company overview - tase · company overview june 28, 2010 investors meeting. safe harbour statement...
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© Copyright 2010 CollPlant1
Company Overview
June 28, 2010
Investors Meeting
Safe Harbour Statement
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All statements, other than statement of historical facts, included in this presentation regarding
our strategy, future operations, financial position, future revenues, projected costs, prospects,
plans and objectives of management are forward looking statements. The words “believe”,
“anticipate”, “plan”, “expect”, “intend”, “may’, “project”, “will”, “would”, and similar expressions
are intended to identify forward-looking statements, although not all forward –looking
statements contain indentifying words. We cannot guarantee that we actually will achieve the
plans, intentions or expectations disclosed in our forward-looking statements and you should
not place undue reliance on our forward-looking statements.
Our statements of “belief” are based primarily upon our results derived to date from our
research and development, our research and development programs with animals, and
discussion with potential partners . We believe that we have a reasonable scientific basis upon
which we have made such statements. It is not possible, however, to predict, based upon
studies in vitro, in animal or human studies whether a new therapeutic agent will be proved
ultimately to be safe and/or effective in humans and approved for commercial use. We cannot
assure that the particular results expected by us will occur.
Except as required by law, we do not assume any obligation to update any forward looking
statements or statements of “belief”. We disclaim any intention or obligation to update or revise
any forward-looking statements or statement of “belief”, whether as a result of new information,
future events or otherwise.
All references to dollars in the presentation are to USD.
CollPlant’s Profile
Production of recombinant human collagen in
bioengineered plants
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Development and manufacturing of raw collagen and
collagen-based products for medical applications
Substantial pipeline including soft and hard tissue
repair products for orthopedic applications and for
advanced wound care products
Weizmann Science Park, Ness Ziona, Israel and
Yesod Hama’ala, Israel
Founded in 2004, listed CLPT in TASE since 5/2010,
35 employees
Platform
Focus
Pipeline
Locations
Background
Collagen is the Most Abundant Biomaterial in Human Body• Collagen is the principal protein of the skin, tendons, cartilage, bone and
connective tissue.
• More than 1,000 medical devices in the market are based on collagen
4Source: Tissue Engineering Options for Ligament Healing, Joseph W. Freeman
A Diagram of Tendon/Ligament Organization
Co-Expression of 5 Genes by Transformation and Cross-Breeding, Generating a Stable Plant Line
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Why Tobacco?
Green Production - the system is a safe alternative to
animal/mammalian expression systems (FDA register January 2007)
Tobacco is easily manipulated using known biotechnology practices
Tobacco produces large biomass, 4-6 weeks to mature plant
Tobacco is not in the food/feed chain (in-line with FDA regulations)
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Collage rhTM collagenFrom Plant to Product
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Cultivation
Harvest of leaves
Crude extraction
Protein purification
Final formulation
Proteolytic conversion
Farming of CollagenProducing Tobacco Plants in Israel
• Contract farmers grow tobacco in
greenhouses
• High return for the farmer, competitive
cost for CollPlant
• Advanced agriculture in Israel
contributing to increasing yields
• The varied climate zones of Israel
allow growing high quality collagen
year-round
• Scalability – fast with no capital
requirements
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„ Bone, cartilage & meniscus repair„ Wound care„ Surgical meshes„ Vascular grafts„ Corneal shields„ Hemostasis„ Surgical sutures„ Drug delivery solutions
Industry is focused on supply of new, safer biomaterials*
* 2008 collagen & HA biomaterials – global strategic business report, March 2008 by Global Industry Analyst Inc.
Uses of Collagen-Based Products
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CollPlant's Business ModelThree Growth Engines
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CollaborationsSupply agreements with top-tier
companies;• Supply collagen-based components
to end products
ProductsCollagen-based products ( )
for soft and hard tissue repair;• Orthopedic & wound healing markets
• Strategic collaborations
Raw MaterialRaw material ( )
For research applications;• Tissue culture & tissue eng. research
Scalability of Collagen Production
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Notes:
(1) Typical product requires 100 mg collagen
(2) Assuming improvement in collagen purification yield by a factor of 2 (2011) and by a factor of 4 (2012)
Vergenix™ Facilitates Proliferation of Human Primary Cells
Control
Puracol
Fibracol
Promogran
Vergenix
0
0.2
0.4
0.6
0.8
1
0
0.2
0.4
0.6
0.8
1
0.0
0.1
0.2
0.3
0.4
Human keratinocytes
Human Endothelial Cells
Human Dermal fibroblasts
Cell
pro
lifera
tion (
AU
)
*
*
*
Cells were seeded in low density and allowed to
proliferate on 6 mm scaffold discs for 72 h. WST-1
assay was used to quantify cell proliferation.
Collage membrane induces increased
human primary dermal cell proliferation
Collage membrane Control (cover-slip)
72 h Cell proliferation
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Test Result
Systemic Toxicity Passed
Cytotoxicity Passed
Hemolysis Passed
Muscle Implantation Passed
Intracutaneous Passed
Endotoxins by LAL Passed
Maximization Sensitization Passed
Pyrogen (LAL) Passed
ETO Residuals Passed
ISO 10993 Biocompatibility Studies
Study conducted at NAMSA
CollPlant’s Roadmap
14Focus on Major Unmet Medical Need
2010 2011 2012
High Strength Matrices*
Composed of polymeric
core & collagen shell
Applications:
• Hernia meshes
• Heart valve leaflets
Composite Membrane
structures
Moldable Putty
Wound Dressing
Matrix
Flowable Wound
Matrix
Applications:
• Bone void filler
• Osseous defectsApplications:
• Tunneled wounds
• Surgical wounds
• Ulcers
• Draining wounds
Applications:
• Surgical wounds
• Ulcers
• Draining wounds
Vergenix-WD
Microspheres for sustain
release of BMP to augment
bone and soft tissue repair
Notes*:
1.Thin strong matrices for minimally invasive surgery
2.Can be produced in different geometries
cGMP
Capability
Scalability &
3rd party mfg.
Biodegradable Implant
for repair of rotator cuff tears
Vergenix-FG
Resilin
Video
Vergenix-B
Biodegradable Implant
for repair of ACL
New biomaterials with
unique physical properties
Vergenix™ Wound Dressing Sheet
• 510(k) submitted to FDA followedby RFD
• Supporting in-vivo study in pigsdemonstrated equivalence
• Human studies in Israel will belaunched in Q4, 2010
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In development; optimization is on-going:
• Focus on cohesiveness, flowability and fluid absorption
• Supporting in-vitro models and analytical methods;
−Equivalence in supporting human cell proliferation to Integraflowable gel
• Small scale pilot in-vivo study shows jump start in wound healing
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Vergenix™ Flowable Gel
• In development, optimization is ongoing, focus on cohesiveness osteoconductivity
• In-vitro models being designed
• CRO for in-vivo currently being identified
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Vergenix™ Putty for Bone Repair
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The Commercial Opportunity
Tissue Engineered Musculoskeletal ProductsPotential US Market Forecast
19Source: Medtech Insight, Tissue Engineering and Cell Transplantation:
Technologies, Opportunities and Evolving Markets in the US
Market SegmentPotential
patients, 2010
Projected
Average Price
($)
Potential
Market, 2010
($M)
Bone Repair & Replacement 1,650,000 4,500 7,425
Joint/Cartilage Repair & replacement 4,400,000 4,500 19,800
Ligament Repair & Replacement 880,000 2,700 2,376
Meniscal Repair & Replacement 990,000 2,500 2,475
Total 7,920,000 - 32,076
KneeRotator cuff ExtremitiesSpine
Bone Graft Market Segments$2.4B Market Size
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Growth Factor ($870M, 36%)
Cell Based ($110M, 4%)Synthetics
($250M, 10%)
DBM($430M, 18%)
Allograft ($765M, 32%)
• Medtronic (90%)
• Stryker
• Osteocel
• Osiris
• Nuvasive
• Synthes
• Biomet
• Wright Medical
• Smith & Nephew
• RTI
• Kensey Nash
• DePuy
• Orthovita
• MTF
• LifeNet Health
• AlloSource
• Isotis
• RTI
• OsteoTech
Tissue Engineered Skin Replacements & SubstitutesPotential US Market Forecast
21Source: Medtech Insight, Tissue Engineering and Cell Transplantation:
Technologies, Opportunities and Evolving Markets in the US
Notes:
1. Ulcer types: Acute pressure, arterial, chronic pressure, diabetic foot & venous.
2. Other applications for skin substitutes include dermabrasion site treatment, fasciotomy site treatment, Mohs
surgery site treatment, skin graft donor site treatment, and traumatic wound repair.
Market SegmentPotential
patients, 2010
Projected
Average Price
($)
Potential
Market, 2010
($M)
Abdominal Wall repair Products 162,000 1,200 194
Breast Repair Products 37,100 1,200 45
Burn Treatment Products 30,900 3,000 93
Face, Head & Neck Reconstruction Products 78,750 1,200 95
Ulcer Treatmet Products 4,158,000 4,000 16,632
Products for Other Applications 104,000 1,200 125
Total 308,750 - 17,183
Hernia repairBreast repairUlcer treatment Neck reconstruction
The Commercial OpportunityOrthobiologics
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Rotator cuff (325,000 US)ACL (250,000 US) Hand/Wrist tendons (115,000 US)
Spinal fusion (200,000 US)Putty for BMP delivery
Nucleus Pulposus (300,000 US) Meniscectomy 875,000 USRepair 64,000US
Assuming ASP of $3K the annual US market
potential for the above indications is $3.75B.
So
urc
e: M
ed
tech
In
sig
ht
Potential Strategic Partners
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Tendon Repair Applications
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Quadriceps tendon rupture
Rotator cuff repair
Biceps tendon
Patellar tendon rupture
Achilles tendon tear
No tissue repair technology currently exists for large tendon and
muscle defects that is natural, strong, large, has good suture retention
and provides enhanced wound healing.
Extracellular Matrix Patches for Tendon Repair
„ Indication: rotator cuff repair augmentation
„ Rationale:‟ Natural, three-dimensional and mechanically robust
scaffold that may have ability “off-load” the repair
‟ A chemically and structurally instructive environmentfor host cells leading to integration and the formationof bridging tissues
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Commercial Scaffolds for Tendon & Ligament Repair
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Representative Stress-Strain Curves for Commercially Available ECM Scaffolds
274mm wide by 300mm long strips were tested (Aurora et al.,2007)
Raw Material DistributionCollage rh™
„ Signed Distribution agreement with FUNAKOSHI Co., Ltd.(Japan), a leading distributor for the R&D market.
„ Distribution agreement with WAKO (Japan) is currentlyunder negotiation.
„ Initiated discussions with Sigma Aldrich regarding addingCollage rh™ to their products catalog.
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StatusPatent NameNo
National Phase
Allowed: EP, SA, NZ, SG
Priority Sep 2004
COLLAGEN PRODUSING PLANTS AND METHODS OF GENERATING AND USING SAME
1
National Phase
Priority Oct 2007
METHODS OF PROCESSING RECOMBINANT PROCOLLAGEN2
National Phase
Priority Nov 2007
PREPARATION OF POLYSACCHARIDE COMPOSITES WITH RESILINPROTEIN COMPOSITIONS
3
PCT Application – Apr 2009METHODS OF GENERATING PROCOLLAGEN AND METHODS UTILIZING PROCOLLAGEN TO ACCELERATE ENHANCE WOUND HEALING AND/OR PREVENT SCAR FORMATION
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Provisional - Nov 2009METHOD OF GENERATING COLLAGEN FIBERS5
Robust Intellectual Property
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Board and Management
Senior Management:„ Yehiel Tal, CEO
Regentis Biomaterials, ProChon Biotech, Kulicke & Soffa.
„ Oded Shoseyov, Prof., CSO, Co-FounderHebrew University of Jerusalem.
„ Alon Bloomenfeld, CFOBiomedix, Runcom technologies, BrightCom Technologies.
„ Noa Lapidot, PhD, EVP Operations & Dev.Intec Pharma, Sol-Gel Technologies, Electric Fuel, Teva.
„ Hagit Amitai, PhD, VP R&DCompugen, QBI, Quantomix , InterPharm-Serono.
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Board of Directors:„ Efi Cohen-Arazi, Chairman
Intec Pharma, Amgen, Immunex, Serono.
• Ran NussbaumPontifax VC.
• Elad NaggarBiomedix Incubator, Endogun, MindGuard.
• Oded Shoseyov, Prof.Co-Founder.
• Alon Dumanis, PhDDocor International Management.
• Liron EderyR.E.G.L.
• Eyal BigonTFG.
Consultants & Medical Advisors
Consultants:„ Avram Hershko, Prof. Technion IL, Nobel Laureate in Chemistry (2004)„ Abhay Pandit, Prof. National University of Ireland, Galway, Therapeutic Factors„ Ben Walthall, PhD Ex VP Zimmer, Tendon, Cartilage & Bone Repair „ Kathe Derwin, PhD Cleveland Clinic, Rotator Cuff„ Arthur Gertzman, Ex VP MTF ‟ Bone Void Fillers & Polymers
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Medical Advisors:„ Prof. Ofer Levy, MD Royal Berkshire Hospital UK, Shoulder & Elbow„ Lawrence Gulotta, MD Hospital for Special Surgery US, Rotator Cuff„ Gabi Agar, MD Assaf Harofeh Hospital IL, Knee (ACL, Cartilage, Meniscus)„ Eran Tamir, MD Assaf Harofeh Hospital IL, Wound Care
Financials
„ Became public on May 2010, raising ~14.5M NIS
„ Cash status as of May 31st 2010 ~20M NIS
„ OCS grant of 3.9M NIS for 2010 R&D projects
„ Average monthly expenses 1.6M NIS
„ Applying for additional grants
„ Expected initial income during 2011
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Use of Proceeds
„ Technology research and development
„ New products development
„ Regulatory and clinical activities
„ Increasing production capacity
„ Ongoing row material production
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The CollPlant Opportunity
„ Unique, protected technology„ Clear, Unmet Medical Need„ Large, growing multi-billion $ market„ Large scale production capability of recombinant human collagen
„ Platform for biomaterials, regenerative medicine and drug delivery
„ Rich and attractive pipeline„ Experienced & knowledgeable leadership Team
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Thank You
www.collplant.com
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