Company Presentation February 2020 Forward looking Statement This - - PowerPoint PPT Presentation

Company Presentation

February 2020

This presentation contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, we are using forward-looking statements when we discuss the expected timing of obtaining regulatory approval for our various patient trials and clinical data readout, proposed trials that may occur in the future, the timing and implementation of our collaborations with various partners and the execution of definitive agreements relating to such collaborations and the potential benefits and impact our products could have on improving patient health care. These forward-looking statements and their implications are based on the current expectations of our management only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with

• ur process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical

settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause our actual results or performance to differ materially from those contemplated in such forward-looking

• statements. Except as otherwise required by law, we undertake no obligation to publicly release any revisions to these forward-looking statements to reflect

events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting us, reference is made to our reports filed from time to time with the Securities and Exchange Commission

Forward looking Statement

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• Cell therapy company focused on Regenerative Medicine
• Several Off-the-shelf placenta-derived cell product candidates
• Two ongoing Phase III studies in ischemia associated with

diabetes complications and in muscle regeneration

• Favorable safety profile and efficacy data from hundreds of

patients treated worldwide

• Best-in-class cell manufacturing technology producing highest

quality cell products at a commercial scale

• Strong IP portfolio (over 120 granted & allowed patents)
• Publicly listed in Nasdaq and TASE
• Cash and cash equivalents ~$17.5 million (as of Dec. 31, 2019)
• Full time employees: 150

Pluristem Therapeutics

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 Complexity of the disease

Innovative treatments are needed to treat complex diseases

The Economic Impact

Some of the world’s largest economies are now facing subsequent increases in health-care costs.

The Human Impact

Aging is often associated with debilitating medical conditions, many of which are still unmet needs.

 Longer lifespans

Lifespan has increased significantly, Nearly 2 billion people across the world are expected to be over 60 years old by 2050 (World Health Organization)

The Need for Cell Therapy

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Placenta-Derived Cells

• Ethically accepted
• Rich & diverse
• Pro-angiogenic & Immunoregulatory
• Young donors
• Unlimited source & easy to collect
• Ability to manufacture treatments for
• ver 20,000 patients per placenta

The Placenta Project was Launched by the US National Institutes of Health (NIH) in 2013 to further explore the role of the placenta in health and disease

http://www.the-scientist.com/?articles.view/articleNo/43618/title/The-Prescient-Placenta/

Marketing-ready Industrialized Technology Platform

Manufacturing Process Approved by:

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• State-of-the-art,

proprietary bioreactor system which provides a 3D micro-environment for cells that mimics the human body condition

• Controlled,

automated, efficient and scalable manufacturing technology

• Marketing

ready, cost effective industrialized platform

• Controlling the conditions within our bioreactors

allows us to produce several unique patented products

PLURISTEM

in one slide

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Placenta Technology Allogeneic

• ff-the-shelf

Simple IM administration Adaptive slow release secretion of cytokines

Long term regenerative effect

Indication Product Candidate Location Pre-Clinical Phase I Phase II Phase III Funding

Clinical Pipeline

via FDA Animal Rule

Critical Limb Ischemia Intermittent Claudication Muscle Regeneration following Hip Fracture Acute Radiation Syndrome* PLX-PAD PLX-PAD PLX-PAD PLX-R18 Graft Versus Host Disease PLX-PAD Incomplete recovery following bone marrow transplantation PLX-R18 U.S., Europe Israel U.S., Europe South Korea, Israel U.S., Europe Israel U.S. Israel U.S., Israel

* FDA Orphan Drug Designation

*

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• Extensive pre-clinical data in various indications; such as ischemic stroke, TNBC, CNS

PLX-PAD Peripheral Arterial Disease

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• CLI is caused by fatty deposits in leg arteries that obstruct blood flow
• Risk factors include smoking, diabetes, obesity, cardiovascular problems and hypertension
• CLI patients suffer from severe pain, skin wounds, tissue necrosis and poor quality of life
• High risk of leg amputation and death
• Up to 35% of patients are unsuitable or will not benefit from revascularization

Peripheral Arterial Disease - Critical Limb Ischemia (CLI)

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PLX-PAD is designed to treat CLI by reducing inflammation and stimulate the growth of blood vessels to bring oxygenated blood to ischemic tissue

5 Year Mortality Rate Inpatient & Outpatient Treatment Costs by Rutherford Category

Clinical Development in Peripheral Arterial Disease

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• Completed two Phase I studies in CLI- U.S. & Germany (N=27)

 Good safety profile  Increase in tissue perfusion, 60% reduction in the risk for death or amputation  Dose identification- two treatments of 300 million cells, two months apart

• Completed Phase II study in intermittent claudication (IC)- U.S., Germany, S. Korea & Israel

 Good safety profile  Significant increase in walking distance , reduction in surgical events and HbA1c and CRP levels  Confirmation of Phase III design including- dose (300m cells), dose regimen (2 administrations)

• Ongoing Phase III study in CLI- U.S., Europe & Israel (N=246)

 Completed enrollment of half of the study’s population (n=123) in April 2019. EU Adaptive Pathways Program allows for an interim analysis following 12 months follow-up, which may allow for conditional marketing approval in Europe

(N=172)

Ongoing CLI Phase III Study - Overview

Design Phase III, randomized, Double-Blind, Placebo-controlled (2:1) Study population CLI subjects with minor tissue loss, unsuitable for revascularization Countries Germany, UK, U.S., Poland, Hungary, Czech republic, Bulgaria, Macedonia, Israel Sample size 246 patients Doses tested 300M cells vs. Placebo (randomization ratio 2:1) Administration IM injections in the affected leg, 2 treatments at 8-week interval Primary efficacy endpoint Time to occurrence of major amputation of leg or death (AFS) Main Secondary & exploratory efficacy endpoints Composite efficacy endpoint; Pain; Complete wound healing; Quality-of-life; Adjudicated amputations; TcPO2; cytokine levels Follow Up length 52 Weeks

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€ 7.6 million grant from the EU Horizon 2020 program

Disclaimer: The results presented above are a small sample of the ongoing trial, chosen by the principal investigator, and are not representative of the full trial population. These results may not be typical and could be materially different from the results reported at the completion of the trial. Investors are cautioned to consider this sample data at their own risk.

Before 1st treatment Before 2nd treatment

Patient #1 Patient #2

After 1 year FU

Patient #3

Ongoing CLI Phase III Study

• CLI Expanded Access Program

cleared by FDA to enroll patients unsuitable for inclusion in the

• ngoing Phase 3 clinical trial
• Program to enroll an initial 100

CLI Rutherford Category 5 patients

• FDA approved cost recovery for

the treatment

CLI Expanded Access Program (EAP)

PLX-PAD Muscle Regeneration

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PLX-PAD is designed to stimulate muscle regeneration – gain muscle strength and volume

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There are currently no approved treatments for post-operative regeneration of injured or weak skeletal muscle

* Source: Simran Mundi, Bharadwaj Pindiprolu, Nicole Simunovic, Mohit Bhandari

Muscle Regeneration Following Hip Fracture

• Hip fracture often results in serious long-term complications,

including pain, functional decline and disability

• Up to 30% of hip fracture patients die within 1 year due to

immobility associated diseases

• Annual treatment costs in the U.S. are between $10 to $15

billion, and are expected to rise due to aging population

• Attributable costs for hip fracture are $80,000, demonstrating

the cost burden of long term care after fracture

Contralateral (non–operated)

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Muscle Regeneration

Phase I/II Study of PLX-PAD for Muscle Injury Following Total Hip Replacement (N=20)

Change in Volume Improvement of 300% P=0.004 Change in Strength Improvement of 500% P=0.0067 Change in Strength Improvement of 4000% P=0.012

• PLX-PAD demonstrated a significant increase in muscle strength & volume

compared to placebo

• First study to show efficacy of cell therapy in skeletal muscle injury

Ongoing Muscle Regeneration Phase III Study

Design Phase III, randomized, Double-Blind, Placebo-controlled Study population Patients suffering from muscle injury following arthroplasty for hip fracture Countries U.S., Germany, UK, Denmark, Israel Sample size 240 patients Doses tested 150M cells vs. Placebo (randomization ratio 1:1) Administration IM injections in the operated leg on the day of surgery Primary efficacy endpoint Short Physical Performance Battery (SPPB) score at week 26 Main Secondary & exploratory efficacy endpoints Muscle strength, muscle mass & volume, hospitalization time, lower extremity measure Follow Up length 26 (efficacy), 52 weeks (safety)

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€ 7.4 million grant from the EU Horizon 2020 program

PLX-R18 Hematological Deficiencies

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• Acute Radiation Syndrome (ARS)
• Studies conducted and funded by U.S. government (NIH, DOD)
• FDA has cleared Pluristem’s Investigational New Drug (IND) application for PLX-R18 in the treatment
• f ARS in case of nuclear events
• FDA Orphan Drug Designation
• Phase I - Incomplete Hematopoietic Recovery Following

Hematopoietic Cell Transplantation (HCT)

• N= 24
• Open-label trial, allows for interim data analysis
• Clinical sites in U.S & Israel
• FDA Orphan Drug Designation
• Data from first two cohorts showed PLX-R18 led to increased production of

platelets & red blood cells, ultimately reducing the number of required transfusions

Hematological Programs

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PLX-R18 is designed to stimulate the regeneration of damaged bone marrow to produce blood cells (white, red and platelets)

Acute Radiation Syndrome (ARS) – The Need

ARS occurs following acute exposure to very high levels of radiation and involves severe lethal injuries to the bone marrow as well as to other organs and systems within the body

• Screening- PLX-R18 release a combination of therapeutic proteins in response to the patient’s

needs and doesn’t require pre-screening

• Treatment in mass casualty event- PLX-R18 can be quickly administered by simple

intramuscular injections and does not require genetic or tissue matching, suitable to treat large number of victims exposed

• Comprehensive therapy- currently approved MCMs are all myeloid colony stimulating factors

(increase white blood cells only), and may lead to severe side effects. PLX-R18 stimulates the regeneration of all three blood lineages

PLX-R18 as Treatment for ARS (via the FDA Animal Rule)

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Series of studies conducted by the U.S. National Institutes of Health (NIH), testing PLX-R18 as a potential treatment for ARS

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Regulatory support Governmental agencies collaborators

Significant Regulatory and Government Support

Targeted projects in the coming year

Pluristem keeps IP and manufacturing rights in all collaborations

Partnerships and Collaborations

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Zami Aberman Executive Chairman Efrat Livne-Hadass VP Human Resources Racheli Ofir, Ph.D. VP Research & Intellectual Property Chen Franco-Yehuda CFO Yaky Yanay President & CEO

Management Team

Efrat Kaduri Director of Marketing & Business Development Lior Raviv VP Operations & Development Orly Amiran VP Quality Assurance

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Liran Shani, M.D. Acting VP Clinical & Medical Affairs

Investor.relations@Pluristem.com Israel +972-74-710-8600 U.S. +1-347-973-2098 www.Pluristem.com

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