Medical Jan 2018-EN - Elbit Imaging · INSIGHTEC Overview 85+ global active ... INSIGHTEC, the...

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1 Elbit Medical Technologies Ltd. Investors Presentation Elbit Medical January 2018

Transcript of Medical Jan 2018-EN - Elbit Imaging · INSIGHTEC Overview 85+ global active ... INSIGHTEC, the...

Page 1: Medical Jan 2018-EN - Elbit Imaging · INSIGHTEC Overview 85+ global active ... INSIGHTEC, the Israeli company that develops an MRI-based treatment…" • If you have never heard

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Elbit Medical Technologies Ltd. Investors Presentation

Elbit Medical

January 2018

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Legal Information This presentation includes forward‐looking information, as defined in the Securities Law, 5728‐1968, which includes, inter alia, forecasts, assessments, estimates and other information relating to future events and matters, the realization of which is uncertain and not under the control of the Company and / or INSIGHTEC LTD (INSIGHTEC) and / or of Gamida Cell Ltd. ("Gamida"). The forward‐looking information included in the presentation may not materialize, in whole or in part, or may materialize differently than expected, or may be affected by factors that can not be estimated in advance and which are not under the control of the Company and / or INSIGHTEC and / or Gamida, due to a change in one of the risk factors that characterize the Company's activity and / or INSIGHTEC and / or Gamida, as well as developments in the economic environment and external factors that affect the Company and / or INSIGHTEC and / or Gamida in their areas of activity.

The main facts and data that served as the basis for this information are facts and data regarding the current state of the Company and / or INSIGHTEC and / or Gamida and their businesses, facts and data regarding the current state of the areas of activity and macroeconomic facts and data, as known to the Company and / or to INSIGHTEC and / or to Gamida at the time of preparation of this presentation, including statistical and public data and publications published by various bodies and authorities whose contents have not been examined by the Company and / or INSIGHTEC and / or Gamida independently, and therefore the Company and / or INSIGHTEC and / or Gamida are not responsible for their correctness.In order to remove any doubt, it is clarified that the Company does not undertake to update and / or modify the information included in the presentation in order to reflect events and / or circumstances that will occur after the date of the presentation.

This presentation contains partial and selective information only, which the Company considered appropriate to share with its shareholders and the general public investing in the Company's securities. This information may not be included in the Company's financial and other reports as published to the public, or the presentation of the information contained in the presentation is different from the manner in which such information is included in such publications. This presentation contains a summary of the topics described in it, in the context in which they are discussed, and not the full information available to the Company in relation to these matters. This presentation does not include the full results and financial information of the Company and their explanations and / or the Company's business plans or the description of all of its activities, and it is not intended to replace and / or replace the need to review the reports that the Company published to the public by law, including the Company's annual and by‐annual reports and also the immediate reports (the "Reports" or "the Company's Reports"). In any case of contradiction between the data included in this presentation and the data included in the Company's accompanying reports, the data appearing in the Company's reports should be deemed binding on the Company. In addition, the Company is exposed to risk factors as detailed in the Company's reports published by law, including in the Periodic Report, which may affect the results of its operations and / or its ability to realize its plans.

Also, the company is exposed to risk factors as detailed in the company reports published to the public by law, including the periodical report that may affect the results of its activity and / or its ability to realize its plans.

This presentation should not be considered as an offer or an invitation to purchase securities of the Company. The sale of securities will be made only in accordance with a prospectus whose publication will be approved by the Securities Authority. 

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17.9% )13.6%* (Company value: 160M USD According to the last investment

Business Card Elbit Medical Technologies Ltd. ("Elbit Medical") is a

public company listed for trade on the Tel Aviv Stock Exchange

Company value - NIS 270 million The Company has owner loans in the amount of NIS

150 million to Elbit Imaging, with a maturity date of January 1, 2019.

The company has two affiliated companies

24.9% )20.7%* (USD Company value: 550M According to the last investment

(and before the end of its second stage)

* Fully diluted

Holding percentage on a fully diluted basis.

An affiliate company that was incorporated in Israel in 1998, and engages in the research and 

development of cell‐based medical products for the treatment of cancer and rare blood diseases

An affiliated company that was incorporated in Israel in 1999 and is engaged in the

development, production and marketing of focused magnetic imaging equipment for non-invasive treatments in tumors within the human

body using an ultrasound beam

Elbit Medical

89.2% )fully diluted –about 86% (

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Using MR‐guided Focused 

Ultrasound Technology, INSIGHTEC is 

revolutionizing therapy by making it completely 

non‐invasive

INSIGHTEC - The Future of Robotic Surgery

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INSIGHTEC Overview

85+ global active sites

168 Patents$376 million invested to date

20+ new papers expected in the next 6 months

~100 peer reviewed clinical papers

3 FDA and CE approved applications 

~240 employees~$25 million of revenue in 2016

6 major new FDA indications expected by 

2022 

16,000+ patients treated globally

By the NumbersCompany Description

• Founded in 1999 in Israel by engineers and physicists from leading academia and medical devices industry, currently employing 240 employees

• INSIGHTEC is developing the Exablate, the first MRI-guided ultrasound-guided device to be approved by the FDA

• The first company to develop a technology that successfully targets and inserts ultrasound waves through the skull

• One technology: five markets – neurology, oncology, targeted brain drug delivery, women's health and urology

• Deep relationships with key industry players and medical academic institutions

• Global strategic partnerships with GE and Siemens

• INSIGHTEC installations at leading medical sites in U.S., Europe and Asia

• The value of the company (according to the investment round in December 2017 and before the end of its second stage) - $ 550 million

The head office is located in Haifa,

with offices in the United States,

China, Japan and Europe

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Transactions in INSIGHTEC Shares in 2017 On December 14, 2017, INSIGHTEC signed an investment agreement with Koch Disruptive Technologies, a subsidiary of Koch

Industries, Inc. (Hereinafter - "the Investor"), in the framework of which the Investor and other investors will invest in INSIGHTEC an amount of between $ 75 million and $ 150 million, in exchange for the allocation of preferred E shares of INSIGHTEC.

On December 28, 2017, the first stage of the transaction was completed, in which INSIGHTEC raised approximately $ 90 million (of which $ 75 million was received from the investor).

In consideration for the investment, INSIGHTEC issued new preferred shares of INSIGHTEC (hereinafter: the "Preferred Shares"), which immediately after their allotment constitute 19.7% of the issued share capital (and 16.5% fully diluted) of INSIGHTEC.

Following the investment and the allocation of the prefered shares, the Company holds approximately 24.9% (20.7% fully diluted) of the issued share capital of INSIGHTEC.

In accordance with the terms of the investment agreement, INSIGHTEC can increase the scope of raising up to $ 150 million

from the investor and from other investors at additional completion dates (to be implemented no later than January 31, 2018). The second stage of the investment round will be carried out at INSIGHTEC'S value of $ 550 million (assuming

full dilution). The holders of preferred shares shall have priority rights in the event of dividend distribution and material events as detailed in

the investment documents.

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• What has the second largest US conglomerate lost in Tirat Carmel?

• "This brought the Charles and David Koch empire, whose revenues are estimated at $ 115 billion a year, to invest $ 75 million precisely in the dream of INSIGHTEC, the Israeli company that develops an MRI-based treatment…"

• If you have never heard of the Koch brothers, who have recently invested in INSIGHTEC, which develops MRI-based therapy, at a value of $ 500 million, that's fine. It just means that they manage to meet their goal. Charles (82) and David (77) Koch are fanatical to their almost complete anonymity, maintaining maximum secrecy.

• The conglomerate sends arms to every area. From oil to mineral water, from fertilizer to toilet paper. Koch Industries has refineries in Alaska, Texas and Minnesota, and about 6,000 kilometers of oil pipelines. The company owns Lycra, the Brawny Paper Towels Company and the Georgia-Pacific Wood Products Company.

• The question is what has caused the empire that employs 120,000 people around the world and is estimated to have income (??? )הכנסות כמה? that INSIGHTEC attracted Koch Disruptive Technologies, Koch Industries' subsidiary, especially due to a change in its management in recent years. This became overwhelmingly American - and gave birth to the ties with the brothers.

• INSIGHTEC conducted a road show for capital raising, in which they presented their vision to institutions and investors in the US. The aim of the capital raising is mainly to finance a new direction - initial trials of injecting drugs for brain tumors, in the hope that the new management will break into this hot market.

• The road show was led by the Chairman and CEO Morris Ferré, who in his past, went through a big exit: He sold the medical robot maker MAKO (MAKO Surgical) at the end of 2013 to Stryker, one of the leading medical equipment corporation, at $ 1.65 billion.

• Koch Disruptive Technologies heard - and were impressed.

• Koch's first investment, $ 90 million, was made with other investors and was reported on December 14.

• The brothers' share was $ 75 million. The consideration: new preferred E shares, at a value of $ 460 million for INSIGHTEC.

• These investors now hold 19.7% of the company's issued share capital (16.5% on a fully diluted basis). In addition, they and existing shareholders were granted the right to invest up to an additional sum of $ 75 million by the end of January, in exchange for additional preferred shares.

From the Press ...

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Evolution of Surgery

Open Surgery Minimally Invasive Surgery Robotic Surgery Non‐Invasive 

MRgFUS

CUTTING EDGE TECHNOLOGY… WITHOUT THE CUTTING

INSIGHTEC’S technology

The focused ultrasound generates heat at the focal point and destroys the targeted tissue

MRI imaging allows identification and direction to the target and real‐time monitoring of the 

treatment by measuring temperatures

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The Non-invasive Future of Surgery

“It may sound like science fiction or Star Trek to some, but it isn’t. Named one of the 50 greatest inventions by TIME magazine, and credited with “changing medicine” by Fortune magazine, focused ultrasound is a new, highly disruptive, game‐changing, non‐invasive therapeutic technology that has the potential to be as revolutionary to therapy as magnetic resonance scanning (MRI) has been to diagnosis.” 

MR‐Guided Focused Ultrasound In The News 

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Exhalate – How Does it Work?

UltrasoundHigh intensity focused ultrasound energy generates heat at a focal point up to ablation of the targeted tissue

Magnetic Resonance Imaging (MRI)MRgFUS uses focused ultrasound to ablate the target tissue under Real Time MRI Guidance and Control

How It WorksUp to 1,000 independently controlled rays of ultrasound are transmitted to a focal point where the rays converge, transforming energy to heat, ablating the targeted tissueusing MRI to monitor treatment outcomes in real time, adjusting treatment parameters to achieve the planned result

• Interacts with an MRI system (T1.5 and T3).

• In the body system - a separate cradle for each application

A non‐invasive platform that unites two technologies ‐ high‐intensity focused ultrasound and MRI imaging

Neuro Oncology

TARGETED BRAIN DRUG DELIVERY 

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Regulation Status

An initial tremor Palliative care in bone metastasis is painful

Fibroids in the womb

FDA

OncologyNeurosurgery

In addition, the company has regulatory approvals in various countries around the world.

Women's Health

Fibroids in the womb and adenomiosis

Prostate cancer

Cancerous and benign tumors in bone

Primary tremor, Parkinson tremor, and neuropathic pain

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MRgFUS Surgery Regulatory Roadmap

FDA ApprovalPivotal Study

FDA Approval510K StudyProstate

FDA ApprovalPivotal StudyFeasibility StudyBrain Tumors Ablation

FDA ApprovalFeasibility Study Pivotal StudyDrug Delivery forNeuro‐oncology

FDA ApprovalPivotal StudyFeasibility StudyLiver/PancreasClinical Research

FDA ApprovalPivotal StudyFeasibility StudyEpilepsy Clinical Trials 

2017 2018 2019 2020 2021 2022

Parkinson’s Disease 

NEU

ROLO

GYONCO

LOGY

FDA ApprovalFeasibility Study Pivotal StudyDrug Delivery forOncology Indications

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Large US Neuro Market Opportunity

~122,000 POTENTIAL US 

PATIENTS

Patient Population MRgFUS Potential Annual Patients

Essential Tremor

Prevalence 7‐10MIncidence 70KRefractory 10%

50,000

Parkinson’s Disease

Prevalence 1‐ 1.5MIncidence 60KRefractory 40%

25,000

EpilepsyPrevalence 2.2M,Incidence 150K. Refractory 30%

22,000

Brain Tumors Incidence / Prevalence 250,000 patients 25,000

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Expanding Global Presence

INSIGHTEC has direct and indirect sales presence in key regions globally and is growing

Miami

DallasTirat Carmel Shanghai

Tokyo

HeadquarterOfficesNeurosurgery Treatment Center

Women’s Health Treatment CenterOncology Treatment Center

Rome

Americas24 USA2 Canada1 Mexico1 Brazil

Europe4 Germany11 Italy2 UK2 Switzerland2 Spain1 Poland3 France

Asia 10 Japan4 Korea8 China2 Singapore1 Taiwan1 Malaysia2 Australia4 India1 Vietnam6 Russia1 Kazakhstan2 Israel1 HK

The company's appliances are deployed in 120 of the world's

leading medical centers

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168

Strong & Comprehensive IP

+ Strong IP and comprehensive patent protection of technology portfolio

+ Patent portfolio constitutes a significant barrier to entry for competitors

+ On-going intensive innovation pipeline

Approved Patents

Submitted applications in process of approval

Patent applications in development 

48

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Extensive Barriers to Entry

Development Costs

IP Protection

Regulatory Approval

+ Significant time and money spent on clinical trials+ Very long lead time for clinical trials and approval cycles+ Only company to have neuro regulatory approval + In advanced trials for other applications

+ $285 million spent on development over 18 year period, including $48 million since 2014

+ Very complex technology that takes years to develop with highly specialized technical skills

+ IP protection on 18 years of technology development+ 168 approved patents to date

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Experienced Management Team

• Seasoned medical device executive

• Previously, Chairman of the Board and CEO of MAKO Surgical Corp.

• Doctor of Medicine and Master of Public Health

• The visionary behind MRgFUStechnology 

• Previously President of Diasonics and Elbit Medical Imaging

• PhD in Electro Optics and BSc in Electrical Engineering

MAURICE R. FERRÉ, MD CEO & Chairman of Board

KOBI VORTMAN‚ PHD Founder & Vice Chairman

of the Board

EYAL ZADICARIO, PHDGeneral Manager

JUN (JIM) TAOCCO

NADIR ALIKACEM‚ PHDVP Global Regulatory

Affairs & CRO

RONI KARIEVP and CFO

• Leader of the MRgFUS R&D team

• Experience with R&D of multi‐disciplinary technology

• PhD in Computer Science and BSc in Aeronautical Engineering

• Broad experience in business strategy with private equity firms and GE

• Previously VP of Strategy & BusDev at Constellium

• MBA and MSc in Material Engineering

• Expert in regulatory strategy

• Previously Asst. Professor at UT Southwestern Medical Center and Scientist at Saint Francois’ D’AssiseHospital

• Postdoctoral fellowship, PhD& MSc in Physics

• Experienced Finance Executive

• Previously CFO at Diagnostic Tech, Finance Manager at NetManage & Controller of Elbit Group

• CPA, BA in Economics & Accounting

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Shareholders and Scope of Investments in INSIGHTEC

To date, INSIGHTEC has invested $ 376 million in its shareholders

Elbit’s group investment in INSIGHTEC

amounts to about $ 116 million 20.7%

21.3%

13.7%

7.4%

4.6%

6.9%

3.4%

3.4%

18.6%

Ownership structure (fully diluted(

ELBIT Medical

York Fund

Koch

Exigent

GE Group

M Ferre Group

GEOC

MTA group

Others

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Development of biotechnological

products based on cells

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Gamida Cell – A World Leader in Stem Cell Therapy

An ambitious clinical development program, backed by adequate financing and an experienced management team

Gamida Cell is engaged in the development of products for curing cancer and rare genetic diseases. 

The company has developed several products based on NAM technology platform for cell proliferation:

NiCord® ‐ a treatment for hematological malignancies 

• Efficiency and safety: Good results in Phase II trials - rapid and effective engraftment, and improved transplant results.

• Production capacity and technology transfer under GMP conditions

• A “Breakthrough Therapy” designation granted by the FDA• An "Orphan Drug" designation was granted in the United

States and Europe• A Phase III trial has commenced (appr. 120 patients)

CordIn ™  - a treatment for rare hematological disorders 

Efficacy and safety: Promising initial results in a Phase II trial in sickle cell anemia; Phase I trial in aplastic anemia

NK cells product – A clinical trial has begun for the treatment of blood cancers in the United States

Major shareholders • Novartis• Elbit Medical • CBI

Company value • Company value according to the last investment round in July

2017 - $ 120 million (before the money).

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Investment Round in Gamida Cell

On July 9, 2017, an investment round of $ 40 million ("the investment") was completed at Gamida Cell Ltd. ("Gamida Cell") at a value of $ 120 million (before the money), led by Shavit Capital Fund, to which Novartis and other investors, including VMS Investment Group, Israel Biotech Fund, IHCV and ClalBiotechnology Industries Ltd. (the "Investors"). In return for the investment, prefered shares were allotted to the investors ("the allotted shares") at a value of $ 120 million (before the money) to Gamida Cell. In addition, investors were granted options to purchase preferred shares in a quantity constituting 60% of the number of shares allotted (the "Options"). The exercise price of the options is 120% of the price per share paid by the investors on the closing date of the transaction. The options may be exercised during a period of up to 5 years from the closing date of the transaction. Upon completion of the investment, the Company holds 17.9% of Gamida Cell (13.6% fully diluted).

Gamida Cell has raised $ 135 million so far.

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NiCord®-Area of Activity and Scope of the Target Market

Bone marrow transplantation in patients with leukemia has been an accepted and life-saving treatment for

50 years…

Every year about 70 thousand patients are candidates for bone marrow transplant from a donor (about

40,000 in the US, Europe and Japan).

In practice, bone marrow transplants are performed only in about 40,000 patients.

About 30,000 patients are left untreated each year, the main reason being that they have no suitable donor

in time.

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Over 800,000 cord blood units are frozen in public blood banks around the world

NiCord® -Cord Blood as an Alternative to Bone Marrow Transplantation

There is no need for a complete tissue matching

with the patient

Readily available using a computerized system

of cord blood banks

Pitfalls in cord blood plantation:Benefits of Cord Blood Transplantation:

A small amount of stem cells

Slow engraftment results in poorer clinical

outcomes

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NAM-A Unique Technology for the Enrichment of Cord Blood in Stem Cells

Cord Blood GMP Production site at the Company's facility in Israel

Enrichment of stem cells in culture with

Gamida's unique technology

NiCord® shipedfrozen to hospitals

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NiCord® -Treatment of Malignant Diseases of the Circulatory System

NiCord® is based on cord blood stem cells enriched with NAM technology.

Results from Phase I / II were presented at the ASH 2017 Annual Meeting.

Phase III for NiCord® has commenced in the USA, Europe and Asia. Appr. 120 patients will be treated in an open,

randomized and controlled trial.

The control group - patients who underwent transplantation in one or two non-enriched cord blood units.

A primary endpoint for the trial-time for engraftment.

Primary endpoint results of the study and BLA submission- 2020.

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CordIn ™ -Treatment of Non-malignant Blood Diseases Sickle cell anemia is a life-threatening blood disease caused by a genetic defect in the production of hemoglobin.

The incidence of diseases is high in the Mediterranean, China, India, Asia, and the African-American population. The

number of sick persons in the United States is about 100,000.

The average life expectancy of these patients is about 50 years.

The cost of treating these patients in the US is estimated at more than $ 8 million over a lifetime.

There are few treatments that treat the symptoms of the disease but do not cure it. Bone marrow transplantation was

proven to be a complete cure for patients.

Gamida Cell has been applied in 12 patients so far. Positive initial results were published at ASH 2016.

Recruitment of patients continues.

Beginning of I / II Phase II trial in patients with aplastic anemia and myelodysplastic disease with CordIn ™. The trial

will be conducted in the United States and is expected to recruit up to 29 patients between the ages of 4 and 55, the

first patient successfully treated.

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NiCord® Provides Significant Benefits to Patients, Hospitals and Payers

Patients• Better clinical results• Rapid hematopoietic and immunity recovery• Reduced morbidity

Hospital• Shorter hospital stay - 10 - 20 days• Improved efficiency in beds utilization (census), allows more patients to get to transplant• Savings in resource exploitation• Additional budget for the implant itself is available in many cases

Payer• Reduced treatment charges

• NiCord® requires only 1 CB unit$

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Gamida Cell Pipeline

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An Experienced Management Team

Has more than 20 years of experience in research, development, registration, and launch of hematology and oncology drugs. Previously served as the VP and Head of Global Medical Affairs at Pfizer Oncology.B.A. from Johns Hopkins University and an M.D. from New York University School of Medicine. 

RONIT SIMANTOV, M.D.CHIEF MEDICAL OFFICER

TONY PELEDCHIEF SCIENTIFIC OFFICER AND VICE 

PRESIDENT OF R&D

YAEL MARGOLINPRESIDENT

JULIAN ADAMS, PH.D.CHAIRMAN & CHIEF EXECUTIVE OFFICER

Co‐founder of the company and the researcher whose discoveries have led to Gamida Cell’s key clinical achievements, which are supported by many patents.Previously served as a scientist at the Hematology Department, Hadassah University Hospital, Jerusalem, Israel and has more than 15 years of experience in hematopoiesis and stem cell research.

Has more than 35 years of experience in the venture capital, pharmaceutical and biotech industries.Served as CEO of Gamida Cell from 2005‐2017. During this time, she led Gamida Cell from pre‐clinical development through phase 3 international registration studies, the receipt of a Breakthrough Therapy Designation for the company’s lead product, strategic collaborations and the raising of $100 million from various financing initiatives.Served as vice president of Denali Ventures LLC, a healthcare specialized venture capital firm, and a program manager at TevaPharmaceuticals.Holds a Ph.D. in Biology from the Weizmann Institute of Science and was a post‐doctoral associate at the Yale University School of Medicine.

Has more than 30 years of experience in drug discovery and development with a strong focus on cancer research.Previously served as chief scientific officer and president of Clal Biotechnology Industries.Has won several awards for his drug development efforts throughout his career.Received a B.S. from McGill University and a Ph.D. from the Massachusetts Institute of Technology. He also earned a Doctor of Science, honoris causa, from McGill University.

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Goals for the Coming Years

CordIn ™Phase II (Hemoglobinopathies)results

NiCord ®phase III begin

NiCord ®Phase III results

Clinical

NK Cellsphase I/II begin

2017 2018 2019 2020

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Shareholders and the Scope of Investments in Gamida Cell

To date, Gamma Cell has invested about $

135 million.

The Elbit Group's share in the investment is

$ 15.7 million

13.6%

17.9%

14.3%

9.0%8.7%

8.7%

18.1%

9.8%

Ownership structure (fully diluted)

Elbit Medical

Novartis

CBI

IHCV

Shavit

VMS

Others

ESOP

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Main Achievements of INSIGHTEC and Gamida

2017/4 INSIGHTEC-FDA

approval for treatment of

significant tremor

2017/7 Gamida-Raising $

40 million at a market value of $

120 million (before the

money(

2017/8 Gamida – Trial

commencement for CordIn™ in aplastic anemia

patients

2017/10 INSIGHTEC-FDA

approval to begin Phase III study using

the brain system

2017/12 INSIGHTEC-

Completion of the first stage of an

investment transaction in

which INSIGHTEC raised

approximately $ 90 million.

2017 בשנת

11/2017Gamida – CEO appointment

and opening of office in USA

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Thank You!

Elbit Medical

January 2018