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CLAL Biotechnology Industries Ltd.

Investor Presentation Feb 14, 2021

6730_rns_2021-02-14_bb7252a4-0667-4a6e-b72f-0800859552c0.pdf

Investor Presentation

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CORPORATE PRESENTATION FEBRUARY 2021

DISCLAIMER

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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.

INVESTMENT OPPORTUNITIES IN HEALTHCARE

Large and Growing Industry

  • Revenues > \$1.3 trillion
  • High profit margins, strong cash-flows, significant multiples
  • Resistant to economic cycles
  • Multiple opportunities

Investment Approach

  • Transatlantic deal sourcing
  • Active lead/co-lead investor
  • Long-term investment expertise
  • Exit-driven investments

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Compelling Exit Markets

  • Attractive M&A environment
  • Cash-rich corporate acquirers
  • Significant premiums
  • IPOs: tangible exit option

CLAL BIOTECHNOLOGY INDUSTRIES

Leading, publicly traded, life sciences investment company (TASE: CBI)

Collaborations with global healthcare companies and major investment funds

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

PERFORMANCE IN 2020

Cadent acquired by Novartis for \$210-770M

\$300M raised by portfolio companies

Positive phase 3 readouts

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Neon acquired by BioNTech for \$67M

NIS 36M dividend and up to NIS 10M buyback underway

BLA submission

CBI's share price

DIVERSE CLINICAL DEVELOPMENT ACTIVITY

Company Pre-Clinical Phase 1 Phase 2 Phase 3 Market
MediWound
(Nasdaq: MDWD)
35% Severe burns/ chronic wounds
FDNA 2% Genetic diagnostics
MinInvasive 20% Orthopedics
Sight 4% Blood diagnostics
Gamida
Cell
(Nasdaq: GMDA)
5% Cell therapy
Biokine 25% Marrow cells mobilization in cancer
Colospan 21% GI surgery
Cadent CNS disorders
eXIthera 45% Anticoagulation
Anchiano
(Nasdaq: ANCN)
19% Oncology
Pi Cardia 8% Cardiac valve repair
Elicio 17% Vaccines

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Acquired by Novartis. CBI is entitled to additional \$65M in contingent considerations

BALANCED AND DIVERSIFIED PORTFOLIO

VALUE CREATION OVER 3 YEARS

MULTIPLE NEAR-TERM PIPELINE CATALYSTS

H1 2021

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ELI-002 phase 1/2 trial initiation Omidubicel BLA submission
Motixafortide phase 3 trial readout NexoBrid
FDA approval
EP-7041 phase 2 trial initiation GDA-201 phase 2 trial initiation
EscharEx
phase 2 trial interim data
MIJ-821 phase 2 trial readout
Anchiano

Chemomb
M&A
Shortcut POC trial initiation
OLO launch
Omidubicel BLA submission
NexoBrid
FDA approval
GDA-201 phase 2 trial initiation
MIJ-821 phase 2 trial readout

H2 2021

PORTFOLIO HIGHLIGHTS

DRIVING THE IMMUNE SYSTEM TO ELIMINATE CANCER

Potent next generation, lymph node-targeting, immuno-modulatory 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 durable eradication
  • Solid intellectual property; ongoing relationship with founding MIT laboratory
  • ELI-002: anti-mKRAS therapeutic vaccine for mKRAS-positive pancreatic and colorectal cancers; phase 1b to start in Q1 2021
  • Pipeline includes a combination with CAR-T for better efficacy in solid tumors
  • 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 Science. 2019, 12; 365(6449): 162–168

Lymph node targeting better unlocks the power of the immune response

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 3 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 2 trial

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• A large phase 2 trial of EscharEx vs. 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

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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 have significant bleeding risk
  • Factor XI antagonists inhibit the intrinsic clotting pathway, related to cardiovascular risk, 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, without associated spontaneous bleeding

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

  • Phase 1 trial 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 2 trial evaluating EP-7041 in COVID-19 patients in ICU, and a trial in the setting of extracorporeal circulation (e.g., ECMO), are being planned

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

THE WORLD LEADER IN CORD BLOOD STEM CELL THERAPY

Unique technology for cellular expansion

Omidubicel – cord blood-derived stem cell therapy for hematological malignancies

  • Orphan drug status and 'Breakthrough Therapy' designation granted by FDA
  • Phase 3 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 2 in aplastic anemia is ongoing

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GDA-201 – phase 1 trial in hematological malignancies is ongoing; promising early evidence of clinical activity observed in advanced non-Hodgkin's lymphoma

Phase 3 trial primary endpoint: cumulative incidence of neutrophil engraftment

Omidubicel is designed to enhance the life-saving benefits of cord blood stem cell transplant

UNIQUE NON-IMPLANT-BASED AORTIC VALVE REPAIR

Innovative catheter-based therapies for stenotic aortic valves

Leaflex™: a novel catheter-based approach for treating calcified stenotic aortic valves through leaflet scoring

  • Successfully completed a proof-of-concept trial in humans
  • A trial to evaluate Leaflex™'s long term effects is ongoing; trial completion expected in 2022
  • Partnered with Sofinnova and Venus Medtech (China)

ShortCut™: a catheter-based device designed to avert coronary blockade during Transcatheter Aortic Valve Replacement (TAVR) by prior splitting of the aortic valve leaflets

• First patients successfully treated

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Leaflex™: next generation valve repair, foregoing the need for valve replacement

BIRD'S-EYE VIEW

Company Field Lead Product Stage Market Cap %(2) Next Catalyst Timing
MediWound Wound care NexoBrid Market \$151M(1) 35% EscharEx
interim readout
H1/2021
Gamida
Cell
Cell Therapy Omidubicel Phase 3 \$699M(1) 5% Omidubicel
BLA submission
H2/2021
Cadent CNS disorders MIJ-821 Phase 2 \$210-770M 12% MIJ-821 phase 2 results H2/2021
Elicio Vaccines ELI-002 Preclinical NA 17% ELI-002 phase 1/2 initiation H1/2021
Sight Blood diagnostics OLO Market NA 2% OLO launch H1/2021
Biokine Marrow Transplant Motixafortide Phase 3 NA 25% Motixafortide phase 3 readout H1/2021
Pi Cardia Cardiac valve repair Leaflex Phase 2 NA 6% Leaflex
interim readout
H2/2022
eXIthera Anticoagulation EP-7041 Phase 2 NA 45% EP-7041 phase 2 initiation H1/2021
Anchiano Oncology CM-101 Phase 2 \$32M(1) 19% Anchiano/ Chemomb
M&A
H1/2021
FDNA Genetic diagnostics Face2Gene Market NA 1% Telehealth launch H1/2021
Colospan GI surgery CG-100 Phase 3 NA 11% CG-100 pivotal trial readout H1/2024
MinInvasive Orthopedics OmniCuff Market NA 10% Financing H1/2021

(1) Based on Nasdaq quotes as of February 12, 2021

(2) Represents ownership percentage by CBI only (direct and indirect ownership)

REASONS TO INVEST IN CBI

EXPERIENCED MANAGEMENT TEAM

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Transatlantic well-connected team with sound scientific, medical, and commercial expertise

YOUR CONTACT

Clal Biotechnology Industries Ltd.

3 Azrieli Center Triangle Tower, 45th floor 132 Menachem Begin Tel Aviv, 6702301 Israel

Phone: +972 3 6121616 [email protected]

www.cbi.co.il

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