OREANDA-NEWS. Auris Medical Holding AG , a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today provided a business update and announced financial results for the first quarter ended March 31, 2016.

"We are focused on the continued progress of our two Phase 3 development programs evaluating AM-101 for acute inner ear tinnitus and AM-111 for acute inner ear hearing loss," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "In preparation for the upcoming data readout of the TACTT2 trial in August, we look forward to hosting a Key Opinion Leader meeting next month."

Development Program Updates

AM-101 for Acute Inner Ear Tinnitus

  • Completed enrollment of over 330 patients in the Phase 3 TACTT2 trial. The TACTT2 trial is being conducted primarily in North America under a Special Protocol Assessment (SPA) with the US Food and Drug Administration. Top-line results from this trial are expected in August 2016.
  • Progressing toward completion of enrollment in the Phase 3 TACTT3 trial. The TACTT3 trial is being conducted in Europe and enrollment of approximately 630 patients (300 in the acute stage and 330 in the post-acute stage) is expected to be completed by the end of the second quarter of 2016. Top-line results from this trial are expected in the fourth quarter of 2016.
  • Continued with the preparation of regulatory submissions for the marketing authorization of AM-101 in the US 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

  • Advanced enrollment into the Phase 3 HEALOS trial. The HEALOS trial is being conducted in several European and Asian countries and began recruiting in November 2015. The trial aims to enroll approximately 255 patients with severe to profound idiopathic sudden sensorineural hearing loss.
  • Moved toward initiation of the Phase 3 ASSENT trial. The ASSENT trial will be conducted in the US, Canada and South Korea and is scheduled to initiate in the upcoming months. The trial is set to enroll approximately 300 patients with severe to profound idiopathic sudden sensorineural hearing loss. 

Other Developments 

  • Elected Armando Anido as a member of the Board of Directors and Chairman of the Compensation Committee. Mr. Anido is the Chairman and Chief Executive Officer of Zynerba Pharmaceuticals. Prior to joining Zynerba, he served as Chief Executive Officer of NuPathe, Inc., and Auxilium Pharmaceuticals, Inc. Prior to Auxilium, Mr. Anido held commercial leadership roles at MedImmune, Glaxo Wellcome and Lederle Labs. Mr. Anido holds a BS in Pharmacy and an MBA, both from West Virginia University.
  • Welcomed Andrea Braun as Head of Regulatory and Quality Affairs and member of the Executive Management Committee. In this newly created position, Ms. Braun is leading the Company's regulatory affairs, quality and pharmacovigilance activities. Prior to Auris Medical, she served in various regulatory affairs positions, including as Head of EU Regulatory Affairs at Roche and Head of Global Regulatory Affairs Biologics at Alvotech. Ms. Braun received her state examination in pharmacy from the University of Heidelberg, Germany, and holds a PhD in immunology from the University of Basel, Switzerland.
  • Sven Zimmermann, who has served as Auris Medical's Chief Financial Officer since 2014, has decided to leave the Company for personal reasons this summer. A search for his replacement has been initiated.

       
First Quarter 2016 Financial Results

  • Cash and cash equivalents totaled CHF 41.39 million at March 31, 2016.
  • Total operating expenses for the first quarter of 2016 were CHF 7.36 million compared to CHF 7.16 million for the first quarter of 2015.
  • Research and development expenses for the first quarter of 2016 were CHF 6.14 million compared to CHF 6.23 million for the first quarter of 2015.
  • General and administrative expenses for the first quarter of 2016 were CHF 1.22 million compared to CHF 0.93 million for the first quarter of 2015.
  • Net loss for the first quarter of 2016 was CHF 8.90 million, or CHF 0.26 per share, compared to CHF 8.05 million, or CHF 0.28 per share, for the first quarter of 2015. The net loss includes a net unrealized foreign currency exchange loss of 1.54 million in the first quarter of 2016 compared to a loss of 0.89 million in the first quarter of 2015.