- Results from first AM-111 Phase 3 trial expected in third
quarter of 2017
- Addition of AM-125 expands clinical-stage pipeline into
vestibular disorders
- Conference call set for 8 am ET (1 pm CET) today
Zug, Switzerland, March 14, 2017 - 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 full year ended December 31, 2016.
"We are proud to be leading the charge in the development of
new, much-needed therapies for inner ear disorders," commented
Thomas Meyer, Auris Medical's founder, Chairman and Chief Executive
Officer. "We are moving toward the upcoming Phase 3 results from
the AM-111 HEALOS trial for acute inner hearing loss while also
progressing with Keyzilen®, our late-stage tinnitus program.
Furthermore, we are finalizing our plans for AM-125 in Meniere's
disease and vestibular vertigo and look forward to initiating a
second Phase 1 trial later this year. With the addition of AM-125,
we have built a broad, diverse pipeline of drug candidates that
present multiple opportunities for Auris Medical to help
patients."
Development Program Updates
AM-111 for Acute Inner Ear Hearing Loss
- Received fast track designation from the FDA for AM-111 in
acute sensorineural (inner ear) hearing loss, highlighting the
seriousness of the condition as well as the unmet medical
need.
- 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. Auris
Medical expects to complete enrollment in the second quarter of
2017 and announce top-line results from this trial in the third
quarter of 2017.
- Continued ramp-up of 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. Auris Medical expects
to announce top-line results from this trial in the second half of
2018.
Keyzilen® (AM-101) for Acute Inner Ear Tinnitus
- Resumed enrollment in the Phase 3 TACTT3 trial, which is being
conducted in Europe. The trial previously enrolled more than 300
patients during the acute tinnitus stage (Stratum A) and
approximately 330 patients during the post-acute tinnitus stage
(Stratum B). An additional 60 patients are now being enrolled in
each stratum. Auris Medical expects to announce top-line results
from the expanded trial in early 2018.
- Completed the AMPACT open-label studies, which evaluated the
long-term safety of Keyzilen®. Auris Medical expects to announce
results from these studies in the second quarter of 2017.
AM-125 for Meniere's Disease and Vestibular Vertigo
- Entered into an agreement with Otifex Therapeutics Pty. Ltd. to
purchase various assets related to intranasal betahistine,
including preclinical and clinical data as well as certain
intellectual property rights. In a Phase 1 trial conducted by
Otifex, intranasal betahistine showed good tolerance and a
significantly higher bioavailability than reported for oral
betahistine administration.
- Under the product code AM-125, Auris Medical is developing
betahistine in a spray formulation for the intranasal treatment of
Meniere's disease and vestibular vertigo. Oral betahistine is
approved for the treatment of Meniere's disease and vestibular
vertigo and marketed in more than 80 countries worldwide. Auris
Medical plans to initiate a second Phase 1 trial in
2017.
Other Developments
- Extended the AM-102 King's College London collaboration, which
is focused on the discovery of small molecule compounds for a
second-generation tinnitus treatment. Auris Medical expects to
select a lead compound by year-end 2017.
- Completed a public offering of 10,000,000 common shares and
10,000,000 warrants with net proceeds of $9.1 million. The common
shares and warrants were sold in units comprised of one common
share and one warrant at the price of $1.00 per unit. Each warrant
entitles its holder to purchase 0.70 of a common share at the price
of $1.20 per share.
- Anne Sabine Zoller, who has served as Auris Medical's General
Counsel since 2015, has decided to leave the Company in the coming
months to pursue another opportunity.
Full Year 2016 Financial Results
- Cash and cash equivalents totaled CHF 32.4 million at December
31, 2016, which does not include the $9.1 million of net proceeds
received from the February 2017 public offering.
- Total operating expenses for 2016 were CHF 30.2 million
compared to CHF 30.9 million for 2015.
- Research and development expenses for 2016 were CHF 24.8
million compared to CHF 26.5 million for 2015.
- General and administrative expenses for 2016 were CHF 5.4
million compared to CHF 4.3 million for 2015.
- Net loss for 2016 was CHF 30.7 million, or CHF 0.89 per share,
compared to CHF 29.7 million, or CHF 0.92 per share, for 2015.
Auris Medical expects that its operating expenses in 2017 will
be in the range of CHF 28.0 to 32.0 million. With the proceeds from
the February 2017 offering, the Company's cash runway has been
extended into the first quarter of 2018.
Annual General Meeting
Auris Medical's Annual General Meeting will take place in Zug,
Switzerland, on April 13, 2017, at 10:00 am CET. At the meeting,
the Company will propose the re-election of its current members of
the Board of Directors with the exception of Professor Wolfgang
Arnold and James I. Healy. The Board of Directors proposes the
election of Mats Blom as a new Board member.
Mats Blom is Senior Vice President and Chief Financial Officer
(CFO) of Zealand Pharma A/S. Prior to joining Zealand, he served as
CFO of Swedish Orphan International, an orphan drug company
acquired by BioVitrum in 2009. In addition, Mr. Blom has extensive
managerial experience and has held CFO positions at Active Biotech
AB and Anoto Group AB. Previously, he served as a management
consultant at Gemini Consulting and Ernst & Young. Mats Blom
holds a BA in Business Administration and Economics from the
University of Lund and an MBA from IESE University of Navarra,
Barcelona.
"We would like to thank Wolfgang Arnold and James Healy for
their great contribution to our Board of Directors," Thomas Meyer
said. "At the same time, we are delighted to propose the election
of Mats Blom to our Board of Directors. Mats has built a great
track record in key roles with several innovative European biotech
and pharmaceutical companies and will provide great support as we
advance our clinical-stage programs and move toward
commercialization."
Auris Medical's Annual Report on Form 20-F for the year ended
December 31, 2016 was filed with the Securities and Exchange
Commission. A copy of the Annual Report and the agenda for
the Annual General Meeting is available on the Company's website
www.aurismedical.com in the Investors section.
Today's Conference Call & Webcast Information
Auris Medical will host a conference call and webcast to discuss
the full year 2016 financial results and to provide a general
business update today, March 14, 2017, at 8:00 am ET (1:00 pm CET).
To participate in this conference call, dial 1-877-280-3488 (USA)
or +1-646-254-3372 (International), and enter passcode 7503630. A
live webcast of the conference call will be available in the
Investors 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 focused on the
Phase 3 development of treatments for acute inner ear hearing loss
(AM-111) and for acute inner ear tinnitus (Keyzilen®; AM-101) by
way of intratympanic administration with biocompatible gel
formulations. In addition, Auris Medical is pursuing intranasal
betahistine for Meniere's disease and vestibular vertigo (AM-125)
as well as early-stage research and development projects. The
Company was founded in 2003 and is headquartered in Zug,
Switzerland. The shares of 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, prevailing market conditions, whether the Company
will consummate the offering of shares and warrants on the expected
terms, or at all, the satisfaction of closing conditions related to
the offering and risks related to the application of the net
proceeds, if any, from the offering. There can be no assurance that
the Company will be able to complete the offering at the
anticipated size or on the anticipated terms, or at all. In any
event, the Company may continue to need additional funding and may
be unable to raise capital when needed, which could force the
Company to delay, reduce or eliminate its product development
programs or commercialization efforts. Other risks and
uncertainties relating to the Company's business include the timing
and conduct of clinical trials of Auris Medical's product
candidates, including the likelihood that the TACTT3 clinical trial
with Keyzilen® 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 1350,
investors@aurismedical.com
Media contact: David Schull, Russo Partners,
1-858-717-2310,david.schull@russopartnersllc.com
AURIS MEDICAL HOLDING AGConsolidated
Statement of Profit or Loss and Other Comprehensive Loss For
the Years Ended December 31, 2016 and 2015 (in CHF)
|
|
|
|
2016 |
|
2015 |
|
|
Research and
development |
|
|
|
(24,776,763) |
|
(26,536,176) |
|
|
General and
administrative |
|
|
|
(5,446,512) |
|
(4,341,570) |
|
|
Operating
loss |
|
|
|
(30,223,275) |
|
(30,877,746) |
|
|
Interest income |
|
|
|
67,565 |
|
36,562 |
|
|
Interest expense |
|
|
|
(828,547) |
|
(7,985) |
|
|
Foreign currency
exchange gain/(loss), net |
|
|
|
(100,097) |
|
1,144,106 |
|
|
Revaluation gain from
derivative financial instruments |
|
|
|
291,048 |
|
- |
|
|
Loss before
tax |
|
|
|
(30,793,306) |
|
(29,705,063) |
|
|
Income tax gain |
|
|
|
131,055 |
|
- |
|
|
Net loss
attributable to owners of theCompany |
|
|
|
(30,662,251) |
|
(29,705,063) |
|
|
Other comprehensive
loss: |
|
|
|
|
|
|
|
|
Items that will
never be reclassified toprofit or loss |
|
|
|
|
|
|
|
|
Remeasurement of
defined benefit liability, |
|
|
|
|
|
|
|
|
net of taxes of CHF
0 |
|
|
|
(394,102) |
|
(53,916) |
|
|
Items that are or
may be reclassified toprofit or loss |
|
|
|
|
|
|
|
|
Foreign currency
translation differences, |
|
|
|
|
|
|
|
|
net of taxes of CHF
0 |
|
|
|
(19,723) |
|
(12,712) |
|
|
Other comprehensive
loss,net of taxes of CHF 0 |
|
|
|
(413,825) |
|
(66,628) |
|
|
Total comprehensive
loss attributableto owners of the Company |
|
|
|
(31,076,076) |
|
(29,771,691) |
|
|
Basic and diluted loss
per share |
|
|
|
(0.89) |
|
(0.92) |
|
|
AURIS MEDICAL HOLDING AG Consolidated
Statement of Financial Position (in CHF)
|
|
|
|
December 31,2016 |
|
December 31,2015 |
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
Non-current
assets |
|
|
|
|
|
|
Property and
equipment |
|
|
|
369,294 |
|
222,570 |
Intangible assets |
|
|
|
1,482,520 |
|
1,482,520 |
Other non-current
receivables |
|
|
|
114,778 |
|
38,066 |
Total non-current
assets |
|
|
|
1,966,592 |
|
1,743,156 |
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
Other receivables |
|
|
|
296,531 |
|
650,716 |
Prepayments |
|
|
|
952,595 |
|
181,044 |
Cash and cash
equivalents |
|
|
|
32,442,222 |
|
50,237,300 |
Total current
assets |
|
|
|
33,691,348 |
|
51,069,060 |
|
|
|
|
|
|
|
Total
assets |
|
|
|
35,657,940 |
|
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 |
|
|
|
(83,544) |
|
(63,821) |
Accumulated
deficit |
|
|
|
(112,344,303) |
|
(81,578,733) |
Total shareholders'
equity attributable to owners of the Company |
|
|
|
14,142,849 |
|
44,741,912 |
|
|
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
|
|
Loan |
|
|
|
10,151,498 |
|
- |
Derivative financial
instruments |
|
|
|
117,132 |
|
- |
Employee benefits |
|
|
|
2,092,434 |
|
1,575,833 |
Deferred tax
liabilities |
|
|
|
196,582 |
|
327,637 |
Total non-current
liabilities |
|
|
|
12,557,646 |
|
1,903,470 |
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
Loan |
|
|
|
2,212,706 |
|
- |
Trade and other
payables |
|
|
|
1,837,997 |
|
1,205,522 |
Accrued expenses |
|
|
|
4,906,742 |
|
4,961,312 |
Total current
liabilities |
|
|
|
8,957,445 |
|
6,166,834 |
Total
liabilities |
|
|
|
21,515,091 |
|
8,070,304 |
Total equity and
liabilities |
|
|
|
35,657,940 |
|
52,812,216 |
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