- Progressing toward completed enrollment of the AM-111 Phase 3
HEALOS trial
- Key Opinion Leader event scheduled for June 16 in New York
City
- Conference call set for 8 am ET (2 pm CET) today
Zug, Switzerland, May 11, 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 first quarter ended March 31, 2017.
"The first quarter was one of continued progress
for all programs and recognition of the significant unmet medical
need of acute inner ear hearing loss with receipt of fast track
designation for AM-111. In addition, we recently announced results
from the AMPACT studies that confirm the long-term safety of
Keyzilen®," commented Thomas Meyer, Auris Medical's founder,
Chairman and Chief Executive Officer. "We are now moving toward key
development milestones that reflect our work to address what are
known as the big three otology disorders: hearing loss, tinnitus
and vertigo. For AM-111 in hearing loss, we expect to complete
enrollment of the Phase 3 HEALOS trial in the upcoming weeks.
Furthermore, we continue to progress with the Phase 3 Keyzilen®
TACTT3 trial for tinnitus and are preparing to initiate a second
Phase 1 trial for AM-125 in vertigo. We look forward to reviewing
these development programs at our Key Opinion Leader event on June
16 in New York City."
Development Program Updates
AM-111 for Acute Inner Ear Hearing Loss
- Received fast track designation from the U.S. Food and Drug
Administration (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 Europe and Asia. 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 and announce top-line
results from this trial in the fall of this year.
- Continued ramping up 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.
- Scheduled to host a scientific symposium at the 21st IFOS ENT
World Congress on June 26, 2017, in Paris, France. The symposium,
Recent Advances in the Treatment of Acute Hearing Loss, will
feature several experts in the field of hearing loss research.
Keyzilen® (AM-101) for
Acute Inner Ear Tinnitus
- Completed the AMPACT1 and AMPACT2 open-label extension studies
and reported results that confirm the long-term safety of
Keyzilen®. In addition, exploratory efficacy analyses further
support early treatment from onset of inner ear tinnitus and
suggest potential benefits of repeating treatment cycles. The
AMPACT studies were conducted at the request of the FDA to generate
safety data from chronic intermittent use of Keyzilen® for up
to 12 months.
- Progressed with 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.
AM-125 for 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.
- Progressed with plans to develop betahistine in a spray
formulation for the intranasal treatment of vertigo. Auris Medical
plans to initiate a second Phase 1 trial in 2017 to further test
the safety, tolerability and pharmacokinetics of AM-125.
Other Developments
- Elected Mats Blom, MBA, to the board of directors. He
currently serves as Senior Vice President and Chief Financial
Officer (CFO) of Zealand Pharma A/S. Prior to joining Zealand,
Blom was CFO of Swedish Orphan International, Active Biotech
AB and Anoto Group AB. He holds a BA in Business
Administration and Economics from the University of
Lund and an MBA from IESE University of
Navarra, Barcelona.
- 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 the end of this
year.
- Completed a public offering of 10,000,000 common shares and
11,350,000 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.
First Quarter 2017 Financial Results
- Cash and cash equivalents at March 31, 2017, totaled CHF 33.8
million.
- Total operating expenses for the first quarter of 2017 were CHF
7.4 million compared to CHF 7.4 million for the first quarter of
2016.
- Research and development expenses for the first quarter of 2017
were CHF 6.0 million compared to CHF 6.1 million for the first
quarter of 2016.
- General and administrative expenses for the first quarter of
2017 were CHF 1.4 million compared to CHF 1.2 million for the first
quarter of 2016.
- Net loss for the first quarter of 2017 was CHF 8.4 million, or
CHF 0.22 per share, compared to CHF 8.9 million, or CHF 0.26 per
share, for the first quarter of 2016.
The Company continues to expect that its operating
expenses in 2017 will be in the range of CHF 28 to 32 million and
that existing cash and cash equivalents will enable the funding of
operations into the first quarter of 2018.
Upcoming Events
- 18th Annual Bio€quity Europe, May 22-23, 2017, in Paris,
France
- World Tinnitus Congress and International Tinnitus Seminar, May
22-24, 2017, in Warsaw, Poland
- Auris Medical Key Opinion Leader Meeting, June 16, 2017, in New
York City, USA
- 21st IFOS ENT World Congress, June 24-28, 2017, in Paris,
France
Key Opinion Leader Meeting & Webcast
Scheduled for June 16, 2017
Auris Medical will host a Key Opinion Leader
breakfast at 8 am ET on Friday, June 16, 2017, in New York City.
The meeting will focus on Auris Medical's development-stage
pipeline and feature a keynote presentation by Elias Michaelides,
MD, who serves as Associate Professor of Surgery, Otolaryngology
and Director of the Hearing and Balance Program at Yale School of
Medicine.
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 2017 financial results and to
provide a general business update today, May 11, 2017, at 8 am ET
(2 pm CET). To participate in this conference call, dial
1-877-280-3459 (USA) or +1-646-254-3374 (International), and enter
passcode 5733572. 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 AGCondensed
Consolidated Interim Statement of Profit or Loss and Other
Comprehensive Loss (unaudited) For the Three Months Ended March
31, 2017 and 2016 (in CHF)
|
|
THREE MONTHSENDED MARCH 31 |
|
|
2017 |
|
2016 |
Research and
development |
|
(5,981,419) |
|
(6,140,175) |
General and
administrative |
|
(1,425,491) |
|
(1,222,032) |
Operating
loss |
|
(7,406,910) |
|
(7,362,207) |
Interest income |
|
31,297 |
|
10,885 |
Interest expense |
|
(421,435) |
|
(2,745) |
Foreign currency
exchange loss, net |
|
(338,160) |
|
(1,544,845) |
Revaluation gain from
derivative financial instruments |
|
233,123 |
|
- |
Transaction costs |
|
(506,234) |
|
- |
Loss before
tax |
|
(8,408,319) |
|
(8,898,912) |
Income tax gain |
|
8,191 |
|
- |
Net loss
attributable to owners of the Company |
|
(8,400,128) |
|
(8,898,912) |
Other comprehensive
loss: |
|
|
|
|
Items that will
never be reclassified to profit or loss |
|
|
|
|
Remeasurements of
defined benefit liability |
|
227,827 |
|
(260,469) |
Items that are or
may be reclassified to profit or loss |
|
|
|
|
Foreign currency
translation differences |
|
19,925 |
|
41,820 |
Other comprehensive
income/(loss) |
|
247,752 |
|
(218,649) |
Total comprehensive
loss attributable to owners of the Company |
|
(8,152,376) |
|
(9,117,561) |
Basic and diluted loss
per share |
|
(0.22) |
|
(0.26) |
AURIS MEDICAL HOLDING AG Condensed
Consolidated Interim Statement of Financial Position
(unaudited) (in CHF)
|
|
MARCH 31, 2017 |
|
DECEMBER 31,2016 |
|
|
|
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
Property and
equipment |
|
336,350 |
|
369,294 |
Intangible assets |
|
1,556,823 |
|
1,482,520 |
Other non-current
financial assets |
|
76,702 |
|
114,778 |
Total non-current
assets |
|
1,969,875 |
|
1,966,592 |
|
|
|
|
|
Current
assets |
|
|
|
|
Other receivables |
|
371,451 |
|
296,531 |
Prepayments |
|
877,280 |
|
952,595 |
Cash and cash
equivalents |
|
33,846,525 |
|
32,442,222 |
Total current
assets |
|
35,095,256 |
|
33,691,348 |
|
|
|
|
|
Total
assets |
|
37,065,131 |
|
35,657,940 |
|
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
|
Equity |
|
|
|
|
Share capital |
|
17,731,881 |
|
13,731,881 |
Share premium |
|
113,348,971 |
|
112,838,815 |
Foreign currency
translation reserve |
|
(63,619) |
|
(83,544) |
Accumulated
deficit |
|
(120,462,704) |
|
(112,344,303) |
Total shareholders'
equity attributable to owners of the Company |
|
10,554,529 |
|
14,142,849 |
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
Loan |
|
8,954,361 |
|
10,151,498 |
Derivative financial
instruments |
|
4,974,474 |
|
117,132 |
Employee benefits |
|
1,895,110 |
|
2,092,434 |
Deferred tax
liabilities |
|
188,391 |
|
196,582 |
Total non-current
liabilities |
|
16,012,336 |
|
12,557,646 |
|
|
|
|
|
Current
liabilities |
|
|
|
|
Loan |
|
3,295,145 |
|
2,212,706 |
Trade and other
payables |
|
2,094,386 |
|
1,837,997 |
Accrued expenses |
|
5,108,735 |
|
4,906,742 |
Total current
liabilites |
|
10,498,266 |
|
8,957,445 |
Total
liabilities |
|
26,510,602 |
|
21,515,091 |
Total equity and
liabilities |
|
37,065,131 |
|
35,657,940 |
Auris Medical (NASDAQ:EARS)
Gráfico Histórico do Ativo
De Set 2024 até Out 2024
Auris Medical (NASDAQ:EARS)
Gráfico Histórico do Ativo
De Out 2023 até Out 2024