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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 16, 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 16, 2024, Incannex Healthcare
Inc. announced a Complete Successful Pre-IND Meeting with the FDA for CannQuit-N; a Novel Solution for Tobacco Smoking Cessation. 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.
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 16, 2024 |
|
/s/ Joel Latham |
|
Name: |
Joel Latham |
|
Title: |
Chief Executive Officer and President |
2
Exhibit 99.1
![](https://www.sec.gov/Archives/edgar/data/1873875/000121390024014713/ex99-1_001.jpg) |
Date: February 16, 2024
Public Announcement (NASDAQ: IXHL) |
Incannex Complete Successful Pre-IND Meeting
with the FDA for CannQuit-N;
a Novel Solution for Tobacco Smoking Cessation
MELBOURNE, Australia and NEW YORK, Feb.
16, 2024: Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex or the Company), a leading cannabinoid and psychedelic medicine biotechnology
company, is pleased to announce the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and
Drug Administration (FDA) regarding the development of CannQuit-N for tobacco smoking cessation and control of relapse.
The pre-IND teleconference included representatives
from various divisions of the FDA covering all regulatory aspects of the CannQuit-N development program. The Agency had reviewed the CannQuit-N
meeting package and provided recommendations on key design aspects of the proposed clinical trials, including the timing of efficacy endpoints
and specific details on safety endpoints. The FDA also confirmed proposed strategies for manufacturing and quality control are appropriate.
The productive discussion with the FDA is an important
milestone for the development of CannQuit-N and will guide the continued development of the drug product.
About CannQuit-N
CannQuit-N is a smoking cessation chewing gum
that combines controlled-release of cannabidiol (CBD) with nicotine. Incannex holds granted patents on chewing gums that combine CBD and
nicotine. The combination of CBD and nicotine is hypothesised to better assist addicted smokers to quit smoking than traditional nicotine
containing chewing gum, an NRT (nicotine replacement therapy) per annum which totalled $2.92 bln in 2021 and is expected to grow to $7.93
by 2029 at CAGR of 13.31%. https://www.databridgemarketresearch.com/reports/global-nicotine-replacement-therapy-market
CBD has been found to inhibit the α7 nicotinic
acetylcholine receptor which plays a role in the reinforcing effects of nicotine. Interactions of endocannabinoids with the CB1 receptor
are essential in mediating behaviours associated with addiction and there are preliminary clinical observations suggesting that CBD may
help to reduce the number of cigarettes smoked in a day.
Medicated chewing gums deliver their active ingredients
directly into the circulation of the oral mucosa, ensuring that the effects of the ingredients are delivered rapidly, but also in a sustained
manner to reduce cravings for longer than other delivery methods. Rapid onset and sustained effect are both qualities desirable for the
treatment of addiction disorders. Furthermore, the act of chewing, known as mastication, has complex stimulating mechanisms including
anxiolytic effects which have been demonstrated in other scientific assessments.
Incannex Healthcare Inc.
Level 39, Rialto South Tower, 525 Collins
Street, Melbourne VIC 3000
Email: admin@incannex.com.au
![](https://www.sec.gov/Archives/edgar/data/1873875/000121390024014713/ex99-1_001.jpg) |
Date: February 16, 2024
Public Announcement (NASDAQ: IXHL) |
Cigarette smoking and nicotine addiction causes
a wide variety of preventable diseases and remains a leading cause of preventable death in the United States, where it is responsible
for more than 480,000 deaths per year, including nearly 42,000 deaths from second-hand smoke exposure. The total economic cost of smoking
in the US is estimated at more than US$300 billion per annum. This includes nearly US$225 billion in direct medical care for adults and
more than $156 billion in lost productivity.
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 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
Investors: investors@incannex.com.au
Incannex Healthcare Inc.
Level 39, Rialto South Tower, 525 Collins
Street, Melbourne VIC 3000
Email: admin@incannex.com.au
![](https://www.sec.gov/Archives/edgar/data/1873875/000121390024014713/ex99-1_001.jpg) |
Date: February 16, 2024
Public Announcement (NASDAQ: IXHL) |
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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