What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2025-03-14 compared with 2024-03-29 · 489 added, 447 removed, 474 unchanged (66% of the section changed)

4 unchanged sentences

is the parent company of Bullfrog

and Bullfrog AI Management, LLC.

which were incorporated in Delaware and Maryland, in 2017 and 2021, respectively.

operations are currently conducted through BullFrog AI Holdings, Inc.

The Company’s principal business address is 325 Ellington

Blvd, Unit 317, Gaithersburg, MD 20878.

and Bullfrog AI Management, LLC, which were incorporated in Delaware and Maryland, in 2017 and 2021, respectively.

All our operations

are currently conducted through Bullfrog AI Holdings, Inc.

The Company’s principal business address is 325 Ellington Blvd, Unit

317, Gaithersburg, MD 20878.

Our website address is www.bullfrogai.com .

The references to our website in this Form

10-K are inactive textual references only.

The information on our website is neither incorporated by reference into this Form 10-K.

The references to our website in this Annual Report on

Form 10-K (the “Form 10-K”) are inactive textual references only.

The information on our website is not incorporated into

this Form 10-K.

of Bullfrog AI, Inc.

March 2020, BullFrog AI, Inc.

received an investment from TEDCO - the Technology Development Corporation of Maryland, a State of Maryland

Investment Fund – pursuant to the issuance of a $200,000 convertible note with an 18-month term, 6% annual interest rate, and a

20% discount.

In June 2020, BullFrog AI Holdings, Inc.

June 2020, Bullfrog AI Holdings, Inc.

acquired Bullfrog AI, Inc.

pursuant to an exchange agreement under which each

share of Bull Frog AI, Inc.

common stock was exchanged for a share of common stock of BullFrog AI Holdings, Inc.

Immediately prior to

the share exchange, each outstanding common share of BullFrog AI, Inc.

pursuant to an exchange agreement under which each share of Bullfrog

common stock was exchanged for a share of common stock of the Company.

Immediately prior to the share exchange, each outstanding

common share of Bullfrog AI, Inc.

was split into 25 shares of common stock.

Pursuant to the agreement,

24,223,975 shares of the Company’s common stock were issued to the shareholders of BullFrog AI, Inc.

in exchange for 100% of the

outstanding stock of BullFrog AI, Inc.

Pursuant to the share exchange agreement, 24,223,975 shares

of the Company’s common stock were issued to the shareholders of Bullfrog AI, Inc.

in exchange for 100% of the outstanding stock

of Bullfrog AI, Inc.

Upon completion of the exchange, Bullfrog AI, Inc.

became the Company’s wholly-owned subsidiary

and the shareholders of BullFrog AI, Inc.

became the Company’s wholly-owned subsidiary and the shareholders

of Bullfrog AI, Inc.

held 100% of the common stock of the Company.

As a result, BullFrog AI Holdings, Inc.

a total of $330,442 in net liabilities of BullFrog AI, Inc.

Both of the entities were controlled before and after the transactions by

the same controlling shareholder.

As a result, the Company assumed a total of $330,442 in net liabilities

of Bullfrog AI, Inc.

Both of the entities were controlled before and after the transactions by the same controlling shareholder.

AI Corporate History

was incorporated in the State of Delaware on August 25, 2017.

Vininder Singh is the founder, CEO and chairman of BullFrog AI.

Vininder Singh, the Chief Executive Officer, was the founder,

CEO and chairman of Bullfrog AI, Inc.

Business Overview

new therapeutics will fail at some point in preclinical or clinical development.

22 unchanged sentences

platform currently has more advanced versions of these algorithms and is applying them in multiple data analytics projects.

February 26, 2024, the Company announced the appointment of Dr.

Chittenden, PhD, DPhil, PStat, as its new Chief Scientific

January 31, 2024, the Company entered into an underwriting agreement with WallachBeth Capital, LLC as representative of the several underwriters

named therein, relating to the issuance and sale of an aggregate of (i) 1,028,710 shares of common stock, par value $0.00001 per share

and 478,429 pre-funded warrants in lieu of common stock (“Pre-Funded Warrants”) or 1,507,139 shares of common stock (or Pre-Funded

Warrants) in lieu thereof, and accompanying warrants to purchase 1,507,139 shares of common stock at a combined public offering price

of $3.782 per share (inclusive of the Pre-Funded Warrant exercise price) for gross proceeds of approximately $5,700,000, prior to deducting

underwriting discounts and offering expenses.

Recent Developments

February 2025, we announced our entry into a collaboration agreement with Eleison Pharmaceuticals Inc.

(“Eleison”), a Phase

III oncology company focused on novel chemotherapeutic treatments for rare cancers.

Through this collaboration, we will apply our proprietary

Bullfrog Data Networks™ solution, powered by the bfLEAP® platform, to analyze clinical data from Eleison’s ongoing Phase

III trial and previous clinical studies of glufosfamide, an investigational treatment for pancreatic cancer.

The platform will evaluate

the current trajectory of the trial with respect to safety signals, extract predictive biomarkers for efficacy and safety performance

from prior studies to support future trial design, and provide data-driven insights to optimize Eleison’s planned clinical trials

for inhaled lipid-complexed cisplatin (ILC) and dibromodulcitol (DBD).

These insights are expected to streamline trial efficiency and

improve decision-making for Eleison’s broader oncology pipeline.

plan to achieve our business objectives by enabling the successful development of drugs and biologics using a precision medicine approach

1 unchanged sentence

The bfLEAP™ platform utilizes both supervised and unsupervised machine

learning - as such, it is able to reveal real/meaningful connections in the data without the need for a prior hypothesis.

machine learning uses labeled input and output data, while an unsupervised learning algorithm does not.

as such, it is able to reveal meaningful connections in the data without the need for a prior hypothesis.

Supervised machine

learning uses labeled input and output data, while an unsupervised learning algorithm does not.

In supervised learning, the algorithm

15 unchanged sentences

We believe the bfLEAP™ analytics

platform is a potentially disruptive tool for analysis of pre-clinical and/or clinical data sets, such as the robust pre-clinical and

clinical trial data sets being generated in translational R&D and clinical trial settings.

In November 2021, we amended the agreement

platform is a potentially disruptive tool for analysis of pre-clinical and clinical data sets, such as the robust pre-clinical and clinical

trial data sets being generated in translational R&D and clinical trial settings.

In November 2021, we amended our license agreement

with JHU-APL to include additional advanced AI technology.

2 unchanged sentences

The July 8, 2022 JHU-APL license

provides the Company with new intellectual property and also encompasses most of the intellectual property from the February 2018 license.

believe bfLEAP™ will inform/enable decision making throughout the development cycle:

Phase - Analyze and categorize discovery phase data to better define highest-value leads from groups of candidates, for advancement

to preclinical phase of development.

Integrate data from high-throughput screening, pharmacodynamics assays, pharmacokinetics assays,

and other key data sets to create the most accurate profile of a pool of therapeutic candidates.

There is often a high degree of

similarity among closely related therapeutics in a candidate pool - bfLEAP™ is able to harmonize disparate data streams for

a more nuanced understanding of each candidate’s characteristics/potency.

Data - Large-scale/multivariate analysis of pre-clinical and/or early-stage clinical data sets.

In these settings, bfLEAP could be

used to find novel drug targets, elucidate mechanism of action (MOA), predict potential off-target effects/side effects, uncover

specific genetic/phenotypic background(s) with highest correlation to therapeutic response, etc.

These insights from bfLEAP™

analysis can be used to inform decision making/study design at the subsequent step(s) of therapeutic/diagnostic development, including

first-inhuman/Phase I RCTs.

Development - Advanced/multivariate analysis of PhI and/or PhII clinical trials data, to find niche populations of highly responsive

patients and/or inform patient selection for later-stage CT(s).

This can be used to decrease overall study risk for larger clinical

trials - including Phase II trials, and any Phase III Registration Clinical Trials.

The bfLEAP™ platform analysis can also

be used to more precisely understand complex correlations between therapeutic treatment and adverse events, side effects, and other

undesirable responses which could jeopardize clinical trial success.

provides the Company with new intellectual property and also encompasses most of the intellectual property from our original February

2018 license agreement with JHU-APL.

believe bfLEAP™ will inform and enable decision making throughout the development cycle:

Phase - Analyze and categorize discovery phase data to better define highest-value leads

from groups of candidates, for advancement to preclinical phase of development.

data from high-throughput screening, pharmacodynamics assays, pharmacokinetics assays, and

other key data sets to create the most accurate profile of a pool of therapeutic candidates.

There is often a high degree of similarity among closely related therapeutics in a candidate

pool - bfLEAP™ is able to harmonize disparate data streams for a more nuanced understanding

of each candidate’s characteristics/potency.

● Pre-Clinical

Data - Large-scale, multivariate analysis of pre-clinical and early-stage clinical data

In these settings, bfLEAP could be used to find novel drug targets, elucidate mechanism

of action, predict potential off-target effects/side effects, uncover specific genetic/phenotypic

background(s) with highest correlation to therapeutic response, etc.

These insights from

bfLEAP™ analysis can be used to inform decision making and study design at the subsequent

step(s) of therapeutic and diagnostic development, including first-inhuman/Phase I randomized

controlled trials.

Development – Advanced, multivariate analysis of Phase I and Phase II clinical

trials data, to find niche populations of highly responsive patients and/or inform patient

selection for later-stage clinical trials.

This can be used to decrease overall study risk

for larger clinical trials - including Phase II trials, and any Phase III Registration Clinical

The bfLEAP™ platform analysis can also be used to more precisely understand

complex correlations between therapeutic treatment and adverse events, side effects, and

other undesirable responses which could jeopardize clinical trial success.

platform is agnostic to the disease indication or treatment modality and therefore we believe that it is of value in the development

2 unchanged sentences

the rights to a drug from a biopharmaceutical industry company or academia;

the proprietary bfLEAP™ AI/ML platform to determine a multi-factorial profile for a patient that would best respond to the

conduct a clinical trial to validate the drug’s use for the defined “high-responder” population;

the rescued drug asset with the new information back to a large player in the pharma industry, following positive results of the

clinical trial.

the proprietary bfLEAP™ AI/ML platform to determine a multi-factorial profile for a

patient that would best respond to the drug;

conduct a clinical trial to validate the drug’s use for the defined “high-responder”

and sell the rescued drug asset with the new information back to a large player in the pharma

industry, following positive results of the clinical trial.

part of our strategy, we will continue evolving our intellectual property, analytical platform and technologies, build a large portfolio

6 unchanged sentences

However, we currently have a strategic relationship with a leading rare

disease non-profit organization for artificial intelligence/machine learning (“AI/ML”) analysis of late-stage clinical data.

We have acquired the rights to a series of preclinical and early clinical drug assets from universities and entered into a strategic

collaboration with a world-renowned research institution to create a HSV1 viral therapeutic platform to engineer immunotherapies for

colorectal cancer.

We have signed exclusive worldwide license agreements with Johns Hopkins University for a cancer drug that targets

glioblastoma (brain cancer), pancreatic cancer, and other cancers.

We have also signed an exclusive worldwide license with George Washington

University for another cancer drug that targets hepatocellular carcinoma (liver cancer), and other liver diseases.

platform was originally developed by The Johns Hopkins University Applied Physics Laboratory (“JHU-APL”).

JHU-APL uses the

same technology for applications related to national defense.

Over several years, the software and algorithms have been used to identify

relationships, patterns, and anomalies, and make predictions that otherwise may not be found.

These discoveries and insights provide

an advantage when predicting a target of interest, regardless of industry or sector.

We have applied the technology to various clinical

data sets and have identified novel relationships that may provide new intellectual property, new drug targets, and other valuable information

that may help with patient stratification for a clinical trial thereby improving the odds for success.

The platform has not yet aided

in the development of a drug that has reached commercialization.

However, we have licensed one drug candidate that has completed a Phase

1 trial and a second candidate that is in the preclinical stages.

Our aim is to use our technology on current and future available data

to help us better determine the optimal path for development.

disease non-profit organization for AI/ML analysis of late-stage clinical data.

We have acquired the rights to a series of preclinical

and early clinical drug assets from universities and entered into a strategic collaboration with a world-renowned research institution

to create a HSV1 viral therapeutic platform to engineer immunotherapies for colorectal cancer.

We have signed exclusive worldwide license

agreements with Johns Hopkins University for a cancer drug that targets glioblastoma (brain cancer), pancreatic cancer, and other cancers.

We have also signed an exclusive worldwide license with George Washington University for another cancer drug that targets hepatocellular

carcinoma (liver cancer), and other liver diseases.

platform was originally developed by JHU-APL.

JHU-APL uses the same technology for applications related to national defense.

years, the software and algorithms have been used to identify relationships, patterns, and anomalies, and make predictions that otherwise

may not be found.

These discoveries and insights provide an advantage when predicting a target of interest, regardless of industry or

We have applied the technology to various clinical data sets and have identified novel relationships that may provide new intellectual

property, new drug targets, and other valuable information that may help with patient stratification for a clinical trial thereby improving

the odds for success.

The platform has not yet aided in the development of a drug that has reached commercialization.

However, we have

licensed one drug candidate that has completed a Phase I trial and a second candidate that is in the preclinical stages.

Our aim is to

use our technology on current and future available data to help us better determine the optimal path for development.

we have not generated significant revenues from our AI/ML operations, we anticipate generating revenue in the future from the following

3 unchanged sentences

We provide the customer with an analysis of large complex

data sets using our proprietary Artificial Intelligence / Machine Learning platform called bfLEAP™.

This platform is designed to

predict targets of interest, patterns, relationships, and anomalies.

Our service model involves a cash fee plus the potential for rights

to new intellectual property generated from the analysis, which can be performed at the discovery, preclinical, or clinical stages of

drug development.

data sets using our proprietary AI/ML platform called bfLEAP™.

This platform is designed to predict targets of interest, patterns,

relationships, and anomalies.

Our service model involves fees in cash, equity or other consideration and, in some instances, the potential for rights to new intellectual property generated

from the analysis, which can be performed at the discovery, preclinical, or clinical stages of drug development.

Collaborative

plan to enter into collaborative arrangements with biotechnology and pharmaceutical companies who have drugs that are in development

or have failed late Phase 2 or Phase 3 trials.

or have failed late Phase II or Phase III trials.

The collaborations may also be at the discovery or preclinical stages of drug development.

Our revenue will be a combination of fee for service cash payments and success fees based on achieving certain milestones as determined

by each specific arrangement.

Our revenue will be a combination of fee for service payments and success fees based on achieving certain milestones as determined by

each specific arrangement.

There may also be fees or legal rights associated with the development of new intellectual property.

of Rights to Certain Drugs

may acquire the rights to drugs that have failed late Phase 2 or Phase 3 trials and generate revenues by using our platform to accurately

may acquire the rights to drugs that have failed late Phase II or Phase III trials and generate revenues by using our platform to accurately

determine the profile of patients that would respond to the drugs, conduct a clinical trial to test our findings either independently

7 unchanged sentences

Market/Indications

– AI/ML platform for analysis of preclinical and/or clinical data

analytics platform derived from technology developed at JHU-APL and licensed by the Company.

Biotechnology

and pharmaceutical companies and other organizations.

targeting Beta2-spectrin in the treatment of human diseases developed at George Washington University licensed by the Company

Hepatocellular

carcinoma (HCC), treatment of obesity, non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis.

Has not yet initiated

clinical testing.

formulation of Mebendazole developed at Johns Hopkins University and licensed by the Company

bfLEAP™ – AI/ML platform for analysis of

preclinical and clinical data

AI/ML analytics platform

derived from technology developed at JHU-APL and licensed by the Company.

Biotechnology and pharmaceutical

companies and other organizations.

Small interfering RNA targeting

Beta2-spectrin in the treatment of human diseases developed at George Washington University and licensed by the Company.

has not yet initiated clinical testing.

Hepatocellular carcinoma,

treatment of obesity, non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis.

Improved formulation of

Mebendazole developed at Johns Hopkins University and licensed by the Company.

Product has begun the process of clinical testing

but has not received regulatory approval for commercialization.

Glioblastoma.

Has begun the process of clinical testing but has not received regulatory approval for commercialization.

January 14, 2022, the Company entered into an exclusive, worldwide, royalty-bearing license from George Washington University (GWU) for

rights to use siRNA targeting Beta2-spectrin in the treatment of human diseases, including hepatocellular carcinoma (HCC).

covers methods claimed in three U.S.

and worldwide patent applications, and also includes use of this approach for treatment of obesity,

non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis.

This program is currently in the preclinical stage of development.

The Company recently initiated proof-of-concept studies on this asset and will use the outcome of these studies to inform a clinical

January 14, 2022, the Company entered into an exclusive, worldwide, royalty-bearing license from George Washington University (“GWU”)

for rights to use siRNA targeting Beta2-spectrin in the treatment of human diseases, including hepatocellular carcinoma (“HCC”).

The license covers methods claimed in three U.S.

and worldwide patent applications, and also includes use of this approach for treatment

of obesity, non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis.

This program is currently in the preclinical stage

of development.

The Company initiated proof-of-concept studies on this asset and will use the outcome of these studies to inform a clinical

development plan that would include initiation of IND-enabling studies.

dysfunction-associated steatotic liver disease (MASLD, which until recently was called non-alcoholic fatty liver disease, or NAFLD) is

a condition in which excess lipids, or fat, build up in the liver.

This condition, which is more common in people who have obesity and

related metabolic diseases including type 2 diabetes, affects as many as 24% of adults in the US and is associated with risk of progression

to more serious conditions, including metabolic dysfunction-associated steatohepatitis (MASH), with associated liver inflammation and

fibrosis, and HCC.

Evidence in animal models of obesity suggest that a protein called β2-spectrin may play a key role in lipid accumulation,

tissue fibrosis, and liver damage, and targeting expression or activity of this protein may be a useful approach in treating MASH and

liver cancer (Rao et al., 2021).

February 2022, the Company entered into an exclusive, worldwide, royalty-bearing license from Johns Hopkins University (JHU) for the

use of an improved formulation of Mebendazole for the treatment of any human cancer or neoplastic disease.

This formulation shows potent

activity in animal models of different types of cancer and has been evaluated in a Phase I clinical trial in patients with high-grade

dysfunction-associated steatotic liver disease (known as MASLD, which until recently was called non-alcoholic fatty liver disease, or

NAFLD) is a condition in which excess lipids, or fat, build up in the liver.

This condition, which is more common in people who have

obesity and related metabolic diseases including type 2 diabetes, affects as many as 24% of adults in the United States and is associated

with risk of progression to more serious conditions, including metabolic dysfunction-associated steatohepatitis (“MASH”), with associated

liver inflammation and fibrosis, and HCC.

Evidence in animal models of obesity suggest that a protein called β2-spectrin may play

a key role in lipid accumulation, tissue fibrosis, and liver damage, and targeting expression or activity of this protein may be a useful

approach in treating MASH and liver cancer (Rao et al., 2021).

February 2022, the Company entered into an exclusive, worldwide, royalty-bearing license with Johns Hopkins University (“JHU”)

for the use of an improved formulation of Mebendazole for the treatment of any human cancer or neoplastic disease.

This formulation shows

potent activity in animal models with different types of cancer and has been evaluated in a Phase I clinical trial in patients with high-grade

glioma (NCT01729260).

9 unchanged sentences

with this asset to enable evaluation of safety in humans.

October 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from Johns Hopkins University (JHU) and the

Institute of Organic Chemistry and Biochemistry (IOCB) of the Czech Academy of Sciences for rights to commercialize N-substituted

prodrugs of mebendazole that demonstrate improved solubility and bioavailability.

The license covers prodrug compositions and use

for treating disease as claimed in multiple US and worldwide patent applications.

Patents have since been issued in the United

States and Australia and are still in the prosecution phase in other territories.

In September 2023 the Company announced results

from a preclinical study demonstrating the effectiveness of BF-223, a compound chosen from this class, in an animal model for

glioblastoma.

The Company is currently formulating a strategy for initiating IND-enabling studies on BF-223 and is conducting

outreach to identify partners that may want to license or partner in the development of BF-223.

October 2022, the Company entered into an exclusive, world-wide, royalty-bearing license with JHU and the Institute of Organic Chemistry

and Biochemistry (“IOCB”) of the Czech Academy of Sciences for rights to commercialize N-substituted prodrugs of mebendazole

that demonstrate improved solubility and bioavailability.

The license covers prodrug compositions and use for treating disease as claimed

in multiple United States and worldwide patent applications.

Patents have since been issued in the United States and Australia and are

still in the prosecution phase in other territories.

In September 2023, the Company announced results from a preclinical study demonstrating

the effectiveness of BF-223, a compound chosen from this class, in an animal model for glioblastoma.

The Company is currently formulating

a strategy for initiating IND-enabling studies on BF-223 and is conducting outreach to identify partners that may want to license or

partner in the development of BF-223.

bfLEAP™ Analytics Platform

1 unchanged sentence

bfLEAP™) derived from

technology developed at The Johns Hopkins University Applied Physics Laboratory (JHU-APL).

The bfLEAP™ platform is based on an

exclusive, world-wide license granted by Johns Hopkins University Applied Physics Laboratory.

The license covers three (3) issued patents,

as well as a new provisional patent application, non-patent rights to proprietary libraries of algorithms and other trade secrets, which

also includes modifications and improvements.

On July 8, 2022, the Company entered into an exclusive, world-wide, royalty-bearing license

from JHU-APL for the additional technology developed to enhance the bfLEAP™ platform.

The new license provides additional intellectual

property rights including patents, copyrights and knowhow to be utilized under the Company’s bfLEAP™ analytical AI/ML platform.

Under the terms of the new License Agreement, JHU will be entitled to eight (8%) percent of net sales for the services provided by the

Company to other parties and 3% for internally development drug projects in which the JHU license was utilized.

The new license also

contains tiered sub licensing fees that start at 50% and reduce to 25% based on revenues.

believe the bfLEAP™ analytics platform is a potentially disruptive tool for analysis of pre-clinical and/or clinical data sets,

such as the robust pre-clinical and clinical trial data sets being generated in translational R&D and clinical trial settings.

input data for bfLEAP™ can include raw data (preclinical and/or clinical readouts), categorical data, sociodemographic data of

patients, and various other inputs.

technology developed at JHU-APL.

The bfLEAP™ platform is based on an exclusive, world-wide license granted by JHU-APL.

covers three (3) issued patents, as well as a new provisional patent application, non-patent rights to proprietary libraries of algorithms

and other trade secrets, which also includes modifications and improvements.

On July 8, 2022, the Company entered into an exclusive,

world-wide, royalty-bearing license from JHU-APL for the additional technology developed to enhance the bfLEAP™ platform.

license provides additional intellectual property rights including patents, copyrights and knowhow to be utilized under the Company’s

bfLEAP™ analytical AI/ML platform.

Under the terms of the new license agreement, JHU-APL will be entitled to eight percent (8%)

of net sales for the services provided by the Company to other parties and three percent (3%) for internally developed drug projects

in which the JHU-APL license was utilized.

The new license also contains tiered sub licensing fees that start at 50% and reduce to 25%

based on revenues.

believe the bfLEAP™ analytics platform is a potentially disruptive tool for analysis of pre-clinical and clinical data sets, such

as the robust pre-clinical and clinical trial data sets being generated in translational R&D and clinical trial settings.

data for bfLEAP™ can include raw data (preclinical and/or clinical readouts), categorical data, sociodemographic data of patients,

and various other inputs.

Thus, the bfLEAP™ platform is capable of capturing the particular genetic and physical characteristics

8 unchanged sentences

believe that the combination of (a) scalable analytics (i.e., large data or short/wide data), (b) state-of-the-art proprietary algorithms,

c) unsupervised machine learning, and d) streamlined data ingestion/visualization makes bfLEAP™ one of the most flexible and powerful

new platforms available on the market.

Company will continue to evolve and improve bfLEAP™, and some of the proceeds from this offering may be used toward that effort

either in-house or with development partners like The Johns Hopkins University Applied Physics Lab.

(c) unsupervised machine learning, and (d) streamlined data ingestion and visualization makes bfLEAP™ one of the most flexible

and powerful new platforms available on the market.

Company will continue to evolve and improve bfLEAP™.

Data Networks™

Company’s Bullfrog Data Networks™ solution incorporates publicly available, proprietary, and custom data sources to generate

novel insights toward target identification and validation, understanding mechanism of action, clinical trial optimization, drug repurposing,

Bullfrog Data Networks™ can be created for any therapeutic area, and we use this technology in our own research and development

pipeline including in oncology and central nervous system indications.

Our approach finds patient subgroups with similar molecular signatures

and identifies the most relevant genes driving disease biology.

Data networks created from this process generate insights that allow

researchers to accelerate drug discovery and development and increase the odds of technical and regulatory success.

In February 2025,

we entered into a collaboration agreement with Eleison Pharmaceuticals Inc.

(“Eleison”), a Phase III oncology company focused

on novel chemotherapeutic treatments for rare cancers, where we will apply our proprietary Bullfrog Data Networks™ solution, powered

by the bfLEAP® platform, and we plan to offer this solution to other biotechnology and pharmaceutical companies going forward.

Institute for Brain Development

1 unchanged sentence

the Lieber Institute for Brain Development (“LIBD”).

The Partnership Agreement covers the right of BullFrog AI to leverage its bfLEAP™

platform to mine LIBD’s comprehensive brain data, including transcriptomic, genomic, DNA methylation, cell-line, clinical, and

imaging data to identify previously unrecognized relationships.

The goal of the partnership is to identify previously unrecognized relationships

between genes and pathways in the brain and the development of neurologic and psychiatric disorders, thereby facilitating the development

of more effective treatments for diseases of the human brain.

The collaboration will proceed in two stages, with the first involving

unsupervised construction of graphical models to reveal relationships between brain diseases and genomic/biologic attributes, with the

goal of identifying new biomarkers and drug targets across disorders.

The second stage will involve creating disease-specific models

that will enable identification of genes and pathways within these respective disorders.

The Partnership Agreement has a one-year term

of data exclusivity to complete the first stages of analyses, with a two-year extension option as performance milestones are met.,

The Partnership Agreement covers the right of the Company to leverage

its bfLEAP™ platform to mine LIBD’s comprehensive brain data, including transcriptomic, genomic, DNA methylation, cell-line,

clinical, and imaging data to identify previously unrecognized relationships.

The goal of the partnership is to identify previously unrecognized

relationships between genes and pathways in the brain and the development of neurologic and psychiatric disorders, thereby facilitating

the development of more effective treatments for diseases of the human brain.

The collaboration will proceed in two stages, with the

first involving unsupervised construction of graphical models to reveal relationships between brain diseases and genomic/biologic attributes,

with the goal of identifying new biomarkers and drug targets across disorders.

The second stage will involve creating disease-specific

models that will enable identification of genes and pathways within these respective disorders.

The Partnership Agreement had a one-year

term of data exclusivity to complete the first stages of analyses, with a two-year extension option as performance milestones are met.

contemplated in the Partnership Agreement, on October 16, 2023, the Company and LIBD entered into a commercial agreement (the “Commercial

2 unchanged sentences

receives net sales or income from the licensing of “Licensed Products” (as defined in the Commercial Agreement) in the application

of machine learning and/or artificial intelligence for research and development in drug development, and specifically includes therapeutic

of machine learning and artificial intelligence for research and development in drug development, and specifically includes therapeutic

products, patient selection strategies, and target identification, but excludes diagnostics and incidental uses of machine learning and/or

14 unchanged sentences

from sublicensing LIBD Data.

The Company shall pay LIBD a royalty based on net sales of all Licensed Products sold by the Company and/or

The Company shall pay LIBD a royalty based on net sales of all Licensed Products sold by the Company and

its affiliates.

3 unchanged sentences

for CATIE Schizophrenia Case Study

Company worked with the Lieber Institute for Brain Development to analyze data from the landmark CATIE trials.

The CATIE trials were

the largest trials ever conducted for anti-psychotic medications.

BullFrog analyzed CATIE data from ~200 schizophrenia patients, with

a library of almost 1 million genetic data points for each patient, more than 200 non-genetic attributes per patient, and 4 different

medications used in the trial.

For each of the four medications used, bfLEAP™ analysis revealed new, previously unknown relationships

between individual genetic variants and negative patient symptoms.

The genetic loci identified represent potential druggable targets,

as well as potential stratifying criteria for future clinical trials in schizophrenia.

part of the Partnership Agreement, the Company worked with LIBD to analyze data from the landmark Clinical Antipsychotic Trials of Intervention

Effectiveness (“CATIE”) trials.

The CATIE trials were the largest trials ever conducted for anti-psychotic medications.

Company analyzed CATIE data from ~200 schizophrenia patients, with a library of almost 1 million genetic data points for each patient,

more than 200 non-genetic attributes per patient, and 4 different medications used in the trial.

For each of the four medications used,

bfLEAP™ analysis revealed new, previously unknown relationships between individual genetic variants and negative patient symptoms.

The genetic loci identified represent potential druggable targets, as well as potential stratifying criteria for future clinical trials

in schizophrenia.

performed another analysis on the data using our new advanced clustering algorithms bfLEAP 2.0 but focused on one particular drug named

25 unchanged sentences

has executed a joint development deal for a biologics discovery phase opportunity that is directed toward targeted cancer therapeutics.

The Company has also obtained exclusive worldwide rights to a Phase 2 ready glioblastoma drug and a discovery phase hepatocellular carcinoma

The Company has also obtained exclusive worldwide rights to a Phase II ready glioblastoma drug and a discovery phase hepatocellular carcinoma

drug from universities.

2 unchanged sentences

The success of

our partnered clinical development programs will require adequate availability of raw materials and/or drug product for our R&D and

our partnered clinical development programs will require adequate availability of raw materials and drug product for our R&D and

clinical trials, and, in some cases, may also require establishment of third-party arrangements to obtain finished drug product that

4 unchanged sentences

Market Opportunity

aim of our business is to “rescue” drugs that have failed in phase 3 clinical trials by using our technology to analyze all

available data with the goal of designing a precision medicine clinical trial that will have a better chance of being successful.

graphic below illustrates the estimated market opportunity for these failed drugs.

The top arrow shows the number of failed phase 3 trials

for several disease categories over a 5-year period.

The arrows below provide our assumptions for narrowing or discounting certain parameters

associated with the market size calculation.

The final arrow shows the math behind the $47.1B.

To date, we have not penetrated the failed

drug market, however;

aim of our business is to “rescue” drugs that have failed in Phase III clinical trials by using our technology to analyze

all available data with the goal of designing a precision medicine clinical trial that will have a better chance of being successful.

The graphic below illustrates the estimated market opportunity for these failed drugs.

The top arrow shows the number of failed Phase

III trials for several disease categories over a 5-year period.

The arrows below provide our assumptions for narrowing or discounting

certain parameters associated with the market size calculation.

The final arrow shows the math behind the $47.1 billion market opportunity.

To date, we have not penetrated the failed drug market, however;

we are actively searching for failed drug opportunities.

10 unchanged sentences

asset to a company that will commercialize the drug.

The Company may receive future royalties in come transactions.

The Company may receive future royalties in some transactions.

following graphic illustrates the global revenue forecast for applying AI in the pharmaceutical industry, as well as the increase in

2 unchanged sentences

Polymorph For Treatment And Prevention Of Tumors

United States

PCT/US2016/016968

United States

Czech Republic

60 2016 067 384.3

United Kingdom

Prodrugs with Enhanced Solubility and Oral Bioavailability

United States

PCT/US2019/017291

United States

of SPTBN1 to treat Obesity/NASH and Obesity/NASH-driven cancer

1 unchanged sentence

Hopkins University Applied Physics Lab Licensed Intellectual Property:

and Method for Distributed Graph Processing

Apparatus and Method for

Distributed Graph Processing

Patent 10,146,801

Johns Hopkins University

and Apparatus for Analysis and Classification of High Dimensional Data Sets

The Johns Hopkins University

Method and Apparatus for

Analysis and Classification of High Dimensional Data Sets

Patent 10,936,965

Johns Hopkins University

Low Entropy Mixture Model

The Johns Hopkins University

Generalized Low Entropy

Mixture Model

Patent 10,839,256

Johns Hopkins University

The Johns Hopkins University

hold the following licenses related to our intellectual property:

of Rights Granted

Hopkins University Applied Physics Lab

exclusive rights for therapeutics development and analytical services

Washington University

exclusive rights for therapeutics development

Hopkins University

exclusive rights for therapeutics development

Johns Hopkins University Applied Physics Lab

Bullfrog AI, Inc.

Worldwide, exclusive rights for therapeutics development

and analytical services

George Washington University

Bullfrog AI Holdings

Worldwide, exclusive rights for therapeutics development

Johns Hopkins University

Bullfrog AI Holdings

Worldwide, exclusive rights for therapeutics development

Technology License

February 7, 2018, the Company entered into an exclusive, world-wide, royalty-bearing license from JHU-APL for the technology.

covers three (3) issued patents, one (1) new provisional patent application, non-patent rights to proprietary libraries of algorithms

and other trade secrets, the license also includes modifications and improvements.

In October of 2021, the Company executed an amendment

to the original license which represents improvements and new advanced analytics capabilities.

In consideration of the rights granted

to the Company under the License Agreement JHU received a warrant equal to five percent (5%) of the then fully diluted equity base of

the Company, which shall be diluted following the closing of the IPO.

Under the terms of the License Agreement, JHU will be entitled

to eight percent (8%) royalty on net sales for the services provided by the Company in which the JHU licensed technology was utilized,

as well as fifty percent (50%) of all sublicense revenues received by the Company.

In addition, the Company is required to pay JHU an

annual maintenance fee of $1,500.

Minimum annual royalty payments are $20,000 for 2022, $80,000 for 2023, and $300,000 for 2024 and beyond,

if cumulative annual royalty payments do not reach these levels, the amount due to JHU to reach the annual minimum is due by January

31st of the following year.

Failure to make annual royalty payments is considered a material breach under the agreement and upon notice

from JHU of a material breach, the Company shall have 60 days to cure the material breach.

February 7, 2018, the Company entered into an exclusive, world-wide, royalty-bearing license with JHU-APL (the “2018 License Agreement”).

The license covers three (3) issued patents, one (1) new provisional patent application, non-patent rights to proprietary libraries of

algorithms and other trade secrets, as well as modifications and improvements.

In October 2021, the Company executed an amendment to

the original license for improvements and new advanced analytics capabilities.

In consideration of the rights granted to the Company

under the 2018 License Agreement, JHU-APL received a warrant equal to five percent (5%) of the then fully diluted equity base of the

Company, which was diluted following the closing of our initial public offering.

Under the terms of the 2018 License Agreement, JHU-APL

will be entitled to an eight percent (8%) royalty on net sales for the services provided by the Company as well as fifty percent (50%)

of all sublicense revenues received by the Company on services and sublicenses in which the JHU-APL licensed technology was utilized.

In addition, the Company is required to pay JHU-APL an annual maintenance fee of $1,500.

Minimum annual royalty payments are $20,000

for 2022, $80,000 for 2023, and $300,000 per year for 2024 and beyond.

If cumulative annual royalty payments do not reach these levels,

the amount due to JHU-APL to reach the annual minimum is due by January 1st of the following year.

Failure to make annual royalty payments

is considered a material breach under the agreement and, upon notice from JHU-APL of a material breach, the Company will have 60 days

to cure the material breach.

July 8, 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from JHU-APL for the additional technology developed

to enhance the bfLEAP™ platform.

The new license provides additional intellectual property rights including patents, copyrights,

and knowhow to be utilized under the Company’s bfLEAP™ analytical AI/ML platform.

This license supersedes the previous license.

In consideration of the new license, the Company issued 39,879 shares of common stock.

Under the terms of the new License Agreement,

JHU will be entitled to eight percent (8%) of net sales for the services provided by the Company to other parties and three percent (3%)

for internally development drug projects in which the JHU license was utilized.

The new license also contains tiered sub licensing fees

that start at 50% and reduce to 25% based on revenues.

In addition, the Company is required to pay JHU an annual maintenance fee of $1,500.

Minimum annual payments are set to be $30,000 for 2022, $80,000 for 2023, and $300,000 for 2024 and beyond, all of which are creditable

by royalties.

The financial terms of the new license agreement replace the original terms and are not duplicative.

to enhance the bfLEAP™ platform (the “2022 License Agreement”).

The new license provides additional intellectual property

rights including patents, copyrights, and knowhow to be utilized under the Company’s bfLEAP™ analytical AI/ML platform.

2022 License Agreement supersedes the previous 2018 License Agreement.

In consideration of the new license, the Company issued 39,879

shares of common stock to JHU-APL.

Under the terms of the 2022 License Agreement, JHU-APL will be entitled to eight percent (8%) of net

sales for the services provided by the Company to other parties and three percent (3%) for internally developed drug projects in which

the JHU-APL license is utilized.

The new license also contains tiered sub licensing fees that start at 50% and reduce to 25% based on

In addition, under the new license agreement, the minimum annual royalty payments are $30,000 for 2022, $80,000 for 2023, and

$300,000 per year for 2024 and beyond, all of which are creditable by royalties.

The financial terms of the new license agreement replace

the original terms from the 2018 License Agreement and are not duplicative.

May 31, 2023, the Company and JHU-APL entered into Amendment Number 1 of the July 8, 2022 License Agreement whereby the Company gained

access to certain improvements including additional patents and knowhow in exchange for a series of payments totaling $275,000.

of these payments for $75,000 was due in July 2023 followed by payments of $75,000, $75,000, and $50,000 in years 2025, 2026 and 2027,

respectively.

The amendment also reduced the 2023 minimum annual royalty payment to $60,000, all other financial terms remain the same.

As of December 31, 2023, we have accrued $60,000 of the 2023 minimum annual royalty payments.

of these payments for $75,000 was paid in July 2023 and the remaining payments of $75,000, $75,000, and $50,000 are due in years 2025,

2026 and 2027, respectively.

The amendment also reduced the 2023 minimum annual royalty payment to $60,000, all other financial terms

remain the same.

As of December 31, 2024, we have accrued $300,000 of the 2024 minimum annual royalty payments, and the entire accrued

balance was paid in January 2025.

Washington University - Beta2-spectrin siRNA License

1 unchanged sentence

Beta2-spectrin in the treatment of human diseases, including HCC.

The license covers methods claimed in three US and worldwide patent

The license covers methods claimed in three U.S.

and worldwide patent

applications, and also includes use of this approach for treatment of obesity, non-alcoholic fatty liver disease, and non-alcoholic steatohepatitis.

3 unchanged sentences

however, the plan is to conduct this work over the next 24 months.

All R&D to date on this candidate has been

conducted by the licensor of the technology, George Washington University.

The term of the agreement began on January 14, 2022 and ends

on the expiration date of the last patent to expire or 10 years after the first sale of a licensed product if no patents have been issued.

The license can be terminated by the licensee upon 60 days’ written notice, or by the licensor if the Company is more than 30 days

late in paying amounts owed to the licensor and does not make payment upon demand, or in the event of any material breach of the license

that is not cured within 45 days.

All R&D on this candidate to date has been

conducted by the licensor of the technology, GWU.

The term of the agreement began on January 14, 2022 and ends on the expiration date

of the last patent to expire or 10 years after the first sale of a licensed product if no patents have been issued.

The license can be

terminated by the licensee upon 60 days’ written notice, or by the licensor if the Company is more than 30 days late in paying

amounts owed to the licensor and does not make payment upon demand, or in the event of any material breach of the license that is not

cured within 45 days.

Non-alcoholic

fatty liver disease (“NAFLD”) is a condition in which excess lipids, or fat, build up in the liver.

This condition, which is more common

in people who have obesity and related metabolic diseases including type 2 diabetes, affects as many as 24% of adults in the US and is

associated with risk of progression to more serious conditions, including non-alcoholic steatohepatitis (NASH), with associated liver

inflammation and fibrosis, and hepatocellular carcinoma (HCC).

Evidence in animal models of obesity suggest that a protein called β2-spectrin

may play a key role in lipid accumulation, tissue fibrosis, and liver damage, and targeting expression or activity of this protein may

be a useful approach in treating NASH and liver cancer (Rao et al., 2021).

This condition, which

is more common in people who have obesity and related metabolic diseases including type 2 diabetes, affects as many as 24% of adults

in the United States and is associated with risk of progression to more serious conditions, including non-alcoholic steatohepatitis (“NASH”),

with associated liver inflammation and fibrosis, and hepatocellular carcinoma (“HCC”).

Evidence in animal models of obesity

suggest that a protein called β2-spectrin may play a key role in lipid accumulation, tissue fibrosis, and liver damage, and targeting

expression or activity of this protein may be a useful approach in treating NASH and liver cancer (Rao et al., 2021).

consideration of the rights granted to the Company under the license agreement, GWU received a $20,000 license initiation fee.

the terms of the License Agreement, GWU will be entitled to a three percent (3%) royalty on net sales subject to quarterly minimums

once the first sale has occurred subsequent to regulatory approval, as well sublicense or assignment fees in the event the Company

sublicenses or assigns their rights to use the technology.

The Company will also reimburse GWU for previously incurred and ongoing

patent costs.

The Sublicense and Assignment fee amounts decline as the Company advances the clinical development of the licensed

The license agreement also contains milestone payments for clinical development through the approval of a New Drug Application (NDA) and

commercialization.

payments made to GWU to date include the $20,000 License Initiation Fee and an additional $6,550 to reimburse the licensor for past

patent costs.

Aggregate future milestone costs could reach $860,000 if the drug successfully completes clinical trials and is the

subject of an NDA to the U.S.

Future milestones on sales revenue are limited to $1 million on the first $20 million in net

the terms of the license agreement, GWU will be entitled to a three percent (3%) royalty on net sales subject to quarterly minimums once

the first sale has occurred subsequent to regulatory approval, as well sublicense or assignment fees in the event the Company sublicenses

or assigns their rights to use the technology.

The Company will also reimburse GWU for previously incurred and ongoing patent costs.

The sublicense and assignment fee amounts decline as the Company advances the clinical development of the licensed technology.

agreement also contains milestone payments for clinical development through the approval of a New Drug Application (“NDA”) and commercialization.

future milestone costs could reach $860,000 if the drug successfully completes clinical trials and is the subject of an NDA to the U.S.

Future milestones on sales revenue are limited to $1 million on the first $20 million in net sales.

of December 31, 2024 and 2023, there has been no accrual for royalties since we have not begun to generate applicable revenue.

3 unchanged sentences

Hopkins University – Mebendazole License

February 22, 2022, the Company entered into an exclusive, worldwide, royalty-bearing license from JHU for the use of an improved formulation

February 22, 2022, the Company entered into an exclusive, worldwide, royalty-bearing license with JHU for the use of an improved formulation

of Mebendazole for the treatment of any human cancer or neoplastic disease.

This formulation shows potent activity in animal models of

This formulation shows potent activity in animal models with

different types of cancer, and has been evaluated in a Phase I clinical trial in patients with high-grade glioma (NCT01729260).

10 unchanged sentences

written notice, or by the licensor in the event of any material breach of the license that is not cured within 30 days.

consideration of the rights granted to the Company under the license agreement, JHU will receive a staggered Upfront License Fee of

$250,000, with the first $50,000 payment due within 30 days of the effective date.

The Company will also reimburse JHU for

previously incurred and ongoing patent costs.

Under the terms of the license agreement, JHU will be entitled to three- and one-half

percent (3.5%) royalty on net sales by the Company.

In addition, the Company is required to pay JHU minimum annual royalty payments

of $5,000 for 2023, $10,000 for 2024, $20,000 for 2025, $30,000 for 2026 and $50,000 for 2027 and each year after until the first

commercial sale after which the annual minimum royalty shall be $250,000.

The license agreement also contains milestone payments for

clinical development steps through the approval of an NDA and commercialization.

Aggregate payments made to date include the initial

$50,000 upfront fee and an additional $79,232 to reimburse the licensor for past patent costs.

Aggregate future milestone costs

could reach $1,500,000 if the drug successfully completes Phase II and III clinical trials and is approved for sale and marketing by

Future milestones on sales revenue are $1 million on the first $20 million in sales revenue, $2 million in the

first-year cumulative sales revenue exceeds $100 million, $10 million in the first-year cumulative sales revenue exceeds $500

million, and $20 million in the first-year cumulative sales revenue exceeds $1 billion.

As of December 31, 2023 and 2022, the

balance of accrued expense related to this license agreement was $10,000 and $242,671, respectively.

The Company assessed whether

the license should be capitalized and determined that the licensed program is in the early stage and therefore may not be

the Company expensed the license fee and will expense development costs until commercial viability is

In consideration

of the rights granted to the Company under the license agreement, JHU received a staggered upfront license fee of $250,000, with the

first $50,000 paid in 2022 and the remaining balance of $200,000 paid in 2023.

The Company also reimbursed JHU for previously incurred

and ongoing patent costs.

Under the terms of the license agreement, JHU will be entitled to three- and one-half percent (3.5%) royalty

on net sales by the Company in which the JHU license was utilized.

In addition, the Company is required to pay JHU minimum annual royalty

payments of $5,000 for 2022, $10,000 for 2023, $20,000 for 2024, $30,000 for 2025 and $50,000 for 2026 and each year after until the

first commercial sale, after which the annual minimum royalty shall be $250,000.

The license agreement also contains milestone payments

for clinical development steps through the approval of an NDA and commercialization.

Aggregate future milestone costs could reach $1,500,000

if the drug successfully completes Phase II and III clinical trials and is approved for sale and marketing by the United States FDA.

Future milestones on sales revenue are $1 million on the first $20 million in sales revenue, $2 million in the first-year cumulative

sales revenue exceeds $100 million, $10 million in the first-year cumulative sales revenue exceeds $500 million, and $20 million in the

first-year cumulative sales revenue exceeds $1 billion.

As of December 31, 2024 and 2023, the balance of accrued expense related to this

license agreement was $20,000 and $10,000, respectively.

The Company assessed whether the license should be capitalized and determined

that the licensed program is in the early stage and therefore may not be recoverable;

the Company expensed the license fee and will expense

development costs until commercial viability is likely.

Hopkins University – Mebendazole Prodrug License

October 13, 2022, the Company entered into an exclusive, worldwide, royalty-bearing license from JHU and the Institute of Organic

Chemistry and Biochemistry (IOCB) of the Czech Academy of Sciences for rights to commercialize N-substituted prodrugs of mebendazole

October 13, 2022, the Company entered into an exclusive, worldwide, royalty-bearing license with JHU and the Institute of Organic Chemistry

and Biochemistry (“IOCB”) of the Czech Academy of Sciences for rights to commercialize N-substituted prodrugs of mebendazole

that demonstrate improved solubility and bioavailability.

The license covers prodrug compositions and use for treating disease as

claimed in multiple US and worldwide patent applications.

The term of the agreement began on October 13, 2022 and continues until

the date of expiration of the last to expire patent, or for 20 years from the effective date of the agreement if no patents are

The license can be terminated by the Company upon 90 days’ written notice, or by the licensor in the event of any

material breach of the license that is not cured by the Company within 30 days.

consideration for the rights granted to the Company under the License Agreement JHU and IOCB will receive a staggered upfront

license fee of $100,000.

The Company will also reimburse JHU and IOCB for previously incurred patent costs totaling $33,265 and will

be responsible for reimbursing licensors for future patent costs.

Under the terms of the License Agreement, the licensors will be

entitled to a four percent (4%) royalty on net sales subject to annual minimums upon first commercial sale of a licensed product, as

well sublicense or assignment fees in the event the Company sublicenses or assigns their rights to use the technology.

Sublicense fee amount declines as the Company advances the clinical development of licensed technology.

The Company is required to

pay minimum annual royalties (MAR) beginning in year 4 of the agreement.

The MAR for year 4 will be $5,000, increasing to $10,000 in

year 5, $20,000 in year 6, $30,000 in year 7, and $50,000 in year 8 and subsequent years.

The Company will be responsible for

milestone payments for patent issuance of up to $50,000 and clinical development milestones up to and including approval of an NDA

The license covers prodrug compositions and use for treating disease as claimed

in multiple U.S.

and worldwide patent applications.

The term of the agreement began on October 13, 2022 and continues until the date

of expiration of the last to expire patent, or for 20 years from the effective date of the agreement if no patents are issued.

can be terminated by the Company upon 90 days’ written notice, or by the licensor in the event of any material breach of the license

that is not cured by the Company within 30 days.

consideration for the rights granted to the Company under the license agreement, JHU and IOCB will receive a staggered upfront license

fee of $100,000.

The Company also reimbursed JHU and IOCB for previously incurred patent costs totaling $33,265 and will be responsible

for reimbursing licensors for future patent costs.

Under the terms of the license agreement, the licensors will be entitled to a four

percent (4%) royalty on net sales subject to annual minimums upon first commercial sale of a licensed product, as well as sublicense

or assignment fees in the event the Company sublicenses or assigns their rights to use the technology.

The sublicense fee amount declines

as the Company advances the clinical development of licensed technology.

The Company is required to pay minimum annual royalties beginning

in year 4 of the agreement.

The minimum annual royalty for year 4 will be $5,000 (2026), increasing to $10,000 in year 5 (2027), $20,000

in year 6 (2028), $30,000 in year 7 (2029), and $50,000 in year 8 and subsequent years (2030 and beyond).

The Company will be responsible

for milestone payments for patent issuance of up to $50,000 and clinical development milestones up to and including approval of an NDA

totaling up to $2.3 million.

The Company will be required to pay a commercial milestone of $1 million once sales reach $20 million

in the US, $2 million when sales in the US reach $100 million, $10 million when US sales reach $500 million, and $20 million when US

sales exceed $1 billion.

of December 31, 2023 and 2022, the balance of accrued expense related to this license agreement was $0 and $133,238, respectively.

Company assessed whether the license should be capitalized and determined that the licensed program is in the early stage and therefore

may not be recoverable;

The Company will be required to pay a commercial milestone of $1 million once sales reach $20 million in

the United States, $2 million when sales in the United States reach $100 million, $10 million when United States sales reach $500 million,

and $20 million when United States sales exceed $1 billion.

of December 31, 2024 and 2023, the balance of accrued expense related to this license agreement was $0.

The Company assessed whether

the license should be capitalized and determined that the licensed program is in the early stage and therefore may not be recoverable;

the Company expensed the license fee and will expense development costs until commercial viability is likely.

45 unchanged sentences

planning clinical trials, they will compete with the drugs discussed below and will likely compete with other drugs currently in development.

analytics industry and application of AI in healthcare is growing rapidly.

analytics industry and application of AI/ML in healthcare is growing rapidly.

Competition exists along the entire continuum of the drug

4 unchanged sentences

is adept at processing and analyzing incomplete data and making predictions that we do not believe other technologies are capable of

Finally, bfLEAP has the ability to extract the most important features for analysis out of extremely large complex data sets using

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.

2 unchanged sentences

The ability to make predictions, find relationships and patterns and

anomalies in extremely large complex data sets has been demonstrated by the Applied Physics Lab in other applications and sectors.

the algorithms used by bfLEAP are proprietary and protected, having been developed at Johns Hopkins University Applied Physics Lab.

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.

FDA does not currently require approval of AI technologies used to aid in therapeutics, but that could change in the future.

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.

FDA does not currently require approval of AI/ML technologies used to aid in therapeutics, but that could change in the future.

will regulate any clinical trials conducted by the Company.

26 unchanged sentences

requirements may subject a company to a variety

of administrative or judicial sanctions, such as FDA refusal to approve pending new drug applications (NDAs), warning or untitled letters,

product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil penalties and

criminal prosecution.

of administrative or judicial sanctions, such as FDA refusal to approve pending new drug applications (“NDAs”), warning or

untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, injunctions, fines, civil

penalties and criminal prosecution.

Pharmaceutical

1 unchanged sentence

typically involves preclinical laboratory

and animal tests, the submission to FDA of an investigational new drug application (IND) which must become effective before clinical

testing may commence, and adequate and well-controlled clinical trials to establish the safety and effectiveness of the drug for each

indication for which FDA approval is sought.

Satisfaction of FDA pre-market approval requirements typically takes many years and the

actual time required may vary substantially based upon the type, complexity and novelty of the product or disease.

and animal tests, the submission to the FDA of an investigational new drug application (“IND”) which must become effective

before clinical testing may commence, and adequate and well-controlled clinical trials to establish the safety and effectiveness of the

drug for each indication for which FDA approval is sought.

Satisfaction of FDA pre-market approval requirements typically takes many

years and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease.

tests include laboratory evaluation of product chemistry, formulation and toxicity, as well as animal trials to assess the characteristics

2 unchanged sentences

including good laboratory practices.

The results of preclinical testing are submitted to FDA as part of an IND along with other information,

The results of preclinical testing are submitted to the FDA as part of an IND along with other information,

including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol.

3 unchanged sentences

after the submission of each IND is required prior to the commencement of clinical testing in humans.

If FDA has neither commented on

nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin.

If the FDA has neither commented

on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin.

Clinical trials involve the administration

8 unchanged sentences

Each protocol involving testing on U.S.

patients and subsequent protocol amendments must be submitted to FDA

as part of the IND.

patients and subsequent protocol amendments must be submitted to the

FDA as part of the IND.

trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap.

1, the initial introduction of the drug into healthy human subjects or patients, the drug is tested to assess metabolism, pharmacokinetics,

I, the initial introduction of the drug into healthy human subjects or patients, the drug is tested to assess metabolism, pharmacokinetics,

pharmacological actions, side effects associated with increasing doses, and, if possible, early evidence of effectiveness.

Phase 2 usually

Phase II usually

involves trials in a limited patient population to determine the effectiveness of the drug for a particular indication, dosage tolerance

1 unchanged sentence

If a drug demonstrates evidence of effectiveness and an

acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain the additional information about clinical efficacy

and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit FDA to evaluate the

overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug.

In most cases, FDA requires

two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the drug.

A single Phase 3 trial with other confirmatory

evidence may be sufficient in rare instances, such as where the study is a large multicenter trial demonstrating internal consistency

and a statistically very persuasive finding of a clinically meaningful effect on mortality, irreversible morbidity, or prevention of

a disease with a potentially serious outcome and confirmation of the result in a second trial would be practically or ethically impossible.

completion of the required clinical testing, an NDA is prepared and submitted to FDA.

FDA approval of the NDA is required before marketing

of the product may begin in the U.S.

The NDA must include the results of all preclinical, clinical and other testing and a compilation

of data relating to the product’s pharmacology, chemistry, manufacture and controls.

The cost of preparing and submitting an NDA

is substantial.

The submission of most NDAs is additionally subject to a substantial application user fee, and the applicant under an

approved NDA is also subject to an annual program fee for each prescription product.

acceptable safety profile in Phase II evaluations, Phase III trials are undertaken to obtain the additional information about clinical

efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to

evaluate the overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug.

cases, the FDA requires two adequate and well-controlled Phase III clinical trials to demonstrate the efficacy of the drug.

Phase III trial with other confirmatory evidence may be sufficient in rare instances, such as where the study is a large multicenter

trial demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on mortality,

irreversible morbidity, or prevention of a disease with a potentially serious outcome and confirmation of the result in a second trial

would be practically or ethically impossible.

completion of the required clinical testing, an NDA is prepared and submitted to the FDA.

FDA approval of the NDA is required before

marketing of the product may begin in the U.S.

The NDA must include the results of all preclinical, clinical and other testing and a

compilation of data relating to the product’s pharmacology, chemistry, manufacture and controls.

The cost of preparing and submitting

an NDA is substantial.

The submission of most NDAs is additionally subject to a substantial application user fee, and the applicant under

an approved NDA is also subject to an annual program fee for each prescription product.

These fees are typically increased annually.

of applications for drugs granted Orphan Drug Designation are exempt from these user fees.

may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to an outside

advisory committee – typically a panel that includes clinicians and other experts – for review, evaluation, and a recommendation

as to whether the application should be approved.

FDA is not bound by the recommendation of an advisory committee, but it generally follows

such recommendations.

approving an NDA, FDA will typically inspect one or more clinical sites to assure compliance with GCP.

Additionally, FDA will inspect

the facility or the facilities at which the drug is manufactured.

FDA will not approve the product unless compliance with current good

manufacturing practices (cGMPs) is satisfactory and the NDA contains data that provide substantial evidence that the drug is safe and

effective in the indication studied.

Sponsors of applications for drugs granted Orphan Drug Designation are exempt from these user fees.

FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to

an outside advisory committee – typically a panel that includes clinicians and other experts – for review, evaluation, and

a recommendation as to whether the application should be approved.

The FDA is not bound by the recommendation of an advisory committee,

but it generally follows such recommendations.

approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP.

Additionally, the FDA will

inspect the facility or the facilities at which the drug is manufactured.

The FDA will not approve the product unless compliance with

current good manufacturing practices (cGMPs) is satisfactory and the NDA contains data that provide substantial evidence that the drug

is safe and effective in the indication studied.

Track Designation

is required to facilitate the development, and expedite the review, of drugs that are intended for the treatment of a serious or life-threatening

disease or condition for which there is no effective treatment and which demonstrate the potential to address unmet medical needs for

the condition.

Under the Fast Track program, the sponsor of a new drug candidate may request that FDA designate the drug candidate for

a specific indication as a Fast Track drug concurrent with, or after, the filing of the IND for the drug candidate.

FDA must determine

if the drug candidate qualifies for Fast Track Designation within 60 days of receipt of the sponsor’s request.

a submission is granted Fast Track Designation, the sponsor may engage in more frequent interactions with FDA, and FDA may review sections

of the NDA before the application is complete.

This rolling review is available if the applicant provides, and FDA approves, a schedule

for the submission of the remaining information and the applicant pays applicable user fees.

However, FDA’s time period goal for

reviewing an application does not begin until the last section of the NDA is submitted.

While we may seek Fast Track Designation, there

is no guarantee that we will be successful in obtaining any such designation.

Even if we do obtain such designation, we may not experience

a faster development process, review or approval compared to conventional FDA procedures.

A Fast Track Designation does not ensure that

the product candidate will receive marketing approval or that approval will be granted within any particular timeframe.

Additionally,

Fast Track Designation may be withdrawn by FDA if FDA believes that the designation is no longer supported by data emerging in the clinical

trial process.

FDA is required to facilitate the development, and expedite the review, of drugs that are intended for the treatment of a serious or

life-threatening disease or condition for which there is no effective treatment and which demonstrate the potential to address unmet

medical needs for the condition.

Under the Fast Track program, the sponsor of a new drug candidate may request that the FDA designate

the drug candidate for a specific indication as a Fast Track drug concurrent with, or after, the filing of the IND for the drug candidate.

FDA must determine if the drug candidate qualifies for Fast Track Designation within 60 days of receipt of the sponsor’s request.

a submission is granted Fast Track Designation, the sponsor may engage in more frequent interactions with the FDA, and the FDA may review

sections of the NDA before the application is complete.

This rolling review is available if the applicant provides, and the FDA approves,

a schedule for the submission of the remaining information and the applicant pays applicable user fees.

However, the FDA’s time

period goal for reviewing an application does not begin until the last section of the NDA is submitted.

While we may seek Fast Track

Designation, there is no guarantee that we will be successful in obtaining any such designation.

Even if we do obtain such designation,

we may not experience a faster development process, review or approval compared to conventional FDA procedures.

A Fast Track Designation

does not ensure that the product candidate will receive marketing approval or that approval will be granted within any particular timeframe.

Additionally, Fast Track Designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data

emerging in the clinical trial process.

Post-Approval

an NDA is approved, a product will be subject to certain post-approval requirements.

For instance, FDA closely regulates the post-approval

For instance, the FDA closely regulates the post-approval

marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored

3 unchanged sentences

event reporting and submission of periodic reports are required following FDA approval of an NDA.

FDA also may require post-marketing

testing, known as Phase 4 testing, REMS and surveillance to monitor the effects of an approved product, or FDA may place conditions on

an approval that could restrict the distribution or use of the product.

In addition, quality control, drug manufacture, packaging and

labeling procedures must continue to conform to cGMPs after approval.

Drug manufacturers and certain of their subcontractors are required

to register their establishments with FDA and certain state agencies.

Registration with FDA subjects entities to periodic unannounced

inspections by FDA, during which the Agency inspects manufacturing facilities to assess compliance with cGMPs.

Accordingly, manufacturers

must continue to expend time, money, and effort in the areas of production and quality-control to maintain compliance with cGMPs.

authorities may withdraw product approvals or request product recalls if a company fails to comply with regulatory standards, if it encounters

problems following initial marketing, or if previously unrecognized problems are subsequently discovered.

The FDA also may require post-marketing

testing, known as Phase IV testing, REMS and surveillance to monitor the effects of an approved product, or the FDA may place conditions

on an approval that could restrict the distribution or use of the product.

In addition, quality control, drug manufacture, packaging

and labeling procedures must continue to conform to cGMPs after approval.

Drug manufacturers and certain of their subcontractors are

required to register their establishments with FDA and certain state agencies.

Registration with the FDA subjects entities to periodic

unannounced inspections by the FDA, during which the Agency inspects manufacturing facilities to assess compliance with cGMPs.

manufacturers must continue to expend time, money, and effort in the areas of production and quality-control to maintain compliance with

Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with regulatory

standards, if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently discovered.

seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent whose claims cover the applicant’s

3 unchanged sentences

be cited by potential generic competitors in support of approval of an abbreviated new drug application (“ANDA”).

An ANDA provides for

marketing of a drug product that has the same active ingredients in the same strengths and dosage form as the listed drug and has been

shown through bioequivalence testing to be therapeutically equivalent to the listed drug.

Other than the requirement for bioequivalence

testing, ANDA applicants are not required to conduct, or submit results of, preclinical or clinical tests to prove the safety or effectiveness

of their drug product.

Drugs approved in this way are commonly referred to as “generic equivalents” to the listed drug and

can often be substituted by pharmacists under prescriptions written for the original listed drug.

provides for marketing of a drug product that has the same active ingredients in the same strengths and dosage form as the listed drug

and has been shown through bioequivalence testing to be therapeutically equivalent to the listed drug.

Other than the requirement for

bioequivalence testing, ANDA applicants are not required to conduct, or submit results of, preclinical or clinical tests to prove the

safety or effectiveness of their drug product.

Drugs approved in this way are commonly referred to as “generic equivalents”

to the listed drug and can often be substituted by pharmacists under prescriptions written for the original listed drug.

ANDA applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDA’s Orange Book.

12 unchanged sentences

The filing of a patent infringement lawsuit within 45

days of the receipt of a such certification automatically prevents the FDA from approving the ANDA until the earlier of 30 months, expiration

days of the receipt of such a certification automatically prevents the FDA from approving the ANDA until the earlier of 30 months, expiration

of the patent, settlement of the lawsuit, or a decision in the infringement case that is favorable to the ANDA applicant.

NDA approval of a new chemical entity (NCE) that drug receives five years of marketing exclusivity during which FDA cannot receive any

ANDA seeking approval of a generic version of that drug.

NDA approval of a new chemical entity (“NCE”) that drug receives five years of marketing exclusivity during which the FDA cannot receive

any ANDA seeking approval of a generic version of that drug.

An ANDA may be submitted one year before NCE exclusivity expires if a Paragraph

5 unchanged sentences

(other than bioavailability studies) conducted or sponsored by the sponsor that were essential to approval of the application.

approve an ANDA for a generic drug that includes the change during the period of exclusivity.

cannot approve an ANDA for a generic drug that includes the change during the period of exclusivity.

Term Extension

3 unchanged sentences

(the time between NDA submission and approval up to a maximum of five years).

The time can be shortened if FDA determines that the applicant

did not pursue approval with due diligence.

The total patent term after the extension may not exceed 14 years, and only one patent can

The time can be shortened if the FDA determines that the

applicant did not pursue approval with due diligence.

The total patent term after the extension may not exceed 14 years, and only one

patent can be extended.

For patents that might expire during the application phase, the patent owner may request an interim patent extension.

interim patent extension increases the patent term by one year and may be renewed up to four times.

An interim patent extension increases the patent term by one year and may be renewed up to four times.

For each interim patent extension

52 unchanged sentences

Capital Resources

of February 10, 2023, the Company has 4 full-time employees and consultants, including its Chief Executive Officer Vininder Singh and

its Chief Financial Officer, Dane Saglio and 7 part-time employees, advisors, and consultants.

None of these employees are covered by

a collective bargaining agreement, and we believe our relationship with our employees is good.

We also engage consultants on an as-needed

basis to supplement existing staff.

the Company does not own any real property.

of December 31, 2024, the Company had 9 full-time employees, including its Chief Executive Officer, Vininder Singh, and 8 part-time employees,

advisors, and consultants, including its Chief Financial Officer, Josh Blacher.

None of these employees are covered by a collective bargaining

agreement, and we believe our relationship with our employees is good.

We also engage consultants on an as-needed basis to supplement

existing staff.

believe that our future success will depend, in part, on our continued ability to attract, hire and retain qualified personnel.

In particular,

we depend on the skills, experience and performance of our senior management and R&D personnel.

We compete for qualified personnel

with other healthcare technology, pharmaceutical, and healthcare companies, as well as universities and non-profit research institutions.

We provide competitive compensation and benefits programs to help meet the needs of our employees.

In addition to salaries, these programs

include incentive compensation plans, healthcare and insurance benefits, a retirement plan, paid time off, and family leave, among others.

We also use targeted equity-based grants with vesting conditions to facilitate retention of personnel, particularly for our key employees.

the Company does not own or lease any real property.

All of the Company’s employees work virtually.

9 unchanged sentences

intended to be used in connection with this annual report.

All of our operations are currently conducted through BullFrog AI Holdings,

All our operations are currently conducted through Bullfrog AI Holdings, Inc.

file annual, quarterly, and current reports, proxy statements and other information with the U.S.

7 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business