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[8-K] Beyond Air, Inc. Reports Material Event

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(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K
Rhea-AI Filing Summary

Beyond Air (NASDAQ: XAIR) reported several significant developments in this 8-K filing:

Key Events:

  • Released financial results for fiscal quarter and year ended March 31, 2025 (detailed results not provided in filing)
  • Appointed Robert Goodman to Board of Directors on June 16, 2025 - Qualified as independent director under Nasdaq standards - Notable experience with BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific, and Pfizer
  • Submitted PMA supplement application to FDA for LungFit PH II, their next-generation therapeutic nitric oxide generator

The company filed two press releases as exhibits (99.1 and 99.2) detailing the financial results and FDA submission respectively. The appointment of Goodman strengthens the board with extensive healthcare industry expertise, while the FDA submission represents a significant regulatory milestone for their therapeutic device development program.

Beyond Air (NASDAQ: XAIR) ha riportato diversi sviluppi importanti in questo deposito 8-K:

Eventi principali:

  • Pubblicati i risultati finanziari per il trimestre e l'anno fiscale terminati il 31 marzo 2025 (risultati dettagliati non forniti nel deposito)
  • Nomina di Robert Goodman nel Consiglio di Amministrazione il 16 giugno 2025 - Qualificato come direttore indipendente secondo gli standard Nasdaq - Esperienza significativa con BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific e Pfizer
  • Presentata una domanda di supplemento PMA alla FDA per LungFit PH II, il loro generatore terapeutico di ossido nitrico di nuova generazione

L'azienda ha depositato due comunicati stampa come allegati (99.1 e 99.2) che dettagliano rispettivamente i risultati finanziari e la presentazione alla FDA. La nomina di Goodman rafforza il consiglio con una vasta esperienza nel settore sanitario, mentre la presentazione alla FDA rappresenta una tappa regolatoria significativa per il loro programma di sviluppo del dispositivo terapeutico.

Beyond Air (NASDAQ: XAIR) informó varios desarrollos importantes en esta presentación 8-K:

Eventos clave:

  • Publicó resultados financieros para el trimestre fiscal y el año terminado el 31 de marzo de 2025 (resultados detallados no proporcionados en la presentación)
  • Nombró a Robert Goodman en la Junta Directiva el 16 de junio de 2025 - Calificado como director independiente según los estándares de Nasdaq - Experiencia destacada en BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific y Pfizer
  • Presentó una solicitud de suplemento PMA a la FDA para LungFit PH II, su generador terapéutico de óxido nítrico de próxima generación

La compañía presentó dos comunicados de prensa como anexos (99.1 y 99.2) que detallan los resultados financieros y la presentación a la FDA, respectivamente. El nombramiento de Goodman fortalece la junta con amplia experiencia en la industria de la salud, mientras que la presentación a la FDA representa un hito regulatorio importante para su programa de desarrollo de dispositivos terapéuticos.

Beyond Air (NASDAQ: XAIR)는 이번 8-K 보고서에서 여러 중요한 발전 사항을 보고했습니다:

주요 내용:

  • 2025년 3월 31일 마감 분기 및 회계연도 재무 결과 발표 (상세 결과는 보고서에 포함되지 않음)
  • 로버트 굿맨(Robert Goodman)을 2025년 6월 16일 이사회에 임명 - 나스닥 기준에 따른 독립 이사 자격 보유 - BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific, Pfizer에서의 풍부한 경험 보유
  • 차세대 치료용 일산화질소 발생기인 LungFit PH II에 대한 FDA PMA 보충 신청서 제출

회사는 재무 결과와 FDA 제출 관련 보도자료 두 건(첨부문서 99.1 및 99.2)을 제출했습니다. 굿맨의 임명은 의료 산업 분야의 폭넓은 전문성을 이사회에 더하며, FDA 제출은 치료 기기 개발 프로그램에서 중요한 규제 이정표를 의미합니다.

Beyond Air (NASDAQ : XAIR) a annoncé plusieurs développements importants dans ce dépôt 8-K :

Événements clés :

  • Publication des résultats financiers pour le trimestre et l'exercice clos le 31 mars 2025 (résultats détaillés non fournis dans le dépôt)
  • Nomination de Robert Goodman au conseil d'administration le 16 juin 2025 - Qualifié en tant qu'administrateur indépendant selon les normes Nasdaq - Expérience notable chez BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific et Pfizer
  • Dépôt d'une demande de supplément PMA auprès de la FDA pour LungFit PH II, leur générateur thérapeutique d'oxyde nitrique de nouvelle génération

La société a déposé deux communiqués de presse en annexes (99.1 et 99.2) détaillant respectivement les résultats financiers et la soumission à la FDA. La nomination de Goodman renforce le conseil d'administration avec une vaste expertise dans le secteur de la santé, tandis que la soumission à la FDA représente une étape réglementaire importante pour leur programme de développement de dispositifs thérapeutiques.

Beyond Air (NASDAQ: XAIR) meldete mehrere bedeutende Entwicklungen in dieser 8-K-Einreichung:

Wichtige Ereignisse:

  • Veröffentlichung der Finanzergebnisse für das Quartal und das Geschäftsjahr, das am 31. März 2025 endete (detaillierte Ergebnisse nicht in der Einreichung enthalten)
  • Ernennung von Robert Goodman in den Vorstand am 16. Juni 2025 - Qualifiziert als unabhängiges Vorstandsmitglied gemäß Nasdaq-Standards - Bedeutende Erfahrung bei BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific und Pfizer
  • Einreichung eines PMA-Ergänzungsantrags bei der FDA für LungFit PH II, ihren therapeutischen Stickstoffmonoxid-Generator der nächsten Generation

Das Unternehmen reichte zwei Pressemitteilungen als Anlagen (99.1 und 99.2) ein, die die Finanzergebnisse bzw. die FDA-Einreichung detaillieren. Die Ernennung von Goodman stärkt den Vorstand mit umfangreicher Erfahrung in der Gesundheitsbranche, während die FDA-Einreichung einen bedeutenden regulatorischen Meilenstein für ihr therapeutisches Geräteentwicklungsprogramm darstellt.

Positive
  • Submitted PMA supplement application to FDA for LungFit PH II, representing potential expansion of product portfolio with next-generation nitric oxide generator
  • Appointed Robert Goodman to Board of Directors, bringing valuable healthcare industry experience from leadership roles at BioTelemetry, Philips Healthcare, and Pfizer
Negative
  • None.

Insights

Beyond Air submits FDA approval application for next-gen LungFit PH II device while strengthening board with healthcare industry veteran.

This 8-K contains significant news with Beyond Air's submission of a Premarket Approval (PMA) supplement application to the FDA for their next-generation LungFit PH II nitric oxide generator. PMA supplements are typically filed when a company wants to make significant modifications to an already-approved medical device. This indicates Beyond Air is evolving its product line with potentially enhanced capabilities while building on their existing regulatory foundation. Rather than pursuing an entirely new PMA (which would be more time-consuming and costly), this supplement approach could accelerate market entry if approved.

The filing also reveals the appointment of Robert Goodman to the Board of Directors. Goodman brings valuable experience from both large companies (Philips Healthcare, Thermo Fisher Scientific, Pfizer) and specialized cardiac monitoring firms (BioTelemetry, Cardiocore). His background spanning public companies, PE-backed businesses, and early-stage ventures suggests Beyond Air is strengthening its board with expertise in scaling medical device commercialization. His military background could also benefit the company when navigating complex regulatory environments or government contracts.

While the filing mentions financial results were announced, it doesn't disclose the actual performance metrics, making it impossible to assess the company's current financial trajectory. This combined regulatory and governance update points to a company preparing for next-stage growth through product evolution and enhanced leadership.

Beyond Air (NASDAQ: XAIR) ha riportato diversi sviluppi importanti in questo deposito 8-K:

Eventi principali:

  • Pubblicati i risultati finanziari per il trimestre e l'anno fiscale terminati il 31 marzo 2025 (risultati dettagliati non forniti nel deposito)
  • Nomina di Robert Goodman nel Consiglio di Amministrazione il 16 giugno 2025 - Qualificato come direttore indipendente secondo gli standard Nasdaq - Esperienza significativa con BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific e Pfizer
  • Presentata una domanda di supplemento PMA alla FDA per LungFit PH II, il loro generatore terapeutico di ossido nitrico di nuova generazione

L'azienda ha depositato due comunicati stampa come allegati (99.1 e 99.2) che dettagliano rispettivamente i risultati finanziari e la presentazione alla FDA. La nomina di Goodman rafforza il consiglio con una vasta esperienza nel settore sanitario, mentre la presentazione alla FDA rappresenta una tappa regolatoria significativa per il loro programma di sviluppo del dispositivo terapeutico.

Beyond Air (NASDAQ: XAIR) informó varios desarrollos importantes en esta presentación 8-K:

Eventos clave:

  • Publicó resultados financieros para el trimestre fiscal y el año terminado el 31 de marzo de 2025 (resultados detallados no proporcionados en la presentación)
  • Nombró a Robert Goodman en la Junta Directiva el 16 de junio de 2025 - Calificado como director independiente según los estándares de Nasdaq - Experiencia destacada en BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific y Pfizer
  • Presentó una solicitud de suplemento PMA a la FDA para LungFit PH II, su generador terapéutico de óxido nítrico de próxima generación

La compañía presentó dos comunicados de prensa como anexos (99.1 y 99.2) que detallan los resultados financieros y la presentación a la FDA, respectivamente. El nombramiento de Goodman fortalece la junta con amplia experiencia en la industria de la salud, mientras que la presentación a la FDA representa un hito regulatorio importante para su programa de desarrollo de dispositivos terapéuticos.

Beyond Air (NASDAQ: XAIR)는 이번 8-K 보고서에서 여러 중요한 발전 사항을 보고했습니다:

주요 내용:

  • 2025년 3월 31일 마감 분기 및 회계연도 재무 결과 발표 (상세 결과는 보고서에 포함되지 않음)
  • 로버트 굿맨(Robert Goodman)을 2025년 6월 16일 이사회에 임명 - 나스닥 기준에 따른 독립 이사 자격 보유 - BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific, Pfizer에서의 풍부한 경험 보유
  • 차세대 치료용 일산화질소 발생기인 LungFit PH II에 대한 FDA PMA 보충 신청서 제출

회사는 재무 결과와 FDA 제출 관련 보도자료 두 건(첨부문서 99.1 및 99.2)을 제출했습니다. 굿맨의 임명은 의료 산업 분야의 폭넓은 전문성을 이사회에 더하며, FDA 제출은 치료 기기 개발 프로그램에서 중요한 규제 이정표를 의미합니다.

Beyond Air (NASDAQ : XAIR) a annoncé plusieurs développements importants dans ce dépôt 8-K :

Événements clés :

  • Publication des résultats financiers pour le trimestre et l'exercice clos le 31 mars 2025 (résultats détaillés non fournis dans le dépôt)
  • Nomination de Robert Goodman au conseil d'administration le 16 juin 2025 - Qualifié en tant qu'administrateur indépendant selon les normes Nasdaq - Expérience notable chez BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific et Pfizer
  • Dépôt d'une demande de supplément PMA auprès de la FDA pour LungFit PH II, leur générateur thérapeutique d'oxyde nitrique de nouvelle génération

La société a déposé deux communiqués de presse en annexes (99.1 et 99.2) détaillant respectivement les résultats financiers et la soumission à la FDA. La nomination de Goodman renforce le conseil d'administration avec une vaste expertise dans le secteur de la santé, tandis que la soumission à la FDA représente une étape réglementaire importante pour leur programme de développement de dispositifs thérapeutiques.

Beyond Air (NASDAQ: XAIR) meldete mehrere bedeutende Entwicklungen in dieser 8-K-Einreichung:

Wichtige Ereignisse:

  • Veröffentlichung der Finanzergebnisse für das Quartal und das Geschäftsjahr, das am 31. März 2025 endete (detaillierte Ergebnisse nicht in der Einreichung enthalten)
  • Ernennung von Robert Goodman in den Vorstand am 16. Juni 2025 - Qualifiziert als unabhängiges Vorstandsmitglied gemäß Nasdaq-Standards - Bedeutende Erfahrung bei BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific und Pfizer
  • Einreichung eines PMA-Ergänzungsantrags bei der FDA für LungFit PH II, ihren therapeutischen Stickstoffmonoxid-Generator der nächsten Generation

Das Unternehmen reichte zwei Pressemitteilungen als Anlagen (99.1 und 99.2) ein, die die Finanzergebnisse bzw. die FDA-Einreichung detaillieren. Die Ernennung von Goodman stärkt den Vorstand mit umfangreicher Erfahrung in der Gesundheitsbranche, während die FDA-Einreichung einen bedeutenden regulatorischen Meilenstein für ihr therapeutisches Geräteentwicklungsprogramm darstellt.

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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): June 18, 2025

 

Beyond Air, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware   001-38892   47-3812456

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

900 Stewart Avenue, Suite 301

Garden City, NY 11530

(Address of Principal Executive Offices and Zip Code)

 

(516) 665-8200

Registrant’s Telephone Number, Including Area Code

 

 

(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 (see General Instruction A.2. below):

 

Written communication 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(s)   Name of each exchange on which registered
Common Stock, par value $.0001 per share   XAIR   The Nasdaq Stock Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

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. ☐

 

 

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On June 17, 2025, Beyond Air, Inc. (the “Company”) issued a press release announcing financial results for its fiscal quarter and year ended March 31, 2025. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

This information, including the exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.

 

Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

Appointment of Director

 

On June 16, 2025, the Board of Directors (the “Board”) of the Company appointed Robert Goodman as a member of the Board. Mr. Goodman’s career spans public companies, private equity–backed businesses, and early-stage ventures, where has held leadership roles at BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific, and Pfizer. A retired U.S. Army officer, Mr. Goodman earned his undergraduate degree from Norwich University.

 

The Board has determined that Mr. Goodman qualifies as an independent director under the corporate governance standards of the Nasdaq Stock Market LLC. As of the time of this filing, the Board has not made a determination regarding the committees of the Board, if any, to which Mr. Goodman will be appointed. Mr. Goodman will receive typical compensation for his service as a non-employee member of the Board. 

 

There are no arrangements or understandings between Mr. Goodman and any other person pursuant to which he was selected as a director, and there are no transactions in which the Company is a party and in which Mr. Goodman has a material interest subject to disclosure under Item 404(a) of Regulation S-K. 

 

Item 8.01. Other Events.

 

On June 16, 2025, the Company issued a press release announcing that it submitted a premarket approval (PMA) supplement application to the U.S. Food and Drug Administration (FDA) for LungFit PH II, the next-generation therapeutic nitric oxide generator. A copy of the press release is filed as Exhibit 99.2 to this current report on Form 8-K and is incorporated by reference into this Item 8.01.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit

No.

  Description
99.1   Press Release of Beyond Air, Inc., dated as of June 17, 2025.
99.2   Press Release of Beyond Air, Inc., dated as of June 16, 2025.
104   Cover Page Interactive Data File (embedded within the inline XBRL document).

 

 

 

 

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.

 

  BEYOND AIR, Inc.
   
Date: June 18, 2025 By: /s/ Steven A. Lisi
  Name: Steven A. Lisi
  Title Chief Executive Officer

 

 

 

 

 

 

 

 

FAQ

What major events did XAIR (Beyond Air) announce in its June 2025 8-K filing?

XAIR announced three significant events: 1) The release of financial results for fiscal quarter and year ended March 31, 2025, 2) The appointment of Robert Goodman as a new Board member, and 3) The submission of a PMA supplement application to the FDA for LungFit PH II, their next-generation therapeutic nitric oxide generator.

Who is Robert Goodman and when was he appointed to XAIR's Board of Directors?

Robert Goodman was appointed to XAIR's Board on June 16, 2025. He's a retired U.S. Army officer with extensive healthcare industry experience, having held leadership positions at BioTelemetry, Philips Healthcare, Cardiocore, Thermo Fisher Scientific, and Pfizer. He qualifies as an independent director under Nasdaq standards and received his undergraduate degree from Norwich University.

What regulatory submission did XAIR make for LungFit PH II in June 2025?

On June 16, 2025, XAIR submitted a premarket approval (PMA) supplement application to the U.S. Food and Drug Administration (FDA) for LungFit PH II, which is their next-generation therapeutic nitric oxide generator.

When did XAIR release its fiscal year 2025 financial results?

XAIR issued a press release announcing its financial results for the fiscal quarter and year ended March 31, 2025 on June 17, 2025. The detailed financial results were included in Exhibit 99.1 of the 8-K filing.

What compensation will Robert Goodman receive as a new XAIR board member?

According to the filing, Mr. Goodman will receive typical compensation for his service as a non-employee member of the Board. The specific committee appointments and compensation details were not determined at the time of the filing.
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