AgeX’s Successful Non-Dilutive Funding Journey: How AgeX … · 2019. 1. 28. · 3 ease-al...
Transcript of AgeX’s Successful Non-Dilutive Funding Journey: How AgeX … · 2019. 1. 28. · 3 ease-al...
"AgeX’s Successful Non-Dilutive Funding Journey: How AgeX
Obtained Initial Non-Dilutive Funding for Our Programs"
January 9, 2019
CONFIDENTIAL – Not for Distribution
© 2019 AgeX Therapeutics, Inc.
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Forward Looking Statements
2 - CONFIDENTIAL – Not for Distribution © 2018 AgeX Therapeutics, Inc. -
The matters discussed in this presentation include forward looking statements which are subject to various risks,
uncertainties, and other factors that could cause actual results to differ materially from the results anticipated. Such risks and
uncertainties include but are not limited to the success of AgeX Therapeutics and its affiliates including its parent company
BioTime, Inc. in developing new stem cell products and technologies; results of clinical trials of such products; the ability of
Agex and BioTime and its licensees to obtain additional FDA and foreign regulatory approval to market products; competition
from products manufactured and sold or being developed by other companies; the price of and demand for such products;
and the ability of Agex to raise the capital needed to finance its current and planned operations. 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. As actual results may differ materially from the results anticipated in these forward-
looking statements they should be evaluated together with the many uncertainties that affect the business of Agex and
BioTime and its other subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities
and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.
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Dis
ease
-fre
e su
rviv
al
Sustainable Health
Normal Aging
Compression of Morbidity
Problem: Decades of Slow Decline with 1 or More Degenerative Diseases
AgeX– Mission: Apply Advanced Biotechnology to Human Aging
Age of Onset of Morbidity
*Andersen et al. J Gerontol A Biol Sci Med Sci. 2012 Apr;67(4)
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Regeneration is the Key to Sustainable Health
iTR: induced Tissue Regeneration
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Exosomes
Aging Adult
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Therapeutic Angiogenesis
Embryonic Progenitors
Pluripotent stem cells
iTR: induced Tissue Regeneration
Can We Induce Embryonic Programs to Regenerate Adult Tissue?
Cells
Highly Regenerative Cells/Exosomes
Drugs
Embryonic
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iTR: induced Tissue Regeneration
Can We Induce Embryonic Programs to Regenerate Adult Tissue?
Product Generation Cardiovascular Metabolic
Cells 1st VASC1 BAT1
EV 2nd VASC1-EV BAT1-EV
Drugs 3rd VASC1-Rx BAT1-Rx
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The PureStem Embryonic
Progenitor Cell Bank
PureStem®: Industrial Scale Source of Young Stem Cells
•Scalable•Pure•Stable Identity•Diverse•Young/Highly Regenerative
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The Power of Scale
Steel Manufacturing – mid 1800’s
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The Power of Scale
Steel Manufacturing – late 1800’s
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The Power of Scale
Industrial Scale Stem Cell Manufacturing –Clinical Studies
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Scale-Up at Embryonic Progenitor Stage
Harness the potential of
pluripotent stem cells
Pu
reSt
em T
ech
no
logy
Pluripotent Stem Cells
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Scale-Up at Embryonic Progenitor StageP
ure
Stem
Tec
hn
olo
gy
hES Cells
>200 Clonal Progenitor
Stem Cell Lines
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TRF Length
(kbp)
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10
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Age
Neonatal Hayflick Limit
Germ-Line &
Pluripotent SCs
(Telomerase +)
Somatic
(Telomerase -)
Population Doublings
22 34 43 55 65 72 82 90
Decre
asin
g T
elo
mere
Length
with A
ge
PureStem Cell Lines have Long Telomeres
Young Cells = Long Telomeres
14Regen Med 2012 Jul;7(4):481-501
Very Long Replicative Lifespan
Embryonic Telomere Length = High Scalability
Adult MSCs
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Industrial Scale Cell Manufacturing
Consistent Large Scale Production from Single Cell Source
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Cell Identity + Diversity: 140 Distinct Cell Types
Microarray analysis
BoneCartilage
Smooth
Muscle
Endothelial
Pericyte
Brown Fat
Fate Space Mapping
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BAT1: Clonal Brown Fat Progenitors – Obesity
UCP1
3D Culture in HyStem®
Oil Red O
2D Culture
Phase
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VASC1 : Clonal Endothelial Progenitors - Cardiovascular
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Monoclonal Endothelium
GFP Endothelium (168 hrs)
99.7%
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2nd Generation VASC1: Extracellular Vesicle (EV) Therapy
• Adult Stem Cells are effective in variety of disease models
• Paracrine Effect: EV are often as effective as cells
• Problem: Scale-Up of Adult Stem Cells is a barrier to success
• Opportunity: PureStem® Technology applied to EV therapeutics
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EV Papers Premise:
Our Second Gen VASC1 Non-Dilutive Funding Experience
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• Screen PureStem Cell Lines for angiogenic EV production
• Select candidates Tx based on activity and EV cargo
• Test in animal model of ischemia
Approach: Scale-up Angiogenic Activity
Our Second Gen VASC1 Non-Dilutive Funding Experience
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Our Second Gen VASC1 Non-Dilutive Funding Experience
Preliminary Data- PureStem EVs are Angiogenic- Scalable EV production
Identify Collaborator / Animal Model- Peripheral Artery Disease- Stroke
1st Phase I – Not Funded
Revision – Not Funded
2nd Phase I – Not Funded New Collaborator
and Indication3rd Phase 1 – Not Funded
Revision– Impact Score = 20
Bring in FreeMind
Funding @ $386k for 1yr
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Our iTR Non-Dilutive Funding Experience
Metabolically Reprogrammed Mesenchymal Stem Cells for Treating Osteoporosis
Ex-Vivo Gene Therapy
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Our iTR Non-Dilutive Funding Experience
Preliminary Data- Gene Mod MSCs skew
toward Osteogenesis
Identify Collaborator / Animal Model- Osteoporosis
1st Phase I – Impact Score = 35
Funding @ $225k for 1yr
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Lessons Learned
• Define your Product in title• Show feasibility in Ph I• Collaborate to expand expertise• Scientific Rigor – statistics, Abs• Get to know your Program Officer• Be persistent
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Lessons Learned – Have a strong premise
“If they buy the premise, they’ll buy the bit”