Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 74

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 74
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ovaro
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.

Renovaro Cube’s employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

Renovaro
Cube is exposed to the risk of fraud, misconduct, or other illegal activity by its employees, independent contractors, consultants, commercial
partners and vendors. Misconduct by these parties could include intentional, reckless and negligent conduct that fails to comply with
the rules and regulations of the Centers for Medicare & Medicaid Services (the “CMS”), the FDA, the EMA, the MRHA and
other comparable regulatory authorities; provide true, complete and accurate information to such regulatory authorities; comply with manufacturing
and clinical laboratory standards; comply with healthcare fraud and abuse laws in the United Kingdom, Europe and, in the future, the United
States and similar fraudulent misconduct laws; or report financial information or data accurately or to disclose unauthorized activities
to Renovaro Cube. When Renovaro Cube begins commercializing its products in the United Kingdom and Europe and, in the future, the United
States, its potential exposure under such laws will increase significantly, and its costs associated with compliance with such laws are
also likely to increase. In particular, research, sales, marketing, education and other business arrangements in the healthcare industry
are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices, as well as off-label product
promotion. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, educating, marketing and promotion,
sales and