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EARS

Auris Medical Holding AG NASDAQ Capital Market
$2.86
Open: $2.95 High: $3.06 Low: $2.78 Close: $2.86
Range: 2021-05-06 - 2021-05-07
Volume: 1,376,592
Market: Closed
Powered by Finage Stock APIDelayed data
EARS
Auris Medical Holding AG Bahnhofstrasse 21 Zug , 6300 http://www.aurismedical.com
Auris Medical Holding AG is a clinical-stage biopharmaceutical company. It is engaged in the development of novel products for the treatment of inner ear disorders. Its product candidate is AM-101.
  • CEO: Thomas Meyer
  • Employees: 24
  • Sector: Healthcare
  • Industry: Biotechnology
EARS News
Latest news about the EARS
  • Auris Medical Announces Positive Preclinical and Clinical Outcomes with AM-301 and Details Plans for Market Launch

    Clinical evaluation of AM-301 nasal spray in allergic rhinitis meets primary endpoint Extended protection achieved over several hoursPreliminary preclinical data suggest therapeutic utility post SARS-CoV-2 infectionProduct launch under BentrioTM brand in selected European countries towards end of Q2 2021 Hamilton, Bermuda, April 13, 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, and its affiliate Altamira Medica Ltd. today provided an update on its AM-301 program for protection against airborne viruses and allergens. “We are very pleased to report on major progress with our AM-301 nasal spray program, which is moving in large steps forward towards the start of commercialization”, commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “AM-301 has been designed to provide a triple protective effect by acting as a protective layer on the nasal mucosa, trapping and helping to remove airborne particles and through humidification of the mucosa. Fresh preclinical and clinical data confirm AM-301’s protective effects in case of exposure to airborne allergens and suggest potential utility of the product also in case of ongoing infection from SARS-CoV-2. We have numerous additional studies ongoing or planned and look forward to sharing further outcomes, including through scientific communications.” AM-301 effectively alleviates allergy symptoms in clinical pollen challenge Altamira Medica recently completed the treatment phase of its open-label randomized cross-over clinical investigation of AM-301 in 36 patients with allergic rhinitis to grass pollen. Study participants were administered a single dose of AM-301 nasal spray or a comparator product prior to controlled pollen exposure for four hours in an allergen challenge chamber. The challenge was repeated with the alternate treatment following a wash-out period. Preliminary analyses show that AM-301 met the primary endpoint of non-inferiority in the Total Nasal Symptom Score (TNSS) relative to the marketed comparator product, which serves as the predicate device for the planned 510(k) submission to the US Food and Drug Administration (FDA). In addition, the treatment was well tolerated. Proof of substantial equivalence to the predicate device is a key requirement for market clearance under the 510(k) regulatory pathway. Furthermore, the allergen challenge study demonstrated a rapid onset and long durability of AM-301’s protective effect, as measured by a clinically relevant 1-point reduction in the TNSS compared to unprotected pollen exposure. On average, the protective effect was maintained for at least three hours. These clinical observations are in line with the results from a new in vitro study based on a barrier diffusion model. The assay, which was performed at 35°C and 90% relative humidity to mimic conditions within the nasal cavity, showed that a thin layer of AM-301 prevented Timothy grass pollen from diffusing into an agar block for up to 6 hours, the maximum duration of the experiment. AM-301 helps to reduce growth in infectious titer in ongoing SARS-CoV-2 infection In parallel with the outcomes from the allergy studies, Altamira Medica obtained first data from testing AM-301 after the start of infection of human nasal epithelium cells with SARS-CoV-2. In a previous study in the same type of assay, AM-301 had been shown to be highly effective in reducing the infectious viral titer when daily treatment was started right before inoculation of the cells, i.e. in a preventative fashion. In the new experiment, daily treatment with AM-301 started 24 or 30 hours post inoculation. Saline- and vehicle-treated and untreated cell cultures served as controls. In control cultures, SARS-CoV-2 replicated efficiently over four days, resulting in a rapid increase in viral titer (as measured by the Median Tissue Culture Infectious Dose, TCID50, in Vero cells). Daily treatment with AM-301 resulted in a statistically significant deceleration of the viral titer growth compared to controls (p-value <0.01, linear mixed-effects model). At Day 4 of the experiment, viral titers were 73.7 to 94.5% lower compared to controls. Selection of BentrioTM brand name for commercialization With the ongoing progress in the development and testing of AM-301, the Company expects to meet the essential requirements for marketing the product in Europe under the CE mark shortly. Altamira Medica intends to launch the commercialization of AM-301 under the brand name BentrioTM in selected European countries starting in June 2021, employing various on- and offline distribution channels. The Company expects to expand market coverage rapidly during the second half of 2021, including collaborations with future licensing partners. The expansion will be supported by significant, scalable contract manufacturing capacity. Upon readiness for CE mark conformity, Altamira Medica expects to submit a 510(k) pre-market notification application to the FDA requesting regulatory clearance for AM-301 for the intended use in allergy. Regarding the intended use in viral infections, the Company continues to be engaged in a dialogue with the FDA on the applicable regulatory pathway. Conference Call & Webcast Auris Medical's management team will host a live conference call and webcast to present a business update on the AM-301 program at 8:00 am Eastern Time (2:00 pm Central European Time). To participate in this conference call, dial +1-877-870-9135 (US, toll free) or +44-2071-928-338 (international), and enter passcode 5649276. 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 AM-301 AM-301 is a drug-free nasal spray for personal protection against airborne viruses and allergens. Upon application into the nose, AM-301 forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of viruses or allergens with cells; in addition, the composition serves to bind such particles and help with their discharge and to humidify the nasal mucosa. Together, this is designed to reduce the risk of upper respiratory tract viral infections and promote alleviation of allergic symptoms. 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, the approval and timing of commercialization of AM-301, 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. Investor contact: investors@aurismedical.com

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  • Auris Medical to Provide Business Update on AM-301 Program on Tuesday, April 13, 2021

    Hamilton, Bermuda, April 8, 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 announced that it will provide a business update on its AM-301 program for protection against airborne viruses and allergens on Tuesday, April 13, 2021. Following the announcement, Auris Medical's management team will host a live conference call and webcast at 8:00 am Eastern Time (2:00 pm Central European Time). To participate in this conference call, dial +1-877-870-9135 (US, toll free) or +44-2071-928-338 (international), and enter passcode 5649276. 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 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.” Investor contact: investors@aurismedical.com

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  • Auris Medical Provides Business Update and Reports Second Half and Full Year 2020 Financial Results

    Clinical evaluation of AM-301 nasal spray in allergen protection progressingLaunch of AM-301 expected in selected markets towards the end of second quarter 2021 Phase 2 trial with AM-125 in acute vertigo expected to complete enrollment in third quarter 2021Equity and cash position significantly strengthenedStrategy review ongoing 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 Initiated Part B of TRAVERS trial. Following the positive results from the interim analysis in the Phase 2 trial with AM-125, including a dose dependent improvement in patients’ performance of the “Tandem Romberg” and the “Standing on Foam” balance tests, the two highest doses, 10 and 20 mg, were selected by the Company to be tested against placebo in 72 patients in Part B of the trial. Enrollment into Part B started in October 2020.COVID-19 pandemic causing temporary delay in enrollment. Recruitment into the TRAVERS trial slowed down considerably in early 2021 as several study sites postponed elective procedures and temporarily reduced or suspended clinical research activities. Candidates for participation in the TRAVERS trial undergo certain types of neurosurgery, which are elective procedures. Recruitment rates recovered somewhat in March, but they may continue to be impacted for some time. Although sites are expected to catch up on enrollment once COVID-19 related restrictions are relaxed, the Company expects that results from the trial will become only available in the third quarter of 2021, at the earliest. AM-301 for Protecting Against Airborne Viruses and Allergens Initiated clinical investigation of AM-301 in allergic rhinitis. In January 2021, the Company announced the initiation of an open-label randomized cross-over study that will enroll 36 patients with allergic rhinitis to grass pollen. Study participants are administered a single dose of AM-301 nasal spray or a comparator product (one puff into each nostril) prior to controlled pollen exposure for four hours in an allergen challenge chamber. The challenge is repeated with the alternate treatment following a wash-out period. The difference in the Total Nasal Symptom Score (TNSS) between the two treatments over the 4-hour exposure will serve as the primary efficacy endpoint; the investigation shall demonstrate clinical non-inferiority of AM-301 to the comparator product. Results from the clinical investigation are expected to become available in a few weeks.Continued preclinical testing program. The Company has initiated or planned several in vitro and in vivo tests to generate additional data for the intended use in allergies and viral infection. These will assess, among others, the potential capacity of AM-301 reduce the viral titer post infection with SARS-CoV-2, the effects of AM-301 on some of the new virus strains as well as on other types of virus, and the durability of its barrier function against pollen.Advanced preparations for launch in selected markets late in the second quarter 2021. The Company expects to meet the requirements for CE marking, a prerequisite for commercializing AM-301 in Europe, in the second quarter of 2021 and is currently scaling up the manufacturing process for launch of the product in selected European markets towards the end of the quarter. In the US, the Company is engaged in a dialogue with the FDA on the proposed product development plan and the applicable regulatory pathway. The Company continues to expect that AM-301 will be eligible for clearance through the 510(k) pathway for the intended use in allergy. Corporate Developments Retained full control over Altamira Medica affiliate. The Company increased the share capital of Altamira Medica Ltd. (“Altamira”), its affiliate dedicated to developing and commercializing AM-301, from CHF 0.5 to 3 million to accommodate the progress of the program. A convertible loan of CHF 1.5 million to Altamira was converted in two steps in shares of Auris Medical Holding Ltd., allowing the Company to retain full control of its affiliate.Raised CHF 16.6 million (gross) in equity. The Company significantly strengthened its balance sheet and cash position through several transactions in December 2020 and March 2021. These included the placement of 2,000,000 common shares with certain institutional investors at an offering price of $4.00 per share as well as the exercise of 2,161,280 warrants held by the investors in the May 2019 offering at an exercise price of CHF 4.34. All warrants issued through the May 2019 Offering have been exercised by now.Continued strategy review. In September 2020, the Company’s Board of Directors started a process to explore, review and evaluate a broad range of potential strategic alternatives with the aim of unlocking the potential of the Company’s assets and maximize shareholder value. In this context, the Board has been holding discussions with several parties about certain potential transactions. At this point, there can be no assurance the Company’s strategy review will result in the completion of any particular course of action, and there is no defined timeline for completion of the review process. Second Half 2020 Financial Results Total operating expenses for the second half of 2020 were CHF 2.9 million compared to CHF 3.2 million for the second half of 2019.Research and development expenses for the second half of 2020 were CHF 2.0 million compared to CHF 2.0 million for the second half of 2019.1General and administrative expenses for the second half of 2020 were CHF 1.1 million compared to CHF 1.1 million for the second half of 2019.Net loss for the second half of 2020 was CHF 5.5 million, or CHF 0.75 per share, compared to CHF 3.0 million, or CHF 0.83 per share, for the second half of 2019.Cash and cash equivalents at December 31, 2020, totaled to CHF 11.3 million. Full Year 2020 Financial Results Total operating expenses for 2020 were CHF 5.3 million compared to CHF 7.3 million for 2019. Research and development expenses for 2020 were CHF 2.9 million compared to CHF 3.3 million for 2019.1 General and administrative expenses for 2020 were CHF 2.6 million compared to CHF 3.9 million for 2019. Net loss attributable to owners of the Company for 2020 was CHF 8.2 million, or CHF 1.36 per share, compared to CHF 6.6 million, or CHF 2.28 per share, for 2019. 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. Investor contact: investors@aurismedical.com 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 2019Other 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 17,882Interest 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) 663,725Transaction 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) 21,284 193,837Net 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 16,446Other 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, 2019ASSETS Non-current assets Property and equipment 46,636 66,672Intangible assets 9,115,410 6,765,613Other non-current receivables 20,001 20,001Total non-current assets 9,182,047 6,852,286 Current assets Other receivables 80,861 335,299Prepayments 277,589 434,231Derivative financial instruments — 219,615Cash and cash equivalents 11,258,870 1,384,720Total current assets 11,617,320 2,373,865 Total assets 20,799,367 9,226,151 EQUITY AND LIABILITIES Equity Share capital 114,172 1,650,380Share premium 177,230,300 157,191,707Foreign 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 4,353Employee benefit liability 867,376 760,447Deferred tax liabilities 125,865 147,149Total non-current liabilities 999,559 911,949 Current liabilities Loan 523,920 —Derivative financial instruments 310,439 —Trade and other payables 762,453 938,247Accrued expenses 1,433,106 1,339,822Total current liabilities 3,029,918 2,278,069Total liabilities 4,029,477 3,190,018Total 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.

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  • Auris Medical Holding Ltd. to Host Earnings Call

    NEW YORK, NY / ACCESSWIRE / March 31, 2021 / Auris Medical Holding Ltd. (NASDAQ:EARS) will be discussing their earnings results in their 2020 Second Half Earnings call to be held on March 31, 2021 at 8:00 AM Eastern Time.

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  • Auris Medical to Report Second Half and Full Year 2020 Financial Results and Provide Business Update on Wednesday, March 31, 2021

    Hamilton, Bermuda, March 24, 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 announced that it will provide a business update and report its financial results for the second half and full year 2020 on Wednesday, March 31, 2021. Following the announcement, Auris Medical's management team will host a live conference call and webcast at 8:00 am Eastern Time (2:00 pm Central European Time). To participate in this conference call, dial +1-877-870-9135 (US, toll free) or +44-2071-928-338 (international), and enter passcode 5649276. 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 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.” Investor contact: investors@aurismedical.com

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  • Auris Medical Announces Initiation of Clinical Investigation of AM-301 in Allergic Rhinitis

    Hamilton, Bermuda, January 29, 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 announced with its affiliate Altamira Medica AG the initiation of a clinical investigation of AM-301 in allergic rhinitis. The clinical investigation is an open-label randomized cross-over study that will enroll 36 patients with allergic rhinitis to grass pollen. Study participants will be administered a single dose of AM-301 nasal spray or a comparator product (one puff into each nostril) prior to controlled pollen exposure for four hours in an allergen challenge chamber. The challenge will be repeated with the alternate treatment following a wash-out period. The difference in the Total Nasal Symptom Score (TNSS) between the two treatments over the 4-hour exposure will serve as the primary efficacy endpoint; the investigation shall demonstrate clinical non-inferiority of AM-301 to the comparator product. “We are very excited to initiate the clinical investigation of AM-301 for its intended use of alleviating allergic symptoms triggered by inhalation of airborne allergens,” commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “Allergic rhinitis from exposure to allergens such as pollen, house dust or animal hair is affecting 7.8% of the adult US population and 9% of children and can have a major impact on well-being and quality of life. Despite its high prevalence, there is still no cure for it. With AM-301, we are seeking to provide a simple, drug-free and yet effective means for protection of the nasal mucosa against airborne allergens.” Results from the allergen challenge chamber study are expected in Q2 2021. Beside the development of AM-301 for use in allergy management, Altamira Medica is advancing the testing of the nasal spray for use in the protection against infections from airborne viruses such as SARS-CoV-2. “Like all of us in the past few weeks, we have been watching with growing concern the spreading of various SARS-CoV-2 mutations around the world,” stated Thomas Meyer. “Given AM-301’s mode of action and inherent broad spectrum, we are confident that the nasal spray will exert protective effects also in case of the new strains. For confirmation, we are planning to test AM-301 against them in reconstituted human nasal epithelia cells shortly.” The Company maintains its objective of introducing AM-301 in selected markets in late Q2 2021. About AM-301 AM-301 is a drug-free nasal spray for personal protection against airborne viruses and allergens. Upon application into the nose, AM-301 forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of viruses or allergens with cells; in addition, the composition serves to bind such particles and help with their discharge. Together, this is designed to reduce the risk of upper respiratory infections and promote alleviation of allergic symptoms. 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 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, 2019, 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: investors@aurismedical.com

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  • Auris Medical Provides Business Update

    * Net cash inflow of $13.4 million from recent registered direct offering and warrant exercises   * AM-301 program progressing towards clinical and regulatory milestones  * Strategy review ongoing Hamilton, Bermuda, December 15, 2020 – 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 related to the Company’s funding position, its AM-301 program for the protection against airborne pathogens and allergens and the ongoing strategy review process.Significant change in funding position On December 2, 2020, the Company entered into securities purchase agreements with several institutional investors for the purchase and sale of 2,000,000 common shares at an offering price of $4.00 per share, pursuant to a registered direct offering. The net proceeds of the offering, which closed on December 4, 2020, were approximately $7.3 million. In addition, certain investors in the May 2019 financing of common shares and warrants exercised warrants for 1,263,845 common shares at the exercise price of CHF 4.34 (approximately $4.82) per share, for net proceeds of CHF 5.5 million. Taken together, these two transactions provided net proceeds of approximately $13.4 million to the Company.Further progress with AM-301 program     The Company’s AM-301 program for the development of a drug-free nasal spray for protection against airborne pathogens and allergens, is progressing towards important milestones. The Company’s affiliate Altamira Medica Ltd. is planning to conduct a clinical investigation of AM-301 with human volunteers in an allergen challenge chamber in Europe. Subject to approval by the relevant Ethics Committee, the study is expected to start in the first quarter 2021 and to conclude within approximately 3 months. The Company expects to meet the requirements for CE marking, a prerequisite for commercializing AM-301 in Europe, in the second quarter of 2021. Further, Altamira Medica has requested guidance from the FDA on the proposed product development plan, the applicable regulatory pathway, as well as the potential eligibility for Emergency Use Authorization of AM-301 for use against SARS-CoV-2.Strategy review ongoing  On September 17, 2020, the Company announced that its Board of Directors had initiated a review of strategic options with the objective of unlocking the potential of its assets and maximize shareholder value. Following the review of various scenarios and opportunities, the Board has entered into discussions with a number of parties about certain potential transactions. At this point, there can be no assurance the Company’s strategy review will result in the completion of any particular course of action, and there is no defined timeline for completion of the review process.“We are very pleased about the recent capital raises which have significantly strengthened our cash and equity position“, commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “We estimate that our cash runway now extends to the end of 2021 or into early 2022, thus covering a period during which we expect to reach important milestones. These include the read-out from the Phase 2 clinical trial with AM-125 in acute vertigo and readiness for commercialization of our AM-301 nasal spray for the protection against airborne pathogens and allergens.”    About AM-301 AM-301 is a drug-free nasal spray for personal protection against airborne pathogens and allergens. Upon application into the nose, AM-301 forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of viruses or other pathogens and allergens with cells; in addition, the composition serves to “trap” such particles and help with their discharge. Together, this is designed to reduce the risk of upper respiratory infections and promote alleviation of allergic symptoms. In an in vitro model of reconstituted human nasal epithelia infected with SARS-CoV-2, daily treatment with AM-301, beginning right before inoculation, showed effective protection against viral infection. 48 hours post-infection, average virus titers were 90.0% lower than those observed in controls (p<0.01). 72 hours and 96 hours post-infection, average virus titers were 99.2 and 99.4% lower, respectively (p<0.001).  About Auris MedicalAuris 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 pathogens 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 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, 2019, 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:investors@aurismedical.com

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  • Have Insiders Been Buying Auris Medical Holding Ltd. (NASDAQ:EARS) Shares?

    We often see insiders buying up shares in companies that perform well over the long term. Unfortunately, there are also...

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  • Auris Medical Holding to Present at the 13th Annual LD Micro Main Event Conference

    Hamilton, Bermuda, December 7, 2020 – 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 announced that Chairman and CEO Thomas Meyer will present at the 13th Annual LD Micro Main Event investor conference on Tuesday, December 15, 2020, at 10:40 a.m. EST. The event will be webcast live and available via the event homepage https://ve.mysequire.com/. About Auris MedicalAuris 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 pathogens 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.”Investor contact:investors@aurismedical.com

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  • Auris Medical Holding Ltd. Prices $8,000,000 Common Shares Offering Priced At-the-Market

    Hamilton, Bermuda, December 2, 2020 – Auris Medical Holding Ltd. (NASDAQ: EARS) (“Auris” or the “Company”), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, rhinology and allergy and CNS disorders, today announced it has entered into securities purchase agreements with institutional investors for the purchase and sale of 2,000,000 common shares, par value CHF 0.01 per share, at an offering price of $4.00 per share, pursuant to a registered direct offering, priced at-the-market under Nasdaq rules. The gross proceeds of the offering will be approximately $8,000,000 before deducting fees and other estimated offering expenses. The Company intends to use the net proceeds for working capital and general corporate purposes. The closing of the registered direct offering is expected to take place on or about December 4, 2020, subject to the satisfaction of customary closing conditions.  A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering.This offering was made pursuant to an effective shelf registration statement on Form F-3 (File No. 333-228121) previously filed with the U.S. Securities and Exchange Commission (the “SEC”).  This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.  A prospectus supplement relating to the common shares will be filed by Auris with the SEC.  When available, copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC's website at www.sec.gov or from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, New York 10022 or by email at prospectus@allianceg.com. About Auris MedicalAuris 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 pathogens 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 release may contain forward-looking statements that are within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by certain words or phrases such as "may", "will", "aim", "will likely result", "believe", "expect", "will continue", "anticipate", "estimate", "intend", "plan", "contemplate", "seek to", "future", "objective", "goal", "project", "should", "will pursue" and similar expressions or variations of such expressions. These forward-looking statements reflect the Company's current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the Company. Please refer to the Company's most recent Forms 20-F and subsequent filings with the SEC for a further discussion of these risks and uncertainties. The Company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release.Investor contact:investors@aurismedical.com

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  • Auris Medical Reports Positive In vitro Efficacy Data for AM-301 in Protecting Against Sars-CoV-2 Infection

    * Up to 99.4% reduction of viral titer in human epithelial cell culture (p<0.001) * Results suggest potential for AM-301 nasal spray to mitigate risk of Sars-CoV-2 infectionHamilton, Bermuda, December 1, 2020 – 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 announced positive efficacy data from testing AM-301 in vitro. AM-301 is a drug-free nasal spray being developed by the Company’s affiliate Altamira Medica for protection against airborne pathogens and allergens.AM-301 was tested for its capability to prevent or mitigate SARS-CoV-2 infection of nasal epithelial cells, which are part of the nasal mucosa and the first barrier against continuously inhaled substances such as pathogens and allergens. The experiment was performed over four days on reconstituted human nasal epithelia, which are frequently used to study the effects of human respiratory viruses. In saline-treated control cultures, Sars-CoV-2 replicated efficiently, resulting in a rapid increase in viral titer (as measured by the Median Tissue Culture Infectious Dose, TCID50). In contrast, daily treatment with AM-301, beginning right before inoculation, showed effective protection against viral infection. 48 hours post-infection, average virus titers were 90.0% lower than those observed in controls (p<0.05). 72 hours and 96 hours post-infection, average virus titers were 99.2 and 99.4% lower, respectively (p<0.001). Even when unbound virus was not removed daily through apical washing, allowing the virus to accumulate in the culture for 4 days, the reduction in viral titer was 92.4% compared to saline-treated controls (p<0.001).    “We are very excited to see the protective effects of AM-301 against Sars-CoV-2 confirmed in an assay that very closely replicates real-life conditions in the human nose“, commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “Our first experiments in September showed that AM-301’s key component trapped up to 99% of Sars-CoV-2 when brought into contact with a viral suspension. Now, with our newly developed spray formulation, we have direct evidence that AM-301 has the potential to significantly mitigate the risk of infection of nasal mucosal cells. We look forward to taking AM-301 through additional tests and advancing the program towards the submission of regulatory applications in 2021.”    About AM-301 AM-301 is a drug-free nasal spray for personal protection against airborne pathogens and allergens. Upon application into the nose, AM-301 forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of viruses or other pathogens and allergens with cells; in addition, the composition serves to “trap” such particles and help with their discharge. Together, this is designed to reduce the risk of upper respiratory infections and promote alleviation of allergic symptoms.  About Auris MedicalAuris 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 pathogens 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 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, 2019, 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: investors@aurismedical.com   Attachment * Auris Medical Altamira New Virus Protection Data 2020-12-01

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  • Auris Medical Launches Website for AM-301-focused Subsidiary, Altamira Medica

    Hamilton, Bermuda, November 20, 2020 – 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 announced the launch of a dedicated website for its affiliate Altamira Medica Ltd. The website, www.altamiramedica.com, offers quick and easy access to information about the Company’s development of AM-301, a drug-free nasal spray intended for self-protection against risks from exposure to airborne viruses and allergens.    Altamira Medica Ltd. was set up in September 2020 as a subsidiary of Auris Medical Holding Ltd. to focus on and expedite the development of AM-301. Upon application into the nose, AM-301 forms a protective gel layer on the nasal mucosa. This thin film is designed to prevent the contact of airborne viruses and allergens with cells; in addition, the composition serves to “trap” such particles and help with their discharge. Together, this is designed to reduce the risk of upper respiratory infections and promote alleviation of allergic symptoms. The potential protective effects of AM-301 have been demonstrated to date in a SARS-CoV-2 assay. A short contact between AM-301’s key component and the virus suspension was sufficient to reduce the viral infectious load by up to 99%.“We are proud to provide further updates on our AM-301 program through the new dedicated website“, commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “Since the announcement of the program, we have received a lot of positive feedback on our approach of providing a simple, effective and affordable means for reducing risk when potentially exposed to airborne viruses or allergens. We are working hard to advance the AM-301 project quickly and aim to submit regulatory applications in 2021.” Altamira Medica’s website will be continuously updated with development updates, relevant background information and press releases.  About Auris MedicalAuris 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). With AM-301, the Company is developing a nasal spray for protection against airborne pathogens and allergens. 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 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, 2019, 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: Joseph Green Edison Advisor for Auris Medical 646-653-7030 jgreen@edisongroup.comorinvestors@aurismedical.com

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  • RedHill's (RDHL) RHB-204 Gets FDA Orphan Drug Designation

    RedHill (RDHL) gets Orphan Drug status from the FDA for the treatment of nontuberculous mycobacteria (NTM) disease.

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  • Why Auris Medical's Stock Is Trading Higher Today

    Auris Medical (NASDAQ: EARS) shares are trading higher on Tuesday as traders seem to be mistaking the company for Auris Health, which was acquired by Johnson & Johnson (NYSE: JNJ).Auris Medical is not related to Auris Health.See Also: Johnson & Johnson Sued Over Failing To Deliver Promised Post-Merger Returns To Auris InvestorsAuris Medical Holding Ltd is a clinical-stage biopharmaceutical company. The company develops novel products for the treatment of inner ear disorders. It has two projects in advanced clinical development Keyzilen for the treatment of acute inner ear tinnitus and AM-111 for the treatment of acute inner ear hearing loss.Auris Medical shares traded up 27.90% to $1.08 on Tuesday at the time of publication. The stock has a 52-week high of $2.28 and a 52-week low of 65 cents.See more from Benzinga * Options Trades For This Crazy Market: Get Benzinga Options to Follow High-Conviction Trade Ideas * Why Medigus Stock Is Trading Higher Today * Why J.Jill's Stock Is Trading Higher Today(C) 2020 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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  • Auris Medical Announces Initiation of Part B of TRAVERS Phase 2 Study with AM-125 in Vertigo

    Hamilton, Bermuda, October 13, 2020 – 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 announced that the first patient has been randomized in Part B of its “TRAVERS” Phase 2 trial of AM-125 (intranasal betahistine) in acute vertigo. This follows the positive read-out from the interim analysis on Part A of the study in early September 2020, the completion of enrollment into the oral treatment group, and the receipt of regulatory clearance for Part B in the first three of the participating study countries. In Part B of the TRAVERS trial, the Company will enroll 72 patients who suffer from acute vertigo following neurosurgery. They will be randomized to receive either 10 or 20 mg of intranasal betahistine or a placebo three times daily for four weeks. The improvement in the “Standing on Foam” test from baseline to Day 14 will be the primary efficacy endpoint; the improvement in the “Tandem Romberg” test to Day 42 (i.e. two weeks after completion of treatment) will be the key secondary efficacy endpoint. The two tests measure how long patients are able to maintain balance on a foam mat or with the two feet aligned one after the other, respectively, while they have their eyes closed. As the Company remained blinded to treatment allocation during the interim analysis, the corresponding data from Part A will be pooled with those from Part B.“In Part A of the TRAVERS trial, we demonstrated good safety and tolerability of AM-125 and observed a compelling dose response effect with active treated patients, showing up to 1.9 to 2.4 times better performance in key balance tests,” commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “With Part B, we aim to confirm these positive outcomes with the two highest doses in a larger patient sample and, based on those results, advance the program into Phase 3 development. For patients suffering from vertigo, regaining balance as quickly as possible is of utmost importance. Unlike other vertigo drugs that suppress the vestibular function to treat just short-term symptoms such as nausea, AM-125 acts as a vestibular stimulant to enhance and accelerate vestibular compensation and help patients to ‘get back on their feet’.”The Company expects to complete enrollment into Part B of the TRAVERS trial by the end of the first quarter 2021, provided that the Covid-19 pandemic does not cause further restrictions on patient enrollment.   About Betahistine Betahistine is a small molecule structural analog of histamine, which acts as an agonist at the H1 and as an antagonist at the H3 histamine receptors. Unlike histamine, it crosses the blood-brain-barrier. It is known to enhance inner ear and cerebral blood flow, increase histamine turnover and enhance histamine release in the brain, increase release of acetylcholine, dopamine and norepinephrine in the brain and to result in general brain arousal. The compound has a very good safety profile, yet it is also known that its clinical utility is held back by poor bioavailability. Intranasal administration of betahistine has been shown to result in 5 to 29 times higher bioavailability.About AM-125 Intranasal betahistine is being developed under project code AM-125 for the treatment of acute vertigo. Betahistine has been shown to increase cochlear, vestibular and cerebral blood flow, facilitate vestibular compensation and inhibit neuronal firing in the vestibular nuclei. Betahistine for oral administration is approved in about 115 countries, with the US being a notable exception, for the treatment of vertigo and Meniere’s disease.About Auris MedicalAuris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology 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). With AM-301, the Company is developing a nasal spray for protection against airborne pathogens and allergens. 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 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, 2019, 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: Joseph Green Edison Advisor for Auris Medical 646-653-7030 jgreen@edisongroup.comorinvestors@aurismedical.com

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  • Auris Medical Provides Business Update and Reports First Half 2020 Financial Results

    * Advancing Phase 2 trial with AM-125 in acute vertigo based on positive interim data * Positive outcome from AM-201 trial in prevention of antipsychotic-induced weight gain * Addition of new intranasal program with development of drug-free spray for protection against airborne pathogens and allergens * Review of strategic options initiatedHamilton, Bermuda, September 17, 2020 – 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 2020 financial year ended June 30, 2020.“Over the past few months we reached major milestones with our intranasal betahistine program, reporting positive safety and tolerability data as well as significant efficacy signals in two clinical trials,” stated Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “The demonstration of a dose-dependent improvement in various vertigo measures provides further evidence for the therapeutic potential of AM-125 as a vestibular stimulant. Further, the reduction in antipsychotic-induced weight gain in our AM-201 trial suggests the potential of the drug in other therapeutic indications. In addition, we are now leveraging our experience with intranasal delivery into the development of a drug-free nasal spray for protection against airborne pathogens and allergens. We are very excited about this new program given the large number of people affected by allergic rhinitis and the strong need for personal protection against airborne pathogens, highlighted by the current Covid-19 pandemic.”Development Program UpdatesAM-125 for Treating Acute Vertigo * Reported positive results from interim analysis in Phase 2 trial with AM-125 in acute vertigo. On September 3, 2020 the Company announced top-line data from Part A of the TRAVERS trial, which enrolled 33 patients suffering from vertigo following neurosurgery. The patients were treated with AM-125 (intranasal betahistine) at 1, 10 or 20 mg or placebo (3 x daily) for four weeks. At the highest dose of 20 mg, AM-125-treated patients improved their performance of the “Tandem Romberg” and the “Standing on Foam” balance tests from baseline to 14 days post-surgery (primary endpoint) on average 1.9 to 2.4 times more than placebo-treated patients (6.0 vs. 3.1 and 10.5 vs. 4.3 seconds, respectively). In contrast to placebo, the improvement from baseline was statistically significant for AM-125 20 mg and for all active dose groups, respectively (p<0.02 and p<0.01 to p<0.05, respectively). * Selected doses and key endpoints for Part B of TRAVERS trial. Based on the results from the interim analysis, the two highest doses, 10 and 20 mg, were selected by the Company to be tested against placebo in 72 patients in Part B of the trial. The improvement in the “Standing on Foam” test two weeks post-surgery will be the sole primary efficacy endpoint, whereas the improvement in the “Tandem Romberg” test six weeks post-surgery will be the key secondary efficacy endpoint. Part B of the trial is expected to start shortly, as open label testing of oral betahistine for reference purposes will be completed (n=16).  AM-201 for Preventing Antipsychotic-Induced Weight Gain * Reported positive results from Phase 1b trial with AM-201 in antipsychotic-induced weight gain. On May 26, 2020, the Company reported top-line results from its Phase 1b trial in 80 healthy volunteers who were treated with oral olanzapine 10 mg and AM-201 (intranasal betahistine) at up to 30 mg or placebo 3x daily for four weeks. At the highest dose of 30 mg, the mean weight gain from baseline in AM-201-treated participants was 2.8 kg compared against 3.7 kg in control subjects; the primary efficacy endpoint of mean reduction in weight gain was 0.9 kg and statistically significant (p<0.02; n=81 with pre-specified Bayesian augmented controls). In a next step, following additional pre-clinical testing, the Company intends to file for an IND in 2021.AM-301 for Protecting Against Airborne Pathogens and Allergens   * Initiated development of a nasal spray for protection against airborne pathogens and allergens. On September 8, 2020 the Company announced that it had initiated under product code AM-301 the development of a drug-free nasal spray for personal protection against airborne pathogens and allergens. AM-301 is a gel which works by forming a protective layer on the nasal mucosa, acting as a physical barrier against airborne pathogens and allergens. In addition, the composition serves to “trap” such particles and help with their discharge. Together, this is designed to reduce the risk of infection and promote alleviation of allergic symptoms. * Demonstrated significant binding of SARS-CoV-2 in vitro. Testing the key component of AM-301 at various concentrations in a SARS-CoV-2 assay demonstrated a reduction in the viral infectious load of up to 99%. The Company intends to perform additional testing involving various pathogens and allergens.Corporate Developments * Set up new subsidiary dedicated to AM-301. The new subsidiary, Altamira Medica Ltd. (“Altamira”), is based in Zug, Switzerland, and has a share capital of CHF 0.5 mn. Currently owned 100% by Auris Medical Holding Ltd., ownership in Altamira is expected to decrease as other investors will be invited to join as shareholders once additional financing is required. * Raised CHF 1.5 million through a convertible loan. Under the agreement, Altamira obtained CHF 1.5 mn from FiveT Capital Holding Ltd., a Swiss investment management firm, to fund the development of AM-301. The loan has a term of 18 months, carries an interest rate of 8% p.a. and is convertible including accrued interest into common shares of either Altamira or Auris Medical Holding Ltd. * Initiated a review of strategic options. The Company’s Board of Directors has started a process to explore, review and evaluate a broad range of potential strategic alternatives. These alternatives include but are not limited to the partnering of its various clinical and preclinical programs, or a sale or merger of the Company, in an effort to unlock the potential of those assets and maximize shareholder value. * Regained compliance with Nasdaq minimum bid price requirement. On August 20, 2020, the Company received a letter from Nasdaq stating that because the Company’s shares had a closing bid price at or above $1.00 per share for a minimum of ten (10) consecutive business days, the Company’s stock had regained compliance with the Minimum Bid Price Requirement for continued listing on Nasdaq, and that the matter was closed. * Effected reduction in par value per share. As approved by the Company’s annual general meeting, the par value of each common share was reduced from CHF 0.40 to CHF 0.01, effective June 30, 2020. The transaction was cash neutral with the reduction in issued share capital being credited to the contributed surplus account.First Half 2020 Financial Results * Total operating expenses for the first half of 2020 were CHF 2.4 million compared to CHF 4.1 million for the first half of 2019. * Research and development expenses for the first half of 2020 were CHF 0.9 million compared to CHF 1.3 million for the first half of 2019.1 * General and administrative expenses for the first half of 2020 were CHF 1.5 million compared to CHF 2.8 million for the first half of 2019. * Net loss for the first half of 2020 was CHF 2.7 million, or CHF 0.58 per share, compared to CHF 3.7 million, or CHF 1.66 per share, for the first half of 2019.The Company expects its total cash needs in 2020, including project AM-301, to be in the range of CHF 7.0 to 8.5 million for expected total operating expenses of CHF 4.5 to 5.5 million and expected capitalized research and development expenses of CHF 2.5 to 3.0 million.Conference Call & Webcast InformationAuris Medical will host a conference call and webcast to present its first-half 2020 results and a business update today, September 17, 2020, at 8:30 am Eastern Time (2:30 pm Central European Time). To participate in this conference call, dial 1-877-870-9135 (US toll free) or +44 2071 928 338 (international), and enter passcode 5286195. 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 MedicalAuris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology 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). With AM-301, the Company is developing a nasal spray for protection against airborne pathogens and allergens. 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, whether the U.S. Food and Drug Administration (“FDA”) and regulatory authorities in other jurisdictions will agree with Auris Medical’s plans for the regulatory pathway for AM-301 and its other product candidates, whether the safety and efficacy of AM-301, and other regulatory requirements, can be established to the satisfaction of the FDA and other regulatory authorities, 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, 2019, 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: Joseph Green Edison Advisors for Auris Medical 646-653-7030 jgreen@edisongroup.comOrinvestors@aurismedical.comAURIS MEDICAL HOLDING LTD. Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Loss For the Six Months Ended June 30, 2020 and 2019 (in CHF)  SIX MONTHS ENDED JUNE 30    2020 2019  Research and development (884,747) (1,304,291)  General and administrative (1,535,960) (2,803,267)  Operating loss (2,420,707) (4,107,558)  Interest expense (3,152) (25,261)  Foreign currency exchange gain/(loss), net (30,022) (264,121)  Revaluation gain / (loss) from derivative financial instruments 4,353 531,245  Transaction costs (219,615) -  Loss before tax (2,669,143) (3,865,695)  Income tax gain/(loss) 10,642 261,394  Net loss attributable to owners of the Company (2,658,501) (3,604,301)  Other comprehensive income/(loss):      Items that will never be reclassified to profit or loss      Remeasurement of defined benefit liability (78,010) (115,366)  Items that are or may be reclassified to profit or loss      Foreign currency translation differences 16,396 6,666  Other comprehensive income/(loss) (61,614) (108,700)  Total comprehensive loss attributable to owners of the Company (2,720,115) (3,713,001)         Basic and diluted loss per share (0.58) (1.66)  Average weighted number of shares outstanding, adjusted for effect of reverse stock split 4,585,054 2,173,307  AURIS MEDICAL HOLDING LTD. Condensed Consolidated Statement of Financial Position  (in CHF)  JUNE 30, 2020 DECEMBER 31,              2019     ASSETS     Non-current assets      Property and equipment 54,434 66,672  Intangible assets 7,499,491 6,765,613  Other non-current financial receivables 20,001 20,001  Total non-current assets 7,573,926 6,852,286         Current assets      Other receivables 151,019 335,299  Prepayments 198,843 434,231  Derivative financial instruments - 219,615  Cash and cash equivalents 39,939 1,384,720  Total current assets 389,801 2,373,865         Total assets 7,963,727 9,226,151         EQUITY AND LIABILITIES      Equity      Share capital 50,591 1,650,380  Share premium 159,786,160 157,191,707  Foreign currency translation reserve (11,169) (27,565)  Accumulated deficit (155,346,991) (152,778,389)  Total shareholders (deficit)/equity attributable to owners of the Company 4,478,591 6,036,133         Non-current liabilities      Derivative financial instruments - 4,353  Loan 50,000 -  Employee benefits 876,776 760,447  Deferred tax liabilities 136,507 147,149  Total non-current liabilities 1,063,283 911,949         Current liabilities      Trade and other payables 1,256,352 938,247  Accrued expenses 1,165,501 1,339,822  Total current liabilities 2,421,853 2,278,069  Total liabilities 3,485,136 3,190,018  Total equity and liabilities 7,963,727 9,226,151  * * * 1 Does not include capitalized costs related to expenses for the AM-125 program in accordance with IAS38.

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  • Auris Medical to Report First Half 2020 Financial Results and Provide Business Update on Thursday, September 17, 2020

    Hamilton, Bermuda, September 11, 2020 – 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 announced that it will provide a business update and report its financial results for the first half 2020 on Thursday, September 17, 2020. Following the announcement, Auris Medical's management team will host a live conference call and webcast at 8:30 am Eastern Time (2:30 pm Central European Time). To participate in this conference call, dial 1-877-870-9135 (US toll free) or +44 2071 928 338 (international), and enter passcode 5286195. 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 MedicalAuris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology 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). With AM-301, the Company is developing a nasal spray for protection against airborne pathogens and allergens. 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.”Investor contact:  Joseph Green Edison Advisor for Auris Medical 646-653-7030 jgreen@edisongroup.comorinvestors@aurismedical.com

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  • Auris Medical Launches Development of Drug-Free Nasal Spray for Protection against Airborne Pathogens and Allergens

    * Development of AM-301 nasal spray initiated with aim of regulatory submission in 2021 * Key component of AM-301 shown to reduce SARS-CoV-2 viral infectious load in vitro by up to 99% * Creation of dedicated subsidiary, Altamira Medica Ltd, to focus solely on AM-301 development program * CHF 1.5 m convertible loan arranged in support of development programHamilton, Bermuda, September 8, 2020 – 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 announced the launch of the development of AM-301, a drug-free nasal spray for protection against airborne pathogens and allergens, based on positive data obtained in a SARS-CoV-2 assay. In order to expedite the development process, Auris Medical set up a new subsidiary, Altamira Medica Ltd. (“Altamira”), based in Zug, Switzerland, and has already obtained funding through a CHF 1.5 m convertible loan agreement.Seeking protection against airborne pathogens and allergens AM-301 is a gel which works by forming a protective layer on the nasal mucosa, acting as a physical barrier against airborne pathogens and allergens. Under normal conditions, human beings take in approximately 90% of air through their noses, which are therefore particularly exposed to airborne pathogens and allergens. The thin protective film formed by the AM-301 gel helps to prevent the contact of such pathogens and allergens with cells; in addition, the composition serves to “trap” such particles and help with their discharge. Together, this is designed to reduce the risk of infection and promote alleviation of allergic symptoms.Promising results in SARS-CoV-2 assayThe potential protective effects of AM-301 have been demonstrated to date in a SARS-CoV-2 virus assay. In this experiment, the key component of AM-301 was added in various concentrations to a suspension of the virus for various time periods. Virus particles were then collected from the suspension and transferred onto cell cultures for incubation, allowing for viral replication and infection of adjacent cells. The experiment showed that after only 5 minutes of contact between AM-301’s key component and the virus suspension the viral infectious load was reduced by up to 99%. The Company intends to perform additional testing involving various pathogens and allergens. Addressing need for personal protection “The current Covid-19 pandemic has drastically highlighted the risks of airborne transmission of viruses and the need for protective measures such as proper ventilation in buildings and the wearing of face masks“, commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “With AM-301, we are seeking to provide a simple and effective means for personal protection in settings or places with increased risk of exposure to airborne pathogens, such as public transportation, flights, cruises, sport events, concerts or university lectures. In addition to its potential protection against SARS-CoV-2 and other pathogens, we believe AM-301 could provide help to people suffering from allergic rhinitis by reducing their exposure to airborne allergen particles e.g. from pollens, house dust or animal hair.” Aiming for regulatory submissions in 2021 For AM-301, the Company can draw on its experience from the development of nasal sprays with betahistine for the treatment of vertigo (AM-125) or antipsychotic-induced weight gain (AM-201). Unlike the betahistine nasal sprays, AM-301 does not contain any active substance, and the Company believes it will be regulated and marketed as an “over-the-counter” medical device. The Company will advance and complete the development of AM-301 through its new Altamira subsidiary. Following the conduct of further studies in safety and efficacy, the Company is targeting submission of regulatory applications to the U.S. Food and Drug Administration (“FDA”) and regulatory authorities in other jurisdictions in 2021. Altamira plans to initiate discussions with regulatory authorities regarding the regulatory pathway for AM-301 shortly. The Company intends to market AM-301 in collaboration with partners.Funding with financial or strategic investors   Altamira is currently a 100% subsidiary of Auris Medical Holding Ltd.; going forward, the Company expects its ownership in Altamira to decrease as financial or strategic investors will be invited to join as shareholders as additional financing will be required. In a first transaction, FiveT Capital Holding Ltd. (“FiveT”), a Swiss investment management firm, provided a convertible loan to Altamira. The loan has a principal amount of CHF 1.5 m, a duration of 18 months, and carries an interest rate of 8% p.a. Under the terms of the agreement, FiveT will have the right to convert the loan or parts thereof including accrued interest into common shares of either Altamira or Auris Medical Holding Ltd., subject to additional provisions and certain restrictions. The Company has filed a copy of the convertible loan agreement on Form 6-K with the Securities and Exchange Commission and will file a registration statement on Form F-3 to register for resale the common shares of the Company that may be issued upon conversion. About Auris MedicalAuris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology 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). With AM-301, the Company is developing a nasal spray for protection against airborne pathogens and allergens. 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, whether the U.S. Food and Drug Administration (“FDA”) and regulatory authorities in other jurisdictions will agree with Auris Medical’s plans for the regulatory pathway for AM-301 and its other product candidates, whether the safety and efficacy of AM-301, and other regulatory requirements, can be established to the satisfaction of the FDA and other regulatory authorities, 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, 2019, 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: Joseph Green Edison Advisor for Auris Medical 646-653-7030 jgreen@edisongroup.comorinvestors@aurismedical.com

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  • Auris Medical Announces Positive Interim Data from TRAVERS Phase 2 Study with AM-125 in Vertigo

    * Dose dependent improvement in balance tests over placebo in Part A of TRAVERS trial * Improvement 1.9 to 2.4 times greater with highest dose than with placebo * Trial to proceed with Part B to test AM-125 10 and 20 mg vs. placebo  Hamilton, Bermuda, September 3, 2020 – 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 announced positive top-line data from the interim analysis of its Phase 2 “TRAVERS” trial with intranasal betahistine in vertigo (AM-125).The interim analysis was based on Part A of the trial, which enrolled 33 patients suffering from vertigo following neurosurgery who were treated with AM-125 1, 10 or 20 mg or placebo (3 x daily) for four weeks. It demonstrated a dose-dependent improvement in balance as well as good safety and tolerability of ascending doses of AM-125. At the highest dose of 20 mg (3 x daily), AM-125-treated patients improved their performance of the “Tandem Romberg” and the “Standing on Foam” balance tests from baseline to 14 days post-surgery (primary endpoint) on average 1.9 to 2.4 times more than placebo-treated patients (6.0 vs. 3.1 and 10.5 vs. 4.3 seconds, respectively). In contrast to placebo, the improvement from baseline was statistically significant for AM-125 20 mg and for all active dose groups, respectively (p<0.02 and p<0.01 to p<0.05, respectively). These positive results were supported by similar improvements in additional efficacy measures, including additional objective as well as clinician- and patient-reported outcomes.“We are very excited and encouraged by the good safety and tolerability as well as the strong and consistent signals of AM-125’s clinical efficacy observed in this first part of the TRAVERS trial,” commented Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “For patients suffering from vertigo, regaining balance as quickly as possible is of utmost importance. Unlike other vertigo drugs that suppress the vestibular function to treat just short-term symptoms such as nausea, AM-125 acts as a vestibular stimulant to enhance and accelerate vestibular compensation and help patients to ‘get back on their feet’. There is a strong medical need for a novel drug in this area, with e.g. 35.4% of the US population aged 40 years and older suffering from vestibular dysfunction (i.e. failing the “Standing on Foam” test).1 We look forward to advancing the AM-125 program further in order to bring this innovative nasal spray to patients.”  Based on the results from the interim analysis, the two highest doses, 10 and 20 mg, were selected by the Company to be tested against placebo in 72 patients in Part B of the trial. As the Company remained blinded to treatment allocation during the interim analysis, the corresponding data from Part A will be pooled with those from Part B. The improvement in the “Standing on Foam” test will become the sole primary efficacy endpoint. This test measures how long patients are able to maintain balance on a foam mat (to obscure proprioceptive input) with their eyes closed (to eliminate visual input), relying primarily on vestibular input from their inner ears. The improvement in the more challenging “Tandem Romberg” test, which is performed with eyes closed and the two feet to aligned one after the other, will become the key secondary efficacy endpoint. Prior to starting Part B of the trial, open label testing of oral betahistine for reference purposes will be completed (n=16).About Betahistine Betahistine is a small molecule structural analog of histamine, which acts as an agonist at the H1 and as an antagonist at the H3 histamine receptors. Unlike histamine, it crosses the blood-brain-barrier. It is known to enhance inner ear and cerebral blood flow, increase histamine turnover and enhance histamine release in the brain, increase release of acetylcholine, dopamine and norepinephrine in the brain and to result in general brain arousal. The compound has a very good safety profile, yet it is also known that its clinical utility is held back by poor bioavailability. Intranasal administration of betahistine has been shown to result in 5 to 29 times higher bioavailability.About AM-125 Intranasal betahistine is being developed under project code AM-125 for the treatment of acute vertigo. Betahistine has been shown to increase cochlear, vestibular and cerebral blood flow, facilitate vestibular compensation and inhibit neuronal firing in the vestibular nuclei. Betahistine for oral administration is approved in about 115 countries, with the US being a notable exception, for the treatment of vertigo and Meniere’s disease.About Auris MedicalAuris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology 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). 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 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, 2019, 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: Joseph Green Edison Advisor for Auris Medical 646-653-7030 jgreen@edisongroup.comorinvestors@aurismedical.com  * * * 1 Agrawal Y et al. (2009), Disorders of Balance and Vestibular Function in US Adults - Data From the National Health and Nutrition Examination Survey, 2001-2004, Arch Intern Med. 169(10):938-944.

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  • Auris Medical Regains Listing Compliance with NASDAQ Minimum Bid Requirement

    Hamilton, Bermuda, August 20, 2020 – 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 announced that it has regained compliance with the Nasdaq listing requirements. On August 20, 2020, the Company received a letter from Nasdaq stating that because the Company’s shares had a closing bid price at or above $1.00 per share for a minimum of ten (10) consecutive business days, the Company’s stock had regained compliance with the Minimum Bid Price Requirement for continued listing on Nasdaq, and that the matter is now closed. About Auris MedicalAuris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology and CNS disorders. The company is focused on the development of intranasal betahistine for the treatment of vertigo (AM-125) and for the prevention of antipsychotic-induced weight gain and somnolence (AM-201). These projects have gone through two Phase 1 trials and moved 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 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 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, 2019, 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: Joseph Green Edison Advisor for Auris Medical 646-653-7030 jgreen@edisongroup.comorinvestors@aurismedical.com

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