Medicinova, Inc. · NASDAQ:MNOV
Medicinova — Investor Presentation (February 2012)
47 slides from Medicinova's investor presentation, Feb 15, 2012
Slide 1: Accelerating the global development and commercialization of innovative pharmaceuticals
Accelerating the global development and commercialization of innovative pharmaceuticals Exhibit 99.1
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 statements regarding M
Slide 3: MediciNova Overview
MediciNova Overview: • Founded in September 2000 • Headquartered in San Diego, CA, with an additional office in Tokyo, Japan • Dual listing on NasdaqGM as MNOV and Osaka Securities Exchange as 4875 • $39.2 million market cap (NasdaqGM) as of 2/14/2012 (aggregate value of 18.3 million shares outstand
Slide 4: Business Model
In-License: • Novel, small-molecule product candidates with significant clinical or preclinical data packages and attractive market opportunities Conduct Proof-of-Concept Clinical Trials: • Conduct Phase 1 and Phase 2 clinical trials to demonstrate safety and efficacy of compound Two Pathways After
Slide 5: Product Candidates
Product Candidates Preclinical Phase 1 Phase 2 Phase 3 Bedoradrine Sulfate (MN-221) Program Acute Exacerbations of Asthma Exacerbations of COPD Preterm Labor Ibudilast (MN-166/AV11) Program Progressive Multiple Sclerosis Neuropathic Pain Drug Addiction Asthma, IC, Cancer, GAD, OAB, Thrombosis Commer
Slide 6: Significant Milestones
Significant Milestones *Anticipated completion dates based on current projections **Tentative based on availability of non-dilutive financing Milestone: Timeline*: Complete an Equity Raise ($~7.9M net) 1Q, 2011 Commence Enrollment in Phase 1 Ibudilast trial for Meth. addiction 2Q, 2011 Sign Chinese
Slide 7: MN-221: Acute Exacerbations of Asthma, COPD
MN-221: • Acute Exacerbations of Asthma • Exacerbations of COPD
Slide 8: Acute Exacerbations of Asthma (AEA)
Acute Exacerbations of Asthma (AEA) Definition: • Long-lasting and severe asthma episode that is not responsive to initial bronchodilator or corticosteroid therapy Market Opportunity*: • Approximately 1.9 million annual emergency room visits in the U.S. • ~500,000 annual hospitalizations in U.S. (~5
Slide 9: COPD Exacerbations
COPD patients are generally more ill than asthmatics with overall higher hospitalizations and mortality. A COPD exacerbation is a sustained worsening of the patient's condition, from the stable state and beyond normal day-to-day variations, that is acute in onset. COPD exacerbations are associated w
Slide 10: MN-221: A novel, highly selective beta2-adrenergic receptor agonist
MN-221: A novel, highly selective - adrenergic receptor agonist Potential advantages over current therapy: 1. Improved Efficacy • Route of administration (IV vs. inhalation) 2. Improved Safety • High selectivity for receptor versus • Partial agonist for receptor* 3. Reduced Health Care Expenses • Re
Slide 11: Acute Asthma Treatment Flow in Emergency Departments
525,000 *Source: Weber, Silverman et al, American Journal of Medicine, 2002, Volume 113; pp 371 Acute Asthma Treatment Flow in Emergency Departments (EDs) in the U.S. 965,000 935,000 935,000 410,000 525,000 Input: 1,900,000 patients with acute exacerbations of asthma present at U.S. EDs annually st
Slide 12: MN-221-CL-007: Ongoing Phase 2b Trial
• Randomized, placebo-controlled, double-blind, multi-center Phase 2 clinical trial • Up to 170 - 200 patients with severe, acute exacerbations of asthma (FEV 50% predicted) at multiple US emergency department sites • Two treatment groups of up to 85-100 patients/group • 1,200µg infusion of MN-221 o
Slide 13: MN-221 Asthma Clinical Endpoints for CL-007 Phase 2b Trial
MN-221 Asthma Clinical Endpoints for CL-007 Phase 2b Trial 1 2 3 MN-221 CL-007 Efficacy Endpoints FEV Area Under the Curve (AUC) of the change from baseline in FEV (% predicted) during the 3-hour Treatment Period Reduction in Hospital Admissions Clearly-recognized Clinical and Pharmacoeconomic Benef
Slide 14: MN-221-CL-012: Ongoing Phase 1b Trial
• Randomized, placebo-controlled, double-blind, Phase 1b clinical trial • stable moderate-to-severe COPD patients (30% FEV 80%) • Two treatment groups • 1,200µg infusions of MN-221 every 12 hours (15 pts.) for 3 days • Placebo (5 pts.) • Primary objective is to determine the safety and tolerability
Slide 15: MN-221 Clinical Development
MN-221 Clinical Development Acute Asthma Program: • Multiple doses tested at infusion length of 15min, 1hr, and 2hr • Completed 2 trials in asthmatics with stable disease • CL-004 • CL-005 • Completed Phase 2a trial in patients with AEA in the ED • CL-006 • Ongoing Phase 2b proof-of-concept study in
Slide 16: MN-221 Potential Development
MN-221 Potential Development Other Indications?
Slide 17: MN-221: Market Opportunity and Patent Summary
MN-221: Market Opportunity and Patent Summary
Slide 18: MN-221 Market Opportunity
MN-221 Market Opportunity* Market Acute Asthma COPD Exacerbations US $375-400 million $380-420 million Europe $200-300 million $200-300 million Rest of World $150-250 million $150-250 million Worldwide MN-221 Sales Potential $725-950 million $730-970 million Combined Worldwide MN-221 Sales Potential
Slide 19: Pharmacoeconomic Benefit
Pharmacoeconomic Benefit: Price of MN-221 vs. % Hospitalizations Source: Guidepoint Global survey of Medical Directors at U.S. managed care companies
Slide 20: MN-221 Patent Summary
MN-221 Patent Summary • The U.S. patent for MN-221 has composition of matter and method of use claims and is set to expire no earlier than February • Corresponding composition of matter patents in various other countries • U.S. patent expiration does not include Waxman-Hatch patent term restoration
Slide 21: Ibudilast (MN-166/AV-411)
Ibudilast (MN-166/AV-411): • Progressive Multiple Sclerosis • Neuropathic Pain • Addiction
Slide 22: Ibudilast Overview
Ibudilast • Oral administration • Safe and well tolerated • Approved in Japan/Korea over 3.2M patient exposures • > 420 subjects treated with ibudilast • Dosing up to 100 mg single dose • Mechanism(s) of action primarily: • Inhibition of macrophage Migration Inhibitor Factor (MIF) • PDE-4,10 inhibit
Slide 23: Ibudilast – Ongoing and Future Development
1Q 2012 2Q 2012 3Q 2012 4Q 2012 Ibudilast (MN-166/AV11) Program *Pending Grant / Partner Funding Ibudilast (MN-166/AV11) Program Progressive MS* / Neuropathic Pain* Phase 2b Trial (POC) Opioid Dependence Columbia University – Phase 2a Trial Medication Overuse Headache Pain Univ. Adelaide – Phase 2a
Slide 24: Strategy for Ibudilast's Development
• Collaboration with Development Partner: 1. Advance to Phase 2b Proof-of-Concept in MS and/or Pain 2. Provide competitive economics for first in class therapy 3. Could be collaboration through: i. Pharma partner ii. Project financing iii. Shared-risk with competitive CRO agreement • Sustain NIDA-sp
Slide 25: Patent/Commercial Overview
MS Neuropathic Pain AV1013 AV1013 Enantiomer MIF Inh. screen Acute & Sub- chronic Pain Addiction Progressive MS Issued or Allowed Patent/Commercial Overview Method of Use Composition of Matter Key: Exp. 2018 Exp. 2025 Exp. 2027 Exp. 2027 Exp. 2026 Exp. 2029 Exp. 2027 Exp. 2028 Pending MOH Pain Anxie
Slide 26: MediciNova
MEDICINOVA
Slide 27: Financial Overview
Financial Overview • ~18.3 million shares outstanding of common + preferred on an as converted basis • Cash Runway into 2013 • $2.5 million additional payment from Kissei • $7.5 million raised in private stock sale to Kissei Pharmaceutical Co., Ltd. • $8.7 million in cash & cash equivalents as of 9/
Slide 28: MediciNova Corporate Summary
MediciNova Corporate Summary *Anticipated completion dates based on current projections 1. Top-Line Results from CL-007 Trial 2. Top-Line Results from CL-012 Trial 3. Announce Plan for Ibudilast Raised ~$18M in 2011 Cash Runway into 2013 Clinical development expertise Strong international presence,
Slide 29: Addendum: Data from Completed Trials
Addendum Data from Completed Trials MN-221 Ibudilast (MN-166/AV411)
Slide 30: MN-221: Data from Completed Trials
MN-221: Data from Completed Trials • Asthma Program: CL-004, CL-005, CL-006 • COPD Program: CL-010 • Safety Review
Slide 31: MN-221 Clinical Results: Stable Asthmatics
MN-221 Clinical Results Improved Lung Function at Different Dosing Levels: Stable Asthmatics CL-004: Stable Mild/Moderate Asthmatics CL-005: Stable Moderate/Severe Asthmatics
Slide 32: MN-221 Clinical Results: Lung Function and Clinical Outcome
14.0% 8.7% 46% 25% MN-221 Clinical Results Improved Lung Function and Clinical Outcome Above and Beyond Standard of Care (SOC) Mean change in FEV from baseline was 5.3% higher in the MN-221 dose groups versus the placebo group MN-221 reduced the hospitalization rate by 45% SOC + placebo SOC + placeb
Slide 33: MN-221 Clinical Results: COPD Patients
MN-221 Clinical Results Improved Lung Function at Different Dosing Levels: COPD Patients CL-010: Stable Moderate/Severe COPD Patients
Slide 34: MN-221 Safety Review
• MediciNova has preclinical data and clinical data which demonstrates the safety of MN-221. • In summary, we have not seen clinically significant safety concerns with MN-221 and it has been tested in ~300 subject to date. • In the ongoing CL-007 trial our Data Safety Monitoring Board has reviewed s
Slide 35: Safety Data: MN-221-CL-006
Safety Data: MN-221-CL-006 Mean Heart Rate - Change from Baseline * All patients received Standard of Care including inhaled albuter ol, inhaled ipratropium, and steroids. Note: Baseline heart rate: 90 bpm for placebo, 95 bpm for 240µg, 103 bpm for 450µg, and 119 bpm for 1000-1080 µg Source: Draft C
Slide 36: Human Beta-Adrenergic Receptor Selectivity
Test Drug 1 IC 50 (M) 2 IC 50 (M) 2 -Adrenoceptor Selectivity (IC 50 for 1 / IC 50 for 2 ) Human -Adrenergic Receptor Selectivity Levalbuterol 7.40E-06 1.40E-06 5.3 Albuterol 9.40E-06 1.60E-06 5.9 Terbutaline 6.00E-05 6.50E-06 9.2 MN-221 5.90E-06 1.40E-07 42.4
Slide 37: MN-221 Poster Presentations
• MN-221-CL-004: Evaluation of MN-221 (bedoradrine), a Novel, Highly Selective Beta2-Adrenergic Receptor Agonist in Mild to Moderate Asthma via Intravenous Infusion (Poster #145) • MN-221-CL-005: Comparison of Administration Rates of MN-221 (bedoradrine), a Novel, Highly Selective Beta2 Receptor Ago
Slide 38: Ibudilast: Data from Completed Trials
Ibudilast (MN-166/AV411): Data from Completed Trials Multiple Sclerosis Program Neuropathic Pain Program Drug Abuse/Addiction Program Safety Review
Slide 39: Placebo-controlled, Randomized, Double-blind Phase II Study
Placebo-controlled, Randomized, Double-blind Phase II Study: • Year 1 - Placebo, 30 mg/day, 60mg/day • Year 2 - 30 mg/day, 60mg/day • 297 patients (~100 patients/group) @ 25 sites in Serbia, Ukraine, Belarus, Bulgaria and Romania Key Inclusion Criteria: • Males or females aged 18 to 55 years, with r
Slide 40: MN-166-CL-001 Study Results
P-Value: 0.0 4 P-Value: 0.035 MN-166-CL-001 Study Results P-Value: 0.02 6 P-Value: 0.00 4 P-Value: 0.0 9 P-Value: 0.0 8 Note: P-values listed on this slide compare placebo group to 60mg/day group of MN-166 Indicative of Potential Neuroprotective Effect: • Reduced brain volume loss • Reduced conversi
Slide 41: MN-166-CL-001: Efficacy Review (One Year)
MN-166-CL-001: Efficacy Review (One Year) Endpoints Indicative of Disease Modifying Effect (Chronic aspects of MS): Endpoints Relating to Acute Clinical Benefit: Brain Volume Loss Progression to PBH EDSS progression 0.4 0.8 1.2 1.6 Dose (mg/d) 0.1 0.2 0.3 0.4 Dose (mg/d) Dose (mg/d) Dose (mg/d) Time
Slide 42: Secondary Progressive MS – Subset Analysis
Treatment Group (patient n) Secondary Progressive MS – Subset Analysis Subset of MS Patients: Placebo 30 mg/day Low Dose Group 60 mg/day High Dose Group % Brain Volume Change % Brain Volume Change Magnitude of Effect % Brain Volume Change Magnitude of Effect RRMS -1.2 (81) -1.1 (69) 8% less -0.8 (75
Slide 43: Diabetic Peripheral Neuropathic Pain Study: AV411-010
Diabetic Peripheral Neuropathic Pain Study: AV411-010 Design: Two-center (Australian), Phase 1b/2a, randomized, double-blind, placebo-controlled, parallel-group study. Subjects: • Patients, aged 18 to 75 years, with painful diabetic peripheral neuropathy (DPN) or complex regional pain syndrome (CRPS
Slide 44: Reduction Observed in Opioid Usage
Reduction Observed in Opioid Usage
Slide 45: Greater % of Responders Above Ibudilast Plasma Thresholds
Greater % of “Responders” Above Ibudilast Plasma Thresholds Plasma Ibudilast Parameter VAS ‘Responder’ % AUC 0-24h > 1000 ng*hr/mL 60% < 1000 ng*hr/mL 25% C max > 60 ng/mL 64% < 60 ng/mL 14% C min > 27 ng/mL 55% < 27 ng/mL 29% Next Steps for Neuropathic Pain: Twelve week Phase DPN trial. Potential f
Slide 46: Investigator-Led Development
• Recent validation of CNS action in opioid withdrawal & analgesia • Ongoing Methamphetamine interaction Phase 1b • Opioid self-administration Phase 2a initiating • Ongoing Phase 2a Medication Overuse Headache Pain trial • Randomized, double-blind, placebo-controlled, investigator-initiated (Dr. Pai
Slide 47: References
© ¢ — Barkhof, F. et al. {budifast in Relapsing-Remiting Multiple Sclerosis: a Neuroprotectant? Neurology, Mar30 2010. ° Fox,R. Primary Neuroprotection: the Holy Grail of Multiple Sclerosis Therapy. Neurology, Mar30 2010. * — Kagitan-Shimono K. and Mohril. J Neuroinflammation. An-inflammatory Therap