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UNITED
STATES
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 February 1, 2024
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.) |
Suite 105, 8 Century Circuit Norwest,
NSW 2153 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
8.01
On
February 1, 2024, Incannex Healthcare Inc. announced that Clarion Clinics has received approval from the Therapeutic Good Administration
to prescribe MDMA for the treatment of PTSD and Psilocybin for Treatment- Resistant Depression at the Melbourne Clinic. Further information
is included in the press release attached as Exhibit 99.1 hereto, which is incorporated by reference into this Item 8.01.
Item
9.01 Financial Statements and Exhibits.
(d) Exhibits
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:
February 1, 2024 |
|
/s/ Joel Latham |
| |
Name: |
Joel Latham |
| |
Title: |
Chief Executive Officer and President |
2
Exhibit 99.1
Date: February 1, 2024
Public Announcement (NASDAQ: IXHL)
CLARION CLINICS OPEN FOR PSYCHEDELIC-ASSISTED
TREATMENTS
Highlights:
| ● | Clarion’s
Head of Psychiatry, Professor Suresh Sundram, has been approved by the TGA to prescribe MDMA
for Post-traumatic Stress Disorder and psilocybin for Treatment-resistant Depression, alongside
extensive psychotherapy. |
| ● | Clarion
Clinics’ built-for-purpose clinic in Melbourne is now open for treatment, and will
begin screening patients immediately. |
| ● | Clarion
Clinics represents Australia’s leading track record in psychedelic-assisted therapies,
and has developed a best-practice model of care that is substantially longer and more tailored
than other psychedelic treatment programs, including those within clinical trials. |
February
1, 2024 – Incannex Healthcare Inc (Nasdaq: IXHL) (‘Incannex’ or ‘the Company’) a pharmaceutical company
developing proprietary medicinal cannabinoid products and psychedelic assisted psychotherapies for unmet needs is pleased to announce
that Clarion Clinic’s co-Founder and Head of Psychiatry, Professor Suresh Sundram, has received Authorised Prescriber approval
from the Therapeutic Goods Administration (TGA) to prescribe MDMA in the treatment of Post-traumatic Stress Disorder (PTSD) and psilocybin
for Treatment-resistant Depression (TRD) at its first built-for-purpose clinic based in Melbourne, Australia, a city of approximately
5.2M people.
The Australian TGA Authorised Prescriber Scheme
is designed to provide access to certain drugs that are not on the Australian Register of Therapeutic Goods (ARTG) by specially authorising
experienced medical practitioners to prescribe them for certain indications. On July 1, 2023, following promising clinical trial results,
the TGA down-scheduled MDMA and psilocybin for use in the treatment of PTSD and TRD respectively. This change in drug classification,
from Schedule 9 (prohibited substances) to Schedule 8 (controlled drug) is the first down-scheduling of any psychedelic drug globally,
permitting the use of these drugs in clinical service delivery through the Authorised Prescriber Scheme.
Clarion Clinics is a collaboration between Australia’s
leading psychedelic-assisted therapy professionals and scientists, and Incannex. Clarion Clinics, Abbottsford, will be the first dedicated
psychedelic-assisted therapy clinic in Australia. Located on the Yarra riverfront in Abbottsford, Melbourne, the clinic has been positioned,
designed, and fitted out specifically to facilitate an optimal environment for psychedelic-assisted therapy.
“This treatment is potentially life-changing
for many people in Australia. Clarion is at the leading edge of mental healthcare, has the right protocols, and an experienced team ready
to help people through these challenging conditions,” Peter Widdows, Incannex Director responsible for Clarion Clinics, said.
Incannex Healthcare Inc.
Level 39, Rialto South Tower, 525 Collins
Street, Melbourne VIC 3000
Email: admin@incannex.com.au
Date: February 1, 2024
Public Announcement (NASDAQ: IXHL)
“Our clinical, support, and leadership teams
at Clarion represent Australia’s strongest track record in delivering psychedelic-assisted therapies – I’m looking forward
to embarking on the next chapter in our field’s development alongside these brilliant, skilled and compassionate professionals who
are all focused on supporting the best possible outcomes for people who access this treatment. Our evidence-informed, extended, and patient-centric
treatment model has been designed to harness what we know about how these therapies work towards the highest levels of safety and lasting
benefits for the people we treat,” said Dr Paul Liknaitzky, Clarion Clinics co-founder,
“I’m grateful to the TGA for their
endorsement of my experience and qualifications to deliver this ground-breaking treatment, which clinical trials have shown to be beneficial
to a significant number of people who haven’t responded to, or have ceased to respond to, standard treatments. Clarion has been
developed to offer a truly patient centric model of care and I look forward to working with a great team, dedicated to helping people
with difficult to treat mental health conditions,” Prof. Suresh Sundram, Clarion co-founder and Head of Psychiatry, said.
“Being early entrants into this field in
Australia will position Incannex, via Clarion, at the forefront of psychedelic-assisted therapies, and will facilitate the smooth and
safe expansion into more clinics nation-wide, as we roll out the treatment protocols and business model. We believe regulations regarding
the use of psychedelic-assisted therapies will change in other countries too, following Australia’s lead and as new drugs receive
regulatory approval. Clarion will be well placed contribute to and benefit from progressive changes globally.” Joel Latham, CEO
and President of IXHL, said.
This announcement has been approved for release to NASDAQ by the
Incannex Board of Directors.
END
About Incannex Healthcare Inc.
Incannex is a clinical stage pharmaceutical development
company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of obstructive
sleep apnoea (OSA), traumatic brain injury (TBI) and concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis,
inflammatory bowel disease, anxiety disorders, addiction disorders, and pain, among other indications.
U.S. FDA approval and registration, subject to
ongoing clinical success, is being pursued for each drug and therapy under development. Each indication under investigation currently
has no, or limited, existing registered pharmacotherapy (drug) treatments available to the public and represent major global economic
opportunities to Incannex and its shareholders.
Incannex Healthcare Inc.
Level 39, Rialto South Tower, 525 Collins
Street, Melbourne VIC 3000
Email: admin@incannex.com.au
Date: February 1, 2024
Public Announcement (NASDAQ: IXHL)
Incannex has a strong patent filing strategy in
place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. The Company
holds 19 granted patents and 30 pending patent applications. Incannex is listed on the NASDAQ as IXHL
Website: www.incannex.com.au
Investors: investors@incannex.com.au
Forward-looking statements
This press release contains "forward-looking
statements" within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of
1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates,
as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex's
views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change.
Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information,
future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex's views as of any date
after the date of this press release.
Contact Information:
Incannex Healthcare Inc.
Mr Joel Latham
Chief Executive Officer, President and Director
admin@incannex.com.au
Investor Relations Contact – United States
Laine Yonker
Edison Group
+1 (610) 716 2868
lyonker@edisongroup.com
Incannex Healthcare Inc.
Level 39, Rialto South Tower, 525 Collins
Street, Melbourne VIC 3000
Email: admin@incannex.com.au
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