Auris Medical Holding Ltd Provides Corporate Update
May 23 2019 - 9:00AM
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, 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.
Outlook
- 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.”
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 jgreen@edisongroup.com
or
investors@aurismedical.com
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.
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