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CLAL Biotechnology Industries Ltd.

Investor Presentation Nov 22, 2020

6730_rns_2020-11-22_aafa789a-cd5f-4b68-90cf-594c47a9ac90.pdf

Investor Presentation

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CORPORATE PRESENTATION NOVEMBER 2020

SAFE HARBOR

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This presentation contains forward-looking statements within the meaning of the Israeli securities law that involve risks and uncertainties. These forward-looking statements relating to future events and future performance of the Company and the portfolio companies, jointly or separately, such as statements regarding, but are not limited to, market opportunities, strategy, competition, the further development and potential safety and efficacy of the products, the projected revenue and expense levels and the adequacy of the 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 as well as by the portfolio companies. 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 the 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 the 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 the portfolio companies make in connection with treatment protocols; uncertainties related to the ability to attract and retain partners for the technologies and products under development; infringement of the intellectual property; market penetration of competing products; raising sufficient funds needed to support the research and development efforts, and other factors described in our 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 portfolio companies 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 portfolio companies, directors, officers, employees or any other person accept 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.

The Company is continuously monitoring the impact of the worldwide spread of the corona virus (COVID-19) on its activities and the activities of its portfolio companies. At this time, there is a material uncertainty regarding the economic and other ramifications of the spread of COVID-19. This spread might have a negative effect on the activities of the Company and its portfolio companies, including, but not limited to, their market value, the ability to raise capital (governmental, private or public), the ability to materialize the Company's holdings, the possibility to advance strategic transactions, and the ability to carry out R&D and regulatory activities.

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 the Company shares or its portfolio companies 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 or our portfolio companies securities.

WHAT TO LOOK FOR IN 2021

2 FDA marketing approvals

3 advanced clinical trial readouts

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COVID-19 vaccine first-in-human trial

CLAL BIOTECHNOLOGY INDUSTRIES

Leading life sciences investment company traded on the stock exchange (TASE: CBI)

Collaborations with global healthcare companies and major investment funds

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CBI

Portfolio of well-funded biotech/ med-tech companies; ~\$400M raised in 2019/2020

Advanced technologies from leading US/IL institutions addressing major unmet needs

Team based in Tel Aviv and Boston

EXPERIENCED MANAGEMENT TEAM

DIVERSE CLINICAL DEVELOPMENT ACTIVITY

Company Pre-Clinical Phase I Phase II Phase III Market
MediWound
(Nasdaq: MDWD)
35% Severe burns/ chronic wounds
Gamida
Cell
(Nasdaq: GMDA)
6% Cord blood stem cells for transplantation
Biokine 25% Marrow cells mobilization in cancer
Cadent 13% CNS disorders
eXIthera 45% Anticoagulation
Elicio 17% Vaccines

BALANCED POTFOLIO

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PORTFOLIO COMPANIES

THE WORLD LEADER IN CORD BLOOD STEM CELL THERAPY

Unique technology for the expansion of cord blood-derived stem cells

Omidubicel – treatment for hematological malignancies

  • Orphan drug status and 'Breakthrough Therapy' designation granted by FDA
  • Phase III trial (n=125) completed
    • Primary endpoint of neutrophil engraftment achieved, with median time to engraftment of 12 days in the omidubicel group vs. 22 days in the comparator group (p<0.001)
    • Trial met all 3 secondary endpoints (day 42 platelet engraftment, Grade 2/3 infections by day 100 post-transplant, days alive out of the hospital by day 100 posttransplant)
  • Phase II in aplastic anemia is ongoing

GDA-201 – phase I in hematological malignancies is ongoing; promising early evidence of clinical activity observed in advanced non-Hodgkin's lymphoma

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Phase III trial primary endpoint: cumulative incidence of neutrophil engraftment

Omidubicel is designed to enhance the life-saving benefits of cord blood stem cell transplant (Nasdaq: GMDA)

Develops, manufactures & commercializes drugs for burns and wound care

NexoBrid - an enzymatic orphan drug for burn debridement

  • Marketed in the EU and other territories; becoming standard of care
  • Phase III trial for FDA approval has met the primary and all secondary endpoints; BLA submitted and accepted for review by FDA
  • Strategic agreements of up to \$202 million with BARDA: funding all of NexoBrid's R&D activities and procuring NexoBrid for \$16.5 million
  • License agreement with Vericel (Nasdaq: VCEL) for NexoBrid in North America

EscharEx - an enzymatic drug for chronic wound debridement

  • Positive results in initial phase II trial
  • A large phase II study comparing EscharEx to standard of care in venous leg ulcers initiated; interim data expected in H1/2021

Kaplan-Meier estimates for time to complete eschar removal

Evidence-based breakthrough technology addressing large and growing markets (Nasdaq: MDWD)

TARGETING TUMOR MICROENVIRONMENT TO FIGHT CANCER

Small molecules and peptides disrupting cancer cell communications

Motixafortide (BL-8040) - a novel high-affinity antagonist of CXCR4, mobilizing hematopoietic stem cells; orphan drug status in US and EU

  • Developed by BioLineRx (Nasdaq: BRLX) under a worldwide exclusive license
  • Phase II has shown that a single injection of motixafortide mobilized sufficient cells for transplantation as 4-6 injections of G-CSF, the current standard of care
  • A phase III trial in hematopoietic stem cell mobilization for autologous marrow transplantation in multiple myeloma has been recently stopped for success as the primary endpoint was met
  • Motixafortide is also being developed as a therapy for solid tumors (phase I/II), acute myeloid leukemia (phase II) and for ARDS (phase Ib)

BKT300 - a small molecule in pre-clinical research that interferes with a key cell cycle regulator over-expressed in tumor cells, aimed for solid and non-solid cancers

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Motixafortide dose-dependent mobilization of while blood cells (WBC) from the bone marrow into blood stream; red arrows indicate the time of the two injections of motixafortide (n=6/group) Clin Cancer Res, 2017, 23; 6790–801

Innovative arsenal for combating tumor expansion with multiple potential applications

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NOVEL THERAPIES FOR NEUROLOGICAL AND PSYCHIATRIC CONDITIONS

Developing drugs for CNS disorders

Positive or negative modulation of brain NMDA receptors:

  • MIJ821 for treatment-resistant depression; licensing deal with Novartis provides for milestone payments of up to \$386 million, plus royalties; a phase II trial recently completed enrolment
  • CAD-9303 for schizophrenia; currently in phase I

Modulation of ion channels to treat movement disorders

  • CAD-1883 drug for spinocerebellar ataxia (SCA) and essential tremor
    • A phase II trial in essential tremor has indicated proof of concept
    • Granted Orphan Drug status by FDA for SCA

Robust improvements in spiral drawing in essential tremor patients who responded to CAD-1883 in a Phase 2a trial

Presented at the 3rd Pan American Parkinson's Disease and Movement Disorders Congress, February 15, 2020

An attractive portfolio of products to treat CNS debilitating diseases; targeting multi billion \$ markets

DRIVING THE IMMUNE SYSTEM TO ELIMINATE CANCER

Developing potent next generation, lymph node-targeting, immunomodulatory therapeutic and prophylactic vaccines for cancer and infectious diseases

  • Lymph node targeting aims to achieve potent immune activation, robust T cell response, immune memory, and, in cancer, tumor eradication and durable cure
  • Solid intellectual property; ongoing relationship with founding MIT laboratory
  • Preclinical data from Elicio's COVID-19 vaccine indicate:

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  • Up to 25-fold more T cell response over benchmark vaccines and >265-fold greater neutralizing antibody levels than recovering patients
  • Potent CD8 and CD4 T cell presence in lung tissue and respiratory fluid
  • Expertise in cancer therapeutics; an executive team with a track record of success and exits with novel platform biotechnology companies
  • ELI-002: anti-KRAS therapeutic vaccine for KRAS-positive pancreatic and colorectal cancers; phase I/II to start in Q1 2021
  • Pipeline includes a combination with CAR-T for better efficacy in solid tumors

Science. 2019, 12; 365(6449): 162–168

Lymph node targeting better unlocks the power of the immune response

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THROMBOSIS PREVENTION AVOIDING BLEEDING RISK

World leader in developing novel, safer, first-in-class antithrombotic drugs

  • Despite the benefits of available anticoagulants, all convey significant bleeding risk
  • Factor XI antagonists inhibit the intrinsic clotting pathway, related to cardiovascular risk, but not the extrinsic pathway, critical to bleeding control in surgery and trauma
  • Humans with genetically low levels of factor XI have deceased incidence of thrombosis, which is not associated with spontaneous bleeding

EP-7041 - a novel, IV, selective small molecule Factor XIa inhibitor

  • Phase I in healthy volunteers showed good tolerance, predictable dosedependent increase in aPTT (efficacy marker) and rapid start and end of activity
  • Strategic collaboration with Haisco Pharmaceutical Group (002653:CH)
  • Phase II trial evaluating EP-7041 in COVID-19 patients in ICU, and a trial in the setting of extracorporeal membranous oxygenation (ECMO) are being planned

Phase I trial coagulation data

Factor XIa inhibition may finally dissociate anti-thrombotic effect from bleeding risk

MED-TECH PORTFOLIO

Sight Diagnostics Colospan Pi-Cardia MinInvasive FDNA
Commercializing
OLOTM, a novel AI and
optical, FDA approved,
point-of-care system for
complete blood count
Worldwide launch
activities
Significant COVID-19
related opportunities
Recently completed
\$71M financing
Developing CG-100, an
anastomosis protection
device for colorectal
surgery to prevent
anastomotic leaks,
forgoing the need for a
protective colostomy
CE Approved device
Clinical trial to support
PMA is ongoing in US,
EU and Israel
Developing LeaflexTM, a
novel catheter for
treating calcified aortic
stenosis without a need
for valve replacement
Proof-of-concept clinical
trial completed
successfully; a trial to
evaluate durability is
ongoing
Recently completed
\$27M financing;
initiated a strategic
collaboration with
Venus (China)
Commercializing
OmniCuffTM
-
a
minimally invasive
system for rotator cuff
tear repair
Excellent clinical
outcomes in clinical
trials and in routine use
FDA Approved
Received NMPA
(CFDA) approval;
partnering with
Microport
in China
Deploying Face2Gene:
AI-based platform to
detect physiological
patterns to reveal
disease-causing genetic
variants
Used by 70% of the
world's geneticists
(2,000 sites; over 130
countries)
Telehealth opportunity
boosted by COVID-19

LOOKING AHEAD

UPCOMING EVENTS - VALUE CREATING MILESTONES

(*) The above events may be delayed/ cancelled/ otherwise varied in relation to the spread of the COVID-19 pandemic

READY TO MATERIALIZE

WWW.CBI.CO.IL

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