introducing collplant · source: "worldwide wound management, 2008-2017: established and...
TRANSCRIPT
Introducing CollPlant
Biomed, May 2015
CollPlant: rhCollagen products for tissue repair
CLPT: TASE
Forward looking statements
2
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.
In a nutshell
3
We are a clinical-stage regenerative medicine company focused on developing
and commercializing tissue repair products
Our product candidates 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 market opportunity for our initial product candidates exceeds $5 billion
Two products (wounds, tendons) will receive CE mark in 2015
Co-developing a bone void filler with a US strategic collaborator
$50M raised to date. Quoted on OTCQX marketplace since April 2015
4
J.H.-C. Wang / Journal of Biomechanics 39 (2006) 1563–1582
Bones
Skin
Tendons
Ligaments
Collagen is the main component of connective tissue, and is the most abundant protein in mammals
Current tissue repair products are based on collagen derived from bovine, porcine or human cadavers
5
HUMAN CADAVERS
$2.1B Cap
$1.3B Cap
processing bovine/porcine material or human cadavers.3 grades (fiber, fibril, soluble) are used for tissue repair scaffolds
Pure rhCollagen monomers are used for tissue repair scaffolds
Clear advantages over traditional Collagen sources
6
PLANT
BASED
Non-allergenic
Non-immunogenic
No pathogens
Bio-functionality
Hydrophilicity
Homogeneity
Purity
Safety,Market access
Acceleratesprimary humancell proliferationFaster tissue healing
Faster cell infiltration and better controlledrelease of GF
Uniquely strong and aligned structures which are reproducible& thermally stable
Plant-derived vs. tissue-extracted collagen
7
Collagen
• Partially denatured
(crosslinked)
• Low cell binding
domains
rhCollagen
• Perfect alpha helix
• High cell binding
domains
Cell binding domains
Fast cell
proliferation and
fast tissue repair
Slow cell
proliferation and
slow tissue repair
• Foreign body response
• Edema
• Inflammation
Fully
functional
3-D matrix• Thin fibers/high
surface areaD-banding
Partially
functional
3-D matrix• Thick fibers/low
surface areaPartial
D-banding
TISSUE-EXTRACTED PLANT-DERIVED
Cell binding domains
Scalable production process
8
GROWING EXTRACTIONPURIFICATION
& FILLINGEND PRODUCTFABRICATION
Clean room facility
Leaves Pellets Collagen
Low cost space
Collagen
configurations
Sheets Fibers 3DP BioInk Microspheres
Compounds &
composites
Putty Malleable Paste Flowable gel
Fibers and
textiles
Knitted meshesNon-woven
meshesrhCollagen
meshesrhCollagen coated polymeric fibers
CollPlant has developed a large portfolio of technologies that are used to create high-quality tissue repair products
9
Source: WFIRM
Our strategy
10
Position rhCollagen as the standard of care in our target markets
Promote rhCollagen as a platform technology, applicable in a broad
range of markets
Commercialize our product candidates through a network of
collaborative partners and distributors
Expand our manufacturing capacity to support commercialization of
our product candidates
Develop other recombinant proteins through our plant-based
technology
The lead product candidates
* Diabetic Foot Ulcers market only is $0.5B
11
$3.0B*$3.0B
& trauma
Soft
Tis
sue
Injectable, Matrix, Membrane for tendon, Cartilage and Meniscus Repair
2012 2013 2014 2015 2016
Vergenix™STR Soft Tissue Repair matrix
12
rhCollagen/PRP matrix
Intended in the treatment of tendinopathy (non-
ruptured tendon injuries)
Controlled release of platelets-derived growth factors
$2.0B W/W market potential
Status: clinical study (20 subjects) in process
CE approval planned for 2015
Tennis elbow
3M+
Hand tendons
300K
Jumper’s knee
300K
Rotator cuff
400K
Achilles tendon
250K
ACL
200K
Vergenix™STR - $1.5B* Market Potential
13
* ~4M procedures, market potential is 2M procedures (50%) x $750ASP = $1.5B potential market (US)
Annual procedures per indication, US only
Soft
Tis
sue
Injectable, Matrix, Membrane for tendon, Cartilage and Meniscus Repair
2012 2013 2014 2015 2016
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
Vergenix™STR kit
14
Soft
Tis
sue
Injectable, Matrix, Membrane for tendon, Cartilage and Meniscus Repair
2012 2013 2014 2015 2016
Preclinical study demonstrated faster healing rate with Vergenix™STR
15
A faster healing rate with Vergenix™STR was evidenced by:
• A decrease in inflammatory mononuclear cell levels (Figure A)
• Faster mature fibrosis (Figure B)
• A reduction in the severity of the presence of immature
granulation tissue(Figure C)
A B C
Study indicated that treatment of injured tendon with Vergenix™STR
resulted in a faster healing rate compared to treatment with PRP alone
Soft
Tis
sue
Injectable, Matrix, Membrane for tendon, Cartilage and Meniscus Repair
2012 2013 2014 2015 2016
Achilles tendon
Animal specie: rat (n=54)
Vergenix™STR clinical trial status
16
Forward Looking Statement: The Company wishes to emphasize that these are only factual subjective impressions based on non-medical conversations with enrolled
patients to date. It should be noted that to date the Company has not yet received interim nor final data and has not yet conducted data analysis . The company will update as
part of an immediate report on the final results of the trial when completed and only after final analysis of the entire date. There is no certainty as to the date and / or results of
the final findings of the study received , and / or the success or failure of said trial.
Fourteen (14) patients treated
Ten (10) patients reached the 1st month follow up, five (5) patients the 2nd
month follow up and three (3) reached the 3rd month follow up
Majority of patients reported improvement in pain & functional disability
(i.e. reduction in PRTEE score and increased arm strength)
Soft
Tis
sue
Injectable, Matrix, Membrane for tendon, Cartilage and Meniscus Repair
2012 2013 2014 2015 2016
Vergenix™FG wound filler
17
Source: "Worldwide Wound Management, 2008-2017: Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and
Rest of World"
Indications: Chronic vascular ulcers, diabetic,
pressure, venous, surgical wounds
$3B potential market ($500M ulcers only)
Scaffold for cellular invasion / capillary growth
Pivotal pig study confirmed superiority over
market leader
Status: clinical study (20 subjects) in process
CE approval planned for 2015
Significant potential in advanced wound care
18
Source, The future of wound care, Stuart Jackson & Jeffery Stevens (2006)
1.0
0.8
0.4
0.2
0.1
Diabetic foot ulcers
Trauma/surgery
Venous ulcers
Pressure ulcers
Burns
Number of wounds (millions)
Treated with advanced methods
1.4
8.0
1.3
1.6
1.5
FG has better wound closure rates
19
Source: Cutaneous Wound Healing After Treatment with Plant-Derived Human Recombinant Collagen Flowable Gel. Shani Shilo et al
TISSUE ENGINEERING: Part A, Volume 00, Number 00, 2013, Mary Ann Liebert, Inc. DOI: 0.1089/ten.tea.2012.0345
-20
0
20
40
60
80
100
0 5 10 15 20
CommercialControl
VergenixFG
Days
% wound closure
50% in 10 days
• Epithelialization was more extensive for the Vergenix™FG-treated wounds
• Vergenix™FG induces earlier blood vessel formation (angiogenesis) and resolution indicating enhanced wound healing, compared to market reference
Clinical trial statusFull wound closure after 4 weeks
20
Company’s immediate report dated March 18, 2015 [MAGNA 2015-01-053488].
Patient 1 Day 0Day 28
(wound closed)
Patient 3 Day 0Day 28
(wound closed)
Patient 2 Day 0Day 28
(wound closed)
• Fifteen (15) patients treated
• Excellent wound size reduction for the first 10 patients
- 70 % of the patients had wound closure between 80% to 100% after 4 weeks
Vergenix™BVF: Bone void filler + growth factor
21
* Source: The Global Orthobiologics Market: Players, products and technologies driving change - 2008 Espicom Business Intelligence
Composition: rhCollagen and minerals
Indication: trauma and spinal fusion
$3.0B potential w/w market ($1.5B for
spine* & $1.5B for trauma)
Controlled release of growth factor
Degradation synced with tissue growth
Status: preclinical studies
Covers a broad range of bone fractures
22
Fixation
Synthetic substitutes
Allografts
Autografts
Vergenix™BVF
BASIC
FRACTURES
NON-UNION
FRACTURESBone injury severity scale
3D Bioprinting with rhCollagen-based BioInk
Common materials: collagen, gelatin, gelatin/chitosan, gelatin/alginate, gelatin fibrinogen, Lutrol F127/alginate and alginate
Murphy and Atala, Nature Biotech, 2014
29
Source: Wake Forest Institute for
Regenerative Medicine (WFIRM)
Example of 3D printer
3D bioprinting is being applied to regenerative medicine to address the need
for complex scaffolds, or for tissues and organs suitable for transplantation
CollPlant investment considerations
24
Possesses the only viable technology that can produce truly human
collagen
Advancing regenerative medicine with innovative rhCollagen products
initially aimed at orthopedics and wound healing
Near-term opportunity with U.S. strategic collaborator
Commercialization of two lead products expected in Europe in 1Q 2016
Broadly applicable technology; future indications may include
Bioprinting/BioInk, ophthalmology and ACL repair
Strong IP position
Proven management team
