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USC, Pitt; Advisor to JAFCO, Tanabe Director, Avigen, Inc. Richard Gammans, PhD, MBA Richard Gammans, PhD, MBA Chief Development Officer 30 Incara, Indevus, BMS Kenneth W. Locke, PhD Kenneth W. Locke, PhD Chief Scientific Officer 23 Tanabe Research Laboratories USA, Indevus, Hoechst Shintaro Asako, CPA Shintaro Asako, CPA Chief Financial Officer 8 KPMG USA (Audit), Arthur Andersen USA Masatsune Okajima, CMA Masatsune Okajima, CMA VP, Head of Japanese Office 15 Daiwa Securities SMBC, Sumitomo Capital Securities, Sumitomo Bank MediciNova, Inc. 2007 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 Value Creation through Establishment of Partnerships 20
Proven mechanism of action ( 2 adrenergic agonist) 2. Rapid, reliable IV delivery (vs. inhaled/nebulized) 3. Safer (greater selectivity = fewer cardiovascular SE) 13 MediciNova, Inc. 2007 14 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) Anticipated commencement date: Q1 08 Results expected as early as Q3 08 MediciNova, Inc. 2007 15 MediciNova, Inc. 2007 16 MediciNova, Inc. 2007 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 patent granted; patent protection through 2023 17 MediciNova, Inc. 2007 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 18 MediciNova, Inc. 2007 19 Leadership Years Experience Background Yuichi Iwaki, MD, PhD Yuichi Iwaki, MD, PhD CEO President 31 Prof.
Based on clinical and radiologic findings, MN 166 has the potential to modify disease progression by mitigating neuronal damage and to meet the need for a new MS therapy sought by the MS scientific community. MediciNova, Inc. 2007 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 (via PGI 2 and/or adenosine receptors) (Current and Developing Treatments Are Not Neuroprotective) 7 MediciNova, Inc. 2007 Brain volume changes are linked to axonal loss 1.2 0.79 0 0.2 0.4 0.6 0.8 1 1.2 1.4 Placebo 20mg, TID % Decrease in Brain Volume 8 MediciNova, Inc. 2007 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 inhibitor Inhibits nitric oxide and reactive oxygen species production Inhibits Th1 cytokine production (IFN g, TNF a, IL 1b, IL 6) 9 (MN 166 Similar Acute Efficacy to Current and Developing Treatments) P Value: 0.0438 P Value: 0.033 MediciNova, Inc. 2007 Phase III endpoint for certain FDA approved MS products 10 MediciNova, Inc. 2007 11 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 as March 2008 Commence MTD Study Anticipated commencement date: Q2 08 Results expected as early as Q4 08 MediciNova, Inc. 2007 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: Beta agonists, inhaled or nebulized (all patients) Corticosteroids, IV or oral (66 77% of pts) *Source: National Center for Health Statistics/CDC 12 Phase IIa Study Ongoing; Results Expected in October 2007 MediciNova, Inc. 2007 1.
You should not rely unduly on these forward looking statements, which speak only as of the date hereof. We undertake no obligation to update publicly or revise any forward looking statements discussed in this presentation. MediciNova, Inc. 2007 3 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 formulation to treat Status Asthmaticus patients Diverse Pipeline: Additional upside with six more compounds in development for various indications MediciNova Headquarters: San Diego, CA MediciNova, Inc. 2007 4 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 Seek partnership for compound MediciNova, Inc. 2007 5 * Extended Dosing (4 Hour Infusion) ** Anticipated commencement and completion dates based on current projections Filing as early as 2H 10 Phase IIa** Phase IIb** Phase III** Phase II** Phase III (EU)** Phase III (USA)** NDA Ph IIa* MTD** MediciNova, Inc. 2007 In an oral delivery form, MN 166 provides a high degree of safety with a broader ( neuroprotective + anti inflammatory ) efficacy profile than interferons.
These forward looking statements may be preceded by, followed by or otherwise include the words believes, expects, anticipates, intends, estimates, projects, can, could, may, will, would or similar expressions. Actual results or events may differ materially from those expressed or implied in any forward looking statements due to various factors, including, without limitation, the risks and uncertainties inherent in clinical trials and product development and commercialization, such as the uncertainty in results of clinical trials for our product candidates, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approvals, our reliance on third parties and the timing, cost and design of future clinical trials and research activities, the timing of our expected filings with the FDA, the failure to execute strategic plans or strategies successfully, our collaborations with third parties, intellectual property and contract rights, and the other risks and uncertainties described in our filings with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2006 and our subsequent periodic reports on Forms 10 Q and 8 K.
MediciNova, Inc. 2007 Accelerating the global development and commercialization of innovative pharmaceuticals September 2007 Exhibit 99.1 MediciNova, Inc. 2007 2 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 development programs and clinical trials, our industry, our financial condition, liquidity and capital resources, the efficacy and potential benefits of our product candidates and other statements that are not historical facts.