CLPT: TASE Febbuary 2016 2 Forward looking statements The - - PowerPoint PPT Presentation

1

Febbuary 2016 CLPT: TASE

1

2

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.

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)

4

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.
• Omrix

Biopharmaceuticals

• Interpharm

Philippe Bensimon VP RA/QA/CA

• Maquet-Getinge
• 3M Medical

Shomrat Shurtz Senior Director BD

• Protalix
• BBDO Proximity
• Clal holdings

4

5

P4Hα P4Hβ LH-3 Post translational modifications Col1α1 Col1α2

n- Propeptide c-Propeptide Stable production in tobacco plant Structural genes Enzyme genes

CollPlant’s technology: co-expression in plants

• f 5 human genes essential for the production
• f functional type I human recombinant Collagen

5

6

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 Epitenon 280 nm 64 n 1 nm 100 nm 1-20 μm 20-200 μm 500 μm

Collagen is the most basic building block

6

7

Multiple functions of collagen in tissue healing

Hemostasis & early inflammation (0-24 h) Late inflammation (48 h)

• Hemostasis
• Platelet activation
• Cells recruitment
• Support angiogenesis
• Growth factors

binding and release

Collagen Fibroblast

Cell proliferation (72 h) Remodeling (weeks to months)

• Support granulation

tissue formation

• Support epithelial

growth

• Support

mesenchymal stem cell growth, differentiation and tissue remodeling

Collagen

7

8

What is out there today and its limitations?

8

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

9

Clear advantages over tissue-extracted collagen

Better bio-functionality

Accelerates primary human cell proliferation Faster tissue healing Plant-derived rhCollagen

Superior homogeneity

Uniquely strong and aligned structures which are reproducible & thermally stable

Improved safety and greater purity

Non-allergenic Non-immunogenic No pathogens

Novel applications

Ideal building block for products with unique properties (e.g. BioInk)

9

10

Scalable production process

GROWING EXTRACTION PURIFICATION & FILLING END PRODUCT FABRICATION

Clean room facility Low cost space

Leaves Pellet Collagen

11

Sheets Fibers 3DP BioInk Microspheres Putty Malleable Paste Flowable gel Knitted meshes Non-woven meshes rhCollagen meshes rhCollagen coated polymeric fibers

Underlying technology supports a large portfolio

• f high-value tissue repair products

Source: WFIRM

Collagen configurations Compounds & composites Fibers & textiles

12

The lead product candidates

& trauma

Bone void filler Soft Tissue Repair Matrix Wound filler Wound care Orthopedics

12

13

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 (40 subjects) , positive interim results CE marking expected in Q2, 2016 Indication: Treatment of tendinopathy (tendon inflammation) by promoting healing of the tendon injury

14

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=a00297 Prevalence 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

15

15

PRP collection tube from any commercial PRP Kit

Kit

16

clinical trial status

• 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.

• 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.

17 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 83 36 68 92

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

– Clinical study status

18

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

19

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

• f

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 CollPlant-run manufacturing facility for the production of rhCollagen and the product in the U.S.

CollPlant executes non-binding term sheet with leading US partner

20

Covers a broad range of bone fractures

Fixation Synthetic substitutes Allografts Autografts

Vergenix™BVF

BASIC FRACTURES NON-UNION FRACTURES

Bone injury severity scale

21

Wound filler

Indications: Chronic vascular ulcers, diabetic, pressure, venous, surgical wounds Pig studies confirmed superiority over market leader Scaffold for cellular infiltration and capillary growth to promote optimal wound healing $3B potential market ($500M ulcers only) Status: clinical study (20 subjects) – positive final results CE marking expected in Q1, 2016

Source: "Worldwide Wound Management, 2008-2017: Established and Emerging Products, Technologies and Markets in the U.S., Europe, Japan and Rest of World"

22

Company’s immediate report dated November 26, 2015 [MAGNA 2015-01-164958].

Patient 1

Day 0 Day 28 (wound closed)

Patient 3

Day 0 Day 28 (wound closed)

Patient 2

Day 0 Day 28 (wound closed)

Clinical trial status Full 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

23

Our strategy

Position rhCollagen as the “gold standard” platform technology for collagen-based products in existing and new markets Establish regulatory process for rhCollagen-based end products using VergenixSTR and VergenixFG as precedent Utilize collaborative partners and distributors to develop and commercialize our technology and products Expand our manufacturing capacity to support commercialization

• f rhCollagen-based end products

Expand our pipeline through ongoing development of new products Employ our proprietary plant-based technology to advance

• ur leadership position

23

24

CollPlant IP portfolio

Patent Name Application # Priority Date Patent Status

Collagen Producing Plants and Methods

• f Generating and Using Same

WO2006/035442 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 Polysaccharides WO2009069123 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 Procollagen WO2009/128076 4/2008 National Phase:Europe, Canada, China(DIV), India, Israel Granted: USA(Allowed) Methods of Processing Recombinant Procollagen WO2009/053985 10/2007 Granted: USA, Israel, Europe Compositions comprising collagen and PRP for tissue regeneration WO2014/147622 3/2013 PCT (Published) Cross-linked Resilin-containing materials W2015/068160 1 1/ 2013 PCT (Published) Adhesive biopolymers and uses thereof WO2013/030840 9/2011 National Phase: USA, Europe, Israel

25

Sales & marketing

• * PMS - Post marketing Surveillance

The initial target market is Europe due to the ease of entry and the

• pportunity to develop a significant physician base of experience

We will enter into distribution agreements with established distributors in Europe for commencement of sales after CE marking We will initiate with our EU KOLs PMS* studies to generate additional clinical data to support product sales and reimbursement After CE marking, we may approach the Chinese market with Trauwin,

• ur Chinese strategic shareholder, or others

In parallel to the EU and China commercial activities, we plan to partner with a leading US company selling regenerative medical products We will establish strategic collaborations for other products

26

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