Otonomy Inc (NASDAQ:OTIC) issued financial report for the quarter closed September 30, 2017 and released an update on its product pipeline and corporate activities. The company also issued a separate update reporting positive data from the AVERTS-2 Phase 3 study of OTIVIDEXä in subjects with Ménière’s disease.
David A. Weber, Ph.D., the CEO and President of Otonomy, expressed that the announcement of successful data for OTIVIDEX in the AVERTS-2 study is a vital milestone for the firm and renews their commitment and excitement to continuing the registration plan for OTIVIDEX in Ménière’s disease.
They consider that the continuation of OTIVIDEX advancement for Ménière’s disease and the development of their other programs targeting vital unmet medical needs including tinnitus and hearing loss offer an attractive path forward for company. They plan to use their strong balance sheet, supported by their latest cost reduction initiatives, to achieve value creation objectives in the advancement of their pipeline.
Otonomy intends to meet with the U.S. FDA in the Q1 2018 to assess the AVERTS Phase III clinical trial study and discuss clinical needs for OTIVIDEX registration in subjects with Ménière’s disease. It plans to complete the pipeline assessment and prioritization, and showcase a development program for multiple preclinical and clinical programs in the Q1 2018.
For the quarter closed September 30, 2017, Otonomy reported cash/cash equivalents and short-term investments of $134.3 million versus $196.4 million as of the close of December 31, 2016. Net sales of OTIPRIO came at $0.3 million for Q3 2017 as well as for the third quarter of 2016. GAAP operating expenses came at $21.3 million for Q3 2017 versus $27.8 million for the same quarter of 2016.
Otonomy reaffirms its projections that GAAP operating expenses for FY2017 will be in between $95 million and $100 million. The company anticipates its cash balance to come in a range of $120 million to $125 million at the close of 2017.