Company: SHPH
Filing Date: 2025-02-13
Form Type: S-1
Source: 0001493152-25-006202
Chunk: 31

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-13
Form: S-1
Chunk 31
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 profitability.

We are a clinical stage pharmaceutical company, preparing to commence Phase II clinical trials of our lead drug candidate, with a limited operating history upon which you can evaluate our business and prospects. Specialty pharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We do not currently have any product candidates in advanced clinical trials or approved for sale, and we continue to incur significant research and development and general and administrative expenses related to our operations. In addition, we have limited experience and have not yet demonstrated an ability to successfully overcome many of the risks and uncertainties frequently encountered by companies in new and rapidly evolving fields, particularly in the specialty pharmaceutical industry. We have not generated any revenue and have incurred losses in each year since our founding in December 2012. Our accumulated deficit as of December 31, 2023 was $25.4 million. We expect to continue to incur significant losses for the foreseeable future. Even if we achieve profitability in the future, we may not be able to sustain profitability in subsequent periods.

| 18 |

We currently have no source of product sales revenue.

We have not yet completed clinical trials and thus do not yet have commercial sales of our products and have not yet not generated any revenues from commercial sales of our product candidates. Our ability to generate product revenue depends upon our ability to develop and commercialize products, including any of our current product candidates or other product candidates that we may develop, in-license or acquire in the future. We do not anticipate generating revenue from the sale of products for the foreseeable future. Our ability to generate future product revenue from our current or future product candidates also depends on a number of additional factors, including our ability to:

| ● | complete                                                                                                                            
 research and clinical development of current and future product candidates, either directly or through collaborative relationships; |
| ● | establish                                                                                                                           
 and maintain supply and manufacturing relationships with third parties, and ensure adequate and legally compliant manufacturing of  
 bulk drug substances and drug products to maintain that supply;                                                                     |
| ● | obtain                                                                                                                              
 regulatory approval from relevant regulatory authorities in jurisdictions where we intend to market our product candidates, either  
 directly or through collaborative relationships;                                                                                    |
| ● | launch                                                                                                                              
 and commercialize future product candidates for which we obtain marketing approval, if any, through collaborative partners;         |
| ● | obtain                                                                                                                              
 coverage and adequate product reimbursement from third-party payors, including government payors;                                   |
| ● | achieve                                                                                                                             
 market acceptance for our products, if any;                                                                                         |