Otonomy 8-K Includes Press Release With Corporate, Product Pipeline Update

Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided an update on its product pipeline and financial guidance. Consistent with

Benzinga · 01/09/2020 12:29

Otonomy, Inc. (NASDAQ:OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided an update on its product pipeline and financial guidance. Consistent with previously stated timing, the company expects to have results for the Phase 3 trial of OTIVIDEX in Ménière’s disease in the third quarter of 2020, the Phase 1/2 trial of OTO-313 in tinnitus patients in the second quarter of 2020, and the Phase 1/2 trial of OTO-413 in patients with hearing loss in the second half of 2020.

 

The company finished 2019 with approximately $61 million in cash, cash equivalents and short term investments and expects that its current capital is sufficient to fund operations through the three clinical trials and into 2021.

 

“We are excited to begin 2020, a potentially transformational year for Otonomy driven by our three clinical trial readouts, each of which is a meaningful milestone given the significant patient population, high disease burden, and lack of approved drug treatments,” said David A. Weber, Ph.D., president and CEO of Otonomy. “While successful completion of these clinical trials is our highest priority, we also continue to advance multiple preclinical programs including our gene therapy collaboration targeting congenital hearing loss.”

 

Product Pipeline Update

 


 OTIVIDEX: Enrollment in Phase 3 Clinical Trial in Ménière’s Disease is Ongoing with Results Expected in the Third Quarter of 2020. Otonomy has completed one successful Phase 3 trial and is conducting this additional pivotal trial to support a submission for U.S. registration of OTIVIDEX in Ménière’s disease. The company plans to enroll approximately 160 patients in the United States and Europe.
 

 

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 OTO-313: Enrollment in Phase 1/2 Clinical Trial in Tinnitus is Ongoing with Results Expected in the Second Quarter of 2020. Otonomy has successfully completed the initial safety cohort of this randomized, double-blind, placebo-controlled trial, and is enrolling approximately 50 patients with persistent tinnitus in the exploratory efficacy study cohort. OTO-313 is a sustained-exposure formulation of the potent and selective NMDA receptor antagonist gacyclidine.
 

 


 OTO-413: Enrollment in Phase 1/2 Clinical Trial in Hearing Loss is Ongoing with Results Expected in the Second Half of 2020. Otonomy is enrolling hearing loss patients in a Phase 1/2 clinical trial of OTO-413, which is a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF). The Phase 1/2 trial is a randomized, double-blind, placebo-controlled, single ascending dose study designed to evaluate the safety and exploratory efficacy of OTO-413 in patients with speech-in-noise hearing difficulty.
 

 


 Advancing multiple preclinical programs for treatment and prevention of hearing loss.
 

 
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 GJB2 gene therapy program: Otonomy and Applied Genetic Technologies Corporation (AGTC) are collaborating to co-develop and co-commercialize an AAV-based gene therapy to restore hearing in patients with hearing loss caused by a mutation in the gap junction protein beta 2 gene (GJB2) -- the most common cause of congenital hearing loss.
 

 
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 OTO-6XX: development program targeting hair cell regeneration for severe hearing loss.
 

 
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 OTO-510: otoprotection program for patients at risk for cisplatin-induced hearing loss.
 

 

Financial Updates and Guidance

 


 Cash Position: Cash, cash equivalents, and short-term investments totaled approximately $61 million as of December 31, 2019. This balance includes proceeds from a $15 million term loan completed in December 2018.
 

 


 Operating Expenses: Otonomy expects that non-GAAP operating expenses for 2020 will be in the range of $35-$38 million, and that GAAP operating expenses will be in the range of $45-$48 million.
 

 


 Cash Runway: Otonomy expects that its current cash, cash equivalents, and short term investments will be sufficient to fund the company through completion of the OTIVIDEX Phase 3 trial, OTO-313 Phase 1/2 trial, and OTO-413 Phase 1/2 trial in 2020, and will support company operations into 2021.