Auris Med Provides Business Update And Reports Second Quarter 2017 Financial Results
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"We continue to make great progress with our clinical-stage pipeline, including the completed enrollment of our AM-111 HEALOS trial in acute inner ear hearing loss and the ramp up of our AM-125 program with intranasal betahistine for Meniere's disease and other vestibular disorders," commented
Development Program Updates
- Hosted an investor and analyst event in New York City focused on Auris Medical's clinical-stage pipeline. The presentation highlighted AM-125 and the upcoming Phase 3 data readouts for AM-111 and Keyzilen®.
AM-111 for Acute Inner Ear Hearing Loss
- Completed enrollment in the Phase 3 HEALOS trial, which is being conducted in
Europe andAsia . The trial enrolled 256 patients with severe to profound idiopathic sudden sensorineural hearing loss.Auris Medical expects to announce top-line results from HEALOS in the fourth quarter of this year.
- Continued ramping up the Phase 3 ASSENT trial, which is being conducted in the US,
Canada , andSouth 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 ASSENT in the second half of 2018.
- Hosted a scientific symposium at the 21st
IFOS ENT World Congress inParis . The symposium, Recent Advances in the Treatment of Acute Hearing Loss, featured several experts in the field of hearing loss research.
Keyzilen® (AM-101) for Acute Inner Ear Tinnitus
- Completed the AMPACT1 and AMPACT2 open-label extension studies and reported results that confirm the long-term safety of Keyzilen®. In addition, exploratory efficacy analyses further support early treatment of inner ear tinnitus and suggest potential benefits of repeating treatment cycles. The AMPACT studies were conducted at the request of the
U.S. Food and Drug Administration (FDA ) to generate safety data from chronic intermittent use of Keyzilen® for up to 12 months.
- Progressed with 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). Additional patients are now being enrolled in each stratum.Auris Medical expects to complete enrollment in the third quarter of 2017 and announce top-line results from TACTT3 in early 2018.
AM-125 for Meniere's Disease and Other Vestibular Disorders
- Completed the acquisition of various assets related to intranasal betahistine from
Otifex Therapeutics Ltd. In addition,Auris Medical obtained from an undisclosed party the right to use certain proprietary preclinical and clinical data that will support the AM-125 development program and future regulatory filings.
- Progressed with plans to initiate a second Phase 1 trial in the fourth quarter of 2017 to further test the safety, tolerability and pharmacokinetics of AM-125. In a Phase 1 trial conducted by Otifex, intranasal betahistine showed good tolerance and a significantly higher bioavailability than reported for oral betahistine administration.
- Established a
Scientific Advisory Board for AM-125 comprised of global leaders in the field of vestibular disorders. The members areElias Michaelides , MD;Michael Strupp , MD;Hinrich Staecker , MD, PhD; andPaul Van de Heyning , MD, PhD.
- Scheduled to host a symposium during the American Academy of Otolaryngology-Head and Neck Surgery Foundation Annual Meeting & OTO Experience on September 11, 2017, in Chicago. The symposium, Targeting Histamine Receptors for Vertigo Therapy, will feature several experts in the field of vestibular disorders.
Second Quarter 2017 Financial Results
- Cash and cash equivalents at
June 30, 2017 , totaledCHF 26.2 million .
- Total operating expenses for the second quarter of 2017 were
CHF 6.0 million compared toCHF 9.0 million for the second quarter of 2016.
- Research and development expenses for the second quarter of 2017 were
CHF 4.7 million compared toCHF 7.3 million for the second quarter of 2016.
- General and administrative expenses for the second quarter of 2017 were
CHF 1.2 million compared toCHF 1.7 million for the second quarter of 2016.
- Net loss for the second quarter of 2017 was
CHF 5.4 million , orCHF 0.12 per share, compared toCHF 8.4 million , orCHF 0.25 per share, for the second quarter of 2016.
The Company continues to expect that its operating expenses in 2017 will be in the range of
Upcoming Events
- American Academy of Otolaryngology-Head and Neck Surgery Foundation Annual Meeting & OTO Experience,
September 10-13, 2017 ,Chicago, Illinois
- LEERINK Partners Roundtable Series: Rare Disease & Immuno-Oncology,
September 27-28, 2017 ,New York, New York
Today's Conference Call & Webcast Information
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