Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 1145

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 1145
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 of profitability;

29

    ●
    its inability to effectively market to, collaborate with, and secure coverage or reimbursement from third-party payors;

    ●
    its failure to comply with applicable regulatory requirements governing the sale, marketing, reimbursement and commercialization of its products; and

    ●
    unforeseen costs and expenses associated with creating an independent commercialization organization.

Risks Related to the Development of Our Product
Candidates

Renovaro
Cube’s and BioSymetrics’ products are not subject to FDA or other government regulatory clearance or approval if they are
not intended to be used for the diagnosis, treatment or prevention of disease. However, as Renovaro Cube and BioSymetrics expands their
product line to encompass products that are intended to be used for the 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 failure
to obtain or comply with such approvals and clearances could have an adverse effect on its business, financial condition, and 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 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
or BioSymetrics fails to obtain, or experiences significant delays in obtaining, regulatory approvals for diagnostic products that it
develops in the future, Renovaro Cube and BioSymetrics may not be able to launch or successfully commercialize such products in a timely
manner, or at all.

In addition,
if Renovaro Cube’s and BioSymetrics’ 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