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[8-K] Incannex Healthcare Limited American Reports Material Event

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

Incannex Healthcare Inc. (Nasdaq: IXHL) filed a Form 8-K on 8 Aug 2025 announcing that it has received “positive patient-reported outcomes and compelling Phase 2 efficacy data� for IHL-42X, its drug candidate for obstructive sleep apnoea (OSA). The disclosure is provided via a press release attached as Exhibit 99.1 and incorporated under Item 8.01; no financial statements or other quantitative information accompany the notice. The report, signed by CEO Joel Latham, signals meaningful clinical progress for a core pipeline asset but leaves key metrics—statistical significance, safety profile and regulatory timeline—undisclosed. Investors must consult the referenced press release for comprehensive data and next-step development plans.

Incannex Healthcare Inc. (Nasdaq: IXHL) ha presentato un modulo 8-K l'8 agosto 2025, annunciando di aver ricevuto “esiti positivi riportati dai pazienti e dati convincenti di efficacia della Fase 2� per IHL-42X, il suo candidato farmaco per l'apnea ostruttiva del sonno (OSA). La comunicazione è fornita tramite un comunicato stampa allegato come Exhibit 99.1 e incorporato sotto l'Elemento 8.01; la notifica non include bilanci o altre informazioni quantitative. Il rapporto, firmato dall'amministratore delegato Joel Latham, segnala un progresso clinico significativo per un asset chiave della pipeline, ma non rivela metriche fondamentali come la significatività statistica, il profilo di sicurezza e la tempistica regolatoria. Gli investitori devono consultare il comunicato stampa menzionato per dati completi e i piani di sviluppo futuri.

Incannex Healthcare Inc. (Nasdaq: IXHL) presentó un Formulario 8-K el 8 de agosto de 2025 anunciando que ha recibido “resultados positivos reportados por pacientes y datos convincentes de eficacia en la Fase 2� para IHL-42X, su candidato a medicamento para la apnea obstructiva del sueño (OSA). La divulgación se realiza mediante un comunicado de prensa adjunto como Exhibit 99.1 e incorporado bajo el Ítem 8.01; no se acompañan estados financieros ni otra información cuantitativa. El informe, firmado por el CEO Joel Latham, indica un progreso clínico significativo para un activo clave en la cartera, pero no revela métricas clave como la significancia estadística, el perfil de seguridad ni el cronograma regulatorio. Los inversores deben consultar el comunicado de prensa referido para obtener datos completos y los planes de desarrollo a seguir.

Incannex Healthcare Inc. (Nasdaq: IXHL)� 2025� 8� 8� Form 8-K� 제출하며 폐쇄� 수면 무호흡증(OSA) 치료� 후보� IHL-42X� 대� “환� 보고 긍정� 결과 � 설득� 있는 2� 효능 데이터�� 받았다고 발표했습니다. � 공시� Exhibit 99.1� 첨부� 보도자료� 통해 제공되며, 항목 8.01� 포함되어 있습니다. 재무제표� 기타 정량� 정보� 포함되어 있지 않습니다. CEO Joel Latham� 서명� � 보고서는 핵심 파이프라� 자산� 중요� 임상 진전� 알리지�, 통계� 유의�, 안전� 프로� � 규제 일정 � 주요 지표는 공개하지 않았습니�. 투자자들은 포괄적인 데이터와 향후 개발 계획� 위해 참조� 보도자료� 확인해야 합니�.

Incannex Healthcare Inc. (Nasdaq : IXHL) a déposé un formulaire 8-K le 8 août 2025, annonçant avoir reçu « des résultats positifs rapportés par les patients et des données d'efficacité convaincantes de phase 2 » concernant IHL-42X, son candidat médicament pour l'apnée obstructive du sommeil (AOS). La divulgation est fournie via un communiqué de presse joint en tant qu'Exhibit 99.1 et intégré à la rubrique 8.01 ; aucun état financier ni autre information quantitative n'accompagne l'avis. Le rapport, signé par le PDG Joel Latham, indique des progrès cliniques significatifs pour un actif clé du pipeline, mais ne révèle pas les indicateurs clés tels que la signification statistique, le profil de sécurité et le calendrier réglementaire. Les investisseurs doivent consulter le communiqué de presse référencé pour obtenir des données complètes et les plans de développement à venir.

Incannex Healthcare Inc. (Nasdaq: IXHL) reichte am 8. August 2025 ein Formular 8-K ein und gab bekannt, dass es „positive patientenberichtete Ergebnisse und überzeugende Wirksamkeitsdaten aus Phase 2� für IHL-42X, seinen Wirkstoffkandidaten gegen obstruktive Schlafapnoe (OSA), erhalten hat. Die Offenlegung erfolgt über eine als Exhibit 99.1 beigefügte Pressemitteilung, die unter Punkt 8.01 aufgenommen wurde; Finanzberichte oder weitere quantitative Informationen sind der Mitteilung nicht beigefügt. Der Bericht, unterzeichnet vom CEO Joel Latham, signalisiert bedeutende klinische Fortschritte für einen wichtigen Pipeline-Wirkstoff, lässt jedoch wichtige Kennzahlen � statistische Signifikanz, Sicherheitsprofil und regulatorischen Zeitplan � offen. Investoren sollten die referenzierte Pressemitteilung für umfassende Daten und weitere Entwicklungspläne konsultieren.

Positive
  • Phase 2 efficacy success for IHL-42X strengthens IXHL’s clinical pipeline and supports potential entry into the obstructive sleep apnoea market.
Negative
  • No quantitative efficacy or safety metrics released, preventing investors from gauging the magnitude and durability of the reported benefit.

Insights

TL;DR: Phase 2 success for IHL-42X is a pipeline de-risking event that could boost IXHL valuation, but detailed data still required.

The 8-K confirms positive Phase 2 outcomes for IHL-42X in OSA—a large, underserved market. Even without hard numbers, the language “compelling� and “positive patient-reported outcomes� implies clinically meaningful benefit, lowering development risk and strengthening IXHL’s negotiating position with potential partners. Absence of safety issues is inferred but not stated; investors should await full data to assess effect size, dosing and adverse events. If results hold, IXHL could progress to Phase 3, a key valuation inflection. Lack of financials is immaterial given the event-driven nature of the filing.

Incannex Healthcare Inc. (Nasdaq: IXHL) ha presentato un modulo 8-K l'8 agosto 2025, annunciando di aver ricevuto “esiti positivi riportati dai pazienti e dati convincenti di efficacia della Fase 2� per IHL-42X, il suo candidato farmaco per l'apnea ostruttiva del sonno (OSA). La comunicazione è fornita tramite un comunicato stampa allegato come Exhibit 99.1 e incorporato sotto l'Elemento 8.01; la notifica non include bilanci o altre informazioni quantitative. Il rapporto, firmato dall'amministratore delegato Joel Latham, segnala un progresso clinico significativo per un asset chiave della pipeline, ma non rivela metriche fondamentali come la significatività statistica, il profilo di sicurezza e la tempistica regolatoria. Gli investitori devono consultare il comunicato stampa menzionato per dati completi e i piani di sviluppo futuri.

Incannex Healthcare Inc. (Nasdaq: IXHL) presentó un Formulario 8-K el 8 de agosto de 2025 anunciando que ha recibido “resultados positivos reportados por pacientes y datos convincentes de eficacia en la Fase 2� para IHL-42X, su candidato a medicamento para la apnea obstructiva del sueño (OSA). La divulgación se realiza mediante un comunicado de prensa adjunto como Exhibit 99.1 e incorporado bajo el Ítem 8.01; no se acompañan estados financieros ni otra información cuantitativa. El informe, firmado por el CEO Joel Latham, indica un progreso clínico significativo para un activo clave en la cartera, pero no revela métricas clave como la significancia estadística, el perfil de seguridad ni el cronograma regulatorio. Los inversores deben consultar el comunicado de prensa referido para obtener datos completos y los planes de desarrollo a seguir.

Incannex Healthcare Inc. (Nasdaq: IXHL)� 2025� 8� 8� Form 8-K� 제출하며 폐쇄� 수면 무호흡증(OSA) 치료� 후보� IHL-42X� 대� “환� 보고 긍정� 결과 � 설득� 있는 2� 효능 데이터�� 받았다고 발표했습니다. � 공시� Exhibit 99.1� 첨부� 보도자료� 통해 제공되며, 항목 8.01� 포함되어 있습니다. 재무제표� 기타 정량� 정보� 포함되어 있지 않습니다. CEO Joel Latham� 서명� � 보고서는 핵심 파이프라� 자산� 중요� 임상 진전� 알리지�, 통계� 유의�, 안전� 프로� � 규제 일정 � 주요 지표는 공개하지 않았습니�. 투자자들은 포괄적인 데이터와 향후 개발 계획� 위해 참조� 보도자료� 확인해야 합니�.

Incannex Healthcare Inc. (Nasdaq : IXHL) a déposé un formulaire 8-K le 8 août 2025, annonçant avoir reçu « des résultats positifs rapportés par les patients et des données d'efficacité convaincantes de phase 2 » concernant IHL-42X, son candidat médicament pour l'apnée obstructive du sommeil (AOS). La divulgation est fournie via un communiqué de presse joint en tant qu'Exhibit 99.1 et intégré à la rubrique 8.01 ; aucun état financier ni autre information quantitative n'accompagne l'avis. Le rapport, signé par le PDG Joel Latham, indique des progrès cliniques significatifs pour un actif clé du pipeline, mais ne révèle pas les indicateurs clés tels que la signification statistique, le profil de sécurité et le calendrier réglementaire. Les investisseurs doivent consulter le communiqué de presse référencé pour obtenir des données complètes et les plans de développement à venir.

Incannex Healthcare Inc. (Nasdaq: IXHL) reichte am 8. August 2025 ein Formular 8-K ein und gab bekannt, dass es „positive patientenberichtete Ergebnisse und überzeugende Wirksamkeitsdaten aus Phase 2� für IHL-42X, seinen Wirkstoffkandidaten gegen obstruktive Schlafapnoe (OSA), erhalten hat. Die Offenlegung erfolgt über eine als Exhibit 99.1 beigefügte Pressemitteilung, die unter Punkt 8.01 aufgenommen wurde; Finanzberichte oder weitere quantitative Informationen sind der Mitteilung nicht beigefügt. Der Bericht, unterzeichnet vom CEO Joel Latham, signalisiert bedeutende klinische Fortschritte für einen wichtigen Pipeline-Wirkstoff, lässt jedoch wichtige Kennzahlen � statistische Signifikanz, Sicherheitsprofil und regulatorischen Zeitplan � offen. Investoren sollten die referenzierte Pressemitteilung für umfassende Daten und weitere Entwicklungspläne konsultieren.

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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): August 8, 2025

 

Incannex Healthcare Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-41106   93-2403210

(State or other Jurisdiction

of Incorporation)

  (Commission File Number)  

(IRS Employer

Identification No.)

 

Suite 105, 8 Century Circuit Norwest,

NSW 2153 Australia

  Not applicable
(Address of Principal Executive Offices)   (Zip Code)

 

Registrant’s Telephone Number, including Area Code: +61 409 840 786

 

(Former Name or Former Address, if Changed Since Last Report): Not Applicable

 

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 exchange on which registered
Common Stock, $0.0001 par value per share   IXHL   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 (§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.

 

 

 

 

 

Item 8.01 Other Events.

 

On August 8, 2025, Incannex Healthcare Inc. Receives Positive Patient-Reported Outcomes and Compelling Phase 2 Efficacy Data for IHL-42X in Obstructive Sleep Apnoea. Further information is included in the press release attached as Exhibit 99.1 hereto, which 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 Incannex Healthcare Inc., dated August 8, 2025.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

1

 

 

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.

 

  Incannex Healthcare Inc.
     
Date: August 8, 2025   /s/ Joel Latham
  Name:  Joel Latham
  Title: Chief Executive Officer and President

 

2

FAQ

What did Incannex Healthcare (IXHL) disclose in its Aug 8 2025 Form 8-K?

IXHL reported positive patient-reported outcomes and compelling Phase 2 efficacy data for IHL-42X in obstructive sleep apnoea.

What is IHL-42X and why is it important to IXHL?

IHL-42X is the company’s lead investigational therapy for obstructive sleep apnoea; success could open a sizeable commercial opportunity.

Were any financial results included in the filing?

No financial statements or earnings data were provided; the 8-K focuses solely on the clinical update.

Where can investors find the detailed Phase 2 results?

Full data are contained in the press release attached as Exhibit 99.1 to the 8-K.

Who signed the Form 8-K for Incannex Healthcare?

The document was signed by CEO and President Joel Latham on 8 Aug 2025.

Is IXHL classified as an emerging growth company?

The filing indicates IXHL does not qualify as an emerging growth company.
Incannex Healthcare Ltd

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