Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 52

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 52
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 treatment of these same indications. If we are unable to compete
effectively with any existing products, new treatment methods and new technologies, we may be unable to commercialize therapeutic products
that we may develop in the future, which could adversely impact our potential revenues, results of operations and financial condition
or lead to abandonment of product candidates in our pipeline.

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Our reliance on third parties, such as university laboratories, contract manufacturing organizations and contract or clinical research organizations, may result in delays in completing, or a failure to complete, non-clinical testing or clinical trials if they fail to perform under our agreements with them.

In the course of the development
of our pipeline, we have and expect to continue to engage university laboratories, non-profit organizations, independent contractors,
other biotechnology companies or clinical manufacturing organizations to conduct and manage research and development, pre-clinical and
clinical studies and to manufacture materials for us to be used in pre-clinical and clinical testing. Due to engagements with these organizations,
many important aspects of our research have been and will be out of our direct control. If any of these organizations we may engage in
the future, fail to perform their obligations under our agreements with them or fail to perform non-clinical testing and/or clinical trials
in a satisfactory manner, we may face delays in completing our clinical trials, as well as commercialization of any of our product candidates.
Furthermore, any loss or delay in obtaining contracts with such entities may also delay the completion of our clinical trials, regulatory
filings and the potential market approval of our product candidates.

Changes in healthcare law and implementing regulations, including government restrictions on pricing and reimbursement, as well as healthcare policy, may negatively impact our ability to generate revenues.

In the United States and some foreign jurisdictions, there have been a number of proposed legislative and regulatory changes related to the healthcare system that could affect our ability to profitably sell or commercialize our product candidates for which we obtain marketing approval in the future. The potential pricing and reimbursement environment for our product candidates may change in the future and become more challenging due to, among other reasons, policies advanced by the current or any new presidential administration, federal agencies, healthcare legislation passed by Congress, or fiscal challenges faced by all levels of government health administration authorities, or by similar changes in foreign countries. The implementation of any such changes could have a material adverse effect on our competitive
position, business, financial condition, results of operations, and prospects, including our share price and ability