STOCK TITAN

[8-K] Vaxart, Inc. Reports Material Event

Filing Impact
(Neutral)
Filing Sentiment
(Neutral)
Form Type
8-K

On October 8, 2025, Vaxart, Inc. disclosed that BARDA (through ATI) issued a Follow-Up Notice narrowing the scope of a Project Agreement to exclude "Paused Work." The company said ongoing activities will continue for the approximately 5,000 participants already enrolled in the Trial and that Vaxart will continue to receive funding to evaluate those participants. Vaxart stated it believes the Trial data from enrolled participants could provide useful insights and a foundation of evidence to potentially advance its COVID program. The filing clarifies these changes are furnished and not "filed" under Section 18, and it includes standard forward-looking statement language about risks and uncertainties.

Il 8 ottobre 2025, Vaxart, Inc. ha divulgato che BARDA (tramite ATI) ha emesso una Notifica di Follow-Up che restringe l'ambito di un Accordo di Progetto escludendo "Paused Work". L'azienda ha dichiarato che le attività in corso continueranno per circa 5,000 partecipanti già iscritti al Trial e che Vaxart continuerà a ricevere finanziamenti per valutare quei partecipanti. Vaxart ha affermato di ritenere che i dati del Trial provenienti dai partecipanti iscritti potrebbero fornire utili intuizioni e una base di evidenze per potenzialmente avanzare il proprio programma COVID. La documentazione chiarisce che tali cambiamenti sono forniti e non "filed" ai sensi della Sezione 18, e include una formulazione standard sulle dichiarazioni previsionali riguardo rischi e incertezze.

El 8 de octubre de 2025, Vaxart, Inc. dio a conocer que BARDA (a través de ATI) emitió una Notificación de Seguimiento que reduce el alcance de un Acuerdo de Proyecto para excluir "Paused Work". La empresa dijo que las actividades en curso continuarán para aproximadamente 5,000 participantes ya inscritos en el Ensayo y que Vaxart continuará recibiendo financiamiento para evaluar a esos participantes. Vaxart declaró que cree que los datos del Ensayo de los participantes inscritos podrían proporcionar ideas útiles y una base de evidencia para potencialmente avanzar su programa de COVID. La presentación aclara que estos cambios se proporcionan y no se "presentan" conforme a la Sección 18, e incluye un lenguaje estándar de declaraciones prospectivas sobre riesgos e incertidumbres.

2025년 10월 8일에 Vaxart, Inc.는 BARDA(ATI를 통해)가 프로젝트 계약의 범위를 축소하고 "Paused Work"를 제외하도록 하는 추후 통지를 발행했다고 밝혔습니다. 회사는 이미 시험에 등록한 대략 5,000명의 참가자에 대해 진행 중인 활동이 계속될 것이며 Vaxart가 해당 참가자들을 평가하기 위해 자금 지원을 계속받게 될 것이라고 말했습니다. Vaxart는 등록 참가자로부터 얻은 시험 데이터가 유용한 통찰력을 제공하고 코로나19 프로그램을 잠재적으로 진전시키기 위한 증거 기반이 될 수 있다고 밝혔습니다. 이 제출은 이러한 변경 사항이 "파일링"이 아니라 섹션 18에 따라 "제출"되었다고 명시하고, 위험과 불확실성에 대한 표준 예측성 진술 문구를 포함합니다.

Le 8 octobre 2025, Vaxart, Inc. a déclaré que BARDA (via ATI) a émis un avis de suivi réduisant la portée d'un accord de projet et excluant les « Paused Work ». La société a indiqué que les activités en cours se poursuivraient pour environ 5 000 participants déjà inscrits à l'essai et que Vaxart continuerait à recevoir un financement pour évaluer ces participants. Vaxart a déclaré estimer que les données de l'essai provenant des participants inscrits pourraient fournir des perspectives utiles et une base de preuves pour potentiellement faire progresser son programme COVID. Le dépôt précise que ces modifications sont fournies et non « déposées » en vertu de la Section 18, et il comprend un langage standard sur les déclarations prospectives concernant les risques et les incertitudes.

Am 8. Oktober 2025 hat Vaxart, Inc. bekannt gegeben, dass BARDA (durch ATI) eine Follow-Up-Mitteilung herausgegeben hat, die den Umfang einer Projektvereinbarung reduziert und "Paused Work" ausschließt. Das Unternehmen erklärte, dass laufende Aktivitäten für die ca. 5.000 Teilnehmer fortgesetzt werden, die sich bereits an der Studie beteiligt haben, und dass Vaxart weiterhin Mittel erhalten wird, um diese Teilnehmer zu bewerten. Vaxart sagte, dass die Studienergebnisse der eingeschriebenen Teilnehmer nützliche Einblicke liefern und eine evidenzbasierte Grundlage darstellen könnten, um sein COVID-Programm potenziell voranzubringen. Die Einreichung klärt, dass diese Änderungen bereitgestellt und nicht gemäß Abschnitt 18 "eingereicht" sind, und enthält übliche Formulierungen zu zukunftsgerichteten Aussagen über Risiken und Unsicherheiten.

في 8 أكتوبر 2025، أعلنت شركة Vaxart, Inc. أن BARDA (عبر ATI) أصدرت إخطار متابعة يضيق نطاق اتفاق مشروع لاستبعاد "Paused Work". وقالت الشركة إن الأنشطة الجارية ستستمر لما يقارب 5,000 من المشاركين الذين تم تسجيلهم بالفعل في التجربة، وأن Vaxart ستستمر في الحصول على تمويل لتقييم هؤلاء المشاركين. وأفادت Vaxart بأنها تعتقد أن بيانات التجربة من المشاركين المسجلين قد توفر رؤى مفيدة وأساساً من الأدلة لإحراز تقدم في برنامجها الخاص بـ COVID. توضح الوثيقة أن هذه التغييرات مُقدمة وليست "مقدمة" بموجب القسم 18، وتشتمل على عبارات معيارية حول التوقعات المستقبلية عن المخاطر والشكوك.

2025年10月8日,Vaxart, Inc. 公布 BARDA(通过 ATI)发布了一份后续通知,将一项项目协议的范围缩小,排除“Paused Work”。公司表示,正在进行的活动将继续覆盖已在试验中注册的约 5,000 名参与者,并且 Vaxart 将继续获得资金以评估这些参与者。Vaxart 表示,来自已注册参与者的试验数据可能提供有用的洞见,并为可能推进其 COVID 项目提供证据基础。该备案澄清这些变更是“提供”,而非根据第18条“提交”,并包含关于风险与不确定性的前瞻性声明的标准表述。

Positive
  • Funding continuity is preserved for evaluation of the approximately 5,000 enrolled participants
  • Substantial enrolled dataset remains available to inform the COVID program's development decisions
Negative
  • Project scope narrowed to exclude Paused Work, which may curtail future activities under the agreement
  • Uncertainty about future work under the Project Agreement could affect longer-term program support

Insights

Follow-Up Notice narrows work but preserves enrolled-trial data and funding.

The Follow-Up Notice limits the Project Agreement to exclude Paused Work, while confirming continued follow-up and funded evaluation for the roughly 5,000 enrolled participants. That preserves a sizable safety and efficacy dataset which can be analyzed to inform development decisions for the COVID program.

Key dependencies include the quality and completeness of the follow-up data, and whether the dataset meets regulatory standards for decision-making. Expect analysis and internal decision points over the coming months as data are reviewed.

Contract scope narrowed; funding for current participants remains but future work is excluded.

The notice appears to definitively delimit the Project Agreement to exclude Paused Work, which reduces the scope of obligations under that agreement. However, funding tied to evaluation of enrolled participants will continue, which mitigates immediate revenue disruption related to the active dataset.

Risks include potential termination or non-renewal of future work and the administrative process to codify scope changes. Monitor any follow-up documentation or budget adjustments affecting near-term cash flow and program timelines.

Il 8 ottobre 2025, Vaxart, Inc. ha divulgato che BARDA (tramite ATI) ha emesso una Notifica di Follow-Up che restringe l'ambito di un Accordo di Progetto escludendo "Paused Work". L'azienda ha dichiarato che le attività in corso continueranno per circa 5,000 partecipanti già iscritti al Trial e che Vaxart continuerà a ricevere finanziamenti per valutare quei partecipanti. Vaxart ha affermato di ritenere che i dati del Trial provenienti dai partecipanti iscritti potrebbero fornire utili intuizioni e una base di evidenze per potenzialmente avanzare il proprio programma COVID. La documentazione chiarisce che tali cambiamenti sono forniti e non "filed" ai sensi della Sezione 18, e include una formulazione standard sulle dichiarazioni previsionali riguardo rischi e incertezze.

El 8 de octubre de 2025, Vaxart, Inc. dio a conocer que BARDA (a través de ATI) emitió una Notificación de Seguimiento que reduce el alcance de un Acuerdo de Proyecto para excluir "Paused Work". La empresa dijo que las actividades en curso continuarán para aproximadamente 5,000 participantes ya inscritos en el Ensayo y que Vaxart continuará recibiendo financiamiento para evaluar a esos participantes. Vaxart declaró que cree que los datos del Ensayo de los participantes inscritos podrían proporcionar ideas útiles y una base de evidencia para potencialmente avanzar su programa de COVID. La presentación aclara que estos cambios se proporcionan y no se "presentan" conforme a la Sección 18, e incluye un lenguaje estándar de declaraciones prospectivas sobre riesgos e incertidumbres.

2025년 10월 8일에 Vaxart, Inc.는 BARDA(ATI를 통해)가 프로젝트 계약의 범위를 축소하고 "Paused Work"를 제외하도록 하는 추후 통지를 발행했다고 밝혔습니다. 회사는 이미 시험에 등록한 대략 5,000명의 참가자에 대해 진행 중인 활동이 계속될 것이며 Vaxart가 해당 참가자들을 평가하기 위해 자금 지원을 계속받게 될 것이라고 말했습니다. Vaxart는 등록 참가자로부터 얻은 시험 데이터가 유용한 통찰력을 제공하고 코로나19 프로그램을 잠재적으로 진전시키기 위한 증거 기반이 될 수 있다고 밝혔습니다. 이 제출은 이러한 변경 사항이 "파일링"이 아니라 섹션 18에 따라 "제출"되었다고 명시하고, 위험과 불확실성에 대한 표준 예측성 진술 문구를 포함합니다.

Le 8 octobre 2025, Vaxart, Inc. a déclaré que BARDA (via ATI) a émis un avis de suivi réduisant la portée d'un accord de projet et excluant les « Paused Work ». La société a indiqué que les activités en cours se poursuivraient pour environ 5 000 participants déjà inscrits à l'essai et que Vaxart continuerait à recevoir un financement pour évaluer ces participants. Vaxart a déclaré estimer que les données de l'essai provenant des participants inscrits pourraient fournir des perspectives utiles et une base de preuves pour potentiellement faire progresser son programme COVID. Le dépôt précise que ces modifications sont fournies et non « déposées » en vertu de la Section 18, et il comprend un langage standard sur les déclarations prospectives concernant les risques et les incertitudes.

Am 8. Oktober 2025 hat Vaxart, Inc. bekannt gegeben, dass BARDA (durch ATI) eine Follow-Up-Mitteilung herausgegeben hat, die den Umfang einer Projektvereinbarung reduziert und "Paused Work" ausschließt. Das Unternehmen erklärte, dass laufende Aktivitäten für die ca. 5.000 Teilnehmer fortgesetzt werden, die sich bereits an der Studie beteiligt haben, und dass Vaxart weiterhin Mittel erhalten wird, um diese Teilnehmer zu bewerten. Vaxart sagte, dass die Studienergebnisse der eingeschriebenen Teilnehmer nützliche Einblicke liefern und eine evidenzbasierte Grundlage darstellen könnten, um sein COVID-Programm potenziell voranzubringen. Die Einreichung klärt, dass diese Änderungen bereitgestellt und nicht gemäß Abschnitt 18 "eingereicht" sind, und enthält übliche Formulierungen zu zukunftsgerichteten Aussagen über Risiken und Unsicherheiten.

false 0000072444 0000072444 2025-10-08 2025-10-08
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported):
 
October 8, 2025
 
 
Vaxart, Inc.
 
 
(Exact name of registrant as specified in its charter)
 
 
 
Delaware
 
001-35285
 
59-1212264
(State or other jurisdiction of incorporation)
 
(Commission File Number)
 
(IRS Employer Identification No.)
         
170 Harbor Way, Suite 300, South San Francisco, California
 
94080
(Address of principal executive offices)
 
(Zip Code)
 
 
Registrant’s telephone number, including area code:
 
(650) 550-3500
 
 
 
Not Applicable
 
 
(Former name or former address, if changed since last report.)
 
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
 
Trading symbol
 
Name of each exchange on which registered
Common Stock, $0.0001 par value
 
VXRT
 
*
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging Growth Company          
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 
* The registrant’s common stock is quoted on the OTCQX® Best Market under the symbol “VXRT.”
 
 

 
Item 7.01
 
Regulation FD Disclosure.
 
As previously disclosed, on August 5, 2025, Vaxart, Inc. (the “Company”) received written notification (the “Previous Notice”) in the form of a stop work order, directing the Company to stop work on all of the Company’s efforts with respect to Project Agreement No. 01; RRPV-24-04-NGVx-003, as modified through June 13, 2024 (the “Project Agreement”), under the Consortium Base Agreement with ATI, 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 (such work subject to the foregoing stop work order, “Paused Work”). The Company was, however, permitted to continue efforts associated with the per protocol follow-up for the 10,000-person cohort, to the extent already dosed, in connection with the Phase 2b comparative study evaluating the Company's oral pill COVID-19 vaccine candidate (the “Trial”). The Company also disclosed that the Previous Notice further indicated that a follow-up notice with further details will follow.
 
On October 8, 2025, the Company received a notice (the “Follow-Up Notice”) from ATI, clarifying the scope of the Project Agreement. The Follow-Up Notice sets forth that BARDA intends to conclusively delimit the Project Agreement to exclude Paused Work. Despite this change, the approximately 5,000 participants already enrolled in the Trial will continue to be followed. Further, the Company will continue to receive funding with respect to its evaluation of the foregoing participants.
 
The Company believes that the Trial data from the enrolled participants will provide useful insights and a strong foundation of evidence that could potentially advance its COVID program.
 
The information in this Item 7.01 is being furnished and shall not be deemed “filed” with the Securities and Exchange Commission for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.
 
Forward-Looking Statements
 
Statements contained or incorporated by reference in this Current Report on Form 8-K, which relate to other than strictly historical facts such as statements about the Company’s expectations as to Trial results or data and its belief that such results or data will be sufficient to support any development decisions or regulatory approval. The words “believe,” “expect,” “intend,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date of this Current Report on Form 8-K. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, risks and uncertainties associated with the Company’s ability to achieve successful results in the Trial, the possibility that Trial outcomes may differ from current expectations of management, the Company’s continuing operating losses, and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other filings with the U.S. Securities and Exchange Commission. The Company undertakes no obligation to publicly update or revise any forward-looking statements, other than as may be required under applicable law.
 
 

 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
Date: October 10, 2025
 
VAXART, INC.
     
   
/s/ Steven Lo
   
Steven Lo
   
President and Chief Executive Officer
 
 

FAQ

What did Vaxart (VXRT) disclose on October 8, 2025?

Vaxart disclosed receipt of a Follow-Up Notice stating the Project Agreement will be conclusively limited to exclude Paused Work, while follow-up and funded evaluation will continue for about 5,000 enrolled Trial participants.

Will Vaxart still receive funding for the Trial?

Yes. The company said it will continue to receive funding specifically for evaluation of the existing enrolled participants.

How many participants are affected?

Approximately 5,000 participants already enrolled in the Trial will continue to be followed and evaluated.

Does this notice terminate Vaxart's entire Project Agreement with BARDA/ATI?

No. The notice narrows the agreement to exclude Paused Work but does not state the entire Project Agreement was terminated; follow-up for enrolled participants and related funding will continue.

Will the Trial data still be useful for Vaxart's COVID program?

Vaxart stated it believes the enrolled participants' data will provide useful insights and a foundation of evidence that could potentially advance its COVID program.
Vaxart Inc

OTC:VXRT

VXRT Rankings

VXRT Latest News

VXRT Latest SEC Filings

VXRT Stock Data

103.16M
225.15M
0.99%
9.94%
9.28%
Biotechnology
Biological Products, (no Disgnostic Substances)
Link
United States
SOUTH SAN FRANCISCO