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CLAL Biotechnology Industries Ltd. — Investor Presentation 2020
Aug 24, 2020
6730_rns_2020-08-24_e1713d74-45c0-4318-b234-38f74b9eef0c.pdf
Investor Presentation
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CORPORATE PRESENTATION AUGUST 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. For additional information, please refer to Section 1 in the first part of the Company's first quarter for the year 2020 report.
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.
CLAL BIOTECHNOLOGY INDUSTRIES
Leading life sciences investment company traded on the stock exchange (TASE: CBI)

Collaborations with global pharmaceutical companies and major investment funds

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A member of Len Blavatnik's Access Industries group

Portfolio of 7 well-funded biotech companies + a med-tech VC


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


EXPERIENCED MANAGEMENT TEAM

DIVERSE CLINICAL DEVELOPMENT ACTIVITY
| Company | Pre-Clinical | Phase I | Phase II | Phase III | Market |
|---|---|---|---|---|---|
| MediWound 35% (Nasdaq: MDWD) |
severe burns/chronic wounds | ||||
| Gamida Cell 6% (Nasdaq: GMDA) |
cord blood stem cells | ||||
| Biokine 25% |
marrow cells mobilization in cancer | ||||
| Cadent 13% |
CNS disorders | ||||
| eXIthera 45% |
anticoagulation | ||||
| Elicio 20% |
cancer immunotherapy | ||||
| Anchiano 19% (Nasdaq: ANCN) |
oncology |
BALANCED POTFOLIO

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)
- Phase II in aplastic anemia is ongoing
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GDA-201 – phase I in hematological malignancies is ongoing; promising early evidence of clinical activity observed in advanced non-Hodgkin's lymphoma
Completed a \$69 million follow-on (Nasdaq: GMDA) in Q2/2020
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

REVOLUTIONIZING WOUND CARE
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
- 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
- Currently in phase III as a hematopoietic stem cell mobilization agent for autologous marrow transplantation in multiple myeloma
- 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
- Motixafortide is also being developed as a therapy for solid tumors (phase I/II) and for acute myeloid leukemia (phase II)
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 depression; licensing deal with Novartis provides for milestone payments of up to \$386 million, plus royalties; phase II recently completed enrolment
- CAD-9303 for cognitive deficits in 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
\$40 million financing; BD discussions for strategic collaborations An attractive portfolio of products to treat CNS

Robust improvements in spiral drawing in essential tremor patients who responded to CAD-1883 in a Phase 2a trial
Presented at the 3 rd Pan American Parkinson's Disease and Movement Disorders Congress, February 15, 2020
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+ pancreatic and colorectal cancers; phase I/II to start towards the end of 2020
- Pipeline includes a combination with CAR-T for better efficacy in solid tumors
\$48 million financing; BD discussions for strategic collaborations

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 the setting of extracorporeal circulation is 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 5- part complete blood count Marketing ParasightTM for the diagnosis of malaria Significant COVID 19 related opportunities |
Developing innovative anastomosis protection device for colorectal surgery to prevent anastomotic leaks, forgoing the need for a protective colostomy CE Approved device FDA approved IDE (PMA – Class III device) |
Developing LeaflexTM, a novel catheter for treating calcified aortic stenosis without a need for valve replacement; Successfully completed proof of concept in humans Developing the ShortCutTM catheter, for a better TAVR preparation |
Developing OmniCuffTM - a minimally invasive system for rotator cuff repair Excellent clinical outcome in clinical trials and routine use Approved by FDA and EMA |
Developing Face2Gene: AI based technologies 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 the COVID-19 |
LOOKING AHEAD
13 CLINICAL TRIALS ACROSS THE PORTFOLIO
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| Preclinical | Phase I | Phase II | Phase III |
|---|---|---|---|
| 7 preclinical programs | Gamida Cell GDA-201: NHL , multiple myeloma |
MediWound EscharEx: chronic wounds |
MediWound/ Vericel Nexobrid: burns (long term follow up) severe |
| Cadent CAD-9303: schizophrenia |
Biokine/ BiolineRx BKT140/Motixafortide: r/r AML |
MediWound/ Vericel Nexobrid: burns (pediatric) severe |
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| Biokine/ BiolineRx Motixafortide: pancreatic cancer |
Biokine/ BiolineRx Motixafortide: cell mobilization stem |
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| Biokine/ BiolineRx Motixafortide: gastric cancer |
Gamida Cell Omidubicel: cord blood stem cells transplants |
||
| Cadent/ Novartis MIJ821: resistant depression |
|||
| Cadent CAD-1883: spinocerebellar ataxia |
|||
| Gamida Cell Omidubicel: aplastic anemia severe |
|||
| Oncology | |||
| Neuroscience | |||
| Hematology |
Wound care
UPCOMING EVENTS - VALUE CREATING MILESTONES

(*) The above events may be delayed/ cancelled/ otherwise varied in relation to the spread of the COVID-19 pandemic
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Clinical Regulatory Financial Business
READY TO MATERIALIZE


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