Professional Documents
Culture Documents
ProMIS NS
ProMIS NS
8,
2015
TM
Company.
ProMIS
Neurosciences,
Inc.,
is
a
development
stage
biotech
company
that
discovers
and
develops
precision
diagnostics
and
therapeutics
for
early
detection
and
effective
treatment
of
neurodegenerative
diseases,
in
particular
Alzheimers
disease
(AD)
and
amyotrophic
lateral
sclerosis
(ALS).
TM
ProMIS
Neurosciences,
Inc.
will
be
the
new
name
for
the
company
currently
known
as
Amorfix
Life
Sciences,
Ltd,
founded
in
2004
and
publicly
traded
as
AMF
on
the
Toronto
Stock
Exchange
(TSX).
Re-launch,
New
Strategic
Direction.
The
Companys
scientific
foundation
is
centered
on
the
growing
knowledge
base
relating
to
diseases
characterized
by
the
presence
of
abnormal,
misfolded
proteins.
Numerous
diseases
exhibit
protein
misfolding,
among
them
certain
cancers,
and
several
neurodegenerative
diseases,
such
as
Alzheimers
disease
(AD),
amyotrophic
lateral
sclerosis
(ALS)
and
Parkinsons
disease
(PD).
Recent
published
evidence
indicates
that
for
a
given
misfolded
protein
there
exist
multiple
prion-like
strains,
each
strain
representing
a
specific
target
against
which
therapeutics
can
be
developed.
Accordingly,
as
its
primary
objective,
the
Company
will
focus
on
the
discovery
and
development
of
precision
diagnostics
and
therapeutics
directed
against
the
several
strains
of
beta-amyloid
(A)
in
Alzheimers.
New
Management
Team.
The
three-member
senior
management
team
will
include
Dr.
Neil
Cashman,
the
Companys
current
Chief
Scientific
Officer.
In
addition,
two
pharmaceutical
industry
veterans
and
biotech
entrepreneurs,
with
over
60
years
cumulative
experience
in
key
aspects
of
drug
development
and
commercialization
plan
to
join
the
team:
Eugene
Williams
as
Executive
Chairman
and
Dr.
Elliot
Goldstein
as
Chief
Executive
Officer.
Changes
to
the
current
Board
of
Directors
are
also
planned
to
support
the
re-
launch
and
reinforce
the
new
strategic
focus.
Core
Science
&
Technology.
The
re-launched
company
will
be
based
around
the
leading
science
of
Dr.
Neil
Cashman,
Professor
of
Medicine
at
the
University
of
British
Columbia,
Neuroscientist
at
the
Brain
Research
Center,
Academic
Director
of
the
Vancouver
Coastal
Hospital
ALS
Center,
and
Scientific
Director
of
PrioNet
Canada,
a
Center
of
Excellence
Network
for
research
into
prions
and
prion
diseases.
DR.
Cashman
has
over
300
publications
with
over
10,000
citations
and
45
patent
applications.
For
over
two
decades,
Neil
Cashman
has
been
among
the
leaders
in
the
field
of
misfolded
proteins
and
is
one
of
several
leading
researchers
of
strain
specific
protein
misfolding.
Misfolded
proteins
showing
prion-like
strains
include:
beta-amyloid
(A
oligomers)
in
AD,
superoxide
dismutase1
(SOD1)
and
TDP43
in
ALS,
alpha-synuclein
in
PD,
and
TAU
in
multiple
neurodegenerative
diseases
such
as
Alzheimers,
chronic
traumatic
encephalopathy
and
certain
forms
of
Parkinsons.
Intellectual
Property.
Based
primarily
on
the
research
discoveries
in
Dr.
Cashmans
lab,
the
Company
has
exclusive
access
to
critical
IP
and
proprietary
know-how
in
the
field.
The
Companys
broad
patent
estate
consists
of
eight
patent
families
issued
or
pending.
TM
Amorfix
utilizes
its
computational
discovery
platform,
ProMIS ,
to
predict
novel
targets
known
as
Disease
Specific
Epitopes
(DSEs)
on
the
molecular
surface
of
misfolded
proteins.
Amorfix
owns
the
exclusive
rights
to
the
Genus
patent
relating
to
misfolded
SOD1
in
ALS,
and
currently
has
a
preclinical
monoclonal
antibody
therapeutic
directed
against
this
target.
Deal.
The
Company
is
seeking
to
raise
a
minimum
of
CDN
$1.5MM,
up
to
a
maximum
of
CDN
$2.5MM
via
a
private
placement
at
CDN
$0.03
per
share,
at
a
pre-money
valuation
of
approximately
CDN
$2.0MM.
There
are
no
warrants
attached
to
this
Offering,
which
is
open
to
current
shareholders
and
accredited
investors.
The
Offer
is
pending
shareholder
approval
at
the
Companys
Annual
General
Meeting
scheduled
th
for
June
29 ,
2015.
June
8,
2015
!
Use
of
Proceeds.
The
primary
objective
will
be
to
identify
Alzheimers
disease
specific
epitopes
(targets)
on
one
or
more
strain
specific
A
oligomers
and
file
for
patent
protection
in
major
jurisdictions.
The
development
of
such
IP
is
the
essential
first
step
on
the
path
to
creating
precision
diagnostics
and
therapeutics
against
these
targets
in
Alzheimers.
In
addition,
the
proceeds
of
this
Offering
will
be
used
for
maintenance
of
the
current
and
emerging
IP
estate,
engagement
of
the
new
senior
management
team,
payment
of
outstanding
debts,
and
general
corporate
purposes.
The
Company
anticipates
that
upon
closing
of
this
deal
and
successful
achievement
of
its
primary
objective,
a
second
fund
raising
can
be
initiated
6-10
months
hence
at
a
step
up
in
valuation.
---------------------------------------------------------Investment
Highlights------------------------------------------------------------------
1)
2)
3)
TM
ProMIS
Neurosciences
is
addressing
what
is
probably
the
greatest
area
of
unmet
need
in
healthcare
-
neurodegenerative
disease,
especially
Alzheimer's
As
other
disease
areas
have
been
successfully
addressed
by
advances
in
medicine,
the
population
is
aging
successfully.
Alzheimer's
is
already
an
epidemic,
one
that
will
grow
dramatically
over
the
coming
decades.
By
age
85,
more
than
35%
of
the
population
suffers
from
symptomatic
dementia.
We
now
know
that
the
disease
processes
that
lead
to
these
symptoms
start
decades
earlier.
Today,
over
5
million
people
in
the
US
and
Canada
suffer
from
clinical
Alzheimer's,
and
over
15
million
have
the
earliest
stage
disease
known
as
Mild
Cognitive
Impairment
(MCI).
More
than
25
million
have
an
ongoing
disease
process
that
will
likely
progress
to
fully
symptomatic
dementia.
The
cost
of
illness
in
the
US
alone
is
$450
BB,
with
half
of
it
in
medical
costs,
and
half
in
cost
of
caregiving.
These
numbers
are
expected
to
triple
over
the
next
30
years.
While
there
are
palliative
treatments,
there
are
no
effective
therapies
for
Alzheimer's
today.
Recent
advances
have
increased
confidence
that
we
understand
the
scientific
basis
of
Alzheimer's,
and
are
on
the
path
to
effective
treatment
Abnormal,
misfolded
versions
of
two
natural
proteins,
beta-amyloid
((A)
and
Tau,
appear
to
be
the
root
cause
of
Alzheimer's
disease.
The
proteins
misfold
into
a
toxic
version
often
called
a
prion,
or
referred
to
as
prion-like
(a
misfolded
protein).
These
toxic
versions
of
proteins
form
tangles
and
fibrils,
leading
to
neuronal
death
and
the
cognitive
decline
of
Alzheimer's.
There
have
been
numerous
efforts
over
recent
years
to
create
effective
therapy
by
addressing
these
biologic
pathways.
Such
efforts
have
led
to
disappointment
until
very
recently,
when
Biogen
Idec
announced
results
of
an
early
phase
clinical
trial
late
in
2014.
Its
product,
BIIB037
(Aducanumab),
generated
encouraging
positive
results
in
a
phase
1
study
of
Alzheimer's
patients.
Biogen's
market
value
was
$71BB
on
December
1,
2014
before
any
public
announcement
about
the
results
of
BIIB037.
It
rose
to
$91BB
by
February
2,
2015
after
the
announcement,
an
increase
in
value
of
$20BB,
and
has
stayed
at
that
level
since.
These
data
support
the
notion
that
the
right
therapies,
addressing
misfolded
A
and
Tau
and
applied
early
enough
in
the
disease,
could
be
very
effective.
ProMIS
Neurosciences
believes
that
there
is
at
least
one
more
iteration
of
improvement
in
these
therapies
that
we
need
to
take,
and
ProMIS
will
address
that.
"Precision
Medicine"
-
targeting
the
right
drug
to
the
right
patient
by
using
both
a
diagnostic
and
a
therapeutic
together
-
has
had
dramatic
positive
impact
in
a
number
of
diseases.
It
appears
to
be
important
in
Alzheimer's
and
neurodegenerative
disease
as
well.
The
precision
medicine
approach,
as
outlined
recently
in
the
New
York
Times,
has
led
to
major
June
8,
2015
4)
5)
breakthroughs
in
cancer
treatment.
Cancers
are
being
treated
based
on
their
specific
genetic
mutation(s),
instead
of
using
the
traditional
approach
of
treatment
based
on
the
organ
in
which
the
cancer
first
appeared.
According
to
the
head
of
the
FDA
review
division,
Dr.
Richard
Pazdur,
Conventional
therapy
might
give
a
response
rate
of
10-20%,
the
newer
drug
has
a
response
rate
of
50-60%................these
are
response
rates
we
havent
seen
before
in
diseases
(NYT
Feb
25,
2015).
Similarly,
the
biologic
cause
of
cystic
fibrosis,
mutations
of
the
gene
coding
for
CFTR
(cystic
fibrosis
transmembrane
conductance
regulator),
has
been
well
known
for
a
long
time.
However,
only
recently
has
precision
medicine
allowed
development
of
highly
effective
therapies
for
this
devastating
disease.
Vertex's product KALYDECO (ivacaftor) targets two genetic subsets of the disease. The Cystic Fibrosis
Foundation
supported
the
products
development
financially,
and
sold
its
royalty
rights
in
KALYDECO
to
a
third
party
for
$3.3BB.
Recent
scientific
advances
have
shown
that
for
each
of
the
misfolded
prion-like
proteins
that
drive
Alzheimers
(A,
Tau)
and
ALS
(SOD1,
TDP43)
there
exist
multiple
distinct
strains.
These
strains
may
be
associated
with
different
rates
of
disease
progression.
If
the
example
from
other
diseases
also
proves
true
in
the
neurodegenerative
field,
then
precision
medicine
targeting
those
specific
strains
may
show
similar
dramatic
improvement
in
treatment
effect.
TM
ProMIS
Neurosciences
is
well
positioned
to
apply
the
leading
science
and
patented
processes
of
its
CSO,
Neil
Cashman,
to
create
specific
diagnostics
and
therapeutics
for
distinct
misfolded
protein
strains,
ushering
in
the
era
of
precision
medicine
in
Alzheimers
and
other
neurodegenerative
diseases.
ProMIS's
goal
is
to
build
a
broad
IP
portfolio
of
strain
specific
therapeutics
and
companion
diagnostics
over
the
next
3-5
years,
and
advance
its
lead
programs
to
the
clinic.
This
may
lead
to
M&A
exit
opportunities
on
favorable
terms.
--------------------------------------------Summary
Investment
Highlights-------------------------------------------------------------
June
8,
2015
-------------------------------------------------------------Risk
Factors--------------------------------------------------------------------------------------
TM
ProMIS
Neurosciences
competes
in
the
highly
risky
healthcare
market.
Investors
should
carefully
review
the
risk
factors,
and
should
not
invest
capital
they
are
not
in
a
position
to
lose.
Risk
factors
include:
o
o
o
o
o
o
o
o
o
o
The
re-launched
company
has
limited
operating
history,
and
may
have
difficulties
recruiting
or
retaining
qualified
personnel
necessary
to
execute
the
company's
plans.
The
company
may
have
difficulties
raising
follow
on
financing,
or
may
have
to
accept
unfavorable
terms.
The
Company
may
be
unable
to
identify
relevant
targets
(DSEs).
IP
relating
to
DSEs
may
not
be
granted.
Issued
IP
may
be
successfully
challenged
by
third
parties.
It
may
not
be
possible
to
create
therapeutics
and
companion
diagnostics
targeting
the
DSEs.
It
may
not
be
possible
to
manufacture
the
companion
diagnostics
and
therapeutics.
The
therapeutic
products
and
companion
diagnostics
may
fail
during
development
for
reasons
of
poor
safety,
lack
of
efficacy,
or
other
issues.
The
therapeutics
and
companion
diagnostics
may
not
receive
regulatory
approvals.
Other
companies
may
be
able
to
create
competitive
products
that
are
better,
or
faster
to
market.
This
information
release
may
contain
certain
forward-looking
information.
Such
information
involves
known
and
unknown
risks,
uncertainties
and
other
factors
that
may
cause
actual
results,
performance
or
achievements
to
be
materially
different
from
those
implied
by
statements
herein,
and
therefore
these
statements
should
not
be
read
as
guarantees
of
future
performance
or
results.
All
forward-looking
statements
are
based
on
the
Company's
current
beliefs
as
well
as
assumptions
made
by
and
information
currently
available
to
it
as
well
as
other
factors.
Readers
are
cautioned
not
to
place
undue
reliance
on
these
forward-looking
statements,
which
speak
only
as
of
the
date
of
this
information
release.
Due
to
risks
and
uncertainties,
including
the
risks
and
uncertainties
identified
by
the
Company
in
its
public
securities
filings,
actual
events
may
differ
materially
from
current
expectations.
The
Company
disclaims
any
intention
or
obligation
to
update
or
revise
any
forward-looking
statements,
whether
as
a
result
of
new
information,
future
events
or
otherwise.