What changed in this filing

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Item 1. Business

2024-03-29 compared with 2023-04-25 · 460 added, 325 removed, 461 unchanged (63% of the section changed)

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was incorporated in the State of Nevada on February 6, 2020.

Our principal business address is 325 Ellington

Bullfrog AI Holdings, Inc.

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.

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

AI, Inc., a wholly owned subsidiary acquired through a share exchange, has the sole purpose of housing and protecting all of the

organization’s intellectual property.

BullFrog AI Management, LLC is a wholly owned

subsidiary that handles all HR and payroll activities.

of BullFrog AI

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.

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.

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.

acquired BullFrog AI, Inc.

pursuant to an exchange agreement

under which each share of Bull Frog 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.

was split into 25 shares of common

Share amounts in our financial statements for 2021 and 2020 have been adjusted to reflect this forward share split and shares

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.

Upon completion of the exchange, BullFrog AI,

became the Company’s wholly-owned subsidiary and the shareholders of BullFrog AI, Inc.

held 100% of the common stock of

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.

Upon completion of the exchange, 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.

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

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

This transaction is being

accounted for as a common control transaction and all entities are being presented as if the transactions took place at the

beginning of the earliest period presented.

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

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

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

This is the primary driver of the high cost of developing

new therapeutics.

A major part of the difficulty in developing new therapeutics is efficient integration of complex and highly dimensional

data generated at each stage of development to de-risk subsequent stages of the development process.

Artificial Intelligence and Machine

Learning (AI/ML) has emerged as a digital solution to help address this problem.

use artificial intelligence and machine learning to advance medicines for both internal and external projects.

We are committed to increasing

the probability of success and decreasing the time and cost involved in developing therapeutics.

Most current AI/ML platforms still fall

short in their ability to synthesize disparate, high-dimensional data for actionable insight.

Our platform technology, named, bfLEAP™,

is an analytical AI/ML platform derived from technology developed at The Johns Hopkins University Applied Physics Laboratory (JHU-APL),

which is able to surmount the challenges of scalability and flexibility currently hindering researchers and clinicians by providing a

more precise 1 , multi-dimensional understanding of their data.

We are deploying bfLEAP™ for use at several critical

stages of development for internal programs and through strategic partnerships and collaborations with the intention of streamlining

data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics,

and impacting the lives of countless patients that may otherwise not receive the therapies they need.

In an August 2021 publication in DeepAI.org (https://deepai.org/publication/random-subspace-mixture-models-for-interpretable-anomaly-detection),

the algorithms used in bfLEAP were compared to 10 of the most popular clustering algorithms in the world using 12 data sets.

result showed that the algorithms used in bfLEAP had the highest average score when measuring speed and accuracy of prediction.

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.

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

via our proprietary artificial intelligence platform bfLEAP.

We will execute our plan by doing all or any of the following:

with biopharmaceutical companies in a fee for service model to assist and enable them with their drug development programs, acquiring

rights to and rescuing drugs that have failed FDA review following pivotal Phase 2 or Phase 3 clinical trials (we refer to this rescue

process as “drug rescue”), acquiring rights to drugs that are in early stage clinical trials and have not failed FDA review, and

discovering new drugs and biologics.

process for enhancing and developing late-stage failed drugs is to:

the rights to the failed drug from a biopharmaceutical industry company or university,

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.

In supervised learning, the algorithm

“learns” from the training dataset by iteratively making predictions on the data and adjusting for the correct answer.

learning, also known as unsupervised machine learning, uses machine learning algorithms to analyze and cluster unlabeled datasets.

algorithms discover hidden patterns or data groupings without the need for human intervention.

Algorithms used in the bfLEAP™ platform

are designed to handle highly imbalanced data sets to successfully identify combinations of factors that are associated with outcomes

with our strategic partners and collaborators, our primary goal is to improve the odds of success at any stage of pre-clinical and clinical

therapeutics development.

Our primary business model is improving the success and efficiency of drug development which is accomplished

either through acquisition of drugs or partnerships and collaborations with companies that are developing drugs.

We hope to accomplish

this through strategic acquisitions of current clinical stage and failed drugs for in-house development, or through strategic partnerships

with biopharmaceutical industry companies.

We are able to pursue our drug asset enhancement business by leveraging a powerful and proven

AI/ML platform (trade name:

bfLEAP™) initially derived from technology developed at JHU-APL.

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

with JHU-APL to include additional advanced AI technology.

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 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.

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

of biologics or small molecules.

process for our drug asset enhancement program is to:

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 likely with a partner to validate the drug’s use for the defined “high-responder” population;

the rescued drug asset with new information back to the pharma industry, following positive results of the clinical trial.

also plan to deploy this strategy for all discovery and early stage clinical candidates.

The common objective is to monetize our assets

as quickly as possible with no current plan to commercialize any asset.

As part of our strategy, we will continue evolving our intellectual

property, analytical platform and technologies, build a large portfolio of drug candidates, and implement a model that reduces risk and

increases the frequency of cash flow from rescued drugs.

This strategy will include strategic partnerships, collaborations, and relationships

along the entire business value chain.

did not produce any revenues through 2021;

we generated our first revenues in late 2022 from our services related to the relationship

with a pharmaceutic company.

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.

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

of drug candidates, and implement a model that reduces risk and increases the frequency of cash flow from rescued drugs.

This strategy

will include strategic partnerships, collaborations, and relationships along the entire drug development value chain, as well as acquisitions

of the rights to developing failed drugs and possibly the underlying companies.

date, we have not conducted clinical trials on any pharmaceutical drugs and our platform has not been used to identify a drug candidate

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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 hepatoceullar

carcinoma (liver cancer), and other liver diseases.

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.

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

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.

fee for service partnership offering is designed for biopharmaceutical companies, as well as other organizations, of all sizes that have

challenges analyzing data throughout the drug development process.

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.

On September 28, 2022, BullFrog AI entered into a $185,000 service contract with Sapu Biosciences, LLC, a subsidiary of Oncotellic Therapeutics

The scope of the contract is focused on uncovering novel insights related to oncology clinical data for one of their candidate

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.

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

three sources:

fee for service partnership offering model is designed for biopharmaceutical companies, as well as other organizations, of all sizes

that have challenges analyzing data throughout the drug development process.

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.

Collaborative

will also seek to enter into collaborative arrangements with pharmaceutical companies who have drugs that have failed late Phase 2

or Phase 3 trials.

Our revenue from such collaborations will be based on achieving certain milestones as determined by each specific

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.

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.

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

of Rights to Certain Drugs

certain circumstances, we may also acquire rights to drugs that are in early stage clinical trials, use our technology to produce a successful

later stage precision medicine trial, and divest the asset.

The same process may apply to the discovery of new 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

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

or with a clinical partner, and finally sell the drug back to pharmaceutical companies.

We have and may continue acquiring the rights

to drugs that have not yet failed any trials.

We will use our technology to improve the chances for success, conduct a trial, and divest

When divesting assets, the transaction may involve a combination of upfront payments, milestone payments based on clinical

success, and royalties on sales of the product.

Product/Platform

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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).

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.

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This program is currently in the preclinical stage of development.

The Company has not yet initiated development activities or IND-enabling studies on this asset;

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

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 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).

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

The Company recently 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

glioma (NCT01729260).

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with this asset to enable evaluation of safety in humans.

are able to leverage our drug rescue business by leveraging a powerful and proven AI/ML platform (trade name:

bfLEAP™) initially

derived from technology developed at JHU-APL.

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.

The input data for bfLEAP™ can include raw

data (preclinical and/or clinical readouts), categorical data, sociodemographic data of patients, and various other inputs.

bfLEAP™ platform is capable of capturing the “human experience” of patients in an unbiased manner, and contextualizing

it against other disparate data sources from patients (e.g.

molecular data, physiological data, etc.) for less biased and more meaningful

conclusions (i.e.

more ethical AI/ML).

It is also uniquely scalable – the bfLEAP™ platform is able to perform analysis on

large, high-volume data sets (i.e.

‘big data’) and also able to analyze highly disparate “short and wide” data

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.

bfLEAP™ Analytics Platform

are able to pursue our drug rescue business by leveraging a powerful and proven AI/ML platform (trade name:

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.

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

of patients in an unbiased manner, and contextualizing it against other disparate data sources from patients (e.g.

molecular data, physiological

data, etc.) for less biased and more meaningful conclusions.

It is also uniquely scalable - the bfLEAP™ platform is able to perform

analysis on large, high-volume data sets (i.e.

‘big data’) and also able to analyze highly disparate “short and wide”

data as well.

In terms of visualization, bfLEAP™ is able to integrate with most commonly used visualization tools for graph analytics.

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

Platform Technology

will continue to evolve and improve bfLEAP™, either in-house or with development partners like JHU-APL.

platform is based on an exclusive, worldwide license granted by JHU.

plan to leverage our proprietary AI/ML platform developed over several years at one of the top innovation institutions in the world which

has already been successfully applied in multiple sectors.

In terms of underlying intellectual property, we have secured a worldwide

exclusive license from JHU-APL for the technology – this license covers 3 issued patents, as well as 1 new provisional patent application,

non-patent rights to proprietary libraries of algorithms and other trade secrets, and also includes modifications and improvements.

addition, we have a unique business model designed to reduce risk and increase the frequency of cash flow.

Company has recently licensed new technology from JHU-APL to evolve the bfLEAP platform to bfLEAP

This new and improved platform will enable more robust analysis of data with faster and higher precision prediction of the most

important variables for identifying patient response to a drug.

forward, the Company will continue to evolve the platform and either develop or acquire new capabilities and technologies.

These development

efforts may be in house or in collaboration with an existing or new technology partners.

The Company plans on hiring talent in data science

and software development to bolster its in house capabilities.

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.

Institute for Brain Development

September 8, 2023, the Company entered a data use and technology partnership agreement (the “Partnership Agreement”) with

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.,

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

Agreement”) that sets forth the key terms for commercialization of products and services developed under the Partnership Agreement.

Pursuant to the Commercial Agreement, LIBD granted the Company a worldwide, royalty-bearing exclusive license so long as the Company

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

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

artificial intelligence on data derived from research.

Generally, “Licensed products” are any product or service which incorporates,

results from, or is derived from LIBD’s Data (meaning finished brain-related data, including but not limited to DNA methylation,

RNAseq, genomic, DNA methylation, cell-line, clinical, and imaging data, and the specified data set forth in the Partnership Agreement)

and that the Company or its affiliate develops during the term of the Partnership Agreement, and any improvements thereof after the term

of the Partnership Agreement, and all Licensed Products or services derived therefrom by the Company or its affiliates.

Licensed Products

may include, but are not limited to, biomarker and target identification, target validation, mapping unmet needs, identifying genetic

risk factors and predictive modeling.

Company was also granted the right to sublicense, to use the deliverables under the Partnership Agreement, and LIBD’s intellectual

property rights in the data, to (i) use, sell, distribute for sale, have distributed for sale, offer for sale, have sold, import and

have imported Licensed Products and (ii) to develop, have developed, make, have made Licensed Products that are derived from Licensed

Products developed during the term of the Partnership Agreement, and any improvements made following the term.

The Company is prohibited

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

its affiliates.

Commercial Agreement, generally, may be terminated at any time by either the Company or LIBD if either party defaults or breaches any

material term of the agreement or files for protection under bankruptcy laws, makes an assignment for the benefit of creditors, appoints

or suffers appointment of a receiver, trustee, or similar agent over its property.

for CATIE Schizophrenia Case Study

The 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.

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.

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

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for Cardiovascular Case Study

The Company worked with an international collaborator in cardiovascular devices to analyze data from an ongoing clinical trial for a new device.

Company worked with an international collaborator in cardiovascular devices to analyze data from an ongoing clinical trial for a new

BullFrog analyzed data from ~55 patients, with a library of almost 15,000 unique attributes of data for each patient.

The data also included

adverse events, and key demographic information.

For this collaborator, bfLEAP™ analysis was able to provide ground truth for the

company - confirming multiple correlations and non-correlations within the data.

In terms of actionable output, the analytical results

confirmed at least two demographic co-variates for the ongoing trial, and also provided a starting point for deeper physiological and

molecular studies.

also included adverse events, and key demographic information.

For this collaborator, bfLEAP™ analysis was able to provide ground

truth for the company - confirming multiple correlations and non-correlations within the data.

In terms of actionable output, the analytical

results confirmed at least two demographic co-variates for the ongoing trial, and also provided a starting point for deeper physiological

and molecular studies.

Supply Chain and Customer Base

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Since we are a digital biopharmaceutical

company, our clinical development programs will also require, in some cases, establishment of third-party relationships for execution

company, our clinical development programs will also require, in some cases, the establishment of third-party relationships for execution

and completion of clinical trials.

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have exclusive worldwide rights to the following patents related to our intellectual property:

Hopkins University Licensed Intellectual Property:

Improved Formulation of Mebendazole and Drug Combination to Improve Anti-cancer Activity

Johns Hopkins University

Improved Formulation of Mebendazole and Drug Combination to Improve Anti-cancer Activity

PCT/US2016/016968

Johns Hopkins University

Polymorph For Treatment And Prevention Of Tumors

Johns Hopkins University

Polymorph For Treatment And Prevention Of Tumors

Johns Hopkins University

POLYMORPH FOR TREATMENT AND PREVENTION OF TUMORS

Johns Hopkins University

Improved Formulation of Mebendazole and Drug Combination to Improve Anti-cancer Activity

1ZL20168-0014427.4

Johns Hopkins University

Improved Formulation of Mebendazole and Drug Combination to Improve Anti-cancer Activity

Johns Hopkins University

Polymorph For Treatment And Prevention Of Tumors

Johns Hopkins University

CONTINUATION:

Mebendazole Polymorph For Treatment And Prevention Of Tumors

Johns Hopkins University

Washington University Licensed Intellectual Property:

provisional patent numbers 63/113,745 and 63/147,141 were both converted into a single PCT application (PCT/US2021/059245) with an expiration

date of November 12, 2041, as shown in table below.

PCT/US2016/016968

2016 067 384.3

Prodrugs with Enhanced Solubility and Oral Bioavailability

PCT/US2019/017291

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

PCT/US2021/059245

Hopkins University Applied Physics Lab Licensed Intellectual Property:

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exclusive rights for therapeutics development

February 7, 2018, we entered into a License Agreement (the “License Agreement”) with JHU-APL, a Maryland limited liability company (“JHU”).

Pursuant to the License Agreement, JHU-APL granted the

Company exclusive rights to intellectual property of JHU related to analytical services for applications in biological and chemical derived

pharmaceutical therapeutics.

The License Agreement provides for the grant of an exclusive, worldwide, royalty-bearing license by JHU

to the Company, with the right to sublicense, in order to conduct research using the patent rights and know-how and to develop and commercialize

products in the field using the patent rights and know-how.

In consideration of the rights granted to the Company under the License Agreement,

the Company granted JHU received a warrant equal to five (5%) percent of the then fully diluted equity base of the Company, which was

diluted following our public offering.

Under the terms of the License Agreement, the Company is required to use commercially reasonable

efforts to meet certain development milestones and minimum net sales milestones, and JHU will be entitled to eight (8%) percent of net

sales for the services provided by the Company in which the JHU license was utilized, as well as fifty (50%) percent of all sublicense

revenues received by the Company.

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

The Company is

also obligated to make minimum annual payments.

These minimum annual payments to JHU were amended on September 3, 2020 to $20,000 in

calendar year 2022, $80,000 in calendar year 2023, $300,000 in calendar year 2024, and $300,000 in calendar year 2025 and each year thereafter,

which may be offset against royalties paid by the Company for the year in which the minimum annual royalty becomes due.

License Agreement will, unless sooner terminated, continue in each country until the date of expiration of the last to expire patent

included within the patent rights in that country, or if no patents issue, then for 10 years.

The License Agreement may be terminated

by the Company upon 60 days’ written notice in its discretion.

The License Agreement may also be terminated by JHU if the Company

is in material breach of the License Agreement and fails to cure such breach within a 60-day cure period commencing upon notice.

breach by the Company may include a delinquency with respect to payment or the failure by the Company to timely achieve a specified milestone.

also have exclusive, worldwide licenses to other intellectual property from JHU that are being held as trade secrets related to our algorithm

libraries, pattern recognition, shallow-and-wide data sets, and time series correlation.

We anticipate that new intellectual property

(patents, copyrights, trademarks, trade secrets, etc.) will be generated through the course of executing our strategic development projects,

and also through the course of improving, modifying, and scaling our bfLEAP™ platform.

In October 2021, we amended the agreement

with JHU-APL to include additional advanced AI technology.

Currently, the latest patent grant date was in March 2021.

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

(the “2022 License Agreement”).

This 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 2022

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 is utilized.

The 2022 License Agreement also contains

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

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 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.

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.

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.

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.

Washington University - Beta2-spectrin siRNA License

January 14, 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from GWU for rights to use siRNA targeting Beta2-spectrin in the treatment of human diseases, including HCC.

covers methods claimed in three US and worldwide patent applications, and also includes use of this approach for treatment of obesity,

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

January 14, 2022, the Company entered into an exclusive, world-wide, royalty-bearing license from GWU for rights to use siRNA targeting

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

The license covers methods claimed in three US 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 has not yet initiated development activities or IND-enabling studies on this asset;

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

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 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.

The Company has not yet initiated development activities or IND-enabling

studies on this asset;

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.

Non-alcoholic

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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 technology.

agreement also contains milestone payments for clinical development through the approval of an 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

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

a New Drug Application (NDA) to the U.S.

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

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

of December 31, 2023 and 2022, there has been no accrual for royalties since we have not begun to generate applicable revenue.

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 License

February 22, 2022, the Company entered into an exclusive, worldwide, royalty-bearing license from 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

glioma (NCT01729260).

The trial, an open-label dose-escalation study, assessed the safety of the improved formulation with adjuvant temozolomide

in 24 patients with newly diagnosed gliomas.

Investigators observed no dose-limiting toxicity in patients receiving all but the highest

tested dose (200mg/kg/day).

Four of the 15 patients receiving the maximum tested dose of 200mg/kg/day experienced dose-limiting toxicity,

all of which were reversed by decreasing or eliminating the dose given.

There were no serious adverse events attributed to mebendazole

at any dose during the trial.

The Company is currently formulating a strategy to conduct additional clinical trials with this asset to

enable evaluation of safety in humans.

February 22, 2022, the Company entered into an exclusive, worldwide, royalty-bearing license from 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 glioma (NCT01729260).

an open-label dose-escalation study, assessed the safety of the improved formulation with adjuvant temozolomide in 24 patients with newly

diagnosed gliomas.

Investigators observed no dose-limiting toxicity in patients receiving all but the highest tested dose (200mg/kg/day).

Four of the 15 patients receiving the maximum tested dose of 200mg/kg/day experienced dose-limiting toxicity, all of which were reversed

by decreasing or eliminating the dose given.

There were no serious adverse events attributed to mebendazole at any dose during the trial.

The Company is currently formulating a strategy to conduct additional clinical trials with this asset to enable evaluation of safety

license covers six (6) issued patents and one (1) pending application, with the term of the agreement beginning on February 22, 2022

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

In 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 $79,232.53

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 the US FDA.

Future milestones on sales revenue are $1M on

the first $20M in sales revenue, $2M in the first year cumulative sales revenue exceeds $100M, $10M in the first year cumulative sales

revenue exceeds $500M, and $20M in the first year cumulative sales revenue exceeds $1B.

– 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 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, 2022and

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

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.

The Sublicense fee amount declines

as the Company advances the clinical development of the 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 totaling up to $2.3M.

The Company will be required

to pay a commercial milestone of $1M once sales reach $20M in the US, $2M when sales in the US reach $100M, $10M when US sales reach

$500M, and $20M when US sales exceed $1B.

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

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

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

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

September 26, 2023, the Company announced positive data in a preclinical study investigating the anti-cancer activity of a novel prodrug

of mebendazole for the treatment of glioblastoma.

The study assessed the relative efficacy of BF-222, a novel formulation of mebendazole

that has been evaluated in clinical trials, and BF-223, a novel prodrug of mebendazole with improved solubility and bioavailability relative

to BF-222, compared with placebo in mice that had been implanted with tumor cells as a model for human glioblastoma.

Animals treated

with BF-223 had an average survival time of 27.9 days compared with 27.3 days for mice treated with BF-222 and 23.4 days for mice given

Mice treated with BF-223 were administered 80% of the dose that mice treated with BF-222 received, and improved outcomes for

both treatment groups were statistically significant compared to placebo.

In addition, animals treated with equivalent doses of BF-222

and BF-223 showed comparable and significant reduction in tumor growth compared to control animals during the study.

pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis

127 unchanged sentences

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.

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.

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Attorney offices within the DOJ, and state and local governments.

For example, research, sales, marketing and

scientific/educational grant programs have to comply with the anti-fraud and abuse provisions of the Social Security Act, the federal

For example, research, sales, marketing,

and scientific/educational grant programs have to comply with the anti-fraud and abuse provisions of the Social Security Act, the federal

false claims laws, the privacy and security provisions of the Health Insurance Portability and Accountability Act (HIPAA) and similar

51 unchanged sentences

Our website address is www.bullfrogai.com .

The references to our website in this annual report are

inactive textual references only.

The information on our website is neither incorporated by reference into this annual report nor intended

to be used in connection with this annual report.

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

The references to our website in this annual report

are inactive textual references only.

The information on our website is neither incorporated by reference into this annual report nor

intended to be used in connection with this annual report.

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

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

Securities Exchange Commission (the

These filings are available to the public on the Internet at the SEC’s website at http://www.sec.gov.

reporting companies are not required to provide the information required by this item.

UNRESOLVED STAFF COMMENTS

These filings are available to the public through the SEC’s website at http://www.sec.gov .

All statements

made in any of our securities filings, including all forward-looking statements or information, are made as of the date of the document

in which the statement is included unless otherwise specified, and we do not assume or undertake any obligation to update any of those

statements or documents unless we are required to do so by law.

reporting companies are not required to provide the information required by this item.

Company’s principal business address is 325 Ellington Blvd, Unit 317, Gaithersburg, MD 20878, and the telephone number at such

address is 408-663-5247.

Currently, the Company does not own any real property.

All of the Company’s employees work virtually.

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