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Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES...

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CORPORATE PRESENTATION 1
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Page 1: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

CORPORATE PRESENTATION

1

Page 2: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

SAFE HARBORThis presentation contains forward-looking statements within the meaning of the Israeli securities laws that involve risks and uncertainties. These forward-lookingstatements relating to future events or our future performance, such as statements regarding, but are not limited to, our market opportunities, our strategy, our competition,the further development and potential safety and efficacy of our products, our projected revenue and expense levels and the adequacy of our available cash resources.Some of the information contained herein is based upon or derived from information provided by third-party consultants and other industry sources. We have notindependently verified and cannot assure the accuracy of any data obtained by or from these sources.

Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, level of activity, performance orachievements to be materially different than expressed or implied by these forward-looking statements. Drug discovery and development involve a high degree of risk. Youshould not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are in some casesbeyond our control and which could materially affect actual results, level of activity, performance or achievements. These risks and other factors include, among others,risks relating to: the successful preclinical development of our product candidates; the completion of clinical trials; the successful completion of the regulatory process withthe FDA and other regulatory bodies, including the FDA’s review of any filings we make in connection with treatment protocols; uncertainties related to the ability to attractand retain partners for our technologies and products under development; infringement of our intellectual property; market penetration of competing products; raisingsufficient funds needed to support our research and development efforts, and other factors described in our Israeli public filings, including the recent Annual Report. Thesefactors are updated from time to time through the filing of periodic and immediate statements with the Israel Securities Authority. Any forward-looking statements containedin this presentation are made as of the presentation date and the Company is under no obligation to revise or update these forward-looking statements.

Although we believe that the expectations reflected in these forward-looking statements are based upon reasonable assumptions, no assurance can be given that suchexpectations will be attained or that any deviations will not be material. No reliance may be placed for any purpose whatsoever on the information contained in thispresentation or on its completeness. No representation or warranty, express or implied, is given by us or on our behalf and/or our subsidiaries or any of our directors,officers or employees or any other person as to the accuracy or completeness of the information or opinions contained in this presentation. Neither we nor any of oursubsidiaries, directors, officers, employees or any other person accepts any liability, whatsoever, for any loss howsoever arising, directly or indirectly, from any use of suchinformation or opinions or otherwise arising in connection therewith.

This presentation does not constitute or form part of, and should not be construed as constituting or forming part of, any offer or invitation to sell or issue, or any solicitationof any offer to purchase or subscribe for, any of our shares, nor shall any part of this presentation nor the fact of its distribution form part of or be relied on in connectionwith any contract or investment decision relating thereto, nor does it constitute a recommendation regarding our securities.

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Page 3: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

The largest life sciences investment company

in Israel

Subsidiary of Clal Industries (member of Len Blavatnik’s

Access Industries)

Offices in Tel Aviv and Boston

Significant holdings in private and public companies in Israel

and the US

Israeli and US management team

Traded on the Tel Aviv Stock Exchange (TASE: CBI)

Shareholders

CLAL BIOTECHNOLOGY INDUSTRIES –A LIFE SCIENCES INVESTMENT COMPANY

3

InstitutionalInvestors

20%

Public15%

Teva16%

Clal Industries (Access)

49%

Access

CII

CBI

Page 4: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

Tier-1 Partners

INVESTMENT HIGHLIGHTS

4

Expertise in drug

development; focused

on late stage clinical

programs

Advanced technologies

from the best institutions

and minds in Israel as

well as US and Europe

Mature portfolio of late

stage companies;

expecting several IPOs

and M&As in 2018

Portfolio companies with

available resources to

support their clinical

programs

Collaborations with

multinational

pharmaceutical

companies and major

investment funds

Drug candidates for

significant unmet

medical needs with

multibillion dollar market

potential

Page 5: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

EXPERIENCED MANAGEMENT TEAM

5

Ofer Gonen - CEO

Ofer Goldberg - VP

Assaf Segal - CFO

Gilad Rosenberg –

Medical Director

William Koster –

Investment Advisor

Julian Adams –

Scientific Advisor

Page 6: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

MAJOR DEVELOPMENTS IN THE PREVIOUS YEAR

6

‘Breakthrough therapy’

designation granted;

phase III trial initiated

EscharExTM readout;

BARDA agreement

Positive phase II

readouts towards

initiation of phase III

Collaborations in

immuno-oncology

Clinical proof of

feasibility; ongoing BD

discussions

Clinical proof of

feasibility; crossover

financing

Novartis collaboration

progress; acquisition of

Ataxion

Financing rounds and

strategic collaborations

Page 7: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

DIVERSE CLINICAL DEVELOPMENT ACTIVITY

7

Company Pre-Clinical Phase I Phase II Phase III Market

MediWound(NASDAQ: MDWD)

35%

Gamida Cell 18%

Biokine 27%

BioCancell(TASE:BICL)

36%

Curetech 53%

Neon 5%

eXIthera 54%

Cadent 24%

Vedantra 66%

severe burns/chronic wounds

cord blood stem cells

marrow cells mobilization in cancer

bladder cancer

cancer immunotherapy

cancer immunotherapy

anticoagulation

CNS disorders

cancer immunotherapy

Page 8: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

LATE STAGE COMPANIES

Page 9: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

9

A WORLD LEADER IN STEM CELL THERAPY

Cord blood-derived stem cell products

NiCord ® - treatment for hematological malignancies

• Efficacy and safety demonstrated in a phase II trial, with rapid

engraftment, short hospitalization and reduced mortality

• A ‘Breakthrough Therapy’ designation granted by the FDA

• Phase III trial ongoing, 120 patients to be enrolled

CordIn ® - treatment for rare hematological disorders

• Efficacy and safety are evidenced in a phase II trial in sickle cell

disease; phase II trial in aplastic anemia is underway

• Orphan drug status

An ambitious clinical development program, backed by adequate financing and an experienced management team, all support a significant planned IPO on NASDAQ

NK cells program – phase Ib in hematological malignancies initiated

$40 million financing round recently completed; Dr. Julian Adams nominated CEO

and Chairman

Page 10: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

10

A POTENTIAL BREAKTHROUGH IN THE TREATMENT OF BLADDER CANCER

Selective biological therapy for the treatment of cancer

BC-819 - a drug activated by a gene product present only in tumor cells, for the

treatment of bladder cancer

• Promising phase II clinical trial results; low recurrence rate in

patients unresponsive to previous treatments

• Currently in preparation for 2 pivotal trials:

• Single arm study in patients ineligible for standard of care BCG

• Phase III trial assessing the combination of BCG and BC-819

Expedited approval of a novel bladder cancer

therapy necessitates a strategic deal or a Nasdaq

offering

BioCancell’s experienced management team is led by Frank Haluska, MD, PhD,

an oncologist who headed the successful development of ponatinib and brigatinib

by Ariad Pharmaceuticals

Finalizing $23 million PIPE; Nasdaq IPO planned for H2 2018; BD discussions for

licensing deal

Page 11: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

11

REVOLUTIONIZING WOUND CARE

Developing, manufacturing and commercializing drugs for burns and wound care

NexoBridTM - an enzymatic preparation for burn debridement

• Efficacy, safety and tolerability established in global clinical trials

• Marketed in the EU and other territories; NexoBrid is becoming standard of care

• Expecting completion in 2018 of 2 pivotal trials for FDA approval

• Strategic agreement of up to $132 million with BARDA; funding of clinical development and future purchasing of approved product

EscharExTM - an enzymatic preparation for the debridement of chronic wounds

• Good results in phase II

• Agreements with the FDA on pivotal development plan

• Hundreds of millions $ market potential

Maximizing the burn market sales potential and

turning MediWound’s vision for chronic wound

care into reality

Recently, Stephen Wills appointed Chairman;

Negotiating a strategic deal with an undisclosed partner

Page 12: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

OTHER ACTIVITIES

Page 13: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

13

OTHER ACTIVITIES

Immunotherapy company developing personalized vaccines against neoantigens – the products of mutated tumor

genes; breakthrough clinical results recently published in Nature; Collaboration with BMS; over $170M raised from

investors including Third Rock, Fidelity and Wellington

Anti-cancer drugs; lead candidate, BL-8040, a CXCR4 antagonist, is being developed by BiolineRx (NASDAQ:

BLRX) under a licensing agreement providing for a future 40:60 revenue split; BL-8040 recently entered a Phase III

trial in stem cell mobilization; it is also evaluated in a number of phase II trials for various cancer indications

Positive or negative modulation of brain receptors and ion channels; a drug candidate for depression has

completed Phase I; licensing deal with Novartis provides for milestone payments of up to $386 million, plus

royalties; drug candidates for schizophrenia and movement disorders are expected to enter clinical testing in 2018

and 2019; investment partners with Novartis and Atlas Ventures

Developing novel, broad-spectrum, immune modulating antibody for the treatment of cancer; lead product,

pidilizumab, a humanized monoclonal antibody with a checkpoint inhibitor functionality, completed multiple Phase II

clinical trials; the company was recently acquired by Insight Innovations for up to $555M plus royalties; pivotal trial

in DIPG is expected to begin later this year

Page 14: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

14

OTHER ACTIVITIES

MIT-originated technologies enabling effective activation of the immune system against specific tumor-associated

or infectious antigens; clinical trials with cancer vaccines against HPV+ and KRAS+ cancer is expected in 2019;

collaboration with Neon Therapeutics

An intravenous anticoagulant employing the unique mechanism of factor XIa inhibition; Potential for reduced

bleeding compared to existing anticoagulants; a phase I trial demonstrated high anticoagulation activity with

desirable PK/PD profile and favorable safety results; an oral drug candidate, with broad market potential, is in pre-

clinical development for chronic cardiovascular care

A diverse portfolio of advanced medical device companies developing unique products in surgery, orthopedics,

cardiology and diagnostics; ongoing collaboration with major medical device companies

Page 15: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

LOOKING AHEAD

Page 16: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

GOALS FOR THE COMING YEARS

16

MediWound

Gamida Cell

Biokine

BioCancell

Cadent

Vedantra

eXIthera

CureTech

Neon

Anatomy

EscharExphase III

2018 2019 2020

Sales to BARDA(subject to EUA)

NexoBridphase III results

NexoBridFDA approval

NK Cellsphase I/II

IPOCordInPhase II (Hemoglobinopathies) results

Nicordphase III results

BL-8040marrow mobilization phase III

BL-8040mobilizationphase II results

BL-8040pancreatic ca.phase II results

BL-8040solid tumorsphase Ib results

BL-8040AMLphase IIb results

FinancingBC-819 204 pivotaltrial

IPOBC-819 301 Phase III pivotal trial

Depression phase I results (Novartis)

IPO/financing

SCA & Essential Tremorphase Ib trials

SCA & Essential Tremorphase II trials

Cognitive deficits in Schizophrenia phase II

Pre INDmeeting

HPV+ cancervaccinephase Ib

KRAS+ cancervaccinephase Ib

EP-7041phase I results

EP-7041licensing deal

EP-7041phase II

Pidilizumablicensing deal

Pidilizumabpivotal DIPG

Series Cfinancing

NEO-PV-01phase I results

IPONEO-PV-01phase I extended data (melanoma, NSCLC)

ColospanUS pivotal trial

Pi-Cardiaclinical trial

MinInvasiveOmniCuff US launch

Sight CBC FDA approval

Clinical FinancialRegulatory Business

Cognitive deficits in Schizophrenia phase I

EP-7384 Oral drug candidate nomination

FDNA financing

Sight CBC pivotal trial

Page 17: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

REASONS TO INVEST IN CBI

• Expertise in drug development; focused on late stage clinical programs

• Advanced technologies from the best institutions and minds in Israel as well as US and Europe

• Drug candidates for significant unmet medical needs with multibillion dollar market potential

• Mature portfolio of late stage companies; expecting several IPOs and M&As in 2018

• Portfolio companies with available resources to support their clinical programs

• Collaborations with multinational pharmaceutical companies and major investment funds

Page 18: Corporate Presentation - CBIStock Exchange (TASE: CBI) Shareholders CLAL BIOTECHNOLOGY INDUSTRIES – A LIFE SCIENCES INVESTMENT COMPANY 3 Institutional Investors 20% Public 15% Teva

TURNING SCIENCE INTO INDUSTRY

18 WWW.CBI.CO.IL


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