- 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 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 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
Auris Medical (NASDAQ:EARS)
Historical Stock Chart
From Aug 2024 to Sep 2024
Auris Medical (NASDAQ:EARS)
Historical Stock Chart
From Sep 2023 to Sep 2024