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May 2014
Check-Cap
Creating a new standard of colon 3D imagery
Non Confidential
EFTA00605809
Company Overview
Ow
Founded - 2005
Corporate Headquarters - Carmel, Israel
Employees - 35
Investors — Overall $25m Raised
through March 3152 2014:
GE Ventures, Pontifax Ventures,
Jacobs Investment (Qualcomm),
Counterpoint, Docor, BXR Partners,
Emigrant Saving Bank,
Biomedix (BMDX:TASE) & more.
Cash $3.2m as of May 2014
Current Burn Rate - - $400k
Target Bridge - $6-8m
Insider Participation - $3-4m
Most Recent Valuation (2012) - $64m
2
iliircap
EFTA00605810
A patient friendly screening method
First imaging capsule for
Colorectal Cancer screening (CRC)
I No bowel cleansing required
Designed for increased compliance
Cap
EFTA00605811
Check-Cap Our vision
To become the leading supplier
of colon cancer screening technology
and significantly reduce
global mortality from CRC. ti
EFTA00605812
"The most preventable, yet least prevented cancer"
—Journal of the National Cancer Institute
EFTA00605813
The importance of CRC screening
Structural Tests - enable both Polyp Detection and Cancer Prevention
Stool / Blood Tests - enable Cancer Detection
Highly Survivable in Early stages
Spell to other er-porM1
Mama
trMa,
Mood
fig/ vessel
Illustration courtesy of the
Notional Cancer Institute
Stage I
93%
Stage II
72-85%
Stage III
44-83%
Stage IV
8%
Testing Compliance Key
Less than 50% of the recommended
population in the U.S is screened for CRC,
while less than 30% is screened in Europe.
6
qiiirCap
EFTA00605814
Compelling Market Size
Target population of 365 million people aged 50 to 75 in U.S, Europe and Japan.
> 36 million require screening annually.(1)
Population between
50.75
2015
2016
2017
2018
2019
2020
USA
89,545
90,996
92,179
93,182
94,297
95,618
Europe
233,971
236,374
239,113
242.268
245,372
248,526
Japan
41,397
41,071
40,889
40,843
40,814
41,002
TOTAL
364,913
368,441
372,181
376,293
380,483
385,147
op
•
i r r
> $18 billion total market opportunity per annumm
(1) Assumes one screening for members of the target population every 1O years.
(2) Based on an average selling price of $5OO.
7
EFTA00605815
Attractive Market Opportunity
Poorly
Addressed by
Current
Methods
Check-Cap
Offers a
Differentiated
Solution
•
Current technologies may compromise accuracy or patient safety and comfort
•
Colonoscopies involve significant risks and require aggressive bowel cleansing
•
Patient compliance levels far below those recommended by physician societies
•
Does not require uncomfortable bowel cleansing_necessary for other methods
•
Innovative and proprietary technology platform avoids traditional issues
•
Designed to be attractive to physicians and patients, increasing patient compliance
8
EFTA00605816
Reasons for Avoiding Existing CRC Screening Procedures
Computed
Tomographic
Colonography
Camera pill
a
%.a
Embarrassment
11%
Concern
over pain
13%
Fasting
requirements
15%
Other
reasons 8%
Laxative
Preparation
32%
Insertion of
tube 21%
Check-Cap imaging capsule addresses all these concerns
9
Source: Mayo Clinic Proc. 2007;82(6):666-671. Figure 1, Most troubling part of colon testing. Responses to the question,
"What do you feel is the most troublesome part of colon testing?'
EFTA00605817
Current Primary Modalities
Detection of polyps > 50%
(Cancer Prevention vs Detection)
O
O
00
oZS
t.)
CU
Li-
Colonoscopy
Safety
Comfort
X
v
bowel cleansing
n Cross Infection n Embarrassment
Pre-Cancerous Efficacy*
1
Sensitivity - 95%
Specificity - 95%
Computed Tomographic
v
Insufflation
Radiation
y bowel cleansing
Sensitivity - 85%
Colonography (CTC)
X Pain
Specificity - 95%
ssfa.- O) Optic Capsules
Ni&
Fecal Occult Blood Test
\I Stool DNA
In clinical trials
Blood Tests
In clinical trials
Vt
X_ bowel cleansing
Sensitivity - 70%
Specificity - 85%
1
V
1
V
X
Sensitivity - 23%
Specificity - 97%
Sensitivity - 42%
Specificity - 87%
x
Sensitivity - 50%
Specificity - 90%
Key Competitors
OLYMPUS PENTAX
PHILIPS
SIEMENS
OLYMPUS
GleING
I
exact
stierces
epigenomics
dip
Imaging Capsule
io
In clinical trials
1
V
/
Target Sensitivity > 80%
Target Specificity > 90%
EFTA00605818
/
The Check-Cap Solution
EFTA00605819
Check-Cap -maging Technology
tittering
X-ray Fluorescence
Less contrast = Less Absorption - Increase in Comptons
Compton backscattered flux of photons detected
by the capsule are attenuated by the colon
contents in direct proportion to their distance
traveled in the colon contents, as some of the
photons are absorbed by the contrast agent
Capsule in
Capsule In
Standby Mode
The x-ray Florescence flux detected by
the capsule's detectors depends monotonically on the
distance traveled in the colon contents mixed
with the contrast agent
12
EFTA00605820
3D Capsule Technology vs. Optics
EFTA00605821
3P Image Reconstruction
I Cap
CapScanViewer 1 OA
STUDY - Nov. 2014 Erasmus MC University Hospital, Rotterdam
ID-AB20 166585
Dr. Amer
Pil"
Bookmarks
2
45
O
•
itl
Psptay cottons
v trans line
(4; Ground Piano
o
measurements
(i) tcokmarks
Standart 30
It —
qua
The data viewer
EFTA00605822
Trial Clinical Data
Reconstruction (3D)
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Clinical Proof of Concept
"The Check-Cap novel imaging technology has been proven to be safe and feasible in our preliminary
clinical experience. It has successfully demonstrated imaging of prep-less human colon at ultra-low
dose compared to existing X-Ray based modalities. These results underpin the great potential of
Check-Cap imaging technology to become a very appealing tool for screening of pre-cancerous
polyps and colorectal cancer. Once efficacy is demonstrated, this clearly could make a fantastic
impact on screening and consequently on survival rates from this disease"
> Professor Nadir Arber,
Head of Integrated Cancer Prevention Center,
Tel Aviv Sourasky Medical Center, Israel
16
EFTA00605824
Clinical proof of concept — Demonstrated Capabilities
-
3D imaging and representation (with no preparation)
-
Reliable correlation between Compton Backscattering & X-Ray Florescence data, leading to clinical diameters values
-
Automatic scan in motion triggered by predefined Activation Algorithm settings
-
Colon segment position data with high accuracy
-
All subjects reported smooth passage of capsule along the GI tract
-
Acceptable surface imaging using ultra low dose accumulated during procedure
-
Contrast material (oral) well tolerated by subjects
Quantitative colon surface detection and reconstruction along movement track
Results of studies suggest procedure is safe and uneventful
Results of first studies indicate that the current lower limit for visible feature size is 5- 6 mm,
and —10mm polyps should be well within the imaging capability of the Check-Cap capsule.
We believe that improvements in hardware and algorithm should enable us to decrease the lower
limit of visible feature size to 2 mm, to provide high detection rate for 5 mm polyps & very high
detection rate for 10 mm polyps.
17
EFTA00605825
Clinical Trial Data
Reconstruction Stages (fused CMT and XRF) - PP100204_P42-Scan01
Reconstruction Stages (fused CMT and XRF)
1. Preprocessed
3. Tubed 3D Reconstruction
ellitill
e
4. Path 3D reform
2. Fillet 3D Reconstruction
18
EFTA00605826
Commercializable Tracking System
ELS III — Preliminary concept II
ego
Check-Cap 3D VIEWER
Check-App - Patient Interface
Receiver Unit including Position Tracking System
Disposable Patch on Patient's Back
Data
Download
Capsule
in Colon
S
Receiver
I2F
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X-ray radiation control
mSv
16
14
12
10
8
6
4
2
0
Low Energy
Low Radiation Exposure
Typical Organ Radiation Doses from Various Radiologic Studies
As reference. below is Data from the National Council on Radiation Protection
and Measurements. 'Ionizing Radiation Exposure of the Population of the
United States' March 3. 2009:
CT procedure
Range for effective dose (msv)
Chest
4-18
Abdomen and pelvis
3-25
Virtual colonoscopy
5-15
Whole-body screening
5-15
Angrography. heart
5-32
Check-Cap
Dental
Lateral Chest
Screening
Adult
Barium Enema
Imaging
Radiography
Radiography
Mammography Abdominal CT
giiircap
EFTA00605828
Clinical Data Generation
Motility Clinical Trial
Completed
Sample size - 60 subjects.
Site — Hamburg, Germany.
End points:
GI Motility information
for Activation Algorithm.
CE Pivotal trial
Sample size — 40-60 subjects.
Sites — 2 in Israel,
1 in the Netherlands, possibly 1 more.
End points:
Safety — Continued.
Feasibility — Continued.
Image resolution, Polyp Imaging
First clinical cases of
the Imaging Capsule
Completed
•
FDA Pivotal trial
Clinical
Proof of Concept
Completed
Sample size - 10 subjects.
Site — Tel Aviv Medical Center.
End points:
Safety — Demonstrated.
Feasibility — Demonstrated.
Sample size — 800 subjects.
Sites — 10 in the US, 5 in Europe.
End points:
Safety — Continued. Feasibility — Continued. Image resolution, Polyp Imaging.
Sensitivity & Specificity in detection of polyps 10 mm & above, 6-9 mm:
A
i.
•
I
I
Compared
to upuLai culuilustupy.
B. Possibly on specific segments:
Clinical surveillance.
Patients negative FOBT when additional info is needed.
Patients with incomplete colonoscopy.
Patients who cannot tolerate prep.
Patients with tortuous anatomy etc.
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Anticipated Development, Clinical & Financial Roadmap
Product
Development
C.E Trials &
European
Market
US Trials &
Regulations
2nd Gen Capsule Development
Inc. cost reduction and optimization
Q3-Q4 2013
2014
Clinical Activation & Clinical Reconstruction algorithm
op
(Design freeze @ O4/14)
TLV Hospital
TLV & Erasmus (NL)
Clinical Proof of
Concept (5 par.)
Clinical AA
(10 par.)
CE Pivotal
(50-60 par.)
US Protocol, site selection
and study design
Request
for
FDA trial
initiation
Post marketing
in Europe
(200 participants)
US Pivotal Trial
800 participants
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Reimbursement Aspects
Current Status
Covered for CRC screening*:
FOBT
Barium Enema
Flexible Sigmoidoscopy
Optical Colonoscopy
Not Covered for CRC Screening Yet:
CTC (Covered by some private insurers)
Stool DNA
Colon - Capsule Endoscopy:
Given's capsule received FDA clearance
Cost effectiveness models have been
designed for Europe
SB & ESO capsules are covered
Our Strategy
• Collect information about expected
increase in screening adherence rate
(expected increase > 25%)
• Collect information about direct and
indirect Costs (expected decrease > 15%)
•
Emphasized findings are limited to
intra-colon only (as opposed to CTC)
•
Utilize capsule endoscopy value story
to demonstrate cost effectiveness
• Penetrate private insurers first as
differentiating service
•
Work with ACG, AGA, ACS to achieve
reimbursement as quickly as possible
* All Medicare beneficiaries age 50 and older are covered;
However, when an individual is at high risk, there is no minimum age required to receive a screening colonoscopy or a barium
enema rendered in place of that screening colonoscopy.
EFTA00605831
Reimbursement Aspects
ea Original Bride
Cost-effectiveness of capsule endoscopy in screening
for colorectal cancer
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mondiad taw* NW
sm.., Aar 'aria:.
Sabre...ad and study arm Caplideendoscopy
rancopy and cipauk adman was d 16 le
t Minim Cdon • hn recent
shmvn acapUble
and $2, 244 pa hIc- war favtrd. regret twit
t
t
r
... until colonoscopy adherence was decreased
to 83%, corresponding to a 17% difference in
adherence between the two strategies."
Cost of treating CRC is
$14 billion annually in
the US and $99 billion
globally *
17% increase in adherence = capsule endoscopv more cost
effective than screening colonoscopy
EFTA00605832
New Health Care Law
One benefit of the new health care law: Free colon
cancer tests
1 in 3 U.S. adults have never been screened but will now have
coverage for this and other preventive services
Published: November 07. 2013 10:30 AM
If you've put off getting screened for colon cancer because you
didn't have health insurance, there's good news. Under the new
health care law. colorectal screening tests are availble at no
cost to you.
About a third of U.S. adults ages 50 to 75 have never been
screened for colon cancer or are not up to date with screening
recommendations, according to a new survey from the Centers
for Disease Control and Prevention. And more than half of
those people had no health insurance. But through the new
health law, more Americans will have access to health
coverage and preventive services such as colorectal cancer
screening tests.
During a colonoscopy. doctors can detect and
remove polyps (shown here in red).
25
EFTA00605833
Bridge Financing
•
Target raise: US$6m. Minimum: US$4m; Maximum: US$8m
•
Terms highly attractive:
Discount
25
25%
Interest
5%
Warrant coverage
100% *
* Warrants for four years, at 120% of Offering price
26
EFTA00605834
Intellectual Property
Check-Cap has received patent grants from the U.S. patent office as well as from China,
EPO, Japan, Hong Kong and India for the core technology — "Intra lumen polyp detection".
Our granted patents (2010-11) cover an ingestible capsule with a radiation source
and radiation detectors that, when used in conjunction with a radio opaque contrast
agent, is adapted to detect clinically relevant findings in the colon.
Utilizing X-ray florescence and Compton back scatterings, the capsule is able to
measure the distance between the capsule and the colon wall and to distinguish
between gas and clinically significant findings in the gastrointestinal tract.
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Company Leadership
Management Team
• Guy Neev - CEO since March 2008.
14 years of executive management experience.
Chief Executive Officer at Cappella. Business unit manager at Boston Scientific.
• Alex Ovadia - VP of
since January 2013.
11 years of experience in managing complex
projects at Philips Medical.
10 years of development management positions at Elbit Systems.
• Yoav Kimchy - Founder and CTO since Feb 2005.
12 years of executive
experience Vice President
at V-Target Ltd.
Director of cardiovascular research at Impulse Dynamics Ltd.
• Lior Torem - CFO Since Mar 2010.
Strong Chief Financial Officer experience in both private and public companies.
CFO at Tigo Energy Vice President of finance at Actelis Networks Inc
28
EFTA00605836
Scientific Advisors
Dr. Douglas K. Rex - Professor of Medicine, Indiana University School of Medicine
rIll Dr. Perry Pickhardt - Professor of Medicine, University of Wisconsin Medical School
Dr. Peter Fitzgerald - Professor of Cardiology, Stanford University Medical School
Dr. Nadir Arber — Professor of Medicine, Tel Aviv Medical Center
Steve Hanley - Former President, Covidien's Imaging Solutions unit
*Partial list
29
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Summary
• Target Bridge raise: US $6-8m
• Innovative disruptive technology with clear competitive advantage
• Very attractive market opportunity
• Feasibility & safety clinically proven
• Well defined regulatory pathway
• Core patents granted in all major territories
• Seasoned management & advisory teams
• Leading and committed investors
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Thank You
es
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