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1 Febbuary 2016 CLPT: TASE 1

CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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Page 1: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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Febbuary 2016

CLPT: TASE

1

Page 2: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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.

Page 3: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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 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)

Page 4: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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

4

Page 5: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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

5

Page 6: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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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Page 7: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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

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Page 8: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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

Page 9: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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Clear advantages over tissue-extracted collagen

Better bio-functionality

Accelerates primary humancell proliferationFaster tissue healing

Plant-derived rhCollagen

Superior homogeneity

Uniquely strong and aligned structures which are 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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Page 10: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

10Scalable production process

GROWING EXTRACTIONPURIFICATION

& FILLINGEND PRODUCTFABRICATION

Clean room facilityLow cost space

Leaves Pellet Collagen

Page 11: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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

Page 12: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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The lead product candidates

& trauma

Bone void filler Soft Tissue Repair Matrix Wound filler

Wound careOrthopedics

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Page 13: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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 (40 subjects) , positive interim results

CE marking expected in Q2, 2016

Indication: Treatment of tendinopathy (tendon inflammation)

by promoting healing of the tendon injury

Page 14: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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

Page 15: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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PRP collection tubefrom any commercial PRP KitKit

Page 16: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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.

Page 17: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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

83

36

68

92

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

– Clinical study status

Soft

Tis

sue

Injectable, Matrix, Membrane for tendon, Cartilage and Meniscus Repair

2012 2013 2014 2015 2016

Page 18: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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

Page 19: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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

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

Page 20: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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

Page 21: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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"

Page 22: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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 statusFull 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

Page 23: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

23Our 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

of rhCollagen-based end products

Expand our pipeline through ongoing development of new products

Employ our proprietary plant-based technology to advance

our leadership position

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Page 24: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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 11/2013 PCT (Published)

Adhesive biopolymers and uses thereof WO2013/030840 9/2011 National Phase: USA, Europe, Israel

Page 25: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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Sales & marketing

• * PMS - Post marketing Surveillance

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

opportunity 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,

our 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

Page 26: CLPT: TASE Febbuary 2016 - Collplant · CLPT: TASE 1. 2 Forward looking statements ... (5) the level of adoption of our products by medical practitioners (6) the emergence of other

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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