Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 41

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 41
---
| ● | publicity concerning Renovaro Cube’s products or competing products; and                                                                                                                                                                                            |
| ● | the strength of Renovaro Cube’s marketing and distribution support.                                                                                                                                                                                                 |

The failure
of Renovaro Cube’s 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 products and the technology underlying them do not receive sufficient favorable exposure in peer-reviewed publications,
the rate of physician and market acceptance of Renovaro Cube’s products and positive reimbursement or coverage decisions for Renovaro
Cube’s 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 products, and Renovaro Cube’s inability
to control when, if ever, results are published may delay or limit Renovaro Cube’s 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 products, once launched, would materially harm Renovaro Cube’s business,
financial condition and results of operations.

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

Renovaro
Cube continues to expand its research and development efforts to use its proprietary AI platform to develop new products, including in
disease areas beyond cancer. The commercialization of any new products will require the completion of certain clinical development activities,
regulatory activities and the expenditure of additional cash resources. Renovaro Cube cannot assure you that it can successfully complete
the clinical development of any such products.

Renovaro
Cube also cannot assure you that it will be able to reduce its expenditures sufficiently, generate sufficient revenue from products that
it successfully commercializes or otherwise mitigate the risks associated with its business to raise enough capital to develop and commercialize
new products. In addition, once Renovaro Cube’s development