Hyperion Defi, Inc. · NASDAQ:HYPD
Hyperion Defi — Eyenovia — Investor Presentation (November 2019)
24 slides from Hyperion Defi's investor presentation, Nov 19, 2019
Slide 1: Making it Possible November 2019
Making it Possible November 2019
Slide 2: Forward-looking statements
Except for historical information, all of the statements, expectations, and assumptions contained in this presentation are forward - looking statements . Forward - looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictio
Slide 3: Eyenovia: Building the Smart Eye Care Company of the Future
Eyenovia: Building the Smart Eye Care Company of the Future • Specialty ophthalmic biopharmaceutical company developing a late stage pipeline of microdose therapeutics in areas of key fro nt and back - of - the - eye indications • Validated microdosing approach through multiple Phase II/III studies
Slide 4: Multiple Late Stage Clinical Assets
3 Multiple Late Stage Clinical Assets Back - of - the - eye Indications Front - of - the - eye Indications Preclinical/Formulation Phase I Phase II Phase III Anticipated 2020 Milestones Micro Pine Reduction of Pediatric Myopia Progression CHAPERONE Enrollment Completion Micro Line Improvement in nea
Slide 5: Significant Clinical Experience and Validation
Reduced Systemic Levels Improved Ocular Tolerability MicroDose Efficacy Microdose delivery of phenylephrine was associated with significantly less systemic exposure (Ianchulev, 2017) Microdosing May Reduce Side Effects 1 Mydriasis with microdose phen - trop fixed combination (Wirta, 2019) 4 Signific
Slide 6: Progressive Myopia: Back-of-the-eye disease affecting ~5M in the U.S.
5 Progressive Myopia: Back - of - the - eye disease affecting ~ 5M in the U.S . (1) Eye and Contact Lens. 2004; 30 (2) Arch Ophthalmol. 2003 Aug;121(8):1141 - 7). (3) Ophthalmology. 2016;123:1036 - 1042 (4) Ophthalmology. 2016;123:391 - 399 • Pathologic elongation of sclera/retina which can lead to
Slide 7: There are no known FDA-approved Pharmaceutical Therapies for Myopia
• Significant unmet need as demonstrated by ATOM1, ATOM2 & LAMP studies • Compounding of atropine in the absence of FDA - approved therapeutic driven by clinical need • Mostly distributed by compounding pharmacies with limited central quality control 6 There are no known FDA - approved Pharmaceutica
Slide 8: Micro Pine for Progressive Myopia
• Micro Pine is Eyenovia’s proprietary piezo - compatible microdose formulation of atropine • One of the first topical therapeutic approaches to prevent a number of back - of - the - eye diseases • Single Phase III CHAPERONE trial initiated in June 2019 • Primary EP: Change in refractive error (myop
Slide 9: Presbyopia: the Progressive Loss of Ability to Focus on Nearby Objects
Etiology • Non - preventable, age - related hardening of the lens Symptoms • Tendency to hold reading material farther away to make the letters clearer • Blurred vision at normal reading distance • Eye strain, headaches after reading or doing close - up work Risk Factors • Age • Medical conditions a
Slide 10: Presbyopia is a Widely Prevalent Vision Correction Issue
• Prevalence expected to increase and affect ~123 million Americans by 2020, representing over 1/3 of United States population; driven by aging population • Nearly everyone experiences some degree of presbyopia after age 40 • Up to 1/3 of presbyopia sufferers are un - managed • Presbyopia is a signi
Slide 11: Pilocarpine: Dual Action Mechanism
• Pilocarpine is a Miotic (cholinergic) and has a clinically established dual action mechanism • Accommodation and extended - depth of focus • Optimized profile through microdose Pilocarpine: Dual Action Mechanism Pin - Hole Effect Improves Near Vision 1 Pilocarpine Topical Near Vision Effect 2 Pilo
Slide 12: Micro Line: Targeted Corneal Horizontal Delivery with Gentle Microdose
Indication • For the improvement in near vision in patients with presbyopia • Provides approximately 3 - 4 hours of near vision with a single microRx spray Program Overview • Two Phase III trials ready for initiation in 2020 Commercial • Estimated addressable population: Adults between 40 - 65 years
Slide 13: Micro Line: Phase III Program
12 Micro Line : Phase III Program • Two double - masked, placebo - controlled, cross - over superiority trials – Phase III (microdosed pilocarpine 1.0%, 2.0% and placebo) • Primary endpoint: binocular distance corrected near visual acuity • Expect both studies to be initiated and completed in 2020 V
Slide 14: Micro Stat for Mydriasis
• Pharmacologic mydriasis is part of the comprehensive eye exam – Estimated 80 million office - based comprehensive and diabetic eye exams and 4 million ophthalmic surgical dilations performed annually in the United States – Essential for diabetic retinopathy, glaucoma and retina disease screening •
Slide 15: Micro Stat Phase III Key Take-Aways
1. Significant, prompt mydriasis achieved with microdose fixed - combination Phen - Trop 2. Micro Stat achieved superior efficacy over single - agent components 3. Mydriasis >6 mm achieved in >93% of patients at 35 minutes post - dose • Clinically meaningful for both office retinal exam and surgical
Slide 16: Optejet: Eyenovia's Unique Technology
• Novel microdosing technology designed for optimal drug delivery – Piezo - print microdosing to increase precision and reduce waste – Approximately 75% less drug and exposure to preservatives (based on 8µL dose) – Designed to eliminate drug overflow for a more comfortable patient experience – Non -
Slide 17: EYN PG21: Patients More Likely to Instill Medication with Optejet
16 EYN PG21: Patients More Likely to Instill Medication with Optejet™ Optejet™ Technician Administration Optejet™ Self Administration Total Evaluable Administrations 150 53 Successful Delivery on First Attempt 95% 88% Touching Ocular Surface 0% 0% *Arch Ophthalmol 2009;127:6:732 - 6; Am J Ophthalmol
Slide 18: Microdosing May Reduce Side Effects
• Conventional eye drops may overdose the ocular surface by as much as 300% 1 - 3 – This potentially can cause significant ocular and systemic side effects 4 • Microdosing has the potential to address these issues by reducing the amount of drug and exposure to preservatives Drops Microdose Microdosi
Slide 19: Eyenovia's Platform Unlocks Pharmaceutical Pipeline Opportunity
Next - Generation Ophthalmic Therapeutics • Eyenovia’s microdose therapeutics follow the 505(b)2 registration pathway and are NOT currently regulated as medical devices or drug - device combinations • FDA considers the Optejet™ to be a container system Eyenovia products aim to provide pharmaceutical
Slide 20: Experienced Leadership Team
Experienced Leadership Team 19 Dr. Sean Ianchulev, MD, MPH CEO, CMO and Co - Founder • Head of ophthalmology research and directed development and FDA approval of Lucentis, most successful ophthalmic drug for Genentech • Iantech founder for cataract device approved by FDA in 2016 and inventor of Int
Slide 21: Board of Directors
Board of Directors Dr. Fred Eshelman Chairman Founder and former CEO of PPDI, founding chairman of Furiex Pharmaceuticals, and founder of Eshelman Ventures Dr. Ernest Mario Board Member Former Chairman and CEO of Reliant Pharmaceuticals, ALZA, and Glaxo Holdings Dr. Curt LaBelle Board Member Managin
Slide 22: Multiple Inflection Points in 2020
21 Multiple Inflection Points in 2020 Micro Pine: Progressive Myopia 2020 Enrollment completion Micro Line: Presbyopia 2020 Phase III trial initiation and completion Micro Stat: Mydriasis 2020 NDA submission
Slide 23: Financials
Financials 22 Nasdaq: EYEN Share Price 1 $2.83 Market Cap (fully diluted) $56M Common Shares Outstanding 2 17.1M Equity Grants Outstanding Under Stock Plans 2 2.3M Fully Diluted Shares 19.4M Cash 3 $18.3M Debt None 1 As of 11/15/19 2 As of 11/8/19 3 As of 9/30/19
Slide 24: Making it Possible November 2019
Making it Possible November 2019