SER US Equity☆

Item 1A. Risk Factors 27

Item 1B. Unresolved Staff Comments 57

Item 2. Properties 57

Item 3. Legal Proceedings 57

Item 4. Mine Safety Disclosures 57

Part II

Item 6. Selected Financial Data 58

Item 7A. Quantitative and Qualitative Disclosures about Market Risk 68

Item 8. Financial Statements and Supplementary Data 71

Item 9A. Controls and Procedures 99

Item 9B. Other Information 99

Part III

Item 10. Directors, Executive Officers, and Corporate Governance 100

Item 11. Executive Compensation 102

Item 14. Principal Accounting Fees and Services 114

Part IV

Item 15. Exhibits, Financial Statement Schedules 115

PART

I

Certain

statements contained herein are forward-looking statements, within the meaning of the Private Securities Litigation Reform Act

of 1995, including, but not limited to, statements pertaining to future financial and/or operating results, future growth in research,

technology, clinical development, and potential opportunities for AgeX, along with other statements about the future expectations,

beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not

historical fact (including, but not limited to statements that contain words such as “will,” “believes,”

“plans,” “anticipates,” “expects,” “estimates”) should also be considered to be

forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent

in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory

approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ

materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the

many uncertainties that affect the businesses of AgeX, particularly those mentioned in the cautionary statements found in AgeX’s

filings with the Securities and Exchange Commission. AgeX disclaims any intent or obligation to update these forward-looking statements.

References

to “ AgeX,” “our” or “us” mean AgeX Therapeutics, Inc.

The

description or discussion, in this Form 10-K, of any contract or agreement is a summary only and is qualified in all respects

by reference to the full text of the applicable contract or agreement.

INDUSTRY

AND MARKET DATA

This

Annual Report (“Report”) on Form 10-K contains market data and industry forecasts that were obtained from industry

publications, third-party market research and publicly available information. These publications generally state that the information

contained therein has been obtained from sources believed to be reliable. While we believe that the information from these publications

is reliable, we have not independently verified such information.

This

Report also contains estimates and other statistical data made by independent parties and by us relating to market size and growth

and other data about our industry. We obtained the industry and market data in this Report from our own research as well as from

industry and general publications, surveys and studies conducted by third parties, some of which may not be publicly available.

Such data involves a number of assumptions and limitations and contains projections and estimates of the future performance of

the industries in which we operate that are subject to a high degree of uncertainty. We caution you not to give undue weight to

such projections, assumptions and estimates.

Item

1. Business

Overview

of Business

We

are a biotechnology company focused on the development and commercialization of novel therapeutics targeting human aging and degenerative

diseases. Our mission is to apply our comprehensive experience in fundamental biological processes of human aging to a broad range

of age-associated medical conditions. We believe that demand for therapeutics addressing such conditions is on the rise, commensurate

with the demographic shift of aging in the United States and many other industrialized countries.

Our

proprietary technology, based on telomerase-mediated cellular immortality and regenerative biology, allows us to utilize telomerase-expressing

regenerative pluripotent stem cell (“PSCs”) for the manufacture of cell-based therapies to regenerate tissues afflicted

with age-related chronic degenerative disease. We own or have licenses to a number of patents and patent applications used in

the generation of these product candidates, including intellectual property related to PSC-derived clonal embryonic progenitor

cell lines (PureStem® technology) and HyStem® delivery matrices. Our technology platform also includes

UniverCyteTM which uses the HLA-G gene to potentially confer low immune observability to cells, so as to suppress rejection

of transplanted cells and tissues. AgeX plans to use or license the use of this patented technology to produce genetically-modified

master cell banks of pluripotent stem cells that can then be differentiated into any young cell type of the human body that now

express the immune tolerogenic molecule.

Our

product candidates in the discovery stage include two cell-based therapies derived from telomerase-positive PSCs and two product

candidates derived from our proprietary induced Tissue Regeneration (iTRTM) technology. We are also sponsoring

a research program to derive neural stem cells from PSCs to treat degenerative diseases such as Huntington’s Disease. We

will need to conduct or sponsor research and development work, or license our technology to other biotechnology or pharma companies

interested in furthering research and development, as part of our plan to develop these cell- and drug-based therapies, each targeting

large unmet needs in age-related medicine.

Development

of Our Business

AgeX

was incorporated during 2017 as a subsidiary of Lineage Cell Therapeutics, Inc. (“Lineage”), formerly known as BioTime,

Inc. On August 17, 2017, we entered into an Asset Contribution and Separation Agreement (the “Asset Contribution Agreement”)

with Lineage pursuant to which Lineage contributed certain assets and cash to us in exchange for 28,800,000 shares of our common

stock.

The

assets contributed to us by Lineage included laboratory equipment, patents, patent applications, and certain human pluripotent

cell lines and human embryonic progenitor cell lines and shares of LifeMap Sciences, Inc. common stock representing a controlling

interest in that company. Concurrently with the contribution of assets to us by Lineage under the Asset Contribution Agreement,

we entered into a License Agreement with Lineage pursuant to which Lineage has licensed to us, with rights to sublicense, certain

intellectual property, including patents and patent applications and know-how for use in the development, manufacture and commercialization

of products or services for the prevention, treatment, amelioration, diagnosis or monitoring of all human and non-human animal

diseases and conditions except for the field of medical products, devices and services for the reserved Lineage fields of orthopedic,

ophthalmic, and medical aesthetic uses (the “Lineage Exclusive Field”). In addition, Lineage retains an option right,

on terms to be negotiated, to license iTR patents in research, development, manufacturing and commercialization of treatments

based on iTR in the Lineage Exclusive Field. The licensed patents and know-how relate generally to (a) PureStem® human

embryonic progenitor cell lines, and (b) methods of manufacturing and quality control analysis of cell based therapies

derived from pluripotent stem cells. We also received an option to license certain Lineage retained rights outside of orthopedic

indications unless a license grant would compete with a Lineage program or products in the Lineage Exclusive Field.

Lineage

and certain Lineage subsidiaries also entered into agreements pursuant to which they have licensed or sublicensed to us, on a

non-exclusive, world-wide, royalty bearing basis, certain additional patents and patent rights and know-how relating to HyStem®

hydrogel technology, human embryonic progenitor cell technology, and human pluripotent stem cell lines and technology

for use outside the Lineage Exclusive Fields, or in the case of certain sublicense rights, fields previously licensed to third

parties.

The

human embryonic progenitor cell lines, human pluripotent stem cell lines, and patents contributed or licensed or sublicensed to

us by Lineage and its subsidiaries include our initial product candidates AGEX-BAT1 brown adipocytes and AGEX-VASC1 young vascular

cells, and our foundation technologies PureStem®, HyStem® and induced tissue

regeneration or iTR technology.

Concurrently

with the acquisition of assets from Lineage, we sold 4,950,000 shares of common stock for $10.0 million in cash primarily to investors

other than Lineage. At the close of the financing, Lineage owned 85.4% of our issued and outstanding shares of common stock. On

June 7, 2018, we sold 2.0 million shares of common stock for $2.50 per share to Juvenescence Limited (“Juvenescence”)

for aggregate cash proceeds to us of $5.0 million. That financing along with the 2017 sales of shares of common stock and subsequent

sales of common stock purchase warrants to other private investors allowed us to focus our initial resources on our pre-clinical

research and development programs.

On

August 30, 2018, Lineage sold 14.4 million of its shares of AgeX common stock to Juvenescence. Upon completion of the transaction,

Lineage’s ownership in AgeX was reduced from 80.4% to 40.2% of our issued and outstanding shares of common stock, and Juvenescence’s

ownership in AgeX was increased from 5.6% to 45.8% of our issued and outstanding shares of common stock. As a result, beginning

on August 30, 2018, we were no longer considered a subsidiary of Lineage for financial reporting purposes, because on that date,

Lineage experienced a “loss of control” of a subsidiary, as defined by generally accepted accounting principles in

the United States.

On

November 28, 2018 (the “Distribution Date”) Lineage distributed to its shareholders, on a pro rata basis, 12,697,028

shares of the AgeX common stock it then held (the “Distribution”). Immediately after the Distribution, Lineage retained

1,718,972 shares of AgeX common stock, representing approximately 4.8% of the common stock then issued and outstanding. Following

the Distribution, our common stock began publicly trading on the NYSE American under the symbol “AGE”.

During

August 2018, we expanded our technology platforms by acquiring from Escape Therapeutics, Inc. patents and patent applications

related to HLA-G-modified cells and methods of generating allogeneic cells with reduced risk of being rejected by patients regardless

of the HLA class I haplotype. These patents are the foundation for our UnivercyteTM technology platform.

On

March 2, 2021, we announced that AgeX and LyGenesis, Inc. (“LyGenesis”), a privately held biotechnology company developing

cell therapies that enable organ regeneration, will proceed to negotiate an agreement for a merger of the two companies. LyGenesis

recently received U.S. Food and Drug Administration clearance for its Investigational New Drug application to conduct a Phase

2a clinical trial on the safety, tolerability, and efficacy of its lead cell therapy for patients with end-stage liver disease,

with study initiation planned for 2021.

Based

on the terms currently being discussed, a newly formed subsidiary of AgeX would merge into LyGenesis. At the closing of the merger,

AgeX would issue to LyGenesis stockholders a number of shares of AgeX common stock representing two-thirds of the total number

of shares of AgeX common stock to be outstanding immediately following the consummation of the merger on a fully diluted basis,

but prior to the issuance of additional shares in a contemplated capital raising transaction following the execution of a merger

agreement and contingent on the closing of the merger. Under the terms being discussed, if the merger is completed, AgeX’s

pre-merger stockholders would receive an 80% economic interest in AgeX’s induced tissue regeneration or iTR technology;

the terms and structure of such economic interest have not yet been determined.

There

can be no assurance that the negotiations between AgeX and LyGenesis will result in the execution of a definitive merger agreement

on the terms being discussed or at all, or, if a merger agreement is entered into, that the merger will be consummated. The completion

of any merger would be subject to approval by a special independent committee of the AgeX Board of Directors and by the respective

Boards of Directors of both companies. The merger would also be subject to approval by AgeX stockholders and LyGenesis stockholders,

including in each case approval by both a majority of the outstanding shares and by the holders of a majority of the shares not

held by Juvenescence Limited.

Juvenescence,

the largest shareholder of AgeX, is also the largest shareholder of LyGenesis. Juvenescence beneficially owns approximately 52.7%

of the AgeX common stock determined as disclosed in its most recent amendment to its Schedule 13D filed with the Securities and

Exchange Commission, and owns approximately 48% of the common stock of LyGenesis (assuming the conversion of its convertible debt

into equity). The Chairman of AgeX’s Board of Directors, Dr. Gregory Bailey, is the Chief Executive Officer of Juvenescence.

Two directors of LyGenesis, James Mellon and David Ellam, are the Chairman and the Chief Financial Officer of Juvenescence, respectively.

On

March 15 2021, AgeX disposed of its interest in its majority-owned subsidiary LifeMap Sciences, Inc. through a cash-out merger.

See Note 9 to our consolidated financial statements included elsewhere in this Report.

Additional

Information

AgeX

is incorporated in the State of Delaware. Our common shares trade on the NYSE American under the symbol “AGE.” Our

principal executive offices are located at 1101 Marina Village Parkway, Suite 201, Alameda, CA 94501, and our phone number at

that address is (510) 671-8370. Our website address is www.agexinc.com. The information on, or that can be accessed through our

website is not part of this Report. We make available, free of charge through our website, our most recent annual report on Form

10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and any amendments to those reports, as soon as reasonably

practicable after the reports are electronically filed with or furnished to the Securities and Exchange Commission (the “SEC”).

iTRTM,

and UniverCyteTM, are trademarks of AgeX Therapeutics, Inc. HyStem® and PureStem® are

registered trademarks of Lineage Cell Therapeutics, Inc.

Emerging

Growth Company

We

are an “emerging growth company” under the Jumpstart our Business Startups Act of 2012 or the JOBS Act. As an emerging

growth company, we may take advantage of specified reduced disclosure and other requirements that are otherwise applicable, in

general, to public companies that are not emerging growth companies. These provisions include:

● reduced disclosure about our executive compensation arrangements;

We

will remain an “emerging growth company” until the earliest of: (i) the last day of the fiscal year in which we have

total annual gross revenues of $1.07 billion or more; (ii) the last day of our fiscal year following the fifth anniversary of

the date of the first sale of our common equity securities pursuant to an effective registration statement under the Securities

Act of 1933, as amended (the “Securities Act”); (iii) the date on which we have issued more than $1.0 billion in nonconvertible

debt securities during the previous three years; or (iv) the date on which we are deemed to be a “large accelerated filer”

under the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

The

JOBS Act permits an emerging growth company to take advantage of an extended transition period to comply with new or revised accounting

standards applicable to public companies. However, we have elected to comply with newly adopted or revised accounting standards

when they become applicable to public companies because our financial statements were previously consolidated with those of our

former parent company Lineage Cell Therapeutics, Inc. which is not an emerging growth company under the JOBS Act and is therefore

not permitted to delay the adoption of new or revised accounting standards that become applicable to public companies. This election

under the JOBS Act to not delay the adoption of new or revised accounting standards is irrevocable.

Overview

of Our Opportunity in Age-Related Diseases

To

date, conventional pharmaceutical approaches to the chronic degenerative conditions associated with aging have provided limited

benefit. Often the approaches offer merely relief from the symptoms of ageing and age-related disease, rather than targeting

underlying disease processes. We believe this is about to change through harnessing the power of new cellular and molecular technologies.

We aim to lead this coming revolution with our pioneering technologies to restore tissue and organ function. Our cell therapy

approach is focused on generating and delivering new cells to patients. Our iTR approach is focused on reversing the age of cells

already in the body, where our research team in February 2020 published that they had converted the cells of a 114-year-old

to young pluripotent stem cells in the lab [J. Lee et al., Induced pluripotency and spontaneous reversal of cellular aging

in supercentenarian donor cells, Biochemical and Biophysical Research Communication, https://doi.org/10.1016/j.bbrc.2020.02.092].

Aging

is one of the most significant demographic trends of our time. As shown in Figure 1, the U.S. Census Bureau projects a sharp rise

in the number of Americans over 80 years of age, with an acceleration occurring between the years 2020 and 2030.

Figure

1. Projected increase in the numbers of the U.S. population over 80 years of age (U.S. Census Bureau)

This

demographic shift associated with 76 million aging baby boomers poses a significant challenge to our healthcare system and our

economy as a whole. The unsolved problem relates to the fact that chronic conditions account for about 80% of total health care

expenditures in the United States, with the elderly having a higher prevalence of chronic degenerative disease than the young.

Approximately 80% of older adults have one chronic disease, and 68% have two or more.

Our

technology platforms reflect over 25 years of research and development in cell immortality and regenerative medicine. It is designed

to address some of the largest unmet needs of an aging population by translating state-of-the-art laboratory science relating

to aging into meaningful therapeutic biologicals and drugs.

Overview

of Our Product Candidates

Our

product pipeline includes two cell-based and two iTR-based product candidates in development.

Our

lead cell-based therapeutic candidates in development are AGEX-BAT1 and AGEX-VASC1:

Our

lead small molecule drug-based therapeutic candidate for induced Tissue Regeneration (iTR) in discovery is AGEX-iTR1547 and our

lead biologic candidate for iTR is AGEX-iTR1550:

Our

currently marketed research products include cGMP ES Cells (human embryonic stem or “hES”) cells produced under current

good manufacturing practices (or “cGMP”) and PSC-derived cells for research:

Overview

of Our Technology Platforms

The

technology underlying our product development programs is based on telomerase-mediated cellular immortality and regenerative

biology. By “telomerase-mediated cellular immortality” we refer to the fact that cells that express sufficient

levels of a protein called telomerase are capable of replicating without limit. By “regenerative biology,” we

refer to novel methods to regenerate tissues afflicted with age-related chronic degenerative disease such as peripheral

vascular disease and ischemic heart disease as well as age-related metabolic disorders such as those associated

with Type II diabetes and obesity, as well as others. We utilize telomerase-expressing regenerative Pluripotent Stem

Cells, or PSCs, for the manufacture of cell-based therapies. We own or have licensed numerous patents and patent applications

covering methods and compositions relating to this technology platform.

Our core technology platforms provide us with a strong foundation for successfully addressing many of the diseases of ageing

by focusing on broad therapeutic applicability and commercially scalable technologies:

1.

PureStem: AgeX’s allogeneic cell derivation and manufacturing platform, based on human embryonic progenitors,

which are cells in state of development between embryonic stem cells and adult cells. We believe PureStem has the

potential to solve several major challenges faced by the cell therapy industry by generating cellular therapeutics which would:

● be commercialized as “off-the-shelf” products

● be pure and industrially scalable

● have lower cost of goods per unit

● be amenable to traditional pharma supply chain logistics

In addition,

we believe PureStem cells may have advantages over mesenchymal stem cells (MSCs), which may only survive transiently in the body

and exert any short-term benefit by releasing paracrine factors, which may limit their potential of MSCx.

MSCs

neither engraft nor become specialized cells. On the other hand, cells derived from PureStem progenitors will be young, not prone

to the disadvantages associated with older cells, and are expected to become permanently engrafted in the body to deliver a true

regenerative outcome. To date, AgeX has isolated more than 200 cell types from PureStem.

2.

UniverCyteTM: AgeX’s pioneering technology to genetically modify allogeneic donor cells to potentially become

hypoimmunogenic/universal, so they can potentially be transplanted into all patients in an off-the- shelf manner, without the

normal need for human leukocyte antigen (HLA) matching between donor and receipt or immunosuppression. UniverCyte utilizes a potent

molecule called HLA-G. HLA is a group of related proteins that helps the immune system distinguish the body’s own proteins

from proteins made by foreign invaders such as viruses and bacteria. HLA-G’s only known physiological role

in nature is to prevent destruction of a semi-allogeneic fetus by the maternal immune system. UniverCyte could potentially avoid immune rejection of transplanted

cells, solving a major challenge facing the allogeneic cell therapy industry. In addition to utilizing UniverCyteTM for its

own future cell therapy products, AgeX may make UniverCyteTM available to other cell therapy companies through licensing

arrangements.

3.

HyStem®: Delivery technology to stably engraft cells or slowly release small molecules in the body for greater

safety and efficacy. The key advantages of HyStem® over competitors may include: (1) higher cell

retention, survival, proliferation and engraftment; (2) biodegradability which can be fine-tuned; (3) non-immunogenicity; (4)

immunosuppressive in nature; (5) ease of usage; and (6) scalability.

4.

Induced Tissue Regeneration (iTRTM): The aim of iTR is to return aged cells back to a youthful state, thereby inducing

a capacity for scarless regeneration characteristic of early developing tissues, without reverting cells to pluripotency. This

technology is sometimes referred to as “partial reprogramming” or “epigenetic reprogramming of aging”.

This novel approach may trigger complete regeneration of cells, and potentially even complex tissues, damaged as a result of age-related

degenerative processes or trauma. The premise behind iTR is that aging, and in turn degenerative diseases of old age, are a result

of the loss of two characteristics of cells; namely, replicative immortality and regenerative capacity. These two characteristics

are present in embryonic cells but are lost at the embryonic to fetal transition (EFT). With this loss, humans can no longer generate

new cells or repair damaged cells scarlessly and in sufficient numbers to maintain health. We discovered that cells begin expressing

the gene COX7A1 at the EFT when regeneration is commonly lost. Therefore the gene may be a key inhibitor of cellular regeneration.

For example, we have discovered that restoring a regenerative pattern of COX7A1 gene expression may facilitate hair regeneration

in mouse models. In addition, we have invented multiple platforms for delivering iTR using small molecules as well as biologic

strategies such as those using gene therapy to transiently express reprogramming factors. We have filed patent applications on

the use of iTR in a wide array of degenerative conditions including cancer.

5.

ESI cell lines: AgeX has six clinical-grade human embryonic stem cell lines, they are distinguished as the first clinical-grade

human pluripotent stem cell lines created under current Good Manufacturing Practice as described in Cell Stem Cell (2007;1:490-4).

They are listed on the National Institutes of Health (NIH) Stem Cell Registry in the USA and are among the best characterized

and documented stem cell lines in the world. ESI-053 is among only a few pluripotent stem cell lines from which a derived cell

therapy product candidate has been granted FDA IND clearance for human studies. The FDA cleared an IND application from ImStem

Biotechnology, one of our sublicensees, for a MSC product derived from ESI-053 for multiple sclerosis. This was believed to be

the first MSC product derived from an pluripotent stem line to be accepted for a human trial by the FDA. The ESI cell lines are

available as research or clinical grade product, and have been offered since 2006.

Business

Strategy

Each

of our four proprietary platform technologies, PureStem® for cell derivation and manufacturing, UniverCyteTM

for generation of hypoimmunogenic cells, iTRTM for reversing the age of cells already in the body and HyStem®

for cell or small molecule-based iTR delivery, presents AgeX with a multiplicity of attractive opportunities which

we may pursue. Given these platform technologies may be highly desirable to multiple academic and biopharma companies due to their

broad applicability and potentially important clinical and commercial benefits, AgeX plans to pursue different business models

for these platforms:

Each

of these models may provide particular benefits to AgeX in terms of financing and efficiency of operations. However, each alternative

has potential disadvantages as well. If AgeX out-licenses its technology it will avoid the costs and risks of research and development,

clinical trials, regulatory approval, manufacturing, and commercialization of product candidates, but the revenues AgeX would

receive from commercialization of products developed under those arrangements would likely be limited to royalties on product

sales and potentially licensing fees and milestone payments representing a relatively small portion of total product revenues.

Similarly, co-development and marketing or similar arrangements would permit AgeX to share costs and risks but would also require

AgeX to share revenues from the product candidates that may be successfully developed and commercialized. See “Risk Factors”

elsewhere in this Report for information about certain risks associated with reliance on arrangements with third parties for research,

product development, clinical trials, manufacturing, and commercializing product candidates.

We

may finance our iTR research and development through Reverse Bio. To the extent that such financing is obtained through the sale

of capital stock or other equity securities to investors or other biopharma companies by Reverse Bio, or the sale of Reverse Bio

shares held by AgeX, our equity interest in Reverse Bio and its iTR business would be diluted.

Background

of Human Aging

Cell

Immortality

There

is a growing consensus in the scientific community that human aging is due in large part to the aging of individual cells in the

various tissues of the body (somatic cells). In contrast, the reproductive lineage of cells (germ-line) perpetuate the human species

from generation-to-generation without limit and continue to generate new people over the millennia.

In

1961, Dr. Leonard Hayflick first reported that normal human cells in the body (unlike the germ-line) can proliferate for only

a finite number of times (typically fewer than 100 times). This phenomenon, known as the “Hayflick Limit”, “cell

mortality”, or “cellular aging”, is a normal property of somatic cells. In the 1990s, our CEO, Dr. Michael D.

West, founded a biotechnology company called Geron Corporation, where his team isolated for the first time the human gene called

“Telomerase Reverse Transcriptase” or “telomerase.” In 1998, Geron scientists in collaboration with scientists

at the University of Texas Southwestern Medical Center at Dallas, published the result that telomerase could stop the aging of

human cells, or could “immortalize” them.

Figure

2. The Germ-line/soma dichotomy wherein germ-line cells express telomerase, maintain telomere length, and exhibit replicative

immortality, while body (somatic) cells lack telomerase, showing progressive telomere shortening until they reach the Hayflick

limit.

In

1994, Dr. West’s group demonstrated through an assay for measuring telomerase activity that nearly 90% of cancer cell types

cultured in the laboratory or tumors surgically removed from patients abnormally express telomerase. This broke the then dogma

that there was no common mechanism at work in cancer. Scientists have concluded that cell mortality, while being detrimental in

old age, benefits us early in life by helping to repress cancer cell growth. Figure 2 illustrates this dichotomy wherein immortal

cells such as the germ-line cells that perpetuate the species are immortal through telomerase activity while body (somatic) cells

lack telomerase expression, and as a result show progressive telomere shortening and a finite lifespan (are mortal).

The

Weismann Barrier

Early

in the evolution of life, primitive unicellular and even multicellular organisms may have lacked programmed aging as a result

of the potential of their cells having the potential for both replicative immortality and regeneration. However, in more complex

animals such as mammals, somatic cells lose not only replicative immortality, but after most organ systems are formed during embryonic

development, they also lose full regenerative potential. This repression of both telomerase-mediated cell immortality and regeneration

potential is called the “Weismann Barrier” (see Figure 3).

Figure

3. The Weismann Barrier coincides with the loss of both replicative immortality and regeneration. Levels of expression of the

gene COX7A1 provide a useful marker of the loss of regenerative potential.

PSCs

represent the earliest stages of human development and are the first normal human cells cultured in the laboratory that display

both telomerase-mediated replicative immortality and regenerative potential. Therefore, our scientists utilized these cells as

well as the primitive regenerative cells derived from them, called “PureStem®” cell lines, in research

where they were compared to diverse adult cells on the mortal side of the Weismann barrier to uncover the mechanisms regulating

the loss of regenerative potential. Artificial intelligence algorithms were used to parse millions of gene expression data points

and the results were published in late 2017. Figure 3 shows the Weismann Barrier and the associated rise of a gene expression

marker of the non-regenerative state designated COX7A1. This proprietary marker, along with other insights obtained from

the research, provides us with a window into this biology and a means of screening for agents capable of restoring a regenerative

state to old nonregenerative cells. It is anticipated that such agents may not only reset the pattern of gene expression in adult

cells back to that their regenerative counterparts but may also induce tissue regeneration when applied in vivo in the

context of age-related degenerative disease. Since the previously mentioned 2017 publication described the re-emergence of the

regenerative phenotype in the majority of cancer cell lines, the discoveries may open the door to potentially important diagnostic

and therapeutic implications as well.

Pluripotent

Stem Cells (PSCs)

Figure

4. Pluripotent Stem Cells (PSCs) possess both telomerase-mediated replicative immortality and regenerative potential, capable

of producing all human cell types.

In

an effort to utilize telomerase-mediated immortality and regenerative biology in the development of novel therapeutics, in the

mid-1990s, Dr. West, organized a collaboration with Drs. James Thomson, John Gearhart, and Roger Pedersen that led to the first

isolation of PSCs. In contrast to other types of cells, PSCs are unique by at least two important criteria. The first criterion

relates to the ability of pluripotent cells to proliferate, or make more copies of themselves, indefinitely, that is to say, they

are “immortal”. The second relates to the ability of PSCs to differentiate into any of the hundreds of specialized

cell types in the body. This replicative immortality of PSCs facilitates the industrial scalability of product. We believe that

many of these cell types have potential for regenerating function in tissues damaged by degenerative diseases when transplanted.

A small sampling of these cell types is shown in Figure 4. Unlike PSCs, adult stem cells typically have severely-reduced scale-up

potential (are mortal unlike immortal PSCs), and have passed the Weismann Barrier, and are therefore limited in their ability

to regenerate normal tissue when transplanted in vivo. Therefore, we believe that PSC-based cellular therapeutics

have significant competitive advantages over cell-based therapeutics being developed by many adult stem cell companies.

Our

Technology Platforms

PureStem®

Technology

Regulatory

approval of cell- and tissue-based products require high standards of quality control. In the case of stem cell-derived products,

there is a high standard for insuring the known identity, purity, and reproducibility of the cells to be administered. PSCs provide

certain advantages over adult stem cell products when used in the manufacture of cell-based therapeutics for the treatment of

age-related disease. These advantages include:

PureStem®

technology is based on the observation that embryonic anlagen of many tissues in the human body are naturally comprised

of highly proliferative cells with relatively long telomere length. Therefore, it is possible to generate clonal lineages of these

cells in vitro. Cells derived from adult tissues commonly permanently cease to divide after a certain number of doublings,

a condition known as senescence. In addition, adult and even fetal tissues largely contain differentiated cells often with limited

or no capacity of replication in vitro. As a result, the clonal expansion of human embryonic progenitor cell types allows

not only a novel and more facile point of scalability but also generates populations of cells that are multipotent instead of

pluripotent, and therefore markedly easier to define identity, purity, and potency.

We

have studied the fate of over 200 diverse PureStem cell lines in thousands of differentiation conditions. This was accomplished

by thawing individual cryopreserved PureStem cell lines, culturing them in the laboratory, and then exposing the cells to factors

that differentiate cells such as protein growth and differentiation factors, hormones, and small molecules implicated in causing

cells to change from one type of cell into another (differentiation). Using individual cells from the over 200 diverse PureStem

cell lines previously isolated and cryopreserved, we treated the diverse cells with thousands of differentiation conditions, prepared

RNA, and determined the gene expression pattern of the cells using gene expression microarrays. These experiments have shown that

the PureStem cell lines display site-specific markers that identify not only the type of cells, but also where in the body the

cells would normally reside. Therefore, in the example of cartilage cells, it was possible to produce diverse types of cartilage

in this manner. We have licensed from our former parent company Lineage Cell Therapeutics, Inc. (“Lineage”) PureStem

applications outside of orthopedics, medical aesthetics, and certain ophthalmological applications.

We

have chosen two PureStem applications for our initial product development based on unmet medical need along with other factors.

The first product candidates are AGEX-BAT1, brown adipose tissue or BAT cells for the treatment of metabolic disorders such as

obesity or Type II diabetes, and AGEX-VASC1, vascular endothelial progenitors for the treatment of age-related ischemic disease

such as that leading to peripheral vascular disease and ischemic heart disease. These cells will be formulated

in a delivery matrix designated HyStem® to promote viability of the graft as well as to localize the cells to the

intended site in the body.

HyStem®

Delivery Technology

HyStem®

is a patented biomaterial that mimics the extracellular matrix that is the structural network of macromolecules surrounding

cells in the body. The extracellular matrix is essential for normal cellular function and survival of transplanted cells. Many

tissue engineering and regenerative cell-based therapies are expected to benefit from the delivery of therapeutic cells in a matrix

for precise localized delivery and survival. HyStem is a unique hydrogel that has been shown to support cellular attachment in

vivo. Current research at medical institutions has shown that HyStem is compatible with a wide variety of cells and tissue

types including those of the brain, bone, skin, cartilage, vascular system and heart. The technology underlying HyStem hydrogels

was developed at the University of Utah and was been exclusively licensed to Lineage for human therapeutic applications and sublicensed

to AgeX for certain fields. The HyStem technology is based on a unique thiol cross-linking chemistry to prepare hyaluronan-based

matrices as hydrogels. Since the first published report in 2002, there have been numerous academic scientific publications supporting

the biocompatibility of thiol cross-linked hyaluronan-based matrices and their applications as medical devices and in cell culture,

tissue engineering, and animal models of cell-based therapies.

Figure

5. AgeX plans to utilize the HyStem technology for the delivery of cell-based therapeutics.

Due

to the unique cross-linking chemistry, HyStem matrices have the ability to be safely combined with living cells and subsequently

injected or applied locally as a hydrogel which allows the gel to conform to the three-dimensional contour of a tissue. Building

upon this platform, we initially plan to use HyStem for cell-based therapy.

The

building blocks for HyStem hydrogels may vary with the application but typically include combinations of hyaluronan, gelatin,

or heparin, each of which has been thiol-modified. Hydrogels are formed by cross-linking mixtures of these thiolated macromolecules

with polyethylene glycol diacrylate (PEGDA). The rate of gelation and the hydrogel stiffness can be controlled by varying the

amount of cross-linker. An important attribute of HyStem hydrogels is their large water content, over 98%. As a result, these

hydrogels have a high permeability for oxygen, nutrients, and other water-soluble metabolites.

UniverCyteTM

Our

UniverCyteTM technology uses a proprietary, novel, modified form of HLA-G and is intended to permit donor cells

to be transplanted into patients without donor-patient tissue matching and without administering immunosuppressant medication.

Immunosuppressive drugs can reduce patient resistance to infectious diseases and cancers as well as cause organ and other toxicities.

Reducing or eliminating the need for immunosuppressants after cell transplantation by use of hypoimmunogenic cells may make therapies

universally available. We plan to use or license the use of this patented technology to produce genetically-modified master cell

banks of pluripotent stem cells that can then be differentiated into any young cell type of the human body that now express the

immune tolerogenic molecule.

Products

and Product Candidates

Our

Therapeutic Product Candidates

AGEX-BAT1

- Brown Adipose Tissue (BAT) Progenitors

Brown

adipose tissue (BAT) is abundant early in life but lost precipitously with age. This tissue is believed to generate heat through

expression of a gene called UCP1. In addition, the high levels of glucose and lipid uptake by the tissue is believed to

balance metabolism in young people. In contrast, central obesity and Type II diabetes has been correlated with low levels of BAT.

Figure

6. Human tissue-derived BAT cells (left) stained red for the presence of UCP1 show a minority of cells being true BAT cells. PureStem-derived

AGEX-BAT1 cells are uniformly UCP1 positive.

The

demonstration in published literature in the public domain that the transplantation of BAT from young mice to obese diabetic mice

resulted in weight loss and increased insulin sensitivity has led to a search for a source of industrially-scalable clinical grade

BAT cells as well as an appropriate matrix for lipotransfer. There currently is no FDA-approved matrix for cell transplantation.

However, Lineage has obtained a CE Mark for the marketing of HyStem (Renevia) for cell-assisted lipotransfer procedures in Europe.

Therefore, we believe HyStem can be used for the delivery of BAT cells produced using PureStem technology. As shown in Figure

6, the AGEX-BAT1 progenitors strongly express the BAT marker UCP1 when induced to differentiate and show a relatively high

degree of purity compared to human tissue-derived BAT.

We

have entered into a Sponsored Research Agreement with Ohio State University using AGEX-BAT1 in mice to determine whether transplantation

of AgeX-BAT1 cells may lead to improvements in diet-induced obesity, metabolic health including glucose metabolism, and cardiac

function. For purposes of this proof of concept work, two different cell transplant matrices will be tested, HyStem and a 3-D

silk scaffold.

AGEX-VASC1

- Vascular Progenitors

PureStem

technology can also yield highly purified embryonic vascular components. As shown below, select clonal lines express markers

such as VE-Cadherin (CDH5) and PECAM1, as well as VWF and other markers of venous, arterial, and lymphatic endothelium. Flow cytometry

shows purity indistinguishable from 100%.

In

addition to vascular endothelial cells, we have characterized vascular smooth muscle cell progenitors. This makes it possible

for us to construct two of the key cellular components of arterial vessels, such as those compromised in coronary artery disease.

Figure

7. PureStem-derived vascular endothelial cell lines are capable of regenerating young vasculature (bottom left) and appear to

have essentially 100% purity by FACs analysis.

HyStem

hydrogels have been successfully used in cell transplantation research in animal models and in a CE marked product developed

by Lineage for autologous adipose tissue preparations to restore and/or augment facial volume as a treatment of facial lipoatrophy

after subcutaneous fat volume loss. AgeX’s near term goal is to optimize process development for planned animal preclinical

testing of AgeX-VASC1 formulated in HyStem for delivery into ischemic heart tissue to regenerate collateral circulation.

AGEX-iTR1547

— Induced Tissue Regeneration (iTRTM)

Leveraging

our assets in pluripotency and bioinformatics, we have performed research manipulating cellular immortality and regenerative biology

in human cells. In 2010, our scientists while at Lineage demonstrated the reversal of the developmental aging of human

cells using transcriptional reprogramming technology. In 2017, we published certain markers of the Weismann barrier, and the high

prevalence of a reversion back before the Weismann barrier in diverse cancer cell types cultured in vitro.

We

extended this research to determine whether reprogramming can be modified to only reverse the aging of cells back before the

Weismann Barrier, not back to pluripotency. We have utilized for example the gene COX7A1 as a marker of cells that

have lost regenerative potential (crossed the Weismann Barrier). As shown in Figure 8, our proprietary formulation

AGEX-iTR1547 has demonstrated initial capability of reducing the expression of the marker gene COX7A1 back to before

the Weismann Barrier without reverting the cells to pluripotency. When implemented in vivo, this partial

reprogramming, or iTR, would be expected to induce tissue regeneration, and when combined with telomerase, could modulate

both cellular immortality and regenerative biology for therapeutic effect. In addition to the small molecule product

candidate designated iTR1547, we have invented biological interventions based, for example, on gene therapy. Our inventions

relating to iTR biologics disclose both DNA and RNA-based strategies. Our gene delivery iTR product candidate is designated

iTR1550. We are performing research to optimize AGEX-iTR1547 and in parallel a gene delivery formulation designated

AGEX-iTR1550 in order to initiate preclinical studies of one or both of the agents on the scarless regeneration of the

skin.

Figure

8. PSCs such as ES Cells and PureStem EP Cells display a regenerative capacity like cells that have not cross the Weismann Barrier.

During pre- and post-natal development, skin cells become increasingly incapable of scarless regeneration as reflected in increasing

COX7A1 expression. iPS cell reprograming reverts cells back to pluripotency, while AgeX-iTR1547 reverts cells back only

to a point prior to the Weismann Barrier (regenerative state).

Status

and Development Plan

The

product candidates we have chosen are in the discovery stage of development. Prior to filing an Investigational New Drug (IND)

application for the initiation of clinical trials of our initial product candidates, AGEX-BAT1, AGEX-VASC1, and AGEX-ITR1547/AGEX-iTR1550

a number of important research and development goals will need to be achieved, including discovery-level research for the qualification

of reagents used in the manufacture of the product, completion of the standard operating procedures to be used (SOPs), complete

the methods and documentation for characterization of the product; and producing and testing the genetic modifications in the

master cell banks of the pluripotent stem cells under current Good Manufacturing Practices (cGMP) in order to produce product

that will not illicit immune rejection following transplantation. In addition, we will be required to expand the numbers of the

pluripotent stem cell master cell banks for future use; produce working cell banks from which the product will be manufactured

for clinical trials; produce the relevant product under cGMP conditions; and expand the number of relevant cells and cryopreserve

them under cGMP conditions. In addition, we will be required to design the pre-clinical studies including the study endpoints,

perform biosafety testing and release the first clinical batch based on preliminary characterization results, and complete full

product characterization. Biosafety testing will necessarily include pilot testing in animals such as (NOD/SCID) mice, dosing

spiking studies at early and later endpoints, tumorgenicity and biodistribution studies to determine whether the cells form undesired

tumors or migrate to inappropriate sites respectively in the animal. Lastly, we will need to define the clinical trial and regulatory

strategy and hold Pre-Pre-IND and Pre-IND meetings with the Food and Drug Administration (FDA), as well as successfully submit

an investigational new drug application or IND to the FDA and receive clearance to begin trials. Thereafter, we will need to demonstrate

safety and efficacy of the product in human clinical trials in Phase I and II trials, and continued safety and efficacy for achieving

the desired endpoint in Phase III trials, potentially then leading to product registration. See “Risk Factors — Risks

Related to Our Business Operations” for discussion of risks relating to product development and clinical trials. These include,

but are not limited to, failure to successfully complete the aforementioned studies due to the failure of the product, processes,

or skills of our employees, unforeseen delays in the development process, failure to raise requisite financing, or failure to

receive permission from the FDA to advance product development. To the extent we license development of one or more product candidates

to third parties or enter into a collaboration arrangements for product development, our licensees or collaborators would need

to undertake and achieve the foregoing goals.

Because

our product candidates are still in the discovery stage, our choice of product candidates and development plans are subject to

change based on a variety of factors. We may determine to abandon the development of one or more of our product candidates, or

we may prioritize the development of one or more product candidates, or we may select or acquire and prioritize the development

of new product candidates. Our choice and prioritization of product candidates for development will be influenced by a variety

of factors, including but not limited to:

Other

Products

Neural

Stem Cells

During

January 2020 we began a research collaboration under a Sponsored Research Agreement with the University of California at Irvine

(UCI) using our PureStem technology to derive neural stem cells, with the goal of developing cellular therapies to treat neurological

disorders and diseases. The collaboration’s initial work is expected to be concluded during 2021. The primary goal of the

research will be to develop a robust method of deriving neural stem cells from PSCs in sufficient quantity and with sufficient

purity and identity for use in cell based therapy. The initial focus will be on Huntington’s disease, while other potential

targets may include Parkinson’s, Alzheimer’s, and stroke. UCI has already accumulated safety and efficacy animal data

that may support an IND submission to the FDA for the commencement of clinical trials to treat

Huntington’s disease.

The

collaboration includes an opportunity for us to organize a company to be jointly owned with UCI and certain researchers to pursue

clinical development and commercialization of cell therapies derived using licensed inventions arising from the research program,

as well as certain patent pending technology for neural stem cell derivation, and certain technical data to support IND submissions.

ESI

BIO Research Products

We,

through our ESI BIO research product division, market a number of products related to pluripotent stem cells including, research-grade

as well as cGMP-grade human PSC lines. We plan to contract with third parties where the third parties to allow them to utilize

cGMP PSC lines in defined fields of application in exchange for certain compensation including the payment of royalties to us

if they are successful in developing and commercializing a product.

Subsidiaries

As

of and for the year ended December 31, 2020, AgeX consolidated the following subsidiaries:

Subsidiary Field of Business AgeX Ownership Country

LifeMap Sciences (1) Biomedical, gene and disease databases and tools 80.7% USA

All

material intercompany accounts and transactions between AgeX and its subsidiaries have been eliminated in consolidation.

Manufacturing

We

presently do not have any manufacturing facilities and we will need to rely on third party contract manufacturers for the production

of our cell lines and product candidates and to comply with quality manufacturing processes and controls.

Facilities

Until

December 31, 2020, when our lease expired, our offices and research laboratory were located in approximately 23,911 square feet

of space in a building in an office and research park at 965 Atlantic Avenue, Alameda, California. On November 3, 2020, AgeX entered