Auris Medical Provides Business Update and Reports Fourth Quarter and Full Year 2018 Financial Results
14 Março 2019 - 8:00AM
- Phase 1 trial confirmed superior bioavailability of intranasal
betahistine as well as good safety and tolerability
- Intranasal betahistine program progressing towards
proof-of-concept studies in acute vertigo (AM-125) and
antipsychotic-induced weight gain (AM-201)
- Detailed results from HEALOS Phase 3 trial with Sonsuvi®
published in peer-reviewed journal
- Full repayment of loan facility to result in a significant
reduction of interest expense and strengthened balance sheet
- Redomiciliation to Bermuda to reduce costs and better align
with U.S. capital market practices
Zug, Switzerland, March 14, 2019 - Auris Medical
Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to
developing therapeutics that address important unmet medical needs
in neurotology, today provided a business update and announced
financial results for the fourth quarter and full year ended
December 31, 2018.
"Following the successful Phase 1 trial for our
intranasal betahistine program in 2018, we have been busy preparing
two proof-of-concept studies that will initiate soon and from which
we expect to obtain interim and final results, respectively, in the
second half of 2019," stated Thomas Meyer, Auris Medical's founder,
Chairman and CEO. "While we progress with our intranasal
betahistine developments, we have also made important strides in
reducing operating and financial expenses and improving our
corporate flexibility. Thanks to the recent repayment of the
Hercules loan facility and the planned redomiciliation under
Bermuda law, we believe we are in a better position to grow the
business and focus on creating shareholder value."
Development Program Updates
AM-125 for Vertigo
- Progressed with preparations for TRAVERS Phase 2 trial with
AM-125 in acute vertigo. The TRAVERS trial will enroll 138 patients
that suffer from acute vertigo following surgical removal of a
vestibular schwannoma, a tumor growing behind the inner ear. The
selection of clinical trial sites in several European countries and
Canada has essentially been completed and the first approval from a
competent authority has already been received. In Part A of the
TRAVERS trial, five ascending doses of AM-125 or placebo,
administered three times daily over a total of four weeks, will be
tested in a total of 50 patients. In addition, oral betahistine 48
mg will be tested in 16 patients under open-label conditions for
reference. Based on an interim analysis, two doses will be selected
and tested in an estimated 72 patients in Part B.
AM-201 for Antipsychotic-Induced Weight Gain
- Progressed with preparations for Phase 1b trial with AM-201 in
antipsychotic-induced weight gain. The trial will be conducted at a
single trial site in a European country and enroll 50 healthy
volunteers who will receive either AM-201 or placebo concomitantly
with olanzapine over four weeks. Doses will be escalated in five
steps, as in the TRAVERS trial. The trial has been approved by the
local ethics committee (institutional review board) and the
competent authority and is expected to start recruitment before the
end of the first quarter of 2019.
Other developments related to betahistine
- Acquired Orphan Drug Designation for betahistine in the
treatment of obesity associated with Prader-Willi syndrome (PWS).
PWS is a rare genetic disorder characterized by progressive
obesity, behavioral issues, delayed cognition and sleep
disturbances. Emerging research suggests positive effects of H3
histamine receptor inhibition on cognitive disability and excessive
daytime sleepiness. Betahistine acts as an H3 receptor antagonist
and uniquely, also as an agonist at the H1 histamine receptor,
which plays a crucial role in the regulation of food intake. The
Company acquired the Orphan Drug Designation from its previous
holder with the transfer being recorded by the U.S. Food and Drug
Administration (FDA).
- Obtained rights to two U.S. patents relating to treatment of
two mental disorders with betahistine. The Company entered into a
binding Letter of Intent to acquire exclusive rights to in-license
two U.S. patents relating to the use of betahistine for the
treatment of atypical depression and attention-deficit /
hyperactivity disorder (ADHD). The Company expects to close the
transaction in the second quarter of 2019.
- Announced independent evidence for betahistine's role in
promoting the retrieval of forgotten memories. In a peer-reviewed
article, evidence was presented that betahistine promotes the
retrieval of forgotten memories in mice and human beings.[1]
Notably it was shown in a study with 38 healthy adult volunteers
that treatment with betahistine overall improved the percentage of
correct memories (p<0.05), enhanced the retrieval of more
difficult items and benefited participants with poor performance
under placebo treatment (p<0.01).
Sonsuvi® / AM-111 for Acute Inner Ear Hearing Loss
- Published detailed results from HEALOS Phase 3 trial. The
detailed results from HEALOS, a randomized, double-blind,
placebo-controlled study evaluating the efficacy, safety and
tolerability of AM-111 in 256 patients suffering from severe to
profound sudden deafness were published in Otology &
Neurotology, one of the leading journals in the field of scientific
and clinical inner ear research.[2] While the HEALOS trial did not
meet the primary efficacy endpoint in the overall study population,
post-hoc analyses revealed a statistically significant hearing
improvement with AM-111 from baseline to Day 28 in the
subpopulation of patients with profound hearing loss (n=98). The
AM-111 0.4 mg/mL treatment group showed a mean improvement of 42.7
dB vs. 26.8 dB in the placebo group (p=0.0176). AM-111 was
well-tolerated and the primary safety endpoint was met.
- Continued partnering process for AM-111. As previously
announced, the Company decided to refocus its development
activities on the intranasal betahistine program and to seek
partners or other sources of non-dilutive funding for its
late-stage development programs. In this context, the Company
initiated a structured partnering process with an international
transaction advisory firm to identify potential partners for the
AM-111 development program.
Keyzilen® / AM-101 for Acute Inner Ear
Tinnitus
- Defined development path for Keyzilen® / AM-101. Given the
strong unmet medical need among tinnitus sufferers as well as the
positive data obtained with Keyzilen® from non-clinical studies,
two Phase 2 trials and the two open label AMPACT trials, the
Company has assessed how to address the issues arising from
elements in the design and conduct in the unsuccessful TACTT2 and
TACTT3 trials and take the program forward. Based on this, the
Company has defined a development path forward and is currently
exploring options for its implementation through partnering and /
or non-dilutive funding.
Corporate Developments
- Made early repayment of loan facility with Hercules Capital,
Inc. On January 31, 2019, the Company made the final payment to
Hercules under the facility, comprising the last amortization rate
as well as an end of term charge, 12 months ahead of the original
schedule. With the final payment, all covenants and collateral in
favor of Hercules have been lifted. The repayment will result in a
significant reduction of the Company's interest expense, improve
its balance sheet and enhance its financial flexibility.
- Relocating the Company's domicile to Bermuda. On March 8, 2019,
an extraordinary general meeting of shareholders approved with an
overwhelming majority the transfer of the Company from Zug,
Switzerland to Hamilton, Bermuda, a related memorandum of
continuance and new by-laws under Bermuda law. The redomiciliation
is expected to become effective before the end of March 2019 upon
registration of the Company with the Registrar of Companies in
Bermuda. With the move, the Company expects to gain more corporate
flexibility, achieve cost savings and operate under a jurisdiction
that is more familiar to U.S. investors.
Fourth Quarter 2018 Financial Results
- Total operating expenses for the fourth quarter of 2018 were
CHF 0.7 million compared to CHF 5.4 million for the fourth quarter
of 2017.
- Research and development expenses for the fourth quarter of
2018 were CHF 0.03 million compared to CHF 4.3 million for the
fourth quarter of 2017.[3]
- General and administrative expenses for the fourth quarter of
2018 were CHF 0.6 million compared to CHF 1.2 million for the
fourth quarter of 2017.
- Net loss for the fourth quarter of 2018 was CHF 3.7 million, or
CHF 0.12 per share, compared to CHF 4.6 million, or CHF 1.05 per
share, for the fourth quarter of 2017.
- Cash and cash equivalents at December 31, 2018, totaled CHF 5.4
million.
Full Year 2018 Financial Results
- Total operating expenses for 2018 were CHF 11.0 million
compared to CHF 24.4 million for 2017.
- Research and development expenses for 2018 were CHF 6.7 million
compared to CHF 19.2 million for 2017.3
- General and administrative expenses for 2018 were CHF 4.3
million compared to CHF 5.2 million for 2017.
- Net loss for 2018 was CHF 11.5 million, or CHF 0.72 per share,
compared to CHF 24.4 million, or CHF 5.58 per share, for 2017.
The Company expects that its operating expenses
in 2019 will be in the range of CHF 10 to 13 million.
Conference Call & Webcast
Information
Auris Medical will host a conference call and
webcast to present the fourth quarter and full year 2018 financial
results and to provide a business update today, March 14, 2019, at
8:00 am Eastern Time (1:00 pm Central European Time). To
participate in this conference call, dial +1-866-966-1396 (toll
free) or +1-631-510-7495 (International), and enter passcode
2489938. 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 approximately two hours 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 and central nervous system
disorders. The company is focused on the development of intranasal
betahistine for the treatment of vertigo (AM-125) and for the
treatment of antipsychotic-induced weight gain and somnolence
(AM-201). These projects have gone through two Phase 1 trials and
will move into proof-of-concept studies in 2019. In addition Auris
Medical has two Phase 3 programs under development: Sonsuvi®
(AM-111) for acute inner ear hearing loss and Keyzilen® (AM-101)
for acute inner ear tinnitus. 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 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 and that
such trials 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, 2017 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.
Investor contact: Joseph Green / Andrew Gibson Edison
Advisors for Auris Medical 646-653-7030 / 7719
jgreen@edisongroup.com / agibson@edisongroup.com
Or
investors@aurismedical.com
AURIS MEDICAL HOLDING AGCondensed
Consolidated Statement of Profit or Loss and Other Comprehensive
Loss For the Three and Twelve Months Ended December 31, 2018
and 2017 (in CHF)
|
|
THREE MONTHS ENDED DECEMBER 31 |
|
TWELVE MONTHS ENDED DECEMBER 31 |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Research and
development |
|
(34,923) |
|
(4,285,200) |
|
(6,689,589) |
|
(19,210,842) |
General and
administrative |
|
(634,869) |
|
(1,153,036) |
|
(4,264,534) |
|
(5,150,409) |
Operating
loss |
|
(669,792) |
|
(5,438,236) |
|
(10,954,123) |
|
(24,361,251) |
Interest income |
|
- |
|
7 |
|
- |
|
53,570 |
Interest expense |
|
(90,982) |
|
(391,994) |
|
(1,070,177) |
|
(1,640,394) |
Foreign currency
exchange gain/(loss), net |
|
40,055 |
|
104,794 |
|
(139,870) |
|
(824,592) |
Revaluation gain /
(loss) from derivative financial instruments |
|
(2,781,791) |
|
1,667,168 |
|
1,350,071 |
|
3,372,186 |
Transaction costs |
|
- |
|
(520,532) |
|
(520,125) |
|
(1,026,766) |
Loss before
tax |
|
(3,502,510) |
|
(4,578,793) |
|
(11,334,224) |
|
(24,427,247) |
Income tax
gain/(loss) |
|
(188,356) |
|
(6,800) |
|
(162,177) |
|
17,773 |
Net loss
attributable to owners of the Company |
|
(3,690,866) |
|
(4,585,593) |
|
(11,496,401) |
|
(24,409,474) |
Other comprehensive
income/(loss): |
|
|
|
|
|
|
|
|
Items that will
never be reclassified to profit or loss |
|
|
|
|
|
|
|
|
Remeasurement of
defined benefit liability |
|
(17,670) |
|
(106,120) |
|
1,277,192 |
|
271,980 |
Items that are or
may be reclassified to profit or loss |
|
|
|
|
|
|
|
|
Foreign currency
translation differences |
|
2,152 |
|
(4,819) |
|
(10,964) |
|
50,497 |
Other comprehensive
income/(loss) |
|
(15,518) |
|
(110,939) |
|
1,266,228 |
|
322,477 |
Total comprehensive
loss attributable to owners of the Company |
|
(3,706,384) |
|
(4,696,532) |
|
(10,230,173) |
|
(24,086,997) |
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share |
|
(0.12) |
|
(1.05) |
|
(0.72) |
|
(5.58) |
Average weighted number
of shares outstanding, adjusted for effect of reverse stock
split |
|
30,427,094 |
|
4,374,187 |
|
15,900,865 |
|
4,374,187 |
AURIS MEDICAL HOLDING AGCondensed
Consolidated Statement of Financial Position (in CHF)
|
|
DECEMBER 31, 2018 |
|
DECEMBER 31, 2017 |
|
|
|
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
|
Property and
equipment |
|
33,895 |
|
252,899 |
|
Intangible assets |
|
3,535,240 |
|
1,629,100 |
|
Derivative financial
instruments |
|
226,865 |
|
- |
|
Other non-current
financial receivables |
|
16,001 |
|
76,710 |
|
Total non-current
assets |
|
3,812,001 |
|
1,958,709 |
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
Other receivables |
|
320,374 |
|
241,281 |
|
Prepayments |
|
351,283 |
|
652,913 |
|
Cash and cash
equivalents |
|
5,393,207 |
|
14,973,369 |
|
Total current
assets |
|
6,064,864 |
|
15,867,563 |
|
|
|
|
|
|
|
Total
assets |
|
9,876,865 |
|
17,826,272 |
|
|
|
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
|
|
Equity |
|
|
|
|
|
Share capital |
|
710,336 |
|
19,349,556 |
|
Share premium |
|
149,286,723 |
|
114,648,228 |
|
Foreign currency
translation reserve |
|
(44,011) |
|
(33,047) |
|
Accumulated
deficit |
|
(146,303,398) |
|
(136,126,946) |
|
Total shareholders
(deficit)/equity attributable to owners of the Company |
|
3,649,650 |
|
(2,162,209) |
|
|
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
|
Loan |
|
- |
|
5,584,297 |
|
Derivative financial
instruments |
|
675,328 |
|
1,836,763 |
|
Employee benefits |
|
648,287 |
|
1,962,970 |
|
Deferred tax
liabilities |
|
340,986 |
|
178,809 |
|
Total non-current
liabilities |
|
1,664,601 |
|
9,562,839 |
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Loan |
|
1,435,400 |
|
4,542,109 |
|
Trade and other
payables |
|
1,836,335 |
|
1,200,820 |
|
Accrued expenses |
|
1,290,879 |
|
4,682,713 |
|
Total current
liabilities |
|
4,562,614 |
|
10,425,642 |
|
Total
liabilities |
|
6,227,215 |
|
19,988,481 |
|
Total equity and
liabilities |
|
9,876,865 |
|
17,826,272 |
|
[1] Nomura et al., Central histamine boosts perirhinal cortex
activity and restores forgotten object memories, Biol Psychiatry
2019, in press.
[2] Staecker et al., Efficacy and Safety of AM-111 in the
Treatment of Acute Unilateral Sudden Deafness - A Double-Blind,
Randomized, Placebo-Controlled Phase 3 Study, Otol Neurotol 2019,
in press.
[3] Does not include capitalized costs related to expenses for
the AM-125 program in accordance with IAS38.
- Auris Medical 4th Quarter and Full Year 2018.pdf
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