Innovative Treatments in Neurotology, Rhinology and Allergy and CNS Disorders

Corporate Presentation

January 2021

NASDAQ: EARS | Contact: investors@aurismedical.com

Forward-looking Statements

This presentation 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, whether the U.S. Food and Drug Administration ("FDA") and regulatory authorities in other

jurisdictions will agree with Auris Medical's plans for the regulatory pathway for AM-301 and its other product candidates, whether the safety and efficacy of AM-301, and other regulatory requirements, can be established to the satisfaction of the FDA and other regulatory authorities, 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.

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Dedicated to Targeted Drug Delivery

Innovative Treatments in Neurotology, Rhinology and Allergy and CNS Disorders

The Company

Key Development Programs

  • Founded in 2003
  • Pioneer role in neurotology
  • Expanding into rhinology and allergy and CNS disorders
  • Focus on nasal spray products
  • Headquartered in Hamilton, Bermuda
  • Operations in Basel, Switzerland
  • IPO in August 2014 on Nasdaq (EARS)

Betahistine nasal spray for treating acute vertigo

  • Reformulation of oral betahistine (histamine analog)
  • Intranasal delivery provides 5-29 x higher plasma exposure
  • Global market potential > $1bn in vertigo

Drug-free nasal spray to protect against airborne viruses and allergens

  • Applies thin gel film on nasal mucosa
  • Triple action: mechanical barrier, binds particles, humidifies mucosa
  • Global market for OTC allergy remedies > $4bn

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Investment Highlights

Large U.S. and

Great unmet

Relatively low

Existing

Several data

Partnering

Seeking to

global market

medical need

development risk

markets

events coming

potential

increase

opportunities

up in 2021

shareholder

value

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Project Pipeline

Partnering ProjectsActive Projects

Product

Indication

Preclin.

Phase 1

Phase 2

Phase 3

Next Key Milestones*

AM-125

Vertigo

Phase 2 enrollment completed

Betahistine nasal spray

(Q2 2021)

AM-201

Antipsychotic-

IND

Betahistine nasal spray

induced weight gain

(Q3 2021)

AM-301

Airborne viruses and

Allergen Challenge Chamber Trial

Drug-free nasal spray

allergens

(Q1/Q2 2021)

Sonsuvi® (AM-111)

ASNHL (sudden

Preparing for Phase 3 study Partnering

Brimapitide

deafness)

/ non-dilutive funding

Keyzilen® (AM-101)

Acute inner ear

Preparing for Phase 2/3 study

Esketamine

tinnitus

Partnering / non-dilutive funding

AM-102

Tinnitus

Select lead compound

Undisclosed

*Dates of key milestones are indicative and subject to change

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Intranasal Betahistine

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Intranasal Betahistine for Treating Vertigo

AM-125 Acts as a Vestibular Stimulant

Superior bioavailability of intranasal betahistine

  1. Agrawal et al., 2009
  2. Murdin et al., 2015
  3. Oral betahistine, manu- facturer prices (IMS).
  • 35.4% of the US population ≥ 40 years experience vestibular dysfunction1
  • Lifetime prevalence of vertigo interfering with daily activities is 3-8%2
  • Betahistine - unique vestibular stimulant
    • World-wideSOC, but no longer marketed in US
    • Current worldwide annual sales ~$450 million3
  • Rx options in US essentially limited to vestibular suppressants
  • AM-125addresses betahistine's weak point = poor oral bioavailability (~1%)
  • Capture part of existing oral betahistine market
  • Bring betahistine back to US

(ng/mL)

25

Oral 48 mg

5 mg

concentration

20

10 mg

15

20 mg

40 mg

plasma

10

betahistine

5

Median

0

0.0

0.5

1.0

1.5

2.0

2.5

3.0

Time post-dose (h)

  • Betahistine targets the histaminergic system
    • Increases inner ear and cerebral blood flow
    • Increases histamine turnover and enhances histamine release in CNS
    • Enhances release of acetylcholine, dopamine and norepinephrine in CNS
  • Relative bioavailability of AM-125 vs. oral betahistine (daily dose) = 5 to 29 x

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What Is Vertigo?

The problem

  • Spinning or wheeling sensation
  • Disorientation, imbalance, falls, nausea, vomiting, anxiety

Pathophysiology

  • Normally, left and right vestibular organs transmit consistent position and acceleration information to the brain
  • When a pathology disrupts signaling unilaterally, imbalance in vestibular tone can lead to illusory perception of movement

Potential causes

  • Functional: Meniere's disease, labyrinthitis
  • Neurosensory: vestibular neuritis
  • Mechanical: benign paroxysmal positional vertigo
  • Tumor surgery: vestibular schwannoma resection

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Higher Bioavailability Translates Into Better Efficacy

Posture

Acute, symptomatic effects Chronic, restoring effects

Support Surface (Normalized)

Postoperative Time (Days)

Tighilet et al. (2018). Betahistine treatment in a cat model of vestibular pathology: pharmacokinetic and pharmacodynamic approaches. Front Neurol. 11(9):431.

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Cats undergoing unilateral section of vestibular nerve

  • surgery-inducedacute vertigo

When treated with high dose betahistine, cats experienced:

  • Faster improvement of acute symptoms than lower dosages
  • Accelerated vestibular compensation
  • Significant increase of histaminergic activity in hypothalamus
  • Substantially higher bioavailability
  • Similar effect with low dose betahistine + MAO inhibitor selegiline

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AM-125 Development & Milestones

AM-125 Development Plan

Recent and Upcoming Milestones

Target Indication and Patient Benefit

  • Treatment of acute peripheral vertigo
  • Enhance vestibular function
  • Improve and accelerate vestibular compensation
  • Get patients back on their feet asap!

Clinical Milestones

First Ph1 trial in 40 healthy volunteers (2015)

Second Ph1 trial in 72 healthy volunteers (2018)

Both showing significantly higher bioavailability vs. oral delivery

Tandem Romberg Test

(sec.)

10

9

8

maintained

7

6

5

4

3

balance

2

1

0

Time

-1

0

1

2

3

4

5

6

Week

Placebo

1 mg

10 mg

20 mg

Interim results from TRAVERS Phase 2 trial Part A in 31 patients suffering from acute vertigo following neurosurgery, treated t.i.d. for four weeks

Treatment safe and well tolerated (maximum 40 mg t.i.d.)

Ph2 trial in 118 acute vertigo patients (ongoing)

Acute vertigo following neurosurgery

Treatment for 4 weeks, 2-weektreatment-freefollow-up

Battery of balance tests + HRQOL questionnaires

  • Part A: dose dependent improvement in balance + other outcomes
  • Continuing with 10 and 20 mg t.i.d. in Part B
  • Data read-out in summer 2021
  • IND and start Phase 3 in late 2021

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Potential Other Indications for Intranasal Betahistine

Further Histaminergic Targets

AM-201 in Antipsychotic-Induced Weight Gain

  • Key role of histamine in regulation of wide range of behavioral and physiological functions
    • Appetite, drinking, sleep, wakefulness, learning, attention and memory….
  • Available preclinical and clinical data suggest therapeutic benefits in…
    • Prader-WilliSyndrome
    • ADHD
    • Atypical depression
    • Epilepsy
    • Retrieval of forgotten memories
    • Cognitive function in dementia
  • Weight gain and somnolence major side effects of antipsychotics such as olanzapine (OLZ) or clozapine
    • Inhibit H1 histamine receptor
    • ~550,000 patients in US, EU Top5, JP
  • Ph1b study in healthy volunteers in Europe (n=80)
    • Concomitant treatment with olanzapine for 4 weeks
    • Treatment well tolerated
    • Dose dependent reduction in OLZ- induced weight gain
    • Mean reduction AM-301 30 mg vs. placebo = 0.9 kg (p<0.02)
  • LSmeans = 0.9 kg

4.5

P < 0.02

4.0

(kg)

3.5

3.0

gain

2.5

Weight

2.0

1.5

1.0

0.5

0.0

OLZ + AM- Controls 301 30 mg

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Protection against Airborne Viruses and Allergens

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We Seek to Treat or Protect Against Viruses and Allergens

1 www.aaaai.org, Allergy Statistics

  • Covid-19pandemic highlighted risks of airborne viruses
    • Sars-CoV-2,influenza, rhinovirus…
  • Airborne allergens
    • 7.8% of adult US population and 9% of children suffer from allergic rhinitis1
  • Up to 90% of air inhaled via nose
  • Limitations of masks, avoidance / distancing
  • AM-301is a medical device for self-protection
    • Strengthen nasal mucosa as body's first line of defense
    • Well-established,safe ingredients (drug free)
    • Apply 3 x per day or as needed
    • Polyvalence

Protective barrier

Binding of virus & allergen particles

Nasal mucosa

Humidification of nasal mucosa

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AM-301 Development & Milestones

AM-301 Development Plan

  • Further preclinical testing ongoing or planned
    • Additional viruses apart from SARS-CoV-2
    • Allergen protection
  • Clinical evaluation in allergen challenge chamber (Q1/Q2 2020)
  • Seeking EUA for Covid-19 in US
  • 510(k) for mitigation of allergic rhinitis symptoms
  • CE mark / conformity in Europe (Q2 2021)
  • Seeking commercialization with partner(s)
    • Positioning as "Over the counter" product
  • Sustainable market in allergy management

Highly Effective in Sars-CoV-2 Assay

Assay in fully differentiated human nasal epithelia inoculated with SARS-CoV-2, daily treatment with AM-301 over 4 days

  • Average virus titers with AM-301 were
    • 90.0% lower after 48 hours (p<0.01)
    • 99.2% lower after 72 hours (p<0.001)
    • 99.4% lower than 96 hours (p<0.001)

than those observed in controls).

  • Even when unbound virus was not removed daily through apical washing, allowing the virus to accumulate in the culture for 4 days, the reduction in viral titer was 92.4%.

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Hearing Loss and Tinnitus Programs

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Sonsuvi ® (AM-111) and Keyzilen® (AM-101)

Sonsuvi ® (AM-111) for Acute Inner Ear Hearing Loss

  • Prevents or attenuates hearing loss by protecting hair cell functionality
  • Cell-penetratingpeptide (brimapitide; JNK inhibitor)
  • Single dose by intratympanic injection
  • Orphan Drug (FDA and EMA), Fast Track (FDA)
  • Phase 3 trial demonstrated significant and clinically relevant improvement in hearing recovery in acute profound hearing loss
  • Second Phase 3 trial planned, incorporating regulatory feedback

Outer hair cells

Inner hair cells

Guinea pig treated with AM-

Treated with placebo four

111 four hours post trauma

hours post trauma

Keyzilen® (AM-101) for Acute Inner Ear Tinnitus

  • Attenuates tinnitus intensity by blocking aberrant excitation of NMDA receptors
  • Small molecule (esketamine; NMDA receptor antagonist)
  • Three doses by intratympanic injection
  • Fast Track
  • Two positive Phase 2 trials
  • Failed to meet endpoints in Phase 3 trials primarily due to design issues
  • Phase 2/3 trial planned, incorporating regulatory feedback
    • Incorporating learnings from Phase 3
    • Including novel objective diagnostic and measures

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Conclusion

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Upcoming Value-Creating Milestones

Strategic review of the company initiated in September 2020 in an effort to unlock the potential of Auris's four clinical stage programs and several pre- clinical projects; Evaluating all options including but not limited to partnering of clinical and pre-clinical programs, or sale or merger of the company

Q1 2020

Additional in vitro AM-301 data

Q2 2021

Clinical AM-301 data

Q2 2021

Launch AM-301 in selected markets

Q2 2021

Completion recruitment Part B AM-125 Ph2 trial

Q3 2021

Read-out from Part B AM-125 Ph2 trial

Q4 2021

IND AM-125

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Investment Highlights

Large U.S. and

Great unmet

Relatively low

Existing

Several data

Partnering

Seeking to

global market

medical need

development risk

markets

events coming

potential

increase

opportunities

up in 2021

shareholder

value

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Appendix

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Our Core Team

Thomas Meyer, PhD

Founder, Chairman and CEO

CEO and BoD member Disetronic

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

Elmar Schaerli, CPA

Chief Financial Officer

  • 30 years private and public company finance and accounting experience in biotech and medtech

Founder and CEO of ante treuhand (fiduciary firm)

Ilja Hohenfeld, PhD

Fabio Fais, MSc

Director, Translational Medicine

Director, CMC Projects

Global Trial Leader at Actelion

DP Project Leader (Fellow)

at Novartis Pharma

Clinical Project Manager at ICON

Team Leader Formulation Dev.,

Crucell

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Intellectual Property

ProgramCoverage

AM-125 /AM-201

  • US Patent 10,456,386 «Pharmaceutical Composition Comprising Betahistine» (to 2038)
  • Corresponding European patent allowed
  • Up to 10 years of data protection in Europe
  • Acquired two US patents relevant to antipsychotic induced weight gain (to 2024)
  • Acquired rights to two US patents covering use in ADHD and depression (to 2025/27)

AM-111

AM-101

AM-301

  • Substance matter patents (to 2027+)
  • Use patent (to 2023)
  • Orphan drug designation
  • Use patents (to 2025/2027)
  • Formulation patent (to 2025)
  • US provisional application filed

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Financial Highlights

Continued reduction in operating expense levels

Operating Loss

6

MILLIONS

4

-41%

CHF

CHF 4.1

2

CHF 2.4

0

6M ended June 30, 2019

6M ended June 30, 2020

Key figures

6M 2020

6M 2019

(CHF 1,000, except per share data)

Operating expenses

2,420

4,107

Net loss

2,658

3,604

Per share

0.58

1.66

Total liabilities

3,485

3,190

Shareholders' equity

4,479

6,036

Cash inflow from $8 m offering + warrant exercises in Dec 2020: $ 13.4 m

Cash runway: to end of 2021 or into Q1 2022

Shares outstanding (Dec 31, 2020): 11.42 million

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Auris Medical Holding Ltd. published this content on 04 January 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 22 January 2021 15:55:06 UTC