Medicinova, Inc. · NASDAQ:MNOV
Medicinova — Investor Presentation (April 2008)
28 slides from Medicinova's investor presentation, Apr 29, 2008
Slide 1: Accelerating the global development and commercialization of innovative pharmaceuticals
Exhibit 99.1 Accelerating the global development and commercialization of innovative pharmaceuticals April 2008
Slide 2: Forward-Looking Statements
Forward-Looking Statements Statements in this presentation that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward- looking statements include, without limitation,
Slide 3: Corporate Overview: MediciNova, Inc.
Corporate Overview: MediciNova, Inc. Development Company Focused on Differentiated Product Candidates • Unique access to differentiated, potentially high-value assets primarily from Japanese alliances New Approaches to Treat Serious Medical Conditions: • MN-221: IV Status Asthmaticus candidate • Pot
Slide 4: Business Model: Return On Investment
Business Model: Return On Investment In-License: • Product candidates with significant clinical or preclinical data Conduct Proof-of-Concept Clinical Trials: • Conduct Phase I and Phase II clinical trials to demonstrate efficacy of compound Two Pathways Towards ROI After Phase II: • Continue interna
Slide 5: MN-221 Development Plan
MN-221 Development Plan NDA† *Anticipated commencement and completion dates based on current projections **We also plan to conduct an advanced clinical trial of MN-221 in pediatric patients with status asthmaticus; however, we have not yet determined whether this clinical trial will be initiated in
Slide 6: MN-221: A New Approach to Treating Status Asthmaticus
MN-221: A New Approach to Treating Status Asthmaticus Definition: • Long-lasting and severe asthma episode that is not responsive to initial bronchodilator or corticosteroid therapy MN-221: • Novel, highly selective 2-adrenergic receptor agonist • Greater selectivity • Partial agonist for 1 receptor
Slide 7: MN-221: Market Opportunity
MN-221: Market Opportunity Market Opportunity: • Approximately 1.9 million emergency room visits in the US each year* • 500,000 hospitalizations • Approximately 4,000 deaths annually in the US* • Potential $500 M market opportunity for MediciNova Current Standard of Care*: • Beta agonists (all patie
Slide 8: Competitive Advantages of MN-221
Competitive Advantages of MN-221 1. Proven mechanism of action 2-adrenergic ( agonist) 2. Rapid, reliable IV delivery (vs. inhaled / nebulized) 3. Safer (greater selectivity = fewer cardiovascular SE) © MediciNova, Inc. 2008 8
Slide 9: MN-221: Positive Phase IIa data
MN-221: Positive Phase IIa data Phase IIa study design • Randomized, placebo-controlled, double-blind, sequential dose escalation • 23 subjects with mild-to-moderate asthma • Primary objective • To determine the efficacy of a single 15-minute treatment with intravenous MN-221 • Secondary objective •
Slide 10: MN-221-CL-002: Primary Efficacy Variable
MN-221-CL-002: Primary Efficacy Variable Change from Pre-Infusion FEV1 at 15 min (ITT) Placebo .35 1.0 3.5 10 16 30 ug/min ug/min ug/min ug/min ug/min ug/min © MediciNova, Inc. 2008 10
Slide 11: MN-221: Safety
MN-221: Safety Phase IIa Safety Findings: • No clinically significant cardiovascular, ECG or vital sign changes, or any other safety concerns observed at doses up to 30 micrograms/minute for 15 minutes or any time point thereafter • 60 micrograms/minute infusion improved FEV1 significantly (p< 0.000
Slide 12: MN-221: Next Steps
MN-221: Next Steps Commence two Phase IIb studies to test efficacy of MN-221 in status asthmaticus patients in the emergency room Single Blind (~32 patients) • Anticipated commencement date: 1H’08 • Results expected as early as 2H’08 Double Blind (~200 patients) • Anticipated commencement date: 2H’0
Slide 13: MN-166 Overview
MN-166 Overview • Multiple Sclerosis • Autoimmune disease • Progressive loss of neuromuscular function • Relapsing forms • Progressive forms • Damage to myelin sheath • Damage to neuronal axon © MediciNova, Inc. 2008 13
Slide 14: MN-166 Overview
MN-166 Overview Multiple Sclerosis Market: • Approximately $7.2 B worldwide sales in 2006* Current Standard of Care: • Beta interferons, Copaxone ®, Tysabri ® • Administered either by intramuscular or subcutaneous injection or infusion MN-166: • Anti-inflammatory andneuroprotective properties invitr
Slide 15: There Are Substantial Unmet Needs in MS
There Are Substantial Unmet Needs in MS Description Current agents offer only 30-50% relapse reduction Efficacy Neutralizing antibodies can diminish efficacy over time (relapse rate) Most patients ultimately progress; neurodegeneration leads to functional disability AEs – including flu-like symptoms
Slide 16: Current Clinical Studies: MN-166-CL-001
Current Clinical Studies: MN- 166-CL-001 Placebo-controlled, randomized, double-blind Phase II study: • Year 1 0- , 10 mg tid, 20 mg tid • Year 2 1- 0 mg tid, 20 mg tid • n ~ 100 MS patients/group @ 25 sites in Serbia, Ukraine, Belarus, Bulgaria and Romania Key inclusion criteria: • Males or females
Slide 17: MN-166 Targets Primarily Chronic Aspects of MS
MN-166 Targets Primarily Chronic Aspects of MS MN-166 Effects Outcomes Related to Disease Progression in RRMS Patients Clinical and MRI Outcomes: • Prolong time to relapse (by 127 days.) P-Value:0.044 • Sustained disability progression was significantly less likelyP-Value: (~50%) 0.026 • Reduced Bra
Slide 18: Acute Efficacy Demonstrated: Time to First Relapse
Acute Efficacy Demonstrated: Time to First Relapse © MediciNova, Inc. 2008 18
Slide 19: Sustained Disability Progression
Sustained Disability Progression TREATMENT Placebo to Active 30 mg 60 mg Time Period (N=100) (N=94) (N=98) 1 Year 8 (8.0%) 5 (5.3%) 4 (4.1%) 2 Years 8/51 (15.7%) 13/49 (26.5%) 10 (10.6%) 10 (10.2%) 20/194 (10.4%) 21/100 (21%) p=0.0264 Disability Progression is defined as a sustained increase in EDSS
Slide 20: Chronic Efficacy Demonstrated: Effects on Brain Volume
Chronic Efficacy Demonstrated: Effects on Brain Volume Percent Brain Volume Reduction 24 (0 months) - N=71 1.59 N=70 1.79 N=34 2.08 N=45 2.12 Percent Brain Volume Reduction Brain volume loss was significantly less (p=0.030) in patients receiving 60 mg per day of MN-166 for 24 months compared to the
Slide 21: Reduction of Persistent Black Hole (PBH) Formation
Reduction of Persistent Black Reduction Hole (PBH)of Persistent Formation, a Sign of Axonal Loss Blackion Treatment Groups Parameter Placebo 30 mg/day 60 mg/day # Patients w. New Lesions at Month 272 64 56 Mean Proportion of Lesions Evolving to PBH 0.24 0.20 0.16 Relative Risk (for Evolution to PBH)
Slide 22: MN-166 Overview-Safety
MN-166 Overview-Safety •MN-166 was very well tolerated in Phase II study: 89%(264 of 297) of subjects completed the first 12 months of the study 82.5% (245 of 297) of subjects completed the full 24 months of the study duetoadverseeffectswasinfrequent •Discontinuation (5.1%in60mg/dayfor24months,2.1%
Slide 23: Safety Comparison with Other Oral Agents
Safety Comparison with Other Oral Agents Current Safety Profile Compound Sponsor Phase from Phase II trials MN-166 MediciNova Phase II Mild, transient GI upset Liver Blood pressure FTY 720 Novartis Phase III Dyspnea enzymes Heart rate Lymphopenia Merck Nausea, Cladribine Phase III Fever Leucopenia S
Slide 24: Commercially-Attractive Diversified Portfolio
Commercially-Attractive Diversified Portfolio © MediciNova, Inc. 2008 24
Slide 25: Near-Term Clinical Milestones
Near-Term Clinical Milestones MN-221 for Status Asthmaticus • Single-blindPhaseIIbstudytotestefficacy- commencement date:1H’08 • Results as early as 2H’08 • Double-blind PhaseIIbstudytotestefficacy- commencement date:2H’08 • Results as early as 2H’09 • SecondPhaseIIastudyforextendeddosing- commencem
Slide 26: Key Financials
Key Financials Dual Listing: • MNOV (NasdaqGM), December 2006 • 4875 (OsakaHercules), – February 2005 • Limited liquidity due to low float Cash: $70.6 M as of 12/31/07 Market cap as of 4/15/08: ~$49.6 M Shares outstanding: 11.9 M © MediciNova, Inc. 2008 26
Slide 27: Management Team with Global Experience
Management Team with Global Experience Years Leadership Background Experience Yuichi Iwaki, MD, PhD 32 Prof. USC, Formerly Prof. Pitt; CEO & President Advisor to JAFCO, Tanabe Director, Avigen, Inc. RichardGammans Gammans, , PhD, Gammans, PhD, MBA , PhD, MBA MBA 30 Incara, Indevus, BMS Chief Develop
Slide 28: Investment Highlights
Investment Highlights MN-221 (Status Asthmaticus): • Proven mechanism of action • Highly selective with improved safety profile vs. standard of care • Low risk / high reward proposition • Positive efficacy data • Low development costs to market MN-166 (Multiple Sclerosis): • Current treatment of MS