AgeX’s Successful Non-Dilutive Funding Journey: How AgeX … · 2019. 1. 28. · 3 ease-al...

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"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.

Transcript of AgeX’s Successful Non-Dilutive Funding Journey: How AgeX … · 2019. 1. 28. · 3 ease-al...

Page 1: AgeX’s Successful Non-Dilutive Funding Journey: How AgeX … · 2019. 1. 28. · 3 ease-al Sustainable Health Normal Aging Compression of Morbidity Problem: Decades of Slow Decline

"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)

15

10

5

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

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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”