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. 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. 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. 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. 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). 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 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. 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. Tillkännagivande • Jun 25
Vaxart, Inc.(NasdaqCM:VXRT) dropped from Russell 2000 Dynamic Index Vaxart, Inc.(NasdaqCM:VXRT) dropped from Russell 2000 Dynamic Index Tillkännagivande • Jun 07
Vaxart, Inc. Announces Last Subject Dosed in Phase 2 Trial of Its Bivalent Norovirus Candidate, and All Subjects Challenge Study of Monovalent Norovirus Candidate Vaxart, Inc. announced that the last subject has completed dosing in the Phase 2 clinical trial of its oral pill bivalent norovirus vaccine candidate. In addition, all patients have been challenged in its challenge study of its G.1.1 monovalent vaccine candidate. No vaccine related SAEs have been reported to date in either trial, consistent with the safety profile observed in all norovirus trials. Vaxart continues to expect to report topline data from the ongoing Phase 2 dose-ranging study (NCT05626803) of its bivalent norovirus vaccine candidate in mid-2023. The primary endpoints are safety and immunogenicity, with the objective of determining dose levels for Phase 3 development. The Company also expects to report topline data from the ongoing Phase 2 challenge study (NCT05212168) of Vaxart’s G1.1 monovalent norovirus vaccine candidate during Third Quarter 2023. Primary endpoints include safety and reduction in acute gastroenteritis (AGE) caused by norovirus infection, while additional endpoints include reduction in AGE severity, reduction in shedding, and immunogenicity, with the objective of determining efficacy against norovirus G1.1-induced AGE. Tillkännagivande • Feb 15
Vaxart, Inc. Doses First Subject in the Phase 2 Clinical Trial of Its Bivalent Norovirus Candidate Vaxart, Inc. announced that it has dosed the first subject in the Phase 2 clinical trial of its oral tablet bivalent norovirus candidate. The dose-ranging study is designed to identify a vaccine dose for a potential Phase 3 clinical trial. As previously reported, Vaxart’s bivalent vaccine candidate demonstrated robust immunogenicity, with an IgA ASC response rate of 78% for the GI.1 strain and 93% for the GII.4 strain, with no interference observed. This Phase 2 clinical trial is expected to enroll approximately 135 healthy adults at three sites in the United States. The first 10 subjects will receive open label high-dose vaccine and the remaining subjects will be randomized to high- or low-dose vaccine (N=50 for each arm) or placebo (N=25). The primary endpoints are safety and immunogenicity with the objective of determining dose levels for Phase 3 development. Vaxart expects to report topline data from the Phase 2 study in mid-2023. Vaxart’s bivalent norovirus oral tablet candidate is differentiated from other norovirus vaccines in development because it generates both systemic and mucosal immunity, is delivered through the mouth and is stable at room temperature, making it much easier to distribute and administer than injected vaccines. Tillkännagivande • Dec 20
Vaxart, Inc. Names Phillip Lee as Chief Financial Officer Vaxart, Inc. announced that it has appointed Phillip Lee as its Chief Financial Officer (CFO), effective immediately. Mr. Lee has almost 15 years of strategic finance and advisory experience in the biotechnology industry. During his career, he has helped raise over $1 billion of capital and worked on more than $20 billion of M&A transactions, including partnerships, asset acquisitions, mergers, spin-offs and royalty monetizations. Most recently, he was CFO and Chief Operating Officer at Clover Biopharmaceuticals and prior to that held finance leadership positions at several biotechnology companies. Mr. Lee began his career as an investment banker and was a principal and founding member of Centerview Partners’ healthcare advisory practice. Mr. Lee earned dual bachelor’s degrees in Electrical Engineering and Computer Sciences and Business Administration from the University of California, Berkeley. Tillkännagivande • Oct 21
Vaxart, Inc. to Report Q3, 2022 Results on Nov 08, 2022 Vaxart, Inc. announced that they will report Q3, 2022 results at 4:00 PM, US Eastern Standard Time on Nov 08, 2022 Tillkännagivande • Sep 02
Vaxart, Inc. Announces Positive Top-line Phase II Clinical Study Data Demonstrating Safety and Immunogenicity of Its Wuhan S-Only COVID-19 Pill Vaccine Candidate Vaxart, Inc. reported positive top-line data from the first part of a planned two-part Phase II study of its Wuhan S-only oral pill COVID-19 vaccine candidate, VXA-CoV2-1.1-S. The data demonstrate that the trial met its primary safety and secondary immunogenicity endpoints and will inform ongoing development of new Omicron-based vaccine constructs. Serum neutralizing antibodies rose after oral vaccination, and the increases were particularly notable in subjects who had previously received an mRNA vaccine. Additionally, all subjects who had a mucosal immune response to the Wuhan-based vaccine had mucosal immune responses that cross-reacted with the Omicron variants, including BA 4/5, as well as other coronaviruses. Vaxart is the first company to advance an oral pill COVID-19 vaccine to Phase II clinical development. Study Key Findings The VXA-CoV2-1.1-S vaccine construct was safe and well-tolerated. No vaccine-related solicited grade 3 adverse events (AEs) and no vaccine-related serious adverse events (SAEs) were reported. Vaccination with VXA-CoV2-1.1-S increased levels of SARS-CoV-2-specific serum IgG and IgA antibodies at Days 29 and 57. The geometric mean titer (GMT) increase of SARS-CoV-2-specific serum neutralizing antibodies from Day 1 to Day 57 ranged by cohort between 1.2- and 2-fold, with higher increases for higher doses. Among 18-55 year-old subjects previously vaccinated with mRNA vaccines, the geometric mean titer (GMT) of SARS-CoV-2-specific serum neutralizing antibodies increased 1.6-fold, from 481 AU/ml at Day 1 to 778 AU/ml at Day 57. The subjects who had lower starting titers showed greater increases after oral boosting. Approximately 50% of all subjects, as well as 50% of subjects that previously received an mRNA vaccine, had at least a 1.5-fold increase in mucosal IgA antibodies. All subjects who had a mucosal response to Wuhan S from VXA-CoV2-1.1-S (a Wuhan-based vaccine) also had mucosal immune responses that cross-reacted with the Omicron variants, including BA 4/5, as well as other coronaviruses. This includes subjects that had previously received an mRNA-based vaccine. SARS-CoV-2-specific T cell responses were observed in the majority of subjects after the second dose of VXA-CoV2-1.1-S. As previously announced, Vaxart is evaluating new Omicron-based constructs as Omicron-only monovalent vaccine candidates and as bivalent candidates in combination with the Company’s Wuhan constructs. Vaxart will also compare the clinical results of its S-only and S+N constructs to determine the best path forward in developing a vaccine that can hinder viral infection and transmission for current and emerging variants. These constructs are expected to be evaluated in preclinical models this year and to advance to clinical trials in the first half of 2023. The Company expects to move forward with the best possible vaccine constructs for its planned COVID-19 Omicron challenge in the second half of 2023 with hVIVO, as well as larger trials in the U.S. and internationally. Part 1 of the open-label, Phase II study enrolled 66 healthy adult volunteers, including subjects who had or had not received prior mRNA COVID-19 vaccination, ages 18-55 years and 56-75 years. Subjects were randomized into six cohorts stratified by age, vaccination history and dose. Subjects received either a high or a low dose of VXA-CoV2-1.1-S on Day 1 and Day 29, and immune responses were assessed prior to vaccine administration on Day 1, Day 29 and on Day 57. Tillkännagivande • Sep 01
Vaxart, Inc. Appoints Ray Stapleton as Chief Technology Officer Vaxart, Inc. announced that it has named Ray Stapleton, Ph.D., as its Chief Technology Officer (CTO), effective immediately. Dr. Stapleton joins Vaxart from Genocea, where he served as CTO and Executive Vice President, working to develop next generation personalized immunotherapies in the forms of vaccines and cell therapies. Dr. Stapleton joined Genocea in January 2021, bringing more than 20 years of industry experience to the company, having led technical, quality and manufacturing operations at commercial and clinical stage biopharmaceutical companies. Before that, he served as President and Chief Operating Officer of American Type Culture Collection (ATCC), as well as a member of the Board of Directors of both ATCC and ATCC Global. Prior to ATCC, Dr. Stapleton worked in senior manufacturing and technical operations roles at Iovance Biotherapeutics, Inc. and Synthetic Biologics, Inc. after spending 15 years in positions of increasing responsibility in Merck and Company's manufacturing organization. At Merck, Dr. Stapleton led a complex science, technology, and engineering organization at a manufacturing site responsible for supporting Merck's $5 billion annual revenue vaccine business. Dr. Stapleton earned a bachelor's degree in Biology from Mary Washington College in Fredericksburg, Virginia and received his PhD in Microbial Ecology from the University of Tennessee, Knoxville. He has served as peer reviewer for a half dozen scientific journals, co-authored 17 peer-reviewed manuscripts, and holds multiple patents. Tillkännagivande • Aug 26
Vaxart, Inc. Announces Board Changes Vaxart, Inc. announced that Elaine J. Heron, Ph.D. was appointed to the Company’s Board of Directors, effective August 25, 2022. The Company also announced that Dr. Julie Cherrington has stepped down from the Board of Directors, effective August 25, 2022. Dr. Heron will join the Board’s Science and Technology Committee as well as the Audit Committee, replacing Dr. Cherrington on those committees. Dr. Heron currently serves on the boards of BioMarin Pharmaceutical, Inc., a leader in developing and commercializing first- or best-in-class therapies for rare genetic diseases, Palvella Therapeutics, Inc., a private clinical-stage therapeutics company, Visgenx, Inc., a private early-stage therapeutics company, and Watershed Medical, Inc., a private early-stage therapeutics company. Dr. Heron also serves as an advisor to Kyto Technology and Life Science, Inc. From February 2009 to October 2015, Dr. Heron served as Chair and CEO of Amplyx Pharmaceuticals, Inc., a private drug development company acquired by Pfizer, Inc. From July 2001 to October 2008, Dr. Heron was Chair and CEO of Labcyte Inc., a private biotechnology company. Before joining Labcyte Inc., she spent six years in positions of increasing responsibility at the Applied Biosystems Group of Applera Corporation, a biotechnology company, including the position of General Manager and Vice President of Sales and Marketing. Dr. Heron earned a B.S. in chemistry with highest distinction, a Ph.D. in analytical biochemistry from Purdue University, and an M.B.A. from Pepperdine University. Tillkännagivande • Aug 09
Vaxart, Inc. Appoints W. Mark Watson to Its Board of Directors Vaxart, Inc. announced that W. Mark Watson was appointed to the Company’s Board of Directors, effective August 4, 2022. Mr. Watson will become Chair of the Company’s Audit Committee, effective October 1. Robert A. Ye did, a member of the Board and the Audit Committee, was appointed Interim Chairperson of the Audit Committee, to serve until Mr. Watson becomes Chair. The Company also announced that after years of service and dedication, Karen Wilson stepped down from the Board of Directors, effective August 4, 2022.Mr. Watson is a Certified Public Accountant with over 40 years of experience in public accounting and auditing, having spent his entire career from January 1973 to June 2013 at Deloitte Touche Tohmatsu and its predecessor, most recently as Central Florida Marketplace Leader. He has served as lead audit partner and lead client service partner on public companies ranging from middle market firms to Fortune 500 enterprises. Mr. Watson also serves as Chairman of the Board of Directors and Chairman of the Audit Committee of Inhibitor Therapeutics, Inc. He previously served as a director and member of the Audit Committee of Sykes Enterprises, Inc. and BioDelivery Sciences International, Inc. A member of American Institute of Certified Public Accountants and the Florida Institute of Certified Public Accountants, Mr. Watson is qualified to serve on the Board due to his expertise in public accounting and his experience with life science and pharmaceutical companies. He received his undergraduate degree in Accounting from Marquette University. Tillkännagivande • Jul 21
Vaxart, Inc. Publishes Clinical Data Suggesting its Oral COVID-19 Pill Vaccine Candidate Induces Long-Lasting Mucosal Immune Responses that are Highly Cross-Reactive Vaxart, Inc. reported additional phase 1 clinical data published on medRixv.org, indicating that its Spike/Nucleocapsid (S+N) oral tablet COVID-19 vaccine induced long-lasting mucosal IgA antibodies against SARS-CoV-2 the virus that causes COVID-19, and all tested coronaviruses. The neutralizing activity of these IgA antibodies in responders was higher than that measured in convalescent samples. Vaxart had previously disclosed results from this study showing its vaccine candidate was well-tolerated and immunogenic. This additional data supports its potential to improve immune responses at mucosal surfaces and improve public health responses to the COVID-19 pandemic. Vaxart intends to publish the complete data from the study in a peer-reviewed journal. The data reported now are from a phase 1 dose-ranging, open-label clinical trial (NCT04563702) in which the S+N vaccine candidate was evaluated in 35 healthy adult volunteers who tested negative for SARS-CoV-2 by PCR and rapid antigen tests. Subjects received a low dose with a boost at Day 29 or a single low or high dose of the S+N oral tablet vaccine candidate. Nasal samples were collected and analyzed for SARS-CoV-2-specific IgA. In the study, 46% of subjects had at least a 1.5-fold increase in SARS-CoV-2-specific secretory IgA compared with pre-vaccination levels. In a separate study, nasal and saliva samples were collected from individuals with prior SARS-CoV-2 infection. Analysis of nasal and saliva samples for neutralizing activity (sVNT) against SARS-CoV-2 showed that 50% of the vaccinated subjects had more neutralizing activity than those with prior infections, and this enhanced neutralizing capacity persisted 6 months post vaccination. Tillkännagivande • Jun 05
Vaxart, Inc. Presents New Preclinical Data Demonstrate Two of it's COVID-19 Vaccine Candidates Protect Against Omicron Vaxart, Inc. reported positive preliminary preclinical data demonstrating that two COVID-19 vaccine candidates targeting either the SARS-CoV-2 spike (S) protein for Wuhan or S protein for Omicron protected hamsters when challenged with the Omicron BA.1 variant. "Approved COVID-19 vaccines afford less protection against infection from new SARS-CoV-2 variants compared with the original parental strain against which they were developed. A broadly cross-reactive vaccine may be the most effective way to protect against current and future variants. The data reported are from a study in which the S-only Wuhan and Omicron vaccine candidates were compared in a hamster challenge model. Animals were immunized mucosally on days zero and 28 and challenged on day 56 with an Omicron varia of SARS-CoV-2-2. Both vaccines produced antibody responses to the S protein of Omicron, with the Omicron candidate slightly better at making serum IgG antibodies to the matched protein. Weight loss, lung viral titers, and viral shedding were reduced in animals receiving either vaccine candidate compared to unvaccinated animals. These findings demonstrate that in this preclinical model both vaccine candidates protect against the Omicron variant.t. Earlier this year, Vaxart announced that data from its non-human primate study showed that the S-only candidate generated antibodies to the original COVID-19 Wuhan strain and those antibodies also react strongly with the Beta, Delta, Alpha and Gamma variants of SARS-CoV-2 in the serum and nasal mucosa of non-human primates. Tillkännagivande • Jun 03
Vaxart Reports Positive Preliminary Data from the Phase 1b Trial of its Oral Norovirus Vaccine Candidates in Elderly Adults Vaxart reported positive preliminary data from its recently completed Phase 1b trial of its oral vaccine candidate in subjects aged 55 – 80 years (NCT04854746). Results of the trial show a robust immune response across all doses, with a dose-dependent production of IgA antibody secreting cells (ASCs), consistent with previous studies conducted in younger populations. The results also demonstrate that the vaccine candidate was well tolerated with a favorable safety profile. These data support the continued development of Vaxart’s oral norovirus vaccine candidate in adult populations, including elderly adults, and add to the growing body of evidence supporting its clinical utility. Vaxart is conducting a Phase 2 clinical challenge study of its norovirus vaccine candidate in adult volunteers. Norovirus is the leading cause of acute gastroenteritis that produces vomiting and diarrhea among people of all ages. The World Health Organization’s (WHO) Product Development for Vaccines Advisory Committee has identified norovirus as a priority disease for vaccine development. The virus causes up to 21 million cases, 109,000 hospitalizations and 900 deaths annually in the United States. Adults over the age of 65 years are especially vulnerable to norovirus infection, with 7.5% of this population infected annually. Norovirus also has a negative health economic impact, which has been estimated to cost $10.6 billion annually in the United States alone. Key findings from the Phase 1b study in elderly patients include: Robust immune response across all doses, with a dose dependent IgA ASC response IgA ASC responses were consistent with previous studies in younger subjects All solicited adverse events were mild or moderate with generally similar rates of events between the vaccine groups and placebo Vaxart is also reporting preliminary data from a Phase 1 boosting regimen of its norovirus vaccine candidate. These data show that the candidate was able to successfully boost antibody responses, with antibody responses trending better with administration spread out over 3 months versus a shorter interval. Vaxart has previously reported that booster administration at a year post first dose was able to return antibody titers to levels similar to what was observed after the first dose. Tillkännagivande • May 20
Vaxart Announces the Publication of Studies in the Peer-Reviewed Journal Science Translational Medicine That Suggest Mucosal Immunization Could Decrease SARS-CoV-2 Transmission Vaxart’s (NASDAQ: VXRT) S-only oral COVID-19 vaccine candidate inhibited the transmission of SARS-CoV-2. The report also described updated results from Vaxart’s Phase I clinical trial that suggest Vaxart’s other vaccine candidate, the one targeting both the S and N proteins, could be effective against a range of diverse coronaviruses. The study compared various measures of immunity and viral shedding in hamster cohorts immunized with Vaxart’s S-only vaccine candidate (administered orally and intranasally), an intramuscular protein vaccine control and placebo. The vaccinated hamsters were then infected with high doses of SARS-CoV-2 to create vaccine breakthrough and exposed to naïve animals during the breakthrough period. The study authors concluded that Vaxart’s S-only construct “reduced disease and decreased airborne transmission in a hamster model.” The publication also reported results from the Phase I clinical study of Vaxart’s S+N vaccine candidate showing that it stimulated SARS-CoV-2-specific IgA antibodies in saliva and nasal samples from human subjects and was cross-reactive to many different coronaviruses that are more divergent than circulating variants of SARS-CoV-2. The S-only data from the hamster transmission preclinical study was initially reported last October in the non-peer reviewed journal bioRxiv. Vaxart first reported the potential cross-reactive properties of its S+N vaccine candidate in May 2021. The new Science Translational Medicine publication includes additional detail regarding IgA antibody responses in human subjects. Vaxart has moved to Phase II clinical trials with the S-only vaccine candidate and expects to report those results later this year. Vaxart has also completed and published preliminary Phase I results from its S+N vaccine candidate. As previously stated, the company plans to compare the S-only and S+N vaccine candidates and to decide which approach offers the best way forward for its COVID-19 vaccine development program, particularly in the face of emerging variant strains. Tillkännagivande • Apr 01
Margaret Echerd Notifies as Senior Vice President and Principal Accounting Officer of Vaxart, Inc, Effective as of May 5, 2022 On March 28, 2022, Margaret Echerd notified Vaxart, Inc. that she intends to retire as Senior Vice President and Principal Accounting Officer, effective as of May 5, 2022. Reported Earnings • Feb 26
Full year 2021 earnings: EPS in line with expectations, revenues disappoint Full year 2021 results: US$0.58 loss per share (down from US$0.36 loss in FY 2020). Net loss: US$70.5m (loss widened 119% from FY 2020). Revenue missed analyst estimates by 12%. Over the next year, revenue is forecast to grow 1,526%, compared to a 61% growth forecast for the pharmaceuticals industry in Germany. Tillkännagivande • Feb 15
Vaxart, Inc. Appoints Edward B. Berg as Senior Vice President and General Counsel Vaxart, Inc. announced the appointment of Edward B. Berg as the Company's first in-house General Counsel and Senior Vice President, effective February 14, 2022. Mr. Berg has practiced law for more than 30 years and has represented Fortune 500 and mid-cap companies in biotechnology, pharmaceuticals and life sciences. He joins Vaxart from BioMarin Pharmaceutical Inc., where he served as VP, Deputy General Counsel since 2018. Board Change • Feb 14
High number of new and inexperienced directors There are 11 new directors who have joined the board in the last 3 years. The company's board is composed of: 11 new directors. No experienced directors. 1 highly experienced director. Independent Director Mike Finney is the most experienced director on the board, commencing their role in 2007. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Breakeven Date Change • Jan 21
Forecast to breakeven in 2024 The 5 analysts covering Vaxart expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$25.2m in 2024. Average annual earnings growth of 66% is required to achieve expected profit on schedule. Board Change • Jan 21
High number of new and inexperienced directors There are 11 new directors who have joined the board in the last 3 years. The company's board is composed of: 11 new directors. No experienced directors. 1 highly experienced director. Independent Director Mike Finney is the most experienced director on the board, commencing their role in 2007. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Breakeven Date Change • Jan 01
Forecast to breakeven in 2024 The 5 analysts covering Vaxart expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$25.2m in 2024. Average annual earnings growth of 65% is required to achieve expected profit on schedule. Tillkännagivande • Dec 17
Vaxart to Test Cross-Reactivity of Its Covid-19 Oral Tablet Vaccine Against Omicron Vaxart, Inc. said it plans to test the cross-reactivity of its oral tablet COVID-19 vaccine candidate against the Omicron SARS-CoV-2 variant in two different studies expected to begin next month. In the second study, Vaxart will conduct an animal Omicron challenge study to assess how its current Phase II COVID-19 vaccine candidate performs in comparison to an Omicron-specific vaccine candidate that Vaxart is developing. Vaxartdeliberately engineered its COVID-19 vaccine candidate to be cross-reactive against emerging variants based on Vaxart scientists’ early recognition of the risk of emerging variants of SARS-CoV-2. In May 2021, the Company announced Phase I clinical test results demonstrating that its vaccine candidate, VXA-CoV2-1, produced broad cross-reactive T cell and IgA responses against other, non-COVID coronaviruses. Injectable vaccines primarily stimulate serum IgG responses, but Vaxart’s COVID-19 vaccine candidate has been shown to trigger mucosal IgA in the nose, mouth and lungs, where SARS-CoV-2 infection occurs. Mucosal IgA antibodies contain four or more antigen-binding sites, while IgG antibodies contain only two. Breakeven Date Change • Dec 08
No longer forecast to breakeven The 5 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$6.39m in 2023. New consensus forecast suggests the company will make a loss of US$29.6m in 2023. Board Change • Dec 08
High number of new and inexperienced directors There are 11 new directors who have joined the board in the last 3 years. The company's board is composed of: 11 new directors. No experienced directors. 1 highly experienced director. Independent Director Mike Finney is the most experienced director on the board, commencing their role in 2007. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. 
