Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-Q/A
Source: 0001731122-25-000250
Chunk: 106

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-Q/A
Chunk 106
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 diagnosis of disease, certain of its products will become subject to regulation by the FDA, or comparable
international agencies, including requirements for regulatory clearance or approval of such products before they can be marketed. Such
regulatory approval processes or clearances may be expensive, time-consuming, and uncertain, and Renovaro Cube’s failure to obtain
or comply with such approvals and clearances could have an adverse effect on its business, financial condition, or operating results.
In addition, changes to the current regulatory framework, including the imposition of additional or new regulations, could arise at any
time during the development or marketing of Renovaro Cube’s future products, which may negatively affect its ability to obtain or
maintain FDA or comparable regulatory approval of its products, if required.

Diagnostic
products are regulated as medical devices by the FDA and comparable international agencies and may require either clearance from the FDA
or such other comparable agencies following the 510(k) pre-market notification process or pre-market approval from the FDA, in each case
prior to marketing. Obtaining the requisite regulatory approvals can be expensive and may involve considerable delay. If Renovaro Cube
fails to obtain, or experiences significant delays in obtaining, regulatory approvals for diagnostic products that it develops in the
future, Renovaro Cube may not be able to launch or successfully commercialize such products in a timely manner, or at all.

In addition,
if Renovaro Cube’s products labelled as “For Research Use Only. Not for use in diagnostic procedures,” or RUO, are used,
or could be used, for the diagnosis of disease, the regulatory requirements related to marketing, selling, and supporting such products
could change or be uncertain, even if such use by Renovaro Cube’s customers is without its consent. If the FDA or other regulatory
agencies assert that any of Renovaro Cube’s RUO products are subject to regulatory clearance or approval, Renovaro Cube’s
business, financial condition, or results of operations could be adversely affected.

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

As the
regulatory framework for machine learning technology and AI evolves, Renovaro Cube’s business, financial condition, and results
of operations may be adversely affected. The regulatory framework for machine learning technology, AI and automated decision-making is
evolving. It is possible that new laws and regulations will be adopted