Corporate Presentation - CBI · development of ponatinib and brigatinib by Ariad Pharmaceuticals...
Transcript of Corporate Presentation - CBI · development of ponatinib and brigatinib by Ariad Pharmaceuticals...
Corporate Presentation
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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
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
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
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
Turning Science into Industry