Corporate Presentation - CBI · development of ponatinib and brigatinib by Ariad Pharmaceuticals...

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Corporate Presentation

Transcript of Corporate Presentation - CBI · development of ponatinib and brigatinib by Ariad Pharmaceuticals...

Page 1: Corporate Presentation - CBI · development of ponatinib and brigatinib by Ariad Pharmaceuticals Recently, a process to delist the company from TASE has been initiated as a preliminary

Corporate Presentation

Page 2: Corporate Presentation - CBI · development of ponatinib and brigatinib by Ariad Pharmaceuticals Recently, a process to delist the company from TASE has been initiated as a preliminary

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This presentation contains forward-looking statements within the meaning of the Israeli securities laws that involve risks and uncertainties.

These forward-looking statements 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 not independently

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 or achievements to be materially different than expressed or implied by these forward-looking statements. Drug

discovery and development involve a high degree of risk. You should not place undue reliance on forward-looking statements since they

involve known and unknown risks, uncertainties and other factors which are in some cases beyond 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 with the 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 attract and retain partners for our technologies and products under development;

infringement of our intellectual property; market penetration of competing products; raising sufficient funds needed to support our research

and development efforts, and other factors described in our Israeli public filings, including the recent Annual Report. These factors are

updated from time to time through the filing of periodic and immediate statements with the Israel Securities Authority. Any forward-looking

statements contained in 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 such expectations 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 this presentation 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 our subsidiaries,

directors, officers, employees or any other person accepts any liability, whatsoever, for any loss howsoever arising, directly or indirectly,

from any use of such information 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 solicitation of 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 connection with any contract or investment decision relating thereto, nor does it

constitute a recommendation regarding our securities.

Safe Harbor

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Clal Biotechnology Industries – A Life Sciences Investment Company

Shareholders

Institutional

20%

Public

15%

Teva

16%

Clal Industries

(Access Industries)

49%

• The largest life sciences investment company in Israel; traded on the Tel Aviv Stock Exchange

• A subsidiary of Clal Industries (a member of Len Blavatnik’s international Access Industries)

• Offices in Tel Aviv and Boston; Israeli and US management team, experienced in drug development

• A variety of clinical-stage drug candidates for significant unmet medical needs with multibillion dollar

market potential

• Significant holdings in private and public companies in Israel and the US

• Ongoing collaborations with the multinational pharmaceutical companies, major investment funds and

leading research centers

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BioCancell

New management;Ready for phase III

GamidaCell

‘Breakthrough therapy’ designation granted; Phase III trial initiated

Vedantra

Collaborations in immuno-oncology

MediWound

EscharEx readout; BARDA agreement

Cadent

Novartis collaboration; acquisition of Ataxion

Neon

Clinical feasibility; preparing for an IPO

Anatomy

Fund raising and diverse collaborations

Major Developments in the Previous Year

eXIthera

Clinical feasibility; ongoing BD

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Diverse Clinical Development Activity

Gamida Cell

MediWound

Curetech

BioCancell

Biokine

Cadent

eXIthera

Vedantra

Neon

Company

35%

18%

27%

44%

24%

5%

53%

66%

54%

cancer immunotherapy

cancer immunotherapy

CNS disorders

cancer immunotherapy

marrow mobilization in cancer

cord stem cells

bladder cancer

severe burns/chronic wounds

Pre-Clinical Phase I Phase II MarketPhase III

anticoagulation

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Significant Holdings

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Gamida Cell – A World Leader in Stem Cell Therapy

Cord blood-derived stem cells products

NiCord® - a 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

• A Phase III trial has commenced, 120 patients to be enrolled

CordIn® - a treatment for rare hematological disorders

• Efficacy and safety in sickle cell disease evidenced in a Phase II

trial; a phase II trial in aplastic anemia is underway

• Orphan drug status

NK cell product – initiated clinical trial in hematological malignancies

Recently, a $40 million funding round has been completed; Dr. Julian

Adams nominated CEO and Chairman

An ambitious clinical development program backed by

adequate financing and an experienced management

team all support a significant IPO on NASDAQ

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Maximizing the burn market sales potential, and turning

MediWound’s vision for chronic wound care into reality

MediWound: Revolutionizing Wound Care

Developing, manufacturing and commercializing drugs for

burns and wound care

NexoBridTM - an enzymatic agent for burn debridement

• Efficacy, safety and tolerability established in global clinical trials

• Marketed in Europe 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 to fund

development and future purchasing

EscharExTM - an enzymatic agent for the debridement of

chronic wounds

• Good results in phase II trials

• Agreements with the FDA towards pivotal development plan

• Market potential of hundreds of millions of $

Recently, Stephen Wills appointed Chairman; $25M follow-on

completed

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BioCancell – A Breakthrough in the Treatment of Bladder Cancer

Selective biological drugs 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:

• A single arm study in patients unable to receive SoC BCG

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

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

Recently, a process to delist the company from TASE has been

initiated as a preliminary step to a private investment of $ 20-25

million; BD discussions for licensing deal are underway

Expedited approval of a novel bladder cancer therapy

necessitates a strategic deal or a NASDAQ offering

Page 10: Corporate Presentation - CBI · development of ponatinib and brigatinib by Ariad Pharmaceuticals Recently, a process to delist the company from TASE has been initiated as a preliminary

Other Activities

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Other Activities

Personalized vaccines against neoantigens – the products of mutated tumor genes;

The breakthrough results from the first human trial have recently been published in

Nature; Collaborations with Third Rock Ventures and BMS

Positively or negatively modulating 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; drugs candidates for

schizophrenia and movement disorders are expected to enter clinical testing in 2018;

collaborations with Novartis and Atlas Ventures

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

Potential for reduced bleeding rate compared to existing anticoagulants; A phase I trial

demonstrated the desired anticoagulant activity with favorable safety results; An oral drug

candidate with a broad market potential is in pre-clinical development

Advancing pidilizumab, an immune-modulating antibody; a number of Phase II clinical

trials have been completed; The rights for pidilizumab were regained from Pfizer;

Business development efforts are underway to enable the drug’s continued clinical

development

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Other Activities

An MIT-originated technology enabling the effective activation of the immune system;

Cancer vaccines - the first clinical trials are expected in 2018 (against HPV, KRAS);

Malaria vaccine - positive results from a primate study funded by the Gates Foundation;

collaboration with Neon Therapeutics

Anti-cancer drugs; The lead candidate, BL-8040 is being developed by BiolineRx

(Nasdaq: BLRX) under a licensing agreement providing for a future 60:40 revenue split;

BL-8040 is being evaluated in a number of phase II trials for various cancer indications

and is about to start a phase III trial in stem cell mobilization

A diverse portfolio of advanced medical device companies developing unique products

in surgery, orthopedics, cardiology and diagnostics; ongoing collaborations with major

medical device companies

Page 13: Corporate Presentation - CBI · development of ponatinib and brigatinib by Ariad Pharmaceuticals Recently, a process to delist the company from TASE has been initiated as a preliminary

Looking Ahead

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Goals for the Coming Years

Gamida Cell

2017 2018 2019

CordInPhase II (Hemoglobinopathies)results

Nicordphase III

BC-819 204 pivotaltrial

BC-819 301 Phase IIIpivotal trial

Depression phase I results(Novartis)

HPV cancer vaccinephase Ib

EP-7041phase I results

Pidilizumabpivotal DIPG

MediWound

Biokine

Cadent

BioCancell

Vedantra

eXIthera

CureTech

EP-7041licensing deal

Financing

Schizophrenia phase II

Nicordphase III results

IPO/financing

Malaria Primates results

NexoBridphase III 12m results

EscharExphase III

Sales toBARDA(subject to EUA)

NexoBridFDA approval

Clinical

Financial

Regulatory

Business

NK Cellsphase I/II

EP-7041phase II

SCA & Essential Tremorphase Ib trials

SCA & Essential Tremorphase II trials

IPO/financing

2020

BL-8040mobilizationphase III

BL-8040mobilizationphase II results

BL-8040pancreasphase II results

BL-8040solid tumorsphase Ib results

BL-8040AMLphase IIb results

KRAS cancer vaccinephase Ib

NEO-PV-01phase I results

Neon Series Cfinancing

IPO/financing

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

Pidilizumablicensing deal

Anatomy ColospanUS pivotal

Pi-Cardia:clinical trial

Sight CBC FDA approval

MinInvasive: OmniCuff US launch

Pre INDmeeting

IPO

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Turning Science into Industry