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Find Drugs for Cardiology/Vascular Diseases in Phase II Clinical Development in UNITED STATES

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            Lead Product(s): CLBS12

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: Honedra

            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

            Details:

            Caladrius Biosciences has received trademark registration from the Japan Patent Office (“JPO”) for the Company’s use of HONEDRA® as the brand name for CLBS12, its SAKIGAKE-designated product candidate for the treatment of Critical Limb Ischemia and Buerger’s Disease.

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            Lead Product(s): RUC-4

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: RUC-4

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 03, 2020

            Details:

            The data show that subcutaneous administration of RUC-4 resulted in a potent, rapid, and sustained platelet inhibition effect that largely resolved after two hours.

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            Lead Product(s): BIO89-100

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: BIO89-100

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 03, 2020

            Details:

            Multi-center, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of BIO89-100 administered weekly or every two weeks for 8 weeks.

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            Lead Product(s): Sodium Nitrite

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: JAN101

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 03, 2020

            Details:

            Working closely with selected bottling and labeling partner, Eurofins CDMO, the company is currently on track to initiate GMP production of JAN101 to support planned Phase 2b trials to treat peripheral artery disease (PAD).

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            Lead Product(s): Levosimendan

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 31, 2020

            Details:

            Phase 2 HELP Study of levosimendan in PH-HFpEF have been accepted for presentation as a Late-Breaking Clinical Trial at this year’s Heart Failure Society of America (HFSA) Annual Scientific Meeting to be held September 30, 2020-October 6, 2020.

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            Lead Product(s): Sodium Nitrite

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: JAN101

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership August 28, 2020

            Details:

            The Partnership aims at JanOne is preparing its investigational new drug (IND) application for FDA submission for JAN101 as a potential treatment for vascular complications caused by Covid-19.

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            Lead Product(s): Omega-3 pentaenoic acid

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: MAT9001

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 27, 2020

            Details:

            The ENHANCE-IT study is assessing MAT9001’s effectiveness in reducing triglyceride levels and other important lipid markers, as well as characterizing bioavailability and blood levels of eicosapentaenoic acid (EPA) and other omega-3 fatty acids.

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            Lead Product(s): Sodium Nitrite

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: JAN101

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 26, 2020

            Details:

            Initial JAN101 engineering batch is complete. JAN101 formulation is a patented proprietary compound of sodium nitrite that has been successful in Phase 1 and Phase 2a studies to enhance the blood flow and vascular function needed to treat PAD and Covid-19 complications.

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            Lead Product(s): Obicetrapib

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: AMG 899

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: NewAmsterdam Pharma

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Acquisition August 25, 2020

            Details:

            NewAmsterdam Pharma is currently working with the U.S. Food and Drug Administration (FDA) on a comprehensive Phase 3 clinical development program, including a cardiovascular outcome trial (CVOT) for obicetrapib.

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            Lead Product(s): Vupanorsen

            Therapeutic Area: Cardiology/Vascular Diseases Product Name: AKCEA-ANGPTL3-LRx

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

            Partner/Sponsor/Collaborator: Ionis Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 24, 2020

            Details:

            The Phase 2 dose-ranging clinical trial evaluated the safety and efficacy of vupanorsen in patients with hypertriglyceridemia, type 2 diabetes, and non-alcoholic fatty liver disease (NAFLD).

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