Auris Medical Provides Business Update and Reports Full

New Post Public Reply Private Reply Replies (0) Message Board
News Desk 2018
22
Auris Medical Provides Business Update and Reports Full Year 2016 Financial Results
  • Results from first AM-111 Phase 3 trial expected in third quarter of 2017
  • Addition of AM-125 expands clinical-stage pipeline into vestibular disorders
  • Conference call set for 8 am ET (1 pm CET) today

Zug, Switzerland, March 14, 2017 - 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 full year ended December 31, 2016.

"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.

             

Full Year 2016 Financial Results

  • Cash and cash equivalents totaled CHF 32.4 million at December 31, 2016, which does not include the $9.1 million of net proceeds received from the February 2017 public offering.
  • Total operating expenses for 2016 were CHF 30.2 million compared to CHF 30.9 million for 2015.
  • Research and development expenses for 2016 were CHF 24.8 million compared to CHF 26.5 million for 2015. 
  • General and administrative expenses for 2016 were CHF 5.4 million compared to CHF 4.3 million for 2015. 
  • Net loss for 2016 was CHF 30.7 million, or CHF 0.89 per share, compared to CHF 29.7 million, or CHF 0.92 per share, for 2015.

Auris Medical expects that its operating expenses in 2017 will be in the range of CHF 28.0 to 32.0 million. With the proceeds from the February 2017 offering, the Company's cash runway has been extended into the first quarter of 2018.

Annual General Meeting

Auris Medical's Annual General Meeting will take place in Zug, Switzerland, on April 13, 2017, at 10:00 am CET. At the meeting, the Company will propose the re-election of its current members of the Board of Directors with the exception of Professor Wolfgang Arnold and James I. Healy. The Board of Directors proposes the election of Mats Blom as a new Board member.

Mats Blom is Senior Vice President and Chief Financial Officer (CFO) of Zealand Pharma A/S. Prior to joining Zealand, he served as CFO of Swedish Orphan International, an orphan drug company acquired by BioVitrum in 2009. In addition, Mr. Blom has extensive managerial experience and has held CFO positions at Active Biotech AB and Anoto Group AB. Previously, he served as a management consultant at Gemini Consulting and Ernst & Young. Mats Blom holds a BA in Business Administration and Economics from the University of Lund and an MBA from IESE University of Navarra, Barcelona.

"We would like to thank Wolfgang Arnold and James Healy for their great contribution to our Board of Directors," Thomas Meyer said. "At the same time, we are delighted to propose the election of Mats Blom to our Board of Directors. Mats has built a great track record in key roles with several innovative European biotech and pharmaceutical companies and will provide great support as we advance our clinical-stage programs and move toward commercialization."

Auris Medical's Annual Report on Form 20-F for the year ended December 31, 2016 was filed with the Securities and Exchange Commission.  A copy of the Annual Report and the agenda for the Annual General Meeting is available on the Company's website www.aurismedical.com in the Investors section. 

Today's Conference Call & Webcast Information

Auris Medical will host a conference call and webcast to discuss the full year 2016 financial results and to provide a general business update today, March 14, 2017, at 8:00 am ET (1:00 pm CET). To participate in this conference call, dial 1-877-280-3488 (USA) or +1-646-254-3372 (International), and enter passcode 7503630. A live webcast of the conference call will be available in the Investors section of the Auris Medical website at www.aurismedical.com and a replay of the conference call will be available following the live call.

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 focused on the Phase 3 development of treatments for acute inner ear hearing loss (AM-111) and for acute inner ear tinnitus (Keyzilen ® ; AM-101) by way of intratympanic administration with biocompatible gel formulations. In addition, Auris Medical is pursuing intranasal betahistine for Meniere's disease and vestibular vertigo (AM-125) as well as early-stage research and development projects. The Company was founded in 2003 and is headquartered in Zug, Switzerland. The shares of Auris Medical Holding AG trade on the NASDAQ Global Market under the symbol "EARS."

Forward-looking Statements

This press release may contain statements that constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements are statements other than historical fact and may include statements that address future operating, financial or business performance or Auris Medical's strategies or expectations. In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expects," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "potential," "outlook" or "continue," and other comparable terminology. Forward-looking statements are based on management's current expectations and beliefs and involve significant risks and uncertainties that could cause actual results, developments and business decisions to differ materially from those contemplated by these statements. These risks and uncertainties include, but are not limited to, prevailing market conditions, whether the Company will consummate the offering of shares and warrants on the expected terms, or at all, the satisfaction of closing conditions related to the offering and risks related to the application of the net proceeds, if any, from the offering. There can be no assurance that the Company will be able to complete the offering at the anticipated size or on the anticipated terms, or at all. In any event, the Company may continue to need additional funding and may be unable to raise capital when needed, which could force the Company to delay, reduce or eliminate its product development programs or commercialization efforts. Other risks and uncertainties relating to the Company's business include the timing and conduct of clinical trials of Auris Medical's product candidates, including the likelihood that the TACTT3 clinical trial with Keyzilen ® will not meet its endpoints, the clinical utility of Auris Medical's product candidates, the timing or likelihood of regulatory filings and approvals, Auris Medical's intellectual property position and Auris Medical's financial position, including the impact of any future acquisitions, dispositions, partnerships, license transactions or changes to Auris Medical's capital structure, including future securities offerings. These risks and uncertainties also include, but are not limited to, those described under the caption "Risk Factors" in Auris Medical's Annual Report on Form 20-F and future filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date they are made, and Auris Medical does not undertake any obligation to update them in light of new information, future developments or otherwise, except as may be required under applicable law. All forward-looking statements are qualified in their entirety by this cautionary statement.

Company contact: Cindy McGee, Head of Investor Relations and Corporate Communications, +41 61 201 1350, investors@aurismedical.com

Media contact: David Schull, Russo Partners, 1-858-717-2310, david.schull@russopartnersllc.com

AURIS MEDICAL HOLDING AG Consolidated Statement of Profit or Loss and Other Comprehensive Loss For the Years Ended December 31, 2016 and 2015 (in CHF)

        2016   2015    
Research and development       (24,776,763)   (26,536,176)    
General and administrative       (5,446,512)   (4,341,570)    
Operating loss       (30,223,275)   (30,877,746)    
Interest income       67,565   36,562    
Interest expense       (828,547)   (7,985)    
Foreign currency exchange gain/(loss), net       (100,097)   1,144,106    
Revaluation gain from derivative financial instruments         291,048     -     
Loss before tax       (30,793,306)   (29,705,063)    
Income tax gain       131,055     -     
Net loss attributable to owners of the Company       (30,662,251)   (29,705,063)    
Other comprehensive loss:                
Items that will never be reclassified to profit or loss                
Remeasurement of defined benefit liability,                
net of taxes of CHF 0       (394,102)   (53,916)    
Items that are or may be reclassified to profit or loss                
Foreign currency translation differences,                
net of taxes of CHF 0       (19,723)   (12,712)    
Other comprehensive loss, net of taxes of CHF 0       (413,825)   (66,628)    
Total comprehensive loss attributable to owners of the Company       (31,076,076)   (29,771,691)    
Basic and diluted loss per share       (0.89)   (0.92)    

AURIS MEDICAL HOLDING AG Consolidated Statement of Financial Position  (in CHF)

        December 31, 2016   December 31, 2015
             
ASSETS            
Non-current assets            
Property and equipment       369,294   222,570
Intangible assets       1,482,520   1,482,520
Other non-current receivables       114,778   38,066
Total non-current assets       1,966,592   1,743,156
             
Current assets            
Other receivables       296,531   650,716
Prepayments       952,595   181,044
Cash and cash equivalents       32,442,222   50,237,300
Total current assets       33,691,348   51,069,060
             
Total assets       35,657,940   52,812,216
             
EQUITY AND LIABILITIES            
Equity            
Share capital       13,731,881   13,721,556
Share premium       112,838,815   112,662,910
Foreign currency translation reserve       (83,544)   (63,821)
Accumulated deficit       (112,344,303)   (81,578,733)
Total shareholders' equity attributable to owners of the Company       14,142,849   44,741,912
             
Non-current liabilities            
Loan       10,151,498     - 
Derivative financial instruments       117,132     - 
Employee benefits       2,092,434   1,575,833
Deferred tax liabilities       196,582   327,637
Total non-current liabilities       12,557,646   1,903,470
             
Current liabilities            
Loan       2,212,706     - 
Trade and other payables       1,837,997   1,205,522
Accrued expenses       4,906,742   4,961,312
Total current liabilities       8,957,445   6,166,834
Total liabilities       21,515,091   8,070,304
Total equity and liabilities       35,657,940   52,812,216
Scroll down for more posts ▼

Top 10 Most Recent News Articles

USPS Honors 150 Years of the U.S. Coast Guard Academy

Updated Category News Views 7

Honoring Tradition and Service The good ol’ U.S. Postal Service is at it again, giving a tip of the hat to a slice of American military heritage. This time, they’re putting out a new stamp to celebrate the 150th anniversary of the U.S. Coast Guard Academy. And you know where they did the honors? Right there on Custom House Pier in New London, Connecticut, a place that...

Continue Reading
U.S. Green Beret's Mission: Clearing Landmines in Ukraine

Updated Category News Views 3

The Rise of "Safe Ground" on Prime Video This isn't your typical feel-good story—it’s about grit and the unending fight for 'normalcy' where war left scars. Safe Ground, now streaming on Prime Video, showcases Ryan Hendrickson, a U.S. Army Green Beret whose story takes a sharp turn after stepping on an IED in 2010. The day he almost became just another statistic...

Continue Reading
D-Wave Faces Legal Questions After CFO Exit and Losses

Updated Category News Views 3

Trouble Brews at D-Wave Quantum Smack in the middle of market chaos, D-Wave Quantum Inc. (NASDAQ: QBTS) seems to have hit a rather gnarly pothole. With disappointing revenue figures for Q2 of 2026—coming in at a measly $3.08 million, far below the expected range of $4.03 million to $4.08 million—investors have more than enough reasons to be irked. When the numbers...

Continue Reading
Tam-Peli Steps Up in SCLC Battle: Trial Insights

Updated Category News Views 5

Noteworthy Developments in Small-Cell Lung Cancer Treatment Let's dive into a story straight from the world of small-cell lung cancer (SCLC) that doesn't take any prisoners. The antidote making waves is tambotatug pelitecan, or Tam-Peli for short, showcasing its might in the unrelenting fight against relapsed SCLC. The phase III TAISHAN-302 trial puts Tam-Peli...

Continue Reading
Damp or Dry: The Battle for Healthy Air in Colorado

Updated Category News Views 5

The Hidden Cost of Colorado's Dry Air Dry climate isn't just a seasonal inconvenience—it's a real hidden cost to living comfortably and healthily in Colorado. With winters colder than a brass monkey's tail and summers that don't offer much relief in terms of humidity, your home's air quality is on the front line. So, what's the financial tale here, and how do you come...

Continue Reading
Ris-Rez May Set New Standard in Relapsed SCLC

Updated Category News Views 4

The Game-Changing Results Innovation in pharmaceuticals sometimes feels like a waiting game, but when a fresh breakthrough like this rolls in, it lights up the whole landscape. Risvutatug rezetecan, or Ris-Rez for short, has shown promising potential in the fight against relapsed small-cell lung cancer (SCLC) that has progressed after platinum-based therapy. Survival...

Continue Reading
PureHealth's Acid Reflux Solutions: An Investor's Insight

Updated Category News Views 4

Digestive Wellness: The Emerging Opportunity Some days, it feels like everybody's got a gripe about their gut. You nod along at the lunch counter, folks buzzing about digestive this and acid that. But when PureHealth Research pops up with their fancy supplements, well, even the stock market's noisier nonsense starts sounding a bit quieter. They're banking big on the...

Continue Reading
Trial Disappointment: No Significant Gains in NSCLC

Updated Category News Views 6

Dissecting the Nuances of the EVOKE-03/KEYNOTE-D46 Trial Every once in a while, we come across a trial that rattles cages in the research community. Today, it's the EVOKE-03/KEYNOTE-D46 trial, a collision of hope and hard-knock reality. This Phase 3 trial, which sought to explore the potential combo of sacituzumab govitecan (SG) and pembrolizumab on metastatic non-small...

Continue Reading
PwC US and India Unite for Global Consultancy Powerhouse

Updated Category News Views 5

Rearranging the Consultancy Chessboard Piling onto the game of consultancy realignments, PwC just made a move reminiscent of playing strategy poker. They're tossing together PwC US and PwC India's advisory capabilities for a new joint venture. It’s like pushing two puzzle pieces to make a single colorful picture that stretches from the U.S. all the way to the...

Continue Reading
Pizza: The Unlikely Symbol of Universal Togetherness

Updated Category News Views 6

Why Pizza Is More Than Just Food They say a slice of pizza can tell a story. Whether it's a late-night snack amongst college buddies or the centerpiece of a family's Friday tradition, pizza unites like few others can. It morphs from a study aid into a tool for togetherness without skipping a beat, much like a chameleon of the food world. And no one understands this better...

Continue Reading

Top 5 Most Recently Viewed Articles

Waller Supports Fed's Strategic Interest Rate Adjustment

Updated Category News Views 141

Waller Backs Fed's Rate Adjustment Strategy In a recent conversation about the Federal Reserve's monetary policy, Board of Governors Member Christopher Waller provided insights into the FOMC's choice to cut interest rates by 50 basis points. This announcement drew considerable attention during an interview broadcasted on a well-known financial news channel. These remarks...

Continue Reading
BayCare Welcomes Lynnette A. Clinton as New Chief Information Officer

Updated Category News Views 268

BayCare Health System Welcomes Lynnette A. Clinton Lynnette A. Clinton has made a significant return to BayCare Health System, taking on the key role of Chief Information Officer (CIO). Having previously served as the vice president of applications, Clinton is recognized for her leadership skills and dedication to advancing healthcare technology. Leadership Role and...

Continue Reading
FLSmidth Announces Successful Share Buy-Back Transactions

Updated Category News Views 212

FLSmidth's Strategic Share Buy-Back Program FLSmidth & Co. A/S has embarked on a significant share buy-back initiative aimed at enhancing shareholder value and demonstrating confidence in its operational capabilities. The company, a leading supplier of technology and services to the global mining industry, announced a program that allows for the repurchase of shares up to...

Continue Reading
Patrick Industries Boosts Quarterly Dividend for Investors

Updated Category News Views 121

Patrick Industries Announces Dividend Increase Patrick Industries, Inc. (NASDAQ: PATK) recently revealed an increase in its quarterly cash dividend, a move that reflects the company's lasting commitment to its shareholders and the robustness of its operational model. This decision comes as part of the company's ongoing strategy to deliver rewarding returns to investors....

Continue Reading
Omega Healthcare: Leading the Way in Ambulatory RCM Services

Updated Category News Views 117

Omega Healthcare Celebrates Recognition in RCM Services Omega Healthcare has been honored with the prestigious 2026 Best in KLAS award, distinguishing itself as a top performer in Ambulatory RCM Services. With an outstanding overall performance score of 92.2, this recognition marks a significant milestone for the company, reflecting its commitment to delivering...

Continue Reading