Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 18

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 18
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 development or commercial collaborations. Further, once news of discussions regarding possible collaborations are known in the general
public, regardless of whether the news is accurate, failure to announce a collaboration agreement, or the entity’s announcement
of a collaboration with an entity other than Renovaro Cube or BioSymetrics, could result in adverse speculation about either, their products
or technology, resulting in harm to their reputation and business. In addition, establishing collaborations is difficult and time-consuming and
may require significant financial investment. Potential collaborators may elect not to work with Renovaro Cube or BioSymetrics based on
their assessment of their financial, regulatory, or intellectual property position. Even if Renovaro Cube or BioSymetrics establishes
new collaborations, they may not result in the successful development or commercialization of their products or technology.

If
Renovaro Cube or BioSymetrics is unable to establish sales and marketing capabilities, they may not be successful in commercializing their
products.

Renovaro
Cube and BioSymetrics have only limited sales and marketing infrastructures and no experience as a company in the sale, marketing and
distribution of screening or diagnostic tests. In preparation of a commercial launch, Renovaro Cube and BioSymetrics are rapidly hiring
additional personnel in sales and marketing.

Factors that may inhibit
Renovaro Cube’s or BioSymetrics’ efforts to each commercialize any of their respective products include:

    ●
    its 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;

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