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Item 1. Business

2025-03-31 compared with 2024-04-16 · 378 added, 210 removed, 83 unchanged (88% of the section changed)

believe the world needs—and deserves—a new approach to innovating that harnesses the power of large groups of stakeholders

who work together to ensure that the most promising innovations make it into the hands of people who need them most.

were incorporated in the State of Delaware on September 28, 2017, and our headquarters are in Richmond, Virginia.

The company was founded

with a mission of bringing stakeholders together, to transform promising innovations into products and services that could address some

of the most challenging needs.

The socialization of innovation through engaging stakeholders in every aspect of it, is key to transforming

more innovations, more rapidly, and more efficiently.

inception, the first innovation we took on was an immune modulation technology titled ADI/Adimune with a focus on prolonging life and

enhancing life quality of patients that have undergone organ transplants.

Since then, we expanded our portfolio of innovations, and we

continue to evaluate a variety of promising health innovations.

is not about a single idea or a single molecule.

It is about making sure the right innovation is made possible.

Our business model has

three main components as follows:

Overview and Mission

We believe the world needs—and

deserves—a new approach to innovating that harnesses the power of large groups of stakeholders who work together to ensure that

the most promising innovations make it into the hands of people who need them most.

We were incorporated in the

State of Delaware on September 28, 2017, and our headquarters are in Mountain View, California.

The company was founded with a mission

of bringing stakeholders together, to transform promising innovations into products and services that could address some of the most challenging

The socialization of innovation through engaging stakeholders in every aspect of it, is key to transforming more innovations, more

rapidly, and more efficiently.

At inception, the first innovation

we took on was an immune modulation technology titled ADI/Adimune with a focus on prolonging life and enhancing life quality of patients

that have undergone organ transplants.

Since then, we expanded our portfolio of innovations, and we continue to evaluate a variety of

promising health innovations.

Aditxt is not about a single

idea or a single molecule.

We believe that it is about making sure the right innovation is made possible.

Our business model has three

main components as follows:

Securing an Innovation:

Our process begins with identifying and securing innovations through licensing or acquisition of an innovation asset.

from a variety of sources including research institutions, government agencies, and private organizations.

Assets come from a variety of sources including research institutions, government agencies, and private organizations.

Growing an Innovation:

Once an innovation is secured, we surround it with activation resources that take a systemized approach to bringing that idea to

Our activation resources include innovation, operations, commercialization, finance, content and engagement, personnel, and

administration.

Once an innovation is secured, we surround it with activation resources that take a systemized approach to bringing that idea to life.

Our activation resources include innovation, operations, commercialization, finance, content and engagement, personnel, and administration.

Monetizing an Innovation:

Our goal is for each innovation to become commercial-stage and financially and operationally self-sustainable, to create shareholder

engage various stakeholders for each of our programs on every level.

This includes identifying researchers and research institution partners,

such as Stanford University;

Our goal is for each innovation to become commercial-stage and financially and operationally self-sustainable, to create shareholder value.

We engage various stakeholders

for each of our programs on every level.

This includes identifying researchers and research institution partners, such as Stanford University;

leading health institutions to get critical trials underway, such as Mayo Clinic;

manufacturing partners

who enable us to take innovations from preclinical to clinical;

municipalities and governments, such as the city of Richmond and the

state of Virginia and public health agencies who work with us to launch our program, Pearsanta’s laboratory;

and thousands of shareholders

around the globe.

We seek to enable promising innovation to become purposeful products that have the power to change lives.

Value Proposition

believe that far too often, promising treatment or technology does not reach commercialization due to lack of expertise, key resources,

or efficiency.

As a result, potentially life-changing and lifesaving treatments are not available to the individuals who so desperately

seeks to bring the holistic concept of an efficient, socialized ecosystem for advancing and accelerating innovations.

seek to license or acquire promising innovations.

We will then form and build out a subsidiary around each innovation and support the

subsidiaries through innovation, operation, commercialization, content and engagement, finance, personnel, and administration to thrive

and grow as a successful, monetizable business.

our inception, we have built infrastructure consisting of innovation, operation, commercialization, content and engagement, finance,

personnel, and administration, to support the rapid transformation of untapped innovations.

Each of the main components of our infrastructure

has established global access to partnerships with industry leaders, top-rated research and medical institutions, universities, manufacturing

and distribution companies, and critical infrastructure such as CLIA-certified state-of-the art labs and GMP manufacturing.

Shifting Landscape of Innovation

manufacturing partners who enable us to take innovations

from preclinical to clinical;

municipalities and governments, such as the city of Richmond and the state of Virginia and public health

agencies who work with us to launch our program, Pearsanta’s laboratory;

and thousands of shareholders around the globe.

to enable promising innovation to become purposeful products that have the power to change lives.

Our Value Proposition

We believe that far too often,

promising treatment or technology does not reach commercialization due to lack of expertise, key resources, or efficiency.

potentially life-changing and lifesaving treatments are not available to the individuals who so desperately need them.

Aditxt seeks to bring the holistic

concept of an efficient, socialized ecosystem for advancing and accelerating innovations.

We seek to license or acquire promising

We will then form and build out a subsidiary around each innovation and support the subsidiaries through innovation, operation,

commercialization, content and engagement, finance, personnel, and administration to thrive and grow as a successful, monetizable business.

Since our inception, we have

built infrastructure consisting of innovation, operation, commercialization, content and engagement, finance, personnel, and administration,

to support the rapid transformation of untapped innovations.

Each of the main components of our infrastructure has established global

access to partnerships with industry leaders, top-rated research and medical institutions, universities, manufacturing and distribution

companies, and critical infrastructure such as CLIA-certified state-of-the art labs and manufacturing.

The Shifting Landscape of Innovation

in general, and health innovations specifically, require significant resources.

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Promising Innovations Possible, Together”.

deserve innovative solutions, which have never been more within reach.

We believe the best idea, best product and the best solution will

come from creating an ecosystem where all stakeholders, such as vendors, customers, municipalities, and shareholders contribute.

we disrupt the way we’re innovating, through our collaborative model, we believe we can move faster and more efficiently to activate

viable solutions that have the potential to make a measurable impact.

Growth Strategy

believe that the era of precision and personalized medicine is here and that people around the globe would benefit from health diagnostics

and treatments that more accurately pinpoint the problems and more precisely treat the condition.

In addition to our current programs,

Adimune and Pearsanta, we look to bring in future health innovations in the areas of software and AI, medical devices, therapeutics,

and other technologies that take a fundamentally different approach to health because they prioritize personalized precision medicine,

timely disease root cause analysis, and targeted treatments.

over year, we plan to continue building our infrastructure and securing more personalized and precision health innovations that align

with our mission.

These opportunities may come in different forms such as IP, an early-stage company, or a late-stage company.

continue to scale our systemized approach to the innovation process, making large-scale automation and enterprise systems available to

our portfolio companies at every stage of their growth.

Specifically, certain subsidiaries will need to grow through further M&A

activities, operational infrastructure implementation, and development or acquisition of critical technologies.

is led by an entrepreneurial team with passion for transforming promising innovations into successful businesses.

Our leadership come

from a variety of different industries, with collective expertise in founding startup innovation companies, developing and marketing

biopharmaceutical and diagnostic products, designing clinical trials, manufacturing, and management of private and public companies.

We have deep experience in identifying and accessing promising health innovations and developing them into products and services with

the ability to scale.

We understand the capital markets, both public and private, as well as M&A and facilitating complex IPOs.

following are profiles of three subsidiaries we have formed, including the terms of the intellectual property licenses that have been

sublicensed from Aditxt to help build each of the businesses.

ADITXT PROGRAMS

in January 2023, Adimune™, Inc.

We believe that people deserve

innovative solutions, which have never been more within reach.

We believe the best idea, best product and the best solution will come

from creating an ecosystem where all stakeholders, such as vendors, customers, municipalities, and shareholders contribute.

When we disrupt

the way we’re innovating, through our collaborative model, we believe we can move faster and more efficiently to activate viable

solutions that have the potential to make a measurable impact.

Our Growth Strategy

We believe that the era of

precision and personalized medicine is here and that people around the globe would benefit from health diagnostics and treatments that

more accurately pinpoint the problems and more precisely treat the condition.

In addition to our current programs, Adimune and Pearsanta,

we look to bring in future health innovations in the areas of software and AI, medical devices, therapeutics, and other technologies that

take a fundamentally different approach to health because they prioritize personalized precision medicine, timely disease root cause analysis,

and targeted treatments.

Year over year, we plan to

continue building our infrastructure and securing more personalized and precision health innovations that align with our mission.

opportunities may come in different forms such as IP, an early-stage company, or a late-stage company.

We will continue to scale our systemized

approach to the innovation process, making large-scale automation and enterprise systems available to our portfolio companies at every

stage of their growth.

Specifically, certain subsidiaries will need to grow through further M&A activities, operational infrastructure

implementation, and development or acquisition of critical technologies.

Aditxt is led by an entrepreneurial

team with passion for transforming promising innovations into successful businesses.

Our leadership come from a variety of different industries,

with collective expertise in founding startup innovation companies, developing and marketing biopharmaceutical and diagnostic products,

designing clinical trials, manufacturing, and management of private and public companies.

We have deep experience in identifying and accessing

promising health innovations and developing them into products and services with the ability to scale.

We understand the capital markets,

both public and private, as well as M&A and facilitating complex IPOs.

The following are profiles

of three subsidiaries we have formed, including the terms of the intellectual property licenses that have been sublicensed from Aditxt

to help build each of the businesses.

THE ADITXT PROGRAMS

We are a commercial-stage company

with a mission of bringing stakeholders together, to transform promising innovations into products and services that could address some

of the most challenging needs .

Our current focus spans five critical areas:

immune health, precision health, population health,

women’s health, and neurologic health.

We are developing a robust portfolio and pipeline of products at various stages of development

and also regularly seek to acquire complementary assets and products through acquisitions and other strategic transactions.

below is a summary of our current programs.

Immune Health

Type 1 diabetes

Immune Health

Stiff-persons syndrome

Immune Health

Skin allografting

Precision Health

AditxtScore Ab

Precision Health

AditxtScore NAb

Precision Health

Endometriosis

Precision Health

Flu A/B, COVID

Precision Health

AditxtScore T1D

Type 1 diabetes

Precision Health

AditxtScore CNS

Brain Scientific

NeuroCap/NeuroEEG

Epilepsy/TBI/Dementia

ADIMUNE, INC.

Formed in January 2023, Adimune™,

(“Adimune”) is focused on leading our immune modulation therapeutic programs.

proprietary immune modulation product Apoptotic DNA Immunotherapy™, or ADI-100™, utilizes a novel approach that mimics the

way our bodies naturally induce tolerance to our own tissues.

Adimune’s proprietary immune modulation

product Apoptotic DNA Immunotherapy™ (ADI™) utilizes a novel approach that mimics the way our bodies naturally induce tolerance

to our own tissues.

It includes two DNA molecules designed to deliver signals to induce tolerance.

ADI-100 has been successfully tested in several preclinical models (e.g., skin grafting, psoriasis, type 1 diabetes, multiple sclerosis).

May 2023, Adimune entered into a clinical trial agreement with Mayo Clinic to advance clinical studies targeting autoimmune diseases

of the central nervous system (“CNS”) with the initial focus on the rare, but debilitating, autoimmune disease Stiff Person

Syndrome (“SPS”).

According to the National Organization of Rare Diseases, the exact incidence and prevalence of SPS is unknown;

ADI-100, the first product candidate

based on the ADI platform, is designed to tolerize against an antigen known as glutamic acid decarboxylase (“GAD”), which

is implicated in type-1 diabetes, psoriasis, and in many autoimmune diseases of the CNS and has been successfully tested in several preclinical

models (e.g., skin grafting, psoriasis, type 1 diabetes, multiple sclerosis).

All preclinical studies ADI-100

have been completed providing several data points supporting the potential effectiveness of ADI-100 in restoring durable tolerance over

the 10-month duration of the T1D studies both in prevention and treatment study designs.

Preclinical safety and toxicology studies have

shown absence of drug toxicity, no antibody formation to the drug product, and a lack of persistence in all organs evaluated.

Adimune has demonstrated in three separate preclinical studies that ADI-100 does not impair the responsiveness of the immune system to

combat infection, cancer, or the tumor fighting capabilities of checkpoint inhibitors.

Good Manufacturing Process

(GMP) clinical-grade drug substances have been successfully manufactured by a qualified contract manufacturer.

The clinical grade drug

substances are now being prepared for shipment to another contract manufacturer to be formulated into the final drug product in preparation

for stability testing and use in the clinical trials pending required regulatory submissions.

Lastly, two remaining drug product release

assays specifically designed for ADI-100 are in the final stages of validation to be used once the final drug product is ready.

Preclinical and manufacturing

data, including the clinical-grade drug substance, are essential components of the complete dossier that we intend to submit to the regulatory

agencies, which evaluate the safety and quality of the final drug product to be administered in the clinical trials.

Adimune has had pre-submission

meetings with the regulatory agency in Germany and has completed the additional studies requested.

For the clinical trials that

are planned in Germany, Adimune has engaged with a Contract Research Organization (CRO) to manage the process, including site selection

for clinical studies planned in psoriasis and type 1 diabetes.

In parallel, Adimune is working with the Mayo Clinic to prepare the IND

package for FDA submission and is awaiting a pre-IND meeting expected in the second quarter of this year to review the package before

full submission.

In May 2023, Adimune entered into a clinical trial agreement with Mayo Clinic to advance clinical studies targeting autoimmune

diseases of the central nervous system (“CNS”) with the initial focus on the rare, but debilitating, autoimmune disease Stiff

Person Syndrome (“SPS”).

According to the National Organization of Rare Diseases, the exact incidence and prevalence of SPS

however, one estimate places the incidence at approximately one in one million individuals in the general population.

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ADI-100 will initially be tested for safety and efficacy.

ADI-100 is designed to tolerize against an antigen known as glutamic acid decarboxylase (“GAD”), which is implicated in type-1

diabetes, psoriasis, and in many autoimmune diseases of the CNS.

IND-enabling work is also near completion in support of a Clinical

Trial Application submission to the Paul Ehrlich Institute, the regulatory agency in Germany, to initiate clinical trials in psoriasis

and type 1 diabetes.

discovery of immunosuppressive (anti-rejection and monoclonal) drugs over 40 years ago has made possible life-saving organ transplantation

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than five years.

Aditxt, Adimune has the right of use to the exclusive worldwide license for commercializing ADI nucleic acid-based technology (which

is currently at the pre-clinical stage) from Loma Linda University.

ADI uses a novel approach that mimics the way the body naturally

induces tolerance to our own tissues (“therapeutically induced immune tolerance”).

While immune suppression requires continuous

administration to prevent rejection of a transplanted organ, induction of tolerance has the potential to retrain the immune system to

accept the organ for longer periods of time.

ADI may allow patients to live with transplanted organs with significantly reduced immune

ADI is a technology platform which we believe can be engineered to address a wide variety of indications.

Aditxt, Adimune has the right of use to the exclusive worldwide license for commercializing ADI nucleic acid-based technology (which is

currently at the pre-clinical stage) from Loma Linda University.

ADI uses a novel approach that mimics the way the body naturally induces

tolerance to our own tissues (“therapeutically induced immune tolerance”).

While immune suppression requires continuous administration

to prevent rejection of a transplanted organ, induction of tolerance has the potential to retrain the immune system to accept the organ

for longer periods of time.

ADI may allow patients to live with transplanted organs with significantly reduced immune suppression.

is a technology platform which we believe can be engineered to address a wide variety of indications.

is a nucleic acid-based technology ( e.g.

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system to accept the tissues, similar to how natural apoptosis reminds our immune system to be tolerant to our own “self”

various groups have promoted tolerance through cell therapies and ex vivo manipulation of patient cells (i.e., takes

place outside the body), to our knowledge, we will be unique in our approach of using in-body induction of apoptosis to promote tolerance

to specific tissues.

In addition, ADI treatment itself will not require additional hospitalization but only an injection of minute

amounts of the therapeutic drug into the skin.

While various groups have promoted tolerance through

cell therapies and ex vivo manipulation of patient cells (i.e., takes place outside the body), to our knowledge, we will

be unique in our approach of using in-body induction of apoptosis to promote tolerance to specific tissues.

In addition, ADI treatment

itself will not require additional hospitalization but only an injection of minute amounts of the therapeutic drug into the skin.

preclinical studies have demonstrated that ADI treatment significantly and substantially prolongs graft survival, in addition to successfully

“reversing” other established immune-mediated inflammatory processes.

Agreement with Loma Linda University (“LLU”)

March 15, 2018, we entered into a License Agreement with LLU, which was subsequently amended on July 1, 2020.

Pursuant to the LLU License

Agreement, we obtained the exclusive royalty-bearing worldwide license to all intellectual property, including patents, technical information,

trade secrets, proprietary rights, technology, know-how, data, formulas, drawings, and specifications, owned or controlled by LLU and/or

any of its affiliates (the “LLU Patent and Technology Rights”) and related to therapy for immune-mediated inflammatory diseases

(the Adi™ technology).

License Agreement with Loma Linda University (“LLU”)

On March 15, 2018, we entered

into a License Agreement with LLU, which was subsequently amended on July 1, 2020.

Pursuant to the LLU License Agreement, we obtained

the exclusive royalty-bearing worldwide license to all intellectual property, including patents, technical information, trade secrets,

proprietary rights, technology, know-how, data, formulas, drawings, and specifications, owned or controlled by LLU and/or any of its affiliates

(the “LLU Patent and Technology Rights”) and related to therapy for immune-mediated inflammatory diseases (the Adi™

In consideration for the LLU License Agreement, we issued 1 shares of Common Stock to LLU.

Formed in January 2023, our majority owned subsidiary Pearsanta™,

(“Pearsanta”) seeks to take personalized medicine to a new level by delivering “Health by the Numbers.” On

November 22, 2023, Pearsanta entered into an assignment agreement with FirstVitals LLC, an entity controlled by Pearsanta’s CEO,

Ernie Lee (“FirstVitals”), pursuant to which FirstVitals assigned its rights in certain intellectual property and website

domain to Pearsanta in consideration of the issuance of 500,000 shares of Pearsanta common stock to FirstVitals.

On December 18, 2023,

the board of directors of Pearsanta adopted the Pearsanta 2023 Omnibus Equity Incentive Plan (the “Pearsanta Omnibus Incentive Plan”),

pursuant to which it reserved 15 million shares of common stock of Pearsanta for future issuance under the Pearsanta Omnibus Incentive

Plan and the Pearsanta 2023 Parent Service Provider Equity Incentive Plan (the “Pearsanta Parent Service Provider Plan”) and

approved the issuance of 9.32 million options, exercisable into shares of Pearsanta common stock under the Pearsanta Parent Service Provider

Plan and the issuance of 4.0 million options, exercisable into shares of Pearsanta common stock, subject to vesting, and 1.0 million restricted

common stock shares under the Pearsanta Omnibus Incentive Plan.

its founding, Pearsanta has been building the platform for enabling our vision of lab quality testing, anytime, anywhere.

Pearsanta’s platform is for it to be the transactional backbone for sample collection, sample processing (on- and off-site), and

This will require the development and convergence of multiple components developed by Pearsanta, or through transactions with

third parties, including collection devices, “lab-on-a-chip” technologies, Lab Developed Test (LDT) assays, a data-driven

analysis engine, and telemedicine.

According to a comprehensive research report by Market Research Future, the clinical and consumer

diagnostic market is estimated to hit $429.3 billion by 2030.

believe that timely and personalized testing enables far more informed treatment decisions.

Pearsanta’s platform is being developed

as a seamless digital healthcare solution.

This platform will integrate at-location sample collection, Point-of-Care (“POC”)

and LDT assays, and an analytical reporting engine, with telemedicine-enabled visits with licensed physicians to review test results

and, if necessary, order a prescription.

Pearsanta’s goal of extending its platform to enable consumers to monitor their health

more proactively as the goal is to provide a more complete picture about someone’s dynamic health status, factoring in genetic

makeup and their response to medication.

The POC component of Pearsanta would enable diagnostic testing at-home, at work, in pharmacies,

and more to generate results quickly so that an individual can access necessary treatment faster.

With certain infections, prescribing

the most effective treatment according to one’s numbers can prevent hospital emergency room admissions and potentially life-threatening

consequences.

of indication-focused tests for the evaluation of advanced urinary tract infections (“UTIs”),

COVID-19/flu/respiratory syncytial virus, sexually transmitted infections, gut health, pharmacogenomics (i.e., how your genes affect

the way your body responds to certain therapeutics), and sepsis.

We believe that these offerings are novel and needed as the current

standard of care using broad spectrum antibiotic treatment can be ineffective and potentially life-threatening.

For example, improperly

prescribed antibiotics may approach 50% of outpatient cases.

Further, according to an article published in Physician’s Weekly,

only 1% of board-certified critical care medicine physicians are trained in infectious disease.

Technologies – AditxtScore TM

PEARSANTA, INC.

Formed in January 2023, our

majority owned subsidiary Pearsanta™, Inc.

(“Pearsanta”) seeks to take personalized medicine to a new level by delivering

“Health by the Numbers.” On November 22, 2023, Pearsanta entered into an assignment agreement with FirstVitals LLC, an entity

controlled by Pearsanta’s CEO, Ernie Lee (“FirstVitals”), pursuant to which FirstVitals assigned its rights in certain

intellectual property and website domain to Pearsanta in consideration of the issuance of 8,334 shares of Pearsanta common stock to FirstVitals.

On December 18, 2023, the board of directors of Pearsanta adopted the Pearsanta 2023 Omnibus Equity Incentive Plan (the “Pearsanta

Omnibus Incentive Plan”), pursuant to which it reserved 15 million shares of common stock of Pearsanta for future issuance under

the Pearsanta Omnibus Incentive Plan and the Pearsanta 2023 Parent Service Provider Equity Incentive Plan (the “Pearsanta Parent

Service Provider Plan”) and approved the issuance of 9.32 million options, exercisable into shares of Pearsanta common stock under

the Pearsanta Parent Service Provider Plan and the issuance of 4.0 million options, exercisable into shares of Pearsanta common stock,

subject to vesting, and 1.0 million restricted common stock shares under the Pearsanta Omnibus Incentive Plan.

On January 4, 2024, Pearsanta

completed its acquisition of certain assets of MDNA Life Sciences Inc., pursuant to which Pearsanta acquired the Mitomic® Technology

platform, patents, and intellectual property in consideration of 5 shares of the Company’s Common Stock, Warrants to purchase 5 shares

of the Company’s Common Stock, and 5,000 shares of the Pearsanta Series A Convertible Preferred Stock.

On January 13,

2025, the Company announced that its Board of Directors authorized management to explore taking Pearsanta public via a proposed initial

public offering in 2025.

On March 21, 2025, Pearsanta

acquired certain patents related to the detection of DNA adducts for detection of changes to the DNA that may lead to potentially disease-causing

mutations, in consideration of 200 shares of Pearsanta Series B Preferred Stock.

We believe that the best approach

may be its early detection.

Pearsanta is pioneering the development of molecular tests based on the mitochondrial genome to develop tests

for early detection of cancer.

Though further technical development and clinical validation is required to determine efficacy in multiple

diseases and disease states, our management believes that the unique structural and functional characteristics of mitochondrial DNA (mtDNA),

and more specifically mutated mtDNA, make mtDNA a biological system for biomarker identification, early disease detection, monitoring,

risk assessment, and therapeutic targeting.

Pearsanta acquired the assets

of MDNA Life Sciences Inc.

on January 4, 2024.

Through the acquisition of these assets, and in particular the Mitomic Technology platform,

patents, and intellectual property, our management believes that the Pearsanta is well positioned for research and discovery of mitochondrial

DNA based biomarkers, and though untested and requiring clinical validation, the development and commercial application of mitochondrial

DNA based biomarkers for a wide spectrum of human diseases.

Pearsanta is continuing to

leverage this technology to discover mitochondrial DNA based biomarkers.

Though Pearsanta has no commercially available FDA or foreign

regulator approved products, Pearsanta has two product candidates in develop and hopes to enter the cancer screening market with these

two product candidates, and if proven successful continue to discover mitochondrial DNA based biomarkers and develop a pipeline of disease

screening and diagnostics tests.

The current in-development products include a potential product for prostate cancer diagnosis and a potential

product for the detection of endometriosis.

Pearsanta has also discovered mitochondrial DNA based biomarkers, which it believes are associated

with ovarian cancer and lung cancer;

and Pearsanta intends to pursue the biomarker identification phase of development for pancreatic,

liver, breast, stomach, esophageal, and colorectal cancers.

Licensed Technologies – AditxtScore TM

issued Pearsanta an exclusive worldwide sub-license for commercializing the AditxtScore™ technology which provides a personalized

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drugs, supplements, bone marrow and solid organ transplants, and cancer.

It has broad applicability to many other agents of clinical

interest impacting the immune system, including those not yet identified such as emerging infectious agents.

is being designed to enable individuals and their healthcare providers to understand, manage and monitor their immune profiles and to

stay informed about attacks on or by their immune system.

We believe AditxtScore can also assist the medical community and individuals

by being able to anticipate the immune system’s potential response to viruses, bacteria, allergens, and foreign tissues such as

transplanted organs.

This technology may be able to serve as a warning signal, thereby allowing for more time to respond appropriately.

Its advantages include the ability to provide simple, rapid, accurate, high throughput assays that can be multiplexed to determine the

immune status with respect to several factors simultaneously, in approximately 3-16 hours.

In addition, it can determine and differentiate

between distinct types of cellular and humoral immune responses (e.g., T and B cells and other cell types).

It also provides for simultaneous

monitoring of cell activation and levels of cytokine release (i.e., cytokine storms).

are actively involved in the regulatory approval process for AditxtScore assays for clinical use and securing manufacturing, marketing,

and distribution partnerships for application in the various markets.

To obtain regulatory approval to use AditxtScore as a clinical

assay, we have conducted validation studies to evaluate its performance in detection of antibodies and plan to continue conducting additional

validation studies for new applications in autoimmune diseases.

It has broad applicability to many other agents of clinical interest

impacting the immune system, including those not yet identified such as emerging infectious agents.

AditxtScore is being developed

to enable individuals and their healthcare providers to understand, manage and monitor their immune profiles and to stay informed about

attacks on or by their immune system.

We believe AditxtScore can also assist the medical community and individuals by being able to anticipate

the immune system’s potential response to viruses, bacteria, allergens, and foreign tissues such as transplanted organs.

This technology

may be able to serve as a warning signal, thereby allowing for more time to respond appropriately.

Its advantages include the ability

to provide simple, rapid, accurate, high throughput assays that can be multiplexed to determine the immune status with respect to several

factors simultaneously, in approximately 3-16 hours.

In addition, it can determine and differentiate between distinct types of cellular

and humoral immune responses (e.g., T and B cells and other cell types).

It also provides for simultaneous monitoring of cell activation

and levels of cytokine release (i.e., cytokine storms).

collaboration with its partners, the platforms underlying AditxtScore are being further evaluated for evaluating the immune status of

individuals including those with hypersensitivity to certain antigens (e.g., patients with autoimmunity).

These tests may become tools

that can monitor dynamic changes after administration of immunotherapies designed to tolerize to these target antigens.

sophistication of the AditxtScore technology includes the following:

sensitivity/specificity.

higher dynamic range, greatly reducing signal to noise compared to conventional assays.

to customize assays and multiplex a large number of analytes with speed and efficiency.

to test for cellular immune responses (i.e., T and B cells and cytokines).

● proprietary

reporting algorithm.

Agreement with Leland Stanford Junior University (“Stanford”)

February 3, 2020, we entered into an exclusive license agreement (the “February 2020 License Agreement”) with Stanford with

regard to a patent concerning a method for detection and measurement of specific cellular responses.

Pursuant to the February 2020 License

Agreement, we received an exclusive worldwide license to Stanford’s patent with regard to use, import, offer, and sale of Licensed

Products (as defined in the agreement).

The license to the patented technology is exclusive, including the right to sublicense, beginning

on the effective date of the agreement, and ending when the patent expires.

Under the exclusivity agreement, we acknowledged that Stanford

had already granted a non-exclusive license in the Nonexclusive Field of Use, under the Licensed Patents in the Licensed Field of Use

in the Licensed Territory (as those terms are defined in the “February 2020 License Agreement”).

However, Stanford agreed

not to grant further licenses under the Licensed Patents in the Licensed Field of Use in the Licensed Territory.

On December 29, 2021,

we entered into an amendment to the February 2020 License Agreement which extended our exclusive right to license the technology deployed

in AditxtScore TM and securing worldwide exclusivity in all fields of use of the licensed technology.

in April of 2023, Adivir™, Inc.

is a wholly owned subsidiary, dedicated to the clinical and commercial development of innovative

products, including anti-viral and other anti-infective products, for population health.

These products have the potential to address

a wide range of infectious diseases, including those that currently lack viable treatment options.

greater sensitivity/specificity.

20-fold higher dynamic range, greatly reducing signal to noise compared to conventional assays.

ability to customize assays and multiplex a large number of analytes with speed and efficiency.

ability to test for cellular immune responses (i.e., T and B cells and cytokines).

proprietary reporting algorithm.

License Agreement with Leland Stanford Junior University (“Stanford”)

On February 3, 2020, we entered

into an exclusive license agreement (the “February 2020 License Agreement”) with Stanford with regard to a patent concerning

a method for detection and measurement of specific cellular responses.

Pursuant to the February 2020 License Agreement, we received an

exclusive worldwide license to Stanford’s patent with regard to use, import, offer, and sale of Licensed Products (as defined in

the agreement).

The license to the patented technology is exclusive, including the right to sublicense, beginning on the effective date

of the agreement, and ending when the patent expires.

Under the exclusivity agreement, we acknowledged that Stanford had already granted

a non-exclusive license in the Nonexclusive Field of Use, under the Licensed Patents in the Licensed Field of Use in the Licensed Territory

(as those terms are defined in the “February 2020 License Agreement”).

However, Stanford agreed not to grant further licenses

under the Licensed Patents in the Licensed Field of Use in the Licensed Territory.

On December 29, 2021, we entered into an amendment

to the February 2020 License Agreement which extended our exclusive right to license the technology deployed in AditxtScore TM and

securing worldwide exclusivity in all fields of use of the licensed technology.

Acquired Technologies – Mitomic®

Technology Platform

In January 2024 Pearsanta acquired

the assets comprising our Mitomic® Technology platform from MDNA Life Sciences Inc.

This platform seeks to harness the unique properties

of mitochondrial DNA (“mtDNA”) to detect disease through non-invasive, blood-based liquid biopsies.

Though further technical

development and clinical validation is required to determine efficacy in multiple diseases and disease states, our management believes

that the unique structural and functional characteristics of mtDNA, and more specifically mutated mtDNA, make mtDNA a biological system

for biomarker identification, early disease detection, monitoring, risk assessment, and therapeutic targeting.

Pearsanta plans to license

distribution rights through various agreements with U.S.-based and international business partners to commercialize our Mitomic® Technology,

should Mitomic® tests be successfully developed and successfully approved by the FDA or a foreign regulator.

We believe our biomarker

portfolio covers many high-clinical need cancers, with potential applications outside oncology.

Aditxt leases and operates

a state-of-the-art facility located in Richmond VA, that is a high-complexity, CLIA-certified, and CAP-accredited laboratory equipped

to accommodate rapid development and rollout of innovative laboratory tests for the clinical market.

Our laboratory facility is optimized

for contamination prevention including dedicated workspaces for key functions;

advanced molecular biology capabilities including digital

PCR, real-time PCR, automated electrophoresis with scale-up capacity and redundancy;

and automated and semi-automated (robotic) processes

for DNA/RNA isolation and liquid handling to achieve efficient and standardized workflows.

Our Mitomic® Products and Product Candidates

The Mitomic® Technology

targets mutations in mitochondrial DNA to detect disease.

Every human cell is home to multiple copies of mitochondrial DNA, some of which

become mutated beyond repair when cells are stressed by diseases such as cancer.

Though further technical development and clinical validation

is required to determine efficacy, Mitomic® tests are being designed to detect this mutated DNA, which can accumulate from the very

early stages of a disease.

If the development of Mitomic® tests is successful and if Mitomic® tests can achieve their still unproven

objective of early disease detection, our Mitomic® Technology presents an opportunity to detect disease before it presents clinically.

The Mitomic® Technology

platform is designed to identify biomarker targets, develop robust assays, discover new biomarkers, and develop new products.

The biomarker

identification program is based on the identification of a new class of molecules generated through a process associated with mitochondria.

The Mitomic® Technology platform has already discovered biomarkers which are believed to be associated with cancer and has generated

an “in-silico” database, which is an experiment that generates thousands of potential biomarkers, developed through computer

software and simulation.

To date, the Mitomic® Technology

biomarker discoveries have identified numerous biomarker targets from the in-silico database and we plan to use these biomarker targets

in its various assay development programs.

Mitomic® Prostate Test

(MPT™) is currently in development and is being designed as a blood-based assay that quantifies the level of the 3.4kb mitochondrial

DNA deletion.

Published analytical data for the 3.4kb mitochondrial DNA deletion associated with prostate cancer, suggests the 3.4kb mitochondrial

DNA deletion may be able to identify clinically significant prostate cancer for men in the prostate-specific antigen (PSA) grey zone (PSA

< 10ng/ml) and if proven through ongoing clinical study, the 3.4kb mitochondrial DNA deletion may be able to aid in the decision to

Some of the significant clinical challenges that have not been met for prostate cancer are that up to 50% of men will be ‘over’

diagnosed with cancer that never harms them 1 and the risks associated with treatment of low-grade cancers (≤ Gleason 6)

appear to outweigh the benefits –e.g.

urinary incontinence, erectile dysfunction.

1 NIH National Cancer Institute reports

this number is even higher at ~ 75% based on 5-year survival rates.

Seer database (https://seer.cancer.gov/statfacts/html/prost.html).

Our Mitomic® Prostate Test

is in development and is being designed with the following objectives:

– The test is expected to be completed using a patient’s blood sample and is not expected to require an algorithm.

New Information – If ongoing clinical studies support the published analytical data for the 3.4kb mitochondrial DNA deletion, healthcare

providers will be provided with new information related to clinically significant prostate cancer – independent of PSA, age, and

family history.

Mitomic Endometriosis Test

(MET™) is currently in development and is being designed as a blood-based assay that quantifies the level of one or more mitochondrial

DNA deletions which published analytical data suggest are associated with endometriosis – a condition affecting approximately 1

in 10 women according to Endometriosis World and the World Health Organization.

The Mitomic Endometriosis Test is intended for use in

females of child-bearing age who present symptoms of endometriosis to determine whether medical or surgical intervention is warranted.

Endometriosis occurs when the

tissue of the uterus (endometrium) grows on areas where it does not belong, most often on the ovaries, fallopian tubes, outer surface

of the uterus, and tissues holding the uterus, but can be found almost anywhere in the body.

Endometriosis is challenging to identify,

and on average takes ten years to diagnose, and when patients are finally diagnosed, greater than 90% have moderate to severe symptoms.

Acquired Technologies – Adductomics Technology

On March 21 ,

2025, Pearsanta acquired certain patents related to the detection and analysis of DNA adducts.

DNA adducts are chemically modified nucleotides

that result from exposure to carcinogens and other damaging agents, serving as early indicators of genomic instability and increased cancer

The acquired technology includes proprietary mass-tag enhancements designed to improve the sensitivity and specificity of DNA adduct

detection across a full genomic landscape.

Pearsanta intends to develop this platform to enable

a comprehensive, panoramic assessment of DNA adducts using urine, blood, or solid tissue samples.

This approach aims to provide actionable

insights into DNA damage before mutations occur, offering the potential to identify environmental or biological factors that contribute

to cancer risk.

The development roadmap includes further validation of the technology and the creation of commercially available diagnostic

While still in the early stages, Pearsanta anticipates that additional development over the next two to three years will advance

this platform toward clinical and commercial applications.

Formed in April of 2023, Adivir™,

is a wholly owned subsidiary, dedicated to the clinical and commercial development of innovative products, including anti-viral and

other anti-infective products, for population health.

These products have the potential to address a wide range of infectious diseases,

including those that currently lack viable treatment options.

April 18, 2023, we entered into an Asset Purchase Agreement (the “Asset Purchase Agreement”) with Cellvera Global Holdings

12 unchanged sentences

cash, and (B) future revenue sharing payments for a term of seven years.

GRA holds an exclusive, worldwide license for the antiviral

medication, Avigan® 200mg, excluding Japan, China and Russia.

GRA holds an exclusive, worldwide license for the antiviral medication,

Avigan® 200mg, excluding Japan, China and Russia.

The other 50% interest in GRA is held by Agility, Inc.

15 unchanged sentences

by the Company of a release from Agility;

(vi) Execution

of an agreement acceptable to the Company with respect to the acquisition by the Company of certain intellectual property presently held

by a third party;

(vii) Execution

of an amendment to an asset purchase agreement previously entered into by Cellvera with a third party that effectively grants the Company

the rights to acquire the intellectual property from the third party under such agreement;

Execution of an agreement acceptable to the Company with respect to the acquisition by the Company of certain intellectual property presently held by a third party;

Execution of an amendment to an asset purchase agreement previously entered into by Cellvera with a third party that effectively grants the Company the rights to acquire the intellectual property from the third party under such agreement;

(viii) Receipt

2 unchanged sentences

Owner, to the sale and purchase of the Acquired Assets and Assumed Liabilities pursuant to the Assert Purchase Agreement.

can be no assurance that the conditions to closing will be satisfied or that the proposed acquisition will be completed as proposed or

October 2024, the Company received notice that Cellvera was the subject of a liquidation proceeding and that a liquidator had been appointed

by the order of the Eastern Caribbean Supreme Court.

As a result, the Company does not presently believe that the proposed

acquisition of Cellvera will be completed as proposed or at all.

Our commitment to building

2 unchanged sentences

need to uncover new treatments or commercialize existing ones that treat life-threatening global viral infections.

have forty-seven (47) full time employees as of December 31, 2023.

We consider the relations

with our employees to be good.

We twenty-six (26) full

time employees as of December 31, 2024.

We consider the relations with our employees to be good.

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