A Phase 2, Double-Blind, Multi-Center, Randomized, Placebo-Controlled, Dose-Ranging Trial to Determine the Safety, Immunogenicity and Efficacy of an Adenoviral-Vector Based Vaccine Expressing Severe Acute Respiratory Syndrome (SARS-CoV-2) and dsRNA Adjuvant Administered Orally

Part 1: An open label, dose and age escalation phase to evaluate the safety and immunogenicity of VXA-CoV2-1.1-S with a repeat-dose vaccination schedule in healthy adults aged 18 - 75 years old that are either vaccine naive or have received prior vaccination with an mRNA (messenger ribonucleic acid) vaccine for the prevention of COVID-19.
Part 2: This phase will assess the efficacy of prophylactic VXA-CoV2-1.1-S against confirmed COVID-19 occurring from 7 days after second dose with a repeat-dose vaccination schedule in healthy adults compared to placebo. Safety and immunogenicity of VXA-CoV2-1.1-S will also be evaluated in this phase.

开始日期2021-10-01

申办/合作机构

Vaxart, Inc.

100 项与 S-only COVID-19 vaccines (Vaxart) 相关的临床结果

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100 项与 S-only COVID-19 vaccines (Vaxart) 相关的转化医学

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100 项与 S-only COVID-19 vaccines (Vaxart) 相关的专利（医药）

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项与 S-only COVID-19 vaccines (Vaxart) 相关的文献（医药）

2024-01-16·Cancers

COVID-19 Outcomes in Patients with Hematologic Malignancies in the Era of COVID-19 Vaccination and the Omicron Variant.

Article

作者: Joaquín Martínez-López ; Javier de la Cruz ; Rodrigo Gil-Manso ; Víctor Jiménez Yuste ; José María Aspa-Cilleruelo ; Cristian Escolano Escobar ; Javier López-Jiménez ; Rafael Duarte ; Cristina Jacome Yerovi ; José-Ángel Hernández-Rivas ; Regina Herráez ; Keina Quiroz-Cervantes ; Rosalía Bustelos-Rodriguez ; Celina Benavente ; Pilar Martínez Barranco ; Mariana Bastos Oteiro ; Adrián Alegre ; Jaime Pérez-Oteyza ; Elena Ruiz ; Eriel Alexis Marcheco-Pupo ; Ángel Cedillo ; Teresa de Soto Álvarez ; Patricia García Ramirez ; Rosalía Alonso Trillo ; Pilar Herrera ; María Luisa Bengochea Casado ; Andrés Arroyo Barea ; Jose Manuel Martin De Bustamante ; Javier Ortiz ; María Calbacho Robles ; Julio García-Suárez ; Asociación Madrileña de Hematología y Hemoterapia (AMHH)

A greater understanding of clinical trends in COVID-19 outcomes among patients with hematologic malignancies (HM) over the course of the pandemic, particularly the Omicron era, is needed. This ongoing, observational, and registry-based study with prospective data collection evaluated COVID-19 clinical severity and mortality in 1818 adult HM patients diagnosed with COVID-19 between 27 February 2020 and 1 October 2022, at 31 centers in the Madrid region of Spain. Of these, 1281 (70.5%) and 537 (29.5%) were reported in the pre-Omicron and Omicron periods, respectively. Overall, patients aged ≥70 years (odds ratio 2.16, 95% CI 1.64-2.87), with >1 comorbidity (2.44, 1.85-3.21), or with an underlying HM of chronic lymphocytic leukemia (1.64, 1.19-2.27), had greater odds of severe/critical COVID-19; odds were lower during the Omicron BA.1/BA.2 (0.28, 0.2-0.37) or BA.4/BA.5 (0.13, 0.08-0.19) periods and among patients vaccinated with one or two (0.51, 0.34-0.75) or three or four (0.22, 0.16-0.29) doses. The hospitalization rate (75.3% [963/1279], 35.7% [191/535]), rate of intensive care admission (30.0% [289/963], 14.7% [28/191]), and mortality rate overall (31.9% [409/1281], 9.9% [53/536]) and in hospitalized patients (41.3% [398/963], 22.0% [42/191]) decreased from the pre-Omicron to Omicron period. Age ≥70 years was the only factor associated with higher mortality risk in both the pre-Omicron (hazard ratio 2.57, 95% CI 2.03-3.25) and Omicron (3.19, 95% CI 1.59-6.42) periods. Receipt of prior stem cell transplantation, COVID-19 vaccination(s), and treatment with nirmatrelvir/ritonavir or remdesivir were associated with greater survival rates. In conclusion, COVID-19 mortality in HM patients has decreased considerably in the Omicron period; however, mortality in hospitalized HM patients remains high. Specific studies should be undertaken to test new treatments and preventive interventions in HM patients.

2021-09-01·Annals of medicine and surgery (2012)

Preparedness of current and future Saudi Pediatricians to face vaccine hesitancy: Cross-sectional study within the capital city of Saudi Arabia, Riyadh.

Article

作者: Yossef Alnasser ; Mahdi A Alnamnakani ; Jawahir M Abuhaimed ; Lulwah Z Alshiha ; Nouf M Alhamid ; Ghada A Alalshaikh

Background:

Vaccines have helped in eradicating many communicable diseases. They are considered major players in preserving children's health. However, concerns about vaccines' ingredients and safety became hot topics globally. With doubt, some parents became hesitant to vaccinate their children. A recent study documented high prevalence of vaccine hesitancy among Saudi parents.

Objectives:

This study aims to explore preparedness of current and future pediatricians to face vaccine hesitancy, a growing public health issue in Saudi Arabia.

Methods:

This study adopted non-interventional cross-sectional online questionnaire specifically designed to encompass general vaccine hesitancy related questions including Covid-19's vaccines.

Results:

The study recruited 119 participants form three main tertiary centers in Riyadh. Trainees were the majority with pediatric consultants representing 22%. Females were more than half of total participants (53%). Although familiarity with the term "vaccine hesitancy" was common, it was affected by training level. Among participants, 66% heard about it from social media. Furthermore, only 32% received designated training. Knowledge was suboptimal among all levels except for those who received formal training. Despite 80% encountered vaccine hesitancy, only 55% consider it a common public health issue. Attitude toward vaccine hesitant parents was negative among male physicians (odds ratio of 2.3, P value 0.045). Additionally, majority consider it a form of child neglect (95%). In regard to COVID19's vaccine, 31% were reluctant to get vaccinated themselves.

Conclusion:

Pediatric workforce in Saudi Arabia commonly encounters vaccine hesitancy. The strong stand against vaccine hesitant parents might affect rapport with families. Sub-optimal knowledge, negative attitude and emerging COVID19 vaccine hesitancy might negatively impact future efforts. Tailored training and innovative educational platforms are essentials to address vaccine hesitancy in Saudi Arabia.

2021-09-01·Clinical and experimental vaccine research

Are the COVID-19's vaccines efficient on the most dangerous variant of SARS-CoV-2?

Article

作者: Poorya Davoodi ; Atousa Hashemi

项与 S-only COVID-19 vaccines (Vaxart) 相关的新闻（医药）

2023-09-06

·BioSpace

Vaxart Announces Topline Data from the Phase 2 Challenge Study of its Monovalent Norovirus Vaccine Candidate

Study met 5 of 6 primary endpoints Vaccine was safe and well tolerated with no vaccine-related serious adverse events (SAEs) Vaccination led to a statistically significant reduction in infection rate, a non-statistically significant reduction in norovirus acute gastroenteritis (AGE), and a substantial reduction in viral shedding Conference call today at 5:00 p.m. ET SOUTH SAN FRANCISCO, Calif., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today 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. “Challenge studies use higher quantities of virus than an individual may encounter during a naturally occurring infection, yet our vaccine candidate demonstrated a significant effect on infection and viral shedding, even though it did not achieve a statistically significant reduction in norovirus AGE,” said Dr. James F. Cummings, Vaxart’s Chief Medical Officer. “The magnitude of the reduction in shedding could have an impact on transmission and may have important public health benefits, as norovirus spreads rapidly among people gathering in large numbers, including settings such as daycare centers, nursing homes, and workplaces, and may reduce the potential spread of the infection to families at home.” Key Study Findings: Primary Endpoints: 29% reduction in the rate of infection in the vaccinated cohort compared with placebo (82% vs. 58%) (p=0.003) 21% reduction in the rate of norovirus AGE in the vaccinated cohort compared with placebo (45% vs. 57%) that was not statistically significant (p=0.149) Significant increase in the induction of norovirus-specific IgA antibody-secreting cells (ASC) in the vaccinated cohort, with a 79% response rate in the vaccinated cohort, compared with 2.5% in the placebo cohort (p<0.001) on Day 8 post-vaccination; mean response was 375 ASC per million cells for the vaccinated cohort, compared with 26 ASC per million cells for placebo Significant increase in the induction of HBGA blocking anti-bodies in the vaccinated cohort (GMFR 3.23) compared with the placebo cohort (GMFR 1.0) on Day 29 post-vaccination (p<0.001) Significant increases in norovirus-specific serum IgA (GMFR 7.14) and IgG (GMFR 4.64) in the vaccinated cohort compared with placebo from baseline to Day 29 post-vaccination (p<0.001) No vaccine-related SAEs or dose-limiting toxicities were reported, consistent with the safety pro in all of Vaxart’s norovirus trials Pre-specified Analysis: 85% decrease in viral shedding in the vaccinated cohort compared with placebo No statistically significant difference in disease severity in the vaccinated cohort compared with placebo “The results of this study highlight the potentially distinctive pro mucosal vaccination and the potential that our oral pill vaccines may have in protecting against infection and blocking transmission – potential benefits that have also been seen with our influenza vaccine. We are excited to further our understanding of these data and determine the optimal path forward for our norovirus program,” added Dr. Cummings. 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. Next Steps 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. Conference Call The Vaxart senior management team will host a conference call to discuss the data, beginning at 5:00 p.m. ET today. The conference call can be accessed using the following information: Webcast: Click here Date: Wednesday, September 6, 2023 – 5:00 p.m. ET Domestic: 877-407-6184 International: 201-389-0877 Conference ID: 13740946 A replay of the webcast will be available for 30 days on Vaxart’s website at following the conclusion of the event. About Vaxart Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against norovirus, coronavirus, seasonal influenza, and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists. Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart's strategy, prospects, plans and objectives, results from preclinical and clinical trials and the timing of such results, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "should," "believe," "could," "potential," "will," "expected," “anticipate,” "plan," and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart's ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart's expectations regarding clinical results and trial data, and the timing of receiving and reporting such clinical results and trial data; and Vaxart's expectations with respect to the effectiveness of its product candidates. Vaxart may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement, and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart's product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart's product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart's or its partners' control; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain, and enforce necessary patent and other intellectual property protection; that Vaxart's capital resources may be inadequate; Vaxart's ability to resolve pending legal matters; Vaxart's ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the "Risk Factors" sections of Vaxart's Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law. Contacts Vaxart Media Relations: Mark Herr Vaxart, Inc. mherr@vaxart.com (203) 517-8957 Investor Relations: Andrew Blazier FINN Partners IR@vaxart.com (646) 871-8486

疫苗临床2期临床结果临床3期

2023-08-03

·BioSpace

Vaxart Provides Business Update and Reports Second Quarter 2023 Financial Results

On track to report topline data from Phase 2 GI.1 norovirus vaccine challenge study in Q3 2023 Cash runway extended into Q3 2024 Conference call today at 4:30 p.m. ET SOUTH SAN FRANCISCO, Calif., Aug. 03, 2023 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced its business update and financial results for the second quarter of 2023. “During the second quarter, we continued to advance our oral pill vaccine programs and deliver on our planned timelines for this year,” said Andrei Floroiu, Vaxart’s Chief Executive Officer. “Positive preliminary topline data from our Phase 2 bivalent norovirus vaccine candidate builds on the growing body of evidence supporting Vaxart’s platform and the potential advantages of mucosal vaccination. “We are excited about the potential for our norovirus vaccine program, the only one formulated for oral administration and delivery to the gastrointestinal system,” Mr. Floroiu continued. “We anticipate reporting topline data from our GI.1 norovirus challenge study during the third quarter, which will help inform the next steps for this program.” Recent Business Highlights Norovirus Vaccine Developments In July 2023, Vaxart reported positive preliminary topline data from the Phase 2 dose-ranging clinical trial of its oral pill bivalent norovirus vaccine candidate. The study met all primary endpoints, as the vaccine was well-tolerated with robust immunogenicity. Data from this study and from Vaxart’s forthcoming norovirus challenge study will help inform selection of the dose to be used in a larger Phase 2b study. These studies are expected to enable an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss plans for a Phase 3 trial. Vaxart now has obtained robust immunogenicity data from seven clinical trials in both young adults and elderly populations. These trials have shown a favorable safety profile, as the vaccine candidates have been well tolerated with no vaccine related serious adverse events. COVID-19 Vaccine Developments Vaxart continues to progress its COVID-19 vaccine program and believes the cross-reactivity of the current constructs suggests a pathway for developing a pan-betacoronavirus vaccine. The Company is assessing next steps. Anticipated 2023 Clinical Milestones Vaxart continues to make progress on its anticipated milestones in 2023: Topline data from the ongoing Phase 2 challenge study of Vaxart’s GI.1 norovirus vaccine candidate is expected in Q3 2023. Initiation of a Bill & Melinda Gates Foundation-funded clinical trial to evaluate the ability of Vaxart’s norovirus vaccine candidate to induce antibodies in breast milk and transfer of antibodies to young infants. Financial Results for the Three Months Ended June 30, 2023 Vaxart ended the second quarter of 2023 with cash, cash equivalents, restricted cash and marketable securities of $67.9 million, compared to $71.8 million as of March 31, 2023. The decrease was primarily due to cash used in operations, which was partially offset by $13.6 million of net proceeds from a public offering completed in June 2023. The offering extends the Company’s expected cash runway into the third quarter of 2024. Vaxart reported a net loss of $22.6 million for the second quarter of 2023, compared to $29.4 million for the second quarter of 2022. Net loss per share for the second quarter of 2023 was $0.16, compared to a net loss of $0.23 per share in the second quarter of 2022. Revenue for the second quarter of 2023 was $1.4 million, compared to no revenue in the second quarter of 2022. Revenue in the second quarter of 2023 was primarily from revenue recognized for work performed under Vaxart’s grant from the Bill & Melinda Gates Foundation. Research and development expenses were $18.8 million for the second quarter of 2023, compared to $19.9 million for the second quarter of 2022. The decrease was primarily due to decreases in manufacturing costs, personnel-related costs and clinical trial expenses related to the Company’s COVID-19 vaccine candidates, partially offset by increased clinical trial expenses related to its norovirus vaccine candidates. General and administrative expenses were $5.6 million for the second quarter of 2023, compared to $9.3 million for the second quarter of 2022. The decrease is primarily due to a decrease in litigation settlement cost, legal and professional fees and directors' and officers' insurance, partially offset by an increase in personnel stock-based costs. Conference Call The Vaxart senior management team will host a conference call to discuss the business update and financial results for the second quarter of 2023 today, beginning at 4:30 p.m. ET. The conference call can be accessed using the following information: Webcast: Click here Date: Thursday, August 3, 2023 – 4:30 p.m. ET Domestic: 877-407-0832 International: 201-689-8433 Conference ID: 13739413 Investors may submit written questions in advance of the conference call to ir@vaxart.com. A replay of the webcast will be available for 30 days on Vaxart’s website at following the conclusion of the event. About Vaxart Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against norovirus, coronavirus, seasonal influenza, and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists. Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart's strategy, prospects, plans and objectives, results from preclinical and clinical trials, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "should," "believe," "could," "potential," "will," "expected," “anticipate,” "plan," and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxart's ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart's expectations regarding clinical results and trial data; and Vaxart's expectations with respect to the effectiveness of its product candidates. Vaxart may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement, and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart's product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart's product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart's or its partners' control; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain, and enforce necessary patent and other intellectual property protection; that Vaxart's capital resources may be inadequate; Vaxart's ability to resolve pending legal matters; Vaxart's ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the "Risk Factors" sections of Vaxart's Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law. Contacts Vaxart Media Relations: Investor Relations: Mark Herr Andrew Blazier Vaxart, Inc. Finn Partners mherr@vaxart.com IR@Vaxart.com (203) 517-8957 (646) 871-8486 Vaxart, Inc. Condensed Consolidated Balance Sheets June 30, December 31, 2023 2022 (Unaudited) (1) (in thousands) Assets Cash, cash equivalents and restricted cash(2) $ 43,277 $ 46,013 Investments in marketable debt securities 24,628 49,704 Accounts receivable 29 20 Prepaid and other assets 4,835 7,282 Property and equipment, net 13,918 15,585 Right-of-use assets, net 26,804 25,715 Intangible assets, net 4,654 5,020 Goodwill 4,508 4,508 Total Assets $ 122,653 $ 153,847 Liabilities and stockholders’ equity Accounts payable $ 4,199 $ 5,514 Deferred grant revenue 275 2,000 Accrued and other liabilities 6,312 8,315 Operating lease liabilities 20,996 21,705 Liability related to sale of future royalties 5,798 5,716 Total liabilities 37,580 43,250 Stockholders’ equity 85,073 110,597 Total liabilities and stockholders’ equity $ 122,653 $ 153,847 (1) Derived from the audited consolidated financial statements of Vaxart, Inc. for the year ended December 31, 2022, included on the Form 10-K filed with the Securities and Exchange Commission on March 15, 2023. (2) Cash, cash equivalents and restricted cash includes $0.3 million and $2.0 million of restricted cash as of June 30, 2023 and December 31, 2022, respectively. Vaxart, Inc. Condensed Consolidated Statements of Operations (Unaudited) 3 Months Ended June 30, 6 Months Ended June 30, 2023 2022 2023 2022 (in thousands, except share and per share amounts) Revenue $ 1,358 $ - $ 2,033 $ 85 Operating expenses: Research and development 18,813 19,926 38,435 38,129 General and administrative 5,598 9,321 12,223 15,979 Total operating expenses 24,411 29,247 50,658 54,108 Loss from operations (23,053 ) (29,247 ) (48,625 ) (54,023 ) Other income and (expenses), net 522 (168 ) 983 (473 ) Loss before income taxes (22,531 ) (29,415 ) (47,642 ) (54,496 ) Provision for income taxes 19 15 48 35 Net loss $ (22,550 ) $ (29,430 ) $ (47,690 ) $ (54,531 ) Net loss per share, basic and diluted $ (0.16 ) $ (0.23 ) $ (0.35 ) $ (0.43 ) Shares used in computing net loss per share, basic and diluted 139,594,238 126,428,298 137,403,416 126,111,777

疫苗临床2期财报临床结果

2023-07-27

·GlobeNewswire-Health Care

Vaxart to Host Second Quarter 2023 Business Update and Financial Results Conference Call on August 3

Conference call to begin at 4:30 p.m. ET SOUTH SAN FRANCISCO, Calif., July 27, 2023 (GLOBE NEWSWIRE) -- Vaxart, Inc. (NASDAQ: VXRT) today announced it will provide a business update and report financial results for the second quarter ended June 30, 2023 after the market close on Thursday, August 3, 2023. The Vaxart senior management team will host a conference call on the same day, beginning at 4:30 p.m. ET. The conference call can be accessed using the following information: Webcast: Click hereDate: Thursday, August 3, 2023 – 4:30 p.m. ETDomestic: (877) 407-0832International: (201) 689-8433Conference ID: 13739413 Investors may submit written questions in advance of the conference call to ir@vaxart.com. A replay of the webcast will be available on the Company’s website at www.vaxart.com following the conclusion of the event. About VaxartVaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxart’s development programs currently include pill vaccines designed to protect against norovirus, coronavirus, seasonal influenza, and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxart’s first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists. Contacts Vaxart Media Relations:Investor Relations:Mark HerrAndrew BlazierVaxart, Inc.FINN Partnersmherr@vaxart.com IR@vaxart.com (203) 517-8957(646) 871-8486

疫苗财报

100 项与 S-only COVID-19 vaccines (Vaxart) 相关的药物交易

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研发状态

适应症	最高研发状态	国家/地区	公司
新型冠状病毒感染	临床2期	美国更多	Vaxart, Inc. 更多

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05067933 (Biospace) 人工标引	临床2期	新型冠状病毒感染	66	VXA-CoV2-1.1-S	(糧繭鹹齋襯選齋襯製窪) = 膚範夢願網鹹糧餘繭膚獵憲淵餘鏇願淵憲遞膚 (窪選淵鹹壓獵網願夢壓 ) 更多	积极	2022-09-01