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get Multiple Sclerosis Insight for Personalized Control Knowledge… May 2012 Dr. Avi Dukler, President & CEO TASE: GLCM Overview and business story

Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

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Page 1: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

get Multiple Sclerosis Insight for Personalized Control

Knowledge…

May 2012 Dr. Avi Dukler, President & CEO

TASE: GLCM

Overview and business story

Page 2: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

TASE: GLCM

Some of the information on this document may contain projections or other forward-looking statements regarding future events or the future financial performance of Glycominds Ltd. or Glycominds Inc.

We wish to caution you that these statements are only predictions and that actual events or results may differ materially.

We refer you to the documents that Glycominds files from time to time with the Israeli Securities Authorization and Tel-Aviv Stock Exchange, specifically, Glycominds’ most recent prospectus dated February 15, 2011. This document contains and identifies important factors that could cause the actual results to differ materially from those contained in our projections or forward-looking statements, including, among others, changes in the demand for Glycominds’ products; changes in economic conditions generally or technology spending in particular; changes in the competitive dynamics of Glycominds’ markets; changes in the LDT regulation; changes in the USA reimbursement system.

Glycominds assumes no obligation, and does not intend, to update these forward-looking statements.

DisclosureForward-Looking Statements

2

Page 3: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

Highlights

Operates in a high growth market with limited competition

11

22

33

44

55

A commercial stage biomarker company

Breakthrough, novel blood tests for Multiple Sclerosis and Crohn’s Disease

Operates CLIA clinical laboratory in Simi Valley, CA

Strong IP and proprietary technology platform

3TASE: GLCM

Generates revenues demonstrating a valid business model66

Page 4: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

SPECIALTY LAB &

MULTIPLE SCLEROSIS

MARKETS

TASE: GLCM

Page 5: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

3% of esoteric labs creates 33% of a $62 billion market

5TASE: GLCM

Page 6: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

Double digit growth for esoteric testing

6TASE: GLCM

Page 7: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

High Growth on Multiple Sclerosis US Market

�Almost 500,000 MS patients in the US

�18.5% growth on drug market472,000Total US MS Patients (est)

222,000 PatientsNot on

Therapy

80,000 RRMS

CIS

101,000SPMS

40,000PPMS

250,000 Treated Patients

226,000RRMS

CIS

17,000SPMS

7,000PPMS

~25,000BetaseronPatients

~63,000 AvonexPatients

~100,000 COPAXONE

Patients

~51,000 Rebif

Patients

~10,000 TysabriPatients

~25,000 Retail

Pharmacy

~60,000 Specialty Pharmacy

~15,000 Mail

Order

Sales ~$6.4B 18.5%

Jan 2011 Size Growth

7TASE: GLCM

Page 8: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

GLYCAN BIOMARKERS FOR MSSCIENCE & TECHNOLOGY

TASE: GLCM

Page 9: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

What Can Biomarkers Do?

Change Managed Care Efficiency and Costs

9TASE: GLCM

Page 10: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

Potential Mechanism of ActionNon-Cellular component of BBB Basement Membrane

Contains Collagen Type IV

Ruotsalainen et al., 2005

EAE brain stained for anti-GAGA4 (70598) or its anti-Ha control

Anti-GAGA4 (green) Anti-Ha (green)

• Data looks promising, but the secondary antibody alone also produces some green staining.

• More research is currently being conducted

Laminin

Provided courtesy of V. Wee Yong, Professor, University of Calgary

• Number of glycosylated hydroxylysineresidues varies among the various collagen types.

• For instance, Type IV collagen found in basement membranes (BM) and type VI collagen found in blood vessels have large number of modifications.

10TASE: GLCM

Page 11: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

Next Generation in Glycan Technology for Clinical Development

From Discovery to Clinical Products� Established capability to work with small volume of specimens

� Performed extensive screening to discover and validate glycan biomarkers

� Obtained robust analysis for clinical validation

� Developed design-control process for product development and production

� Delivered regulated menu of laboratory developed tests

Glycan immobilization

Screening glycan arrays array cell analysis Lab developed test

11TASE: GLCM

Issued patents is the US*8,129,128; 8,048,639; 7,906,291; 7,608,414; 7,592,150; 7,572,592 ; 7,537,900; 6,994,966; 6,972,172

* Not include patent applications and over 100 issued and granted patents outside the US

Page 12: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

Leading a Revolution in Managed Care

2009 2010 2011 2012* 2013 2014*

12

* Estimated

TASE: GLCM

Page 13: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

THE PRODUCTS:BLOOD TESTS FOR MS

TASE: GLCM

Page 14: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

MRI alone can NOT be sufficient for timely diagnosis, * “No better explanation” is challenging for general neurologist

MS is still diagnosis of exclusions –

Today

Series of MRI

Spinal Tap

The Solution

“There must be no better explanation for the clinical presentation, and objective evidence must be present to support a diagnosis of MS”

Critical time is lost

Glycominds test expedites diagnosis and can double the effective window for early treatment.

14* Polman et al ANN NEUROL 2011;69:292–302

Saving $11,000 of first diagnosis year

Brettschneider et al Journal of Neuroimmunology 2009;217:95-101.

TASE: GLCM

Page 15: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

Patient: Improve early diagnosis; eliminate unnecessary disabilities

� Value Proposition:

Value and Size of Opportunity for

Market Size:

Suspected MS

cases 100,000 p.a.

New CIS/MS patients 31,000 new cases p.a.*

$120 Million

p.a.$1,290 / gMS Dx

charged

Physician: Gain differential diagnosis; decide based on patients at risk

US Payer: Save first year of diagnosis work-up costs

� Size of the US Market for gMSDx test:

15TASE: GLCM

Glycominds as market leader will take 30-40% market share in next 5 years

Page 16: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

The Solution

Early treatment windows, many treatment options and different efficacy/ safety profiles creates an unmet medical need for a Risk / Benefit decisions tool for

newly diagnosed and breakthrough cases

MS is heterogeneous disease, prognosis is challenging

Betaseron®

(IFNß-1b)

BG-12(Dimethyl Fumarate)

Avonex®

(IFNß-1a)

Rebif®

(IFNß-1b)

Copaxone®

(glatiramer acetate)

Extavia®

(IFNß-1b)

Tysabri®(natalizumab)

Novantrone®

(Imitoxantrone

Gilenya®

(fingolimod)

Lemtrada®

(alemtuzumab)

AubagioTM

(Teriflunomide)

Ofatumumab

Breakthrough blood test that predicts patients’ risk level for sustained disability progression

16

Ocrelizumab

Daclizumab

Freedman M. et al. Multiple Sclerosis Journal , published online Dec 2011.

TASE: GLCM

Page 17: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

Patient: Improve early diagnosis; eliminate unnecessary disabilities

� Value Proposition:

Value and Size of Opportunity for

Market Size:

80,000 p.a.

~15% p.a. out of 276,000 RRMSpatients

prior significants disabilities

31,000 new cases p.a..

$300 Million

p.a.

$3,920 / gMS EDSS charged

Physician: Gain differential diagnosis; decide based on patients at risk

US Payer: Save drug costs and gain extra QALY (Dominant in cost effectiveness model)

17TASE: GLCM

� Size of the US Market for gMSDx test:

Glycominds as market leader will take 30-40% market share in next 5 years

Page 18: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

The Solution

Risk for severe side effects in Multiple Sclerosis is associated with suppressive immune system.

Pipeline: The Risk Management challenge

Tysabri®(natalizumab)

Novantrone®

(Imitoxantrone

Gilenya®

(fingolimod)

Campath®

(alemtuzumab)

Glycominds test may predict risk for severe side effects based on immunosupressive system

PML

Leukemia

Herpes Zoster, malignancy

Secondary Autoimmunity

18TASE: GLCM

Page 19: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

GO TO MARKET

TASE: GLCM

Page 20: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

Fully integrated clinical laboratory with nation-wide CLIA certifications

20TASE: GLCM

Page 21: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

21

Built an impacting marketing team in the US

TASE: GLCM

Page 22: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

22

Built an effective sales reps team in the West Coast

Sales force USA West Coast Penetration

Quarterly Reported Test in the West Coast

TASE: GLCM CONFIDENTIALYour Logo

Page 23: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

West Coast

South West

South

North West

Great Lakes

New York

NorthEast

Central North E

Central North W

Central SouthSouth

East

2012 sales force plan

Extending sales reps in Q1-2013

Significant Growth Potential in Diagnosis of Multiple Sclerosis in the US

23TASE: GLCM

Page 24: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

Patient Education

Patient and Caregiver Outreach Campaign

Social Networks Patient Associations

24TASE: GLCM

Page 25: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

Patients

ProvidersPayers

Obtaining network of PPO agreements

Done in Q4-11-Q1-2012: What to Expect:

25TASE: GLCM CONFIDENTIALYour Logo

Page 26: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

‘Flying below radar” approach with five first tier insurance plans that cover 50% of the commercial market (100 million lives) to reach critical mass, and medical policy coverage in 2013

Medical Policy Coverage Decisions with Target Healthcare Plans in 2013

26

(WA)

(PA)

(CA)

(NJ)

TASE: GLCM

Page 27: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

COMPETITION

TASE: GLCM

Page 28: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

MRI is the main biomarker inMultiple Sclerosis

Sagittal T1-weighted MRI depicts multiple hypointense lesions in the corpus callosum; this finding is characteristic of multiple sclerosis.

Coronal fluid-attenuated inversion recovery (FLAIR) MRI in a patient with multiple sclerosis demonstrates periventricular high–signal intensity lesions, which exhibit a typical distribution for multiple sclerosis.

Axial T2-weighted MRI in a patient with multiple sclerosis demonstrates numerous white matter plaques in a callosal and pericallosal white matter distribution.

Axial diffusion-weighted MRI in a patient with multiple sclerosis shows several hyperintenselesions, a feature of inflammatory disease activity.

1628TASE: GLCM

Page 29: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

Other blood tests for MS are evolving

1629TASE: GLCM

Differential diagnosis of NMO� NMO-IgG tests is commercially available

as a differential diagnosis of NMO from MS

� The NMO test is provided by Mayo Clinic,

ARUP and Ahtena labs

JC Virus Stratification� StratifyJCV is a companion diagnostics

tests for Tysabri (a FDA approved

monocolonal Ab for MS with a risk for PML

based on a JC virus infection

� StratifyJCV was developed by Biogen Idec

(Tysabri manufacturer ) and provides in the

US by Quest Diagnostics

Page 30: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

BUSINESS MODEL

TASE: GLCM

Page 31: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

Glycominds, center of excellence for Multiple Sclerosis

Proprietary Technology

Critical Unmet

Medical Need

Dominant Health

Economic

Glycominds, center of excellence for Multiple Sclerosis

High Value, Low Volume.

Huge market with very high margins

Innovative Science and Business Model Delivering Value to Patients and Shareholders

31TASE: GLCM

Page 32: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

MANAGEMENT,HISTORY OF DELIVERY

AND MILESTONES

TASE: GLCM

Page 33: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

Leadership Team Experienced Board of Directors

Dr. Avinoam A. Dukler, Founder, Director, President & CEO

Leading Glycominds business and strategy since inspection

Mr. Ofer Shainberg, Chief Financial Officer

LLM, CPA, MBA.

Expert in financial management in fast growing companies

Mr. Randy Ringold, General Manager CLIA labFounder and General Manger of VDxI Inc.

(acquired by IDEXX Laboratories)

Former VP at Quest Diagnostics

Mrs. Benita Elkon Baitner, Director of Sales & Marketing

RN in ICU and public health

Former Product manager at Pfizer and Abbott

Dr. Nir Dotan,

Founder, Chief Technology Officer, VP R&D

Expert in glycan technology

Founder, leading the company technology since its inception

Dr. Norman Kachuck, MD, Medical Director

Multiple Sclerosis Specialist

Former associate professor of Neurology, Keck School of Medicine of USCDirector, MS Comprehensive Care and Research Center

Mr. Hanan Gilutz, Chairman

Master degree in Management;

Former VP Marketing at Orbotech (NASDAQ:ORBK)

Former manager at McKinsey & Co.

Dr. Chen M. Even, Director

Senior VP Commercial Operations, DiaSorin Sp.a (MSE:DIA)

A leading diagnostic company Market-CAP €1.7 BILLION

Mr. Robert Taub, DirectorFounder, Former CEO of Omrix Biopharmaceutical

(acquired by J&J for $438 million) MBA INSEAD

Mr. Amir Hayek, Director

Chairman of the Israeli Import and Trade Institute

Mrs. Hila Karah, Director

CIO in Eurotrust Ltd.

Former partner in Perspective hedge fund,

Former senior analyst in Oracle hedge fund

Dr. Avinoam A. Dukler, Founder, Director, President & CEO

33TASE: GLCM

Page 34: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

2011 was strong year. We delivered:

Raised net $7M in TASE IPO and PIPE

Built effective logistics operation and sales force in Western USA

Signed on a network of agreements with PPO, covering 50 million lives

Completed CLIA regulation and accreditation with CMS and 48 states

Extended IP portfolio via several patent issuances in the US and worldwide

Entered into a series of research collaborations to expand product awareness

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22

33

44

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34TASE: GLCM

Page 35: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

2012 Expected Milestones

Strengthen Our Financial Position� Close financial round

Invest in Commercial Capability� Expand US sales force� Constantly improving reimbursement payments via PPO agreements� Medical Policy coverage decision with first local healthcare insurance plan

Advance Research and Development� Announce new clinical data for the disability test to increase awareness and� Report gMS-Classifier2 results for CIS prediction to CDMS to enable acceptance� Conduct other-neurological disease clinical study to extend market potential

35TASE: GLCM

Page 36: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

ACTIVE IVD & SPECIALTY LABS

M&A MARKET

TASE: GLCM

Page 37: Glycominds Presentation May2012 v1 · (natalizumab) Novantrone ® (Imitoxantrone Gilenya ® (fingolimod ) Lemtrada ® (alemtuzumab) Aubagio TM (Teriflunomide) Ofatumumab Breakthrough

t

High multiples on sales (x5-10) for strategic and growth companies

Active Dx M&A Market

New players (GE, Novartis, Nestle Healthcare, Japanese PE ) acquiring US labs

Over $15 billion of Dx transactions in the last 18 months

Source: Public Announcements, Dx=Diagnostics systems and kits

18 MONTHS Dx M&A TRANSACTIONS > $100M

DATE ACQUIRER TYPE TARGET TYPE DEAL VALUE ($M)

Sep-10 LabCorp Lab Genzyme IVD 925

Oct-10 GE Healthcare Dx/Equip Clarient Lab 587

Jan-11 Novartis Pharma Genoptix Lab 470

Feb-11 Quest Diagnostics Lab Athena Lab 740

Mar-11 Quest Diagnostics Lab Celera Lab 671

May-11 Thermo Fisher Dx/Equip Phadia Lab 3,500

May-11 Nestle Food/Health Prometheus Dx-Rx/Lab 1,130

Jun-11 Qiagen Dx/Tool Iphsogen IVD 101

Jul-11 Roche (Ventana) Dx Mtm Laboratories IVD 260

Aug-11 Qiagen Dx/Tool Cellestis IVD 374

Sep-11 PerkinElmer Dx/Equip Caliper IVD 600

Oct-11 Miraca Holdings (Japan) Japanese Lab Caris Diagnostics Lab 725

May-12 Hologic Imaging/surgey Gen-Probe IVD 3,700

May-12 Agilent Technologies Dx/Tool Dako IVD 2,200

TOTAL 15,983 *

* Not including Roche $6.7 billion hostile bid to Illumina shareholders

37TASE: GLCM