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Press Release

Otonomy Announces Multiple Presentations at Society for Neuroscience Annual Meeting including OTO-413 Presentation Selected as "Hot Topic"

SAN DIEGO, Oct. 30, 2018 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for otology, today announced multiple presentations related to the company's programs in hearing loss and tinnitus at the upcoming Society for Neuroscience (SfN) Annual Meeting, to be held November 3-7, in San Diego. A presentation demonstrating the therapeutic potential of OTO-413, a sustained-exposure otic formulation of brain-derived neurotrophic factor (BDNF), for the repair of cochlear synaptopathy in speech-in-noise hearing difficulties has been selected by SfN as a Neuroscience 2018 Hot Topic.

“At Otonomy, we have a singular focus on understanding the neuroscience of the ear and on delivering breakthrough treatments to the millions living with the often debilitating effects of conditions like tinnitus, Ménière’s disease and hearing loss. Hearing loss, in particular, is an area of extreme unmet need that can lead to social isolation, lower quality of life, and higher rates of dementia and depression,” said David A. Weber, Ph.D., president and chief executive officer of Otonomy. “Recent scientific advances have shown that the loss of synaptic connections between inner ear hair cells and spiral ganglion neurons contributes to speech-in-noise hearing difficulties. We are thrilled that the Society for Neuroscience has chosen to highlight data demonstrating the ability of OTO-413 to potentially repair cochlear synaptopathy. We are also excited to advance OTO-413 into clinical trials next year for patients with speech-in-noise hearing difficulties, and expect that this will be the first such trial evaluating a potential treatment for cochlear synaptopathy.”

Otonomy's presentations for the OTO-413 program are as follows:

  • Neuroscience 2018 Hot Topic: "Development of intratympanically administered neurotrophic factor BDNF for the treatment of speech-in-noise hearing difficulties (cochlear synaptopathy)" by Jacques et al., poster presentation on November 6 from 9:00 a.m.12:00 p.m. PST.
  • "Effect of Trk receptor monoclonal antibodies and recombinant neurotrophins on neuron survival, neurite morphology, and synaptogenesis in rat ex vivo models relevant to hearing loss" by Szobota et al., poster presentation on November 6 from 9:00 a.m. - 12:00 p.m. PST.

An additional presentation will be made related to Otonomy's tinnitus program:

  • "Preclinical and clinical development of OTO-311, a sustained-exposure formulation of the NMDA receptor antagonist gacyclidine, for the treatment of tinnitus" by Piu et al., poster presentation on November 5 from 1:00 p.m. - 4:00 p.m. PST.

About Otonomy

Otonomy is a biopharmaceutical company dedicated to the development of innovative therapeutics for otology. The company pioneered the application of drug delivery technology to the ear in order to develop products that achieve sustained drug exposure from a single local administration. This approach is covered by a broad patent estate and is being utilized to develop a pipeline of products addressing important unmet medical needs including Ménière’s disease, hearing loss, and tinnitus. For additional information please visit www.otonomy.com.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or the future financial or operating performance of Otonomy. Forward-looking statements in this press release include, but are not limited to, the timing of the OTO-413 Phase 1/2 clinical study in hearing loss patients, and statements by Otonomy’s president and CEO. Otonomy's expectations regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: Otonomy’s limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy's ability to obtain additional financing; Otonomy’s dependence on the regulatory success and advancement of its product candidates; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy’s ability to adequately demonstrate the safety and efficacy of its product candidates, the nonclinical and clinical results for its product candidates, which may not support further development, and challenges related to patient enrollment in clinical trials; Otonomy’s ability to obtain regulatory approval for its product candidates; side effects or adverse events associated with Otonomy’s product candidates; Otonomy’s ability to successfully commercialize its product candidates, if approved; competition in the biopharmaceutical industry; Otonomy’s dependence on third parties to conduct nonclinical studies and clinical trials; Otonomy’s dependence on third parties for the manufacture of its product candidates; Otonomy’s dependence on a small number of suppliers for raw materials; Otonomy’s ability to protect its intellectual property related to its product candidates in the United States and throughout the world; expectations regarding potential market size, opportunity and growth; Otonomy’s ability to manage operating expenses; implementation of Otonomy’s business model and strategic plans for its business, products and technology; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in Otonomy’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 8, 2018, and Otonomy's future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Otonomy as of the date hereof. Otonomy disclaims any obligation to update any forward-looking statements, except as required by law.

Contacts:

Media Inquiries:
Spectrum
Leticia Diaz
Vice President
202.587.2517
ldiaz@spectrumscience.com

Investor Inquiries:
Westwicke Partners
Robert H. Uhl
Managing Director
858.356.5932
robert.uhl@westwicke.com

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Source: Otonomy, Inc.