1 1 CLPT: TASE Febbuary 2016
2 Forward looking statements The following overview contains forward-looking You are cautioned not to place undue reliance on these statements that include, but are not limited to, projections forward-looking statements, which speak only as of the about our business and our future revenues, expenses date of this overview. and profitability. Forward-looking statements involve In order to have a comprehensive understanding and known and unknown risks, uncertainties and other factors information over the Company, including the risks its which may cause the actual events, results, performance, activity is subject to, you must review the Company's circumstances or achievements of the Company to be Immediate and Periodical reports (in Hebrew) with the materially different from those expressed or implied by Israeli Security Authority and the Tel Aviv Stock Exchange such forward-looking statements due to factors that and with the OTCQX and Company's web site (in English). include, but are not limited to: (1) our ability to develop and The Company undertakes no obligation to update any bring to market new products (2) our ability to successfully forward-looking statements, to report events or to report complete any necessary or required pre-clinical and/or the occurrence of unanticipated events that may lead to clinical studies with our products, if so requires (3) our the actual events, results, performance, circumstances or ability to receive regulatory clearance or approval to achievements of the Company being different than as market our products, if so requires, including due to envisaged by such forward looking statements. changes in regulatory environment (4) our success in This overview by no means establishes an offer to implementing our sales, marketing and manufacturing purchase or sale the Company's securities nor an plans (5) the level of adoption of our products by medical invitation to receive such offer and is intended for practitioners (6) the emergence of other products that may informative purposes only. 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.
3 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 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 (tendons, wounds) expected to commence sales in Europe this year 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)
Oded Shoseyov Yehiel Tal CEO Prof./Founder/CSO • Regentis • Pauli Clean Tech 4 Experienced 4 • CBD Tech. Biomaterials • ProChon Biotech • Fulcrum-SPD management team • Kulicke & Soffa • Melodea • Hebrew University Industries Eran Rotem Ilan Belzer Nadav Orr, PhD CFO COO VP R&D • Tefron (ex • BioHarvest • Ethicon NYSE,TASE) • Proteologics Ltd. Biosurgery, • Healthcare Tech. • Omrix Johnson & (NASDAQ) Biopharmaceuticals Johnson &Gamida • Interpharm • E&Y Shomrat Shurtz Philippe Senior Director BD Bensimon VP RA/QA/CA • Protalix • BBDO Proximity • Maquet-Getinge • Clal holdings • 3M Medical
CollPlant ’ s technology: co-expression in plants 5 5 of 5 human genes essential for the production of functional type I human recombinant Collagen Stable production Enzyme genes Structural genes in tobacco plant P4H α Col1 α 1 P4H β Col1 α 2 LH-3 n- Propeptide c-Propeptide Post translational modifications
Collagen Collagen Collagen Primary Secondary Tertiary Tendon unit Bones molecule fibril fiber fiber bundle fiber bundle fiber bundle (subfascicle) (fascicle) 6 6 α 1 α 2 Endotenon 64 n Skin Fibroblast Epitenon 280 nm Collagen is the most basic Tendons building block Ligaments J.H.-C. Wang / Journal of Biomechanics 39 (2006) 1563 – 1582 1-20 μ m 20-200 μ m 500 μ m 1 nm 100 nm
Multiple functions of collagen in tissue healing 7 7 Hemostasis & early inflammation (0-24 h) Late inflammation (48 h) • Hemostasis • Support angiogenesis • Platelet activation • Growth factors • Cells recruitment binding and release Collagen Remodeling (weeks to months) Cell proliferation (72 h) Collagen Fibroblast • Support • Support granulation mesenchymal tissue formation • Support epithelial stem cell growth, differentiation and growth tissue remodeling
What is out there today and its limitations? 8 8 TISSUE-EXTRACTED PLANT-DERIVED Cell binding domains Cell binding domains Collagen rhCollagen • Partially denatured (crosslinked) • Perfect triple helix • Low cell binding domains • High cell binding domains Partially functional 3-D matrix Fully functional 3-D matrix Thick fibers/low surface area Thin fibers/high surface area Partial D-banding D-banding Slow cell proliferation and Fast cell proliferation slow tissue repair and fast tissue repair • Foreign body response • Edema • Inflammation
Clear advantages over tissue-extracted collagen 9 9 Plant-derived rhCollagen Accelerates primary human cell proliferation Better bio-functionality Faster tissue healing Uniquely strong and aligned structures which are Superior homogeneity reproducible & thermally stable Non-allergenic Improved safety and greater purity Non-immunogenic No pathogens Ideal building block for Novel applications products with unique properties (e.g. BioInk)
Scalable production process 10 Leaves Pellet Collagen PURIFICATION END PRODUCT GROWING EXTRACTION & FILLING FABRICATION Low cost space Clean room facility
Underlying technology supports a large portfolio 11 of high-value tissue repair products Source: WFIRM Collagen configurations Sheets Fibers 3DP BioInk Microspheres Compounds & composites Putty Malleable Paste Flowable gel Fibers & textiles rhCollagen coated Knitted meshes Non-woven meshes rhCollagen meshes polymeric fibers
The lead product candidates 12 12 Orthopedics Wound care Bone void filler Soft Tissue Repair Matrix Wound filler & trauma
13 Soft Tissue Repair matrix rhCollagen/PRP matrix Indication: Treatment of tendinopathy (tendon inflammation) by promoting healing of the tendon injury Enables controlled release of growth factors and serves as scaffold to support cell proliferation $2.0B W/W market potential Status: clinical study (40 subjects) , positive interim results CE marking expected in Q2, 2016
US market potential 14 Annual procedures per indication Tennis elbow Rotator cuff 3M+ 400K http://www.aafp.org/afp/2007/0301/p701.html http://www.aaos.org/news/aaosnow/jan11/cover1.asp Hand tendons Achilles tendon 300K 250K Risk factors for hand-wrist disorders in repetitive work http://www.achillestendon.com/Injuries.html F Thomsen, S Mikkelsen, J H Andersen Jumper ’ s knee ACL 300K 200K http://orthoinfo.aaos.org/topic.cfm?topic=a00297 Prevalence of patellar tendinopathy in non-elite-athletes J. Zwerver, S.W. Bredeweg, I. van den Akker-Scheek
15 15 PRP collection tube Kit from any commercial PRP Kit
16 clinical trial status • 40 patients treated • At 3- months, 83% of the patients (N=23) showed at least 25% reduction in PRTEE (improvement in pain & functional disability) when compared to baseline • At 6- months, 92% of the patients (N=13) showed at least a 25 % reduction in PRTEE scoring. • 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.
– Clinical study status 17 Patients Success Rate (%) (Improvement of 25 % in pain and motion 1 ) 100 90 92 80 83 70 68 67 60 50 48 40 30 36 20 10 0 Steroids PRP Vergenix STR 3-month 6-month 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
18 Bone Void Filler + growth factor Indications: Trauma and spinal fusion Composition: rhCollagen and ceramic granules, in combination with bio-functional molecules Scaffold for cell proliferation and controlled release of growth factor for bone regeneration Scaffold degradation synchronized with tissue growth $3.0B potential w/w market ($1.5B for spine* & $1.5B for trauma) Status: preclinical studies * Source: The Global Orthobiologics Market: Players, products and technologies driving change - 2008 Espicom Business Intelligence
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