Otonomy Q1 2019 Financial Results & Business Update

[HootOwl]

Press Release from August 1st

Press Release
Otonomy Reports Second Quarter 2019 Financial Results and Provides Corporate Update

• Clinical-stage programs on track with results expected from three trials in 2020
  
• Current capital funds operations into 2021

Conference call and webcast today at 4:30 p.m. EDT

SAN DIEGO, Aug. 01, 2019 (GLOBE NEWSWIRE) -- Otonomy, Inc. (NASDAQ: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter ended June 30, 2019 and provided an update on its product pipeline and corporate activities. The company will host a conference call and webcast today at 4:30 p.m. EDTto discuss recent highlights and financial results.

"We are on track in executing our business plan and focused on reporting clinical results from three trials in 2020 -- the Phase 3 trial of OTIVIDEX in Ménière's disease, the Phase 1/2 clinical trial of OTO-313 in tinnitus and the Phase 1/2 trial of OTO-413 in hearing loss," said David A. Weber, Ph.D., president and CEO of Otonomy. "We are also tracking to our financial plan and guidance that will enable our existing capital to fund operations through these three clinical trial results next year and into 2021."

Product Pipeline Update

• OTIVIDEX™: Enrollment in Phase 3 Clinical Trial in Ménière's Disease is Ongoing with Results Expected in the First Half 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.

• OTO-313: Enrollment in Phase 1/2 Clinical Trial in Tinnitus is Ongoing with Results Expected in the First Half of 2020. In April, Otonomy initiated enrollment of the first patients in a Phase 1/2 clinical trial for OTO-313, a sustained-exposure formulation of the NMDA receptor antagonist gacyclidine, in tinnitus patients. The randomized, double-blind, placebo-controlled trial included an initial safety cohort, which has been successfully completed, followed by an exploratory efficacy study that is currently enrolling approximately 50 patients with tinnitus.

• OTO-413: Preparing to Initiate a Phase 1/2 Clinical Trial in Hearing Loss Patients in the Third Quarter of 2019. OTO-413 is a sustained-exposure formulation of brain-derived neurotrophic factor (BDNF) in development for the repair of cochlear synaptopathy, an underlying cause of hearing loss. Otonomy is preparing to initiate a Phase 1/2 clinical trial in the third quarter of 2019 that will enroll approximately 40 patients with speech-in-noise hearing loss.

"Additionally, I would like to take this opportunity to express my best wishes to Dr. Kathie Bishop, chief scientific officer, who has resigned in order to join a former colleague in an early-stage venture," said Dr. Weber. "We appreciate the support that Kathie provided during the last two years as we positioned the company for our upcoming clinical milestones and look forward to her continued involvement as a scientific advisor."

Anticipated Upcoming Milestones

• In third quarter of 2019, initiate a Phase 1/2 clinical trial of OTO-413 in hearing loss patients.

• In first half of 2020, complete OTO-313 Phase 1/2 clinical trial.

• In first half of 2020, complete Phase 3 trial for OTIVIDEX in Ménière's disease.

• In second half of 2020, complete OTO-413 Phase 1/2 clinical trial.

 

[HootOwl]

Forgot to add their corporate presentation from the August press release.

 

[Lulu187]

There are multiple members on this site that have had this BDNF treatment but they are keeping quiet about it.

Why are they keeping quiet about it?

 

[Ela Stefan]

Well, the researchers at UCI are very transparent about how little they know, and that this is more of an exploratory trial. If you read their brief a lot of verbiage surrounds trying to figure out what will work best. The basis of this trial is a 2003 study quoted from their detail page here:

"Most recently in a preliminary study in 2003, Rubinstein et al, used a needle electrode passed through the ear drum to suppress tinnitus. The authors used a high pulse rate of 4,800 pulse-per- second (pps) for their electrical stimulation. They found that 5 of 11 (45%) subjects with electrical stimulation of the inner ear through the ear drum using a needle electrode showed substantial or complete tinnitus suppression with either no perception or only a transient perception of the stimulus. Three (27%) showed tinnitus suppression with the perception of the stimulus and three showed no suppression of the tinnitus."

But we can discuss more on the other thread.

Hi! Do you know if the suppression of the tinnitus was permanent? I mean did it last after the electrical stimulation finished?

 

[weab00]

Why are they keeping quiet about it?

NDA.