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.
1 | www.aurismedical.com | NASDAQ: EARS |
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
2 | www.aurismedical.com | NASDAQ: EARS |
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 | ||||||
3 | www.aurismedical.com | NASDAQ: EARS |
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
4 | www.aurismedical.com | NASDAQ: EARS |
Intranasal Betahistine
5 | www.aurismedical.com | NASDAQ: EARS |
Intranasal Betahistine for Treating Vertigo
AM-125 Acts as a Vestibular Stimulant
Superior bioavailability of intranasal betahistine
- Agrawal et al., 2009
- Murdin et al., 2015
- 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
6 | www.aurismedical.com | NASDAQ: EARS |
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
7 | www.aurismedical.com | NASDAQ: EARS |
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.
8
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
www.aurismedical.com | NASDAQ: EARS
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
9 | www.aurismedical.com | NASDAQ: EARS |
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
10 | www.aurismedical.com | NASDAQ: EARS |
Protection against Airborne Viruses and Allergens
11 | www.aurismedical.com | NASDAQ: EARS |
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 |
12 | www.aurismedical.com | NASDAQ: EARS |
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%.
13 | www.aurismedical.com | NASDAQ: EARS |
Hearing Loss and Tinnitus Programs
14 | www.aurismedical.com | NASDAQ: EARS |
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
15 | www.aurismedical.com | NASDAQ: EARS |
Conclusion
16 | www.aurismedical.com | NASDAQ: EARS |
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 |
17 | www.aurismedical.com | NASDAQ: EARS |
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 | ||||||
18 | www.aurismedical.com | NASDAQ: EARS |
Appendix
19 | www.aurismedical.com | NASDAQ: EARS |
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 |
20 | www.aurismedical.com | NASDAQ: EARS |
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
21 | www.aurismedical.com | NASDAQ: EARS |
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
22 | www.aurismedical.com | NASDAQ: EARS |
This is an excerpt of the original content. To continue reading it, access the original document here.
Attachments
- Original document
- Permalink
Disclaimer
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