Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 47

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 47
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 inability to recruit and retain adequate numbers of effective sales, marketing, reimbursement, customer service, medical affairs    
 and other support personnel;                                                                                                        |
| ● | the                                                                                                                                 
 inability of sales personnel to persuade adequate numbers of customers, including healthcare systems and healthcare providers, to   
 use its products;                                                                                                                   |
| ● | the                                                                                                                                 
 inability to price its products at a sufficient price point to ensure an adequate and attractive level of profitability;            |
| ● | 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 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 expands its 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 Renovaro Cube’s 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 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