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CLAL Biotechnology Industries Ltd.

Investor Presentation Jan 8, 2023

6730_rns_2023-01-08_2da187d6-39f6-4725-b2ce-d9aaf92b6ebb.pdf

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LASER FOCUSED ON VALUE

Corporate Presentation January 2023

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, as well as, development of medical technologies, 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. No assurance can be given that the expectations reflected in the forward-looking statements will be attained or that any deviations will not be material.

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.

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 OPPORTUNITY THAT COMES WITH EXPERIENCE

With over two decades of investment experience, a seasoned transatlantic leadership team and a crystalized portfolio of HealthTech companies, CBI is laser focused on value.

Our seasoned team of unparalleled corporate finance, medical and market access experts across Israel and Boston propels innovative companies from idea to exit. A publicly traded company (TASE:CBI), we invest in biotech, and medical technology companies that are developing proprietary solutions to unmet medical needs. Our diverse portfolio covers various therapeutic indications in oncology, cardiology, neuroscience, tissue repair, and stem cell therapy.

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The value to our portfolio companies is maximized through collaborations with other prominent investment funds, such as Third Rock Ventures, Fidelity, Wellington, Atlas Ventures, Consensus Business Group and Israel Biotech Fund. Our companies have also collaborated with major pharma companies, such as BMS, Merck, Novartis and Regeneron.

Public 23%

Teva 16%

CBI's shareholders

Clal industries 48%

Institutionals 13%

CBI is regulated by the Israeli Securities Authority and audited by PwC. It's controlling shareholder is Mr. Len Blavatnik via Access Industries.

PORTFOLIO HOLDING CHART

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(*) CBI holds, directly, an additional 2% (**) CBI's share in milestone payments from Novartis

CBI'S UNDERLYING ASSETS & PORTFOLIO HOLDINGS

Company Name Type CBI
Interest*
Stage Area Solution
Private (USA) 31% Phase 2 Anticoagulation Factor XIa
inhibitor for thrombosis prevention -
avoiding bleeding risk
h
c
e
t
o
Bi
Private (USA) 12% Phase 1/2 Cancer Immunotherapy Unique approach to activate the immune system and fight cancer
Public [Nasdaq:
MDWD]
22% Market Tissue Repair Novel tissue repair treatment, targeting wound care and severe burns
Public
[Nasdaq: GMDA]
4% Pending
approval
Cancer Cell Therapy World leader in cord blood stem cell therapy
Private (IL) 25% Pending
approval
Stem Cells Mobilization in Cancer Best-in-class stem cell mobilizing treatment for autologous
transplantation
Earnouts*** 12%*** Phase 2 CNS Disorders Treat negative and cognitive symptoms in schizophrenia
&
s
e
h
c
t
vi
al
e
e
D
H
al
al
c
di
t
gi
e
Di
M
Private (IL) 11% Pivotal
study
Colorectal Cancer Surgery Alternative solution to diverting stoma
Private (IL) 4%** Pivotal
study
Cardiac Valve Repair Novel low profile catheter for the treatment of aortic stenosis
Private (IL) 1% Market Blood Diagnostics Sight's OLO, performs a complete blood count in minutes
Private (IL) 1% Market Genetic Diagnostics Early detection of rare disease with the help of AI
al
s
ci
t
e
n
s
a
s
n
a
Fi
Public
[TASE: CPTP]
7% - Biomed Investments -
SPAC [Nasdaq:
CCTS]
6% - Healthcare SPAC A SPAC targeting Israeli related healthcare companies

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(*) CBI holdings/interest reflects the overall interest CBI has in the asset (**) Includes 2% held directly by CBI (***) Milestone payments, Sold to Novartis

VALUE GENERATION Last 5 years at a glance

Nasdaq IPOs

Strategic Collaborations 5

Completed Phase 3 3 novel drugs

M&As 3

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Financing Over \$1 Billion raised

Initiated Clinical trials 7

MULTIPLE PIPELINE CATALYSTS

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2022 2023
ELI-002 phase 1/2 trial initiation NexoBrid®
US marketing approval
Omidubicel BLA submission Frunexian phase 2 trial initiation
MIJ-821 phase 2 trial readout ELI-002 phase 1/2 trial readout
First ShortcutTM
procedures in humans
Omidubicel US marketing approval
EscharEx®
phase 2 trial readout
APHEXDA US marketing approval
2022
NexoBrid®
BLA submission
NexoBrid®
US/EU expansion
for pediatric
APHEXDA NDA submission Frunexian phase 2 readout
MW005 phase 2 trial readout EscharEx®
phase 3 trial initiation
7 GDA-201 phase 1/2 trial initiation ELI-002 initiation of Regeneron combination study
Nasdaq SPAC -
M&A or acquisition

ANTICIPATING 3 FDA APPROVALS IN 2023

Clinical and regulatory progress in 2023 creates opportunity for new collaborations, potential M&As or IPOs

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Selected Portfolio Companies

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UNIQUE APPROACH TO ACTIVATE THE IMMUNE SYSTEM AND FIGHT CANCER

Private US company in the field of immune therapy

CEO- Robert Connelly; Chairman- Julian Adams; Headquarters- Boston, MA

Elicio develops a disruptive novel approach to activate the immune system. The MIT-originated Amphiphile, or AMP, technology improves the immune response by direct and preferential lymph node-targeting.

ELI-002 is being developed as treatment for cancers driven by KRAS mutations (such as pancreatic and colorectal cancers)

ELI-002 is tested in a single agent Phase 1/2 clinical trial (AMPLIFY-201). Initial safety, dose escalation, and correlative biomarker data is expected in the second half of 2023

ELI-002 will be tested in combination with the anti-PD1 Libtayo® (cemiplimab), under a collaboration with Regeneron, as treatment for KRAS mutated cancers. Study is planned to begin in 2023

The company received a \$2.8 Million Grant from the Gastro-Intestinal Research Foundation (GIRF) to support the development of an AMP platform therapeutic cancer vaccine(s) against the validated cancer targets BRAF and p53

The company's Amphiphile technology based pipeline includes a combination therapy with TCR-T and CAR-T for better efficacy in solid tumors, as well as multiple potent adjuvants

Highlights

  • The Amphiphile Vaccine technology is a novel disruptive approach to unlock the therapeutic power of the immune system
  • ELI-002 phase 1/2 redout is expected in H2/2023
  • ELI-002 combination phase 2 study, with Regeneron's anti-PD1 Libtayo® will begin in 2023
  • The AMP technology has multiple potential implementations such as: cancer treatment, novel vaccines development and improvement of cell therapy
  • Completed round C of \$37M in October 2022

FACTOR XI INHIBITOR FOR THROMBOSIS PREVENTION – AVOIDING BLEEDING RISK

Private US company in the field of anti-coagulation

CEO- Neil Hayward; Chairman- William Koster; Headquarters- Boston, MA

eXIthera develops small molecule Factor XIa inhibitors. Factor XIa is a promising target in the coagulation cascade because it is a major driver of thrombus growth, with a minimal role in haemostasias. The new class of Factor XIa anti-coagulation drugs in development to prevent thrombosis without the increased risk of bleeding complications associated with available anticoagulants.

Frunexian

(EP-7041) is a short acting, potent anti-coagulant with a favorable kinetics Frunexian completed a phase 1 trial in healthy volunteers that showed that IV administration of Frunexian was safe and well tolerated with a predictable dose-dependent increase in aPTT and activity that starts and ends promptly

Frunexian is a short acting, potent anticoagulant with a favorable kinetics profile

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Frunexian phase 2 trial in ICU COVID-19 patients is planned for initiation in Q1 2023

eXIthera signed a strategic agreement with Haisco Pharmaceuticals Group (002653:CH) for the development and commercialization of Frunexian in China

Frunexian is suitable for treatment of various extracorporeal circulation conditions such as ECMO, CABG and dialysis

Highlights

  • Factor XIa inhibitors are a promising new class of anti-coagulants
  • Frunexian is the leading, IV administered, short acting factor XIa inhibitor suitable for use in extracorporeal circulation and beyond
  • Strategic collaboration signed with Haisco for China

Novel tissue repair treatment targeting wound care and severe burns

Nasdaq-traded Israeli company (Nasdaq: MDWD)

CEO- Ofer Gonen; Chairman- Nachum (Homi) Shamir; Headquarters- Yavne, Israel

MediWound develops a pipeline of drugs that target wound care, burns and tissue repair using a proprietary enzymatic technology platform

EscharEx® an enzymatic drug for the treatment of chronic and hard-to-heal wounds due to Venous Leg Ulcers (VLUs) and Diabetes Foot Ulcers (DFUs). Targeting a multibillion \$ market.

  • In phase 2-
  • EscharEx® treated patients achieved a significantly higher incidence of complete debridement, EscharEx: 63% vs. Standard-of-Care: 30%
  • Quick time to debridement over 90% of the patients that achieved completed debridement, did so within 7 days

NexoBrid®

an FDA approved enzymatic orphan drug for burn debridement, marketed in the EU and other territories. US product launch is expected in Q2 2023. US Department of Defense and BARDA strategic agreements of up to \$213 million

MediWound signed an exclusive license and supply agreements with Vericel Corporation (Nasdaq: VCEL) to commercialize NexoBrid® in North America (NA)

Highlights

NexoBrid ® - Treatment for burns

  • FDA Approved
  • Product Launch expected in Q2 2023

EscharEx ® - Wound care treatment

  • Successfully completed Phase 2
  • Pivotal study expected to begin in 2023

Leadership

• Company is structured to meet marketing and development goals

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THE WORLD LEADER IN CORD BLOOD STEM CELL THERAPY

Nasdaq-traded Israeli company (Nasdaq: GMDA)

CEO- Abigail L. Jenkins; Chairman- Robert Blum; Headquarters- Boston, MA

Gamida Cell is pioneering a diverse approach to cellular therapy that utilizes nicotinamide (NAM) to expand multiple cell types, including stem cells and natural killer (NK) cells, while maintaining their original phenotype and potency.

Omidubicel

  • a NAM-enabled stem cell therapy, a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant solution for patients with hematologic malignancies.
  • Phase 3 trial in patients suffering from hematological malignancies that require stem cell transplantation completed; all endpoints were met (rapid engraftment; low rate of infections and reduction in hospitalization days).
  • Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the FDA
  • BLA for US approval was submitted; PDUFA date due in May 1 st 2023

GDA-201

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NK cell-based cancer therapy that leverages the NAM technology;

  • Phase 1 trial in non-Hodgkin lymphoma patients demonstrated significant clinical activity of GDA-201 in combination with rituximab
  • Phase 1/2 trial in R/R lymphoma using a cryopreserved, readily available formulation of GDA-201 in combination with rituximab was initiated in H2/2022

Highlights

Omidubicel

  • Offering transplant solution for patients with hematological malignancies
  • Omidubicel is the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S FDA
  • FDA approval expected in May 2023
  • State of the art manufacturing facility in Israel

GDA-201

  • Novel cryopreserved, readily available NK cells based treatment
  • Clinical benefit demonstrated in phase 1 study
  • Phase 1/2 study in R/R lymphoma is ongoing

Leadership

• Company is structured to meet marketing and development goals

CXCR4 INHIBITOR FOR MOBILIZATION OF HEMATOPOIETIC STEM CELLS TO SUPPORT AUTOLOGOUS TRANSPLANTATION

Private Israeli company in the field of stem cell mobilization CEO- Amnon Peled; Chairman- Laurance Shaw; Headquarters- Rehovot, Israel

Biokine developed APHEXDA (Motixafortide; BL-8040) a CXCR4 antagonist, that was licensed to BioLineRx (Nasdaq: BLRX). APHEXDA, by blocking the CXCR4-SDF1 axis, promotes mobilization and trafficking of hematopoietic stem cells (HSCs), immune cells and cancer cells from the bone marrow and the lymph nodes to the peripheral blood.

APHEXDA

Best-in-class stem

cell mobilizing treatment for autologous stem cell transplantation

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  • developed for mobilization of HSCs for autologous transplantation and as treatment of solid tumors and other hematological malignancies.
    • Phase 3 study in stem cell mobilization to support autologous stem cell transplant completed; all endpoints were met (rapid engraftment; low rate of infections and reduction in hospitalization days)
    • NDA for US approval was submitted; PDUFA date due on September 9 th 2023
    • Completed phase 2 studies as treatment for solid tumors and hematological malignancies, as a single agent and in combination with chemotherapy and immune oncology drug
    • BioLineRx entered into a collaboration agreement with GenFleet Therapeutics to test APHEXDA in pancreatic cancer in China

Highlights

  • APHEXDA is a best-in-class stem cell mobilizing treatment for autologous stem cell transplantation
  • FDA approval expected in September 2023
  • BioLineRx entered into a collaboration with GenFleet Therapeutics for China

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NON-IMPLANT, CATHETER-BASED SOLUTIONS FOR TREATING HEART VALVES

Private Israeli company in the field of heart valve repair CEO- Erez Golan; Chairman- Jacques R. Seguin ; Headquarters- Rehovot, Israel

Pi-Cardia is a global leader in the development of unique non-implant based solutions for treating heart valve repair.

  • Leaflex™ catheter performs mechanical scoring of valve calcification, restoring leaflets' mobility and improving valve hemodynamics. The Leaflex™ catheter is a costeffective, durable standalone treatment.
    • Designed to defer Aortic Valve Replacement (TAVR) in patients who may be too young for the procedure.
    • It can also be used as a preparatory step for improving the outcome of TAVR in heavily-calcified and bicuspid aortic valves
    • Clinical trial is ongoing

ShortCut™ Designed to split the leaflets of a pre-existing valve to enable safe TAVR in patients at risk for coronary obstruction or compromised coronary access.

  • Product targets the currently estimated at \$5 billion TAVR market that is predicted to double over the next five years, with the expansion into lowrisk younger patients
  • Pivotal study is ongoing in EU and US
  • Product is expanded to Mitral Valve splitting

Highlights

  • World leading non-implant heart valve repair devices
  • Addressing high unmet medical need
  • Leaflex™ and ShortCut™ devices are in clinical studies

LeaflexPerformer Next Generation Aortic valve Repair

ShortCut Catheter First Dedicated Leaflet Splitting Solution

NOW IS THE OPPORTUNITY

Let's Talk!

www.cbi.co.il

[email protected]

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3 Azrieli Center | 132 Menachem Begin Tel Aviv, 6701101 | Israel

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