AgeX Therapeutics Issues Year-End Letter to Shareholders
December 09 2019 - 7:00AM
Business Wire
AgeX Therapeutics, Inc. (“AgeX”; NYSE American: AGE), a
biotechnology company focused on developing therapeutics for human
aging and regeneration, issued a letter to shareholders from
Michael D. West, PhD, founder and CEO, and Gregory Bailey, MD,
Chairman, reflecting on progress made in AgeX’s first year as a
public company, as well as current initiatives and future
plans.
The letter follows.
Dear AgeX Stockholders,
In this, our first year as a public company, we have built a
foundation for a revolutionary company in the fields of cell
therapy and tissue regeneration. To date, conventional
pharmaceutical approaches to the chronic degenerative conditions
associated with aging have provided little benefit, often only
offering relief from the symptoms of disease, rather than targeting
underlying disease processes. Our belief is that 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 which could generate and deliver new cells
to patients through our cell therapy focus, and which may reverse
the age of cells already in the body through our iTR™ platform. We
believe that our new technologies will lead to true cell
regeneration and replacement to potentially cure degenerative
diseases by targeting aged or damaged cells, tissues and
organs.
Over the last year, we have worked hard to achieve certain goals
to set the fundamental basis to create shareholder value going
forward:
- We moved into our new San Francisco Bay Area R&D facility,
comprising 15,700-square-feet of office and laboratory space, where
we have built-out and validated current Good Manufacturing Practice
(cGMP)-capable manufacturing suites, to allow for the manufacture
of clinical-grade cellular therapeutic candidates for product
development, clinical trials and partnering efforts.
- We commenced work to engineer our pluripotent stem cell lines
with our immunotolerance UniverCyte™ technology to generate
hypoimmunogenic/universal cells, which would evade a patient’s
immune system and hence could potentially be given to all patients
without co-administration of immunosuppressant drugs. We believe
this gives us a strong competitive edge over other companies
struggling with transplant rejection. In the coming year, we plan
to create a UniverCyte-modified pluripotent stem cell cGMP master
cell bank, from which we could potentially derive any human cell
type for our in-house product development programs or to provide
cells to third party pharma companies to pursue other products. We
are gathering and analyzing experimental data in a manner to allow
for scientific publications to aid validation of our platform and
to support collaboration and licensing efforts.
- We added to our Board of Directors experts in financing,
R&D, and cell therapy to ensure we have access to the best
possible strategic and execution guidance:
- Gregory Bailey, M.D., our Chairman, is the CEO of
Juvenescence Limited, our largest shareholder.
- Annalisa Jenkins, M.B.B.S., F.R.C.P., is an experienced
pharmaceutical industry executive, who is the former Head of Global
R&D and Executive VP of Global Development and Medical at Merck
Serono, and former Senior VP and Head of Global Medical Affairs at
Bristol Myers-Squibb.
- Michael May, Ph.D. is CEO of Canada’s Centre for
Commercialization of Regenerative Medicine (CCRM), a leading and
highly successful public-private partnership, which he has grown
from inception to over 100 experts, and which under his leadership
has raised over $100M, with spin-off companies and academic
partners supported by CCRM securing an additional $750M.
- We published two papers in the peer-reviewed scientific journal
Regenerative Medicine to provide an update on our progress and to
highlight our technologies to the industry. The first, “Toward a
Unified Theory of Aging and Regeneration,” outlines the theory
behind our iTR™ program. The second, “Engineering Strategies for
Generating Hypoimmunogenic Cells with High Clinical and Commercial
Value,” is a joint paper with Juvenescence, which reviews the most
promising approaches to producing universal cells, and emphasizes
the advantages of our UniverCyte™ technology. Interest in our
papers has been high, with both ranking in the top 2% of almost 14
million research papers tracked by Altmetric.
- We established our own accounting and administration
capabilities, and ended our shared facilities and services
agreement with Lineage Cell Therapeutics, Inc. (formerly BioTime,
Inc.).
- We filed numerous new patent applications and saw success in
obtaining new patent issuances, adding to our portfolio of more
than 400 patents and patent applications worldwide in cell-based
therapeutics.
To optimize shareholder value, we have undertaken a strategic
review of our business opportunities, and we have four key
take-away messages for the coming year and beyond:
- It is increasingly clear to us that our acquisition of patents
related to the generation of ‘universal’ cells was timely and
strategic. There is growing interest in such technologies by large
biotechnology and pharmaceutical companies.
- It has become evident over the past year that partial cellular
reprogramming to reverse the age of cells is set to open up a whole
new field of pioneering therapeutics. We aspire to lead in this
revolution using our partial cellular reprogramming technology
“iTR™”.
- Going forward we plan to strengthen our capacity of executing
on external licensing and collaboration deals with third parties as
well as in-house cell therapy product development. It has become
apparent to us through conversations with industry veterans that
both our immunotolerance UniverCyte™ platform for the generation of
universal cells and our pluripotent stem cell-based PureStem®
platform for the derivation and manufacturing of allogeneic,
off-the-shelf cells could be transformative for the entire cell
therapy industry. While developing our own therapeutic products, we
also plan to be reactive to opportunities to partner non-core
applications of these technologies with other companies to maximize
value for our shareholders by expanding our reach in cell therapy
and regeneration. We hope to announce initial collaborations in the
coming months. UniverCyte™ would potentially be game-changing for
the whole cell therapy industry by allowing the transplantation of
non-self, donor cells into all patients without the need for
powerful immunosuppressant drugs, which are associated with serious
side effects, including infections and cancers, as well as kidney
and liver toxicity. The UniverCyte™ platform aims to utilize a
proprietary, novel, modified form of the powerful immunomodulatory
molecule HLA-G, which in nature seems to be a dominant player in
protecting a baby from destruction by the mother's immune system
during pregnancy, the only known physiological state of immune
tolerance toward foreign tissue in humans. On the other hand, our
pluripotent stem cell-based PureStem® platform could potentially
overcome numerous industry barriers. PureStem® cells would have
eight potential advantages compared to other adult stem cell- or
pluripotent stem cell-based therapies, including lower
manufacturing costs, industrial scalability, off-the-shelf usage,
high purity, non-tumorgenicity, young age (so they are not prone to
the disadvantages associated with older cells), aptitude for
permanent cell engraftment, and potential to manufacture any human
cell type. We have two in-house product candidates, both targeting
highly prevalent diseases of old age, with a high unmet medical
need, and which are for multi-billion-dollar markets. Our lead
internal program going forward will be AgeX-BAT1, which is brown
fat cells for the treatment of type II diabetes. The last year has
seen significant investment in cell therapy product candidates for
diabetes by investors and large biotech. Earlier this year, we
published a paper, “Clonal Derivation of White and Brown Adipocyte
Progenitor Cell Lines from Human Pluripotent Stem Cells,” in the
peer-reviewed scientific journal Stem Cell Research & Therapy,
which showed that our PureStem® platform generated highly pure,
identifiable and scalable brown adipose cells, expressing active
adipokines. Our second internal program will be AgeX-VASC1,
composed of vascular endothelial progenitor cells for tissue
ischemia, such as peripheral vascular disease and potentially
cardiac and CNS ischaemia. Once we have a UniverCyte-modified
pluripotent stem cell cGMP master cell bank, we will re-derive
universal versions of AgeX-BAT1 and AgeX-VASC1 and then work to
establish proof-of-concept in animal models.
- Given the immense level of excitement around partial cellular
reprogramming to take aged or diseased cells inside the body back
to a more youthful state, we incorporated Reverse Bioengineering,
Inc. as an AgeX subsidiary to develop our revolutionary iTR™
platform. Reverse Bio will allow for a dedicated focus on iTR™ in
terms of equity financing and advancing our iTR™ technology to
proof-of-concept in an animal model as quickly as possible.
We care deeply about our mission and the needs of our
stockholders. We appreciate your support and the dedication of our
scientists and employees as we forge a new future for medicine. We
invite you to join us for the Annual Meeting of Stockholders on
Monday, December 30, 2019. For those of you who cannot attend in
person, our corporate update from that meeting will be webcast for
your convenience.
Sincerely,
Michael D. West, Ph.D.
Gregory Bailey, M.D.
Chief Executive Officer
Chairman of the Board
About AgeX Therapeutics
AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on
developing and commercializing innovative therapeutics for human
aging. Its PureStem® and UniverCyte™ manufacturing and
immunotolerance technologies are designed to work together to
generate highly-defined, universal, allogeneic, off-the-shelf
pluripotent stem cell-derived young cells of any type for
application in a variety of diseases with a high unmet medical
need. AgeX has two preclinical cell therapy programs: AGEX-VASC1
(vascular progenitor cells) for tissue ischemia and AGEX-BAT1
(brown fat cells) for Type II diabetes. AgeX’s revolutionary
longevity platform induced Tissue Regeneration (iTR™) aims to
unlock cellular immortality and regenerative capacity to reverse
age-related changes within tissues. AGEX-iTR1547 is an iTR-based
formulation in preclinical development. HyStem® is AgeX’s delivery
technology to stably engraft PureStem cell therapies in the body.
AgeX is developing its core product pipeline for use in the clinic
to extend human healthspan and is seeking opportunities to
establish licensing and collaboration agreements around its broad
IP estate and proprietary technology platforms.
For more information, please visit www.agexinc.com or connect
with the company on Twitter, LinkedIn, Facebook, and YouTube.
Forward-Looking Statements
Certain statements contained in this release are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. 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 forward-looking
statements. Forward-looking statements involve risks and
uncertainties. 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 business of AgeX Therapeutics, Inc. and its
subsidiaries, particularly those mentioned in the cautionary
statements found in more detail in the “Risk Factors” section of
AgeX’s Annual Report on Form 10-K and Quarterly Reports on Form
10-Q filed with the Securities and Exchange Commissions (copies of
which may be obtained at www.sec.gov). Subsequent events and
developments may cause these forward-looking statements to change.
AgeX specifically disclaims any obligation or intention to update
or revise these forward-looking statements as a result of changed
events or circumstances that occur after the date of this release,
except as required by applicable law.
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Media Contact for AgeX:
Bill Douglass Gotham Communications, LLC bill@gothamcomm.com
(646) 504-0890
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