corporate presentation - cbistock exchange (tase: cbi) shareholders clal biotechnology industries...
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CORPORATE PRESENTATION
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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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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
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InstitutionalInvestors
20%
Public15%
Teva16%
Clal Industries (Access)
49%
Access
CII
CBI
Tier-1 Partners
INVESTMENT HIGHLIGHTS
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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
EXPERIENCED MANAGEMENT TEAM
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Ofer Gonen - CEO
Ofer Goldberg - VP
Assaf Segal - CFO
Gilad Rosenberg –
Medical Director
William Koster –
Investment Advisor
Julian Adams –
Scientific Advisor
MAJOR DEVELOPMENTS IN THE PREVIOUS YEAR
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‘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
DIVERSE CLINICAL DEVELOPMENT ACTIVITY
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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
LATE STAGE COMPANIES
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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
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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
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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
OTHER ACTIVITIES
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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
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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
LOOKING AHEAD
GOALS FOR THE COMING YEARS
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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
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
TURNING SCIENCE INTO INDUSTRY
18 WWW.CBI.CO.IL