OREANDA-NEWS. Auris Medical Holding AG (NASDAQ: EARS), 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 second quarter ended June 30, 2016.

"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 Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "Apart from this, we are pleased with the progress of our second Phase 3 asset, AM-111 for the treatment of acute sensorineural hearing loss, which is progressing with enrollment into the HEALOS and ASSENT trials. Furthermore, we have appointed Thomas Jung to our management team as Chief Development Officer to support our clinical, preclinical and pharmaceutical development activities."

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 and South 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 join Auris Medical in September. Dr. Jung previously served as the Chief Medical Officer at Delenex Therapeutics AG and spent 13 years at Novartis, most recently as Head, Translational Medicine for the European Union.
     
  • Received $12.5 million in financing from a loan facility agreement with Hercules Capital, Inc.

Second Quarter 2016 Financial Results

  • Cash and cash equivalents at June 30, 2016, totaled CHF 32.8 million, which does not include the $12.5 million received in July 2016 as part of the loan facility.
     
  • Total operating expenses for the second quarter of 2016 were CHF 9.0 million compared to CHF 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 to CHF 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 to CHF 0.9 million for the second quarter of 2015.
     
  • Net loss for the second quarter of 2016 was CHF 8.43 million, or CHF 0.25 per share, compared to CHF 10.96 million, or CHF 0.34 per share, for the second quarter of 2015. The net loss includes a net unrealized foreign currency exchange gain of CHF 0.6 million in the second quarter of 2016 compared to a foreign currency exchange loss of CHF 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 CHF 33.0 to 38.0 million and believes that existing cash and cash equivalents, including the $12.5 million loan, will enable the funding of operations until year-end 2017.

Today's Conference Call & Webcast Information

Auris Medical will host a conference call and webcast to discuss the top-line results from the TACTT2 trial, the second quarter 2016 financial results and to provide a general business update today, August 18, 2016, at 8:00 am Eastern Time (2:00 pm Central European Time). To participate in this conference call, dial 1-877-280-3459 (USA) or +1-646-254-3387 (International), and enter passcode 9451099. 

About Auris Medical

Auris Medical is a Swiss biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology. The Company is currently focusing on the Phase 3 development of treatments for acute inner ear tinnitus (KeyzilenTM; AM-101) and for acute inner ear hearing loss (AM-111) by way of intratympanic administration with biocompatible gel formulations. In addition, Auris Medical is pursuing early-stage research and development projects. The Company was founded in 2003 and is headquartered in Zug, Switzerland. The shares of the parent company Auris Medical Holding AG trade on the NASDAQ Global Market under the symbol "EARS."

 

Auris Medical Holding AG
Condensed Consolidated Interim Statement of Loss and Other Comprehensive Loss (unaudited)
(in CHF)

    THREE MONTHS
ENDED JUNE 30		   SIX MONTHS
ENDED JUNE 30
    2016   2015   2016   2015
Research and development    
-7,278,563		   -8,750,891   -13,418,738   -14,980,787
General and administrative   -1,725,114   -980,187   -2,947,146   -1,910,106
Operating loss   -9,003,677   -9,731,078   -16,365,884   -16,890,893
Interest income   15,281   5,210   26,166   10,268
Interest expense   -2,514   -2,540   -5,259   -4,604
Foreign currency exchange gain/(loss), net   558,908   -1,230,018   -985,937   -2,125,308
Loss before tax   -8,432,002   -10,958,426   -17,330,914   -19,010,537
Income tax expense   -   -   -   -
Net loss attributable to owners of the Company   -8,432,002   -10,958,426   -17,330,914   -19,010,537
Other comprehensive loss:                
Items that will never be reclassified to                
profit or loss                
Remeasurements of defined benefit liability, net of taxes of CHF 0   -347,398   -306   -607,867   -229,170
Items that are or may be reclassified to                
profit or loss                
Foreign currency translation differences,                
net of taxes of CHF 0   -15,856   38,501   25,964   56,863
Other comprehensive (loss)/income,   -363,254   38,195   -581,903   -172,307
net of taxes of CHF 0        
Total comprehensive loss attributable
to owners of the Company		   -8,795,256   -10,920,231   -17,912,817   -19,182,844
 

Basic and diluted loss per share

   -0.25   -0.34   -0.50   -0.62

Auris Medical Holding AG
Condensed Consolidated Interim Statement of Financial Position (unaudited)
(in CHF)

    JUNE 30, 2016   DECEMBER 31, 2015
     
ASSETS        
Non-current assets        
Property and equipment   185,324   222,570
Intangible assets   1,482,520   1,482,520
Other non-current receivables   38,066   38,066
Total non-current assets   1,705,910   1,743,156
         
Current assets        
Other receivables   1,387,380   650,716
Prepayments   17,789   181,044
Cash and cash equivalents   32,780,841   50,237,300
Total current assets   34,186,010   51,069,060
         
Total assets   35,891,920   52,812,216
         
         
Equity        
Share capital   13,731,881   13,721,556
Share premium   112,838,815   112,662,910
Foreign currency translation reserve   -37,858   -63,821
Accumulated deficit   -99,440,625   -81,578,733
Total shareholders' equity attributable to owners of the Company   27,092,213   44,741,912
         
Non-current liabilities        
Employee benefits   2,245,431   1,575,833
Deferred tax liabilities   327,637   327,637
Total non-current liabilities   2,573,068   1,903,470
         
Current liabilities        
Trade and other payables   660,341   1,205,522
Accrued expenses   5,566,298   4,961,312
Total current liabilities   6,226,639   6,166,834
         
Total liabilities   8,799,707   8,070,304
         
Total equity and liabilities   35,891,920   52,812,216

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