Company: LNAI
Filing Date: 2025-09-29
Form Type: 10-K
Source: 0001731122-25-001316
Chunk: 1136

Company: Lunai Bioworks Inc.
Filing Date: 2025-09-29
Form: 10-K
Item: Item 1
Chunk 1136
---
 agreements;

    ●
    obtain, maintain, protect and enforce their intellectual property portfolio, including intellectual property obtained through license agreements;

    ●
    provide additional infrastructure to support continued research and development operations and any planned commercialization efforts in the future;

    ●
    as part of the combined company, meets the requirements and demands of being a public company; and

    ●
    defends against any product liability claims or other lawsuits related to its products.

Renovaro
Cube has never generated revenue from its cancer diagnostics AI platform, and does not expect any near-term revenue to offset
Renovaro Cube’s ongoing operating expenses, and may never be able to maintain profitability.

Renovaro
Cube’s ability to generate revenue from product sales and maintain profitability in the future depends on its ability to commercialize
its products. Renovaro Cube cannot be certain that it will be able to do so successfully as planned, if at all, 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:

24

    ●
    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;

    ●
    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;