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            Usona Institute

            • Development Update

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            Lead Product(s): Psilocybine

            Therapeutic Area: Psychiatry/Psychology Product Name: PSIL201

            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 03, 2020

            Details:

            The scalability, controllability, and reproducibility in this newly developed procedure demonstrate that a classic reaction can produce pharmaceutical-grade psilocybin at a large scale in fewer steps.

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            Lead Product(s): PRAX-114

            Therapeutic Area: Psychiatry/Psychology Product Name: PRAX-114

            Highest Development Status: Phase II Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Eventide Asset Management

            Deal Size: $110.0 million Upfront Cash: Undisclosed

            Deal Type: Series C Financing July 28, 2020

            Details:

            Praxis' pipeline consists of PRAX-114, now under Phase 2 development for the treatment of major depressive disorder and perimenopausal depression; PRAX-944, under Phase 2 for essential tremor; and PRAX-562, in Phase 1 for pediatric epilepsy and adult cephalgia.

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            Lead Product(s): PDC-1421

            Therapeutic Area: Psychiatry/Psychology Product Name: ABV-1505

            Highest Development Status: Phase II Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 28, 2020

            Details:

            Last patient last visit (LPLV) marked the final step toward the completion of ABV-1505 Phase II Part I clinical trial in treatment of adult attention-deficit hyperactivity disorder (ADHD).

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            Lead Product(s): Brilaroxazine

            Therapeutic Area: Psychiatry/Psychology Product Name: RP5063

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Tenzing

            Deal Size: $119.0 million Upfront Cash: Undisclosed

            Deal Type: Merger July 21, 2020

            Details:

            The acquisition adds Reviva's lead product candidate, RP5063 (brilaroxazine), for the treatment of schizophrenia, bipolar disorder, and major depressive disorder, to Tenzing's Pipeline.

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            Lead Product(s): Vafidemstat

            Therapeutic Area: Psychiatry/Psychology Product Name: ORY-2001

            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 July 06, 2020

            Details:

            ORYZON has presented the final data from its Phase IIa clinical trial REIMAGINE at the 28th European Congress of Psychiatry, EPA 2020, Results demostrate that Vafidemstat reduces aggression in the three psychiatric disorders studied.

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            Lead Product(s): Dextromethadone

            Therapeutic Area: Psychiatry/Psychology Product Name: REL-1017

            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 June 23, 2020

            Details:

            The patent that will issue from this allowed application provides broad coverage in Canada for REL-1017 (d-methadone, dextromethadone,) for the treatment of symptoms associated with a wide range of psychological and psychiatric disorders.

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            Lead Product(s): TAK-831

            Therapeutic Area: Psychiatry/Psychology Product Name: TAK-831

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Neurocrine Biosciences

            Deal Size: $2,015.0 million Upfront Cash: $120.0 million

            Deal Type: Licensing Agreement June 16, 2020

            Details:

            Under the terms of the agreement, Takeda granted an exclusive license to Neurocrine Biosciences for seven pipeline programs, including three clinical stage assets for schizophrenia, treatment-resistant depression and anhedonia.

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            Lead Product(s): Vafidemstat

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Small molecule

            Partner/Sponsor/Collaborator: Spanish Ministry of Science and Innovation

            Deal Size: $0.7 million Upfront Cash: Undisclosed

            Deal Type: Funding June 15, 2020

            Details:

            Oryzon's project “VENCER: Vafidemstat Efficacy in the treatment against Schizophrenia and other related pathologies has been approved for funding by the Spanish Ministry of Science and Innovation under the 2019 call of the governmental R&D “RETOS-COLABORACION” program.

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            Lead Product(s): PDC-1421

            Therapeutic Area: Psychiatry/Psychology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 15, 2020

            Details:

            Patient enrollment has been completed for a Phase II Part I clinical trial at the University of California. Primary objective of clinical trial is to determine the effective dosage of ABV-1505 in treatment of adult attention-deficit hyperactivity disorder (ADHD).

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            Lead Product(s): Lysergide

            Therapeutic Area: Psychiatry/Psychology 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 June 04, 2020

            Details:

            The company intends to initiate a Phase 2b human efficacy trial that will focus on experiential doses of LSD, administered by a therapist. This is the first experiential, psychedelic-assisted therapy to be added to the company’s drug development pipeline.

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