Auris Medical Holding (EARS) Posts FY16 Loss of $0.89/Share, Provides Business Update

Auris Medical Holding (NASDAQ: EARS) reported FY16 EPS of ($0.89), versus ($0.92) last year.

"We are proud to be leading the charge in the development of new, much-needed therapies for inner ear disorders," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "We are moving toward the upcoming Phase 3 results from the AM-111 HEALOS trial for acute inner hearing loss while also progressing with Keyzilen®, our late-stage tinnitus program. Furthermore, we are finalizing our plans for AM-125 in Meniere's disease and vestibular vertigo and look forward to initiating a second Phase 1 trial later this year. With the addition of AM-125, we have built a broad, diverse pipeline of drug candidates that present multiple opportunities for Auris Medical to help patients."

Development Program Updates

AM-111 for Acute Inner Ear Hearing Loss

• Received fast track designation from the FDA for AM-111 in acute sensorineural (inner ear) hearing loss, highlighting the seriousness of the condition as well as the unmet medical need.
• Progressed with enrollment in the Phase 3 HEALOS trial, which is being conducted in several European and Asian countries. The trial aims to enroll approximately 255 patients with severe to profound idiopathic sudden sensorineural hearing loss. Auris Medical expects to complete enrollment in the second quarter of 2017 and announce top-line results from this trial in the third quarter of 2017.
• Continued ramp-up of the Phase 3 ASSENT trial, which is being conducted in the US, Canada and South Korea. The trial aims to enroll approximately 300 patients with severe to profound idiopathic sudden sensorineural hearing loss. Auris Medical expects to announce top-line results from this trial in the second half of 2018.

Keyzilen® (AM-101) for Acute Inner Ear Tinnitus

• Resumed enrollment in the Phase 3 TACTT3 trial, which is being conducted in Europe. The trial previously enrolled more than 300 patients during the acute tinnitus stage (Stratum A) and approximately 330 patients during the post-acute tinnitus stage (Stratum B). An additional 60 patients are now being enrolled in each stratum. Auris Medical expects to announce top-line results from the expanded trial in early 2018.
• Completed the AMPACT open-label studies, which evaluated the long-term safety of Key­zilen®. Auris Medical expects to announce results from these studies in the second quarter of 2017.

AM-125 for Meniere's Disease and Vestibular Vertigo

• Entered into an agreement with Otifex Therapeutics Pty. Ltd. to purchase various assets related to intranasal betahistine, including preclinical and clinical data as well as certain intellectual property rights. In a Phase 1 trial conducted by Otifex, intranasal betahistine showed good tolerance and a significantly higher bioavailability than reported for oral betahistine administration.
• Under the product code AM-125, Auris Medical is developing betahistine in a spray formulation for the intranasal treatment of Meniere's disease and vestibular vertigo. Oral betahistine is approved for the treatment of Meniere's disease and vestibular vertigo and marketed in more than 80 countries worldwide. Auris Medical plans to initiate a second Phase 1 trial in 2017.

Other Developments

• Extended the AM-102 King's College London collaboration, which is focused on the discovery of small molecule compounds for a second-generation tinnitus treatment. Auris Medical expects to select a lead compound by year-end 2017.
• Completed a public offering of 10,000,000 common shares and 10,000,000 warrants with net proceeds of $9.1 million. The common shares and warrants were sold in units comprised of one common share and one warrant at the price of $1.00 per unit. Each warrant entitles its holder to purchase 0.70 of a common share at the price of $1.20 per share.
• Anne Sabine Zoller, who has served as Auris Medical's General Counsel since 2015, has decided to leave the Company in the coming months to pursue another opportunity.

For earnings history and earnings-related data on Auris Medical Holding (EARS) click here.

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