Incannex reports positive Phase 2 anxiety trial

Incannex Healthcare Inc. reported positive results from a Phase 2 clinical trial of its investigational therapy PSX-001 (Psi-GAD) for generalized anxiety disorder.

Rhea-AI Filing Summary

Incannex Healthcare Inc. reported positive results from a Phase 2 clinical trial of its investigational therapy PSX-001 (Psi-GAD) for generalized anxiety disorder. The company disclosed the outcome as an other event and directed readers to a detailed press release for more information, indicating that the trial met encouraging benchmarks for this mental health condition. This update highlights progress in Incannex’s clinical development pipeline, although specific efficacy or safety data are contained in the accompanying press release rather than in this report.

Insights

Biotech and clinical development analyst

Incannex reports encouraging Phase 2 data in anxiety disorder.

Incannex Healthcare Inc. states that it has positive results from a Phase 2 trial of PSX-001 (Psi-GAD) in generalized anxiety disorder. Phase 2 studies typically assess both signals of efficacy and safety to decide whether a program should advance to larger, confirmatory trials.

The brief disclosure does not provide numerical outcomes, effect sizes, or safety details, which are instead contained in the referenced press release. Without those specifics, it is difficult to gauge how robust the results are or how PSX-001 might compare to existing treatments.

From an investment perspective, the update indicates that the program has cleared an important clinical milestone and remains active in development. Future disclosures in company communications and later-stage trial designs will be important to understand the potential path toward approval and commercialization, based on this Phase 2 outcome.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Incannex Healthcare Inc. (IXHL) report in this filing?

Incannex Healthcare Inc. reported that it has positive results from a Phase 2 clinical trial of PSX-001 (Psi-GAD) for generalized anxiety disorder, disclosed as an other event.

What is PSX-001 (Psi-GAD) in the Incannex Healthcare Inc. (IXHL) update?

PSX-001 (Psi-GAD) is an investigational therapy being developed by Incannex Healthcare Inc. and was evaluated in a Phase 2 clinical trial for generalized anxiety disorder.

Which stage of clinical development is Incannex Healthcare Inc. (IXHL) reporting on?

Incannex Healthcare Inc. is reporting on a Phase 2 clinical trial, indicating an intermediate stage of clinical development between early safety studies and larger confirmatory trials.

Does the Incannex Healthcare Inc. (IXHL) report include detailed Phase 2 trial data?

The report itself only states that results are positive and refers readers to a press release attached as an exhibit for detailed information about the Phase 2 trial of PSX-001.

How did Incannex Healthcare Inc. (IXHL) communicate the Phase 2 results publicly?

Incannex Healthcare Inc. filed a current report and attached a press release as an exhibit, incorporating that press release by reference for the full description of the Phase 2 trial results.

What condition was targeted in the Incannex Healthcare Inc. (IXHL) Phase 2 trial?

The Phase 2 clinical trial evaluated PSX-001 (Psi-GAD) as a potential treatment for generalized anxiety disorder.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 08/26/2025 - 08:00 AM Learn about SEC filing dates

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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 26, 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 26, 2025, Incannex Healthcare Inc. Reports Positive Results from Phase 2 Clinical Trial of PSX-001 (Psi-GAD) for Generalised Anxiety Disorder. 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 26, 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 26, 2025		/s/ Joel Latham
	Name:	Joel Latham
	Title:	Chief Executive Officer and President

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