Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 282

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 282
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(b)(2) NDA. Even
if we are able to utilize the Section 505(b)(2) regulatory pathway for one or more of our drug candidates, there is no guarantee this
would ultimately lead to faster product development or earlier approval.

Moreover,
any delay resulting from our inability to pursue the FDA’s 505(b)(2) pathway could result in new competitive products reaching
the market more quickly than our drug candidates, which may have a material adverse impact our competitive position and prospects. Even
if we are allowed to pursue the FDA’s 505(b)(2) pathway, we cannot assure you that our drug candidates will receive the requisite
approvals for commercialization.

We
may use our financial and human resources to pursue a particular research program or drug candidate and fail to capitalize on programs
or drug candidates that may be more profitable or for which there is a greater likelihood of success.

Because
we have limited financial and human resources, we may forego or delay pursuit of opportunities with certain programs or drug candidates
or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail
to capitalize on viable commercial products or more profitable market opportunities. Our spending on current and future R&D programs
and future drug candidates for specific indications may not yield any commercially viable products. We may also enter into additional
strategic collaboration agreements to develop and commercialize some of our programs and potential drug candidates in indications with
potentially large commercial markets. If we do not accurately evaluate the commercial potential or target market for a particular drug
candidate, we may relinquish valuable rights to that drug candidate through strategic collaborations, licensing or other royalty arrangements
in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such drug candidate.

We
have conducted, and intend to conduct, clinical trials for certain of our drug candidates at sites outside of the United States, and
the U.S. regulatory agencies may not accept data from trials conducted in such locations.

As
noted above, we have conducted trials for our drug candidates pursuant to Australian law and intend to conduct future and current trials
for these candidates pursuant to FDA regulations in an effort to obtain FDA approval. The FDA’s acceptance of data from clinical
trials conducted outside the United States may be subject to certain conditions or may not be accepted at all, and other comparable non-U.S.
regulatory authorities may have similar restrictions and conditions with respect to clinical trials conducted outside of their respective
jur