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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil

            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 29, 2021

            Details:

            Remestemcel-L reduced mortality through 60 days in the pre-specified population under 65 years old. In these patients the benefit was further increased when remestemcel-L was used with dexamethasone as part of standard of care.

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil

            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 17, 2020

            Details:

            The DSMB noted that the trial of remestemcel-L in ventilator-dependent patients with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19 infection is not likely to meet the 30-day mortality reduction endpoint at the planned 300 patient enrolment.

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil

            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 02, 2020

            Details:

            Clinical data provided to the FDA supporting the potential of remestemcel-L to address the unmet medical need of COVID-19 ARDS included results from a pilot study of remestemcel-L under emergency compassionate use at New York’s Mt Sinai Hospital in March-April this year.

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil

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

            Partner/Sponsor/Collaborator: Novartis Pharmaceuticals Corporation

            Deal Size: $1,355.0 million Upfront Cash: $50.0 million

            Deal Type: Collaboration November 20, 2020

            Details:

            Addition of remestemcel-L could expand Novartis' respiratory portfolio by adding potential first-in-class ARDS therapy using innovative cell-based technology with platform potential.

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            Lead Product(s): Remestemcel-L

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ryoncil

            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 11, 2020

            Details:

            The Phase 3 trial aims to confirm findings from a pilot study at New York’s Mt Sinai Hospital where nine of 12 ventilator-dependent patients were successfully discharged from hospital a median of 10 days after receiving two intravenous doses of remestemcel-L within five days.