Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 1120

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 1120
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 as well as the trials are subject to regulations of the FDA and/or its regulatory
counterparts in the other countries. Upon successful completion of clinical trials, approval to market the treatment for a particular
patient population may be requested from the FDA in the United States and/or its counterparts in other countries.

Applications submitted to the
FDA are subject to an unpredictable and potentially prolonged approval process. Despite good-faith communication and collaboration between
the applicant and the FDA during the development process, the FDA may decide, upon final review of the data, that the application does
not satisfy its criteria for approval or requires additional product development or further preclinical or clinical studies. Even if FDA
regulatory approval(s) are obtained, a marketed product is subject to continual review, and later discovery of previously unknown problems
or failure to comply with the applicable regulatory requirements may result in restrictions on the marketing of a product or withdrawal
of the product from the market as well as possible civil or criminal sanctions.

Sponsors of clinical trials are
required to register, and report results for, all controlled, clinical investigations, other than Phase 1 investigations, of a product
subject to FDA regulation. Trial registration may require public disclosure of certain confidential commercial development data.

The process of obtaining regulatory
approvals and the subsequent compliance with appropriate federal, state, local and foreign statutes and regulations require the expenditure
of substantial time and financial resources. Failure to comply with the applicable U.S. requirements at any time during the product development
process, approval process or after approval, may subject an applicant to administrative or judicial sanctions. FDA sanctions could include,
among other actions, refusal to approve pending applications, withdrawal of an approval, a clinical hold, warning letters, product recalls
or withdrawals from the market, product seizures, total or partial suspension of production or distribution injunctions, fines, refusals
of government contracts, restitution, disgorgement or civil or criminal penalties. Any agency or judicial enforcement action could have
a material adverse effect on our business, financial condition, results of operations and cash flows.

Other Healthcare
Laws and Compliance Regulations

Although we currently do not have
any products on the market, we may also be subject to additional healthcare regulations and enforcement by the federal government and
by authorities in the states and foreign jurisdictions in which we conduct our business. In the United States, among other things, the
research, manufacturing, distribution, sale and promotion of pharmaceutical and biological products are potentially subject to regulation
and enforcement by various federal, state and