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Company Presentation June 2015

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Page 1: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

Company Presentation

June 2015

Page 2: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

This presentation has been prepared for informational purposes only and does not purport to be all-inclusive. We have based all 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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Forward-Looking Statements

Page 3: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

Rich product portfolio at various clinical and commercial stages

Proven management team with strong track record of success,

backed by strategic investors with significant biopharmaceutical

experience

Unique model encouraging knowledge and cost synergies

Strong news flow will provide multiple value inflection events

through 2016 and beyond

Targeting large and growing patient populations with significant

unmet medical needs

3

Company Highlights

Page 4: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

Corporate and Financial Summary

Israel Makov, former President & CEO of Teva Pharmaceuticals

Dilip Shanghvi, founder and managing director of Sun Pharma,

India’s largest pharmaceutical company by market cap1

Dan Oren, founder, President & CEO of Dexcel Pharma, the 2nd

largest pharmaceutical manufacturer in Israel2

Rock One, Hong Kong based company specialized in the

biomed and high-tech industries

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Str

ate

gic

In

vest

ors

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

644.7 million shares outstanding; 872.2 million fully diluted

Backed by strategic investors with significant biopharmaceutical experience:

Institutional (16%)

Public (29%)

Strategic Investors (55%)

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

Page 5: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

Ophthalmic Therapeutics &

Diagnostics

BioLight - Current Structure

5

Cancer Diagnostics

46%* 100%

* Controlling ownership

Page 6: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

XLVision Ophthalmic Portfolio

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Page 7: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

More than 100M patients worldwide = ~$3B market

Accounts for 40% of all visits to U.S. eye doctors

Unmet medical needs:

Diagnostics, personalized treatments & treatment monitoring

~70M patients worldwide = ~$5B market

Unmet medical needs:

Low compliance to eye drops

Significant side effects with existing treatments

Eye-D®

IOPtiMateTM

TeaRxTM

Ophthalmic Portfolio - Targeting Large and Growing Patient Populations

Gla

uco

ma

Dry

Eye

OphRx

More than 30M patients worldwide = ~$3B market

Unmet medical need:

Current therapies require frequent intravitreal injections

AM

D

7

Page 8: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

Eye-D®

Controlled Release Drug-Delivery Insert Platform

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Page 9: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

A broad platform technology

IP includes strong protection for chemical structures for entire PGA Class and a method patent for elution profile

Long-term controlled release 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® - A Novel Rx Eye Insert Solution

Thickness 300 m 3 mm x 7.5 mm

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Humans: invisible below lower eye lid

Simple in-office procedure

The Solution

Page 10: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

Eye-D® - Market Potential

10 Source: American Glaucoma Society Glaucoma Research Foundation

Additional potential:

Expand to rest of the world

Additional applications for drug delivery beyond Glaucoma - anterior & posterior segments

Additional applications beyond ocular uses

~10M Glaucoma patients in the U.S.

~3M diagnosed

patients

~2M patients prescribed

with latanoprost

~1M patients getting other

treatments (drugs &

surgeries)

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

Annual Eye-D® insert price estimated at $800 per year

Page 11: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

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Eye-D® - Latanoprost Insert Development Status

A 505(b)(2) regulatory approval pathway

Phase 1/2a clinical trial to evaluate safety and

efficacy of 3 doses of latanoprost ongoing across

the U.S.

• 3 months insert duration

• 3 arms, 1 control arm (latanoprost eye drops)

• Investigator masked for dose

• Up to 68 patients in 7 centers in the U.S.

Results expected in H1/16

Page 12: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

IOPtiMate™ Non-Penetrating Medical Procedure for Glaucoma

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Page 13: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

Refractive: 1983 - IntraLasik

Glaucoma: The IOPtiMateTM

Cataract: 2009 - Laser Capsulotomy

Laser - A Magic Word in Ophthalmology

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Page 14: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

The IOPtiMateTM Procedure - High Efficacy and Safety

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The IOPtiMateTM system

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 the current complex and highly risky

glaucoma surgery into a safe and precise laser-assisted

procedure

Page 15: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

Worldwide Clinical Results

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 7

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

Page 16: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

$1.5B global market potential

IOPtiMateTM Market Potential

16 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 globally

~0.5M trabeculectomy

& shunts procedures

~1M trabeculoplasty

procedures

Estimated reimbursement of $1,000

Page 17: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

More than 1,500 clinical procedures

performed globally to-date

4 Regulatory approvals in Europe, China,

Mexico and Israel and additional in process

Current commercial focus on Asia and EU markets

Distribution agreements in place in multiple locations - commercial sales began in Q4/14

20 Systems installed worldwide

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IOPtiMateTM Current Status

Page 18: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

TeaRxTM

Multi-Parameter Diagnostic Test

for Dry Eye Syndrome

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Page 19: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

The TeaRxTM 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 (DES)

TeaRxTM - A Breakthrough Diagnosis Solution for Dry Eye Syndrome

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Advantages:

Multiple parameters

Low-cost & easy to use

Easy reading

Sub-groups identification

Page 20: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

Only 1 drug currently has FDA approval (Restasis,

Allergan); approx. 12 new drugs in Phase II/Phase III

development

Strong demand for personalized treatment and

companion diagnostics solutions

Current diagnostics (e.g. osmolarity) cannot

determine cause of this multi-factorial syndrome

More than 100 million people suffer from moderate-

to-severe DES worldwide, 40 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 - Market Potential

Diagnostics Treatment

The reason for 40% of all visits to U.S. eye doctors

~300 million people globally suffer from one or more

DES symptoms

Existing reimbursement codes

Page 21: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

TeaRxTM - Development & Commercial Status

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Completed 1st human clinical trial in the U.S.

Significant correlation of benchmark tests to the TeaRxTM parameters

Ongoing 2nd clinical trial to assess the effectiveness of the tests in

tears of healthy subjects as well as patients with severe DES

Study results are expected in H2/2015

Rich patent portfolio

Existing reimbursement codes

Collaboration with Ora Inc.

Page 22: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

OphRx Novel Lyotropic Delivery Platform

for Ocular Uses

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Page 23: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

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Technology is based on crystal liquid vehicles for the improvement of molecule transport across membranes

Unique crystal liquids structure allows loading of different kind of molecules and release them in different target areas

Proven successful commercial uses in other industries

Successful demonstration of ocular bioavailability for the technology has been performed

OphRx Technology Platform - Lyotropic Liquid Crystals (LLC)

The Platform Structure

(Illustration)

Page 24: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

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Serves as a technology platform for transporting drugs across membranes in different areas within the eye

Controlled release drugs capabilities

Can solubilize very large loads of therapeutic

Safe to use (GRAS ingredients)

Protecting unstable drugs

Clear and stable formulations

OphRx Potential Advantages for Ophthalmic Uses

Page 25: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

70 Million patients,

$5 Billion market

Glaucoma

100 Million patients,

$3 Billion market

Dry Eye Syndrome

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30 Million patients,

$3 Billion market

Age-Related Macular Degeneration (AMD)

OphRx - Market Potential

Page 26: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

IOPtiMateTM

Ophthalmic Portfolio Value Inflection Events Through 2016

26

• Phase 1/2a clinical trial results (H1/2016)

• Preparation for Phase 2/b (H2/2016)

• Expanding IOPtiMateTM sales

• Securing regulatory approvals in Canada, Taiwan and additional countries

• Regulatory process in the U.S.

Eye-D®

• Clinical trial results (H2/2015)

• Industrialization (H1/2016)

• Regulatory process in the U.S. (H1/2016)

TeaRxTM

OphRx • Pre-Clinical results (H1/2016)

• Preparation for human trials to (start in H1/2017)

Page 27: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

Micromedic

Cancer Diagnostics Portfolio

Page 28: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

Rich Portfolio Focused on Market Needs

Screening Monitoring Diagnosis Personalized

Treatment

Multiple Myeloma

Cervical Cancer

Bladder Cancer

Other Indications

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POC Projects

CellDetect®

Bladder CellDetect®

Bladder

CellDetect®

Cervical

BRONJ

BRCA Brain Metastasis

CellDetect®

CTC CellDetect®

Lung CellDetect®

Prostate

Page 29: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

A powerful oncology histochemical diagnosis platform

targeting multiple applications

The CellDetect® Technology Overview

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PAP Test CellDetect® Test

Proprietary assay containing unique extract and dyes

Only assay allowing color discrimination between Normal and

Neoplastic cells alongside morphological examination

Standard processes utilized in pathology laboratories

Applicable for liquid-based and conventional cytology

The CellDetect® technology allows the same number of pathologists to perform significantly higher number of tests!

Page 30: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

Sensitivity Specificity

76-85% 90-95% CellDetect®

55-79% 79-97% PAP Test

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 & commercial activity in India

Cervical Cancer Screening - Unmet Need in Emerging Markets

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Source: Globocan 2012 Diagn Cytopathol. 2012 40(12):1054-61 (Epub 2011 May 31) Obstet Gynecol 2008;111:167–77

The CellDetect® Staining was found to be more accurate and cost effective then the HPV test

Page 31: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

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

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

• Over 1.5M annual monitoring tests currently performed in the US alone and around 4 million annual cystoscopies performed in the U.S.

• Excellent multi-center clinical trial results

• Awaiting CE approval

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

Bladder Cancer Detection - A large Market Opportunity

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7th most common cancer in men world wide and among most expensive to treat

No. of cases Performance

96 84.4% Sensitivity

121 82.7% Specificity

The CellDetect® staining was found to be more easy to use, cost effective and accurate in both early and later stage tumors than other non-invasive tests

Page 32: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

CellDetect® Cervical

Cancer Diagnostics Value Inflection Events Through 2016

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• Awaiting CE approval

• Initiate sales in Europe (H1/2016)

• Regulatory process in the U.S. (H1/2016)

• Expending sales in China

• Initiate sales in India (H2/2015)

• Additional markets penetration

CellDetect® Bladder

• Clinical trial in multiple myeloma patients results (H2/2015) BRONJ

Others • Seeking for strategic partners

• Completion of CellDetect® POC trials

Page 33: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

In Summary

Page 34: Company Presentation - BioLight · 2017-11-29 · $1.5B global market potential IOPtiMateTM Market Potential 16 Source: Market Scope. 2011 Comprehensive Report on the Global Dry Eye

Leading Team

Multiple Opportunities in High Growth Markets

Unique Business Model

Strong Pipeline

Investment Highlights

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Reduced risk related to diverse portfolio of ground-breaking technologies

Attractive offering targeting large and growing patient populations with significant unmet medical needs

Increased ROI through unique business model conductive to accelerate innovation

Management team and strategic investors with track record of success