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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
Keyzilen® (AM-101) for Acute Inner Ear Tinnitus
AM-125 for Meniere's Disease and Vestibular Vertigo
Full Year 2016 Financial Results
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."
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, email@example.com
Media contact: David Schull, Russo Partners, 1-858-717-2310,
AURIS MEDICAL HOLDING AG
Consolidated Statement of Profit or Loss and Other Comprehensive Loss
For the Years Ended December 31, 2016 and 2015
|Research and development||(24,776,763)||(26,536,176)|
|General and administrative||(5,446,512)||(4,341,570)|
|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|
|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
| Total comprehensive loss attributable|
to owners of the Company
|Basic and diluted loss per share||(0.89)||(0.92)|
AURIS MEDICAL HOLDING AG
Consolidated Statement of Financial Position
| December 31,|
| December 31,|
|Property and equipment||369,294||222,570|
|Other non-current receivables||114,778||38,066|
|Total non-current assets||1,966,592||1,743,156|
|Cash and cash equivalents||32,442,222||50,237,300|
|Total current assets||33,691,348||51,069,060|
|EQUITY AND LIABILITIES|
|Foreign currency translation reserve||(83,544)||(63,821)|
|Total shareholders' equity attributable to owners of the Company||14,142,849||44,741,912|
|Derivative financial instruments||117,132||-|
|Deferred tax liabilities||196,582||327,637|
|Total non-current liabilities||12,557,646||1,903,470|
|Trade and other payables||1,837,997||1,205,522|
|Total current liabilities||8,957,445||6,166,834|
|Total equity and liabilities||35,657,940||52,812,216|
Hearing, auditory perception, or audition is the ability to perceive sound by detecting vibrations, changes in the pressure of the surrounding medium through time, through an organ such as the ear. Sound may be heard through solid, liquid, or gaseous mat...
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