- 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
program
Hamilton, 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
assay
The 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 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, 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.com
or
investors@aurismedical.com
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