What changed in this filing

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Item 1. Business

2021-03-30 compared with 2020-04-06 · 546 added, 576 removed, 39 unchanged (97% of the section changed)

GloboCare Corp.

is a clinical-stage, leading CellTech bio-developer dedicated to advancing and empowering innovative, transformative

immune effector cell therapy and exosome technology.

Avalon also provides strategic advisory and outsourcing services to facilitate

and enhance its clients’

growth, development, as well as competitiveness in healthcare and CellTech industry markets.

Avalon’s

subsidiary and joint venture structure contribute to investor flexibility and R&D focus, enabling Avalon to establish our

leading role in the fields of immune effector cell therapy (including CAR-T and CAR-NK), as well as exosome-based regenerative

therapeutics (our ACTEX™

achieves and fosters seamless integration of unique verticals to bridge and accelerate innovative research, bio-process development,

clinical programs and product commercialization.

The Company is a

clinical-stage, vertically integrated, leading CellTech bio-developer dedicated to advancing and empowering innovative, transformative

immune effector cell therapy, exosome technology, as well as COVID-19 related diagnostics and therapeutics.

The Company also provides

strategic advisory and outsourcing services to facilitate and enhance its clients’

growth and development, as well as competitiveness

in healthcare and CellTech industry markets.

Through its subsidiary structure with unique integration of verticals from innovative

R&D to automated bioproduction and accelerated clinical development, the Company is establishing a leading role in the fields

of cellular immunotherapy (including CAR-T/NK), exosome technology (ACTEX™), and COVID-19 related vaccine and therapeutics.

Avalon achieves and

fosters seamless integration of unique verticals to bridge and accelerate innovative research, bio-process development, clinical

programs and product commercialization.

Avalon’s upstream innovative research includes:

Co-development

of Avalon Clinical-grade Tissue-specific Exosome (“ACTEX™”) with Weill Cornell Medicine

therapeutic and diagnostic targets development utilizing QTY-code protein design technology with Massachusetts Institute of

Technology (MIT)

Co-development

of next generation, transposon-based, multi-target CAR-T, CAR-NK and other immune effector cell therapeutic modalities with

Avalon’s

midstream bio-processing and bio-production facility is located in Nanjing, China with state-of-the-art, automated GMP and QC/QA

infrastructure for standardized bio-manufacturing of clinical-grade cellular products involved in our clinical programs in immune

effector cell therapy, regenerative therapeutics, as well as bio-banking.

Avalon’s

downstream medical team and facility consists of top-rated affiliated hospital network and experts specialized in hematology,

oncology, cellular immunotherapy, hematopoietic stem/progenitor cell transplant, as well as regenerative therapeutics.

clinical programs include:

Avalon has initiated its first-in-human clinical trial of CD19 CAR-T candidate, AVA-001 in August 2019 at the Hebei Yanda Lu Daopei

Hospital and Beijing Lu Daopei Hospital in China (the world’s single largest CAR-T treatment network with over 600 patients

being treated with CAR-T) for the indication of relapsed/refractory B-cell acute lymphoblastic leukemia and non-Hodgkin Lymphoma.

Development of Avalon Clinical-grade Tissue-specific Exosome (“ACTEX™”)

Novel therapeutic and diagnostic targets development utilizing QTY-code protein design technology with Massachusetts Institute of Technology (MIT) including using the QTY code protein design technology for development of a hemofiltration device to treat Cytokine Storm.

Co-development of next generation, transposon-based, multi-target CAR-T, CAR-NK and other immune effector cell therapeutic modalities with Arbele Limited.

Strategic partnership with the University of Natural Resources and Life Sciences (BOKU) in Vienna, Austria to develop an S-layer vaccine that can be administered by an intranasal or oral route against SARS-CoV-2, the novel coronavirus that causes COVID-19 disease.

Avalon’s midstream

bio-processing and bio-production facility is located in Nanjing, China with state-of-the-art, automated GMP and QC/QA infrastructure

for standardized bio-manufacturing of clinical-grade cellular products involved in our clinical programs in immune effector cell

therapy, regenerative therapeutics, as well as bio-banking.

Avalon’s downstream

medical team and facility consists of top-rated affiliated hospital network and experts specialized in hematology, oncology, cellular

immunotherapy, hematopoietic stem/progenitor cell transplant, as well as regenerative therapeutics.

Our major clinical programs

Avalon has initiated its first-in-human clinical trial of CD19 CAR-T candidate, AVA-001 in August 2019 at the Hebei Yanda Lu Daopei Hospital and Beijing Lu Daopei Hospital in China (the world’s single largest CAR-T treatment network with over 600 patients being treated with CAR-T) for the indication of relapsed/refractory B-cell acute lymphoblastic leukemia and non-Hodgkin Lymphoma.

The AVA-001 candidate (co-developed with China Immunotech Co.

Ltd) is characterized by the utilization of 4-1BB (CD137) co-stimulatory

signaling pathway, conferring a strong anti-cancer activity during pre-clinical study.

It also features a shorter bio-manufacturing

time which leads to advantage of prompt treatment to patients with these dreadful hematologic malignancies.

Avalon has plans to

recruit 20 patients (under registered clinical trial NCT03952923) for safety and efficacy studies.

Avalon’s transposon-based, multi-targeted CAR-T candidate, AVA-101 (co-developed with Arbele Corp.) will enter pre-clinical

process development and validation phase.

AVA-101 features non-viral, transposon-engineered CAR-T with multiple anti-cancer targets,

as well as possessing molecular safety-switch mechanism to minimize the side effects, such as cytokine release syndrome and neurotoxicity,

often associated with conventional CAR-T cellular therapy.

Following the pre-clinical process development and validation phase,

Avalon anticipates that it intends to pursue first-in-human clinical study of this next generation of potentially more effective

and safer CAR-T candidate.

Avalon has recently completed the standardized bio-production process of tissue-specific, clinical-grade exosomes, a co-development

endeavor with Weill Cornell Medicine with focus on angiogenic exosomes derived from endothelial cells which promote blood vessel

formation and wound healing.

Avalon is further developing this technology platform into a therapeutic candidate, AVA-202, and

plan to initiate international multi-centered clinical studies in unmet medical areas of vascular diseases and wound healing,

including treatment of diabetic foot ulcer.

commercialization phase of Avalon’s ACTEX™-based product development is underway to enter the markets of skin care,

scar removal, and hair growth through in-house development and strategic partnership.

May 29, 2018, Avalon Shanghai entered into a Joint Venture Agreement with Jiangsu Unicorn Biological Technology Co., Ltd., or

Unicorn, pursuant to which a company named Epicon Biotech Co., Ltd.

(“Epicon”) was formed on August 14, 2018.

is owned 60% by Unicorn and 40% by Avalon Shanghai.

Within two years of execution of the Joint Venture Agreement, Unicorn shall

invest cash into Epicon in an amount not less than RMB 8,000,000 (approximately $1.1 million) and the premises of the laboratories

of Nanjing Hospital of Chinese Medicine for exclusive operation by Epicon, and Avalon Shanghai shall invest cash into Epicon in

an amount not less than RMB 10,000,000 (approximately $1.4 million).

The board of directors of Epicon shall consist of five members

with Unicorn appointing three members and Avalon Shanghai appointing two members.

Epicon will be focused on cell preparation,

third party testing, biological sample repository for commercial and scientific research purposes and the clinical transformation

of scientific achievements.

As of December 31, 2019, Unicorn has invested the premises of the laboratories of Nanjing BENQ hospital

as GMP level research and manufacture facility and Avalon Shanghai has contributed RMB 4,100,000 (approximately $0.6 million).

Epicon is focused on cell preparation, third party testing, biological sample repository for commercial and scientific research

purposes and the clinical transformation of scientific achievements.

July 18, 2018, the Company formed a wholly owned subsidiary, Avactis Biosciences, Inc., a Nevada corporation, which aims to focus

on accelerating commercial activities related to cell-based technology and its application in immune effector cell therapy (such

The subsidiary is designed to integrate and optimize our global scientific and clinical resources to further advance

the use of immune effector cell therapy in oncology and other unmet medical areas.

August 6, 2018, the Company entered into a strategic partnership agreement with Weill Cornell’s cGMP Cellular Therapy Facility

and Laboratory for Advanced Cellular Engineering headed by Dr.

Yen-Michael Hsu.

This strategic partnership aims to co-develop

bio-production and standardization procedures in procurement, storage, processing, clinical study protocols, and bio-banking for

Chimeric Antigen Receptor (CAR)-T therapy, in accordance with the Foundation of Accreditation for Cellular Therapy (FACT) and

American Association of Blood Banks (AABB) standards.

This partnership also includes a CAR-T education program to support and

foster collaborative research and training programs for scientists and clinicians between Weill Cornell and Hebei Yanda LuDaopei

Hospital, which is our main affiliated clinical facility as well as the world’s single largest medical institution in CAR-T

July 22, 2019, Avalon established a strategic partnership with GE Healthcare in order to accelerate Avalon’s standardization,

automation and bio-production for clinical-grade CAR-T cells and other immune-effector cells for cellular immunotherapy, as well

as exosomes/extracellular vesicles-based regenerative therapeutics.

This partnership combines GE Healthcare’s renowned expertise

in the design and development of innovative bio-manufacturing technologies and Avalon’s scientific and clinical expertise

for the cellular medicine industry.

This enables Avalon to execute on the complete development lifecycle from innovation through

bio-production to the delivery and management of treatment at hospitals for patients.

This infrastructure and depth of capabilities

ensures the successful execution of the company’s ongoing clinical trials.

Under this partnership, both Avalon and GE Healthcare

will strategically establish automated and standardized GMP cell production capabilities.

Avalon will be given access to GE Healthcare’s

cell processing expertise and products in the form of FlexFactory Cell Therapy platform, FastTrak process development and training

services, as well as extensive SOP and validation protocol library.

Additionally, user training will be conducted both at GE Healthcare

and on-site at Avalon’s Nanjing Epicon GMP facility with access to GE Healthcare’s expert bio-manufacturing resources.

In conjunction with Avalon’s extensive clinical network in China, this strategic partnership empowers Avalon to improve

manufacturing throughput and efficiency, alleviate cost burden, and minimize variability in the automated and standardized bio-production

process of clinical-grade cellular products (such as CAR-T, CAR-NK, and stem cell-derived exosomes/EV), therefore, accelerating

the development of Avalon’s clinical and commercialization programs in cellular medicines.

the year ended December 31, 2019 we generated revenue by providing medical related consulting services in advanced areas of immunotherapy

and second opinion/referral services through our wholly-owned subsidiary Avalon (Shanghai) Healthcare Technology Co., Ltd., or

Avalon Shanghai.

Ltd) is characterized by the utilization of 4-1BB (CD137) co-stimulatory signaling pathway, conferring a strong anti-cancer activity during pre-clinical study.

It also features a shorter bio-manufacturing time which leads to the advantage of prompt treatment to patients where timing is important related hematologic malignancies.

Avalon has successfully completed the first-in-human clinical trial of its AVA-001 anti-CD19 CAR-T cell therapy as a bridge to allogeneic bone marrow transplantation for patients with relapsed/refractory B-cell acute lymphoblastic leukemia at the Lu Daopei Hospital (registered clinical trial number NCT03952923) with excellent efficacy (90% complete remission rate) and minimal adverse side effects.

Avalon is currently expanding the patient recruitment for AVA-001 to include relapsed/refractory non-Hodgkin lymphoma patients.

ACTEX™:

Stem cell-derived Avalon Clinical-grade Tissue-specific Exosomes (ACTEX™) is one of the core technology platforms that has been co-developed by Avalon GloboCare and Weill Cornell Medicine.

The Company formed a strategic partnership with HydroPeptide, LLC, a leading epigenetics skin care company, to engage in co-development and commercialization of a series of clinical-grade, exosome-based cosmeceutical and orthopedic products.

As part of this agreement, the Company signed a three-way Material Transfer Agreement between Avalon GloboCare, HydroPeptide and Weill Cornell Medicine.

FLASH-CAR™:

The Company advanced its next generation immune cell therapy using RNA-based, non-viral FLASH-CAR™

technology co-developed with the Company’s strategic partner Arbele Limited.

The adaptable FLASH-CAR™

platform can be used to create personalized cell therapy from a patient’s own cells, as well as off-the-shelf cell therapy from a universal donor.

Our leading candidate, AVA-011, is currently at process development stage to generate clinical-grade cell-therapy products for subsequent clinical studies.

AVA-Trap™:

Avalon’s AVA-Trap™

therapeutic program plans to enter animal model testing followed by expedited clinical studies with the goal of providing an effective therapeutic option to combat COVID-19 and other life-threatening conditions involving cytokine storms.

The Company initiated a sponsored research and co-development project with Massachusetts Institute of Technology (MIT) led by Professor Shuguang Zhang as Principal Investigator in May 2019.

Using the unique QTY code protein design platform, six water-soluble variant cytokine receptors have been successfully designed and tested to show binding affinity to the respective cytokines.

year ended December 31, 2020 we generated revenue by providing medical related consulting services in advanced areas of immunotherapy

and second opinion/referral services through our wholly-owned subsidiary Avalon (Shanghai) Healthcare Technology Co., Ltd., or Avalon

We also own and operate rental commercial real property in New Jersey, where we are headquartered.

We discontinued

sales of exosome isolation systems in China and the US through our joint venture Genexosome Technologies, Inc.

Feedback received

from our research partners is that our exosome isolation systems did not produce consistent results and did not deliver high exosome

yields and concentrations.

We discontinued sales of

exosome isolation systems in China and the US through our joint venture Genexosome Technologies, Inc.

has not significantly impacted Company operations or the work performed as part of our clinical trials in China.

trials are being conducted at Hebei Yanda Lu Daopei Hospital and Beijing Lu Daopei Hospital.

Both hospitals are considered primarily

hematology specialty hospitals and experienced minor disruption as part of the pandemic.

Information/Company History

were incorporated under the laws of the State of Delaware on July 28, 2014 under the name Global Technologies Corp.

18, 2016, we changed our name to Avalon GloboCare Corp.

and completed a reverse split of our shares of common stock at a ratio

The clinical trials are

being conducted at Hebei Yanda Lu Daopei Hospital and Beijing Lu Daopei Hospital.

Both hospitals are considered primarily hematology specialty

hospitals and experienced minor disruption as part of the pandemic.

Corporate Information/Company History

We were incorporated under

the laws of the State of Delaware on July 28, 2014 under the name Global Technologies Corp.

On October 18, 2016, we changed our

name to Avalon GloboCare Corp.

and completed a reverse split of our shares of common stock at a ratio of 1:4.

We own 100% of the capital

12 unchanged sentences

In July 2017, we formed Genexosome Technologies Inc., a Nevada corporation, or Genexosome.

On October 25, 2017,

we and Genexosome entered into a Securities Purchase Agreement pursuant to which we acquired 600 shares of Genexosome in consideration

of $1,326,087 in cash and 500,000 shares of our common stock.

On October 25, 2017, Genexosome entered into and closed a Stock Purchase

Agreement with Beijing Jieteng (Genexosome) Biotech Co.

Ltd., a corporation incorporated in the People’s Republic of China,

or Beijing Genexosome, and Yu Zhou, MD, PhD, the sole shareholder of Beijing Genexosome, pursuant to which Genexosome acquired

all of the issued and outstanding securities of Beijing Genexosome in consideration of a cash payment in the amount of $450,000.

On October 25, 2017, Genexosome entered into and closed an Asset Purchase Agreement with Dr.

Zhou, pursuant to which we acquired

all assets, including all intellectual property and the exosome separation system, held by Dr.

Zhou pertaining to the business

of researching, developing and commercializing exosome technologies in consideration of $876,087 in cash, 500,000 shares of our

common stock and 400 shares of common stock of Genexosome.

As a result of the above transactions, we hold 60% of Genexosome and

Zhou holds 40% of Genexosome.

July 18, 2018, we formed a wholly owned subsidiary, Avactis Biosciences Inc.

(“Avactis”), a Nevada corporation, which

will be focused on accelerating commercial activities related to cellular therapies, including regenerative medicine with stem/progenitor

cells as well as cellular immunotherapy including CAR-T, CAR-NK, TCR-T and others.

The subsidiary is designed to integrate and

optimize our global scientific and clinical resources to further advance the use of cellular therapies to treat certain cancers.

October 23, 2018, Avactis and Arbele Limited (“Arbele”) agreed to the establishment of AVAR BioTherapeutics (China)

(“AVAR”), a Sino-foreign equity joint venture, pursuant to an Equity Joint Venture Agreement (the “AVAR

Agreement”), which will be owned 60% by Avactis and 40% by Arbele.

The purpose and business scope of the Joint Venture is

to research, develop, produce, sell, distribute and generally commercialize CAR-T/CAR-NK/TCR-T/universal cellular immunotherapy

Avactis is required to contribute USD $10 million (or equivalent in RMB) in cash and/or services, which shall

be contributed in tranches based on milestones to be determined jointly by AVAR and Avactis in writing subject to Avactis’

Effective October

25, 2017, Genexosome owns 100% of the capital stock of Beijing Jieteng (Genexosome) Biotech Co., Ltd., a corporation incorporated

in the People’s Republic of China on August 7, 2015 (“Beijing Genexosome”), and the Company holds 60% of Genexosome

Yu Zhou holds 40% of Genexosome.

Beijing Genexosome is engaged in providing development services and selling developed

items to customers in China.

On May 29, 2018, Avalon

Shanghai entered into a Joint Venture Agreement with Jiangsu Unicorn Biological Technology Co., Ltd., or Unicorn, pursuant to

which a company named Epicon Biotech Co., Ltd.

(“Epicon”) was formed on August 14, 2018.

Epicon is owned 60% by Unicorn

and 40% by Avalon Shanghai.

Within five years of execution of the Joint Venture Agreement, Unicorn shall invest cash into Epicon

in an amount not less than RMB 8,000,000 (approximately $1.2 million) and the premises of the laboratories of Nanjing Hospital

of Chinese Medicine for exclusive operation by Epicon, and Avalon Shanghai shall invest cash into Epicon in an amount not less

than RMB 10,000,000 (approximately $1.5 million).

The board of directors of Epicon shall consist of five members with Unicorn

appointing three members and Avalon Shanghai appointing two members.

As of December 31, 2020, Unicorn has invested the premises

of the laboratories of Nanjing BENQ hospital as GMP level research and manufacture facility and Avalon Shanghai has contributed

RMB 4,500,000 (approximately $0.7 million).

Epicon is focused on cell preparation, third party testing, biological sample repository

for commercial and scientific research purposes and the clinical transformation of scientific achievements.

On July 18, 2018, we formed

a wholly owned subsidiary, Avactis Biosciences Inc.

(“Avactis”), a Nevada corporation, which will be focused on accelerating

commercial activities related to cellular therapies, including regenerative medicine with stem/progenitor cells as well as cellular

immunotherapy including CAR-T, CAR-NK, TCR-T and others.

The subsidiary is designed to integrate and optimize our global scientific

and clinical resources to further advance the use of cellular therapies to treat certain cancers.

On October 23, 2018, Avactis

and Arbele Limited (“Arbele”) agreed to the establishment of AVAR BioTherapeutics (China) Co.

(“AVAR”),

a Sino-foreign equity joint venture, pursuant to an Equity Joint Venture Agreement (the “AVAR Agreement”), which will

be owned 60% by Avactis and 40% by Arbele.

The purpose and business scope of the Joint Venture is to research, develop, produce,

sell, distribute and generally commercialize CAR-T/CAR-NK/TCR-T/universal cellular immunotherapy in China.

Avactis is required

to contribute USD $10 million (or equivalent in RMB) in cash and/or services, which shall be contributed in tranches

based on milestones to be determined jointly by AVAR and Avactis in writing subject to Avactis’

cash reserves.

Within 30 days, Arbele shall make contribution of USD $6.66 million in the form of entering into a License Agreement

with AVAR granting AVAR with an exclusive right and license in China to its technology and intellectual property pertaining to

CAR-T/CAR-NK/TCR-T/universal cellular immunotherapy technology and any additional technology developed in the future with terms

and conditions to be mutually agreed upon Avactis and AVAR and services.

As of the date hereof, AVAR is in process of being established

and the License Agreement has not been finalized.

following diagram illustrates our corporate structure:

and Marketing

seek to develop new business through relationships driven by our senior management, which have extensive contacts throughout the

healthcare system.

Our senior management will be seeking opportunities for joint ventures, strategic relationships and acquisitions

in consulting, biomedical innovations, and telemedicine, and rehabilitation centers.

currently generate revenue from related party strategic relationships through Avalon Shanghai that provide consultative services

in advanced areas of immunotherapy and second opinion/referral services.

In addition, our services are targeted at serving our

clients and using our insights and deep expertise to produce tangible and significant results.

Our services include research studies,

executive education, daily online executive briefings, tailored expert advisory services, and consulting and management services.

We typically charge an annual fee.

Through our services, we attempt to have our clients focus on important problems by providing

an analysis of the evolving healthcare industry and the methods prevalent in the industry to solve those problems through counsel,

business planning and support.

We tailor these solutions to the client’s specific strategic challenges, operational issues,

and management concerns.

days, Arbele shall make contribution of USD $6.66 million in the form of entering into a License Agreement with AVAR granting AVAR

with an exclusive right and license in China to its technology and intellectual property pertaining to CAR-T/CAR-NK/TCR-T/universal

cellular immunotherapy technology and any additional technology developed in the future with terms and conditions to be mutually

agreed upon Avactis and AVAR and services.

As of the date hereof, the License Agreement has not been finalized.

The following diagram illustrates

our corporate structure:

Sales and Marketing

We seek to develop new

business through relationships driven by our senior management, which have extensive contacts throughout the healthcare system.

Our senior management will be seeking opportunities for joint ventures, strategic relationships and acquisitions in consulting,

biomedical innovations, and telemedicine, and rehabilitation centers.

We currently generate

revenue from related party strategic relationships through Avalon Shanghai that provide consultative services in advanced areas

of immunotherapy and second opinion/referral services.

In addition, our services are targeted at serving our clients and using

our insights and deep expertise to produce tangible and significant results.

Our services include research studies, executive

education, daily online executive briefings, tailored expert advisory services, and consulting and management services.

charge an annual fee.

Through our services, we attempt to have our clients focus on important problems by providing an analysis

of the evolving healthcare industry and the methods prevalent in the industry to solve those problems through counsel, business

planning and support.

We tailor these solutions to the client’s specific strategic challenges, operational issues, and management

We plan to expand our business services throughout the United States via our “Technology + Service”

“Avalon Cell”.

Partnerships and Acquisitions

are actively seeking potential strategic partnerships in our area of focus.

In addition, we are actively seeking target acquisitions

that add accretive value to our strategic plan.

There is no guarantee that we will be able to successfully sign a definitive agreement,

close or implement such business arrangement.

will focus on the following markets in developing our core business:

“Avalon Cell”

as the future of medicine, we believe cell-based therapeutics will replace pharmaceuticals as a more effective and functional

modality in disease treatment.

We are actively engaging in this revolutionary trend and positioning to take a leading role in

cell-based technology and therapeutics.

Strategic Partnerships and Acquisitions

We are actively seeking

potential strategic partnerships in our area of focus.

In addition, we are actively seeking target acquisitions that add accretive

value to our strategic plan.

There is no guarantee that we will be able to successfully sign a definitive agreement, close or implement

such business arrangement.

We will focus on the following

markets in developing our core business:

Platform “Avalon

Regarded as the future

of medicine, we believe cell-based therapeutics will replace pharmaceuticals as a more effective and functional modality in disease

We are actively engaging in this revolutionary trend and positioning to take a leading role in cell-based technology

and therapeutics.

The business model for our “Avalon Cell”

platform is based on stringent criteria

in the selection and evaluation of candidate projects at different stages of their developmental cycle.

We particularly focus

on projects that have strong intellectual property and distinctive innovation, as well as being translational, application-driven,

and commercialization-ready.

platform is based on stringent criteria in the selection

and evaluation of candidate projects at different stages of their developmental cycle.

We particularly focus on projects that have

strong intellectual property and distinctive innovation, as well as being translational, application-driven, and commercialization-ready.

Our technology-based platform, “Avalon Cell”, comprises four programs:

technology, small extracellular vesicles that have great potential to be used in diagnostics (“liquid biopsy”)

and regenerative therapeutics.

We have commenced developing collaborative sites at Weill Cornell Medical College in the United

States, as well as Lu Daopei Hospital of Daopei Medical Group and Da An Gene Co, Ltd.

in China, focusing on exosome-based

diagnostics and therapeutics.

cells, namely therapeutics involving the cells that line blood vessels and regulate exchanges between the bloodstream and

surrounding tissue.

These programs will occur with our collaborative sites at Weill Cornell Medical College Department of

Pathology and Ansary Stem Cell Institute, focusing on standardization of endothelial derived exosomes and therapeutics;

immunotherapy (including cells such as NK, DC-CIK, CAR-T).

Technologies, Inc.

our majority-owned subsidiary, Genexosome Technologies, Inc., or Genexosome, during certain periods of 2019, marketed and sold

our proprietary exosome isolation systems.

Exosomes are small extracellular vesicles that we believe may be used as a vehicle

for drug delivery in the treatment of various diseases, and biomarkers for early stage diagnosis and as enhancements to certain

cosmetic treatments and procedures.

We discontinued sales of exosome isolation systems in China and the US through our joint venture

Genexosome Technologies, Inc.

Feedback received from our research partners is that our exosome isolation systems did not produce

consistent results and did not deliver high exosome yields and concentrations.

RT 9 Properties, LLC

May 2017, we acquired commercial property located in Freehold, New Jersey.

This property is now our corporate headquarters and

contains several commercial tenants that generate revenue through rental income.

currently generate revenue by providing medical related consulting services in advanced areas of immunotherapy and second opinion/referral

services through Avalon (Shanghai) Healthcare Technology Co., Ltd., or Avalon Shanghai.

Our medical related consulting services

include research studies, executive education, daily online executive briefings, tailored expert advisory services, and consulting

and management services.

Through our services we attempt to have our clients focus on important problems by providing an analysis

of the evolving healthcare industry and the methods prevalent in the industry to solve those problems through counsel, business

planning and support.

The revenue generated from our related parties in China is managed by our employees residing in China and

contactors who are retained as needed.

● Novel therapeutic and diagnostic targets development utilizing

QTY-code protein design technology with Massachusetts Institute of Technology (MIT) including using the QTY code protein design

technology for development of a hemofiltration device to treat Cytokine Storm.

● Co-development of next generation, transposon-based, multi-target

CAR-T, CAR-NK and other immune effector cell therapeutic modalities with Arbele Limited.

● Strategic partnership with the University

of Natural Resources and Life Sciences (BOKU) in Vienna, Austria to develop an S-layer vaccine that can be administered by an intranasal

or oral route against SARS-CoV-2, the novel coronavirus that causes COVID-19 disease.

Exosome technology, small extracellular vesicles that have great potential to be used in diagnostics (“liquid biopsy”) and regenerative therapeutics.

We have commenced developing collaborative sites at Weill Cornell Medical College in the United States, as well as Lu Daopei Hospital of Daopei Medical Group and Da An Gene Co, Ltd.

in China, focusing on exosome-based diagnostics and therapeutics.

Avalon RT 9 Properties,

In May 2017, we acquired

commercial property located in Freehold, New Jersey.

This property is now our corporate headquarters and contains several commercial

tenants that generate revenue through rental income.

Avalon Shanghai

We currently generate revenue

by providing medical related consulting services in advanced areas of immunotherapy and second opinion/referral services through

Avalon (Shanghai) Healthcare Technology Co., Ltd., or Avalon Shanghai.

Our medical related consulting services include research

studies, executive education, daily online executive briefings, tailored expert advisory services, and consulting and management

Through our services we attempt to have our clients focus on important problems by providing an analysis of the evolving

healthcare industry and the methods prevalent in the industry to solve those problems through counsel, business planning and support.

The revenue generated from our related parties in China is managed by our employees residing in China and contactors who are retained

Consulting services have been provided by Avalon Shanghai under the contract include:

scientific research consulting services;

experts, medical institutions and other resources in the United States in support of scientific research;

technical education and training;

in publication of academic papers.

intend to pursue the acquisition and development of healthcare related technologies for cell related diagnostics and therapeutics

through acquisition, licensing or joint ventures with major universities and biotech companies.

We will also consider a third

avenue of investing in certain technologies for cell related diagnostics and therapeutics.

goal is to obtain, maintain and enforce patent rights for our products, formulations, processes, methods of use and other proprietary

technologies, preserve our trade secrets, and operate without infringing on the proprietary rights of other parties, both in the

United States and abroad.

Our policy is to actively seek to obtain, where appropriate, the broadest intellectual property protection

possible for our current product candidates and any future product candidates, proprietary information and proprietary technology

through a combination of contractual arrangements and patents, both in the United States and abroad.

Even patent protection, however,

may not always afford us with complete protection against competitors who seek to circumvent our patents.

providing scientific research consulting services;

integrating experts, medical institutions and other resources in the United States in support of scientific research;

providing technical education and training;

assisting in publication of academic papers.

Strategic Development

We intend to pursue the

acquisition and development of healthcare related technologies for cell related diagnostics and therapeutics through acquisition,

licensing or joint ventures with major universities and biotech companies.

We will also consider a third avenue of investing in

certain technologies for cell related diagnostics and therapeutics.

Genexosome Technologies,

Through our majority-owned subsidiary, Genexosome Technologies,

Inc., or Genexosome, during certain periods of 2019, marketed and sold our proprietary exosome isolation systems.

small extracellular vesicles that we believe may be used as a vehicle for drug delivery in the treatment of various diseases, and

biomarkers for early stage diagnosis and as enhancements to certain cosmetic treatments and procedures.

We discontinued sales of

exosome isolation systems in China and the US through our joint venture Genexosome Technologies, Inc.

Feedback received from our

research partners is that our exosome isolation systems did not produce consistent results and did not deliver high exosome yields

and concentrations.

Intellectual Property

Our goal is to obtain,

maintain and enforce patent rights for our products, formulations, processes, methods of use and other proprietary technologies,

preserve our trade secrets, and operate without infringing on the proprietary rights of other parties, both in the United States

Our policy is to actively seek to obtain, where appropriate, the broadest intellectual property protection possible

for our current product candidates and any future product candidates, proprietary information and proprietary technology through

a combination of contractual arrangements and patents, both in the United States and abroad.

Even patent protection, however, may

not always afford us with complete protection against competitors who seek to circumvent our patents.

If we fail to adequately

3 unchanged sentences

confidentiality agreements that prohibit the disclosure and use of confidential information and, where applicable, require disclosure

and assignment to us of the ideas, developments, discoveries and inventions relevant to our technologies and important to our

Technologies, Inc.

discontinued sales of exosome isolation systems in China and the US through our joint venture Genexosome Technologies, Inc.

received from our research partners is that our exosome isolation systems did not produce consistent results and did not deliver

high exosome yields and concentrations.

There are other companies that produce exosome isolation systems.

our current consulting business in the People’s Republic of China, or PRC or China, we compete with a number of advisory

firms offering similar service including consulting and strategy firms;

and assignment to us of the ideas, developments, discoveries and inventions relevant to our technologies and important to our business.

Avalon Shanghai

In our current consulting

business in the People’s Republic of China, or PRC or China, we compete with a number of advisory firms offering similar

service including consulting and strategy firms;

market research, data, benchmarking, and forecasting providers;

technology vendors and services firms;

technology vendors

and services firms;

healthcare information technology firms;

1 unchanged sentence

outsourcing firms;

and specialized providers of educational and training services.

Other organizations, such as state and national trade associations,

group purchasing organizations, non-profit think-tanks, and database companies, also may offer research, consulting, tools, and

education services to health care and education organizations.

believe that the principal competitive factors in our market include quality and timeliness of our services, strength and depth

of relationships with our clients, ability to meet the changing needs of current and prospective clients, measurable returns on

customer investment, and service and affordability.

our business develops and we expand through joint ventures, acquisitions and strategic partnerships in the U.S.

and PRC, we will

have competition with other direct service providers, emerging technologies and medical communication platforms.

to maintain a competitive advantage through intellectual property, superior quality management and cutting-edge technology.

RT 9 Properties LLC

executive commercial building in Freehold, New Jersey is located on a major highway and is one of the largest buildings in the

surrounding areas.

It is centrally located and maintains high occupancy.

There are other commercial properties in the vicinity

that offer similar amenities.

However, premier executive offices are limited and as such we expect to continue to maintain high

occupancy in the near term.

Manufacturing

discontinued sales of exosome isolation systems in China and the US through our joint venture Genexosome Technologies, Inc.

received from our research partners is that our exosome isolation systems did not produce consistent results and did not deliver

high exosome yields and concentrations.

During 2019, Genexosome maintained its manufacturing facilities in leased premises located

in Beijing, China and our owned executive commercial building in Freehold, New Jersey.

Currently, this manufacturing facility

is idle as we discontinued sale of the product.

of March 30, 2020, we employed 8 employees, seven of which are full time employees.

None of our employees are represented by a

collective bargaining arrangement.

healthcare industry in the PRC and U.S.

is highly regulated and subject to changing political, legislative, regulatory, and other

Further, the healthcare industry is currently undergoing rapid change.

We are uncertain how, when or in what context

these new changes will be adopted or implemented.

These new regulations could create unexpected liabilities for us, could cause

us or our members to incur additional costs and could restrict our or our clients’

Many of the laws are complex

and their application to us, our clients, or the specific services and relationships we have with our members are not always clear.

Our failure to anticipate accurately the application of these laws and regulations, or our other failure to comply, could create

liability for us, result in adverse publicity, and otherwise negatively affect our business.

efforts to develop its legal system over the past several decades, including but not limited to legislation dealing with economic

matters such as foreign investment, corporate organization and governance, commerce, taxation and trade, the PRC continues to

lack a comprehensive system of laws.

Further, the laws that do exist in the PRC are often vague, ambiguous and difficult to enforce,

which could negatively affect our ability to do business in China and compete with other companies in our segments.

September 2006, the Ministry of Commerce, or MOFCOM, promulgated the Regulations on Foreign Investors’

Mergers and Acquisitions

of Domestic Enterprises, or the M&A Regulations, in an effort to better regulate foreign investment in the PRC.

Regulations were adopted in part as a needed codification of certain joint venture formation and operating practices, and also

in response to the government’s increasing concern about protecting domestic companies in perceived key industries and those

associated with national security, as well as the outflow of well-known trademarks, including traditional Chinese brands.

based company doing business in the PRC, we seek to comply with all PRC laws, rules and regulations and pronouncements,

and endeavor to obtain all necessary approvals from applicable PRC regulatory agencies such as the MOFCOM, the State Assets Supervision

and Administration Commission, the State Administration for Taxation, the State Administration for Industry and Commerce, the

China Securities Regulatory Commission, and the State Administration of Foreign Exchange, or SAFE.

and specialized providers

of educational and training services.

Other organizations, such as state and national trade associations, group purchasing organizations,

non-profit think-tanks, and database companies, also may offer research, consulting, tools, and education services to health care

and education organizations.

We believe that the principal

competitive factors in our market include quality and timeliness of our services, strength and depth of relationships with our

clients, ability to meet the changing needs of current and prospective clients, measurable returns on customer investment, and

service and affordability.

As our business develops

and we expand through joint ventures, acquisitions and strategic partnerships in the U.S.

and PRC, we will have competition with

other direct service providers, emerging technologies and medical communication platforms.

We will seek to maintain a competitive

advantage through intellectual property, superior quality management and cutting-edge technology.

Avalon RT 9 Properties

Our executive commercial

building in Freehold, New Jersey is located on a major highway and is one of the largest buildings in the surrounding areas.

is centrally located and maintains high occupancy.

There are other commercial properties in the vicinity that offer similar amenities.

However, premier executive offices are limited and as such we expect to continue to maintain high occupancy in the near term.

Genexosome Technologies,

We discontinued sales

of exosome isolation systems in China and the US through our joint venture Genexosome Technologies, Inc.

Feedback received from

our research partners is that our exosome isolation systems did not produce consistent results and did not deliver high exosome

yields and concentrations.

There are other companies that produce exosome isolation systems.

As of March 29, 2021, we

employed eight employees, six of which are full time employees.

None of our employees are represented by a collective bargaining

Government Regulation

The healthcare industry

in the PRC and U.S.

is highly regulated and subject to changing political, legislative, regulatory, and other influences.

the healthcare industry is currently undergoing rapid change.

We are uncertain how, when or in what context these new changes will

be adopted or implemented.

These new regulations could create unexpected liabilities for us, could cause us or our members to incur

additional costs and could restrict our or our clients’

Many of the laws are complex and their application to

us, our clients, or the specific services and relationships we have with our members are not always clear.

Our failure to anticipate

accurately the application of these laws and regulations, or our other failure to comply, could create liability for us, result

in adverse publicity, and otherwise negatively affect our business.

Despite efforts to develop

its legal system over the past several decades, including but not limited to legislation dealing with economic matters such as

foreign investment, corporate organization and governance, commerce, taxation and trade, the PRC continues to lack a comprehensive

system of laws.

Further, the laws that do exist in the PRC are often vague, ambiguous and difficult to enforce, which could negatively

affect our ability to do business in China and compete with other companies in our segments.

In September 2006, the

Ministry of Commerce, or MOFCOM, promulgated the Regulations on Foreign Investors’

Mergers and Acquisitions of Domestic Enterprises,

or the M&A Regulations, in an effort to better regulate foreign investment in the PRC.

The M&A Regulations were adopted

in part as a needed codification of certain joint venture formation and operating practices, and also in response to the government’s

increasing concern about protecting domestic companies in perceived key industries and those associated with national security,

as well as the outflow of well-known trademarks, including traditional Chinese brands.

based company

doing business in the PRC, we seek to comply with all PRC laws, rules and regulations and pronouncements, and endeavor to obtain

all necessary approvals from applicable PRC regulatory agencies such as the MOFCOM, the State Assets Supervision and Administration

Commission, the State Administration for Taxation, the State Administration for Industry and Commerce, the China Securities Regulatory

Commission, and the State Administration of Foreign Exchange, or SAFE.

Approval Process

research, development, testing, manufacture, labeling, promotion, advertising, distribution and marketing, among other things,

of our product candidates are extensively regulated by governmental authorities in the United States and other countries.

United States, the FDA regulates drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and its implementing regulations.

Failure to comply with the applicable U.S.

requirements may subject us to administrative or judicial sanctions, such as the FDA’s

refusal to approve a pending new drug application, or NDA, or a pending biologics license application, or BLA, warning letters,

product recalls, product seizures, total or partial suspension of production or distribution, injunctions and/or criminal prosecution.

Pharmaceutical

products such as ours may not be commercially marketed without prior approval from the FDA and comparable regulatory agencies

in other countries.

In the United States, the process to receiving such approval is long, expensive and risky, and includes the

following steps:

laboratory tests, animal studies, and formulation studies;

to the FDA of an IND for human clinical testing, which must become effective before human clinical trials may begin;

and well-controlled human clinical trials to establish the safety and efficacy of the drug for each indication;

to the FDA of an NDA or BLA;

completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance

with current good manufacturing practices, or cGMPs;

potential FDA audit of the preclinical and clinical trial sites that generated the data in support of the NDA or BLA;

ability to obtain clearance or approval of companion diagnostic tests, if required, on a timely basis, or at all;

review and approval of the NDA or BLA.

and foreign governmental authorities is a significant factor affecting our ability to commercialize any of our products,

as well as the timing of such commercialization and our ongoing research and development activities.

The commercialization of

drug products requires regulatory approval by governmental agencies prior to commercialization.

Various laws and regulations govern

or influence the research and development, non-clinical and clinical testing, manufacturing, processing, packing, validation,

safety, labeling, storage, record keeping, registration, listing, distribution, advertising, sale, marketing and post-marketing

commitments of our products.

The lengthy process of seeking these approvals, and the subsequent compliance with applicable laws

and regulations, require expending substantial resources.

results of pre-clinical testing, which include laboratory evaluation of product chemistry and formulation, animal studies to assess

the potential safety and efficacy of the product and its formulations, details concerning the drug manufacturing process and its

controls, and a proposed clinical trial protocol and other information must be submitted to the FDA as part of an IND that must

be reviewed and become effective before clinical testing can begin.

The study protocol and informed consent information for patients

in clinical trials must also be submitted to an independent Institutional Review Board, or IRB, for approval covering each institution

at which the clinical trial will be conducted.

Once a sponsor submits an IND, the sponsor must wait 30 calendar days before initiating

any clinical trials.

If the FDA has comments or questions within this 30-day period, the issue(s) must be resolved to the satisfaction

of the FDA before clinical trials can begin.

In addition, the FDA, an IRB or the company may impose a clinical hold on ongoing

clinical trials due to safety concerns.

If the FDA imposes a clinical hold, clinical trials can only proceed under terms authorized

Our pre-clinical and clinical studies must conform to the FDA’s Good Laboratory Practice, or GLP, and Good Clinical

Practice, or GCP, requirements, respectively, which are designed to ensure the quality and integrity of submitted data and protect

the rights and well-being of study patients.

Information for certain clinical trials also must be publicly disclosed within certain

time limits on the clinical trial registry and results databank maintained by the NIH.

clinical testing involves a three-phase process;

The research, development,

testing, manufacture, labeling, promotion, advertising, distribution and marketing, among other things, of our product candidates

are extensively regulated by governmental authorities in the United States and other countries.

In the United States, the FDA regulates

drugs under the Federal Food, Drug, and Cosmetic Act, or the FDCA, and its implementing regulations.

Failure to comply with the

applicable U.S.

requirements may subject us to administrative or judicial sanctions, such as the FDA’s refusal to approve

a pending new drug application, or NDA, or a pending biologics license application, or BLA, warning letters, product recalls, product

seizures, total or partial suspension of production or distribution, injunctions and/or criminal prosecution.

Pharmaceutical products

such as ours may not be commercially marketed without prior approval from the FDA and comparable regulatory agencies in other countries.

In the United States, the process to receiving such approval is long, expensive and risky, and includes the following steps:

pre-clinical laboratory tests, animal studies, and formulation studies;

submission to the FDA of an IND for human clinical testing, which must become effective before human clinical trials may begin;

adequate and well-controlled human clinical trials to establish the safety and efficacy of the drug for each indication;

submission to the FDA of an NDA or BLA;

satisfactory completion of an FDA inspection of the manufacturing facility or facilities at which the drug is produced to assess compliance with current good manufacturing practices, or cGMPs;

a potential FDA audit of the preclinical and clinical trial sites that generated the data in support of the NDA or BLA;

the ability to obtain clearance or approval of companion diagnostic tests, if required, on a timely basis, or at all;

FDA review and approval of the NDA or BLA.

Regulation by U.S.

foreign governmental authorities is a significant factor affecting our ability to commercialize any of our products, as well as

the timing of such commercialization and our ongoing research and development activities.

The commercialization of drug products

requires regulatory approval by governmental agencies prior to commercialization.

Various laws and regulations govern or influence

the research and development, non-clinical and clinical testing, manufacturing, processing, packing, validation, safety, labeling,

storage, record keeping, registration, listing, distribution, advertising, sale, marketing and post-marketing commitments of our

The lengthy process of seeking these approvals, and the subsequent compliance with applicable laws and regulations, require

expending substantial resources.

The results of pre-clinical

testing, which include laboratory evaluation of product chemistry and formulation, animal studies to assess the potential safety

and efficacy of the product and its formulations, details concerning the drug manufacturing process and its controls, and a proposed

clinical trial protocol and other information must be submitted to the FDA as part of an IND that must be reviewed and become effective

before clinical testing can begin.

The study protocol and informed consent information for patients in clinical trials must also

be submitted to an independent Institutional Review Board, or IRB, for approval covering each institution at which the clinical

trial will be conducted.

Once a sponsor submits an IND, the sponsor must wait 30 calendar days before initiating any clinical trials.

If the FDA has comments or questions within this 30-day period, the issue(s) must be resolved to the satisfaction of the FDA before

clinical trials can begin.

In addition, the FDA, an IRB or the company may impose a clinical hold on ongoing clinical trials due

to safety concerns.

If the FDA imposes a clinical hold, clinical trials can only proceed under terms authorized by the FDA.

pre-clinical and clinical studies must conform to the FDA’s Good Laboratory Practice, or GLP, and Good Clinical Practice,

or GCP, requirements, respectively, which are designed to ensure the quality and integrity of submitted data and protect the rights

and well-being of study patients.

Information for certain clinical trials also must be publicly disclosed within certain time limits

on the clinical trial registry and results databank maintained by the NIH.

Typically, clinical testing

involves a three-phase process;

however, the phases may overlap or be combined:

I clinical trials typically are conducted in a small number of volunteers or patients to assess the early tolerability and

safety profile, and the pattern of drug absorption, distribution and metabolism;

II clinical trials typically are conducted in a limited patient population with a specific disease in order to assess appropriate

dosages and dose regimens, expand evidence of the safety profile and evaluate preliminary efficacy;

III clinical trials typically are larger scale, multicenter, well-controlled trials conducted on patients with a specific

disease to generate enough data to statistically evaluate the efficacy and safety of the product, to establish the overall

benefit-risk relationship of the drug and to provide adequate information for the registration of the drug.

therapeutic product candidate being studied in clinical trials may be made available for treatment of individual patients, in

certain circumstances.

Pursuant to the 21st Century Cures Act (Cures Act), which was signed into law in December 2016.

The manufacturer

of an investigational product for a serious disease or condition is required to make available, such as by posting on its website,

its policy on evaluating and responding to requests for individual patient access to such investigational product.

results of the pre-clinical and clinical testing, chemistry, manufacturing and control information, proposed labeling and other

information are then submitted to the FDA in the form of either an NDA or BLA for review and potential approval to begin commercial

In responding to an NDA or BLA, the FDA may grant marketing approval, request additional information in a Complete Response

Letter, or CRL, or deny the approval if it determines that the NDA or BLA does not provide an adequate basis for approval.

generally contains a statement of specific conditions that must be met in order to secure final approval of an NDA or BLA and

may require additional testing.

If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically

issue an approval letter, which authorizes commercial marketing of the product with specific prescribing information for specific

indications, and sometimes with specified post-marketing commitments and/or distribution and use restrictions imposed under a

Risk Evaluation and Mitigation Strategy program.

Any approval required from the FDA might not be obtained on a timely basis, if

the conditions for an NDA or BLA approval is the requirement that the manufacturing operations conform on an ongoing basis with

In complying with cGMPs, we must expend time, money and effort in the areas of training, production and quality control

within our own organization and at our contract manufacturing facilities.

A successful inspection of the manufacturing facility

by the FDA is usually a prerequisite for final approval of a pharmaceutical product.

Following approval of the NDA or BLA, we

and our manufacturers will remain subject to periodic inspections by the FDA to assess compliance with cGMPs requirements and

the conditions of approval.

We will also face similar inspections coordinated by foreign regulatory authorities.

of Clinical Trial Information

of certain clinical trials of FDA-regulated products are required to register and disclose certain clinical trial information.

Information related to the product, patient population, phase of investigation, trial sites and investigators, and other aspects

of the clinical trial are then made public as part of the registration.

Sponsors are also obligated to disclose the results of

their clinical trials after completion.

Disclosure of the results of these trials can be delayed in certain circumstances for

up to two years after the date of completion of the trial.

Competitors may use this publicly available information to gain knowledge

regarding the progress of development programs.

Development and Review Programs

FDA has a Fast Track program that is intended to expedite or facilitate the process for reviewing new drugs and biological products

that meet certain criteria.

Specifically, new drugs and biological products are eligible for Fast Track designation if they are

intended to treat a serious or life-threatening condition and demonstrate the potential to address unmet medical needs for the

Fast Track designation applies to the combination of the product and the specific indication for which it is being

The sponsor of a new drug or biologic may request the FDA to designate the drug or biologic as a Fast Track product at

any time during the clinical development of the product.

Unique to a Fast Track product, the FDA may consider for review sections

of the marketing application on a rolling basis before the complete application is submitted, if the sponsor provides a schedule

for the submission of the sections of the application, the FDA agrees to accept sections of the application and determines that

the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the application.

product submitted to the FDA for marketing, including under a Fast Track program, may be eligible for other types of FDA programs

intended to expedite development and review, such as priority review and accelerated approval.

Under the Breakthrough Therapy

program, products intended to treat a serious or life-threatening disease or condition may be eligible for the benefits of the

Fast Track program when preliminary clinical evidence demonstrates that such product may have substantial improvement on one or

more clinically significant endpoints over existing therapies.

Additionally, FDA will seek to ensure the sponsor of a breakthrough

therapy product receives timely advice and interactive communications to help the sponsor design and conduct a development program

as efficiently as possible.

Any product is eligible for priority review if it has the potential to provide safe and effective

therapy where no satisfactory alternative therapy exists or a significant improvement in the treatment, diagnosis or prevention

of a disease compared to marketed products.

The FDA will attempt to direct additional resources to the evaluation of an application

for a new drug or biological product designated for priority review in an effort to facilitate the review.

Additionally, a product

may be eligible for accelerated approval.

Drug or biological products studied for their safety and effectiveness in treating serious

or life-threatening illnesses and that provide meaningful therapeutic benefit over existing treatments may receive accelerated

approval, which means that they may be approved on the basis of adequate and well-controlled clinical studies establishing that

the product has an effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit, or on the basis of

an effect on a clinical endpoint other than survival or irreversible morbidity.

As a condition of approval, the FDA may require

that a sponsor of a drug or biological product receiving accelerated approval perform adequate and well-controlled post-marketing

clinical studies.

In addition, the FDA currently requires as a condition for accelerated approval the pre-approval of promotional

materials, which could adversely impact the timing of the commercial launch of the product.

Fast Track designation, Breakthrough

Therapy designation, priority review and accelerated approval do not change the standards for approval but may expedite the development

or approval process.

Medicine Advanced Therapies (RMAT) Designation

FDA has established a Regenerative Medicine Advanced Therapy, or RMAT, designation as part of its implementation of the 21st Century

Cures Act, or Cures Act.

The RMAT designation program is intended to fulfill the Cures Act requirement that the FDA facilitate

an efficient development program for, and expedite review of, any drug that meets the following criteria:

(1) it qualifies as

a RMAT, which is defined as a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination

product using such therapies or products, with limited exceptions;

(2) it is intended to treat, modify, reverse, or cure a serious

or life-threatening disease or condition;

and (3) preliminary clinical evidence indicates that the drug has the potential to address

unmet medical needs for such a disease or condition.

Like breakthrough therapy designation, RMAT designation provides potential

benefits that include more frequent meetings with FDA to discuss the development plan for the product candidate, and eligibility

for rolling review and priority review.

Products granted RMAT designation may also be eligible for accelerated approval on the

basis of a surrogate or intermediate endpoint reasonably likely to predict long-term clinical benefit, or reliance upon data obtained

from a meaningful number of sites, including through expansion to additional sites.

RMAT-designated products that receive accelerated

approval may, as appropriate, fulfill their post-approval requirements through the submission of clinical evidence, clinical studies,

patient registries, or other sources of real world evidence (such as electronic health records);

through the collection of larger

confirmatory data sets;

Phase I clinical trials typically are conducted in a small number of volunteers or patients to assess the early tolerability and safety profile, and the pattern of drug absorption, distribution and metabolism;

Phase II clinical trials typically are conducted in a limited patient population with a specific disease in order to assess appropriate dosages and dose regimens, expand evidence of the safety profile and evaluate preliminary efficacy;

Phase III clinical trials typically are larger scale, multicenter, well-controlled trials conducted on patients with a specific disease to generate enough data to statistically evaluate the efficacy and safety of the product, to establish the overall benefit-risk relationship of the drug and to provide adequate information for the registration of the drug.

A therapeutic product candidate

being studied in clinical trials may be made available for treatment of individual patients, in certain circumstances.

to the 21st Century Cures Act (Cures Act), which was signed into law in December 2016.

The manufacturer of an investigational product

for a serious disease or condition is required to make available, such as by posting on its website, its policy on evaluating and

responding to requests for individual patient access to such investigational product.

The results of the pre-clinical

and clinical testing, chemistry, manufacturing and control information, proposed labeling and other information are then submitted

to the FDA in the form of either an NDA or BLA for review and potential approval to begin commercial sales.

In responding to an

NDA or BLA, the FDA may grant marketing approval, request additional information in a Complete Response Letter, or CRL, or deny

the approval if it determines that the NDA or BLA does not provide an adequate basis for approval.

A CRL generally contains a statement

of specific conditions that must be met in order to secure final approval of an NDA or BLA and may require additional testing.

If and when those conditions have been met to the FDA’s satisfaction, the FDA will typically issue an approval letter, which

authorizes commercial marketing of the product with specific prescribing information for specific indications, and sometimes with

specified post-marketing commitments and/or distribution and use restrictions imposed under a Risk Evaluation and Mitigation Strategy

Any approval required from the FDA might not be obtained on a timely basis, if at all.

Among the conditions for

an NDA or BLA approval is the requirement that the manufacturing operations conform on an ongoing basis with cGMPs.

with cGMPs, we must expend time, money and effort in the areas of training, production and quality control within our own organization

and at our contract manufacturing facilities.

A successful inspection of the manufacturing facility by the FDA is usually a prerequisite

for final approval of a pharmaceutical product.

Following approval of the NDA or BLA, we and our manufacturers will remain subject

to periodic inspections by the FDA to assess compliance with cGMPs requirements and the conditions of approval.

We will also face

similar inspections coordinated by foreign regulatory authorities.

Disclosure of Clinical

Trial Information

Sponsors of certain clinical

trials of FDA-regulated products are required to register and disclose certain clinical trial information.

Information related

to the product, patient population, phase of investigation, trial sites and investigators, and other aspects of the clinical trial

are then made public as part of the registration.

Sponsors are also obligated to disclose the results of their clinical trials

after completion.

Disclosure of the results of these trials can be delayed in certain circumstances for up to two years after the

date of completion of the trial.

Competitors may use this publicly available information to gain knowledge regarding the progress

of development programs.

Expedited Development

and Review Programs

The FDA has a Fast Track

program that is intended to expedite or facilitate the process for reviewing new drugs and biological products that meet certain

Specifically, new drugs and biological products are eligible for Fast Track designation if they are intended to treat

a serious or life-threatening condition and demonstrate the potential to address unmet medical needs for the condition.

designation applies to the combination of the product and the specific indication for which it is being studied.

The sponsor of

a new drug or biologic may request the FDA to designate the drug or biologic as a Fast Track product at any time during the clinical

development of the product.

Unique to a Fast Track product, the FDA may consider for review sections of the marketing application

on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections

of the application, the FDA agrees to accept sections of the application and determines that the schedule is acceptable, and the

sponsor pays any required user fees upon submission of the first section of the application.

Any product submitted

to the FDA for marketing, including under a Fast Track program, may be eligible for other types of FDA programs intended to expedite

development and review, such as priority review and accelerated approval.

Under the Breakthrough Therapy program, products intended

to treat a serious or life-threatening disease or condition may be eligible for the benefits of the Fast Track program when preliminary

clinical evidence demonstrates that such product may have substantial improvement on one or more clinically significant endpoints

over existing therapies.

Additionally, FDA will seek to ensure the sponsor of a breakthrough therapy product receives timely advice

and interactive communications to help the sponsor design and conduct a development program as efficiently as possible.

is eligible for priority review if it has the potential to provide safe and effective therapy where no satisfactory alternative

therapy exists or a significant improvement in the treatment, diagnosis or prevention of a disease compared to marketed products.

The FDA will attempt to direct additional resources to the evaluation of an application for a new drug or biological product designated

for priority review in an effort to facilitate the review.

Additionally, a product may be eligible for accelerated approval.

or biological products studied for their safety and effectiveness in treating serious or life-threatening illnesses and that provide

meaningful therapeutic benefit over existing treatments may receive accelerated approval, which means that they may be approved

on the basis of adequate and well-controlled clinical studies establishing that the product has an effect on a surrogate endpoint

that is reasonably likely to predict a clinical benefit, or on the basis of an effect on a clinical endpoint other than survival

or irreversible morbidity.

As a condition of approval, the FDA may require that a sponsor of a drug or biological product receiving

accelerated approval perform adequate and well-controlled post-marketing clinical studies.

In addition, the FDA currently requires

as a condition for accelerated approval the pre-approval of promotional materials, which could adversely impact the timing of

the commercial launch of the product.

Fast Track designation, Breakthrough Therapy designation, priority review and accelerated

approval do not change the standards for approval but may expedite the development or approval process.

Regenerative Medicine

Advanced Therapies (RMAT) Designation

The FDA has established

a Regenerative Medicine Advanced Therapy, or RMAT, designation as part of its implementation of the 21st Century Cures Act, or

The RMAT designation program is intended to fulfill the Cures Act requirement that the FDA facilitate an efficient development

program for, and expedite review of, any drug that meets the following criteria:

(1) it qualifies as a RMAT, which is defined as

a cell therapy, therapeutic tissue engineering product, human cell and tissue product, or any combination product using such therapies

or products, with limited exceptions;

(2) it is intended to treat, modify, reverse, or cure a serious or life-threatening disease

or condition;

and (3) preliminary clinical evidence indicates that the drug has the potential to address unmet medical needs for

such a disease or condition.

Like breakthrough therapy designation, RMAT designation provides potential benefits that include more

frequent meetings with FDA to discuss the development plan for the product candidate, and eligibility for rolling review and priority

Products granted RMAT designation may also be eligible for accelerated approval on the basis of a surrogate or intermediate

endpoint reasonably likely to predict long-term clinical benefit, or reliance upon data obtained from a meaningful number of sites,

including through expansion to additional sites.

RMAT-designated products that receive accelerated approval may, as appropriate,

fulfill their post-approval requirements through the submission of clinical evidence, clinical studies, patient registries, or

other sources of real world evidence (such as electronic health records);

through the collection of larger confirmatory data sets;

or via post-approval monitoring of all patients treated with such therapy prior to approval of the therapy.

Post-Approval

even after a drug has been approved by the FDA for sale, the FDA may require that certain post-approval requirements be satisfied,

including the conduct of additional clinical studies.

If such post-approval requirements are not satisfied, the FDA may withdraw

its approval of the drug.

In addition, holders of an approved NDA or BLA are required to report certain adverse reactions to the

FDA, comply with certain requirements concerning advertising and promotional labeling for their products, and continue to have

quality control and manufacturing procedures conform to cGMPs after approval.

The FDA periodically inspects the sponsor’s

records related to safety reporting and/or manufacturing facilities;

this latter effort includes assessment of compliance with

Accordingly, manufacturers must continue to expend time, money, and effort in the area of production and quality control

to maintain cGMPs compliance.

Healthcare Fraud and Abuse Laws

the U.S., our activities are potentially subject to regulation by various federal, state and local authorities in addition to

the FDA, including but not limited to, the Centers for Medicare and Medicaid Services, or CMS, other divisions of the U.S.

of Health and Human Services (such as the Office of Inspector General and the Health Resources and Service Administration), the

Department of Justice, or the DOJ, and individual U.S.

Post-Approval Requirements

Oftentimes, even after

a drug has been approved by the FDA for sale, the FDA may require that certain post-approval requirements be satisfied, including

the conduct of additional clinical studies.

If such post-approval requirements are not satisfied, the FDA may withdraw its approval

In addition, holders of an approved NDA or BLA are required to report certain adverse reactions to the FDA, comply

with certain requirements concerning advertising and promotional labeling for their products, and continue to have quality control

and manufacturing procedures conform to cGMPs after approval.

The FDA periodically inspects the sponsor’s records related

to safety reporting and/or manufacturing facilities;

this latter effort includes assessment of compliance with cGMPs.

manufacturers must continue to expend time, money, and effort in the area of production and quality control to maintain cGMPs compliance.

Other Healthcare

Fraud and Abuse Laws

In the U.S., our activities

are potentially subject to regulation by various federal, state and local authorities in addition to the FDA, including but not

limited to, the Centers for Medicare and Medicaid Services, or CMS, other divisions of the U.S.

Department of Health and Human

Services (such as the Office of Inspector General and the Health Resources and Service Administration), the U.S.

Department of

Justice, or the DOJ, and individual U.S.

Attorney offices within the DOJ, and state and local governments.

For example, sales, marketing and scientific/educational grant programs may have to comply with the anti-fraud and abuse provisions

of the Social Security Act, the false claims laws, the privacy and security provisions of the Health Insurance Portability and

Accountability Act, or HIPAA, and similar state laws, each as amended, as applicable.

federal Anti-Kickback Statute prohibits, among other things, any person or entity from knowingly and willfully offering, paying,

soliciting or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return

for purchasing, leasing, ordering or arranging for the purchase, lease or order of any item or service reimbursable, in whole

or in part, under Medicare, Medicaid or other federal healthcare programs.

The term remuneration has been interpreted broadly

to include anything of value.

The Anti-Kickback Statute has been interpreted to apply to arrangements between therapeutic product

manufacturers on one hand and prescribers, purchasers, and formulary managers on the other.

There are a number of statutory exceptions

and regulatory safe harbors protecting some common activities from prosecution.

The exceptions and safe harbors are drawn narrowly

and practices that involve remuneration that may be alleged to be intended to induce prescribing, purchasing or recommending may

be subject to scrutiny if they do not qualify for an exception or safe harbor.

Failure to meet all of the requirements of a particular

applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute.

Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its

facts and circumstances.

Additionally, the intent standard under the Anti-Kickback Statute was amended by the ACA to a stricter

standard such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it

in order to have committed a violation.

In addition, the ACA codified case law that a claim including items or services resulting

from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False

Claims Act, or FCA.

federal false claims and civil monetary penalty laws, including the FCA, which imposes significant penalties and can be enforced

by private citizens through civil qui tam actions, prohibit any person or entity from, among other things, knowingly presenting,

or causing to be presented, a false or fraudulent claim for payment to, or approval by, the federal healthcare programs, including

Medicare and Medicaid, or knowingly making, using, or causing to be made or used a false record or statement material to a false

or fraudulent claim to the federal government.

For example, sales,

marketing and scientific/educational grant programs may have to comply with the anti-fraud and abuse provisions of the Social Security

Act, the false claims laws, the privacy and security provisions of the Health Insurance Portability and Accountability Act, or

HIPAA, and similar state laws, each as amended, as applicable.

The federal Anti-Kickback

Statute prohibits, among other things, any person or entity from knowingly and willfully offering, paying, soliciting or receiving

any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing,

ordering or arranging for the purchase, lease or order of any item or service reimbursable, in whole or in part, under Medicare,

Medicaid or other federal healthcare programs.

The term remuneration has been interpreted broadly to include anything of value.

The Anti-Kickback Statute has been interpreted to apply to arrangements between therapeutic product manufacturers on one hand and

prescribers, purchasers, and formulary managers on the other.

There are a number of statutory exceptions and regulatory safe harbors

protecting some common activities from prosecution.

The exceptions and safe harbors are drawn narrowly and practices that involve

remuneration that may be alleged to be intended to induce prescribing, purchasing or recommending may be subject to scrutiny if

they do not qualify for an exception or safe harbor.

Failure to meet all of the requirements of a particular applicable statutory

exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute.

Instead, the legality

of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances.

Additionally, the intent standard under the Anti-Kickback Statute was amended by the ACA to a stricter standard such that a person

or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a

In addition, the ACA codified case law that a claim including items or services resulting from a violation of the federal

Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal False Claims Act, or FCA.

The federal false claims

and civil monetary penalty laws, including the FCA, which imposes significant penalties and can be enforced by private citizens

through civil qui tam actions, prohibit any person or entity from, among other things, knowingly presenting, or causing to be presented,

a false or fraudulent claim for payment to, or approval by, the federal healthcare programs, including Medicare and Medicaid, or

knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim to the

federal government.

A claim includes “any request or demand”

for money or property presented

For instance, historically, pharmaceutical and other healthcare companies have been prosecuted under these

laws for allegedly providing free product to customers with the expectation that the customers would bill federal programs for

Other companies have been prosecuted for causing false claims to be submitted because of the companies’

of the product for unapproved, off-label, and thus generally non-reimbursable, uses.

created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing, or attempting

to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any money

or property owned by, or under the control or custody of, any healthcare benefit program, including private third-party payors,

willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or

covering up by trick, scheme or device, a material fact or making any materially false, fictitious or fraudulent statement in

connection with the delivery of or payment for healthcare benefits, items or services.

Like the Anti-Kickback Statute, the ACA

amended the intent standard for certain healthcare fraud statutes under HIPAA such that a person or entity no longer needs to

have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

states have similar, and typically more prohibitive, fraud and abuse statutes or regulations that apply to items and services

reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.

Additionally, to the

extent that our product candidates may in the future be sold in a foreign country, we may be subject to similar foreign laws.

may be subject to data privacy and security regulations by both the federal government and the states in which we conduct our

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing

regulations, imposes requirements relating to the privacy, security and transmission of individually identifiable health information.

Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to business associates, independent

contractors, or agents of covered entities that receive or obtain protected health information in connection with providing a

service on behalf of a covered entity.

HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil

and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil

actions for damages or injunctions in federal courts to enforce HIPAA and seek attorneys’

fees and costs associated with

pursuing federal civil actions.

In addition, many state laws govern the privacy and security of health information in specified

circumstances, many of which differ from each other in significant ways, are often not pre-empted by HIPAA, and may have a more

prohibitive effect than HIPAA, thus complicating compliance efforts.

expect our product, after approval, may be eligible for coverage under Medicare, the federal health care program that provides

health care benefits to the aged and disabled, and covers outpatient services and supplies, including certain pharmaceutical products,

that are medically necessary to treat a beneficiary’s health condition.

In addition, the product may be covered and reimbursed

under other government programs, such as Medicaid and the 340B Drug Pricing Program.

The Medicaid Drug Rebate Program requires

pharmaceutical manufacturers to enter into and have in effect a national rebate agreement with the Secretary of the Department

of Health and Human Services as a condition for states to receive federal matching funds for the manufacturer’s outpatient

drugs furnished to Medicaid patients.

Under the 340B Drug Pricing Program, the manufacturer must extend discounts to entities

that participate in the program.

As part of the requirements to participate in certain government programs, many pharmaceutical

manufacturers must calculate and report certain price reporting metrics to the government, such as average manufacturer price,

or AMP, and best price.

Penalties may apply in some cases when such metrics are not submitted accurately and timely.

Additionally,

the federal Physician Payments Sunshine Act, or the Sunshine Act, within the ACA, and its implementing regulations, require that

certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid

or the Children’s Health Insurance Program (with certain exceptions) report annually to CMS information related to certain

payments or other transfers of value made or distributed to physicians and teaching hospitals, or to entities or individuals at

the request of, or designated on behalf of, the physicians and teaching hospitals and to report annually certain ownership and

investment interests held by physicians and their immediate family members.

for money or property presented to the U.S.

For instance, historically, pharmaceutical and other healthcare companies have been prosecuted under these laws for allegedly providing

free product to customers with the expectation that the customers would bill federal programs for the product.

Other companies

have been prosecuted for causing false claims to be submitted because of the companies’

marketing of the product for unapproved,

off-label, and thus generally non-reimbursable, uses.

HIPAA created additional

federal criminal statutes that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme

to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any money or property owned by,

or under the control or custody of, any healthcare benefit program, including private third-party payors, willfully obstructing

a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up by trick, scheme

or device, a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of

or payment for healthcare benefits, items or services.

Like the Anti-Kickback Statute, the ACA amended the intent standard for

certain healthcare fraud statutes under HIPAA such that a person or entity no longer needs to have actual knowledge of the statute

or specific intent to violate it in order to have committed a violation.

Many states have similar,

and typically more prohibitive, fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid

and other state programs, or, in several states, apply regardless of the payor.

Additionally, to the extent that our product candidates

may in the future be sold in a foreign country, we may be subject to similar foreign laws.

We may be subject to data

privacy and security regulations by both the federal government and the states in which we conduct our business.

HIPAA, as amended

by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and its implementing regulations, imposes

requirements relating to the privacy, security and transmission of individually identifiable health information.

Among other things,

HITECH makes HIPAA’s privacy and security standards directly applicable to business associates, independent contractors,

or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf

of a covered entity.

HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties

directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or

injunctions in federal courts to enforce HIPAA and seek attorneys’

fees and costs associated with pursuing federal civil

In addition, many state laws govern the privacy and security of health information in specified circumstances, many of

which differ from each other in significant ways, are often not pre-empted by HIPAA, and may have a more prohibitive effect than

HIPAA, thus complicating compliance efforts.

We expect our product,

after approval, may be eligible for coverage under Medicare, the federal health care program that provides health care benefits

to the aged and disabled, and covers outpatient services and supplies, including certain pharmaceutical products, that are medically

necessary to treat a beneficiary’s health condition.

In addition, the product may be covered and reimbursed under other government

programs, such as Medicaid and the 340B Drug Pricing Program.

The Medicaid Drug Rebate Program requires pharmaceutical manufacturers

to enter into and have in effect a national rebate agreement with the Secretary of the Department of Health and Human Services

as a condition for states to receive federal matching funds for the manufacturer’s outpatient drugs furnished to Medicaid

Under the 340B Drug Pricing Program, the manufacturer must extend discounts to entities that participate in the program.

As part of the requirements to participate in certain government programs, many pharmaceutical manufacturers must calculate and

report certain price reporting metrics to the government, such as average manufacturer price, or AMP, and best price.

may apply in some cases when such metrics are not submitted accurately and timely.

Additionally, the federal

Physician Payments Sunshine Act, or the Sunshine Act, within the ACA, and its implementing regulations, require that certain manufacturers

of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s

Health Insurance Program (with certain exceptions) report annually to CMS information related to certain payments or other transfers

of value made or distributed to physicians and teaching hospitals, or to entities or individuals at the request of, or designated

on behalf of, the physicians and teaching hospitals and to report annually certain ownership and investment interests held by physicians

and their immediate family members.

Failure to report accurately could result in penalties.

In addition, many states also govern the reporting of payments or other transfers of value, many of which differ from each other

in significant ways, are often not pre-empted, and may have a more prohibitive effect than the Sunshine Act, thus further complicating

compliance efforts.

Legislation and Regulations

time to time, legislation is drafted, introduced and passed in Congress that could significantly change the statutory provisions

governing the testing, approval, manufacturing and marketing of products regulated by the FDA.

In addition to new legislation,

FDA regulations and policies are often revised or interpreted by the agency in ways that may significantly affect our business

and our products.

It is impossible to predict whether further legislative changes will be enacted or whether FDA regulations,

guidance, policies or interpretations will be changed or what the effect of such changes, if any, may be.

In addition, many states also govern

the reporting of payments or other transfers of value, many of which differ from each other in significant ways, are often not

pre-empted, and may have a more prohibitive effect than the Sunshine Act, thus further complicating compliance efforts.

New Legislation and Regulations

From time to time, legislation

is drafted, introduced and passed in Congress that could significantly change the statutory provisions governing the testing, approval,

manufacturing and marketing of products regulated by the FDA.

In addition to new legislation, FDA regulations and policies are

often revised or interpreted by the agency in ways that may significantly affect our business and our products.

It is impossible

to predict whether further legislative changes will be enacted or whether FDA regulations, guidance, policies or interpretations

will be changed or what the effect of such changes, if any, may be.

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