Company: BFRG
Filing Date: 2025-04-25
Form Type: 424B5
Source: 0001641172-25-006297
Chunk: 45

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-04-25
Form: 424B5
Chunk 45
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| ● | the                                                                                                              
 results may not meet the level of statistical significance required by the FDA or other regulatory agencies; and |
| ● | the                                                                                                              
 FDA or other regulatory agencies may require us to carry out additional studies.                                 |

We have limited experience in conducting and managing later stage clinical trials necessary to obtain regulatory approvals, including approval by the FDA. However, this risk would be mitigated in the event the Company is successful entering into a co-development agreement with a pharma partner for late stage clinical development. The time required to complete clinical trials and for the FDA and other countries’ regulatory review processes is uncertain and typically takes many years. Our analysis of data obtained from preclinical and clinical trials is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. We may also encounter unanticipated delays or increased costs due to government regulation from future legislation or administrative action or changes in FDA policy during the period of product development, clinical trials, and FDA regulatory review.

| 9 |

We will rely on third parties for manufacturing of our clinical drug supplies; our dependence on these manufacturers may impair the development of our drug candidates.

We have no ability to internally manufacture the drug candidates that we need to conduct our clinical trials for the products that we acquire. For the foreseeable future, we expect to continue to rely on third-party manufacturers and other third parties to produce, package and store sufficient quantities of our drug candidates and any future drug candidates for use in our clinical trials. We may face various risks and uncertainties in connection with our reliance on third-party manufacturers, including:

| ● | reliance                                                                                                                                 
 on third-party manufactures for regulatory compliance and quality assurance;                                                             |
| ● | the                                                                                                                                      
 possibility of breach of the manufacturing agreement by the third-party manufacturer because of factors beyond our control;              |
| ● | the                                                                                                                                      
 possibility of termination or nonrenewal of our manufacturing agreement by the third-party manufacturer at a time that is costly         
 or inconvenient for us;                                                                                                                  |
| ● | the                                                                                                                                      
 potential that third-party manufacturers will develop know-how owned by such third-party manufacturers in connection with the production 
 of our drug candidates that is necessary for the manufacture of our drug candidates; and                                                 |
| ● | reliance                                                                                                                                 
 on third-party manufacturers to assist us in preventing inadvertent disclosure or theft of our proprietary knowledge.                    |

Our drug candidates may be complicated and expensive to manufacture. If our third-party manufacturers fail to deliver our drug candidates for clinical use on a timely basis, with sufficient