Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-Q/A
Source: 0001731122-25-000250
Chunk: 94

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-Q/A
Chunk 94
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 timely basis could have a material adverse effect on Renovaro Cube’s
results of operations and business.

Even if Renovaro Cube commercially launches its AI platform and other products, they may fail to achieve the degree of market acceptance necessary for commercial success.

The commercial
success of Renovaro Cube’s AI platform and other future products will depend upon the degree of market acceptance by consumers,
including self-insured employers, integrated health systems, healthcare providers, patients and, over the long-term, third-party payors.
The degree of market acceptance of Renovaro Cube’s products will depend on a number of factors, including:

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| ● | the performance                                                                                                                      
 and clinical utility of its products as demonstrated in clinical validation and published in peer-reviewed journals;                 |
| ● | Renovaro                                                                                                                             
 Cube’s ability to demonstrate the clinical utility of its products and their potential advantages to the medical community;          |
| ● | the ability                                                                                                                          
 of Renovaro Cube’s products to demonstrate the same performance in real-world intended use populations as in clinical                
 validation;                                                                                                                          |
| ● | the willingness                                                                                                                      
 of consumers, including self-insured employers, integrated health systems, healthcare providers, patients and others in the          
 medical community to utilize Renovaro Cube’s products;                                                                               |
| ● | the willingness                                                                                                                      
 of commercial third-party payors and government payors to cover and reimburse for Renovaro Cube’s products, the scope                
 and amount of which will likely affect an individual’s willingness or ability to pay for Renovaro Cube’s products and likely         
 heavily influence healthcare providers’ decisions to recommend Renovaro Cube’s products;                                             |
| ● | with respect                                                                                                                         
 to products under development that Renovaro Cube intends to launch for use in a broad asymptomatic population, the concern that such 
 products could lead to over-diagnosis or a high false-positive rate and unnecessary medical procedures and costs;                    |
| ● | the introduction                                                                                                                     
 of competing products, including the expansion of the capabilities of existing products;                                             |
| ● | the market                                                                                                                           
 acceptance of existing competitive products, including tests that are currently reimbursed;                                          |
| ● | publicity                                                                                                                            
 concerning Renovaro Cube’s products or competing products; and                                                                       |
| ● | the strength                                                                                                                         
 of Renovaro Cube’s marketing and distribution support.                                                                               |

The failure
of Renovaro Cube’s AI platform, once introduced, to be listed in