NASDAQ: BFRG

BullFrog
AI Corporate History

BullFrog
AI, Inc. 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.

Business
Overview

Most
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 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.

We
use AI/ML 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, 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 precise1, 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.

1
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. The end
result showed that the algorithms used in bfLEAP had the highest average score when measuring speed and accuracy of prediction. The bfLEAP
platform currently has more advanced versions of these algorithms and is applying them in multiple data analytics projects.

4

Recent
Developments

As
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. On
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. The Company
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
capital.

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

Our
Strategy

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

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Together
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, 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 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.

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

● Discovery
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 and potency.

● Pre-Clinical
Data – Large-scale, multivariate analysis of pre-clinical and early-stage clinical
data sets. 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.

● Clinical
Development – Advanced, multivariate analysis of Phase I and Phase II clinical
trials data, to find niche populations of highly responsive patients and/or inform patient
selection for later-stage clinical trials. This can be used to decrease overall study risk
for larger clinical trials, including Phase II trials, and any Phase III Registration Clinical
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.

Our
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.

The
process for our drug asset enhancement program is to:

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

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

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

● divest
and sell the rescued drug asset with the new information back to a large player in the pharma
industry, following positive results of the clinical trial.

6

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 drug development value chain, as well as acquisitions
of the rights to developing failed drugs and possibly the underlying companies.

To
date, we have not conducted clinical trials on any pharmaceutical drugs and our platform has not been used to identify a drug candidate
that has received regulatory approval for commercialization. However, we currently have a strategic relationship with a leading rare
disease non-profit organization for AI/ML analysis of late-stage clinical data. We have acquired the rights to a series of preclinical
and early clinical drug assets from universities and entered into a strategic collaboration with a world-renowned research institution
to create a HSV1 viral therapeutic platform to engineer immunotherapies for colorectal cancer. We have signed exclusive worldwide license
agreements with Johns Hopkins University for a cancer drug that targets glioblastoma (brain cancer), pancreatic cancer, and other cancers.
We have also signed an exclusive worldwide license with George Washington University for another cancer drug that targets hepatocellular
carcinoma (liver cancer), and other liver diseases.

Our
platform was originally developed by JHU-APL. JHU-APL uses the same technology for applications related to national defense. Over several
years, the software and algorithms have been used to identify relationships, patterns, and anomalies, and make predictions that otherwise
may not be found. These discoveries and insights provide an advantage when predicting a target of interest, regardless of industry or
sector. We have applied the technology to various clinical data sets and have identified novel relationships that may provide new intellectual
property, new drug targets, and other valuable information that may help with patient stratification for a clinical trial, thereby improving
the odds for success. The platform has not yet aided in the development of a drug that has reached commercialization; however, we have
licensed one drug candidate that has completed a Phase I trial and a second candidate that is in the preclinical stages. Our aim is to
use our technology on current and future available data to help us better determine the optimal path for development.

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

Contract
Services

Our
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 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
Arrangements

We
plan to enter into collaborative arrangements with biotechnology and pharmaceutical companies who have drugs that are in development
or have failed late Phase II or Phase III trials. The collaborations may also be at the discovery or preclinical stages of drug development.
Our revenue will be a combination of fee for service 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.

Acquisition
of Rights to Certain Drugs

We
may acquire the rights to drugs that have failed late Phase II or Phase III trials and generate revenues by using our platform to accurately
determine the profile of patients that would respond to the drugs, conduct a clinical trial to test our findings either independently
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
the asset. 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.

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Our
Products

Product/Platform

Description

Target
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.

BullFrog
Data Networks™

AI-powered
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.

bfPREP™

AI-powered
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.

siRNA

Small
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.

Mebendazole

Improved
formulation of Mebendazole developed at Johns Hopkins University and licensed by the Company. Product has begun the process of clinical
testing but has not received regulatory approval for commercialization.

Glioblastoma.

In
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”).
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. 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.

Metabolic
dysfunction-associated steatotic liver disease (known as MASLD, which until recently was called non-alcoholic fatty liver disease, or
NAFLD) is a condition in which excess lipids, or fat, build up in the liver. This condition, which is more common in people who have
obesity and related metabolic diseases including type 2 diabetes, affects as many as 24% of adults in the United States and is associated
with risk of progression to more serious conditions, including metabolic dysfunction-associated steatohepatitis (“MASH”),
with associated liver inflammation and fibrosis, and HCC. Evidence in animal models of obesity suggest that a protein called β2-spectrin
may play a key role in lipid accumulation, tissue fibrosis, and liver damage, and targeting expression or activity of this protein may
be a useful approach in treating MASH and liver cancer (Rao et al., 2021).

8

In
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
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 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. 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.

In
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.

Our
bfLEAP™ Analytics Platform

We
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. 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.

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. The 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.

We
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 and visualization makes bfLEAP™ one of the most flexible
and powerful new platforms available on the market.

We
intend to continue to evolve and improve bfLEAP™.

BullFrog
Data Networks™

The
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
pipeline including in oncology and central nervous system indications. Our approach finds patient subgroups with similar molecular signatures
and identifies the most relevant genes driving disease biology. 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. In February
2025, we entered into a collaboration agreement with Eleison Pharmaceuticals Inc. (“Eleison”), a Phase III oncology company
focused on novel chemotherapeutic treatments for rare cancers, where we 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.

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bfPREP™

The
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. By preparing
high-quality, integrated datasets, bfPREPTM 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 NetworksTM ecosystem,
supporting applications such as biomarker discovery, drug target identification, and clinical trial optimization. We believe that bfPREPTM
enables life sciences organizations to move from fragmented raw data to AI-ready datasets much more efficiently.

New
Scenario-Based Decision Engine

In late
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 NetworksTM 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
process.

Lieber
Institute for Brain Development

In
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. The goal of the partnership is to identify previously unrecognized
relationships between genes and pathways in the brain and the development of neurologic and psychiatric disorders, thereby facilitating
the development of more effective treatments for diseases of the human brain. The collaboration will proceed in two stages, with the
first involving unsupervised construction of graphical models to reveal relationships between brain diseases and genomic/biologic attributes,
with the goal of identifying new biomarkers and drug targets across disorders. The second stage will involve creating disease-specific
models that will enable identification of genes and pathways within these respective disorders. The Partnership Agreement had a one-year
term of data exclusivity to complete the first stages of analyses, with a two-year extension option as performance milestones are met.

As
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. 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 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 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.

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

The
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.

Summary
for CATIE Schizophrenia Case Study

As
part of the Partnership Agreement, the Company worked with LIBD to analyze data from the landmark Clinical Antipsychotic Trials of Intervention
Effectiveness (“CATIE”) trials. The CATIE trials were the largest trials ever conducted for anti-psychotic medications. The
Company analyzed CATIE data from ~200 schizophrenia patients, with a library of almost 1 million genetic data points for each patient,
more than 200 non-genetic attributes per patient, and 4 different medications used in the trial. For each of the four medications used,
bfLEAP™ analysis revealed new, previously unknown relationships between individual genetic variants and negative patient symptoms.
The genetic loci identified represent potential druggable targets, as well as potential stratifying criteria for future clinical trials
in schizophrenia.

We
performed another analysis on the data using our new advanced clustering algorithms, bfLEAP 2.0, but focused on one particular drug named
Olanzapine. Our bfLEAP™ 2.0 analytical results identified previously unknown, multi-dimensional associations among newly identified
genetic variants, drug clearance, clinical trial sites, and clinical outcome variables in schizophrenia patients.

FIGURE
1 – bfLEAP™ Analytical Map

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Each
green node represents a different sampling of the data, and arrows point to attributes (blue nodes) which were found to be key indicators
according to that sampling. Attribute importance is determined by how many samplings identify that attribute as an indicator (i.e., number
of incoming arrows to each blue node).

Identification
of clustered multi-variate associations (e.g., novel genetic variants, drug clearance, substance abuse) could help us (1) identify novel
drug targets, (2) predict which patients are most likely to respond, and (3) identify modifiable factors that could contribute to better
outcomes.

Summary
for Cardiovascular Case Study

We
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. 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.

Our
Supply Chain and Customer Base

We
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
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.

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Our
Market Opportunity

One
aim of our business is to “rescue” drugs that have failed in Phase III clinical trials by using our technology to analyze
all available data with the goal of designing a precision medicine clinical trial that will have a better chance of being successful.
The graphic below illustrates the estimated market opportunity for these failed drugs. The top arrow shows the number of failed Phase
III trials for several disease categories over a 5-year period. The arrows below provide our assumptions for narrowing or discounting
certain parameters associated with the market size calculation. The final arrow shows the math behind the $47.1 billion market opportunity.
To date, we have not penetrated the failed drug market, however; we are actively searching for failed drug opportunities.

Identification
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.

13

The
following graphic illustrates the global revenue forecast for applying AI in the pharmaceutical industry, as well as the increase in
anticipated market spend and annual growth rate for AI solutions per certain application areas.

Intellectual
Property

Patents

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

Mebendazole
Polymorph For Treatment And Prevention Of Tumors

Serial
Number

Country

Status

Issue
Date

Expiration
Date

62/112,706

United
States

Converted

N/A

N/A

PCT/US2016/016968

PCT

Nationalized

N/A

N/A

11,110,079

United
States

Granted

9/7/2021

2/8/2036

17/402,131

United
States

Abandoned

N/A

N/A

18/525,209

United
States

Pending

N/A

N/A

16747414.7

Europe

Granted

12/15/2021

2/8/2036

16747414.7

Czech
Republic

Granted

12/15/2021

2/8/2036

16747414.7

France

Granted

12/15/2021

2/8/2036

60
2016 067 384.3

Germany

Granted

12/15/2021

2/8/2036

16747414.7

Ireland

Granted

12/15/2021

2/8/2036

502022000018341

Italy

Granted

12/15/2021

2/8/2036

16747414.7

Spain

Granted

12/15/2021

2/8/2036

16747414.7

Switzerland

Granted

12/15/2021

2/8/2036

16747414.7

United
Kingdom

Granted

12/15/2021

2/8/2036

253854

Israel

Granted

6/26/2021

2/8/2036

2016800144274

China

Granted

6/25/2021

2/8/2036

201717028684

India

Granted

12/1/2020

2/8/2036

2017-541687

Japan

Granted

11/18/2020

2/8/2036

Mebendazole
Prodrugs with Enhanced Solubility and Oral Bioavailability

Serial
Number

Country

Status

Issue
Date

Expiration
Date

62/627,810

United
States

Converted

N/A

N/A

PCT/US2019/017291

PCT

Nationalized

N/A

N/A

11,712,435

United
States

Granted

8/1/2023

2/8/2039

2019216757

Australia

Granted

1/4/2024

2/8/2039

19751700.6

Europe

Pending

N/A

N/A

3,090,691

Canada

Pending

N/A

N/A

14

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

Serial
Number

Country

Status

Filing
Date

Expiration
Date

63/113,745

United
States

Converted

11/13/2020

N/A

63/147,141

United
States

Converted

2/8/2021

N/A

PCT/US2021/059245

United
States

Nationalized

11/12/2021

N/A

2023-528428

Japan

Filed

11/12/2021

N/A

18/252,771

United
States

Filed

5/12/2023

N/A

21892928.9

Europe

Filed

6/13/2023

N/A

2021800763877

Canada

Filed

11/12/2021

N/A

Johns
Hopkins University Applied Physics Lab Licensed Intellectual Property

Title

Serial
Number

File
Date

Country

Status

Expiration
Date

Assignee

Apparatus
and Method for Distributed Graph Processing

U.S.
Patent 10,146,801

7/13/2015

US

Granted

3/2/2037

The
Johns Hopkins University

Method
and Apparatus for Analysis and Classification of High Dimensional Data Sets

U.S.
Patent 10,936,965

10/5/2017

US

Granted

9/25/2038

The
Johns Hopkins University

Generalized
Low Entropy Mixture Model

U.S.
Patent 10,839,256

4/2/2018

US

Granted

12/15/2038

The
Johns Hopkins University

Licenses

We
hold the following licenses related to our intellectual property:

Licensor

Licensee

Description
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

JHU-APL
Technology License

In
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, 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.

15

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 “2022 License Agreement”). 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
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 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.

In
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.

George
Washington University - Beta2-spectrin siRNA License

In
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
(3) 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 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
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 United States and is associated with risk of progression to more serious conditions, including non-alcoholic steatohepatitis (“NASH”),
with associated liver inflammation and fibrosis, and hepatocellular carcinoma (“HCC”). Evidence in animal models of obesity
suggest that a protein called β2-spectrin may play a key role in lipid accumulation, tissue fibrosis, and liver damage, and targeting
expression or activity of this protein may be a useful approach in treating NASH and liver cancer (Rao et al., 2021).

In
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.

Aggregate
future milestone costs could reach $860,000 if the drug successfully completes clinical trials and is the subject of an NDA to the United
States FDA. Future milestones on sales revenue are limited to $1 million on the first $20 million in net sales.

16

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.

Johns
Hopkins University – Mebendazole License

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

The
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
costs. 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.

Johns
Hopkins University – Prodrug License

In
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.

In
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. 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.

17

In
September 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
the placebo. 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.

Competition

The
pharmaceutical and biotechnology industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis
on proprietary products. The immuno-oncology, neuroscience, and rare disease segments of the industry in particular are highly competitive.
While we believe that our technology, development experience and scientific knowledge provide competitive advantages, we face potential
competition from many different sources, including major pharmaceutical, specialty pharmaceutical, and biotechnology companies, academic
institutions and governmental agencies, and public and private research institutions.

Many
of our competitors may have significantly greater financial resources and expertise in research and development, manufacturing, preclinical
studies, conducting clinical trials, obtaining regulatory approvals, and marketing approved medicines than we do. Mergers and acquisitions
in the pharmaceutical, biotechnology, and diagnostic industries may result in even more resources being concentrated among a smaller
number of our competitors. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel
and in establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary
to or necessary for our programs. Smaller or early-stage companies may also prove to be significant competitors, particularly through
collaborative arrangements with large and established companies.

The
key competitive factors affecting the success of all of our product candidates, if approved, are likely to be their efficacy, safety,
convenience, price, the effectiveness of companion diagnostics in guiding the use of related therapeutics, if any, the level of generic
competition and the availability of reimbursement from government and other third-party payors.

Our
commercial opportunity could be reduced or eliminated if our competitors develop and commercialize medicines that are safer, are more
effective, have fewer or less severe side effects, are more convenient or are less expensive than any medicines we may develop. Our competitors
also may obtain FDA or other regulatory approval for their medicines more rapidly than we may obtain approval for ours, which could result
in our competitors establishing a strong market position before we are able to enter the market. In addition, our ability to compete
may be affected in many cases by insurers or other third-party payors seeking to encourage the use of generic medicines. There are many
generic medicines currently on the market for certain of the indications that we are pursuing, and additional generics are expected to
become available over the coming years. If our therapeutic product candidates are approved, we expect that they will be priced at a significant
premium over competitive generic medicines.

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

18

bfLEAPTM

The
analytics industry and application of AI/ML in healthcare is growing rapidly. Competition exists along the entire continuum of the drug
development process from discovery to commercialization and beyond. We believe the weakness of the industry is the quality of the data
and we believe bfLEAPTM provides several competitive advantages, that will position the Company for success, First, bfLEAPTM
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, bfLEAPTM 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. Finally,
the algorithms used by bfLEAPTM 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.

Government
Regulation

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

Our
clinical development programs will, in some cases, require regulatory review of preclinical and/or clinical data by the FDA or other
governing agencies, and subsequent compliance with applicable federal, state, local, and foreign statutes and regulations. The results
of the clinical trials that we conduct will be evaluated by the FDA and other regulatory bodies. The comments and approvals that are
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 bfLEAPTM platform, will de-risk the
development process and improve the chances for success.

Government
Regulation and Product Approval

Government
authorities in the United States, at the federal, state and local level, and in other countries and jurisdictions extensively regulate,
among other things, the research, development, testing, manufacture, quality control, approval, packaging, storage, recordkeeping, labeling,
advertising, promotion, distribution, marketing, post-approval monitoring and reporting, and import and export of pharmaceutical products.
The processes for obtaining regulatory approvals in the United States and in foreign countries and jurisdictions, along with subsequent
compliance with applicable statutes and regulations and other regulatory authorities, require the expenditure of substantial time and
financial resources.

FDA
Approval Process

In
the United States, pharmaceutical products are subject to extensive regulation by the FDA. The Federal Food, Drug, and Cosmetic Act (“FD&C
Act”) and other federal and state statutes and regulations govern, among other things, the research, development, testing, manufacture,
storage, recordkeeping, approval, labeling, promotion and marketing, distribution, post-approval monitoring and reporting, sampling and
import and export of pharmaceutical products. 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 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
before clinical testing may commence, and adequate and well-controlled clinical trials to establish the safety and effectiveness of the
drug for each indication for which FDA approval is sought. Satisfaction of FDA pre-market approval requirements typically takes many
years and the actual time required may vary substantially based upon the type, complexity and novelty of the product or disease.

19

Preclinical
tests include laboratory evaluation of product chemistry, formulation and toxicity, as well as animal trials to assess the characteristics
and potential safety and efficacy of the product. The conduct of the preclinical tests must comply with federal regulations and requirements,
including good laboratory practices. The results of preclinical testing are submitted to the FDA as part of an IND along with other information,
including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol. Long-term preclinical
tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted. A 30-day waiting period
after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA has neither commented
on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin. Clinical trials involve the administration
of the investigational new drug to healthy volunteers or patients under the supervision of a qualified investigator. Clinical trials
must be conducted: (i) in compliance with federal regulations; (ii) in compliance with good clinical practice, or GCP, an international
standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators, and monitors;
as well as (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness
criteria to be evaluated. Each protocol involving testing on United States patients and subsequent protocol amendments must be submitted
to the FDA as part of the IND.

Clinical
trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap. In Phase
I, the initial introduction of the drug into healthy human subjects or patients, the drug is tested to assess metabolism, pharmacokinetics,
pharmacological actions, side effects associated with increasing doses, and, if possible, early evidence of effectiveness. Phase II usually
involves trials in a limited patient population to determine the effectiveness of the drug for a particular indication, dosage tolerance
and optimum dosage, and to identify common adverse effects and safety risks. If a drug demonstrates evidence of effectiveness and an
acceptable safety profile in Phase II evaluations, Phase III trials are undertaken to obtain the additional information about clinical
efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit the FDA to
evaluate the overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug. In most
cases, the FDA requires two adequate and well-controlled Phase III clinical trials to demonstrate the efficacy of the drug. A single
Phase III trial with other confirmatory evidence may be sufficient in rare instances, such as where the study is a large multicenter
trial demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on mortality,
irreversible morbidity, or prevention of a disease with a potentially serious outcome and confirmation of the result in a second trial
would be practically or ethically impossible.

After
completion of the required clinical testing, an NDA is prepared and submitted to the FDA. FDA approval of the NDA is required before
marketing of the product may begin in the 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
annually. Sponsors of applications for drugs granted Orphan Drug Designation are exempt from these user fees.

The
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.

Before
approving an NDA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP. Additionally, the FDA will
inspect the facility or the facilities at which the drug is manufactured. The FDA will not approve the product unless compliance with
current good manufacturing practices (cGMPs) is satisfactory and the NDA contains data that provides substantial evidence that the drug
is safe and effective in the indication studied.

Fast
Track Designation

The
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 demonstrates the potential to address unmet
medical needs for the condition. Under the Fast Track program, the sponsor of a new drug candidate may request that the FDA designate
the drug candidate for a specific indication as a Fast Track drug concurrent with, or after, the filing of the IND for the drug candidate.
FDA must determine if the drug candidate qualifies for Fast Track Designation within 60 days of receipt of the sponsor’s request.

20

If
a submission is granted Fast Track Designation, the sponsor may engage in more frequent interactions with the FDA, and the FDA may review
sections of the NDA before the application is complete. This rolling review is available if the applicant provides, and the FDA approves,
a schedule for the submission of the remaining information and the applicant pays applicable user fees. However, the FDA’s time
period goal for reviewing an application does not begin until the last section of the NDA is submitted. While we may seek Fast Track
Designation, there is no guarantee that we will be successful in obtaining any such designation. Even if we do obtain such designation,
we may not experience a faster development process, review or approval compared to conventional FDA procedures. A Fast Track Designation
does not ensure that the product candidate will receive marketing approval or that approval will be granted within any particular timeframe.
Additionally, Fast Track Designation may be withdrawn by the FDA if the FDA believes that the designation is no longer supported by data
emerging in the clinical trial process.

Post-Approval
Requirements

Once
an NDA is approved, a product will be subject to certain post-approval requirements. For instance, the FDA closely regulates the post-approval
marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion, industry-sponsored
scientific and educational activities and promotional activities involving the internet. Drugs may be marketed only for the approved
indications and in accordance with the provisions of the approved labeling.

Adverse
event reporting and submission of periodic reports are required following FDA approval of an NDA. The FDA also may require post-marketing
testing, known as Phase IV testing, REMS and surveillance to monitor the effects of an approved product, or the FDA may place conditions
on an approval that could restrict the distribution or use of the product. In addition, quality control, drug manufacture, packaging
and labeling procedures must continue to conform to cGMPs after approval. Drug manufacturers and certain of their subcontractors are
required to register their establishments with FDA and certain state agencies. Registration with the FDA subjects entities to periodic
unannounced inspections by the FDA, during which the Agency inspects manufacturing facilities to assess compliance with cGMPs. Accordingly,
manufacturers must continue to expend time, money, and effort in the areas of production and quality-control to maintain compliance with
cGMPs. Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with regulatory
standards, if it encounters problems following initial marketing, or if previously unrecognized problems are subsequently discovered.

Generic
Competition

In
seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent whose claims cover the applicant’s
product. Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA’s Approved
Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Drugs listed in the Orange Book can, in turn,
be cited by potential generic competitors in support of approval of an abbreviated new drug application (“ANDA”). An ANDA
provides for marketing of a drug product that has the same active ingredients in the same strengths and dosage form as the listed drug
and has been shown through bioequivalence testing to be therapeutically equivalent to the listed drug. Other than the requirement for
bioequivalence testing, ANDA applicants are not required to conduct, or submit results of, preclinical or clinical tests to prove the
safety or effectiveness of their drug product. Drugs approved in this way are commonly referred to as “generic equivalents”
to the listed drug and can often be substituted by pharmacists under prescriptions written for the original listed drug.

The
ANDA applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDA’s Orange Book.
Specifically, the applicant must certify that (i) the required patent information has not been filed; (ii) the listed patent has expired;
(iii) the listed patent has not expired but will expire on a particular date and approval is sought after patent expiration; or (iv)
the listed patent is invalid or will not be infringed by the new product (a Paragraph IV certification). The ANDA applicant may also
elect to submit a section viii statement certifying that its proposed ANDA label does not contain (or carve out) any language regarding
the patented method-of-use rather than certify to a listed method-of-use patent. If the applicant does not challenge the listed patents
or certifies that the listed patents will not be infringed by the new product, the ANDA application will not be approved until all the
listed patents claiming the referenced product have expired. If the ANDA applicant has provided a Paragraph IV certification, the NDA
and patent holders may then initiate a patent infringement lawsuit in response. The filing of a patent infringement lawsuit within 45
days of the receipt of such a certification automatically prevents the FDA from approving the ANDA until the earlier of 30 months, expiration
of the patent, settlement of the lawsuit, or a decision in the infringement case that is favorable to the ANDA applicant.

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Exclusivity

Upon
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.

Patent
Term Extension

After
NDA approval, owners of relevant drug patents may apply for up to a five-year patent extension. The allowable patent term extension is
calculated as half of the drug’s testing phase (the time between IND application and NDA submission) and all of the review phase
(the time between NDA submission and approval up to a maximum of five years). The time can be shortened if the FDA determines that the
applicant did not pursue approval with due diligence. The total patent term after the extension may not exceed 14 years, and only one
patent can be extended. For patents that might expire during the application phase, the patent owner may request an interim patent extension.
An interim patent extension increases the patent term by one year and may be renewed up to four times. For each interim patent extension
granted, the post-approval patent extension is reduced by one year. The director of the United States Patent and Trademark Office must
determine that approval of the drug covered by the patent for which a patent extension is being sought is likely. Interim patent extensions
are not available for a drug for which an NDA has not been submitted.

Other
Healthcare Laws

In
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. Department 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. 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.

Also,
many states have similar fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid and other
state programs, or, in several states, apply regardless of the payor.

Data
privacy and security regulations by both the federal government and the states in which business is conducted may also be applicable.
HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations,
imposes requirements relating to the privacy, security and transmission of individually identifiable health information. HIPAA requires
covered entities to limit the use and disclosure of protected health information to specifically authorized situations and requires covered
entities to implement security measures to protect health information that they maintain in electronic form. Among other things, HITECH
made HIPAA’s security standards directly applicable to business associates, independent contractors or agents of covered entities
that receive or obtain protected health information in connection with providing a service on behalf of a covered entity. HITECH also
created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business
associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce
the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions. In addition, state laws
govern the privacy and security of health information in specified circumstances, many of which differ from each other in significant
ways and may not have the same effect, thus complicating compliance efforts.

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Insurance
Coverage and Reimbursement

Significant
uncertainty exists as to the insurance coverage and reimbursement status of any products for which we may obtain regulatory approval.
In the United States, sales of any product candidates for which regulatory approval for commercial sale is obtained will depend in part
on the availability of coverage and adequate reimbursement from third-party payors. Third-party payors include government authorities
and health programs in the United States such as Medicare and Medicaid, managed care providers, private health insurers and other organizations.
These third-party payors are increasingly reducing reimbursements for medical products and services. The process for determining whether
a payor will provide coverage for a drug product may be separate from the process for setting the reimbursement rate that the payor will
pay for the drug product. Third-party payors may limit coverage to specific drug products on an approved list, or formulary, which might
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.

Human
Capital Resources

As
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.

We
believe that our future success will depend, in part, on our continued ability to attract, hire and retain qualified personnel. In particular,
we depend on the skills, experience and performance of our senior management and R&D personnel. We compete for qualified personnel
with other healthcare technology, pharmaceutical, and healthcare companies, as well as universities and non-profit research institutions.
We provide competitive compensation and benefits programs to help meet the needs of our employees. In addition to salaries, these programs
include incentive compensation plans, healthcare and insurance benefits, a retirement plan, paid time off, and family leave, among others.
We also use targeted equity-based grants with vesting conditions to facilitate retention of personnel, particularly for our key employees.

Properties

Currently,
we do not own or lease any real property. All of our employees work virtually.

Legal
Proceedings

We
are not a party to any legal proceedings.

Corporate
Information

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

Available
Information

We
file annual, quarterly, and current reports, proxy statements and other information with the U.S. Securities Exchange Commission (the
“SEC”). 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.

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