Auris Medical Provides Business Update and Reports First Quarter 2016 Financial Results
May 11 2016 - 6:41AM
- Key Opinion Leader meeting focused on AM-101 scheduled for June
14 in New York City
- Top-line results from pivotal TACTT2 trial of AM-101 in acute
inner ear tinnitus expected in August
- Conference call today at 8 am Eastern Time / 2 pm Central
European Time
Basel, Switzerland, May 11, 2016 (GLOBE
NEWSWIRE) -- Auris Medical Holding AG (NASDAQ: EARS), a
clinical-stage company dedicated to developing therapeutics that
address important unmet medical needs in otolaryngology, today
provided a business update and announced financial results for the
first quarter ended March 31, 2016.
"We are focused on the continued progress of our
two Phase 3 development programs evaluating AM-101 for acute inner
ear tinnitus and AM-111 for acute inner ear hearing loss,"
commented Thomas Meyer, Auris Medical's founder, Chairman and Chief
Executive Officer. "In preparation for the upcoming data readout of
the TACTT2 trial in August, we look forward to hosting a Key
Opinion Leader meeting next month."
Development Program Updates
AM-101 for Acute Inner Ear Tinnitus
- Completed enrollment of over 330 patients in the Phase 3 TACTT2
trial. The TACTT2 trial is being conducted primarily in North
America under a Special Protocol Assessment (SPA) with the US Food
and Drug Administration. Top-line results from this trial are
expected in August 2016.
- Progressing toward completion of enrollment in the Phase 3
TACTT3 trial. The TACTT3 trial is being conducted in Europe and
enrollment of approximately 630 patients (300 in the acute stage
and 330 in the post-acute stage) is expected to be completed by the
end of the second quarter of 2016. Top-line results from this trial
are expected in the fourth quarter of 2016.
- Continued with the preparation of regulatory submissions for
the marketing authorization of AM-101 in the US and Europe, as well
as pre-commercial activities in preparation for the planned future
launches of AM-101.
AM-111 for Acute Inner Ear Hearing Loss
- Advanced enrollment into the Phase 3 HEALOS trial. The HEALOS
trial is being conducted in several European and Asian countries
and began recruiting in November 2015. The trial aims to enroll
approximately 255 patients with severe to profound idiopathic
sudden sensorineural hearing loss.
- Moved toward initiation of the Phase 3 ASSENT trial. The ASSENT
trial will be conducted in the US, Canada and South Korea and is
scheduled to initiate in the upcoming months. The trial is set to
enroll approximately 300 patients with severe to profound
idiopathic sudden sensorineural hearing loss.
Other Developments
- Elected Armando Anido as a member of the Board of Directors and
Chairman of the Compensation Committee. Mr. Anido is the Chairman
and Chief Executive Officer of Zynerba Pharmaceuticals. Prior to
joining Zynerba, he served as Chief Executive Officer of NuPathe,
Inc., and Auxilium Pharmaceuticals, Inc. Prior to Auxilium, Mr.
Anido held commercial leadership roles at MedImmune, Glaxo Wellcome
and Lederle Labs. Mr. Anido holds a BS in Pharmacy and an MBA, both
from West Virginia University.
- Welcomed Andrea Braun as Head of Regulatory and Quality Affairs
and member of the Executive Management Committee. In this newly
created position, Ms. Braun is leading the Company's regulatory
affairs, quality and pharmacovigilance activities. Prior to Auris
Medical, she served in various regulatory affairs positions,
including as Head of EU Regulatory Affairs at Roche and Head of
Global Regulatory Affairs Biologics at Alvotech. Ms. Braun received
her state examination in pharmacy from the University of
Heidelberg, Germany, and holds a PhD in immunology from the
University of Basel, Switzerland.
- Sven Zimmermann, who has served as Auris Medical's Chief
Financial Officer since 2014, has decided to leave the Company for
personal reasons this summer. A search for his replacement has been
initiated.
First Quarter 2016 Financial Results
- Cash and cash equivalents totaled CHF 41.39 million at March
31, 2016.
- Total operating expenses for the first quarter of 2016 were CHF
7.36 million compared to CHF 7.16 million for the first quarter of
2015.
- Research and development expenses for the first quarter of 2016
were CHF 6.14 million compared to CHF 6.23 million for the first
quarter of 2015.
- General and administrative expenses for the first quarter of
2016 were CHF 1.22 million compared to CHF 0.93 million for the
first quarter of 2015.
- Net loss for the first quarter of 2016 was CHF 8.90 million, or
CHF 0.26 per share, compared to CHF 8.05 million, or CHF 0.28 per
share, for the first quarter of 2015. The net loss includes a net
unrealized foreign currency exchange loss of 1.54 million in the
first quarter of 2016 compared to a loss of 0.89 million in the
first quarter of 2015.
AM-101 Key Opinion Leader Meeting &
Webcast Scheduled for June 14, 2016
Auris Medical will host a Key Opinion Leader
breakfast focused on the Phase 3 program and market opportunity of
AM-101 and the treatment of acute inner ear tinnitus on Tuesday,
June 14, 2016, at 8:00 am Eastern Time in New York City. The
meeting will feature a keynote presentation by Hinrich Staecker,
MD, PhD, who serves as Professor of Otolaryngology at the
University of Kansas Medical Center and a principal investigator in
the TACTT2 trial.
To reserve a seat, please contact Cindy McGee via e-mail at
investors@aurismedical.com. A live webcast of the event will be
available in the Investor Relations section of the Auris Medical
website at www.aurismedical.com and a replay of the presentation
will be available following the event.
Today's Conference Call & Webcast Information
Auris Medical will host a conference call and
webcast to discuss the first quarter 2016 financial results and to
provide a general business update today, May 11, 2016, at 8:00 am
Eastern Time (2:00 pm Central European Time). To participate in
this conference call, dial 1-855-217-7942 (USA) or +1-646-254-3374
(International), and enter passcode 9629643. 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 otolaryngology. The Company is currently
focusing on the development of treatments for acute inner ear
tinnitus (AM-101) and for acute inner ear hearing loss (AM-111) by
way of intratympanic injection with biocompatible gel formulations.
In addition, Auris Medical is pursuing early-stage research and
development projects. The Company was founded in 2003 and is
headquartered in Zug, Switzerland. The shares of the parent company
Auris Medical Holding AG trade on the NASDAQ Global 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, 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 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.
Contact: Cindy McGee, Head of Investor Relations and Corporate
Communications, +41 61 201 13 50, investors@aurismedical.com
Auris Medical Holding AG Condensed Consolidated
Interim Statement of Loss and Other Comprehensive Loss (unaudited)
(in CHF thousands, except per share data)
|
Three Months Ended March 31, |
|
2016 |
|
2015 |
|
Research and development
expenses |
(6,140) |
|
(6,230) |
|
General and administrative
expenses |
(1,222) |
|
(930) |
|
Operating loss |
(7,362) |
|
(7,160) |
|
Interest income |
11 |
|
5 |
|
Interest expense |
(3) |
|
(2) |
|
Foreign currency exchange
gains/(losses), net |
(1,545) |
|
(895) |
|
Loss before tax |
(8,899) |
|
(8,052) |
|
Income tax expense |
- |
|
- |
|
Net loss attributable to
owners of the Company |
(8,899) |
|
(8,052) |
|
Other comprehensive
income: |
|
|
|
|
Items that will never be
reclassified to profit or loss: |
|
|
|
|
Remeasurements of defined
benefits liability, net of taxes |
(261) |
|
(229) |
|
Items that are or may be
reclassified to profit or loss: |
|
|
|
|
Foreign currency
translation differences, net of taxes |
42 |
|
18 |
|
Other comprehensive
income |
(219) |
|
(211) |
|
Total comprehensive loss
attributable to owners of the Company |
(9,118) |
|
(8,263) |
|
Loss per share, basic and
diluted |
(0.26) |
|
(0.28) |
|
Weighted average common
shares outstanding, basic and diluted |
34,329,704 |
|
29,013,214 |
|
Currency rate CHF /
USD |
0.9936 |
|
0.9613 |
|
Auris Medical Holding AG Condensed Consolidated
Interim Statement of Financial Position (unaudited) (in CHF
thousands)
|
March 31, 2016 |
|
December 31, 2015 |
Assets |
|
|
|
Non-current assets |
|
|
|
Property and
equipment |
198 |
|
223 |
Intangible assets |
1,483 |
|
1,483 |
Other non-current
receivables |
38 |
|
38 |
Total non-current
assets |
1,719 |
|
1,744 |
Current assets |
|
|
|
Current financial assets
and other receivables |
675 |
|
651 |
Prepayments |
109 |
|
181 |
Cash and cash
equivalents |
41,393 |
|
50,237 |
Total current assets |
42,177 |
|
51,069 |
Total assets |
43,896 |
|
52,813 |
Equity and
Liabilities |
|
|
|
Equity |
|
|
|
Share capital |
13,732 |
|
13,722 |
Share premium |
112,841 |
|
112,663 |
Foreign currency
translation reserve |
(22) |
|
(64) |
Accumulated deficit |
(90,659) |
|
(81,579) |
Total shareholders' equity
attributable to owners of the Company |
35,892 |
|
44,742 |
Non-current
liabilities |
|
|
|
Employee benefits |
1,868 |
|
1,576 |
Deferred tax
liabilities |
328 |
|
328 |
Total non-current
liabilities |
2,196 |
|
1,904 |
Current liabilities |
|
|
|
Trade and other
payables |
1,208 |
|
1,206 |
Accrued expenses |
4,600 |
|
4,961 |
Total current
liabilities |
5,808 |
|
6,167 |
Total liabilities |
8,004 |
|
8,071 |
Total equity and
liabilities |
43,896 |
|
52,813 |
Currency rate CHF /
USD |
0.9619 |
|
1.0014 |
HUG#2011637
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