Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 137

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 137
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51

A potential
breakthrough therapy designation by the FDA for our drug candidates may not lead to a faster development or regulatory review or approval
process, and it does not increase the likelihood that our drug candidates will receive marketing approval.

We
may seek a breakthrough therapy designation from the FDA for one or more of our drug candidates. A breakthrough therapy is defined as
a drug product that is intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease
or condition, and preliminary clinical evidence indicates that the drug product may demonstrate substantial improvement over existing
therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.
For drug products that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor
of a clinical trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed
in ineffective control regimens. Drug products designated as breakthrough therapies by the FDA could also be eligible for accelerated
approval.

Designation
as a breakthrough therapy is within the discretion of the FDA. Accordingly, even if we believe one of our drug candidates meets the criteria
for designation as a breakthrough therapy, the FDA may disagree and instead determine not to make such designation. In any event, the
receipt of a breakthrough therapy designation for a drug candidate may not result in a faster development process, review or approval,
compared to drugs considered for approval under conventional or other accelerated FDA procedures and does not ensure ultimate approval
by the FDA. In addition, even if one or more of our drug candidates qualify and are designated as a breakthrough therapy, the FDA may
later decide that the drug products no longer meet the conditions for designation and the designation may be rescinded.

We
may seek Fast Track designation for one or more of our other drug candidates in the future. Even if we apply for Fast Track designation
in the future, we might not receive such designation, and even if we do, such designation may not actually lead to a faster development
or regulatory review or approval process.

If
a drug candidate is intended for the treatment of a serious condition and nonclinical or clinical data demonstrate the potential to address
an unmet medical need for this condition, a product sponsor may request an FDA Fast Track designation from the FDA. If we seek Fast Track
designation for a drug candidate, we may not receive it from the FDA. However, even if we receive Fast Track designation, Fast Track
designation does not ensure that