Company: BFRG
Filing Date: 2025-04-25
Form Type: 424B5
Source: 0001641172-25-006297
Chunk: 44

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-04-25
Form: 424B5
Chunk 44
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 products. Because of the nature of clinical trials, we do not know whether future planned clinical trials will begin on time, if at all. Delays in the commencement of clinical trials could significantly increase our drug development costs and delay our ability to successfully sell or license our drug candidates. In addition, many of the factors that may cause, or lead to, a delay in the commencement of clinical trials may also ultimately lead to denial of regulatory approval of a drug candidate. The commencement of clinical trials can be delayed for a variety of reasons, including delays in:

| ● | demonstrating                                                                                                              
 sufficient safety and efficacy in past clinical trials to obtain regulatory approval to commence a further clinical trial; |
| ● | convincing                                                                                                                 
 the FDA that we have selected valid endpoints for use in proposed clinical trials; and                                     |
| ● | obtaining                                                                                                                  
 institutional review board approval to conduct a clinical trial at a prospective site.                                     |

In addition, the commencement of clinical trials may be delayed due to insufficient patient enrollment, which is a function of many factors, including the size of the patient population, the nature of the protocol, the proximity of patients to clinical sites, the availability of effective treatments for the relevant disease and the eligibility criteria for the clinical trial.

If we are unable to obtain U.S. and/or foreign regulatory approval, we will be unable to resell or license our drug candidates.

Our drug candidates will be subject to extensive governmental regulations relating to, among other things, research, testing, development, manufacturing, safety, efficacy, record keeping, labelling, marketing and distribution of drugs. Rigorous preclinical testing and clinical trials and an extensive regulatory approval process are required in the U.S. and in many foreign jurisdictions prior to the commercial sale of drug candidates. Satisfaction of these and other regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays. It is possible that no drug candidate that we present to the FDA will obtain marketing approval which will significantly diminish the value and desirability of our product candidates. In connection with the clinical trials for our drug candidates, we face risks that:

| ● | the                                                                                                              
 drug candidate may not prove to be efficacious;                                                                  |
| ● | the                                                                                                              
 drug candidate may not prove to be safe;                                                                         |
| ● | the                                                                                                              
 drug candidate may not be readily co-administered or combined with other drugs or drug candidates;               |
| ● | the                                                                                                              
 results may not confirm the positive results from earlier preclinical studies or clinical trials;