Otonomy, Inc. provided an update on its product pipeline and financial guidance. The company expects to have clinical trial results for three programs in 2020 including the previously announced Phase 3 trial of OTIVIDEX in Ménière’s disease in the first half of 2020, Phase 1/2 trial of OTO-313 in tinnitus patients in the first half of 2020, and Phase 1/2 trial of OTO-413 in patients with hearing loss in the second half of 2020. The company finished 2018 with approximately $97 million in cash, cash equivalents and short term investments that includes proceeds from a $15 million term loan from Oxford Finance LLC completed in December 2018. Otonomy expects that its current capital is sufficient to fund operations through the three clinical trials and into 2021. Product Pipeline Updates: OTIVIDEX: Phase 3 trial in Ménière’s disease enrolling patients with results expected in the first half of 2020.Otonomy has completed one successful Phase 3 trial (AVERTS-2) and is conducting this additional pivotal trial to support a submission for U.S. registration of OTIVIDEX in Ménière’s disease. The company plans to enroll approximately 160 patients, with the design and conduct of this trial based on the AVERTS-2 trial; OTO-313: Phase 1/2 trial in tinnitus patients expected to start in the second quarter of 2019 with results in the first half of 2020. OTO-313 is an improved sustained-exposure formulation of the NMDA receptor antagonist gacyclidine. A Phase 1 study of the initial formulation, OTO-311, indicated no safety concerns. The Phase 1/2 clinical trial includes an initial safety cohort followed by an exploratory efficacy study that will enroll approximately 50 patients with unilateral tinnitus. A number of exploratory efficacy endpoints will be assessed following a single intratympanic injection of OTO-313 or placebo including the Tinnitus Functional Index (TFI), a clinically validated tinnitus measure; OTO-413: Phase 1/2 trial in hearing loss patients expected to start in the third quarter of 2019 with results in the second half of 2020. OTO-413 is a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF) in development for the repair of cochlear synaptopathy, an underlying pathology in age-related and noise-induced hearing loss that manifests as speech-in-noise hearing difficulty (problem understanding speech in a noisy setting). The Phase 1/2 trial will enroll approximately 32 hearing loss patients in an ascending dose design. Patients will receive a single intratympanic injection of OTO-413 or placebo and be assessed for safety, tolerability, and multiple exploratory efficacy endpoints; OTO-510: IND enabling activities to be initiated for cisplatin-induced hearing loss (CIHL) otoprotection program. CIHL is an important unmet medical need with no approved therapies and approximately 500,000 patients including 5,000 children undergoing chemotherapy with ototoxic platinum-based agents each year in the United States. The impact on children can be especially devastating with documented negative effects on speech development, academic performance and socialization. OTO-510 is a sustained-exposure formulation of an undisclosed small molecule designed for intratympanic administration to provide otoprotection without tumor protection; OTO-6XX:Development candidate selected for regenerative hearing loss program. The regeneration of cochlear hair cells is an active area of research in the neurotology field because of its potential to improve hearing function in patients with severe loss. Otonomy has demonstrated regeneration of hair cells in a nonclinical proof-of-concept model using a class of small molecules formulated for sustained-exposure local delivery, and has selected a lead compound for development; and OTIPRIO: Co-promotion partnership with Mission Pharmacal in acute otitis externa (AOE) proceeding as planned. Preparations are underway for Mission to launch OTIPRIO to high volume pediatric and primary care physician offices in advance of the peak summer season for treating AOE. This agreement is expected to generate positive OTIPRIO cashflow, which can provide support for Otonomy's pipeline development activities.