[8-K] Incannex Healthcare Limited American Reports Material Event

Rhea-AI Filing Summary

Incannex Healthcare Inc. (Nasdaq: IXHL) filed a Form 8-K on 8 Aug 2025 announcing that it has received “positive patient-reported outcomes and compelling Phase 2 efficacy data” for IHL-42X, its drug candidate for obstructive sleep apnoea (OSA). The disclosure is provided via a press release attached as Exhibit 99.1 and incorporated under Item 8.01; no financial statements or other quantitative information accompany the notice. The report, signed by CEO Joel Latham, signals meaningful clinical progress for a core pipeline asset but leaves key metrics—statistical significance, safety profile and regulatory timeline—undisclosed. Investors must consult the referenced press release for comprehensive data and next-step development plans.

Positive

• Phase 2 efficacy success for IHL-42X strengthens IXHL’s clinical pipeline and supports potential entry into the obstructive sleep apnoea market.

Negative

• No quantitative efficacy or safety metrics released, preventing investors from gauging the magnitude and durability of the reported benefit.

Insights

Biopharma Equity Analyst

TL;DR: Phase 2 success for IHL-42X is a pipeline de-risking event that could boost IXHL valuation, but detailed data still required.

The 8-K confirms positive Phase 2 outcomes for IHL-42X in OSA—a large, underserved market. Even without hard numbers, the language “compelling” and “positive patient-reported outcomes” implies clinically meaningful benefit, lowering development risk and strengthening IXHL’s negotiating position with potential partners. Absence of safety issues is inferred but not stated; investors should await full data to assess effect size, dosing and adverse events. If results hold, IXHL could progress to Phase 3, a key valuation inflection. Lack of financials is immaterial given the event-driven nature of the filing.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 8, 2025

Incannex Healthcare Inc.

(Exact name of registrant as specified in its charter)

Delaware		001-41106		93-2403210
(State or other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

Suite 105, 8 Century Circuit Norwest, NSW 2153 Australia		Not applicable
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, including Area Code: +61 409 840 786

(Former Name or Former Address, if Changed Since Last Report): Not Applicable

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol		Name of exchange on which registered
Common Stock, $0.0001 par value per share		IXHL		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter)

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 Other Events.

On August 8, 2025, Incannex Healthcare Inc. Receives Positive Patient-Reported Outcomes and Compelling Phase 2 Efficacy Data for IHL-42X in Obstructive Sleep Apnoea. Further information is included in the press release attached as Exhibit 99.1 hereto, which is incorporated by reference into this Item 8.01.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release of Incannex Healthcare Inc., dated August 8, 2025.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	Incannex Healthcare Inc.
Date: August 8, 2025		/s/ Joel Latham
	Name:	Joel Latham
	Title:	Chief Executive Officer and President

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FAQ

What did Incannex Healthcare (IXHL) disclose in its Aug 8 2025 Form 8-K?

IXHL reported positive patient-reported outcomes and compelling Phase 2 efficacy data for IHL-42X in obstructive sleep apnoea.

What is IHL-42X and why is it important to IXHL?

IHL-42X is the company’s lead investigational therapy for obstructive sleep apnoea; success could open a sizeable commercial opportunity.

Were any financial results included in the filing?

No financial statements or earnings data were provided; the 8-K focuses solely on the clinical update.

Where can investors find the detailed Phase 2 results?

Full data are contained in the press release attached as Exhibit 99.1 to the 8-K.

Who signed the Form 8-K for Incannex Healthcare?

The document was signed by CEO and President Joel Latham on 8 Aug 2025.

Is IXHL classified as an emerging growth company?

The filing indicates IXHL does not qualify as an emerging growth company.