Auris Medical Provides Business Update and Reports Third Quarter 2016 Financial Results
November 10 2016 - 6:30AM
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 third quarter ended Sept.
30, 2016.
“We are focused on the efficient execution of
our two Phase 3 programs for acute inner ear hearing loss and
tinnitus,” commented Thomas Meyer, Auris Medical’s founder,
Chairman and Chief Executive Officer. “With AM-111 for acute inner
ear hearing loss, we continue to progress with enrollment for
the HEALOS trial and expect top-line results in the second half of
next year. As we communicated recently for the KeyzilenTM program
for acute inner ear tinnitus, we are implementing changes to the
TACTT3 protocol based on findings from TACTT2 and working toward
continuation of patient enrollment. We very much appreciate the
continued strong interest and encouragement from the tinnitus
community and remain fully committed to bringing KeyzilenTM to
patients.”
Development Program Updates
AM-111 for Acute Inner Ear Hearing
Loss
- Surpassed the enrollment midpoint 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 as
per previous guidance.
- Continued ramp-up of the Phase 3 ASSENT trial, which is being
conducted in the U.S., 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.
KeyzilenTM (AM-101) for Acute Inner Ear
Tinnitus
- Announced additional results from the Phase 3 TACTT2 trial.
Although the trial did not meet its co-primary efficacy endpoints,
the data show greater improvements as compared to placebo in the
Tinnitus Functional Index (TFI) for active-treated patients who
suffered from tinnitus following otitis media and who suffered from
severe or extreme tinnitus.
- Submitted a protocol amendment to regulatory agencies in Europe
for the TACTT3 trial. Under the amendment, the TFI will be elevated
from a key secondary endpoint to an alternate primary endpoint,
patient subgroups (for patients with tinnitus following otitis
media and patients with severe or extreme tinnitus), will be
included in confirmatory testing and 60 additional patients will be
recruited in each of Stratum A and Stratum B. Auris Medical expects
to resume enrollment in the TACTT3 trial in early 2017 and announce
top-line results from the expanded trial in early 2018.
- Prepared for a Type C Meeting with the U.S. Food and Drug
Administration scheduled for early December 2016. Auris Medical
seeks feedback from the FDA on the outcomes from the TACTT2 trial,
the changes to the TACTT3 protocol and the regulatory path forward.
- Participated in the 2016 Annual Meeting & OTO EXPOSM of the
American Academy of Otolaryngology-Head and Neck Surgery Foundation
(AAO-HNSF) in San Diego. During the meeting, Hinrich Staecker, MD,
PhD, presented the favorable safety outcomes from the TACTT2 trial,
and Auris Medical hosted a corporate symposium featuring several
experts in the field of tinnitus research.
Management Team Update
- Appointed Hernan Levett as Chief Financial Officer. Mr. Levett
will join Auris Medical in January 2017. He is currently Head of
Group Controlling at Acino Pharma AG and previously served as Vice
President of Finance and Administration Europe at InterMune
International AG. In addition, he spent 10 years at Novartis, most
recently as Chief Financial Officer of Novartis Chile SA.
Third Quarter 2016 Financial
Results
- Cash and cash equivalents at Sept. 30, 2016, totaled CHF 37.5
million.
- Total operating expenses for the third quarter of 2016 were CHF
7.5 million compared to CHF 7.2 million for the third quarter of
2015.
- Research and development expenses for the third quarter of 2016
were CHF 6.3 million compared to CHF 5.9 million for the third
quarter of 2015.
- General and administrative expenses for the third quarter of
2016 were CHF 1.2 million compared to CHF 1.3 million for the third
quarter of 2015.
- Net loss for the third quarter of 2016 was CHF 7.9 million, or
CHF 0.23 per share, compared to CHF 5.2 million, or CHF 0.15 per
share, for the third quarter of 2015. Net loss for the third
quarter of 2016 includes interest expense of 0.4 million payable
under the loan agreement with Hercules Capital, Inc., and a net
unrealized foreign currency exchange loss of CHF 0.2 million, which
compares to a foreign currency exchange gain of CHF 2.0 million in
the third 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. Existing cash and cash equivalents are expected to enable
the funding of operations until fall 2017.
Today’s Conference Call & Webcast
Information
Auris Medical will host a conference call and
webcast to discuss the third quarter 2016 financial results and to
provide a general business update today, Nov. 10, 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 +1-646-254-3373
(International), and enter passcode 6069780. 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, including the likelihood that the
TACTT3 clinical trial with KeyzilenTM 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.
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 AGCondensed Consolidated Interim Statement of Loss and
Other Comprehensive Loss (unaudited)(in CHF) |
|
|
|
|
|
THREE MONTHS
ENDED SEPTEMBER 30, |
|
NINE MONTHS
ENDED SEPTEMBER 30, |
|
2016 |
|
2015 |
|
2016 |
|
2015 |
Research and
development |
-6,344,600 |
|
-5,884,313 |
|
-19,763,338 |
|
-20,865,100 |
General and
administrative |
-1,197,541 |
|
-1,326,750 |
|
-4,144,687 |
|
-3,236,856 |
Operating
loss |
-7,542,141 |
|
-7,211,063 |
|
-23,908,025 |
|
-24,101,956 |
Interest income |
18,118 |
|
12,873 |
|
44,284 |
|
23,141 |
Interest expense |
-404,453 |
|
-1,608 |
|
-409,712 |
|
-6,212 |
Foreign currency
exchange gain/(loss), net |
-191,687 |
|
1,988,870 |
|
-1,177,624 |
|
-136,438 |
Revaluation gain/(loss)
from derivative financial instrument |
228,190 |
|
- |
|
228,190 |
|
- |
Loss before
tax |
-7,891,973 |
|
-5,210,928 |
|
-25,222,887 |
|
-24,221,465 |
Income tax expense |
- |
|
- |
|
- |
|
- |
Net loss
attributable to owners of the |
|
|
|
|
|
|
|
Company |
-7,891,973 |
|
-5,210,928 |
|
-25,222,887 |
|
-24,221,465 |
Other
comprehensive loss: |
|
|
|
|
|
|
|
Items that will
never be reclassified to |
|
|
|
|
|
|
|
profit or
loss |
|
|
|
|
|
|
|
Remeasurement of
defined benefit liability, |
23,412 |
|
-3,792 |
|
-584,455 |
|
-232,962 |
net of taxes of CHF
0 |
|
|
|
|
|
|
|
Items that are
or may be reclassified to |
|
|
|
|
|
|
|
profit or
loss |
|
|
|
|
|
|
|
Foreign currency
translation differences, |
5,968 |
|
-40,524 |
|
31,932 |
|
16,339 |
net of taxes of CHF
0 |
|
|
|
|
|
|
|
Other
comprehensive income/(loss), |
29,380 |
|
-44,316 |
|
-552,523 |
|
-216,623 |
net of taxes of
CHF 0 |
|
|
|
|
|
|
|
Total
comprehensive loss attributable to owners of the
Company |
-7,862,593 |
|
-5,255,244 |
|
-25,775,410 |
|
-24,438,088 |
Basic and diluted loss
per share |
-0.23 |
|
-0.15 |
|
-0.73 |
|
-0.76 |
|
|
|
|
Auris Medical
Holding AGCondensed Consolidated Interim Statement of Financial
Position (unaudited)(in CHF) |
|
|
|
|
|
|
SEPTEMBER 30, 2016 |
DECEMBER 31, 2015 |
|
|
ASSETS |
|
|
|
Non-current
assets |
|
|
|
Property and
equipment |
|
161,960 |
222,570 |
Intangible assets |
|
1,482,520 |
1,482,520 |
Other non-current
receivables |
|
114,766 |
38,066 |
Total
non-current assets |
|
1,759,246 |
1,743,156 |
|
|
|
|
Current
assets |
|
|
|
Other receivables |
|
1,449,480 |
650,716 |
Prepayments |
|
261,669 |
181,044 |
Cash and cash
equivalents |
|
37,526,723 |
50,237,300 |
Total current
assets |
|
39,237,872 |
51,069,060 |
|
|
|
|
Total
assets |
|
40,997,118 |
52,812,216 |
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
Equity |
|
|
|
Share capital |
|
13,731,881 |
13,721,556 |
Share premium |
|
112,838,815 |
112,662,910 |
Foreign currency
translation reserve |
|
-31,889 |
-63,821 |
Accumulated
deficit |
|
-107,201,111 |
-81,578,733 |
Total
shareholders’ equity attributable to owners of the
Company |
|
19,337,696 |
44,741,912 |
|
|
|
|
Non-current
liabilities |
|
|
|
Loan |
|
10,630,681 |
- |
Derivative financial
instrument |
|
177,650 |
- |
Employee benefits |
|
2,250,936 |
1,575,833 |
Deferred tax
liabilities |
|
327,637 |
327,637 |
Total
non-current liabilities |
|
13,386,904 |
1,903,470 |
|
|
|
|
Current
liabilities |
|
|
|
Loan |
|
1,042,736 |
- |
Trade and other
payables |
|
1,613,602 |
1,205,522 |
Accrued expenses |
|
5,616,180 |
4,961,312 |
Total current
liabilities |
|
8,272,518 |
6,166,834 |
Total
liabilities |
|
21,659,422 |
8,070,304 |
Total equity
and liabilities |
|
40,997,118 |
52,812,216 |
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