Auris Med Provides Business Update And Reports Second Quarter 2016 Financial Results
ZUG,
"As stated earlier today, we are disappointed with the top-line results from the TACTT2 trial with KeyzilenTM for acute inner ear tinnitus and we continue to assess the full dataset. We plan to complete this analysis and meet with the regulatory agencies prior to the TACTT3 readout, which is expected in the fourth quarter," commented
Development Program Updates
Keyzilen TM (AM-101) for Acute Inner Ear Tinnitus
-
Announced top-line results from the Phase 3 TACTT2 trial in acute inner ear tinnitus. The TACTT2 trial did not meet the two co-primary efficacy endpoints of statistically significant changes in tinnitus loudness and tinnitus burden compared to placebo. Data from the TACTT2 trial support the positive safety profile established in previous studies.
-
Completed enrollment of the Phase 3 TACTT3 trial with more than 300 patients during the acute tinnitus stage (Stratum A) and approximately 330 patients during the post-acute tinnitus stage (Stratum B). The trial, which is being conducted in
Europe , is a randomized, double-blind, placebo-controlled trial in acute and post-acute inner ear tinnitus following traumatic cochlear injury or otitis media. The primary endpoint is the change in tinnitus loudness from baseline to Day 84; the change in the TFI is the key secondary efficacy outcome. Top-line results from this trial are expected in the fourth quarter of 2016.
-
Received fast track designation from the
FDA for KeyzilenTM in acute peripheral (inner ear) tinnitus following traumatic cochlear injury or otitis media in adults, highlighting the seriousness of the condition as well as the unmet medical need.
AM-111 for Acute Inner Ear Hearing Loss
-
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. Top-line results from this trial are expected in the second half of 2017.
-
Initiated 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. Top-line results from this trial are expected in the first half of 2018.
Other Developments
-
Appointed
Thomas Jung , MD, PhD, as Chief Development Officer. In this newly created position, Dr. Jung will lead the Company's clinical, preclinical and pharmaceutical development activities. He will joinAuris Medical in September. Dr. Jung previously served as the Chief Medical Officer atDelenex Therapeutics AG and spent 13 years atNovartis , most recently as Head, Translational Medicine for theEuropean Union .
-
Received
$12.5 million in financing from a loan facility agreement withHercules Capital, Inc.
Second Quarter 2016 Financial Results
-
Cash and cash equivalents at
June 30, 2016 , totaledCHF 32.8 million , which does not include the$12.5 million received inJuly 2016 as part of the loan facility.
-
Total operating expenses for the second quarter of 2016 were
CHF 9.0 million compared toCHF 9.7 million for the second quarter of 2015.
-
Research and development expenses for the second quarter of 2016 were
CHF 7.3 million compared toCHF 8.8 million for the second quarter of 2015.
-
General and administrative expenses for the second quarter of 2016 were
CHF 1.7 million compared toCHF 0.9 million for the second quarter of 2015.
-
Net loss for the second quarter of 2016 was
CHF 8.43 million , orCHF 0.25 per share, compared toCHF 10.96 million , orCHF 0.34 per share, for the second quarter of 2015. The net loss includes a net unrealized foreign currency exchange gain ofCHF 0.6 million in the second quarter of 2016 compared to a foreign currency exchange loss ofCHF 1.2 million in the second quarter of 2015.
The Company continues to expect that its operating expenses in 2016 will be in the range of
Today's Conference Call & Webcast Information
About