Form 8-K

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): September 26, 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 UBS Global Life Sciences Conference on September 26, 2007 at 2:00 p.m. Eastern 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:   September 26, 2007     By:   /s/ Shintaro Asako
        Shintaro Asako
        Vice President and Chief Financial Officer


EXHIBIT INDEX

 

Exhibit   

Description

99.1    Slide presentation of the Registrant
Slide presentation of the Registrant
©
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. 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.


©
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. 
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.
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. 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