Stonegate Updates Coverage on Incannex Healthcare Inc. (IXHL) 3Q 2025 - Update
Incannex Healthcare (NASDAQ: IXHL) has received positive Phase 2 trial results for its IHL-42X treatment for Obstructive Sleep Apnea (OSA). The study demonstrated significant reductions in Apnoea-Hypopnoea Index (AHI), with up to 83% reduction in the high-dose group and 79% in the low-dose group compared to placebo.
The treatment showed strong safety profile with no serious adverse events reported. Patient outcomes were notably positive, with 57.6% of participants reporting OSA improvement, and 89.5% describing the changes as meaningful. Additionally, IXHL has eliminated approximately 347M Series A Warrants through $24.7M in ATM proceeds, improving its financial position.
The company is also advancing other pipeline candidates, including PSX-001 for GAD and IHL-675A for rheumatoid arthritis, with Phase 2 data expected in 2H25.
Incannex Healthcare (NASDAQ: IXHL) ha annunciato risultati positivi della fase 2 per il suo trattamento IHL-42X contro l'apnea ostruttiva del sonno (OSA). Lo studio ha mostrato riduzioni significative dell'Indice Apnea-Ipopnea (AHI), con una riduzione fino all'83% nel gruppo ad alto dosaggio e del 79% nel gruppo a basso dosaggio rispetto al placebo.
Il trattamento ha evidenziato un profilo di sicurezza favorevole senza eventi avversi gravi segnalati. Gli esiti dei pazienti sono stati molto positivi: il 57,6% dei partecipanti ha riportato un miglioramento dell'OSA e l'89,5% ha giudicato i cambiamenti come significativi. Inoltre, IXHL ha annullato circa 347 milioni di warrant di Serie A grazie a 24,7 milioni di dollari raccolti tramite ATM, rafforzando la propria posizione finanziaria.
La società sta inoltre portando avanti altri candidati in pipeline, tra cui PSX-001 per il disturbo d'ansia generalizzato (GAD) e IHL-675A per l'artrite reumatoide, con dati di fase 2 attesi nella seconda metà del 2025.
Incannex Healthcare (NASDAQ: IXHL) ha obtenido resultados positivos en la fase 2 de su tratamiento IHL-42X para la Apnea Obstructiva del Sueño (OSA). El estudio demostró reducciones significativas en el Índice de Apnea-Hipopnea (AHI), con hasta un 83% de reducción en el grupo de alta dosis y un 79% en el de baja dosis frente al placebo.
El tratamiento presentó un perfil de seguridad sólido sin eventos adversos graves reportados. Los resultados de los pacientes fueron destacadamente positivos: el 57,6% de los participantes informó mejoría de la OSA, y el 89,5% calificó los cambios como significativos. Además, IXHL ha eliminado aproximadamente 347 millones de warrants de la Serie A mediante 24,7 millones de dólares procedentes de ATM, mejorando su posición financiera.
La compañía también avanza con otros candidatos en su pipeline, incluidos PSX-001 para el trastorno de ansiedad generalizada (GAD) e IHL-675A para la artritis reumatoide, con datos de fase 2 previstos para la segunda mitad de 2025.
Incannex Healthcare (NASDAQ: IXHL)가 폐쇄성 수면무호흡증(OSA) 치료제 IHL-42X의 2상 결과에서 긍정적인 성과를 발표했습니다. 연구에서는 무호흡·저호흡 지수(AHI)의 유의한 감소를 보였으며, 고용량군에서 최대 83%, 저용량군에서 79% 감소를 보였습니다(위약 대비).
치료제는 심각한 이상사례 없이 우수한 안전성 프로파일을 나타냈습니다. 환자 결과도 눈에 띄게 긍정적이어서 참가자의 57.6%가 OSA 개선을 보고했으며 89.5%는 변화를 의미 있다고 평가했습니다. 또한 IXHL은 ATM(장외주식매출)을 통해 2,470만 달러를 확보하여 대략 3억4,700만 달러어치의 시리즈 A 워런트를 소멸시켜 재무구조를 개선했습니다.
회사는 또한 GAD(범불안장애)용 PSX-001과 류마티스 관절염용 IHL-675A 등 다른 파이프라인 후보물질도 개발 중이며, 2025년 하반기에 2상 데이터가 기대됩니다.
Incannex Healthcare (NASDAQ: IXHL) a annoncé des résultats positifs de son essai de phase 2 pour le traitement IHL-42X de l'apnée obstructive du sommeil (AOS). L'étude a montré des réductions significatives de l'indice d'apnée-hypopnée (IAH), allant jusqu'à 83 % de réduction dans le groupe à forte dose et 79 % dans le groupe à faible dose par rapport au placebo.
Le traitement a présenté un bon profil de sécurité, sans événements indésirables graves signalés. Les résultats chez les patients sont très positifs : 57,6 % des participants ont rapporté une amélioration de l'AOS, et 89,5 % ont jugé les changements significatifs. De plus, IXHL a annulé environ 347 millions de warrants de série A grâce à 24,7 M$ de produits ATM, renforçant ainsi sa position financière.
La société fait également progresser d'autres candidats en pipeline, notamment PSX-001 pour le trouble anxieux généralisé (TAG) et IHL-675A pour la polyarthrite rhumatoïde, des données de phase 2 étant attendues au second semestre 2025.
Incannex Healthcare (NASDAQ: IXHL) hat positive Ergebnisse der Phase-2-Studie für sein IHL-42X-Präparat gegen obstruktive Schlafapnoe (OSA) veröffentlicht. Die Studie zeigte signifikante Senkungen des Apnoe-Hypopnoe-Index (AHI), mit bis zu 83% Reduktion in der Hochdosisgruppe und 79% in der Niedrigdosisgruppe gegenüber Placebo.
Die Behandlung wies ein gutes Sicherheitsprofil auf; schwere unerwünschte Ereignisse wurden nicht berichtet. Die Patientenergebnisse waren deutlich positiv: 57,6% der Teilnehmer berichteten von einer Verbesserung der OSA, und 89,5% empfanden die Veränderungen als bedeutsam. Zudem hat IXHL rund 347 Mio. Series-A-Warrants durch 24,7 Mio. USD an ATM-Erlösen ausgelöscht, wodurch sich die finanzielle Lage verbessert hat.
Das Unternehmen treibt außerdem weitere Kandidaten in der Pipeline voran, darunter PSX-001 für generalisierte Angststörung (GAD) und IHL-675A für rheumatoide Arthritis, wobei Phase-2-Daten für die zweite Hälfte 2025 erwartet werden.
- Strong Phase 2 results with up to 83% AHI reduction in high-dose group
- No serious adverse events reported, demonstrating good safety profile
- 57.6% of participants reported OSA improvement with 89.5% noting meaningful changes
- Elimination of 347M potentially dilutive warrants through $24.7M ATM proceeds
- Multiple pipeline candidates advancing with near-term catalysts
- Raised $24.7M through ATM offering, potentially diluting existing shareholders
Insights
IXHL's Phase 2 OSA drug shows 83% symptom reduction with strong safety profile, while company strengthens finances by eliminating 347M dilutive warrants.
Incannex Healthcare's Phase 2 trial results for their sleep apnea treatment IHL-42X demonstrate remarkable efficacy, with statistically significant reductions in the Apnoea-Hypopnoea Index (AHI) compared to placebo. The high-dose group achieved up to
What makes these results even more compelling is the combination of efficacy with strong safety data. No serious adverse events were reported during the treatment period, addressing a critical hurdle in drug development. Patient-reported outcomes further validate the clinical findings, with
On the financial front, Incannex has eliminated approximately 347 million potentially dilutive Series A Warrants using
Beyond their lead asset, Incannex is diversifying risk with multiple clinical programs. Their psilocybin-based PSX-001 for generalized anxiety disorder has received IND clearance in both the U.S. and U.K., while IHL-675A is progressing through Phase 2 trials for rheumatoid arthritis with data expected in the second half of 2025. This creates multiple potential value-creating catalysts over the next 12-18 months.
Dallas, Texas--(Newsfile Corp. - August 19, 2025) - Incannex Healthcare Inc. (NASDAQ: IXHL): Stonegate Capital Partners updates their coverage on Incannex Healthcare Inc. (NASDAQ: IXHL). Recently, IXHL has made significant progress on its IHL-42X asset after very positive topline results from the Phase 2 study have returned, with more granular data trickling in. Both the low and high dose groups achieved a statistically significant reduction in percentage change in Apnoea-Hypopnoea Index (AHI) from baseline compared to placebo. With AHI being the primary indicator of success, we are excited by the phenomenal topline results with maximum AHI reductions of up to
To view the full announcement, including downloadable images, bios, and more, click here.
Key Takeaways:
The RePOSA, Phase 2 trial showed statistically significant reductions in Apnoea-Hypopnoea Index (up to
83% in the high-dose group), alongside broad improvements in patient-reported outcomes and no serious adverse events, highlighting both efficacy and safety.IXHL eliminated ~347M potentially dilutive Series A Warrants through ~
$24.7M in ATM proceeds, materially improving financial flexibility and positioning the company to advance IHL-42X toward commercialization.Beyond IHL-42X, IXHL is progressing PSX-001 (psilocybin for GAD, with IND clearance in the U.S. and U.K.) and IHL-675A (Phase 2 in rheumatoid arthritis, data expected 2H25), providing multiple clinical and regulatory catalysts.
Click image above to view full announcement.
About Stonegate
Stonegate Capital Partners is a leading capital markets advisory firm providing investor relations, equity research, and institutional investor outreach services for public companies. Our affiliate, Stonegate Capital Markets (member FINRA) provides a full spectrum of investment banking services for public and private companies.
Contacts:
Stonegate Capital Partners
(214) 987-4121
info@stonegateinc.com
Source: Stonegate, Inc.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/263124
FAQ
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