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[{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Direct Biologics Receives FDA Approval to Initiate 'EXIT-COVID-19,' a Phase II Investigational New Drug Trial","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Bioclinica","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Bioclinica Partners with Direct Biologics to Provide Interactive Response Technology (IRT) Solution for COVID-19 Study","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Direct Biologics Initiates Patient Enrollment in the Phase II EXIT COVID-19 Clinical Trial","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Direct Biologics Announces First Patient Treated Under Phase II Expanded Access Protocol Using ExoFlo\u2122 to Treat COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"December 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Direct Biologics Granted FDA Approval of Third IND Application for the Use of ExoFlo in Mild-to-Moderate COVID-19 Infusion Therapy","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase II"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Approves Direct Biologics to Proceed with a Landmark Phase 3 Acute Respiratory Distress Syndrome (ARDS) Trial","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Good Works II Acquisition Corp.","pharmaFlowCategory":"D","amount":"$75.0 million","upfrontCash":"$75.0 million","newsHeadline":"Good Works II Acquisition Corp. and Direct Biologics, LLC Announce a Definitive Agreement for a Business Combination","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Direct Biologics Reports Compelling Results From Phase 2 Trial With ExoFlo\u2122 in Hospitalized Patients With Respiratory Failure or Moderate-to-Severe Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Direct Biologics Announces Initiation of Phase 1 Clinical Trial for Medically Refractory Crohn\u2019s Disease","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"March 2023","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase I"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Direct Biologics Reports Compelling Data as ExoFlo\u2122 Expanded Access Program in Hospitalized COVID-19 Patients with Moderate-to-Severe ARDS Surpasses 100 Subjects","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Direct Biologics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Direct Biologics Receives FDA Clearance to Initiate Phase 1b\/2a Clinical Trial of ExoFlo\u2122 in Patients with Medically Refractory Perianal Fistulizing Crohn\u2019s Disease","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"April 2023","url1":"","url2":"","graph1":"Gastroenterology","graph2":"Phase I"}]

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            Development Status

            Details:

            DB-001 (ExoFlo) is a regenerative medicine product candidate, designed to leverage the anti-inflammatory, immunomodulatory and regenerative properties of bone marrow MSC-derived EVs. Currently in development for medically refractory perianal fistulizing crohn’s disease.

            Lead Product(s): ExoFlo

            Therapeutic Area: Gastroenterology Product Name: DB-001

            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 26, 2023

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            DB-001 (ExoFlo) is a regenerative medicine product candidate, designed to leverage the anti-inflammatory, immunomodulatory and regenerative properties of bone marrow MSC-derived EVs. Currently in development for treating severe or critical COVID-19.

            Lead Product(s): ExoFlo

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: DB-001

            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 April 19, 2023

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            DB-001 (ExoFlo) is a regenerative medicine product candidate, designed to leverage the anti-inflammatory, immunomodulatory and regenerative properties of bone marrow MSC-derived EVs. Currently in development for treating severe or critical COVID-19.

            Lead Product(s): ExoFlo

            Therapeutic Area: Gastroenterology Product Name: DB-001

            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 21, 2023

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            DB-001 (ExoFlo) is a regenerative medicine product candidate, designed to leverage the anti-inflammatory, immunomodulatory and regenerative properties of bone marrow MSC-derived EVs. Currently in development for treating severe or critical COVID-19.

            Lead Product(s): ExoFlo

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: DB-001

            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 March 14, 2023

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            Details:

            ExoFlo received regenerative medicine advanced therapy (“RMAT”) designation for the treatment of severe or critical COVID-19 from the U.S. Food and Drug Administration (“FDA”).

            Lead Product(s): ExoFlo

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: DB-001

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

            Partner/Sponsor/Collaborator: Good Works II Acquisition Corp.

            Deal Size: $75.0 million Upfront Cash: $75.0 million

            Deal Type: Agreement October 13, 2022

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            Details:

            ExoFlo is an extracellular signal product isolated from human bone marrow MSCs that contains growth factors and extracellular vesicles including exosomes, to treat Acute Respiratory Distress Syndrome due to Covid-19.

            Lead Product(s): DB-001

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: ExoFlo

            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 April 21, 2022

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            ExoFlo provides signaling proteins that have been shown to modulate inflammation and may stimulate bioactivity and direct cellular communication.

            Lead Product(s): DB-001

            Therapeutic Area: Infections and Infectious Diseases Product Name: ExoFlo

            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 June 29, 2021

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            Details:

            ExoFlo is an investigational new drug that has not been approved or licensed by FDA. It is an extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs).

            Lead Product(s): DB-001

            Therapeutic Area: Infections and Infectious Diseases Product Name: ExoFlo

            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 December 30, 2020

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            Details:

            Under the terms of the agreement, Direct Biologics will leverage Bioclinica’s Interactive Response Technology (IRT) for their EXIT COVID-19 study, a multi-center FDA phase II clinical trial for the use of ExoFlo™ to treat COVID-19 acute respiratory distress syndrome (ARDS).

            Lead Product(s): DB-001

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: ExoFlo

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

            Recipient: Bioclinica

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership September 09, 2020

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            Details:

            EXIT COVID-19 has initiated enrollment of 75 COVID-19 patients with moderate-to-severe ARDS at multiple research sites across the U.S. The primary efficacy endpoints will be all-cause mortality and median days to recovery.

            Lead Product(s): DB-001

            Therapeutic Area: Infections and Infectious Diseases Product Name: ExoFlo

            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 September 09, 2020

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