Dallas, Texas--(Newsfile Corp. - October 1, 2026) - Incannex Healthcare Inc. (NASDAQ: IXHL): Stonegate Capital Partners updates their coverage on Incannex Healthcare Inc. (NASDAQ: IXHL). IXHL's FY26 update moves the IHL-42X story from DReAMzz preparation into active clinical execution, with first-patient dosing underway and the balance sheet providing runway for at least 12 months of planned operations. The study is evaluating approximately 120 patients across nine dose combinations and 14 U.S. sites, with completion expected in mid-2027. In our view, the next several quarters should be measured primarily by enrollment cadence, dose optimization, and whether DReAMzz supports a more clearly defined Phase 3 design rather than near-term P&L trends. This sequencing should improve confidence in dose selection and Phase 3 trial design before IXHL commits to the higher development spending associated with late-stage studies.

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Key Takeaways:

• IHL-42X has moved from regulatory preparation into active clinical execution. DReAMzz is enrolling approximately 120 patients across nine dose combinations and 14 U.S. sites, with completion expected in mid-2027. The study is specifically intended to refine the dose ratio ahead of the planned Phase 3 program rather than replicate RePOSA's efficacy work.
• The balance sheet meaningfully reduces near-term financing pressure, but it does not eliminate longer-term capital requirements. IXHL had $68.4M of unrestricted cash as of September 24 and management says this supports at least 12 months of planned spending; the 10-K also explicitly says substantial additional funding will be required beyond that period.
• Pipeline prioritization has become clearer. PSX-001 remains the principal secondary clinical asset, while IHL-675A's Australian Phase 2 RA study was terminated due to recruitment challenges and produced insufficient data to assess efficacy or safety. The equity story is therefore increasingly concentrated around IHL-42X and the eventual DReAMzz-to-Phase 3 transition.

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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.

Source: Stonegate, Inc.

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