Company: SHPH
Filing Date: 2025-01-15
Form Type: S-1
Source: 0001493152-25-002253
Chunk: 28

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-01-15
Form: S-1
Chunk 28
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 potential future product sales revenues. Our expenses also could increase beyond expectations if we decide to or are required by the FDA, or comparable foreign regulatory authorities, to perform studies or trials in addition to those that we currently anticipate. Even if we complete the development and regulatory processes described above, we anticipate incurring significant costs associated with launching and commercializing these products.

The market may not be receptive to our product candidates based on our novel therapeutic modality, and we may not generate any future revenue from the sale or licensing of product candidates.

Even if approval is obtained for a product candidate, we may not generate or sustain revenue from sales of the product due to factors such as whether the product can be sold at a competitive cost and otherwise accepted in the market. The product candidates that we are developing are based on new delivery platform therapeutic approaches (there currently is no drug which has FDA approval for indications of radiation sensitization). Market participants with significant influence over acceptance of new treatments, such as physicians and third-party payors, may not accept our delivery platform, and we may not be able to convince the medical community and third-party payors to accept and use, or to provide favorable reimbursement for, any product candidates developed by us. Market acceptance of our product candidates will depend on, among other factors:

| ● | timing                                                           
 of our receipt of any marketing and commercialization approvals; |

| ● | terms                                                                                                    
 of any approvals and the countries in which approvals are obtained;                                      |
| ● | safety                                                                                                   
 and efficacy of our product candidates, which are determinations solely within the authority of the FDA; |

| 19 |

| ● | prevalence                                                                                      
 and severity of any adverse side effects associated with our product candidates;                |
| ● | warnings                                                                                        
 contained in any labeling approved by the FDA or other regulatory authority;                    |
| ● | convenience                                                                                     
 and ease of administration of our product candidates;                                           |
| ● | success                                                                                         
 of our physician education programs;                                                            |
| ● | availability                                                                                    
 of adequate government and third-party payor reimbursement;                                     |
| ● | pricing                                                                                         
 of our products, particularly as compared to alternative treatments; and                        |
| ● | availability                                                                                    
 of alternative effective products for indications our product candidates are intended to treat. |

We will require substantial additional financing in order to obtain marketing approval of our product candidates and commercialize our product candidates; a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product