Form 8-K
8-K — Incannex Healthcare Inc.
Accession: 0001213900-26-098213
Filed: 2026-09-09
Period: 2026-09-09
CIK: 0001873875
SIC: 2834 (PHARMACEUTICAL PREPARATIONS)
Item: Regulation FD Disclosure
Item: Financial Statements and Exhibits
Documents
8-K — ea0304782-8k_incannex.htm (Primary)
EX-99.1 — PRESS RELEASE DATED AS OF SEPTEMBER 9, 2026 (ea030478201ex99-1.htm)
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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): September 9, 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 September
9, 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 September 9, 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: September 9, 2026
/s/ Joel Latham
Name:
Joel Latham
Title:
Chief Executive Officer and President
2
EX-99.1 — PRESS RELEASE DATED AS OF SEPTEMBER 9, 2026
EX-99.1
Filename: ea030478201ex99-1.htm · Sequence: 2
Exhibit 99.1
Incannex Healthcare Provides Corporate Update
on Clinical Progress, Intellectual Property and Capital Position
● Patient dosing commenced in the DReAMzz Phase 2 dose-optimization study of IHL-42X in obstructive sleep apnea
● U.S. composition and methods of treatment patent granted covering IHL-42X with baseline expiry in 2040
● Approximately $70 million in cash and no debt, including more than A$11.2 million in non-dilutive capital received during 2026
NEW YORK and MELBOURNE, Australia, September 9, 2026 -- Incannex
Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company developing
innovative combination therapies for high-impact indications, today provides a corporate update reporting the dosing of the first patient
in its DReAMzz Phase 2 study of IHL-42X in obstructive sleep apnea, the grant of a U.S. composition patent covering IHL-42X, and a cash
position of approximately $70 million with no debt.
Incannex President and CEO Joel Latham stated, “The commencement
of patient dosing in DReAMzz marks a key milestone in the clinical development of IHL-42X. The protocol, which was shaped by our clinical
advisory board and incorporates feedback from the FDA, was designed to produce the dose-selection data we need to enter a Phase 3 registration
program with confidence. The program is well protected, with the recently granted composition patent extending protection to 2040, and
well funded by our healthy cash position.”
IHL-42X for Obstructive Sleep Apnea
On August 25, 2026, Incannex announced the commencement of patient
dosing in DReAMzz, a Phase 2 crossover dose-optimization study of IHL-42X in patients with obstructive sleep apnea. The study is being
conducted across 13 clinical trial sites in the United States, each of which has received Institutional Review Board approval.
DReAMzz is designed to refine the dosing profile of IHL-42X and to
inform the design of a subsequent Phase 3 registration program. The study protocol was developed with input from the Company’s Obstructive
Sleep Apnea Clinical Advisory Board, comprising physicians and researchers in sleep medicine and respiratory disease, and was reviewed
by the U.S. Food and Drug Administration, with agency feedback incorporated into the final design.
Incannex previously completed the RePOSA Phase 2 study, which enrolled
121 subjects across 16 sites in the United States and reported positive topline results in August 2025. Patients enrolled in RePOSA were
non-compliant with, intolerant of, or naive to positive airway pressure therapy. Both the low-dose and high-dose IHL-42X groups demonstrated
greater percentage reductions in the apnea-hypopnea index relative to baseline than placebo, and greater reductions in the oxygen desaturation
index than placebo, in each case with statistical significance. Individual reductions in apnea-hypopnea index of up to 83 percent were
observed. The FDA granted Fast Track designation to IHL-42X in December 2025.
PSX-001 for Generalized Anxiety Disorder
PSX-001, the Company’s oral synthetic psilocybin therapeutic,
continues to advance as a differentiated potential treatment for generalized anxiety disorder (GAD), a significant and underserved mental
health condition.
In August 2025, the Company reported positive topline results from
the completed 73-subject PsiGAD1 Phase 2 study. These encouraging results provide a strong clinical foundation for the program’s
next stage of development. The Company also has an open U.S. Investigational New Drug application for PsiGAD2, a Phase 2b dose-comparison
study, supporting continued regulatory and clinical progress in the United States.
To sharpen PSX-001’s competitive positioning and expand its potential,
the Company has assembled a clinical advisory board of leading experts in psychiatry, psychiatric drug development and mental health treatment.
Working with these key opinion leaders, the Company has developed innovative strategies for advancing psilocybin-based therapies in GAD
and other high-value mental health indications.
The Company has also presented a refined development strategy to the
UK Medicines and Healthcare products Regulatory Agency (MHRA) through a scientific advice meeting. Feedback from the MHRA, combined with
continued input from the clinical advisory board, is actively informing the program’s clinical and regulatory pathway.
With positive Phase 2 results, an open U.S. IND, regulatory engagement
in the UK and guidance from internationally recognized experts, PSX-001 has multiple catalysts supporting its continued advancement. The
Company believes these achievements strengthen the program’s differentiation and position PSX-001 to address substantial unmet patient
need while creating meaningful long-term value for shareholders.
Intellectual Property
On June 25, 2026, the United States Patent and Trademark Office granted
Incannex a patent titled, “Compositions and Methods of Treatment for Obstructive Sleep Apnea,” with claims directed to the IHL-42X
composition and associated methods of treatment. The patent carries a baseline expiry of July 9, 2040. The Company is evaluating eligibility
for patent term extension in the event of future marketing approval.
Financial Position
As of 31 August 2026, Incannex held approximately $70 million in cash
and cash equivalents and carried no debt.
During 2026, the Company received more than A$11.2 million in non-dilutive
capital through the Australian Research and Development Tax Incentive program, comprising an A$6.0 million refund announced in June 2026
in respect of fiscal year 2025 and an additional A$5.1 million refund announced in August 2026.
2
About IHL-42X
IHL-42X is an oral fixed-dose combination of dronabinol and acetazolamide
being developed for the treatment of obstructive sleep apnea. The two components act on distinct physiological processes associated with
the condition. Dronabinol activates muscles in the upper airway and dampens afferent vagal feedback, stabilizing respiratory patterns
and dilating the upper airway. Acetazolamide inhibits carbonic anhydrase, prompting respiratory drive at lower carbon dioxide levels.
IHL-42X holds Fast Track designation from the U.S. Food and Drug Administration.
About PSX-001
PSX-001 is an oral synthetic psilocybin therapeutic being developed
for the treatment of generalized anxiety disorder.
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 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
This press release contains forward-looking statements within the meaning
of the United States Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding
the development, clinical performance, regulatory progress and potential commercialization of the Company’s drug candidates; the
design, conduct, timing and anticipated outcomes of clinical trials; the potential benefits of regulatory designations; the Company’s
intellectual property protection and potential patent term extension; the sufficiency of its capital resources; and potential shareholder
value. Words such as “may,” “could,” “should,” “anticipate,” “believe,” “continue,”
“estimate,” “expect,” “intend,” “plan,” “potential,” “predict,”
“project,” “will,” “would” and similar expressions identify forward-looking statements.
Forward-looking statements are based on management’s current
expectations and are subject to risks and uncertainties that could cause actual results to differ materially. These include the risks
that clinical trials may be delayed, may not meet their endpoints or may identify safety concerns; earlier clinical results may not predict
later outcomes; regulatory authorities may require additional studies or may delay or deny approval; regulatory feedback and Fast Track
designation may not result in an accelerated or successful approval pathway; and the Company may experience difficulties with patient
enrollment, clinical sites, contractors or manufacturing. Intellectual property risks include the possibility that patents may be challenged,
narrowed, invalidated, circumvented or found unenforceable; may not prevent competing products; may not provide protection in all relevant
jurisdictions; or may not qualify for patent term extension. The Company may also face third-party intellectual property claims. Additional
risks include the possibility that the Company’s cash resources may be used more quickly than anticipated and that additional financing
may be required.
Other risks are described under “Risk Factors” 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 in its subsequent filings
with the SEC, available at www.sec.gov. Readers should not place undue reliance on forward-looking statements, which speak only as of
their date. Except as required by law, the Company undertakes no obligation to update them.
Investor & Media Contacts
CORE IR
(212) 655-0924
investors@incannex.com
media@incannex.com.au
3
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