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Photobiomodulation for Dry Age-Related Macular Degeneration Clark E. Tedford, Ph.D. – CEO

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Page 1: Photobiomodulation for Dry Age-Related Macular Degeneration · Large and Growing Macular Degeneration (AMD) Market •Worldwide prevalence of AMD expected to reach 196Mn by 2020 and

Photobiomodulation for Dry Age-Related Macular Degeneration

Clark E. Tedford, Ph.D. – CEO

Page 2: Photobiomodulation for Dry Age-Related Macular Degeneration · Large and Growing Macular Degeneration (AMD) Market •Worldwide prevalence of AMD expected to reach 196Mn by 2020 and

Significant Opportunity for Value Creation

LARGE MARKET OPPORTUNITY

$XB+ Global Market opportunity for first indication in Age Related Dry AMDEU CE Mark – ApprovedExpected US Clearance: 2021

China Approval: 2021

Excellent safety profile

Creating LEVEL 1 CLINICAL EVIDENCE

High efficacy and durability

Three clinical studies show clinically meaningful benefits

ATTRACTIVE PRODUCT PROFILE

• Non- Invasive• Implant & Injection-Free● Preserves future options● Familiar to

Ophthalmologists● High benefit / low risk

TRANSFORMATIVE POTENTIAL

Novel Technology Addresses Clinical Effectiveness and Payer Opportunity

New procedures for providers with lower cost of care

SurgeryPharma

Valeda Light Delivery System

Confidential - Do Not Distribute 2

Page 3: Photobiomodulation for Dry Age-Related Macular Degeneration · Large and Growing Macular Degeneration (AMD) Market •Worldwide prevalence of AMD expected to reach 196Mn by 2020 and
Page 4: Photobiomodulation for Dry Age-Related Macular Degeneration · Large and Growing Macular Degeneration (AMD) Market •Worldwide prevalence of AMD expected to reach 196Mn by 2020 and

• Europe CE mark approved for commercialization

• LIGHTSITE III, US trial IDE approved

• LIGHTSITE I, A prospective, sham-controlled dry AMD study with positive clinical and pathology outcomes accepted for publication in Retina, a top-tier ophthalmology journal

• Selling instruments to support initial EU launch

• Closed Series A in 2016 and Series B in 2017

• Awarded five grants of ~$4.0M ($2.5M NIH grant awarded in 1Q 2019 to support LIGHTSITE III)

• Robust Intellectual Property position – 10 patents issued and multiple PCT National phase applications

Progress Update

4Confidential - Do Not Distribute

Page 5: Photobiomodulation for Dry Age-Related Macular Degeneration · Large and Growing Macular Degeneration (AMD) Market •Worldwide prevalence of AMD expected to reach 196Mn by 2020 and

Large and Growing Macular Degeneration (AMD) Market

• Worldwide prevalence of AMD expected to reach 196Mn by 2020 and increase to 288Mn by 2040

• U.S. AMD prevalence today 10-11Mn with direct health care costs in North America of $98Bn

• Dry type: No proven treatments

• Two types: § Dry type, affecting 90%§ Wet type, affecting 10%

• Wet type: Intra-ocular anti-VEGF injections§ Costly ($1500-2000 per injection/month)§ Invasive

Anti-VEGF injectionConfidential - Do Not Distribute5

Page 6: Photobiomodulation for Dry Age-Related Macular Degeneration · Large and Growing Macular Degeneration (AMD) Market •Worldwide prevalence of AMD expected to reach 196Mn by 2020 and

Business Model with Multiple Revenue Sources

Confidential - Do Not Distribute 6

Sale/Service + Disposables + Buy to Bill revenue

Page 7: Photobiomodulation for Dry Age-Related Macular Degeneration · Large and Growing Macular Degeneration (AMD) Market •Worldwide prevalence of AMD expected to reach 196Mn by 2020 and

Distribution Partners

7Confidential - Do Not Distribute

Ø Optos/Nikon – UK– France– Germany– Spain– Portugal– Switzerland– Sweden– Finland– Norway– Austria– Netherlands

Ø Miloftalmica– Italy

Ø Direct Distribution– Other approved

EU countries– Australia/NZ

Ø Andrec– Columbia– Ecuador– Guatemala– El Salvador– Dominican

Republic– Costa Rica– Panama– Honduras– Nicaragua

Page 8: Photobiomodulation for Dry Age-Related Macular Degeneration · Large and Growing Macular Degeneration (AMD) Market •Worldwide prevalence of AMD expected to reach 196Mn by 2020 and

CONFIDENTIAL 8

The Effect of PBM on Vision in Early Stage Dry AMD Patients and Correlation to Geographic

Atrophy (GA) with Central Foveola Involvement

• Subset of high PBM responders with 5+ letter improvement

• 11 of 12 (91.6%) did not have foveola GA involvement

• Subset of Low PBM responders with <5 letters improvement

• 10 of 12 (83.3%) had foveola GA involvement

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High Responders

Page 9: Photobiomodulation for Dry Age-Related Macular Degeneration · Large and Growing Macular Degeneration (AMD) Market •Worldwide prevalence of AMD expected to reach 196Mn by 2020 and

12/09/19 Confidential - Do Not Distribute 9

The Effect of PBM on Central Drusen Volume in a LIGHTSITE I Subject

Baseline

Month 12 after 2 PBM sessions

Page 10: Photobiomodulation for Dry Age-Related Macular Degeneration · Large and Growing Macular Degeneration (AMD) Market •Worldwide prevalence of AMD expected to reach 196Mn by 2020 and

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Key Timings and Milestones

Valeda CommercializationH2

2017H1

2018H2

2018H1

2019H2

2019H1

2020H2

2020H1

2021H2

2021

Commercial Manufacturing

NIH AMD Study

EU Study

Regulatory

US Study

EU LIGHTSITE II

LIGHTSITE ICommercial Manufacture Regulatory Stage

CE Mark

Confidential - Do Not Distribute

Valeda Commercial Manufacturing

LIGHTSITE I

EU LIGHTSITE II

OUS/FDA

US LIGHTSITE III

CE Approval

US LIGHTSITE III Study

Page 11: Photobiomodulation for Dry Age-Related Macular Degeneration · Large and Growing Macular Degeneration (AMD) Market •Worldwide prevalence of AMD expected to reach 196Mn by 2020 and

Lumithera Provides Compelling Value Proposition to Stakeholders

Patients• Safely, non-invasively, & effectively addresses a huge unmet medical need – Dry AMD providing a significant improvement in their QOL.

Physicians• Can for the first time provide a therapy to their patients for Dry AMD backed by clinical data and an excellent safety profile• Valeda treatments bring additional procedural volume to their practices without compromising other activitiesCollaborators/Investors• Opportunities for corporate strategic investors and medical schools to work in collaboration with LumiThera to conduct POC test, market validation or strategic business alliance• Large, untapped market opportunity with clinical, technical, & IP leadership positions• Capital efficient business plan with experienced management team and scientific advisors Confidential - Do Not Distribute

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