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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): May 30, 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 J.M. Dutton Health Science Small Cap Conference on May 30, 2007 at 10:10 a.m. Pacific time and at the Friedman Billings Ramsey Growth Conference on May 31, 2007 at 2:20 p.m. Eastern time. A copy of the slide presentation to be used by the Registrant at these conferences is attached hereto as Exhibit 99.1.

The information in this Item 7.01, including Exhibit 99.1 furnished herewith, is furnished pursuant to Item 7.01 and shall not be deemed “filed” for any purpose, including for the 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 Item 7.01 of this Current Report on Form 8-K shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in any such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Number   

Description

99.1    Slide presentation dated May 30, 2007

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: May 30, 2007     By:   /s/ Shintaro Asako
       

Shintaro Asako

Vice President and Chief Financial Officer

EXHIBIT INDEX

 

Number   

Description

99.1    Slide presentation dated May 30, 2007
Slide presentation dated May 30, 2007
©
MediciNova, Inc. 2007
Accelerating
the global development
and commercialization of
innovative pharmaceutical
products
Accelerating
the global development
and commercialization of
innovative pharmaceutical
products
Exhibit 99.1

©
MediciNova, Inc. 2007
This
presentation
may
contain
“forward
looking
statements”
within
the
meaning
of
the
Private
Securities
Litigation
Reform
Act
of
1995.
These
statements
include
statements
regarding
the
expected
progress
of
the
development
of
the
Company’s
product
candidates
and
potential
licensing,
collaboration
and
partnering
plans.
These
statements
are
based
on
certain
assumptions
made
by
the
Company’s
management
that
are
believed
to
be
reasonable
at
the
time.
Such
statements
are
subject
to
a
number
of
assumptions,
risks
and
uncertainties,
many
of
which
are
beyond
the
control
of
the
Company,
including
results
of
clinical
studies,
interest
of
potential
collaborators
in
the
market
and
other
risks
and
uncertainties,
including
those
described
in
the
Company’s
filings
with
the
Securities
and
Exchange
Commission.
These
assumptions,
risks
and
uncertainties
could
cause
the
Company’s
actual
results
to
differ
materially
from
those
implied
or
expressed
by
the
forward-looking
statements.
Safe Harbor Statement
Safe Harbor Statement

©
MediciNova, Inc. 2007
•
US-based pharmaceutical development company:
–
Unique access to differentiated, high-value, lower-risk in-licensed assets from
Japanese alliances
–
Focused on mid-to-late stage clinical development
–
Management team has global development/commercialization experience
•
Commercially-attractive clinical pipeline:
–
8 compounds in 10 different therapeutic indications;           
7 programs in Phase II or later
–
Key market advantages for each unique molecule
–
Multi-billion dollar collective market potential
•
Well-capitalized:
–
$212
M
raised
from
inception;
$98
M
cash,
equiv.
&
mkt
securities
as
of
3/31/07
–
Successful IPO ($122.5 M gross) on Osaka Securities Exchange (OSE; code:
4875) in February 2005
–
NASDAQ
listing
December
2006
(MNOV);
recent
NASDAQ
offering
(1
M
shares
@ $12) in February 2007 to introduce MNOV to new US shareholders
Corporate Overview
Corporate Overview

©
MediciNova, Inc. 2007
Business Model
Business Model
•
In-license high-value, differentiated small molecule product candidates at the late
preclinical-early Phase II clinical development stage at attractive terms from mid-sized
Japanese pharmaceutical companies
•
Add significant value through rapid advancement of product candidates through
proof-of-concept Phase II/III clinical trials
•
Secure strategic alliances at key value inflection points
•
Selectively retain and commercialize certain product candidates for maximum ROI
Drug Development
Research
Late Preclinical
Phase I
Phase II
Phase III
Sales/
Marketing
Partner:
$$$$$
Commercialize:
$$$$$$$$$$
In-License:
$

©
MediciNova, Inc. 2007
Proven Global Success of Drugs
In-Licensed from Japan
Proven Global Success of Drugs
In-Licensed from Japan
Drugs discovered in Japan are being snapped up by Western companies:
Drug
(Date Launched)
Treatment
Japanese
Discoverer
Partner in U.S.
Peak World-Wide
Sales
Pravachol
(1991)
High
cholesterol
Sankyo
Bristol-Myers
Squibb
$3.3 billion
Prevacid
(1995)
Heartburn
Takeda
Abbott
$4.3 billion
Aricept
(1997)
Alzheimer's
Eisai
Pfizer
$1.1 billion
Abilify
(2002)
Schizophrenia
Otsuka
Bristol-Myers
Squibb
$2 billion (a)
Crestor
(2003)
High
cholesterol
Shionogi
AstraZeneca
$4 billion (a)
(a) Analyst estimate
Source: the companies
Others: Pepcid
(Merck), Cardizem
(Aventis), Lupron
(TAP), Atacand
(AstraZeneca),
Biaxin
(Abbott), Levaquin
(J&J), Noroxin
(Merck), Tequin
(BMS) ….MORE

©
MediciNova, Inc. 2007
Japanese Pharma
Alliances
Japanese Pharma
Alliances
•
Unique access to mid-sized Japanese pharma
companies with no U.S. and/or European
development capabilities
•
Acquire rights to select, high quality compounds
in U.S. and select ex-U.S. markets
•
Favorable deal terms:
–
Modest milestone payments (e.g., no more than $1M
upfront)
–
Reasonable royalties (e.g., 14% maximum on U.S.
sales > $500M)
–
No stacking royalties (i.e., ~65/35% split with
originator on out-licensing)
•
Proven track record –
8 compounds acquired in 6
years
•
Self-renewing model
Japanese Pharmaceutical Company
2005 Sales ($M)
Takeda
10,208
Daiichi-Sankyo
8,330
Astellas
7,836
Eisai
4,845
Sumitomo
2,874
Chugai
2,863
Taisho
2,540
Mitsubishi
2,129
Shionogi
1,812
Tanabe
1,563
Ono
1,320
Kyowa-Hakko
1,422
Meiji
995
Santen
842
Hisamitsu
759
Tsumura
741
Kaken
681
Mochida
618
Kyorin
602
Kissei
553
MediciNova
partner
Conduct US trials directly

©
MediciNova, Inc. 2007
Commercially-Attractive
Diversified Portfolio
Commercially-Attractive
Diversified Portfolio
6 Years
8 Compounds
10 Indications
6 Years
8 Compounds
10 Indications
Product candidate (indication)
Preclinical
Phase 1
MN-166 (Multiple sclerosis)
MN-305 (Anxiety Disorders/Insomnia)
MN-221 (Status Asthmaticus)
MN-001 (Bronchial asthma)
MN-001 (Interstitial cystitis)
MN-029 (Solid tumors)
Phase 2
Phase 3
MN-246 (Urinary incontinence)
Approval
MN-221 (Preterm labor)
MN-447 & MN-462 (Thrombosis)

©
MediciNova, Inc. 2007
MN-221 (Status Asthmaticus)
MN-221 (Status Asthmaticus)
Source
Kissei Pharmaceutical (2004)
Market Potential
5th
yr sales ~ $500 M
Advantages
–
Clinically-proven mechanism of action
(highly selective
2
-adrenergic
receptor agonist)
–
Greater cardiovascular safety (less
1
-
adrenergic receptor stimulation)
–
More reliable, effective and rapid route
of administration (i.v. vs. inhaled)
Milestones
US Phase II –
Results 3Q07

©
MediciNova, Inc. 2007
Trends in Asthma
Trends in Asthma
1980
2000
2002
Outpatient visits
7,137,000
1,036,000
1,225,000
Emergency room
visits
1,835,000
1,898,000
Physician office
visits
9,332,000
12,692,000
Hospitalizations
408,000
465,000
484,000
Deaths
2,891
4,487
4,261
Total cost in 2004: $11.5 billion direct and $4.6 billion indirect expenses
source: National Center for Health Statistics/CDC

©
MediciNova, Inc. 2007
MN-221 Competitive Advantages
MN-221 Competitive Advantages
Compound
Dosing
Proven
Mechanism
Rapid
Action
Reliable
Delivery
Safety Issues
MN-221
IV (Ph II)
Yes
Yes
Yes
No
ß-Agonists
Inhaled;
nebulized
Yes
Yes
No
Cardiovascular
(palpitations)
Singulair
IV (Ph III)
No
?
Yes
No
Zyflo
IV (Ph I / II)
No
?
Yes
Liver toxicity

©
MediciNova, Inc. 2007
Human
-Adrenergic Receptor Selectivity
Human
-Adrenergic Receptor Selectivity
Drug
Adrenoceptor
(IC
50
,
M)
2
-Adrenoceptor
Selectivity
1
2
(IC
50
for
1
/IC
50
for
2
)
MN-221
1.39
0.0224
62.1
Albuterol
(Salbutamol)
5.63
1.56
3.61
S(-)-Propranolol
0.00127
0.00094
1.35
Displacement of [³H]-cyanopindolol or [³H]-CGP12177 binding in membrane preparations expressing human cloned
1
-
and
2
-adrenoceptors, respectively
MN-221
selectively
binds
to
human
2
-adrenergic
receptors.

©
MediciNova, Inc. 2007
Reduction in Bronchoconstriction
Reduction in Bronchoconstriction
Recovery
from
Ragweed-induced
Bronchoconstriction
in
Dogs
0
1
2
3
4
5
0
10
20
30
40
50
60
70
80
90
100
110
120
Vehicle
MN-221 (400
g/kg)
baseline
response
MN-221 (120
g/kg)
MN-221 (
0
g/kg)
MN-221 (12
g/kg)
MN-221
g/kg)
MN-221 (0.4
g/kg)
peak
response
Time after Injection (minutes)

©
MediciNova, Inc. 2007
•
Study Objectives:
–
To determine the efficacy of a single 15-minutes treatment with intravenous MN-
221 in subjects with mild-to-moderate asthma.
–
To determine the efficacy of two sequential 15-minutes infusion of MN-221
separated by 20 minutes in subjects with mild-to-moderate asthma.
•
Study Design:
–
Randomized, double-blind, placebo-controlled multi-center trial
•
Study Population:
–
Up to 28 subjects will be randomized in order to complete all dosing
approximately 20-28 subjects.
•
Primary Outcome Measure:
–
The primary efficacy analysis of change from baseline in FEV1 will utilize
ANCOVA, adjusting for treatment, site and baseline FEV1.  The primary
comparison will be between each MN-221 treatment group and placebo.
Phase IIa
Study Outline
Phase IIa
Study Outline

©
MediciNova, Inc. 2007
MN-221 Value-Added/Next Steps
MN-221 Value-Added/Next Steps
At Acquisition
•
Large preclinical and early clinical database (in preterm labor)
Value-Added
•
Initiated cGMP
product manufacturing
•
Changed clinical dosing paradigm
•
Determined safety of new dosing paradigm (through Phase I
testing)
•
New indication –
Status Asthmaticus
Next Steps
•
Phase IIa
proof-of-concept testing (in progress)
•
Phase IIb
in status asthmaticus

©
MediciNova, Inc. 2007
MN-221 Summary
MN-221 Summary
•
Significant market opportunity (to $500M peak sales)
•
Improved selectivity for
2
-adrenergic receptor over older agents
•
Improved safety (fewer cardiovascular side effects) compared to
older
-agonists
•
I.V. formulation (reliable and rapid delivery)
•
Recent composition and use patents issued in the US, Europe &
Japan
•
Well-tolerated in Phase I; little effect on heart rate
•
Phase II (asthma) initiated 4Q06; Results 3Q07
•
Ability to push rapidly to market and sell with a small focused
sales force

©
MediciNova, Inc. 2007
MN-166 (Multiple Sclerosis)
MN-166 (Multiple Sclerosis)
Source
Kyorin
Pharmaceutical (2004)
Market Potential
5th
yr sales ~ $1 B
Advantages
–
Oral treatment for MS
–
16 years proven clinical safety and
efficacy in inflammatory disorders
(asthma, stroke) in Japan
–
Large preclinical and clinical database
(3.2M patients treated; >15,000 in
formal clinical safety database)
–
New US use patent
Milestones
Positive Phase II results 1Q07;
Phase III to start 4Q07 -
1Q08

©
MediciNova, Inc. 2007
MS Demographics and Market
MS Demographics and Market
•
Multiple sclerosis, an inflammatory disease of the central
nervous system, affects 250,000 to 350,000 people in the U.S.
and 2.5 million worldwide.
•
Relapsing-remitting MS is the most common type of the disease,
affecting 65 –
85% of patients, and most patients with RRMS will
eventually progress to the secondary progressive form of the
disease.
•
In 2006, the global market for MS therapies was $5.8 billion.
–
Avonex
$1.7B
–
Rebif
$1.5B
–
Copaxone
$1.4B
–
Betaseron
$1.2B

©
MediciNova, Inc. 2007
Unmet Need
MN-166
Interferon Products
More convenient dosing
Oral
Intravenous or subcutaneous injection
(Injection site pain, swelling and itching)
Greater efficacy
At least comparable
efficacy observed in
early trials
Current relapse reduction rate is ~33%
Longer duration of effect
No neutralizing
antibodies formed; no
loss of effect
Relative benefit gained from existing
drugs
may
decline
over
time
-
possibly
due to presence of neutralizing
antibodies
Halt disease progression
At least comparable
early trends in Phase II
Avonex
reduced the risk of disease
progression by ~37% in patients treated
for 2 years compared to placebo
Better safety profile
Only mild, transient GI
side effects noted in
Phase II
Common side effects include injection
site reactions, flu-like symptoms,
depression, liver problems and blood
abnormalities
MN-166 Competitive Advantages
MN-166 Competitive Advantages

©
MediciNova, Inc. 2007
Mechanism(s) of Action
Mechanism(s) of Action
•
Anti-inflammatory
–
Phosphodiesterase
IV inhibitor
–
Leukotriene
inhibitor
–
Inhibits nitric oxide and reactive oxygen species production
–
Inhibits Th1 cytokine production (IFN-
, TNF-
, IL-1
, IL-6)
•
Neuroprotective
–
Stimulates Th2 cytokine production (IL-4, IL-10)
–
Stimulates neurotrophic
factor release (NGF, GDNF, NT-4)
–
Cerebrovasodilator
(via PGI
2
and/or adenosine receptors)

©
MediciNova, Inc. 2007
Reduction of Relapse Rate
in 6 MS Patients
Normalization of Serum Cytokine
Levels in 11 MS Patients
Cytokine
% Change
Th1
IFN-
-28
TNF-
-35
Th2
IL-4
+119
IL-10
+64
0
1
2
3
4
5
Pre-Treatment
Post-Treatment
MN-166 Key Pilot Clinical Data
MN-166 Key Pilot Clinical Data

©
MediciNova, Inc. 2007
Phase II Clinical Protocol
Phase II Clinical Protocol
•
Phase II placebo-controlled, randomized, double-blind (monotherapy) study
year 1 –
0 (placebo), 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.

©
MediciNova, Inc. 2007
Phase II Clinical Protocol
Phase II Clinical Protocol
•
Key Exclusion Criteria:
–
Treatment
with
systemic
immunosuppressants
(including
investigational
treatments),
such
as
infliximab,
natalizumab,
cyclophosphamide,
mitoxantrone,
azothioprine,
methotrexate,
linomide,
cyclosporine
or
deoxysperagualine
within
6
months
of
the
Week
-2
cranial
MRI
scan;
–
Treatment
with
total
lymphoid
irradiation
or
cladribine
at
any
time;
–
Treatment with interferons
within 45 days of the Week -2 cranial MRI scan;
–
History of recent relapse and treatment with corticosteroids or ACTH within 45 days of the Week -2
cranial MRI scan.
•
Assessments –
During the core period, patients will return to the study center for
assessments at month 1, 2, 4, 6, 8, 10 and 12 (Visits 3-9) following study drug
administration.  Patients who continue to be eligible for the study and who wish to
continue study treatment, will continue to the extension period and will return to the
study center after 13, 14, 16, 18, 20, 22 and 24 months (Visits 10-16).
•
1
o
endpoint –
cumulative number of active (Gd-enhancing (T1) and non-enhancing
new/enlarging (T2)) lesions on cranial MRI scans over 12 months of treatment
•
2
o
endpoints –
annualized relapse rate after 12 months; baseline-adjusted cumulative
volume of Gd-enhancing lesions over 12 months of treatment + a number of additional
exploratory endpoints

©
MediciNova, Inc. 2007
Key Phase II Clinical Outcome Data
Key Phase II Clinical Outcome Data
Outcome Measure
p-value
(pbo
vs. 60 mg/day)
Annualized relapse rate*:
pbo
-
0.8, 60 mg -
0.6 (completers)
pbo
-
0.9, 60 mg -
0.7 (ITT)
0.0752
0.1106
Time to first relapse (ITT)*:
Median for 60 mg > 1 year
Median for pbo
-
244 days
0.0438
% of subjects exacerbation-free for 1 year (ITT)*:
pbo
-
41%, 60 mg -
56.1%
0.033
EDSS (% worsened)(ITT):
pbo
-
30%, 60 mg -
21.4%
0.1771
IDSS (AUC of change from baseline EDSS):
pbo: -0.05, 60 mg: -0.24 (completers)
pbo: -0.05, 60 mg: -0.16 (ITT)
0.0365
0.1761
Disability
progression (worsened  
1.0 on EDSS for 4 mo)(ITT):
pbo
-
8%, 60 mg -
4%
0.334
*
Phase 3 FDA-Approvable Endpoints

©
MediciNova, Inc. 2007
Effects on Time to First Relapse
Effects on Time to First Relapse
Time to first relapse (ITT): Median for pbo
-
244 days, Median for 60 mg > 1 year, p=0.0438
Statistically
Significant
Approvable
Phase
3
endpoint

©
MediciNova, Inc. 2007
Key Phase II Radiological Data*
Key Phase II Radiological Data*
Outcome Measure (ITT)
p-value
(pbo
vs. 60 mg/day)
% brain
volume change:
pbo: -1.2%, 60 mg: -0.79%
0.0352
Cumulative volume of Gd-enhancing T1 lesions:
pbo
-
2355 mm
3
, 60 mg -
1927 mm
3
0.087
Cumulative number of active (Gd-enhancing (T1) and non-enhancing
new/enlarging (T2)) lesions -
study 1
0
outcome:
pbo
-
26.2, 30 mg -
24.6, 60 mg -
21.1 (means)
0.735
*Surrogates of clinical activity
Reductions in lesion volume and % brain volume change, coupled with significant
improvements in clinical outcome, suggest that MN-166 may have antiinflammatory
and neuroprotective
effects (e.g., reduction in demyelination
and axonal injury)

©
MediciNova, Inc. 2007
Effects of MN-166 on Change in Brain Volume (ITT)
Placebo
60 mg/day
-1.50
-1.25
-1.00
-0.75
-0.50
-0.25
0.00
Placebo
60 mg/day
Treatment Group
Effects on Brain Volume
Effects on Brain Volume
% brain volume change: pbo: -1.2%, 60 mg: -0.79%, p=0.0352
Brain volume loss is linked to disease progression

©
MediciNova, Inc. 2007
Key Phase II Safety Data
Key Phase II Safety Data
•
MN-166 was very well tolerated; 89% of subjects completed
the first 12 months (core) of the study
•
Side effects were generally mild and self-limiting
•
No statistically significant adverse effects were observed
•
No laboratory or ECG findings
•
Mild, self-limiting GI side effects were the only adverse
events to occur at ~2-fold that of the placebo rate (pbo
–
7.8%, 30 mg/d –
14.7%, 60 mg/d –
22.2%); tolerance to the GI
side effects occurred rapidly (2-4 days)
•
Superior safety profile
to interferons
and other oral MS
treatments in development

©
MediciNova, Inc. 2007
MN-166 Summary
MN-166 Summary
•
Marketed
product
(for
bronchial
asthma
and
cerebrovascular
disorders)
in
Asia since 1989
•
Extensive preclinical and clinical database:
–
Data from ~15,000 patients in clinical trial and post-marketing database
–
Extensive toxicology package, including carcinogenicity testing in one species
•
Antiinflammatory
and
neuroprotective
properties
in
vitro
and
in
vivo
•
Newly-issued (2002) use patent in U.S.
•
Oral formulation (no injections!)
•
Efficacy and safety confirmed in 297-patient Phase II clinical study in
relapsing MS patients
•
Comparable efficacy to interferons
and other oral MS agents in development
with a superior safety profile
•
Potential effects on disability/disease progression

©
MediciNova, Inc. 2007
Management Team
with Global Experience
Management Team
with Global Experience
LEADERSHIP
Years
Experience
Life Sciences Background
Yuichi Iwaki, MD, PhD
CEO & President
31
Prof. USC, Pitt; Advisor to JAFCO, Tanabe
Director, Avigen, Inc.
Richard Gammans, PhD, MBA
Chief Development Officer
30
Incara, Indevus, BMS
Kenneth W. Locke, PhD
Chief Scientific Officer
23
Tanabe Research Laboratories USA,
Indevus, Hoechst
Shintaro
Asako, CPA
Chief Financial Officer
8
KPMG USA (Audit), Arthur Andersen USA
Masatsune
Okajima, CMA
VP, Head of Japanese Office
15
Daiwa Securities SMBC, Sumitomo Capital
Securities, Sumitomo Bank
Lynn Terhorst, MBA
VP, Business Planning & Analysis
24
Ligand, General Electric Medical
Systems, Hybritech, Molecular Biosystems
Bonnie Feldman, DDS, MBA
VP, Investor Relations & Corporate     
Communications
24
Clinical Advisors, D3 Capital,
Lippert/Heilshorn, Sutro
& Co.

©
MediciNova, Inc. 2007
MediciNova, Inc. Today
MediciNova, Inc. Today
•
Market-driven, commercially-focused mid-stage pharma
company
•
Innovative business model:
–
Steady inflow of high-quality molecules, primarily from mid-size Japanese pharma
–
Focus on large, lucrative, underserved markets
–
Therapeutic & and molecular diversity lowers risk & optimizes reward
•
Rich mid-
to late-stage clinical development pipeline:
–
6 years, 8 compounds, 10 indications
–
Small molecules with clear market advantages & strong IP
–
Multi-billion dollar market potential
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Portfolio growth strategy: build to profitability through out-
licensing & retained commercial rights
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Well-capitalized: poised for success