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JP Morgan Healthcare Conference January 2015

JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

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Page 1: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

JP Morgan Healthcare Conference January 2015

Page 2: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

This presentation has been prepared for informational purposes only and does not purport to be all-inclusive. We have based the forward-looking statements on our current expectations and projections about future events. These forward-looking statements are subject to known and unknown risks, uncertainties and assumptions about us and our affiliate companies. There can be no assurance that such results will be realized and actual results in each case could differ materially from those currently anticipated in such statements as a result of various factors. BioLight is not under any obligation to update or correct any future forecasts and/or forecasting statements to reflect events or circumstances after the date of this presentation. BioLight makes no express or implied representation or warranty as to the achievement of the forecasts or the accuracy or completeness of the information contained herein. BioLight expressly disclaims any and all liability which may be based on such information, errors therein or omissions therefrom. This presentation does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or sell securities of BioLight.

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Safe Harbor Statement

Page 3: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

World renowned leading management team and strong investor

base

3

Company Highlights

Balanced portfolio focused on ophthalmic and cancer diagnostics

solutions targeting multibillion-dollar growing markets

Two technologies at initial commercial stage

Unique model encouraging knowledge and cost synergies

Traded in the TASE (BOLT) and in the OTCQX (BLGTY)

Page 4: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

Ophthalmic Field

Developing and commercializing technologies in Glaucoma and Dry Eye Syndrome

BioLight - Addressing Two Medical Fields with Market Potential of Multibillion-Dollar

4

Cancer Diagnostics Field

Developing and commercializing diagnostics tools for different types of cancers

Page 5: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

Our Ophthalmic Field Portfolio:

Glaucoma and Dry Eye Syndrome

5

Page 6: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

More than 100M patients worldwide

Accounts for 40% of visits to eye doctors

Unmet needs:

Diagnostics

Treatment

Monitoring

~70M patients worldwide

$5 billion market

Unmet needs:

Low compliance to eye-drops

Significant side effects to existing

treatments

Eye-D®

IOPtiMateTM

TeaRx

6

Our Ophthalmology Portfolio - Targets Growing Unmet Needs

Gla

uco

ma

Dry

Eye

Page 7: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

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Eye-D®

Controlled release drug-delivery insert platform

Page 8: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

A broad platform technology

Strong patent protection

Long-term controlled release drug through subconjunctival insert to be used as a platform for eye drops

First indication targets the market leading Glaucoma generic drug latanoprost (Xalatan® by Pfizer)

Eye-D® Solution - Novel Rx Eye Insert

Thickness 300 m 3 mm x 7.5 mm

8

Humans: invisible below lower eye lid

Simple in-office procedure

The Solution

Page 9: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

Eye-D® - Market Potential

9 Source: American Glaucoma Society Glaucoma Research Foundation

Additional potential:

• Expand to rest of the world markets

• Use beyond Glaucoma - anterior & posterior segments

• Applications beyond ocular drugs uses

~10M Glaucoma patients in the U.S.

~3M diagnosed

patients

~2M patients

prescribe with

latanaprost

~1M patients getting other

treatments (drugs &

surgeries)

$3.2B market potential of Latanoprost insert in the U.S. alone

Insert price estimated at annual of $800 per eye

Page 10: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

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Eye-D® - Latanoprost Insert Development Status

A 505(b)(2) regulatory approval pathway

Phase 1/2a clinical trial ongoing in 7 centers in the U.S.

Results expected in H2/15

Additional indications under review

Page 11: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

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IOPtiMate™

Non-penetrating medical procedure for Glaucoma

Page 12: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

The IOPtiMateTM Procedure - Efficiency and Safety!

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The IOPtiMateTM system

• A new laser-assisted surgical tool that enables eye

surgeons to perform an accurate Deep Sclerectomy

Glaucoma Surgery

• Reduces elevated intraocular pressure by thinning the

sclera without penetrating the eyeball

• Transforms complex and highly risky glaucoma surgery

into a safe and precise laser-assisted procedure

Page 13: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

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Worldwide Clinical Results Performed on 111 patients in 9 sites with 5-years follow up

Source: Am J Ophthalmol. 2009 Nov;148(5):670-84; 2009 Aug 11; Three-year follow-up of the tube versus trabeculectomy study; Gedde SJ, American Journal of Ophthalmology (2007) Volume: 143, Issue: 1, Pages: 23-31; Surgical complications In the Tube Versus Trabeculectomy Study during the first year of follow-up; Steven J Gedde

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Page 14: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

$1.5B global market potential

The IOPtiMateTM Market Potential

14

Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011

Company estimations

~1.5M annual surgical

procedures

~0.5M trabeculectomy

& shunts procedures

~1M trabeculoplasty

procedures

Estimated reimbursement of $1,000 in the U.S.

Page 15: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

• More than 700 clinical procedures

performed globally to date

• 4 Regulatory approvals in Europe, China,

Mexico and Israel, additional in process

• Distribution agreements in place in multiple

locations - commercial sales begun in Q4/14

• Systems installed worldwide

15

IOPtiMateTM Status

Page 16: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

16

TeaRx

Point-of-care multi-parameter diagnostic

test for Dry Eye Syndrome

Page 17: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

The TeaRx approach is to assemble several

parameters to achieve a rapid, simple, semi-

quantitative analysis of the tear film

A novel multi-parameter diagnostic test that

enables diagnosis, companion diagnostics

and monitoring of Dry Eye Syndrome

TeaRx - A Breakthrough Solution for Dry Eye Syndrome Diagnostics

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Advantages:

• Multiple parameters

• Low-cost & easy to use

• Easy reading

• Companion diagnostics potential

Page 18: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

Only 1 drug has FDA approval (Restasis,

Allergan) which treats only 20% of the patients

High need for personalized treatment and

companion diagnostics solutions

About 12 new drugs in Phase II/Phase III

development stage

About 100 million people suffer from the

syndrome worldwide, 20-30 million in the U.S.

alone

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Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011

Companiesandmarkets.com , Apr 2013

Dry Eye Syndrome - High Need for Diagnostics and Treatment

Diagnostics Treatment

The reason for 40% of the eye doctor visits

~300 million people suffer from the symptoms

Page 19: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

TeaRx - Development Status

Human clinical trials in U.S. and Israel

Results expected in Q1/15

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Page 20: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

IOPtiMateTM

Ophthalmic Portfolio 2015 Events

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• Phase 1/2a clinical trial results H2/2014

• Preparation for Phase 2b

• Expanding IOPtiMate sales

• Securing regulatory approvals in Canada, Taiwan and

additional countries

Eye-D®

• Clinical trial results (Q1/15)

• Industrialization TeaRx

• Investing in new ophthalmic technologies

Page 21: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

Our Cancer Diagnostics Portfolio

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Page 22: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

Source: *WHO, Globocan 2008, NIH ,American Cancer Society 2012 **Harvard Business Review

On average 25% of existing cancer treatments are effective & varies from one patient to another

Diagnostic tests allow matching of effective treatment to patient and maximizing treatment value

Cancer is the leading cause of death worldwide (around 13% of all deaths)

and is expected to reach 9 million deaths in 2015

Early detection by advanced diagnostic methods saves lives

Cancer Diagnostics Market - Unmet Need

Personalized Medicine

22

2000 2008 2015 2030

6.3 7.6

8.9

13.1

9.9

12.7

14.9

21.3

Global Cancer Incidence

Global Cancer Mortality

Page 23: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

CellDetect®

Prostate/CTC

Rich Portfolio Focused on Market Needs

Screening Monitoring Diagnosis Personalized Treatment

Multiple Myeloma

Cervical Cancer

Bladder Cancer

Other Indications

Colon-MarCarePlex™

BRCA

CellDetect®

Bladder

CellDetect® Bladder

Brain Metastasis

(Lung)

BRONJ

CellDetect® Cervical

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Page 24: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

CellDetect®

A powerful oncology histochemical

diagnostics platform

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Page 25: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

The CellDetect® Technology Overview

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Proprietary kit containing unique extract and dyes

Standard processes utilized in pathology laboratories

The only assay allowing color discrimination between

and cells and morphological examination

The CellDetect® technology allows the same number of pathologists

to perform significant higher number of tests

PAP Test CellDetect® Test

Page 26: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

The 4th most common cancer in women world wide

• ~200M annual tests globally with market potential of billions of dollars

• 9 of 10 cervical cancer deaths occur in emerging markets that do not have an effective screening process

• Markets require a simple, accurate low cost solution

• Market potential of 500M tests in China and India

• CE and SFDA regulatory approvals

• Initiated commercial activity in China

• On-going clinical activity in India

Cervical Cancer Detection - Unmet Need in Emerging Markets

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Source: Globocan 2012

Sensitivity Specificity

CellDetect® 92% 80%

Pap Test 79% 82%

HPV Test 84% 39%

Page 27: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

• Up to 80% recurrence requires life long monitoring & treatment

• Making it the most expensive to treat on a per patient basis

• Current gold standard tests are invasive, expensive, or lack clinical efficacy

• Over 1.5M annual monitoring tests currently performed in the US alone

• On-going multi-center clinical trial

Source: Avalere, globocan 2012, Bladder Cancer Advocacy Network; Bladder Cancer Fact Sheet

Bladder Cancer Detection - A large Market Opportunity

27

The 7th most diagnosed cancer in men worldwide

Proof of Concept & Blinded Study Interim Results

Sensitivity Specificity

CellDetect® 88-95% 68-89%

Page 28: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

Bladder cancer urine test

Circulating Tumor

Cells blood test

Cervical cancer

test

Prostate cancer urine test

Lung cancer sputum

test CellDetect®

Platform

Platform Automation

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CellDetect® Platform

Page 29: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

BRONJ A diagnostic test for detecting patients at

risk to develop BRONJ

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Page 30: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

Cancer Indications Osteoporosis

Source: Globocan 2012

≤12%

100,000 Annual

Multiple Myeloma patients

60,000 Annual

Prostate Cancer

patients

300,000 Annual Breast Cancer

patients

≤18% ≤7%

200M Osteoporosis

patients

≤ 200,000

Target market

BRONJ prevalence

The BRONJ Potential Market

BRONJ - a devastating side effect of bisphosphonates therapy resulting in bone necrosis of the jaw

There is no available test for predicting BRONJ

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Development Status

• Multiple Myeloma clinical trials ongoing in U.S. and Israel

• Extension of clinical trial to other indications in 2015

Page 31: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

CellDetect® Cervical

Cancer Diagnostics Portfolio 2015 Events

31

• Multicenter clinical trial results - Q1/15

• Regulatory filing based on clinical trial results

• Expending sales in China

• Initiate sales in India - H2/15

• Additional markets penetration

CellDetect® Bladder

• Clinical trial in multiple myeloma patients results - Q1/15

• Extended trial to other indications - H2/15 BRONJ

Page 32: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

45.00%

20.00%

35.00%

Corporate and Financial Summary

• Israel Makov, the former President & CEO of

Teva Pharmaceuticals

• Dilip Shanghvi , the founder and managing

director of Sun Pharma, India’s largest

pharmaceutical company by market cap1

• Dan Oren , the founder, President & CEO of

Dexcel Pharma, the 2nd largest pharmaceutical

manufacturer in Israel2

Sources: 1. Crisil Ratings 2. IATI, Israel Advanced Technology Industries 32

Pri

vate

In

vest

ors

• Traded on Tel Aviv Stock Exchange (BOLT) and OTCQX (BLGTY)

• 521.3 million shares outstanding; 791.1 million fully diluted

• Market Cap of $25M, Avg. Trading Volume 2.03 million shares

• Backed by private investors with significant biopharmaceutical experience and reputable institutional

investors as follows:

Private Strategic Investors (45%)

Institutional (20%) Public (35%)

Page 33: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

Corporate and Financial Summary (cont.)

Strong Cash Position

• $9 million as of September 30, 2014

• Funds operational needs into 2016 and investment in new technologies

• Expected significant milestones and value creating events during this time period

Other

• Included in the Tel-Aviv Biomed Index (TA – Biomed) and also in the Tel-Aviv Technology index

(TA – BlueTech), effective June 15, 2014

• Since then tripled its weight in the TA- Biomed Index

• Analysts coverage initiated recently by Zacks and Merriman Capital

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Page 34: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

BioLight Offers

34

Technologies

Multiple Opportunities in High Growing markets

Unique Business Model

Leading Team

Balanced and focused innovative technologies

Targeting growing markets of multiple billions of dollars

Unique business model conductive to accelerate innovation

World renowned management team and based investors

Page 35: JP Morgan Healthcare Conference January 2015 · Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye Products Market. St. Louis, Mo: Market Scope, November 2011 Companiesandmarkets.com

Heading Towards a Bright Future….

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Thank You!