Stonegate Updates Coverage on Incannex Healthcare Inc. (IXHL) 1Q 2026
Incannex Healthcare (NASDAQ: IXHL) updated coverage following 1Q 2026 activity and Phase 2 results. IHL-42X showed statistically significant Apnoea‑Hypopnoea Index (AHI) reductions versus placebo, with maximum AHI reductions up to 83% (high dose) and 79% (low dose). Exit interviews reported 57.6% of participants perceived meaningful OSA improvement. Safety was favorable with no serious adverse events and mainly mild, transient treatment‑emergent events. Management is preparing FDA interactions for Phase 3 planning. The company reported quarter‑end cash of $73.3M, net loss of $6.4M, and operating expenses of $6.8M, which the company says supports at least twelve months of runway. PSX‑001 showed meaningful anxiety reduction and a multi‑jurisdiction PsiGAD2 study is being prepared under an open IND.
Incannex Healthcare (NASDAQ: IXHL) ha aggiornato la copertura in seguito all'attività del 1Q 2026 e ai risultati della fase 2. IHL-42X ha mostrato riduzioni statisticamente significative dell'indice di apnee e ipopnee (AHI) rispetto al placebo, con riduzioni massime di 83% (alta dose) e 79% (bassa dose). Le interviste di uscita hanno riportato che 57,6% dei partecipanti hanno percepito un miglioramento significativo dell'OSA. Sicurezza favorevole con nessun evento avverso grave e principalmente eventi transitori lievi legati al trattamento. Il management sta preparando interazioni con la FDA per la pianificazione della fase 3. L'azienda ha riportato una cassa di fine trimestre di $73,3M, una perdita netta di $6,4M e spese operative di $6,8M, che l'azienda dice garantire almeno dodici mesi di runway. PSX-001 ha mostrato una significativa riduzione dell'ansia e uno studio PsiGAD2 multi-giurisdizionale è in fase di preparazione sotto una IND aperta.
Incannex Healthcare (NASDAQ: IXHL) actualizó la cobertura tras la actividad del 1T 2026 y los resultados de la fase 2. IHL-42X mostró reducciones estadísticamente significativas del índice de apneas-hipopneas (AHI) frente al placebo, con reducciones máximas de 83% (dosis alta) y 79% (dosis baja). Las entrevistas de salida reportaron que el 57,6% de los participantes percibió una mejora significativa de la OSA. La seguridad fue favorable sin eventos adversos graves y con principalmente eventos transitorios leves relacionados con el tratamiento. La dirección se está preparando para interactuar con la FDA para la planificación de la fase 3. La empresa reportó efectivo al cierre del trimestre de $73,3M, una pérdida neta de $6,4M y gastos operativos de $6,8M, que la empresa dice respaldar al menos doce meses de runway. PSX-001 mostró una reducción significativa de la ansiedad y se está preparando un estudio PsiGAD2 multi jurisdiccional bajo un IND abierto.
Incannex Healthcare (NASDAQ: IXHL)는 1Q 2026 활동 및 2상 결과에 따라 커버리지를 업데이트했습니다. IHL-42X는 위약대비 수면호흡무호흡지수(AHI) 감소를 통계적으로 유의하게 보였으며, 최대 AHI 감소는 83% (고용량) 및 79% (저용량)였습니다. 종료 면담에서 참가자의 57.6%가 의미 있는 수면무호흡증 개선을 느꼈다고 보고했습니다. 안전성은 우호적이었고 심각한 이상반응은 없었으며 주로 경미하고 일시적인 치료 관련 사건이었습니다. 경영진은 3상 계획을 위한 FDA 상호작용을 준비 중입니다. 회사는 분기말 현금이 $73.3M, 순손실 $6.4M, 영업비용 $6.8M를 보고했으며, 이는 회사가 적어도 12개월의 운영기간(runway)을 지지한다고 말합니다. PSX-001은 의미 있는 불안 감소를 보였고 다국가 PsiGAD2 연구가 열린 IND 하에 준비 중입니다.
Incannex Healthcare (NASDAQ : IXHL) a révisé sa couverture suite à l'activité du 1S2026 et aux résultats de la phase 2. IHL-42X a montré des réductions statistiquement significatives de l'indice d'apnée-hypopnée (AHI) par rapport au placebo, avec des réductions maximales d'83% (dose élevée) et d'79% (dose basse). Des entretiens de sortie ont rapporté que 57,6% des participants ont perçu une amélioration significative de l'OSA. La sécurité était favorable, sans événements indésirables graves et principalement des événements transitoires légers liés au traitement. La direction prépare des interactions avec la FDA pour la planification de la phase 3. L'entreprise a déclaré une trésorerie de fin de trimestre de $73,3M, une perte nette de $6,4M et des dépenses opérationnelles de $6,8M, ce qui, selon l'entreprise, assure au moins douze mois de runway. PSX-001 a montré une réduction significative de l'anxiété et une étude PsiGAD2 multi-juridiction est en préparation sous une IND ouverte.
Incannex Healthcare (NASDAQ: IXHL) hat seine Berichterstattung nach Aktivitäten im 1Q 2026 und Ergebnisse der Phase 2 aktualisiert. IHL-42X zeigte statistisch signifikante Reduzierungen des Apnoe-Hypopnoe-Index (AHI) gegenüber Placebo, mit maximalen Reduzierungen von 83% (Hohe Dosis) und 79% (Niedrige Dosis). Exit-Interviews berichteten, dass 57,6% der Teilnehmer eine bedeutende Verbesserung der obstruktiven Schlafapnoe (OSA) wahrnahmen. Die Sicherheit war günstig, ohne schwerwiegende unerwünschte Ereignisse und überwiegend milde, vorübergehende behandlungsbedingte Ereignisse. Das Management bereitet FDA-Interaktionen für die Planung der Phase 3 vor. Das Unternehmen meldete Bargeld am Quartalsende von $73,3M, einen Nettoverlust von $6,4M und Betriebsausgaben von $6,8M, was laut Unternehmen eine Laufzeit von mindestens zwölf Monaten unterstützt. PSX‑001 zeigte eine bedeutsame Reduzierung der Angst, und eine multi‑jurisdiktionale PsiGAD2‑Studie wird unter einer offenen IND vorbereitet.
Incannex Healthcare (NASDAQ: IXHL) قام بتحديث التغطية عقب نشاط الربع الأول 2026 ونتائج المرحلة الثانية. IHL-42X أظهر انخفاضات ذات دلالة إحصائية في مؤشر انقطاع النفس أثناء النوم/انخفاض التنفس (AHI) مقارنة بالدواء الوهمي، مع انخفاضات قصوى في 83% (جرعة عالية) و79% (جرعة منخفضة). أشارت مقابلات الخروج إلى أن 57.6% من المشاركين شعروا بتحسن ملموس في اضطراب النوم الانسدادي أثناء النوم. السلامة كانت مواتية دون أحداث جانبية خطيرة وبشكل رئيسي أحداث خفيفة وعابرة مرتبطة بالعلاج. الإدارة تجمع تجرِبة FDA للتخطيط للمرحلة الثالثة. ذكرت الشركة وجود سيولة عند نهاية الربع تبلغ $73.3M، وخسارة صافية $6.4M، ونفقات تشغيلية $6.8M، وتقول الشركة إن ذلك يدعم على الأقل اثني عشر شهراً من الخطة التشغيلية. أظهر PSX-001 انخفاضاً ملحوظاً في القلق ويُجرى إعداد دراسة PsiGAD2 متعددة الاختصاصات بموجب IND مفتوح.
- AHI reduction up to 83.0% in Phase 2
- 57.6% of participants reported meaningful OSA improvement
- No serious adverse events reported in IHL-42X Phase 2
- Quarter-end cash $73.3M supporting ≥12 months runway
- PSX-001 delivered meaningful anxiety reduction in Phase 2
- Quarter net loss of $6.4M
- Quarter operating expenses of $6.8M
- Management must complete FDA interactions before Phase 3 initiation
Dallas, Texas--(Newsfile Corp. - November 20, 2025) - Incannex Healthcare Inc. (NASDAQ: IXHL): Stonegate Capital Partners updates their coverage on Incannex Healthcare Inc. (NASDAQ: IXHL). In 4Q25, Incannex continued to build the clinical and patient-reported evidence base for IHL-42X in obstructive sleep apnoea (OSA), following full Phase 2 RePOSA data and exit-interview analyses. Both low- and high-dose IHL-42X achieved statistically significant reductions in Apnoea-Hypopnoea Index (AHI) versus placebo, with maximum AHI reductions of up to
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Key Takeaways:
- IHL-42X Phase 2 showed significant AHI reductions up to
83.0% and management is preparing FDA interactions for Phase 3 planning. - PSX-001 delivered meaningful anxiety reduction in Phase 2 and the team is preparing the multi-jurisdiction PsiGAD2 study under an open IND.
- Quarter-end cash was
$73.3M with net loss$6.4M and operating expenses$6.8M supporting at least twelve months of runway.
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Source: Stonegate, Inc.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/275311
FAQ
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