Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 139

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 139
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) over the last decade, certain brand-name pharmaceutical
companies and others have objected to the FDA’s interpretation of Section 505(b)(2). If the FDA’s interpretation of Section
505(b)(2) is successfully challenged, or Congress were to amend the statute to alter the currently available regulatory pathway, the
FDA may change its 505(b)(2) policies and practices, which could delay or even prevent the FDA from approving any NDA we submit under
Section 505(b)(2). In addition, the pharmaceutical industry is highly competitive, and Section 505(b)(2) NDAs are subject to special
requirements designed to protect the patent rights of sponsors of previously approved drugs referenced in a Section 505(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.