Key Opinion Leaders Call- PLX-R18Hematological Programs

& Acute Radiation SyndromeSeptember 16, 2019

This presentation contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federalsecurities laws. For example, we are using forward-looking statements when we discuss the expected timing of obtaining regulatory approval for our variouspatient trials and clinical data readout, proposed trials that may occur in the future, the timing and implementation of our collaborations with various partnersand the execution of definitive agreements relating to such collaborations and the potential benefits and impact our products could have on improving patienthealth care. These forward-looking statements and their implications are based on the current expectations of our management only, and are subject to anumber of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The followingfactors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and marketrequirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved byregulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may beunable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop withour 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 clinicalsettings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harmrecipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure onpricing resulting from competition, which could cause our actual results or performance to differ materially from those contemplated in such forward-lookingstatements. Except as otherwise required by law, we undertake no obligation to publicly release any revisions to these forward-looking statements to reflectevents or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertaintiesaffecting 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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• Acute Radiation Syndrome (ARS)- Studies conducted and funded by U.S. government (NIH, DOD)- Data for studies conducted under the FDA animal rule suggest the potential of PLX-R18 cells to stimulate

the regeneration of damaged bone marrow to increase survival and produce blood cells, critically needed for this very sick patient population

- FDA has cleared Pluristem’s Investigational New Drug (IND) application for PLX-R18 in the treatment of 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 and Israel− FDA Orphan Drug Designation

Hematological and ARS Programs

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• Cell therapy company focused on Regenerative Medicine• Off-the-shelf placenta-derived cell product candidates• Two ongoing Phase III studies• Publicly listed in Nasdaq and TASE• Favorable safety profile and efficacy data from hundreds

of patients treated worldwide

• Best-in-class cell manufacturing technology producinghighest quality cell products at a commercial scale

• Strong IP portfolio (over 120 granted patents)• Full time employees: 160

Pluristem Therapeutics

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PLURISTEM in one slide

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Placenta

Technology

Allogeneic off-the-shelf

Simple IM administration

Adaptive slow release secretion of cytokines

Long term regenerative effect

Indication ProductCandidate Location Pre-Clinical Phase I Phase II Phase III Funding

Clinical Pipeline

FDA Animal Rule

Critical Limb Ischemia

Intermittent Claudication

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

Key Opinion Leaders CallHematological Programs

Jacob M. Rowe, MD

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• Hematopoietic cell transplantation (HCT), is a standard treatment in various malignant and non-malignant conditions

• Diseases commonly treated with HCT include multiple myeloma, non-Hodgkins lymphoma, Hodgkinsdisease, acute myeloid leukemia, aplastic anemia or thalassemia, as well as non-malignant diseasesand autoimmune disorders

• Transplant patients require extensive care and monitoring, and sometimes need intensive treatmentfor complications

• The current treatment for incomplete hematopoietic recovery after transplantation includesadministration of factors stimulating blood cell growth, such as granulocyte-colony stimulating factor(G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), and erythropoietin.

• A significant number of patients do not respond to current treatment and may require frequenttransfusions, which expose them to transfusion-related risks such as allo-sensitization and infectionsthat are also associated with significant costs

Hematopoietic Cell Transplantation- Overview

Incomplete Hematopoietic Recovery Following HCT Phase I Study - Overview

Design Phase I, Open Label Study

Study population Incomplete hematopoietic recovery persisting at list 3 months following HCT

Countries U.S., IsraelSample size 24 patients

Doses tested for PLX-R18* 1m/kg (n=3), 2m/kg (n=6), 4m/kg (n=15)

Administration IM injections, 2 treatments at 5 days interval

Primary efficacy endpoint Safety

Main Secondary & exploratory endpoints

Change in platelets, hemoglobin and neutrophil level, transfusion frequency/dependency, QoL

Follow Up length 52 Weeks

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* Granted an FDA-Orphan drug designation

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Incomplete Hematopoietic Recovery Following HCT Phase I Study – Overview of 1st and 2nd Cohort

Incomplete hematopoietic recovery persisting at list 3 months following HCTPlatelet ≤50,000/µL and/orHemoglobin ≤8 g/dL and/or

Absolute neutrophil count ≤1,000/µL

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0

20

40

60

80

100

120

140

160

-4 -2 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52

Plat

elet

s (x1

0^3/

uL)

Weeks from treatment

Platelets

Median Cohort 1 Median Cohort 2

PLX 1st PLX 2nd

140-400 x10^3/uL

Platelets 6 months follow up• Median increase of platelets in cohort 1 and cohort 2 was 130% and 170% respectively • A 65% reduction in platelets transfusion was observed compared to last month before

treatment in both cohorts

Incomplete Hematopoietic Recovery Following HCT Phase I Study – Overview of 1st and 2nd Cohort

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6

8

10

12

14

-4 -2 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52

Hem

oglo

bin

(g/d

L)

Weeks from treatment

Hemoglobin

Median Cohort 1 Median Cohort 2

PLX 1st PLX 2nd

11.6-16.4 g/dL

Incomplete Hematopoietic Recovery Following HCT Phase I Study – Overview of 1st and 2nd Cohort

Platelets 6 months follow up• Median increase in hemoglobin levels in cohort 1 and cohort 2 was 34% and 36% respectively • A 68% reduction in RBC transfusion was observed compared to last month before treatment

in both cohorts

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0

1

2

3

4

-4 -2 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52

Neu

trop

hils

(x10

^3/u

L)

Weeks from treatment

Neutrophils

Median Cohort 1 Median Cohort 2

PLX 1st PLX 2nd

1.96-7.23 x10^3/uL

Neutrophils 6 months follow up• A modest response in Neutrophil level was seen in both cohorts

Incomplete Hematopoietic Recovery Following HCT Phase I Study – Overview of 1st and 2nd Cohort

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Recruitment for 1st and 2nd cohort was completed Following DSMB approval 3rd cohort is now enrolling FDA Orphan drug designation approval for incomplete hematopoietic recovery

Incomplete Hematopoietic Recovery Following HCT Phase I Study – Study Status

• Primary endpoint- Safety data –No unexpected toxicities were reported for PLX-R18IM administration of PLX-R18 cells was safe and well tolerated

• Initial results shown in 1st and 2nd cohort, suggest PLX-R18 ability to stimulate the regeneration ofdamaged bone marrow to produce platelets and red cells, critically needed for this very sick patientpopulation and reduce their need of blood transfusions

• The same trend seems to continue even at 9 months of follow-up. Additional data is still collected• Cohort 3, targeting dose of 4 million cells/kg, in now enrolling patients in U.S. and Israel

PLX-R18 Potential Benefits for the Treatment of Hematological Deficiencies

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PLX-R18 may benefit additional bone marrow deficiency syndromes

Benefits of PLX-R18• Multifactorial clinical effect, secretion of range of cytokines in response to patient’s clinical condition• Off the shelf approach, easy administration• Clinical grade, high quality cells• Current clinical data suggest the potential of PLX-R18 cells to stimulate the regeneration of damaged

bone marrow to produce blood cells, critically needed for this very sick patient population and reducetheir need for blood transfusions

Key Opinion Leaders CallRadiation Nuclear Medical Countermeasures

Bert W. Maidment, Ph.D.

Executive ConsultantBWMaidment LLC

Overland Park, Kansas

DisclaimerThe views expressed in this presentation are my own and are neither endorsed by nor do they

represent the opinions of the US Federal Government

Dr. Maidment was the former Assistant Director, Radiation Nuclear Countermeasures Program at the National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division of Allergy, Immunology, and Transplantation (NIH/NIAID/DAIT) until retiring in 2016. He is now consulting for the biomedical and pharmaceutical research and development communities in academia and industry. His expertise spans from basic biomedical research and development, product development, to clinical development. He has experience building start-up companies, industry divisions, and federal government programs. He received his doctorate in Experimental Pathology from the State University of New York at Buffalo, School of Medicine and Biomedical Sciences and performed his research at the Roswell Park Cancer Institute.

Bert W. Maidment, Ph.D.

Types of Radiation Exposure Radiological terrorist

events– RDD (Dirty Bombs)– RED– Food or Water

Contamination Nuclear detonation Accident

– Power Plant Release– Sealed radiological

sources

Health Impacts of Radiation Exposure

Radiation Countermeasure Needs

■Radionuclide Threats• Am-241• Co-60• Cs-137• I-131• Ir-192• Po-210• Pu-238/239• Sr-90• U-235

■ Late Effects• Carcinogenesis• Cardiovascular Disease• Cataractogenesis

■Acute Radiation Syndrome/Delayed Effects of Acute Radiation Exposure (ARS/DEARE)

• Hematopoietic ARS: • Neutropenia• Thrombocytopenia• Anemia• Lymphopenia

• GI ARS• CNS Injury• Cutaneous Injury• Lung Injury• Kidney Injury• Combined Radiation Injury

■Biodosimetry Methods and Devices

Mechanisms of Action―Anti-oxidants―Anti-inflammatories―Anti-apoptotics―Growth factors and cytokines―Cell-based therapies―Others

Radionuclides―Blocking agents―Decorporation agents―Enhancement of mucociliary clearance

Types of Radiation/Nuclear Medical Countermeasures

Neupogen®―Granulocyte Colony Stimulating Factor (GCSF)― Increased NHP survival by ~39%―FDA approved March 2015

Neulasta®―Pegylated Granulocyte Colony Stimulating Factor (peg-GCSF)― Increased NHP survival by ~42%―FDA approved November 2015

Leukine®―Granulocyte-Macrophage Colony Stimulating Factor (GMCSF)―FDA approved March 2018

FDA Approved Radiation/Nuclear Medical Countermeasures

Radiation Countermeasure Gaps

■Acute Radiation Syndromes and Delayed Effects of Acute Radiation Exposure

• Hematopoietic ARS: • Neutropenia• Thrombocytopenia• Anemia• Lymphopenia

• GI ARS• CNS Injury• Cutaneous Injury• Lung Injury• Kidney Injury• Combined Radiation Injury• Vascular Endothelial Cell Injury

Radiation Countermeasure Characteristics

For Public Health Radiation Emergency Incident

• Safety (also in normal healthy subjects)• Efficacy• Mechanisms of action well-understood• Civilian indication: administered 24 hours or more after exposure• Military indication: Pre-exposure prophylaxis and post-exposure• Product approved for other medical indications: • Ease of distribution (SNS or VMI), doctors familiar with use • Ease of administration in mass casualty incident• Stability and Storage• Demographic concerns: pediatric to elderly populations

Pluristem’s PLX-R18 Advantages

- Cellular Product – putative apocrine mechanisms of action- Ease of administration by intramuscular route and potential for auto-

injector technology- Potentially administered by First Responders, sparing health

professional resources during an emergency incident- Efficacy shown in NHPs (FDA’s preferred animal model)- Non-clinical data show increased neutrophil and platelet production- Potential for efficacy in gastrointestinal, kidney and lung radiation

exposures- Clinical safety studies show product is well-tolerated- Development for other medical indications- Maturity of cGMP manufacture

Key Opinion Leaders CallAcute Radiation SyndromeArik Eisenkraft, MD, MHA

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PLX Cells Proposed Mechanism of Action

ARS Projects- Overview

Late Post Exposure

Department of Defense (DOD)Warfighter and Immediate Response

Department of Health and Human Services (DHHS)First Responders and Hospitals

Armed Forces Radiobiology Research Institute

NIAID/NIH

Chronic Phase (Months-Years)Response

Phase

Exposure

Timeline

ResearchInstitutes &

Agencies

Governmental Departments

Initial Response (hours)

Clinical Syndrome

24h

Pre-exposure

Acute Phase (Days-Weeks)

DEARE (Months-Years)ARS (Hours-Weeks)

Early Post Exposure

Monitoring of survival, body weight, blood profile (CBC), BM count, Plasma cytokines

C3H mice irradiation770 RAD Study Design

Bone histology at day 23

PLX-R18 Small Animal Studies Following the FDA Animal Rule

68% Survival Increase29

Placebo - 50%

20M/Kg - 67%

4/10M/Kg - 83/86%

Non irradiated and low radiation - 100%

Legend:

R : RadiatedR-ID: Low RadiationNR : Non-Radiated

R-00 : Not TreatedR-04 : 4 million cells per kgR-10 : 10 million cells per kgR-20 : 20 million cells per kg

PLX-R18 Large Animal study Following the FDA Animal RuleLD30/45

62 irradiated and non-irradiated Rhesus monkeys

Three cell doses:

• 4 M/cells/ Kg

• 10 M/cells/ Kg

• 20 M/cells/ Kg

Safety

Efficacy

35% Survival Increase(LD50)

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Collaboration with Fukushima Medical UniversityEvaluating PLX-R18 cells as a treatment for radiation damage to the GI and BM

0

20

40

60

80

100

120

0 2 4 6 8 10 12 14

Surv

ival

(%)

Days after radiation exposure

w/o irradiation + Vehicle (n=3)

w/o irradiation + PLX-R18 (n=3)

PBI-BM40 (14Gy) + Vehicle (n=8)

PBI-BM40 (14Gy) + PLX-R18 (n=8)

TBI (11Gy) (n=3)

PLX 1st PLX 2nd

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• 30% increase in survival rate and reduced weight loss• Increased white blood cell and platelet counts • Preserve GI stem cells activity and prevent severe damage to the

intestines

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PLX-R18

Placebo

GT3

Saline

PLX-R18

Placebo

GT3

Saline

0 1 0 2 0 3 00

2 5

5 0

7 5

1 0 0

T im e p o s t- ir ra d ia t io n (d a y s )

Pe

rce

nt

su

rviv

al

74%

13%

S a l in e

G T 3

P la s m a -L y te

P L X -R 1 84%

100%

Log-rank test p < 0.0001Log-rank test p = 0.0003

PLX-R18 is Efficacious Upon Prophylactic Treatment (-24 hr)Relevant to first responders who are called to help and rescue victims of an event

50-70% Survival Increase

Pluristem’s PLX-R18 Advantages• Cellular product with apocrine MOA, potentially a multi-organ therapy for ARS: Non-clinical (Mice/NHP) and clinical data show efficacy - increased neutrophil and platelet production

Potential for efficacy in gastrointestinal, kidney and lung radiation exposures

Clinical safety studies show product is well-tolerated

• Ease of administration by intramuscular route and no need for tissue matching• Could be administered by various medical providers including First Responders• Development for other medical indications (BMT, hematological indications, mustard gas injury, trauma…)• Maturity of cGMP manufacture (approved by regulators, breakthrough production means)• Cryopreservation is an advantage when deployment is needed in limited resources setting

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Key Opinion Leaders CallPLX-R18

Yaky Yanay, CEO

PLX-R18 Product Development

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Completion of the development and registration of

PLX-R18 for ARS, targeting government purchase contract

Completion of Phase I study

ARSPrograms

Hematological Programs

FDA- Agreed on the regulatory pathway NIH- Supporting additional mechanism studies• DoD-Further small and large animal studies in

relevant DoD models• BARDA- Government contract, submission by

end of September Large animal study strategically designed

to show the superiority of our product in comparison to current standard of care

Full contract

Recruitment for 1st and 2nd cohort was completed

Following DSMB approval 3rd cohort targeting dose of 4 million cells/kg, in now enrolling patients in U.S. and Israel

• Expansion to additional hematological indications

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

www.Pluristem.com

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Thank you

Slide Number 1Slide Number 2Slide Number 3Slide Number 4Slide Number 5Slide Number 6Slide Number 7Hematopoietic Cell Transplantation- OverviewIncomplete Hematopoietic Recovery Following HCT Phase I Study - OverviewIncomplete Hematopoietic Recovery Following HCT Phase I Study – Overview of 1st and 2nd CohortIncomplete Hematopoietic Recovery Following HCT Phase I Study – Overview of 1st and 2nd CohortIncomplete Hematopoietic Recovery Following HCT Phase I Study – Overview of 1st and 2nd CohortIncomplete Hematopoietic Recovery Following HCT Phase I Study – Overview of 1st and 2nd CohortIncomplete Hematopoietic Recovery Following HCT Phase I Study – Study StatusSlide Number 15Slide Number 16Slide Number 17Slide Number 18Health Impacts of Radiation ExposureRadiation Countermeasure NeedsSlide Number 21Slide Number 22Radiation Countermeasure GapsRadiation Countermeasure CharacteristicsPluristem’s PLX-R18 AdvantagesSlide Number 26Slide Number 27Slide Number 28PLX-R18 Small Animal Studies Following the FDA Animal RulePLX-R18 Large Animal study Following the FDA Animal RuleSlide Number 31Slide Number 32Pluristem’s PLX-R18 AdvantagesSlide Number 34PLX-R18 Product DevelopmentSlide Number 36