Form 8-K

8-K — Incannex Healthcare Inc.

Accession: 0001213900-26-080622

Filed: 2026-07-23

Period: 2026-07-23

CIK: 0001873875

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — ea0298674-8k_incannex.htm (Primary)

EX-99.1 — PRESS RELEASE DATED AS OF JULY 23, 2026 (ea029867401ex99-1.htm)

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8-K — CURRENT REPORT

8-K (Primary)

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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): July 23, 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 July

23, 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 July 23, 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: July 23, 2026

/s/ Joel Latham

Name:

Joel Latham

Title:

Chief Executive Officer and President

EX-99.1 — PRESS RELEASE DATED AS OF JULY 23, 2026

EX-99.1

Filename: ea029867401ex99-1.htm · Sequence: 2

Exhibit

99.1

Incannex

Commences Participant Screening in DReAMzz Phase 2 Study of IHL-42X for Obstructive Sleep Apnea

● First

clinical sites approved and actively screening potential participants

● Represents

another major milestone in the advancement of IHL-42X towards Phase III development

● IHL-42X

has received FDA Fast Track designation, highlighting its potential to address the significant

unmet medical need in obstructive sleep apnea and supporting a potentially expedited regulatory

pathway

● Study

designed to optimize both objective sleep metrics and patient-reported outcomes to support

regulatory approval and commercial differentiation

● Builds

upon previously announced positive Phase 2 data demonstrating up to 83% reduction in AHI

and significant improvements across multiple patient-reported outcome measures

● Obstructive

sleep apnea affects an estimated one billion people globally, with no FDA-approved oral pharmaceutical

therapies currently available

MELBOURNE,

Australia and NEW YORK, 23 July, 2026 – Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”),

a clinical-stage biopharmaceutical company developing innovative therapies for high-impact indications, is pleased to announce that participant

screening has commenced in the Company’s DReAMzz Phase 2 dose confirmation study evaluating IHL-42X for the treatment of obstructive

sleep apnea (“OSA”). IHL-42X has previously been granted Fast Track designation by the U.S. Food and Drug Administration

(“FDA”), underscoring its potential to address the significant unmet medical need in OSA and providing opportunities for

more frequent interactions with the FDA throughout the development process, supporting a potentially expedited pathway towards regulatory

review.

The

first tranche of clinical trial sites have now received approval to commence screening potential participants for the DReAMzz study,

marking another important milestone in the advancement of Incannex’s lead clinical program towards Phase III development. Additional

clinical sites are expected to commence screening activities as they receive the necessary approvals.

Potential

participants will be identified through site patient databases and public outreach initiatives before undergoing screening assessments

against the study’s predefined inclusion and exclusion criteria.

The

commencement of screening represents the transition of the DReAMzz study into active clinical recruitment and follows significant operational

progress made by the Company, including the appointment of a global CRO, completion of drug product manufacturing activities, finalization

of import and export permits, and the establishment of clinical and drug distribution infrastructure required to support the study.

The

DReAMzz study has been strategically designed to optimize the dosing profile of IHL-42X while further evaluating the relationship between

objective sleep metrics and patient-reported outcomes. The additional data generated from the study is expected to strengthen both the

regulatory package and commercial positioning of IHL-42X ahead of the Company’s planned Phase III development program.

Importantly,

patient-reported outcomes are becoming increasingly relevant in both regulatory review and commercialization strategies for therapies

targeting chronic diseases such as OSA, particularly where improvements in quality of life, fatigue and overall patient wellbeing represent

meaningful treatment objectives alongside objective clinical endpoints.

Joel

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

“The

commencement of participant screening is another major milestone for the IHL-42X development program and represents the culmination of

significant work undertaken by our clinical, regulatory and manufacturing teams over recent months.

“We

believe IHL-42X has the potential to fundamentally change the treatment paradigm for obstructive sleep apnea. While existing treatment

options are often associated with poor patient compliance and there are currently no FDA-approved oral pharmaceutical therapies available

for OSA, IHL-42X has already demonstrated compelling efficacy across both objective sleep metrics and patient-reported outcomes in our

previous Phase 2 study.

“The

FDA’s decision to grant Fast Track designation to IHL-42X provides further validation of both the significant unmet medical need

in OSA and the potential of our program. Fast Track designation is reserved for therapies intended to treat serious conditions and that

have the potential to address unmet medical needs, and we believe it further reinforces the significant opportunity that exists for IHL-42X

as we advance towards Phase III development.

“DReAMzz

has been specifically designed to further optimize our dosing strategy ahead of Phase III development while generating additional data

that will strengthen both our regulatory submission strategy and the commercial profile of IHL-42X. We remain highly encouraged by the

potential opportunity ahead of us in a market affecting an estimated one billion people globally.”

About

the DReAMzz Study

The

DReAMzz study is a randomized, crossover Phase 2 dose confirmation study designed to further optimize the dosing profile of IHL-42X.

The study is expected to generate important data evaluating dose optimization across objective sleep metrics and patient-reported outcomes

that will inform the Company’s planned Phase III clinical development program.

The

study builds upon previously announced positive Phase 2 results, which demonstrated statistically significant reductions in Apnea-Hypopnea

Index (“AHI”) versus placebo, with reductions of up to 83% observed. IHL-42X also demonstrated statistically significant

improvements across multiple patient-reported outcome measures, including fatigue and sleep related impairment, while maintaining a favorable

safety profile.

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 apnea, 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,

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, 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 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

(212)

655-0924

investors@incannex.com

media@incannex.com.au

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