Auris Medical Reports Third Quarter 2017 Financial Results and Provides Business Update
November 28 2017 - 6:40AM
- HEALOS trial with AM-111 did not meet the primary efficacy
endpoint, but showed statistically and clinically significant
effect in profound acute hearing loss subpopulation
- Phase 3 results from Keyzilen® TACTT3 trial expected in first
quarter of 2018
- Conference call and live webcast set for 8:00 am ET (2:00 pm
CET) today
Zug, Switzerland, November 28, 2017 - Auris
Medical Holding AG (NASDAQ: EARS), a clinical-stage company
dedicated to developing therapeutics that address important unmet
medical needs in otolaryngology, today announced financial results
for the third quarter ended September 30, 2017 and provided a
business update.
"The read-out from the HEALOS Phase 3 trial with
AM-111 in acute inner ear hearing loss is a major milestone for
Auris," commented Thomas Meyer, Auris Medical's founder, Chairman
and Chief Executive Officer. "Although the trial did not meet our
expectations on the primary efficacy endpoint in the overall study
population, we are very pleased to see the statistically and
clinically significant treatment effects in the profound hearing
loss subpopulation. Considering the high unmet medical need, we
look forward to discussing the regulatory pathway for AM-111 with
the regulatory agencies. In addition, we continue to focus on the
development of Keyzilen® for acute inner ear tinnitus, with
top-line Phase 3 results expected in early 2018, and AM-125 for
vertigo, which is preparing for Phase 1."
Development Program Updates
AM-111 for Acute Inner Ear Hearing
Loss
- Reported top-line data from HEALOS, a randomized
placebo-controlled Phase 3 clinical trial with AM-111 in patients
suffering from severe to profound sudden deafness. Overall, the
trial did not meet the primary efficacy endpoint of a statistically
significant improvement in hearing from baseline to Day 28 compared
to placebo for either the AM-111 0.4 mg/mL or AM-111 0.8 mg/mL
treatment groups. The mean hearing improvement was 38.4 dB for
patients in the AM-111 0.4 mg/mL group compared to 33.4 dB for the
placebo group (p=0.226). For patients in the AM-111 0.8 mg/mL group
the mean improvement was 36.6 dB (p=0.448).
- A post-hoc analysis of the subpopulation with profound acute
hearing loss (i.e. mean hearing threshold of 90 dB or higher; n=98)
revealed a clinically relevant and statistically significant
improvement in the AM-111 0.4 mg/mL treatment group. The
improvement at Day 28 was 42.7 dB in the AM-111 0.4 mg/mL group vs.
26.8 dB in the placebo group (p=0.0176). In the AM-111 0.8 mg/mL
group the improvement was 37.3 dB (p=0.126).
- AM-111 was well tolerated in the HEALOS trial, and the primary
safety endpoint was met. There was no significant difference in the
occurrence of clinically relevant hearing deterioration between
either of the active treated groups and the placebo group at Day
28.
- The Company plans to discuss the HEALOS results and the
regulatory pathway with health authorities. In addition, the
Company will terminate the ASSENT trial early as it is very similar
in design to the HEALOS trial and, based on the new findings, is no
longer adequate for testing AM-111.
Keyzilen® (AM-101) for Acute Inner Ear
Tinnitus
- Completed patient recruitment for the Phase 3 TACTT3 trial,
which is being conducted in Europe. In total, the trial enrolled
741 patients; 373 patients were enrolled within the first three
months from tinnitus onset (acute stage) and 368 patients were
enrolled between three to twelve months from onset (post-acute
stage). Auris Medical expects to announce top-line results from
TACTT3 in the first quarter of 2018.
AM-125 for Vertigo
- 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.
- Received regulatory feedback from the U.S. Food and Drug
Administration through a Pre-IND meeting and from two European
health authorities. The feedback is being incorporated in the
Company's development plans for AM-125, including the planned
second Phase 1 clinical trial with AM-125. The study is expected to
start enrolling patients during the first quarter of 2018 and will
seek to determine the maximum tolerated dose with single and
repeated dosing.
- Hosted a symposium, Targeting Histamine Receptors for Vertigo
Therapy, during the American Academy of Otolaryngology-Head and
Neck Surgery Foundation Annual Meeting & OTO Experience on
September 11, 2017, in Chicago.
Corporate Developments
- Executed share purchase agreements with Lincoln Park Capital
Fund, LLC for up to $15.0 million to provide additional
operational flexibility.
Other Developments
- Thomas Jung, MD, PhD, who joined Auris Medical in 2016 as Chief
Development Officer, has decided to leave the Company by the end of
the year to pursue a new career
opportunity.
Third Quarter 2017 Financial Results
- Cash and cash equivalents at September 30, 2017, totaled CHF
20.2 million.
- Total operating expenses for the third quarter of 2017 were CHF
5.6 million compared to CHF 7.5 million for the third quarter of
2016.
- Research and development expenses for the third quarter of 2017
were CHF 4.2 million compared to CHF 6.3 million for the third
quarter of 2016.
- General and administrative expenses for the third quarter of
2017 were CHF 1.3 million compared to CHF 1.2 million for the third
quarter of 2016.
- Net loss for the third quarter of 2017 was CHF 6.0 million, or
CHF 0.14 per share, compared to CHF 7.9 million, or CHF 0.23 per
share, for the third quarter of 2016.
The Company expects that its operating expenses
in 2017 will be lower than the previous guidance of CHF 28 to 32
million and that existing cash and cash equivalents will enable the
funding of operations into the second quarter of 2018.
Conference Call & Webcast
Information
Auris Medical will host a conference call and
webcast to discuss the top-line results from the HEALOS trial, the
third quarter 2017 financial results and to provide a general
business update today, November 28, 2017, at 8:00 am Eastern Time
(2:00 pm Central European Time). To participate in this conference
call, dial 1-877-280-1254 (USA) or +1-646-254-3365 (International),
and enter passcode 4997511. 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 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 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 Capital 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 facts 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", or the negative of these terms or 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 for the year ended December 31, 2016, and in Auris
Medical's other filings with the SEC, which are available free of
charge on the Securities Exchange Commission's website at:
www.sec.gov. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect,
actual results may vary materially from those indicated. All
forward-looking statements and all subsequent written and oral
forward-looking statements attributable to Auris Medical or to
persons acting on behalf of Auris Medical are expressly qualified
in their entirety by reference to these risks and uncertainties.
You should not place undue reliance on forward-looking statements.
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.
Investor contact: Daniel Ferry, LifeSci Advisors,
1-617-535-7746, investors@aurismedical.com
Media contact: David Schull, Russo Partners,
1-858-717-2310, david.schull@russopartnersllc.comAURIS MEDICAL
HOLDING AGCondensed Consolidated Interim Statement of Profit
or Loss and Other Comprehensive Loss (unaudited)For the Three
and Nine Months Ended September 30, 2017 and 2016 (in CHF)
|
|
THREE MONTHSENDED SEPTEMBER 30 |
|
NINE MONTHSENDED SEPTEMBER 30 |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Research and
development |
|
(4'221'324) |
|
(6'344'600) |
|
(14'925'642) |
|
(19'763'338) |
General and
administrative |
|
(1'336'217) |
|
(1'197'541) |
|
(3'997'373) |
|
(4'144'687) |
Operating
loss |
|
(5'557'541) |
|
(7'542'141) |
|
(18'923'015) |
|
(23'908'025) |
Interest income |
|
7'788 |
|
18'118 |
|
53'563 |
|
44'284 |
Interest expense |
|
(416'956) |
|
(404'453) |
|
(1'248'400) |
|
(409'712) |
Foreign currency
exchange gain/loss, net |
|
1'650 |
|
(191'687) |
|
(929'386) |
|
(1'177'624) |
Revaluation gain/loss
from derivative financial instruments |
|
(55'613) |
|
228'190 |
|
1'705'018 |
|
228'190 |
Transaction costs |
|
0 |
|
0 |
|
(506'234) |
|
0 |
Loss before
tax |
|
(6'020'672) |
|
(7'891'973) |
|
(19'848'454) |
|
(25'222'887) |
Income tax gain |
|
8'191 |
|
0 |
|
24'573 |
|
0 |
Net loss
attributable to owners of the Company |
|
(6'012'481) |
|
(7'891'973) |
|
(19'823'881) |
|
(25'222'887) |
Other comprehensive
loss: |
|
|
|
|
|
|
|
|
Items that will
never be reclassified toprofit or loss |
|
|
|
|
|
|
|
|
Remeasurement of
defined benefit liability |
|
94'463 |
|
23'412 |
|
378'100 |
|
(584'455) |
Items that are or
may be reclassified toprofit or loss |
|
|
|
|
|
|
|
|
Foreign currency
translation differences |
|
(4'594) |
|
5'968 |
|
55'316 |
|
31'932 |
Other comprehensive
income/(loss) |
|
89'869 |
|
29'380 |
|
433'416 |
|
(552'523) |
Total comprehensive
loss attributableto owners of the Company |
|
(5'922'612) |
|
(7'862'593) |
|
(19'390'465) |
|
(25'775'410) |
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share |
|
(0.14) |
|
(0.23) |
|
(0.48) |
|
(0.73) |
AURIS MEDICAL HOLDING AGCondensed
Consolidated Interim Statement of Financial Position
(unaudited) (in CHF)
|
|
SEPTEMBER 30, 2017 |
|
DECEMBER 31,2016 |
|
|
|
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
Property and
equipment |
|
273'282 |
|
369'294 |
Intangible assets |
|
1'629'100 |
|
1'482'520 |
Other non-current
financial assets |
|
76'702 |
|
114'778 |
Total non-current
assets |
|
1'979'084 |
|
1'966'592 |
|
|
|
|
|
Current
assets |
|
|
|
|
Other receivables |
|
299'970 |
|
296'531 |
Prepayments |
|
447'456 |
|
952'595 |
Cash and cash
equivalents |
|
20'198'415 |
|
32'442'222 |
Total current
assets |
|
20'945'841 |
|
33'691'348 |
|
|
|
|
|
Total
assets |
|
22'924'925 |
|
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 |
|
(28'228) |
|
(83'544) |
Accumulated
deficit |
|
(131'530'523) |
|
(112'344'303) |
Total shareholders'
equity attributable to owners of the Company |
|
(477'899) |
|
14'142'849 |
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
Loan |
|
6'626'525 |
|
10'151'498 |
Derivative financial
instruments |
|
3'502'577 |
|
117'132 |
Employee benefits |
|
1'815'329 |
|
2'092'434 |
Deferred tax
liabilities |
|
172'009 |
|
196'582 |
Total non-current
liabilities |
|
12'116'440 |
|
12'557'646 |
|
|
|
|
|
Current
liabilities |
|
|
|
|
Loan |
|
4'406'208 |
|
2'212'706 |
Trade and other
payables |
|
1'150'326 |
|
1'837'997 |
Accrued expenses |
|
5'729'850 |
|
4'906'742 |
Total current
liabilities |
|
11'286'384 |
|
8'957'445 |
Total
liabilities |
|
23'402'824 |
|
21'515'091 |
Total equity and
liabilities |
|
22'924'925 |
|
35'657'940 |
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