Company: IXHL
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001213900-25-092837
Chunk: 47

Company: Incannex Healthcare Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 47
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 pharmaceutical options.

1

Our Strategy

Our mission is to advance novel therapies, leveraging
evidence-based innovation, with the potential to transform the lives of people suffering from serious, chronic conditions and unmet medical
needs. Our three lead programs were created internally and prioritized based on their potential to offer new therapeutic approaches and
long-term patient benefits.

We aim to maximize value to our stockholders and
to provide important new treatment options to patients in need of new therapeutic options. Key elements of our strategy include:

●Advance our novel investigational drug candidates through pivotal and registrational clinical development programs. We are
pursuing approval from the FDA through the submission of New Drug Applications (“NDAs”) for all our three lead drug candidates.
We plan to seek market authorization in the United States for our drug candidates and following U.S. approval, we plan to strategically
expand into the European Union, United Kingdom, Japan, Australia, and Canada. These regions represent significant opportunities due to
their large healthcare systems, established regulatory frameworks, and high market demand for innovative therapies. By securing approvals
in these key regions, we aim to maximize the global commercial potential of our drug candidates.

●Seek streamlined regulatory pathways for our drug candidates. We and our consultants and advisors believe that each of our lead
drug candidates may be eligible to qualify for one or more FDA expedited review programs (e.g. breakthrough therapy designation, accelerated
approval, priority review and/or Fast Track designation). Each of these programs target conditions that currently have limited, inadequate,
or no approved pharmaceutical treatment options. FDA expedited review programs may facilitate the development and potentially expedite
review of drugs to treat serious conditions and fill an unmet medical need. Where appropriate, we also intend to pursue the FDA’s
505(b)(2) pathway, enabling more efficient approval by leveraging existing data from approved products and established active ingredients.

●Maintain a strong intellectual property portfolio. We believe we have developed a global intellectual property strategy to
support our development and ultimate global commercial objectives. We are monitoring the results of our R&D programs to identify new
intellectual property and intend to pursue protection in the United States, Europe, Japan, Israel, and other key global markets.

●Maximize the value of our pipeline and drug candidates. We are actively pursuing FDA registration for our lead drug candidates
currently in development. Our approach focuses on advancing novel, scientifically validated therapies with strong clinical potential.
Simultaneously, we will retain the flexibility to explore strategic partnerships, licensing agreements, and