Form 8-K

8-K — Incannex Healthcare Inc.

Accession: 0001213900-26-071745

Filed: 2026-06-25

Period: 2026-06-25

CIK: 0001873875

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — ea0295769-8k_incannex.htm (Primary)

EX-99.1 — PRESS RELEASE DATED AS OF JUNE 25, 2026 (ea029576901ex99-1.htm)

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8-K — CURRENT REPORT

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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): June 25, 2026

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.)

Rialto South Tower

Level 23, 525 Collins Street

Melbourne, VIC 3008 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

7.01 Regulation FD Disclosure.

On June

25, 2026, Incannex Healthcare Inc. (the “Company”) issued the press release furnished as Exhibit 99.1.

The information

contained in Item 7.01 in this Current Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be

deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),

or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities

Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.

Description

99.1

Press Release dated as of June 25, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

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: June 25, 2026

/s/ Joel Latham

Name:

Joel Latham

Title:

Chief Executive Officer and President

EX-99.1 — PRESS RELEASE DATED AS OF JUNE 25, 2026

EX-99.1

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Exhibit 99.1

Incannex Secures U.S. Patent Grant for IHL-42X

in Obstructive Sleep Apnoea

MELBOURNE, Australia and NEW YORK, 25 June 2026 – Incannex Healthcare

Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company developing innovative

combination therapies for high-impact indications, today announced that the United States Patent and Trademark Office (USPTO) has granted

a key patent titled “Compositions and Methods of Treatment for Obstructive Sleep Apnea.”

The granted patent includes claims directed to the proprietary IHL-42X

composition and its associated therapeutic methods for the treatment of obstructive sleep apnoea (OSA). The patent is expected to have

a baseline expiry date of 9 July 2040 and the Company is exploring its eligibility for patent term extension following potential U.S.

Food and Drug Administration (FDA) approval, with a view to further enhancing the long-term exclusivity of the asset.

The grant of this patent represents a significant milestone in the

advancement of IHL-42X and materially strengthens Incannex’s intellectual property portfolio supporting its lead clinical program.

The Company continues to actively review data generated across the IHL-42X development program with the objective of filing additional

patent applications to further expand and protect the commercial and strategic value of the asset.

IHL-42X is being developed as a novel oral combination therapy for

the treatment of OSA, a condition with substantial unmet medical need, where long-term patient compliance and treatment effectiveness

remain key challenges.

The strengthened U.S. patent position significantly enhances the commercial

value of IHL-42X by protecting the Company’s proprietary oral combination therapy and supporting long-term market exclusivity. Together

with FDA Fast Track designation, positive Phase II clinical data and ongoing advancement into the DReAMzz dose optimisation study, the

patent further strengthens the strategic positioning of IHL-42X as a potentially differentiated pharmaceutical treatment for obstructive

sleep apnoea.

Joel Latham, President and Chief Executive Officer of Incannex, commented:

“The grant of this U.S. patent represents another major milestone

in the evolution of the IHL-42X program and further validates what we believe is one of the most compelling development opportunities

in sleep medicine. Obstructive sleep apnoea affects an estimated one billion people globally and remains a significantly underserved market

where current treatment options continue to suffer from poor long-term patient adherence. We believe this creates an extraordinary commercial

opportunity for a safe, effective and convenient oral pharmaceutical therapy.

“Over the past twelve months we have continued to build significant

momentum across every aspect of the program. Following the successful RePOSA Phase II study, IHL-42X was granted FDA Fast Track designation,

our intellectual property portfolio has continued to strengthen, and we are now approaching patient recruitment in our DReAMzz dose optimisation

study, which is expected to further de-risk and optimise our Phase III development strategy.

“Importantly, this patent provides protection for our proprietary

composition and methods of treatment through at least 2040, with the potential for additional patent term extension following regulatory

approval. Combined with the clinical progress we have achieved, we believe IHL-42X is becoming an increasingly valuable pharmaceutical

asset with the potential to address one of the largest unmet needs in sleep medicine. We remain focused on executing our development strategy

and creating significant long-term value for both patients and shareholders.”

IHL-42X Clinical Development Update

Incannex is nearing the commencement of patient recruitment in the

DReAMzz Phase 2 study. The study has received central IRB approval along with the first tranche of site-specific IRB approvals. Study-specific

Schedule I researcher registrations with the DEA are underway. The first site has received all necessary approvals and will commence screening

in the near future, with additional sites to follow as the required approvals are received. Study drug supply has been shipped from the

manufacturer to the distribution partner for secondary packaging and clinical trial labelling in preparation for patient dosing.

The DReAMzz study is designed as a crossover dose optimisation study

intended to further refine the dosing profile of IHL-42X and strengthen the design of the planned Phase III development program. The study

is expected to generate additional data evaluating the relationship between dose optimisation, objective sleep metrics, and patient-reported

outcomes, which are becoming increasingly important in both regulatory review and commercial positioning within the OSA market.

About Incannex Healthcare Inc.

Incannex Healthcare Inc. is a clinical-stage biopharmaceutical company

developing innovative combination therapies and next-generation medicines for conditions with significant unmet medical need. The Company’s

lead programs include IHL-42X for obstructive sleep apnoea, IHL-675A for rheumatoid arthritis and PSX-001 for generalized anxiety disorder.

Incannex is committed to advancing therapies that address multiple biological pathways with the goal of improving patient outcomes and

creating long-term shareholder value. For more information, please visit www.incannex.com.

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking

statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These

statements include, but are not limited to, statements relating to management’s expectations regarding the development, regulatory

progress and commercialization of the Company’s drug candidates, potential benefits of equity research coverage, the potential value

of the Company’s drug candidates and business, and potential shareholder value. When or if used in this communication, the words

“may,” “could,” “should,” “anticipate,” “believe,” “estimate,”

“expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they

relate to the Company, its operations or its management, may identify forward-looking statements. The forward-looking statements contained

in this press release are based on management’s current expectations and projections about future events. Nevertheless, actual results

or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements.

These risks and uncertainties, many of which are beyond our control, include: the risk that the Company’s estimates and current

projections regarding the sufficiency of its current cash on hand to fund the Company’s planned operations may be incorrect and

the Company may use these resources faster than anticipated, the potential risk that equity research coverage may not result in increased

investor awareness or liquidity, risks associated with the clinical development of IHL-42X and PSX-001, and other risks described in the

section entitled “Risk Factors” described in the Company’s annual report on Form 10-K for the fiscal year ended June

30, 2025, filed with the SEC on September 29, 2025, and the other reports it files from time to time, including subsequently filed annual,

quarterly and current reports, which can be obtained on the SEC website at www.sec.gov and are made available on the Company’s website

upon their filing with the SEC. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only

as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company

does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this

press release except as required by law.

Investor & Media Contacts

CORE IR

(212) 655-0924

investors@incannex.com

media@incannex.com.au

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