Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 24

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 24
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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.

32

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 to raise capital.

We have limited experience
in drug development and may not be able to successfully develop any drugs, which would cause us to cease operations.

We have never successfully developed
a new drug and brought it to market. Our management and clinical teams have experience in drug development, but they may not be able to
successfully develop any drugs. Our ability to achieve revenues and profitability in our business will depend on, among other things,
our ability to develop products internally or to obtain rights to them from others on favorable terms; complete laboratory testing and
human studies; obtain and maintain necessary intellectual property rights to our products; successfully complete regulatory review to
obtain requisite governmental agency approvals; enter into arrangements with third parties to manufacture our products on our behalf;
and enter into arrangements with third parties to provide sales and marketing functions. If we are unable to achieve these