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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 May
7, 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 May 7, 2024, Incannex Healthcare Inc. announced
that it has successfully completed a Pre-IND Meeting with the FDA for CannQuit-O for treatment of opioid use disorder. 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: May 7, 2024 |
/s/ Joel Latham |
| |
Name: |
Joel Latham |
| |
Title: |
Chief Executive Officer and President |
2
Exhibit 99.1
Date: May 7, 2024
Public
Announcement (NASDAQ: IXHL)
Incannex Complete Successful Pre-IND Meeting
with the FDA for CannQuit-O for treatment of opioid use disorder
MELBOURNE, Australia and NEW YORK, May
7, 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-O for treatment of Opioid Use Disorder (OUD).
The pre-IND teleconference included representatives
from various divisions of the FDA providing input on the CannQuit-O development program. The Agency had reviewed the CannQuit-O meeting
package and provided recommendations on the proposed clinical development strategy, including patient populations, the selection and timing
of efficacy endpoints and safety monitoring. These recommendations were discussed during the preIND teleconference where the company had
the opportunity to seek further clarification on the agency’s initial response.
The productive discussion with the FDA is an important
milestone for the development of CannQuit-O and provides Incannex with clarity on the data required to open an IND with the FDA for this
product and provides valuable guidance for successful clinical development in the OUD indication.
Incannex Chief Scientific Officer Dr Mark Bleackley
said: “Opioid use disorder is a significant issue impacting millions of patients and their families. Developing new therapies, such
as CannQuit-O, is critical for helping control the disease and improve quality of life for those who are suffering from the disease and
those around them. Feedback from the FDA on the proposed development strategy for CannQuit-O will be taken on board so that the outcomes
of research activities meet agency expectations and ensure that the appropriate steps are being taken towards drug registration.”
About CanQuit-O
CannQuit-O is a chewable tablet with unique characteristics
provided by novel combination of registered/ FDA-approved polymers allowing for rapid and sustained release of its active ingredients,
including an opioid agonist, antagonist and cannabidiol (CBD). The working hypothesis is that the bioavailability profile of the drugs
can be significantly improved when formulated as water-soluble, chewable tablet. Incannex owns patents on chewable formulations cannabinoids
and opioid agonists and/or antagonists and it is hypothesised that this combination of active pharmaceutical ingredients and delivery
system will provide benefits for sufferers of OUD, of which there are estimated 26.8 million people worldwide1.
In the USA the opioid epidemic has been declared a public health emergency, affecting millions with the misuse of prescription opioids
and illicit substances. According to the National Institute of Health (NIH), by far the largest components of the overall economic burden,
however, are the value of reduced quality of life from opioid use disorder ($390.0 billion) and life lost to opioid overdose ($480.7 billion).
These two cost components account for over 85% of the total economic burden2.
| 1 | https://www.nature.com/articles/s41572-019-0137-5 |
| 2 | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8091480 |
Incannex Healthcare Inc.
Level 39, Rialto South Tower, 525 Collins
Street, Melbourne VIC 3000
Email: admin@incannex.com.au
Date: May 7, 2024
Public
Announcement (NASDAQ: IXHL)
The Global OUD market size was valued at USD 2.8
Billion in 2022 and is estimated to grow at CAGR of 10.7% from 2022-2032, reaching USD 7.8 Billion in 2032. Asia Pacific is expected to
grow the fastest during the forecasted period3.
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.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.
| 3 | https://www.sphericalinsights.com/reports/opioid-use-disorder-oud-market |
Incannex Healthcare Inc.
Level 39, Rialto South Tower, 525 Collins
Street, Melbourne VIC 3000
Email: admin@incannex.com.au
Date: May 7, 2024
Public
Announcement (NASDAQ: IXHL)
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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