Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-Q/A
Source: 0001731122-25-000250
Chunk: 103

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-Q/A
Chunk 103
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, including creating compliant programs and processes, and managing the regulatory requirements 
 for its products, while complying with its contractual obligations to contractors and other third parties;                                  |
| ● | expanding                                                                                                                                   
 its operational, financial and management controls, reporting systems and procedures; and                                                   |
| ● | managing                                                                                                                                    
 the increasing complexity associated with a larger organization and expanded operations.                                                    |

Renovaro
Cube’s future financial performance and its ability to commercialize its products will depend, in part, on its ability to effectively
manage any future growth. Renovaro Cube’s management may also have to divert a disproportionate amount of its attention away from day-to-day activities
in order to manage these growth activities. Renovaro Cube’s ability to successfully manage its expected growth is uncertain given
the fact that Renovaro Cube has been in full operation as an independent company focusing on cancer diagnostics AI only since 2018. Renovaro
Cube’s executive management team’s lack of long-term experience working together may adversely impact their ability
to effectively manage its business and growth.

If Renovaro
Cube is not able to effectively expand its organization by hiring new employees, it may not be able to successfully implement the tasks
necessary to commercialize its products, which would have a negative impact on Renovaro Cube’s business and result of operations.

Risks Related to Renovaro Cube’s Legal Compliance and Litigation

Changes in funding or disruptions at the EMA, the MRHA, and other government agencies caused by funding shortages or global health concerns could hinder Renovaro Cube’s ability to hire and retain key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of Renovaro Cube’s business may rely, which could negatively impact its business.

The ability
of the EMA, the MRHA, and, in the future, the FDA and other government agencies to review and clear or approve new products or changes
to existing products can be affected by a variety of factors, including government budget and funding levels, statutory, regulatory and
policy changes, the agency’s ability to hire and retain key personnel and accept the payment of user fees, government shutdowns
and other events that may otherwise affect the agency’s ability to perform routine functions. For example, average review times
at the FDA have fluctuated in recent years as a result of such factors. In addition, government funding