Stonegate Updates Coverage on Incannex Healthcare Inc. (NasdaqGM:IXHL) 2Q 2026

Key Takeaways

  • IHL-42X receives fast track approval
  • $68.9M in reported cash & cash equivalents
  • Positive Phase 2 results for PSX-001

DALLAS, TX -- February 18, 2026 --Incannex Healthcare Inc. (NasdaqGM:IXHL): Stonegate Capital Partners updates their coverage on Incannex Healthcare Inc. (NasdaqGM: IXHL). Incannex continued to build the clinical and patient-reported evidence base for IHL-42X in obstructive sleep apnea (OSA), following full Phase 2 RePOSA data and exit-interview analyses. Both low and high-dose IHL-42X achieved statistically significant reductions in Apnea-Hypopnoea Index (AHI) versus placebo, with maximum AHI reductions of up to 83% in the high-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. IHL-42X was well tolerated across both dose cohorts, reinforcing its potential for broad use.

IHL-42X Next Steps: After two successful Phase 2 studies, management used 4Q25 to pivot IHL-42X from pure data generation toward regulatory and late-stage planning. The Company is preparing for formal FDA interactions to define the registrational path, including Phase 3 design, primary and secondary endpoints, and potential expedited-review options. We expect IXHL to update the market after FDA discussions conclude and the forward development strategy is finalized, positioning IHL-42X for late-stage trials in 2026. IHL-42X has received FDA Fast Track designation, recognizing the serious nature of OSA and the significant unmet need for an approved oral pharmacotherapy, given current reliance on device-based treatments with poor adherence.

Financing: IXHL exited 2Q26 with a strong balance sheet, reporting $68.9M in cash and equivalents. The Company generated $71.7M in proceeds from share issuances while maintaining disciplined use of its ATM facility. Incannex also strengthened its capital structure by eliminating all outstanding Series A warrants, removing legacy dilution overhang, and authorizing a $20M share repurchase program, under which 3.1M shares were repurchased during the period. Together, these actions reflect a well-capitalized position and proactive capital management strategy to support continued clinical advancement. We believe IXHL now has several years of cash runway with enough funding to support IHL-42X up to commercialization and potentially move PSX-001 through a potential phase 3.

PSX-001 and IHL-675A Update: In CY25, Incannex reported positive Phase 2 results for PSX-001 (Psi-GAD), establishing it as a second major value driver. The randomized, placebo-controlled study showed a statistically significant and clinically meaningful reduction in HAM-A scores, with 44.1% of patients achieving ≥50% response and 27% reaching remission. The Company is progressing PSX-001 into next-phase clinical and regulatory planning, including preparation for a registrational study and multi-jurisdiction development. Meanwhile, IHL-675A remains in Phase 2 development for rheumatoid arthritis and represents a complementary anti-inflammatory platform asset supporting long-term growth.

Valuation: We use a probability-adjusted Discounted Cash Flow Model when valuing IXHL. Our valuation model returns a valuation range of $1.90 to $2.24 with a midpoint of $2.06 based on a discount rate range of 11.25% to 13.75% and a current risk adjustment range of 13% to 18%. Further details on our model can be found on page 5 of this report. We note that this model is highly levered to the out years due to the long term nature of IXHL's industry, leading to the potential for dramatic re-ratings as new information becomes available.


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.

Key Takeaways

  • IHL-42X receives fast track approval
  • $68.9M in reported cash & cash equivalents
  • Positive Phase 2 results for PSX-001

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Dave Storms
Director of Research Stonegate Capital Markets
Dave is the Director of Research for Stonegate Capital Markets and provides contract research and valuation services for Stonegate Capital Partners. Dave joined the firm in 2022 and covers multiple sectors. Prior to this, he was an equity research analyst at Goldman Sachs. He was formerly a Senior investment analyst at Beneficial Financial Group, an analyst at Valuation Research Corporation, and an investment analyst with The Board of Pensions (PCUSA) focused on public equities
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