Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 25

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 25
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 objectives,
we will be forced to cease operations.

Disruptions at the FDA and
other government agencies caused by funding shortages or global health concerns could hinder their ability to hire, retain or deploy key
leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely
manner or at all, which could negatively impact our business.

The ability of the FDA to review
and approve new products can be affected by a variety of factors, including government budget and funding levels, the ability to hire
and retain key personnel and accept the payment of user fees, and statutory, regulatory, and policy changes. Average review times at the
agency have fluctuated in recent years as a result. In addition, government funding of other government agencies that fund research and
development activities is subject to the political process, which is inherently fluid and unpredictable.

Our gene therapy product candidates
are still in development and will require extensive clinical testing before we are prepared to submit an application for marketing approval
to regulatory authorities. We cannot predict with any certainty if or when we might submit any such application for regulatory approval
for our product candidates or whether any such application will be approved by the applicable regulatory authority in our target markets.
Human clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.
For instance, regulatory authorities may not agree with our proposed endpoints for any clinical trials of our gene therapy product candidates,
which may delay the commencement of our clinical trials.

Clinical trials are expensive,
time-consuming, difficult to design and implement, and involve an uncertain outcome.

Our therapeutic product candidates
are still in development and will require extensive clinical testing before we are prepared to submit an application for marketing approval
to regulatory authorities. We cannot predict with any certainty if or when we might submit any such application for regulatory approval
of our product candidates or whether any such application will be approved by the applicable regulatory authority in our target markets.
Human clinical trials are expensive and difficult to design and implement, in part because they are subject to rigorous regulatory requirements.
For instance, regulatory authorities may not agree with our proposed endpoints for any clinical trials of our product candidates, which
may delay the commencement of our clinical trials. The clinical trial process is also time-consuming. We estimate that clinical trials
of our product candidates will take at least several years to complete.

33

A number of companies in the biopharmaceutical
industry have suffered significant setbacks in advanced clinical trials due to lack of efficacy or adverse