Download - June 2016 CLPT: TASE
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June 2016
CLPT: TASE
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Forward looking statements
The following overview contains forward-looking
statements that include, but are not limited to, projections
about our business and our future revenues, expenses
and profitability. Forward-looking statements involve
known and unknown risks, uncertainties and other factors
which may cause the actual events, results, performance,
circumstances or achievements of the Company to be
materially different from those expressed or implied by
such forward-looking statements due to factors that
include, but are not limited to: (1) our ability to develop and
bring to market new products (2) our ability to successfully
complete any necessary or required pre-clinical and/or
clinical studies with our products, if so requires (3) our
ability to receive regulatory clearance or approval to
market our products, if so requires, including due to
changes in regulatory environment (4) our success in
implementing our sales, marketing and manufacturing
plans (5) the level of adoption of our products by medical
practitioners (6) the emergence of other products that may
make our products obsolete (7) protection and validity of
patents and other intellectual property rights and (8) the
effect of competition by other companies and/or
technologies.
You are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the
date of this overview.
In order to have a comprehensive understanding and
information over the Company, including the risks its
activity is subject to, you must review the Company's
Immediate and Periodical reports (in Hebrew) with the
Israeli Security Authority and the Tel Aviv Stock Exchange
and with the OTCQX and Company's web site (in English).
The Company undertakes no obligation to update any
forward-looking statements, to report events or to report
the occurrence of unanticipated events that may lead to
the actual events, results, performance, circumstances or
achievements of the Company being different than as
envisaged by such forward looking statements.
This overview by no means establishes an offer to
purchase or sale the Company's securities nor an
invitation to receive such offer and is intended for
informative purposes only.
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Overview
We are a clinical stage regenerative medicine company focused on developing and
commercializing high value tissue repair products intended to accelerate healing
while reducing inflammation and pain
Our products are based on our proprietary plant-based technology for the production
of type I recombinant human collagen (rhCollagen)
We are initially focused on the orthobiologics and advanced wound care markets
The worldwide market opportunity for our initial product candidates exceeds $5 billion
Two products (tendons, wounds) expected to commence sales in Europe this year
(Vergenix FG received CE Mark in February 2016)
Co-developing a bone void filler with a leading US strategic collaborator
to address a multi-billion dollar opportunity in spine and trauma
Listed in Tel-Aviv Stock Exchange (TASE:CLPT)
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Yehiel Tal
CEO
• Regentis
Biomaterials
• ProChon Biotech
• Kulicke & Soffa
Industries
Oded Shoseyov
Prof./Founder/CSO
• Pauli Clean Tech
• CBD Tech.
• Fulcrum-SPD
• Melodea
• Hebrew University
Eran Rotem
CFO
• Tefron (ex
NYSE,TASE)
• Healthcare Tech.
(NASDAQ)
&Gamida
• E&Y
Experienced
management team
Nadav Orr, PhD
VP R&D
• Ethicon
Biosurgery,
Johnson &
Johnson
Ilan Belzer
COO
• BioHarvest
• Proteologics Ltd.
• OmrixBiopharmaceuticals
• Interpharm
Philippe
Bensimon
VP RA/QA/CA
• Maquet-Getinge
• 3M Medical
Shomrat Shurtz
Senior Director BD
• Protalix
• BBDO Proximity
• Clal holdings
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Avram Hershko,
Prof.
Nobel Laureate
(Chemistry)
Technion
Arthur Gertzman
Bone void fillers,
polymers
Ex MTF
Scott Rodeo, MD
Rotator cuff
Hospital for Special
Surgery
Scientific & clinical
advisors
Ofer Levy, MD
Shoulder and
elbow
Royal Berkshire
hospital
Vicki Rosen, Prof.
Musculoskeletal
regeneration
Harvard
Abhay Pandit,
Prof.
Biomaterials, tissue
engineering
University of
Ireland
Gabi Agar, MD
ACL, cartilage,
meniscus
Assaf Harofeh
Hospital
Thomas Serena,
MD
Penn North
Centers
for Advanced
Wound Care
Joseph M. Lane,
MD
Connective tissue
repair
Hospital for Special
Surgery
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P4Hα
P4Hβ
LH-3
Post translational
modifications
Col1α1
Col1α2
n- Propeptide c-Propeptide
Stable production
in tobacco plantStructural genes Enzyme genes
CollPlant’s technology: co-expression in plantsof 5 human genes essential for the productionof functional type I human recombinant Collagen
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J.H.-C. Wang / Journal of Biomechanics 39 (2006) 1563–1582
Bones
Skin
Tendons
Ligaments
Collagen
fibril
Collagen
molecule
Collagen
fiber
Primary
fiber bundle
(subfascicle)
Secondary
fiber bundle
(fascicle)
Tertiary
fiber bundle
Tendon unit
α2 α1
Fibroblast
Endotenon
Epitenon280 nm
64 n
1 nm 100 nm 1-20 μm 20-200 μm 500 μm
Collagen is the most basic
building block
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Clear advantages over tissue-extracted collagen
Better bio-functionalityAccelerates primary humancell proliferationFaster tissue healing
Plant-derived rhCollagen
Superior homogeneityUniquely strong and aligned structures, reproducible & thermally stable
Improved safety and greater purityNon-allergenic
Non-immunogenic
No pathogens
Novel applicationsIdeal building block for products with unique properties (e.g. BioInk)
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What is out there today and its limitations?9
D-banding
TISSUE-EXTRACTED PLANT-DERIVED
Fully functional 3-D matrix
Thin fibers/high surface area
Slow cell proliferation and
slow tissue repair
• Foreign body response
• Edema
• Inflammation
Partial
D-banding
Partially functional 3-D matrix
Thick fibers/low surface area
Fast cell proliferation
and fast tissue repair
Cell binding domains Cell binding domains
rhCollagen
• Perfect triple helix
• High cell binding domains
Collagen
• Partially denatured (crosslinked)
• Low cell binding domains
10Scalable production process
GROWING EXTRACTIONPURIFICATION
& FILLINGEND PRODUCTFABRICATION
Clean room facilityLow cost space
Leaves Pellet Collagen
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Sheets Fibers 3DP BioInk Microspheres
Putty Malleable Paste Flowable gel
Knitted meshes Non-woven meshes rhCollagen meshesrhCollagen coated polymeric fibers
Underlying technology supports a large portfolioof high-value tissue repair products
Source: WFIRM
Collagen configurations
Compounds & composites
Fibers & textiles
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The lead product candidates
& trauma
Bone void filler Soft Tissue Repair Matrix Wound filler
Wound careOrthopedics
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Soft Tissue Repair matrix
rhCollagen/PRP matrix
Enables controlled release of growth factors and serves as scaffold
to support cell proliferation
$2.0B W/W market potential
Status: clinical study (first 20 subjects) – positive final results.
Additional 20 subjects - positive interim results
CE marking expected in 2016. In advanced discussions with global
orthobiologic and Sports Medicine companies to market in Europe
Indication: Treatment of tendinopathy (tendon inflammation)
by promoting healing of the tendon injury
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Tennis elbow
3M+
Hand tendons
300K
Jumper’s knee
300K
Rotator cuff
400K
Achilles tendon
250K
ACL
200K
Annual procedures per indication
US market potential
http://www.aafp.org/afp/2007/0301/p701.html http://www.aaos.org/news/aaosnow/jan11/cover1.asp
http://www.achillestendon.com/Injuries.html
http://orthoinfo.aaos.org/topic.cfm?topic=a00297Prevalence of patellar tendinopathy in non-elite-athletes J. Zwerver,
S.W. Bredeweg, I. van den Akker-Scheek
Risk factors for hand-wrist disorders in repetitive work
F Thomsen, S Mikkelsen, J H Andersen
1515
PRP collection tubefrom any commercial PRP KitKit
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clinical trial status
• 40 patients treated
• Final results with first 20 patients:
• At 3- months, 80% of the patients (N=20) reported
at least 25% reduction in PRTEE (improvement in
pain & functional disability) when compared to
baseline
• At 6- months, 90% of the patients (N=20) reported
at least a 25 % reduction in PRTEE scoring
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1 Positive Effect of an Autologous Platelet Concentrate in Lateral Epicondylitis in Double-Blind Randomized Controlled Trial. Platelet-Rich Plasma versus
Corticosteroid injection with a 1-year follow up. Peerbooms et Al The America Journal of Sports Medicine Vol. 38 No 2 2010
48
67
80
36
68
90
0
10
20
30
40
50
60
70
80
90
100
Steroids PRP Vergenix STR
Patients Success Rate (%) (Improvement of 25 % in pain and motion1)
3-month 6-month
– Comparison to Standard of Care
Soft
Tis
sue
Injectable, Matrix, Membrane for tendon, Cartilage and Meniscus Repair
2012 2013 2014 2015 2016
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Composition: rhCollagen and ceramic granules, in combination with
bio-functional molecules
Indications: Trauma and spinal fusion
$3.0B potential w/w market ($1.5B for spine* & $1.5B for trauma)
Scaffold for cell proliferation and controlled release of growth factor
for bone regeneration
Scaffold degradation synchronized with tissue growth
Status: preclinical studies
Bone Void Filler + growth factor
* Source: The Global Orthobiologics Market: Players, products and technologies driving change - 2008 Espicom Business Intelligence
$1.7M of development support from strategic partner in 2015, similar
commitment in 2016
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July 12, 2015 -- CollPlant announced today that it has signed a non-binding
term sheet with a leading U.S company in the field of orthobiologics, for the
further development, and commercialization and supply of a novel
absorbable bio-active surgical matrix intended for use in spinal fusion and
trauma applications.
Upon execution of a definitive agreement, CollPlant will receive milestones
payments for the license to use its technology, and single-digit royalty
payments for future global sales.
The U.S company will participate in costs associated with the building of a
new CollPlant manufacturing facility for the production of rhCollagen and
the product.
CollPlant executes non-binding term sheet with leading US partner
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Covers a broad range of bone fractures
Fixation
Synthetic substitutes
Allografts
Autografts
Vergenix™BVF
BASIC
FRACTURES
NON-UNION
FRACTURESBone injury severity scale
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Wound filler
Indications: Chronic vascular ulcers, diabetic, pressure, venous and
surgical wounds
Pig studies showed VergenixTM FG superior to market leader
Scaffold for cellular infiltration and capillary growth to promote optimal
wound healing
$3B potential market ($500M ulcers only)
Clinical study (20 subjects) – positive final results
CE marking received in February, 2016
Product launch in Europe – in process
Source: "Worldwide Wound Management, 2008-2017: Established and Emerging Products, Technologies and Markets
in the U.S., Europe, Japan and Rest of World"
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Company’s immediate report dated November 26, 2015 [MAGNA 2015-01-164958].
Patient 1 Day 0Day 28
(wound closed)
Patient 3 Day 0Day 28
(wound closed)
Patient 2 Day 0Day 28
(wound closed)
Clinical trial - Final resultsFull wound closure after 4 weeks
• Final results show average wound closure rates of 80% at 4 weeks
• Full wound closure was observed in nine of the 20 patients (45%) after 4 weeks following
a single administration unlike current standard of care requiring multiple treatments
23Future opportunities
Surgical wounds
rhCollagen-AM matrix intended for the
management of surgical and trauma
wounds
Source: Murphy and Atala, Nature Biotech, 2014
3D bioprinting is being applied to regenerative medicine to address the need
for complex scaffolds, or for tissues and organs suitable for transplantation
3D Bioprinting
with rhCollagen-based BioInk
Tendon repair
injectable rhCollagen/PRP matrix
intended for treatment of partial or
full tendon tears (ACL, RCR etc.)
24CollPlant IP portfolio
Patent Name Application #Priority
DatePatent Status
Collagen Producing Plants and Methods
of Generating and Using SameWO2006/035442 9/2004
National Phase: USA (CIP -DIV), Brazil, Europe(DIV),
India(DIV)
Granted: USA(CIP), Europe, Europe(DIV) (allowed), Hong
Kong ,Hong Kong(DIV) ,Canada, Japan Japan(DIV), Australia
(DIV-1), Australia (DIV-2), Mexico, China, South Africa, ,
Singapore, India, Israel, New Zealand.
Compositions Comprising Fibrous
Polypeptides and PolysaccharidesWO2009069123 11/2007
National Phase: Israel(DIV), Japan(DIV), USA(DIV-3)
Granted: USA,USA(DIV-1), USA(DIV-2), Australia,
Israel(Allowed),Europe(Allowed)
Methods of Generating Collagen Fibers WO2011/064773 11/2009 National Phase: Europe, USA, Hong Kong
Methods of Generating and Using
ProcollagenWO2009/128076 4/2008
National Phase:Europe, Canada, China(DIV), India, Israel
Granted: USA(Allowed)
Methods of Processing Recombinant
ProcollagenWO2009/053985 10/2007 Granted: USA, Israel, Europe
Compositions comprising collagen and
PRP for tissue regenerationWO2014/147622 3/2013 PCT (Published)
Cross-linked Resilin-containing materials W2015/068160 1/2013 PCT (Published)
Adhesive biopolymers and uses thereof WO2013/030840 9/2011 National Phase: USA, Europe, Israel
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Sign a definitive License & Supply agreement with our U.S.
strategic partner, regarding Vergenix BVF product
Final clinical results for the Vergenix STR (40 patients)
Vergenix STR CE mark achievement
Vergenix FG Distribution agreement
Vergenix™STR Distribution agreement
VergenixSTR – first sales
VergenixFG – first sales
Sign with another strategic collaborator
Anticipated 12 month milestones
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CollPlant investment highlights
Only viable technology currently available that can produce
truly human collagen
Multi-billion dollar market: innovative rhCollagen products
initially aimed at orthopedics and wound healing
Near-term revenues: U.S. strategic collaborator license and
commercialization of two lead products in Europe in 2016
Broadly applicable technology: future indications may include
BioInk for 3D Bioprinting, ACL repair and surgical wounds
Strong IP position
Proven management team