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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Auris Medical Holding AG | NASDAQ:EARS | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 3.045 | 3.02 | 3.10 | 0 | 01:00:00 |
Zug, Switzerland, November 28, 2017 - Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced financial results for the third quarter ended September 30, 2017 and provided a business update.
"The read-out from the HEALOS Phase 3 trial with AM-111 in acute inner ear hearing loss is a major milestone for Auris," commented Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive Officer. "Although the trial did not meet our expectations on the primary efficacy endpoint in the overall study population, we are very pleased to see the statistically and clinically significant treatment effects in the profound hearing loss subpopulation. Considering the high unmet medical need, we look forward to discussing the regulatory pathway for AM-111 with the regulatory agencies. In addition, we continue to focus on the development of Keyzilen® for acute inner ear tinnitus, with top-line Phase 3 results expected in early 2018, and AM-125 for vertigo, which is preparing for Phase 1."
Development Program Updates
AM-111 for Acute Inner Ear Hearing Loss
Keyzilen® (AM-101) for Acute Inner Ear Tinnitus
AM-125 for Vertigo
Corporate Developments
Other Developments
Third Quarter 2017 Financial Results
The Company expects that its operating expenses in 2017 will be lower than the previous guidance of CHF 28 to 32 million and that existing cash and cash equivalents will enable the funding of operations into the second quarter of 2018.
Conference Call & Webcast Information
Auris Medical will host a conference call and webcast to discuss the top-line results from the HEALOS trial, the third quarter 2017 financial results and to provide a general business update today, November 28, 2017, at 8:00 am Eastern Time (2:00 pm Central European Time). To participate in this conference call, dial 1-877-280-1254 (USA) or +1-646-254-3365 (International), and enter passcode 4997511. A live webcast of the conference call will be available in the Investor Relations 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 neurotology. 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 developing intranasal betahistine for 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 Capital 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 facts 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", or the negative of these terms or 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, Auris Medical's need for and ability to raise substantial additional funding to continue the development of its product candidates, 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 for the year ended December 31, 2016, and in Auris Medical's other filings with the SEC, which are available free of charge on the Securities Exchange Commission's website at: www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated. All forward-looking statements and all subsequent written and oral forward-looking statements attributable to Auris Medical or to persons acting on behalf of Auris Medical are expressly qualified in their entirety by reference to these risks and uncertainties. You should not place undue reliance on forward-looking statements. 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.
Investor contact: Daniel Ferry, LifeSci Advisors, 1-617-535-7746, investors@aurismedical.com
Media contact: David Schull, Russo Partners, 1-858-717-2310, david.schull@russopartnersllc.comAURIS MEDICAL HOLDING AGCondensed Consolidated Interim Statement of Profit or Loss and Other Comprehensive Loss (unaudited)For the Three and Nine Months Ended September 30, 2017 and 2016 (in CHF)
THREE MONTHSENDED SEPTEMBER 30 | NINE MONTHSENDED SEPTEMBER 30 | |||||||
2017 | 2016 | 2017 | 2016 | |||||
Research and development | (4'221'324) | (6'344'600) | (14'925'642) | (19'763'338) | ||||
General and administrative | (1'336'217) | (1'197'541) | (3'997'373) | (4'144'687) | ||||
Operating loss | (5'557'541) | (7'542'141) | (18'923'015) | (23'908'025) | ||||
Interest income | 7'788 | 18'118 | 53'563 | 44'284 | ||||
Interest expense | (416'956) | (404'453) | (1'248'400) | (409'712) | ||||
Foreign currency exchange gain/loss, net | 1'650 | (191'687) | (929'386) | (1'177'624) | ||||
Revaluation gain/loss from derivative financial instruments | (55'613) | 228'190 | 1'705'018 | 228'190 | ||||
Transaction costs | 0 | 0 | (506'234) | 0 | ||||
Loss before tax | (6'020'672) | (7'891'973) | (19'848'454) | (25'222'887) | ||||
Income tax gain | 8'191 | 0 | 24'573 | 0 | ||||
Net loss attributable to owners of the Company | (6'012'481) | (7'891'973) | (19'823'881) | (25'222'887) | ||||
Other comprehensive loss: | ||||||||
Items that will never be reclassified toprofit or loss | ||||||||
Remeasurement of defined benefit liability | 94'463 | 23'412 | 378'100 | (584'455) | ||||
Items that are or may be reclassified toprofit or loss | ||||||||
Foreign currency translation differences | (4'594) | 5'968 | 55'316 | 31'932 | ||||
Other comprehensive income/(loss) | 89'869 | 29'380 | 433'416 | (552'523) | ||||
Total comprehensive loss attributableto owners of the Company | (5'922'612) | (7'862'593) | (19'390'465) | (25'775'410) | ||||
Basic and diluted loss per share | (0.14) | (0.23) | (0.48) | (0.73) |
AURIS MEDICAL HOLDING AGCondensed Consolidated Interim Statement of Financial Position (unaudited) (in CHF)
SEPTEMBER 30, 2017 | DECEMBER 31,2016 | |||
ASSETS | ||||
Non-current assets | ||||
Property and equipment | 273'282 | 369'294 | ||
Intangible assets | 1'629'100 | 1'482'520 | ||
Other non-current financial assets | 76'702 | 114'778 | ||
Total non-current assets | 1'979'084 | 1'966'592 | ||
Current assets | ||||
Other receivables | 299'970 | 296'531 | ||
Prepayments | 447'456 | 952'595 | ||
Cash and cash equivalents | 20'198'415 | 32'442'222 | ||
Total current assets | 20'945'841 | 33'691'348 | ||
Total assets | 22'924'925 | 35'657'940 | ||
EQUITY AND LIABILITIES | ||||
Equity | ||||
Share capital | 17'731'881 | 13'731'881 | ||
Share premium | 113'348'971 | 112'838'815 | ||
Foreign currency translation reserve | (28'228) | (83'544) | ||
Accumulated deficit | (131'530'523) | (112'344'303) | ||
Total shareholders' equity attributable to owners of the Company | (477'899) | 14'142'849 | ||
Non-current liabilities | ||||
Loan | 6'626'525 | 10'151'498 | ||
Derivative financial instruments | 3'502'577 | 117'132 | ||
Employee benefits | 1'815'329 | 2'092'434 | ||
Deferred tax liabilities | 172'009 | 196'582 | ||
Total non-current liabilities | 12'116'440 | 12'557'646 | ||
Current liabilities | ||||
Loan | 4'406'208 | 2'212'706 | ||
Trade and other payables | 1'150'326 | 1'837'997 | ||
Accrued expenses | 5'729'850 | 4'906'742 | ||
Total current liabilities | 11'286'384 | 8'957'445 | ||
Total liabilities | 23'402'824 | 21'515'091 | ||
Total equity and liabilities | 22'924'925 | 35'657'940 |
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