1. Q2 2015 Executive Summary
(NanoScan Imaging, LLC)
Contact
Information:
NANOSCAN
IMAGING,
LLC
497
Black
Swan
Lane
Berwyn,
PA
19312
Mobile:
610-­‐608-­‐1569
Fax:
610
296
7749
www.nanoscanimaging.com
dskerrett@aol.com
Management
Team:
Don
Skerrett,
Chief
Executive
Officer;
Mark
Carvlin,
PhD,
VP
Business
Development
&
Chief
Scientific
Officer;
Linda
Nardone,
PhD,
RAC,
VP
Chief
Regulatory
Officer;
Mary
Osbakken,
MD,
PhD,
Chief
Medical
Officer;
Peter
van
der
Kam,
VP
Chief
Operating
Officer
Board
Members:
Zahi
Fayad,
PhD,
FAHA,
FACC,
Professor,
Radiology
and
Medicine
at
Mount
Sinai
School
of
Medicine,
New
York;
Wayne
Davis,
Co-­‐
Founder
&
Vice
President
of
Govt.
Affairs
at
Harvest
Power;
Chaitan
Divgi,
MD,
Professor
of
Clinical
Radiology
and
Director
of
Kreitchman
PET
Center
at
Columbia
University;
Gene
Cooper,
PhD,
former
Executive
Vice
President
of
R&D
at
Elan;
Peter
Haabestad,
Guardian
Capital
Partners;
Robert
Lee,
PhD,
Sr.
Executive
at
Particle
Sciences;
Barry
Marrs,
PhD,
Former
Director
of
R&D
at
DuPont
and
Hercules;
Jim
Mulshine,
MD,
Academic
Provost,
Rush
University
Medical
Center;
Larry
Sternson,
PhD,
former
President
of
Elan’s
Drug
Delivery
business.
Industry:
Radiopharmaceuticals,
Diagnostic
Imaging.
Type
of
Financing
Sought:
Convertible
Debt.
Pre-­‐Money
Valuation:
TBD
Total
External
Capital
Invested:
$1.9
(from
Founders
and
F&F)
Investment
Sought:
$6.8MM
in
three
tranches
-­‐
$1.5MM,
$2.0MM
&
$3.3MM
Professionals:
Fesnak
&
Associates;
Royer
Cooper
Cohen
Braunfeld
LLC
(RCCB)
-­‐
John
Royer;
TD
Bank
Company:
NanoScan
Imaging
(“NSI”)
was
formed
to
improve
and
extend
the
clinical
utility
of
N1177,
a
novel
iodinated
nanoparticulate
CT
contrast
agent
targeting
the
$8.6
billion
radiopharmaceutical
market.
Breakthrough
Technology:
N1177
gives
physicians
better,
safer
ways
to
diagnose
cardiovascular
disease
and
cancer.
Safety:
Offers
significant
safety
advantages
over
conventional
CT
and
MRI
contrast
agents.
Chief
advantage
is
lack
of
renal
toxicity.
Clinical
Acceptance:
96%
of
doctors
surveyed
said
they
are
“likely”
or
“very
likely”
to
switch
from
their
current
contrast
agent
to
an
agent
with
decreased
renal
toxicity.
New
Formulations
and
New
IP:
N1177
was
originally
developed
to
replace
traditional
water-­‐soluble
iodine
contrast
agents.
Breakthrough
studies
in
prestigious
medical
journals
(e.g.
Nature
Medicine)
strongly
suggest
that
NSI
re-­‐enter
Phase
I
clinical
trials
with
an
improved
IV
version
using
the
original
active
pharmaceutical
ingredient
(API).
New
IP
will
be
filed
on
new
formulations,
marked
by
1)
a
significant
reduction
in
particle
size,
2)
a
corresponding
upgrade
to
“generally
regarded
as
safe”
(GRAS)
excipients
and
3)
significantly
lower
manufacturing
costs.
N1177
currently
has
a
broadly
defined
but
aging
patent
estate
that
provides
freedom
to
operate
but
limits
NSI’s
ability
to
generate
compelling
new
IP
around
the
present
“nanocrystal”
formulation.
New
formulation
claims
tying
together
“composition”
and
“use”
for
a
smaller
particle
size
were
allowed
in
2014
in
Japan
(JPA.2010-­‐518439),
and
similar
claims
are
expected
to
be
granted
in
the
US
and
other
jurisdictions
for
the
proposed
new
formulations.
Management:
NSI’s
management
team
is
comprised
of
industry
experts
with
strong
backgrounds
in
the
technology,
the
market,
pre-­‐clinical
and
clinical
drug
development,
licensing,
manufacturing,
strategic
partnership
development
and
regulatory
affairs.
Don
Skerrett,
CEO,
is
a
serial
entrepreneur
and
President
of
the
Pharmaceutical
Consulting
Consortium
International
(PCCI),
an
association
of
400
senior-­‐
level
life
sciences
practitioners
that
has
helped
almost
100
early-­‐stage
therapeutics,
diagnostics,
medical
device,
vaccine
and
mobile
health
companies
get
to
the
next
level.
Peter
van
der
Kam,
COO,
was
a
senior
marketing
and
operations
executive
at
Merck
and
later
directed
Wyeth’s
European
operations;
Peter
is
also
a
key
member
of
PCCI’s
unique
outreach
team.
Mark
Carvlin,
CSO,
has
worked
closely
with
N1177
for
more
than
15
years
starting
with
NSI’s
predecessors,
Imcor
and
Photogen;
he
is
a
former
VC;
Mark
also
served
as
Senior
Market
Manager
of
Magnetic
Resonance
Products
at
Bristol-­‐Myers
Squibb
Diagnostics;
when
BMS
sold
its
diagnostics
division
to
Bracco,
Mark
moved
with
the
asset
to
direct
Bracco’s
product
development.
Linda
Nardone,
VP
Regulatory
Affairs,
managed
the
development
of
Omnipaque®,
Omniscan®
and
Bexxar®
from
proof
of
concept
through
clinical
and
FDA
approvals
all
the
way
into
commercial
channels
and
post-­‐marketing.
Mary
Osbakken,
Chief
Medical
Officer,
is
a
cardiologist
and
a
PhD
radiologist;
she
has
held
executive
posts
at
Sanofi-­‐Aventis,
Covance
and
Bristol-­‐
Meyers
Squibb
and
has
worked
with
multiple
drug
and
medical
device
start-­‐ups.
Disruptive
Platform
Technology:
N1177
promises
multiple,
significant
“platform”
opportunities:
a)
General
imaging
agent
replacing
most
water-­‐soluble
iodine
contrast
agents;
b)
Extended
residence
time
allows
radiologists
up
to
15
minutes
to
image
multiple
vascular
beds
in
a
single
pass
(e.g.
carotids
and
peripheral
arteries);
c)
Nodal
mapping
of
metastatic
cancers;
d)
Organ
perfusion,
includes
detection
of
liver
and
other
cancers;
e)
Identification
of
vascular
inflammation
/
plaque
/
vulnerable
plaque;
f)
CNS
and
autoimmune
diseases
where
inflammation
plays
a
central
role;
g)
As
a
targeted
delivery
system
for
anti-­‐inflammatory
cardiovascular
and
anti-­‐cancer
therapeutics.
Competition:
There
are
no
approved
products
and
no
known
safer
CT-­‐enhancing
compounds
in
clinical
development
considered
to
be
a
direct
competitive
threat
to
N1177
in
any
of
the
above
applications.
Regulatory
Strategy:
1)
Applied
for
orphan
drug
designations
for
the Diagnosis and Staging of Primary
Liver Cancer and Intrahepatic Bile Duct Cancer in patients with renal insufficiency for whom standard
MRI and/or CT contrast media are contraindicated or cannot be administered;
US
annual
Incidence
of
33,190
cases/US
exposure
estimated
to
be
176,904
patients/Global
Incidence
of
745,000
cases;
once
approved
in
US
N1177
will
be
eligible
for
a
50%
tax
credit
on
clinical
development
expenses,
development
grants,
priority
FDA
guidance
and
guaranteed
seven-­‐year
market
exclusivity.
2)
NSI
will
also
seek
regulatory
approval
for
general
CT/Xray
imaging,
which
is
the
same
as
its
predecessor
Omnipaque
and
other
major
water-­‐soluble
CT
imaging
agents.
NSI
plans
to
re-­‐enter
Phase
I
clinical
trials
with
a
significantly
improved
version
of
N1177,
which
promises
better
imaging
quality
and
enhanced
bioavailability
without
the
risk
of
renal
toxicity.
Exit:
NSI
is
talking
to
acquisition
candidates
and
plans
to
sell
N1177
to
a
diagnostic
pharmaceutical
company
after
successful
proof
of
concept
in
early
clinical
trials
in
three
to
four
years.
The
Company’s
value
at
that
time
could
be
in
the
$50
-­‐
$100
million
range
and
return
a
significant
multiple.