Medicinova, Inc. · NASDAQ:MNOV
Medicinova — Investor Presentation (January 2008)
27 slides from Medicinova's investor presentation, Jan 7, 2008
Slide 1: Accelerating the global development and commercialization of innovative pharmaceuticals
Accelerating the global development and commercialization of innovative pharmaceuticals January 2008 Exhibit 99.1
Slide 2: Forward-Looking Statements
This presentation contains forward-looking statements that involve risks and uncertainties. These forward- looking statements include, but are not limited to, statements regarding our strategies and objectives, our plans for the development and commercialization of our product candidates, including
Slide 3: Corporate Overview: Development Company Focused on Low-Risk Product Candidates
Development Company Focused on Low-Risk Product Candidates • Unique access to differentiated, high-value assets primarily from Japanese alliances New Approaches to Treat Serious Medical Conditions: • MN-221: IV Status Asthmaticus candidate • Estimated $500 M US opportunity for MediciNova • MN: 166:
Slide 4: Business Model
In-License: • Product candidates with significant clinical or pre-clinical data Proof-of-Concept Trials: • Conduct Phase I and Phase II trials to demonstrate efficacy of compound in US Two Pathways Towards ROI After Phase II: • Continue internal development of compound towards commercialization • Se
Slide 5: MN-221 Development Plan
NDA † MN-221 Development Plan MN-221 Development Plan Note: Development plans / timelines for MN-221 are subject to change *Anticipated commencement and completion dates based on current projections † Filing as early as 2H’10
Slide 6: MN-166 Development Plan
Phase II* Phase III (EU)*/** Phase III (USA)*/** Pursuing Partnering Opportunities *Anticipated commencement and completion dates based on current projections ** Phase III studies, as well as Bioequivalence and MTD studies, will be delayed until a corporate partnership is secured for MN-166 MN-166 D
Slide 7: 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 receptor in the heart • Full agonist for receptor in the lungs •
Slide 8: 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 patients) • Inhaled or nebulized
Slide 9: Competitive Advantages of MN-221
1. Proven mechanism of action ( -adrenergic agonist) 2. Rapid, reliable IV delivery (vs. inhaled / nebulized) 3. Safer (greater selectivity = fewer cardiovascular SE) Competitive Advantages of Competitive Advantages of MN-221 MN-221
Slide 10: MN-221: Positive Phase IIa data
Phase IIa 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 • To determine the MTD (Maximum Tolerat
Slide 11: MN-221-CL-002: Primary Efficacy Variable
Change from Pre-Infusion FEV1 at 15 min (ITT) Placebo .35 ug/min 1.0 ug/min 3.5 ug/min ug/min ug/min ug/min MN-221-CL-002: Primary MN-221-CL-002: Primary Efficacy Variable Efficacy Variable
Slide 12: MN-221: Safety
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 signific
Slide 13: MN-221: Next Steps
Commence Two Phase IIb study 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: 1H’08 • Results expected
Slide 14: MN-166 Overview
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
Slide 15: Multiple Sclerosis Market; MN-166 Overview
Multiple Sclerosis Market • Approximately $6.2 B worldwide sales in 2005* Current Standard of Care: • Beta interferons, Copaxone, Tysabri • Administered either by intramuscular or subcutaneous injection or infusion MN-166: • Anti-inflammatory and neuroprotective properties in vitro and in vivo • Sti
Slide 16: There are substantial unmet needs in the treatment of MS
Efficacy (relapse rate) • Insufficient efficacy on relapses • Most patients ultimately progress (disability/neurodegeneration) • Neutralizing antibodies can diminish efficacy over time • Neutralizing antibodies can diminish efficacy over time • Uncomfortable and potentially dangerous AEs • Rare but
Slide 17: Chronic Efficacy Demonstrated: Effects on Brain Volume
Brain volume changes are linked to axonal loss Chronic Efficacy Demonstrated: Chronic Efficacy Demonstrated: Effects on Brain Volume Effects on Brain Volume 1.20
Slide 18: MN-166 Targets Both Chronic and Acute Aspects of MS
MN-166 Similar Acute Efficacy to Current and Developing Treatments Anti-inflammatory Outcomes: • Pilot studies found reduced relapse rate and Th1 Th2 cytokine shift • Prolong time to relapse (> 1yr.) • Increased % relapse-free (56%) • Decreased T1-Gd lesion volume Reduces Relapses via Inhibiting Inf
Slide 19: Acute Efficacy Demonstrated: Time to First Relapse
Phase III endpoint for certain FDA-approved MS products Acute Efficacy Demonstrated: Acute Efficacy Demonstrated: Time to First Relapse Time to First Relapse
Slide 20: MN-166 Overview-Safety
• MN-166 was very well tolerated; 89% of subjects completed the first months of the study • Discontinuation for AE was infrequent (placebo - 1, 30mg/d - 2, 60 mg/d - 3) • Side effects were generally mild and self-limiting • No statistically significant adverse effects were observed • No adverse labo
Slide 21: Safety Comparison with Other Oral Agents
Compound Sponsor Current Phase Safety Profile from Phase II trials MN-166 MediciNova Phase II Mild, transient GI upset FTY 720 Novartis Phase III Blood pressure Heart rate Dyspnea Liver enzymes Lymphopenia Cladribine Merck Serono Phase III Fever Nausea, Vomiting Leucopenia BG-12 Biogen-Idec Phase II
Slide 22: Current Clinical Studies: MN-166-CL-001
Phase II placebo-controlled, randomized, double-blind study • year 1 - 0, 10 mg tid, 20 mg tid • year 2 - 10 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 aged 18 to 55 years, with relapsing remit
Slide 23: Diversified Portfolio: Partnering Opportunities
Partnering Opportunities MN-001 (Bronchial Asthma) Phase III ready MN-001 (Interstitial Cystitis) Phase II ready MN-305 (Generalized Anxiety Disorder) Phase II ready MN-029 (Solid Tumors) Phase II ready MN-221 (Preterm Labor) Phase II ready MN-246 (Urinary Incontinence) Phase I ongoing MN-447 / MN-4
Slide 24: Near-Term Clinical Milestones
MN-221 for Status Asthmaticus • Single Blind Phase IIb study to test efficacy - commencement date: 1H’08 • Results as early as 2H’08 • Double Blind Phase IIb study to test efficacy - commencement date: 1H’08 • Results as early as 1H’09 • Second Phase IIa study for extended dosing - commencement date
Slide 25: Key Financials
Dual Listing: • MNOV (NasdaqGM), December 2006 • 4875 (Osaka – Hercules), February 2005 • Limited liquidity due to low float Cash: $75.96 M as of 9/30/07 Market cap as of 1/03/07: ~$55.6 M Shares outstanding: 11.9 M Fully diluted shares outstanding: 14.0 M Key Financials Key Financials
Slide 26: ss Bo BS |S
ss Bo BS |S © MEDICINOVA
Slide 27: 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 • Estimated $500 M market opportunity for MediciNova MN-166 (Multiple Scleros