Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 40

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 40
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(the “EMA”), the Medicines and Healthcare products Regulatory Agency (“MHRA”) or other regulatory agencies to
delay its launch, narrow or change its intended use or product claims, modify or expand its clinical validation, perform future additional
clinical validation, either pre- or post-approval, or conduct clinical trials. Even if Renovaro Cube is able to generate
revenue from the sale of any products, Renovaro Cube may not become profitable and may need to continue to obtain additional funding to
continue its operations.

Even if we commercially launch Renovaro Cube’s AI platform and other products, they may fail to achieve the degree of market acceptance necessary for commercial success.

The commercial
success of Renovaro Cube’s AI platform and other future products will depend upon the degree of market acceptance by consumers,
including self-insured employers, integrated health systems, healthcare providers, patients and, over the long-term, third-party payors.
The degree of market acceptance of Renovaro Cube’s products will depend on a number of factors, including:

| ● | the performance and clinical utility of its products as demonstrated in clinical validation and published in peer-reviewed journals;                                                                                                                                                                                                                        |
| ● | Renovaro Cube’s ability to demonstrate the clinical utility of its products and their potential advantages to the medical community;                                                                                                                                                                                                                        |
| ● | the ability of Renovaro Cube’s products to demonstrate the same performance in real-world intended use populations as in clinical validation;                                                                                                                                                                                                               |
| ● | the willingness of consumers, including self-insured employers, integrated health systems, healthcare providers, patients and others in the medical community to utilize Renovaro Cube’s products;                                                                                                                                                          |
| ● | the willingness of commercial third-party payors and government payors to cover and reimburse for Renovaro Cube’s products, the scope and amount of which will likely affect an individual’s willingness or ability to pay for Renovaro Cube’s products and likely heavily influence healthcare providers’ decisions to recommend Renovaro Cube’s products; |

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| ● | with respect to products under development that Renovaro Cube intends to launch for use in a broad asymptomatic population, the concern that such products could 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;                                                                                                                                                              |