Company: INDP
Filing Date: 2025-02-12
Form Type: S-1
Source: 0001493152-25-006068
Chunk: 38

Company: Indaptus Therapeutics, Inc.
Filing Date: 2025-02-12
Form: S-1
Chunk 38
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 laws and other healthcare reform measures that may be adopted in the future may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, new payment methodologies and additional downward pressure on the price that we receive for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize Decoy20 and any future product candidates, if approved.

Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any product candidates that we may develop.

We will face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk if we commercially sell any product candidates that we may develop. If we cannot successfully defend ourselves against claims that our product candidates caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

| ● | decreased                                                                  
 demand for any product candidates that we may develop;                     |
| ● | injury                                                                     
 to our reputation and significant negative media attention;                |
| ● | regulatory                                                                 
 investigations that could require costly recalls or product modifications; |
| ● | withdrawal                                                                 
 of clinical trial participants;                                            |
| ● | significant                                                                
 costs to defend the related litigation;                                    |
| ● | substantial                                                                
 monetary awards to trial participants or patients;                         |
| ● | loss                                                                       
 of potential revenue;                                                      |
| ● | the                                                                        
 diversion of management’s attention away from managing our business; and   |
| ● | the                                                                        
 inability to commercialize any product candidates that we may develop.     |

Although we maintain product liability insurance coverage, it may not be adequate to cover all liabilities that we may incur and is subject to deductibles and coverage limitations. We anticipate that we will need to increase our insurance coverage when and if we successfully commercialize any product candidate. Insurance coverage is increasingly expensive. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. If we are unable to obtain insurance at acceptable cost or otherwise protect against potential product liability claims, we will be exposed to significant liabilities, which may materially and adversely affect our business and financial position. These liabilities could prevent or interfere with our commercialization efforts.

| 27 |

We are subject to a multitude of manufacturing risks, any of which could substantially