Corporate Presentation January 2018 Forward-Looking Statements - - PowerPoint PPT Presentation

Corporate Presentation January 2018

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Forward-Looking Statements

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

• bligation 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

• f an offer to subscribe for or buy or sell securities of BioLight.

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• 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 burden of treatment
• Improving compliance, efficacy and safety of treatment
• Offering better diagnosis and personalize treatment
• Optimizing delivery of medications

Overview

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Corporate Information

• Traded on Tel Aviv Stock Exchange (BOLT)
• 3.6 million shares outstanding
• 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

Strategic Investors Strategic Investors

Public (33%) Institutional (10%) Strategic Investors (57%)

• Collection of ocular disorders characterized by progressive loss of visual

field due to optic nerve damage

• Usually involves uncontrolled increase in Inter Ocular Pressure (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 the back of the eye

• Leading cause of permanent vision loss and irreversible blindness

among people aged 60 and older

Targeting Three Major Ophthalmic Conditions

Glaucoma Over 80 million patients worldwide

(~7.3 million in U.S.)

Glaucoma Over 80 million patients worldwide

(~7.3 million in U.S.)

Dry Eye Syndrome 350 million patients worldwide

(50 million in U.S.)

Dry Eye Syndrome 350 million patients worldwide

(50 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.)

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• High need for objective, accurate and easy to use diagnostic tools
• Strong demand for personalized treatment and companion

diagnostics solutions

• High need for new drugs with better tolerability, efficacy with

lower ocular and systemic side effects

• High need for objective, accurate and easy to use diagnostic tools
• Strong demand for personalized treatment and companion

diagnostics solutions

• High need for new drugs with better tolerability, efficacy with

lower ocular and systemic side effects

• Low compliance with prescribed administration of eye drops
• Safer and more precise alternative to the complex and risky

surgeries

• Reduce burden of treatment
• Low compliance with prescribed administration of eye drops
• Safer and more precise alternative to the complex and risky

surgeries

• Reduce burden of treatment

Eye-D Eye-D IOPtiMateTM IOPtiMateTM TeaRxTM TeaRxTM

Glaucoma Glaucoma Dry Eye Dry Eye

OphRx LLC OphRx LLC

• Reduce burden of treatment
• Greater efficacy & safety of medication
• Reduce burden of treatment
• Greater efficacy & safety of medication

AMD AMD

Addressing Several Significant Unmet Medical Needs

6 LIPITEARTM LIPITEARTM

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Our goal is to become a leading ophthalmic company by:

Our Strategy

Developing and expanding a balanced and diverse pipeline of

• phthalmic products

and product candidates Targeting large and growing patient populations with significant unmet needs Maintaining a global diverse network of

• phthalmic specialists

to accelerate knowledge synergies and innovation Pursuing strategic partnership

• pportunities

Establishing a sales force to maximize the commercial potential of our products

Eye-D

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Approximately 50% of glaucoma patients may be non-compliant with their drug therapy administration

Compliance is Key for Treatment Efficacy

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Source: Compliance and adherence in glaucoma management Alan Robin1 and Davinder S Grover

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Eye-D: Product Positioning

No need for daily eye drops Effective for 3-6 months Easy and safe in-office procedure Glaucoma standard

• f care medication,

preservative free Simple design, solid IP

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Our Solution: Eye-D

• 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

• VS-101 Phase 1/2a clinical study in the U.S. as part of 505(b)(2) regulatory

pathway was completed

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Clinical Results Demonstrate Safety & Efficacy

Phase 1/2a protocol:

• Randomized, blinded, controlled
• Compared three different insert elution rates (high, medium & low ) with latanoprost eye drops

(control group)

• 39 subjects, 3 months duration

Day 1 Day 4 Day 84

Demonstrated:

• Proof of concept in humans achieved
• Safety endpoint achieved (no unanticipated findings, no severe adverse events)
• Evidence for efficacious/preferred dose (high dose)
• Supporting information for improving retention in Phase 2b

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Clinical Results Demonstrate Safety & Efficacy

Safety Safety Efficacy Efficacy Supporting Information Supporting Information

• No severe adverse

events were reported

• No conjunctival

scarring, no infections

• >90% of the related

adverse events were mild and transient

• Evidence for

efficacious/preferred dose

• Procedure

standardization:

• Location
• Depth
• Suture
• Inserter
• Etc…

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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 10-25% of newly prescribed patients don’t refill their 2nd

• prescription. ~40-60% of

newly prescribed patients are still taking their meds at end of year 1 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

Source: Market Scope: Charting the course of the eye care market.; Glaucoma Now – Issue No 2, 2013 Clinical Issues: Patient acceptance of ocular implants for Glaucoma Drug Delivery. Quigley HA Glaucoma: What Every Patient Should Know 2011; Friedman DS et al Invest Ophthalmol Vis Sci. 2007; Glaucoma Research Foundation; Market Scope

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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 The procedure is automated, easy to perform providing a safer and more precise alternative to the complex and risky glaucoma surgeries IOPtiMateTM system can be combined with any

• phthalmic microscope

and CLASS is performed as an

• utpatient procedure,

requiring only local anesthesia

The IOPtiMateTM System: Transforming Glaucoma Surgery

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Worldwide Clinical Results Demonstrate High Efficacy & Safety

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

Clinical Trials Overview:

Data from multi-center clinical study performed on 111 patients in 9 sites with 5-years follow up demonstrate:

• Significant long term IOP reduction, stable over time
• Extremely low post operative complication rate
• Long term reduction in medication

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Worldwide Clinical Results Demonstrate High Efficacy & Safety

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

• f 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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Binding Agreement of Investment in and Acquisition of IOPtima

On November 21st 2017, we have entered into a binding agreement for the investment in and the acquisition in stages of IOPtima by the Chengdu Kanghong Pharmaceutical Group Co:

First stage (Q1/2018) $7M investment into IOPtima (pre-money valuation of $30M) Second stage (H2/2018) – acquiring 40% shares from shareholders (valuation of $42M) Third stage (Q2/2019) - acquiring 20% shares from shareholders (valuation of $40- $56M) Forth stage (Q2/2021) - acquiring 20% shares from shareholders (valuation of $40- $56M)

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Designed to enable a wider range of

• phthalmic 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, Canada and Latin America Over 4,000 CLASS procedures already conducted worldwide to-date

IOPtiMateTM System Market Opportunity

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TeaRx™

Dry Eye Syndrome – Significant Unmet Needs

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350 million people worldwide suffer from Dry Eye Syndrome (DES) There is a need for objective, actionable information that physicians can use to understand the root cause of patients complaints, enable personalized treatment, determine the effectiveness of the selected therapy and enable effective follow-up

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TeaRxTM: Transforming Dry Eye Disease-Management

TeaRxTM uses proprietary technology to deliver fast, semi-quantitative, personalized insights to the causes of dry eye:

Collecting and diluting Collecting and diluting A multichannel cassette- testing several biomarkers simultaneously A multichannel cassette- testing several biomarkers simultaneously Scoring based on intensity scale card

• r electronic

reader Scoring based on intensity scale card

• r electronic

reader Friendly output of multivariate algorithm Friendly output of multivariate algorithm

Companion Diagnostics

Specifically tailored biomarker assay development in order to identify responders population for specific MOA

Point of Care

A rapid, simple, office based, semi-quantitative analysis of the tear film

Clinical trials

• Strong correlation with benchmark tests (n=200)
• 86% sensitivity and 87% specificity in identifying DES (n=74)
• Final statistical results from an additional clinical trial (n=82)

are expected Q1 2018

Next steps

• FDA pivotal trial –H2 2018
• Developing TearRx next generation, an electronic reader;

additional biomarkers providing more information to physician

• CE approval H1 2018

Collaboration

• Inserting our companion diagnostics tool into Phase 3 clinical

trial for a DES drug

• Collaborating with a medical device company

Next steps

• Partnering with additional companies to develop specific

algorithms and testing them in the context of clinical trials

TeaRxTM: Novel Platform, Multiple Applications

The TeaRxTM is a novel platform for diagnosing and monitoring Dry Eye Syndrome

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TeaRxTM: Positive Clinical Trials Results

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• In a 200 DES patients study, the TeaRx demonstrated strong correlation with the

widely used benchmark tests (Schirmer, BUT, Staining, Questionnaire)

• In a 74 patients study, the TeaRx showed a 86% sensitivity and 87% specificity in

distinguishing between DES patients and healthy subjects

• A recent study enrolled 82 subjects (41 healthy, 41 with DES). We expect to have the

final statistical results Q1 2018

• FDA Pivotal trial, planned for H2 2018

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TeaRxTM Market Opportunity

Source: MasterEyeAssociates: Definition of Dry Eye Disease; Improving the screening, diagnosis, and treatment of Dry Eye Disease: Expert Recommendations From The 2014 Dry Eye Summit; The economic burden of dry eye disease in the United States: a decision tree analysis.

Existing tests diagnose signs & symptoms and measure

• nly single tear component

Existing tests diagnose signs & symptoms and measure

• nly single tear component

Only 2 drug currently have FDA approval, Restasis, Allergan and Xiidra, Shire. Approx. 12 new drugs in Phase 2/Phase 3 Only 2 drug currently have FDA approval, Restasis, Allergan and Xiidra, Shire. Approx. 12 new drugs in Phase 2/Phase 3 Strong demand for personalized treatment and companion diagnostics solutions Strong demand for personalized treatment and companion diagnostics solutions 350 million people are effected by Dry Eye Syndrome worldwide, of whom 50 million are in the U.S. 350 million people are effected by Dry Eye Syndrome worldwide, of whom 50 million are in the U.S.

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. No gold standard solution No gold standard solution Many therapeutics fail in Phase 3 due to

• Patients selection
• End points definitions

Many therapeutics fail in Phase 3 due to

• Patients selection
• End points definitions

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

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LIPITEAR™

LIPITEARTM : Product Description and Advantages

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• LIPITEAR™ - microemulsion consists of phospholipidis and triglycerides which forms a tear film-like elastic

lipid shield, a class III medical device, certified with a CE.

• LIPITEAR™ is indicated for use for ocular surgery post-operative (e.g. refractive surgery, cataract surgery

and corneal transplant), corneal erosions and Dry eye Syndrome

• LIPITEAR™ is the only product in the eye drop market with a clinically proven indication of enhancement
• f corneal re-epithelization following mechanical, traumatic and surgical epithelial loss
• While other treatments for dry eye are mainly water-based artificial

tears supplemented with variety of viscose substances, LIPITEAR™

• ffers a formula which is the closest to the natural tear film and can

restore both the aqua layer and the protective lipid layer of the tear

• film. This quality results in a prolonged relieving effect of severe dry

eye symptoms

The LIPITEARTM Platform Technology

• The LIPITEARTM is a micro-emulsion technology which consists of a combination of

phospholipids and triglycerides

• Phospholipids advantages:
• Stabilize the tear film
• Maintain the tear film lipid structure organized in an orderly and elastic manner
• Triglycerides advantages:
• Reconstitute the physiological lipid shield, which controls the evaporation of tear film and

its optical properties

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The LIPITEARTM Plus: Platform Technology

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Being a micro-emulsion vehicle, the technology can be used as a drug delivery platform

Its unique pharmaceutical advantages include:

• Longer contact time between the drug and the eye surface,

increasing compliance

• Dual treatment - dry eye treatment + treatment of other ocular

diseases using one eye drop

• Potential slow release capabilities with lipid solubility drugs

Leveraging platform technology capabilities to:

• Formulate advanced pharmaceutical preparations of

new as well as for known drugs

• Formation of an elastic lipid shield above the cornea
• Incorporation of lipophilic drug molecules
• Combination of hydrophilic and lipophilic molecules in one

preparation

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LIPITEARTM Plus: Pipeline Opportunity

Indication OTC/Rx Status

LPC-001 LIPITEAR + nutrition supplement Dry eye OTC Post Pre- Clinical LPC-002 LIPITEAR + new anti

• xidant mechanism

Dry eye and anti-aging processes OTC/Rx Pre-Clinical LPC-003 LIPITEAR new indication Eye protection OTC Post Pre- Clinical LPC-004 LIPITEAR + glaucoma API Dry eye + Glaucoma Rx Pre-Clinical LPC-005 LIPITEAR + new dose API Ocular inflammation Rx Pre-Clinical

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OphRx LLC

An alternative solution to current ocular drug delivery modalities Topical drug delivery for both the front and the back of the eye

OphRx LLC Technology Platform

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Changing the Current Interavitreal Injections Administration To Eye Drops Administration

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• Technology designed for improved molecules’ transport across membranes
• Unique liquid crystals structures allow loading of different kind of molecules and their

release at different target areas

• Tailor-made formulations based on nano-sized, self-assembled liquid droplets and on

modified lyotropic liquid crystalline 2-3 dimensional structures loaded with API molecules that are effectively released upon interaction with target tissues

• Indifferent to hydrophobic/hydrophilic constrains
• Results of preclinical studies showed that the delivery platform enables a safer more

efficient drug delivery for both the front and back of the eye

OphRx LLC Drug Delivery Technology Platform

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• Cost effective technology:

few months project for new molecule formulation

• High safety profile:

Leveraging commercially used APIs All used particles and excipients are FDA-approved

• As easy to prepare as alka seltzer in a glass
• Dedicated IP per molecule

OphRx LLC Drug Delivery Technology Advantages

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Pipeline includes:

• Topical administration for back of the eye indications
• High potency for front of the eye indications

Commercial value:

• Leveraging on commercial APIs
• Short route for new-molecules development
• Enhanced bioavailability
• Reduced side effects
• New claims based on bioavailability and new doses
• Potentially extending patent protection as a new delivery method
• Strong IP per molecule

OphRx LLC Pipeline and Commercial Value

AMD affects 30 to 50 million people worldwide, of whom 15 million are in the U.S. Only 2 drugs currently have FDA approval with limited efficacy and tolerability DES affects 350 million people worldwide, of whom 50 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

• f which stem from current need for frequent intravitreal

injections

OphRx LLC Market Opportunity

DES DES AMD AMD

• Potential for becoming the standard of care demonstrating high

correlation with existing tests and superb diagnosis capabilities

• Third U.S. clinical trial completed awaiting results
• Collaboration with a pharma company for companion diagnostics
• Potential for becoming the standard of care demonstrating high

correlation with existing tests and superb diagnosis capabilities

• Third U.S. clinical trial completed awaiting results
• Collaboration with a pharma company for companion diagnostics
• Phase 1/2a completed
• Safety achieved, evidence for efficacious dose
• Phase 1/2a completed
• Safety achieved, evidence for efficacious dose
• Front of the eye indication in pre-clinical stage
• Back of the eye indication in formulation stage
• Front of the eye indication in pre-clinical stage
• Back of the eye indication in formulation stage

BioLight : Portfolio Status

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• Thousands of successful commercial procedures
• Signed agreement with Kanghong
• Thousands of successful commercial procedures
• Signed agreement with Kanghong
• First commercial product marketed in Europe
• 5 new indications in pre-clinical stage
• First commercial product marketed in Europe
• 5 new indications in pre-clinical stage

Eye-D Eye-D IOPtiMateTM IOPtiMateTM TeaRxTM TeaRxTM

Glaucoma Glaucoma Dry Eye Dry Eye

OphRx LLC OphRx LLC

AMD AMD

LIPITEARTM LIPITEARTM

• CE H1/2018
• FDA Pivotal trial H2/2018, Approval H1/2019
• Global launch H2/2019
• Companion diagnostics collaborations 2018-19
• CE H1/2018
• FDA Pivotal trial H2/2018, Approval H1/2019
• Global launch H2/2019
• Companion diagnostics collaborations 2018-19
• Preparations for Phase 2b
• Preparations for Phase 2b
• Completion of pre-clinical studies
• Completion of pre-clinical studies

BioLight : Next Milestones

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• Collaboration with Kanghong
• Collaboration with Kanghong
• Sales ramp up, launch in additional countries
• R&D process with 5 indications
• Sales ramp up, launch in additional countries
• R&D process with 5 indications

Eye-D Eye-D IOPtiMateTM IOPtiMateTM TeaRxTM TeaRxTM

Glaucoma Glaucoma Dry Eye Dry Eye

OphRx LLC OphRx LLC

AMD AMD

LIPITEARTM LIPITEARTM

Multiple Opportunities in High-Growth Markets Our pipeline addresses a number of significant unmet medical needs of large and growing patient populations Multiple Opportunities in High-Growth Markets Our pipeline addresses a number of significant unmet medical needs of large and growing patient populations Strong Leadership Team Notable combination of world- renowned key shareholders and experienced management team as well as a network of ophthalmic specialists Strong Leadership Team Notable combination of world- renowned key shareholders and experienced management team as well as a network of ophthalmic specialists

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In Summary

Innovative Business Model Multi-product pipeline in various commercialization and development stages that, if successful, are expected to 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 Innovative Business Model Multi-product pipeline in various commercialization and development stages that, if successful, are expected to 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