Stonegate Updates Coverage on Incannex Healthcare Inc. (IXHL) 1Q 2026

Rhea-AI Summary

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.

Positive

• 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

Negative

• 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 83% in the high-dose arm and 79% in the low-dose arm,. Exit interviews showed 57.6% of participants reported perceived improvement in their OSA, and most of those described the change as meaningful to daily life, citing better sleep quality, less fatigue, and improved daily functioning. IHL-42X was well tolerated across both dose cohorts, with no serious adverse events and mainly mild, transient treatment-emergent events, reinforcing its potential for broad use if approved.

To view the full announcement, including downloadable images, bios, and more, click here.

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.

Click image above to view full announcement.

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About Stonegate

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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/275311

FAQ

What Phase 2 results did Incannex (IXHL) report for IHL-42X on November 20, 2025?

IHL-42X achieved statistically significant AHI reductions versus placebo, with maximum reductions up to 83% (high dose) and 79% (low dose).

How did patients report improvement in Incannex (IXHL) IHL-42X Phase 2 exit interviews?

Exit interviews showed 57.6% of participants reported perceived improvement, citing better sleep, less fatigue, and improved daily functioning.

What safety profile did Incannex (IXHL) report for IHL-42X in Phase 2?

IHL-42X was reported as well tolerated with no serious adverse events and mainly mild, transient treatment‑emergent events.

What cash and runway did Incannex (IXHL) report for the quarter ending 1Q 2026?

Quarter-end cash was $73.3M, which the company said supports at least twelve months of runway.

What were Incannex (IXHL) quarterly loss and operating expenses reported in 1Q 2026?

The company reported a net loss of $6.4M and operating expenses of $6.8M for the quarter.

What regulatory steps does Incannex (IXHL) plan after Phase 2 IHL-42X results?

Management is preparing FDA interactions to discuss and plan a Phase 3 program.