Auris Medical Provides Business Update and Reports Fourth Quarter and Full Year 2017 Financial Results
March 22 2018 - 9:05AM
- Initiated second Phase 1 clinical trial with intranasal
betahistine
- Preparing for health authority discussions of regulatory
pathway for AM-111 program
- Analyses of Keyzilen® trial outcomes ongoing
- Company to review strategic options
Zug, Switzerland, March 22, 2018 - 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, 2017.
"We are making good progress with our AM-125
program for the intranasal treatment of vertigo with betahistine,"
commented Thomas Meyer, Auris Medical's founder, Chairman and Chief
Executive Officer. "We obtained further animal data confirming the
superior bioavailability of intranasal betahistine relative to oral
betahistine and look forward to obtaining additional data in humans
through our recently initiated second Phase 1 trial. As we prepare
to discuss the regulatory pathway for our AM-111 program with
health authorities and continue to analyze the outcomes from our
Keyzilen® trials, we are reviewing our strategic options focused on
enhancing shareholder value."
Development Program Updates
AM-125 for Vertigo
- Initiated second Phase 1 clinical trial with AM-125. The study
will seek to determine the maximum tolerated dose with single and
repeated dosing and generate additional data on the bioavailability
of intranasal betahistine in humans. Results are expected to become
available by mid-year. An earlier single dose Phase 1 clinical
trial with intranasal betahistine up to 40 mg had shown a relative
bioavailability which was 20-40 times higher compared with plasma
levels in an independent Phase 1 clinical trial with oral
betahistine at 3 x 48 mg/day.[1]
- Reported results from a single-dose pharmacokinetic study in
Beagle dogs. Betahistine concentrations were determined in blood
plasma following intranasal administration of the compound at doses
up to 120 mg, oral administration up to 48 mg/kg and intravenous
administration at 0.44 mg/kg. The absolute bioavailability reached
27% to 82% with intranasal betahistine and 2 to 6% with oral
betahistine. The relative bioavailability of intranasal betahistine
against oral betahistine was in a range of 5 to 35 times.
AM-111 for Acute Inner Ear Hearing
Loss
- Prepared for discussions of AM-111 data and regulatory pathway
with health authorities. The Company initiated a scientific advice
procedure with the European Medicines Agency and plans to engage
also in discussions with the FDA in in the second quarter of 2018.
Data from a further 31 patients who enrolled in the ASSENT trial
with profound acute hearing loss are expected towards the end of
the first quarter of 2018. ASSENT is the sister trial of the
previously completed HEALOS study.
Keyzilen® (AM-101) for Acute Inner Ear
Tinnitus
- Announced preliminary top-line data from the TACTT3 trial,
indicating that the study did not meet its primary efficacy
endpoint of a statistically significant improvement in the Tinnitus
Functional Index score from baseline to Day 84 in the active
treated group compared to placebo either in the overall population
or in the otitis media subpopulation. The Company is investigating
the outcomes, including those in the previously conducted sister
trial TACTT2, and will provide an update in due course.
Corporate Developments
- Completed a direct registered offering of approximately 12.5
million common shares to investors at a price of $0.44 per share
with net proceeds of $4.9 million. The Company also issued warrants
to purchase up to an aggregate of approximately 7.5 million common
shares in a concurrent private placement. The warrants have
an exercise price of $0.50 per share.[2]
- Effected a 1 for 10 share reverse split through the merger of
the Company with one of its subsidiaries. The post-merger common
shares of Auris Medical Holding AG began trading on the Nasdaq
Capital Market on March 14, 2018.
Other Developments
- Elected Alain Munoz, MD, to the Board of Directors. Dr Munoz is
a French entrepreneur and independent management consultant in the
pharmaceutical and biotechnology industry. He previously served on
our Board of Directors between 2007 and 2015.
- Re-elected Thomas Meyer (Chairman), Armando Anido, Calvin
Roberts and Mats Blom to the Board of Directors. Oliver Kubli and
Berndt Modig did not stand for re-election.
Fourth Quarter and Full Year 2017 Financial
Results
Fourth Quarter 2017 Financial Results
- Cash and cash equivalents at December 31, 2017, totaled CHF
15.0 million.
- Total operating expenses for the fourth quarter of 2017 were
CHF 5.4 million compared to CHF 6.3 million for the fourth quarter
of 2016.
- Research and development expenses for the fourth quarter of
2017 were CHF 4.3 million compared to CHF 5.0 million for the
fourth quarter of 2016.
- General and administrative expenses for the fourth quarter of
2017 were CHF 1.2 million compared to CHF 1.3 million for the
fourth quarter of 2016.
- Net loss for the fourth quarter of 2017 was CHF 4.6 million, or
CHF 0.10 per share, compared to CHF 5.6 million, or CHF 0.16 per
share, for the fourth quarter of 2016.[3]
Full Year 2017 Financial Results
- Total operating expenses for 2017 were CHF 24.4 million
compared to CHF 30.2 million for 2016.
- Research and development expenses for 2017 were CHF 19.2
million compared to CHF 24.8 million for 2016.
- General and administrative expenses for 2017 were CHF 5.2
million compared to CHF 5.5 million for 2016.
- Net loss for 2017 was CHF 24.4 million, or CHF 0.56 per share,
compared to CHF 30.7 million, or CHF 0.89 per share, for
2016.[4]
The Company expects that its operating expenses
in 2018 will be in the range of CHF 10 to 12 million.
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."
Auris Medical's Annual Report on Form 20-F for
the year ended December 31, 2017 was filed with the Securities and
Exchange Commission. A copy of the Annual Report is available
on the Company's website www.aurismedical.com in the Investors
section.
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 results of Auris
Medical's review of strategic options and the outcome of any action
taken as a result of such review, the timing and conduct of
clinical trials of Auris Medical's product candidates, 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 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.
Company contact: Hernan Levett, Chief Financial Officer, +41 61
201 1350Investor contact: Daniel Ferry, LifeSci Advisors,
1-617-535-7746investors@aurismedical.com
AURIS MEDICAL HOLDING AGCondensed
Consolidated Statement of Profit or Loss and Other Comprehensive
LossFor the Three and Twelve Months Ended December 31, 2017 and
2016 (in CHF)
|
|
THREE MONTHSENDED DECEMBER 31 |
|
TWELVE MONTHSENDED DECEMBER 31 |
|
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Research and
development |
|
(4,285,200) |
|
(5,013,425) |
|
(19,210,842) |
|
(24,776,763) |
General and
administrative |
|
(1,153,036) |
|
(1,301,825) |
|
(5,150,409) |
|
(5,446,512) |
Operating
loss |
|
(5,438,236) |
|
(6,315,250) |
|
(24,361,251) |
|
(30,223,275) |
Interest income |
|
7 |
|
23,281 |
|
53,570 |
|
67,565 |
Interest expense |
|
(391,994) |
|
(418,835) |
|
(1,640,394) |
|
(828,547) |
Foreign currency
exchange gain/(loss), net |
|
104,794 |
|
1,077,527 |
|
(824,592) |
|
(100,097) |
Revaluation gain from
derivative financial instruments |
|
1,667,168 |
|
62,858 |
|
3,372,186 |
|
291,048 |
Transaction costs |
|
(520,532) |
|
0 |
|
(1,026,766) |
|
0 |
Loss before
tax |
|
(4,578,793) |
|
(5,570,419) |
|
(24,427,247) |
|
(30,793,306) |
Income tax
gain/(loss) |
|
(6,800) |
|
0 |
|
17,773 |
|
131,055 |
Net loss
attributable to owners of the Company |
|
(4,585,593) |
|
(5,570,419) |
|
(24,409,474) |
|
(30,662,251) |
Other comprehensive
income/(loss): |
|
|
|
|
|
|
|
|
Items that will
never be reclassified toprofit or loss |
|
|
|
|
|
|
|
|
Remeasurement of
defined benefit liability |
|
(106,120) |
|
190,353 |
|
271,980 |
|
(394,102) |
Items that are or
may be reclassified toprofit or loss |
|
|
|
|
|
|
|
|
Foreign currency
translation differences |
|
(4,819) |
|
(51,655) |
|
50,497 |
|
(19,723) |
Other comprehensive
income/(loss) |
|
(110,939) |
|
138,698 |
|
322,477 |
|
(413,825) |
Total comprehensive
loss attributableto owners of the Company |
|
(4,696,532) |
|
(5,431,721) |
|
(24,086,997) |
|
(31,076,076) |
|
|
|
|
|
|
|
|
|
Basic and diluted loss
per share[5] |
|
(0.10) |
|
(0.16) |
|
(0.56) |
|
(0.89) |
AURIS MEDICAL HOLDING AGCondensed
Consolidated Statement of Financial Position (in CHF)
|
|
DECEMBER 31, 2017 |
|
DECEMBER 31,2016 |
|
|
|
ASSETS |
|
|
|
|
Non-current
assets |
|
|
|
|
Property and
equipment |
|
252,899 |
|
369,294 |
Intangible assets |
|
1,629,100 |
|
1,482,520 |
Other non-current
financial receivables |
|
76,710 |
|
114,778 |
Total non-current
assets |
|
1,958,709 |
|
1,966,592 |
|
|
|
|
|
Current
assets |
|
|
|
|
Other receivables |
|
241,281 |
|
296,531 |
Prepayments |
|
652,913 |
|
952,595 |
Cash and cash
equivalents |
|
14,973,369 |
|
32,442,222 |
Total current
assets |
|
15,867,563 |
|
33,691,348 |
|
|
|
|
|
Total
assets |
|
17,826,272 |
|
35,657,940 |
|
|
|
|
|
EQUITY AND
LIABILITIES |
|
|
|
|
Equity |
|
|
|
|
Share capital |
|
19,349,556 |
|
13,731,881 |
Share premium |
|
114,648,228 |
|
112,838,815 |
Foreign currency
translation reserve |
|
(33,047) |
|
(83,544) |
Accumulated
deficit |
|
(136,126,946) |
|
(112,344,303) |
Total shareholders,
(deficit)/equity attributable to owners of the Company |
|
(2,162,209) |
|
14,142,849 |
|
|
|
|
|
Non-current
liabilities |
|
|
|
|
Loan |
|
5,584,297 |
|
10,151,498 |
Derivative financial
instruments |
|
1,836,763 |
|
117,132 |
Employee benefits |
|
1,962,970 |
|
2,092,434 |
Deferred tax
liabilities |
|
178,809 |
|
196,582 |
Total non-current
liabilities |
|
9,562,839 |
|
12,557,646 |
|
|
|
|
|
Current
liabilities |
|
|
|
|
Loan |
|
4,542,109 |
|
2,212,706 |
Trade and other
payables |
|
1,200,820 |
|
1,837,997 |
Accrued expenses |
|
4,682,713 |
|
4,906,742 |
Total current
liabilities |
|
10,425,642 |
|
8,957,445 |
Total
liabilities |
|
19,988,481 |
|
21,515,091 |
Total equity and
liabilities |
|
17,826,272 |
|
35,657,940 |
[1] The overall design of that trial is described in Barak et
al. (2016), Journal of Psychopharmacology 30(3):
237-241.
[2] The issue price and exercise price do not reflect the effect
of the subsequent reverse stock split.
[3] Per share figures not adjusted for effect of subsequent
reverse stock split.
[4] Per share figures not adjusted for effect of subsequent
reverse stock split.
[5] Not adjusted for effect of subsequent reverse stock
split.
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