Hamilton, Bermuda, May 23, 2019 (GLOBE NEWSWIRE) -- Auris Medical Holding Ltd. (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, including a review of recent clinical, regulatory and operational highlights and progress.
“In the past few months, we continued to make substantial progress with our intranasal betahistine development program, moving into two proof-of-concept studies,” stated Thomas Meyer, Auris Medical’s founder, Chairman and CEO. “At the same time, we executed on our repositioning and turnaround strategy: we significantly strengthened our balance sheet through the early repayment of our loan facility and a share offering; increased our corporate flexibility by moving the holding company to Bermuda; and enhanced our competitive position by expanding our portfolio of intellectual property related to betahistine. In addition, we advanced our partnering discussions around the AM-111 program in hearing loss and defined a clear path forward for our AM-101 program in tinnitus, which will allow us to maximize the potential of these promising, late-stage assets.”
Development Program Updates
AM-125 for Vertigo
- Progressed TRAVERS Phase 2 trial assessing AM-125, intranasal betahistine, in acute vertigo. The TRAVERS trial will enroll 138 patients that suffer from acute vertigo following surgical removal of a vestibular schwannoma, a tumor growing behind the inner ear. Study site initiations are starting now as approvals from relevant European regulatory agencies and ethics committees are coming in. In Part A of the TRAVERS trial, five ascending doses of AM-125 or placebo, administered three times daily over a total of four weeks, will be tested in a total of 50 patients. In addition, oral betahistine 48 mg will be tested in 16 patients under open-label conditions for reference. Based on an interim analysis, which is expected for the fourth quarter 2019, two doses will be selected and tested in an estimated 72 patients in Part B.
AM-201 for Antipsychotic-Induced Weight Gain
- Progressed Phase 1b proof-of-concept trial assessing AM-201, intranasal betahistine, for prevention of antipsychotic-induced weight gain and somnolence. The trial is conducted at a single trial site in Europe and is enrolling 50 healthy volunteers who receive either AM-201 or placebo concomitantly with olanzapine over four weeks. After reaching the midpoint in enrollment in early May, the Company expects to complete recruitment before the end of the second quarter of 2019. Top-line data are expected during the third quarter of 2019.
Other developments related to betahistine
- Closed purchase of two U.S. patents related to the use of betahistine for the treatment of depression and attention-deficit / hyperactivity disorder (ADHD). The Company acquired full ownership of U.S. patents 8,119,668 and 8,242,148 with key claims directed towards the treatment of depression and ADHD with betahistine. With these recent additions, the Company’s portfolio of betahistine related intellectual property has grown to five issued U.S. patents.
Sonsuvi® / AM-111 for Acute Inner Ear Hearing Loss
- Published detailed results from HEALOS Phase 3 trial. The detailed results from HEALOS, a randomized, double-blind, placebo-controlled study evaluating the efficacy, safety and tolerability of AM-111 in 256 patients suffering from severe to profound sudden deafness were published in Otology & Neurotology, one of the leading journals in the field of scientific and clinical inner ear research.1
- Continued strategic partnering process for further development of AM-111. As the Company has been refocusing its development activities on the intranasal betahistine program, discussions have been initiated and are ongoing for partnering the AM-111 development program.
Keyzilen® / AM-101 for Acute Inner Ear Tinnitus
- Defined development path for Keyzilen® / AM-101 in acute inner ear tinnitus. The Company has designed a new Phase 2/3 trial which shall, in two stages, reaffirm the efficacy of Keyzilen® / AM-101 in the treatment of acute tinnitus following traumatic cochlear injury and provide confirmatory efficacy data to support a filing for marketing authorization. It will incorporate learnings from the previous late-stage trials, notably with regard to the collection of patient reported outcomes and certain elements of study conduct. In addition, it will explore the use of a novel method for objective tinnitus diagnosis and measurement. The Company intends to discuss and validate the Phase 2/3 trial design with the U.S. Food and Drug Administration (“FDA”) and European Medicines Agency (“EMA”).
Finance & Corporate Developments
- Made early repayment of loan facility to Hercules Capital, Inc., 12 months ahead of the initial schedule. The repayment has enabled a significant reduction of the Company’s interest expense and improvement of its balance sheet, enhancing financial flexibility.
- Relocated the domicile of Auris Medical Holding from Zug, Switzerland, to Hamilton, Bermuda. With the benefit of the redomiciliation, the Company has gained more corporate flexibility, and it can achieve cost savings and operate under a jurisdiction that is more familiar to U.S. investors.
- Regained compliance with Nasdaq minimum bid price rule. Following a 1-for-20 reverse stock split effective May 1, 2019, the Company regained compliance with Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market.
- Completed public offering of common stock with gross proceeds of $8.4 million. In May 2019, the Company placed 440,000 common shares and 1,721,280 pre-funded warrants (each exercisable for one common share) together with an identical number of warrants in an underwritten offering with a small group of institutional investors. The proceeds will be used for general corporate purposes, including the funding of the ongoing proof-of-concept trials with intranasal betahistine. As per previous guidance, the Company intends to use non-dilutive funding for its other development programs, AM-101 and AM-111, as part of its refocusing on the intranasal betahistine program.
- Changed from quarterly to semi-annual financial reporting. As announced during the Annual General Meeting held on May 8, 2019, the Company, in accordance with rules and regulations of the Securities and Exchange Commission (the “SEC”) applicable to Foreign Private Issuers, intends to file financial reports going forward on a semi-annual instead of a quarterly basis. The next financial statements will therefore be filed for the first six months ended June 30, 2019. The switch will free up internal resources and help to reduce administrative expenses; it will have no impact on the Company’s policy of timely disclosure of material developments through ad hoc press releases and business updates.
- Completion of enrolment for Phase 1b trial of AM-201 expected for the second quarter of 2019, followed by the read-out of the trial in the third quarter of 2019.
- Feedback from FDA and EMA on design of the Phase 2/3 trial with AM-101 expected during the third quarter of 2019.
- Interim analysis of Phase 2 trial of AM-125 expected in the fourth quarter of 2019.
- Filing of IND for AM-201 expected in the fourth quarter of 2019.
About Auris Medical
Auris Medical is a biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in neurotology and mental health supportive care. 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 progressed to 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.”
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.
Edison Advisors for Auris Medical
1 Staecker et al., Efficacy and Safety of AM-111 in the Treatment of Acute Unilateral Sudden Deafness – A Double-Blind, Randomized, Placebo-Controlled Phase 3 Study, Otol Neurotol 2019, 40(5):584-594.