Track topics on Twitter Track topics that are important to you
Zug, Switzerland, August 15, 2018 - Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, today announced financial results for the second quarter ended June 30, 2018 and provided a business update.
"In the past weeks and months we took important steps to reposition our Company", stated Thomas Meyer, Auris Medical's founder, Chairman and CEO. "We have refocused our strategy on developing intranasal betahistine for vertigo and mental health supportive care, two areas of great unmet medical need, where betahistine is already well known or has shown promising results, respectively. Based on the superior bioavailability obtained with intranasal delivery compared to the currently used oral formulation, we see a great potential for our AM-125 and AM-201 development programs. As part of the strategic repositioning of the Company, we intend to move forward with our late-stage programs in acute inner ear hearing loss and tinnitus through strategic partnering and/or with non-dilutive funding. Accordingly, we have been able to reduce the Company's level of operating expenses significantly, which, together with the recent equity raise, has strengthened our financial position."
Development Program Updates
AM-125 for Vertigo
AM-201 for Olanzapine-Induced Weight Gain
AM-111 for Acute Inner Ear Hearing Loss
Corporate and Other Developments
Second Quarter 2018 Financial Results
The Company continues to expect that its operating expenses in 2018 will be in the range of CHF 10 to 12 million.
Conference Call & Webcast Information
Auris Medical will host a conference call and webcast to present the second quarter 2018 financial results and to provide a business update today, August 15, 2018, at 8:00 am Eastern Time (2:00 pm Central European Time). To participate in this conference call, dial 888-254-3590 (USA) or +1 929-477-0448 (International), and enter passcode 8636087. 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 and mental disorders supportive care. The company is focused on the development of intranasal betahistine for the treatment of vertigo (AM-125) and for the treatment of antipsychotic-induced weight gain and somnolence (AM-201). This program is currently in Phase 1. In addition Auris Medical has two Phase 3 programs under development: AM-111 for acute inner ear hearing loss and Keyzilen® (AM-101) for acute inner ear tinnitus. 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."
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 ability to pursue strategic partnering and non-dilutive funding for its Phase 3 programs, the results of Auris Medical's review of strategic options and the outcome of any action taken as a result of such review, the timing and conduct of clinical trials of Auris Medical's product candidates, 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, 2017, 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.
Company contact: Hernan Levett, Chief Financial Officer, +41 61 201 1350
AURIS MEDICAL HOLDING AG
Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Loss
For the Three Months Ended June 30, 2018 and 2017 (in CHF)
| THREE MONTHS|
ENDED JUNE 30
|Research and development||(2'014'400)||(4'722'899)|
|General and administrative||(1'098'707)||(1'235'665)|
|Foreign currency exchange loss, net||22'376||(592'876)|
|Revaluation gain from derivative financial instruments||607'262||1'527'508|
|Loss before tax||(3'088'255)||(5'419'463)|
|Income tax gain||8'727||8'191|
|Net loss attributable to owners of the Company||(3'079'528)||(5'411'272)|
|Other comprehensive loss:|
| Items that will never be reclassified to|
profit or loss
|Remeasurement of defined benefit liability, net of taxes of CHF 0.00||804'301||55'810|
| Items that are or may be reclassified to|
profit or loss
|Foreign currency translation differences, net of taxes of CHF 0.00||(34'164)||39'985|
| Other comprehensive income,|
net of taxes of CHF 0
| Total comprehensive loss attributable|
to owners of the Company
|Basic and diluted loss per share||(0.50)||(1.22)|
|Average weighted number of shares outstanding, adjusted for effect of reverse stock split|| |
AURIS MEDICAL HOLDING AG
Condensed Consolidated Statement of Financial Position
| JUNE 30, |
| DECEMBER 31,|
|Property and equipment||206'591||252,899|
|Derivative financial instruments||252'351||-|
|Other non-current financial receivables||76'710||76,710|
|Total non-current assets||2'199'415||1,958,709|
|Cash and cash equivalents||4'421'771||14,973,369|
|Total current assets||5'268'283||15,867,563|
|EQUITY AND LIABILITIES|
|Foreign currency translation reserve||(52'076)||(33,047)|
|Total shareholders (deficit)/equity attributable to owners of the Company||(3'548'451)||(2,162,209)|
|Derivative financial instruments||412'552||1,836,763|
|Deferred tax liabilities||161'357||178,809|
|Total non-current liabilities||1'565'097||9,562,839|
|Trade and other payables||2'274'746||1,200,820|
|Total current liabilities||9'451'052||10,425,642|
|Total equity and liabilities||7'467'698||17,826,272|
 The overall design of that trial is described in Barak et al. (2016), Journal of Psychopharmacology 30(3): 237-241.
 Tighilet B, Léonard J, Watabe I, Bernard-Demanze L, Lacour M (2018). Betahistine treatment in a cat model of vestibular pathology: pharmacokinetic and pharmacodynamic approaches. Front Neurol. 11(9):431.
 Loss per share for second quarter 2017 adjusted for subsequent reverse stock split.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Psychiatry is the study of mental disorders and their diagnosis, management and prevention. Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...