Form 8-K

8-K — Incannex Healthcare Inc.

Accession: 0001213900-26-046408

Filed: 2026-04-22

Period: 2026-04-22

CIK: 0001873875

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — ea0287297-8k_incannex.htm (Primary)

EX-99.1 — PRESS RELEASE DATED AS OF APRIL 22, 2026 (ea028729701ex99-1.htm)

GRAPHIC (ea028729701_ex99-1img1.jpg)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K — CURRENT REPORT

8-K (Primary)

Filename: ea0287297-8k_incannex.htm · Sequence: 1

false

0001873875

2026-04-22

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

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): April 22, 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 April

22, 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 April 22, 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: April 22, 2026

/s/ Joel Latham

Name:

Joel Latham

Title:

Chief Executive Officer and President

EX-99.1 — PRESS RELEASE DATED AS OF APRIL 22, 2026

EX-99.1

Filename: ea028729701ex99-1.htm · Sequence: 2

Exhibit 99.1

Incannex Healthcare PSX-001 Program Aligns with

White House Executive Order Accelerating Access to

Psychedelic Treatments for Serious Mental Illness

Company’s oral synthetic psilocybin program

advances within significantly improved regulatory environment

MELBOURNE, Australia and NEW YORK, April 22, 2026 (GLOBE NEWSWIRE)

— Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies,

today supports the White House Executive Order signed by President Donald J. Trump on April 18, 2026, titled, “Accelerating Medical

Treatments for Serious Mental Illness.” The Company believes its PSX-001 development program aligns with the goals outlined in the

Executive Order and believes the data demonstrated to date, along with a more amenable regulatory environment, may provide significant

hope for those suffering from anxiety disorders.

“We agree with the Administration’s

recognition that the mental health crisis in America demands a new level of regulatory urgency and scientific ambition,” commented

Incannex CEO Joel Latham. “For years, patients suffering from debilitating anxiety disorders have had limited options, particularly

for those who fail first-line treatments. PSX-001, our oral synthetic psilocybin therapeutic for Generalized Anxiety Disorder, is designed

for exactly these patients and this Executive Order represents a meaningful step toward ensuring that novel, evidence-based therapies

like ours can reach them without unnecessary delay.”

PSX-001: Rigorous

Science, Compelling Data, a Clear Path Forward

PSX-001 is an oral, fixed-dose synthetic psilocybin

formulation in development for Generalized Anxiety Disorder (GAD), a condition affecting an estimated 280 million people globally and

approximately 6.8 million in the United States. In Incannex’s completed Phase 2 clinical trial, PSX-001 demonstrated statistically

significant and clinically meaningful improvements across all primary and secondary endpoints:

● 12.8-point reduction in HAM-A anxiety scores versus 3.6 points for placebo

(p<0.0001)

● 44% rate of clinically meaningful response (≥50% anxiety reduction) —

four times the placebo rate

● 27% remission rate (HAM-A ≤7) — five times the placebo rate, sustained

through 11 weeks

● No serious adverse events and a single discontinuation across 73 patients

The Executive Order’s direction to the FDA

to prioritize review of psychedelic compounds with Breakthrough Therapy designations create Right to Try pathways for investigational

psychedelics, and initiate DEA rescheduling upon successful Phase 3 completion. The move also addresses systemic barriers that have historically

constrained the development and commercialization of this entire therapeutic category. Incannex views these measures as meaningfully reducing

regulatory and commercial risk for the psilocybin class broadly.

“This Executive Order underscores what the

clinical evidence has been telling us for years, that psilocybin and related compounds represent a genuinely transformative opportunity

in mental health”, Mr. Latham continued. “We are well-funded with over $70 million in cash and no debt, our U.S. IND is active,

and we believe our Phase 2 data is among the strongest in the oral psilocybin space. We are advancing PSX-001 with urgency and scientific

rigor, and we welcome a regulatory environment that shares that sense of urgency.”

About PSX-001

PSX-001 is an investigational oral synthetic psilocybin

therapeutic in development for Generalized Anxiety Disorder. Incannex completed a 73-patient Phase 2 clinical trial in Australia in 2025,

reporting statistically significant and durable improvements in anxiety, functioning, depression, and quality of life measures. PSX-001

is the first oral synthetic psilocybin therapeutic in development for GAD.

About Incannex Healthcare Inc.

Incannex is leading the way in developing combination medicines that target the underlying biological pathways associated with chronic

conditions, including obstructive sleep apnea, rheumatoid arthritis and generalized anxiety disorder. The Company is advancing three clinical-stage

product candidates based on evidence-based innovation and supported by streamlined operations. Incannex’s lead clinical program, IHL-42X,

is an oral fixed-dose combination of dronabinol and acetazolamide designed to target underlying mechanisms and act synergistically in

the treatment of obstructive sleep apnea. In a Phase 2 development program, IHL-675A is an oral fixed-dose combination of cannabidiol

and hydroxychloroquine sulfate designed to act synergistically to alleviate inflammatory conditions, such as rheumatoid arthritis. Approved

for Phase 2 clinical development, PSX-001 is an oral synthetic psilocybin treatment for the treatment of generalized anxiety disorder.

Incannex’s programs target disorders that have limited, inadequate, or no approved pharmaceutical treatment options. For additional information

on Incannex, please visit our website at 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 share

repurchase program, expectations regarding use of the Company’s cash on hand, the potential value of the Company’s drug candidates

and business, including these values as compared to available cash, opportunities, the strategy, timing and future development of the

Company’s drug candidates, the potential value of the Company and its drug candidates 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 or suspend the share repurchase program and other risks described in the

section entitled “Risk Factors” described in the prospectus supplement and 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

GRAPHIC

Filename: ea028729701_ex99-1img1.jpg · Sequence: 3

Binary file (20326 bytes)

Download ea028729701_ex99-1img1.jpg

XML — IDEA: XBRL DOCUMENT

XML

Filename: R1.htm · Sequence: 8

v3.26.1

Cover

Apr. 22, 2026

Cover [Abstract]

Document Type

8-K

Amendment Flag

false

Document Period End Date

Apr. 22, 2026

Entity File Number

001-41106

Entity Registrant Name

Incannex Healthcare

Inc.

Entity Central Index Key

0001873875

Entity Tax Identification Number

93-2403210

Entity Incorporation, State or Country Code

Entity Address, Address Line One

Rialto South Tower

Entity Address, Address Line Two

Level 23

Entity Address, Address Line Three

525 Collins Street

Entity Address, City or Town

Melbourne, VIC

Entity Address, Country

Entity Address, Postal Zip Code

3008

City Area Code

+61

Local Phone Number

409 840 786

Written Communications

false

Soliciting Material

false

Pre-commencement Tender Offer

false

Pre-commencement Issuer Tender Offer

false

Title of 12(b) Security

Common Stock, $0.0001 par value per share

Trading Symbol

IXHL

Security Exchange Name

NASDAQ

Entity Emerging Growth Company

true

Elected Not To Use the Extended Transition Period

false

- Definition

Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.

+ References

No definition available.

+ Details

Name:

dei_AmendmentFlag

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Area code of city

+ References

No definition available.

+ Details

Name:

dei_CityAreaCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Cover page.

+ References

No definition available.

+ Details

Name:

dei_CoverAbstract

Namespace Prefix:

dei_

Data Type:

xbrli:stringItemType

Balance Type:

Period Type:

duration

- Definition

For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

+ References

No definition available.

+ Details

Name:

dei_DocumentPeriodEndDate

Namespace Prefix:

dei_

Data Type:

xbrli:dateItemType

Balance Type:

Period Type:

duration

- Definition

The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

+ References

No definition available.

+ Details

Name:

dei_DocumentType

Namespace Prefix:

dei_

Data Type:

dei:submissionTypeItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 1 such as Attn, Building Name, Street Name

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine1

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 2 such as Street or Suite number

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine2

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 3 such as an Office Park

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine3

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the City or Town

+ References

No definition available.

+ Details

Name:

dei_EntityAddressCityOrTown

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

ISO 3166-1 alpha-2 country code.

+ References

No definition available.

+ Details

Name:

dei_EntityAddressCountry

Namespace Prefix:

dei_

Data Type:

dei:countryCodeItemType

Balance Type:

Period Type:

duration

- Definition

Code for the postal or zip code

+ References

No definition available.

+ Details

Name:

dei_EntityAddressPostalZipCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityCentralIndexKey

Namespace Prefix:

dei_

Data Type:

dei:centralIndexKeyItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if registrant meets the emerging growth company criteria.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityEmergingGrowthCompany

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if an emerging growth company has elected not to use the extended transition period for complying with any new or revised financial accounting standards.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 7A

-Section B

-Subsection 2

+ Details

Name:

dei_EntityExTransitionPeriod

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

Name:

dei_EntityFileNumber

Namespace Prefix:

dei_

Data Type:

dei:fileNumberItemType

Balance Type:

Period Type:

duration

- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

Namespace Prefix:

dei_

Data Type:

dei:edgarStateCountryItemType

Balance Type:

Period Type:

duration

- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityRegistrantName

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

dei_

Data Type:

dei:employerIdItemType

Balance Type:

Period Type:

duration

- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

dei_PreCommencementIssuerTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration