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Company PresentationPAD KOL Day- December 14, 2018

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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Critical Limb Ischemia

CLI CONSTITUTES THE MOST ADVANCED STAGE OF CHRONIC PERIPHERAL ARTERIAL DISEASE (PAD) AND INCLUDES REST PAIN AND ISCHEMIC FOOT LESIONSCLI IS CAUSED BY FATTY DEPOSITS IN LEG ARTERIES

THAT OBSTRUCT BLOOD FLOWRISK FACTORS INCLUDE SMOKING, DIABETES, HEAVY

WEIGHT, CARDIOVASCULAR PROBLEMS & HYPERTENSION

The problem

Chronic CLI, defined as > 2 weeks of rest pain, ulcers, or tissue loss attributed to arterial occlusive disease

Associated with great loss of both limb and life

Major amputation and death are the ultimate consequences of CLI, and a 1-year amputation rate of 15-25% is commonly reported, while amputation & mortality rate ranges 30-40%

Goals of therapy Reducing cardiovascular risk factors, relieving ischemic pain, healing

ulcers, preventing major amputation, improving quality of life and increasing survival

Wounds 5 Year Mortality vs Cancer

90

70

100

50

10

0

Perc

ent (

%)

30

80

60

40

208

18 18

45 47 4855

64

86

97

How do we fix CLI

The single evidence-based recommendation for treatment is revascularization

Does everyone do well with this? (1,3,4)

NO

How do we fix CLI

1414 patients had PVI; 71% with tissue loss

1-year – survival 80%, amputation free survival 71%, and freedom from major amputation were 81%,

Determinants of survival and major amputation after peripheral endovascular intervention for critical limb ischemia; Vierthaler, Luke et al. Journal of Vascular Surgery , Volume 62 , Issue 3 , 655 - 664.e8

The “tried and true” and why we are trying something new!

Prevent III Data 1 year survival 84% 1 year primary patency

61% 1 year primary assisted

patency 77% 1 year secondary patency

80% 1 year limb salvage 88%

Nov 2001 – Oct 2003 – 1404

patients with CLI were

randomized – 1 year f/u, 75% had tissue loss

What are we doing about this….

Predicting bad outcomes

Predictors of poor open surgery outcomes

Dialysis dependency

Tissue loss

Age >75

Anemia (hematocrit <30%)

Advanced coronary artery disease

Predictors of poor endoluminal therapy

outcomes Current smoking

High modified PREVENT III score

Poor preoperative ambulation status

High MACEs

Discharge disposition SNFA. Schanzer, J. Mega, J. Meadows, R.H. Samson, D.F. Bandyk, M.S. ConteRiskstratification in critical limb ischemia: derivation and validation of a model to predict amputation-free survival using multicenter surgical outcomes dataJ Vasc Surg, 48 (2008), pp. 1464-1471. Schanzer, P.P. Goodney, Y. Li, M. Eslami, J. Cronenwett, L. Messina, et al.Validation of the PIII CLI risk score for the prediction of amputation-free survival in patients undergoing infrainguinal autogenous vein bypass for critical limb ischemiaJ Vasc Surg, 50 (2009), pp. 769-775

J Vasc Surg. 2015 Dec;62(6):1555-63. doi: 10.1016/j.jvs.2015.06.228. Epub 2015 Sep 26.Objective performance goals after endovascular intervention for critical limb ischemia.Davies MG1, El-Sayed HF2

Who needs more?

85% of patients get

a revascularization15%

are notcandidates for

revascularization

20% of patients

don’t benefit

How can we save limbs with CLI?

What we need to look at: Hyperbaric Oxygen Intermittent compression Spinal chord stimulation Medications Gene therapy Stem cell therapy Allogeneic

NOT GREAT

MAYBE A CURE

A Cure – Really?

Gene TherapyGene therapy utilizing growth factors, Vascular EndothelialGrowth Factor (VEGF), Fibroblast Growth Factor (FGF) andHepatocyte Growth Factor (HGF), has been investigated inmostly smaller clinical trials, with varying success withregard to the major efficacy endpoint, amputation-freesurvival (AFS).

A Cure – Really?

Cell therapy The potential benefit of cell therapy is that cell secretion is

multifactorial and therefore not based solely on a single growth factor.

Initiated by a Japanese study (11) comparing bone-marrow-and peripheral blood mononuclear cells (PBMC) injected into the limb muscles of patients with PAD, several cell-based studies have been performed, specifically in CLI patients with no option for revascularization.

Though the majority of studies have utilized intramuscular injections of the growth factor, the largest trial treated with with intra-arterial infusions of bone-marrow mononuclear cells

At 6 months there was no difference in the rate of major amputation

A Cure – Really?

Autologous or allogeneic cell utilization From an immunological point of view, autologous cell treatment

may theoretically provide an immunological advantage. Nevertheless, it has been shown that cells harvested from older

individuals, and in particular those with cardiovascular riskfactors or critical limb ischemia, are reduced in number andfunctionality

Furthermore, harvesting autologous cells from bone marrowinvolves an invasive procedure, while peripheral blood utilizationrequires granulocyte colony stimulation factor (G-CSF) treatmentthat potentially may cause harm due to the high white bloodcell content that is developed

A Cure – Potential Solution

PLX-PAD- Allogeneic Cell Therapy PLX-PAD is a cell therapy product, composed of placental

expanded adherent stromal cells. While PLX-PAD cells exhibitmembrane marker expression typical of classicalmesenchymal stromal cells, they have a minimal ability todifferentiate in vitro into cells of mesodermal lineage.

Allogeneic MSCs have been shown to exhibit lowimmunogenicity thus, utilizing allogeneic younger, morepotent cells, rather than treatment with cells harvested fromthe diseased patients themselves, therefore should be ofbenefit.

In this respect PLX-PAD cells from young healthy placentaltissue has the potential for higher efficacy than previouslyseen with autologous cell products.

Therapeutic Development for CLI

Single Chemical

Compound

Autologous Cell Therapy

Single Biological Compound Cocktail of

Chemical / Biological

compoundsHGF FGFVEGF

CD34

Bone Marro

w

Allogeneic Cell Therapy

Disease ComplexityComplex diseases

requires adaptive multi-factorial treatments

Healthy donor, young cells; Immediate availability of cell

Non-limited quantity Consistent cell quality and

standardization Immuno-privileged

PLX-PAD Mechanism of Action

Live Cellvizio imaging following IV administration of FITC labeled Dextran in Hind Limb Ischemic

Preclinical Model

Placebo

PLX-PAD treated

Placebo PLX-PAD

Day 21

Day 0

PLX-PAD increase tibia blood flow in vivo

Clinical Development Status -PLX-PAD in PAD

• Two completed Phase I/II studies in CLI in U.S. and Germany, N=27

• Appropriate safety profile

• Positive trends of efficacy (pain reduction and increase in tissue perfusion), defining inclusion/exclusion criteria for pivotal studies

• Dose identification: two treatments of 300 million cells, two months apart• Completed multinational Phase II study in intermittent claudication (IC) - U.S., Germany, S. Korea and

Israel, N=172 • Appropriate safety profile• Increase in Maximal Walking Distance • Reduce number of surgeries • Significant reduction in HbA1c and CRP levels• Confirmation to the phase III design including: dose (300m cells), dose regimen (2 administrations),

safety• Ongoing multinational Pivotal Phase III study in CLI in U.S., Europe and Israel N=246

• Primary endpoint- time to event (amputation or death)• Dosing regimen: 2 treatments of 300 million cells, two months apart

• Amputation Free Survival at 6 months:

• US (total n=12) - 100%

• Germany (total n=15) - 93%• Comparison to published data on no-option CLI:

‒ TASC II: 20% death and 40% major amputations in 6m

‒ TAMARIS (n=259 control pts.): 76% AFS in 6m (196/259)

‒ Meta-analyses (Benoit 2011, Weems 2015): 67%-77% AFS at 6m ‒ The majority of events usually occur in the first 6m

Phase I/II CLI Clinical Trials – PLX-PAD

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Hemodynamic Efficacy Parameters

• Improvement of the quality of life within the first 3m• Higher improvement at 2 weeks repeated dosing• Improvement in quality of life maintained for 12m

Increase of mean TcPO2

• Improvement of TcPO2 - after 1 month• Earlier and higher improvement at 2 weeks repeated dosing• Improvement in TcPO2 maintained for 24 months in German study

Reduction of Pain Score (VAS)USA Germany

• Overall pain decrease at month 3 • Most notable decrease with repeated dose

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Phase II IC Study PLX-PAD-MWD 300-300 Million Group

* p = 0.032, 0.014** p = 0.019, 0.015*** p = 0.044, 0.017

At least 1 RevascularizationEvent n (%)

PBO-PBO(N=50)

300M-PBO(N=37)

150M-150M(N=37)

300M-300M(N=48)

300M-300M(N=11)

2 DonorsWeek 65 6 (12.0) 6 (16.2) 7 (18.9) 3 (6.3) 0 (0)

Hazard Ratio* 1.50 1.64 0.51 NA95% CI 0.48, 4.66 0.55, 4.88 0.13, 2.05p-value 0.485 0.376 0.345

Odds Ratio** 1.52 1.77 0.49 NA95% CI 0.36, 6.36 0.45, 7.15 0.07, 2.49p-value 0.716 0.515 0.527

Phase II IC Study PLX-PAD-Clinically driven Revascularization by Week 65

PBO-PBO(n=51)

300-300(n=48)

Major amputations 3.9 % 0 %

Malignancies 7.8 % 2.1 %

Infections 33.3 % 33.3 %

Peripheral vascular disorders 29.4 % 22.9 %

Cardiac disorders 9.8 % 6.3 %

Renal disorders 9.8 % 6.3 %

Ophthalmologic disorders 11.8 % 4.2 %

Phase II IC Study PLX-PAD-Favorable Safety Profile

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 patientsDoses tested 300M cells vs. Placebo (randomization ratio 2:1)

Administration IM injections in the affected leg, 2 treatments, at 8-week intervalPrimary 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 12 months

Before

Area:1.4cm²

8 Weeks After

Area:0 cm² Full Wound Closure

Area:4.3 cm² Area:0.2cm²Reduction of

96%

Ongoing Phase III CLI Study

Before

Area:9.8 cm²

8 Weeks After

Area:0.5cm²Reduction of 95%

Area:6.8 cm² Area:3.1 cm²Reduction of

54%

Ongoing Phase III CLI Study

Where is the need ?

14 days after failed bypass surgery Or non progression of healing or actual failure

This RX may be a common adjunct

2 weeks after failed percutaneous revascularization Should check PVRs – TCPO2 – 1 week after procedure

Patients without target vessels in the foot

Non ambulatory but alert and oriented patients With no target vessels

Other co morbidities

LARGER THAN THE CURRENT

TRIAL

PERIPHERAL ARTERY DISEASE (PAD& CRITICAL LIMB ISCHEMIA (CLI)

PREVALENCE, ECONOMIC COST AND MARKET OPPORTUNITY

Mary L. Yost, M.B.A. President THE SAGE GROUP LLC Research and Consulting

PERIPHERAL ARTERY DISEASE (PAD)

2015 U.S. PREVALENCE OF

SELECTED CHRONIC DISEASES(Millions)

Source: Alzheimer’s Assoc, American Cancer Society, American Heart Association, Heidenreich PA. Circulation 2011;123:933-44, Menke A. JAMA 2015; 314:1021-9 and Yost ML. CLI Suppl 2016 THE SAGE GROUP.

PAD: THE IGNORED CARDIOVASCULAR DISEASE

UNDERESTIMATED

UNDERDIAGNOSED

UNDERTREATED

MORBIDITY, MORTALITY & COSTS

Source: Yost ML. PAD Vol. I THE SAGE GROUP 2003.

U.S. COMPARISON OF PAD ESTIMATES

YEAR CRIQUI/PARTNERS

(Mill)

DIABETES METHOD

(Mill)

NEHLER

(Mill)

1995 8-12 11 13

2015 11-18 20 18

Source: Criqui MH. Circulation 1985; 71:510-15, Nehler MA. J Vasc Surg 2014;60: 686-95 and Yost ML. CLI US epidemiology supplement 2016 THE SAGE GROUP.

AGE & DIABETESSIGNIFICANT PAD RISK FACTORS

PAD Prevalence ↑ with AgeAge 40-59 = 3%Age 70+ = 19%

Diabetes & PAD Population Age 50 + PAD Prevalence 10% to 20% in Normal GlucosePAD Prevalence 30% to 40% in DM

Yost ML. CLI Vol I & II Atlanta, GA. THE SAGE GROUP; 2010. Criqui MH. Circulation 1985; 71:510.

U.S. PAD PREVALENCE 2015-2030

(Millions)

Source: Yost ML. CLI US epidemiology supplement 2016. THE SAGE GROUP.

AGING & DIABETES DRIVING GLOBAL PAD GROWTH

Source: UN Population Division and International Diabetes Federation.

PAD WORLDWIDE ESTIMATES

164 Million 2000

202 Million 2010

24% due to Aging

Source: Fowkes FGR. Lancet 2013; 382(9901): 1329-40.

PAD COUNTRY/REGIONAL PREVALENCE

(Millions)

COUNTRY/REGION 2015

CHINA 42-60

INDIA 41-54

WESTERN EUROPE 29

UNITED STATES 20

SOUTH AMERICA 16

JAPAN 10

MEXICO 5

TOTAL 163-194

Source: Yost ML. CLI US Supplement 2016, Yost ML. PAD & CLI W Europe 2017, Yost PAD & CLI Japan 2017, Yost ML. China PAD & CLI 2017, Yost ML. India PAD 2018, Yost ML. South America Diabetes & PAD 2013 and Yost ML. Mexico Diabetes & PAD 2014.

PAD THE MOST PREVALENT CARDIOVASCULAR DISEASE

(Millions)

CVD = Cerebrovascular Disease IHD = Ischemic Heart Disease (AMI + Angina + Chronic IHD + Ischemic CHF)

Source: Roth GA. J Am Coll Cardiol. 2017 Jul 4;70(1):1-25 and Fowkes FGR. Lancet 2013;382(9901):1329-40.

ECONOMIC COSTS

$223†-$414‡ BILLION

†U.S. REACH population inpatient costs + outpatient medication = $11,280 X 19.8 Mil PAD in 2015 ‡Margolis managed care population all-cause hospitalizations + medications + other =

$20,895 x 19.8 Mil PAD. Per pt. costs in 2015 $.

PADANNUAL ECONOMIC BURDEN*

*Total Costs Inpatient and Outpatient in 2015

Source: Mahoney EM. Circ Cardiovasc Qual Outcomes 2008;1:38-45, Margolis J. J Manag Care Pharm 2005; 11(9): 727-24 and Yost ML. Real cost of PAD 2011 THE SAGE GROUP.

HOSPITAL COSTS REPRESENT MAJORITY OF PAD COSTS

Source Mahoney EM. Circ Cardiovasc Qual Outcomes 2008;1:38-45, Margolis J. J Manag Care Pharm 2005; 11(9):727-24 and Yost ML. Real cost of PAD 2011 THE SAGE GROUP.

NON-PAD COSTS ARE SIGNIFICANT

Source: Mahoney EM. Circ Cardiovasc Qual Outcomes 2008;1:38-45, Mahoney EM. Circ Cardiovasc Qual Outcomes 2010;3:642-51, Margolis J. J Manag Care Pharm 2005;11(9):727-24, Hirsch AJ. Vasc Med 2008;13:209-15 and Jaff MR. Ann Vasc Surg 2010;24:577-87.

WHO PAYS THE PAD BILL?

Source: AHRQ. Healthcare Cost and Utilization Project. HCUP Query. ICD-9 diagnosis codes PAD 440.20-29, 443.9 & 443.81. https://www.ahrq.gov/research/data/hcup/index.html. Last updated Jan 2018. Accessed Jan 29, 2018.

10%-21% Medicare Patients Treated for PAD

(2003-2012)

$22,756-$72,159* Expenditure per Patient(Range reflects definition of PAD and types of treatments included, i.e. LT Care)

AK Amputation Third Most Commonly Performed Procedure

PAD PATIENTS IN MEDICARE

*2015$ X 2015 Medicare beneficiaries w/ PAD

Source: Kalbaugh CA. J Am Heart Assoc 2017;6:e003796, Nehler MR. J Vasc Surg 2014:60(3);686-95, Hirsch AJ. Vasc Med 2008;13:209-15, Jaff MR. Ann Vasc Surg 2010;24:577-87 and Yost ML. Real cost of PAD 2011 THE SAGE GROUP.

2015 ANNUAL MEDICARE EXPENDITURES PAD & AVERAGE

Source: Jaff MR. Ann Vasc Surg 2010;24:577-87, CMS .gov. CMS releases 2015 national health expenditures and Yost ML. Real cost of PAD 2011. THE SAGE GROUP.

2015 ANNUAL ECONOMIC BURDEN*

(Billions $)

*Direct costs in the United States: PAD & CAD costs inflated to 2015 $. Direct cost of diabetes is 2012 and cancer 2014.

Source: Yost ML. Real cost of PAD 2011 THE SAGE GROUP, Mahoney EM. Circ Cardiovasc Qual Outcomes 2008;1:38-45, American Cancer Society website and ADA Diabetes Care 2013;36(4):1033-46.

CRITICAL LIMB ISCHEMIA(CLI)

THE MOST SEVERE AND DEADLY FORM OF PAD

PAD/CLI AMPUTATION & MORTALITY INCREASE WITH DISEASE SEVERITY

Source: Reinecke H. Eur J 2015; Eur Heart J. 2015 Apr 14;36(15):932-8.

2.0-3.4 Million

≈700,000-800,000 Treated w/ Revascularization or Amputation-Major & Minor

2015 U.S. CLI PREVALENCE

Source: Yost ML. CLI US supplement 2016 THE SAGE GROUP, Nehler MA. J Vasc Surg 2014;60:686-95, Yost ML. PAD. Interventional market analysis based on treatment with angioplasty or atherectomy. THE SAGE GROUP 2012 and Kolte D. Circulation 2017;136:167-76.

U.S. CLI PREVALENCE 2015-2030

(Millions)

Source: Yost ML. CLI US epidemiology supplement 2016. THE SAGE GROUP.

GLOBAL CLI ESTIMATES-2010(Millions)

*Nehler CLI 11.3% of Prevalent PAD**Yost CLI 15% of Prevalent PAD

Source: Fowkes FGR. Lancet 2013; 382(9901): 1329-40, Nehler MA. J Vasc Surg 2014; 60:686-95 and Yost ML. CLI US supplement 2016 THE SAGE GROUP

PAD CLI CLI 11%* 15%**

202 22 30

COUNTRY/REGIONAL CLI PREVALENCE

(Millions)

COUNTRY/REGION 2015

CHINA 5.6-6.3

INDIA 4.2-6.2

WESTERN EUROPE 4.2

UNITED STATES 3.4

SOUTH AMERICA 1.5

JAPAN 1.0

MEXICO 0.6

TOTAL CLI 20.5-23.2

Source: Yost ML. CLI US Supplement 2016, Yost ML. PAD & CLI W Europe 2017, Yost PAD & CLI Japan 2017, Yost ML. China PAD & CLI 2017, Yost ML. India PAD 2018, Yost ML. South America Diabetes & PAD 2013 and Yost ML. Mexico Diabetes & PAD 2014.

TREATMENT COSTS INCREASE WITH DISEASE SEVERITY

Source: Mustapha JA . J Am Heart Assoc 2018;7e009724.

MA Frequently the First and Only Treatment for CLI

65,000-80,000 MA Performed Annually

$11.3 Billion Inpatient & Outpatient Costs

$67 Billion Total Costs*

MAJOR AMPUTATION (MA)

*Direct Inpatient and Outpatient Costs, Lifetime Costs and Unreimbursed Patient Costs in 2015 $

Source: Allie DE. Eurointervention 2005; 1(1): 60-69, Goodney PP. Cardiovasc Qual Outcomes 2012;5:94-102. 2012, Yost ML. Cost-benefit analysis of critical limb ischemia in the era of the Affordable Care Act. Endovasc Today 2014, Dillingham TR. Arch Phys Med Rehabil 2005;86:480-6 and THE SAGE GROUP estimates.

CLI INTERVENTIONAL COSTS

PATIENT COST (2016$)

TYPE OF COST

Dua $24,700* Hospital Cost ET & BP

Kolte $31,400 Hospital Cost ET,BP, MA

Agarwal $31,700* Hospital Cost ET

$32,500* Hospital Cost BP

Mustapha $49,200 BP Inpatient & Outpatient

$49,700 ET Inpatient & Outpatient

$55,700 MA Inpatient & Outpatient

KolteMustapha

CLI Costs(CLI treatments only)

$4-$12 Billion

*2015 $ ET = Endovascular, BP=Bypass & MA = Major Amputation

Source: Dua A. Ann Vasc Surg 2016;33:144-8, Agarwal S. J Am Coll Cardiol 2016;67:1901-13, Kolte D. Circulation 2017;136:167-76, Mustapha JA . J Am Heart Assoc 2018;7e009724.

CLI A LARGE MARKET

WITH SIGNIFICANT POTENTIAL

U.S.CLI LIMB MARKETPOTENTIAL VS 2015 ACTUAL

(Numbers in 000’s)

Yost ML. U.S. CLI by Rutherford Category. Prevalence and markets in patients and limbs. THE SAGE GROUP. 2017.

U.S. 2015 CLI INTERVENTIONAL MARKET

(Limbs R 4-6)

$23.5 Billion*

*Inpatient Interventional Cost = $31,400Interventional = BP, ET and MA

Source: Yost ML. U.S. CLI by Rutherford Category. Prevalence and markets in patients and limbs. THE SAGE GROUP. 2017 and Kolte D. Circulation 2017;136:167-76.

U.S. CELL THERAPYMARKET OPPORTUNITY

($ Billions)

*Cell therapy priced at $35,000 based on current PAD/CLI treatment costs.

Source: Yost ML. U.S. CLI by Rutherford Category. Prevalence and markets in patients and limbs. THE SAGE GROUP and THE SAGE GROUP estimates.

PAD IS HIGHLY PREVALENT AND COMMONLY UNDERESTIMATED

PAD MACROECONOMIC COST IS HIGH $223-$414 BILLION

HOSPITAL COSTS ACCOUNT FOR THE MAJORITY OF TOTAL PAD COSTS

HOSPITAL COSTS ARE SIGNIFICANTLY INCREASED BY CARDIOVASCULAR AND NON-PAD EVENTS

2015 ECONOMIC BURDEN OF PAD EXCEEDS THAT OF DIABETES, CAD AND ALL CANCERS COMBINED

CONCLUSIONS

U.S. CLI ESTIMATED AT 2.0 TO 3.4 MILLION

MORTALITY AND AMPUTATION INCREASE WITH DISEASE SEVERITY

CLI COSTS INCREASE WITH DISEASE SEVERITY—EARLIER DIAGNOSIS AND TREATMENT LIKELY TO REDUCE COSTS

CLI PER PATIENT COSTS FOR INTERVENTIONAL THERAPY ARE HIGH—INPATIENT COSTS $31,000-$33,000 INPATIENT + OUTPATIENT COSTS $49,000-$56,000

THE MARKET OPPORTUNITY FOR CELL THERAPIES ESTIMATED AT $4.4 TO $9.1 BILLION—ASSUMING SAFETY AND EFFICACY FAVORABLE

CONCLUSIONS

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

Placenta Derived Cells

• Ethically accepted• Rich & Diverse• Highly potent

Pro-angiogenicImmunoregulatory

• Young donors • Unlimited source & Easy to

collect• Ability to manufacture

treatments for over 20,000 patients per placenta

The Placenta Project wasLaunched by the US NationalInstitutes of Health (NIH) tofurther explore the role of theplacenta in health and disease

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

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Best In Class GMP Facility3D Manufacturing, In-house Cell Production

Manufacturing Process Approved by:65

Pluristem Approach

66

Quality

Cold Chain

Technology Raw Materials Manufacturing

Clinical Development

Regulation

Process Development

Reduces inflammationStimulates growth of collateral

blood vesselsStimulates repair of damaged

muscle

PLX-R18 PLX-PADPLX-IMMUNE

PLX Products

Stimulates regeneration of damaged bone marrow

to produce blood cells (white, red and platelets)

Inhibits Cancer Cell Growth

Next step- apply for IND approval of clinical trials

Phase III - Radiation Exposure DamagePhase I - Bone Marrow Deficiencies

Phase II - Intermittent Claudication (IC)Phase III – Critical Limb Ischemia (CLI)

Phase III- Hip Fracture

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Indication

Critical Limb Ischemia (CLI)

Intermittent Claudication (IC)

Hip Fracture

Acute Radiation Syndrome (ARS)

Location

U.S.Europe, Israel*

U.S., EuropeSouth Korea,

Israel

U.S. Europe, Israel

U.S.

Company Pipeline

Pre-Clinical Phase 2Phase 1 Phase 3Product

PLX-PAD

PLX-PAD

PLX-PAD

PLX-R18

* One Multinational trial- U.S- phase 3, Europe- via adaptive pathway allowing early marketing approval

FDA Animal Rule

68

Funding

69

70

Accelerated Pathways Adaptive Pathways

A Change In Regulatory Environment-Regenerative Medicine

“Cell therapies…hold significant promise for transformative and

potentially curative treatments for some of humanity’s most troubling

and intractable maladies”

FDA COMMISSIONER SCOTT GOTTLIEB, M.D., AUGUST 2017

21st Century Cures Act

Critical Limb Ischemia (CLI) Hip Fracture Acute Radiation Syndrome (ARS)

Special Pathways

FDA Expanded Access FDA Fast Track Approval EMA Adaptive Regulatory

Pathway PMDA Accelerated Regulatory

Pathway

EMA Adaptive Regulatory Pathway

FDA Animal Rule Pathway FDA Orphan Drug Designation

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Phase III Clinical Development Program

Critical Limb Ischemia (CLI) Hip Fracture Acute Radiation Syndrome (ARS)

Study Phase III, single pivotal Phase III Phase III Ready (FDA Animal Rule)

Countries U.S., Europe, Israel U.S., Europe, Israel U.S.

N (size) 246 Patients 240 Patients 120 NHPs

Expected Data

Europe- H1 2020U.S.- H1 2021

H2 2020 H2 2019

Funding 8 million $- European Union 8.7 million $- European Union

Full funding- U.S. government

Special Pathways

FDA Expanded AccessFDA Fast Track ApprovalEMA Adaptive Regulatory PathwayPMDA Accelerated Regulatory Pathway

EMA Adaptive Regulatory Pathway

FDA Animal Rule PathwayFDA Orphan Drug Designation

COMPANY CONFIDENTIAL

Based on these assumptions, PLX-PAD has the potential to achieve sales of ~$1.4B in the US CLI market

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Assumptions and Sales: CLIForecast Results

CLI Patient Share EmergingCompetitors’ Share

Market Access Factor Price

Scenario 22.5% 40% 50% $25,000

worldwide sales: ~$2.7B US sales: ~$1.4B

CLI Expanded Access Program (EAP)

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• CLI Expanded Access Program cleared by FDA to enrollpatients unsuitable for inclusion in the ongoing Phase 3clinical trial

• Program to enroll an initial 100 CLI Rutherford Category 5patients

• FDA approved cost recovery for the treatment

EAP allows for the collection of real-world data while the Phase 3 trial is ongoing

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Pluristem keeps IP and manufacturing rights in all collaborations

Partnerships and Collaborations

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Expected Milestones

Data Phase III CLI (Europe)

Data Phase III CLI (U.S)

3 Indications Approved for

Marketing

Expanded Access real world data

End of Enrollment Phase III CLI (EU)

End of Enrollment Phase III CLI (U.S)

H1/2019 H2/2019 H1/2020 H2/2020 H1/2021

• Expanded Access Program- Collection of real-world data in parallel to pivotal Phase III study, including revenues from treatments.

• Fast Track Designation- FDA guidance and increased possibility for a priority review • Adaptive Pathway Program (EMA)- perusing conditional marketing approval following

data on 50% (n=123) of patients

Data Pivotal ARS

Data Phase III Hip Fracture

Contract with US Gov. ARS

Investor.relations@Pluristem.com Israel +972-74-710-8600U.S. +1-914-512-4109

www.Pluristem.com

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