FWP 1 zk1516103.htm zk1516103.htm


 Issuer Free Writing Prospectus
 Filed Pursuant to Rule 433
 Registration Statement No. 333-201250
 Dated January 23, 2015
 (To Preliminary Prospectus dated January 23, 2015)
  
Free Writing Prospectus
Check-Cap Ltd. Company Presentation
  
This free writing prospectus relates to the proposed public offering of units, each consisting of one ordinary share and one-half of a warrant to purchase
one ordinary share of Check-Cap Ltd. (the “Company”), that is being registered on a Registration Statement on Form F-1 (No. 333-201250)
(the “Registration Statement”) and should be read together with the preliminary prospectus dated January 23, 2015 included in that Registration
Statement, which can be accessed through the following link:
The Company has filed a registration statement (including a preliminary prospectus) with the SEC for the offering to which this communication relates.
Before you invest, you should read the preliminary prospectus in that registration statement (including the risk factors described therein) and other
documents the Company has filed with the SEC for more complete information about the Company and this offering. You may get these documents for
free by visiting EDGAR on the SEC Web site at www.sec.gov. Alternatively, the Company, any underwriter or any dealer participating in the offering will
arrange to send you the prospectus if you request it by calling Chardan Capital Markets, LLC at +1 (646) 465-9000.
 
 

 
Colon 3D imaging capsule
for colorectal cancer screening
Company Presentation January 2015
 
 

 
3
 Disclaimers
This presentation highlights basic information about us
and the offering. Because it is a summary, it does not
contain all of the information you should consider
before investing.
 
Check-Cap Ltd. (the “Company”) has filed a registration
statement (including a preliminary prospectus) with the
Securities and Exchange Commission for the offering to
which this presentation relates. The registration
statement has not yet become effective. Before you
invest, you should read the preliminary prospectus in
that registration statement and other documents that
the Company has filed (including the risk factors
described therein) with the Securities and Exchange
Commission for more complete information about the
Company and the offering. You may get these
documents for free by visiting EDGAR on the
Commission’s website at www.sec.gov. Alternatively,
we will arrange to send you the preliminary prospectus
if you contact Chardan Capital Markets, LLC, Attention:
Scott Blakeman, 17 State Street, Suite 1600, New York,
NY 10004, telephone: 646-465-9000.
 
This presentation shall not constitute an offer to sell or
the solicitation of an offer to sell or the solicitation of an
offer to buy any securities of the Company nor shall
there be any sale of securities in any jurisdiction in
which such offer, solicitation or sale would be unlawful
prior to registration or qualification under the securities
laws of any such jurisdiction.
 
Forward-Looking Statements
This presentation contains certain statements that may
be deemed to be “forward looking statements” within
the meaning of Section 27A of the Securities Act and
Section 21E of the Securities Exchange Act of 1934, as
amended.
 
Forward looking statements appear in a number of
places throughout this presentation and include
statements regarding our intentions, beliefs,
projections, outlook, analyses or current expectations
concerning, among other things, our ongoing and
planned product development and clinical trials; the
timing of, and our ability to make, regulatory filings and
obtain and maintain regulatory approvals for our
product candidates; our intellectual property position;
the degree of clinical utility of our products, particularly
in specific patient populations; our ability to develop
commercial functions; expectations regarding product
launch and revenue; our results of operations, cash
needs, and spending of the proceeds from this offering;
financial condition, liquidity, prospects, growth and
strategies; the industry in which we operate; and the
trends that may affect the industry or us.
 
We may, in some cases, use terms such as “believes,”
“estimates,” “anticipates,” “expects,” “plans,” “intends,”
“may,” “could,” “might,” “will,” “should,” “approximately”
or other words that convey uncertainty of future events
or outcomes to identify these forward-looking
statements. Although we believe that we have a
reasonable basis for each forward-looking statement
contained in this presentation, we caution you that
forward-looking statements are not guarantees of future
performance and that our actual results of operations,
financial condition and liquidity, may differ materially
from the forward-looking statements contained in this
presentation as a result of a variety of factors including
but not limited to those risks and uncertainties relating
to difficulties or delays in development, testing,
regulatory approval, production and marketing of the
Company’s product candidate and those risks and
uncertainties associated with the
protection of the Company’s intellectual property rights.
All forward-looking statements attributable to the
Company or persons acting on its behalf are expressly
qualified in their entirety by these factors.
 
You should also read carefully the factors described in
the “Risk Factors” section and other parts of any
offering prospectus we may in the future distribute, in
order to better understand the risks and uncertainties
inherent in our business and underlying any forward-
looking statements. As a result of these factors, we
cannot assure you that the forward-looking statements
in this presentation will prove to be accurate.
Furthermore, if our forward-looking statements prove to
be inaccurate, the inaccuracy may be material. In light
of the significant uncertainties in these forward-looking
statements, you should not regard these statements as
a representation or warranty by us or any other person
that we will achieve our objectives and plans in any
specified timeframe, or at all. You are cautioned not to
place undue reliance on these forward-looking
statements, which speak only as of the date of this
presentation. We undertake no obligation to update,
amend or clarify such statements to reflect new
information or events or circumstances occurring after
the date of this presentation or to reflect the occurrence
of unanticipated events.
 
 
 

 
 
4
 Initial Public Offering Summary
* Private placement of $12,000,000 closed into escrow on October 14, 2014 from existing shareholders and additional lenders
in the form of a convertible credit line. Credit line lenders were issued 10 year warrants to purchase an aggregate of 2,658,463
ordinary shares exercisable at NIS 0.20 per share, and may be exercised on a net issuance basis.
Issuer
 Check-Cap Ltd.
Exchange / Ticker
 NASDAQ Capital Markets / CHEKU, CHEK, CHEKW
Offering
 1,200,000 units (100% primary). Each unit to consist of one ordinary share and one-half of
 a warrant to purchase one ordinary share
 The warrants and ordinary shares will trade together as units (“CHEKU”) only during the
 first 45 days of trading, and thereafter, the units will automatically separate and the
 ordinary shares (“CHEK”) and warrants (“CHEKW”) will trade separately
Shares Outstanding
 5,966,114 ordinary shares prior to the offering
Over-Allotment
 15% or 180,000 units (100% primary)
Expected Price Range
 $10.00 - $12.00
Use of Proceeds
 Research and Development, regulatory submissions for product approvals, increase
 manufacturing capabilities for the clinical phase, repayment of indebtedness, working
 capital and general corporate purposes
Joint Book-Running
Managers
 Chardan Capital Markets, LLC and Maxim Group LLC
Co-Manager
 Feltl and Company
Concurrent Private
Placement*
 1,090,910 units (100% primary). Each unit to consist of one ordinary share and one-half of
 a warrant to purchase one ordinary share
 
 

 
5
 Who We Are
* Including $12M in pending Private Placement
Founded - 2005 Located - Carmel, Israel Employees - 37
 $37M Raised* -
 Rich IP Portfolio - 16 patents 23 patents pending
 Target Regulatory Clearance - Europe: 2016, U.S. & Japan: 2017
Clinical Stage Medical Diagnostic for CRC
 GE, Fosun, Pontifax, Jacobs, Counterpoint,
 Docor, BXR, Biomedix, others
 
 

 
6
1st imaging capsule
for colorectal cancer
screening
Designed for
increased compliance
No bowel
cleansing
required
 Our First Product
 
 

 
7
Board of Directors
 Guy Neev - CEO
 
14 years of executive management experience.
 Chief Executive Officer at Cappella.
 Business unit manager at Boston Scientific.
 Alex Ovadia - VP of R&D
 
12 years of experience as Global R&D Director, managing
 complex system projects at Philips Healthcare. 11 years of
 development management positions at Elbit Systems Ltd
.
 Dr. Yoav Kimchy - Founder and CTO
 
12 years of executive R&D experience. Vice President of R&D
 at V-Target Ltd. Director of cardiovascular research at Impulse
 Dynamics Ltd.
 Lior Torem - CFO
 
Strong Chief Financial Officer experience in both private and
 public companies. Chief Financial Officer at Superfish, Inc.
 Vice President of Finance at Actelis Networks, Inc.
 Dr. Yoav Kimchy
 
Founder and Chief Technology Officer
 Tomer Kariv
 
of Pontifax Venture Partners
 Guy Neev
 
Chief Executive Officer
 Dr. Walt Robb
 
Counterpoint Ventures
 Richard Stone 
 
Emigrant Savings Bank
 Alon Dumanis
 
of Docor International Management
 Steve Hanley
 
to join post-IPO (March 2015)
 Yuval Yanai
 
to join post-IPO (March 2015)
Management Team
  Seasoned Management and Board of Directors
 
 

 
 Colorectal Cancer
8
At least 60% of lives could have been saved in
the United States with appropriate screening***
“The most preventable,
yet
least prevented cancer.”
*-  American Cancer Society
**-  World Health Organization
***- Centers for Disease Control and Prevention
 
New cases
current
Deaths
current
Treatment
cost
EU
471k**
228k**
 
U.S.
137k*
50k*
 
World-wide(1)
1.36m**
694k**
$99b(2)
(1) Worldwide new cases current, World Health Organization; http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx
(2) Cost of CRC - ACS; http://www.cancer.org/acs/groups/content/@internationalaffairs/documents/document/acspc-026203.pdf
 
 

 
9
Only about 65% of the recommended population in the United States is screened for CRC,*
while less than 30% is screened in Europe.
*- Centers for Disease Control and Prevention
 Our Goal: Cancer Prevention by Pre-cancerous Polyp Detection
Testing Compliance Key
 
 
Highly Survivable in Early stages
1
2
3
4
Stage
Stage
Stage
Stage
93%
78%
64%
8%
Structural Tests -  enable both polyp detection
       and cancer prevention
Stool / Blood Tests -  enable cancer detection
Illustration courtesy of the
National Cancer Institute
 
 

 
10
* 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?”
 Patient are Hesitant to Undergo Screening with the Current Methods
Standard Colonoscopy*
CTC
Camera
pill
Check-Cap imaging capsule designed to address all these concerns
32%
21%
15%
13%
11%
8%
 
 

 
11
(1) Assumes one screening every 10 years.
(2) Based on an average selling price of $500.
* Source - U.S. Census Bureau; http://www.census.gov/population/international/data/idb/informationGateway.php
50-75 year olds
U.S./EU/Japan
291m
50-75 year olds
China
343m
50-75 year olds
Total
635m
Screening
once every
10 years
Procedures per
year
63m(1)
Average price
per capsule
$500
Annual market
opportunity
$32b(2)
 Compelling Market Size*
 
 

 
 Current Screening Modalities
 Colonoscopy
 CTC
 Optic Capsules
 Fecal Occult
 Blood Test
 Stool DNA
P-
P
P
P
P
P
P
x
x
x
x
P-
P-
x
x-
 Blood Tests
P
x
 Safety
 Comfort
 Efficacy*
In clinical trials
In clinical trials
P
12
 
 

 
13
Imaging Capsule travels naturally
in the GI tract, propelled by peristalsis
The capsule is continuously tracked,
and transmits
data to an external receiver
Capsule detects
CMT
XRF
(X-ray Fluorescence radiation)
Flux attenuated by the colon contents in
direct proportion to distance traveled in the
colon contents, as some of the photons are
absorbed by contrast agent
Flux depends monotonically on the
distance traveled in the colon contents
mixed with contrast agent
Colon Wall Geometry
3D Path
3D Surface
=
+
 Innovative Low-dose X-ray Radar Technology
Capsule emits low-dose X-ray photons
 
 

 
14
Video
 Check-Cap Solution - Designed for Prep Free, Accurate, CRC Screening
* The Check-Cap system is not available for sale or for any clinical use
 
 

 
15
 Patients Continue with their Daily Routine
CPS
During 1-5 days of test
patients continue with
their normal daily routine
Patients are notified by a Check-App interface
Capsule designed to travel naturally in the Colon, transmitting Data to
CPS Receiver Unit
a disposable patch on lower back
Image for illustration only
* The Check-Cap system is not available for sale or for any clinical use
 
 

 
16
Image for illustration only
 Clinician can Review Results in Less than 10 Minutes
Data downloaded from CPS Patch to Check-Cap workstation for analysis:
review time
* The Check-Cap system is not available for sale or for any clinical use
 
 

 
17
 Clinical Data Generation is On-track and Ongoing
60
Germany
40-60
Israel
(Netherlands to be launched)
Ongoing
Proof of Concept
10
Israel
FDA Pivotal Trial*
800
10 U.S. sites
5 EU sites
OUS Registry*
(post marketing)
* Anticipated. Subject to regulatory approval
 
 

 
18
Tissue-equivalent phantom model
  Polyp Detection - Lab Evidence
Preprocessed Surface Data
8mm Polyp in silicon phantom
6mm polyp
8mm polyp
7mm polyp
7mm polyp
8mm polyp
 
 

 
19
10 mm Polyp
in colon
Polyp
preparation
Preprocessed Surface Data
10 mm Polyp preparation
in Bovine Colon Phantom
Preprocessed Surface Data
Bovine Colon Phantom
Autonomous
capsule in Pig Colon
10mm polyp
10mm polyp
  Polyp Detection - Pre-Clinical Evidence
 
 

 
Normal velocity
High velocity
0.6 mm/s
4.3 mm/s
  Polyp Detection - High/Low Capsule Velocity (Lab)
20
 
 

 
Size / Shape Distinction
True Positive vs. False Positive
21
100% TP 0% FP
CMT
XRF
Fused
% FP
  Polyp Detection - Sensitivity and Specificity (Lab)
No
polyp
Polyp
 
 

 
Actual clinical images
  Unlike an Optical Pill, Check Cap Tracks the Capsule Route in the Colon
22
 
 

 
23
Colon full of content
  Proof of Imaging Concept - Clinical Study data
Clinical images from
unprepped human colon
 
 

 
24
Our granted patents (2010-11) are directed to 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
Core patents granted in major jurisdictions
 Strong Intellectual Property
 
 

 
25
Tissue
Density
Imaging
Flat Polyp,
Cancer
Discrimination
 
New
system
concepts
Enhanced Low
Cost Electronics
& Mechanics
Cad Capabilities
Miniaturization
IQ
Enhancement
X-Ray imaging
Catheters
Chronic Sinusitis Imaging
& Sinus Drain Intervention
Acute Artery Occlusion,
Plaque Thickness
Imaging & Intervention
Catheter
  Product Development Roadmap
 
 

 
26
2015
2016
2017
1
Anticipated
Financing
3
Design Freeze
CE Submission
4
2
2
H
1
H
CE Mark
Strategic Discussions
EU Registry Pilot Launch
2nd Pre-IDE
Pivotal Protocol
Submission Finalize
1
EU Registry 1st Release
FDA Trial Launch
Possible Launch in EU*
FDA Trial Ongoing
Release Data from Europe
CMS Discussion
 FDA Submission
CMS Submission
* Funding dependent
All timelines are subject to regulatory approvals
 Target Milestones with a Well-defined Regulatory Pathway
 
 

 
27
Innovative technology with potentially competitive advantage
Attractive market opportunity
Proof of concept clinically demonstrated
Well-defined regulatory pathway
Core patents granted in major jurisdictions
Seasoned management and advisory teams
Established funding history
Summary
 
 

 
28
Appendix
 
 

 
29
* $12M is kept in escrow pending investment in Private Placement. Terms of Private Placement will be based on IPO
price and other terms.
 Established Funding History
 
 

 
30
 IP Status
 
 

 
31
 IP Status
 
 

 
32
mSv
Typical Organ Radiation Doses from Various Radiologic Studies
0.04mSv
 Very Low Radiation Exposure
 
 

 
33
 Proof of Concept Clinically Proven
Professor Nadir Arber,
Head of Integrated Cancer Prevention Center
Tel Aviv Sourasky Medical Center, Israel
“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.