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Incannex (Nasdaq: IXHL) backs sleep apnea research as IHL-42X advances

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(Moderate)
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Form Type
8-K

Rhea-AI Filing Summary

Incannex Healthcare Inc. filed a current report describing a new partnership with the AASM Foundation to support sleep apnea research as its lead drug IHL-42X advances. The company is joining the AASM Foundation’s Corporate Recognition Program and sponsoring a Focused Projects Grant for Junior Investigators on the diagnosis, management, and treatment of sleep apnea, to be awarded in 2026.

The filing highlights recent milestones for IHL-42X, an oral fixed-dose combination of dronabinol and acetazolamide being developed for obstructive sleep apnea, including positive Phase 2 results, FDA Fast Track designation, and progression into the DReAMzz Phase 2 crossover dose-optimisation study ahead of a planned Phase 3 program. Incannex also outlines a broader pipeline that includes IHL-675A for rheumatoid arthritis and PSX-001, a synthetic psilocybin therapy for generalized anxiety disorder.

Positive

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Negative

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Insights

Incannex deepens sleep apnea focus while progressing IHL-42X toward late-stage trials.

Incannex is reinforcing its obstructive sleep apnea strategy by pairing clinical progress on IHL-42X with a new research partnership. The alliance with the AASM Foundation and sponsorship of a 2026 junior investigator grant embed the company within the sleep medicine research ecosystem.

The filing reiterates several value drivers: positive Phase 2 data for IHL-42X, FDA Fast Track designation, and the DReAMzz Phase 2 crossover dose-optimisation study designed to refine dosing ahead of Phase 3. A defined Phase 3 pathway and a fully funded development program for IHL-42X are noted, alongside additional clinical-stage assets IHL-675A and PSX-001 targeting inflammatory disease and generalized anxiety disorder.

Forward-looking statements emphasize that future outcomes depend on clinical results and regulatory interactions. Subsequent company reports are expected to provide more detail on DReAMzz patient dosing and timing of any pivotal Phase 3 trial for IHL-42X.

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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): March 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 March 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 March 25, 2026
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

1

 

 

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: March 25, 2026 /s/ Joel Latham
  Name: Joel Latham
  Title: Chief Executive Officer and President

 

2

 

Exhibit 99.1

 

 

Incannex Healthcare Announces Partnership with the AASM Foundation in Support of Sleep Apnea Research

 

Company Joins AASM Foundation Corporate Recognition Program and Sponsors Junior Investigator Research Grant as IHL-42X Advances Toward Potential Oral Treatment for Obstructive Sleep Apnea

 

Melbourne and New York – 25 March 2026 – Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing combination therapies for high-impact indications, today announced it has entered into a Partnership Agreement with the American Academy of Sleep Medicine (AASM) Foundation. Through this partnership, Incannex has joined the AASM Foundation’s Corporate Recognition Program and will sponsor a Focused Projects Grant for Junior Investigators dedicated to the Diagnosis, Management, and Treatment of Sleep Apnea, to be awarded in 2026.

 

The partnership reflects the Company’s commitment to the broader sleep medicine community as it continues to advance IHL-42X, its lead investigational oral fixed-dose combination of dronabinol and acetazolamide designed to target underlying mechanisms and act synergistically in the treatment of obstructive sleep apnea (OSA).

 

Advancing IHL-42X for Obstructive Sleep Apnea

 

Incannex is developing IHL-42X — an innovative oral fixed-dose combination of dronabinol and acetazolamide — as a potential first-in-class treatment for obstructive sleep apnea (OSA). OSA is a serious and widespread chronic condition affecting hundreds of millions of people globally, yet remains significantly undertreated, with a large proportion of patients unable to tolerate or adhere to existing therapies. This represents a substantial and largely unmet medical need, and a compelling commercial opportunity.

 

The past year has been one of the most productive in Incannex's history, marked by a series of meaningful milestones that have materially strengthened the IHL-42X programme and positioned the Company for the next phase of development:

 

  • Positive Phase 2 clinical trial results demonstrated statistically significant improvements in OSA outcomes, providing strong validation of IHL-42X's therapeutic potential and setting a compelling foundation.
  • FDA Fast Track designation was awarded to IHL-42X, recognising the programme's potential to address a serious unmet medical need and enabling a more collaborative and expedited pathway with the FDA.
  • Advancement into the DReAMzz study — a Phase 2 crossover dose-optimisation trial designed to further enhance the efficacy of IHL-42X ahead of a pivotal Phase 3 programme — reflects the Company's commitment to entering Phase 3 with the strongest possible clinical profile.
  • Establishment of a world-class Clinical Advisory Board, comprising leading international experts in sleep medicine, to provide independent guidance on clinical strategy and study design.
  • A clearly defined and well-supported Phase 3 pathway, underpinned by robust Phase 2 data, regulatory engagement, and a fully funded development programme.
  •  

    The DReAMzz study is designed to further optimise the ratio of the two active ingredients within IHL-42X, with the goal of maximising both objective physiological outcomes and patient-reported quality of life measures. Patient dosing is expected to commence within the coming months — a near-term milestone that underscores the programme's continued momentum and brings Incannex one step closer to delivering a transformative new treatment option for the millions of patients living with OSA.

     

     

     

     

    Supporting the Next Generation of Sleep Medicine Researchers

     

    As a sponsor of the AASM Foundation’s Focused Projects Grant for Junior Investigators, Incannex will support independent research into the Diagnosis, Management, and Treatment of Sleep Apnea, to be awarded in 2026. All materials related to the grant will carry a “Supported by Incannex” credit line. Both organisations will collaborate on press releases, digital promotion, and social media engagement to promote the partnership and the scientific work it supports.

     

    “Obstructive sleep apnea is a serious, chronic condition that remains substantially undertreated — and for too many patients, existing options are simply not sufficient. IHL-42X is designed to address that unmet need, and this partnership with the AASM Foundation reflects our deep commitment to the broader scientific community working to change that. Supporting the next generation of sleep medicine researchers is something we are genuinely proud to do, and we look forward to contributing to the advancement of the field alongside our own clinical program.”

     

    — Dr. Luigi Barbato, MD, Chief Medical Officer, Incannex Healthcare Inc.

     

    About the AASM Foundation

     

    The American Academy of Sleep Medicine (AASM) Foundation is a not-for-profit organisation dedicated to advancing sleep health through research, education, and public awareness. It funds investigators focused on the prevention, diagnosis, and treatment of sleep disorders. For more information, visit foundation.aasm.org.

     

    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 the strategy, timing and future development of the Company’s drug candidates, including the anticipated timing of the DReAMzz Phase 2 crossover dose-optimisation study and a Phase 3 clinical trial for IHL-42X, and the potential value of the Company’s drug candidates and business. 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. Risks and uncertainties include those 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 other reports filed from time to time, which can be obtained on the SEC website at www.sec.gov. 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

     

     

     

    FAQ

    What partnership did Incannex Healthcare (IXHL) announce regarding sleep apnea research?

    Incannex Healthcare announced a Partnership Agreement with the AASM Foundation. The company joined the AASM Foundation’s Corporate Recognition Program and will sponsor a Focused Projects Grant for Junior Investigators dedicated to sleep apnea research, with the award planned for 2026.

    What is Incannex Healthcare’s lead program IHL-42X and what condition does it target?

    IHL-42X is an oral fixed-dose combination of dronabinol and acetazolamide. It is being developed as a potential first-in-class treatment for obstructive sleep apnea, aiming to target underlying mechanisms and act synergistically to improve both physiological outcomes and patient quality of life.

    What recent clinical and regulatory milestones has IHL-42X achieved for Incannex (IXHL)?

    Incannex reports positive Phase 2 trial results for IHL-42X in obstructive sleep apnea and notes that the FDA has granted Fast Track designation. The program has progressed into the DReAMzz Phase 2 crossover dose-optimisation study with a clearly defined Phase 3 pathway and a fully funded development program.

    What is the DReAMzz study mentioned by Incannex Healthcare in relation to IHL-42X?

    The DReAMzz study is a Phase 2 crossover dose-optimisation trial for IHL-42X. It is designed to optimize the ratio of dronabinol and acetazolamide to maximize objective physiological outcomes and patient-reported quality-of-life measures ahead of a planned pivotal Phase 3 program.

    Which other clinical-stage drug candidates are in Incannex Healthcare’s pipeline?

    Beyond IHL-42X, Incannex is advancing IHL-675A, an oral fixed-dose combination of cannabidiol and hydroxychloroquine sulfate for inflammatory conditions such as rheumatoid arthritis, and PSX-001, an oral synthetic psilocybin treatment approved for Phase 2 clinical development in generalized anxiety disorder.

    How does Incannex’s partnership with the AASM Foundation support early-career researchers?

    Incannex will sponsor the AASM Foundation’s Focused Projects Grant for Junior Investigators on sleep apnea. The grant, to be awarded in 2026, will fund independent research, with materials carrying a “Supported by Incannex” credit line and joint promotional efforts through press releases and digital channels.

    What forward-looking risks and cautions does Incannex highlight in this disclosure?

    Incannex notes that statements about strategy, timing, and future development of its drug candidates are forward-looking and may differ materially from actual results. It refers investors to risk factors in its Form 10-K for the year ended June 30, 2025, and other SEC reports for detailed discussion.

    Filing Exhibits & Attachments

    4 documents
    Incannex Healthcare Ltd

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