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 societ脿 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 met脿 del 2025.
Incannex Healthcare (NASDAQ: IXHL) ha obtenido resultados positivos en la fase 2 de su tratamiento IHL-42X para la Apnea Obstructiva del Sue帽o (OSA). El estudio demostr贸 reducciones significativas en el 脥ndice de Apnea-Hipopnea (AHI), con hasta un 83% de reducci贸n en el grupo de alta dosis y un 79% en el de baja dosis frente al placebo.
El tratamiento present贸 un perfil de seguridad s贸lido sin eventos adversos graves reportados. Los resultados de los pacientes fueron destacadamente positivos: el 57,6% de los participantes inform贸 mejor铆a de la OSA, y el 89,5% calific贸 los cambios como significativos. Adem谩s, IXHL ha eliminado aproximadamente 347 millones de warrants de la Serie A mediante 24,7 millones de d贸lares procedentes de ATM, mejorando su posici贸n financiera.
La compa帽铆a tambi茅n 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.
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Incannex Healthcare (NASDAQ: IXHL) a annonc茅 des r茅sultats positifs de son essai de phase 2 pour le traitement IHL-42X de l'apn茅e obstructive du sommeil (AOS). L'茅tude a montr茅 des r茅ductions significatives de l'indice d'apn茅e-hypopn茅e (IAH), allant jusqu'脿 83 % de r茅duction dans le groupe 脿 forte dose et 79 % dans le groupe 脿 faible dose par rapport au placebo.
Le traitement a pr茅sent茅 un bon profil de s茅curit茅, sans 茅v茅nements ind茅sirables graves signal茅s. Les r茅sultats chez les patients sont tr猫s positifs聽: 57,6 % des participants ont rapport茅 une am茅lioration de l'AOS, et 89,5 % ont jug茅 les changements significatifs. De plus, IXHL a annul茅 environ 347 millions de warrants de s茅rie A gr芒ce 脿 24,7 M$ de produits ATM, renfor莽ant ainsi sa position financi猫re.
La soci茅t茅 fait 茅galement progresser d'autres candidats en pipeline, notamment PSX-001 pour le trouble anxieux g茅n茅ralis茅 (TAG) et IHL-675A pour la polyarthrite rhumato茂de, des donn茅es de phase 2 茅tant attendues au second semestre 2025.
Incannex Healthcare (NASDAQ: IXHL) hat positive Ergebnisse der Phase-2-Studie f眉r sein IHL-42X-Pr盲parat gegen obstruktive Schlafapnoe (OSA) ver枚ffentlicht. Die Studie zeigte signifikante Senkungen des Apnoe-Hypopnoe-Index (AHI), mit bis zu 83% Reduktion in der Hochdosisgruppe und 79% in der Niedrigdosisgruppe gegen眉ber Placebo.
Die Behandlung wies ein gutes Sicherheitsprofil auf; schwere unerw眉nschte Ereignisse wurden nicht berichtet. Die Patientenergebnisse waren deutlich positiv: 57,6% der Teilnehmer berichteten von einer Verbesserung der OSA, und 89,5% empfanden die Ver盲nderungen als bedeutsam. Zudem hat IXHL rund 347 Mio. Series-A-Warrants durch 24,7 Mio. USD an ATM-Erl枚sen ausgel枚scht, wodurch sich die finanzielle Lage verbessert hat.
Das Unternehmen treibt au脽erdem weitere Kandidaten in der Pipeline voran, darunter PSX-001 f眉r generalisierte Angstst枚rung (GAD) und IHL-675A f眉r rheumatoide Arthritis, wobei Phase-2-Daten f眉r die zweite H盲lfte 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, .
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
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FAQ
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