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Hamilton, Bermuda, Aug. 15, 2019 (GLOBE NEWSWIRE) --
Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today provided a business update and announced financial results for the first half of the 2019 financial year ended June 30, 2019.
“We made significant progress with our intranasal betahistine program in the first half of 2019 and look forward to reaching important milestones with our two proof-of-concept studies for AM-125 and AM-201 in the coming months,” stated Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “We also continued the ongoing efforts to relaunch our late-stage tinnitus development program. We believe this therapy offers a promising solution for individuals suffering from tinnitus, and we continue to be encouraged by the feedback we receive from patients and physicians. Finally, we took additional steps to strengthen our balance sheet and corporate flexibility over the last few months.”
Development Program Updates
AM-125 for Vertigo
AM-201 for Antipsychotic-Induced Weight Gain
Other developments related to betahistine
Sonsuvi® / AM-111 for Acute Inner Ear Hearing Loss
Keyzilen® / AM-101 for Acute Inner Ear Tinnitus
First Half 2019 Financial Results
The Company reiterates its expectations that operating expenses in 2019 will be in the range of CHF 10 to 13 million.
Conference Call & Webcast Information
Auris Medical will host a conference call and webcast to present its first-half 2019 results and a business update today, August 15, 2019, at 8:00 am Eastern Time (2:00 pm Central European Time). To participate in this conference call, dial +1-866-966-1396 (toll free) or +1-631-510-7495, and enter passcode 2228118. A live webcast of the conference call can be accessed in the Investor Relations section of the Auris Medical website at www.aurismedical.com. A replay will be available approximately two hours following the live call.
About Auris Medical
Auris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders. 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). These projects have gone through two Phase 1 trials and entered into proof-of-concept studies in 2019. In addition Auris Medical has two Phase 3 programs under development: Sonsuvi® (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 Hamilton, Bermuda. The shares of Auris Medical Holding Ltd. 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 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, 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 and that such trials will not meet their 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, 2018 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.
Edison Advisors for Auris Medical
AURIS MEDICAL HOLDING LTD.
Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Loss
For the Six Months Ended June 30, 2019 and 2018 (in CHF)
ENDED JUNE 30
|Research and development||(1'304'291)||(4'957'621)|
|General and administrative||(2'803'267)||(2'459'421)|
|Foreign currency exchange gain/(loss), net||(264'121)||(65'914)|
|Revaluation gain / (loss) from derivative financial instruments||531'245||3'907'958|
|Loss before tax||(3'865'695)||(4'842'471)|
|Income tax gain/(loss)||261'394||17'453|
|Net loss attributable to owners of the Company||(3'604'301)||(4'825'018)|
|Other comprehensive income/(loss):|
|Items that will never be reclassified to|
profit or loss
|Remeasurement of defined benefit liability||(115'366)||1'085'102|
|Items that are or may be reclassified to|
profit or loss
|Foreign currency translation differences||6'666||(19'029)|
|Other comprehensive income/(loss)||(108'700)||1'066'073|
|Total comprehensive loss attributable|
to owners of the Company
|Basic and diluted loss per share||(1.66)||(16.36)|
|Average weighted number of shares outstanding, adjusted for effect of reverse stock split||2‘173‘307||294,914|
AURIS MEDICAL HOLDING LTD.
Condensed Consolidated Statement of Financial Position
|JUNE 30, |
|Property and equipment||19'851||33,895|
|Derivative financial instruments||222'068||226,865|
|Other non-current financial receivables||16'001||16,001|
|Total non-current assets||5'415'791||3,812,001|
|Cash and cash equivalents||5'791'929||5,393,207|
|Total current assets||6'317'661||6,064,864|
|EQUITY AND LIABILITIES|
|Foreign currency translation reserve||(37'345)||(44,011)|
|Total shareholders (deficit)/equity attributable to owners of the Company||8'952'038||3,649,650|
|Derivative financial instruments||139'287||675,328|
|Deferred tax liabilities||79'592||340,986|
|Total non-current liabilities||998'565||1,664,601|
|Trade and other payables||837'283||1,836,335|
|Total current liabilities||1'782'849||4,562,614|
|Total equity and liabilities||11'733'452||9,876,865|
1 R&D expenses in the first half of 2019 were CHF 2.9 million before capitalization of expenses related to the AM-125 program in accordance with IAS38.
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