Otonomy (OTIC) Provides Business Update Related to COVID-19 Pandemic

April 9, 2020 7:33 AM EDT

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Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided a business update related to the COVID-19 pandemic.

“Our first priority during this international crisis has been to ensure the health and safety of our employees, patients enrolled in our clinical trials, and healthcare professionals at our study sites in the United States and Europe,” said David A. Weber, Ph.D., president and CEO of Otonomy. “We are fortunate that the primary endpoint for our OTIVIDEX® Phase 3 trial and key exploratory endpoints in our OTO-313 Phase 2 trial are self-reported by the patient from home thereby preserving the integrity of data collection in these trials even in locations with quarantine restrictions. However, new patient enrollment is being impacted so we are suspending our guidance for the timing of trial results until we better understand the timeline for each study. We continue to carefully manage our spending and believe that our existing capital can fund operations through our multiple clinical trial readouts including the OTIVIDEX Phase 3 trial.”

Otonomy Business Updates

Ongoing OperationsOtonomy has taken steps to protect the health and safety of its employees and community by generally adopting a work from home policy in line with directives from the State of California and guidance from the U.S. Centers for Disease Control and Prevention (CDC). On-site activities have been restricted to certain essential facility and laboratory support functions and social distancing policies have been implemented. Other corporate functions including clinical operations were able to quickly and effectively transition to remote working.

OTIVIDEX Phase 3 Clinical Trial in Ménière’s DiseaseThis trial is being conducted at approximately 60 trial sites dispersed across different regions of the United States and multiple countries in Europe. We believe there is minimal impact of COVID-19 on the integrity of data being collected for enrolled patients because patients report their vertigo episodes via a daily telephone diary and compliance continues to be high. The enrollment of new patients is being managed on a country-by-country and site-by-site basis according to local conditions.

OTO-313 Phase 1/2 Clinical Trial in TinnitusOtonomy has successfully completed the initial safety cohort of this trial, and is conducting the exploratory efficacy study at approximately 15 sites located throughout the United States. Several of the efficacy endpoints are collected by patient-reported daily telephone diary and we switched to completion of the Tinnitus Functional Index (TFI) questionnaire at the patient’s home as well to avoid restrictions on travel or study site visits. The enrollment of new patients is being managed on a site-by-site basis.

OTO-413 Phase 1/2 Clinical Trial in Hearing LossThis is an ascending single dose safety and exploratory efficacy study being conducted at a limited number of trial sites in the United States. We have successfully completed several dose cohorts but have temporarily paused new patient enrollment because site visits are required for extensive hearing assessments to evaluate both safety and exploratory efficacy. Resumption of enrollment will be determined on a site-by-site basis.

Financial GuidanceWe finished 2019 with approximately $61 million in cash, cash equivalents and short-term investments and reiterate that we expect non-GAAP operating expenses for 2020, which reflect spending, to be in the range of $35-$38 million (with GAAP operating expenses that include stock-based compensation to total in the range of $45-$48 million). We believe that this capital is sufficient to fund company operations into 2021 and are managing spending to enable this cash runway to extend through readouts for our three ongoing clinical trials.



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