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[{"orgOrder":0,"company":"Ensysce Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ensysce, a California Based Biotech Company With a Mission to Solve the Opioid Crisis, Exploring a Treatment for COVID-19","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"Ensysce Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"COVISTAT, a Subsidiary of Ensysce Biosciences Is Commencing Phase 1 Study of Novel COVID-19 Treatment","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Ensysce Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ensysce Biosciences\u2019 Covistat Subsidiary \u201cAt Home Coronavirus Pill\u201d Commencing to Phase 2 Clinical Development","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Ensysce Biosciences","sponsor":"National Institute on Drug Abuse","pharmaFlowCategory":"D","amount":"$8.0 million","upfrontCash":"Undisclosed","newsHeadline":"Ensysce Biosciences Receives NIDA Grant for the Clinical Development of its Next Generation Opioid Products with Overdose Protection","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"July 2021","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Ensysce Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ensysce Biosciences Achieves Successful Completion of Part A of MultipleAscending Dose (MAD)\/Bioequivalents (BE) Trial for its Next Generation Opioid, PF614","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I"},{"orgOrder":0,"company":"Ensysce Biosciences","sponsor":"Quotient Sciences","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Ensysce Biosciences and Quotient Sciences Announce a Partnership on the Development and Clinical Testing of Ensysce's PF614-MPAR, a Novel Opioid Designed to Prevent Abuse and Overdose","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"orgOrder":0,"company":"Ensysce Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ensysce Biosciences Begins Patient Dosing In Second Human Abuse Potential Study","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I"},{"orgOrder":0,"company":"Ensysce Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ensysce Biosciences Announces Data from PF614-MPAR-101-Part A Successfully Demonstrating Opioid Overdose Protection","therapeuticArea":"Psychiatry\/Psychology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2022","url1":"","url2":"","graph1":"Psychiatry\/Psychology","graph2":"Phase I"},{"orgOrder":0,"company":"Ensysce Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ensysce Biosciences to Present its Overdose Protection Program at the 4th Annual NIH 'Helping End Addiction Long-Term' (HEAL) Meeting","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"February 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"orgOrder":0,"company":"Ensysce Biosciences","sponsor":"Quotient Sciences","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ensysce Biosciences' PF614-MPAR Enters Final Stage of Phase 1 Study","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Phase I"},{"orgOrder":0,"company":"Ensysce Biosciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ensysce Biosciences Announces IRB Approval of Key Study Protocol","therapeuticArea":"Neurology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2023","url1":"","url2":"","graph1":"Neurology","graph2":"IND Enabling"},{"orgOrder":0,"company":"Ensysce Biosciences","sponsor":"Undisclosed","pharmaFlowCategory":"D","amount":"$1.7 million","upfrontCash":"Undisclosed","newsHeadline":"Ensysce Biosciences Secures $1.7 Million Convertible Note Financing","therapeuticArea":"Neurology","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Neurology","graph2":"IND Enabling"}]

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            Development Status

            Details:

            The financing will support the completion of a time of onset study and regulatory milestones for company's lead product, PF614, a novel trypsin activated abuse protection (TAAP) prodrug of oxycodone, being studied as chronic pain analgesic.

            Lead Product(s): Oxycodone Prodrug

            Therapeutic Area: Neurology Product Name: PF614

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $1.7 million Upfront Cash: Undisclosed

            Deal Type: Private Placement October 24, 2023

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            Details:

            PF614 is a chemically modified opioid product that requires initial metabolic transformation by trypsin in the small intestine for activation to be able to relieve severe pain in patients who require an opioid-level analgesic.

            Lead Product(s): Oxycodone Prodrug

            Therapeutic Area: Neurology Product Name: PF614

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable August 09, 2023

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            PF614-MPAR (oxycodone prodrug) binds and inhibits adenylyl-cyclase and hyperpolarisation of neurons, and decreased excitability, thus reduces severe pain. It is the first opioid drug product that has both abuse deterrent properties as well as overdose protection.

            Lead Product(s): Oxycodone Prodrug,Nafamostat

            Therapeutic Area: Neurology Product Name: PF614-MPAR

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 14, 2023

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            PF614-MPAR (oxycodone prodrug) binds and inhibits adenylyl-cyclase and hyperpolarisation of neurons, and decreased excitability, thus reduces severe pain. It is the first opioid drug product that has both abuse deterrent properties as well as overdose protection.

            Lead Product(s): Oxycodone Prodrug,Nafamostat

            Therapeutic Area: Neurology Product Name: PF614-MPAR

            Highest Development Status: Phase I Product Type: Small molecule

            Recipient: Quotient Sciences

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 25, 2023

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            Details:

            PF614 is a TAAP (Trypsin Activated Abuse Protection) prodrug of oxycodone designed to reduce abuse of this opioid pain medication. PF614 requires exposure to trypsin, which safely turns ‘on' the release of oxycodone.

            Lead Product(s): Oxycodone Prodrug

            Therapeutic Area: Psychiatry/Psychology Product Name: PF614

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 20, 2022

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            Details:

            PF614 is a novel TAAP prodrug of oxycodone. PF614 uses the Ensysce TAAP technology and requires exposure to endogenous human trypsin in the intestines to trigger a two-step activation process to release active dose levels of oxycodone that is then absorbed systemically.

            Lead Product(s): Oxycodone Prodrug

            Therapeutic Area: Psychiatry/Psychology Product Name: PF614

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 28, 2022

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            Details:

            PF614-MPAR (oxycodone prodrug) is a novel opioid combination product for the potential treatment of chronic pain that is designed to prevent both abuse and overdose. This partnership serves as validation of the mission and ultimately the platforms.

            Lead Product(s): Oxycodone Prodrug,Nafamostat

            Therapeutic Area: Neurology Product Name: PF614-MPAR

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Quotient Sciences

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership August 31, 2022

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            Details:

            The Part A of the trial evaluated three dose levels of PF614 showed positive review from the Phase 1b tria, independent Safety Review Committee allowed the trial to proceed to the next dose level.

            Lead Product(s): Oxycodone Prodrug,Nafamostat,Naltrexone Hydrochloride

            Therapeutic Area: Psychiatry/Psychology Product Name: PRF06104

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 04, 2022

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            Details:

            PF614-MPAR™ is designed as an extended-release oxycodone prodrug with both trypsin-activated abuse protection (TAAP) and overdose protection through multi-pill abuse resistance (MPAR™) technology.

            Lead Product(s): PF614

            Therapeutic Area: Psychiatry/Psychology Product Name: PF614-MPAR

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: National Institute on Drug Abuse

            Deal Size: $8.0 million Upfront Cash: Undisclosed

            Deal Type: Funding July 08, 2021

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            Details:

            Covistat will present a summary of its findings that it believes demonstrate the ability of nafamostat, delivered to airways, to inhibit SARS-CoV-2 viral infection and increase mucocilliary clearance in the human airway.

            Lead Product(s): Nafamostat

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 07, 2021

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