Auris Medical Provides Business Update and Reports Second Quarter 2016 Financial Results
August 18 2016 - 7:21AM
- TACTT2 trial with KeyzilenTM for acute inner ear tinnitus did
not meet efficacy endpoints
- Top-line results from TACTT3 trial with KeyzilenTM expected in
the fourth quarter of 2016
- AM-111 Phase 3 program for acute inner ear hearing loss is
ongoing
- Conference call today at 8 am Eastern Time
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 second quarter ended June
30, 2016.
"As stated earlier today, we are disappointed
with the top-line results from the TACTT2 trial with KeyzilenTM for
acute inner ear tinnitus and we continue to assess the full
dataset. We plan to complete this analysis and meet with the
regulatory agencies prior to the TACTT3 readout, which is expected
in the fourth quarter," commented Thomas Meyer, Auris Medical's
founder, Chairman and Chief Executive Officer. "Apart from this, we
are pleased with the progress of our second Phase 3 asset, AM-111
for the treatment of acute sensorineural hearing loss, which is
progressing with enrollment into the HEALOS and ASSENT trials.
Furthermore, we have appointed Thomas Jung to our management team
as Chief Development Officer to support our clinical, preclinical
and pharmaceutical development activities."
Development Program Updates
Keyzilen TM (AM-101) for Acute
Inner Ear Tinnitus
- Announced top-line results from the Phase 3 TACTT2 trial in
acute inner ear tinnitus. The TACTT2 trial did not meet the two
co-primary efficacy endpoints of statistically significant changes
in tinnitus loudness and tinnitus burden compared to placebo. Data
from the TACTT2 trial support the positive safety profile
established in previous studies.
- Completed enrollment of the Phase 3 TACTT3 trial with more than
300 patients during the acute tinnitus stage (Stratum A) and
approximately 330 patients during the post-acute tinnitus stage
(Stratum B). The trial, which is being conducted in Europe, is a
randomized, double-blind, placebo-controlled trial in acute and
post-acute inner ear tinnitus following traumatic cochlear injury
or otitis media. The primary endpoint is the change in tinnitus
loudness from baseline to Day 84; the change in the TFI is the key
secondary efficacy outcome. Top-line results from this trial are
expected in the fourth quarter of 2016.
- Received fast track designation from the FDA for KeyzilenTM in
acute peripheral (inner ear) tinnitus following traumatic cochlear
injury or otitis media in adults, highlighting the seriousness of
the condition as well as the unmet medical need.
AM-111 for Acute Inner Ear Hearing
Loss
- Progressed with enrollment in the Phase 3 HEALOS trial, which
is being conducted in several European and Asian countries. The
trial aims to enroll approximately 255 patients with severe to
profound idiopathic sudden sensorineural hearing loss. Top-line
results from this trial are expected in the second half of 2017.
- Initiated the Phase 3 ASSENT trial, which is being conducted in
the US, Canada and South Korea. The trial aims to enroll
approximately 300 patients with severe to profound idiopathic
sudden sensorineural hearing loss. Top-line results from this trial
are expected in the first half of 2018.
Other Developments
- Appointed Thomas Jung, MD, PhD, as Chief Development Officer.
In this newly created position, Dr. Jung will lead the Company's
clinical, preclinical and pharmaceutical development activities. He
will join Auris Medical in September. Dr. Jung previously served as
the Chief Medical Officer at Delenex Therapeutics AG and spent 13
years at Novartis, most recently as Head, Translational Medicine
for the European Union.
- Received $12.5 million in financing from a loan facility
agreement with Hercules Capital, Inc.
Second Quarter 2016 Financial Results
- Cash and cash equivalents at June 30, 2016, totaled CHF 32.8
million, which does not include the $12.5 million received in July
2016 as part of the loan facility.
- Total operating expenses for the second quarter of 2016 were
CHF 9.0 million compared to CHF 9.7 million for the second quarter
of 2015.
- Research and development expenses for the second quarter of
2016 were CHF 7.3 million compared to CHF 8.8 million for the
second quarter of 2015.
- General and administrative expenses for the second quarter of
2016 were CHF 1.7 million compared to CHF 0.9 million for the
second quarter of 2015.
- Net loss for the second quarter of 2016 was CHF 8.43 million,
or CHF 0.25 per share, compared to CHF 10.96 million, or CHF 0.34
per share, for the second quarter of 2015. The net loss includes a
net unrealized foreign currency exchange gain of CHF 0.6 million in
the second quarter of 2016 compared to a foreign currency exchange
loss of CHF 1.2 million in the second quarter of 2015.
The Company continues to expect that its
operating expenses in 2016 will be in the range of CHF 33.0 to 38.0
million and believes that existing cash and cash equivalents,
including the $12.5 million loan, will enable the funding of
operations until year-end 2017.
Today's Conference Call & Webcast
Information
Auris Medical will host a conference call and
webcast to discuss the top-line results from the TACTT2 trial, the
second quarter 2016 financial results and to provide a general
business update today, August 18, 2016, at 8:00 am Eastern Time
(2:00 pm Central European Time). To participate in this conference
call, dial 1-877-280-3459 (USA) or +1-646-254-3387 (International),
and enter passcode 9451099. 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 Phase 3 development of treatments for acute inner
ear tinnitus (KeyzilenTM; AM-101) and for acute inner ear hearing
loss (AM-111) by way of intratympanic administration 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.
Company contact: Cindy McGee, Head of Investor
Relations and Corporate Communications, +41 61 201 13 50,
investors@aurismedical.com
Media contact: David Schull, Russo Partners, 1-858-717-2310,
david.schull@russopartnersllc.com
Auris Medical Holding AG Condensed Consolidated
Interim Statement of Loss and Other Comprehensive Loss (unaudited)
(in CHF)
|
|
THREE
MONTHS ENDED JUNE 30 |
|
SIX
MONTHS ENDED JUNE 30 |
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
Research and
development |
|
-7,278,563 |
|
-8,750,891 |
|
-13,418,738 |
|
-14,980,787 |
General and
administrative |
|
-1,725,114 |
|
-980,187 |
|
-2,947,146 |
|
-1,910,106 |
Operating
loss |
|
-9,003,677 |
|
-9,731,078 |
|
-16,365,884 |
|
-16,890,893 |
Interest income |
|
15,281 |
|
5,210 |
|
26,166 |
|
10,268 |
Interest expense |
|
-2,514 |
|
-2,540 |
|
-5,259 |
|
-4,604 |
Foreign currency
exchange gain/(loss), net |
|
558,908 |
|
-1,230,018 |
|
-985,937 |
|
-2,125,308 |
Loss before
tax |
|
-8,432,002 |
|
-10,958,426 |
|
-17,330,914 |
|
-19,010,537 |
Income tax expense |
|
- |
|
- |
|
- |
|
- |
Net loss
attributable to owners of the Company |
|
-8,432,002 |
|
-10,958,426 |
|
-17,330,914 |
|
-19,010,537 |
Other comprehensive
loss: |
|
|
|
|
|
|
|
|
Items that will
never be reclassified to |
|
|
|
|
|
|
|
|
profit or
loss |
|
|
|
|
|
|
|
|
Remeasurements of
defined benefit liability, net of taxes of CHF 0 |
|
-347,398 |
|
-306 |
|
-607,867 |
|
-229,170 |
Items that are or
may be reclassified to |
|
|
|
|
|
|
|
|
profit or
loss |
|
|
|
|
|
|
|
|
Foreign currency
translation differences, |
|
|
|
|
|
|
|
|
net of taxes of CHF
0 |
|
-15,856 |
|
38,501 |
|
25,964 |
|
56,863 |
Other comprehensive
(loss)/income, |
|
-363,254 |
|
38,195 |
|
-581,903 |
|
-172,307 |
net of taxes of CHF
0 |
|
|
|
|
Total comprehensive
loss attributable to owners of the Company |
|
-8,795,256 |
|
-10,920,231 |
|
-17,912,817 |
|
-19,182,844 |
Basic
and diluted loss per share |
|
-0.25 |
|
-0.34 |
|
-0.50 |
|
-0.62 |
Auris Medical Holding AG Condensed Consolidated
Interim Statement of Financial Position (unaudited) (in CHF)
|
|
JUNE 30, 2016 |
|
DECEMBER 31, 2015 |
|
|
|
ASSETS |
|
|
|
|
Non-current assets |
|
|
|
|
Property
and equipment |
|
185,324 |
|
222,570 |
Intangible
assets |
|
1,482,520 |
|
1,482,520 |
Other
non-current receivables |
|
38,066 |
|
38,066 |
Total
non-current assets |
|
1,705,910 |
|
1,743,156 |
|
|
|
|
|
Current
assets |
|
|
|
|
Other
receivables |
|
1,387,380 |
|
650,716 |
Prepayments |
|
17,789 |
|
181,044 |
Cash and
cash equivalents |
|
32,780,841 |
|
50,237,300 |
Total
current assets |
|
34,186,010 |
|
51,069,060 |
|
|
|
|
|
Total
assets |
|
35,891,920 |
|
52,812,216 |
|
|
|
|
|
|
|
|
|
|
Equity |
|
|
|
|
Share
capital |
|
13,731,881 |
|
13,721,556 |
Share
premium |
|
112,838,815 |
|
112,662,910 |
Foreign
currency translation reserve |
|
-37,858 |
|
-63,821 |
Accumulated
deficit |
|
-99,440,625 |
|
-81,578,733 |
Total
shareholders' equity attributable to owners of the Company |
|
27,092,213 |
|
44,741,912 |
|
|
|
|
|
Non-current liabilities |
|
|
|
|
Employee
benefits |
|
2,245,431 |
|
1,575,833 |
Deferred
tax liabilities |
|
327,637 |
|
327,637 |
Total
non-current liabilities |
|
2,573,068 |
|
1,903,470 |
|
|
|
|
|
Current
liabilities |
|
|
|
|
Trade and
other payables |
|
660,341 |
|
1,205,522 |
Accrued
expenses |
|
5,566,298 |
|
4,961,312 |
Total
current liabilities |
|
6,226,639 |
|
6,166,834 |
|
|
|
|
|
Total
liabilities |
|
8,799,707 |
|
8,070,304 |
|
|
|
|
|
Total
equity and liabilities |
|
35,891,920 |
|
52,812,216 |
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