Otonomy, Inc. (NASDAQ:OTIC) Q2 2020 Earnings Conference Call - Final Transcript

Aug 04, 2020 • 05:00 pm ET

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Otonomy, Inc. (NASDAQ:OTIC) Q2 2020 Earnings Conference Call - Final Transcript

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Presentation
Operator
Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Q2 2020 Otonomy, Inc. Earnings Conference Call. [Operator Instructions] I would now like to hand the conference over to your speaker today, Robert Uhl from Westwicke ICR. Please go ahead, sir.

Executive
Robert H. Uhl

Good afternoon, and welcome to Otonomy's Second Quarter 2020 Financial Results and Business Update Conference Call. Joining me on the call from Otonomy are Dr. David Weber, President and Chief Executive Officer; and Paul Cayer, 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.

Such statements include, but are not limited to, statements relating to the timing of results, patient enrollment and activity for and the design and conduct of ongoing clinical trials; statements relating to the updated statistical analysis plan for the ongoing Phase 3 clinical trial of OTIVIDEX; expectations regarding advancement of clinical trials; expectations regarding preclinical programs, including potential benefits and development activities; statements relating to the potential benefits and opportunities of, and activities under, the collaboration agreement between Otonomy and AGTC, the co-promotion agreement between Otonomy and ALK-Abello and the license agreement between Otonomy and KYORIN; expectations regarding the outcomes, market opportunity and value potential of Otonomy's clinical and preclinical programs; expectations regarding operating expenses for 2020 and cash runway. Please refer to Otonomy's filings with the SEC, which are available from the SEC or on the Otonomy website, for information concerning the risk factors that could affect the company.

I will now hand the call over to Dave Weber, President and CEO of Otonomy.

Executive
David A. Weber

Thank you, Robert. Good afternoon, everyone, and thank you for joining us on this call to discuss Otonomy's business updates as well as financial results for the second quarter of 2020. While the COVID-19 pandemic has created widespread disruption and challenges in everyone's lives, I am very proud of the focus and commitment that the entire Otonomy team has displayed in continuing to advance our product pipeline and achieving our corporate objectives. To this end, we have been able to accomplish the following in the last several months: we announced positive Phase 1/2 clinical results for our OTO-313 program in tinnitus and are now moving into full Phase 2 development.

We continue to make progress in enrolling our OTIVIDEX Phase 3 trial in Meniere's disease, and at the same time, strengthened the statistical analysis plan for this trial. We successfully advanced through multiple dose escalation cohorts in our OTO-413 Phase 1/2 trial and have nearly completed the expanded enrollment in the high dose cohort. We selected a GJB2 gene therapy product candidate and continue to make good progress in preclinical development activities. As announced yesterday, we completed the license for a novel compound for our OTO-6XX hair cell regeneration program and look