Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 39

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 39
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, and Renovaro Cube’s failure to do so would prevent Renovaro Cube from generating revenue. Furthermore, even
if Renovaro Cube is able to launch its AI platform or other products in a timely manner, Renovaro Cube may not be able to generate sufficient
revenue to offset its costs and maintain profitability. Renovaro Cube’s ability to generate future revenue from product sales depends
heavily on its success in:

| ● | completing clinical development and additional validation of Renovaro Cube’s products and continuing to improve product performance and expand product features over time;                                    |
| ● | seeking, obtaining and maintaining marketing approvals, clearances, licenses, or exemptions that may be necessary or desired for any future products that Renovaro Cube develops;                             |
| ● | establishing a sales force, marketing, medical affairs and distribution infrastructure or, alternatively, collaborating with a commercialization partner sufficient to launch and commercialize its products; |
| ● | obtaining market acceptance by consumers, including self-insured employers, integrated health systems, healthcare providers, patients and third-party payors;                                                 |

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| ● | establishing and maintaining supply and manufacturing relationships with third parties that can timely and consistently provide adequate, in both amount and quality, products and services to support clinical development and the market demand for Renovaro Cube’s future products; |
| ● | achieving adequate coverage or reimbursement recognition from governments, health insurance organizations and other third-party payors for products that Renovaro Cube launches;                                                                                                       |
| ● | addressing any technological and market developments, including competing products;                                                                                                                                                                                                    |
| ● | negotiating favorable terms in any collaboration, licensing, or other arrangements into which Renovaro Cube may enter, and maintaining such existing or future arrangements;                                                                                                           |
| ● | achieving general adoption and acceptance of Renovaro Cube’s products by the medical community;                                                                                                                                                                                        |
| ● | maintaining, protecting and expanding Renovaro Cube’s portfolio of intellectual property rights, including patents, trade secrets, know-how and trademarks;                                                                                                                            |
| ● | defending against third-party interference or infringement claims, if any; and                                                                                                                                                                                                         |
| ● | attracting, 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