Commercializing Health Technologies-

Israel’s Start-up Success

Yaron Ilan, M.D.

Gastroenterology and Liver Units

Department of Medicine

Hebrew University-Hadassah Medical Center

Jerusalem, Israel

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Forward Looking Statements

Please be advised that the information and projections provided in this

presentation may include forward-looking statements with respect to plans,

projections or future performance of the companies presented, the occurrence

of which involves certain risks and uncertainties and is not under the control of

these companies, including, but not limited to, changes in regulatory

environment, success in implementing its research, development, sales,environment, success in implementing its research, development, sales,

marketing and manufacturing plans, protection and validity of patents and other

intellectual property rights, the impact of currency exchange rates and the effect

of competition by other companies.

Disclosure

I have financial relationships with the companies below and the

content of my presentation does include a discussion of the

investigative use of Im122, IMM124, anti-CD3, and glucosylceramide.

Director: Exalenz Biosciences, Plantylight, WAYS

Medical Director: Accelmed; Immuron; Exalenz Biosciences.

Consultant: Teva Pharmaceuticals, ENZO Biochem, Consultant: Teva Pharmaceuticals, ENZO Biochem,

Chiasma Pharma, Plantylight, and Nasvax.

From bench to bedside to commercialization

Seven new developmentsSeven new developments

at the liver unit at Hadassah

5 The Chain of Scientific Discovery:

The Critical Role of the Physician-Scientist

Faxon, MD; Circulation 2002 Apr 16;105(15):1857-60

Bridging the gap

Biomedical Research

Disease

Mechanism

Clinical

trials

New

TherapiesBasic

Research

Patient oriented research

Mechanism trialsTherapiesResearch

Translational Research

From Bench to Bedside

bench bedside

physician- scientist

20 years ago, former NIH director,

James Wyngaarden, articulated this in a paper entitled: “The clinical investigator as an endangered species.”

8

“Fighting extinction of a rare creature, the physician-scientist”.

Disease

Mechanism

Clinical

trials

New

TherapiesBasic

Research

Patient oriented research

Biomedical Research at Hadassah

Mechanism trialsTherapiesResearch

Protected

research

time

Hadasit

Start up

companies

CRC:

Clinical research

center

Hadassah

2 hospitals (locations)

31 operating theaters

9 specialty ICUs

1,130 beds 2011

Hadassah Medical Organization in numbers

1,130 beds

5,000 employees

670 physicians

>1M outpatients/year

of the Israel Academy of Sciences & Humanities

Awards for basic medical research - to Hadassah

researchers>50%

of Bio-Medical Research in Hospitals in Israel is 40%

Research in Hadassah

Conducted at Hadassah40%

Scientific Publications in the Past 4 Years2000

Winners of “Israel Prize” Awards12

� Provides Innovative technologies, Medical Research &

Development Services

� Established 1986

� Promotes and Commercializes IP (>200 active patent families)

� Promotes Collaboration with Industry (services, consulting)

Technology Transfer Company of Hadassah Medical HospitalsTechnology Transfer Company of Hadassah Medical Hospitals

Hadasit

� Established and/or holds equity in dozens of companies

including public companies

�Products: Therapeutics, Diagnostics & Medical Devices

�Over 15 new license and option agreements in 2009-2011

Start-upsLicensing to

established co.Collaborations

and JV

Hadasit - Business Models

MediFreezePlantylight

WAYS[OneDay]Hiterpia

J&JNasVax

[BiolineRx]Biokine

Immuron

GamidaCellProtab

OraMedTheravir

RegeneCure

Target characterization1 � Hadasit

Lead identification2 � Hadasit

Lead optimization3 � Hadasit

Efficacy in animal model4 ���� Hadasit

Pre-clinical5 ���� Hadasit

Manuf. of clinical grade material6 ���� Hadasit

���� Hadasit

���� Hadasit

Hadasit – One-stop shop for biotech companies

Manuf. of clinical grade material6 ���� Hadasit

Phase I7 ���� Hadasit

Phase II8 ���� Hadasit

Phase III9 ���� Hadasit

Regulatory approval10 � Hadasit

Launch11 � Hadasit

Phase IV12 ���� Hadasit

Many ways to reach the target

Breathing

A public companyA public company

ResultsStart10-30 Minutes from Start to Results

The BreathID® Testing Method

Exhaled 13CO2 from 150+

breath samples is

trapped, processed &

analyzed

Patient Drinks 13C -labelled

substrate

Baseline

Measurement

Patient breathes normally

through cannula

• Commercial• Validated in thousands of patients

Validated

• Parts-per-Million accuracy

BreathID® Breath Test System

• Parts-per-Million accuracy• Insensitive to human errors• Automatic online calibration

Reliable

• Automatic and continuous testing• Minimal patient cooperation needed• One-button operation• Immediate results

Easy

18

NAFLD/NASH

Vitamin B12 Insufficiency

Drug Metabolism (personalized medicine)

Carbohydrates and lipids digestion and absorption

Peptic Ulcers (H. pylori)

Gastric Emptying Rate

Gastric Accommodation

Liver reserve, Fibrosis

Lactose Intolerance

Pancreatic Function

Diabetes Insulin Resistance

Oral-Ceacal Transit

Gastric Accommodation

Bacterial Overgrowth

Published: August 17, 2009

Healthy One Day, Dying the Next: A Medical Race

A RARE DISEASE Jessa Perrin, 16, at an exam last week just weeks after undergoing a liver transplant at New York-Presbyterian.

Follow-up of Patients with Severe Acute Liver Disease Using an On-Line Breath Test

A patient with liver failure recovered without

the need for liver transplantation after

showing improvement in his breath test.

Two patients patients who died: Breath

test score remained low despite fluctuating

laboratory values.

A non-invasive alternative to liver biopsy for 75% patients

Prediction of long-term prognosis in patientswith chronic liver disease

575 patients with chronic liver disease

Su

rviv

al

Pro

bab

ilit

y

Low Risk

Medium Risk

American Liver Association 2009 Presidential Plenary

Su

rviv

al

Pro

bab

ilit

y

Time to Death (Days)

High Risk

The U.S. H. pylori Opportunity

H. pylori Incidence

• Bacteria which may reside in the stomach

• ~25% U.S.

• Bacteria which may reside in the stomach

• ~25% U.S.

Potential Market

• ~5M tests per year*

• Average reimbursement is $100

• ~5M tests per year*

• Average reimbursement is $100

Current Market Share

The U.S. H. pylori Opportunity

Potential Market

• ~25% U.S. prevalence

• May lead to• Stomach ulcers• Stomach cancer

• WHO recognized carcinogen

• ~25% U.S. prevalence

• May lead to• Stomach ulcers• Stomach cancer

• WHO recognized carcinogen

reimbursement is $100reimbursement is $100

* Validated in 6 independent surveys, interviews and focus groups which included over 500 U.S. and European PCPs, GIs and Hepatologists

Expeditious Growth

Over 100 Medical Centers in the first year in the USA

25

30

35

34

0

5

10

15

20

Q3/10 Q4/10 Q1/11 Q2/11 Q3 Up to date

79

17

23

Executive Summary

� Proven, commercially solid technology, supported by clinical data from thousands of patients, operating in 150 medical centers worldwide

� Launched 1st U.S. application in H2 2010 for testing H. pylori, a test with established reimbursement and supported by ACG & AGA

� Extensive pipeline targeting multi-million $ markets

26

� Collaboration with large pharma companies

� Publicly traded since 2007 (TASE:EXEN)

� Regulatory approvals for the BreathID® System in major territories (FDA, CE)

� Strong scientific team and advisory board

� 55 patents covering applications and products

Eating

Licensing the IP to a public companyLicensing the IP to a public company

Turning on the “secret button” in our gut

Oral Immunotherapy: Eat your disease

An attractive approach to treat diseases

Hundreds of years ago, Jewish sages wrote in the Talmud:

“If one is bitten by a mad dog, he may eat his liver and be cured.”

• Forty nine subjects with moderate-severe Crohn’s disease

• Oral administration of study drug or placebo for 15 weeks

Remission Response

AlequelTM 39% 50%

Alleviation of Crohn’s colitis by oral tolerance

Placebo 22% 30%

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