Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 26

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 26
---
 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, the number and nature of ongoing trials for other product candidates in development
for our target indications, perceived risk of the delivery procedure, patients with pre-existing conditions that preclude their participation
in any trial, the proximity of patients to clinical sites and the eligibility criteria for the study. Furthermore, the results we have
reported in clinical trials to date and any other results we may report in clinical trials of any of our gene therapy product candidates
in the future may make it difficult or impossible to recruit and retain patients in other clinical trials of those gene therapy product
candidates. Similarly, negative results reported by our competitors about their product candidates may negatively affect patient recruitment
in our clinical trials. Delays or failures in planned