2. Forward–Looking
Statements
This
presenta+on
contains,
and
any
accompanying
oral
presenta+on
would
no
doubt
contain,
forward-‐looking
statements,
within
the
meaning
of
the
Private
Securi+es
Li+ga+on
Reform
Act
of
1995,
regarding
us
(Biocept,
Inc.)
and
our
business.
Forward-‐looking
statements
include
all
statements
that
are
not
historical
facts
and
generally
can
be
iden+fied
by
terms
such
as
an+cipates,
believes,
could,
es+mates,
expects,
intends,
may,
plans,
poten+al,
predicts,
projects,
should,
will,
would,
or
the
nega+ve
of
those
terms
and
similar
expressions.
Forward-‐looking
statements
involve
known
and
unknown
risks,
uncertain+es
and
other
factors
which
may
cause
our
actual
results,
performance
or
achievements
to
be
materially
different
from
any
future
results,
performance
or
achievements
expressed
or
implied
by
the
forward-‐looking
statements.
For
details
about
these
risks,
please
see
our
SEC
filings.
All
forward
looking
statements
contained
in
this
presenta+on
speak
only
as
of
the
date
hereof,
and
except
as
required
by
law,
we
assume
no
obliga+on
to
update
these
forward-‐looking
statements
whether
as
a
result
of
any
new
informa+on,
future
events,
changed
circumstances
or
otherwise.
2
3. Business
Overview
CLIA
facility
in
San
Diego,
CA
Genomic
test
results
sent
to
physicians
R&D
Clinical
Development
CLIA
Lab
R
and
D,
test
kits
manufactured
and
samples
analyzed
Manufacturing
3
4. Investment
Highlights
• OncoCEE™:
measures
circula+ng
tumor
cells
(CTCs)
• OncoCEE-‐BR™
:
first
commercialized
test
for
breast
cancer
• CEE-‐Selector™:
plaorm
expansion
for
muta+on
analysis
• Robust
test
pipeline
focused
on
solid
tumor
genomic
diagnos+cs
including
lung,
breast,
colon,
prostate
and
melanoma
• Established,
cer+fied
and
scalable
CLIA
lab
• Clear
path
to
market
penetra+on
• Established
research
collabora+ons
and
strategic
partnerships
• IPO
completed
February
2014;
gross
proceeds
of
$19
million
4
Commercial
stage
cancer
diagnos0cs
company
with
ground-‐breaking
technology
pla9orm
u0lizing
a
simple
blood
test
5. Mul+faceted
Growth
Strategy
• Commercializa+on
– Clinical,
Commercial
– Biopharma
– Partnerships
• Test
Menu
Build
Out
– test
valida+on
– Clinical
u+lity
studies
– Plaorm
expansion
• Opera+onal
Efficiency
– Automa+on
– Process
improvements
– Increase
Gross
Margin
5
6. Biocept
Execu+ve
Team
6
Michael
Nall
President
and
CEO
Lyle
Arnold,
Ph.D.
SVP,
R&D
and
CSO
Farideh
Bischoff,
Ph.D.
VP
TranslaEonal
Research
and
Clinical
Development
Bill
Kachioff
SVP,
Finance
and
CFO
David
Hale
ExecuEve
Chairman
•
More
than
25
years
in
healthcare
sales,
marke+ng
and
commercial
opera+ons
•
14
years
in
cancer
diagnos+cs
and
genomics
•
Most
recently
GM
N.
American
Sales
and
Marke+ng
for
Clarient,
a
GE
Healthcare
Company
•
Senior
R&D
Leadership
at
Gen-‐Probe,
Incyte
Genomics,
Genta
•
Founder/
Co-‐founder
Oasis
Biosciences,
Molecular
Biosystems,
Aegea
Biotechnologies
•
Former
faculty
member,
UCSD
School
of
Medicine
and
member,
UCSD
Cancer
Center
•
39
issued
US
and
140
issued
and
pending
patents
worldwide
•
Former
Associate
Professor
and
member,
Cancer
Center
at
Baylor
College
of
Medicine
•
Postdoc
at
MD
Anderson
and
Baylor
College
of
Medicine
•
More
than
130
peer
reviewed
papers
and
book
chapters
•
Chairman
and
CEO
of
Hale
BioPharma
Ventures
with
over
35
years
as
a
healthcare
visionary
•
Chairman
of
Santarus
(acquired
by
Salix),
Conatus,
Micromet
(acquired
by
Amgen),
and
SkinMedica
(acquired
by
Allergan)
•
CEO
of
Hybritech
(acquired
by
Lilly)
,
Gensia
(acquired
by
Teva)
•
More
than
20
years
life
sciences
experience
•
14
years
of
experience
in
public
company
finance
•
Abboj
Labs,
Cutera,
Coulter
Pharmacue+cal,
Althea,
Vivus
•
Diverse
finance
and
opera+ons
management
experience
Raaj
Trivedi
VP
Commercial
OperaEons
•
More
than
15
years
in
healthcare
sales,
marke+ng
and
business
development
•
Served
as
VP
of
Marke+ng
and
then
VP
of
Business
Development
at
Clarient
•
Life
Technologies
Commercial
Leader
for
Oncomine
Biomarker
Discovery
Plaorms
7. US
Market
Opportunity
7
Cancer
Type
New
Cases/
Year
Living
with
Cancer
Deaths/
Year
Breast 232,340 2,829,041 39,620
Prostate 238,590 2,617,682 29,720
Lung 228,190 399,431 159,480
Colorectal 142,820 1,154,481 50,830
Melanoma 76,690 921,780 9,480
Total 918,630 7,922,415 289,130
*
Incidence,
prevalence
and
deaths
data
provided
by
Na+onal
Cancer
Ins+tute:
hjp://seer.cancer.gov/staacts/
8. Molecular
Cancer
Tes+ng
Market
8
*GEN
Magazine,
Bold
Predic+on
for
Future
Cancer
Tests
*Frost
and
Sullivan
–
Market
Research
2011
**Jain
Pharma
Biotech
June
2011
CAGR
22.9%
for
US
0
0.5
1
1.5
2
2.5
3
2010
2015
2017
N.
America*
Global**
$
Billions
Market
Characteris9cs:
• Increased
reliance
on
molecular
diagnos+cs
for
treatment
decisions
• Expanding
use
of
targeted
therapies
• Greater
sophis+ca+on
of
oncology
diagnos+cs
• Limited
by
need
for
tumor
+ssue
9. Limita+ons
of
Tissue
Biopsy
Cancer
is
a
heterogeneous
disease
– Molecular
proper+es
differ
within
a
tumor
– Primary
tumor
biopsy
may
not
reflect
current
disease
condi+on
– Therapy
causes
changes
in
tumor
cells
Biopsy
is
invasive
– May
not
be
feasible
based
on
pa+ent
condi+on
or
tumor
accessibility
– Imprac+cal
for
periodic
monitoring
for
progression
/
recurrence
Biopsy
+ssue
is
limited
– Greater
demand
due
to
molecular
profiling
– Surgery
is
costly
9
Liquid
Biopsy
Addresses
Limita9ons
in
Standard
of
Care
10. New
Molecular
Paradigm
–
Liquid
Biopsy
• ctDNA
-‐
CTCs
–
Circula+ng
Tumor
Cells,
cell
free
Circula+ng
tumor
DNA
• ctDNA:
demonstrated
surrogate
for
tumor
+ssue
biopsy
• Can
be
captured
and
characterized
for
biomarkers,
similar
to
+ssue
• Liquid
biopsy
repeatable
throughout
treatment,
par+cularly
when
+ssue
unavailable
• 66%
of
researchers
say
analysis
of
CTCs
will
be
standard
of
care
in
the
next
4
years*
10
*CTC
industry
overview
–
Hanson
and
Wade
2013
Solid
tumors
shed
CTCs
and
ctDNA
into
blood
CTCs
and
ctDNA
travel
via
bloodstream
CTCs
&
ctDNA
analyzed
for
pa+ent
treatment
decisions
Breast
cancer
CTC
11. OncoCEE™
Personalized
Genomic
Diagnos+cs
11
Personalized
Treatment
EGFR/ALK/ROS1
K-‐ras
B-‐raf
ZELBORAF®
(vemurafenib)
TARCEVA®
(erlo+nib)
&
IRESSA®
(gefi+nib)
/
XALKORI
®(crizo+nib)
ERBITUX®
(cetuximab)
&
VECTIBIX®
(panitumumab)
HER2
HERCEPTIN®
(trastuzumab
)
The
Right
Therapy
for
the
Right
Pa9ent
at
the
Right
Time
OncoCEE-‐BR™
Breast
Cancer
OncoCEE-‐ME™
Melanoma
OncoCEE-‐CR™
Colorectal
Cancer
OncoCEE-‐LU™
Non-‐small
Cell
Cancer
12. Intellectual
Property
12
CEE-‐SelectorTM
Muta+on
Analysis
Patent
pending
Biocept
Developed
SoluEons
Patented
CEE®
Microfluidic
Channel
CEE-‐Sure™
Stability
Transport
Tube
Patent
pending
OncoCEE™
Chemistry:
An+body
Cocktail
Patent
pending
One
US
and
associated
foreign
patents
pending
Two
issued
US
patents
and
two
issued
foreign
patents;
mulEple
pending
US
and
foreign
patents
Two
US
and
associated
foreign
patents
pending
for
capture;
one
US
and
associated
foreign
patents
pending
for
detecEon
One
US
and
associated
foreign
patents
pending
13. CEE-‐Selector™
Plaorm
• Allows
for
both
CTC
and
cell
free
ctDNA
analysis
• Detects
1
muta+on
out
of
>10,000
normal
DNA
• Works
with
various
nucleic
acid
targets
(DNA
and
RNA)
• Compa+ble
with
sequencing
and
PCR
instruments
• Mul+plexing
reduces
costs
and
enhances
reimbursement
• Poten+al
applica+ons
in
all
stages
of
cancer
13
MutaEon
determinaEon
sensiEvity
10-‐100x
beSer
than
compeEng
plaTorms*
*
Biocept
internal
data
14. 14
OncoCEE-‐BR™
2015
2013
2014
Product
Valida9on-‐
CLIA
Product
Development-‐
R&D
and
TCD
OncoCEE-‐BR™
(DTC)
OncoCEE-‐PR™
OncoCEE-‐LU™
OncoCEE-‐CR™
OncoCEE-‐ME™
Breast
cancer
Bone
marrow
for
breast
cancer
Prostate
cancer
Non-‐small
cell
lung
cancer
Melanoma
Colorectal
cancer
HER2
OncoCEE-‐GA™
Gastric
cancer
Product
Development
Pipeline
Muta9on
FISH
ER
PR
Pre-‐2013
15. 15
OncoCEE™
Product
Profiles
Product
Tumor
Type
OncoCEE™
CTC
CEE-‐Selector™
OncoCEE-‐BRTM
(launched)
Breast
Enumera+on
of
CTCs
,
HER2,
ER,
PR
Currently
no
clinically
ac+onable
muta+ons
iden+fied
OncoCEE-‐GATM
Gastric
Enumera+on
of
CTCs,
HER2
Currently
no
clinically
ac+onable
muta+ons
iden+fied
OncoCEE-‐LUTM
Lung
Enumera+on
of
CTCs,
ALK,
ROS1
EGFR,
K-‐ras,
B-‐raf
muta+ons
OncoCEE-‐CRTM
Colon
Enumera+on
of
CTCs,
EGFR
K-‐ras,
B-‐raf
muta+ons
OncoCEE-‐PRTM
Prostate
Enumera+on
of
CTCs,
AR,
and
PTEN
dele+on
(blood
or
bone
marrow)
Currently
no
clinically
ac+onable
muta+ons
iden+fied
OncoCEE-‐METM
Melanoma
Enumera+on
of
CTCs
B-‐raf
and
N-‐ras
muta+ons
16. 16
Targeted
Commercializa+on
Strategy
• Raise
awareness
of
the
value
of
ctDNA
• Drive
OncoCEE
adop+on
– Market
directly
to
oncologists
– Develop
key
opinion
leader
speakers
• Build
rela+onships
with
pa+ent
advocacy
groups
• Publish
studies
with
major
cancer
centers
• Par+cipate
in
medical
mee+ngs
/
symposia
• Deepen
payor
rela+onships
and
expand
reimbursement
coverage
• Expand
strategic
partnerships
with
pharma
and
biotech
for
personalized
diagnos+cs
17. 17
Driving
Adop+on
for
Growth
12
Month
Commercial
Team
Build
• Head
of
sales
and
marke+ng
• Regionally
based
sales
team
• Sales
team
for
Pharma
• Managed
care
expert
• Internal
marke+ng
• Leverage
partner
sales
forces
18. 18
Dana-‐Farber
• Metasta+c
Breast
Cancer
pa+ents
with
HER2
nega+ve
primary
biopsy
• CTC
HER2
posi+ve
pa+ents,
as
detected
with
OncoCEE
BR,
placed
on
Hercep+n
•
Sponsored
by
Genentech
•
Results
expected
in
2014014
MD
Anderson
•
Recently
diagnosed
breast
cancer
pa+ents
• 15%
of
CTC
and
28%
of
DTCs
have
HER2
discordance
with
primary
tumor
•
Published
in
Cancer
Medicine
–
April
20132013
Other
studies
• Four
addi+onal
peer
reviewed
published
studies
valida+ng
technology
•
Addi+onal
pending
studies
with
collaborators
•
Planned
study
in
Non
Small
Cell
Lung
Cancer
• Planned
study
in
Non
Small
Cell
Lung
Cancer
Clinical
U+lity
Studies
19. Investment
Highlights
• OncoCEE™:
measures
circula+ng
tumor
cells
(CTCs)
• OncoCEE-‐BR™
:
first
commercialized
test
for
breast
cancer
• CEE-‐Selector™:
plaorm
expansion
for
muta+on
analysis
• Robust
test
pipeline
focused
on
solid
tumor
genomic
diagnos+cs
including
lung,
breast,
colon,
prostate
and
melanoma
• Established,
cer+fied
and
scalable
CLIA
lab
• Clear
path
to
market
penetra+on
• Established
research
collabora+ons
and
strategic
partnerships
• IPO
completed
February
2014;
gross
proceeds
of
$19
million
19
Commercial
stage
cancer
diagnos0cs
company
with
ground-‐breaking
technology
pla9orm
u0lizing
a
simple
blood
test
