Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-Q/A
Source: 0001731122-25-000250
Chunk: 99

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-Q/A
Chunk 99
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es, hurricanes,
fires, extreme weather conditions, medical epidemics, pandemics, global conflict, war and other natural or man-made disasters
or business interruptions. In addition, they may be affected by government shutdowns, changes to applicable laws, regulations and policies,
or withdrawn funding. The occurrence of any of these business disruptions could seriously harm their ability to complete their contracted
services to Renovaro Cube, which may adversely impact its operations and financial condition.

Renovaro Cube’s business and results of operations will suffer if it fails to compete effectively.

The testing
and diagnostic products industry is intensely competitive. Renovaro Cube has competitors both in Europe and abroad, including Grail, Inc.,
Exact Sciences Corporation, Freenome, Inc. and Thrive Earlier Detection Corp., that have stated that they are developing tests designed
to detect cancer. Renovaro Cube’s competitors have, or may have, substantially greater financial, technical and other resources,
such as larger research and development staff and well-established marketing and sales forces, and they may operate in jurisdictions
where lower standards of evidence are required to bring products to market. Renovaro Cube’s competitors may succeed in developing,
acquiring, or licensing, on an exclusive basis or otherwise, tests or services that are more effective or less costly than Renovaro Cube’s
products. In addition, established medical technology, biotechnology, or pharmaceutical companies may invest heavily to accelerate the
discovery and development of tests that could make Renovaro Cube’s products less competitive than Renovaro Cube anticipates.

Renovaro
Cube’s ability to compete successfully will depend largely on its ability to:

| ● | successfully commercialize its products;                                                                                                                       |
| ● | demonstrate compelling advantages in the performance and convenience of its products, including on a cost-competitive basis;                                   |
| ● | achieve market acceptance of its products by consumers, including self-insured employers, integrated health systems, healthcare providers and patients;        |
| ● | achieve adequate coverage or reimbursement by third-party payors for its products;                                                                             |
| ● | differentiate its product from the other tests and products of current and potential competitors;                                                              |
| ● | attract qualified scientific, data science, clinical development, product development and commercial personnel;                                                |
| ● | obtain, maintain, defend and enforce patents and other intellectual property rights and claims as necessary for its products;                                  |
| ● | obtain and maintain any necessary or desirable clearance or approval from regulators in Europe, the United Kingdom, the United States and