Corporate Presentation January 2016 Forward-Looking Statements - - PowerPoint PPT Presentation

Corporate Presentation January 2016

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. Bio Light 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. Bio Light 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. Bio Light expressly disclaims any and all liability which may be based on such information, errors therein

• r 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 Bio Light.

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Forward-Looking Statements

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• Emerging global ophthalmic company
• Focused on discovery, development and commercialization of products

which target ophthalmic conditions including:

• Glaucoma
• Dry eye syndrome (DES)
• Age-related macular degeneration (AMD)
• Products are designed to address a number of significant unmet medical

needs by:

• Reducing patient non-compliance with drug therapy administration
• Improving efficacy and safety of treatment
• Offering better diagnosis
• Optimizing delivery of medications

Overview

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Strategic Investors Strategic Investors

Corporate and Financial Summary

• Traded on Tel Aviv Stock Exchange (BOLT) and on OTCQX (BLGTY)
• 65.2 million shares outstanding; 87.8 million fully diluted
• Backed by strategic investors with significant life sciences experience
• Israel Makov, former President & CEO of Teva Pharma
• Dilip Shanghvi, founder and managing director of Sun

Pharma, India’s largest pharmaceutical company by market cap

• Dan Oren, founder, President & CEO of Dexcel Pharma,

the 2nd largest pharmaceutical manufacturer in Israel

• Rock One, Hong Kong based company specialized in

the biomed and high-tech industries

Public (29%) Institutional (16%) Strategic Investors (55%)

• Collection of ocular disorders characterized by progressive

loss of visual field due to optic nerve damage

• Usually involves uncontrolled increase in IOP
• Can lead to progressive, irreversible vision loss and blindness
• Chronic disease that requires ongoing, lifelong treatment
• Multi-factorial disorder of the ocular surface
• Eye produces insufficient tears or tears with abnormal

composition

• Results in discomfort and visual disturbance
• In most severe forms, can lead to permanent vision loss
• Chronic, degenerative eye disease that affects the macula,

the central part of the retina, at back of the eye

• Leading cause of permanent vision loss and irreversible

blindness among people aged 50 and older

Targeting Three Major Ophthalmic Conditions

Glaucoma

78 million patients worldwide (10 million in U.S.)

Glaucoma

78 million patients worldwide (10 million in U.S.)

DES

100 million patients worldwide (20 – 40 million in U.S.)

DES

100 million patients worldwide (20 – 40 million in U.S.)

AMD

30 – 50 million patients worldwide (15 million in U.S.)

AMD

30 – 50 million patients worldwide (15 million in U.S.) 5

• Lack of objective, quantitative or semi-quantitative

tests to:

• Accurately detect DES / identify its causes
• Assist in generating personalized therapy
• Monitor the effectiveness of selected therapy
• Lack of objective, quantitative or semi-quantitative

tests to:

• Accurately detect DES / identify its causes
• Assist in generating personalized therapy
• Monitor the effectiveness of selected therapy
• Non-compliance with prescribed administration of

eye drops

• Safer and more precise alternative to the complex

and risky surgeries

• Non-compliance with prescribed administration of

eye drops

• Safer and more precise alternative to the complex

and risky surgeries

Eye-DTM Eye-DTM IOPtiMateTM IOPtiMateTM TeaRxTM TeaRxTM

Glaucoma Glaucoma Dry Eye Dry Eye

OphRx LLC OphRx LLC

• Increased patient compliance with therapy
• Greater efficacy of medication and safety
• Increased patient compliance with therapy
• Greater efficacy of medication and safety

AMD AMD Addressing Several Significant Unmet Medical Needs

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Developing and expanding a balanced and diverse pipeline of

• phthalmic products and product candidates

Maintaining a global, diverse network of ophthalmic specialists to accelerate knowledge synergies and innovation Establishing a sales force to maximize the commercial potential of our products Targeting large and growing patient populations with significant unmet needs

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Pursuing strategic partnership opportunities Our goal is to become a leading global ophthalmic company by:

Our Strategy

Eye-D™

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Fewer than 25%

• f experienced

patients correctly administer eye drops Compliance is Key for Treatment Efficacy

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Our Solution: Eye-DTM

• Platform technology that enables a controlled release of ophthalmic

medications over time through a subconjunctival insert

• First product candidate (VS-101), contains latanoprost, the most

prescribed glaucoma medication worldwide

• Safe and simple in-office procedure
• VS-101 is currently in a Phase 1/2a clinical study in the U.S. as part of

505(b)(2) regulatory pathway (results expected by H2-2016)

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Global glaucoma pharmaceutical market is expected to increase from approximately $4.7 billion in 2015 to nearly $6.1 billion in 2020 The most robust growth in glaucoma pharmaceutical sales is expected to occur in the emerging markets of China, India and Latin America Nearly 75% of the patients indicate willingness to undergo a subconjunctival injection, while over 85% of patients willing to accept higher costs than eye drops for such treatments

Eye-D VS-101 Market Opportunity

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IOPtiMate™

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Laser is a Magic Word in Ophthalmology

Refractive 1983 - Excimer Glaucoma 2015 - IOPtiMateTM Cataract 2009 - Laser Capsulotomy

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Novel surgical system that enables a non-penetrating, CO2 laser-assisted procedure known as CLASS (CO2 Laser- Assisted Sclerotomy Surgery) to reduce elevated IOP CLASS is an automated, easy to perform procedure which requires only a short learning curve and provides a safer and more precise alternative to the complex and risky glaucoma surgeries that are currently available IOPtiMateTM system can be combined with any ophthalmic microscope and CLASS is performed as an outpatient procedure, requiring only local anesthesia

The IOPtiMateTM System

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Worldwide Clinical Results Demonstrate High Efficacy & Safety

Clinical Trials Overview:

• Significant long term IOP reduction,

• Extremely low post operative

• Long term reduction in medication
• More than 1,500 clinical procedures

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

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

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Designed to enable a wider range of ophthalmic surgeons to perform glaucoma surgeries Has the potential to replace existing glaucoma medical procedures driving an increase in the quantity and quality of glaucoma surgeries worldwide Currently being marketed primarily in Asia (mainly China, the world’s leading country with glaucoma diagnosed patients), Europe and South America Over 1,500 CLASS procedures already conducted worldwide to-date

IOPtiMateTM System Market Opportunity

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TeaRx™

Current DES Diagnosis Paradigm is Lacking

• DES is a complex syndrome
• Various pathophysiologies
• Common clinical pathway
• Many therapeutic development

failures

• Patient selection?
• Sub-grouping with limited

diagnostic tools?

• Current diagnostic tools are

confined to single parameter testing

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Enables in-office diagnosis, companion diagnostics and monitoring of DES therapy + drug development/research applications

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Multi-assay, objective, semi-quantitative analysis of tear film in order to identify one

• r more underlying causes of DES

TeaRxTM: Breakthrough Diagnosis Solution for DES

• First human clinical trial in the U.S. - 200 subjects
• Significant correlation between TeaRxTM ‘s assays and the existing

benchmark tests

• Second human clinical trial in the U.S. assessed the effectiveness of

the TeaRxTMtest in evaluating tears of healthy subjects as well as of patients suffering from dry eye syndrome (“DES”) – 78 subjects

• Sensitivity of 86% and specificity of 87% and a positive predictive value

(PPV) of 87%

• Demonstrated added value related to the multi-assay approach providing

a more robust diagnostic output

• Supports unique potential for identifying DES sub-populations based on

cause(s) of syndrome

TeaRxTM: Positive Clinical Trials Results

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Strong demand for personalized treatment and companion diagnostics solutions Strong demand for personalized treatment and companion diagnostics solutions Current tests cannot determine cause(s)

• f this multi-factorial syndrome

Current tests cannot determine cause(s)

• f this multi-factorial syndrome

More than 100 million people are effected by DES worldwide, of whom 20- 40 million in the U.S. More than 100 million people are effected by DES worldwide, of whom 20- 40 million in the U.S.

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Diagnostics Treatment

One of the leading causes of patients’ visits to eye care practitioners in the U.S. One of the leading causes of patients’ visits to eye care practitioners in the U.S. Overall estimated annual burden for the U.S. health-care system of approximately $4 billion Overall estimated annual burden for the U.S. health-care system of approximately $4 billion Existing reimbursement codes Existing reimbursement codes

TeaRxTM Market Opportunity

Potential to move clinical development end-points away from subjective signs and symptoms toward objective measurements Potential to move clinical development end-points away from subjective signs and symptoms toward objective measurements

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OphRx LLC

An alternative solution to current ocular drug delivery modalities

Drug delivery using eye drops for both front and back of the eye

OphRx LLC Technology Platform

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• Technology designed for improved molecule

transport across membranes

• Unique crystal liquids structure allows loading of

different kind of molecules and their release in different target areas

• Proven commercial uses in other industries
• Successful demonstration of ocular bioavailability,

enabling front and back of the eye indications

• Currently in preclinical stage of development for

two product candidates:

• OPH-101, an alternative topical treatment to

intravitreal injections for wet AMD

• OPH-100, as treatment for DES

The Platform Structure (Illustration) The Platform Structure (Illustration)

OphRx LLC Technology Platform

AMD affects 30 to 50 million people worldwide, of whom 15 million are in the U.S. Only 1 drug currently has FDA approval with limited efficacy and tolerability DES affects more than 100 million people worldwide, of whom 20-40 million in the U.S. 600,000 new cases diagnosed globally each year, of which

• ver 200,000 are in the U.S

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A number of significant unmet needs in treating AMD, many of which stem from current need for frequent intravitreal injections

OphRx LLC Market Opportunity

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Current Portfolio Status

IOPtiMateTM

• First sales in HK, Hungary, Romania, Poland, Peru and Portugal
• Additional distribution agreements and regulatory approvals in selected

countries worldwide

• Joint-financing agreement with two Asia-based VCs representing a post-

round valuation of approximately $21 million

• Pre-submission for FDA de novo regulatory pathway in 2016

Eye-DTM VS -101

• 505(b)(2) phase 1/2a to be concluded in 2016

TeaRxTM

• Strategic collaboration with ORA
• Positive results from two clinical trials demonstrated robust diagnostic
• utput
• Pre-submission for FDA 510 (k) regulatory pathway in 2016

OphRx LLC

• OPH 100 – DES pre-clinical results of BA, tolerability and efficacy in 2016
• OPH 101 - AMD pre-clinical results of BA, tolerability and efficacy in 2016

Multiple Opportunities in High-Growth Markets Multiple Opportunities in High-Growth Markets Unique Business Model Unique Business Model Strong Leadership Team Strong Leadership Team

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Unique combination of world-renowned key shareholders, experienced management team and network of ophthalmic specialists Our pipeline addresses a number of significant unmet medical needs of large and growing patient populations Multi-product pipeline in various commercialization and development stages that will result in multiple value inflection events, lead to collaborations with other third parties, reduce risk to our business associated with a particular product or product candidate and increase return on investment

In Summary