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Corporate PresentationJanuary 2017
Caring for inner ear disability
• This document has been prepared by Sensorion (the "Company") and is provided for information purposes only. This document does not purport to contain comprehensive or complete
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Disclaimer
Page 2
Disabling Diseases Without Effective TreatmentSignificant $10B+ market opportunity*
Vertigo
InnerEar
Middle Ear
Hearing Loss - Tinnitus
Existing marketed drugs
have limited efficacy and
various side effects
No product license approval
to date
Page 3
Vestibule
Cochlea
* Source: Alcimed, Sensorion
“Pure player” in therapeutics for inner ear disorders (vertigo, hearing loss, and tinnitus)
– $10B untapped market opportunity*
Key Assets
– First-in-class small molecules administered orally
– De-risked pipeline entering phase 2 stage
Selection of drug candidates with clinical data
» SENS-111 for treatment of acute vertigo
» SENS-401 for treatment of sudden sensorineural hearing loss
7 patents families (composition of matter & method of use)
– Technology platform to support pipeline expansion and pharma collaboration
Execution capabilities to reach near term milestone events
– Publicly-traded company with strong balance sheet and experienced leadership team
Corporate Highlights
Page 4* Source: Alcimed, Sensorion
Significant Market Opportunity
* Based on estimated number of treatments per patient per year – excluding the age-related hearing loss segment; Source: Alcimed, Sensorion
Symptomatic treatment of crisis 123 million patients worldwide
Tinnitus(41 million
patients)$2.6B
Vertigo crisis(82 million
patients)$2.5B
$5.1B
Market size*
Anti-lesional curative treatment 21 million patients worldwide
$6.4B
Cancer treatment
toxicity(2 million patients)
$2.6B
$1.8B
Vertigo(8 million patients)
Hearing loss (11 million patients)
$2.0B
Market size*
$10B+ Global Market Potential
Page 5
Well Positioned Versus Competition to Address the Market
Page 6
Oral, IV, subQ drugs easy to take or give
Severe pathologies
Milder pathologies
Inner ear market
Invasive transtympanic injection by ENT specialists
Efficient, In-house Screening Platform Dedicated to Inner Ear
Page 7
15y+ academic & pharma know-how
Comprehensive toolbox to explore vestibular
& cochlear applications
AAALAC certified in-house platform
In vitro target assay
Functional cellular
Ex vivo assay
Toxicology – Manufacturing CMC*
Pharmacodynamics – In vivo disease models
Pharmacokinetics Local & Systemic
Functional cellular – ex vivo assay
In vitro target assay
First in inner ear patient with the best drug candidates
* Outsourced
Phase 2-ready PipelineScreening platform for next generation drugs
Page 8
1
2
3
Screening platform
Reproducible process for next generation products(Internal development & academic/pharma collaborations)
Phase2
Phase1
Product SENS-111Histamine H4 antagonistTreatment of acute vertigo
Product SENS-401Anti-lesional MOATreatment of sudden sensorineural hearing loss
Product Series SENS-300Undisclosed MOAPrevention of drug-induced ototoxicity
US IND granted
Orphan ODD in EU
Candidateselection
Product pipeline
(small molecules)
In vitro target assay
Functional cellular
Ex vivo assay
Toxicology – Manufacturing CMC*
Pharmacodynamics – In vivo disease models
Pharmacokinetics Local & Systemic
Functional cellular – ex vivo assay
In vitro target assay
Potential drug candidates
* Outsourced
Latest development in the histaminergic pathway applied to vertigo treatment
– First-in-class Histamine H4 Receptor antagonist (H4Ra) administered orally and non-sedative
Small molecule new chemical entity covered by composition of matter patent and use patents in inner ear disorders
until 2028 before patent term extension
Attractive drug profile
– MOA: restore balance by reducing neuronal activity in vestibules
– Positive preclinical comparative studies in acute vertigo
– Clinical tolerance demonstrated in 227 healthy volunteers up to 500 mg to date
– Pharmacokinetic profile allowing once-daily dosing
– Preliminary signal of activity on vertigo endpoints measured in clinical phase 1b study
– US IND granted by FDA
On-going implementation of an international Phase 2 study in Acute Unilateral Vestibulopathy with first patient
inclusion expected in Q1.2017
SENS-111 in Acute Vertigo
Page 9* Source: Alcimed, Sensorion
Study objectives
– Evaluate the safety of single and repeated ascending doses of SENS-111
– Determine the pharmacokinetic profile of SENS-111
– Document the effect of a routine vestibular stress test - caloric test
Phase 1 study design
– Randomized placebo controlled in 100 healthy volunteers
– Part A: Single oral dosing from 100 mg to 500 mg
– Part B: 4 to 7 days of daily oral dosing from 50 mg to 250 mg
Vestibular stress test: caloric test
– Routine test for ENT doctors to assess the vestibular function
– Unilateral irrigation of one auditory canal with cold water to induce a transient
vestibular dysfunction lasting for 2 to 3 minutes
– Recording of Vertigo sensation using visual analogic scales (VAS) and Nystagmus
using VideoNystagmoGraphy (VNG)
Page 10
SENS-111Phase 1b study successfully completed
Caloric test
Results*
– Safety
Well tolerated (16% mild adverse events on SENS-111 vs 36% on placebo)
No sedation
– Pharmacokinetics
Linear with doses up to 200 mg/day,
Long elimination half-life (24-48h)
Vestibular stress test
– Induced mild vertigo for 2 to 3 minutes
– Decreased duration of vertigo by 30% (28 sec decrease from 99 sec at baseline,
p<0.05)
– Activity in the 0 to 500-700 ng/mL concentration range
Conclusions
– SENS-111 is well tolerated and can be given once-daily
– Signal of anti-vertigo activity related to plasma concentration consistent with preclinical data
– Large dose window described in human to guide phase 2 dose selection
Page 11
SENS-111Phase 1b study successfully completed
seconds
* Presented at AAO-HNSF, September 18-21, 2016 - San Diego, USA and EACPT, October 6-9, 2016 – Opatija, Croatia
Acute unilateral vestibulopathy
– Pure vestibular dysfunction with sudden occurrence of severe acute vertigo lasting 4-7 days in patients aged between 30
and 60 years (no previous vestibular history, no hearing loss)
– Leads to immediate severely disabling postural imbalance with a tendency to fall
– Can lead to long term complications (40-50%): dizziness, imbalance, abnormal gait, unsteadiness
– Incidence of 3.5 to 15.5 per 100,000 people
– Not properly addressed by drug treatment:
Need for safe (non sedative) and effective drugs
Patient population of the SENS-111 Phase 2 study
Page 12
“AUV is assumed to be an ideal model for vestibular diseases. If this trial shows a benefit of any
agent, the drug is also going to be used in other diseases which lead to dizziness and vertigo”
Pr. Michael Strupp from Ludwig-Maximilians-University Munich, Germany
(KOL event, Sensorion webcast, November 29, 2016)
Primary objective
– To demonstrate the efficacy of SENS-111 100 mg and 200 mg versus placebo in the treatment of Acute Unilateral Vestibulopathy (AUV)
Secondary objectives
– Optimal dose regimen, safety, tolerability, plasma exposure, long term recovery, health economics & quality of life
Primary endpoint
– Vertigo intensity (visual analogic scale) measured by AUC of the VI-VAS in standing position
Other endpoints
– Worst vertigo intensity, Romberg test, nystagmus, nausea, disability (Dizziness Handicap Inventory and Vestibular Disorders Activities of Daily
Living Scale), time to unassisted walk, Health economics (Work Productivity and Activity Impairment questionnaire), PK, safety
Page 13
SENS-111 Phase 2 study objectives & End-points
A multicenter, randomized, double-blind, placebo-controlled study
to assess the efficacy and safety of 2 dose regimens of orally administered SENS-111 (100 mg and 200 mg)
given during 4 days in patients suffering from Acute Unilateral Vestibulopathy
Page 14
SENS-111 Phase 2 study design
Screening Treatment Follow-up
Randomization
D1 D2 D3 D4 D5 D14 D28
Visit Visit Visit Visit Visit Visit Visit
Dosing
Treatment arm – Dose 2
Placebo arm
Treatment arm – Dose 1 25 clinical sites in Europe,
USA, Korea
Correctly powered with 𝛼=5% and β=85% to detect 20% improvement vs placebo– Targeted sample size of 207
patients
– Interim analysis planned
Planning– Start: Q1 2017
– End: Q4 2018
First-in-class small molecule administered orally
– SENS-401 is one enantiomer of SENS-218 (azasetron) a racemate drug only marketed in Asia in
chemotherapy-induced nausea and vomiting (CINV)
– Patent estate
“Use of 5HT3 antagonists in lesional vestibular disorders” patent granted
Additional compound-related patents filed
Attractive drug profile
– Anti-lesional MOA protecting against nerve degeneration and synaptic uncoupling
– Positive preclinical studies* in noise-induced cochlear lesions leading to hearing loss
– Excellent clinical tolerance demonstrated with racemate SENS-218 in Asian and Caucasian
populations
SENS-401 for Sudden Sensorineural Hearing Loss
Page 15
* Presented at the Society for Neuroscience Annual Meeting 2016, November 12-16, 2016 - San Diego, USA
SENS-401Preclinical Data in Noise-induced Cochlear Lesions
Page 16
A daily oral administration of SENS-401 reduces auditory deficit and improves recovery
Randomized treatment post-noise induced trauma (2h exposure at 120 dB) in rats receiving either placebo or SENS-401 PO
Source: Dyrhfjeld-Johnsen et al 2016 SFN abstract,
*
* p< 0.05
Page 17Source: Dyrhfjeld-Johnsen et al 2016 SFN abstract,
Cochleograms
Placebo SENS-401
At D14 after audiometry, the cochleae were removed, and inner and outer hair cells were labelled and counted to obtain a cochleogram
A daily oral administration of SENS-401 reduced hair cell loss
SENS-401Preclinical Data in Noise-induced Cochlear Lesions
*
Cell count
Significant hair cell loss Limited hair cell loss
Histology of hair cell layers
* p< 0.001
Orphan Drug Designation (ODD) granted in Europe for SENS-401 in Sudden Sensorineural Hearing Loss
– Considered by ENT doctors as a case of emergency
– Rapid loss of hearing > 30 dB usually in one ear occurring either at once or over few days
– Secondary to the destruction of inner ear cells and their connections
– Often classified as idiopathic and affects typically adults in their 40s and 50s (prevalence of 4 in 10,000 people in EU i.e.
approx. 205,000 patients)
– No medicine approved
– About half of the patients will not recover their hearing or at least only partially
Active talks with EU & US Regulatory authorities
– Define path forward to Phase 2 program in patients suffering from sudden sensorineural hearing loss
SENS-401 Next Steps in Sudden Sensorineural Hearing Loss
Page 18
Founded in 2009 as an academic spin-off from INSERM, France
IPO in 2015 (Alternext Paris: ALSEN)
– Current share price: €4.95 (as of January 3, 2017)
– Market cap: €34m (as of January 3, 2017)
Financials
– Cash position: €9m (as of June 30, 2016) + €3m (equity line in August 2016)
– Equity line with potential additional funding of €19m
– H1 2016 cash used: €5m
Headquartered in Montpellier, France
– 17 Full time employees (o/w 13 in R&D)
Contact
– Laurent Nguyen, CEO / Paul Bikard, CFO
– E-mail: [email protected]
– Website: www.sensorion-pharma.com
Corporate overview
Page 19
Shareholding structure as of December 31, 2016
34,4%
43,1%
14,4%
4,8% 3,3% Innobio (Bpifrance)
Free float
Inserm Transfert Initiative
Founders and managers
Business Angels
Experienced Leadership Team in Life Sciences to Move Forward
Laurent NguyenChief Executive Officer MD, MPH
20+ years at Roche, Pierre Fabre, Merck KGaA, Hoechst-Roussel
– Solid Marketing & Sales and BD&L (Buy- & Sell-side) experience
Pierre Attali Chief Medical OfficerMD, MSc, Board certified in HGE
30+ years at Synthelabo, Sanofi, BioAlliance Pharma/Onxeo
– 10+ NCE/new formulations registered in EU/US
PhD in Neuroscience and post-doctoral research (Irvine-CA,
Harvard Medical School-Boston, USA)
– 15+ years research in CNS and inner-ear
Jonas Dyhrfjeld-JohnsenHead of PharmacologyPhD
20+ years as auditor (Coopers & Lybrand-PWC, Andersen-E&Y)
and CFO (Transgène, Prestwick Chemical)
– Solid Administration & Finance experience of SMEs
Paul BikardAdministration & Finance Director MSc Lyon Business school
Page 20
Significant Milestones & Investment Catalysts
* Presentation at international scientific conferences ** Subject to R&D progress and/or refinancingPage 21
Corporate & Clinical Platform
SENS-218: Phase 1 completed
SENS-401: selection of one enantiomer of SENS-218 (SFN*)
– Orphan Drug Designation granted in EU
SENS-111:
– preclinical comparative data (IEB*)
– FDA IND clearance
– phase 2 initiation in vertigo
Equity line (€3m exercised, left €19m)
2016
€8m raised during the IPO
SENS-218: Preclinical POC in hearing loss (SFN*, ARO*)
€8m private placement
SENS-111: Phase 1b study completed (AAO-HNS*, EACPT*)
Equity line (€3m exercised, left €22m)
Q2-Q42015
SENS-111: phase 2 patient recruitment in vertigo
SENS-401: clinical development in SSNHL hearing loss
SENS-300: selection of a drug candidate in drug-induced
ototoxicity
2017** Next generation programs
Pipeline expansion
Academic & Pharma collaborations
“Pure player” in therapeutics for inner ear disorders (vertigo, hearing loss, and tinnitus)
– $10B untapped market opportunity*
Key Assets
– First-in-class small molecules administered orally
– De-risked pipeline entering phase 2 stage
Selection of drug candidates with clinical data
» SENS-111 for treatment of acute vertigo
» SENS-401 for treatment of sudden sensorineural hearing loss
7 patents families (composition of matter & method of use)
– Technology platform to support pipeline expansion and pharma collaboration
Execution capabilities to reach near term milestone events
– Publicly-traded company with strong balance sheet and experienced leadership team
Invest and/or partner with us to change the gamePage 22
Why invest in Sensorion?
* Source: Alcimed, Sensorion
Thank You
Caring for inner ear disability