Company: LNAI
Filing Date: 2025-02-19
Form Type: 10-K/A
Source: 0001731122-25-000252
Chunk: 77

Company: Lunai Bioworks Inc.
Filing Date: 2025-02-19
Form: 10-K/A
Chunk 77
---
 approval. If treatment-related serious adverse events (“SAEs”)
or other undesirable side effects or safety concerns, or unexpected characteristics attributable to our product candidates are observed
in any future clinical trials, they may adversely affect or delay our clinical development and commercialization of the effected product
candidate, and the occurrence of these events could have a material adverse effect on our business and financial prospects. Results of
our future clinical trials could reveal a high and unacceptable severity and prevalence of adverse side effects. In such an event, our
trials could be suspended or terminated, and the FDA or other regulatory agency could order us to cease further development of or deny
approval of our product candidates for any or all targeted indications. The drug-related side effects could affect patient recruitment
or the ability of enrolled patients to complete the trial or result in potential product liability claims.

Additionally, if any of our product
candidates receives marketing approval and we or others later identify undesirable or unacceptable side effects or safety concerns caused
by these product candidates, a number of potentially significant negative consequences could result, including:

| ● | regulatory authorities                                                                                                               
 may withdraw, suspend, or limit approvals of such products and require us to take them off the market;                               |
| ● | regulatory authorities                                                                                                               
 may require the addition of labeling statements, specific warnings, a contraindication or field alerts to physicians and pharmacies; |
| ● | regulatory authorities                                                                                                               
 may require a medication guide outlining the risks of such side effects for distribution to patients, or that we implement a REMS    
 or REMS-like plan to ensure that the benefits of the product outweigh its risks;                                                     |

<div align='center'>49</div>

| ● | we may be required to change                                                                                               
 the way a product is distributed or administered, conduct additional clinical trials, or change the labeling of a product; |
| ● | we may be required to conduct additional post-marketing                                                                    
 studies or surveillance;                                                                                                   |
| ● | we may be subject to limitations on how we may promote                                                                     
 the product;                                                                                                               |
| ● | sales of the product may decrease significantly;                                                                           |
| ● | we may be subject to regulatory investigations,                                                                            |
| ● | we may be subject to government enforcement actions,                                                                       
 litigation, or product liability claims; and                                                                               |
| ● | our products may become less competitive, or our reputation                                                                
 may suffer.                                                                                                                |

Any of these events could prevent
us or any collaborators from achieving or maintaining market acceptance of our product candidates or