Sound Pharma is developing the first drugs to treat hearing loss and tinnitus affecting 50M Americans (the largest CNS/PNS disease). It has advanced its novel small molecule (SPI-1005) through 13 studies, across 5 INDs, enrolling >800 patients and has positive Phase 3 data (achieved co-primary endpoints) to support a future NDA in Meniere's disease (MD). SPI-1005 mimics the activity of glutathione peroxidase 1 (GPx1) with its novel selenium chemistry. Under redox stress SPI-1005 can induce GPx1 expression which is often reduced in hearing loss and tinnitus. SPI-1005 significantly improves hearing loss and tinnitus in MD patients following 28 days of oral treatment. No FDA drugs have been approved to treat MD, or any auditory or vestibular diseases. SPI-1005 has shown positive Phase 2 data in other indications including improving noise-induced hearing loss and reducing antibiotic-induced ototoxicity and nephrotoxicity.