Auris Medical Holding (NASDAQ: EARS) reported Q4 EPS of (CHF0.16), versus (CHF0.17) reported last year.

"We achieved significant progress with our development programs in 2015, bringing us closer to the completion of the pivotal AM-101 tinnitus trials and advancing the late-stage AM-111 hearing loss program," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "We look forward to the upcoming results of our Phase 3 AM-101 program, initiating the second of our Phase 3 AM-111 trials and attaining further progress towards our ultimate goal of providing effective and safe inner ear therapeutics for patients."

Development Program Updates

AM-101 for Acute Inner Ear Tinnitus

• Progressed with enrollment into the two pivotal randomized, double-blind, placebo-controlled Phase 3 clinical trials, TACTT2 and TACTT3, in acute inner ear tinnitus following traumatic cochlear injury or otitis media. Patients are randomized to receive either AM-101 0.87 mg/mL or placebo in a 3:2 ratio.
• The TACTT2 trial, which is being conducted primarily in North America, is approaching enrollment completion. Screening for study participation will end shortly and randomization of the last patient is expected by the end of March, in line with previous guidance. TACTT2 is being conducted under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA) and will enroll approximately 330 patients during the acute tinnitus stage.
• The TACTT3 trial, which is being conducted in Europe, has enrolled approximately 80% of the targeted 300 patients during the acute tinnitus stage (Stratum A) and approximately 90% of the targeted 330 patients during the post-acute tinnitus stage (Stratum B). Auris Medical expects to complete enrollment a few months after TACTT2 is fully enrolled.
• Continued with the preparation of regulatory submissions for the marketing authorization of AM-101 in the U.S. and Europe, as well as pre-commercial activities in preparation for the planned future launches of AM-101.

AM-111 for Acute Inner Ear Hearing Loss

• Progressed with Phase 3 development of AM-111, which will comprise two pivotal randomized, double-blind, placebo-controlled trials, HEALOS and ASSENT. The trials enroll patients suffering from severe to profound idiopathic sudden sensorineural hearing loss with randomization to AM-111 0.4 mg/mL or 0.8 mg/mL or placebo in a 1:1:1 ratio.
• The HEALOS trial, which is being conducted in several European and Asian countries, began recruiting in November 2015 and has enrolled approximately 15% of the targeted 255 patients.
• The ASSENT trial, which will be conducted in the U.S., Canada and South Korea, is scheduled to initiate in mid-2016 and will enroll 300 patients.
• Hosted a Key Opinion Leader investor event focused on acute sensorineural hearing loss (ASNHL) and the AM-111 program. The meeting featured a keynote presentation by Adrien A. Eshraghi, MD, which highlighted the high unmet medical need in the treatment of ASNHL.

Other Developments

• Appointed Andrea Braun as Head of Regulatory and Quality Affairs and member of the Executive Management Committee. In this newly created position, Ms. Braun will lead the Company's regulatory affairs, quality and pharmacovigilance activities. She will join Auris Medical in the coming months from Alvotech, where she has been the Head of Global Regulatory Affairs Biologics. Prior to Alvotech, she spent 15 years in various regulatory affairs functions at Roche, becoming Head of EU Regulatory Affairs in 2013, and five years in regulatory affairs at DSM Nutritional Products. Ms. Braun holds a PhD in pharmacy.
• Bettina Stubinski, who has been Auris Medical's Chief Medical Officer since 2013, has decided to leave the Company for personal reasons by the end of the year, i.e. following the expected read out from both TACTT trials. A search for her replacement has been initiated.
• Appointed Cindy McGee as Head of Investor Relations and Corporate Communications. In this newly created position, Ms. McGee will direct and expand the Company's communication activities and further develop and foster relationships with the investment community and media. She previously held various positions with Arena Pharmaceuticals, including Vice President, Investor Relations and Alliance Management, and Ligand Pharmaceuticals and spent several years advising life science companies through her work at investor relations and communications agencies. Ms. McGee holds a BBA from the University of San Diego.

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