UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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 4, 2010
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 (see General Instruction A.2. below):
| ¨ | 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 CALAsia conference in San Diego, California commencing on October 4, 2010 and are scheduled to make a presentation at such conference on October 4, 2010 at 3:30 p.m. Eastern time. The information to be presented by the Registrant at the conference is attached hereto as Exhibit 99.1.
The information in this Current Report on Form 8-K being provided under this Item 7.01, including Exhibit 99.1 furnished herewith, is being furnished and shall not be deemed “filed” for any purpose of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such Section. The information in this current report on Form 8-K shall not be deemed to be 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 filing.
| Item 9.01. | Financial Statements and Exhibits. |
| (d) | Exhibits. |
| 99.1 | Slide Presentation of the Registrant. |
2
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, MediciNova has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| MEDICINOVA, INC. | ||||
| Date: October 4, 2010 | By: | /S/ SHINTARO ASAKO | ||
| Name: | Shintaro Asako | |||
| Title: | Vice President and Chief Financial Officer | |||
3
 Accelerating
the global development
and commercialization of
innovative pharmaceuticals
©
MediciNova, Inc. 2010
Exhibit 99.1 |
 ©
MediciNova, Inc. 2010
Forward-Looking Statements
Forward-Looking Statements
2
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
MediciNova’s clinical trials supporting the safety and efficacy of its product candidates and
the potential novelty of such product candidates as treatments for disease, plans and objectives for
clinical trials and product development, strategies, future performance, expectations,
assumptions, financial condition, liquidity and capital resources. 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 the risks and uncertainties
inherent in clinical trials and product development and commercialization, such as the
uncertainty in results of clinical trials for 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 approval, the risk of failure of the
third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its
product candidates to perform as expected, the risk of increased cost and delays due to delays in
the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the
adequacy of clinical trial designs or the execution of clinical trials and the timing, cost and design
of future clinical trials and research activities; the timing of expected filings with the FDA;
MediciNova’s failure to execute strategic plans or strategies successfully;
MediciNova’s collaborations with third parties; MediciNova’s ability to realize the anticipated
strategic and financial benefits from its acquisition of Avigen, Inc., to integrate the two ibudilast
development programs and to pursue discussions with potential partners to secure a strategic
collaboration to advance the clinical development of the combined development program; the
availability of funds to complete product development plans and MediciNova’s ability to
raise sufficient capital when needed, or at all; intellectual property or contract rights; and the other risks and
uncertainties described in MediciNova’s filings with the Securities and Exchange Commission,
including MediciNova’s annual report on Form 10-K for the year ended December 31, 2009
and its subsequent periodic reports on Forms 10-Q, 10-K and 8-K. You are cautioned not
to place undue reliance on these forward-looking statements, which speak only as of the date
September 28, 2010. MediciNova disclaims any intent or obligation to revise or update these forward-looking
statements.
|
 ©
MediciNova, Inc. 2010
3
MediciNova
Overview:
•
Founded in September 2000
•
Headquartered in San Diego, CA
•
Additional office in Tokyo, Japan
•
Dual-listing on NasdaqGM
as MNOV
and Osaka Securities Exchange as 4875
•
$63.3 million Market Cap (NasdaqGM) as of 9/28/2010
Development Company Focused on Differentiated Product Candidates
•
Unique access to differentiated, potentially high-value assets primarily from
Japanese alliances (Kyorin, Kissei, Mitsubishi Tanabe Pharma, Meiji)
New Approaches to Treat Serious Medical Conditions:
•
MN-221: Intravenous (IV) acute asthma and COPD candidate
•
Potential $1 billion+ combined market opportunity worldwide*
•
MN-166: oral multiple sclerosis, neuropathic pain, drug addiction candidate
Corporate Overview:
Corporate Overview:
MediciNova, Inc.
MediciNova, Inc.
*Source: Internal
MediciNova
projections |
 Business
Model Business Model
In-License therapeutic small molecules from Japan
to develop in US/EU for global markets
In-License:
Product candidates with significant
clinical or preclinical data
Development:
Conduct Proof-of Concept (Phase I and Phase II) clinical trials
Two Pathways to ROI:
1.
Continue internal development of compound towards
commercialization (focus on US market)
2.
Seek partnership for further development of compouds
Manufacture
Market
Market
Manufacture
Out-License
Development
In-License
MediciNova
4
©
MediciNova, Inc. 2010 |
 Why Japan?
Why Japan?
•
Recent Japanese pharma
blockbusters
•
Mid-size pharma
firms generally must partner to reach
global markets
•
Opportunity for US/global developer that understands
Japan
•
Need for globalization by Japanese Pharma
as market lags
behind USA and European markets
*PharmaLive
Special Reports, Top 50 Pharmaceutical Companies & Their Pipelines 2010; August 1,
2010 5
©
MediciNova, Inc. 2010
$0 |
 ©
MediciNova, Inc. 2010
History:Portfolio building based
History:Portfolio building based
on In-licensing
on In-licensing
•
Sep. 2000
Incorporated MediciNova, Inc. in San Diego, CA
•
June
2001
Initiated
research
collaboration
with
Institute
of
Medical
Sciences at University of Tokyo
•
Mar. 2002
In-licensed
MN-001
from Kyorin
Pharmaceutical
•
June 2002
In-licensed
MN-029
from Angiogene
Pharmaceuticals
•
Feb. 2004
In-licensed
MN-221
from Kissei Pharmaceutical
•
Apr. 2004
In-licensed
MN-305
from Mitsubishi Pharma
Corp
•
Oct. 2004
In-licensed
MN-166
from Kyorin
Pharmaceutical
•
Dec. 2004
In-licensed
MN-246
from Mitsubishi Pharma
Corp
•
Oct.
2006
In-licensed
MN-447/462
from
Meiji
Seika
Kaisha,
Ltd.
Currently MediciNova
has in-licensed 8 compounds
6 |
 7
Commercially-Attractive
Commercially-Attractive
Diversified Portfolio
Diversified Portfolio
Stage of development when licensed:
Work completed by MediciNova
(MNOV) since in-license:
©
MediciNova, Inc. 2010 |
          ©
MediciNova, Inc. 2010
8
Leadership
Years
Experience
Background
Yuichi Iwaki, MD, PhD
Yuichi Iwaki, MD, PhD
CEO & President
34
Professor at USC, formerly Professor at University
of Pittsburgh; Advisor to JAFCO, Tanabe
Shintaro
Shintaro
Asako, CPA
Asako,
CPA , CPA
Chief Financial Officer
12
KPMG USA (Audit), Arthur Andersen USA
Kirk Johnson, Ph.D.
Kirk Johnson, Ph.D.
Chief Scientific Officer
20
Avigen, Genesoft
Pharmaceuticals, Chiron
Corporation
Michael Coffee
Michael Coffee
Chief Business Officer
25
Chief Business Officer, Avigen, President of Elan
Pharmaceuticals, North America
Masatsune
Masatsune
Okajima, CMA
Okajima,
CMA , CMA
VP, Head of Japanese
Office
18
Daiwa Securities SMBC,
Sumitomo Capital Securities, Sumitomo Bank
Management Team with
Management Team with
Global Experience
Global Experience |
 ©
MediciNova, Inc. 2010
9
On-going Clinical Activity:
1.
MN-221-CL-007 Phase II Study for Acute Exacerbations of Asthma
•
Anticipated completion 1Q, 2011*
2.
MN-166
Study for Opioid
Withdrawal
•
Anticipated completion in 2H, 2010*
Potential upcoming Business Deals:
1.
Secure a global partnership for MN-166
2.
Secure a strategic partnership for MN-221
3.
Secure partnership for non-core assets to enable continued clinical
development
Current MediciNova
Current MediciNova
Strategy
Strategy
*Anticipated completion dates based on current projections
|