Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 1146

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 1146
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 use by Renovaro Cube’s or BioSymetrics’ customers is without its
consent. If the FDA or other regulatory agencies assert that any of Renovaro Cube’s or BioSymetrics’ RUO products are subject
to regulatory clearance or approval, Renovaro Cube’s or BioSymetrics’ business, financial condition, and results of operations
could be adversely affected.

Regulatory and legislative
developments on the use of AI and machine learning could adversely affect Renovaro Cube’s or BioSymetrics’ use of such technologies
in its platform and other products.

As with
many technological innovations, artificial intelligence presents risks and challenges that could affect its adoption, and therefore our
business. Uncertainty in the legal regulatory regime relating to AI may require significant resources to modify and maintain business
practices to comply with U.S. and non-U.S. laws, the nature of which cannot be determined at this time. It is possible that new laws and
regulations will be adopted in the United Kingdom, the European Union, the United States and/or other foreign jurisdictions, or that existing
laws and regulations may be interpreted in ways that would affect the operation of Renovaro Cube’s or BioSymetrics’ AI platform
and data analytics and the way in which Renovaro Cube or BioSymetrics uses AI and machine learning technology. Further, the cost to comply
with such laws or regulations could be significant and would increase operating expenses, which could adversely affect either’s
business, financial condition and results of operations.

For example,
in Europe, on April 21, 2021, the European Commission proposed a regulation seeking to establish a comprehensive, risk-based governance
framework for AI in the European Union market. The proposed legislation is intended to apply to companies that develop, use and/ or provide
AI in the European Union and includes requirements around transparency, conformity assessments and monitoring, risk assessments, human
oversight, security and accuracy, and proposes fines for breach of up to 6% of worldwide annual turnover. In addition, on September 28,
2022, the European Commission proposed the AI Liability Directive and the revised Product Liability Directive seeking to establish a harmonized
civil liability regime for AI in the European Union in order to facilitate civil claims in respect of harm caused by AI and to include
AI-enabled products within the scope of the European Union’s existing product liability regime. If enacted, this regulatory framework
is expected to have a material impact on the way AI is regulated in the European Union,