Otonomy, Inc.

Welcome to the Q1 2021 Autonomy, Inc. Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1 on your telephone keypad. And if you require any further assistance, just press star 0. I will now turn the call over to your speaker today, Mr. Robert Ohl with the Westwick ICR Community Beginner Conference, sir.

Good afternoon, and welcome to Autonomy's first quarter 2021 financial results and business update conference call. Joining me on the call from Autonomy are Dr. David Weber, President and Chief Executive Officer, and Paul Koehr, Chief Financial and Business Officer. Before I turn the call over to Dr. Weber, I would like to remind you that today's call will include forward-looking statements based on current expectations. Such statements represent management's judgment as of today and may involve risks and uncertainties that could cause actual results to differ materially from expected results. Please refer to Autonomy's filings with the SEC, which are available from the SEC or on the Autonomy website, for information concerning the risk factors that could affect the company. Autonomy specifically disclaims any obligation to update any forward-looking statements except as required by law. I will now turn the call over to Dave Weber, President and CEO of Autonomy.

Thank you, Robert. Good afternoon, everyone, and thank you for joining us on this call to discuss Autonomy's recent business updates as well as financial results for the first quarter of 2021. We are now fully focused on advancing our multiple programs for hearing loss and tinnitus. This is reflected by the following recent accomplishments and activities. In March, we announced initiation of the Phase II clinical trial for OTO 313 in tinnitus, and patient enrollment is underway. Setup activities continue for an expansion of our OTO 413 Phase 1-2 trial in hearing loss patients, and we are on track to initiate the study this quarter. We also have additional details from the proof of concept cohort that I'll highlight in this call. We expect results from both of these trials in mid-2022. In addition, we announced the upcoming presentation of exciting preclinical hearing recovery data for our OTO-825 gene therapy program for congenital hearing loss. I can't discuss specifics of these results before the American Society of Gene and Cell Therapy presentation on Thursday, but we'll provide a high-level summary based on the published abstract. We're also continuing to progress our two other preclinical programs, OTO-510 and OTO-6XX, that respectively target otoprotection for cisplatin-induced hearing loss and hair cell repair and regeneration for severe hearing loss. Finally, we have completed our analysis of the Otividex Phase III trial results. While we continue to believe that steroids provide a benefit to patients with Meniere's disease, Proving this in a clinical trial setting is a significant challenge. We do not see a path forward based on the existing clinical data for Otividex and have decided to not pursue additional development of the product candidate. During this call, I'll provide a brief update on our programs and then ask Paul to summarize the financial results including our recently completed financing that extends our cash runway into the second half of 2023. We can then open up the lines for any questions.