Company: SHPH
Filing Date: 2025-02-13
Form Type: S-1
Source: 0001493152-25-006202
Chunk: 30

Company: Shuttle Pharmaceuticals Holdings, Inc.
Filing Date: 2025-02-13
Form: S-1
Chunk 30
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 recommended and the Company agreed to an expansion of the Phase II clinical trial, necessitating additional capital to complete the trial as well as fund ongoing operations. Additionally, the Phase II clinical trial of Ropidoxuridine has evolved with finalized agreements with all six of the planned site enrolment locations to administer the Phase II clinical trial of Ropidoxuridine and the enrollment of a total of 15 patients, representing 38% of the patients required to complete the first phase of the study. The ability of the Company to continue as a going concern is dependent upon our ability to continue to successfully raise additional equity or debt financing to fund ongoing operations, conduct clinical trials and bring a drug candidate to commercialization to generate revenues.

Our success is primarily dependent on the successful development, regulatory approval and commercialization of our product candidates, all of which are in the early stages of development.

We currently have one clinical stage product candidate in the early stages of development. Ropidoxuridine has undergone an SBIR funded Phase I clinical trial at Lifespan/Rhode Island Hospital. We also have an HDAC inhibitor small molecule platform. The three lead drug candidate molecules are in preclinical phases of development. None of our product candidates have gained marketing approval for sale in the United States or any other country, and we cannot guarantee that we will ever have marketable products. To date, we have invested substantially all of our efforts and financial resources in the research and development and commercial planning for our current product candidate and our HDAC small molecule delivery platform. Our near-term prospects, including our ability to finance our Company and generate revenue, as well as our future growth, will depend heavily on the development, marketing approval and commercialization of our product candidates. The clinical and commercial success of product candidates will depend on a number of factors, including the following:

| ● | building                                                                                                                          
 on favorable results from our Phase I clinical trial for IPdR and proceeding to Phase II and Phase III clinical trials, which may 
 be slower or cost more than we currently anticipate;                                                                              |
| ● | our                                                                                                                               
 ability to demonstrate safety and efficacy of our product candidates, which are ongoing determinations that are solely within the 
 authority of the FDA;                                                                                                             |
| ● | even                                                                                                                              
 if our clinical trials are completed, there can be no assurance that the FDA will agree that we have satisfactorily demonstrated  
 safety or efficacy or that the FDA will not raise new issues regarding the design of our clinical trials;                         |

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