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Item 1. Business

2022-03-31 compared with 2021-03-25 · 638 added, 581 removed, 31 unchanged (98% of the section changed)

are a biotech innovation company with a mission of prolonging life and enhancing its quality by improving the health of the immune

are developing biotechnologies specifically focused on improving the health of the immune system through immune reprogramming

and monitoring.

Our immune reprogramming technologies 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.

Our immune monitoring technologies are designed to provide a personalized comprehensive profile of the immune system and we plan

to utilize them in our upcoming reprogramming clinical trials to monitor subjects’

immune response before, during and after

drug administration.

Reprogramming

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 above-mentioned

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.

focused therapeutic approaches are needed that modulate only the small portion of immune cells that are 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 also potentially allow long-term

survival of transplanted tissues and organs.

the late 1990s, academic research on these approaches was conducted at the Transplant Center at Loma Linda University in connection

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

We are a biotech innovation

company with a mission of prolonging life and enhancing its quality by improving the health of the immune system.

We are developing biotechnologies

specifically focused on improving the health of the immune system through immune mapping and reprogramming.

Our immune mapping technologies

are designed to provide a personalized comprehensive profile of the immune system and we plan to utilize them in our upcoming reprogramming

clinical trials to monitor subjects’ immune response before, during and after drug administration.

Our immune reprogramming technologies

are designed to retrain the immune system to induce tolerance with the objectives of addressing rejection of transplanted organs as well

as ameliorate autoimmune diseases and allergies.

These programs are currently in the pre-clinical stage with one product candidate slated

for GMP manufacturing (clinical grade material) and toxicology studies in preparation for clinical trials.

Immune Reprogramming – Immune Modulation

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 above-mentioned 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 small portion of immune cells that are 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 also potentially allow long-term survival of transplanted tissues and organs.

In the late 1990s, academic

research on these approaches was conducted at the Transplant Center at Loma Linda University in connection with a project that secured

initial grant funding from the U.S.

Department of Defense.

The focus of that project was for

skin grafting 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 in order to induce tolerance to self and transplanted organs.

have an exclusive worldwide license from LLU for commercializing this nucleic acid-based technology (which is currently at the

pre-clinical stage), called Apoptotic DNA Immunotherapy™

(ADi™), which utilizes a novel approach that mimics the way

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

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.

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.

are developing ADi™

products for organ transplantation including skin grafting, autoimmune diseases, and allergies, with the initial

focus on skin allografts and psoriasis, as we believe these indications will be most efficient in providing safety and efficacy data

in clinical trials.

To submit a Biologics License Application (“BLA”) for a biopharmaceutical product, clinical safety and

efficacy must be demonstrated in a series of 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.

approval to initiate the Phase I/IIa studies, an Investigational New Drug Application will be submitted to compile 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 graft in animals that were tolerized with ADi™

compared to animals that receive immune suppression alone.

of graft life was observed despite discontinuation of immune suppression after the first 5 weeks.

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 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.

Later phase trials are planned after successful

completion of these studies in preparation for submission for a BLA to regulatory agencies.

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

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

cells involved in the rejection of tissue and organ transplants.

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

cell death (apoptosis) to reprogram the immune system to stop unwanted attacks on self or transplanted tissues.

Apoptosis is a

natural process of “immune tolerance”

used by the body to clear dying cells and to allow recognition and tolerance

to self-tissue.

triggers this process enabling the natural immune system cells to recognize the targeted tissues as

“self”.

Conceptually, it is designed to retrain the immune system to become accepting of the organ similar to how

natural apoptosis reminds our immune system to be tolerant to our own “self”

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 typically requiring hospitalization), 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™

itself will not require hospitalization, only an injection in minute amounts into the skin.

Chronic Rejection

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.

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 are attacked by the immune system.

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, reducing incidences of chronic rejection.

preclinical studies have demonstrated that ADi™

treatment significantly and substantially prolongs graft survival, in addition

to successfully “reversing”

The focus of that project was for skin grafting for burn victims.

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 in order to induce tolerance to self and transplanted

We have an exclusive worldwide

license from LLU for commercializing this nucleic acid-based technology (which is currently at the pre-clinical stage), called Apoptotic

DNA Immunotherapy™ (ADI™), which utilizes a novel approach that mimics the way our bodies naturally induce 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.

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™

product candidates for organ transplantation including skin grafting, autoimmune diseases including psoriasis and type 1 diabetes (T1D),

and allergies, with an initial focus on psoriasis, T1D, and skin allografting., To submit a Biologics License Application (“BLA”)

for a biopharmaceutical product, clinical safety and efficacy must be demonstrated in a series of clinical studies conducted with human

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/II studies, an Investigational New Drug (IND) Application

will be submitted compiling non-clinical efficacy data as well as manufacturing and pre-clinical or clinical toxicology data.

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 graft 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

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/II 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 another Phase I/II 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™ Advantages

ADI™ is a nucleic acid-based

technology ( e.g.

, DNA-based) which we believe selectively suppresses only those immune cells involved in the rejection of tissues

and transplanted organs.

It does so by tapping into the body’s natural process of cell death (apoptosis) to reprogram 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 enabling the cells of the immune system to recognize

the targeted tissues as “self”.

Conceptually, it is designed to retrain the immune system to become accepting of the organ

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 typically requiring hospitalization), 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 are attacked by the immune system.

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, reducing 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.

immune suppression

in animal models have shown that conditioning/desensitizing the animals to receive the transplant, prolongs the survival of the

transplanted tissue or organ.

These studies have used repeated exposure to low doses of protein components in specific organs

to reduce immunologic recognition and attack on the transplanted organ.

on some of our data, we believe that with ADi™

treatment, recipients can be conditioned/desensitized ahead of transplantation,

thereby retraining the immune system to more readily accept the organ and also reduce the levels of immunosuppressive drugs needed

post-transplantation.

have shown that presence of preformed antibodies prior to transplantation procedures increases the rate of organ rejection.

antibodies can develop in previously transplanted patients, patients who have given birth, and patients who have previously received

blood transfusions.

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

alone, patients with pre-existing

antibodies have much lower chances at qualifying to receive organs due to their increased risk of rejection –

immune suppression.

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 at receiving an organ transplantation.

Key Differentiators

products are typically administered systemically (i.e., by mouth in pill form or injected intramuscularly/intravenously).

requires repeated large doses of the drug to allow sufficient concentrations to reach the affected sites.

is a DNA-based

product that can be injected directly into the skin where the target cells of the immune system reside, thereby significantly

simplifying the delivery of the product and reducing the amount of product needed.

products are less likely to result in formation of neutralizing antibodies, which lend themselves to repeat dosing as may be required

by ADi™

of Goods Advantage

products are DNA-based and cost-effective to manufacture.

Furthermore, DNA-based products are very stable and do not require adherence

to cold chain (temperature-controlled) protocols for shipping.

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 ahead of transplantation, 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 at

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 at receiving an organ transplantation.

ADI™ Key Differentiators

Ease of Delivery

Therapeutic products are typically

administered systemically (i.e., by mouth in pill form or injected intramuscularly/intravenously).

This requires repeated large doses

of the drug to allow sufficient concentrations to reach the affected sites.

ADI™ is a DNA-based product that can be injected directly

into the skin where the target cells of the immune system reside, thereby significantly simplifying the delivery of the product and reducing

the amount of product needed.

Repeat Dosing

DNA-based products are less

likely to result in formation of neutralizing antibodies, which lend themselves to repeat dosing as may be required by ADI™ products.

Cost of Goods Advantage

ADI™ products are DNA-based

and cost-effective to manufacture.

Furthermore, DNA-based products are very stable and do not require adherence to cold chain (temperature-controlled)

protocols for shipping.

This also makes the product ideal for global distribution.

Therapy Delivery System

believe that tolerance induction using ADi™

may potentially obviate the need for hospitalization because it can simply be

injected into the skin.

This approach reduces treatment costs and complexities in treatment delivery.

The anticipated administration

of ADi™

will include an initial priming regimen that will require injections administered once a week for several weeks.

booster or maintenance doses will be provided on an individual basis as determined by immune and inflammation testing.

treatments will be significantly more convenient and comfortable for patients because they do not require removal of patient cells

for ex vivo manipulation.

Technology Platform

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.

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’

This 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 is found.

has been successfully tested in several preclinical models (skin grafting, psoriaris, type 1 diabetes, alopecia areata) and its

efficacy can be attributed to multiple factors:

Simplified Therapy Delivery System

We believe that tolerance induction

using ADI™ may potentially obviate the need for hospitalization because it can simply be injected into the skin.

This approach reduces

treatment costs and complexities in treatment delivery.

The anticipated administration of ADI™ will include an initial priming

regimen that will require injections administered once a week for several weeks.

Thereafter, booster or maintenance doses will be

provided on an individual basis as determined by immune and inflammation testing.

ADI™ treatments will be significantly more

convenient and comfortable for patients because they do not require removal of patient cells for ex vivo manipulation.

ADI™ 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.

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 grafting, psoriasis, type 1 diabetes, alopecia areata and multiple sclerosis) 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 can be manipulated.

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

plasmid DNA) that affect different arms of the immune system, which can be manipulated.

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

1 unchanged sentence

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

Proof of Concept:

Skin Grafting

shown are 5 weeks post-transplantation

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™

group and 7 mice in the control group.

Prior to submission of an Investigational New Drug Application, additional non-clinical

studies will be conducted in a pig model 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.

In addition, IND-enabling safety/toxicology studies will be conducted by a GLP lab to ensure product safety for clinical testing.

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 Application, additional non-clinical studies will be conducted in a pig model 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.

In addition, IND-enabling safety/toxicology studies will be conducted by a GLP lab

to ensure product safety for clinical testing.

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

of female NOD mice developed spontaneous autoimmune diabetes.

90% of female NOD mice developed

spontaneous autoimmune diabetes.

Disease progression may be different for individual animals.

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

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

incorporates an antigen (GAD) expressed in the pancreas

● Administration

of ADi™

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

Alopecia Areata

protects hair follicles from autoimmune attack

believe that understanding the status of an individual’s immune system is key to developing and administering immunotherapies

such as ADi™.

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

personalized comprehensive profile of the immune system.

It is intended to be informative for individual immune responses to viruses,

bacterial antigens, peptides, drugs, 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 future infectious agents.

We plan to brand this technology, and other future licensed and/or in-house developed monitoring technologies collectively as

AditxtScore™.

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 transplanted organs.

It can be useful in anticipating attacks on the

body by having the ability to determine its 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, single platform

assay that can be multiplexed to determine the immune status with respect to several factors simultaneously, in 3-16 hours, as

well as detect antigen and antibody in a single test (i.e.

infectious, recovered, immune).

In addition, it can determine and differentiate

between various types of cellular and humoral immune responses (T and B cells).

It also provides for simultaneous monitoring of

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

plan to utilize AditxtScore™

in our upcoming clinical trials to monitor subjects’

immune response before, during and

after ADi™

drug administration.

We are working with regulatory consultants with the objective to obtain FDA approval for

AditxtScore™

as a clinical assay.

We are currently securing marketing and distribution partnerships for application of AditxtScore™

in the infectious diseases market.

To obtain FDA approval to use AditxtScore™

as a clinical assay, we are performing validation

studies to demonstrate AditxtScore™’s utility to evaluate various components of the immune system reproducibly.

believe that these data will show AditxtScore™’s ability to measure various components of the immune system (e.g.

humoral and cell-mediated immune responses) to provide a broader view of the immune system and its status in health and disease.

Our plan is to submit a 510(K) application to the FDA after compilation of these data.

Beyond infectious diseases, we plan to

develop AditxtScore™

for applications in additional markets such as organ rejection, allergies, drug/vaccine response, and

disease susceptibility.

The following are further descriptions of the applications of AditxtScore TM :

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.

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

are currently no practical, efficient assays available to measure cellular immune responses and available tools do not provide

timely information for patients.

AditxtScore™

can be used to provide a sensitive and rapid tool to determine T 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 a single 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 efficacy.

It can also reveal dysfunction of the immune system potentially contributing

to more severe disease.

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.

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.

AditxtScore™

can be used to develop multiplex assays 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 for simultaneously.

Drug/Vaccine Response

are currently no effective assays to predict and easily assess responses to vaccination.

To determine whether an individual has

responded to a particular vaccine, antibody titers are measured.

This process may take several days.

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.

It can provide an effective and rapid tool for potentially

determining beneficial responses to a vaccine and can be used to monitor titer development 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.

Disease Susceptibility

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 diseases.

Infectious Diseases

diseases can cause a major predicament for scientific and medical professionals, epidemiologists, and infectious disease specialists,

among others, 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

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

This response can be inadequate or too robust or appropriately effective.

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.

Based on the ability to run multiple tests in a single assay, 100 or more agents can potentially

be tested for simultaneously.

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

Agreement with Loma Linda University –

March 8, 2018, we entered into an Assignment Agreement (the “Assignment Agreement”) with Sekris Biomedical, Inc.

(“Sekris”).

Sekris was a party to a License Agreement with Loma Linda University (“LLU”), entered into and made effective on May

25, 2011, and amended on June 24, 2011, July 16, 2012 and December 27, 2012 (the “Original Agreement,”

with the Assignment Agreement, the “Sekris Agreements”).

Pursuant to the Assignment Agreement, Sekris transferred

and assigned all of its rights and obligations in and to and liabilities under the Original Agreement, of whatever kind or nature,

In exchange, on March 8, 2018, we issued a warrant to Sekris to purchase up to 500,000 shares of our common stock (the

“Sekris Warrant”).

The warrant was immediately exercisable and has an exercise price of $4.00 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.

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™

In consideration for the LLU License

Agreement, we issued 25,000 shares of common stock to LLU.

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:

On March 8, 2018, we entered

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

a party to a License Agreement with Loma Linda University (“LLU”), entered into 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”).

Pursuant to the Assignment Agreement, Sekris transferred and assigned all of its rights and obligations

in and to 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 500,000 shares of our common stock (the “Sekris Warrant”).

The warrant was immediately exercisable

and has an exercise price of $4.00 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.

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).

In consideration for the LLU License Agreement, we issued 25,000 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:

$175,000 on March 31, 2022;

2 unchanged sentences

and $500,000 on March 31, 2027.

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

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 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 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

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 due at the end of December 2018, and a final

payment of $60,000 due 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 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 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.

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).

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 a first-in-human clinical

trials on or before March 31, 2022, (ii) the completion of first-in-human (phase I/II) clinical trials by March 31, 2024, (iii)

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.

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) submission of an IND/clinical trial application to initiate first-in-human

clinical trials on or before March 31, 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.

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

Use in the Licensed Territory.

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

We also issued 18,750 shares of the Company’s

common stock to Stanford.

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 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.

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:

of IND-enabling work.

Aditxt has initiated GMP manufacturing of clinical grade material 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 Q4 2022 to initiate the Phase I/II FIH clinical

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:

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

The relative ease of visualization of healing of psoriatic lesions;

The 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 initiated GMP manufacturing of clinical grade material 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.

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 patients.

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 insulin replacement therapy.

We will be identifying clinical

trial centers with adequate patients.

Upon approval by the FDA and/or the applicable 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.

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 FDA and/or the applicable 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 know-how, product ingredients including plasmid DNA molecules, and our patent-pending bacterial strain.

batch runs have been successfully completed to demonstrate our ability to produce the DNA plasmids in a GMP facility.

Based on validation

studies, we are reasonably confident in our ability to produce clinical grade product candidates at larger scales.

The contract manufacturer

has provided a proposal for manufacturing of our clinical grade material, which will be signed and accepted once we are ready to initiate

GMP manufacturing.

We are not currently party to an agreement with this contract manufacturer.

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) 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,

one in patients with psoriasis 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 in skin indications (psoriasis

and skin allografting) because we believe these indications will be most efficient in providing safety and efficacy data in clinical trials.

parallel, we will continue to develop additional product formulations for other indications.

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.

In the U.S., FDA approval is required before any In

Vitro Diagnostic (“IVD”) device can be introduced to the market for clinical use (excluding research purposes).

process does not require clinical trials, but it does require validation data demonstrating accuracy of the device.

Target Market

Psoriasis affects close to

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

Treatments range include 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.

Aditxt believes

that products based on the ADI™ platform will not be associated with similar side effects and can be targeted for use in mild to

moderate cases.

T1D is one of the most common

chronic disorders in children and affects nearly 2 million Americans, and has an incidence and prevalence increasing at alarming rates

in industrialized countries.

Current treatment consists of daily delivery of insulin as replacement therapy, but administration of the

hormone 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 accomplish that long sought after goal, thus increasing

life 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 typically 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 at 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 easy 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 long-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.

Immune Mapping - Immune Monitoring

We believe that understanding

the dynamic status of an individual’s immune system is key to developing and administering precision immunotherapies such as ADI™.

We have secured an exclusive worldwide license for commercializing a technology platform which provides a personalized comprehensive profile

of the immune system.

It is intended to be informative for individual immune responses to viruses, bacterial antigens, peptides, drugs,

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 future infectious agents.

We plan to brand this technology, and other future

licensed and/or in-house developed monitoring technologies collectively as AditxtScore™.

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 transplanted organs.

It can be useful in anticipating attacks on the body by having the ability to

determine its 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, single platform assay that can be multiplexed to determine the immune

status with respect to several factors simultaneously, in 3-16 hours, as well as detect antigen and antibody in a single test (i.e.

recovered, immune).

In addition, it can determine and differentiate between various types of cellular and humoral immune responses (T

and B cells).

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 clinical trials to monitor subjects’ immune response before, during and after ADI™ drug administration.

are working with regulatory consultants with the objective to obtain FDA approval for AditxtScore™ as a clinical assay.

We are currently

securing marketing and distribution partnerships for application of AditxtScore™ in the infectious diseases market.

To obtain FDA

approval to use AditxtScore™ as a clinical assay, we are performing validation studies to demonstrate AditxtScore™’s

utility to evaluate various components of the immune system reproducibly.

We believe that these data will show AditxtScore™’s

ability to measure various components of the immune system (e.g.

humoral and cell-mediated immune responses) to provide a broader view

of the immune system and its status in health and disease.

Our plan is to submit a 510(K) application to the FDA after compilation of

Beyond infectious diseases, we plan to develop AditxtScore™ for applications in additional markets such as organ rejection,

allergies, drug/vaccine response, and disease susceptibility.

The following are further descriptions of the applications of AditxtScore TM :

(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 to determine T 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 a single 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 efficacy.

It can also reveal

dysfunction of the immune system potentially contributing to more severe disease.

(2) 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 assays 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 for simultaneously.

(3) Drug/Vaccine Response

There are currently no effective

assays to predict and easily assess responses to vaccination.

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

antibody titers are measured.

This process may take several days.

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.

It can provide an effective and rapid tool for potentially determining beneficial responses to a vaccine

and can be used to monitor titer development 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.

(4) 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

(5) Infectious Diseases

Infectious diseases can cause

a major predicament for scientific and medical professionals, epidemiologists, and infectious disease specialists, among others, 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.

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 effective.

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.

Based on the ability to run multiple tests in a single assay, 100 or more agents

can potentially be tested for simultaneously.

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, other than as

described below, 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 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 18,750 shares of the Company’s common stock

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.

We are also required to:

(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),

(v) submit a 510(k) application to the FDA, Emergency Use Authorization (“EUA”), or a Laboratory Developed Test (“LDT”)

by March 31, 2021, (vi) obtain FDA approval by December 31, 2021, (vii) complete a prototype assay kit by December 31, 2021 and (viii)

have a written agreement with Stanford on further development and commercialization milestones for specific fields of use by December

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) 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), (v) 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, 2022and (viii) will provide further development and commercialization milestones for specific fields of use in writing by December

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;

(ii) are not diligently developing and commercializing

Licensed Product;

(iii) miss certain performance milestones;

breach of any provision of the February 2020 License Agreement;

(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.

of Operations –

Immune Reprogramming

objectives for skin allograft clinical program:

optimization to determine optimum dose/ratio of product candidate in human subjects requiring skin and other organ and/or

tissue allografts

Clinical Phase I/IIa

First-In-Human (FIH) Study to demonstrate safety and clinical proof-of-concept in human subjects requiring skin allografts

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 requiring skin and other organ and/or tissue allografts.

We have selected this indication for

several reasons, including:

existing preclinical data has shown promising results of ADi™

in prolonging skin allografts;

relative ease of visualization of the graft without the need for biopsies;

need for therapies that allow reduction of levels of immune suppression that are currently used for skin allografts to prevent

rejection of skin, which is highly antigenic.

have already identified a clinical trial center with adequate patients, which we believe will simplify and reduce the time required

for patient recruitment.

Upon approval by the FDA and/or the applicable regulatory agency, and once the exact protocol has been

determined in the preclinical studies, clinical trials will be initiated.

objectives for psoriasis clinical program:

optimization to determine optimum dose of product candidate in psoriasis subjects

Clinical Phase I/IIa

FIH Study to demonstrate safety and clinical proof-of-concept in psoriasis

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 psoriasis patients.

We have selected this indication for several reasons, including:

existing preclinical data has shown promising results of ADi™

in reducing scaling and skin thickness in the mouse model;

The relative ease

of visualization of the lesions to determine clinical effectiveness of the test article.

will be identifying clinical trial centers with adequate patients.

Upon approval by the FDA and/or the applicable regulatory agency

clinical trials will be initiated.

are developing our immune monitoring platforms with the objective of utilizing them as clinical assays in pre-clinical and clinical

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

Approval Process

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.

are working with a contract manufacturer who has the know-how, product ingredients including plasmid DNA molecules, and our patent-pending

bacterial strain.

Several batch runs have been successfully completed to demonstrate our ability to produce the DNA plasmids

in a GMP facility.

Based on validation studies, we are reasonably confident in our ability to produce clinical grade product candidates

at larger scales.

The contract manufacturer has provided a proposal for manufacturing of our clinical grade material, which will

be signed and accepted once we are ready to initiate GMP manufacturing.

We are not currently party to an agreement with this contract

manufacturer.

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) application will be prepared for submission to

the regulatory agencies.

receipt of clearance to initiate clinical testing, the ADi™

product can be tested in human patients.

Our product will

be tested in clinical trials, one in patients with psoriasis and one in patients who require skin allografting.

Therefore, our

first-in-human studies will be combined Phase I/Phase IIa studies in which safety and efficacy data will be obtained.

plan to start with in skin indications (psoriasis and skin allografting) because we believe these indications will be most efficient

in providing safety and efficacy data in clinical trials.

In parallel, we will continue to develop additional product formulations

for other indications.

are developing our immune monitoring platforms with the objective of utilizing them as clinical assays in pre-clinical and clinical

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

U.S., FDA approval is required before any In Vitro Diagnostic (“IVD”) device can be introduced to the market for clinical

use (excluding research purposes).

This process does not require clinical trials, but it does require validation data demonstrating

accuracy of the device.

alone, there are over 36,000 patients who receive organ transplantations each year, with more than 113,000 on transplant

waiting lists.

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.

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.

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 typically require hospitalization.

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

increased incidence of preformed antibodies, these patients may never have the opportunity to receive another organ.

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 at 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 organ.

are gaps between current approaches and what the market needs.

We believe that ADi™

addresses these gaps.

is easy 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 long-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.

these advantages present opportunities for unmet medical needs in the field of organ transplantation, the industry in which we

operate is highly competitive.

A 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.

lease laboratory space in Mountain View, CA, located near resources including Stanford University (“Stanford”).

plan is to work with strategic partners to leverage common resources to accomplish milestones over the next 3 years and potentially

get access to expertise, materials, and infrastructure (such as laboratory space) which we believe can be advantageous to our

We hope that this strategy will reduce costs by obviating the need to duplicate resources.

Property (IP)

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.

technology and its various components are protected by multiple families of patents and patent applications, including

issued patents.

As of the date of this report, our patent portfolio licensed from LLU includes 8 U.S.

patents, 3 U.S.

pending patent applications, 87 foreign patents, and 14 foreign pending patent applications directed to ADi™

and related technologies.

The ADi™

patents are broadly categorized into three groups, one for autoimmune diseases and type

one for organ transplantation and a method of producing plasmid DNA that is mammalian-like to prevent immune activation;

and one providing patent protection for a composition of matter for a tolerance delivery system for antigens of interest that

would be relevant for various given indications.

The third group is the basis for a platform allowing development of a new class

of immunotherapeutics for various indications.

The projected expiration dates for these ADi™

patents ranges from 2021 to

The AditxtScore™

technology licensed from Stanford is protected by a U.S.

patent which encompasses methods, systems

and kits for detection and measurement of specific immune responses.

The patent has been issued by the USPTO and expires on December

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.

March 2021, Aditxt has signed an agreement with a regulatory consultant based in Munich, Germany, which will play a central

role in navigating the first AditxtReprogramming TM therapeutic program through the clinical trial and regulatory

The firm will work with the Aditxt's AditxtReprogramming TM team to submit an Investigational New Drug

application (IND) to the regulatory agency in Germany.

Psoriasis is the first indication being targeted for clinical trial in

the AditxtReprogramming TM therapeutics pipeline.

Other candidates that are advancing toward clinical trials include

for type 1 diabetes and skin allografting.

Plan of Operations –

Immune Monitoring

As previously announced

on August 6, 2020, the initial application of the platform will be AditxtScore™

for COVID-19 which has been designed to provide

a more complete assessment of an individual’s infection and immunity status with respect to the SARS-CoV-2 virus.

status will be 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.

We will soon be expanding the panel to measure other components

of the immune response such as cellular immunity.

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

to remedy such violation.

Plan of Operations – Immune Monitoring

As previously announced on

August 6, 2020, the initial application of the platform will be AditxtScore™ for COVID-19 which has been 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 will

be 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.

We will soon be expanding the panel to measure other components of the immune response

such as cellular immunity.

August 2020, we filed for an Emergency Use Authorization (EUA) with the FDA with the ultimate objective of filing a 510(K) application.

We are in the process of filing an amended application to incorporate additional data and information about the use of the assay.

the meantime, we are providing AditxtScore™

as a service as a Laboratory Developed Test (LDT) to assess immunity status to COVID-19.

On January 14, 2022, we submitted requests to obtain two EUAs for our antibody and neutralizing tests following an 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.

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

In early 2021, we established

our AditxtScore™

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

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

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.

We have forty-three (43)

full time employees.

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.

The ADi™ technology

falls in two main categories, the AditxtReprogramming™ therapeutic program (which includes Apoptotic DNA Immunotherapy™

also known as ADi™) and the AditxtScore™ diagnostic technology.

Both categories are protected by multiple families of patents

and patent applications, including several issued U.S.

The projected expiration dates

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

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

or Stanford and patent applications owned solely by Aditxt, including 7 U.S.

patents, 6 U.S.

applications, 88 foreign patents, and 13

foreign applications.

These patents and patent applications cover three different technical aspects of AditxtReprogramming™, 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 a compositions

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

along with methods of producing such plasmids.

The AditxtScore™ technology

is also protected by 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

As of the 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 2 U.S.

patents, 4 U.S.

applications, and 2 foreign 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 AditxtReprogramming™ therapeutic

program through the clinical trial and regulatory process.

The firm will work with the Aditxt’s AditxtReprogramming™ 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 AditxtReprogramming™ therapeutics pipeline.

Other candidates that are advancing toward clinical trials include

ADi™ for type 1 diabetes and skin allografting.

We have fifty-eight (58) full

time employees.

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