Auris Medical Provides Business Update and Reports First Half 2020 Financial Results
September 17 2020 - 8:00AM
- Advancing Phase 2 trial with AM-125 in acute vertigo based on
positive interim data
- Positive outcome from AM-201 trial in prevention of
antipsychotic-induced weight gain
- Addition of new intranasal program with development of
drug-free spray for protection against airborne pathogens and
allergens
- Review of strategic options initiated
Hamilton, Bermuda, September 17, 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 a business update and announced financial results
for the first half of the 2020 financial year ended June 30,
2020.
“Over the past few months we reached major
milestones with our intranasal betahistine program, reporting
positive safety and tolerability data as well as significant
efficacy signals in two clinical trials,” stated Thomas Meyer,
Auris Medical’s founder, Chairman and CEO. “The demonstration of a
dose-dependent improvement in various vertigo measures provides
further evidence for the therapeutic potential of AM-125 as a
vestibular stimulant. Further, the reduction in
antipsychotic-induced weight gain in our AM-201 trial suggests the
potential of the drug in other therapeutic indications. In
addition, we are now leveraging our experience with intranasal
delivery into the development of a drug-free nasal spray for
protection against airborne pathogens and allergens. We are very
excited about this new program given the large number of people
affected by allergic rhinitis and the strong need for personal
protection against airborne pathogens, highlighted by the current
Covid-19 pandemic.”
Development Program Updates
AM-125 for Treating Acute Vertigo
- Reported positive results from interim analysis in Phase 2
trial with AM-125 in acute vertigo. On September 3, 2020 the
Company announced top-line data from Part A of the TRAVERS trial,
which enrolled 33 patients suffering from vertigo following
neurosurgery. The patients were treated with AM-125 (intranasal
betahistine) at 1, 10 or 20 mg or placebo (3 x daily) for four
weeks. At the highest dose of 20 mg, AM-125-treated patients
improved their performance of the “Tandem Romberg” and the
“Standing on Foam” balance tests from baseline to 14 days
post-surgery (primary endpoint) on average 1.9 to 2.4 times more
than placebo-treated patients (6.0 vs. 3.1 and 10.5 vs. 4.3
seconds, respectively). In contrast to placebo, the improvement
from baseline was statistically significant for AM-125 20 mg and
for all active dose groups, respectively (p<0.02 and p<0.01
to p<0.05, respectively).
- Selected doses and key endpoints for Part B of TRAVERS trial.
Based on the results from the interim analysis, the two highest
doses, 10 and 20 mg, were selected by the Company to be tested
against placebo in 72 patients in Part B of the trial. The
improvement in the “Standing on Foam” test two weeks post-surgery
will be the sole primary efficacy endpoint, whereas the improvement
in the “Tandem Romberg” test six weeks post-surgery will be the key
secondary efficacy endpoint. Part B of the trial is expected to
start shortly, as open label testing of oral betahistine for
reference purposes will be completed (n=16).
AM-201 for Preventing Antipsychotic-Induced
Weight Gain
- Reported positive results from Phase 1b trial with AM-201 in
antipsychotic-induced weight gain. On May 26, 2020, the Company
reported top-line results from its Phase 1b trial in 80 healthy
volunteers who were treated with oral olanzapine 10 mg and AM-201
(intranasal betahistine) at up to 30 mg or placebo 3x daily for
four weeks. At the highest dose of 30 mg, the mean weight gain from
baseline in AM-201-treated participants 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).
In a next step, following additional pre-clinical testing, the
Company intends to file for an IND in 2021.
AM-301 for Protecting Against Airborne Pathogens
and Allergens
- Initiated development of a nasal spray for protection against
airborne pathogens and allergens. On September 8, 2020 the Company
announced that it had initiated under product code AM-301 the
development of a drug-free nasal spray for personal 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. 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.
- Demonstrated significant binding of SARS-CoV-2 in vitro.
Testing the key component of AM-301 at various concentrations in a
SARS-CoV-2 assay demonstrated a reduction in the viral infectious
load of up to 99%. The Company intends to perform additional
testing involving various pathogens and allergens.
Corporate Developments
- Set up new subsidiary dedicated to AM-301. The new subsidiary,
Altamira Medica Ltd. (“Altamira”), is based in Zug, Switzerland,
and has a share capital of CHF 0.5 mn. Currently owned 100% by
Auris Medical Holding Ltd., ownership in Altamira is expected to
decrease as other investors will be invited to join as shareholders
once additional financing is required.
- Raised CHF 1.5 million through a convertible loan. Under the
agreement, Altamira obtained CHF 1.5 mn from FiveT Capital Holding
Ltd., a Swiss investment management firm, to fund the development
of AM-301. The loan has a term of 18 months, carries an interest
rate of 8% p.a. and is convertible including accrued interest into
common shares of either Altamira or Auris Medical Holding Ltd.
- Initiated a review of strategic options. The Company’s Board of
Directors has started a process to explore, review and evaluate a
broad range of potential strategic alternatives. These alternatives
include but are not limited to the partnering of its various
clinical and preclinical programs, or a sale or merger of the
Company, in an effort to unlock the potential of those assets and
maximize shareholder value.
- Regained compliance with Nasdaq minimum bid price requirement.
On August 20, 2020, the Company received a letter from Nasdaq
stating that because the Company’s shares had a closing bid price
at or above $1.00 per share for a minimum of ten (10) consecutive
business days, the Company’s stock had regained compliance with the
Minimum Bid Price Requirement for continued listing on Nasdaq, and
that the matter was closed.
- Effected reduction in par value per share. As approved by the
Company’s annual general meeting, the par value of each common
share was reduced from CHF 0.40 to CHF 0.01, effective June 30,
2020. The transaction was cash neutral with the reduction in issued
share capital being credited to the contributed surplus
account.
First Half 2020 Financial
Results
- Total operating expenses for the first half of 2020 were CHF
2.4 million compared to CHF 4.1 million for the first half of
2019.
- Research and development expenses for the first half of 2020
were CHF 0.9 million compared to CHF 1.3 million for the first half
of 2019.1
- General and administrative expenses for the first half of 2020
were CHF 1.5 million compared to CHF 2.8 million for the first half
of 2019.
- Net loss for the first half of 2020 was CHF 2.7 million, or CHF
0.58 per share, compared to CHF 3.7 million, or CHF 1.66 per share,
for the first half of 2019.
The Company expects its total cash needs in
2020, including project AM-301, to be in the range of CHF 7.0 to
8.5 million for expected total operating expenses of CHF 4.5 to 5.5
million and expected capitalized research and development expenses
of CHF 2.5 to 3.0 million.
Conference Call & Webcast
Information
Auris Medical will host a conference call and
webcast to present its first-half 2020 results and a business
update today, September 17, 2020, at 8:30 am Eastern Time (2:30 pm
Central European Time). To participate in this conference call,
dial 1-877-870-9135 (US toll free) or +44 2071 928 338
(international), and enter passcode 5286195. A live webcast of the
conference call can be accessed in the Investor Relations section
of the Auris Medical website at www.aurismedical.com. A replay 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, 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 Advisors
for Auris Medical 646-653-7030 jgreen@edisongroup.com
Or
investors@aurismedical.com
AURIS MEDICAL HOLDING
LTD.Condensed Consolidated Statement of Profit or
Loss and Other Comprehensive Loss For the Six Months Ended
June 30, 2020 and 2019 (in CHF)
|
|
SIX MONTHS ENDED JUNE 30 |
|
|
|
2020 |
|
2019 |
|
Research and
development |
|
(884,747) |
|
(1,304,291) |
|
General and
administrative |
|
(1,535,960) |
|
(2,803,267) |
|
Operating loss |
|
(2,420,707) |
|
(4,107,558) |
|
Interest
expense |
|
(3,152) |
|
(25,261) |
|
Foreign
currency exchange gain/(loss), net |
|
(30,022) |
|
(264,121) |
|
Revaluation
gain / (loss) from derivative financial instruments |
|
4,353 |
|
531,245 |
|
Transaction
costs |
|
(219,615) |
|
- |
|
Loss
before tax |
|
(2,669,143) |
|
(3,865,695) |
|
Income tax
gain/(loss) |
|
10,642 |
|
261,394 |
|
Net
loss attributable to owners of the Company |
|
(2,658,501) |
|
(3,604,301) |
|
Other
comprehensive income/(loss): |
|
|
|
|
|
Items
that will never be reclassified to profit or loss |
|
|
|
|
|
Remeasurement
of defined benefit liability |
|
(78,010) |
|
(115,366) |
|
Items
that are or may be reclassified to profit or loss |
|
|
|
|
|
Foreign
currency translation differences |
|
16,396 |
|
6,666 |
|
Other
comprehensive income/(loss) |
|
(61,614) |
|
(108,700) |
|
Total
comprehensive loss attributable to owners of the
Company |
|
(2,720,115) |
|
(3,713,001) |
|
|
|
|
|
|
|
Basic and
diluted loss per share |
|
(0.58) |
|
(1.66) |
|
Average
weighted number of shares outstanding, adjusted for effect of
reverse stock split |
|
4,585,054 |
|
2,173,307 |
|
AURIS MEDICAL HOLDING
LTD.Condensed Consolidated Statement of Financial
Position (in CHF)
|
|
JUNE 30, 2020 |
|
DECEMBER 31,
2019 |
|
|
|
ASSETS |
|
|
|
|
Non-current assets |
|
|
|
|
|
Property and
equipment |
|
54,434 |
|
66,672 |
|
Intangible
assets |
|
7,499,491 |
|
6,765,613 |
|
Other
non-current financial receivables |
|
20,001 |
|
20,001 |
|
Total
non-current assets |
|
7,573,926 |
|
6,852,286 |
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
Other
receivables |
|
151,019 |
|
335,299 |
|
Prepayments |
|
198,843 |
|
434,231 |
|
Derivative
financial instruments |
|
- |
|
219,615 |
|
Cash and cash
equivalents |
|
39,939 |
|
1,384,720 |
|
Total
current assets |
|
389,801 |
|
2,373,865 |
|
|
|
|
|
|
|
Total
assets |
|
7,963,727 |
|
9,226,151 |
|
|
|
|
|
|
|
EQUITY
AND LIABILITIES |
|
|
|
|
|
Equity |
|
|
|
|
|
Share
capital |
|
50,591 |
|
1,650,380 |
|
Share
premium |
|
159,786,160 |
|
157,191,707 |
|
Foreign
currency translation reserve |
|
(11,169) |
|
(27,565) |
|
Accumulated
deficit |
|
(155,346,991) |
|
(152,778,389) |
|
Total
shareholders (deficit)/equity attributable to owners of the
Company |
|
4,478,591 |
|
6,036,133 |
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
Derivative
financial instruments |
|
- |
|
4,353 |
|
Loan |
|
50,000 |
|
- |
|
Employee
benefits |
|
876,776 |
|
760,447 |
|
Deferred tax
liabilities |
|
136,507 |
|
147,149 |
|
Total
non-current liabilities |
|
1,063,283 |
|
911,949 |
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Trade and other
payables |
|
1,256,352 |
|
938,247 |
|
Accrued
expenses |
|
1,165,501 |
|
1,339,822 |
|
Total
current liabilities |
|
2,421,853 |
|
2,278,069 |
|
Total
liabilities |
|
3,485,136 |
|
3,190,018 |
|
Total
equity and liabilities |
|
7,963,727 |
|
9,226,151 |
|
1 Does not include capitalized costs related to expenses for the
AM-125 program in accordance with IAS38.
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