generation constructs was sufficiently large (141% for the GI.1 construct and 94% for the GII.4 construct) to demonstrate statistical significance at the higher dose. Key findings from the study show: Significantly increased GI.1 NBAA titers in the cohort receiving the high dose of the second-generation constructs compared with an equivalent dose of the first-generation constructs. A 141% increase in GI.1 NBAA titers was observed, which corresponds to a 3.2 increase in Geometric Fold Response (GMFR) from 2.2 to 5.4.Significantly increased GII.4 NBAA titers in the cohort receiving the high dose of the second-generation constructs compared with an equivalent dose of the first-generation constructs. A 94% increase in NBAA titers was observed, which corresponds to a 1.8 increase in GMFR from 1.9 to 3.7. The low dose of the second-generation constructs produced a numerical increase in NBAA titers compared with the first-generation constructs. 129% increase in NBAA titers for GI.1 was observed, which corresponds to a 2.9 increase in GMFR from 2.2 to 5.1.84% increase in NBAA titers for GII.4 was observed, which corresponds to a 1.6 increase in GMFR from 1.9 to 3.5.With respect to safety, all norovirus vaccine candidates evaluated in this study were well-tolerated, with no vaccine-related serious adverse events. Vaxart intends to publish the complete results of this study in a peer-reviewed journal. Assuming a partnership or other funding, Vaxart expects to conduct a Phase 2b safety and immunogenicity study that could potentially begin as early as the second half of 2025 followed by an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA). A Phase 3 trial could then begin as early as 2026.Vaxart’s oral pill technology works by inducing expression of antigen proteins in the cells of humans’ intestines. Vaxart’s second-generation technology was developed in 2023 and 2024 to achieve two purposes: first, to increase expression levels of the antigen proteins, and thus to greatly increase antibody titers; and second, to improve manufacturability. In pre-clinical experiments, the second-generation constructs substantially improved antibody responses in animal models. The trial reported today, for the updated norovirus vaccine candidate, is the first test in humans of the new technology. Vaxart has also adopted the new technology in its latest COVID-19 vaccine candidate and implemented these improvements throughout its portfolio. There is no approved vaccine against norovirus, a leading cause of acute gastroenteritis (AGE) worldwide that is responsible for outbreaks of infection and illness globally. Each year there are approximately 685 million norovirus infections globally, with 20 million infections occurring annually in the United States. Due to these high rates of infection, norovirus is believed to cause nearly 20% of diarrheal disease globally. Additionally, the economic burden associated with norovirus infection and AGE is estimated at $60 billion worldwide and $10 billion in the United States. New Risk • May 29
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$34m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-US$34m free cash flow). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$103m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (29% increase in shares outstanding). Tillkännagivande • May 28
Vaxart, Inc. Initiates Dosing in 10,000-Participant Portion of Phase 2b COVID-19 Trial Vaxart, Inc. announced the first patient was dosed in the 10,000-participant portion of its ongoing Phase 2b clinical trial evaluating its oral pill COVID-19 vaccine candidate. The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study. It is designed to evaluate the relative efficacy, safety, and immunogenicity of Vaxart's oral COVID-19 vaccine candidate compared to an approved mRNA COVID-19 vaccine in adults who have previously been vaccinated against COVID-19. This portion of the trial follows a positive review of the 30-day safety data from the sentinel cohort of 400 participants by an independent Data Safety Monitoring Board (DSMB). As announced previously, the DSMB recommended that the study proceed without modifications. Funding for this award was received under Project NextGen, an initiative by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), and the National Institute of Allergy and Infectious Diseases (NIAID) to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers. Vaxart’s project award through the Rapid Response Partnership Vehicle (RRPV) Consortium is valued at up to $460.7 million. This project has been funded with federal funds from BARDA, under Other Transaction (OT) number 75A50123D00005. New Risk • May 21
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings are forecast to decline by an average of 3.5% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$122m net loss in 3 years). Shareholders have been diluted in the past year (29% increase in shares outstanding). Major Estimate Revision • May 20
Consensus revenue estimates increase by 171% The consensus outlook for revenues in fiscal year 2025 has improved. 2025 revenue forecast increased from US$8.90m to US$24.2m. Forecast losses expected to reduce from -US$0.313 to -US$0.29 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$6.00 unchanged from last update. Share price rose 22% to US$0.51 over the past week. Reported Earnings • May 16
First quarter 2025 earnings released: US$0.068 loss per share (vs US$0.14 loss in 1Q 2024) First quarter 2025 results: US$0.068 loss per share (improved from US$0.14 loss in 1Q 2024). Revenue: US$20.9m (up US$18.7m from 1Q 2024). Net loss: US$15.6m (loss narrowed 36% from 1Q 2024). Revenue is forecast to grow 34% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 29% per year but the company’s share price has fallen by 51% per year, which means it is significantly lagging earnings. New Risk • May 14
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.3% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 0.3% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$118m net loss in 3 years). Share price has been volatile over the past 3 months (16% average weekly change). Shareholders have been diluted in the past year (29% increase in shares outstanding). Market cap is less than US$100m (US$94.6m market cap). Price Target Changed • May 04
Price target increased by 24% to US$6.00 Up from US$4.83, the current price target is an average from 2 analysts. New target price is 1,234% above last closing price of US$0.45. Stock is down 38% over the past year. The company is forecast to post a net loss per share of US$0.31 next year compared to a net loss per share of US$0.33 last year. Tillkännagivande • Apr 03
Vaxart, Inc., Annual General Meeting, May 21, 2025 Vaxart, Inc., Annual General Meeting, May 21, 2025. New Risk • Mar 30
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$96.0m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (31% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$111m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Market cap is less than US$100m (US$96.0m market cap). Major Estimate Revision • Mar 27
Consensus revenue estimates decrease by 77%, EPS upgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$39.0m to US$8.90m. EPS estimate increased from -US$0.38 to -US$0.313 per share. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target down from US$4.83 to US$4.67. Share price fell 19% to US$0.46 over the past week. Tillkännagivande • Mar 22
Vaxart, Inc. has filed a Follow-on Equity Offering in the amount of $50 million. Vaxart, Inc. has filed a Follow-on Equity Offering in the amount of $50 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Breakeven Date Change • Mar 21
No longer forecast to breakeven The 2 analysts covering Vaxart no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$11.5m in 2027. New consensus forecast suggests the company will make a loss of US$24.1m in 2027. Tillkännagivande • Mar 13
Vaxart, Inc. to Report Fiscal Year 2024 Results on Mar 20, 2025 Vaxart, Inc. announced that they will report fiscal year 2024 results After-Market on Mar 20, 2025 Tillkännagivande • Mar 11
Vaxart, Inc. Announces Clinical Trial Initiation of Norovirus Oral Pill Vaccine Candidate Vaxart, Inc. announced the initiation of a Phase 1, open label, dose ranging clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs. The Phase 1 trial is an open label, dose ranging clinical study designed to evaluate Vaxart's second-generation oral norov virus vaccine constructs head-to- head against its first-generation constructs". The study will measure safety and immune parameters that have correlated to protection in the completed norovirus challenge study. If the Phase 1 trial is successful, and assuming a partnership or other funding, Vaxart expects to conduct a Phase 2 safety and immunogenicity study that could potentially begin as early as the second half of 2025, followed by an End of Phase 2 meeting with the U.S. Food and Drug Administration (FDA). A Phase 3 trial could then begin as early as 2026. Tillkännagivande • Feb 11
Vaxart, Inc. Enters into Modification No. 5 (The “Modification”) to the ATI-RRPV Project Award Agreement Vaxart, Inc. entered into Modification No. 5 (the “Modification”) to the ATI-RRPV Project Award Agreement No. 001, dated June 13, 2024 (the “Project Agreement”), with Advanced Technology International, the Rapid Response Partnership Vehicle’s Consortium Management Firm funded by the Biomedical Advanced Research and Development Authority (“BARDA”) of the U.S. Department of Health and Human Services. As previously disclosed, pursuant to the Project Agreement, the Company received funding to conduct a Phase 2b comparative study (the “Trial”) evaluating the Company’s oral pill COVID-19 vaccine candidate against an mRNA vaccine comparator approved by the U.S. Food and Drug Administration. The Company previously announced that it had completed enrollment of the sentinel cohort portion of the study comprising approximately 400 patients comparing its oral pill XBB candidate against an mRNA XBB comparator and an independent data safety monitoring board recommended the study to proceed without modifications based on initial safety assessment of 30-day data from the sentinel cohort. The Modification increased the total amount of funding currently allotted to the Trial and available for payment to approximately $240.1 million, representing an increase of approximately $105.9 million. The Modification also clarifies the design of the Trial by specifying that the next portion of the Trial will compare the efficacy and safety of the Company’s KP.2 oral vaccine candidate against an mRNA comparator directed against KP.2, and will be comprised of 10,000 participants. The Company is awaiting approval from BARDA to commence dosing in the Trial. Tillkännagivande • Jan 30
Vaxart, Inc. Announces Board and Committee Changes Vaxart, Inc. announced the appointment of Kevin Finney to the Company’s Board of Directors, effective January 28, 2025. Mr. Finney is a seasoned healthcare executive and experienced board member who brings decades of industry leadership experience and operational expertise. Mr. Finney will serve as a member of the Audit and Nominating and Governance Committees of the Board. The Company also announced that Robert A. Yedid has stepped down from the Board of Directors, effective January 28, 2025. About Kevin Finney: Mr. Finney is an experienced biotech executive and director who has held numerous leadership roles in the healthcare industry, leading companies from early stages of development through commercialization. Mr. Finney currently serves as President and Chief Executive Officer of Autobahn Therapeutics and Chairman of its Board of Directors since 2019. Prior to joining Autobahn, Mr. Finney served as President, Chief Operating Officer, and a Director of Abide Therapeutics through the company’s acquisition by Lundbeck in 2019. Prior to this, Mr. Finney founded and served as the Chief Operating Officer of Zavante Therapeutics through the company’s acquisition by Nabriva Therapeutics in 2018. Mr. Finney previously spent a decade as Head of World-Wide Corporate Development at Allergan, Inc. Prior to Allergan, Mr. Finney held executive management roles at Prometheus Laboratories, Inc. (now Nestle Health Science), Amylin Pharmaceuticals, Inc. (now Bristol-Myers Squibb) and the Parke-Davis division of Warner-Lambert (now Pfizer). In addition to his role at Autobahn, Mr. Finney serves on the board of Eirion Therapeutics, and previously served on the boards of Elsie Biotechnologies (now GSK), Taris Biomedical (now J&J) and Anterios (now Allergan). Mr. Finney holds an MBA from the George L. Graziado School of Business, Pepperdine University, and a B.A. in exercise physiology from California State University Long Beach. Kevin Finney and Vaxart Board Chairman Dr. Michael J. Finney are not related. Mr. Finney was also appointed as a member of the Audit Committee and the Nominating and Governance Committee of the Board. On January 24, 2025, the Board also appointed Elaine J. Heron, Ph.D. as a member of the Compensation Committee of the Board, effective January 28, 2025. New Risk • Jan 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 50% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (50% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$41m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Tillkännagivande • Jan 15
Vaxart Highlights Progress of Covid-19, Norovirus and Influenza Programs Vaxart, Inc. provided business updates as the Company continues to advance its oral pill vaccine platform. An independent Data and Safety Monitoring Board (DSMB) recommended the continuation of the Phase 2b study. The DSMB reviewed 30-day safety data 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 FDA is reviewing the 30-day safety data from the sentinel cohort, and, upon favorable review, the study will progress following the Biomedical Advanced Research and Development Authority’s (BARDA’s) approval to the second part of the trial by enrolling approximately 10,000 participants. The primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination. Funding for this award was received under Project NextGen, a $5 billion initiative led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID) to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers. Vaxart’s project award through the Rapid Response Partnership Vehicle (RRPV) is valued at up to $460.7 million. This project has been funded with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); BARDA, under Other Transaction (OT) number 75A50123D00005. Vaxart will proceed with a Phase 1, open label, dose ranging clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs. The study will measure safety and immune parameters that have correlated to protection in the completed norovirus challenge study. The Phase 1 trial is expected to initiate in the first half of 2025 with topline data expected as early as mid-2025. If the Phase 1 trial is successful, the next step, pending a partnership or other funding, would be to conduct a Phase 2 safety and immunogenicity study that could potentially begin as early as the second half of 2025 followed by an End of Phase 2 meeting with the FDA. A Phase 3 trial could then begin as early as 2026. Vaxart continues to advance its avian influenza program. The Company previously published data demonstrating protection in a preclinical model against avian influenza after oral immunization (Clin Vaccine Immunol 2013). Vaxart recently created a new avian influenza vaccine candidate to cover the latest clade 2.3.4.4b. The Company is in the process of conducting several preclinical studies to evaluate the new construct and preparing to manufacture it for clinical use. Vaxart will publish the results of the preclinical studies when complete. Vaxart expected fees and reimbursements under its Project NextGen award of up to $460.7 million, combined with its existing cash, cash equivalents and investments, provides the Company with cash runway into 2026, funding multiple key clinical and regulatory milestones. Vaxart will explore various strategies to extend its cash runway through business development partnerships and non-dilutive funding options with the goal of achieving its upcoming clinical and regulatory milestones and maximizing shareholder value. Tillkännagivande • Jan 14
Vaxart Announces Favorable Dsmb Review of Sentinel Cohort from Covid-19 Phase 2B Clinical Trial Vaxart, Inc. announced that an independent DSMB, which conducted a planned review of the 30-day safety data from a sentinel cohort of 400 participants in its COVID-19 Phase 2b trial, has recommended that the study continue without any modifications. The FDA is reviewing the 30-day safety data from the sentinel cohort, and, upon favorable review as well as BARDA’s approval, the study will progress by enrolling approximately 10,000 participants. The trial will strive to enroll participants in line with U.S. demographics, as well as including at least 25% over the age of 65. The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate compared to an approved mRNA COVID-19 injectable vaccine, in adults previously immunized against COVID-19 infection. Funding for this award was received under Project NextGen, a $5 billion initiative led by BARDA and the National Institute of Allergy and Infectious Diseases to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers. Vaxart’s project award through the Rapid Response Partnership Vehicle is valued at up to $460.7 million. This project has been funded with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under Other Transaction number 75A50123D00005. As a pioneer of oral vaccines, Vaxart was the first U.S. company to complete a Phase 2 clinical trial of an oral vaccine for COVID-19. Tillkännagivande • Jan 01
Vaxart, Inc. Provides Nasdaq Bid Price Non-Compliance Update As previously reported, on July 2, 2024, Vaxart, Inc. (the Company") received a written notice (the Notice") from the Listing Qualifications Department (the Staff") of The Nasdaq Stock Market (Nasdaq") indicating that the Company is not in compliance with the $1.00 Minimum Bid Price requirement set in Nasdaq Listing Rule 5550(a)(2) (the Bid Price Requirement") for continued listing on The Nasdaq Capital Market. On December 31, 2024, Nasdaq notified the Company in writing (the Extension Letter") that while the Company had not regained compliance with the Bid Price Requirement, it was eligible for an additional 180-day compliance period, or until June 30, 2025, to regain compliance with the Bid Price Requirement. Nasdaq's determination was based on the Company having met the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market, with the exception of the Bid Price Requirement, and on the Company's written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. The Notice did not result in the immediate delisting of the Company's common stock from The Nasdaq Capital Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company originally had 180 calendar days, or until December 30, 2024, to regain compliance by maintaining a minimum closing bid price of at least $1.00 per share for a minimum of 10 consecutive trading days. Pursuant to the Extension Letter, the Company now has until June 30, 2025 to regain compliance with the Bid Price Requirement. If at any time during this second 180-day period the closing bid price of the Company's common stock is at least $1.00 per share for a minimum of 10 consecutive business days, Nasdaq stated that they will provide written confirmation of compliance and the matter will be closed. If the Company does not regain compliance during the second 180-day period, then Nasdaq will notify the Company of its determination to delist the Company's securities, at which point the Company would have an opportunity to appeal the delisting determination to a hearings panel. The Company intends to actively monitor the closing bid price of its common stock and is considering its options to regain compliance with the Bid Price Requirement. There can be no assurance that the Company will be able to regain compliance with the Bid Price Requirement or that the Company will otherwise remain in compliance with the other listing standards for The Nasdaq Capital Market. New Risk • Dec 28
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$41m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (50% increase in shares outstanding). Tillkännagivande • Dec 03
Vaxart Completes Enrollment of Sentinel Cohort in Phase 2b Study Evaluating Its COVID-19 Oral Pill Vaccine Candidate Vaxart, Inc. 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. An independent Data and Safety Monitoring Board (DSMB) and the U.S. Food and Drug Administration (FDA) will review 30-day safety data from the sentinel cohort. Upon favorable review by the DSMB and FDA, the study will progress after Biomedical Advanced Research and Development Authority (BARDA) approval to the second part of the trial by enrolling approximately 10,000 participants. The trial will strive to enroll participants in line with U.S. demographics, as well as including at least 25% over the age of 65. The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 infection. The full Phase 2b trial will measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and the incidence of adverse events. The primary endpoint is relative efficacy of Vaxart’s COVID-19 vaccine candidate compared to an approved mRNA comparator for the prevention of symptomatic disease. Primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination. Funding for this award was received under Project NextGen, a $5 billion initiative led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID) to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers. Vaxart’s project award through the Rapid Response Partnership Vehicle (RRPV) is valued at up to $456 million. This project has been funded with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); BARDA, under Other Transaction (OT) number 75A50123D00005. As a pioneer of oral vaccines, Vaxart was the first U.S. company to complete a Phase 2 clinical trial of an oral vaccine for COVID-19. Reported Earnings • Nov 15
Third quarter 2024 earnings: EPS and revenues exceed analyst expectations Third quarter 2024 results: US$0.062 loss per share (improved from US$0.11 loss in 3Q 2023). Revenue: US$4.93m (up 135% from 3Q 2023). Net loss: US$14.1m (loss narrowed 19% from 3Q 2023). Revenue exceeded analyst estimates significantly. Earnings per share (EPS) also surpassed analyst estimates by 41%. Revenue is forecast to grow 50% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 10% per year but the company’s share price has fallen by 56% per year, which means it is significantly lagging earnings. New Risk • Nov 15
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.9% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 1.9% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$13m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (50% increase in shares outstanding). Tillkännagivande • Nov 07
Vaxart, Inc. to Report Q3, 2024 Results on Nov 13, 2024 Vaxart, Inc. announced that they will report Q3, 2024 results After-Market on Nov 13, 2024 Tillkännagivande • Oct 01
Vaxart, Inc. Announces Initiation of Sentinel Cohort for Phase 2B Study Evaluating its Covid-19 Oral Pill Vaccine Candidate Vaxart, Inc. announced the initiation of the sentinel cohort of its Phase 2b clinical trial evaluating Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA vaccine comparator. The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxart’s oral pill COVID-19 vaccine candidate against an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 infection. The trial consists of two parts and will enroll healthy adults 18 years and older in the United States. The first part, for which funding is now approved, is a sentinel cohort comprised of 400 participants, with 200 receiving Vaxart’s COVID-19 vaccine candidate and 200 receiving an approved mRNA vaccine comparator. Once an independent Data and Safety Monitoring Board and FDA review the 30-day safety data of the 400 participants, the second part of the trial will proceed to enroll 10,000 participants. The trial will strive to enroll participants in line with U.S. demographics, as well as including at least 25% over the age of 65. The full Phase 2b trial will measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and the incidence of adverse events. The primary endpoint is relative efficacy of Vaxart’s COVID-19 vaccine candidate compared to an approved mRNA comparator for the prevention of symptomatic disease. Primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination. Funding for this award was received under Project NextGen, a $5 billion initiative led by the Biomedical Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases to accelerate and streamline the development of the next generation of innovative COVID-19 vaccines, therapeutics, and enablers. This project has been funded with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; BARDA, under Other Transaction number 75A50123D00005. As a pioneer of oral vaccines, Vaxart was the first U.S. company to complete a Phase 2 clinical trial of an oral vaccine for COVID-19. New Risk • Sep 11
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$62m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$62m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$84m net loss in 3 years). Shareholders have been diluted in the past year (50% increase in shares outstanding). Tillkännagivande • Aug 28
Vaxart Announces Publication in Vaccines of Preclinical Data Supporting the Potential of Its Mucosal Vaccine Technology Platform in Enabling Therapeutic Vaccination for Hpv-Related Cervical Dysplasia Vaxart, Inc. announced the publication of preclinical data demonstrating the potential of its mucosal vaccine technology platform in enabling therapeutic vaccination against HPV-related cervical dysplasia. The data show that Vaxart’s HPV vaccine constructs can stimulate a potent immune response against the HPV16 proteins E6 and E7 that are known to transform healthy cells into malignant cells. The data, reported in the current issue of Vaccines, also shows that administration of a mucosal vaccine against these proteins in mice with HPV-expressing tumors led to reductions in tumor size and increased survival. Persistent HPV infection plays a causative role in most cases of cervical dysplasia, which leads to cervical cancers if left untreated. While prophylactic HPV vaccines are highly effective if administered prior to infection; they have not demonstrated a therapeutic effect on established infections. In this study published in Vaccines, the therapeutic potential of this platform was assessed in mice bearing HPV-expressing tumors. Animals were treated with vaccine candidates expressing wildtype E6 and E7 antigens from HPV16, engineered E6 and E7 that disrupt their malignant transformation potential, and fragments of E6 and E7 predicted to stimulate an immune response. Key findings from the study include: All vaccines generated a specific T cell response to HPV16 E6 and E7 in mice. All vaccines caused significant reductions in tumor volume and increased survival compared to control groups. Concurrent administration of anti-PD-1 with vaccination further increased animal survival in small and large tumor models compared to vaccination alone. Vaccination led to significant increases in intra-tumoral T cells, including T cells that create a cytotoxic tumor environment, compared with an empty control vaccine. Vaccination led to the generation of antigen-specific cytotoxic T cells. These results suggest that rAd5 vaccines delivered to a mucosal surface may have therapeutic potential in the treatment of HPV-derived cervical dysplasia and might be used to stimulate immune responses against other cancer-related proteins. Vaxart is continuing to evaluate its HPV vaccine candidates. Major Estimate Revision • Aug 23
Consensus revenue estimates increase by 113%, EPS downgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$12.1m to US$25.8m. EPS estimate fell from -US$0.44 to -US$0.467 per share. Biotechs industry in the US expected to see average net income decline 14% next year. Consensus price target of US$4.83 unchanged from last update. Share price rose 22% to US$0.91 over the past week. Reported Earnings • Aug 11
Second quarter 2024 earnings: EPS and revenues miss analyst expectations Second quarter 2024 results: US$0.089 loss per share (improved from US$0.16 loss in 2Q 2023). Revenue: US$6.40m (up 371% from 2Q 2023). Net loss: US$16.5m (loss narrowed 27% from 2Q 2023). Revenue missed analyst estimates by 71%. Earnings per share (EPS) also missed analyst estimates. Revenue is forecast to grow 50% p.a. on average during the next 3 years, compared to a 23% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 1% per year but the company’s share price has fallen by 59% per year, which means it is significantly lagging earnings. Tillkännagivande • Aug 02
Vaxart, Inc. to Report Q2, 2024 Results on Aug 08, 2024 Vaxart, Inc. announced that they will report Q2, 2024 results After-Market on Aug 08, 2024 Tillkännagivande • Jul 06
Vaxart Receives Written Notice from Nasdaq Due to Non-Compliance with the Minimum Bid Price Requirement Set Forth in Nasdaq Listing Rule 5550(a)(2) for Continued Listing on the Nasdaq Capital Market On July 2, 2024, Vaxart, Inc. (the ‘Company’) received a written notice (the ‘Notice’) from the Listing Qualifications Department of The Nasdaq Stock Market (‘Nasdaq’) indicating that the Company is not in compliance with the $1.00 Minimum Bid Price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the ‘Bid Price Requirement’). The Notice does not result in the immediate delisting of the Company’s common stock from The Nasdaq Capital Market. The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share, and, based upon the closing bid price of the Company’s common stock for the 30 consecutive business days for the period of May 17, 2024 through July 1, 2024, the Company no longer meets this requirement. The Notice indicated that the Company will be provided 180 calendar days, or until December 30, 2024, in which to regain compliance, pursuant to Nasdaq Listing Rule 5810(c)(3)(A). If at any time during this 180 calendar day period the closing bid price of the Company’s common stock is at least $1.00 per share for a minimum of ten consecutive business days, the Nasdaq staff (the ‘Staff’) stated that it will provide the Company with a written confirmation of compliance and the matter will be closed. However, under Nasdaq Listing Rule 5810(c)(3)(A), the Staff may exercise its discretion to extend this ten day period as discussed in Rule 5810(c)(3)(H). Alternatively, if the Company fails to regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, the Company may be eligible for an additional 180 calendar day compliance period, provided that the Company (i) meets the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market (except for the Bid Price Requirement), and (ii) provides written notice to Nasdaq of its intention to cure this deficiency during the second compliance period by effecting a reverse stock split, if necessary. In the event the Company does not regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, and if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is not otherwise eligible, the Staff stated that it will provide the Company with notice that its securities will be subject to delisting. At that time, the Company may appeal the delisting determination to a Hearings Panel. The Company intends to actively monitor the closing bid price of its common stock and is considering its options to regain compliance with the Bid Price Requirement. There can be no assurance that the Company will be able to regain compliance with the Bid Price Requirement or that the Company will otherwise remain in compliance with the other listing standards for The Nasdaq Capital Market. Major Estimate Revision • Jun 16
Consensus revenue estimates increase by 865% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$2.59m to US$25.0m. Forecast losses expected to reduce from -US$0.575 to -US$0.553 per share. Biotechs industry in the US expected to see average net income decline 9.9% next year. Consensus price target up from US$5.00 to US$5.25. Share price fell 26% to US$0.57 over the past week. Price Target Changed • Jun 14
Price target increased by 11% to US$5.25 Up from US$4.75, the current price target is an average from 2 analysts. New target price is 817% above last closing price of US$0.57. Stock is down 40% over the past year. The company is forecast to post a net loss per share of US$0.55 next year compared to a net loss per share of US$0.57 last year. Reported Earnings • May 15
First quarter 2024 earnings: EPS in line with analyst expectations despite revenue beat First quarter 2024 results: US$0.14 loss per share (improved from US$0.19 loss in 1Q 2023). Revenue: US$2.18m (up 223% from 1Q 2023). Net loss: US$24.4m (loss narrowed 2.9% from 1Q 2023). Revenue is forecast to grow 52% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 8% per year but the company’s share price has fallen by 48% per year, which means it is performing significantly worse than earnings. Tillkännagivande • May 09
Vaxart, Inc. to Report Q1, 2024 Results on May 13, 2024 Vaxart, Inc. announced that they will report Q1, 2024 results at 4:00 PM, US Eastern Standard Time on May 13, 2024 Tillkännagivande • May 01
Vaxart, Inc., Annual General Meeting, Jun 11, 2024 Vaxart, Inc., Annual General Meeting, Jun 11, 2024, at 08:30 Pacific Standard Time. Agenda: To consider and elect the board of directors's six nominees for director to serve until the next annual meeting of stockholders or until their successors are duly elected and qualified; to consider and adopt an amendment to Restated Certificate of Incorporation to increase the authorized number of shares of our common stock to 350,000,000 shares; to approve, contingent upon approval of Proposal No. 2, an amendment and restatement of our 2019 Equity Incentive Plan to increase the number of shares of common stock reserved for issuance thereunder by 15,000,000 shares to 43,900,000 shares; and to transact such other business matters. Buy Or Sell Opportunity • Mar 18
Now 27% overvalued after recent price rise Over the last 90 days, the stock has risen 89% to US$1.16. The fair value is estimated to be US$0.91, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 38% over the last 3 years. Earnings per share has declined by 16%. For the next 3 years, revenue is forecast to grow by 53% per annum. Earnings are also forecast to grow by 32% per annum over the same time period. Tillkännagivande • Mar 08
Vaxart, Inc. to Report Fiscal Year 2023 Results on Mar 14, 2024 Vaxart, Inc. announced that they will report fiscal year 2023 results After-Market on Mar 14, 2024 Tillkännagivande • Jan 20
Nasdaq Notifies Vaxart's Eligibility for an Additional 180-Day Compliance Period, or Until July 15, 2024, to Regain Compliance with the Bid Price Requirement As previously reported, on July 21, 2023, Vaxart, Inc. (the “Company”) received a written notice (the “Notice”) from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market (“Nasdaq”) indicating that the Company is not in compliance with the $1.00 Minimum Bid Price requirement set in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the “Bid Price Requirement”). On January 19, 2024, Nasdaq notified the Company in writing (the “Extension Letter”) that while the Company had not regained compliance with the Bid Price Requirement, it was eligible for an additional 180-day compliance period, or until July 15, 2024, to regain compliance with the Bid Price Requirement. Nasdaq’s determination was based on the Company having met the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market, with the exception of the Bid Price Requirement, and on the Company’s written notice to Nasdaq of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split, if necessary. The Notice did not result in the immediate delisting of the Company’s common stock from The Nasdaq Capital Market. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company originally had 180 calendar days, or until January 17, 2024, to regain compliance by maintaining a minimum closing bid price of at least $1.00 per share for a minimum of 10 consecutive trading days. Pursuant to the Extension Letter, the Company now has until July 15, 2024 to regain compliance with the Bid Price Requirement. If at any time during this second 180-day period the closing bid price of the Company’s common stock is at least $1.00 per share for a minimum of 10 consecutive business days, Nasdaq stated that they will provide written confirmation of compliance and the matter will be closed. If the Company does not regain compliance during the second 180-day period, then Nasdaq will notify the Company of its determination to delist the Company’s securities, at which point the Company would have an opportunity to appeal the delisting determination to a hearings panel. The Company would remain listed on Nasdaq pending the hearings panel’s decision. The Company intends to actively monitor the closing bid price of its common stock and is considering its options to regain compliance with the Bid Price Requirement. There can be no assurance that the Company will be able to regain compliance with the Bid Price Requirement or that the Company will otherwise remain in compliance with the other listing standards for The Nasdaq Capital Market. Tillkännagivande • Jan 16
Vaxart, Inc. has filed a Follow-on Equity Offering in the amount of $10 million. Vaxart, Inc. has filed a Follow-on Equity Offering in the amount of $10 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 15,384,615
Price\Range: $0.65
Transaction Features: Registered Direct Offering Tillkännagivande • Dec 21
Vaxart, Inc. Announces Last Subject Dosed in Phase 1 Trial of Its Norovirus Vaccine Candidate in Lactating Mothers Vaxart, Inc. announced that it has completed enrollment and dosing in the Phase 1 clinical trial evaluating Vaxart’s oral pill bivalent norovirus vaccine candidate focused on lactating mothers. There is no approved vaccine against norovirus, which sickens approximately 21 million people in the United States each year, and 15% of children under age 5 contract norovirus annually. Approximately 3 million sets of parents are forced by this virus to miss work -- approximately 2.2 days on average -- to care for their children. The annual disease burden from norovirus is $10.6 billion in the U.S. alone. Globally, norovirus has become the leading cause of pediatric gastroenteritis in health care settings in countries that have adopted a rotavirus vaccine program. Pediatric deaths in the United States due to norovirus are rare, but they are much more common in the developing world. The Phase 1, multicenter, randomized, double-blind, placebo-controlled single dose, dose-ranging study is designed to evaluate the safety, tolerability, and immunogenicity of orally administered bivalent GI.1/GII.4 norovirus vaccine in healthy lactating females of at least 18 years of age. The study enrolled 76 subjects at five sites in South Africa. Subjects are randomized into high- or low-dose vaccine (N=30 for each arm) or placebo (N=16). The primary endpoints are: Frequency, duration and severity of solicited symptoms of reactogenicity (local and systemic) for one week following study drug dose; Frequency, duration and severity of unsolicited treatment-emergent adverse events (TEAEs), serious AEs (SAEs), adverse events of special interest (AESIs) and new onset of chronic illness (NOCIs) through the active period (four weeks post dose); Serum VP1-specific (GI.1 and GII.4) IgA on Day 1 (baseline), Day 8 and Day 29 (four weeks post last dose); Breastmilk VP1-specific (GI.1 and GII.4) IgA on Day 1 (baseline), Day 8 and Day 29 (four weeks post last dose). Major Estimate Revision • Nov 09
Consensus revenue estimates increase by 57% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$2.90m to US$4.57m. Forecast losses expected to reduce from -US$0.663 to -US$0.637 per share. Biotechs industry in the US expected to see average net income growth of 0.9% next year. Consensus price target of US$4.50 unchanged from last update. Share price rose 17% to US$0.76 over the past week. Tillkännagivande • Nov 03
Vaxart Doses First Subject in Phase 1 Trial of its Norovirus Vaccine Candidate in Lactating Mothers Vaxart, Inc. announced it has dosed the first subject in its Phase 1 clinical trial evaluating Vaxart’s oral pill bivalent norovirus vaccine candidate focused on lactating mothers. Norovirus sickens approximately 21 million people in the United States each year, and 15% of children under age 5 contract norovirus annually. This would translate into about 3 million sets of parents needing to take time from work (approximately 2.2 days on average) to care for their children. Globally, in countries that have adopted a rotavirus vaccine program, norovirus has become the leading cause of pediatric gastroenteritis in health care settings. Pediatric deaths in the United States due to norovirus are rare, but they are much more common in the developing world. About the VXA-NVV-108 Clinical Trial: The Phase 1, multicenter, randomized, double-blind, placebo-controlled single dose, dose-ranging study is designed to evaluate the safety, tolerability, and immunogenicity of orally administered bivalent GI.1/GII.4 norovirus vaccine in healthy lactating females of at least 18 years of age and their breast-feeding infants (aged 30 days to 11 months). The study is expected to enroll approximately 76 subjects at seven sites in South Africa. Subjects will be randomized into high- or low-dose vaccine (N=30 for each arm) or placebo (N=16). The primary endpoints are: Frequency, duration and severity of solicited symptoms of reactogenicity (local and systemic) for one week following study drug dose; Frequency, duration and severity of unsolicited treatment-emergent adverse events (TEAEs), serious AEs (SAEs), adverse events of special interest (AESIs) and new onset of chronic illness (NOCIs) through the active period (four weeks post dose); Serum VP1-specific (GI.1 and GII.4) IgA on Day 1 (baseline), Day 8 and Day 29 (four weeks post last dose); Breastmilk VP1-specific (GI.1 and GII.4) IgA on Day 1 (baseline), Day 8 and Day 29 (four weeks post last dose). Tillkännagivande • Oct 27
Vaxart, Inc. to Report Q3, 2023 Results on Nov 02, 2023 Vaxart, Inc. announced that they will report Q3, 2023 results After-Market on Nov 02, 2023 New Risk • Oct 25
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$99.1m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-US$93m free cash flow). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$99m net loss in 3 years). Shareholders have been diluted in the past year (20% increase in shares outstanding). Revenue is less than US$5m (US$2.1m revenue). Market cap is less than US$100m (US$99.1m market cap). Tillkännagivande • Sep 07
Vaxart Announces Topline Data from the Phase 2 Challenge Study of Its Monovalent Norovirus Vaccine Candidate Vaxart, Inc. announced top-line data from the Phase 2 challenge study of its oral tablet monovalent norovirus vaccine candidate (NCT05212168). The Phase 2 challenge study enrolled 165 healthy adults, who were randomized 1:1 to receive Vaxart’s monovalent oral tablet vaccine targeting the norovirus GI.1 genotype or placebo. Four weeks after vaccination, subjects were challenged with GI.1 norovirus. The study achieved its primary endpoints of a statistically significant 29% reduction in the rate of norovirus infection between the vaccinated and placebo arms through Day 8 post challenge, a strong induction of norovirus-specific immunoglobulin A (IgA) and immunoglobulin G (IgG) antibodies, and other immune response endpoints. Vaccination also led to a reduction in norovirus AGE in the vaccine arm compared to placebo, but this was not statistically significant. In a prespecified analysis, the study also showed an 85% decrease in viral shedding in the vaccine arm compared with placebo. Norovirus is the leading cause of acute viral gastroenteritis in all age groups in the U.S. However, there are no approved vaccines for noroviruses. In the U.S. alone, the annual disease burden from norovirus is $10.6 billion, as on average norovirus causes 19 to 21 million cases of AGE, infects 15% of all children under the age of 5, and leads to 465,000 emergency department visits, 109,000 hospitalizations and 900 deaths. Vaxart believes the reduction in the rate of infection and increases in multiple immunologic endpoints in this challenge study support the potential for its norovirus vaccine program to provide significant public health benefit. The Company also believes that the numeric reduction in rate of AGE, while not statistically significant, is encouraging, especially given the high dose of challenge virus used in the study, compared with what would occur in a natural infection. Vaxart is currently conducting additional analyses of the data from this challenge study and its prior norovirus trials with the objectives of defining the timing of a larger phase 2b study, and identifying ways to reduce the size and duration of a subsequent Phase 3 registration study. New Risk • Aug 07
New major risk - Revenue and earnings growth Earnings have declined by 44% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$93m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings have declined by 44% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (20% increase in shares outstanding). Revenue is less than US$5m (US$2.1m revenue). Tillkännagivande • Jul 29
Vaxart, Inc. to Report Q2, 2023 Results on Aug 03, 2023 Vaxart, Inc. announced that they will report Q2, 2023 results After-Market on Aug 03, 2023 Tillkännagivande • Jul 27
Vaxart Receives Written Notice from the Listing Qualifications Department of the Nasdaq Regarding Non-Compliance with the $1.00 Minimum Bid Price Requirement On July 21, 2023, Vaxart, Inc. received a written notice from the Listing Qualifications Department of The Nasdaq Stock Market indicating that the Company is not in compliance with the $1.00 Minimum Bid Price requirement set in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market. The Notice does not result in the immediate delisting of the Company’s common stock from The Nasdaq Capital Market. The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share, and, based upon the closing bid price of the Company’s common stock for the 30 consecutive business days for the period of June 7 through July 20, 2023, the Company no longer meets this requirement. The Notice indicated that the Company will be provided 180 calendar days, or until January 17, 2024, in which to regain compliance, pursuant to Nasdaq Listing Rule 5810(c)(3)(A). If at any time during this 180 calendar day period the bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of ten consecutive business days, the Nasdaq staff (the ‘Staff’) stated that it will provide the Company with a written confirmation of compliance and the matter will be closed. However, under Nasdaq Listing Rule 5810(c)(3)(A), the Staff may exercise its discretion to extend this ten day period as discussed in Rule 5810(c)(3)(H). Alternatively, if the Company fails to regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, the Company may be eligible for an additional 180 calendar day compliance period, provided (i) it meets the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market (except for the Bid Price Requirement) and (ii) it provides written notice to Nasdaq of its intention to cure this deficiency during the second compliance period by effecting a reverse stock split, if necessary. In the event the Company does not regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, and if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is not otherwise eligible, the Staff stated that it will provide the Company with written notification that its securities are subject to delisting from The Nasdaq Capital Market. At that time, the Company may appeal the delisting determination to a Hearings Panel. The Company intends to actively monitor the closing bid price of its common stock and is considering its options to regain compliance with the Bid Price Requirement. Tillkännagivande • Jul 12
Vaxart, Inc. Announces Positive Preliminary Topline Data from Dose-Ranging Phase 2 Study of its Bivalent Norovirus Vaccine Candidate Vaxart, Inc. announced positive Topline data from the dose-ranging Phase 2 clinical trial of its oral pill bivalent norovirus vaccine candidate. Preliminary results of the trial (NCT05626803) showed robust serum immune responses across all doses at Day 29 relative to Day 1. Both doses showed a similar increase in serum antibody responses with no statistical difference between the medium and high dose arms. At Day 29, increases in serum IgA, IgG, and BT50, for both the GII.4 and GI.1 strains in the vaccine arms, were similar to those seen in previous norovirus studies conducted by Vaxart. Mucosal and cell-based assay data will be available at a later date. Results from this Phase 2 dose-ranging study also demonstrated that the bivalent norovirus vaccine candidate was well tolerated, with a favorable safety profile that included no vaccine-related serious adverse events (SAEs) and no dose limiting toxicity. Adverse event rates for both doses were similar to placebo. The study enrolled 135 healthy adults at three sites in the United States. The first 10 subjects received open label high-dose vaccine and the remaining subjects were randomized to high- or medium-dose vaccine (N=50 for each arm) or placebo (N=25). This is the seventh clinical trial completed in Vaxart’s norovirus program, and it supports previous findings of robust immunogenicity and benign tolerability. Collectively, the data from these completed trials have shown immune responses from Vaxart’s oral norovirus vaccine constructs to be strong, long-lasting, and comparable to natural infection. Final results could vary slightly from these preliminary data, and additional timepoint measures and mucosal data from this study are expected in the second half of 2023. Vaxart’s Norovirus Program Next Steps: The data reported support the continued development of Vaxart’s oral norovirus vaccine candidate in adult populations and add to the growing body of evidence supporting its clinical utility. These data, along with upcoming topline data from the ongoing Phase 2 G1.1 challenge study, will inform dosage amounts for a bivalent norovirus Phase 2b study, the next step in progressing the vaccine candidate. The Phase 2b study is expected to add safety data that, if successful, will then enable Vaxart to schedule an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (the “FDA”), potentially in 2024. Data from the Phase 2 study announced on July 6, 2023, along with a future Phase 3 study, are required for a Biologics License Applications submission to the FDA as the Company pursues a commercial pathway for its bivalent norovirus candidate. 