Hamilton, Bermuda, March 31, 2021 – Auris Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, rhinology and allergy and CNS disorders, today provided a business update and announced second half and full year 2020 financial results.

“The 2020 business year has been quite transformative for our company as we initiated the development of AM-301, a nasal spray designated for self-protection against airborne viruses and allergens,” stated Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “With a highly dedicated team, we managed to develop in less than six months a drug-free nasal spray that reduced the SARS-CoV-2 viral titer in a model representative of the human nasal mucosa by more than 99%. The project has taken on strong momentum, and we look forward to making AM-301 available to consumers, starting towards the end of the second quarter 2021 in selected markets. With this, we expect to become a commercial stage company quite shortly.” He continued: “The project benefited greatly from our experience acquired with AM-125, our nasal spray for the treatment of acute vertigo. Here, we obtained last year promising interim data in our Phase 2 trial and expect the trial to read out in 2021. Last, but not least, we entered the new business year with a significantly stronger balance sheet, and strengthened our cash position further in the first quarter of 2021.“    

Development Program Updates

AM-125 for Treating Acute Vertigo

AM-301 for Protecting Against Airborne Viruses and Allergens 

Corporate Developments

Second Half 2020 Financial Results

Full Year 2020 Financial Results

The Company expects its total cash needs in 2021 to be in the range of CHF 11.5 to 13 million for expected total operating expenses of CHF 7 to 7.5 million and expected capitalized research and development costs of CHF 4.5 to 5.5 million. Further cash needs may arise in 2021 related to the manufacture of AM-301 as well as marketing and sale activities as the Company intends to commercialize the product in selected markets; these cash needs may initially not be covered by cash flows from product revenues.

Conference Call & Webcast - Rescheduled

Please note that Auris Medical will host a conference call and webcast to present a business update on Tuesday, April 13, 2021, at 8:00 am Eastern Time (2:00 pm Central European Time). This event will be dedicated in full to the AM-301 program and replace the conference call and webcast which was initially scheduled for today, March 31, 2021. Further details will be provided shortly before the event. 

About Auris Medical

Auris Medical is a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, rhinology and allergy and CNS disorders. The Company is focused on the development of intranasal betahistine for the treatment of vertigo (AM-125, in Phase 2) and for the prevention of antipsychotic-induced weight gain and somnolence (AM-201, post Phase 1b). Through its affiliate Altamira Medica, the Company is developing a nasal spray for protection against airborne viruses and allergens (AM-301). 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 with its main operations in Basel, Switzerland. The shares of Auris Medical Holding Ltd. 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, 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, 2020, 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.

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AURIS MEDICAL HOLDING Ltd.
Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Loss
For the Six and Twelve Months Ended December 31, 2020 and 2019 (in CHF)

  SIX MONTHS
ENDED DECEMBER 31		 TWELVE MONTHS
ENDED DECEMBER 31
  2020 2019 2020 2019
Other operating income 174,475 — 174,475 —
Research and development (1,978,232) (2,020,990) (2,862,979) (3,325,281)
General and administrative (1,058,702) (1,130,596) (2,594,662) (3,933,863)
Operating loss (2,862,459) (3,151,586) (5,283,166) (7,259,144)
Interest income 258 17,882 258 17,882
Interest expense (131,999) (3,367) (135,151) (28,628)
Foreign currency exchange gain/(loss), net (303,531) 44,548 (333,553) (219,573)
Revaluation gain / (loss) from derivative financial instruments (2,254,575) 132,480 (2,250,222) 663,725
Transaction costs — — (219,615) —
Loss before tax (5,552,306) (2,960,043) (8,221,449) (6,825,738)
Income tax gain/(loss) 10,642 (67,557) 21,284 193,837
Net loss attributable to owners of the Company (5,541,664) (3,027,600) (8,200,165) (6,631,901)
Other comprehensive income/(loss):        
Items that will never be reclassified to
profit or loss		        
Remeasurement of defined benefit liability, net of taxes of CHF = 0 51,892 43,356 (26,118) (72,010)
Items that are or may be reclassified to
profit or loss		        
Foreign currency translation differences, net of taxes of CHF = 0 72,466 9,780 88,862 16,446
Other comprehensive income/(loss) 124,358 53,136 62,744 (55,564)
Total comprehensive loss attributable
to owners of the Company		 (5,417,306) (2,974,464) (8,137,421) (6,687,465)
         
Basic and diluted loss per share (0.75) (0.83) (1.36) (2.28)
Average weighted number of shares outstanding 7,432,839 3,628,614 6,014,146 2,909,056

AURIS MEDICAL HOLDING Ltd.
Condensed Consolidated Statement of Financial Position
 (in CHF)

  DECEMBER 31,
2020		 DECEMBER 31,         
   2019
ASSETS    
Non-current assets    
Property and equipment 46,636 66,672
Intangible assets 9,115,410 6,765,613
Other non-current receivables 20,001 20,001
Total non-current assets 9,182,047 6,852,286
     
Current assets    
Other receivables 80,861 335,299
Prepayments 277,589 434,231
Derivative financial instruments — 219,615
Cash and cash equivalents 11,258,870 1,384,720
Total current assets 11,617,320 2,373,865
     
Total assets 20,799,367 9,226,151
     
EQUITY AND LIABILITIES    
Equity    
Share capital 114,172 1,650,380
Share premium 177,230,300 157,191,707
Foreign currency translation reserve 61,297 (27,565)
Accumulated deficit (160,635,879) (152,778,389)
Total shareholders’ (deficit)/equity attributable to owners of the Company 16,769,890 6,036,133
     
Non-current liabilities    
Derivative financial instruments 6,318 4,353
Employee benefit liability 867,376 760,447
Deferred tax liabilities 125,865 147,149
Total non-current liabilities 999,559 911,949
     
Current liabilities    
Loan 523,920 —
Derivative financial instruments 310,439 —
Trade and other payables 762,453 938,247
Accrued expenses 1,433,106 1,339,822
Total current liabilities 3,029,918 2,278,069
Total liabilities 4,029,477 3,190,018
Total equity and liabilities 20,799,367 9,226,151



1 Does not include capitalized costs related to expenses for the AM-125 program in accordance with IAS38.