Company: BFRG
Filing Date: 2025-03-14
Form Type: 10-K
Source: 0001493152-25-010367
Chunk: 80

Company: BullFrog AI Holdings, Inc.
Filing Date: 2025-03-14
Form: 10-K
Item: Item 1
Chunk 80
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 available over the coming years. If our therapeutic product candidates are approved, we expect that they will be priced at a significant
premium over competitive generic medicines.

Any
product candidates that we successfully develop and commercialize will compete with existing therapies and new therapies that may become
available in the future. If the product candidates of our priority programs are approved for the indications for which we are currently
planning clinical trials, they will compete with the drugs discussed below and will likely compete with other drugs currently in development.

bfLEAP

The
analytics industry and application of AI/ML in healthcare is growing rapidly. Competition exists along the entire continuum of the drug
development process from discovery to commercialization and beyond. We believe the weakness of the industry is the quality of the data
and we believe bfLEAP provides several competitive advantages, that will position the Company for success, First, bfLEAP is highly scalable
and can process data from small to extremely large complex data sets without the need for additional code being developed. Second, it
is adept at processing and analyzing incomplete data and making predictions that we do not believe other technologies are capable of
doing. Third, bfLEAP has the ability to extract the most important features for analysis out of extremely large complex data sets using
unsupervised machine learning algorithms, thereby greatly simplifying complex problems. Since data quality is a problem that exists in
the healthcare industry, we see these as major differentiators. The ability to make predictions, find relationships and patterns and
anomalies in extremely large complex data sets has been demonstrated by the JHU-APL in other applications and sectors. Finally, the algorithms
used by bfLEAP are proprietary and protected, having been developed at JHU-APL. We believe most of the competitors rely on open-source
algorithms and we also believe that we have already demonstrated our superiority via the August 2021 publication in DeepAI.org.

 17 

Government
Regulation

The
FDA does not currently require approval of AI/ML technologies used to aid in therapeutics, but that could change in the future. The FDA
will regulate any clinical trials conducted by the Company.

Our
clinical development programs will, in some cases, require regulatory review of preclinical and/or clinical data by the FDA or other
governing agencies, and subsequent compliance with applicable federal, state, local, and foreign statutes and regulations. The results
of the clinical trials that we conduct will be evaluated by the FDA and other regulatory bodies.