Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 1152

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 1152
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 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 safety profiles, notwithstanding
promising results in earlier trials, and in the regulatory approval process. In addition, the design of a clinical trial, such as endpoints,
inclusion and exclusion criteria, statistical analysis plans, data access protocols and trial sizing, can determine whether its results
will support approval of a product and flaws in the design of a clinical trial may not become apparent until the clinical trial is well
advanced. If we experience delays in the commencement or completion of our clinical trials, or if we terminate a clinical trial prior
to completion, the commercial prospects of our product candidates could be harmed, and our ability to generate revenues may be delayed.
In addition, any delays in our clinical trials could increase our costs, cause a drop in our stock price, slow down the approval process
and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may harm our business, financial
condition, and results of operations.

Enrollment and retention
of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple
factors outside our control.

We may encounter delays in enrolling,
or be unable to enroll, a sufficient number of patients to complete any of our clinical trials, and even once enrolled we may be unable
to retain a sufficient number of patients to complete any of our trials. Patient enrollment and retention in clinical trials depends on
many factors, including the size of the patient population, the nature of the trial protocol, the effectiveness of our patient recruitment
efforts, delays in enrollment due to travel or quarantine policies, the existing body of safety and efficacy data with respect to the
study candidate, the perceived risks and benefits of gene therapy approaches for the treatment of certain diseases, the number and nature
of competing existing treatments for our target indications