Company PresentationOctober 2020

This presentation contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other US 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 andor 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

2

3

bull Cell therapy company focused on Regenerative Medicine

bull Several Off-the-shelf placenta-derived cell product candidates

bull Two ongoing Phase III studies in critical limb ischemia (CLI)

associated with diabetes complications and in muscle regeneration

bull Playing active role in clinical development for complications

associated with COVID-19

bull Favorable safety profile and efficacy data from hundreds of

patients treated worldwide

bull Best-in-class cell manufacturing technology producing

highest-quality cell products at a commercial scale

bull Strong IP portfolio (over 120 granted patents)

bull Publicly-listed on Nasdaq and TASE

bull Cash ~$59 million (as of June 30 2020)

bull Full time employees ~160

Pluristem Therapeutics

The Need for Cell Therapy

Complexity of the diseaseInnovative treatments are needed to treat complex diseases

The Economic ImpactSome of the worldrsquos largest economies are now facing subsequent increases in health-care costs

The Human ImpactAging is often associated with debilitating medical conditions many of which are still unmet needs

Longer lifespansLifespan has increased significantlyNearly 2 billion people across the world are expected to be over 60 years old by 2050 (World Health Organization)

4

5

Placenta-Derived Cells

bull Ethically accepted

bull Rich amp diverse

bull Pro-angiogenic amp immunoregulatory

bull Young donors after full-term delivery undergoing an elective caesarean section

bull Unlimited source amp easy to collect

bull Ability to manufacture treatments for over 20000 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

httpwwwthe-scientistcomarticlesviewarticleNo43618titleThe-Prescient-Placenta

State-of-the-art 3D bioreactor system forcell expansion that mimics the human body

High Quality Scalable Cost-effective

GMPManufacturing

Automated Batch-to-batch Consistency

One placenta can treat over 20000 patients

6

Manufacturing Process Approved by

Commercial-Scale In-House Technology Platform

bull Cost-effective market-ready industrialized platform

bull Full vertical solution - from raw material to the patientrsquos bed

bull Automated efficient and validated manufacturing technology

bull Fully developed unique cold chain logistics

bull Scalable and tech-transferable technology for additional capacity

bull Off-the-shelf biopharmaceutical No special preparation required

Thawing Device Storage

Advanced cold chain logistics

Quality Control

ManufacturingCell

HarnessingProcess

DevelopmentClinical

Development Cold Chain

GMP

Manufacturing

1 placenta

can treat ~ 20000 patients

Regulatory Approvals

in EU USA Israel South Korea ampJapan

IMInjection

Shipment

Controlled automatedscalable 3D manufacturing facility

7

Full Vertical Solution From Raw Material to the Patientrsquos Bed

Wide Application of Placenta Cells

Market-Ready Scalable Technology

Platform

Off-the-shelf Allogeneic Line

of Products

Simple IM

Administration

Adaptive Slow Secretion of

Cytokines

Long-term Regenerative

Effect

Angiogenesis Muscle regeneration

Immunomodulation reduction of inflammation

8

From the Miracle of Birth to Regenerative Medicine for All

Product Focus Indication Funding LocationData

ReadoutPre-Clinical Phase I Phase II Phase III

PLX

-PA

D

Vascular Diseases

Critical Limb Ischemia Interim analysis-Q4 2020

Intermittent Claudication

Europe Israel US

Europe Israel US South Korea

Inflammatory Diseases

ARDS due to COVID-19 Europe US Q1 2021

Graft Versus Host Disease Israel

Muscle Injuries

Muscle Regeneration following Hip Fracture

Europe Israel US

Q3 2021

PLX

-R1

8

Hematological Deficiencies

Acute Radiation Syndrome US

Incomplete Recovery Following Bone Marrow Transplantation

Israel US Q1 2021

9

Clinical Pipeline

10

PLX-PAD

Peripheral Arterial Disease

bull CLI is caused by fatty deposits in leg arteries that obstruct blood flow

bull Risk factors include smoking diabetes obesity cardiovascular problems and hypertension

bull CLI patients suffer from severe pain skin wounds tissue necrosis and poor quality of life

bull High risk of leg amputation and death

bull Up to 35 of patients are unsuitable or will not benefit from revascularization

Peripheral Arterial Disease ndash Critical Limb Ischemia (CLI)

11

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 amp Outpatient Treatment Costs by Rutherford Category

Clinical Development in Peripheral Arterial Disease

12

Completed two Phase I studies in CLI ndash US amp Germany (N=27)

Good safety profile

Increase in tissue perfusion 60 reduction in the risk for death or amputation

Dose identification ndash two treatments of 300 million cells two months apart

Completed Phase II study in intermittent claudication (IC) ndash US Germany S Korea amp Israel

Good safety profile

Significant increase in walking distance reduction in surgical events and HbA1c and CRP levels

Confirmation of Phase III design including ndash dose (300m cells) dose regimen (2 administrations)

(N=172)

13

Ongoing Phase III study in CLI ndash US Europe amp Israel

Ongoing CLI Phase III Study

bull Expected top-line interim data analysis results in Q42020 (calendar year)

bull Patient enrollment to the full clinical study ongoing

bull Awarded adaptive pathway program in the EU

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

euro 76 million grant from the EU Horizon 2020 program

Design Phase III randomized Double-Blind Placebo-controlled (21)

Study population CLI subjects with minor tissue loss unsuitable for revascularization

Countries Germany UK US Poland Hungary Czech Republic Bulgaria Macedonia Israel

Sample size Randomization will stop when required amount of events (82) is assured

Doses tested 300M cells vs placebo (randomization ratio 21)

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 amp exploratory efficacy endpoints

Composite efficacy endpoint Pain Complete wound healing Quality-of-life Adjudicated amputations TcPO2 Cytokine levels

Follow-up length 52 weeks

Expected top-line interim data analysis results

Q4 calendar year of 2020

14

Ongoing CLI Phase III Study - Overview

PLX-PAD

Muscle Regeneration

15

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

16

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

Muscle Regeneration Following Hip Fracture

bull As the population ages the number of hip fractures continuesto increase

bull Worldwide the total number of hip fractures is expected tosurpass 6 million by the year 2050

bull Hip fracture often leads to serious long-term complicationsincluding pain functional decline and disability

bull Up to 36 mortality rate after one year due to immobilityassociated diseases

Kannus P Parkkari J Sievaumlnen H et al Epidemiology of hip fracturesSimran Mundi et al 2014Jorma Panula et al 2011

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

This presentation contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other US 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 andor 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

2

3

bull Cell therapy company focused on Regenerative Medicine

bull Several Off-the-shelf placenta-derived cell product candidates

bull Two ongoing Phase III studies in critical limb ischemia (CLI)

associated with diabetes complications and in muscle regeneration

bull Playing active role in clinical development for complications

associated with COVID-19

bull Favorable safety profile and efficacy data from hundreds of

patients treated worldwide

bull Best-in-class cell manufacturing technology producing

highest-quality cell products at a commercial scale

bull Strong IP portfolio (over 120 granted patents)

bull Publicly-listed on Nasdaq and TASE

bull Cash ~$59 million (as of June 30 2020)

bull Full time employees ~160

Pluristem Therapeutics

The Need for Cell Therapy

Complexity of the diseaseInnovative treatments are needed to treat complex diseases

The Economic ImpactSome of the worldrsquos largest economies are now facing subsequent increases in health-care costs

The Human ImpactAging is often associated with debilitating medical conditions many of which are still unmet needs

Longer lifespansLifespan has increased significantlyNearly 2 billion people across the world are expected to be over 60 years old by 2050 (World Health Organization)

4

5

Placenta-Derived Cells

bull Ethically accepted

bull Rich amp diverse

bull Pro-angiogenic amp immunoregulatory

bull Young donors after full-term delivery undergoing an elective caesarean section

bull Unlimited source amp easy to collect

bull Ability to manufacture treatments for over 20000 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

httpwwwthe-scientistcomarticlesviewarticleNo43618titleThe-Prescient-Placenta

State-of-the-art 3D bioreactor system forcell expansion that mimics the human body

High Quality Scalable Cost-effective

GMPManufacturing

Automated Batch-to-batch Consistency

One placenta can treat over 20000 patients

6

Manufacturing Process Approved by

Commercial-Scale In-House Technology Platform

bull Cost-effective market-ready industrialized platform

bull Full vertical solution - from raw material to the patientrsquos bed

bull Automated efficient and validated manufacturing technology

bull Fully developed unique cold chain logistics

bull Scalable and tech-transferable technology for additional capacity

bull Off-the-shelf biopharmaceutical No special preparation required

Thawing Device Storage

Advanced cold chain logistics

Quality Control

ManufacturingCell

HarnessingProcess

DevelopmentClinical

Development Cold Chain

GMP

Manufacturing

1 placenta

can treat ~ 20000 patients

Regulatory Approvals

in EU USA Israel South Korea ampJapan

IMInjection

Shipment

Controlled automatedscalable 3D manufacturing facility

7

Full Vertical Solution From Raw Material to the Patientrsquos Bed

Wide Application of Placenta Cells

Market-Ready Scalable Technology

Platform

Off-the-shelf Allogeneic Line

of Products

Simple IM

Administration

Adaptive Slow Secretion of

Cytokines

Long-term Regenerative

Effect

Angiogenesis Muscle regeneration

Immunomodulation reduction of inflammation

8

From the Miracle of Birth to Regenerative Medicine for All

Product Focus Indication Funding LocationData

ReadoutPre-Clinical Phase I Phase II Phase III

PLX

-PA

D

Vascular Diseases

Critical Limb Ischemia Interim analysis-Q4 2020

Intermittent Claudication

Europe Israel US

Europe Israel US South Korea

Inflammatory Diseases

ARDS due to COVID-19 Europe US Q1 2021

Graft Versus Host Disease Israel

Muscle Injuries

Muscle Regeneration following Hip Fracture

Europe Israel US

Q3 2021

PLX

-R1

8

Hematological Deficiencies

Acute Radiation Syndrome US

Incomplete Recovery Following Bone Marrow Transplantation

Israel US Q1 2021

9

Clinical Pipeline

10

PLX-PAD

Peripheral Arterial Disease

bull CLI is caused by fatty deposits in leg arteries that obstruct blood flow

bull Risk factors include smoking diabetes obesity cardiovascular problems and hypertension

bull CLI patients suffer from severe pain skin wounds tissue necrosis and poor quality of life

bull High risk of leg amputation and death

bull Up to 35 of patients are unsuitable or will not benefit from revascularization

Peripheral Arterial Disease ndash Critical Limb Ischemia (CLI)

11

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 amp Outpatient Treatment Costs by Rutherford Category

Clinical Development in Peripheral Arterial Disease

12

Completed two Phase I studies in CLI ndash US amp Germany (N=27)

Good safety profile

Increase in tissue perfusion 60 reduction in the risk for death or amputation

Dose identification ndash two treatments of 300 million cells two months apart

Completed Phase II study in intermittent claudication (IC) ndash US Germany S Korea amp Israel

Good safety profile

Significant increase in walking distance reduction in surgical events and HbA1c and CRP levels

Confirmation of Phase III design including ndash dose (300m cells) dose regimen (2 administrations)

(N=172)

13

Ongoing Phase III study in CLI ndash US Europe amp Israel

Ongoing CLI Phase III Study

bull Expected top-line interim data analysis results in Q42020 (calendar year)

bull Patient enrollment to the full clinical study ongoing

bull Awarded adaptive pathway program in the EU

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

euro 76 million grant from the EU Horizon 2020 program

Design Phase III randomized Double-Blind Placebo-controlled (21)

Study population CLI subjects with minor tissue loss unsuitable for revascularization

Countries Germany UK US Poland Hungary Czech Republic Bulgaria Macedonia Israel

Sample size Randomization will stop when required amount of events (82) is assured

Doses tested 300M cells vs placebo (randomization ratio 21)

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 amp exploratory efficacy endpoints

Composite efficacy endpoint Pain Complete wound healing Quality-of-life Adjudicated amputations TcPO2 Cytokine levels

Follow-up length 52 weeks

Expected top-line interim data analysis results

Q4 calendar year of 2020

14

Ongoing CLI Phase III Study - Overview

PLX-PAD

Muscle Regeneration

15

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

16

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

Muscle Regeneration Following Hip Fracture

bull As the population ages the number of hip fractures continuesto increase

bull Worldwide the total number of hip fractures is expected tosurpass 6 million by the year 2050

bull Hip fracture often leads to serious long-term complicationsincluding pain functional decline and disability

bull Up to 36 mortality rate after one year due to immobilityassociated diseases

Kannus P Parkkari J Sievaumlnen H et al Epidemiology of hip fracturesSimran Mundi et al 2014Jorma Panula et al 2011

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

3

bull Cell therapy company focused on Regenerative Medicine

bull Several Off-the-shelf placenta-derived cell product candidates

bull Two ongoing Phase III studies in critical limb ischemia (CLI)

associated with diabetes complications and in muscle regeneration

bull Playing active role in clinical development for complications

associated with COVID-19

bull Favorable safety profile and efficacy data from hundreds of

patients treated worldwide

bull Best-in-class cell manufacturing technology producing

highest-quality cell products at a commercial scale

bull Strong IP portfolio (over 120 granted patents)

bull Publicly-listed on Nasdaq and TASE

bull Cash ~$59 million (as of June 30 2020)

bull Full time employees ~160

Pluristem Therapeutics

The Need for Cell Therapy

Complexity of the diseaseInnovative treatments are needed to treat complex diseases

The Economic ImpactSome of the worldrsquos largest economies are now facing subsequent increases in health-care costs

The Human ImpactAging is often associated with debilitating medical conditions many of which are still unmet needs

Longer lifespansLifespan has increased significantlyNearly 2 billion people across the world are expected to be over 60 years old by 2050 (World Health Organization)

4

5

Placenta-Derived Cells

bull Ethically accepted

bull Rich amp diverse

bull Pro-angiogenic amp immunoregulatory

bull Young donors after full-term delivery undergoing an elective caesarean section

bull Unlimited source amp easy to collect

bull Ability to manufacture treatments for over 20000 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

httpwwwthe-scientistcomarticlesviewarticleNo43618titleThe-Prescient-Placenta

State-of-the-art 3D bioreactor system forcell expansion that mimics the human body

High Quality Scalable Cost-effective

GMPManufacturing

Automated Batch-to-batch Consistency

One placenta can treat over 20000 patients

6

Manufacturing Process Approved by

Commercial-Scale In-House Technology Platform

bull Cost-effective market-ready industrialized platform

bull Full vertical solution - from raw material to the patientrsquos bed

bull Automated efficient and validated manufacturing technology

bull Fully developed unique cold chain logistics

bull Scalable and tech-transferable technology for additional capacity

bull Off-the-shelf biopharmaceutical No special preparation required

Thawing Device Storage

Advanced cold chain logistics

Quality Control

ManufacturingCell

HarnessingProcess

DevelopmentClinical

Development Cold Chain

GMP

Manufacturing

1 placenta

can treat ~ 20000 patients

Regulatory Approvals

in EU USA Israel South Korea ampJapan

IMInjection

Shipment

Controlled automatedscalable 3D manufacturing facility

7

Full Vertical Solution From Raw Material to the Patientrsquos Bed

Wide Application of Placenta Cells

Market-Ready Scalable Technology

Platform

Off-the-shelf Allogeneic Line

of Products

Simple IM

Administration

Adaptive Slow Secretion of

Cytokines

Long-term Regenerative

Effect

Angiogenesis Muscle regeneration

Immunomodulation reduction of inflammation

8

From the Miracle of Birth to Regenerative Medicine for All

Product Focus Indication Funding LocationData

ReadoutPre-Clinical Phase I Phase II Phase III

PLX

-PA

D

Vascular Diseases

Critical Limb Ischemia Interim analysis-Q4 2020

Intermittent Claudication

Europe Israel US

Europe Israel US South Korea

Inflammatory Diseases

ARDS due to COVID-19 Europe US Q1 2021

Graft Versus Host Disease Israel

Muscle Injuries

Muscle Regeneration following Hip Fracture

Europe Israel US

Q3 2021

PLX

-R1

8

Hematological Deficiencies

Acute Radiation Syndrome US

Incomplete Recovery Following Bone Marrow Transplantation

Israel US Q1 2021

9

Clinical Pipeline

10

PLX-PAD

Peripheral Arterial Disease

bull CLI is caused by fatty deposits in leg arteries that obstruct blood flow

bull Risk factors include smoking diabetes obesity cardiovascular problems and hypertension

bull CLI patients suffer from severe pain skin wounds tissue necrosis and poor quality of life

bull High risk of leg amputation and death

bull Up to 35 of patients are unsuitable or will not benefit from revascularization

Peripheral Arterial Disease ndash Critical Limb Ischemia (CLI)

11

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 amp Outpatient Treatment Costs by Rutherford Category

Clinical Development in Peripheral Arterial Disease

12

Completed two Phase I studies in CLI ndash US amp Germany (N=27)

Good safety profile

Increase in tissue perfusion 60 reduction in the risk for death or amputation

Dose identification ndash two treatments of 300 million cells two months apart

Completed Phase II study in intermittent claudication (IC) ndash US Germany S Korea amp Israel

Good safety profile

Significant increase in walking distance reduction in surgical events and HbA1c and CRP levels

Confirmation of Phase III design including ndash dose (300m cells) dose regimen (2 administrations)

(N=172)

13

Ongoing Phase III study in CLI ndash US Europe amp Israel

Ongoing CLI Phase III Study

bull Expected top-line interim data analysis results in Q42020 (calendar year)

bull Patient enrollment to the full clinical study ongoing

bull Awarded adaptive pathway program in the EU

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

euro 76 million grant from the EU Horizon 2020 program

Design Phase III randomized Double-Blind Placebo-controlled (21)

Study population CLI subjects with minor tissue loss unsuitable for revascularization

Countries Germany UK US Poland Hungary Czech Republic Bulgaria Macedonia Israel

Sample size Randomization will stop when required amount of events (82) is assured

Doses tested 300M cells vs placebo (randomization ratio 21)

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 amp exploratory efficacy endpoints

Composite efficacy endpoint Pain Complete wound healing Quality-of-life Adjudicated amputations TcPO2 Cytokine levels

Follow-up length 52 weeks

Expected top-line interim data analysis results

Q4 calendar year of 2020

14

Ongoing CLI Phase III Study - Overview

PLX-PAD

Muscle Regeneration

15

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

16

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

Muscle Regeneration Following Hip Fracture

bull As the population ages the number of hip fractures continuesto increase

bull Worldwide the total number of hip fractures is expected tosurpass 6 million by the year 2050

bull Hip fracture often leads to serious long-term complicationsincluding pain functional decline and disability

bull Up to 36 mortality rate after one year due to immobilityassociated diseases

Kannus P Parkkari J Sievaumlnen H et al Epidemiology of hip fracturesSimran Mundi et al 2014Jorma Panula et al 2011

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

The Need for Cell Therapy

Complexity of the diseaseInnovative treatments are needed to treat complex diseases

The Economic ImpactSome of the worldrsquos largest economies are now facing subsequent increases in health-care costs

The Human ImpactAging is often associated with debilitating medical conditions many of which are still unmet needs

Longer lifespansLifespan has increased significantlyNearly 2 billion people across the world are expected to be over 60 years old by 2050 (World Health Organization)

4

5

Placenta-Derived Cells

bull Ethically accepted

bull Rich amp diverse

bull Pro-angiogenic amp immunoregulatory

bull Young donors after full-term delivery undergoing an elective caesarean section

bull Unlimited source amp easy to collect

bull Ability to manufacture treatments for over 20000 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

httpwwwthe-scientistcomarticlesviewarticleNo43618titleThe-Prescient-Placenta

State-of-the-art 3D bioreactor system forcell expansion that mimics the human body

High Quality Scalable Cost-effective

GMPManufacturing

Automated Batch-to-batch Consistency

One placenta can treat over 20000 patients

6

Manufacturing Process Approved by

Commercial-Scale In-House Technology Platform

bull Cost-effective market-ready industrialized platform

bull Full vertical solution - from raw material to the patientrsquos bed

bull Automated efficient and validated manufacturing technology

bull Fully developed unique cold chain logistics

bull Scalable and tech-transferable technology for additional capacity

bull Off-the-shelf biopharmaceutical No special preparation required

Thawing Device Storage

Advanced cold chain logistics

Quality Control

ManufacturingCell

HarnessingProcess

DevelopmentClinical

Development Cold Chain

GMP

Manufacturing

1 placenta

can treat ~ 20000 patients

Regulatory Approvals

in EU USA Israel South Korea ampJapan

IMInjection

Shipment

Controlled automatedscalable 3D manufacturing facility

7

Full Vertical Solution From Raw Material to the Patientrsquos Bed

Wide Application of Placenta Cells

Market-Ready Scalable Technology

Platform

Off-the-shelf Allogeneic Line

of Products

Simple IM

Administration

Adaptive Slow Secretion of

Cytokines

Long-term Regenerative

Effect

Angiogenesis Muscle regeneration

Immunomodulation reduction of inflammation

8

From the Miracle of Birth to Regenerative Medicine for All

Product Focus Indication Funding LocationData

ReadoutPre-Clinical Phase I Phase II Phase III

PLX

-PA

D

Vascular Diseases

Critical Limb Ischemia Interim analysis-Q4 2020

Intermittent Claudication

Europe Israel US

Europe Israel US South Korea

Inflammatory Diseases

ARDS due to COVID-19 Europe US Q1 2021

Graft Versus Host Disease Israel

Muscle Injuries

Muscle Regeneration following Hip Fracture

Europe Israel US

Q3 2021

PLX

-R1

8

Hematological Deficiencies

Acute Radiation Syndrome US

Incomplete Recovery Following Bone Marrow Transplantation

Israel US Q1 2021

9

Clinical Pipeline

10

PLX-PAD

Peripheral Arterial Disease

bull CLI is caused by fatty deposits in leg arteries that obstruct blood flow

bull Risk factors include smoking diabetes obesity cardiovascular problems and hypertension

bull CLI patients suffer from severe pain skin wounds tissue necrosis and poor quality of life

bull High risk of leg amputation and death

bull Up to 35 of patients are unsuitable or will not benefit from revascularization

Peripheral Arterial Disease ndash Critical Limb Ischemia (CLI)

11

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 amp Outpatient Treatment Costs by Rutherford Category

Clinical Development in Peripheral Arterial Disease

12

Completed two Phase I studies in CLI ndash US amp Germany (N=27)

Good safety profile

Increase in tissue perfusion 60 reduction in the risk for death or amputation

Dose identification ndash two treatments of 300 million cells two months apart

Completed Phase II study in intermittent claudication (IC) ndash US Germany S Korea amp Israel

Good safety profile

Significant increase in walking distance reduction in surgical events and HbA1c and CRP levels

Confirmation of Phase III design including ndash dose (300m cells) dose regimen (2 administrations)

(N=172)

13

Ongoing Phase III study in CLI ndash US Europe amp Israel

Ongoing CLI Phase III Study

bull Expected top-line interim data analysis results in Q42020 (calendar year)

bull Patient enrollment to the full clinical study ongoing

bull Awarded adaptive pathway program in the EU

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

euro 76 million grant from the EU Horizon 2020 program

Design Phase III randomized Double-Blind Placebo-controlled (21)

Study population CLI subjects with minor tissue loss unsuitable for revascularization

Countries Germany UK US Poland Hungary Czech Republic Bulgaria Macedonia Israel

Sample size Randomization will stop when required amount of events (82) is assured

Doses tested 300M cells vs placebo (randomization ratio 21)

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 amp exploratory efficacy endpoints

Composite efficacy endpoint Pain Complete wound healing Quality-of-life Adjudicated amputations TcPO2 Cytokine levels

Follow-up length 52 weeks

Expected top-line interim data analysis results

Q4 calendar year of 2020

14

Ongoing CLI Phase III Study - Overview

PLX-PAD

Muscle Regeneration

15

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

16

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

Muscle Regeneration Following Hip Fracture

bull As the population ages the number of hip fractures continuesto increase

bull Worldwide the total number of hip fractures is expected tosurpass 6 million by the year 2050

bull Hip fracture often leads to serious long-term complicationsincluding pain functional decline and disability

bull Up to 36 mortality rate after one year due to immobilityassociated diseases

Kannus P Parkkari J Sievaumlnen H et al Epidemiology of hip fracturesSimran Mundi et al 2014Jorma Panula et al 2011

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

5

Placenta-Derived Cells

bull Ethically accepted

bull Rich amp diverse

bull Pro-angiogenic amp immunoregulatory

bull Young donors after full-term delivery undergoing an elective caesarean section

bull Unlimited source amp easy to collect

bull Ability to manufacture treatments for over 20000 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

httpwwwthe-scientistcomarticlesviewarticleNo43618titleThe-Prescient-Placenta

State-of-the-art 3D bioreactor system forcell expansion that mimics the human body

High Quality Scalable Cost-effective

GMPManufacturing

Automated Batch-to-batch Consistency

One placenta can treat over 20000 patients

6

Manufacturing Process Approved by

Commercial-Scale In-House Technology Platform

bull Cost-effective market-ready industrialized platform

bull Full vertical solution - from raw material to the patientrsquos bed

bull Automated efficient and validated manufacturing technology

bull Fully developed unique cold chain logistics

bull Scalable and tech-transferable technology for additional capacity

bull Off-the-shelf biopharmaceutical No special preparation required

Thawing Device Storage

Advanced cold chain logistics

Quality Control

ManufacturingCell

HarnessingProcess

DevelopmentClinical

Development Cold Chain

GMP

Manufacturing

1 placenta

can treat ~ 20000 patients

Regulatory Approvals

in EU USA Israel South Korea ampJapan

IMInjection

Shipment

Controlled automatedscalable 3D manufacturing facility

7

Full Vertical Solution From Raw Material to the Patientrsquos Bed

Wide Application of Placenta Cells

Market-Ready Scalable Technology

Platform

Off-the-shelf Allogeneic Line

of Products

Simple IM

Administration

Adaptive Slow Secretion of

Cytokines

Long-term Regenerative

Effect

Angiogenesis Muscle regeneration

Immunomodulation reduction of inflammation

8

From the Miracle of Birth to Regenerative Medicine for All

Product Focus Indication Funding LocationData

ReadoutPre-Clinical Phase I Phase II Phase III

PLX

-PA

D

Vascular Diseases

Critical Limb Ischemia Interim analysis-Q4 2020

Intermittent Claudication

Europe Israel US

Europe Israel US South Korea

Inflammatory Diseases

ARDS due to COVID-19 Europe US Q1 2021

Graft Versus Host Disease Israel

Muscle Injuries

Muscle Regeneration following Hip Fracture

Europe Israel US

Q3 2021

PLX

-R1

8

Hematological Deficiencies

Acute Radiation Syndrome US

Incomplete Recovery Following Bone Marrow Transplantation

Israel US Q1 2021

9

Clinical Pipeline

10

PLX-PAD

Peripheral Arterial Disease

bull CLI is caused by fatty deposits in leg arteries that obstruct blood flow

bull Risk factors include smoking diabetes obesity cardiovascular problems and hypertension

bull CLI patients suffer from severe pain skin wounds tissue necrosis and poor quality of life

bull High risk of leg amputation and death

bull Up to 35 of patients are unsuitable or will not benefit from revascularization

Peripheral Arterial Disease ndash Critical Limb Ischemia (CLI)

11

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 amp Outpatient Treatment Costs by Rutherford Category

Clinical Development in Peripheral Arterial Disease

12

Completed two Phase I studies in CLI ndash US amp Germany (N=27)

Good safety profile

Increase in tissue perfusion 60 reduction in the risk for death or amputation

Dose identification ndash two treatments of 300 million cells two months apart

Completed Phase II study in intermittent claudication (IC) ndash US Germany S Korea amp Israel

Good safety profile

Significant increase in walking distance reduction in surgical events and HbA1c and CRP levels

Confirmation of Phase III design including ndash dose (300m cells) dose regimen (2 administrations)

(N=172)

13

Ongoing Phase III study in CLI ndash US Europe amp Israel

Ongoing CLI Phase III Study

bull Expected top-line interim data analysis results in Q42020 (calendar year)

bull Patient enrollment to the full clinical study ongoing

bull Awarded adaptive pathway program in the EU

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

euro 76 million grant from the EU Horizon 2020 program

Design Phase III randomized Double-Blind Placebo-controlled (21)

Study population CLI subjects with minor tissue loss unsuitable for revascularization

Countries Germany UK US Poland Hungary Czech Republic Bulgaria Macedonia Israel

Sample size Randomization will stop when required amount of events (82) is assured

Doses tested 300M cells vs placebo (randomization ratio 21)

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 amp exploratory efficacy endpoints

Composite efficacy endpoint Pain Complete wound healing Quality-of-life Adjudicated amputations TcPO2 Cytokine levels

Follow-up length 52 weeks

Expected top-line interim data analysis results

Q4 calendar year of 2020

14

Ongoing CLI Phase III Study - Overview

PLX-PAD

Muscle Regeneration

15

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

16

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

Muscle Regeneration Following Hip Fracture

bull As the population ages the number of hip fractures continuesto increase

bull Worldwide the total number of hip fractures is expected tosurpass 6 million by the year 2050

bull Hip fracture often leads to serious long-term complicationsincluding pain functional decline and disability

bull Up to 36 mortality rate after one year due to immobilityassociated diseases

Kannus P Parkkari J Sievaumlnen H et al Epidemiology of hip fracturesSimran Mundi et al 2014Jorma Panula et al 2011

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

State-of-the-art 3D bioreactor system forcell expansion that mimics the human body

High Quality Scalable Cost-effective

GMPManufacturing

Automated Batch-to-batch Consistency

One placenta can treat over 20000 patients

6

Manufacturing Process Approved by

Commercial-Scale In-House Technology Platform

bull Cost-effective market-ready industrialized platform

bull Full vertical solution - from raw material to the patientrsquos bed

bull Automated efficient and validated manufacturing technology

bull Fully developed unique cold chain logistics

bull Scalable and tech-transferable technology for additional capacity

bull Off-the-shelf biopharmaceutical No special preparation required

Thawing Device Storage

Advanced cold chain logistics

Quality Control

ManufacturingCell

HarnessingProcess

DevelopmentClinical

Development Cold Chain

GMP

Manufacturing

1 placenta

can treat ~ 20000 patients

Regulatory Approvals

in EU USA Israel South Korea ampJapan

IMInjection

Shipment

Controlled automatedscalable 3D manufacturing facility

7

Full Vertical Solution From Raw Material to the Patientrsquos Bed

Wide Application of Placenta Cells

Market-Ready Scalable Technology

Platform

Off-the-shelf Allogeneic Line

of Products

Simple IM

Administration

Adaptive Slow Secretion of

Cytokines

Long-term Regenerative

Effect

Angiogenesis Muscle regeneration

Immunomodulation reduction of inflammation

8

From the Miracle of Birth to Regenerative Medicine for All

Product Focus Indication Funding LocationData

ReadoutPre-Clinical Phase I Phase II Phase III

PLX

-PA

D

Vascular Diseases

Critical Limb Ischemia Interim analysis-Q4 2020

Intermittent Claudication

Europe Israel US

Europe Israel US South Korea

Inflammatory Diseases

ARDS due to COVID-19 Europe US Q1 2021

Graft Versus Host Disease Israel

Muscle Injuries

Muscle Regeneration following Hip Fracture

Europe Israel US

Q3 2021

PLX

-R1

8

Hematological Deficiencies

Acute Radiation Syndrome US

Incomplete Recovery Following Bone Marrow Transplantation

Israel US Q1 2021

9

Clinical Pipeline

10

PLX-PAD

Peripheral Arterial Disease

bull CLI is caused by fatty deposits in leg arteries that obstruct blood flow

bull Risk factors include smoking diabetes obesity cardiovascular problems and hypertension

bull CLI patients suffer from severe pain skin wounds tissue necrosis and poor quality of life

bull High risk of leg amputation and death

bull Up to 35 of patients are unsuitable or will not benefit from revascularization

Peripheral Arterial Disease ndash Critical Limb Ischemia (CLI)

11

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 amp Outpatient Treatment Costs by Rutherford Category

Clinical Development in Peripheral Arterial Disease

12

Completed two Phase I studies in CLI ndash US amp Germany (N=27)

Good safety profile

Increase in tissue perfusion 60 reduction in the risk for death or amputation

Dose identification ndash two treatments of 300 million cells two months apart

Completed Phase II study in intermittent claudication (IC) ndash US Germany S Korea amp Israel

Good safety profile

Significant increase in walking distance reduction in surgical events and HbA1c and CRP levels

Confirmation of Phase III design including ndash dose (300m cells) dose regimen (2 administrations)

(N=172)

13

Ongoing Phase III study in CLI ndash US Europe amp Israel

Ongoing CLI Phase III Study

bull Expected top-line interim data analysis results in Q42020 (calendar year)

bull Patient enrollment to the full clinical study ongoing

bull Awarded adaptive pathway program in the EU

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

euro 76 million grant from the EU Horizon 2020 program

Design Phase III randomized Double-Blind Placebo-controlled (21)

Study population CLI subjects with minor tissue loss unsuitable for revascularization

Countries Germany UK US Poland Hungary Czech Republic Bulgaria Macedonia Israel

Sample size Randomization will stop when required amount of events (82) is assured

Doses tested 300M cells vs placebo (randomization ratio 21)

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 amp exploratory efficacy endpoints

Composite efficacy endpoint Pain Complete wound healing Quality-of-life Adjudicated amputations TcPO2 Cytokine levels

Follow-up length 52 weeks

Expected top-line interim data analysis results

Q4 calendar year of 2020

14

Ongoing CLI Phase III Study - Overview

PLX-PAD

Muscle Regeneration

15

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

16

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

Muscle Regeneration Following Hip Fracture

bull As the population ages the number of hip fractures continuesto increase

bull Worldwide the total number of hip fractures is expected tosurpass 6 million by the year 2050

bull Hip fracture often leads to serious long-term complicationsincluding pain functional decline and disability

bull Up to 36 mortality rate after one year due to immobilityassociated diseases

Kannus P Parkkari J Sievaumlnen H et al Epidemiology of hip fracturesSimran Mundi et al 2014Jorma Panula et al 2011

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

Thawing Device Storage

Advanced cold chain logistics

Quality Control

ManufacturingCell

HarnessingProcess

DevelopmentClinical

Development Cold Chain

GMP

Manufacturing

1 placenta

can treat ~ 20000 patients

Regulatory Approvals

in EU USA Israel South Korea ampJapan

IMInjection

Shipment

Controlled automatedscalable 3D manufacturing facility

7

Full Vertical Solution From Raw Material to the Patientrsquos Bed

Wide Application of Placenta Cells

Market-Ready Scalable Technology

Platform

Off-the-shelf Allogeneic Line

of Products

Simple IM

Administration

Adaptive Slow Secretion of

Cytokines

Long-term Regenerative

Effect

Angiogenesis Muscle regeneration

Immunomodulation reduction of inflammation

8

From the Miracle of Birth to Regenerative Medicine for All

Product Focus Indication Funding LocationData

ReadoutPre-Clinical Phase I Phase II Phase III

PLX

-PA

D

Vascular Diseases

Critical Limb Ischemia Interim analysis-Q4 2020

Intermittent Claudication

Europe Israel US

Europe Israel US South Korea

Inflammatory Diseases

ARDS due to COVID-19 Europe US Q1 2021

Graft Versus Host Disease Israel

Muscle Injuries

Muscle Regeneration following Hip Fracture

Europe Israel US

Q3 2021

PLX

-R1

8

Hematological Deficiencies

Acute Radiation Syndrome US

Incomplete Recovery Following Bone Marrow Transplantation

Israel US Q1 2021

9

Clinical Pipeline

10

PLX-PAD

Peripheral Arterial Disease

bull CLI is caused by fatty deposits in leg arteries that obstruct blood flow

bull Risk factors include smoking diabetes obesity cardiovascular problems and hypertension

bull CLI patients suffer from severe pain skin wounds tissue necrosis and poor quality of life

bull High risk of leg amputation and death

bull Up to 35 of patients are unsuitable or will not benefit from revascularization

Peripheral Arterial Disease ndash Critical Limb Ischemia (CLI)

11

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 amp Outpatient Treatment Costs by Rutherford Category

Clinical Development in Peripheral Arterial Disease

12

Completed two Phase I studies in CLI ndash US amp Germany (N=27)

Good safety profile

Increase in tissue perfusion 60 reduction in the risk for death or amputation

Dose identification ndash two treatments of 300 million cells two months apart

Completed Phase II study in intermittent claudication (IC) ndash US Germany S Korea amp Israel

Good safety profile

Significant increase in walking distance reduction in surgical events and HbA1c and CRP levels

Confirmation of Phase III design including ndash dose (300m cells) dose regimen (2 administrations)

(N=172)

13

Ongoing Phase III study in CLI ndash US Europe amp Israel

Ongoing CLI Phase III Study

bull Expected top-line interim data analysis results in Q42020 (calendar year)

bull Patient enrollment to the full clinical study ongoing

bull Awarded adaptive pathway program in the EU

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

euro 76 million grant from the EU Horizon 2020 program

Design Phase III randomized Double-Blind Placebo-controlled (21)

Study population CLI subjects with minor tissue loss unsuitable for revascularization

Countries Germany UK US Poland Hungary Czech Republic Bulgaria Macedonia Israel

Sample size Randomization will stop when required amount of events (82) is assured

Doses tested 300M cells vs placebo (randomization ratio 21)

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 amp exploratory efficacy endpoints

Composite efficacy endpoint Pain Complete wound healing Quality-of-life Adjudicated amputations TcPO2 Cytokine levels

Follow-up length 52 weeks

Expected top-line interim data analysis results

Q4 calendar year of 2020

14

Ongoing CLI Phase III Study - Overview

PLX-PAD

Muscle Regeneration

15

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

16

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

Muscle Regeneration Following Hip Fracture

bull As the population ages the number of hip fractures continuesto increase

bull Worldwide the total number of hip fractures is expected tosurpass 6 million by the year 2050

bull Hip fracture often leads to serious long-term complicationsincluding pain functional decline and disability

bull Up to 36 mortality rate after one year due to immobilityassociated diseases

Kannus P Parkkari J Sievaumlnen H et al Epidemiology of hip fracturesSimran Mundi et al 2014Jorma Panula et al 2011

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

Wide Application of Placenta Cells

Market-Ready Scalable Technology

Platform

Off-the-shelf Allogeneic Line

of Products

Simple IM

Administration

Adaptive Slow Secretion of

Cytokines

Long-term Regenerative

Effect

Angiogenesis Muscle regeneration

Immunomodulation reduction of inflammation

8

From the Miracle of Birth to Regenerative Medicine for All

Product Focus Indication Funding LocationData

ReadoutPre-Clinical Phase I Phase II Phase III

PLX

-PA

D

Vascular Diseases

Critical Limb Ischemia Interim analysis-Q4 2020

Intermittent Claudication

Europe Israel US

Europe Israel US South Korea

Inflammatory Diseases

ARDS due to COVID-19 Europe US Q1 2021

Graft Versus Host Disease Israel

Muscle Injuries

Muscle Regeneration following Hip Fracture

Europe Israel US

Q3 2021

PLX

-R1

8

Hematological Deficiencies

Acute Radiation Syndrome US

Incomplete Recovery Following Bone Marrow Transplantation

Israel US Q1 2021

9

Clinical Pipeline

10

PLX-PAD

Peripheral Arterial Disease

bull CLI is caused by fatty deposits in leg arteries that obstruct blood flow

bull Risk factors include smoking diabetes obesity cardiovascular problems and hypertension

bull CLI patients suffer from severe pain skin wounds tissue necrosis and poor quality of life

bull High risk of leg amputation and death

bull Up to 35 of patients are unsuitable or will not benefit from revascularization

Peripheral Arterial Disease ndash Critical Limb Ischemia (CLI)

11

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 amp Outpatient Treatment Costs by Rutherford Category

Clinical Development in Peripheral Arterial Disease

12

Completed two Phase I studies in CLI ndash US amp Germany (N=27)

Good safety profile

Increase in tissue perfusion 60 reduction in the risk for death or amputation

Dose identification ndash two treatments of 300 million cells two months apart

Completed Phase II study in intermittent claudication (IC) ndash US Germany S Korea amp Israel

Good safety profile

Significant increase in walking distance reduction in surgical events and HbA1c and CRP levels

Confirmation of Phase III design including ndash dose (300m cells) dose regimen (2 administrations)

(N=172)

13

Ongoing Phase III study in CLI ndash US Europe amp Israel

Ongoing CLI Phase III Study

bull Expected top-line interim data analysis results in Q42020 (calendar year)

bull Patient enrollment to the full clinical study ongoing

bull Awarded adaptive pathway program in the EU

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

euro 76 million grant from the EU Horizon 2020 program

Design Phase III randomized Double-Blind Placebo-controlled (21)

Study population CLI subjects with minor tissue loss unsuitable for revascularization

Countries Germany UK US Poland Hungary Czech Republic Bulgaria Macedonia Israel

Sample size Randomization will stop when required amount of events (82) is assured

Doses tested 300M cells vs placebo (randomization ratio 21)

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 amp exploratory efficacy endpoints

Composite efficacy endpoint Pain Complete wound healing Quality-of-life Adjudicated amputations TcPO2 Cytokine levels

Follow-up length 52 weeks

Expected top-line interim data analysis results

Q4 calendar year of 2020

14

Ongoing CLI Phase III Study - Overview

PLX-PAD

Muscle Regeneration

15

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

16

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

Muscle Regeneration Following Hip Fracture

bull As the population ages the number of hip fractures continuesto increase

bull Worldwide the total number of hip fractures is expected tosurpass 6 million by the year 2050

bull Hip fracture often leads to serious long-term complicationsincluding pain functional decline and disability

bull Up to 36 mortality rate after one year due to immobilityassociated diseases

Kannus P Parkkari J Sievaumlnen H et al Epidemiology of hip fracturesSimran Mundi et al 2014Jorma Panula et al 2011

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

Product Focus Indication Funding LocationData

ReadoutPre-Clinical Phase I Phase II Phase III

PLX

-PA

D

Vascular Diseases

Critical Limb Ischemia Interim analysis-Q4 2020

Intermittent Claudication

Europe Israel US

Europe Israel US South Korea

Inflammatory Diseases

ARDS due to COVID-19 Europe US Q1 2021

Graft Versus Host Disease Israel

Muscle Injuries

Muscle Regeneration following Hip Fracture

Europe Israel US

Q3 2021

PLX

-R1

8

Hematological Deficiencies

Acute Radiation Syndrome US

Incomplete Recovery Following Bone Marrow Transplantation

Israel US Q1 2021

9

Clinical Pipeline

10

PLX-PAD

Peripheral Arterial Disease

bull CLI is caused by fatty deposits in leg arteries that obstruct blood flow

bull Risk factors include smoking diabetes obesity cardiovascular problems and hypertension

bull CLI patients suffer from severe pain skin wounds tissue necrosis and poor quality of life

bull High risk of leg amputation and death

bull Up to 35 of patients are unsuitable or will not benefit from revascularization

Peripheral Arterial Disease ndash Critical Limb Ischemia (CLI)

11

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 amp Outpatient Treatment Costs by Rutherford Category

Clinical Development in Peripheral Arterial Disease

12

Completed two Phase I studies in CLI ndash US amp Germany (N=27)

Good safety profile

Increase in tissue perfusion 60 reduction in the risk for death or amputation

Dose identification ndash two treatments of 300 million cells two months apart

Completed Phase II study in intermittent claudication (IC) ndash US Germany S Korea amp Israel

Good safety profile

Significant increase in walking distance reduction in surgical events and HbA1c and CRP levels

Confirmation of Phase III design including ndash dose (300m cells) dose regimen (2 administrations)

(N=172)

13

Ongoing Phase III study in CLI ndash US Europe amp Israel

Ongoing CLI Phase III Study

bull Expected top-line interim data analysis results in Q42020 (calendar year)

bull Patient enrollment to the full clinical study ongoing

bull Awarded adaptive pathway program in the EU

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

euro 76 million grant from the EU Horizon 2020 program

Design Phase III randomized Double-Blind Placebo-controlled (21)

Study population CLI subjects with minor tissue loss unsuitable for revascularization

Countries Germany UK US Poland Hungary Czech Republic Bulgaria Macedonia Israel

Sample size Randomization will stop when required amount of events (82) is assured

Doses tested 300M cells vs placebo (randomization ratio 21)

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 amp exploratory efficacy endpoints

Composite efficacy endpoint Pain Complete wound healing Quality-of-life Adjudicated amputations TcPO2 Cytokine levels

Follow-up length 52 weeks

Expected top-line interim data analysis results

Q4 calendar year of 2020

14

Ongoing CLI Phase III Study - Overview

PLX-PAD

Muscle Regeneration

15

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

16

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

Muscle Regeneration Following Hip Fracture

bull As the population ages the number of hip fractures continuesto increase

bull Worldwide the total number of hip fractures is expected tosurpass 6 million by the year 2050

bull Hip fracture often leads to serious long-term complicationsincluding pain functional decline and disability

bull Up to 36 mortality rate after one year due to immobilityassociated diseases

Kannus P Parkkari J Sievaumlnen H et al Epidemiology of hip fracturesSimran Mundi et al 2014Jorma Panula et al 2011

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

10

PLX-PAD

Peripheral Arterial Disease

bull CLI is caused by fatty deposits in leg arteries that obstruct blood flow

bull Risk factors include smoking diabetes obesity cardiovascular problems and hypertension

bull CLI patients suffer from severe pain skin wounds tissue necrosis and poor quality of life

bull High risk of leg amputation and death

bull Up to 35 of patients are unsuitable or will not benefit from revascularization

Peripheral Arterial Disease ndash Critical Limb Ischemia (CLI)

11

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 amp Outpatient Treatment Costs by Rutherford Category

Clinical Development in Peripheral Arterial Disease

12

Completed two Phase I studies in CLI ndash US amp Germany (N=27)

Good safety profile

Increase in tissue perfusion 60 reduction in the risk for death or amputation

Dose identification ndash two treatments of 300 million cells two months apart

Completed Phase II study in intermittent claudication (IC) ndash US Germany S Korea amp Israel

Good safety profile

Significant increase in walking distance reduction in surgical events and HbA1c and CRP levels

Confirmation of Phase III design including ndash dose (300m cells) dose regimen (2 administrations)

(N=172)

13

Ongoing Phase III study in CLI ndash US Europe amp Israel

Ongoing CLI Phase III Study

bull Expected top-line interim data analysis results in Q42020 (calendar year)

bull Patient enrollment to the full clinical study ongoing

bull Awarded adaptive pathway program in the EU

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

euro 76 million grant from the EU Horizon 2020 program

Design Phase III randomized Double-Blind Placebo-controlled (21)

Study population CLI subjects with minor tissue loss unsuitable for revascularization

Countries Germany UK US Poland Hungary Czech Republic Bulgaria Macedonia Israel

Sample size Randomization will stop when required amount of events (82) is assured

Doses tested 300M cells vs placebo (randomization ratio 21)

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 amp exploratory efficacy endpoints

Composite efficacy endpoint Pain Complete wound healing Quality-of-life Adjudicated amputations TcPO2 Cytokine levels

Follow-up length 52 weeks

Expected top-line interim data analysis results

Q4 calendar year of 2020

14

Ongoing CLI Phase III Study - Overview

PLX-PAD

Muscle Regeneration

15

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

16

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

Muscle Regeneration Following Hip Fracture

bull As the population ages the number of hip fractures continuesto increase

bull Worldwide the total number of hip fractures is expected tosurpass 6 million by the year 2050

bull Hip fracture often leads to serious long-term complicationsincluding pain functional decline and disability

bull Up to 36 mortality rate after one year due to immobilityassociated diseases

Kannus P Parkkari J Sievaumlnen H et al Epidemiology of hip fracturesSimran Mundi et al 2014Jorma Panula et al 2011

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

bull CLI is caused by fatty deposits in leg arteries that obstruct blood flow

bull Risk factors include smoking diabetes obesity cardiovascular problems and hypertension

bull CLI patients suffer from severe pain skin wounds tissue necrosis and poor quality of life

bull High risk of leg amputation and death

bull Up to 35 of patients are unsuitable or will not benefit from revascularization

Peripheral Arterial Disease ndash Critical Limb Ischemia (CLI)

11

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 amp Outpatient Treatment Costs by Rutherford Category

Clinical Development in Peripheral Arterial Disease

12

Completed two Phase I studies in CLI ndash US amp Germany (N=27)

Good safety profile

Increase in tissue perfusion 60 reduction in the risk for death or amputation

Dose identification ndash two treatments of 300 million cells two months apart

Completed Phase II study in intermittent claudication (IC) ndash US Germany S Korea amp Israel

Good safety profile

Significant increase in walking distance reduction in surgical events and HbA1c and CRP levels

Confirmation of Phase III design including ndash dose (300m cells) dose regimen (2 administrations)

(N=172)

13

Ongoing Phase III study in CLI ndash US Europe amp Israel

Ongoing CLI Phase III Study

bull Expected top-line interim data analysis results in Q42020 (calendar year)

bull Patient enrollment to the full clinical study ongoing

bull Awarded adaptive pathway program in the EU

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

euro 76 million grant from the EU Horizon 2020 program

Design Phase III randomized Double-Blind Placebo-controlled (21)

Study population CLI subjects with minor tissue loss unsuitable for revascularization

Countries Germany UK US Poland Hungary Czech Republic Bulgaria Macedonia Israel

Sample size Randomization will stop when required amount of events (82) is assured

Doses tested 300M cells vs placebo (randomization ratio 21)

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 amp exploratory efficacy endpoints

Composite efficacy endpoint Pain Complete wound healing Quality-of-life Adjudicated amputations TcPO2 Cytokine levels

Follow-up length 52 weeks

Expected top-line interim data analysis results

Q4 calendar year of 2020

14

Ongoing CLI Phase III Study - Overview

PLX-PAD

Muscle Regeneration

15

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

16

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

Muscle Regeneration Following Hip Fracture

bull As the population ages the number of hip fractures continuesto increase

bull Worldwide the total number of hip fractures is expected tosurpass 6 million by the year 2050

bull Hip fracture often leads to serious long-term complicationsincluding pain functional decline and disability

bull Up to 36 mortality rate after one year due to immobilityassociated diseases

Kannus P Parkkari J Sievaumlnen H et al Epidemiology of hip fracturesSimran Mundi et al 2014Jorma Panula et al 2011

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

Clinical Development in Peripheral Arterial Disease

12

Completed two Phase I studies in CLI ndash US amp Germany (N=27)

Good safety profile

Increase in tissue perfusion 60 reduction in the risk for death or amputation

Dose identification ndash two treatments of 300 million cells two months apart

Completed Phase II study in intermittent claudication (IC) ndash US Germany S Korea amp Israel

Good safety profile

Significant increase in walking distance reduction in surgical events and HbA1c and CRP levels

Confirmation of Phase III design including ndash dose (300m cells) dose regimen (2 administrations)

(N=172)

13

Ongoing Phase III study in CLI ndash US Europe amp Israel

Ongoing CLI Phase III Study

bull Expected top-line interim data analysis results in Q42020 (calendar year)

bull Patient enrollment to the full clinical study ongoing

bull Awarded adaptive pathway program in the EU

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

euro 76 million grant from the EU Horizon 2020 program

Design Phase III randomized Double-Blind Placebo-controlled (21)

Study population CLI subjects with minor tissue loss unsuitable for revascularization

Countries Germany UK US Poland Hungary Czech Republic Bulgaria Macedonia Israel

Sample size Randomization will stop when required amount of events (82) is assured

Doses tested 300M cells vs placebo (randomization ratio 21)

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 amp exploratory efficacy endpoints

Composite efficacy endpoint Pain Complete wound healing Quality-of-life Adjudicated amputations TcPO2 Cytokine levels

Follow-up length 52 weeks

Expected top-line interim data analysis results

Q4 calendar year of 2020

14

Ongoing CLI Phase III Study - Overview

PLX-PAD

Muscle Regeneration

15

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

16

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

Muscle Regeneration Following Hip Fracture

bull As the population ages the number of hip fractures continuesto increase

bull Worldwide the total number of hip fractures is expected tosurpass 6 million by the year 2050

bull Hip fracture often leads to serious long-term complicationsincluding pain functional decline and disability

bull Up to 36 mortality rate after one year due to immobilityassociated diseases

Kannus P Parkkari J Sievaumlnen H et al Epidemiology of hip fracturesSimran Mundi et al 2014Jorma Panula et al 2011

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

13

Ongoing Phase III study in CLI ndash US Europe amp Israel

Ongoing CLI Phase III Study

bull Expected top-line interim data analysis results in Q42020 (calendar year)

bull Patient enrollment to the full clinical study ongoing

bull Awarded adaptive pathway program in the EU

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

euro 76 million grant from the EU Horizon 2020 program

Design Phase III randomized Double-Blind Placebo-controlled (21)

Study population CLI subjects with minor tissue loss unsuitable for revascularization

Countries Germany UK US Poland Hungary Czech Republic Bulgaria Macedonia Israel

Sample size Randomization will stop when required amount of events (82) is assured

Doses tested 300M cells vs placebo (randomization ratio 21)

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 amp exploratory efficacy endpoints

Composite efficacy endpoint Pain Complete wound healing Quality-of-life Adjudicated amputations TcPO2 Cytokine levels

Follow-up length 52 weeks

Expected top-line interim data analysis results

Q4 calendar year of 2020

14

Ongoing CLI Phase III Study - Overview

PLX-PAD

Muscle Regeneration

15

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

16

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

Muscle Regeneration Following Hip Fracture

bull As the population ages the number of hip fractures continuesto increase

bull Worldwide the total number of hip fractures is expected tosurpass 6 million by the year 2050

bull Hip fracture often leads to serious long-term complicationsincluding pain functional decline and disability

bull Up to 36 mortality rate after one year due to immobilityassociated diseases

Kannus P Parkkari J Sievaumlnen H et al Epidemiology of hip fracturesSimran Mundi et al 2014Jorma Panula et al 2011

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

euro 76 million grant from the EU Horizon 2020 program

Design Phase III randomized Double-Blind Placebo-controlled (21)

Study population CLI subjects with minor tissue loss unsuitable for revascularization

Countries Germany UK US Poland Hungary Czech Republic Bulgaria Macedonia Israel

Sample size Randomization will stop when required amount of events (82) is assured

Doses tested 300M cells vs placebo (randomization ratio 21)

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 amp exploratory efficacy endpoints

Composite efficacy endpoint Pain Complete wound healing Quality-of-life Adjudicated amputations TcPO2 Cytokine levels

Follow-up length 52 weeks

Expected top-line interim data analysis results

Q4 calendar year of 2020

14

Ongoing CLI Phase III Study - Overview

PLX-PAD

Muscle Regeneration

15

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

16

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

Muscle Regeneration Following Hip Fracture

bull As the population ages the number of hip fractures continuesto increase

bull Worldwide the total number of hip fractures is expected tosurpass 6 million by the year 2050

bull Hip fracture often leads to serious long-term complicationsincluding pain functional decline and disability

bull Up to 36 mortality rate after one year due to immobilityassociated diseases

Kannus P Parkkari J Sievaumlnen H et al Epidemiology of hip fracturesSimran Mundi et al 2014Jorma Panula et al 2011

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

PLX-PAD

Muscle Regeneration

15

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

16

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

Muscle Regeneration Following Hip Fracture

bull As the population ages the number of hip fractures continuesto increase

bull Worldwide the total number of hip fractures is expected tosurpass 6 million by the year 2050

bull Hip fracture often leads to serious long-term complicationsincluding pain functional decline and disability

bull Up to 36 mortality rate after one year due to immobilityassociated diseases

Kannus P Parkkari J Sievaumlnen H et al Epidemiology of hip fracturesSimran Mundi et al 2014Jorma Panula et al 2011

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

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

16

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

Muscle Regeneration Following Hip Fracture

bull As the population ages the number of hip fractures continuesto increase

bull Worldwide the total number of hip fractures is expected tosurpass 6 million by the year 2050

bull Hip fracture often leads to serious long-term complicationsincluding pain functional decline and disability

bull Up to 36 mortality rate after one year due to immobilityassociated diseases

Kannus P Parkkari J Sievaumlnen H et al Epidemiology of hip fracturesSimran Mundi et al 2014Jorma Panula et al 2011

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

Contralateral(nonndashoperated)

17

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

Change in Volume Improvement of 300

P=0004

Change in Strength Improvement of 500

P=00067

Change in Strength Improvement of 4000

P=0012

bull PLX-PAD demonstrated a significant increase in muscle strength amp volume compared to placebo

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

Muscle Regeneration

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

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 US Germany UK Denmark Israel

Sample size 240 patients

Doses tested 150M cells vs placebo (randomization ratio 11)

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 amp exploratory efficacy endpoints

Muscle strength muscle mass amp volume hospitalization time lower extremity measure

Follow-up length 26 (efficacy) 52 weeks (safety)

Expected top-line results Q3 calendar year of 2021

18 euro 74 million grant from the EU Horizon 2020 program

bull More than 60 of the studyrsquos population enrolled

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

PLX-PAD

Coronavirus ndash COVID-19

19

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

Acute Respiratory Distress Syndrome (ARDS)is one of the most common causes of death from COVID-19

PLX-PAD cells have immunomodulatory and cytoprotective properties which may playa meaningful role in mitigating the tissue-damaging effects of COVID-19 on the lungs

20

Severe ARDS Associated with COVID-19

Clinical progressbull Phase II and Expanded Access Program in the USbull Phase II in Europe and in Israelbull Compassionate Use in Israel

Pre-clinical supportImprove oxygenation and reduce lung fibrosis in an ARDS murine model

Decrease the pro-inflammatory M1 and increase the anti‐inflammatory M2 macrophages

Reduce pro-inflammatory cytokine production TNF-α INF-γ and IL-17A from stimulated PBMCs

Induce secretion of the anti-inflammatory cytokines IL-10 and IL-1Ra both inhibitors of the pro-inflammatory cytokine IL-1 from monocytes

Induce an increase in regulatory T (Treg) cells

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

COVID-19 Data

21

28-day follow-up for the first 8 ventilator-dependent COVID-19 patients (Reported May 20)

875 survival rate

75 of patients were off any mechanical ventilation

625 of patients were discharged alive from the hospital compared to 33(38 out of 1151 patients)

Changes in C-Reactive Protein (CRP) test evaluating liver response to inflammation

Encouraging Results from Compassionate Use Programs in the US amp Israel

Blood CRP decreased dramatically in all patientsfollowing PLX-PAD treatments

In data published in the NY area during March-April 2020 for patients requiring mechanical ventilation and discharged alive ndash Richardson S et al Presenting Characteristics Comorbidities and Outcomes Among 5700 Patients Hospitalized with COVID-19 in the New York City Area JAMA 2020 doi101001jama20206775

Barkama et al 2020 Placenta-Derived Cell Therapy to Treat Patients with Respiratory Failure due to COVID-19 In press

Design Phase II randomized Double-Blind Placebo-controlled

Study population Hospitalized mechanically ventilated adult patients suffering from respiratory failure and ARDS due to COVID-19

Countries US

Sample size 140 patients

Study design 600M cells ndash 1 administration300M cells ndash 2 administrations 300M cells 1 administration + Placebo 1 administrationPlacebo ndash 1 administrationPlacebo ndash 2 administrations

Administration IM injections

Primary efficacy endpoint Number of ventilator free days during the 28 days from day 1 through day 28 of the study

Secondary efficacy endpoints All cause mortality Duration of mechanical ventilation mean improvement relative to baseline on a 7-point ordinal scale ICU-free-days hospitalization-free days

Follow Up length Safety and survival follow-up will be conducted at day 60 week 26 and week 52

Expected end of enrollment US phase II study - during the Q1 calendar year of 2021 22

PLX-PAD as a Treatment for ARDS Due to COVID-19 US Trial

PLX-R18

Hematological Deficiencies

23

bull Acute Radiation Syndrome (ARS) Studies conducted and funded by US government (NIH DOD) FDA has cleared Pluristemrsquos Investigational New Drug (IND) application for PLX-R18 in the treatment

of ARS in case of nuclear events FDA Orphan Drug Designation

bull Phase I ndash Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation (HCT) N= 20 enrollment completed Open-label trial allows for interim data analysis Clinical sites in US amp Israel FDA Orphan Drug Designation Data from first two cohorts showed PLX-R18 led to increased production of

platelets amp red blood cells ultimately reducing the number of required transfusions Expected top-line results - during the Q1 calendar year of 2021

Hematological Programs

24

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

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

25

Series of studies conducted by the US National Institutes of Health (NIH) testing PLX-R18 as apotential treatment for ARS

bull EIB signed a euro50 million non-dilutive financing agreement with Pluristem

bull Purpose

To support Pluristemrsquos research and development in the EU to further advance its regenerativecell therapy platform and to assist moving the products in its pipeline to market

A special focus on clinical development of PLX cells as a treatment for complications associatedwith COVID-19

EIB will support up to 50 of the cost of the project

bull Will be available for a period of 3 years in three tranches subject to the achievement of certainclinical regulatory and scaling up milestones first tranche consisting of euro20 million second of euro18million and the third euro12 million

bull Will be payable to the EIB in a single payment following five years from the disbursement of the firstand second tranches and in two annual payments starting on the fourth year from disbursement ofthe third tranche with each tranche having an interest rate of between 3-4

bull EIB would be entitled to receive royalties from future revenues for a period of seven years starting2024 at a rate of 02 to 23 pro-rated to the amounts that the Company received

26

The European Investment Bank (EIB) ndasheuro50 Million Non-Dilutive Financing

PLX-R18

Hematological Deficiencies

23

bull Acute Radiation Syndrome (ARS) Studies conducted and funded by US government (NIH DOD) FDA has cleared Pluristemrsquos Investigational New Drug (IND) application for PLX-R18 in the treatment

of ARS in case of nuclear events FDA Orphan Drug Designation

bull Phase I ndash Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation (HCT) N= 20 enrollment completed Open-label trial allows for interim data analysis Clinical sites in US amp Israel FDA Orphan Drug Designation Data from first two cohorts showed PLX-R18 led to increased production of

platelets amp red blood cells ultimately reducing the number of required transfusions Expected top-line results - during the Q1 calendar year of 2021

Hematological Programs

24

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

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

25

Series of studies conducted by the US National Institutes of Health (NIH) testing PLX-R18 as apotential treatment for ARS

bull EIB signed a euro50 million non-dilutive financing agreement with Pluristem

bull Purpose

To support Pluristemrsquos research and development in the EU to further advance its regenerativecell therapy platform and to assist moving the products in its pipeline to market

A special focus on clinical development of PLX cells as a treatment for complications associatedwith COVID-19

EIB will support up to 50 of the cost of the project

bull Will be available for a period of 3 years in three tranches subject to the achievement of certainclinical regulatory and scaling up milestones first tranche consisting of euro20 million second of euro18million and the third euro12 million

bull Will be payable to the EIB in a single payment following five years from the disbursement of the firstand second tranches and in two annual payments starting on the fourth year from disbursement ofthe third tranche with each tranche having an interest rate of between 3-4

bull EIB would be entitled to receive royalties from future revenues for a period of seven years starting2024 at a rate of 02 to 23 pro-rated to the amounts that the Company received

26

The European Investment Bank (EIB) ndasheuro50 Million Non-Dilutive Financing

bull Acute Radiation Syndrome (ARS) Studies conducted and funded by US government (NIH DOD) FDA has cleared Pluristemrsquos Investigational New Drug (IND) application for PLX-R18 in the treatment

of ARS in case of nuclear events FDA Orphan Drug Designation

bull Phase I ndash Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation (HCT) N= 20 enrollment completed Open-label trial allows for interim data analysis Clinical sites in US amp Israel FDA Orphan Drug Designation Data from first two cohorts showed PLX-R18 led to increased production of

platelets amp red blood cells ultimately reducing the number of required transfusions Expected top-line results - during the Q1 calendar year of 2021

Hematological Programs

24

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

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

25

Series of studies conducted by the US National Institutes of Health (NIH) testing PLX-R18 as apotential treatment for ARS

bull EIB signed a euro50 million non-dilutive financing agreement with Pluristem

bull Purpose

To support Pluristemrsquos research and development in the EU to further advance its regenerativecell therapy platform and to assist moving the products in its pipeline to market

A special focus on clinical development of PLX cells as a treatment for complications associatedwith COVID-19

EIB will support up to 50 of the cost of the project

bull Will be available for a period of 3 years in three tranches subject to the achievement of certainclinical regulatory and scaling up milestones first tranche consisting of euro20 million second of euro18million and the third euro12 million

bull Will be payable to the EIB in a single payment following five years from the disbursement of the firstand second tranches and in two annual payments starting on the fourth year from disbursement ofthe third tranche with each tranche having an interest rate of between 3-4

bull EIB would be entitled to receive royalties from future revenues for a period of seven years starting2024 at a rate of 02 to 23 pro-rated to the amounts that the Company received

26

The European Investment Bank (EIB) ndasheuro50 Million Non-Dilutive Financing

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

25

Series of studies conducted by the US National Institutes of Health (NIH) testing PLX-R18 as apotential treatment for ARS

bull EIB signed a euro50 million non-dilutive financing agreement with Pluristem

bull Purpose

To support Pluristemrsquos research and development in the EU to further advance its regenerativecell therapy platform and to assist moving the products in its pipeline to market

A special focus on clinical development of PLX cells as a treatment for complications associatedwith COVID-19

EIB will support up to 50 of the cost of the project

bull Will be available for a period of 3 years in three tranches subject to the achievement of certainclinical regulatory and scaling up milestones first tranche consisting of euro20 million second of euro18million and the third euro12 million

bull Will be payable to the EIB in a single payment following five years from the disbursement of the firstand second tranches and in two annual payments starting on the fourth year from disbursement ofthe third tranche with each tranche having an interest rate of between 3-4

bull EIB would be entitled to receive royalties from future revenues for a period of seven years starting2024 at a rate of 02 to 23 pro-rated to the amounts that the Company received

26

The European Investment Bank (EIB) ndasheuro50 Million Non-Dilutive Financing

bull EIB signed a euro50 million non-dilutive financing agreement with Pluristem

bull Purpose

To support Pluristemrsquos research and development in the EU to further advance its regenerativecell therapy platform and to assist moving the products in its pipeline to market

A special focus on clinical development of PLX cells as a treatment for complications associatedwith COVID-19

EIB will support up to 50 of the cost of the project

bull Will be available for a period of 3 years in three tranches subject to the achievement of certainclinical regulatory and scaling up milestones first tranche consisting of euro20 million second of euro18million and the third euro12 million

bull Will be payable to the EIB in a single payment following five years from the disbursement of the firstand second tranches and in two annual payments starting on the fourth year from disbursement ofthe third tranche with each tranche having an interest rate of between 3-4

bull EIB would be entitled to receive royalties from future revenues for a period of seven years starting2024 at a rate of 02 to 23 pro-rated to the amounts that the Company received

26

The European Investment Bank (EIB) ndasheuro50 Million Non-Dilutive Financing

27

Regulatory support

Governmental agencies collaborators and

projects

Significant Regulatory and Government Support

28

Pluristem keeps IP and manufacturing rights in all collaborations

Partnerships and Collaborations

29

Chen Franco-YehudaCFO

Liran Shani MDVP Clinical amp Medical Affairs

Efrat Livne-HadassVP Human Resources

Lior RavivVP Operations amp Development

Efrat KaduriDirector of Marketing amp Business Development

Orly AmiranVP Quality Assurance

Racheli Ofir PhD VP Research amp Intellectual Property

Yaky YanayCEO amp President

Zami AbermanExecutive Chairman

Management Team

InvestorrelationsPluristemcom wwwPluristemcom

30

Israel +972-74-710-8600

US +1-347-973-2098

Germany +49-30-2215-0786

28

Pluristem keeps IP and manufacturing rights in all collaborations

Partnerships and Collaborations

29

Chen Franco-YehudaCFO

Liran Shani MDVP Clinical amp Medical Affairs

Efrat Livne-HadassVP Human Resources

Lior RavivVP Operations amp Development

Efrat KaduriDirector of Marketing amp Business Development

Orly AmiranVP Quality Assurance

Racheli Ofir PhD VP Research amp Intellectual Property

Yaky YanayCEO amp President

Zami AbermanExecutive Chairman

Management Team

InvestorrelationsPluristemcom wwwPluristemcom

30

Israel +972-74-710-8600

US +1-347-973-2098

Germany +49-30-2215-0786

29

Chen Franco-YehudaCFO

Liran Shani MDVP Clinical amp Medical Affairs

Efrat Livne-HadassVP Human Resources

Lior RavivVP Operations amp Development

Efrat KaduriDirector of Marketing amp Business Development

Orly AmiranVP Quality Assurance

Racheli Ofir PhD VP Research amp Intellectual Property

Yaky YanayCEO amp President

Zami AbermanExecutive Chairman

Management Team

InvestorrelationsPluristemcom wwwPluristemcom

30

Israel +972-74-710-8600

US +1-347-973-2098

Germany +49-30-2215-0786

InvestorrelationsPluristemcom wwwPluristemcom

30

Israel +972-74-710-8600

US +1-347-973-2098

Germany +49-30-2215-0786