- Phase 1b trial with intranasal betahistine for prevention of
antipsychotic-induced weight gain progressing towards final
read-out
- Phase 2 trial with intranasal betahistine for treatment of
acute vertigo progressing towards interim analysis, but temporarily
slowed down by COVID-19 impact
- Notice of allowance granted for NKCC1 modulators for oral
treatment of tinnitus
- Set-up of subsidiary to bundle tinnitus and hearing loss
development projects for potential partnering
Hamilton, Bermuda,
April 16, 2020 – 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
second half and full year ended December 31, 2019.
“We made substantial progress with our
intranasal betahistine development programs in 2019,” stated Thomas
Meyer, Auris Medical’s founder, Chairman and CEO. “We extended our
patent coverage both in the US and the EU to 2038, initiated our
Phase 2 trial with AM-125 in acute peripheral vertigo and obtained
positive interim results from our Phase 1b trial with AM-201 in
antipsychotic-induced weight gain. We expect to receive top-line
data from the completed AM-201 trial in early May and interim data
from the AM-125 trial in the third quarter, provided that COVID-19
restrictions are lifted. As for our late-stage programs in tinnitus
and hearing loss, we’ve positioned them for partnering by setting
up a dedicated subsidiary, Zilentin Ltd.”
Development Program Updates
AM-125 for Treatment of Acute Peripheral
Vertigo
- Progressed with dose escalation in TRAVERS Phase 2 trial. Since
July 2019, the TRAVERS trial has been enrolling patients suffering
from acute vertigo following certain neurosurgical interventions
affecting the vestibular nerve. In Part A of the TRAVERS trial,
three ascending doses of AM-125 or placebo, administered three
times daily over a total of four weeks, are tested in a total of 30
patients. The results from an interim analysis of Part A will
inform the selection of two doses for further testing against
placebo in an estimated 72 patients in Part B of the trial. In
addition to the ongoing intranasal dose escalation, open label
testing of oral betahistine for reference purposes has
commenced.
- COVID-19 outbreak causing temporary delay in enrollment.
Candidates for participation in the TRAVERS trial undergo certain
types of neurosurgery, which are elective procedures. Due to the
COVID-19 outbreak, the sites participating in the “TRAVERS” trial
have postponed elective procedures and temporarily reduced or
suspended clinical research activities. As a result, enrollment
came to a halt towards the end of March 2020. Although sites are
expected to catch up on enrollment once COVID-19 related
restrictions are relaxed, the Company expects that the interim
analysis following Part A of the trial will be completed only in
the third quarter of 2020, at the earliest.
AM-201 for Prevention of Antipsychotic-Induced
Weight Gain and Somnolence
- Positive interim results in Phase 1b trial. In October 2019 an
interim analysis of the results from the first 50 participants in
the trial showed good safety and tolerability of AM-201 up to a
dose of 3 x 20 mg daily for four weeks. Further, it revealed
relevant reductions in olanzapine-induced weight gain and daytime
sleepiness. In female study participants, who overall showed more
pronounced changes than male participants, a reduction in weight
gain of 1.1 kg against placebo was observed at the highest tested
dose (probability of effectiveness = 90%).
- Progressing towards read-out from Phase 1b trial. Following the
interim analysis, the trial proceeded to the next higher and final
dose level of 30 mg, which was tested in an additional 30 healthy
volunteers, bringing the total for the trial to 80 subjects. The
Company expects to report top-line data in May 2020. The primary
efficacy outcome for the study will be the reduction in weight gain
and the secondary outcome will be the reduction in somnolence.
Other developments related to betahistine
- Obtained U.S. and European patent applications covering
intranasal betahistine. The Company’s intellectual property estate
was substantially expanded through the grant of US patent
10,456,386, entitled “Pharmaceutical Composition Comprising
Betahistine”, which covers composition of matter and methods of use
for formulations of betahistine dihydrochloride for intranasal
delivery. In addition, the Company received an “Intention to Grant”
notice from the European Patent Office (EPO) for its corresponding
European patent application. The new patents are expected to expire
no earlier than February 2038.
- Announced independent in vivo evidence for betahistine’s
anti-epileptic and anti-convulsive activity. In a study published
in Epilepsy & Behavior, an independent research group reported
promising results with pretreatment and repetitive betahistine
treatment in a murine model of epilepsy. The results add further to
the growing list of potential therapeutic uses for
betahistine.
Keyzilen® / AM-101 for Treatment of Acute Inner
Ear Tinnitus
·Received FDA and EMA guidance for Keyzilen®
late-stage clinical development program. The Company received
feedback from the FDA and EMA regarding the design of a new Phase
2/3 trial for the Keyzilen® program. Both agencies supported the
use of the Tinnitus Functional Index (TFI) questionnaire as the
primary efficacy outcome measure. The TFI captures the impact of
tinnitus on the patient’s day-to-day functioning. Furthermore, the
two agencies agreed on a less frequent collection of
patient-reported tinnitus loudness than in the previous Keyzilen®
trials, where daily ratings had turned out to be problematic. The
FDA considers the improvement in tinnitus loudness as a co-primary
efficacy endpoint, whereas the EMA endorsed it as a secondary
efficacy endpoint. In addition, the two agencies endorsed the
planned sample size for the trial.
Other developments related to tinnitus
- Established scientific advisory board for tinnitus programs.
The Company established a Scientific Advisory Board comprising four
internationally renowned experts to support its research and
development programs in the field of tinnitus.
- Received notice of allowance for NKCC1 tinnitus patent. The US
Patent and Trademark Office issued a “Notice of Allowance” and the
European Patent Office a notice of “Intention to Grant” for
the Company’s patent application covering compounds modulating the
sodium potassium chloride co-transporter 1 (NKCC1) for use in the
oral treatment or prevention of tinnitus. As demonstrated in an
animal model of acute noise trauma, administration of an NKCC1
inhibitor resulted in a significant reduction of a biomarker for
the presence of tinnitus (p<0.02).
Corporate Developments
- Appointed Elmar Schaerli as new Chief Financial Officer.
Effective November 1, 2019, Elmar Schaerli, CPA, was appointed the
Company’s new CFO. He succeeds Hernan Levett. On the other hand,
Raoul Dias, General Counsel, left the Company effective March 20,
2020 in order to pursue a new career opportunity.
- Set up new subsidiary for development projects in tinnitus and
hearing loss. In late 2019, the Company formed a new subsidiary,
Zilentin Ltd., to bundle its development projects for the treatment
of tinnitus and hearing loss in a separate entity. These include
Keyzilen® / AM-101 as well as early stage projects in tinnitus as
well as Sonsuvi® / AM-111 in hearing loss. Zilentin Ltd. is
currently a 100% subsidiary and is domiciled in Zug, Switzerland.
Second Half 2019 Financial
Results
- Total operating expenses for the second half of 2019 were CHF
3.2 million compared to CHF 3.5 million for the second half of
2018.
- Research and development expenses for the second half of 2019
were CHF 2.0 million compared to CHF 1.7 million for the second
half of 2018.1
- General and administrative expenses for the second half of 2019
were CHF 1.1 million compared to CHF 1.8 million for the second
half of 2018.
- Net loss for the second half of 2019 was CHF 3.0 million, or
CHF 0.83 per share, compared to CHF 6.7 million, or CHF 5.17 per
share, for the second half of 2018.
- Cash and cash equivalents at December 31, 2019, totaled CHF 1.4
million.
Full Year 2019 Financial
Results
- Total operating expenses for 2019 were CHF 7.3 million compared
to CHF 11.0 million for 2018.
- Research and development expenses for 2019 were CHF 3.3 million
compared to CHF 6.7 million for 2018.1
- General and administrative expenses for 2019 were CHF 3.9
million compared to CHF 4.3 million for 2018.
- Net loss attributable to owners of the Company for 2019 was CHF
6.6 million, or CHF 2.28 per share, compared to CHF 11.5 million,
or CHF 14.46 per share, for 2018.
The Company expects its total cash need in 2020
to be in the range of CHF 7.5 to 10.0 million for expected total
operating expenses of CHF 3.5 to 4.5 million and expected
capitalized research and development expenses of CHF 4.0 to 5.5
million.
Conference Call & Webcast
Information
Auris Medical will host a conference call and
webcast to present the second half and full year 2019 financial
results and to provide a business update today, April 16, 2020, at
8:00 am Eastern Time (2:00 pm Central European Time). To
participate in this conference call, dial +1-866-966-1396 (toll
free) or +44 2071 928011 (International), and enter passcode
8599310. A live webcast of the conference call is
available via this link and also in the Investor Relations section
of the Auris Medical website at www.aurismedical.com. A replay of
the conference call will be available approximately two hours
following the live call.
About Auris Medical
Auris Medical is a biopharmaceutical company
dedicated to developing therapeutics that address important unmet
medical needs in neurotology and CNS disorders. The company is
focused on the development of intranasal betahistine for the
treatment of vertigo (AM-125) and for the prevention of
antipsychotic-induced weight gain and somnolence (AM-201). These
projects have gone through two Phase 1 trials and moved 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
Hamilton, Bermuda with its main operations in Basel, Switzerland.
The shares of Auris Medical Holding Ltd. 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, the delays and other
impacts on Auris Medical’s business and clinical trials that may be
caused by the COVID-19 pandemic, Auris Medical’s need for and
ability to raise substantial additional funding to continue the
development of its product candidates, the ability to pursue
strategic partnering and non-dilutive funding for its Phase 3
programs, 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, 2019, 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: Joseph Green Edison Advisors
for Auris Medical 646-653-7030 / 7719 jgreen@edisongroup.com
Or
investors@aurismedical.com
AURIS MEDICAL HOLDING
Ltd.Condensed Consolidated Statement of Profit or
Loss and Other Comprehensive Loss For the Six and Twelve
Months Ended December 31, 2019 and 2018 (in CHF)
|
|
SIX MONTHS ENDED DECEMBER 31 |
|
TWELVE MONTHS ENDED DECEMBER 31 |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Research and
development |
|
(2,020,990) |
|
(1,731,968) |
|
(3,325,281) |
|
(6,689,589) |
General and
administrative |
|
(1,130,596) |
|
(1,805,113) |
|
(3,933,863) |
|
(4,264,534) |
Operating loss |
|
(3,151,586) |
|
(3,537,081) |
|
(7,259,144) |
|
(10,954,123) |
Interest
income |
|
17,882 |
|
— |
|
17,882 |
|
— |
Interest
expense |
|
(3,367) |
|
(214,020) |
|
(28,628) |
|
(1,070,177) |
Foreign
currency exchange gain/(loss), net |
|
44,548 |
|
(73,956) |
|
(219,573) |
|
(139,870) |
Revaluation
gain / (loss) from derivative financial instruments |
|
132,480 |
|
(2,557,887) |
|
663,725 |
|
1,350,071 |
Transaction
costs |
|
— |
|
(108,809) |
|
— |
|
(520,125) |
Loss
before tax |
|
(2,960,043) |
|
(6,491,753) |
|
(6,825,738) |
|
(11,334,224) |
Income tax
gain/(loss) |
|
(67,557) |
|
(179,630) |
|
193,837 |
|
(162,177) |
Net
loss attributable to owners of the Company |
|
(3,027,600) |
|
(6,671,383) |
|
(6,631,901) |
|
(11,496,401) |
Other
comprehensive income/(loss): |
|
|
|
|
|
|
|
|
Items
that will never be reclassified to profit or loss |
|
|
|
|
|
|
|
|
Remeasurement
of defined benefit liability, net of taxes = CHF 0 |
|
43,356 |
|
192,090 |
|
(72,010) |
|
1,277,192 |
Items
that are or may be reclassified to profit or loss |
|
|
|
|
|
|
|
|
Foreign
currency translation differences, net of taxes = CHF 0 |
|
9,780 |
|
8,065 |
|
16,446 |
|
(10,964) |
Other
comprehensive income/(loss) |
|
53,136 |
|
200,155 |
|
(55,564) |
|
1,266,228 |
Total
comprehensive loss attributable to owners of the
Company |
|
(2,974,464) |
|
(6,471,228) |
|
(6,687,465) |
|
(10,230,173) |
|
|
|
|
|
|
|
|
|
Basic and
diluted loss per share |
|
(0.83) |
|
(5.17) |
|
(2.28) |
|
(14.46) |
Average
weighted number of shares outstanding, adjusted for effect of
reverse stock split |
|
3,628,614 |
|
1,289,639 |
|
2,909,056 |
|
795,043 |
|
|
|
|
|
|
|
|
|
AURIS MEDICAL HOLDING
Ltd.Condensed Consolidated Statement of Financial
Position (in CHF)
|
|
DECEMBER 31, 2019 |
|
DECEMBER 31, 2018 |
|
|
|
ASSETS |
|
|
|
|
Non-current assets |
|
|
|
|
|
Property and
equipment |
|
66,672 |
|
33,895 |
|
Intangible
assets |
|
6,765,613 |
|
3,535,240 |
|
Derivative
financial instruments |
|
— |
|
226,865 |
|
Other
non-current financial receivables |
|
20,001 |
|
16,001 |
|
Total
non-current assets |
|
6,852,286 |
|
3,812,001 |
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
Other
receivables |
|
335,299 |
|
320,374 |
|
Prepayments |
|
434,231 |
|
351,283 |
|
Derivative
financial instruments |
|
219,615 |
|
— |
|
Cash and cash
equivalents |
|
1,384,720 |
|
5,393,207 |
|
Total
current assets |
|
2,373,865 |
|
6,064,864 |
|
|
|
|
|
|
|
Total
assets |
|
9,226,151 |
|
9,876,865 |
|
|
|
|
|
|
|
EQUITY
AND LIABILITIES |
|
|
|
|
|
Equity |
|
|
|
|
|
Share
capital |
|
1,650,380 |
|
710,336 |
|
Share
premium |
|
157,191,707 |
|
149,286,723 |
|
Foreign
currency translation reserve |
|
(27,565) |
|
(44,011) |
|
Accumulated
deficit |
|
(152,778,389) |
|
(146,303,398) |
|
Total
shareholders (deficit)/equity attributable to owners of the
Company |
|
6,036,133 |
|
3,649,650 |
|
|
|
|
|
|
|
Non-current liabilities |
|
|
|
|
|
Derivative
financial instruments |
|
4,353 |
|
675,328 |
|
Employee
benefit liability |
|
760,447 |
|
648,287 |
|
Deferred tax
liabilities |
|
147,149 |
|
340,986 |
|
Total
non-current liabilities |
|
911,949 |
|
1,664,601 |
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Loan |
|
— |
|
1,435,400 |
|
Trade and other
payables |
|
938,247 |
|
1,836,335 |
|
Accrued
expenses |
|
1,339,822 |
|
1,290,879 |
|
Total
current liabilities |
|
2,278,069 |
|
4,562,614 |
|
Total
liabilities |
|
3,190,018 |
|
6,227,215 |
|
Total
equity and liabilities |
|
9,226,151 |
|
9,876,865 |
|
1 Does not include capitalized costs related to expenses for the
AM-125 program in accordance with IAS38.
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