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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): October 17, 2014

 

 

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.)

4275 Executive Square, Suite 650

La Jolla, CA 92037

(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.

On October 17, 2014, MediciNova Inc. (the “Company”) updated the slide presentation to be used by the Company at investor meetings. A copy of the revised slide presentation is furnished as Exhibit 99.1 and is incorporated herein by reference. The Company does not undertake to update this presentation.

The information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities under that Section, nor be deemed to be incorporated by reference into the filings of the registrant under the Securities Act of 1933.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit   
No.    Description
99.1    Slide presentation of the Company.

 

2

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 17, 2014     By:   /s/ Yuichi Iwaki
   

    Yuichi Iwaki, M.D., Ph.D.

    President and Chief Executive Officer

 

3

EXHIBIT INDEX

 

Exhibit   
No.    Description
99.1    Slide presentation of the Company
EX-99.1
©
MediciNova, Inc. 2014
Developing Novel Therapeutics for the
Treatment of Serious Diseases with
Unmet Medical Needs
Exhibit 99.1

©
MediciNova, Inc. 2014
©
MediciNova, Inc. 2014
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,"
“considering”,
“planning”
or
similar
expressions.
These
forward-looking
statements
involve
a
number
of
risks
and
uncertainties
that
may
cause
actual
results
or
events
to
differ
materially
from
those
expressed
or
implied
by
such
forward-looking
statements.
Factors
that
may
cause
actual
results
or
events
to
differ
materially
from
those
expressed
or
implied
by
these
forward-looking
statements
include,
but
are
not
limited
to,
risks
of
obtaining
future
partner
or
grant
funding
for
development
of
MN-166,
MN-221,
MN-001,
and
MN-029
and
risks
of
raising
sufficient
capital
when
needed
to
fund
MediciNova's
operations
and
contribution
to
clinical
development,
risks
and
uncertainties
inherent
in
clinical
trials,
including
the
potential
cost,
expected
timing
and
risks
associated
with
clinical
trials
designed
to
meet
FDA
guidance
and
the
viability
of
further
development
considering
these
factors,
product
development
and
commercialization
risks,
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,
risks
associated
with
the
reliance
on
third
parties
to
sponsor
and
fund
clinical
trials,
risks
regarding
intellectual
property
rights
in
product
candidates
and
the
ability
to
defend
and
enforce
such
intellectual
property
rights,
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
of
expected
filings
with
the
regulatory
authorities,
MediciNova's
collaborations
with
third
parties,
the
availability
of
funds
to
complete
product
development
plans
and
MediciNova's
ability
to
obtain
third
party
funding
for
programs
and
raise
sufficient
capital
when
needed,
and
the
other
risks
and
uncertainties
described
in
MediciNova's
filings
with
the
Securities
and
Exchange
Commission,
including
its
annual
report
on
Form
10-K
for
the
year
ended
December
31,
2013
and
its
subsequent
periodic
reports
on
Forms
10-Q
and
8-K.
You
are
cautioned
not
to
place
undue
reliance
on
these
forward-looking
statements,
which
speak
only
as
of
October
17,
2014.
MediciNova
disclaims
any
intent
or
obligation
to
revise
or
update
these
forward-looking
statements. 
Forward-Looking Statements

©
MediciNova, Inc. 2014
©
MediciNova, Inc. 2014
Novel product candidates
in clinical development with encouraging efficacy
and safety data
MN-166 (ibudilast)
for the treatment of Progressive MS, ALS, and Drug
Dependence
Two large Phase 2b studies ongoing (Progressive MS and methamphetamine)
Initiated clinical development in ALS in 2014
Patents cover Progressive MS and addiction
MN-001
for
the
treatment
of
NASH
(nonalcoholic
steatohepatitis)
and      
IPF
(idiopathic
pulmonary
fibrosis)
MN-221
for the treatment of acute exacerbations of asthma
Well-capitalized
Experienced management team
3
MediciNova Highlights

©
MediciNova, Inc. 2014
©
MediciNova, Inc. 2014
4
MediciNova: Active Programs in
Clinical Development in Sep. 2013
Active Programs as of September 2013

©
MediciNova, Inc. 2014
©
MediciNova, Inc. 2014
5
MediciNova: Active Programs in
Clinical Development in Oct. 2014

©
MediciNova, Inc. 2014
©
MediciNova, Inc. 2014
6
Neurodegenerative Diseases
Progressive
Multiple Sclerosis
“Progressive MS”
•
MS
affects
more
than
400,000
people
in
the
U.S.
and
2.3
million
worldwide
1
•
Patients
experience
a
diminished
quality
of
life
(e.g.
fatigue,
walking
difficulties,
weakness,
pain,
cognitive
changes,
depression)
1
•
Market opportunity:  Total sales of RRMS drugs were $16
billion worldwide in 2013.  We believe Progressive MS
market is at least as large as RRMS market.
•
Approved Drugs:  NONE APPROVED for long-term
treatment of Progressive MS
Amyotrophic
Lateral Sclerosis
(ALS)
“Lou Gehrig's
Disease”
1.
Source: National Multiple Sclerosis Society
2.
Source: ALS Association
3.
Source: Cowen & Co. estimate
4.
Cochrane Database of Systematic Reviews
•
Fatal:
ALS
Life
expectancy
is
2-5
years
2
•
ALS
affects
up
to
30,000
people
in
the
U.S.
2
(Orphan
indication)
•
Market
opportunity:
an
effective
new
drug
for
ALS
could
generate
sales
>$1
billion
per
year
3
•
Approved
Drugs:
RILUZOLE
increases
survival
by
only 2-
3
months
4

©
MediciNova, Inc. 2014
©
MediciNova, Inc. 2014
7
Fibrotic Diseases
Idiopathic
Pulmonary
Fibrosis
“IPF”
Nonalcoholic
Steatohepatitis
“NASH”
•
NASH
prevalence
in
the
U.S.
is
2-5%
1
•
Additional
10-20%
have
“fatty
liver”
due
to
being
overweight
or
obese
1
•
NASH
Market
forecast:
$1.6
billion
by
2020
2
•
Approved
Drugs:
NO
TREATMENT
APPROVED
1.
National Digestive Diseases Information Clearinghouse (NDDIC)
2.
Allied Market Research
3.
Coalition for Pulmonary Fibrosis
4.
Research and Markets
5.
Esbriet prescribing information
•
IPF
prevalence
about
128,000
in
the
U.S.
3
(Orphan
indication)
•
Two-thirds
of
IPF
patients
die
within
5
years
3
•
IPF
Market
forecast:
>$1
Billion
in
2017
4
•
Approved
Drugs:
Esbriet
(pirfenidone)
approved
in
October
2014;
Esbriet
Phase
3
studies
enrolled
mild
to
moderate
IPF;
No
survival
benefit
shown
5

©
MediciNova, Inc. 2014
8
Tipelukast
MN-001
Developing Novel Therapeutics…
MEDICINOVA
MN-166
Ibudilast

©
MediciNova, Inc. 2014
©
MediciNova, Inc. 2014
GLIAL CELL ATTENUATION
Role of Glia:
•
Type of macrophage
•
Increases in number during brain damage
•
Glial activation leads to neurodegeneration
PDE Inhibition:
•
Increases cAMP, reducing inflammation
MIF inhibition
•
Linked to attenuated disease progression in
animal models of MS
9
How does MN-166 work?

©
MediciNova, Inc. 2014
©
MediciNova, Inc. 2014
MN-166 Phase 2 RRMS Data
•
Significant attenuation of brain volume loss (p=0.035)
•
Significant attenuation of conversion of acute lesions to
persistent black holes (p=0.004)
•
Sustained disability progression was significantly less
likely (p=0.026)
•
Significant improvement in time to first relapse (p=0.04)
MN-166 Ongoing NIH-funded Phase 2b study
•
PPMS and SPMS study
•
Results expected early 2017
10
What Do the Data Show?

©
MediciNova, Inc. 2014
©
MediciNova, Inc. 2014
11
What is Fibrosis?
Fibrosis
•
Fibrosis is the development of
excess fibrous connective tissue in
an organ
•
Fibrosis is a result of inflammation,
irritation, or healing (e.g. scar)
•
Cross-linking of collagen and elastin
is the final step in fibrosis
Cross-linking of collagen and elastin
fibrosis

©
MediciNova, Inc. 2014
©
MediciNova, Inc. 2014
12
How does Fibrosis Develop?
Genes Promoting Fibrosis
•
LOXL2
•
Collagen Type 1
•
CCR2
•
MCP-1
•
TIMP-1
LOXL2
Cross-linking of collagen and elastin
fibrosis
Collagen Type 1
CCR2
MCP-1
TIMP-1

©
MediciNova, Inc. 2014
©
MediciNova, Inc. 2014
13
How does MN-001 work?
Tipelukast
MN-001
MN-001
LOXL2
Cross-linking of collagen and elastin
fibrosis
Collagen Type 1
CCR2
MCP-1
TIMP-1
MN-001 Reduces Gene Expression
•
LOXL2
•
Collagen Type 1
•
CCR2
•
MCP-1
•
TIMP-1

©
MediciNova, Inc. 2014
©
MediciNova, Inc. 2014
•
More than 600 human
subjects exposed to MN-001
Phase 2 study of MN-001 in
asthma with positive results
MN-001 was considered
generally safe and well-tolerated
•
Pre-clinical data shows anti-
fibrotic effect in a Dose-
Dependent Manner
•
Improved NAFLD Activity Score
(NAS) via a reduction in
hepatocyte ballooning
•
Reduced fibrosis area
14
What Do the Data Show?
NAFLD Activity Score (NAS)
% of fibrosis area
Tipelukast
MN-001

©
MediciNova, Inc. 2014
©
MediciNova, Inc. 2014
Next Steps –
Progressive MS
15
Q2 2013: Submit New IND
Amendment and New Ph2 Protocol
Q3 2013: FDA approval & Study
Initiation
Q3 2013: Screening begins
Q4 2013: First Patient In
Q1 2015: Last Patient In
Q1 2017: Last Patient Out
1H 2017: Results available
Progressive
Multiple Sclerosis
“Progressive MS”

©
MediciNova, Inc. 2014
©
MediciNova, Inc. 2014
Next Steps -
ALS
16
Amyotrophic
Lateral Sclerosis
(ALS)
“Lou Gehrig's
Disease”
Q3 2014: Submit New ALS Protocol
as IND Amendment
Q3 2014:  FDA Approval to Start
Study
Q3 2014: IRB Submission & Site
Activation
Q3 2014: Study Start-up & Database
Build
Q4 2014: Began Enrollment
TBD:  Last Patient In

©
MediciNova, Inc. 2014
©
MediciNova, Inc. 2014
Next Steps -
NASH
17
Q1 2014: Positive preclinical data in
NASH
Q3 2014: Positive preclinical data in
Advanced NASH
Q3 2014: Prepare IND submission
Q4 2014: Present NASH data at JDDW
ASAP: Submit IND and Protocol
Nonalcoholic
Steatohepatitis
(NASH)
Tipelukast
MN-001

©
MediciNova, Inc. 2014
©
MediciNova, Inc. 2014
18
MN-166
Ibudilast
Tipelukast
MN-001
Timeline
Summary
MEDICINOVA