- Dosing in second Phase 1 clinical trial with intranasal
betahistine nearing completion
- Approaching important interactions with regulatory
agencies
- Progressing with strategic repositioning of Company
Zug, Switzerland, August 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 second quarter ended June 30, 2018 and provided a business
update.
"In the past weeks and months we took important
steps to reposition our Company", stated Thomas Meyer, Auris
Medical's founder, Chairman and CEO. "We have refocused our
strategy on developing intranasal betahistine for vertigo and
mental health supportive care, two areas of great unmet medical
need, where betahistine is already well known or has shown
promising results, respectively. Based on the superior
bioavailability obtained with intranasal delivery compared to the
currently used oral formulation, we see a great potential for our
AM-125 and AM-201 development programs. As part of the strategic
repositioning of the Company, we intend to move forward with our
late-stage programs in acute inner ear hearing loss and tinnitus
through strategic partnering and/or with non-dilutive funding.
Accordingly, we have been able to reduce the Company's level of
operating expenses significantly, which, together with the recent
equity raise, has strengthened our financial position."
Development Program Updates
AM-125 for Vertigo
- Approaching completion of second Phase 1 clinical trial in
healthy volunteers. The third and final part of the randomized
placebo-controlled trial with dose escalation of repeated doses of
AM-125 (three times daily for three days) is nearing completion. In
the first two parts of the trial escalating doses of oral
betahistine up to 384 mg and of intranasal betahistine up to 60 mg
were administered. The trial will provide important additional data
on the pharmacokinetics, safety and tolerability of AM-125. An
earlier single dose Phase 1 clinical trial with intranasal
betahistine up to 40 mg had shown a relative bioavailability which
was 20-40 times higher compared with plasma levels in an
independent Phase 1 clinical trial with oral betahistine at 3 x 48
mg/day.[1] Top-line data from the second Phase 1 trial are expected
to become available in early October 2018.
- Further evidence for dose-dependent effects of betahistine and
relationship to bioavailability in animal model of acute vertigo. A
peer-reviewed article by Tighilet and colleagues in Frontiers in
Neurology[2] showed that a higher dose of betahistine administered
to cats following acute loss of unilateral vestibular function
resulted in faster improvement of acute symptoms than with a lower
dose, accelerated significantly the recovery process. Further, it
was associated with a significant increase of histaminergic
activity in the hypothalamus and substantially higher
bioavailability in blood plasma.
- Initiated scientific advice procedure with the European
Medicines Agency (EMA). The Company initiated a scientific advice
procedure with the EMA to discuss the development plan for AM-125
and in particular the planned Phase 2 clinical trial in acute
vertigo. The Agency's feedback is expected in fall of 2018.
AM-201 for Olanzapine-Induced Weight
Gain
- Initiated AM-201 development program with intranasal
betahistine for prevention of olanzapine-induced weight gain. In
May 2018 the Company announced the expansion of its intranasal
betahistine development program beyond the treatment of vertigo
into mental health supportive care. Under project code AM-201 the
Company will develop intranasal betahistine for the prevention of
weight gain associated with the treatment of olanzapine in
schizophrenia and bipolar disorder. Preclinical and clinical
studies conducted by other parties have demonstrated a key role for
the histamine 1 receptor in olanzapine-induced weight gain and
betahistine's capacity to counteract olanzapine's effect at this
receptor through competitive inhibition.
- Established Scientific Advisory Board for project AM-201. In
order to support the AM-201 development program, the Company
assembled a Scientific Advisory Board comprising Dr Nir Barak
(founder and former Chief Scientific Officer of Obecure, Israel),
Dr Christoph Correll (Professor of Child and Adolescent Psychiatry,
Charité Medical School, Berlin, Germany), Dr John Kane (Professor
and Chairman of Psychiatry at The Donald and Barbara Zucker School
of Medicine at Hofstra/Northwell, Hempstead NY), and Dr John
Newcomer (Professor of Integrated Medical Science, Charles E.
Schmidt College of Medicine, Florida Atlantic University, Boca
Raton FL).
- Initiated preparations for Phase 1
pharmacokinetic/pharmacodynamic clinical trial. The Company has
started preparations for a randomized placebo-controlled Phase 1
trial in healthy volunteers to evaluate the safety,
pharmacokinetics and pharmacodynamic effects of AM-201 in
co-administration with olanzapine. The trial is expected to start
in early 2019.
AM-111 for Acute Inner Ear Hearing
Loss
- Requested 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. The Agency's
feedback is expected during the third quarter of 2018. 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.
Corporate and Other Developments
- Raised further equity in a $7m public offering. On July 17,
2018 we completed an underwritten public offering of 17,948,717
common shares with 6,282,050 Series A warrants and 4,487,179 Series
B warrants. The issue price was $0.39 per share and attached
warrants, resulting in net proceeds to the Company of approximately
$6.2m.
- Departure of Andrea Braun, Head of Regulatory and Quality
Affairs. Andrea Braun, PhD, who joined Auris Medical in 2016, will
leave the Company to pursue a new career opportunity.
Second Quarter 2018 Financial Results
- Cash and cash equivalents at June 30, 2018 totaled CHF 4.4
million.
- Total operating expenses for the second quarter of 2018 were
CHF 3.1 million compared to CHF 6.0 million for the second quarter
of 2017.
- Research and development expenses for the second quarter of
2018 were CHF 2.0 million compared to CHF 4.7 million for the
second quarter of 2017.
- General and administrative expenses for the second quarter of
2018 were CHF 1.1 million compared to CHF 1.2 million for the
second quarter of 2017.
- Net loss for the second quarter of 2018 was CHF 3.1 million, or
CHF 0.50 per share, compared to CHF 5.4 million, or CHF 1.22 per
share, for the second quarter of 2017.[3]
The Company continues to expect that its
operating expenses in 2018 will be in the range of CHF 10 to 12
million.
Conference Call & Webcast
Information
Auris Medical will host a conference call and
webcast to present the second quarter 2018 financial results and to
provide a business update today, August 15, 2018, at 8:00 am
Eastern Time (2:00 pm Central European Time). To participate in
this conference call, dial 888-254-3590 (USA) or +1 929-477-0448
(International), and enter passcode 8636087. 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 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 disorders 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). This program is currently in Phase 1. In addition Auris
Medical has two Phase 3 programs under development: 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 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, 2017, 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.
Company contact: Hernan Levett, Chief Financial Officer, +41 61
201 1350investors@aurismedical.com
AURIS MEDICAL HOLDING AGCondensed
Consolidated Statement of Profit or Loss and Other Comprehensive
LossFor the Three Months Ended June 30, 2018 and 2017 (in
CHF)
|
|
THREE MONTHS ENDED JUNE 30 |
|
|
|
2018 |
|
2017 |
|
Research and
development |
|
(2'014'400) |
|
(4'722'899) |
|
General and
administrative |
|
(1'098'707) |
|
(1'235'665) |
|
Operating
loss |
|
(3'113'107) |
|
(5'958'564) |
|
Interest income |
|
- |
|
14'478 |
|
Interest expense |
|
(507'230) |
|
(410'009) |
|
Foreign currency
exchange loss, net |
|
22'376 |
|
(592'876) |
|
Revaluation gain from
derivative financial instruments |
|
607'262 |
|
1'527'508 |
|
Transaction costs |
|
(97'556) |
|
- |
|
Loss before
tax |
|
(3'088'255) |
|
(5'419'463) |
|
Income tax gain |
|
8'727 |
|
8'191 |
|
Net loss
attributable to owners of the Company |
|
(3'079'528) |
|
(5'411'272) |
|
Other comprehensive
loss: |
|
|
|
|
|
Items that will
never be reclassified toprofit or loss |
|
|
|
|
|
Remeasurement of
defined benefit liability, net of taxes of CHF 0.00 |
|
804'301 |
|
55'810 |
|
Items that are or
may be reclassified toprofit or loss |
|
|
|
|
|
Foreign currency
translation differences, net of taxes of CHF 0.00 |
|
(34'164) |
|
39'985 |
|
Other comprehensive
income,net of taxes of CHF 0 |
|
770'137 |
|
95'795 |
|
Total comprehensive
loss attributableto owners of the Company |
|
(2'309'391) |
|
(5'315'477) |
|
|
|
|
|
|
|
Basic and diluted loss
per share |
|
(0.50) |
|
(1.22) |
|
Average weighted number
of shares outstanding, adjusted for effect of reverse stock
split |
|
6,117,389 |
|
4,432,970 |
|
AURIS MEDICAL HOLDING AGCondensed
Consolidated Statement of Financial Position (in CHF)
|
|
JUNE 30, 2018 |
|
DECEMBER 31,2017 |
|
|
|
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
|
Property and
equipment |
|
206'591 |
|
252,899 |
|
Intangible assets |
|
1'663'763 |
|
1,629,100 |
|
Derivative financial
instruments |
|
252'351 |
|
- |
|
Other non-current
financial receivables |
|
76'710 |
|
76,710 |
|
Total non-current
assets |
|
2'199'415 |
|
1,958,709 |
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
Other receivables |
|
365'694 |
|
241,281 |
|
Prepayments |
|
480'818 |
|
652,913 |
|
Cash and cash
equivalents |
|
4'421'771 |
|
14,973,369 |
|
Total current
assets |
|
5'268'283 |
|
15,867,563 |
|
|
|
|
|
|
|
Total
assets |
|
7'467'698 |
|
17,826,272 |
|
|
|
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
|
|
Equity |
|
|
|
|
|
Share capital |
|
122'348 |
|
19,349,556 |
|
Share premium |
|
136'332'887 |
|
114,648,228 |
|
Foreign currency
translation reserve |
|
(52'076) |
|
(33,047) |
|
Accumulated
deficit |
|
(139'951'610) |
|
(136,126,946) |
|
Total shareholders
(deficit)/equity attributable to owners of the Company |
|
(3'548'451) |
|
(2,162,209) |
|
|
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
|
Loan |
|
- |
|
5,584,297 |
|
Derivative financial
instruments |
|
412'552 |
|
1,836,763 |
|
Employee benefits |
|
991'188 |
|
1,962,970 |
|
Deferred tax
liabilities |
|
161'357 |
|
178,809 |
|
Total non-current
liabilities |
|
1'565'097 |
|
9,562,839 |
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Loan |
|
3'618'095 |
|
4,542,109 |
|
Trade and other
payables |
|
2'274'746 |
|
1,200,820 |
|
Accrued expenses |
|
3'558'212 |
|
4,682,713 |
|
Total current
liabilities |
|
9'451'052 |
|
10,425,642 |
|
Total
liabilities |
|
11'016'149 |
|
19,988,481 |
|
Total equity and
liabilities |
|
7'467'698 |
|
17,826,272 |
|
[1] The overall design of that trial is described in Barak et
al. (2016), Journal of Psychopharmacology 30(3):
237-241.
[2] Tighilet B, Léonard J, Watabe I, Bernard-Demanze L, Lacour M
(2018). Betahistine treatment in a cat model of vestibular
pathology: pharmacokinetic and pharmacodynamic approaches. Front
Neurol. 11(9):431.
[3] Loss per share for second quarter 2017 adjusted for
subsequent reverse stock split.
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