Medicinova, Inc. · NASDAQ:MNOV
Medicinova — Investor Presentation (October 2007)
22 slides from Medicinova's investor presentation, Oct 10, 2007
Slide 1: Accelerating the global development and commercialization of innovative pharmaceuticals
Accelerating the global development and commercialization of innovative pharmaceuticals October 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: – Easy intravenous formulation to treat Status Asthmaticus patients – Safe and potential disease modifying (neuropro
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: A Focused Development Plan
© A Focused Development Plan 2007 2008 2009 2010 2011 Compound 1H | 2H 1H | 2H 1H 2H 1H 2H 1H 2H MN-221 Eta —> =! Asthmaticus) —! : MN-166 (Multiple _ Sclerosis) © MEDICINOVA
Slide 6: Status Asthmaticus: Definition and 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 7: MN-221: Proven mechanism of action
1. Proven mechanism of action ( -adrenergic agonist) 2. Rapid, reliable IV delivery (vs. inhaled/nebulized) 3. Safer (greater selectivity = fewer cardiovascular SE)
Slide 8: MN-221 Phase IIa dose-response results
-0.01 0.06 p=0.3626 0.14 p=0.1377 0.15 p=0.0106 0.30 p<0.0001 0.28 p=0.0006 0.45 p<0.0001 0.30 p<0.0001 -0.1 0.1 0.2 0.3 0.4 0.5 Placebo .35 ug/min 1.0 ug/min 3.5 ug/min 10 ug/min 16 ug/min 30 ug/min 60 ug/min Dose MN-221 Dose-Response p-value < 0.0001
Slide 9: MN-221 safety in Phase IIa
• In the Phase IIa study there were no clinically significant cardiovascular, electrocardiogram (ECG), or vital sign changes, nor were there any other safety concerns observed at any dose tested • MN-221 has been tested in over subjects in the US and Europe to date • Subjects have had infusions of 1
Slide 10: MN-221 upcoming milestones
• Announced positive 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
Slide 11: MN-166 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 the
Slide 12: MN-166 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 13: 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 14: MN-166 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 15: Phase III endpoint for certain FDA-approved MS products
Phase III endpoint for certain FDA-approved MS products
Slide 16: 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 17: Commercially-Attractive Diversified Portfolio
© Commercially-Attractive Diversified Portfolio Product Candidate (indication) MN-001 Bronchial Asthma MN-305 Anxiety Disorders/Insomnia MN-001 Interstitial Cystitis MN-221 Preterm Labor MN-029 Solid Tumors MN-246 Urinary Incontinence MN-447 & MN-462 Thrombosis Pre- Phase 2 Phase 3 re. Clinical Phas
Slide 18: Near-Term Clinical Milestones
(© Near-Term Clinical Milestones © MEDICINOVA
Slide 19: Near-term milestones: 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 20: Dual Listing, cash and market 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 10/09/07: ~$101.27M • Shares outstanding: 11.9M
Slide 21: Management Team with Global Experience
© Management Team with Global Experience ar 2 ds F di i © MEDICINOVA
Slide 22: Unique In-Licensing Approach
• Unique In-Licensing Approach – Access to Differentiated, High-Value, Assets from Primarily Japanese Alliances • Focused Internal Development Plan – MN-221: IV Formulation for Status Asthmaticus – MN-166: Neuroprotective Treatment for Multiple Sclerosis • Broad Pipeline – Multiple Opportunities for