Company: ANIX
Filing Date: 2025-01-10
Form Type: S-8
Source: 0001493152-25-001798
Chunk: 24

Company: Anixa Biosciences Inc
Filing Date: 2025-01-10
Form: S-8
Chunk 24
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/or sell our technologies. We may have difficulty in timing the establishment of these partnerships to achieve the greatest economic benefit for the Company, or in establishing these partnerships at all.

We do not currently have the resources and infrastructure to manufacture, market or sell our products or technologies. While our technologies have generated interest from multiple potential strategic partners, due to the early stage of development of our technologies, we can give no assurance that we will be able to successfully establish any strategic partnerships. Further, even if we elect to engage with a potential strategic partner, development of these partnerships can take an extended period of time in which significant analysis is performed by the potential strategic partner on our technologies and our intellectual property, as well as on the market opportunities and how well our technologies may fit strategically with the partner’s existing business. Accordingly, it will be difficult for us to time the establishment of a strategic partnership to achieve the greatest economic benefit for the Company.

If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit commercialization of our product candidates.

We will face an inherent risk of product liability as a result of the ongoing and upcoming human clinical testing and commercialization of our product candidates. For example, we may be sued if our product candidates cause or are perceived to cause injury or are found to be otherwise unsuitable during clinical testing, manufacturing, marketing or sale. Any such product liability claims may include allegations of defects in manufacturing, defects in design, a failure to warn of dangers inherent in the product, negligence, strict liability or a breach of warranties. Claims could also be asserted under state consumer protection acts. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit or cease commercialization of our product candidates. Even successful defense would require significant financial and management resources. Regardless of the merits or eventual outcome, liability claims may result in:

| ● | decreased                          
 demand for our product candidates; |
| ● | injury                             
 to our reputation;                 |

| 13 |

| ● | withdrawal                                                               
 of clinical trial participants;                                          |
| ● | initiation                                                               
 of investigations by regulators;                                         |
| ● | costs                                                                    
 to defend the related litigation;                                        |
| ● | a                                                                        
 diversion of management’s time and our resources;                        |
| ● | substantial                                                              
 monetary awards to clinical trial participants or patients;              |
| ● | product                                                                  
 recalls, withdrawals or labeling, marketing or promotional restrictions; |
| ● | loss                                                                     
 of potential revenue;                                                    |