Proprietary data of Pluristem Therapeutics Inc.1 Advancing cell therapeutic products for clinical use

Proprietary data of Pluristem Therapeutics Inc.1

Advancing cell therapeutic products for clinical use


This presentation concerning Pluristem Therapeutics may include forward-looking statements which represent Pluristem Therapeutics' expectations or beliefs regarding future events. I caution that such statements involve risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements. Consequently, all such forward-looking statements are qualified by the cautionary language and risk factors set forth in Pluristem Therapeutics' periodic and other reports filed with the SEC.

There can be no assurance that the actual results, events or developments referenced in such forward-looking statements will occur or be realized. Pluristem Therapeutics assumes no obligation to update these forward-looking statements to reflect actual results, changes in assumptions or changes in factors affecting such forward-looking statements.

www.pluristem.com

Forward Looking Statement


• Cell therapy (Biotechnology) company.

• Using off the shelf placental expanded cells to achieve local and

systemic therapeutic effect.

• First in class 3D cell culturing technology allowing for efficient,

controlled production of different cell products in commercial

quantities.

• Active with regulators in USA, EU, South Korea, Australia and Israel.

Pluristem Corporate Overview


• Public company, Traded in:

• Strong balance sheet• Market Cap: ~ $100 million• Cash and marketable securities: $47 million (September 30, 2015)• No debt• Net burn: ~ $22 million• No royalty liability (other than Israeli government) • 165 employees (16 PhD, 4 MD)• IP Ownership: over 50 granted patents and ~150 pending

applications

Financial Glance

PSTI PSTI/ PLTR


Partner Indication Deal structure

IC, CLISouth Korea only

Joint Venture following marketing authorization by the South Korean authorities

Pluristem keeps IP and manufacturing rights in all collaborations

Collaborations

Government Partnership Indication Deal structure

Acute Radiation Syndrome U.S. National Institutes of Health (NIH) to Support Development of PLX-R18

Acute Radiation Syndrome

Pluristem will contribute cells and scientific knowledge, FMU will conduct the studies and provide the required resources.


The PLX Technology


Placenta derived cells• Rich & Diverse• Highly potent - pro-angiogenic - immunoregulatory

• Young donors • Unlimited source• Easy to collect • Ethically accepted• Over 20,000 Doses of 300

million cells per placenta

The Placenta Project- Launched by the US National Institutes of Health (NIH) to Further explore the role of the placenta in health and disease.


3D manufacturing 150,000 doses annually


Culture conditionsPLX-R18Hematological

PLX-PADAngiogenesis

Culture conditions

VEGFIL-10

IL-6bFGF

BDNF

TGFβM

MP-9

NGF

PLX-CNSNeuronal

PLX-IMMUNEImmunological

Human Placenta- A platform for cell products

Culture conditionsCulture conditions


• Broad platform with tailored products per indication• PLX cells can be customized to secrete a specific cytokine

secretion profile to target different indications• Real off the shelf product requiring no additional manipulation

at bedside

• Unique Immunological Properties• No HLA- matching required• Low immunogenicity confirmed :• PLX does not induce in vivo priming of Th1 responses • Repeated IM injections of PLX cells from the same placenta

does not induce patients memory T-cells activation.

• Distinctive MOA• Products demonstrate both local and systemic efficacy via

intramuscular injection

How is PLX Different from the Competition


• Superior Manufacturing• In-house manufacturing which guarantees batch to

batch consistency and high margins

• Near Term Product Approval• First product approval expected 2018 for CLI

How is PLX Different from the Competition


Product 1: PLX-PAD• Reduces inflammation• Stimulates growth of collateral blood vessels• Stimulates repair f damaged muscle


Demonstrated clinical safety and significant efficacy in 3 clinical studies (Two Phase I and one Phase I/II study)

• Muscle Injury following Total Hip Replacement (N=20)

PLX-PAD- Strong Clinical Data

Improvement of 500%

P=0.0067

-10-505

1015202530

Placebo

Time (Weeks)

Change in Volume

from Day 0

6 12 26

150M vs. Placebo : p=0.0040

-20-15-10-505

1015202530

Placebo150M PLX-PAD

6 12 26

150M vs. Placebo p=0.0114

Time (Weeks)

-15-10-505

10152025303540

Placebo150M PLX-PAD

Time (Weeks)6 12 26

150M vs. Placebo : p=0.0067

Injured (operated) Contralateral (non–operated)


Demonstrated clinical safety and significant efficacy in 3 clinical studies (Two Phase I and one Phase I/II study)

• Two Phase I/II Critical Limb Ischemia (N=27)

Pre-Treatment 8 Weeks After TreatmentPre-Treatment

8 Weeks After Treatment

PLX-PAD- Strong Clinical Data

6-8 month follow-up


PLX PAD in CLI via new regulatory pathways

European initiative intended to grant earlier access to drugs meant to treat debilitating and/or life-threatening diseases with unmet medical need.

May 2015 - PLX-PAD cells have been selected for the project. Manufacturing facility approved and inspected by European Qualified Person

for Phase III and marketing. Earlier entry in a multi-billion market (2018)- Conditional marketing approval

in selected population of CLI patient following Initial Phase II study, then post-marketing extension to more CLI patients.

Pluristem intends to expand development of PLX-PAD to additional indicationsvia the Adaptive Pathway project

Pluristem is committed to provide early access of PLX-PAD to Critical limb ischemia (CLI) patients all over the world

Europe - Adaptive Pathways pilot project

1.7 M patients in the major pharmaceutical markets*. Expected to reach 2M in 2020. Two Phase I data with PLX-PAD in CLI patients showing good safety profile and efficacy. Safety data from 150 patients enrolled into IC study to support initial approval in CLI.

*U.S., France, Germany, U.K., Italy, Spain and Japan.

Phase II Trial* Conditional MA*

2016 2017 2018 2019 2020 2021

Collection of real-world Data from treated patients** Full MA

Phase II Trial Two Phase III Trials Full MA

Adaptive Pathways

Traditional Pathway

MA = marketing authorization*Can start marketing product in restricted, niche population**Additional studies in broader population of CLI patients

Target 2018 Product Launch

2021 Traditional Product Launch


New Japanese regulations to accelerate development of drugs in the field of regenerative therapy.

Conditional, time-limited approval for marketing and reimbursement upon proof of safety and a signal of effectiveness. No formal Phase III trial is expected to be required.

April 2015- PLX-PAD quality standards and large-scale manufacturing methods accepted by PMDA.

August 2015- PLX-PAD cells cleared by PMDA for use in clinical trials in Japan.

Pending approval of clinical study design to initiate a Phase II study during H1 2016.

Japan - Accelerated Pathway for Regenerative Medicine

PLX PAD in CLI via new regulatory pathwaysPluristem is committed to provide early access of PLX-PAD to

Critical limb ischemia (CLI) patients all over the world 1.7 M patients in the major pharmaceutical markets*. Expected to reach 2M in 2020. Two Phase I data with PLX-PAD in CLI patients showing good safety profile and efficacy. Safety data from 150 patients enrolled into IC study to support initial approval in CLI.

Conditional MA**

Collection of data from treated patients*** Full MA

Additional Trials to Confirm Safety & Efficacy Full MA

Pathway for Regenerative Medicine

Traditional Pathway

Initial Clinical Study

Exploratory Study*

MA = marketing authorization* If results likely to predict efficacy and confirm safety then conditional, time-limited marketing authorization granted; no confirmation of efficacy needed.** Time limit of 7 years till full MA or withdrawal***Post-marketing safety-monitoring, surveillance and studies

Initial Clinical Study

Target Early Product Launch

Traditional Product Launch


Product 2: PLX-R18• Stimulates regeneration of damaged bone

marrow to produce blood cells (white, red and platelets)

PLX-R18 Pipeline:


PLX-R18 - Targeting Bone Marrow Failure

Main clinical manifestations of low blood counts: Neutropenia: recurrent or severe infections Anemia: fatigue, shortness of breath, pallor, tachycardia Thrombocytopenia: bruising, purpura, petechiae, bleeding

• Bone Marrow Transplant Failure / Incomplete Engraftment FDA IND application approved for Phase I study in the US

• Acute Radiation Syndrome (ARS) – Supported by the NIH (NIAID) Animal Rule pathway Two significant animal trials announced Preparing to submit protocol for large animal trial

• Potential indications include- Chemotherapy, Aplastic Anemia (AA), Acute myeloid leukemia (AML), Myelodysplastic syndrome (MDS)


U.S. National Institutes of Health to Support Development of Pluristem's PLX-R18

Collaboration for ARS with US Government


CMC & Manufacturing Facility for PLX-PAD approved by FDA,

German, EU, South Korean, Japanese & Israeli Regulatory Agencies for 3D culturing for

Phase II, III trials and marketing


IC

CLI-EuropeCLI-JapanOrthopedic Indication

PAH

Preeclampsia

Hematology

ARS

End of enrollment


Company milestonesH1-2016 H2-2016 H1-2017 H2-2017 H1-2018 H2-2018indication

End of enrollment

Data Readout

Licensing deal

Study initiation

Initial approval

Data Readout

End of enrollment

Data Readout

Study initiation

Conditional approval

We will seek to include the indication under the Adaptive licensing pathway- based on discussion with EMA

Pivotal study

Data Readout

BLA application

Conducting additional pre-clinical studies based on discussions with FDA

Product

PLX-

PAD

IND Study initiation

End of enrollment

Data Readout

Adaptive or phase

II/III

PLX-

R18

End of follow up Cohort 2


Zami AbermanChairman & CEO

Efrat Livne-Hadass VP Human Resources

Racheli Ofir, Ph.D.VP Research & Intellectual Property

Sagi MoranVP Operations

Erez Egozi VP Finance

Karine Kleinhaus, M.D., MPHDivisional VP, North America

Yaky YanayPresident & COO

Hillit Mannor Shachar, M.D., M.B.A.VP Business Development

Lior RavivDirector of Development

Esther Lukasiewicz Hagai, M.D., Ph.D. VP Clinical & Medical Affairs

Orly AmiranVP Quality Assurance

Management Team


Documents

Proprietary data of Pluristem Therapeutics Inc.1 Advancing cell therapeutic products for clinical use