Stonegate Updates Coverage on Incannex Healthcare Inc. (IXHL) 3Q 2025 - Update

Rhea-AI Summary

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.

Positive

• 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

Negative

• Raised $24.7M through ATM offering, potentially diluting existing shareholders

Insights

Pharmaceutical Industry Analyst

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 83% AHI reduction, while the low-dose group showed up to 79% improvement. These results are particularly impressive considering AHI is the primary endpoint used to measure OSA treatment efficacy.

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 57.6% of participants reporting perceived improvement in their OSA, and 89.5% of those indicating the improvements were meaningful to their daily lives.

On the financial front, Incannex has eliminated approximately 347 million potentially dilutive Series A Warrants using $24.7 million in ATM proceeds. This strategic financial move significantly improves the company's balance sheet flexibility and reduces future dilution concerns, positioning them to advance IHL-42X toward commercialization.

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 83% for the high-dose group and up to 79% for the low-dose group. In addition to this effectiveness, IHL-42X was tolerated well across both cohorts, having no serious adverse events reported during the treatment period. Lastly, the patient reported outcomes were equally impressive as 57.6% of participants reported a perceived improvement in their OSA, and 89.5% of those reporting improvement described the change as meaningful to their lives. This positions IXHL favorably as it begins the next steps of bringing IHL-42X to market.

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

What were the key results of Incannex's (IXHL) Phase 2 trial for IHL-42X?

The trial showed statistically significant reductions in Apnoea-Hypopnoea Index, with up to 83% reduction in the high-dose group and 79% in the low-dose group, with no serious adverse events reported.

How did patients respond to Incannex's (IXHL) OSA treatment in the Phase 2 trial?

57.6% of participants reported improvements in their OSA condition, with 89.5% of those describing the changes as meaningful to their lives.

What is the status of Incannex's (IXHL) other pipeline candidates?

IXHL is advancing PSX-001 for GAD (with IND clearance in U.S. and U.K.) and IHL-675A in Phase 2 for rheumatoid arthritis, with data expected in 2H25.

How did Incannex (IXHL) address its warrant overhang in 2025?

IXHL eliminated approximately 347M potentially dilutive Series A Warrants through raising $24.7M in ATM proceeds.

What is the safety profile of Incannex's (IXHL) IHL-42X treatment?

The treatment demonstrated a strong safety profile with no serious adverse events reported during the treatment period across both low and high-dose cohorts.