strictly private and confidential information 1. this presentation was prepared for the sake of...

Strictly private and confidential information1

Strictly private and confidential information

This presentation was prepared for the sake of summary and convenience only and it cannot replace a

reviewing of the prospectus and/or the periodic report of Kadimastem Ltd. (hereinafter: “the Company”).

This presentation contains projections, estimates and assessments, as are known to the Company at the time

of preparation of this presentation, referring to the Company and including, inter alia, forward-looking

information as defined in the Securities Law, 5728 – 1968, based on subjective estimates on the part of the

Company in respect of its development potential and based on initial information and documents the

Company received from professional entities relevant to the Company’s development plans.

Forward-looking information is uncertain and mostly is not under the Company’s control and the realization or

non-realization of forward-looking information will be affected, among other things, by the risk factors

characterizing the Company’s activity, as well as developments in the general environment and external

factors affecting the Company’s activity. The Company’s results and achievements in the future may differ

materially from those presented in this presentation and the Company makes no undertaking to update or

revise such projection or estimate and does not undertake to update this presentation.

This presentation does not constitute a proposal to purchase the Company’s securities or an invitation to

receive such offers. Investment in securities in general and in the Company in particular bears risks. One

should take into account that past performance does not necessarily indicate performance in the future.

2

Disclaimer


Vision

Utilize innovative stem cell-based

therapies to treat incurable diseases

3


Company Snapshot

4

Established: 2009

Founders: Yossi Ben Yossef and Professor Michel Revel

(developer of Merck Serono’s blockbuster drug REBIF®)

Differentiate stem cells into a range of functioning cells for:

Regenerative Medicine – using differentiated cells to cure diseases

Drug Screening – using differentiated cells to test effects of

compounds

Agreement with the Merck Serono for drug screening for

multiple sclerosis (MS)


Company Snapshot

5

1,700 m² (18,300 ft²) labs and offices including two clean rooms

30 employees (9 PhD’s)

Experienced Management with extensive biotech experience


Business Model

The drug screening engine reduces dependence on outside funding

6

Regenerative Medicine

DrugScreening


What Are Stem Cells

7

A Cell with a potential to…

Self renew

Differentiate into a variety of cells


Our Platform Technologies

• Insulin producing beta-cells• Brain supporting (glia) and neuronal cells • Accurate and reproducible

• Large scale production capabilities • hESC and iPS cells• Reproducible

Expansion

Differentiation

The basis for both drug screening and regenerative medicine

activities

Highly skilled team can transition between activities as

needed


Commercial Applications

Platform Technologie

s


Drug Screening

Existing project

Additional diseases

Goals

ALS

(Merck Serono)

MS

HD

Diabetes

ALS


Diabetes

10

A group of diseases characterized by excessive levels of blood

sugar

Insulin – a hormone secreted from beta cells in the pancreas

The absence of insulin causes an excessive blood glucose level

that causes cumulative damage

Lack of insulin production or the inability to use it

Inability to produce insulin

>371 million patients worldwide

90%

Type 2

10% Type 1

Source: http://www.idf.org/worlddiabetesday/toolkit/gp/facts-figures

http://www.idf.org/worlddiabetesday/toolkit/gp/facts-figures


Diabetes – Target Market

11

137m patients worldwide

(type 1 diabetes patients +~30% of type 2 diabetes patients - insulin dependent)

~30 million in developed world

Global Epidemic (WHO)

The global market for diabetes management is expected to reach 114$ billion in 2016* Source: the American Diabetes Society (diabetes.org), the World Health Organization (who.int), the International Diabetes Federation (idf.org) and a market

study conducted by the MedMarket Diligence company from 2010 )http://www.mediligence.com/rpt/rpt-d510.htm); also http://www.diabetes.ucsf.edu/clinical-care-education/about-diabetes/type-2-diabetes-faqs * http://www.transparencymarketresearch.com/diabetes-devices-market.html

http://www.diabetes.ucsf.edu/clinical-care-education/about-diabetes/type-2-diabetes-faqs

http://www.diabetes.ucsf.edu/clinical-care-education/about-diabetes/type-2-diabetes-faqs

http://www.transparencymarketresearch.com/diabetes-devices-market.html


Diabetes – Existing Treatments

Monitoring glucose levels and injecting insulin accordingly

• Insulin injections do not prevent the cumulative damage of the disease

• Difficulty in balancing diabetic patients

• Dangerous states of diabetes (hyperglycemia) and “sugar level drops”

(hypoglycemia)

Transplantation of beta cells from cadaveric organ donors

Feasibility proof of concept regarding treatment using beta cells transplant

Shortage in sufficient organ donations

Requires long-term immunosuppression

12


Production and transplantation of stem cell-derived islet-like

structures in patients:

Kadimastem produces islet-like clusters that show glucose-

stimulated insulin secretion.

Restoring the patient’s ability to produce and release insulin and

glucagon

Obviates the need for monitoring blood sugar levels and insulin

injections

Eliminates the life threatening consequences of diabetes

Significant improvement of patients’ life expectancy and quality

of life

13

Diabetes – Our Solution


Diabetes – Our Solution

Stem Cell Expansion

Differentiation into Beta Cells

Sorting of Beta Cells

Re-aggregation into Islet-like

structure

Encapsulation Implantation




s


Drug Screening

Existing project

Diabetes

Additional diseases

Goals

ALS

(Merck Serono)

MS

HD

(Merck Serono)

ALS


ALS

16

A rapidly progressive and fatal neurological disease

Attacks neurons responsible for controlling muscles

(motoneurons)

Leads to loss of muscle control

Disease does not impair a person’s mind

Lou Gehrig 1903 - 1941


ALS – Target Market

17

~150,000 patients

ww ~50,000 diagnosed each year

~137 diagnosed each day

Annual ALS healthcare cost in US alone estimated at $6 billion *

The numbers increase as population ages

Refers to US, Canada, Europe and Australia. http://www.alsa.org/als-care/resources/publications-videos/factsheets/epidemiology.html * http://alliancerm.org/disease/als-and-regenerative-medicine

http://www.alsa.org/als-care/resources/publications-videos/factsheets/epidemiology.html



http://alliancerm.org/disease/als-and-regenerative-medicine


Medications : Rilutek® - the first and only medication approved

by the Food and Drug Administration for slowing ALS

Appears to slow the disease's progression in some people

Physical therapy

Occupational therapy

Speech therapy

ALS - Existing Treatments


Studies have indicated the involvement of malfunctioning

brain-supporting cells (astrocytes) in ALS

Cells become toxic to Motoneurons

Reduced levels of brain’s “well-being”

Our therapeutic approach:

Increase neuronal survival by transplanting functional human

astrocytes into ALS patients

ALS – Our Approach


Therapeutics Development Strategy

• Advance ALS until end of in-vivo trials, in

parallel to Diabetes

• Go/No-Go decision point - Q2 2015:

– Positive in-vivo results in ALS continue to

advance program and slow down Diabetes

– Negative in-vivo results in ALS continue to

advance Diabetes and slow down ALS


ALS Development Timeline

In-vivo IND Clinical Trials

Q2 ‘15$1 M

Q2 ‘19Q2-Q3 ‘16$5 M

Add Strategic Partner

Go/No-Go (Diabetes or ALS)

Q1 ‘14

It is hereby clarified, that the aforementioned assessments, regarding the expected progress of the Company's R&D in the field of ALS is considered prospective information, as defined in the Securities Law, which is based, inter alia, on current quotations, Company's working plan and acquaintance with the regulatory requirements to this date. This information might not realize and the actual results might be substantially different, inter alia, as a result of lack of proper funding for progress in the desired scope of activity, failure of pre-clinical and/or clinical experiments, delay of schedule, regulatory changes in countries where the Company plans to conduct the experiments, etc.


Diabetes Development Timeline

In-vivo trials IND Clinical

Trials

Q4 ‘20Q4 ‘17$7 M

Q2 ‘16$1.5 M

Add Strategic Partner

It is hereby clarified, that the aforementioned assessments, regarding the expected progress of the Company's R&D in the field of diabetes is considered prospective information, as defined in the Securities Law, which is based, inter alia, on current quotations, Company's working plan and acquaintance with the regulatory requirements to this date. This information might not realize and the actual results might be substantially different, inter alia, as a result of lack of proper funding for progress in the desired scope of activity, failure of pre-clinical and/or clinical experiments, delay of schedule, regulatory changes in countries where the Company plans to conduct the experiments, etc.


Increase in Early-Stage Deals

23

Early Stage Deal ValuationPicks Up, But Not Late Stage$80

$60

$50$4

$30

$20

$70

$10

$0

$0 $100 $200 $400 $500

5 year average

2013

Preclinical

Aver

age

Upf

ront

Total Deal Value

$80

$60

$50$40

$30

$20

$70

$10

$0

$0 $100 $200 $400 $500

5 year average 2013

Phase I

Aver

age

Upf

ront

Total Deal Value

$80

$60

$50$40

$30

$20

$70

$10

$0

$0 $100 $200 $400 $500

5 year average

2013

Phase IIIAv

erag

e U

pfro

nt

Total Deal Value

$80

$60

$50$40

$30

$20

$70

$10

$0

$0 $100 $200 $400 $500

5 year average

2013

Phase II

Aver

age

Upf

ront

Total Deal Value

Source: http://www.partnering360.com/insight/showroom/id/429

http://www.partnering360.com/insight/showroom/id/429

http://www.partnering360.com/insight/showroom/id/429




s


Drug Screening

Existing project

Diabetes

ALS

Additional diseases

Goals

(Merck Serono)

MS

HD

ALS


Production of specific, relevant and functional cells from stem cells

Creating simplified models for drug activity, automatically quantified

by imaging based system

Testing how potential drugs affect the cell functionality

A stem cell colony Neuro-glia progenitor cells

Drug Screening

Differentiated cells are affected (or not) by the drug

25


Collaboration with Merck Serono

Goal: Using Kadimastem’s specialized cells for MS drug discovery

The agreement: 1) A non-exclusive collaboration 2) Merck Serono provides potential drugs

4/2012 – Signed drug screening agreement focusing on MS

11/2013 – Signed MOU to advance collaboration to include: $1M grant from Merck Serono Optimizing screening capabilities for MS drugs Development of screening capabilities for ALS and Huntington’s

Diseases

26


Patents

27

Diabetes Therapeuti

cs

ALS Therapeuti

cs

Drug Screening

Stem Cell Enabling

Technologies

Strictly private and confidential information 28

Founded Kadimastem in 2009

12 years of experience in leading investments and building start-up companies in

the field of life sciences

Investment and active involvement in Evogene, VBL, Radvision, Rosetta Genomics,

BiondVax, Comfi, Wisecom

Yossi Ben Yossef – CEO

Founded Kadimastem in 2009

Professor Emeritus of molecular genetics at the Weizmann Institute

Israel Prize laureate

Over 30 years of experience in development and global commercialization of

advanced biotechnological products

Developed Merck’s REBIF® drug for multiple sclerosis ($2.2B USD in sales in 2011)

Professor Michel Revel – Chief Scientist

Management Team


Milestones

Milestones

Initiate in-vivo studies in a diabetic model

Initiate in-vivo studies in a SOD1 ALS animal model

Sign agreements with Pharma companies (MOU Merck

Serono )

ALS – Complete animal testing Q2 2015

Diabetes - complete in-vivo studies on immune-deficient

animals– Q2 2015

Diabetes - complete in-vivo studies on immune-competent

animals– Q2 2016

29

√√√


Strategy

Strategy

Shorten time and cost by licensing and mergers

Adding strategic partner for the development of diabetes

and ALS therapies

Drug screening agreements with additional drug companies

30


Take home messages

Developing drugs to improve patients’ life quality &

expectancy

Therapeutic programs with blockbuster potential

(Diabetes, ALS)

Commercial agreement with Merck-Serono

Highly experienced executive team (CSO developer of

Rebif®)

31


Thank you

strictly private and confidential information 1. this presentation was prepared for the sake of...

Documents

stem cells

initial information

differentiated cells

variety of cells

disclaimer slide

companys securities

companys activity

diseases drug screening