UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 7, 2008
MEDICINOVA, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 001-33185 | 33-0927979 | ||
| (State or other jurisdiction of incorporation) |
(Commission File Number) | (IRS Employer Identification No.) |
4350 La Jolla Village Drive, Suite 950
San Diego, CA 92122
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code: (858) 373-1500
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 7.01 | Regulation FD Disclosure. |
Representatives of MediciNova, Inc. (the “Registrant”) will be attending the 26th Annual JPMorgan Healthcare Conference commencing January 7, 2008. A copy of the slide presentation to be used by the Registrant at one-on-one investor meetings to be held during this conference is attached hereto as Exhibit 99.1.
The information in this Current Report, including Exhibit 99.1 furnished herewith, is being furnished and shall not be deemed “filed” for any purpose, including for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section. The information in this Current Report shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| 99.1 | Slide Presentation of the Registrant. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: January 7, 2008
| MEDICINOVA, INC. | ||
| By: | /s/ Shintaro Asako | |
| Shintaro Asako | ||
| Chief Financial Officer | ||
EXHIBIT INDEX
EXHIBIT
| 99.1 | Slide Presentation of the Registrant. |
 Accelerating the global development and commercialization of innovative pharmaceuticals January 2008 Exhibit 99.1 |
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MediciNova, Inc. 2008 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. 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. 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. Forward-Looking Statements Forward-Looking Statements |
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MediciNova, Inc. 2008 3 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: Oral Multiple Sclerosis candidate • In 2005, approximately $6.2 B in worldwide MS therapeutic sales* Diverse Pipeline: • Six compounds with applications in multiple disease areas Corporate Overview: Corporate Overview: MediciNova, Inc. MediciNova, Inc. *Source: MedAdNews, June 2006 |
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MediciNova, Inc. 2008 4 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 • Seek partnership for compound Business Model:
Business
Model: Return On Investment Return On Investment |
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MediciNova, Inc. 2008 5 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 |
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MediciNova, Inc. 2008 6 *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 Phase II* Phase III (EU)*/** Phase III (USA)*/** MN-166 Development Plan MN-166 Development Plan Pursuing Partnering Opportunities Note: Development plans / timelines for MN-166 are subject to change
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MediciNova, Inc. 2008 7 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 1 receptor in the heart • Full agonist for 2 receptor in the lungs • Improved safety (fewer cardiovascular side effects) compared to older -agonists • IV formulation for acute hospital use • Reliable and rapid delivery • Positive Phase IIa results reported in October 2007 MN-221: A New Approach to MN-221: A New Approach to Treating Status Asthmaticus Treating Status Asthmaticus |
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MediciNova, Inc. 2008 8 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 • Corticosteroids (66-77% of patients) • IV or oral *Source: National Center for Health Statistics / CDC MN-221: Market Opportunity MN-221: Market Opportunity |
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MediciNova, Inc. 2008 1. Proven mechanism of action ( -adrenergic agonist) 2. Rapid, reliable IV delivery (vs. inhaled / nebulized) 3. Safer (greater selectivity = fewer cardiovascular SE) 9 Competitive Advantages of Competitive Advantages of MN-221 MN-221 |
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MediciNova, Inc. 2008 10 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 Tolerated Dose) Primary endpoint met in Phase IIa study completed October 2007 • Achieved statistical significance in its primary endpoint of mean change in FEV1 from
baseline at 15 minutes at doses of 3.5, 10, 16, and 30 micrograms/min of
MN-221 compared to placebo • No clinically significant cardiovascular, ECG or vital sign changes, or any other safety
concerns observed at any dose tested • 60 micrograms/min x 15 min (900 mcg) dose a possible MTD of MN-221 MN-221: Positive Phase IIa data MN-221: Positive Phase IIa data |
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MediciNova, Inc. 2008 Change from Pre-Infusion FEV1 at 15 min (ITT) Placebo .35 ug/min 1.0 ug/min 3.5 ug/min 10 ug/min 16 ug/min 30 ug/min MN-221-CL-002: Primary MN-221-CL-002: Primary Efficacy Variable Efficacy Variable 11 |
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MediciNova, Inc. 2008 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 significantly (p< 0.0001) without
clinically significant cardiovascular, ECG, or vital sign changes;
however, the safety trend led us to believe that this is a possible MTD and higher doses should not be tested Safety Database: • MN-221 has been tested in over 300 subjects in the US and Europe to date • Subjects have had infusions with no clinically significant adverse events at: • 16 micrograms/minute for up to 4 hours and at lower doses for up to 24 hours 12 |
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MediciNova, Inc. 2008 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 as early as 1H’09 Commence second Phase IIa study (~20 patients) for extended dosing (4 hour infusion)
• Anticipated commencement date: 1H’08 • Results expected as early as 2H’08 MN-221: Next Steps MN-221: Next Steps 13 |
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MediciNova, Inc. 2008 14 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 |
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MediciNova, Inc. 2008 15 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 • Stimulates Th2 cytokine production and neurotrophic factor release • Cerebrovasodilator • Inhibits leukotrienes, phosphodiesterases, Th1 cytokine production, nitric oxide
and reactive oxygen species production • Demonstrated effects on brain volume • Targets both chronic and acute aspects of multiple sclerosis • Oral administration MN-166 Overview MN-166 Overview *Source: MedAdNews, June 2006 |
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MediciNova, Inc. 2008 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 fatal PML with Tysabri Safety/ Tolerability • All current drugs injectable (daily – weekly) or infusion (monthly) Administration • Increasing interest in combination therapies given insufficient efficacy with current “core” agents • Black box on combination with Tysabri Combination • Real neuroprotection would be groundbreaking • Current treatments do not address disease progression Neuroprotection There are substantial unmet There are substantial unmet needs in the treatment of MS needs in the treatment of MS Description 16 |
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MediciNova, Inc. 2008 Brain volume changes are linked to axonal loss 17 Chronic Efficacy Demonstrated: Chronic Efficacy Demonstrated: Effects on Brain Volume Effects on Brain Volume 1.20 |
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MediciNova, Inc. 2008 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 Inflammation • Phosphodiesterase IV and Leukotriene inhibitor • Inhibits nitric oxide and reactive oxygen species production • Inhibits Th1 cytokine production (IFN- Y , TNF- , IL-1 , IL-6) 18 P-Value: 0.0438 P-Value: 0.033 MN-166 Targets Both Chronic MN-166 Targets Both Chronic and Acute Aspects of MS and Acute Aspects of MS |
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MediciNova, Inc. 2008 Phase III endpoint for certain FDA-approved MS products 19 Acute Efficacy Demonstrated: Acute Efficacy Demonstrated: Time to First Relapse Time to First Relapse |
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MediciNova, Inc. 2008 20 • MN-166 was very well tolerated; 89% of subjects completed the first 12 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 laboratory or ECG findings • GI side effects as a group were the only adverse events to occur at ~2-fold that of the placebo rate (placebo – 7.8%, 30 mg/d – 14.7%, 60 mg/d – 22.2%) • Tolerance to the GI side effects occurred rapidly (2-4 days) • 12 serious adverse events were reported (placebo – 4, 30 mg – 2, 60 mg – 6); all were not or unlikely to be attributable to treatment • No deaths occurred in the study MN-166 Overview-Safety MN-166 Overview-Safety |
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MediciNova, Inc. 2008 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 III H/A, Nasopharyngitis GI disorders Liver enzymes Laquinimod Teva Phase III Liver enzymes Arthralgia Fibrinogen Hemoglobin Safety Comparison with Other Safety Comparison with Other Oral Agents Oral Agents 21 |
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MediciNova, Inc. 2008 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 remitting (RR) and/or secondary progressive (SP) Multiple Sclerosis with continued relapses; • A definite diagnosis of relapsing MS using the new International Committee recommendations (MacDonald Criteria); • One MRI scan taken two weeks prior to treatment start using a standardized MRI protocol with at least one Gd-enhancing lesion; • An EDSS score of 5.5 or less at the screening and baseline visits. Current Clinical Studies: MN- Current Clinical Studies: MN- 166-CL-001 166-CL-001 22 |
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MediciNova, Inc. 2008 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-462 (Thrombosis) Preclinical Diversified Portfolio Diversified Portfolio 23 |
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MediciNova, Inc. 2008 24 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: 1H’08 • Results as early as 2H’08 MN-166 for Multiple Sclerosis • Announce Two-Year Phase II Results – expected 1H’08 • Pursue Corporate Partnership • Phase III ready 2H’08 Medicinova is constantly evaluating opportunities to partner MN-166 and additional programs Near-Term Clinical Near-Term Clinical Milestones Milestones |
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MediciNova, Inc. 2008 25 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 |
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MediciNova, Inc. 2008 26 Leadership Years Experience Background Yuichi Iwaki, MD, PhD Yuichi Iwaki, MD, PhD CEO & President 32 Prof. USC, Formerly Prof. 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 9 KPMG USA (Audit), Arthur Andersen USA Masatsune Okajima, CMA Masatsune Okajima, CMA VP, Head of Japanese Office 16 Daiwa Securities SMBC, Sumitomo Capital Securities, Sumitomo Bank Management Team with Global Management Team with Global Experience Experience |
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MediciNova, Inc. 2008 27 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 Sclerosis): • Current treatment of MS represents significant unmet medical need • Multi-billion dollar market opportunity • Both chronic and acute efficacy have been demonstrated in clinical studies Robust pipeline • Six compounds with applications in multiple disease areas • Unique access to other differentiated, high-value assets Investment Highlights Investment Highlights |