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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 22, 2020

            Details:

            Independent DSMB unanimously recommends continuation of the global Phase 2/3 study of orally-administered opaganib in severe COVID-19 based on review of unblinded safety data from 155 treated patients.

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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: ABC294640

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 15, 2020

            Details:

            Opaganib, a novel, orally administered sphingosine kinase 2 (SK2) selective inhibitor, administered at 250mg/kg, showed a reduction of thrombosis (blood clotting) in an acute respiratory distress syndrome – a preclinical animal model designed to measure thrombotic risks.

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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 19, 2020

            Details:

            The global Phase 2/3 study with opaganib (Yeliva®, ABC294640) in patients hospitalized with severe COVID-19 pneumonia has received a unanimous recommendation to continue, following a pre-scheduled safety review by an independent Data and Safety Monitoring Board.

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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 16, 2020

            Details:

            U.S. Phase 2 study with opaganib (Yeliva®, ABC294640) in patients hospitalized with severe COVID-19 pneumonia has completed enrollment of the last patient in the study.

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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement October 13, 2020

            Details:

            Collaborations with European and Canadian suppliers for large-scale ramp-up of opaganib manufacturing further strengthens manufacturing capabilities and capacity, in preparation for potential emergency use applications.

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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership October 13, 2020

            Details:

            Collaborations with European and Canadian suppliers for large-scale ramp-up of opaganib manufacturing further strengthens manufacturing capabilities and capacity, in preparation for potential emergency use applications .

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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 22, 2020

            Details:

            The ongoing global Phase 2/3 study with orally-administered opaganib in patients with severe COVID-19 is approved in Italy, the UK, Russia, Israel, Mexico and Brazil; 16 clinical sites initiated globally to date.

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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 08, 2020

            Details:

            Opaganib completely inhibited SARS-CoV-2 viral replication as measured after three days incubation in an in vitro model of human bronchial tissue, comparing favorably with remdesivir, the positive control in the study.

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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 06, 2020

            Details:

            The Phase 2/3 study is set to enroll up to 270 patients with severe COVID-19 pneumonia requiring hospitalization and treatment with supplemental oxygen. Subjects will be randomized at a 1:1 ratio to receive either opaganib or placebo, along with standard-of-care therapy.

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            Lead Product(s): Opaganib

            Therapeutic Area: Infections and Infectious Diseases Product Name: Yeliva

            Highest Development Status: Phase II/ Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 30, 2020

            Details:

            RedHill Biopharma has initiated a global Phase 2/3 clinical study evaluating opaganib (Yeliva®) in patients hospitalized with severe SARS-CoV-2 infection (the cause of COVID-19) and pneumonia requiring treatment with supplemental oxygen.