Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 280

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 280
---
 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later decide that the drug products no longer meet the conditions for designation and the designation may be rescinded.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 we will receive marketing approval or that approval will be granted within any particular time frame.
We may not experience a faster development or regulatory review or approval process with Fast Track designation compared to conventional
FDA procedures. In addition, the FDA may withdraw Fast Track designation if the designation is no longer supported by data from our clinical
development program. Fast Track designation alone does not guarantee qualification for the FDA’s priority review procedures.

We
expect to utilize the FDA’s Section 505(b)(2) pathway for certain of our drug candidates and if that pathway is not available,
the development of our drug candidates will likely take significantly longer, cost significantly more and entail significantly greater
complexity and risk than currently anticipated, and, in any