Medicinova, Inc. · NASDAQ:MNOV
Medicinova — Investor Presentation (September 2007)
20 slides from Medicinova's investor presentation, Sep 26, 2007
Slide 1: Accelerating the global development and commercialization of innovative pharmaceuticals
Accelerating the global development and commercialization of innovative pharmaceuticals September 2007 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: US-Based Pharmaceutical Development Company
US-Based Pharmaceutical Development Company: – Unique access to differentiated, high-value assets primarily from Japanese alliances New Approaches to Treat Serious Medical Conditions: – Safe and potential disease modifying (neuroprotection) therapy for Multiple Sclerosis – Easy intravenous formulati
Slide 4: In-license, proof-of-concept trials, two pathways towards ROI
In-License: – Product candidates ready to enter clinical or preclinical development Proof-of-Concept Trials: – Conduct Phase I and Phase II trials to prove safety and efficacy of compound Two Pathways Towards ROI After Phase II: – Continue internal development of compound towards commercialization –
Slide 5: Focused development pipeline
Phase IIa** Phase IIb** Phase III** Phase II** Phase III (EU)** Phase III (USA)** MTD** * Extended Dosing (4 Hour Infusion) ** Anticipated commencement and completion dates based on current projections † Filing as early as 2H’10 NDA † Ph IIa*
Slide 6: MN-166 oral delivery profile for multiple sclerosis
In an oral delivery form, MN-166 provides a high degree of safety with a broader ( neuroprotective + anti - inflammatory ) efficacy profile than interferons. Based on clinical and radiologic findings, MN-166 has the potential to modify disease progression by mitigating neuronal damage and to meet th
Slide 7: Chronic: neuroprotective effects
CHRONIC: • Neuroprotective Outcome: – Attenuated % brain volume loss ( - 0.79% vs. - 1.2%) – P-Value: 0.0352 • Potentially Slows Disease Progression via Neuroprotection – Stimulates Th2 cytokine production (IL-4, IL-10) – Stimulates neurotrophic factor release (NGF, GDNF, NT-4) – Cerebrovasodilator
Slide 8: Brain volume changes are linked to axonal loss
Brain volume changes are linked to axonal loss 1.2 0.79 0.2 0.4 0.6 0.8 1.2 1.4 Placebo 20mg, TID % Decrease in Brain Volume
Slide 9: Acute: anti-inflammatory outcomes
ACUTE: • 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 Inflammation – Phosphodiesterase IV and Leukotriene inhibit
Slide 10: Phase III endpoint for certain FDA-approved MS products
Phase III endpoint for certain FDA-approved MS products
Slide 11: MN-166 upcoming milestones
• Complete Formulation Work on Once-Daily Dosing – Anticipated completion date: November 2007 • Commence Relative Bioavailability Study (Ex-US) – Anticipated commencement date: Q1’08 • Announce Two-Year Phase II Results – Results expected: March 2008 • Submit US IND – Submission anticipated as early
Slide 12: MN-221 for status asthmaticus: market opportunity
Definition: Long-lasting and severe asthma episode that is not responsive to initial bronchodilator or corticosteroid therapy Market Opportunity: • ~1.9 million emergency room visits in the U.S. each year* • ~500,000 hospitalizations & ~4,000 deaths annually in the U.S.* Current Standard of Care: •
Slide 13: MN-221 advantages
1. Proven mechanism of action ( -adrenergic agonist) 2. Rapid, reliable IV delivery (vs. inhaled/nebulized) 3. Safer (greater selectivity = fewer cardiovascular SE)
Slide 14: MN-221 upcoming milestones
• Announce Phase IIa results in October 2007 • Commence Phase IIb study to test efficacy of MN-221 in Status Asthmaticus patients in the emergency room – Anticipated commencement date: Q2’08 – Results expected as early as Q2’09 • Commence second Phase IIa study for Extended Dosing (4 Hour Infusion)
Slide 15: Commercially-attractive diversified portfolio
( ) Commercially-Attractive Diversified Portfolio Pre- Phase 2 Phase 3 Product Candidate (indication) Phase 1 Cinical Preparation Undergoing Complete «Preparation Undergoing Complete MN-001 Bronchial Asthma MN-305 Anxiety Disorders/Insomnia MN-001 Interstitial Cystitis MN-221 Preterm Labor MN-029 So
Slide 16: Near-term clinical milestones
(© Near-Term Clinical Milestones + Phase il Status Asthmaticus results expected October 2007 . Phase Il Insomnia results expected October 2007 . Two-Year Phase ll results expected March 2008 © MEDICINOVA
Slide 17: Recent developments: MN-305, MN-166, MN-001
• MN-305: For Insomnia – Phase II results expected October 2007 • MN-166: For Multiple Sclerosis – Positive one-year Phase II results announced March 2007 • MN-001: For Asthma – Once-daily formulation work ongoing; completion of new formulation expected as early as Q2’08 – New composition of matter
Slide 18: Dual listing, cash and capitalization
• Dual Listing: – MNOV (NasdaqGM), December 2006 – 4875 (Osaka (Hercules), February 2005 • Cash: $85.9M as of 6/30/07 • Expected Cash Balance: ~$65M as of 12/31/07 • Market cap as of 9/20/07: ~$84.4M • Shares outstanding: 11.6M
Slide 19: Management team with global experience
© Management Team with Global Experience ar 2 ds F di i © cl MEDICINOVA
Slide 20: Unique in-licensing approach
• Unique In-Licensing Approach – Access to Differentiated, High-Value, Assets from Primarily Japanese Alliances • Focused Internal Development Plan – MN-166: Neuroprotective Treatment for Multiple Sclerosis – MN-221: IV Formulation for Status Asthmaticus • Broad Pipeline – Multiple Opportunities for