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[{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pluristem and Charit\u00e9 University of Medicine Berlin Join Forces Targeting COVID-19 Treatment","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Undisclosed","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Undisclosed"},{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable ","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pluristem Receives Response from U.S. BARDA for Acute Radiation Syndrome Research Proposa\n","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"Preclinical","country":"ISRAEL","productType":"Large molecule","productStatus":"New Molecular Entity","date":"March 2020","url1":"","url2":"","graph1":"Trauma (Emergency, Injury, Surgery)","graph2":"Preclinical"},{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Clears Pluristem\u2019s IND Application for Phase II COVID-19 Study","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pluristem Announces Activation of Clinical Sites and Commencement of Patient Enrollment in U.S. FDA Phase II COVID-19 ARDS Trial","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pluristem Provides Clinical Updates on its Phase III Critical Limb Ischemia (CLI) Study","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"ISRAEL","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pluristem Expands its COVID-19 Program to Europe, Receives PEI Clearance to Commence Phase II Study in Germany","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pluristem Announces End of Patient Enrollment in its Phase I Hematology Study","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase I","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Hematology","graph2":"Phase I"},{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pluristem Launches FDA-Cleared COVID-19 Expanded Access Program, Enabling Patient Treatment Outside of Clinical Trial","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pluristem Expands its Phase II COVID-19 European Clinical \n Trial to Israel","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pluristem Announces DMC Recommendation Following Interim Analysis of its Phase III CLI Study","therapeuticArea":"Cardiology\/Vascular Diseases","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Cardiology\/Vascular Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pluristem Reports Positive Topline Phase I Results in Innovative Hematology Program, Which Is First to Study PLX-R18 in Humans","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I"},{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pluristem Brings ARDS Associated with COVID-19 Phase II Studies to Clinical Readout","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2021","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pluristem Completes Enrollment of Its Multinational Phase III Study of Muscle Regeneration Following Hip Fracture Surgery","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"November 2021","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pluristem Releases PLX-R18 Hematology Phase I Study Results: Data Show Increase in All Blood Lines and Reduction in Blood Transfusions","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Immunology","graph2":"Phase I"},{"orgOrder":0,"company":"Pluri","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Pluristem Reports Topline Results from its Phase III Study of Muscle Regeneration Following Hip Fracture Surgery","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2022","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Pluri","sponsor":"European Union\u2019s Horizon Europe","pharmaFlowCategory":"D","amount":"$7.5 million","upfrontCash":"Undisclosed","newsHeadline":"\u20ac7.5 Million Granted to Collaborative PROTO Project led by Charit\u00e9 to Study Pluri\u2019s PLX-PAD Cells for Osteoarthritis Treatment","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Preclinical","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"September 2022","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Preclinical"},{"orgOrder":0,"company":"Pluri","sponsor":"National Institute of Allergy and Infectious Diseases","pharmaFlowCategory":"D","amount":"$4.2 million","upfrontCash":"Undisclosed","newsHeadline":"U.S. National Institutes of Health to Fund $4.2 Million Contract to Advance Development of Pluris PLX-R18 in Conjunction with U.S. DoD as a Medical Countermeasure for Hematopoietic Acute Radiation Syndrome","therapeuticArea":"Trauma (Emergency, Injury, Surgery)","highestDevelopmentStatus":"Phase I","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2023","url1":"","url2":"","graph1":"Trauma (Emergency, Injury, Surgery)","graph2":"Phase I"},{"orgOrder":0,"company":"Pluri","sponsor":"Bar-Ilan University","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Pluri and Bar-Ilan University to Develop PLX Cells for the Treatment of Cocaine Addiction","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Preclinical","country":"ISRAEL","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"February 2024","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Preclinical"}]

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            Details:

            Through the agreement, Pluri will focus on the development of PLX-PAD cells (emiplacel), that exhibit immune-modulating capabilities, for the treatment of patients with cocaine addictions.

            Lead Product(s): Emiplacel

            Therapeutic Area: Psychiatry/Psychology Product Name: PLX-PAD

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Bar-Ilan University

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement February 05, 2024

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            The net funding will be used to advance the development of its PLX-R18 cell therapy as a potential novel treatment for Hematopoietic Acute Radiation Syndrome (H-ARS).

            Lead Product(s): PLX-R18

            Therapeutic Area: Trauma (Emergency, Injury, Surgery) Product Name: PLX-R18

            Highest Development Status: Phase I Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: National Institute of Allergy and Infectious Diseases

            Deal Size: $4.2 million Upfront Cash: Undisclosed

            Deal Type: Funding July 11, 2023

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            The goal of the PROTO project is to utilize Pluri’s PLX-PAD cells in a Phase I/IIa study for the treatment of mild to moderate knee osteoarthritis (OA).

            Lead Product(s): PLX-PAD

            Therapeutic Area: Musculoskeletal Product Name: PLX-PAD

            Highest Development Status: Preclinical Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: European Union’s Horizon Europe

            Deal Size: $7.5 million Upfront Cash: Undisclosed

            Deal Type: Collaboration September 06, 2022

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            Patients treated with PLX-PAD (allogeneic PLX-PAD Cell) showed an increase of 2.3kg from reference (week 6) to week 26 compared to 0.51kg in the placebo group, a 1.8kg difference (p=0.073).

            Lead Product(s): Allogeneic PLX-PAD Cell

            Therapeutic Area: Musculoskeletal Product Name: PLX-PAD

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 13, 2022

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            Results show the potential in the use of PLX-R18 for meaningful advantage over other existing and proposed treatments in post hematopoietic cell transplantation (HCT) patients. PLX-R18 reduced mortality from 29% to 18%1 and was well-tolerated with a favorable safety profile.

            Lead Product(s): PLX-R18

            Therapeutic Area: Immunology Product Name: PLX-R18

            Highest Development Status: Phase I Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 23, 2022

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            PLX-PAD cells demonstrated statistically significant superiority, in ability to increase muscle strength and volume for patients who have undergone total hip replacement surgery due to osteoarthritis.

            Lead Product(s): PLX-PAD

            Therapeutic Area: Musculoskeletal Product Name: PLX-PAD

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 15, 2021

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            The analysis will be based on 89 patients enrolled in the previously announced two Phase II studies, which investigated the safety and efficacy of Pluristem’s PLX cells as a treatment for severe COVID-19 cases complicated by ARDS.

            Lead Product(s): PLX-PAD

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: PLX-PAD

            Highest Development Status: Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 08, 2021

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            The results demonstrate that PLX-R18 has the potential to stimulate the implanted hematopoietic cells to realize their therapeutic potential and generate improved blood counts over the long term in all three blood cell lineages at once.

            Lead Product(s): PLX-R18

            Therapeutic Area: Genetic Disease Product Name: PLX-R18

            Highest Development Status: Phase I Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 29, 2021

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            Based on the review, the DMC concluded that the CLI study is unlikely to meet the primary endpoint by the time of the final analysis. Company to terminate the CLI study of PLX-PAD to focus on different therapeutic areas in its pipeline.

            Lead Product(s): PLX-PAD

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: PLX-PAD

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 09, 2020

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            Pluristem Therapeutics has received approval from the Israeli Ministry of Health to commence patient enrollment in Israel for its COVID-19 Phase II clinical trial, under the protocol that was approved by Germany’s regulatory agency.

            Lead Product(s): PLX-PAD

            Therapeutic Area: Infections and Infectious Diseases Product Name: PLX-PAD

            Highest Development Status: Phase II Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 07, 2020

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