EARS Auris Medical Holding Ltd.

0.96
+0.05  (+5%)
Previous Close 0.91
Open 0.95
52 Week Low 0.65
52 Week High 3.2
Market Cap $4,553,963
Shares 4,759,084
Float 1,564,182
Enterprise Value $-2,552,569
Volume 122,031
Av. Daily Volume 225,983
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Upcoming Catalysts

Drug Stage Catalyst Date
AM-125
Vertigo
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
AM-201
Healthy volunteers
Phase 1b
Phase 1b
Phase 1b data released May 26, 2020. Phase 2 trial planned.
Keyzilen (AM-101)
Acute inner ear tinnitus
Phase 3
Phase 3
Phase 3 data released March 13, 2018 - primary endpoint not met. Noted April 25, 2019 that it intends to discuss a new Phase 2/3 trial with the FDA.
AM-101 (Keyzilen) - TACTT2
Acute inner ear tinnitus
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoints
AM-111 REACH
Surgery-induced hearing loss
Phase 2
Phase 2
Phase 2 trial (REACH) enrollment pending funding.
AM-111 ASSENT
Acute inner ear hearing loss
Phase 3
Phase 3
Phase 3 ASSENT trial terminated - November 28, 2017.
AM-111 HEALOS
Acute inner ear hearing loss
Phase 3
Phase 3
Phase 3 HEALOS trial did not meet primary endpoint - November 28, 2017.

Latest News

    • Administration of intranasal betahistine 30 mg shows statistically significant reduction in olanzapine-induced weight gain
    • Treatment well tolerated and safe with no adverse effects
    • Enrollment into Phase 2 TRAVERS trial with AM-125 resumed following break due to COVID-19 pandemic

    Hamilton, Bermuda, May 26, 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 its Phase 1b trial with AM-201 in antipsychotic-induced weight gain and provided an update on the enrollment into its Phase 2 trial with AM-125 in vertigo.

    The Phase 1b trial demonstrated good…

    • Administration of intranasal betahistine 30 mg shows statistically significant reduction in olanzapine-induced weight gain
    • Treatment well tolerated and safe with no adverse effects
    • Enrollment into Phase 2 TRAVERS trial with AM-125 resumed following break due to COVID-19 pandemic

    Hamilton, Bermuda, May 26, 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 its Phase 1b trial with AM-201 in antipsychotic-induced weight gain and provided an update on the enrollment into its Phase 2 trial with AM-125 in vertigo.

    The Phase 1b trial demonstrated good safety and tolerability of ascending doses of AM-201 as well as a dose-dependent reduction in weight gain in healthy volunteers treated with oral olanzapine (10 mg) for four weeks. At the highest AM-201 dose of 30 mg administered three times daily, the mean weight gain from baseline to the end of the treatment period 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). As expected, intranasal delivery of betahistine allowed for substantially higher concentrations in blood plasma compared with levels previously reported for oral betahistine.

    "We are very pleased with the positive safety, efficacy and pharmacokinetic outcomes achieved with intranasal betahistine in our first clinical trial for the prevention of antipsychotic-induced weight gain", commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "Weight gain and related metabolic or cardiovascular problems are major side effects of olanzapine and other antipsychotic medications, which often results in a major burden on the health and quality of life of patients. We are delighted to see the positive efficacy signals with AM-201 as well as the excellent tolerability of the nasal spray application in the Phase 1b trial." Following completion of the data analysis, the Company intends to prepare a Phase 2 clinical trial and to disclose detailed results from the study in a scientific journal.

    In addition, the Company announced that the Phase 2 TRAVERS trial with AM-125 in acute peripheral vertigo has resumed enrollment. The COVID-19 outbreak had led to a standstill of recruitment towards the end of March 2020 as trial sites postponed elective surgeries, including those generating the type of acute vertigo required for study participation, and temporarily reduced or suspended clinical research activities. As the COVID-19 outbreak has started to subside in several European countries, a small number of trial sites have resumed recruitment in the past few weeks. Barring the reintroduction of COVID-19 related restrictions, the Company expects further sites to reopen in the coming weeks and the interim analysis following Part A of the trial to be completed in the third quarter of 2020.

    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 AM-201

    Intranasal betahistine is being developed under project code AM-201 for the prevention of antipsychotic-induced weight gain and somnolence. Many antipsychotic drugs are known to block the H1 histamine receptor, which is involved in the control of appetite and wakefulness, resulting in weight gain and somnolence as side effects. As an H1 receptor agonist, betahistine is thought to counteract the antipsychotics' inhibitory effects; in addition, betahistine blocks presynaptic H3 histamine autoreceptors, thus increasing histamine release and in turn augmenting betahistine's direct agonistic effects on H1 receptors.

    About Auris Medical

    Auris 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

    or

     

    Primary Logo

    View Full Article Hide Full Article
    • Phase 1b trial with intranasal betahistine for prevention of antipsychotic-induced weight gain progressing towards final read-out
    • Phase 2 trial with intranasal betahistine for treatment of acute vertigo progressing towards interim analysis, but temporarily slowed down by COVID-19 impact
    • Notice of allowance granted for NKCC1 modulators for oral treatment of tinnitus
    • Set-up of subsidiary to bundle tinnitus and hearing loss development projects for potential partnering

           Hamilton, Bermuda, April 16, 2020 – Auris Medical Holding AG (NASDAQ:EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, today provided a business update and announced financial results for the second…

    • Phase 1b trial with intranasal betahistine for prevention of antipsychotic-induced weight gain progressing towards final read-out
    • Phase 2 trial with intranasal betahistine for treatment of acute vertigo progressing towards interim analysis, but temporarily slowed down by COVID-19 impact
    • Notice of allowance granted for NKCC1 modulators for oral treatment of tinnitus
    • Set-up of subsidiary to bundle tinnitus and hearing loss development projects for potential partnering

           Hamilton, Bermuda, April 16, 2020 – Auris Medical Holding AG (NASDAQ:EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology, today provided a business update and announced financial results for the second half and full year ended December 31, 2019.

    "We made substantial progress with our intranasal betahistine development programs in 2019," stated Thomas Meyer, Auris Medical's founder, Chairman and CEO. "We extended our patent coverage both in the US and the EU to 2038, initiated our Phase 2 trial with AM-125 in acute peripheral vertigo and obtained positive interim results from our Phase 1b trial with AM-201 in antipsychotic-induced weight gain. We expect to receive top-line data from the completed AM-201 trial in early May and interim data from the AM-125 trial in the third quarter, provided that COVID-19 restrictions are lifted. As for our late-stage programs in tinnitus and hearing loss, we've positioned them for partnering by setting up a dedicated subsidiary, Zilentin Ltd."

    Development Program Updates

    AM-125 for Treatment of Acute Peripheral Vertigo

    • Progressed with dose escalation in TRAVERS Phase 2 trial. Since July 2019, the TRAVERS trial has been enrolling patients suffering from acute vertigo following certain neurosurgical interventions affecting the vestibular nerve. In Part A of the TRAVERS trial, three ascending doses of AM-125 or placebo, administered three times daily over a total of four weeks, are tested in a total of 30 patients. The results from an interim analysis of Part A will inform the selection of two doses for further testing against placebo in an estimated 72 patients in Part B of the trial. In addition to the ongoing intranasal dose escalation, open label testing of oral betahistine for reference purposes has commenced.
    • COVID-19 outbreak causing temporary delay in enrollment. Candidates for participation in the TRAVERS trial undergo certain types of neurosurgery, which are elective procedures. Due to the COVID-19 outbreak, the sites participating in the "TRAVERS" trial have postponed elective procedures and temporarily reduced or suspended clinical research activities. As a result, enrollment came to a halt towards the end of March 2020. Although sites are expected to catch up on enrollment once COVID-19 related restrictions are relaxed, the Company expects that the interim analysis following Part A of the trial will be completed only in the third quarter of 2020, at the earliest.    

    AM-201 for Prevention of Antipsychotic-Induced Weight Gain and Somnolence

    • Positive interim results in Phase 1b trial. In October 2019 an interim analysis of the results from the first 50 participants in the trial showed good safety and tolerability of AM-201 up to a dose of 3 x 20 mg daily for four weeks. Further, it revealed relevant reductions in olanzapine-induced weight gain and daytime sleepiness. In female study participants, who overall showed more pronounced changes than male participants, a reduction in weight gain of 1.1 kg against placebo was observed at the highest tested dose (probability of effectiveness = 90%).
    • Progressing towards read-out from Phase 1b trial. Following the interim analysis, the trial proceeded to the next higher and final dose level of 30 mg, which was tested in an additional 30 healthy volunteers, bringing the total for the trial to 80 subjects. The Company expects to report top-line data in May 2020. The primary efficacy outcome for the study will be the reduction in weight gain and the secondary outcome will be the reduction in somnolence.

    Other developments related to betahistine

    • Obtained U.S. and European patent applications covering intranasal betahistine. The Company's intellectual property estate was substantially expanded through the grant of US patent 10,456,386, entitled "Pharmaceutical Composition Comprising Betahistine", which covers composition of matter and methods of use for formulations of betahistine dihydrochloride for intranasal delivery. In addition, the Company received an "Intention to Grant" notice from the European Patent Office (EPO) for its corresponding European patent application. The new patents are expected to expire no earlier than February 2038.
    • Announced independent in vivo evidence for betahistine's anti-epileptic and anti-convulsive activity. In a study published in Epilepsy & Behavior, an independent research group reported promising results with pretreatment and repetitive betahistine treatment in a murine model of epilepsy. The results add further to the growing list of potential therapeutic uses for betahistine.

    Keyzilen® / AM-101 for Treatment of Acute Inner Ear Tinnitus

    ·Received FDA and EMA guidance for Keyzilen® late-stage clinical development program. The Company received feedback from the FDA and EMA regarding the design of a new Phase 2/3 trial for the Keyzilen® program. Both agencies supported the use of the Tinnitus Functional Index (TFI) questionnaire as the primary efficacy outcome measure. The TFI captures the impact of tinnitus on the patient's day-to-day functioning. Furthermore, the two agencies agreed on a less frequent collection of patient-reported tinnitus loudness than in the previous Keyzilen® trials, where daily ratings had turned out to be problematic. The FDA considers the improvement in tinnitus loudness as a co-primary efficacy endpoint, whereas the EMA endorsed it as a secondary efficacy endpoint. In addition, the two agencies endorsed the planned sample size for the trial.

    Other developments related to tinnitus

    • Established scientific advisory board for tinnitus programs. The Company established a Scientific Advisory Board comprising four internationally renowned experts to support its research and development programs in the field of tinnitus.  
    • Received notice of allowance for NKCC1 tinnitus patent. The US Patent and Trademark Office issued a "Notice of Allowance" and the European Patent Office  a notice of "Intention to Grant" for the Company's patent application covering compounds modulating the sodium potassium chloride co-transporter 1 (NKCC1) for use in the oral treatment or prevention of tinnitus. As demonstrated in an animal model of acute noise trauma, administration of an NKCC1 inhibitor resulted in a significant reduction of a biomarker for the presence of tinnitus (p<0.02).

    Corporate Developments

    • Appointed Elmar Schaerli as new Chief Financial Officer. Effective November 1, 2019, Elmar Schaerli, CPA, was appointed the Company's new CFO. He succeeds Hernan Levett. On the other hand, Raoul Dias, General Counsel, left the Company effective March 20, 2020 in order to pursue a new career opportunity.
    • Set up new subsidiary for development projects in tinnitus and hearing loss. In late 2019, the Company formed a new subsidiary, Zilentin Ltd., to bundle its development projects for the treatment of tinnitus and hearing loss in a separate entity. These include Keyzilen® / AM-101 as well as early stage projects in tinnitus as well as Sonsuvi® / AM-111 in hearing loss. Zilentin Ltd. is currently a 100% subsidiary and is domiciled in Zug, Switzerland.  

    Second Half 2019 Financial Results

    • Total operating expenses for the second half of 2019 were CHF 3.2 million compared to CHF 3.5 million for the second half of 2018.
    • Research and development expenses for the second half of 2019 were CHF 2.0 million compared to CHF 1.7 million for the second half of 2018.1
    • General and administrative expenses for the second half of 2019 were CHF 1.1 million compared to CHF 1.8 million for the second half of 2018.
    • Net loss for the second half of 2019 was CHF 3.0 million, or CHF 0.83 per share, compared to CHF 6.7 million, or CHF 5.17 per share, for the second half of 2018.
    • Cash and cash equivalents at December 31, 2019, totaled CHF 1.4 million.

    Full Year 2019 Financial Results

    • Total operating expenses for 2019 were CHF 7.3 million compared to CHF 11.0 million for 2018. 
    • Research and development expenses for 2019 were CHF 3.3 million compared to CHF 6.7 million for 2018.1 
    • General and administrative expenses for 2019 were CHF 3.9 million compared to CHF 4.3 million for 2018. 
    • Net loss attributable to owners of the Company for 2019 was CHF 6.6 million, or CHF 2.28 per share, compared to CHF 11.5 million, or CHF 14.46 per share, for 2018.

    The Company expects its total cash need in 2020 to be in the range of CHF 7.5 to 10.0 million for expected total operating expenses of CHF 3.5 to 4.5 million and expected capitalized research and development expenses of CHF 4.0 to 5.5 million.

    Conference Call & Webcast Information

    Auris Medical will host a conference call and webcast to present the second half and full year 2019 financial results and to provide a business update today, April 16, 2020, at 8:00 am Eastern Time (2:00 pm Central European Time). To participate in this conference call, dial +1-866-966-1396 (toll free) or +44 2071 928011 (International), and enter passcode 8599310. A live webcast of the conference call is available via this link and also in the Investor Relations section of the Auris Medical website at www.aurismedical.com. A replay of the conference call will be available approximately two hours following the live call.

    About Auris Medical

    Auris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology and 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, the delays and other impacts on Auris Medical's business and clinical trials that may be caused by the COVID-19  pandemic, 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 / 7719

    Or

       


    AURIS MEDICAL HOLDING Ltd.
    Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Loss
    For the Six and Twelve Months Ended December 31, 2019 and 2018 (in CHF)

        SIX MONTHS
    ENDED DECEMBER 31
      TWELVE MONTHS
    ENDED DECEMBER 31
        2019   2018   2019   2018
    Research and development   (2,020,990)   (1,731,968)   (3,325,281)   (6,689,589)
    General and administrative   (1,130,596)   (1,805,113)   (3,933,863)   (4,264,534)
    Operating loss   (3,151,586)   (3,537,081)   (7,259,144)   (10,954,123)
    Interest income   17,882     17,882  
    Interest expense   (3,367)   (214,020)   (28,628)   (1,070,177)
    Foreign currency exchange gain/(loss), net   44,548   (73,956)   (219,573)   (139,870)
    Revaluation gain / (loss) from derivative financial instruments   132,480   (2,557,887)   663,725   1,350,071
    Transaction costs     (108,809)     (520,125)
    Loss before tax   (2,960,043)   (6,491,753)   (6,825,738)   (11,334,224)
    Income tax gain/(loss)   (67,557)   (179,630)   193,837   (162,177)
    Net loss attributable to owners of the Company   (3,027,600)   (6,671,383)   (6,631,901)   (11,496,401)
    Other comprehensive income/(loss):                
    Items that will never be reclassified to
    profit or loss
                   
    Remeasurement of defined benefit liability, net of taxes = CHF 0   43,356   192,090   (72,010)   1,277,192
    Items that are or may be reclassified to
    profit or loss
                   
    Foreign currency translation differences, net of taxes = CHF 0   9,780   8,065   16,446   (10,964)
    Other comprehensive income/(loss)   53,136   200,155   (55,564)   1,266,228
    Total comprehensive loss attributable
    to owners of the Company
      (2,974,464)   (6,471,228)   (6,687,465)   (10,230,173)
                     
    Basic and diluted loss per share   (0.83)   (5.17)   (2.28)   (14.46)
    Average weighted number of shares outstanding, adjusted for effect of reverse stock split   3,628,614   1,289,639   2,909,056   795,043
                     

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

        DECEMBER 31,
    2019
      DECEMBER 31,
      2018
         
    ASSETS        
    Non-current assets          
    Property and equipment   66,672   33,895  
    Intangible assets   6,765,613   3,535,240  
    Derivative financial instruments     226,865  
    Other non-current financial receivables   20,001   16,001  
    Total non-current assets   6,852,286   3,812,001  
               
    Current assets          
    Other receivables   335,299   320,374  
    Prepayments   434,231   351,283  
    Derivative financial instruments   219,615    
    Cash and cash equivalents   1,384,720   5,393,207  
    Total current assets   2,373,865   6,064,864  
               
    Total assets   9,226,151   9,876,865  
               
    EQUITY AND LIABILITIES          
    Equity          
    Share capital   1,650,380   710,336  
    Share premium   157,191,707   149,286,723  
    Foreign currency translation reserve   (27,565)   (44,011)  
    Accumulated deficit   (152,778,389)   (146,303,398)  
    Total shareholders (deficit)/equity attributable to owners of the Company   6,036,133   3,649,650  
               
    Non-current liabilities          
    Derivative financial instruments   4,353   675,328  
    Employee benefit liability   760,447   648,287  
    Deferred tax liabilities   147,149   340,986  
    Total non-current liabilities   911,949   1,664,601  
               
    Current liabilities          
    Loan     1,435,400  
    Trade and other payables   938,247   1,836,335  
    Accrued expenses   1,339,822   1,290,879  
    Total current liabilities   2,278,069   4,562,614  
    Total liabilities   3,190,018   6,227,215  
    Total equity and liabilities   9,226,151   9,876,865  



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


    Primary Logo

    View Full Article Hide Full Article
    • Phase 1b trial with AM-201 proceeding as planned to data read-out in early May 2020
    • Enrollment into Phase 2 trial with AM-125 impacted by COVID-19 pandemic
    • Company to report 2019 second-half and full year results and provide general business update on April 16, 2020  

    Hamilton, Bermuda, April 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 provided an update on the impact of the COVID-19 pandemic on its ongoing clinical trials with intranasal betahistine.

    The Phase 1b trial with AM-201, intranasal betahistine for the prevention of antipsychotic-induced weight gain and somnolence…

    • Phase 1b trial with AM-201 proceeding as planned to data read-out in early May 2020
    • Enrollment into Phase 2 trial with AM-125 impacted by COVID-19 pandemic
    • Company to report 2019 second-half and full year results and provide general business update on April 16, 2020  

    Hamilton, Bermuda, April 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 provided an update on the impact of the COVID-19 pandemic on its ongoing clinical trials with intranasal betahistine.

    The Phase 1b trial with AM-201, intranasal betahistine for the prevention of antipsychotic-induced weight gain and somnolence, has remained unaffected by the COVID-19 pandemic. The last subject had its last treatment visit in early March 2020. The trial is now progressing towards the read-out of top-line data, which is expected for early May 2020, in accordance with previous guidance.    

    The Phase 2 trial with AM-125, intranasal betahistine for the treatment of acute peripheral vertigo, will be impacted by the COVID-19 outbreak. The outbreak has delayed enrollment into the study. Candidates for participation in this trial undergo certain types of neurosurgery, which are classified as elective procedures. Due to the COVID-19 outbreak, the sites participating in the "TRAVERS" trial have postponed elective procedures and temporarily reduced or suspended clinical research activities. As a result, enrollment came to a halt towards the end of March 2020. Although sites are expected to catch up on enrollment once COVID-19 related restrictions are relaxed, the Company expects that the interim analysis following Part A of the trial will now be completed in the third quarter of 2020, at the earliest.

    The Company expects to report its 2019 second-half and full year results and to provide a general business update on April 16, 2020.

    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 AM-201

    Intranasal betahistine is being developed under project code AM-201 for the prevention of antipsychotic-induced weight gain and somnolence. Many antipsychotic drugs are known to block the H1 histamine receptor, which is involved in the control of appetite and wakefulness, resulting in weight gain and somnolence as side effects. As an H1 receptor agonist, betahistine is thought to counteract the antipsychotics' inhibitory effects; in addition, betahistine blocks presynaptic H3 histamine autoreceptors, thus increasing histamine release and in turn augmenting betahistine's direct agonistic effects on H1 receptors.

    About Auris Medical

    Auris 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, 2018, 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

    or

     

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    • Last subject had last treatment visit in Phase 1b trial with AM-201 in prevention of antipsychotic-induced weight gain and somnolence; data read-out expected for early May 2020
    • Phase 2 trial with AM-125 in treatment of acute peripheral vertigo progressing towards interim analysis in Q2 2020

    Hamilton, Bermuda, March 5, 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 an update on its ongoing clinical trials with intranasal betahistine.

    In the Phase 1b trial with AM-201, intranasal betahistine for the prevention of antipsychotic-induced weight gain and somnolence, the last…

    • Last subject had last treatment visit in Phase 1b trial with AM-201 in prevention of antipsychotic-induced weight gain and somnolence; data read-out expected for early May 2020
    • Phase 2 trial with AM-125 in treatment of acute peripheral vertigo progressing towards interim analysis in Q2 2020

    Hamilton, Bermuda, March 5, 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 an update on its ongoing clinical trials with intranasal betahistine.

    In the Phase 1b trial with AM-201, intranasal betahistine for the prevention of antipsychotic-induced weight gain and somnolence, the last subject just had its last treatment visit. In total, the trial enrolled 80 healthy volunteers who received either AM-201 or placebo concomitantly with the antipsychotic drug olanzapine over four weeks. The study is testing six different doses of AM-201 under a dose escalation protocol. The primary efficacy outcome for the study will be the reduction in weight gain and the secondary outcome will be the reduction in somnolence. The Company expects to report top-line data in early May 2020, in accordance with previous guidance.    

    Meanwhile, the Phase 2 trial with AM-125, intranasal betahistine for the treatment of acute peripheral vertigo, is progressing towards the interim analysis, which is expected in the second quarter of 2020. The positive safety data obtained in the Phase 1b trial with AM-201 allowed for a reduction in the scope of the dose escalation. In addition to the ongoing intranasal dose escalation, open label testing of oral betahistine for reference purposes has commenced. Following the interim analysis in the second quarter, the Company expects to initiate Part B of the trial, which plans to enroll 72 patients for treatment with either a high or a low dose of AM-125 or placebo.

    "We look forward to sharing the results from our two intranasal betahistine trials during the second quarter of 2020," commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "Following positive interim data from the AM-201 trial in October, we will be keen to see the results obtained with the 30 mg dose, the final and highest level which was tested in 30 additional subjects. In our AM-125 trial, we expect the interim analysis to provide important insights into the dose response in acute peripheral vertigo which will help to inform the selection of doses for the larger second part of the trial."

    The Company expects to report its 2019 second-half and full year results and to provide a general business update on March 19, 2020.

    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 AM-201

    Intranasal betahistine is being developed under project code AM-201 for the prevention of antipsychotic-induced weight gain and somnolence. Many antipsychotic drugs are known to block the H1 histamine receptor, which is involved in the control of appetite and wakefulness, resulting in weight gain and somnolence as side effects. As an H1 receptor agonist, betahistine is thought to counteract the antipsychotics' inhibitory effects; in addition, betahistine blocks presynaptic H3 histamine autoreceptors, thus increasing histamine release and in turn augmenting betahistine's direct agonistic effects on H1 receptors.

    About Auris Medical

    Auris 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, 2018, 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

    or

     

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  1. Hamilton, Bermuda, February 25, 2020 - Auris Medical Holding AG (NASDAQ:EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today highlighted the publication of an article describing the anti-epileptic and anti-convulsive activity of betahistine in a mouse model. The peer-reviewed article titled "Betahistine prevents kindling, ameliorates the behavioral comorbidities and neurodegeneration induced by pentylenetetrazole" was recently published in Epilepsy & Behavior, a fast growing international journal covering behavioral aspects of seizures and epilepsy.1

    The article was written by an independent Iranian research group and presents…

    Hamilton, Bermuda, February 25, 2020 - Auris Medical Holding AG (NASDAQ:EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in neurotology and central nervous system disorders, today highlighted the publication of an article describing the anti-epileptic and anti-convulsive activity of betahistine in a mouse model. The peer-reviewed article titled "Betahistine prevents kindling, ameliorates the behavioral comorbidities and neurodegeneration induced by pentylenetetrazole" was recently published in Epilepsy & Behavior, a fast growing international journal covering behavioral aspects of seizures and epilepsy.1

    The article was written by an independent Iranian research group and presents the outcomes of a study on the effects of betahistine on seizure scores, memory deficits, depression, and neuronal loss in a murine model of epilepsy. Seizure was induced by treatment with pentylenetetrazole (PTZ), a common protocol in epilepsy studies. The researchers found that pretreatment and repetitive treatment with intraperitoneal betahistine entirely prevented generalized tonic-clonic seizures induction and significantly diminished seizure intensity. Further, it decreased cell death in the hippocampus and cortex, suggesting a neuroprotective effect of betahistine, and ameliorated the memory deficit and depression induced by PTZ in the kindled animals.

    "The exciting outcomes from this study supplement results from earlier studies which showed that an increase in central histamine level suppresses convulsion activity and provides neuroprotection," commented Thomas Meyer, Auris Medical's founder, Chairman and CEO. "Importantly, they also suggest further potential therapeutic uses for betahistine. While betahistine is currently approved and used world-wide for the treatment of vertigo, there is a growing body of evidence that the drug also enhances learning, cognitive function, atypical depression, or wakefulness, and reduces antipsychotic-induced weight gain. With our AM-125 project, we are targeting the vertigo indication with an intranasal formulation of betahistine that provides significantly higher plasma exposure than the current oral formulation, and with our AM-201 project, we are targeting antipsychotic-induced weight gain and somnolence and have started to expand into other therapeutic areas."

    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. 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. 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 Auris Medical

    Auris 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, 2018, 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

    Or




    1 Yazdi A et al. (2020), Betahistine prevents kindling, ameliorates the behavioral comorbidities and neurodegeneration induced by pentylenetetrazole, Epilepsy Behav 105: 106956.


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