- Positive outcomes from second Phase 1 trial with intranasal
betahistine
- Further evidence for betahistine's preventive effects in
antipsychotic-induced weight gain
- Progressing intranasal betahistine program towards
proof-of-concept studies
- Partnering process initiated for AM-111 program
- Sonsuvi® accepted as brand name for AM-111
Zug, Switzerland, November 15, 2018 - Auris
Medical Holding AG (NASDAQ: EARS), a clinical-stage company
dedicated to developing therapeutics that address important unmet
medical needs in neurotology, today announced financial results for
the third quarter ended September 30, 2018 and provided a business
update.
"We have continued to make great progress with
our intranasal betahistine program and recently reached a major
milestone as the second Phase 1 clinical trial showed exciting
results", stated Thomas Meyer, Auris Medical's founder, Chairman
and CEO. "These positive outcomes include the confirmation of
superior bioavailability provided by the intranasal delivery route
over the currently used oral administration route, which is the
cornerstone of the program. In addition, the trial confirmed that
intranasal betahistine is safe and well tolerated even when taken
in multiple doses. We look forward to taking our next key
development steps with this program that is the start of our
planned proof-of-concept studies in acute vertigo and
olanzapine-induced weight gain."
Development Program Updates
Intranasal betahistine program
- Announced results from second Phase 1 clinical trial in healthy
volunteers. The randomized double blind placebo controlled trial
with dose escalation enrolled a total of 72 subjects. One group of
study participants received a single dose of intranasal betahistine
or placebo and, following a wash-out period, three doses daily for
three days. Single doses were escalated up to 60 mg, and repeated
doses up to 40 mg. The study demonstrated superior bioavailability
over a range of four intranasal betahistine doses compared to the
approved total daily dose for oral betahistine (48 mg); plasma
exposure was 6 to 29 times higher (p-value between 0.056 and
p<0.0001). Further, it confirmed the good safety profile of
intranasal betahistine and showed that the treatment was well
tolerated when administered three times daily for three days. The
maximum tolerated dose for multiple dosing was determined at 40
mg.
AM-125 for Vertigo
- Progressed with preparations for Phase 2 trial with AM-125 in
acute vertigo. The "TRAVERS" Phase 2 trial will enroll 138 patients
suffering from acute vertigo following surgical removal of a
vestibular schwannoma, a tumor growing behind the inner ear. It
will be conducted in several European countries and potentially,
Canada. The TRAVERS trial is expected to start recruitment during
the first quarter of 2019 and will have two parts. In Part A, 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, two doses will be selected and tested in an
estimated 72 patients in Part B.
- Obtained scientific advice from the European Medicines Agency
(EMA). The Company received feedback from the EMA on the
development plan for AM-125 and in particular the planned Phase 2
clinical trial in acute vertigo. The Agency endorsed the use of the
vestibular schwannoma resection model for demonstrating proof of
concept with intranasal betahistine in the treatment of acute
vertigo.
AM-201 for Antipsychotic-Induced Weight Gain
·
Progressed with preparations for a pharmacokinetic/pharmacodynamic
trial with AM-201 in antipsychotic-induced weight gain. The trial
will be conducted in a European country and enroll 50 healthy
volunteers who will receive either AM-201 or placebo concomitantly
with olanzapine over four weeks. Doses will be escalated in five
steps, as in the TRAVERS trial. The trial is expected to start
recruitment during the first quarter of 2019.
·
Further evidence for betahistine's preventive effects in
antipsychotic-induced weight gain. The body of clinical data
demonstrating betahistine's capacity to counteract weight gain
induced by antipsychotic drugs was recently further expanded
through a publication by Smith and colleagues.[1] The authors
conducted a study with oral betahistine 36-48 mg/day or placebo
administered over 12 weeks to adolescents and adults who received
at the same time various antipsychotic drugs. They found that in
the sub-group of patients being treated with olanzapine or
clozapine (n=26), betahistine was significantly better than placebo
in preventing increases in weight (3.1 kg less weight gain than
placebo), body mass index, and waist circumference.
AM-111 for Acute Inner Ear Hearing
Loss
·
Obtained FDA guidance on AM-111 development program. The Company
was granted a type C meeting with the FDA to discuss the
development and regulatory path forward with AM-111. In a written
response the FDA endorsed the proposed choice of primary and
secondary efficacy endpoints, the safety endpoints, as well as the
planned sample size and statistical methodology. In addition, the
FDA provided important guidance on the regulatory path forward. The
Company had previously obtained scientific advice (protocol
assistance) from the EMA, which included endorsement of the
proposed design for a single pivotal trial with AM-111 0.4 mg/mL in
patients suffering from acute profound hearing loss.
·
Sonsuvi® accepted as brand name for AM-111. Sonsuvi®, the proposed
proprietary name for AM-111, has been conditionally approved by the
FDA as well as the EMA, subject to final review at the time of
marketing approval. The brand name is pronounced as "son-SUE-vee"
and has been registered as trademark in various countries.
·
Initiated partnering process for AM-111. As previously announced,
the Company decided to refocus its development activities on the
intranasal betahistine program and to seek partners or other
sources of non-dilutive funding for its late-stage development
programs. In this context, the Company has mandated JSB Partners,
an international transaction advisory firm, to identify potential
partners for the AM-111 development program and provide support for
partnering discussions and negotiations.
Third Quarter 2018 Financial Results
· Cash and cash
equivalents at September 30, 2018 totaled CHF 5.3 million.
· Total operating
expenses for the third quarter of 2018 were CHF 2.9 million
compared to CHF 6.0 million for the third quarter of 2017.
· Research and
development expenses for the third quarter of 2018 were CHF 1.7
million compared to CHF 4.2 million for the third quarter of
2017.
· General and
administrative expenses for the third quarter of 2018 were CHF 1.2
million compared to CHF 1.3 million for the third quarter of
2017.
· Net loss for the
third quarter of 2018 was CHF 3.0 million, or CHF 0.14 per share,
compared to CHF 6.0 million, or CHF 1.36 per share, for the third
quarter of 2017.
· The
Company continues to expect that its operating expenses in 2018
will be in the range of CHF 10 to 12.9 million.
· Since
the closing of the third quarter, exercises of warrants from the
July 2018 offering as well as the sale of shares under the equity
line with LPC have increased shareholders' equity by approximately
CHF 2.7 million.
Conference Call & Webcast
Information
Auris Medical will host a conference call and
webcast to present the third quarter 2018 financial results and to
provide a business update today, November 15, 2018, at 8:00 am
Eastern Time (2:00 pm Central European Time). To participate in
this conference call, dial 1-877-407-0312 (toll free) or +1
201-389-0899 (International), and enter passcode 13685071. A live
webcast of the conference call will be available in the Investor
Relations section of the Auris Medical website at
www.aurismedical.com and a replay of the conference call will be
available approximately two hours following the live call.
About Auris Medical
Auris Medical is a Swiss 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
treatment of antipsychotic-induced weight gain and somnolence
(AM-201). These projects have gone through two Phase 1 trials and
will move into 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 Zug, Switzerland. The shares of Auris Medical
Holding AG 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 fact 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," and 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 timing and conduct of clinical trials of
Auris Medical's product candidates will not meet its endpoints ,
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 and future
filings with the Securities and Exchange Commission.
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. All forward-looking
statements are qualified in their entirety by this cautionary
statement.
Investor contact: Joseph Green / Andrew GibsonEdison
Advisors for Auris Medical646-653-7030 / 7719jgreen@edisongroup.com
/ agibson@edisongroup.com
Or
investors@aurismedical.com
AURIS MEDICAL HOLDING AGCondensed
Consolidated Statement of Profit or Loss and Other Comprehensive
LossFor the Three Months Ended September 30, 2018 and 2017 (in
CHF)
|
|
THREE MONTHS ENDED SEPTEMBER
30 |
|
|
|
2018 |
|
2017 |
|
Research and
development |
|
(1'697'045) |
|
(4'221'324) |
|
General and
administrative |
|
(1'170'244) |
|
(1'336'217) |
|
Operating
loss |
|
(2'867'289) |
|
(5'557'541) |
|
Interest income |
|
- |
|
7'788 |
|
Interest expense |
|
(123'038) |
|
(416'956) |
|
Foreign currency
exchange loss, net |
|
(114'011) |
|
1'650 |
|
Revaluation gain from
derivative financial instruments |
|
223'904 |
|
(55'613) |
|
Transaction costs |
|
(108'809) |
|
- |
|
Loss before
tax |
|
(2'989'243) |
|
(6'020'672) |
|
Income tax gain |
|
8'726 |
|
8'191 |
|
Net loss
attributable to owners of the Company |
|
(2'980'517) |
|
(6'012'481) |
|
Other comprehensive
loss: |
|
|
|
|
|
Items that will
never be reclassified toprofit or loss |
|
|
|
|
|
Remeasurement of
defined benefit liability, net of taxes of CHF 0.00 |
|
209'760 |
|
94'463 |
|
Items that are or
may be reclassified toprofit or loss |
|
|
|
|
|
Foreign currency
translation differences, net of taxes of CHF 0.00 |
|
5'913 |
|
(4'594) |
|
Other comprehensive
income,net of taxes of CHF 0 |
|
215'673 |
|
89'869 |
|
Total comprehensive
loss attributableto owners of the Company |
|
(2'764'844) |
|
(5'922'612) |
|
|
|
|
|
|
|
Basic and diluted loss
per share |
|
(0.14) |
|
(1.36) |
|
Average weighted number
of shares outstanding, adjusted for effect of reverse stock
split |
|
20,944,590 |
|
4,432,970 |
|
AURIS MEDICAL HOLDING AGCondensed
Consolidated Statement of Financial Position (in CHF)
|
|
SEPTEMBER 30, 2018 |
|
DECEMBER 31,2017 |
|
|
|
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
|
Property and
equipment |
|
44'948 |
|
252,899 |
|
Intangible assets |
|
1'663'763 |
|
1,629,100 |
|
Derivative financial
instruments |
|
252'351 |
|
- |
|
Other non-current
financial receivables |
|
15'996 |
|
76,710 |
|
Total non-current
assets |
|
1'977'058 |
|
1,958,709 |
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
Other receivables |
|
309'143 |
|
241,281 |
|
Prepayments |
|
507'329 |
|
652,913 |
|
Cash and cash
equivalents |
|
5'257'881 |
|
14,973,369 |
|
Total current
assets |
|
6'074'353 |
|
15,867,563 |
|
|
|
|
|
|
|
Total
assets |
|
8'051'411 |
|
17,826,272 |
|
|
|
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
|
|
Equity |
|
|
|
|
|
Share capital |
|
481'337 |
|
19,349,556 |
|
Share premium |
|
141'338'003 |
|
114,648,228 |
|
Foreign currency
translation reserve |
|
(46'163) |
|
(33,047) |
|
Accumulated
deficit |
|
(142'514'194) |
|
(136,126,946) |
|
Total shareholders
(deficit)/equity attributable to owners of the Company |
|
(741'017) |
|
(2,162,209) |
|
|
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
|
Loan |
|
- |
|
5,584,297 |
|
Derivative financial
instruments |
|
1'085'089 |
|
1,836,763 |
|
Employee benefits |
|
850'746 |
|
1,962,970 |
|
Deferred tax
liabilities |
|
152'630 |
|
178,809 |
|
Total non-current
liabilities |
|
2'088'465 |
|
9,562,839 |
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Loan |
|
2'144'235 |
|
4,542,109 |
|
Trade and other
payables |
|
1'115'102 |
|
1,200,820 |
|
Accrued expenses |
|
3'444'626 |
|
4,682,713 |
|
Total current
liabilities |
|
6'703'963 |
|
10,425,642 |
|
Total
liabilities |
|
8'792'428 |
|
19,988,481 |
|
Total equity and
liabilities |
|
8'051'411 |
|
17,826,272 |
|
[1] Smith RC et al. (2018). Betahistine effects on
weight-related measures in patients treated with antipsychotic
medications: a double-blind placebo-controlled study.
Psychopharmacology (Berl), in press.
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