Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 1153

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 1153
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, 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 patient enrollment or retention may result in increased costs, program delays or
both, which could have a harmful effect on our ability to develop our gene therapy product candidates or could render further development
impossible. In addition, we expect to rely on clinical trial sites to ensure proper and timely conduct of our future clinical trials and,
while we intend to enter into agreements governing their services, we will be limited in our ability to control their actual performance.

Risks Related to Our Technology and Intellectual
Property

We have licensed a portion
of our intellectual property from our licensors. If we breach any of our license agreements with these licensors, or otherwise experience
disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business.

We hold rights under license agreements
with our licensors that are important to our business. Our research and development platform is built, in part, around patent rights licensed
from such licensors. Under our existing license agreements, we are subject to various obligations, including diligence obligations with
respect to development and commercialization activities, provision of support with respect to development of licensed intellectual property,
prosecution of intellectual property protection, payment obligations upon achievement of certain milestones and royalties on product sales.
In spite of our efforts, our licensors might conclude that we have materially breached our obligations under such license agreements and
might therefore terminate the license agreements, thereby removing or limiting our ability to develop and commercialize products and technology
covered by these license agreements. If any of these licenses are terminated, or if the underlying patents fail to provide the intended
exclusivity, competitors or other third parties would have the freedom to seek regulatory approval of, and to market, products identical
to ours and we may be required to cease our development and commercialization of product candidates covered by any such licenses.