What changed in this filing

/stocks — the workspaceLOADING

Item 1. Business

2023-04-17 compared with 2022-03-31 · 373 added, 391 removed, 278 unchanged (73% of the section changed)

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

We are an innovation company with a mission of

Making Promising Innovations Possible, Together.

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

immune system.

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

Our innovation portfolio includes

the following programs:

- Adimune™ - Immune modulation technologies which are

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

rejection of transplanted organs, autoimmune diseases, and allergies.

- AditxtScore™ - Immune monitoring technologies designed

to provide a personalized comprehensive profile of the immune system.

ADI TM (Immune Modulation Program)

The discovery of immunosuppressive

4 unchanged sentences

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.

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

Furthermore, transplanted organs often

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

New, focused therapeutic approaches

are needed that modulate only the 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.

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

than indiscriminate immune suppression.

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

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

In the late 1990s, academic

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

initial grant funding from the U.S.

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

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

Department of Defense.

The focus of that project was 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

The focus of that project was induction of tolerance for

skin allografting for burn victims.

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

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

induce tolerance to self and transplanted organs.

We have an exclusive worldwide

license 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.

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

stage) from LLU, ADI™ which utilizes a novel approach that mimics the way the body naturally induces tolerance to our own tissues

(“therapeutically induced immune tolerance”).

While immune suppression requires continuous administration to prevent rejection

of a transplanted organ, induction of tolerance has the potential to retrain the immune system to accept the organ for longer periods

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

1 unchanged sentence

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

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

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

To submit a Biologics License Application

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

human subjects.

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

Phase II (efficacy) in affected subjects.

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

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

safety/toxicology data.

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

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

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

Prolongation of graft life was observed despite discontinuation

of immune suppression after the first 5 weeks.

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

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

Additionally, in an induced non-clinical model

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

for assessment of psoriasis skin lesions).

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

patients diagnosed with psoriasis.

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

to improve psoriatic lesions will also be evaluated.

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

treatment to evaluate safety and efficacy.

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

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

of immunosuppressive drugs as well as prolongation of graft life.

ADI™ is a nucleic acid-based

technology ( e.g.

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

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

self and transplanted tissues and organs.

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

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

Apoptosis is a natural process used by the body to

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

ADI™ triggers this process by enabling the cells of the

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

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

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

While efforts have been made

by various groups to promote tolerance through cell therapies and ex vivo manipulation of patient cells (takes place

outside the body 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.

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

specific tissues.

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

amounts of the therapeutic drug into the skin.

Reduce Chronic Rejection

4 unchanged sentences

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.

organ become targets of immune attack.

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

1 unchanged sentence

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

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

Moreover, preclinical studies

7 unchanged sentences

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.

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

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

Preformed Antibodies

4 unchanged sentences

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

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

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

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

5 unchanged sentences

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.

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

these individuals better opportunities for receiving an organ.

Technology Platform

ADI™ utilizes a novel

4 unchanged sentences

to induce tolerance.

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

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

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

4 unchanged sentences

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:

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

to multiple factors:

does not rely on a single mechanistic approach.

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

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

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

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

has been successfully applied to a stringent transplantation model.

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

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

13 unchanged sentences

Prior to submission

of an Investigational New Drug Application, additional non-clinical studies will be conducted in a pig model to establish the precise

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

protocol (e.g.

1 unchanged sentence

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

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

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

to ensure product safety for clinical testing.

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

Proof of Concept:

3 unchanged sentences

Type 1 Diabetes

90% of female NOD mice developed

spontaneous autoimmune diabetes.

Disease progression may be different for individual animals.

Typically, 90% of female NOD

mice develop spontaneous autoimmune diabetes if left untreated.

Disease progression may be different for individual animals much like

the clinical scenario in human patients.

ADI™ was administered

3 unchanged sentences

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

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

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

Agreement with Loma Linda University –

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

License Agreement with Loma Linda University

On March 8, 2018, we entered

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

a party to a License Agreement with 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.

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

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

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

of whatever kind or nature, to us.

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

common stock (the “Sekris Warrant”).

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

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

On March 15, 2018, as amended on July

1, 2020, we entered into a LLU License Agreement directly with Loma Linda University, which amends and restates the Sekris Agreements.

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

10 unchanged sentences

Specifically,

we are required to make the following milestone payments:

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

$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.

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).

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.

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

fee of $100,000.

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

Additionally,

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

following payments to LLU:

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

We are required

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

Additionally, we will owe royalty payments

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

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

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

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

the expiration of all valid patent claims.

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

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

All intellectual property rights in and to LLU Patent and

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

The LLU License Agreement

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

licensed to us is abandoned.

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

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

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

2 unchanged sentences

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)

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

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

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

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

Pre-clinical and Clinical Plans

The resources and efforts used

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

High-level objectives for psoriasis

clinical program:

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.

The resources and efforts

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

High-level objectives for

psoriasis clinical program:

Completion of IND-enabling work.

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

Included in the manufacturing program is stability studies;

the regulatory agency requires

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

Stability data will

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

Aditxt has also completed the in-life portion

of the toxicology studies.

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

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

The FIH clinical studies will

2 unchanged sentences

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).

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

relative ease of visualization of healing of psoriatic lesions;

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

used in moderate to severe cases).

We have identified a contract

2 unchanged sentences

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

High-level objectives for type

1 diabetes (T1D) clinical program:

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.

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

Included in the manufacturing program is stability studies;

4 unchanged sentences

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.

Our clinical studies will

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

We have selected this indication for several reasons, including:

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

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

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

We will be identifying clinical

trial centers with adequate patients.

Upon approval by the 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.

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

High-level objectives for

skin allograft clinical program:

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

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

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

Our clinical studies will combine

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

skin allografts.

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:

3 unchanged sentences

trial centers with adequate patients.

Upon approval by the FDA and/or the applicable regulatory agency clinical trials will be initiated.

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

We are developing our immune

3 unchanged sentences

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.

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.

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

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

The drug substances

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

The product candidate selected

2 unchanged sentences

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.

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

Upon receipt of clearance

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

Our product will be tested in clinical trials

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

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

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

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

We plan to start with 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.

We plan to start with psoriasis and T1D.

we will preparing for clinical trials in skin allografting.

We are developing our immune monitoring platforms

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

The multiplex technologies could potentially

allow evaluation of more analytes with less tissue samples.

Target Market

1 unchanged sentence

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.

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.

While in more recent years, several

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

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

Pre-clinical safety studies by Aditxt have shown that

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

ability to suppress the growth of an implanted melanoma tumor.

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

in patients suffering from mild to moderate psoriasis.

T1D is one of the most common

chronic disorders in children and affects nearly 2 million Americans, 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.

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

industrialized countries.

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

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

Aditxt is leveraging the ADI™

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

the pancreas.

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

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

alone, there are

9 unchanged sentences

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.

take place outside the body and may require hospitalization.

Moreover, transplanted patients

5 unchanged sentences

These patients have much lower

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

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

The potential

3 unchanged sentences

We believe that ADI™ addresses these gaps.

ADI™ is easy to administer (does

ADI™ is simple to administer (does

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

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

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

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

7 unchanged sentences

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

Immune Mapping - Immune Monitoring

AditxtScore TM (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™.

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

in better outcomes for more individuals.

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

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

AditxtScore™ is intended to be informative

for individual immune responses to viruses, bacteria, peptides, drugs, supplements, bone marrow and solid organ transplants and cancer.

It has broad applicability to many other agents of clinical interest impacting the immune system, including those not yet identified such

as emerging infectious agents.

AditxtScore™ is being

2 unchanged sentences

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).

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

This capability may be possible by having the ability

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

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

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

In addition, it can determine and differentiate between various

types of cellular and humoral immune responses (T and B cells and other cell types).

It also provides for simultaneous monitoring of cell

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

We plan to utilize AditxtScore™

in our upcoming 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 :

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

administration.

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

seeking to secure manufacturing, marketing and distribution partnerships for application in the various markets.

To obtain regulatory

approval to use AditxtScore™ as a clinical assay, we have conducted validation studies to evaluate its performance in detection

of antibodies and plan to continue conducting additional validation studies for new applications in autoimmune diseases and transplantation.

(1) Organ Rejection

4 unchanged sentences

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.

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

between various types of cellular immune responses.

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

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

Determination of cellular response has valuable

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

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

(2) Autoimmunity

Our immune system develops

to differentiate self from non-self.

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

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

more effectively.

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

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

and determination of the need for maintenance therapies when needed.

(3) Allergies

8 unchanged sentences

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.

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

Based on the ability of this technology

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

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

(4) Drug/Vaccine Response

There are currently no effective

assays to predict and easily assess responses to vaccination.

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

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

antibody titers are measured.

This process may take several days.

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.

This process may take several days or even weeks.

Furthermore, for vaccines that require a series of injections,

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

AditxtScore™ can be used to determine whether a patient

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

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

It can provide an effective

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

post vaccination.

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

This application can be

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

(5) Disease Susceptibility

7 unchanged sentences

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

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

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

Proper decision making requires understanding

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

This is fundamental to creating effective targeted

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

The immune system plays

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

This response can be inadequate or too robust or appropriately

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

often unknown.

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

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

and how might vaccines and therapies alter

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

or progression be prognosticated.

1 unchanged sentence

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

1 unchanged sentence

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.

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

method for detection and measurement of specific cellular responses.

Pursuant to the February 2020 License Agreement, we received an exclusive

worldwide license to Stanford’s patent regarding use, import, offer, and sale of Licensed Products (as defined in the agreement).

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

and ending when the patent expires.

Under the exclusivity agreement, we acknowledged that Stanford had already granted a non-exclusive

license in the Nonexclusive Field of Use, under the Licensed Patents in the Licensed Field of Use in the Licensed Territory (as those

terms are defined in the February 2020 License Agreement”).

However, Stanford agreed to not grant further licenses under the Licensed

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

On December 29, 2021, we entered into an amendment to the February 2020

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

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

We were obligated to pay and

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

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

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

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

4 unchanged sentences

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, (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:

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

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

We are also required

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

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

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

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

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

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

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

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

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

In addition to the annual

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

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

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

Net Sales are above $5 million annually.

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

notice to Stanford, or by Stanford if we:

(i) are delinquent on any report or payment;

6 unchanged sentences

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.

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.

Plan of Operations

The initial application of

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

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

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

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

In early 2021, we established

3 unchanged sentences

our prospective channel partners, including labs and hospitals.

In August 2020, we filed for

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

On January 14, 2022, we

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

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

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

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

The public health emergency

is planned to be ending in May 2023.

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

considered for EUAs.

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

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

Assays that are not developed for evaluation of infection or

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

Intellectual Property (IP)

We strive to protect and enhance

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

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

Our policy is to seek to protect our proprietary

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

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

of our business.

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

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

We 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;

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;

1 unchanged sentence

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

and to operate without infringing

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

Our innovation portfolio

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

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

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

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

The projected expiration

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

As of the date of

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

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

and other regions.

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

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

various indications.

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

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

indication, along with methods of producing such plasmids.

The AditxtScore™ technology

is also protected by 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.

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

The projected

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

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

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

These patents and patent applications

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

We also possess and/or in-license

4 unchanged sentences

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

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

program through the clinical trial and regulatory process.

The firm will work with the Aditxt’s AditxtReprogramming™ team to

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

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

Psoriasis is the first indication being targeted for clinical

trial in the 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.

trial in the ADI™ therapeutics pipeline.

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

type 1 diabetes and skin allografting.

We have sixty-one (61) full

time employees as of December 31, 2022.

We consider the relations with our employees to be good.

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