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Item 1. Business

2024-04-16 compared with 2023-04-17 · 289 added, 647 removed, 4 unchanged (100% of the section changed)

We are an innovation company with a mission of

Making Promising Innovations Possible, Together.

We develop, build, and grow innovations with a focus on monitoring and modulating the

immune system.

We take a socialized approach to innovation by engaging stakeholders into all aspects of the process.

Our innovation portfolio includes

the following programs:

- Adimune™ - Immune modulation technologies which are

currently at the pre-clinical stage and are designed to retrain the immune system to induce tolerance with an objective of addressing

rejection of transplanted organs, autoimmune diseases, and allergies.

- AditxtScore™ - Immune monitoring technologies designed

to provide a personalized comprehensive profile of the immune system.

ADI TM (Immune Modulation Program)

The discovery of immunosuppressive

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

unwanted immune responses in autoimmune diseases.

However, immune suppression leads to significant undesirable side effects, such as increased

susceptibility to life-threatening infections and cancers, because it indiscriminately and broadly suppresses immune function throughout

While the use of these drugs has been justifiable because they prevent or delay organ rejection, their use for treatment of

autoimmune diseases and allergies may not be acceptable because of the aforementioned side effects.

Furthermore, transplanted organs often

ultimately fail despite the use of immune suppression, and about 40% of transplanted organs survive no more than 5 years.

New, focused therapeutic approaches

are needed that modulate only the immune cells involved in rejection of the transplanted organ, as this approach can be safer for patients

than indiscriminate immune suppression.

Such approaches are referred to as immune tolerance, and when therapeutically induced, may be

safer for patients and potentially allow long-termer survival of transplanted tissues and organs.

In the late 1990s, academic

research on these approaches was conducted at the Transplant Center in Loma Linda University (“LLU”) in connection with a

project that secured initial grant funding from the U.S.

Department of Defense.

The focus of that project was induction of tolerance for

skin allografting for burn victims.

Twenty years of research at LLU and an affiliated incubator led to a series of discoveries that have

been translated into a large patent portfolio of therapeutic approaches that may be applied to the modulation of the immune system to

induce tolerance to self and transplanted organs.

We have an exclusive worldwide

license for commercializing Apoptotic DNA Immunotherapy™ (ADI™) nucleic acid-based technology (which is currently at the pre-clinical

stage) from LLU, ADI™ which utilizes 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

Thus, 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.

We are developing ADI™

products for organ transplantation including skin allografting, autoimmune diseases, and allergies, with the initial focus on psoriasis,

type 1 diabetes and skin allografting, indications for which we have compelling preclinical data.

To submit a Biologics License Application

(“BLA”) for a biopharmaceutical product, clinical safety and efficacy must be demonstrated in clinical studies conducted with

human subjects.

For products in our class of drugs, the first-in-human trials will be a combination of Phase I (safety/tolerability) and

Phase II (efficacy) in affected subjects.

To obtain approval to initiate the Phase I/IIa studies, an Investigational New Drug or Clinical

Trial Application will be submitted that will include a compilation of non-clinical efficacy data as well as manufacturing and pre-clinical

safety/toxicology data.

To date, we have conducted non-clinical studies in a stringent model of skin transplantation using genetically

mismatched donor and recipient animals demonstrating a 3-fold increase in the survival of the skin allograft in animals that were tolerized

with ADI™ compared to animals that receive immune suppression alone.

Prolongation of graft life was observed despite discontinuation

of immune suppression after the first 5 weeks.

In a non-obese diabetic mouse model of type 1 diabetes, we showed reversal of hyperglycemia

with 80% of the animals showing durable glycemic control for the 40-week study period.

Additionally, in an induced non-clinical model

for psoriasis, ADI™ treatment resulted in a 69% reduction in skin thickness and a 38% decrease in skin flaking (two clinical parameters

for assessment of psoriasis skin lesions).

The Phase I/IIa studies in psoriasis will evaluate the safety/tolerability of ADI™ in

patients diagnosed with psoriasis.

Since the drug will be administered in subjects diagnosed with psoriasis, effectiveness of the drug

to improve psoriatic lesions will also be evaluated.

In the type 1 diabetes clinical studies, newly diagnosed subjects will receive ADI™

treatment to evaluate safety and efficacy.

In another Phase I/IIa study, patients requiring skin allografts will receive weekly intra-dermal

injections of ADI™ in combination with standard immune suppression to assess safety/tolerability and possibility of reducing levels

of immunosuppressive drugs as well as prolongation of graft life.

ADI™ is a nucleic acid-based

technology ( e.g.

, DNA-based), which we believe selectively suppresses only those immune cells involved in attacking or rejecting

self and transplanted tissues and organs.

It does so by tapping into the body’s natural process of cell turnover (apoptosis) to

retrain the immune system to stop unwanted attacks on self or transplanted tissues.

Apoptosis is a natural process used by the body to

clear dying cells and to allow recognition and tolerance to self-tissues.

ADI™ triggers this process by enabling the cells of the

immune system to recognize the targeted tissues as “self”.

Conceptually, it is designed to retrain the immune system to accept

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

While efforts have been made

by various groups to promote tolerance through cell therapies and ex vivo manipulation of patient cells (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, only an injection of minute

amounts of the therapeutic drug into the skin.

Reduce Chronic Rejection

While immunosuppressants control

acute rejection during the early time-period after receiving an organ, chronic rejection of the organ that occurs one or more years after

the transplant procedure continues to pose a major challenge for organ recipients.

Chronic rejection has been

likened to autoimmunity (a misdirected immune response that occurs when the immune system goes awry), where specific tissues in the transplanted

organ become targets of immune attack.

In other words, chronic rejection may not be caused just by differences between the donor

and the recipient, but rather by an immune response by the recipient to specific tissues in the organ.

Our pre-clinical studies suggest

that ADI™ has the ability to tolerize to specific tissues in a transplanted organ, and conceivably, reduce incidences of chronic

Moreover, preclinical studies

have demonstrated that ADI™ treatment significantly and substantially prolongs graft survival, in addition to successfully “reversing”

other established immune-mediated inflammatory processes.

Reduce immune suppression

Studies in animal models have

shown that conditioning/desensitizing the animals to receive the transplant, prolongs the survival of the transplanted tissue or organ.

studies have used repeated exposure to low doses of protein components in specific organs to reduce immunologic recognition and attack

on the transplanted organ.

Based on some of our data,

we believe that with ADI™ treatment, recipients can be conditioned/desensitized, thereby retraining the immune system to more readily

accept the organ and also reduce the levels of immunosuppressive drugs needed post-transplantation.

Preformed Antibodies

Studies have shown that presence

of preformed antibodies prior to transplantation procedures increases the rate of organ rejection.

Preformed antibodies can develop in

previously transplanted patients, patients who have given birth, and patients who have previously received blood transfusions.

than 113,000 patients on transplant waiting lists in the U.S.

alone, patients with pre-existing antibodies have much lower chances of

qualifying to receive organs due to their increased risk of rejection – even with immune suppression.

Sadly, transplanted patients

have a probability of needing re-transplantation at some point due to eventual chronic rejection of their transplanted organ, with the

possible exception of some newborn recipients.

With increased incidence of preformed antibodies, these patients may never have the opportunity

to receive another organ.

Based on experimental data, we believe that ADI™ may have the potential to address this issue providing

these individuals better opportunities for receiving an organ.

Technology Platform

ADI™ utilizes a novel

approach that mimics the way our bodies naturally induce tolerance to our own tissues.

It is a technology platform, which we believe

can be engineered to address a wide variety of indications.

ADI™ includes two DNA molecules which are designed to deliver signals

to induce tolerance.

The first DNA molecule encodes a pro-apoptotic protein, which induces ‘programmed’ cell death (apoptosis).

is a core component of the technology because it is intended to greatly increase the recruitment of dendritic cells, which are implicated

in regulating the immune system.

The second DNA molecule encodes the protein of interest (guiding antigen), which is modified to

promote a path of tolerance.

The guiding antigen is intended to result in tolerance induction specific to the tissue where the protein

ADI™ has shown efficacy

in several preclinical models (skin allografting, psoriasis, type 1 diabetes, alopecia areata and others) and its efficacy can be attributed

to multiple factors:

does not rely on a single mechanistic approach.

It has multiple components (interchangeable target antigen, apoptosis, methylated

plasmid DNA) that affect different arms of the immune system, which may collectively play a role in rejecting self or transplanted tissues.

activates key immune cells known to maintain tolerance in test animals and humans.

has been successfully applied to several autoimmune models and a stringent transplantation model.

lends itself to repeat dosing, which may be required to achieve its full potential therapeutic effect.

Proof of Concept:

Skin Grafting

Results shown are 5 weeks

post-transplantation

The proof-of-concept experiment

performed in transplantation was a skin allograft transplantation procedure in which the donor skin was obtained from white BALB/c mice

and transplanted to black C57BL/6 mice.

The experiment was designed to address a more challenging scenario where the donor tissue was

obtained from a donor which is genetically mismatched with the recipient.

This is unlike clinical scenarios where the donor and recipient

are genetically matched as much as possible.

While these experiments were repeated in several separate experiments, the results shown

here were obtained from a study conducted with 14 mice in the ADI™ treatment group and 7 mice in the control group.

Prior to submission

of an Investigational New Drug or Clinical Trial Application, additional non-clinical studies will be conducted to establish the precise

protocol (e.g.

timing of vaccine administration, dosing, and appropriate immunosuppressive agents that will be used in combination with

ADI™) that will be used in the clinical trials.

Pre-clinical safety/toxicology studies have already been conducted by a GLP lab

to ensure product safety for clinical testing.

These studies have shown no signs of toxicity to ADI™ treatment in mice.

Proof of Concept:

causes increased skin thickness and scaling in an established 10-day psoriasis model

treatment resulted in a 69% reduction in skin thickening and 38% reduction in scaling over the 10-day study period

Proof of Concept:

Type 1 Diabetes

Typically, 90% of female NOD

mice develop spontaneous autoimmune diabetes if left untreated.

Disease progression may be different for individual animals much like

the clinical scenario in human patients.

ADI™ was administered

once a week for 8 weeks after each animal developed hyperglycemia.

All animals responded with 80% showing durable response for the entire

40-week study period.

1 or autoimmune diabetes is a condition where the body’s immune system mistakenly attacks cells in the pancreas resulting in diminished

production of insulin, a hormone that is required for regulation of glucose

incorporates an antigen (GAD) expressed in the pancreas

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:

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.

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.

of ADI™ using GAD as the guiding antigen over an 8-week period in animals with T1D restores insulin production and reverses hyperglycemia

License Agreement with Loma Linda University

On March 8, 2018, we entered

into an Assignment Agreement (the “Assignment Agreement”) with Sekris Biomedical, Inc.

a party to a license agreement with LLU, entered and made effective on May 25, 2011, and amended on June 24, 2011, July 16, 2012 and December

27, 2012 (the “Original Agreement,” and together with the Assignment Agreement, the “Sekris Agreements”).

to the Assignment Agreement, Sekris transferred and assigned all of its rights, obligations and liabilities under the Original Agreement,

of whatever kind or nature, to us.

In exchange, on March 8, 2018, we issued a warrant to Sekris to purchase up to 10,000 shares of our

common stock (the “Sekris Warrant”).

The warrant was immediately exercisable and has an exercise price of $200.00 per share.

The expiration date of the warrant is March 8, 2023.

On March 15, 2018, as amended on July 1, 2020, we entered into a LLU License Agreement

directly with Loma Linda University, which amends and restates the Sekris Agreements.

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;

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

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

The convergence of biotech, high-tech, and media offers

new possibilities of accelerating breakthrough innovations faster and more efficiently.

This approach reflects our mission of “Making

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.

(“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.

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;

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

approval by the International Review Board and U.S.

Food and Drug Administration, a human trial for SPS is expected get underway in 2024

with enrollment of 10-15 patients, some of whom may also have type 1 diabetes.

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

procedures and blocking of unwanted immune responses in autoimmune diseases.

However, immune suppression leads to significant undesirable

side effects, such as increased susceptibility to life-threatening infections and cancers, because it indiscriminately and broadly suppresses

immune function throughout the body.

While the use of these drugs has been justifiable because they prevent or delay organ rejection,

their use for treatment of autoimmune diseases and allergies may not be acceptable because of the aforementioned side effects.

often transplanted organs ultimately fail despite the use of immune suppression, and about 40% of transplanted organs survive no more

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.

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

, DNA-based), which we believe selectively suppresses only those immune cells involved

in attacking or rejecting self and transplanted tissues and organs.

It does so by tapping into the body’s natural process of cell

turnover (i.e., apoptosis) to retrain the immune system to stop unwanted attacks on self or transplanted tissues.

Apoptosis is a natural

process used by the body to clear dying cells and to allow recognition and tolerance to self-tissues.

ADI triggers this process by enabling

the cells of the immune system to recognize the targeted tissues as “self.” Conceptually, it is designed to retrain the immune

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.

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 in and 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).

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).

In consideration for the LLU License Agreement, we issued 625 shares of Common Stock to LLU.

Pursuant to the LLU License

Agreement, we are required to pay an annual license fee to LLU.

Also, we paid LLU $455,000 in July 2020 for outstanding milestone payments

and license fees.

We are also required to pay to LLU milestone payments in connection with certain development milestones.

Specifically,

we are required to make the following milestone payments to LLU:

$175,000 on March 31, 2022;

$100,000 on March 31, 2024;

$500,000 on March

and $500,000 on March 31, 2027.

In lieu of the $175,000 milestone payment due on March 31, 2022, the Company paid LLU an extension

fee of $100,000.

Upon payment of this extension fee, an additional year will be added for the March 31, 2022 milestone.

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

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

comprehensive profile of the immune system.

AditxtScore is intended to detect individual immune responses to viruses, bacteria, peptides,

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.

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.

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

LLC (“Cellvera Global”), Cellvera Holdings Ltd.

(“BVI Holdco”), Cellvera, Ltd.

(“Cellvera Ltd.”),

Cellvera Development LLC (“Cellvera Development” and together with Cellvera Global, BVI Holdco, Cellvera Ltd.

Development (the “Sellers”), AiPharma Group Ltd.

(“Seller Owner” and collectively with the Sellers, “Cellvera”),

and the legal representative of Cellvera, pursuant to which, the Company will purchase Cellvera’s 50% ownership interest in G Response

Aid FZE (“GRA”), certain other intellectual property and all goodwill related thereto (the “Acquired Assets”).

expressly stated otherwise herein, capitalized terms used but not defined herein have the meanings ascribed to them in the Asset Purchase

Pursuant to the Asset Purchase Agreement, the consideration for the Acquired Assets consists of (A) $24.5 million,

comprised of:

(i) the forgiveness of the Company’s $14.5 million loan to Cellvera Global, and (ii) approximately $10 million in

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.

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

Additionally,

as consideration for prior expenses incurred by LLU to prosecute, maintain and defend the LLU Patent and Technology Rights, we made the

following payments to LLU:

$70,000 at the end of December 2018, and a final payment of $60,000 at the end of March 2019.

We are required

to defend the LLU Patent and Technology Rights during the term of the LLU License Agreement.

Additionally, we will owe royalty payments

of (i) 1.5% of Net Product Sales (as such terms are defined under the LLU License Agreement) and Net Service Sales on any Licensed Products

(defined as any finished pharmaceutical products which utilizes the LLU Patent and Technology Rights in its development, manufacture or

supply), and (ii) 0.75% of Net Product Sales and Net Service Sales for Licensed Products and Licensed Services (as such terms are defined

under the LLU License Agreement) not covered by a valid patent claim for technology rights and know-how for a three (3) year period beyond

the expiration of all valid patent claims.

We also are required to produce a written progress report to LLU, discussing our development

and commercialization efforts, within 45 days following the end of each year.

All intellectual property rights in and to LLU Patent and

Technology Rights shall remain with LLU (other than improvements developed by or on our behalf).

The LLU License Agreement

shall terminate on the last day that a patent granted to us by LLU is valid and enforceable or the day that the last patent application

licensed to us is abandoned.

The LLU License Agreement may be terminated by mutual agreement or by us upon 90 days written notice to LLU.

LLU may terminate the LLU License Agreement in the event of (i) non-payments or late payments of royalty, milestone and license maintenance

fees not cured within 90 days after delivery of written notice by LLU, (ii) a breach of any non-payment provision (including the provision

that requires us to meet certain deadlines for milestone events (each, a “Milestone Deadline”)) not cured within 90 days after

delivery of written notice by LLU and (iii) LLU delivers notice to us of three or more actual breaches of the LLU License Agreement by

us in any 12-month period.

Additional Milestone Deadlines include:

(i) the requirement to have regulatory approval of an IND application

to initiate first-in-human clinical trials on or before March 31, 2022, which has been extended to March 31, 2023 due to payment of a

$100,000 extension fee paid in March 2022, (ii) the completion of first-in-human (phase I/II) clinical trials by March 31, 2024, (iii)

the completion of Phase III clinical trials by March 31, 2026 and (iv) biologic licensing approval by the FDA by March 31, 2027.

Pre-clinical and Clinical Plans

The resources and efforts

used for the IND-enabling work summarized below supports both the psoriasis and TID clinical programs

High-level objectives for

psoriasis clinical program:

Completion of IND-enabling work.

Aditxt has completed GMP manufacturing of clinical grade drug substances (DNA plasmids) and initiated GMP formulation of clinical grade the drug product (ADI-100) that will be used for the first-in-human studies in subjects with psoriatic lesions.

Included in the manufacturing program is stability studies;

the regulatory agency requires one month of stability data for the GMP material for submission of the clinical trial application (CTA).

Stability data will continue to be gathered while the clinical trials are ongoing and up to 24 months.

Aditxt has also completed the in-life portion of the toxicology studies.

Safety data have been recorded and Aditxt is now awaiting immunotoxicology data, which are forthcoming.

Upon completion of GMP manufacturing and toxicology studies, a CTA will be submitted in Q2 2023 to initiate the Phase I/II FIH clinical trials.

The FIH clinical studies will

combine Phase I (designed to test clinical safety) and Phase IIa (designed to obtain proof of effectiveness in human subjects), in subjects

with psoriatic skin lesions.

We have selected this indication for several reasons, including:

existing preclinical data have shown promising results in reducing scaling and skin thickness in the mouse model;

relative ease of visualization of healing of psoriatic lesions;

need for therapies that suitable and justifiable in individuals with mild to moderate psoriasis (current biologic therapies are primarily

used in moderate to severe cases).

We have identified a contract

research organization with capabilities to conduct a multi-center study and ability to recruit the needed number of subjects to complete

the clinical trials.

Upon approval by the regulatory agency clinical trials will be initiated.

High-level objectives for

type 1 diabetes (T1D) clinical program:

Completion of IND-enabling work.

Aditxt has completed GMP manufacturing of clinical grade drug substances (DNA plasmids) and initiated formulation of the drug product (ADI-100) that will be used for the first-in-human studies in subjects with T1D.

Included in the manufacturing program is stability studies;

the regulatory agency requires one month of stability data for the GMP material for submission of the clinical trial application (CTA).

Stability data will continue to be gathered while the clinical trials are ongoing and up to 24 months.

Aditxt has also completed the in-life portion of the toxicology studies.

Safety data have been recorded and Aditxt is now awaiting immunotoxicology data, which are forthcoming.

Clinical Phase I/II Study to demonstrate safety and clinical proof-of-concept in T1D

Our clinical studies will

combine Phase I (designed to test clinical safety) and Phase II (designed to obtain proof of effectiveness in human subjects), in T1D

We have selected this indication for several reasons, including:

Our existing preclinical data have shown promising results using ADI™ to reverse hyperglycemia in the mouse model;

There is currently no treatment for T1D and the only option for patients suffering from T1D is life-long insulin replacement therapy.

We will be identifying clinical

trial centers with adequate patients.

Upon approval by the regulatory agency clinical trials will be initiated.

High-level objectives for

skin allograft clinical program:

Completion of preclinical studies to identify the appropriate protocol for dosing and combination of ADI™ with immune suppression protocols.

Completion of IND-enabling work including GMP manufacturing and toxicology studies.

Clinical Phase I/II Study to demonstrate safety and clinical proof-of-concept in patients requiring skin allografts.

Our clinical studies will

combine Phase I (designed to test clinical safety) and Phase II (designed to obtain proof of effectiveness in human subjects), in patients

requiring skin allografts.

We have selected this indication for several reasons, including:

Our existing preclinical data have shown promising results using ADI™ to prolong skin allograft survival in mismatched mouse model;

The relative ease of visualization of graft quality without the need for biopsies.

We will be identifying clinical

trial centers with adequate patients.

Upon approval by the regulatory agency clinical trials will be initiated.

We are developing our immune

monitoring platforms with the objective of utilizing them as clinical assays in pre-clinical and clinical studies.

The multiplex technologies

could potentially allow evaluation of more analytes with less tissue samples.

Drug Approval Process

In the United States, FDA

approval is required before any new drugs can be introduced to the market.

We currently have a product candidate for our first-in-human

studies, but as of the date of report, we have not submitted an application to the regulatory agencies for approval.

We are working with a contract

manufacturer who has the knowledge, product ingredients including plasmid DNA molecules, and our patented methylating bacterial strain.

contract manufacturer has completed GMP manufacturing of the plasmid DNA molecules also known as the drug substances.

The drug substances

are planned to be shipped to another GMP facility for formulation and fill/finish process in vials that will be used in the clinical trials.

The product candidate selected

for clinical trials must be subjected to pre-clinical safety/toxicology studies by an independent GLP (Good Laboratory Practice) laboratory

to demonstrate its suitability for clinical testing in human patients.

Upon completion of manufacturing and safety/toxicology testing,

an Investigational New Drug (IND) or Clinical Trial Application will be prepared for submission to the regulatory agencies.

Upon receipt of clearance

to initiate clinical testing, the ADI™ product can be tested in human patients.

Our product will be tested in clinical trials

in patients with psoriasis, T1D and one in patients who require skin allografting.

Therefore, our first-in-human studies will be combined

Phase I/Phase II studies in which safety and efficacy data will be obtained.

We plan to start with psoriasis and T1D.

we will preparing for clinical trials in skin allografting.

We are developing our immune monitoring platforms

with the objective of utilizing them as clinical assays in pre-clinical and clinical studies.

The multiplex technologies could potentially

allow evaluation of more analytes with less tissue samples.

Target Market

Psoriasis affects close to

100 million people worldwide and presents a large market estimated at over $20 billion annually.

Topical and systemic therapeutics including

vitamin D analogs, steroids, retinoids, immunosuppressants and biologics (i.e.

monoclonal antibodies).

While in more recent years, several

classes of biologics have entered the market, most are primarily used for patients suffering from moderate to severe psoriasis because

of their impairment of systemic immune responsiveness to infections and cancers.

Pre-clinical safety studies by Aditxt have shown that

ADI™ does not impair resistance to a systemic infection using a bacterial species known as Listeria monocytogenes or the

ability to suppress the growth of an implanted melanoma tumor.

The absence of immune impairment is important for application of ADI™

in patients suffering from mild to moderate psoriasis.

T1D is one of the most common

chronic disorders in children and affects nearly 2 million Americans with the incidence and prevalence increasing at alarming rates in

industrialized countries.

Current treatment consists of daily administration of insulin as replacement therapy, which can induce life-threatening

hypoglycemia and does not completely prevent morbidity and mortality associated with the disease.

Aditxt is leveraging the ADI™

technology to develop a new class of immunotherapy designed to arrest the autoimmune destruction of the insulin producing beta cells of

the pancreas.

This will be the first therapy to achieve this elusive goal, which can increase the span and quality of life for up to 40,000

of US citizens and about 300,000 people around the world who develop T1D each year, with a 3-5% increase in yearly incidence.

alone, there are

over 36,000 patients who receive organ transplantations each year, with more than 113,000 on transplant waiting lists.

The field of organ transplantation

has been made possible and continues to rely on broad-acting immunosuppressive drugs, high levels of which can result in a compromised

immune system that renders organ recipients susceptible to cancer and potentially life-threatening infections including re-activation

of latent viruses.

In addition, immunosuppressants

control acute rejection during the early time-period after receiving an organ but chronic rejection of the organ remains an unmet challenge

for surgeons and transplant recipients.

While efforts have been made

by various groups to promote tolerance through cell therapies and ex vivo manipulation of patient cells, these procedures

take place outside the body and may require hospitalization.

Moreover, transplanted patients

will need re-transplantation at some point, with the possible exception of some newborn recipients.

With increased incidence of preformed

antibodies, these patients may never have the opportunity to receive another organ.

Preformed antibodies can develop in previously transplanted

patients, patients who have given birth, and patients who have previously received blood transfusions.

These patients have much lower

chances of qualifying to receive organs due to their increased risk of rejection – even with immune suppression.

The potential

to reduce formation of preformed antibodies in these patients will provide better opportunities for them to receive another transplanted

There are gaps between current

approaches and what the market needs.

We believe that ADI™ addresses these gaps.

ADI™ is simple to administer (does

not require ex-vivo treatment of patient cells), it does not appear to suppress the immune system, it may allow patients

to live with transplanted organs with significantly reduced immune suppression, it may provide for longer-term survival of transplanted

tissues and organs, may be more effective because it does not rely on a single immune pathway/mechanism, and potentially provides patients

with pre-existing antibodies a chance to qualify to receive organs.

While these advantages present

opportunities for unmet medical needs in the field of organ transplantation, the industry in which we operate is highly competitive.

small company such as us will meet significant challenges including regulatory requirements for approval of a new class of therapeutic

agents, challenges in large scale manufacturing and marketing, cost of developing a novel therapeutic agent, which may require co-development

partners who may or may not be willing to work with us, and the willingness of transplant surgeons to adopt our therapeutic vaccines in

their existing immune suppression protocols.

These challenges pose risks that we may not be able to overcome.

AditxtScore TM (Immune Monitoring

We believe that understanding

the status of an individual’s immune system is key to understanding health by the numbers and for developing therapeutics that result

in better outcomes for more individuals.

We have secured an exclusive worldwide license for commercializing a technology platform named

AditxtScore™, which provides a personalized comprehensive profile of the immune system.

AditxtScore™ is intended to be informative

for individual immune responses to viruses, bacteria, peptides, 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.

AditxtScore™ is being

designed to allow individuals to understand, manage and monitor their immune profiles in order to be informed about attacks on or by their

immune system.

We believe AditxtScore™ can also assist the medical community in anticipating possible immune responses and reactions

to viruses, bacteria, allergens and foreign tissues such as transplanted organs.

This capability may be possible by having the ability

to determine the body’s potential response and for developing a plan to deal with an undesirable reaction by the immune system.

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

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

In addition, it can determine and differentiate between various

types of cellular and humoral immune responses (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).

We plan to utilize AditxtScore™

in our upcoming pre-clinical and clinical studies to monitor subjects’ immune response before, during and after ADI™ drug

administration.

We are also evaluating plans to obtain regulatory approval for AditxtScore™’s use as a clinical assay and

seeking to secure 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 and transplantation.

(1) Organ Rejection

Typically, by the time a transplanted

or a native organ shows signs of failure, the damage is already done, and reversal of the tissue injury becomes challenging.

early warning signs of damage would be invaluable to reverse or even prevent the damage.

There are currently no practical, efficient assays

available to measure cellular immune responses and available tools do not provide timely information for patients.

can be used to provide a sensitive and rapid tool for pre-transplant monitoring and to determine T and B cell response and to differentiate

between various types of cellular immune responses.

It can be multiplexed providing information about the number of cells responding as

well as quantifying the amounts of various cytokines released by the cells in the same assay.

Determination of cellular response has valuable

applications for prediction, monitoring, early detection, and treatment of disease, including organ failure/rejection, as well as treatment

It can also reveal dysfunction of the immune system that can potentially contribute to more severe disease.

(2) Autoimmunity

Our immune system develops

to differentiate self from non-self.

In autoimmunity, the body’s ability to distinguish this difference is impaired.

early signs of immune misrecognition may allow earlier intervention to reduce tissue destruction and to potential reverse the process

more effectively.

Better tools are needed to recognize immune responses to our own tissues earlier, and with more sensitivity and accuracy.

AditxtScore™ harnesses the promise to develop such tools that can be used for early diagnosis, evaluation of treatment effectiveness

and determination of the need for maintenance therapies when needed.

(3) Allergies

Our immune system protects

us by acting as a barrier against foreign substances and by eliminating them when they penetrate our bodies.

Once the initial exposure

has occurred, memory cells develop to prepare the body against a future exposure.

This process is called immunity.

In certain situations,

however, instead of immunity, the immune system develops memory cells that result in a more severe reaction during a future exposure to

the same substance.

This type of response is called a hypersensitivity response, commonly known as an allergic response.

can be used to develop multiplex panels each designed to test and monitor immune response to allergens.

Based on the ability of this technology

to run multiple tests in a single assay, 100 or more substances can potentially be tested simultaneously.

(4) Drug/Vaccine Response

There are currently no effective

assays to predict and easily assess responses to drugs or vaccines.

To determine whether an individual has responded to a particular vaccine,

antibody titers are measured.

This process may take several days or even weeks.

Furthermore, for vaccines that require a series of injections,

titers are not measured between injections and may not be known for months.

AditxtScore™ can be used to determine whether a patient

is a responder or non-responder (e.g.

individuals with a suppressed immune response may be non-responders).

It can provide an effective

and rapid tool for potentially determining beneficial responses to a vaccine and can be used to monitor levels of immune responsiveness

post vaccination.

It can allow evaluation of multiple vaccines in a single test (for memory B cell detection).

This application can be

useful for vaccines, cancer therapeutics anti-rejection drugs, anti-viral drugs, among others.

(5) Disease Susceptibility

Disease susceptibility can

vary from one individual to another, and it can be a function of various factors, including genetic variability and differences in human

leukocyte antigens (HLA) encoded by major histocompatibility complex (MHC) and responsible for regulation of the immune system in humans.

People with certain HLA types may have higher or lower susceptibility to diseases.

AditxtScore™ can be used to develop assays to

evaluate differences in HLA types in individuals to help elucidate the relationship between certain HLA types and susceptibility to various

(6) Infectious Diseases

Infectious diseases can cause

a major predicament for scientific and medical professionals, epidemiologists, and infectious disease specialists, who need to determine

how to treat patients in real-time while efficacious therapies are still being developed.

Proper decision making requires understanding

why some affected individuals show minor or no symptoms, some recover, and others die.

This is fundamental to creating effective targeted

therapeutics which may differ depending on the underlying profile of the individual at risk for, or with, disease.

The immune system plays

a major role in how any given individual responds to the infectious agent.

This response can be inadequate or too robust or appropriately

Regardless, the kinetics of the response by the cellular and humoral (antibody) immune systems to the infectious agent are

often unknown.

A basic critical question, then, is what do the dynamics of the immune response look like from exposure to and through

the disease period and during convalescence for those who survive and those who don’t;

and how might vaccines and therapies alter

these profiles such that predictions of vaccine/drug efficacy could be inferred prior to vaccination/treatment and/or disease severity

or progression be prognosticated.

AditxtScore™ can be used to help address these questions with multiplex assays each designed to

test and monitor the immune response to infectious agents.

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 regarding 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 regarding 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 to not 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.

We were obligated to pay and

paid a fee of $25,000 to Stanford within 60 days of February 3, 2020.

We also issued 375 shares of the Company’s common stock to

An annual licensing maintenance fee is payable by us on the first anniversary of the February 2020 License Agreement in the

amount of $40,000 for 2021 through 2024 and $60,000 starting in 2025 until the license expires upon the expiration of the patent.

Company is required to pay and has paid $25,000 for the issuances of certain patents.

The Company will pay milestone fees of $50,000 on

the first commercial sales of a licensed product and $25,000 at the beginning of any clinical study for regulatory clearance of an in

vitro diagnostic product developed and a potential licensed product.

The Company paid a milestone fee for a clinical study for regulatory

clearance of an in vitro diagnostic product developed and a potential licensed product of $25,000 in March of 2022.

We are also required

(i) provide a listing of the management team or a schedule for the recruitment of key management positions by March 31, 2020 (which

has been completed), (ii) provide a business plan covering projected product development, markets and sales forecasts, manufacturing and

operations, and financial forecasts until at least $10,000,000 in revenue by June 30, 2020 (which has been completed), (iii) conduct validation

studies by September 30, 2020 (which has been completed), (iv) hold a pre-submission meeting with the FDA by September 30, 2020 (which

has been completed), (iv) submit a 510(k) application to the FDA, Emergency Use Authorization (“EUA”), or a Laboratory Developed

Test (“LDT”) by March 31, 2021 (which has been completed), (vi) develop a prototype assay for human profiling by December

31, 2021 (which has been completed), (vii) execute at least one partnership for use of the technology for transplant, autoimmunity, or

infectious disease purposes by March 31, 2022 (which has been completed) and (viii) provided further development and commercialization

milestones for specific fields of use in writing prior to December 31, 2022.

In addition to the annual

license maintenance fees outlined above, we will pay Stanford royalties on Net Sales (as such term is defined in the February 2020 License

Agreement) during the of the term of the agreement as follows:

4% when Net Sales are below or equal to $5 million annually or 6% when

Net Sales are above $5 million annually.

The February 2020 License Agreement may be terminated upon our election on at least 30 days advance

notice to Stanford, or by Stanford if we:

(i) are delinquent on any report or payment;

(ii) are not diligently developing and commercializing

Licensed Product;

(iii) miss certain performance milestones;

(iv) are in breach of any provision of the February 2020 License Agreement;

or (v) provide any false report to Stanford.

Should any events in the preceding sentence occur, we have a thirty (30) day cure period

to remedy such violation.

Plan of Operations

The initial application of

the platform was AditxtScore™ for COVID-19 which was designed to provide a more complete assessment of an individual’s infection

and immunity status with respect to the SARS-CoV-2 virus.

Infection status is determined by evaluating the presence or absence of the

virus, and immunity status by measuring levels of antibodies against viral antigens and their ability to neutralize the virus.

In early 2021, we established

our AditxtScore™ Immune Monitoring Center in Richmond, Virginia (the “Center”).

The Center operates as a Clinical Laboratory

Improvement Amendments (CLIA) certified facility for the processing of our AditxtScore™ for COVID-19 Lab Developed Test (LDT) for

our prospective channel partners, including labs and hospitals.

In August 2020, we filed for

an Emergency Use Authorization (EUA) with the FDA with the ultimate objective of filing a 510(K) application.

On January 14, 2022, we

submitted requests to obtain two EUAs for our antibody and neutralizing tests following an announcement on November 15, 2021 by the Department

of Health and Human Services that COVID-19 related tests will require FDA review and FDA’s position that COVID-19 tests that have

been in use prior to the announcement must submit applications for EUAs but can continue to operate unless informed otherwise.

meantime, we are providing AditxtScore™ as a service as a Laboratory Developed Test (LDT) to assess immunity status to COVID-19.

The public health emergency

is planned to be ending in May 2023.

Thus, COVID-related assays are no longer considered as priority for review by FDA and will not be

considered for EUAs.

In May, FDA may provide more guidance regarding whether COVID-related assays will revert back to pre-pandemic review

process or whether they will require full regulatory review (e.g.

Assays that are not developed for evaluation of infection or

immunity status to SARS-CoV-2 will continue to be offered as LDTs.

Intellectual Property (IP)

We strive to protect and

enhance the proprietary technology, inventions, and improvements that are commercially important to our business, including seeking,

maintaining and defending patent rights, whether developed internally or licensed from third parties.

Our policy is to seek to protect

our proprietary position by, among other methods, filing patent applications in the United States and in jurisdictions outside of the

United States, to protect our proprietary technology, inventions, improvements and product candidates that are important to the development

and implementation of our business.

We also rely on trade secrets and know-how relating to our proprietary technology and product candidates,

continuing innovation, and in-licensing opportunities to develop, strengthen and maintain our proprietary position in the field of immuno-therapy.

We also plan to rely on data exclusivity, market exclusivity, and patent term extensions when available.

Our commercial success will

depend in part on our ability to obtain and maintain patent and other proprietary protection for our technology, inventions, and improvements;

to preserve the confidentiality of our trade secrets;

to obtain and maintain licenses to use intellectual property owned by third parties;

to defend and enforce our proprietary rights, including any patents that we may own in the future;

and to operate without infringing

on the valid and enforceable patents and other proprietary rights of third parties.

Our innovation portfolio

(1) ADI™ immune modulation technologies, which are currently at the pre-clinical stage and are designed to retrain the

immune system to induce tolerance with an objective of addressing rejection of transplanted organs, autoimmune diseases, and allergies;

and (2) AditxtScore™ immune monitoring technologies designed to provide a personalized comprehensive profile of the immune system.

Both categories are protected by multiple families of patents and patent applications, including several issued U.S.

The projected expiration

dates for the ADI™ patents and patents issuing from pending applications extend until 2043 for some patents.

As of the date of

this report, our patent portfolio for ADI™ includes both patents and patent applications licensed from LLU or Stanford and patent

applications owned solely by Aditxt, including 120 granted patents, 2 allowed patent applications and 30 pending patient applications

and other regions.

These patents and patent applications cover three different technical aspects of ADI™, treatment of

autoimmune diseases and type 1 diabetes, treatment of organ transplantation, and development of a new class of immunotherapeutics for

various indications.

The patents and patent applications cover both methods of treatment for these indications as well as compositions

of matter including plasmids that are able to induce tolerance to antigens or prevention of immune attack on antigens, depending on the

indication, along with methods of producing such plasmids.

The AditxtScore™ technology

is also protected by multiple families of patents and patent applications, including several issued U.S.

The projected

expiration dates for these AditxtScore™ patents and patents issuing from pending applications ranges from 2037 to 2043.

date of this report, our patent portfolio for AditxtScore™ includes both patents and patent applications licensed from Stanford

and patent applications owned solely by Aditxt, including granted patents and 12 applications.

These patents and patent applications

encompass methods, systems and kits for detection and measurement of specific immune responses.

We also possess and/or in-license

substantial know-how and trade secrets relating to the development and commercialization of our product candidates, including related

manufacturing processes and technology.

We plan to continue expanding and strengthening our IP portfolio with additional patent applications

in the future.

In March 2021, Aditxt signed

an agreement with a regulatory consultant based in Munich, Germany, which will play a central role in navigating the first ADI™ therapeutic

program through the clinical trial and regulatory process.

The firm has been working with the Aditxt’s ADI™ team to

submit a clinical trial application to the regulatory agency in Germany.

Psoriasis is the first indication being targeted for clinical

trial in the ADI™ therapeutics pipeline.

Other candidates that are advancing toward clinical trials include ADI™ for

type 1 diabetes and skin allografting.

We have sixty-one (61) full

time employees as of December 31, 2022.

We consider the relations with our employees to be good.

upon the closing, the Share Exchange Agreement previously entered into as of December 28, 2021, between Cellvera Global Holdings, LLC

f/k/a AiPharma Global Holdings, LLC (together with other affiliates and subsidiaries) and the Company, and all other related agreements

will be terminated.

obligations of the Company to consummate the Closing are subject to the satisfaction or waiver, at or prior to the Closing of certain

conditions, including but not limited to, the following:

(i) Satisfactory

completion of due diligence;

(ii) Completion

by the Company of financing sufficient to consummate the transactions contemplated by the Asset Purchase Agreement;

(iii) Receipt

by the Company of all required Consents from Governmental Bodies for the Acquisition, including but not limited to, any consents required

to complete the transfer and assignment of Cellvera’s membership interests in GRA;

of executed payoff letters reflecting the amount required to be fully pay all of each of Seller’s and Seller Owner’s Debt

to be paid at Closing;

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;

(viii) Receipt

of a fairness opinion by the Company with respect to the transactions contemplated by the Asset Purchase Agreement;

by the Company from the Seller Owner of written consent, whether through its official liquidator or the Board of Directors of Seller

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

Our commitment to building

our antiviral portfolio is strategic and timely.

We believe that there has never been a more important time to address the growing global

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.

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