UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 6-K
 
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of February, 2015
___________________________
 
Commission File Number: 001-36582

Auris Medical Holding AG
(Exact name of registrant as specified in its charter)

Bahnhofstrasse 21
6300 Zug, Switzerland
(Address of principal executive office)


Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

Form 20-F
X
 
Form 40-F
 


Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

Yes
   
No
X


Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

Yes
   
No
X

 
 
 

 
 
SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

   
Auris Medical Holding AG
     
By:
/s/ Thomas Meyer
       
Name:
Thomas Meyer
       
Title:
Chief Executive Officer

Date: February 11, 2015
 


 
 

 
 
EXHIBIT INDEX
 
Exhibit Number
Description
99.1
Company Presentation

 

 
 

 
 
 


Company Presentation

February 2015

0
 

 
 


Forward Looking Statements / Safe Harbor

[] This presentation and the accompanying oral commentary contain "forward
-looking" statements that involve substantial risks and uncertainties. All
statements other than statements of historical facts contained in this
presentation and the accompanying oral commentary, including statements
regarding our future financial condition, business strategy and plans and
objectives of management for future operations, are forward looking statements.
In some cases, you can identify forward -looking statements by terminology such
as "believe," "will," "may," "estimate," "continue," "anticipate," "intend,"
"should," "plan," "might," "approximately," "expect," "predict," "could,"
"potentially" or the negative of these terms or other similar expressions.
Forward looking statements appear in a number of places throughout this
presentation and the accompanying oral commentary and include statements
regarding our intentions, beliefs, projections, outlook, analyses or current
expectations concerning, among other things, our ongoing and planned
preclinical development and clinical trials, the timing of and our ability to
make regulatory filings and obtain and maintain regulatory approvals for our
product candidates AM-101 and AM-111, our intellectual property position, our
ability to develop commercial functions, expectations regarding clinical trial
data, our results of operations, cash needs, financial condition, liquidity,
prospects, growth and strategies, the industry in which we operate and the
trends that may affect the industry or us.

[] Forward -looking statements involve known and unknown risks, uncertainties,
assumptions and other factors that may cause our actual results, performance or
achievements to be materially different from any future results, performance or
achievements expressed or implied by the forward -looking statements. These
include, but are not limited to, the timing and conduct of clinical trials of
our product candidates, the clinical utility of our product candidates, the
timing or likelihood of regulatory filings and approvals, our intellectual
property position and our financial position, including the impact of any
future acquisitions, dispositions, partnerships, license transactions or
changes to our capital structure, including future securities offerings.
Forward -looking statements represent our management's beliefs and assumptions
only as of the date of this presentation. Except as required by law, we assume
no obligation to update these forward -looking statements publicly, or to
update the reasons why actual results could differ materially from those
anticipated in the forward -looking statements, even if new information becomes
available in the future.

1
 

 
 


Corporate Overview

[] Auris Medical is a clinical late stage company dedicated to developing inner
ear therapeutics

[] Headquartered in Zug/Basel, Switzerland

[] Founded in 2003

[] IPO completed in August 2014

[] Nasdaq Global Market: EARS

[] 28.9M  shares

[] Market cap $152M (*)

(*) As at February 6, 2015

2
 

 
 


Investment Highlights

1 Tinnitus and hearing loss represent a large unmet medical need

2 Injectable ear therapeutics to change otology as profoundly as injectable eye
therapeutics changed ophthalmology

             Clinical Proof of Concept demonstrated with 2 late stage 3 product
candidates

4 High margin products with $2B addressable global market potential

3
 

 
 


Leadership Team

Thomas Meyer, PhD

Founder, Chairman and CEO

[] Former CEO and BoD member of Disetronic (diabetes care)

[] Instrumental in Disetronic's IPO and managing 20% sales CAGR over many
years

[]  3 bn CHF market cap

Bettina Stubinski, MD, MBA

Chief Medical Officer

[] Former Global Head Clinical Development Multiple Sclerosis at Merck Serono

[] Former Head Clinical Research at Berlin Chemie (Menarini Group)

Sven Zimmermann, PhD

Chief Financial Officer

[] Former CFO of PregLem (women's health)

[] Key role in company's sale to Gedeon Richter

[] Former health care research analyst with UBS

Highly qualified management team with significant experience in the biotech
industry

4
 

 
 


Development Pipeline

Product     Indication                    Preclin. Phase 1 Phase 2 Phase 3       Next Key Milestones(1)
----------- ----------------------------- -------- ------- ------- ------- -----------------------------
                                                                           Data TACTT2
            Acute inner ear tinnitus                                                         Early 2016
AM-101                                                                     Data TACTT3
            ----------------------------- -------- ------- ------- ------- ----------------- -----------
Esketamine
            Post-acute inner ear tinnitus                                  TACTT3 interim    Early 2015
----------- ----------------------------- -------- ------- ------- ------- ----------------- -----------
AM-111      Acute inner ear hearing loss                                   Trial start       Mid 2015
            ----------------------------- -------- ------- ------- ------- ----------------- -----------
D-JNKI-1    Meni[]re's disease                                             Trial application Mid 2015
----------- ----------------------------- -------- ------- ------- ------- ----------------- -----------
AM-102                                                                     Lead compound
            Tinnitus                                                                         Early 2015
Undisclosed                                                                selected
----------- ----------------------------- -------- ------- ------- ------- ----------------- -----------
AM-123                                                                     Lead compound
            Rhinology                                                                        Early 2015
Undisclosed                                                                selected
----------- ----------------------------- -------- ------- ------- ------- ----------------- -----------


Dates of key milestones are indicative and subject to change

Focus on acute inner ear injury with known biology and acute medical needs

5
 

 
 


Inner Ear Disorders -- Great Unmet Medical Need

Tinnitus

[] About 16M patients in the US have tinnitus symptoms severe enough to seek
medical attention

[] About 2M patients cannot function on a normal day-to-day    basis

[] Tinnitus is now the #1 service related disability for all veterans

[] Annual service-related  disability payments for tinnitus to veterans from
all periods of service are expected to exceed $2.75B   by the end of 2016

Hearing Loss

[] 17% of US adults have some degree of hearing loss(1)
[] More than 30M Americans are exposed to hazardous sound levels on a regular
basis(1)
[] Hearing loss is the #2 service related disability for all veterans
[] Only 1 out of 5 people who could benefit from a hearing aid actually wears
one(1)
[] 60,000 people in the US are affected by sudden deafness p.a.(2)

Source: American Tinnitus Association

Sources: (1) American Tinnitus Association, (2) Rauch and Geller, 2012

No effective Standard of Care, no FDA or EMA approved drugs available

6
 

 
 


Some Patient Testimonials

"I have been suffering with tinnitus for 4 months. I will admit my life has
turned for the worse since this occurred. Lost interest in all things and
really don't go out much anymore ...You don't know how I would like to get back
to the way I was."

"You really need to hurry with this new drug. There are millions of people who
are suffering intensely. How would you like it if your baby daughter of only 27
years old called you all day long crying and saying life isn't worth living if
you have tinnitus. "

"Sometimes I geta rumble, most of the time it's just a high pitch that gets
progressively worse at night time and really bad when I'm sick... I really
don't want to as I'm always barely getting by but if I had to take on a loan to
get rid of this I would."

"I feel shattered, I am suffering from tinnitus, violent, invalidating since 4
years and a half, 24 hours a day. Sometimes I look at my box with sleeping
pills and a funny desire is creeping up."

"I have got tinnitus for one month. I have taken glucocorticoids and
vasodilators since the beginning but it didn't improve anything ... Would it be
possible to be enrolled for the trial? I'm willing to pay anything if it is
necessary. "

7
 

 
 


Intratympanic Drug Delivery

[GRAPHIC OMITTED]

[] Short office based ENT procedure

[] Biocompatible, biodegradable sodium hyaluronate gel

[] 0.25  mL injected from pre-filled  syringe under local anesthesia

[] 20-30'  resting period for diffusion across round window membrane

[] Site specific delivery with minimal systemic exposure

[GRAPHIC OMITTED]

[] Proprietary gel formulation

[] IP broadly directed to polymer-based formulations

8

 

 
 

[GRAPHIC OMITTED]



9
 

 
 


AM-101 for Acute Inner Ear Tinnitus

    Significant [] Similar to pain, tinnitus is an unpleasant, unwanted
sensation Unmet Medical [] Significant impact on sleep, ability to concentrate
or relax Need [] Substantial emotional distress and reduced quality of life

Attractive [] Treat tinnitus within first 3 months (= acute) to prevent chronic
suffering Product [] One single treatment cycle comprising 3 i.t. injections
over 3-5 days Profile [] Persistent improvement in tinnitus symptom and impact


Favorable [] No effective SoC, no FDA or EMA approved drugs available Market []
Specialty care market / significant interest by ENTs Dynamics [] Attractive
price reference points (e.g. Tinnitus Retraining Therapy)

Low Risk [] Esketamine is a well-known API
Regulatory [] Extensive interactions with FDA and EMA
Pathway [] Agreement on endpoint model

10
 

 
 


AM-101 Mechanism of Action

[] Cochlear NMDA receptors

-- Regulate surface expression of AMPA receptors -- Neurotrophic role post
acute insult

[] Not involved in normal hearing

[] Acute injury leads to NMDA mediated glutamate excitotoxicity

-- Pathologic Ca(2+) influx into postsynapse -- Similar e. g.  to stroke

[] Aberrant excitation of auditory nerve perceived as tinnitus

-- May become permanent

[] AM-101  / Esketamine is a potent NMDA receptor antagonist

[GRAPHIC OMITTED]

11
 

 
 


AM-101 Clinical Development

                                 Tinnitus Etiology                                             AM-101
        ------------------------ ------------------------------- -------------------------
              Traumatic insult       Otitis media                           Idiopathic        (mg/mL)
------- ------------------------ ------------------------------- ------------------------- -------------
                                                                                                   1 x
Phase 1          Well tolerated                                                              0.03, 0.09,
   N=24       Trend for efficacy                                                             0.27, 0.81
------- ------------------------ ------------------------------- ------------------------- -------------
Phase 2  Dose dependent reduction in various tinnitus PROs              Heterogeneous              3 x
TACTT0       Statistically significant and clinically meaningful Efficacy only in subgroup  0.27 or 0.81
  N=248                                 Well tolerated             Development stopped      over 3 days
        -------------------------------------------------------- ------------------------- -------------
                                                                                             1 x 0.81 or
TACTT1  Meta-analysis with TACTT0 showing best results with                                    3 x 0.81
   N=84                         3 x AM-101 over 3 days                                     over 2 weeks
------- --------------------------------------------------------                           -------------
Phase 3
TACTT2      []tinnitus loudness as primary efficacy outcome                                    3 x 0.87
  N=330                  accepted by both FDA and EMA                                          over 3-5
TACTT3                                   SPA in place                                             days
  N=300
        ------------------------ ------------------------------- ------------------------- -------------


Consistent signals in traumatic and otitis media tinnitus throughout clinical
trials

12
 

 
 


Proof of Concept in Phase 2 (TACTT0)

Tinnitus Loudness (Unilaterals)

48% reduction from baseline

Placebo

AM-101 0.27 mg/mL

AM-101 0.81 mg/mL

[GRAPHIC OMITTED]

Baseline (on 0-100 scale): 50-55 points Clinically relevant change = 20 points
56% responders high dose vs. 23% placebo group N=78 (only unilateral tinnitus
patients)

Tinnitus Loudness (Uni- and Bilaterals)

44% reduction from baseline

[GRAPHIC OMITTED]

Baseline (on 0-100 scale): 50-55 points Clinically relevant change = 20 points
56% responders high dose vs. 32% placebo group N=118 (note: bilateral tinnitus
treated only unilaterally)

Patients with acute tinnitus following acute acoustic trauma or otitis media.

13
 

 
 


Proof of Concept in Phase 2 (Cont'd)

Key Outcomes Day 90

Outcome variable         Placebo      AM-101 0.27        AM-101 0.81
                                           g/mL              g/mL
            ANCOVA Least Square Mean Change from Baseline
[]Tinnitus loudness, 0-           1.4            16.0               24.1
100 pts.                                     0.0308*          0.0005***
                         ------------ ------------------ ----------------
[]Tinnitus annoyance,           10.8             21.7               27.8
0-100 pts.                                    0.0805          0.0047***
                         ------------ ------------------ ----------------
[]Sleep difficulties, 0-        11.8             29.8               38.7
100 pts.                                     0.0234*          0.0003***
                         ------------ ------------------ ----------------
[]Tinnitus Impact (THI-           2.5              5.5                5.9
12), 0-24 pts.                               0.0400*            0.0124*
                         ------------ ------------------ ----------------
Global Patient Impression of Change in Tinnitus Severity
-------------------------------------------------------- ----------------
[]Much" or []very much          35%              44%                64%
improved"

Patient Testimonial (Tinnitus Forum)

"I found a quality of quasi-optimal sleep, I am now sleeping well (I insist
because it was the main discomfort before...) Some days, I didn't hear it
anymore, and over long periods of time (especially at work where I work in a
very quiet office), and I really needed to pay attention to hear it again."

TACTT0 participant, receiving AM-101 0.81 mg/mL

Significant at 5% level, *** 0.5% compared with placebo Patients with
unilateral tinnitus following acute acoustic trauma or otitis media, n= 78.
Primary endpoint tinnitus loudness incl. bilaterals (n=111): 22.4 pts. AM-101
0.81 mg/mL vs. 7.1 pts. placebo, p=0.0033

14
 

 
 


AM-101 Phase 3 Program -- Pivotal Studies

                                          TACTT2                  TACTT3
Region/countries                   USA, Canada, CZ      8 European countries
                                  Tinnitus following acute traumatic cochlear insults or otitis media
Population                                                         (3 months from onset)
# Patients                                    330                     300
# Sites                                       ~60                     ~60
Treatment                            AM-101 0.87 mg/mL or placebo (ratio 3:2), 3 x over 3-5 days
Primary endpoint                                []Tinnitus Loudness (TLQ) Day 84 (0-10 scale)
Treatment effect(1)          []TLQ1.25 (2.2) points    []TLQ1.5 (2.2) points
Effect size(1)                           0.5 (0.8)               0.6 (0.8)
Co-primary endpoint  []Tinnitus Functional Index Day 84                  -
Treatment effect                     []TFI 10 points                     -
Effect size(2)                           0.4 (0.6)
Readout                                   Q1 2016                 Q1 2016


Assumptions for 90% statistical power. (1) TACTT0 values in brackets for
reference, (2) THI-12 values from TACTT0 in brackets for reference

15
 

 
 


AM-101 Phase 3 Program -- Further Studies

[] Post-Acute Stage

[] Multiple regression analysis of TACTT0 suggests efficacy beyond 3-month
acute stage

[] Exploring extension of therapeutic time window up to 12 months in a second
stratum in TACTT3 (300 patients)

[] Interim analysis for futility at enrolment midpoint: Q1 2015

Follow-On Open Label Trials

[] Open label follow-on   trials

[] AMPACT1 (TACTT2)

[] AMPACT2 (TACTT3)

[] Objectives: -- Motivate patients

-- Generate safety data for FDA

[] Up to 3 additional (R)x cycles / replications of TACTT studies

[] All patients receive AM-101  0.87  mg/mL

[] Read-out  during NDA

16
 

 
 


AM-101 Market Potential

Primary Market Research

[] 53 US ENT doctors surveyed (1)

-- 41 general ENTs

-- 12 otologists

[] See an average of 43.5  tinnitus patients in an average month

[] 37.7%  of their tinnitus patients seek treatment during the acute stage (up
to 3 months from onset)

[] 73.6%  of respondents expect their monthly tinnitus patient volume to
increase if an approved i. t.  treatment were available

[] 42.6%  of their tinnitus patients considered as candidates for AM-101  type
of product

(1) Online survey conducted by MedaCorp, Inc. in April 2014

Market Potential

[] Target label = acute peripheral tinnitus following traumatic injury to the
cochlea or otitis media

[] Onset factors account for approx.  25% of tinnitus cases

[] 10% of tinnitus patients seeking treatment would fall within label

[] Bilateral patients: ca.  30%

[] Estim.  250,000 treatable ears p. a.  in US

[] US market potential: $750M

[] Upside from

-- Other onset factors

-- Potential extension of time window

-- More and earlier GP referrals

17
 

 
 



18
 

 
 


AM-111 for Acute Inner Ear Hearing Loss

    Significant [] Significant impact on cognitive and auditory function Unmet
Medical [] Substantially reduced quality of life Need [] Hearing aids cannot
replace functional cochlea

Attractive [] Preserve cochlear function before hearing loss becomes
irreversible Product [] Early, rapid and persistent improvement Profile []
Single dose intratympanic injection, well tolerated

Favorable [] No universal standard of care / no FDA or EMA approved drugs
Market [] Specialty care market -- significant interest by ENTs Dynamics []
Attractive price reference points (e.g. hearing aid)

 Low Risk [] 3 x protocol assistance with EMA , Pre-IND meeting with FDA
Regulatory [] Orphan drug designation (FDA and EMA) Pathway [] Endpoints based
on "classic" audiometry

19
 

 
 


AM-111's Mechanism of Action

[] C-jun  N-terminal  Kinase  (JNK) stress kinase involved in various cochlear
insults

[] Plays key role in apoptosis and inflammation

[] D-JNKI-1    is a 31 amino acid intracellular peptide inhibiting JNK mediated
transcription

[] Therapeutic time window to preserve sensorineural structures / hearing

[] Otoprotection demonstrated in various acute cochlear injury models, e. g.

-- Acute noise trauma

-- Ischemia

-- Infection

-- Inflammation

-- Surgery trauma

[]Otoprotection Following Acute Noise Trauma

Guinea pig hair cells following AAT and treatment with AM-111 4 h post trauma

[GRAPHIC OMITTED]

Guinea pig hair cells following AAT and treatment with placebo 4 h post trauma

[GRAPHIC OMITTED]

20
 

 
 


AM-111 Clinical Development

[] Two trials completed, including one phase 2 RCT

[] Sudden deafness (90%) and acute acoustic trauma (10%) patients

[] Favorable safety profile with no systemic side effects

[] Proof of concept in severe to profound hearing loss patients

-- Hearing loss of 60 dB or more -- highest medical need

-- Mild to moderate cases: High spontaneous recovery preventing demonstration
of clinically relevant improvement [] no longer pursued

[] Audiometric outcomes

-- Rapid and persistent improvement in hearing loss and speech discrimination
-- Results significant and clinically meaningful

[] Effect on tinnitus: higher rate of complete remission

[] Dose finding to be completed

[] Phase 3 program under preparation

-- Protocol assistance from EMA

-- Pre-IND  meeting  with FDA

21
 

 
 


Proof of Concept in Phase 2

Key Outcomes

                                                          AM-111 AM-111 Outcome
variable Placebo 0.4 mg/mL 2.0 mg/mL

ANCOVA Mean Change to Day 7 (Primary Endpoint)

[] Hearing threshold (LS 17.9 29.9 22.7 mean, dB) 0.0174* 0.3186

[] Speech discrimination 9.1 27.4 23.2
(LS mean, %) 0.0186* 0.0609

Frequency at Day 90

[] Complete tinnitus 26 56 48 remission (%) 0.045* 0.152

ANCOVA with baseline value as covariate.
* significant at 5% level compared with placebo
Improvement at 3 worst affected contiguous hearing thresholds (pure tone
average, PTA) in dB, speech discrimination score (20 monosyllabic words) in %
at 80 dB stimulus level Clinically relevant change = 10 dB = twice as loud /
half as loud

% Recovery of Hearing Loss


[GRAPHIC OMITTED]

AM-111 0.4 mg/mL AM-111 2.0 mg/mL Placebo

Treatment benefit of AM-111 0.4 mg/mL against placebo clinically relevant at
all time points

Patients with severe to profound hearing loss, n = 92 (n =76 for tinnitus
data).

22
 

 
 


AM-111 Phase 3 Program

                                            HEALOS           US trial
Region                                   Europe, Asia            US
Population           Severe to profound sudden deafness,     ASNHL
                              within 72 hours from onset (subtype tbd)
# Patients                                       255             tbd
# Sites                                        70-80             tbd
Treatment            1 x AM-111 0.4 mg/mL, 0.8 mg/mL or          tbd
                                   placebo (ratio 1:1:1)
Primary endpoint             []Hearing threshold Day 28
Treatment effect(1)      []Hearing threshold 12 (14) dB
Effect size(1)                              0.5 (0.6)
Readout                                     Q1 2017


Assumptions for 90% statistical power. (1) Phase 2b values in brackets for
reference.

23
 

 
 


AM-111 Market Potential

Primary Market Research

[] 53 US ENT doctors surveyed (1)

-- 41 general ENTs

-- 12 otologists

[] See an average of 11.2  patients with ISSNHL and 6.3  patients with AAT in
an average month

[] 39.9%  seek treatment within first 3 days and 43.3%  have severe to profound
hearing loss

[] 64.2%  of respondents expect their monthly ASNHL patient volume to increase
if an approved i. t.  treatment were available

[] 59.9%  of their ASNHL patients considered as candidates for AM-111  type of
product

(1) Online survey conducted by MedaCorp, Inc. in April 2014

Market Potential

[] Target label = severe to profound ASNHL

-- Sudden deafness (ISSNHL)

-- Acute noise trauma

-- Surgery trauma

[] Bilateral patients: ca.  10%

[] Estim.  105,000 treatable ears p. a.  in US

[] US market potential: $500M

[] Upside from

-- Other onset factors

-- More and earlier GP referrals

24
 

 
 


[GRAPHIC OMITTED]


25
 

 
 



Strong Intellectual Property Portfolio

1 AM-101

[] Use patents issued in 40 countries -- 2024 to 2028 (US)

[] Controlled substance in major markets (schedule III in US)

[] Esketamine currently not marketed in US

2 AM-111

[] Substance of matter patents issued/allowed in 54 countries -- 2020 to 2027
(US)

[] Use patents (hearing loss) issued/allowed in 54 countries -- 2022 to 2027
(US)

[] Additional filings related to tinnitus and Meni[]re's

3 Polymer Formulations

[] Patents related to AM-101  issued/allowed in 15 countries -- 2025

[] Continuation filed for other polymers + other active substances

26
 

 
 


Market Strategy

Commercialization

[] Retain full rights in US and key EU markets to commercialize AM-101  and
AM-111

[] Targeting about 5,000 otologists, neurotologists and general ENTs in US

-- Specialist sales force to call on ENTs -- 40-50  reps in US

-- Smaller number needed than in ophthalmology

[] Selectively partnering in ROW

Further Expansion

[] Product life cycle management

-- Formulation -- Dosing

[] Indication expansion

-- Additional tinnitus or hearing loss triggers -- Extension of therapeutic
time window

[] Additional ENT products

-- In-house  development -- Partnering

27
 

 
 


Financial Overview

Key figures (CHF)                                             Nine months ended               Nine months ended
                                                                    Sep 30, 2014                    Sep 30, 2013
Research and development                                                     -13,036,450                     -10,327,366
General and administrative                                                     -3,552,021                      -1,010,096
Operating loss                                                               -16,588,471                     -11,337,462
Net loss for the period attributable to owners of the Company                -14,212,011                     -11,505,722
Basic and diluted loss per share                                                        -0.69                           -0.79
Cash and cash equivalents                                                     61,892,660                      23,865,842

[] $60.7M   raised through IPO in August 2014

[] Fund RandD expenses for

[] AM-101  clinical program beyond phase 3 read-out

[] Part of AM-111  phase 3 program and early stage programs

Cash runway until mid 2016

28
 

 
 


Investment Highlights

1 Tinnitus and hearing loss represent a large unmet medical need

2 Injectable ear therapeutics to change otology as profoundly as injectable eye
therapeutics changed ophthalmology Clinical Proof of Concept demonstrated with 2 late stage 3 product
candidates

4 High margin products with significant global sales potential

29
 

 
 


[GRAPHIC OMITTED]



30