Quotient Sciences Translational Pharmaceuticals Quotient Sciences Translational Pharmaceuticals

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            Through the acquisition, Regeneron will strengthen its gene therapy and heraing loss programs by gaining Decibel's lead candidate, DB-OTO, which is currently in Phase 1/2 and is an investigational cell-selective, AAV gene therapy to treat congenital, monogenic hearing loss.

            Lead Product(s): DB-OTO

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-OTO

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

            Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

            Deal Size: $213.0 million Upfront Cash: $213.0 million

            Deal Type: Acquisition August 09, 2023

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            DB-OTO is a gene therapy product candidate designed to provide durable restoration (selectively express functional OTOF in the inner hair cells) of hearing to individuals born with profound hearing loss due to mutation of the OTOF gene.

            Lead Product(s): DB-OTO

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-OTO

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

            Partner/Sponsor/Collaborator: Regeneron Pharmaceuticals

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 12, 2023

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            DB-OTO is a gene therapy product candidate designed to provide durable restoration (selectively express functional OTOF in the inner hair cells) of hearing to individuals born with profound hearing loss due to mutation of the OTOF gene.

            Lead Product(s): DB-OTO

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: DB-OTO

            Highest Development Status: Phase I/ 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 March 30, 2023

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            OTO-413 is a proprietary, sustained-exposure formulation of brain-derived neurotrophic factor (BDNF), which is a naturally occurring protein involved in neuron growth and repair.

            Lead Product(s): OTO-413

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-413

            Highest Development Status: Phase I/ 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 October 13, 2022

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            40% (8 of 20) OTO-413 subjects demonstrated a clinically-meaningful improvement on at least one of the three SIN tests at both Days 57 and 85 versus 20% (2 out of 10) for placebo.

            Lead Product(s): Brain-Derived Neurotrophic Factor

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-413

            Highest Development Status: Phase I/ Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 20, 2022

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            Details:

            OTO-413 demonstrated a higher proportion of responders than placebo based on multiple speech-in-noise hearing tests in dose escalation efficacy cohort.

            Lead Product(s): Brain-Derived Neurotrophic Factor

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-413

            Highest Development Status: Phase I/ Phase II Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 15, 2021

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            Pipeline Therapeutics plans to use the proceeds to advance its development candidates PIPE-505, in patients with sensorineural hearing loss, and PIPE-307, in patients with multiple sclerosis.

            Lead Product(s): PIPE-505

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: PIPE-505

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

            Partner/Sponsor/Collaborator: Franklin Templeton

            Deal Size: $80.0 million Upfront Cash: Undisclosed

            Deal Type: Series C Financing February 11, 2021

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            Details:

            Otonomy believes that these higher responder rates for OTO-413 compared to placebo at two consecutive time points across multiple SIN tests demonstrates therapeutic activity and supports continued development of OTO-413 for the treatment of hearing loss.

            Lead Product(s): Brain-Derived Neurotrophic Factor

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-413

            Highest Development Status: Phase I/ Phase II Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 17, 2020

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            Details:

            PIPE-505 is the first small molecule developed specifically for the treatment of sensorineural hearing loss (SNHL) associated with speech-in-noise impairment.

            Lead Product(s): PIPE-505

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: PIPE-505

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

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 23, 2020

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            The trial achieved its objectives by demonstrating a positive clinical signal for OTO-313 based on a TFI responder analysis, with a favorable safety profile.

            Lead Product(s): Gacyclidine

            Therapeutic Area: Otolaryngology (Ear, Nose, Throat) Product Name: OTO-313

            Highest Development Status: Phase I/ 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

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