Auris Medical Provides Business Update and Reports Second Half and Full Year 2020 Financial Results
March 31 2021 - 8:30AM
- Clinical evaluation of AM-301 nasal spray in allergen
protection progressing
- Launch of AM-301 expected in selected markets towards the end
of second quarter 2021
- Phase 2 trial with AM-125 in acute vertigo expected to complete
enrollment in third quarter 2021
- Equity and cash position significantly strengthened
- Strategy review ongoing
Hamilton, Bermuda, March 31, 2021 – Auris
Medical Holding Ltd. (NASDAQ: EARS), a clinical-stage company
dedicated to developing therapeutics that address important unmet
medical needs in neurotology, rhinology and allergy and CNS
disorders, today provided a business update and announced second
half and full year 2020 financial results.
“The 2020 business year has been quite
transformative for our company as we initiated the development of
AM-301, a nasal spray designated for self-protection against
airborne viruses and allergens,” stated Thomas Meyer, Auris
Medical’s founder, Chairman and CEO. “With a highly dedicated team,
we managed to develop in less than six months a drug-free nasal
spray that reduced the SARS-CoV-2 viral titer in a model
representative of the human nasal mucosa by more than 99%. The
project has taken on strong momentum, and we look forward to making
AM-301 available to consumers, starting towards the end of the
second quarter 2021 in selected markets. With this, we expect to
become a commercial stage company quite shortly.” He continued:
“The project benefited greatly from our experience acquired with
AM-125, our nasal spray for the treatment of acute vertigo. Here,
we obtained last year promising interim data in our Phase 2 trial
and expect the trial to read out in 2021. Last, but not least, we
entered the new business year with a significantly stronger balance
sheet, and strengthened our cash position further in the first
quarter of 2021.“
Development Program Updates
AM-125 for Treating Acute Vertigo
- Initiated Part B of TRAVERS trial. Following the positive
results from the interim analysis in the Phase 2 trial with AM-125,
including a dose dependent improvement in patients’ performance of
the “Tandem Romberg” and the “Standing on Foam” balance tests, the
two highest doses, 10 and 20 mg, were selected by the Company to be
tested against placebo in 72 patients in Part B of the trial.
Enrollment into Part B started in October 2020.
- COVID-19 pandemic causing temporary delay in enrollment.
Recruitment into the TRAVERS trial slowed down considerably in
early 2021 as several study sites postponed elective procedures and
temporarily reduced or suspended clinical research activities.
Candidates for participation in the TRAVERS trial undergo certain
types of neurosurgery, which are elective procedures. Recruitment
rates recovered somewhat in March, but they may continue to be
impacted for some time. Although sites are expected to catch up on
enrollment once COVID-19 related restrictions are relaxed, the
Company expects that results from the trial will become only
available in the third quarter of 2021, at the
earliest.
AM-301 for Protecting Against Airborne Viruses
and Allergens
- Initiated clinical investigation of AM-301 in allergic
rhinitis. In January 2021, the Company announced the initiation of
an open-label randomized cross-over study that will enroll 36
patients with allergic rhinitis to grass pollen. Study participants
are administered a single dose of AM-301 nasal spray or a
comparator product (one puff into each nostril) prior to controlled
pollen exposure for four hours in an allergen challenge chamber.
The challenge is repeated with the alternate treatment following a
wash-out period. The difference in the Total Nasal Symptom Score
(TNSS) between the two treatments over the 4-hour exposure will
serve as the primary efficacy endpoint; the investigation shall
demonstrate clinical non-inferiority of AM-301 to the comparator
product. Results from the clinical investigation are expected to
become available in a few weeks.
- Continued preclinical testing program. The Company has
initiated or planned several in vitro and in vivo tests to generate
additional data for the intended use in allergies and viral
infection. These will assess, among others, the potential capacity
of AM-301 reduce the viral titer post infection with SARS-CoV-2,
the effects of AM-301 on some of the new virus strains as well as
on other types of virus, and the durability of its barrier function
against pollen.
- Advanced preparations for launch in selected markets late in
the second quarter 2021. The Company expects to meet the
requirements for CE marking, a prerequisite for commercializing
AM-301 in Europe, in the second quarter of 2021 and is currently
scaling up the manufacturing process for launch of the product in
selected European markets towards the end of the quarter. In the
US, the Company is engaged in a dialogue with the FDA on the
proposed product development plan and the applicable regulatory
pathway. The Company continues to expect that AM-301 will be
eligible for clearance through the 510(k) pathway for the intended
use in allergy.
Corporate Developments
- Retained full control over Altamira Medica affiliate. The
Company increased the share capital of Altamira Medica Ltd.
(“Altamira”), its affiliate dedicated to developing and
commercializing AM-301, from CHF 0.5 to 3 million to accommodate
the progress of the program. A convertible loan of CHF 1.5 million
to Altamira was converted in two steps in shares of Auris Medical
Holding Ltd., allowing the Company to retain full control of its
affiliate.
- Raised CHF 16.6 million (gross) in equity. The Company
significantly strengthened its balance sheet and cash position
through several transactions in December 2020 and March 2021. These
included the placement of 2,000,000 common shares with certain
institutional investors at an offering price of $4.00 per share as
well as the exercise of 2,161,280 warrants held by the investors in
the May 2019 offering at an exercise price of CHF 4.34. All
warrants issued through the May 2019 Offering have been exercised
by now.
- Continued strategy review. In September 2020, the Company’s
Board of Directors started a process to explore, review and
evaluate a broad range of potential strategic alternatives with the
aim of unlocking the potential of the Company’s assets and maximize
shareholder value. In this context, the Board has been holding
discussions with several parties about certain potential
transactions. At this point, there can be no assurance the
Company’s strategy review will result in the completion of any
particular course of action, and there is no defined timeline for
completion of the review process.
Second Half 2020 Financial
Results
- Total operating expenses for the second half of 2020 were CHF
2.9 million compared to CHF 3.2 million for the second half of
2019.
- Research and development expenses for the second half of 2020
were CHF 2.0 million compared to CHF 2.0 million for the second
half of 2019.1
- General and administrative expenses for the second half of 2020
were CHF 1.1 million compared to CHF 1.1 million for the second
half of 2019.
- Net loss for the second half of 2020 was CHF 5.5 million, or
CHF 0.75 per share, compared to CHF 3.0 million, or CHF 0.83 per
share, for the second half of 2019.
- Cash and cash equivalents at December 31, 2020, totaled to CHF
11.3 million.
Full Year 2020 Financial
Results
- Total operating expenses for 2020 were CHF 5.3 million compared
to CHF 7.3 million for 2019.
- Research and development expenses for 2020 were CHF 2.9 million
compared to CHF 3.3 million for 2019.1
- General and administrative expenses for 2020 were CHF 2.6
million compared to CHF 3.9 million for 2019.
- Net loss attributable to owners of the Company for 2020 was CHF
8.2 million, or CHF 1.36 per share, compared to CHF 6.6 million, or
CHF 2.28 per share, for 2019.
The Company expects its total cash needs in 2021
to be in the range of CHF 11.5 to 13 million for expected total
operating expenses of CHF 7 to 7.5 million and expected capitalized
research and development costs of CHF 4.5 to 5.5 million. Further
cash needs may arise in 2021 related to the manufacture of AM-301
as well as marketing and sale activities as the Company intends to
commercialize the product in selected markets; these cash needs may
initially not be covered by cash flows from product revenues.
Conference Call & Webcast -
Rescheduled
Please note that Auris Medical will host a
conference call and webcast to present a business update on
Tuesday, April 13, 2021, at 8:00 am Eastern Time (2:00 pm Central
European Time). This event will be dedicated in full to the AM-301
program and replace the conference call and webcast which was
initially scheduled for today, March 31, 2021. Further details will
be provided shortly before the event.
About Auris Medical
Auris Medical is a clinical-stage company
dedicated to developing therapeutics that address important unmet
medical needs in neurotology, rhinology and allergy and CNS
disorders. The Company is focused on the development of intranasal
betahistine for the treatment of vertigo (AM-125, in Phase 2) and
for the prevention of antipsychotic-induced weight gain and
somnolence (AM-201, post Phase 1b). Through its affiliate Altamira
Medica, the Company is developing a nasal spray for protection
against airborne viruses and allergens (AM-301). 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, 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, 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, 2020, 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:
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, 2020 and 2019 (in CHF)
|
|
SIX MONTHS ENDED DECEMBER 31 |
|
TWELVE MONTHS ENDED DECEMBER 31 |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Other
operating income |
|
174,475 |
|
— |
|
174,475 |
|
— |
Research and
development |
|
(1,978,232) |
|
(2,020,990) |
|
(2,862,979) |
|
(3,325,281) |
General and
administrative |
|
(1,058,702) |
|
(1,130,596) |
|
(2,594,662) |
|
(3,933,863) |
Operating loss |
|
(2,862,459) |
|
(3,151,586) |
|
(5,283,166) |
|
(7,259,144) |
Interest
income |
|
258 |
|
17,882 |
|
258 |
|
17,882 |
Interest
expense |
|
(131,999) |
|
(3,367) |
|
(135,151) |
|
(28,628) |
Foreign
currency exchange gain/(loss), net |
|
(303,531) |
|
44,548 |
|
(333,553) |
|
(219,573) |
Revaluation
gain / (loss) from derivative financial instruments |
|
(2,254,575) |
|
132,480 |
|
(2,250,222) |
|
663,725 |
Transaction
costs |
|
— |
|
— |
|
(219,615) |
|
— |
Loss
before tax |
|
(5,552,306) |
|
(2,960,043) |
|
(8,221,449) |
|
(6,825,738) |
Income tax
gain/(loss) |
|
10,642 |
|
(67,557) |
|
21,284 |
|
193,837 |
Net
loss attributable to owners of the Company |
|
(5,541,664) |
|
(3,027,600) |
|
(8,200,165) |
|
(6,631,901) |
Other
comprehensive income/(loss): |
|
|
|
|
|
|
|
|
Items
that will never be reclassified to profit or loss |
|
|
|
|
|
|
|
|
Remeasurement
of defined benefit liability, net of taxes of CHF = 0 |
|
51,892 |
|
43,356 |
|
(26,118) |
|
(72,010) |
Items
that are or may be reclassified to profit or loss |
|
|
|
|
|
|
|
|
Foreign
currency translation differences, net of taxes of CHF = 0 |
|
72,466 |
|
9,780 |
|
88,862 |
|
16,446 |
Other
comprehensive income/(loss) |
|
124,358 |
|
53,136 |
|
62,744 |
|
(55,564) |
Total
comprehensive loss attributable to owners of the
Company |
|
(5,417,306) |
|
(2,974,464) |
|
(8,137,421) |
|
(6,687,465) |
|
|
|
|
|
|
|
|
|
Basic and
diluted loss per share |
|
(0.75) |
|
(0.83) |
|
(1.36) |
|
(2.28) |
Average
weighted number of shares outstanding |
|
7,432,839 |
|
3,628,614 |
|
6,014,146 |
|
2,909,056 |
AURIS MEDICAL HOLDING
Ltd.Condensed Consolidated Statement of Financial
Position (in CHF)
|
|
DECEMBER 31, 2020 |
|
DECEMBER 31,
|
|
|
|
2019 |
ASSETS |
|
|
|
|
Non-current assets |
|
|
|
|
Property and
equipment |
|
46,636 |
|
66,672 |
Intangible
assets |
|
9,115,410 |
|
6,765,613 |
Other
non-current receivables |
|
20,001 |
|
20,001 |
Total
non-current assets |
|
9,182,047 |
|
6,852,286 |
|
|
|
|
|
Current assets |
|
|
|
|
Other
receivables |
|
80,861 |
|
335,299 |
Prepayments |
|
277,589 |
|
434,231 |
Derivative
financial instruments |
|
— |
|
219,615 |
Cash and cash
equivalents |
|
11,258,870 |
|
1,384,720 |
Total
current assets |
|
11,617,320 |
|
2,373,865 |
|
|
|
|
|
Total
assets |
|
20,799,367 |
|
9,226,151 |
|
|
|
|
|
EQUITY
AND LIABILITIES |
|
|
|
|
Equity |
|
|
|
|
Share
capital |
|
114,172 |
|
1,650,380 |
Share
premium |
|
177,230,300 |
|
157,191,707 |
Foreign
currency translation reserve |
|
61,297 |
|
(27,565) |
Accumulated
deficit |
|
(160,635,879) |
|
(152,778,389) |
Total
shareholders’ (deficit)/equity attributable to owners of the
Company |
|
16,769,890 |
|
6,036,133 |
|
|
|
|
|
Non-current liabilities |
|
|
|
|
Derivative
financial instruments |
|
6,318 |
|
4,353 |
Employee
benefit liability |
|
867,376 |
|
760,447 |
Deferred tax
liabilities |
|
125,865 |
|
147,149 |
Total
non-current liabilities |
|
999,559 |
|
911,949 |
|
|
|
|
|
Current liabilities |
|
|
|
|
Loan |
|
523,920 |
|
— |
Derivative
financial instruments |
|
310,439 |
|
— |
Trade and
other payables |
|
762,453 |
|
938,247 |
Accrued
expenses |
|
1,433,106 |
|
1,339,822 |
Total
current liabilities |
|
3,029,918 |
|
2,278,069 |
Total
liabilities |
|
4,029,477 |
|
3,190,018 |
Total
equity and liabilities |
|
20,799,367 |
|
9,226,151 |
1 Does not include capitalized costs related to expenses for the
AM-125 program in accordance with IAS38.
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