Medicinova, Inc. · NASDAQ:MNOV
Medicinova — Investor Presentation (November 2016)
36 slides from Medicinova's investor presentation, Nov 10, 2016
Slide 1: Corporate Presentation November 2016
Exhibit 99.1 Corporate Presentation November 2016
Slide 2: Forward-Looking Statements
Forward-Looking Statements forward-looking disease, include, include involve events MN-001, potential risks product associated risk commencement, regulatory sufficient December 2disclaims © of 2016 (including to failure the acandidates, plans without cost, differ number and capital MediciNova, any 3
Slide 3: MediciNova Overview
MediciNova MediciNova, Headquarters Dual-Listed NASDAQ: TSE 37No. in of © 2016 US Japan - JASDAQ: Employees MediciNova, MNOV Listed Overview Inc. La Jolla, 4875 is10 ina both publicly-traded, California Inc.the U.S. anddevelopment-stage Japan biopharmaceutical company focused on acquiring and develo
Slide 4: Investment Highlights
Investment Novel MN-166 MN-001 -Approved Large Treatment Well 4Experienced post-stroke © 2016 capitalized safety product (ibudilast) (tipelukast) MediciNova, in ofHighlights database management Japan dizziness Neurological Fibrotic Hyperlipidemia candidates in Diseases 1989 and Inc. in team Diseases
Slide 5: Core Programs
Programs Core MN-166, NEURODEGENERATIVE Progressive NeuroNEXT Carolinas FAST ALS Massachusetts SUBSTANCE Methamphetamine Completed Columbia Alcohol UCLA MN-001, NASH IPF 5Orphan © (Idiopathic 2016 /(Amyotrophic programs/ TRACK Biomarker (Funded (Nonalcoholic Drug Dependence Oral MediciNova, Neuromus
Slide 6: Developing MN-166 Ibudilast
Developing MN-166 6Ibudilast © 2016MN-001 Tipelukast MediciNova, Novel Therapeutics… Inc.
Slide 7: How Does MN-166 Work?
How MIF Linked PDE Increases Reduces GLIAL Neuroprotection 7–Role Activated Type Glial 2016Inhibition of 4does Inhibition of activation MediciNova, to CELL Glia: pro-inflammatory cAMP macrophage attenuated MN-166 during ATTENUATION leads brain work? disease Inc. todamage neurodegeneration MN-166 cyt
Slide 8: Progressive Multiple Sclerosis (MS)
Progressive Multiple Sclerosis (MS)
Slide 9: Progressive MS
Progressive MS DIMINISHED EXPECTED NO 91. © Source: APPROVED AFFECTS 2016 MediciNova, National Multiple MARKET 2.3M+ QUALITY DRUGS Multiple Sclerosis Worldwide1 Inc. OPPORTUNITY* For OFSclerosis LIFE long-term (MS)400,000+ (e.g. Society treatment fatigue, $ 19B+ In United walking Worldwide of Progre
Slide 10: MN-166 Phase 2 Relapsing MS Trial
MN-166 Trial N Multi-arm Multicenter, SAFETY: Results: Did EFFICACY: *-Hit 10 Sustained Significant Cumulative =©important not 297 Design Design: 2016 meet subjects Phase 82% (30 MediciNova, disability 24-month reduction and efficacy neuroprotective number mg/day, 2completed Results with Relapsing p
Slide 11: Reduced Disability Progression
Disability MN-166 21.0% N 10.4% *Placebo 11Proportion =©100 2016 p=0.026 to NPhase Reduced Progression MN-166 MediciNova, = of 1922subjects Relapsing Disability MN-166 Data: with Inc.MS 24 Progression* (two disability Months Trial years)progression MN-166 by 50%Ibudilast (sustained change in EDSS ?1
Slide 12: Reduced Brain Volume Loss
Brain MN-166 Placebo 0.00% 60 -0.20% -0.80% -0.60% -0.40% N -1.00% -0.82% -1.20% 12 -1.40% -1.17% =© mg 100 2016 Volume NMN-166 p=0.035 Phase Reduced =MediciNova, 98Data: 2 Relapsing Brain 12 Months Volume Inc.MS MN-166 Trial Loss Ibudilast
Slide 13: MN-166 SPRINT-MS: Phase 2b Progressive MS Trial
MN-166 SPRINT-MS: PRINCIPAL PRIORITY FUNDING CLINICAL DATA ADDITIONAL SITES Funded Ibudilast Robert Massachusetts University 28 National 13 academic © 2016 COORDINATING Fox, byMultiple Phase was of NIH MediciNova, COORDINATING M.D. medical INVESTIGATOR Iowa the Phase General 2b FUNDING grant first S
Slide 14: MN-166 SPRINT-MS: Trial Design
MN-166 SPRINT-MS: N Interferon-beta Phase Dosing: Primary: Secondary: Enrollment Final © TRIAL 14 STATUS OBJECTIVES = 2016 255 results 2bDESIGN MediciNova, up subjects Ibudilast Phase whole randomized, to disability, completed; expected Trial 100 or 2b brain with glatiramer mg/day Progressive Design
Slide 15: Ibudilast Phase 2b Progressive MS Trial Sites
MN-166 Albert Center Pittsburgh Charlottesville 15 © 2016 Einstein University Ibudilast Phase Ohio MediciNova, SUNY 2b College State of Progressive Colorado University Upstate of Inc. Medicine Vanderbilt –MS Denver University Ibudilast University Emory University of Trial Rochester of University Sit
Slide 16: Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Slide 17: Amyotrophic Lateral Sclerosis
Amyotrophic ALS LIFE An CURRENT 1. 2. 3. 17 Source: Cochrane ©effective AFFECTS 2016 EXPECTANCY ALS Cowen MediciNova, APPROVED Database new Lateral Association ~20,000 drug & Co. Sclerosis of 2-5 forInc. Systematic estimate People DRUGS ALS YRS(ALS) could 1InFATAL RILUZOLE United Reviews generate “L
Slide 18: MN-166 ALS Phase 2 Trial
MN-166 ALS N Phase Principal Duration: Dosing: Safety Enrollment Protocol TRIAL 18 STATUS OBJECTIVES =©up Trial 2016 2and to DESIGN randomized, 60 amendment Ibudilast Phase Investigator: 120 6Design tolerability, MediciNova, mg/day commenced months ALS 2 ALS subjects of ofdouble-blind inMN-166 Trial
Slide 19: Interim ALSFRS-R Data
No Interim ALSFRS-R PLACEBO MN-166 *IMPROVEMENT Note: 19 A©cluster higher 2016 AsALS analysis Phase Mean this of decline MediciNova, Mean Total* Data adverse is Decline 2the of ALS Decline Presented indicates 22% ALSFRS-R 25 first events subjects Trial: 4.55 50% study Inc. 5.80 aInterim at was (0.76
Slide 20: MN-166: Addiction Studies Summary
MN-166: Summary Opioid Methamphetamine Alcohol MN-166 20 © 2016 Withdrawal Self-Administration Dependence Ibudilast Reduced significantly Addiction ofMediciNova, MN-166Subjective Dependence &Study Phase Addiction Analgesia enhanced reduced decreased Inc. Summary 2a Phase Opioid perspiring perseverat
Slide 21: Fibrosis
© MEDICINOVA
Slide 22: What is Fibrosis?
What CROSS-LINKING Fibrosis Cross-linking 22 © 2016 is Fibrosis? is athe MediciNova, result of development collagen ofOF inflammation, COLLAGEN Inc. and ofelastin excessirritation, is AND fibrous the final ELASTIN connective or step healing inFIBROSIS fibrosis (e.g. tissuescar) in development an org
Slide 23: How does MN-001 work?
How Anti-fibrotic Anti-inflammatory Inhibits Reduces Reduced LOXL2 MCP-1 CCR2 Cross-linking MN-001 23 fibrosis © does 2016 TIMP-1 5-lipoxygenase leukotriene Collagen Triglycerides mRNA inflammatory Tipelukast triglycerides MN-001 MediciNova, Activity of expression collagen Type Activity work? (LT) i
Slide 24: More Completed MN-001 Studies
More Completed MN-001 24 © 2016 thanTipelukast Background was 600 MediciNova, Phase considered human 2 study subjects Inc. generally of MN-001 exposed safeinand to asthma MN-001 well-tolerated withinpositive prior studies results
Slide 25: MN-001 NASH Animal Model Data
MN-001 NASH –Animal % NAFLD © 25Improved Reduced 2016 of Fibrosis & model MediciNova, Activity Data NAFLD fibrosis NAFLD Area Tipelukast studies Score Animal area Activity Inc. shows (NAS) in every Model MN-001 Score preclinical Studies (NAS) significantly via model a reduction tested reduced (NASH,
Slide 26: MN-001 IPF Animal Model Data
IPF Ashcroft Animal –MN-001 26 Ashcroft Hydroxyproline ©Animal 2016 model Data significantly Score Score MediciNova, Model Tipelukast study Lung measures content Study shows Hydroxyproline reduced Inc. ispulmonary MN-001 anlung indicator hydroxyproline significantly fibrosis of fibrosis based reduce
Slide 27: Nonalcoholic Steatohepatitis (NASH) and NAFLD
Nonalcoholic Steatohepatitis (NASH) Nonalcoholic Fatty Liver Disease ( NAFLD)
Slide 28: Nonalcoholic Steatohepatitis (NASH)
Nonalcoholic 10-20% NASH NO 1. 2. 28 Allied National ©TREATMENT 2016 AFFECTS MARKET of Market U.S. MediciNova, Institute Steatohepatitis population1 Research FORECAST 2-5% APPROVED of Diabetes of Inc. People has (NASH) $and “FATTY 1.6B InDigestive United ByLIVER” 20202 States1 and due Kidney PREVALE
Slide 29: Tipelukast MN-001 NASH Phase 2 Trial
Tipelukast MN-001 NASH Ongoing N Phase Dosing: Evaluate 1) 2) © Enrolling TRIAL 29 STATUS OBJECTIVES = 2016 Serum Safety 402/subjects DESIGN MediciNova, multicenter, MN-001 NAFLD Phase the and triglyceride effect tolerability; 2with NASH Trial 250 ofproof-of-principle, NASH Inc. levels; MN-001 mg De
Slide 30: Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic Pulmonary Fibrosis (IPF)
Slide 31: Idiopathic Pulmonary Fibrosis (IPF)
Idiopathic 132,000 In ORPHAN LIFE 2-3 IPF By $3B+ APPROVED (pirfenidone) ESBRIET (nintedanib) -OFEV No 1. 2. 3. 4. 31 Approved Phase Pulmonary GlobalData Esbriet OFEV United ©20252 survival YRS1 PREVALENCE MARKET 2016 EXPECTANCY 3-200,000 prescribing studies states1 prescribing Pulmonary INDICATION
Slide 32: Tipelukast MN-001 IPF Phase 2 Trial
Tipelukast MN-001 IPF N Phase Principal Duration: Dosing: 1) 2) Others: © Enrolling TRIAL 32 STATUS OBJECTIVES = 2016 Change Semiannual Trial 152subjects DESIGN Safety MediciNova, randomized, MN-001 Phase Design Investigator: 26 from weeks and rate 2with baseline IPF 750 tolerability; of ofmoderate
Slide 33: MN-001 New Patents
6MN-001 Advanced Treatment Liver Lipid Fibrosis AFLD NAFLD ASH NASH 33New © (Alcoholic 2016 Disorders (Alcoholic Patents Treatment (Nonalcoholic Treatment (Nonalcoholic Tipelukast (tipelukast): NASH of MediciNova, nonalcoholic cover Treatment Steatosis Treatment of fatty ofnonalcoholic MN-001 6fibro
Slide 34: Financial Summary
Financial CASH $25 2015 (9/30/2016) *$7.2 Consolidated 34 2015* Operating Research, (54,206) (8,845,079) © Year 2016 Million Million OPERATING 2014* ended POSITION MediciNova, (12,518) Summary development Expenses $December Statements (9,195,292) Interest CASH ($) Inc. and 31 Of expense Basic BURN p
Slide 35: Timeline
Timeline 166 Ibudilast Progressive 2014 disorders 2016 NASH 2017 Designation Final - •2015 Results MN Presentation Fast • Fast Tipelukast Summary Positive 001 New Track Multiple - Track 6-month Europe - MN Protocol •Preclinical Q4: •at 35 Sclerosis Initiated •AAN double-blind Final Interim Submitted
Slide 36: Investment Highlights
Investment Novel in MN-166 Treatment i.e. Approved Well Experienced 36 Phase © NASH capitalized 2016 product 2(ibudilast) in of clinical (nonalcoholic MediciNova, Highlights management Japan Neurological candidates development in MN-001 1989 Inc. steatohepatitis) team Diseases - post-stroke (tipeluk