VGEN Presentation

1. First
Quarter
2014
VACCINOGEN
-­‐
A
$5+
BILLION
CANCER
VACCINE
OPPORTUNITY
Q1
2014
Stock
Symbol:
VGEN
1

2. Vaccinogen
and
OncoVAX®
A
cancer
vaccine
company
in
its
final
stages
of
clinical
development
with
a
patented
phase
III
asset
-­‐
OncoVAX
Stock
symbol
is
VGEN
Q1
2014
Stock
Symbol:
VGEN
2

3. OncoVAX®
• Cancer
vaccine
• Designed
to
reduce
the
risk
of
recurrence
of
cancer
aLer
surgery
• Uses
the
paNent’s
own
tumor
as
vaccine
source
Q1
2014
Stock
Symbol:
VGEN
3

4. Value
ProposiDon
Late
stage
-­‐
5
clinical
studies,
including
a
staNsNcally
significant
phase
3
trial
$14
billion
global
market
$5
billion
in
US
&
Europe
Solid
patent
protecNon
to
2025
RelaNvely
simple
logisNcs
with
few
variables
Pursuing
an
untapped
market
with
colon
cancer
BeauNfully
addresses
“heterogeneity
of
cancer”
Q1
2014
Stock
Symbol:
VGEN
4

5. OncoVAX® - Clinical II(a)
C
OncoVAX®
–
Phase
IResultslinical
Results
8701 Study - Recurrence-Free Survival* in Stage II Patients
C u m u l a t i v e
P r o b a b i l i t y
8701
Study
-­‐
Recurrence-­‐Free
Survival*
in
Stage
II
PaNents
100
90
80
70
Recurrence-Free Survival
(No. of Recurrences or Deaths)
Population
Control
5-year
OncoVAX® p-value
50
All Patients
49 (38.9%)
N=126
39 (30.5%)
N=128
0.073
40
Stage II
(Intent-to-Treat)
29 (37.7%)
N=77
17 (21.3%)
N=80
0.008
Stage II (Treatment 29(37.7%)
Compliant)
N=77
12 (19.4%)
N=62
0.012
30
60
0
1
2
3
4
5
6
7
8
9
10
11
Y e a r s
Treatment
Control
OncoVAX
* This published, randomized Phase IIIa clinical trial was stratified by tumor stage so that a legitimate analysis by tumor stage could be calculated.
These results are for Stage II colon cancer. Some benefit was seen in Stage III colon cancer however the results were not statistically significant.
This study was accepted by the FDA as supportive data for the next Phase IIIb clinical trial to be conducted under an FDA granted SPA with fast
track designation. The Disease-free Survival clinical endpoint will be used for the interim analysis, which is an accepted basis for FDA approval.
The
results
were
published
in
the
BriNsh
Medical
Journal
The
Lancet
January
30,
1999;
353:
345-­‐350
Q1
2014
Stock
Symbol:
VGEN
5

6. OncoVAX®
–
Phase
Itage
II
PaNents
linical
Results
II(a)
C
OncoVAX® - Clinical
8701
Study
-­‐
Recurrence-­‐Free
Interval
(RFI)
in
S Results
C u m u l a t i v e
P r o b a b i l i t y
8701 Study - Recurrence-Free Interval (RFI) in Stage II Patients
100
90
Difference between treated and control 16.1%
80
70
60
0
1
2
3
4
5
6
7
8
9
10
11
Y e a r s
Treatment
Control
O n c o VA X
Date run: 30NOV00
Greatest difference between treated and control in RFI at 18 months post Vx
Greatest
difference
between
treated
and
control
in
RFI
at
18
months
post
Vx
Q1
2014
Stock
Symbol:
VGEN
6

7. Clinical
history
&
foundaDon
for
OncoVAX®
• 751
paNents
treated
over
five
studies
• Phase
III
trial
showed
61%
improvement
of
survival
• Non
treated
group
–
1/3
of
paNents
recurred
(as
stage
4)
• OncoVAX
treated
group
–
only
1/10
recurred
Q1
2014
Stock
Symbol:
VGEN
7

8. Target
market
IniDal
targets
Annual
cases
in
Western
markets
Stage
II
colon
cancer
160,000
Stage
III
colon
cancer
150,000
310,000
total
cases
of
stage
II
&
III
colon
cancer
in
Western
world
Q1
2014
Stock
Symbol:
VGEN
8

9. Key
consideraDons
Item
Key
benefits
Acceptable
price
per
vaccine
$54,000
-­‐
$70,000
Internal
cost
per
vaccine
$7,000
-­‐
$8,000
US
&
Europe
market
-­‐
stage
2
&
stage
3
300,000
cases
per
year
colon
cancer
Likely
market
penetraNon
30%
to
55%
Asian
colon
cancer
market
potenNal
200,000
cases
per
year
Other
potenNal
targets
Renal
cancer,
melanoma,
ovarian
cancer,
non
small-­‐cell
lung
cancer
Scale?
Yes
–
all
process
are
the
same
across
all
indicaNons
Q1
2014
Stock
Symbol:
VGEN
9

10. Revenue
scenarios
on
just
colon
cancer
@
$55,000
PenetraDon
(Western
Market)
Vaccines
sold
Revenues
10%
20%
30%
40%
50%
60%
31,000
62,000
93,000
124,000
155,000
186,000
$1.7
billion
$3.4
billion
$5.1
billion
$6.8
billion
$8.5
billion
10.2
billion
Q1
2014
Stock
Symbol:
VGEN
10

11. Patent
coverage
• Sterility
Patent
–
covers
the
sterile
manufacturing
process
– Expires
2025
– Approved
in
all
major
markets
• Two
other
patents
being
filed
currently
Q1
2014
Stock
Symbol:
VGEN
11

12. Vaccine
Manufacturing
After injection:
Immune responds by killing
all leftover live tumor cells
3 part process
Step
1
Step
2
Step
3
• 3
grams
of
live
tumor
cells
removed
at
surgery
and
shipped
to
VGEN
• VGEN
makes
cells
into
a
sterile,
“safe
vaccine
–
OncoVAX”
• 30-­‐35
days
later,
VGEN
ships
OncoVAX
back
to
the
hospital
for
final
compounding
and
injecNon
PaNent’s
own
tumor
cells
re-­‐
injected
4
Nmes
in
the
skin
Q1
2014
On
the
3rd
and
4th
injecNon,
the
immune
system
reacts!
Stock
Symbol:
VGEN
12

13. LogisDcs
=
How
we
“de-­‐risk”
this
investment
Vaccine
Material
PaDent’s
own
tumor
Transport
of
Nssue
to
VGEN
Hands
on
manufacturing
Nme
Via
transplant
courier
6
hours
Transport
of
finished
vaccine
AdministraNon
of
vaccine
Internal
costs
per
vaccine
Frozen
via
Fed
Ex
Intradermal
injecNon
$7,000
to
$8,000
Q1
2014
Stock
Symbol:
VGEN
13

14. Colon
Cancer
today
–
sDll
an
untapped
market
Stage
II
colon
cancer
Stage
III
colon
cancer
%
of
all
colon
cancers
40%
37%
Current
treatment
Surgery
only
Surgery
+
chemotherapy
Recurrence
rate
1/3
1/2
Survival
rate
if
cancer
returns
<6%
(now
stage
4)
<6%
(now
stage
4)
Q1
2014
Stock
Symbol:
VGEN
14

15. Heterogeneity within primary tumors
Yachida, et al., Nature 467: 114, 2010.!
Q1
2014
Stock
Symbol:
VGEN
15

16. Coming
up
-­‐
Pivotal,
Confirmatory
Phase
III
(b)
• 550
paNent
phase
III
trial
–
confirmatory
– SPA
and
Fast
Track
• Parallel
phase
I/II
study
for
stage
III
colon
cancer
Q1
2014
Stock
Symbol:
VGEN
16

17. Management
Michael
G.
Hanna
Jr.,
Ph.D.
Andrew
L.
Tussing
President
COO
Debra
Hoopes
Chief
Financial
Adviser
John
Powers
OperaNons
-­‐
LogisNcs
Dinand
Van
der
Linde
Head
of
Europe
Herbert
C.
Hoover,
MD
Q1
2014
CEO,
Chairman
inventor
Chief
Medical
Adviser
Stock
Symbol:
VGEN
17

18. Medical
Advisory
Board
Michael
G.
Hanna,
Jr.,
Ph.D.
Immunology
John
S.
Macdonald,
MD
Specialist
in
Harvard,
B.
Israel,
Georgetown,
GastrointesNnal
Cancer
New
York
Medical.
College
Benjamin
S.
Carson,
MD
Neurosurgery
Johns
Hopkins,
PresidenNal
Medal
of
Freedom,
authored
100+
publicaNons,
4
books
H.C.
Hoover,
MD
Surgical
Oncology
Johns
Hopkins,
Harvard,
inolved
in
all
5
OncoVAX
studies
Jan
Vermorken,
MD,
Ph.D.
Oncology
University
of
Antwerp,
Vrije,
principal
invesNgator
in
previous
8701
phase
III
OncoVAX
trial
Q1
2014
Stock
Symbol:
VGEN
Invent
of
OncoVAX®
NaNonal
Cancer
InsNtute,
authored
225
publicaNons
18

19. Summary
–
De-­‐risking
aspects
of
this
investment
•
•
•
•
•
•
Public
company
–
fully
reporNng
Phase
III
results
in
hand
LogisNcs
–
proven,
stable
and
scalable
Clear
path
ahead
in
colon
cancer
ShiLing
standard
of
care
from
surgery
alone
85%
margins
on
a
mulN-­‐billion
market
Q1
2014
Stock
Symbol:
VGEN
19

20. Contact:
• Andrew
L.
Tussing,
President
&
COO
• atussing@vaccinogeninc.com
• (US)
301
668-­‐8400
Q1
2014
Stock
Symbol:
VGEN
20

21. Forward
Looking
Statements
This
presentaNon
and
related
commentary
may
contain
forward-­‐looking
statements
within
the
meaning
of
the
SecuriNes
Act
of
1933
(the
“Securi(es
Act”)
and
the
SecuriNes
Exchange
Act
of
1934
(the
“Exchange
Act”)
and
are
subject
to
the
safe
harbor
created
by
the
Private
SecuriNes
LiNgaNon
Reform
Act
of
1995.
Vaccinogen
has
based
these
forward-­‐looking
statements
largely
on
our
expectaNons
and
projecNons
about
future
events
and
financial
trends
affecNng
the
financial
condiNon
and/or
operaNng
results
of
its
business.
Forward-­‐looking
statements
involve
risks
and
uncertainNes;
parNcularly
those
risks
and
uncertainNes
inherent
in
the
process
of
discovering,
developing
and
commercializing
drugs
that
are
safe
and
effecNve
for
use
as
human
therapeuNcs.
There
are
important
factors
that
could
cause
actual
results
to
be
substanNally
different
from
the
results
expressed
or
implied
by
these
forward-­‐looking
statements,
including,
among
other
things:
• Vaccinogen’s
ability
to
successfully
manufacture
OncoVAX®
and
other
product
candidates
in
necessary
quanNNes
with
required
quality;
• Vaccinogen’s
ability
to
successfully
obtain
regulatory
approvals
and
commercialize
its
products
that
are
under
development
and
develop
the
infrastructure
necessary
to
support
commercializaNon
if
regulatory
approvals
are
received;
• Vaccinogen’sability
to
complete
and
achieve
posiNve
results
in
ongoing
and
new
clinical
trials;
• Vaccinogen’s
dependence
on
single-­‐source
vendors
for
some
of
the
components
used
in
its
product
candidates;
• the
extent
to
which
the
costs
of
any
products
that
Vaccinogen
is
able
to
commercialize
will
be
reimbursable
by
third-­‐party
payers;
• the
extent
to
which
any
products
that
we
are
able
to
commercialize
will
be
accepted
by
the
market;
• Vaccinogen’s
dependence
on
our
intellectual
property
and
ability
to
protect
its
proprietary
rights
and
operate
its
business
without
conflicNng
with
the
rights
of
others;
• the
effect
that
any
intellectual
property
liNgaNon,
or
product
liability
claims
may
have
on
Vaccinogen’s
business
and
operaNng
and
financial
performance;
• Vaccinogen’s
expectaNons
and
esNmates
concerning
its
future
operaNng
and
financial
performance;
• the
impact
of
compeNNon
and
regulatory
requirements
and
technological
change
on
Vaccinogen’sbusiness;
• Vaccinogen’s
ability
to
recruit
and
retain
key
personnel;
• Vaccinogen’s
ability
to
enter
into
future
collaboraNon
agreements;
and
• anNcipated
trends
in
our
business
and
the
biotechnology
industry
generally
In
addiNon,
in
this
presentaNon
and
related
commentary,
the
words
“believe,”
“may,”
“will,”
“esNmate,”
“conNnue,”
“anNcipate,”
“intend,”
“plan,”
“expect,”
“potenNal,”
or
“opportunity,”
the
negaNve
of
these
words
or
similar
expressions,
as
they
relate
to
Vaccinogen,
its
business,
future
financial
or
operaNng
performance
or
Vaccinogen’s
management,
are
intended
to
idenNfy
forward-­‐looking
statements.
Past
financial
or
operaNng
performance
is
not
necessarily
a
reliable
indicator
of
future
performance
and
you
should
not
use
Vaccinogen’s
historical
performance
to
anNcipate
results
or
future
period
trends.
Because
such
statements
involve
risks
and
uncertainNes,
many
of
which
are
outside
of
Vaccinogen’s
control,
Vaccinogen's
actual
results
and
performance
may
differ
materially
from
the
results
expressed
or
implied
by
such
forward-­‐looking
statements.
Given
these
risks
and
uncertainNes,
readers
are
cauNoned
not
to
place
undue
reliance
on
such
forward-­‐looking
statements.
Other
important
risk
factors
that
may
affect
Vaccinogen's
business,
results
of
operaNons
and
financial
posiNon
are
discussed
in
its
most
recently
filed
RegistraNon
Statement
on
Form
10
and
in
other
SecuriNes
and
Exchange
Commission
filings.
Unless
otherwise
required
by
law,
Vaccinogen
also
disclaims
any
obligaNon
to
update
its
view
of
any
such
risks
or
uncertainNes
or
to
announce
publicly
the
result
of
any
revisions
to
the
forward-­‐looking
statements
made
here.
However,
readers
should
review
carefully
reports
and
documents
that
Vaccinogen
files
periodically
with
the
SecuriNes
and
Exchange
Commission.
Q1
2014
Stock
Symbol:
VGEN
21