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): October 10, 2007
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”) are scheduled to make a presentation at the 2007 BIO InvestorForum on October 10, 2007 at 11:15 a.m. Pacific time. A copy of the slide presentation to be used by the Registrant at 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. |
| Exhibit | Description | |
| 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.
| MEDICINOVA, INC. | ||||||||
| Dated: October 10, 2007 | By: | /s/ Shintaro Asako | ||||||
| Shintaro Asako | ||||||||
| Vice President and Chief Financial Officer | ||||||||
EXHIBIT INDEX
| Exhibit | Description | |
| 99.1 | Slide presentation of the Registrant | |
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MediciNova, Inc. 2007 Accelerating the global development and commercialization of innovative pharmaceuticals October 2007 Exhibit 99.1 |
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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. 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. |
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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: – Easy intravenous formulation to treat Status Asthmaticus patients – Safe and potential disease modifying (neuroprotection) therapy for Multiple Sclerosis Diverse Pipeline: – Additional upside with six more compounds in development for various indications MediciNova Headquarters: San Diego, CA |
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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 |
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MediciNova, Inc. 2007 5 * Extended Dosing (4 Hour Infusion) ** Anticipated commencement and completion dates based on current projections † Filing as early as 2H’10 * 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** |
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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 6 Phase IIa Study; Positive Results October 2007 |
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MediciNova, Inc. 2007 1. Proven mechanism of action ( 2 -adrenergic agonist) 2. Rapid, reliable IV delivery (vs. inhaled/nebulized) 3. Safer (greater selectivity = fewer cardiovascular SE) 7 |
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MediciNova, Inc. 2007 -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 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 8 |
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MediciNova, Inc. 2007 • 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 300 subjects in the US and Europe to date • Subjects have had infusions of 16 micrograms/minute of up to 4-hours with MN-221
with no clinically significant adverse events reported – Subjects have had infusions at lower doses of up to 24-hours with no clinically
significant adverse events reported • MN-221 is a partial agonist for the ß 1 receptor in the heart and a full agonist for the ß 2 receptor in the lungs; which in addition to its high selectivity may explain why no clinically significant cardiac events are seen with this drug 9 |
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MediciNova, Inc. 2007 10 • 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 Infusion) – Anticipated commencement date: Q1’08 – Results expected as early as Q3’08 |
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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.
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. 11 |
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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) 12 |
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MediciNova, Inc. 2007 Brain volume changes are linked to axonal loss 13 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 |
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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) 14 (MN-166 Similar Acute Efficacy to Current and Developing Treatments) P-Value: 0.0438 P-Value: 0.033 |
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MediciNova, Inc. 2007 Phase III endpoint for certain FDA-approved MS products 15 |
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MediciNova, Inc. 2007 16 • 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 |
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MediciNova, Inc. 2007 17 |
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MediciNova, Inc. 2007 18 |
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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 19 |
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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 10/09/07: ~$101.27M • Shares outstanding: 11.9M 20 |
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MediciNova, Inc. 2007 21 Leadership Years Experience Background Yuichi Iwaki, MD, PhD Yuichi Iwaki, MD, PhD CEO & President 32 Prof. 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 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 |
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MediciNova, Inc. 2007 • 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 Value Creation through Establishment of Partnerships 22 |