Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-Q/A
Source: 0001731122-25-000250
Chunk: 92

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-Q/A
Chunk 92
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 hiring and retaining qualified personnel.                                                                                                   |

Renovaro
Cube anticipates incurring substantial costs to commercialize Renovaro Cube’s products. Renovaro Cube’s expenses could increase
beyond expectations if it is required by the U.S. Food and Drug Administration (the “FDA”), the European Medicines Agency
(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 obtain additional funding to continue its
operations.

Renovaro Cube will require additional financing in order to start its commercialization efforts and develop additional products.

To date,
Renovaro Cube has financed its operations primarily through the sale of its equity securities and cash flow from consulting services previously
provided by Renovaro Cube. Renovaro Cube’s product development and clinical validation activities are expensive, and Renovaro Cube
expects to start to spend substantial amounts as it prepares for the launch and commercialization of its AI platform, continues to enhance
its AI platform, broadens the applications of its AI platform and develops new products. In addition, obtaining any necessary or desirable
regulatory approvals and clearances from the FDA, the MHRA, or the EMA for Renovaro Cube’s products will require substantial additional
funding.

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Renovaro
Cube will require additional capital for the development of its AI platform and future products. Renovaro Cube’s future capital
requirements depend on many additional factors, including:

| ● | the cost of development and commercialization activities for Renovaro Cube’s products, including marketing, sales and distribution costs;                                                                                      |
| ● | the timing of, and the costs involved in, obtaining any required or desired regulatory approvals and clearances for Renovaro Cube’s products;                                                                                  |
| ● | the timing, scope, progress, results and costs of developing additional products, and of conducting additional clinical validation or future clinical studies, if required;                                                    |
| ● | the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending and enforcing patent and other intellectual property rights and claims, including litigation costs and the outcome of such litigation;