Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 12

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1A
Chunk 12
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 lead to over-diagnosis or a high false-positive rate and unnecessary medical procedures and costs;

    ●
    the introduction of competing products, including the expansion of the capabilities of existing products;

    ●
    the market acceptance of existing competitive products, including tests that are currently reimbursed;

    ●
    publicity concerning Renovaro Cube’s or BioSymetrics’ products or competing products; and

    ●
    the strength of Renovaro Cube’s and BioSymetrics’ marketing and distribution support.

The failure
of Renovaro Cube’s or BioSymetrics’ AI platform, once introduced, to be listed in physician guidelines or any future clinical
validation to produce favorable results or to be published in peer-reviewed journals could limit the adoption of its AI platform.
In addition, healthcare providers and third-party payors, including Medicare, may rely on physician guidelines issued by industry
groups, medical societies and other key organizations, such as the U.S. Preventive Services Task Force, before utilizing or reimbursing
the cost of any diagnostic or screening test. Although Renovaro Cube has conducted prior clinical validation of its AI platform, this
platform is not yet, and may never be, listed in any such guidelines.

Further,
if Renovaro Cube’s or BioSymetrics’ products and the technology underlying them do not receive sufficient favorable exposure
in peer-reviewed publications, the rate of physician and market acceptance of these products and positive reimbursement or coverage
decisions for these products could be negatively affected. The publication of clinical data in peer-reviewed journals is a crucial
step in commercializing and obtaining reimbursement or coverage for Renovaro Cube’s or BioSymetrics’ products, and Renovaro
Cube’s and BioSymetrics’ inability to control when, if ever, results are published may delay or limit our ability to derive
sufficient revenues from any of its products that are developed using data from a clinical study.

Failure
to achieve broad market acceptance of Renovaro Cube’s or BioSymetrics’ products, once launched, would materially harm Renovaro
Cube’s and BioSymetrics’ business, financial condition and results of operations.

Renovaro
Cube and BioSymetrics may be unable to develop and commercialize new products.

Renovaro
Cube and BioSymetrics continue to expand their research and development efforts to use their proprietary AI platforms to develop new products,
including in disease areas beyond cancer and neurology. The commercial