Auris Medical Provides Business Update and Reports Second Quarter 2017 Financial Results
August 10 2017 - 6:31AM
- Phase 3 results from AM-111 HEALOS trial expected in fourth
quarter 2017
- Phase 3 results from Keyzilen® TACTT3 trial expected in first
quarter 2018
- Conference call set for 8 am EDT (2 pm CEST) today
Zug, Switzerland, August 10, 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 second quarter ended June 30, 2017.
"We continue to make great progress with our
clinical-stage pipeline, including the completed enrollment of our
AM-111 HEALOS trial in acute inner ear hearing loss and the ramp up
of our AM-125 program with intranasal betahistine for Meniere's
disease and other vestibular disorders," commented Thomas Meyer,
Auris Medical's founder, Chairman and Chief Executive Officer.
"Now, we are moving toward initiating a second Phase 1 trial for
AM-125, completing enrollment of the Keyzilen® Phase 3 TACTT3 trial
in tinnitus and announcing top-line Phase 3 results from the HEALOS
trial. With positive HEALOS results, AM-111 has the potential to
become the first-in-class treatment for acute inner ear hearing
loss."
Development Program Updates
- Hosted an investor and analyst event in New York City
focused on Auris Medical's clinical-stage pipeline. The
presentation highlighted AM-125 and the upcoming Phase 3 data
readouts for AM-111 and Keyzilen®.
AM-111 for Acute Inner Ear Hearing Loss
- Completed enrollment in the Phase 3 HEALOS trial, which is
being conducted in Europe and Asia. The trial enrolled 256 patients
with severe to profound idiopathic sudden sensorineural hearing
loss. Auris Medical expects to announce top-line results from
HEALOS in the fourth quarter 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 ASSENT in the second half of
2018.
- Hosted a scientific symposium at the 21st IFOS ENT World
Congress in Paris. The symposium, Recent Advances in the Treatment
of Acute Hearing Loss, featured 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 of inner ear tinnitus and suggest potential
benefits of repeating treatment cycles. The AMPACT studies were
conducted at the request of the U.S. Food and Drug Administration
(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). Additional patients are now being enrolled in each
stratum. Auris Medical expects to complete enrollment in the third
quarter of 2017 and announce top-line results from TACTT3 in early
2018.
AM-125 for Meniere's Disease and Other
Vestibular Disorders
- Completed the acquisition of various assets related to
intranasal betahistine from Otifex Therapeutics Ltd. In addition,
Auris Medical obtained from an undisclosed party the right to use
certain proprietary preclinical and clinical data that will support
the AM-125 development program and future regulatory filings.
- Progressed with plans to initiate a second Phase 1 trial in the
fourth quarter of 2017 to further test the safety, tolerability and
pharmacokinetics of AM-125. In a Phase 1 trial conducted by Otifex,
intranasal betahistine showed good tolerance and a significantly
higher bioavailability than reported for oral betahistine
administration.
- Established a Scientific Advisory Board for AM-125 comprised of
global leaders in the field of vestibular disorders. The members
are Elias Michaelides, MD; Michael Strupp, MD; Hinrich Staecker,
MD, PhD; and Paul Van de Heyning, MD, PhD.
- Scheduled to host a symposium during the American Academy of
Otolaryngology-Head and Neck Surgery Foundation Annual
Meeting & OTO Experience on September 11, 2017,
in Chicago. The symposium, Targeting Histamine Receptors
for Vertigo Therapy, will feature several experts in the field of
vestibular disorders.
Second Quarter 2017 Financial Results
- Cash and cash equivalents at June 30, 2017, totaled CHF 26.2
million.
- Total operating expenses for the second quarter of 2017 were
CHF 6.0 million compared to CHF 9.0 million for the second quarter
of 2016.
- Research and development expenses for the second quarter of
2017 were CHF 4.7 million compared to CHF 7.3 million for the
second quarter of 2016.
- General and administrative expenses for the second quarter of
2017 were CHF 1.2 million compared to CHF 1.7 million for the
second quarter of 2016.
- Net loss for the second quarter of 2017 was CHF 5.4 million, or
CHF 0.12 per share, compared to CHF 8.4 million, or CHF 0.25 per
share, for the second 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
- American Academy of Otolaryngology-Head and Neck
Surgery Foundation Annual Meeting & OTO Experience, September
10-13, 2017, Chicago, Illinois
- LEERINK Partners Roundtable Series: Rare Disease &
Immuno-Oncology, September 27-28, 2017, New York, New York
Today's Conference Call & Webcast
Information
Auris Medical will host a conference call and
webcast to discuss the second quarter 2017 financial results and to
provide a general business update today, August 10, 2017, at 8 am
EDT (2 pm CEST). To participate in this conference call, dial
1-877-280-1254 (USA) or +1-212-444-0896 (International), and enter
passcode 1366409. 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 neurotology. 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 developing intranasal betahistine for
Meniere's disease and other vestibular disorders (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, Auris Medical's need for and ability to raise
substantial additional funding to continue the development of its
product candidates, 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 and Six Months
Ended June 30, 2017 and 2016 (in CHF)
|
|
THREE MONTHSENDED JUNE 30 |
|
SIX MONTHSENDED JUNE 30 |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Research and
development |
|
(4,722,899) |
|
(7,278,563) |
|
(10,704,318) |
|
(13,418,738) |
General and
administrative |
|
(1,235,665) |
|
(1,725,114) |
|
(2,661,156) |
|
(2,947,146) |
Operating
loss |
|
(5,958,564) |
|
(9,003,677) |
|
(13,365,474) |
|
(16,365,884) |
Interest income |
|
13,124 |
|
15,281 |
|
45,775 |
|
26,166 |
Interest expense |
|
(410,009) |
|
(2,514) |
|
(831,444) |
|
(5,259) |
Foreign currency
exchange (loss)/gain, net |
|
(592,876) |
|
558,908 |
|
(931,036) |
|
(985,937) |
Revaluation gain from
derivative financial instruments |
|
1,528,862 |
|
- |
|
1,760,631 |
|
- |
Transaction costs |
|
- |
|
- |
|
(506,234) |
|
- |
Loss before
tax |
|
(5,419,463) |
|
(8,432,002) |
|
(13,827,782) |
|
(17,330,914) |
Income tax gain |
|
8,191 |
|
- |
|
16,382 |
|
- |
Net loss
attributable to owners of the Company |
|
(5,411,272) |
|
(8,432,002) |
|
(13,811,400) |
|
(17,330,914) |
Other comprehensive
loss: |
|
|
|
|
|
|
|
|
Items that will
never be reclassified toprofit or loss |
|
|
|
|
|
|
|
|
Remeasurement of
defined benefit liability, net of taxes of CHF 0 |
|
55,810 |
|
(347,398) |
|
283,637 |
|
(607,867) |
Items that are or
may be reclassified toprofit or loss |
|
|
|
|
|
|
|
|
Foreign currency
translation differences, net of taxes of CHF 0 |
|
39,985 |
|
(15,856) |
|
59,910 |
|
25,964 |
Other comprehensive
income/(loss),net of taxes of CHF 0 |
|
95,795 |
|
(363,254) |
|
343,547 |
|
(581,903) |
Total comprehensive
loss attributableto owners of the Company |
|
(5,315,477) |
|
(8,795,256) |
|
(13,467,853) |
|
(17,912,817) |
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share |
|
(0.12) |
|
(0.25) |
|
(0.33) |
|
(0.50) |
AURIS MEDICAL HOLDING AG Condensed
Consolidated Interim Statement of Financial Position
(unaudited) (in CHF)
|
|
JUNE 30, 2017 |
|
DECEMBER 31,2016 |
|
|
|
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
Property and
equipment |
|
304,344 |
|
369,294 |
Intangible assets |
|
1,556,823 |
|
1,482,520 |
Other non-current
financial assets |
|
76,701 |
|
114,778 |
Total non-current
assets |
|
1,937,868 |
|
1,966,592 |
|
|
|
|
|
Current
assets |
|
|
|
|
Other receivables |
|
320,495 |
|
296,531 |
Prepayments |
|
570,769 |
|
952,595 |
Cash and cash
equivalents |
|
26,238,868 |
|
32,442,222 |
Total current
assets |
|
27,130,132 |
|
33,691,348 |
|
|
|
|
|
Total
assets |
|
29,068,000 |
|
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 |
|
(23,634) |
|
(83,544) |
Accumulated
deficit |
|
(125,716,556) |
|
(112,344,303) |
Total shareholders'
equity attributable to owners of the Company |
|
5,340,662 |
|
14,142,849 |
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
Loan |
|
7,624,868 |
|
10,151,498 |
Derivative financial
instruments |
|
3,446,965 |
|
117,132 |
Employee benefits |
|
1,873,797 |
|
2,092,434 |
Deferred tax
liabilities |
|
180,200 |
|
196,582 |
Total non-current
liabilities |
|
13,125,830 |
|
12,557,646 |
|
|
|
|
|
Current
liabilities |
|
|
|
|
Loan |
|
4,274,327 |
|
2,212,706 |
Trade and other
payables |
|
1,178,347 |
|
1,837,997 |
Accrued expenses |
|
5,148,834 |
|
4,906,742 |
Total current
liabilities |
|
10,601,508 |
|
8,957,445 |
Total
liabilities |
|
23,727,338 |
|
21,515,091 |
Total equity and
liabilities |
|
29,068,000 |
|
35,657,940 |
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