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SAN DIEGO, Aug. 12, 2015 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today reported financial results for the quarter ended June 30, 2015 and provided an update on its corporate activities and product pipeline.
Second Quarter 2015 and Subsequent Highlights
"Our strong momentum continued in the second quarter as we made significant progress on both the regulatory and clinical development fronts," said David A. Weber, Ph.D., president and CEO of Otonomy. "We expect the remainder of 2015 to be equally productive with AuriPro's PDUFA action date set for December 25, 2015, a near-term End-of-Phase 2 meeting scheduled with FDA to review the Phase 2b results in Ménière's disease and discuss plans for the Phase 3 program which we expect to initiate by the end of 2015, and continued clinical development for AuriPro in label expansion indications. In addition, we expect to broaden our clinical pipeline with the submission of an investigational new drug (IND) application to the FDA and initiation of a Phase 1 clinical trial for OTO-311, a potential treatment for tinnitus, by the end of 2015."
Anticipated Upcoming Milestones
Second Quarter Financial Highlights
Otonomy is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. Otonomy's proprietary technology provides sustained exposure of drugs to the ear following a single administration. Otonomy has three product candidates in development. AuriPro™ is an antibiotic that has completed Phase 3 clinical trials in pediatric patients with middle ear effusion at the time of tympanostomy tube placement surgery, and the FDA has assigned a PDUFA action date of December 25, 2015 for the company's New Drug Application. OTO-104 is a steroid that has recently completed a Phase 2b clinical trial in 154 patients with Ménière's disease. Based on these results, Otonomy intends to initiate two parallel Phase 3 trials for OTO-104 in Ménière's disease patients with at least one trial initiated by the end of 2015. OTO-311 is an NMDA receptor antagonist in development as a treatment for 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 Otonomy's future financial or operating performance. Forward-looking statements in this press release include, but are not limited to, Otonomy's expectations regarding the commercial launch of AuriPro in the United States, the Phase 2 clinical trial for AuriPro for the treatment of patients with otitis externa, the initiation of two Phase 3 trials for OTO-104, the timing of the submission of an IND filing to the FDA and initiation of a Phase 1 clinical trial for OTO-311, continued clinical development for AuriPro in label expansion indications, estimated operating expenses for 2015 and Otonomy's chief executive officer's statement regarding the second half of 2015. 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 substantial additional financing; Otonomy's dependence on the regulatory and commercial success of AuriPro and OTO-104 and advancing additional product candidates, such as OTO-311; 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 preclinical and clinical results for its product candidates, which may not support further development of product candidates, 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; competition in the biopharmaceutical industry; Otonomy's dependence on third parties to conduct preclinical studies and clinical trials; Otonomy's dependence on third parties for the manufacture of products; Otonomy's dependence on a small number of suppliers for raw materials; Otonomy's ability to protect its intellectual property related to 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 12, 2015, 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.
|Condensed Statements of Operations|
|(in thousands, except share and per share data)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Research and development||$ 7,289||$ 8,264||$ 15,896||$ 17,255|
|General and administrative||5,352||1,564||8,853||3,129|
|Total operating expenses||12,641||9,828||24,749||20,384|
|Loss from operations||(12,641)||(9,828)||(24,749)||(20,384)|
|Other income (expense)||97||(403)||188||(668)|
|Accretion to redemption value of convertible preferred stock||--||(15)||--||(28)|
|Net loss attributable to common stockholders||$ (12,544)||$ (10,246)||$ (24,561)||$ (21,080)|
|Net loss per share attributable to common stockholders, basic and diluted||$ (0.52)||$ (109.07)||$ (1.04)||$ (237.33)|
|Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted||24,139,791||93,938||23,670,508||88,822|
|As of June 30,||As of December 31,|
|Cash and cash equivalents||$ 190,294||$ 139,810|
|Total stockholders' equity||212,747||153,613|
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