What changed in this filing

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Item 1. Business

2026-03-19 compared with 2025-03-14 · 490 added, 448 removed, 515 unchanged (65% of the section changed)

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AI Holdings, Inc.

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

was incorporated in the State of Nevada in February 2020.

BullFrog AI Holdings, Inc.

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AI Corporate History

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

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

CEO and chairman of Bullfrog AI, Inc.

Business Overview

was incorporated in the State of Delaware in August 2017.

Vininder Singh, the Company’s Chief Executive Officer, was the

founder, CEO and chairman of BullFrog AI, Inc.

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

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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.

A major challenge in developing new therapeutics is efficiently integrating the complex, high-dimensional data generated

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

Artificial intelligence and machine learning (“AI/ML”)

has emerged as a digital solution to help address this problem.

use AI/ML to advance medicines for both internal and external projects.

We are committed to increasing

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

Our platform technology, named, bfLEAP™,

Our platform technology, bfLEAP™,

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

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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.

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),

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

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

via our proprietary artificial intelligence platform bfLEAP.

The bfLEAP™ platform utilizes both supervised and unsupervised machine

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

“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

previously reported, on August 21, 2025, the Company received written notice from The Nasdaq Stock Market LLC (“Nasdaq”)

that the Company was not in compliance with Nasdaq Listing Rule 5550(b)(1), which requires companies listed on The Nasdaq Capital

Market to maintain a minimum of $2,500,000 in stockholders’ equity for continued listing (the “Stockholders’

Equity Requirement”).

The Company submitted a plan to regain compliance with the Stockholders’ Equity Requirement (the

“Plan”) to Nasdaq on September 30, 2025.

In response to the Company’s Plan, on October 7, 2025, the Company

received a letter (the “Extension Letter”) from Nasdaq informing the Company that, based on the Plan, Nasdaq had granted

the Company’s request for an extension until February 17, 2026, to comply with the Stockholders’ Equity Requirement.

February 19, 2026, the Company received a further notice from Nasdaq (the “February Letter”) notifying the Company that

Nasdaq determined that the Company had not met the terms of the extension.

The Company thereafter timely requested a hearing before

an independent Nasdaq Hearings Panel (the “Panel”) that automatically stayed any suspension or delisting action pending

the hearing and the expiration of any extension period granted by the Panel following the hearing.

At the hearing, the Company plans

to present additional details of the Company’s Plan and provide an update on its efforts to regain compliance.

will also request additional time to complete the steps of its Plan and regain compliance with all applicable Nasdaq Listing Rules.

There can be no assurance that the Panel will grant the Company’s request for additional time to regain compliance with Nasdaq

listing rules or that, if the Panel does grant the Company’s request, the Company will be able to regain compliance with the

applicable Nasdaq listing requirements.

If the Company’s common stock and warrants are delisted, it would be more difficult to

buy or sell the Company’s common stock and warrants or to obtain accurate quotations, and the price of the Company’s

common stock and warrants could suffer a material decline.

Delisting could also impair the Company’s ability to raise

February 10, 2026, the Company received a letter from Nasdaq notifying the Company that, for the last 30 consecutive business days, the

closing bid price for the Company’s common stock, par value $0.00001 per share (the “Common Stock”), was below $1.00

per share, which is the minimum closing bid price required for continued listing on the Nasdaq Global Market (the “Minimum Bid

Price Requirement”) pursuant to Nasdaq Listing Rule 5550(a)(2) (the “Bid Price Notice”).

The Bid Price Notice had no

immediate effect on the listing of the Company’s Common Stock and tradeable warrants.

As such, the Company’s Common Stock

will continue to trade on the Nasdaq Capital Market under the symbol “BFRG,” and its tradeable warrants will continue to

trade on the Nasdaq Capital Market under the symbol “BFRGW.” In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company

is provided a compliance period of 180 calendar days from the date of the Bid Price Notice, or until August 10, 2026, to regain compliance

with the Minimum Bid Price Requirement.

If at any time during the 180-calendar day grace period, the closing bid price of the Company’s

Common Stock is at least $1.00 per share for a minimum of ten consecutive business days (unless the Nasdaq staff exercises its discretion

to extend this ten business day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H)), Nasdaq will provide the Company written confirmation

of compliance, and the matter will be closed.

If the Company does not regain compliance during the initial 180-calendar day compliance

period, the Company may be provided a second 180-calendar day period to regain compliance.

If the Company does not regain compliance

within the allotted compliance periods, including any extensions that may be granted by Nasdaq, the Company’s listed securities

will be subject to delisting.

The Company would thereafter have the right to appeal a determination to delist the Company’s securities,

and the Company’s securities would remain listed on the Nasdaq Capital Market until the completion of the appeal process.

intends to monitor the closing bid price of its Common Stock and assess potential options to regain compliance with Nasdaq’s Listing

While the Company plans to review all available options, there can be no assurance that the Company will regain compliance with

the Minimum Bid Price Requirement during the compliance period, secure a second 180-day period to regain compliance with the Minimum

Bid Price Requirement, or maintain compliance with the other Nasdaq listing requirements.

Notably, at a Special Meeting of Stockholders

in October 2025, the Company received stockholder approval to effect a reverse stock split at a ratio of not less than 1-to-2 and not

more than 1-to-15, such ratio and timing to be determined in the discretion of the Company’s Board of Directors.

plan to achieve our business objectives by enabling the successful discovery and/or development of drugs and biologics using a precision

medicine approach via our proprietary artificial intelligence platform bfLEAP™.

The bfLEAP™ platform utilizes both supervised

and unsupervised machine learning;

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

Supervised 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

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

These 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 of interest.

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

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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 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.

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

AI/ML platform, 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 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.

In July 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 our original February

2018 license agreement with JHU-APL.

The July 2022 JHU-APL license 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.

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

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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.

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

of each candidate’s characteristics and 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.

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

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

mechanism of action, predict potential off-target effects and side effects, uncover specific

genetic and phenotypic backgrounds 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 steps of therapeutic and diagnostic development, including first-inhuman

and Phase I randomized controlled trials.

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

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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 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.

We provide the customer with an analysis of large

complex 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 and, in some instances, 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

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Market/Indications

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.

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

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

Biotechnology

and pharmaceutical companies and other organizations.

Data Networks™

bioinformatics solution that integrates and analyzes multi-omics, clinical, and real-world biomedical data to uncover hidden biological

relationships and generate insights that accelerate drug discovery, target identification, and clinical trial design.

Biotechnology

and pharmaceutical companies and other organizations.

data preparation platform that cleans, standardizes, and harmonizes fragmented biomedical datasets (e.g., clinical, omics, and real-world

data) to convert them into analysis-ready, AI-ready data for drug discovery and clinical research.

Biotechnology

and pharmaceutical companies and other organizations.

interfering RNA targeting Beta2-spectrin in the treatment of human diseases developed at George Washington University and licensed

by the Company.

Product has not yet initiated clinical testing.

Hepatocellular

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

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.

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

January 2022, we 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”).

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of development.

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

We initiated proof-of-concept studies on this asset and plan to use the outcome of these studies to inform a clinical

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

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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.

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, we 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

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at any dose during the trial.

The Company is currently formulating a strategy to find a partner to conduct additional clinical trials

with this asset to enable evaluation of safety in humans.

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.

We are currently formulating a strategy to find a partner to conduct additional clinical trials with this

asset to enable evaluation of safety in humans.

October 2022, we 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

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 JHU-APL.

are able to pursue our drug rescue business by leveraging bfLEAP™, our powerful and proven AI/ML platform derived from 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.

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.

In July 2022, we entered into an exclusive, world-wide, royalty-bearing

license from JHU-APL for the additional technology developed to enhance the bfLEAP™ platform, which superseded our original license with JHU-APL.

This license provides additional

intellectual property rights including patents, copyrights and knowhow to be utilized under our bfLEAP™ analytical AI/ML platform.

Under the terms of such 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 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

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

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

It is also uniquely scalable;

the bfLEAP™ platform is able to perform

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

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and powerful new platforms available on the market.

Company will continue to evolve and improve bfLEAP™.

intend to 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™ 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, and more.

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

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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 believe that 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.

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.

(“Eleison”), a Phase III oncology company

focused on novel chemotherapeutic treatments for rare cancers, where we applied 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.

bfPREP™ solution is an AI-powered data preparation tool designed to organize and standardize complex biomedical datasets before

advanced analytics or modeling.

It ingests heterogeneous data sources such as clinical trial records, multi-omics datasets, and real-world

patient data and automatically cleans, harmonizes, and structures them into consistent, analysis-ready formats.

The platform reduces

the time and manual effort researchers typically spend on data curation, which can be a major bottleneck in biomedical research.

high-quality, integrated datasets, bfPREP TM helps ensure that downstream AI models and analytical tools produce more reliable

and reproducible insights.

It is designed to work as part of the company’s broader BullFrog Data Networks TM ecosystem,

supporting applications such as biomarker discovery, drug target identification, and clinical trial optimization.

We believe that bfPREP TM

enables life sciences organizations to move from fragmented raw data to AI-ready datasets much more efficiently.

Scenario-Based Decision Engine

March 2026, the Company is planning to launch a new scenario-based decision engine solution that is an AI-powered analytical environment

designed to support complex decision-making in drug development and biomedical research.

The platform will apply advanced modeling and

simulation techniques to evaluate multiple development scenarios, allowing researchers and executives to explore the potential outcomes

of different clinical, regulatory, and commercialization strategies.

By integrating diverse datasets including biological, clinical,

and operational information, the new scenario-based decision engine will help identify which approaches are most likely to succeed while

highlighting potential risks.

The new scenario-based decision engine is intended to support portfolio prioritization, clinical trial

design, and strategic planning by providing quantitative insight into uncertain R&D decisions.

It will operate alongside the Company’s

broader BullFrog Data Networks TM platform, which supplies the integrated data foundation for its analyses.

Together, we believe

that these capabilities can help life sciences organizations make more informed, data-driven decisions throughout the drug development

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 the Company to leverage

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

September 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 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.

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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

contemplated in the Partnership Agreement, in October 2023, we entered into a commercial agreement (the “Commercial Agreement”)

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

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

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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

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.

and that we or our 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 us or our 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.

were 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.

We are prohibited from sublicensing LIBD

We shall pay LIBD a royalty based on net sales of all Licensed Products sold by the Company and its affiliates.

Commercial Agreement, generally, may be terminated at any time by either us 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, or appoints or

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

for CATIE Schizophrenia Case Study

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for Cardiovascular Case Study

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

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

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

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.

The data also included

adverse events and key demographic information.

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

have launched our businesses using funds from our initial public offering and through our partnerships and relationships.

We have a strategic

relationship with FSHD Society, a leading non-governmental organization, for AI/ML analysis of clinical trial data for patients with

a rare neuromuscular disorder.

We also have several other developing strategic relationships in the project design phase.

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 II ready glioblastoma drug and a discovery phase hepatocellular carcinoma

drug from universities.

Since we intend to conduct late-stage clinical trials with partners on rescued therapeutic assets, there will

be a requirement of drug product or other significant services to plan and execute our clinical development programs.

The success of

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

is manufactured appropriately under industry-standard guidelines, and packaged for clinical use or sale.

Since we are a digital biopharmaceutical

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

and completion of clinical trials.

launched our businesses using funds from our initial public offering and we continue operating and targeting partnerships and relationships

using funds from our subsequent financings.

We have a strategic relationship with FSHD Society, a leading non-governmental organization,

for AI/ML analysis of clinical trial data for patients with a rare neuromuscular disorder.

We also have several other developing strategic

relationships in the project design phase.

The Company 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 II ready glioblastoma

drug and a discovery phase hepatocellular carcinoma drug from universities.

Since we intend to conduct late-stage clinical trials with

partners on rescued therapeutic assets, there will be a requirement of drug product or other significant services to plan and execute

our clinical development programs.

The success of 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 is manufactured appropriately under industry-standard guidelines, and packaged for clinical use

Since we are a digital biopharmaceutical company, our clinical development programs will also require, in some cases, the establishment

of third-party relationships for execution and completion of clinical trials.

Market Opportunity

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Identification

of candidates with potential for rescue may be challenging and require significant resources, and once these assets are identified the

Company may find it challenging to license them under favorable terms in order to create value for shareholders.

Subsequent development

of these assets for clinical testing may require significant effort and resources.

Ultimately, these assets must undergo rigorous clinical

testing and approval by FDA or comparable regulatory authorities in other countries in order to be marketed.

A key part of our strategy

is to partner our R&D programs.

In addition, we do not intend on commercializing drugs and instead will seek to divest each drug

asset to a company that will commercialize the drug.

The Company may receive future royalties in some transactions.

of candidates with potential for rescue may be challenging and require significant resources, and once these assets are identified, we

may find it challenging to license them under favorable terms in order to create value for shareholders.

Subsequent development of these

assets for clinical testing may require significant effort and resources.

Ultimately, these assets must undergo rigorous clinical testing

and approval by FDA or comparable regulatory authorities in other countries in order to be marketed.

A key part of our strategy is to

partner our R&D programs.

In addition, we do not intend on commercializing drugs and instead will seek to divest each drug asset

to a company that will commercialize the drug.

We 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

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Polymorph For Treatment And Prevention Of Tumors

United States

PCT/US2016/016968

United States

Czech Republic

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

Apparatus and Method for

Distributed Graph Processing

and Method for Distributed Graph Processing

Patent 10,146,801

The Johns Hopkins University

Method and Apparatus for

Analysis and Classification of High Dimensional Data Sets

Johns Hopkins University

and Apparatus for Analysis and Classification of High Dimensional Data Sets

Patent 10,936,965

The Johns Hopkins University

Generalized Low Entropy

Mixture Model

Johns Hopkins University

Low Entropy Mixture Model

Patent 10,839,256

The Johns Hopkins University

Johns Hopkins University

hold the following licenses related to our intellectual property:

of Rights Granted

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

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

Technology License

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

February 2018, we 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.

In October 2021, we 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 us as well as fifty percent (50%) of all sublicense revenues

received by us on services and sublicenses in which the JHU-APL licensed technology was utilized.

In addition, we are 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, we will have 60 days to cure the material breach.

July 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 “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 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.

The 2022 License Agreement provides additional intellectual property

rights including patents, copyrights, and know-how to be utilized under the bfLEAP™ analytical AI/ML platform.

This 2022 License

Agreement supersedes the previous 2018 License Agreement.

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

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 us to other parties and three percent (3%) for internally developed drug projects in which the JHU-APL license is utilized.

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

In addition, under the

2022 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 replaces the original terms from the

2018 License Agreement and are not duplicative.

May 2023, we entered into Amendment Number 1 of the July 2022 License Agreement with JHU-APL whereby we gained access to certain improvements

including additional patents and know-how in exchange for a series of payments totaling $275,000.

The first of these payments for $75,000

was paid in July 2023, the second of these payments for $75,000 was paid in June 2025, and the remaining payments of $75,000 and $50,000

are due in 2026 and 2027, respectively.

The amendment also reduced the 2023 minimum annual royalty payment from $80,000 to $60,000 while

all other financial terms remained the same.

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.

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 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 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.

January 2022, we 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 hepatocellular carcinoma (“HCC”).

The license covers methods claimed in three

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 and we have not yet initiated

development activities or IND-enabling studies on this asset.

All R&D on this candidate to date has been conducted by the licensor

of the technology, GWU.

The term of the agreement began in January 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 we are more than 30 days late in paying amounts owed to the licensor and do

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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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 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.

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

Under 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 we sublicense or assign our rights

to use the technology.

We 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.

The license 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 United

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.

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.

we 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 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 with

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.

February 2022, we 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 with 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

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.

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

and ending on the date of expiration of the last to expire patent.

The license can be terminated by the licensee upon 90 days’

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 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 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 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 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.

We are currently formulating a strategy to conduct additional clinical trials with this asset to enable evaluation of safety in humans.

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

ending on the date of expiration of the last to expire patent.

The license can be terminated by the licensee upon 90 days’ 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 us 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

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

the JHU license was utilized.

In addition, we are 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.

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

and therefore may not be recoverable;

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

Hopkins University – Prodrug License

October 2022, we 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

United States and worldwide patent applications.

The term of the agreement began in October 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.

The license can be terminated

by us 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 us under the license agreement, JHU and IOCB received a staggered upfront license fee of $100,000.

We 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

we sublicense or assign our rights to use the technology.

The sublicense fee amount declines as we advance the clinical development of

licensed technology.

We are 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).

We 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.

We 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.

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

be recoverable;

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

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

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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.

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 the 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

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We believe the weakness of the industry is the quality of the data

and we believe bfLEAP provides several competitive advantages, that will position the Company for success, First, bfLEAP is highly scalable

and can process data from small to extremely large complex data sets without the need for additional code being developed.

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

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

unsupervised machine learning algorithms, thereby greatly simplifying complex problems.

Since data quality is a problem that exists in

the healthcare industry, we see these as major differentiators.

The ability to make predictions, find relationships and patterns and

anomalies in extremely large complex data sets has been demonstrated by the JHU-APL in other applications and sectors.

Finally, the algorithms

used by bfLEAP are proprietary and protected, having been developed at JHU-APL.

We believe most of the competitors rely on open-source

algorithms and we also believe that we have already demonstrated our superiority via the August 2021 publication in DeepAI.org.

and we believe bfLEAP TM provides several competitive advantages, that will position the Company for success, First, bfLEAP TM

is highly scalable and can process data from small to extremely large, complex data sets without the need for additional code being developed.

Second, it is adept at processing and analyzing incomplete data and making predictions that we do not believe other technologies are

capable of doing.

Third, bfLEAP TM has the ability to extract the most important features for analysis out of extremely large,

complex data sets using unsupervised machine learning algorithms, thereby greatly simplifying complex problems.

Since data quality is

a problem that exists in the healthcare industry, we see these as major differentiators.

The ability to make predictions and find relationships,

patterns, and anomalies in extremely large, complex data sets has been demonstrated by JHU-APL in other applications and sectors.

the algorithms used by bfLEAP TM 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.

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The comments and approvals that are

obtained are expected to lead to milestone payments under the collaborative agreement.

Accordingly, our ability to navigate the regulatory

process is extremely important to the success of the Company.

We believe that we have a competitive advantage in this process due to

primarily focusing on drug candidates that already have some level of success in clinical trials.

Previous success of a particular candidate

in trials combined with our precision medicine approach to clinical trial design using our bfLEAP platform, will de-risk the development

process and improve the chances for success.

obtained are expected to lead to milestone payments under our agreements.

Accordingly, our ability to navigate the regulatory process

is extremely important to the success of the Company.

We believe that we have a competitive advantage in this process due to primarily

focusing on drug candidates that already have some level of success in clinical trials.

Previous success of a particular candidate in

trials combined with our precision medicine approach to clinical trial design using our bfLEAP TM platform, will de-risk the

development process and improve the chances for success.

Regulation and Product Approval

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import and export of pharmaceutical products.

Failure to comply with applicable U.S.

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.

Failure to comply with applicable United States 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.

Pharmaceutical

product development for a new product or certain changes to an approved product in the U.S.

typically involves preclinical laboratory

product development for a new product or certain changes to an approved product in the United States typically involves preclinical laboratory

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

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criteria to be evaluated.

Each protocol involving testing on U.S.

patients and subsequent protocol amendments must be submitted to the

FDA as part of the IND.

Each protocol involving testing on United States 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.

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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.

marketing of the product may begin in the United States.

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

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.

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.

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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

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

is safe and effective in the indication studied.

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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

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

medical needs for the condition.

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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 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

IV certification is filed.

If there is no listed patent in the Orange Book, there may not be a Paragraph IV certification, and, thus,

no ANDA may be filed before the expiration of the exclusivity period.

Certain changes to a drug, such as the addition of a new indication

to the package insert, can be the subject of a three-year period of exclusivity if the application contains reports of new clinical investigations

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

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

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 IV certification is filed.

If there is no listed patent in the Orange Book, there may not be a Paragraph IV certification,

and, thus, no ANDA may be filed before the expiration of the exclusivity period.

Certain changes to a drug, such as the addition of a

new indication to the package insert, can be the subject of a three-year period of exclusivity if the application contains reports of

new clinical investigations (other than bioavailability studies) conducted or sponsored by the sponsor that were essential to approval

of the application.

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

Term Extension

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the United States, biotechnology company activities are subject to regulation by various federal, state and local authorities in addition

to the FDA, including but not limited to, the Centers for Medicare & Medicaid Services (“CMS”), other divisions of the U.S.

of Health and Human Services (e.g., the Office of Inspector General and the Office for Civil Rights), the U.S.

Department of Justice

(“DOJ”) and individual U.S.

to the FDA, including but not limited to, the Centers for Medicare & Medicaid Services (“CMS”), other divisions of the

Department of Health and Human Services (e.g., the Office of Inspector General and the Office for Civil Rights), the U.S.

of Justice (“DOJ”) and individual U.S.

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

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

state laws, each as amended, as applicable.

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 state laws, each as amended, as applicable.

many states have similar fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid and other

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Third-party payors may limit coverage to specific drug products on an approved list, or formulary, which might

not include all of FDA-approved drugs for a particular indication.

A payor’s decision to provide coverage for a drug product does

not imply that an adequate reimbursement rate will be approved.

Further, coverage and reimbursement for drug products can differ significantly

from payor to payor.

As a result, the coverage determination process is often a time-consuming and costly process that will require us

to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that coverage and

adequate reimbursement will be applied consistently or obtained in the first instance.

not include all of the FDA-approved drugs for a particular indication.

A payor’s decision to provide coverage for a drug product

does not imply that an adequate reimbursement rate will be approved.

Further, coverage and reimbursement for drug products can differ

significantly from payor to payor.

As a result, the coverage determination process is often a time-consuming and costly process that

will require us to provide scientific and clinical support for the use of our products to each payor separately, with no assurance that

coverage and adequate reimbursement will be applied consistently or obtained in the first instance.

Capital Resources

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.

of December 31, 2025, the Company had 9 full-time employees, including its Chief Executive Officer, and 8 part-time employees, advisors,

and consultants, including its Chief Financial Officer.

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.

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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.

Company is not a party to any legal proceedings.

we do not own or lease any real property.

All of our employees work virtually.

are not a party to any legal proceedings.

AI Holdings, Inc.

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

Our principal business address is 325 Ellington Blvd,

Unit 317, Gaithersburg, MD 20878.

was incorporated in the State of Nevada in February 2020.

Our 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 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.

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

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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.

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.

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