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| Item 8.01. | Other Events. |
Attached hereto as Exhibit 99.1 and incorporated herein by reference is a corporate update presentation Eyenovia, Inc. intends to use with various investors and analysts.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Eyenovia, Inc. corporate update presentation dated December 2021 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL Document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| EYENOVIA, INC. | |
| Date: December 6, 2021 | /s/ John Gandolfo |
| John Gandolfo | |
| Chief Financial Officer |
Exhibit 99.1
Making it Possible | December 2021
eyenovia.com 1 Except for historical information, all 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, predictions or any other statements relating to our future activities or other future events or conditions, including estimated market opportunities for our product candidates and platform technology. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward - looking statements due to numerous factors discussed from time to time in documents which we file with the U.S. Securities and Exchange Commission. In addition, such statements could be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment (which could still be adversely impacted by COVID - 19 and resulting social distancing), timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our product candidates; the potential impacts of COVID - 19 and related economic disruptions on our supply chain, including the availability of sufficient components and materials used in our product candidates; the potential advantages of our product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; reliance on third parties to develop and commercialize our product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our product candidates; intellectual property risks; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and our competitive position. Any forward - looking statements speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake any obligation to update any forward - looking statements. Forward - Looking Statements
eyenovia.com 2 Eyenovia at a Glance We have designed our microdose array print (MAP Œ ) technology to improve the lives of patients with ophthalmic diseases and disorders • Advanced options for diseases and disorders with no or few existing therapies • Therapies that reduce patient burden due to tolerability, safety or administration issues • Therapies that improve compliance and adherence All potential market opportunities are estimates only 4 Estimate from Delveinsight Presbyopia Report, December 2020 1 IMS, 2015 5 Eyenovia estimate 2 Mixture of public information, IQVIA , Market Scope and estimates – Feb 2020 3 IQVIA, 2019 1 1 2,3 4 5
eyenovia.com LATE - STAGE THERAPEUTICS PIPELINE Mydcombi Œ for mydriasis / pupil dilation: - Under FDA review MicroPine for pediatric progressive myopia: - Phase 3 CHAPERONE study full enrollment expected 2022 MicroLine for presbyopia / improved near vision: - Phase 3 VISION - 1 study successfully completed 2Q 2021 - Second Phase 3 VISION - 2 study completion targeted 1H 2022 3 DEVELOPMENT AND COMMERCIALIZATION PARTNERSHIPS with leading eyecare companies validate technology and provide significant non - dilutive capital. Arctic Vision – MicroPine , MicroLine and MydCombi for Greater China and South Korea Bausch Health – MicroPine in the US and Canada PLATFORM TECHNOLOGY for potential pipeline expansion into further high - value ophthalmic indications Transforming ophthalmology through the development and commercialization of high - value therapeutics based upon our proprietary Optejet ® Microdose Array Print (MAP Œ ) technology CLINICALLY TESTED in multiple Phase 2 and Phase 3 studies Investment Highlights
eyenovia.com 4 Eyenovia Leadership Team Sean Ianchulev, MD, MPH CEO, CMO and Co - Founder John Gandolfo CFO Michael Rowe COO Jennifer Clasby CVP Regulatory, Clinical and Quality Malini Batheja VP, Pharmaceutical R&D Norbert Lowe VP Sales & Marketing Beth Scott VP, Medical Affairs
eyenovia.com Product Candidate Therapeutic Area Phase 3 NDA MydComb i Œ 1 ( trop+phen ) Pharmacologic Mydriasis MicroLine 1 (pilocarpine) Presbyopia MicroPine 3 (atropine) Progressive Myopia 5 Potential pipeline expansion activities leveraging Optejet ® technology are ongoing * Estimate only |. 1 Out - licensed to Arctic Vision in Greater China and South Korea |. 2 Estimate from DelveInsight Presbyopia report; December 2020 3 Out - licensed to Bausch Health in the US and Canada, and Arctic Vision in Greater China and South Korea |. 4 CHAPERONE oversight and costs assumed by Bausch Health Late - Stage Ophthalmic Pipeline for US Registration in Markets Valued Over $12.7 Billion $250M+ US market opportunity* MIST - 1 MIST - 2 ~$7.7B US market opportunity 2 VISION - 2 $5B+ US market opportunity* CHAPERONE 4 VISION - 1
eyenovia.com Potential overexposure to drug and preservatives • Conventional droppers can overdose the eye by as much as 300%+ 1 • Known to cause ocular and systemic side effects 1 Protruding tip may create cross - contamination risk • More than 50% of administrations touch ocular surface 2 More difficult to use with poor compliance • Requires head tilting and aiming which may be compromised in pediatric and elderly populations • No dosage reminders or tracking which may lead to missed doses 6 1 Abelson, M., 2020. The Hows And Whys Of Pharmacokinetics. ReviewofOphthalmology.com; accessed 11/3/20 2 Brown MM, Brown GC, Spaeth GL. Improper topical self - administration of ocular medication among patients with glaucoma. Can J Ophthalmol . 1984 Feb;19(1):2 - 5. PMID: 6608974. Standard Eyedroppers Have Limited Therapeutic Approaches
eyenovia.com 7 Precise, Physiological Dosing Directly coats the cornea with ~80% less exposure to drug and preservative toxicity (based on 8µL dose). 1 Designed to eliminate drug overflow for a more comfortable patient experience. Efficacy Demonstrated statistical and clinical benefit in IOP reduction, pharmacological mydriasis and presbyopia (improvement in near vision) 1,2,5 Safety Low systemic drug absorption and good ocular tolerability. 3,4 Non - protruding nozzle for no - touch spray application, potentially minimizing risk of cross contamination seen with traditional eyedroppers. Ease of Use Horizontal drug delivery means no need to tilt the head back. Demonstrated first - time success with both medical professionals and patients. 2 Compliance and Adherence Can be paired with smart devices to enable dosage reminders and tracking. 1 Abelson, M., 2020. The Hows And Whys Of Pharmacokinetics. ReviewofOphthalmology.com; accessed 11/3/20. 2 Pasquale L. et al., Clinical Ophthalmology 2018 3 Wirta D. et al, Presentation at 2019 ASCRS meeting. 4 Ianchulev T. et al, Therapeutic Delivery 2018. 5 Presented at Eyecelerator , July 2021 Optejet ® - Microdose Array Print (MAP Œ ) Technology Designed for Optimal Drug Delivery
eyenovia.com 8 Optejet ® | Significant Clinical Experience and Validation Seven Phase 2 or Phase 3 clinical trials to date featured in dozens of publications and major meetings including ASCRS, AAO, AAOpt , OIS and EYEcelerator .
eyenovia.com 9 Optejet ® | Clinical Experience and Validation 0 50 100 150 200 250 300 350 PE 2.5% PE 10% PE 10% μ D Plasma PE ( pg /ml) 101.6 316.3 201.5 p = 0.003 p = 0.021 Drugs in traditional eyedroppers can enter systemic blood circulation and may cause significant side effects . 1 Microdose delivery of phenylephrine 10% (PE - µD) was associated with significantly less systemic exposure than traditional eye drops (PE 10%). 2 REDUCED SYSTEMIC LEVELS 1 Muller, M., van der Velpe , N., Jaap, W., van der Cammen , T.; Syncope and falls due to timolol eye drops. BMJ, 2006 April; 332:960 - 961 2 Ianchulev, I. High - precision piezo - ejection ocular microdosing : Phase II study on local and systemic effects of topical phenylephrine. Ther Deliv , 2018 Jan;9(1):17 - 27
eyenovia.com 10 Microdosing a fixed combination of tropicamide - phenylephrine had a superior mydriatic effect compared to either component formulation 1 MICRODOSE EFFICACY 1. Wirta DL, Walters TR, Flynn WJ, Rathi S, Ianchulev T. Mydriasis with micro - array print touch - free tropicamide+phylephrine fixed combination MIST: pooled randomized phase III trials. Ther Deliv ; 2021 2. Data on File, Eyenovia 2021 * * p=0.018 Combined MIST Studies 1,2 0% 20% 40% 60% 80% 100% Time Post Administration (minutes) Percentage of eyes achieving clinically significant pupil diameter of 5mm or greater 20 Min 35 min Optejet ® | Demonstrated Beneftis in Multiple Phase 3 Studies
eyenovia.com 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 0 5 10 15 20 25 Six - Month Daily Treatment Compliance 28 Children Age 6 – 13 YO 1 11 Optejet ® | Impressive Treatment Compliance 1 Data on file with Eyenovia. 2 Naito, 2018; Patel, 1995; Winfield, 1990 3 Matsui, 1997 Real Improvement in Real World Use Average of compliance rates from published ophthalmic studies 2 Average of compliance rates from published pediatric studies 3 This compares favorably to the approximately 50% compliance rate for pediatric medications as a whole, or the 59 – 69% range published for adult topical ophthalmic drug users 2,3 In an ongoing late - stage trial, among the initial group of children using the Optejet once - daily, average compliance was nearly 90% during 6 consecutive months of Optejet use
eyenovia.com 12 Optejet ® Platform | Potential High - Value Opportunities Estimated Gross Margins Based on $100/Month Price 1 Next - Generation Ophthalmic Therapeutics • Eyenovia's microdose therapeutics are regulated as drug - device combination products, with primary mode of action being the drug. Primary oversight is by CDER, with additional input from FDA device reviewers Eyenovia Products Aim to Provide Competitive Pharmaceutical Margins: • All pipeline products are Eyenovia’s own proprietary micro - formulations • Eyenovia currently owns the pharma - economics of the entire prescription value chain • MicroLine has strong potential as a cash - pay cosmeceutical 82% - 94% 1 Estimates for “at scale” (250,000 annual units minimum)
eyenovia.com 13 What is Presbyopia? Etiology • The progressive loss of ability to focus on nearby objects • Non - preventable, age - related hardening of the lens Sources: Mayo Clinic Presbyopia Overview. Wollfsohn et al. Prog Retin Eye Res. Fernandez et al. J Ophthalm . Accessed December 2018 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 and co - morbidities such as cardiovascular conditions, multiple sclerosis, and type 2 diabetes • Drugs associated with premature symptoms include antidepressants, anti - histamines and diuretics Diagnosis • Basic eye exam, with refraction assessment Normal Vision Presbyopic Vision
eyenovia.com 14 Presbyopia | There Exists a Significant Unmet Need 1 Estimate from DelveInsight Presbyopia report; December 2020 18 million people 40 - 55 years of age who never previously needed glasses suffer from presbyopia in the US alone • Majority of presbyopia patients have never had to wear glasses prior to having difficulty with near vision • Having to wear glasses can be an inconvenience and an outward signal of aging • An alternative to glasses may be valuable and more convenient to patients • Eyenovia’s MicroLine is intended to be a companion product to spectacles, not a replacement • MicroLine provides freedom to use the product as needed A 7.7 billion dollar 1 addressable market
eyenovia.com 15 Why Pilocarpine? A well - known and established drug Pilocarpine has been demonstrated to constrict the pupil of the eye and create a “pinhole” effect that increases the depth of field . Onset 10 - 30 minutes, with duration of action 4 - 8 hours ‒ The most frequently reported adverse reactions occurring in ≥ 5 % of patients in the pilocarpine 2% populations were: headache/brow ache* , accommodative change, blurred vision, eye irritation, visual impairment (dim, dark, or “jumping” vision), and eye pain. * Microdosing is hypothesized to reduce/eliminate headache Pilocarpine estimates based on presentations at 2021 ASCRS
eyenovia.com 16 MicroLine Product Profile Effective at restoring functional vision, such as the ability to read a menu or cell phone Ability to use “as needed” without chronic dosing Rapid onset of action Easy to administer Comfortable instillation with low incidence of brow or headache to drive patient satisfaction and re - use
eyenovia.com 17 VISION - 1 Study Design • Phase 3, double - masked, placebo - controlled, cross - over superiority trial – Microdosed pilocarpine 1%, 2% and placebo ophthalmic sprays • Primary endpoint: mesopic high - contrast binocular DCNVA gain at 120 minutes post - treatment – Analyzed separately for 2 cohorts: baseline DCNVA < 0.6 logMAR and ≥ 0.6 logMAR • Study time period: December 2020 – March 2021 VISION 1 Screening: Age 40 – 60 with Presbyopia Randomized to Treatment (N=84) 1% pilocarpine 2% pilocarpine Placebo
eyenovia.com Key Safety Outcomes All AEs were Transient in Nature 1 Resolved by 3 hours post - dose 2 Cohort of subjects with baseline DCNVA < 0.6 logMAR MicroLine Placebo Moderate Hyperemia 1 2% 0% Instillation Discomfort 2% 0% Brow ache 2% 0% 0 50 100 Upon Instillation 30 minutes post dose Patient Comfort Assessment Placebo MicroLine Very Little Discomfort Quite a bit of Discomfort 1 o Outcome > 3 - line gain OR 7.7 p - value<0.05 Patients Report seeing improvement 71% Exit survey: Percent reporting significant improvement in near vision 2 VISION - 1 Met Primary Endpoint Formulation is Well - Tolerated and Comfortable 18
eyenovia.com 19 Post - Study Survey Indicates Strong Preference for MicroLine In a separate study among 100 presbyopic patients and 100 optometrists . . . x Most likely users were between 40 and 55 years old in the top half of household incomes x A price of approximately $30 - $35 a month is not an issue for the vast majority of potential users x Four hour duration of action is appropriate x Lack of side effects, especially headache, was deemed “very important”
eyenovia.com 20 VISION - 2 Study Design VISION 2 Screening: Age 40 – 55 With Presbyopia Patients Randomized (N=~139) MicroLine Dose 1 (2% pilocarpine) Placebo Topline data anticipated 1H 2022 » Phase 3 double - masked, placebo - controlled, cross - over superiority trial » microdosed pilocarpine 2% and placebo ophthalmic sprays » Primary endpoint: improvement in mesopic distance corrected near visual acuity 2 hours post - treatment » First patient enrolled November 4, 2021
eyenovia.com 21 • Back - of - the - eye disease • Mostly begins in early childhood, with a genetic link to myopic parents 1 • Pathologic elongation of sclera/retina which can lead to significant morbidity and visual sequelae 2 • Retinal detachment • Myopic retinopathy • Vision loss • Quality of life • Currently, no FDA - approved drug therapies to slow myopia progression • Atropine may slow myopia progression by 60% or more 3 1 Jones LA, Sinnott LT, Mutti DO, Mitchell GL, Moeschberger ML, Zadnik K. Parental history of myopia, sports and outdoor activities, and future myopia. Invest Ophthalmol Vis Sci. 2007 Aug;48(8):3524 - 32. 2 Eye and Contact Lens. 2004; 30 3 Chia A, Chua WH, Cheung YB, et al. Atropine for the treatment of childhood Myopia: Safety and efficacy of 0.5%, 0.1%, and 0.0 1% doses (Atropine for the Treatment of Myopia 2). Ophthalmology 2012;119:347 - 354 4 Theophanous C. Myopia Prevalence and Risk Factors in Children. Clinical Ophthalmology. December 2018. U.S. Census Bureau, Cur re nt Population Survey, Annual Social and Economic Supplement, 2019. Affects ~25M children in the US alone, with ~5M considered to be at high risk 4 Progressive Myopia
eyenovia.com Current treatment options for myopia include: – Eyeglasses – Contact Lenses – Orthokeratology – Atropine Atropine 0.01% must be compounded by a specialty pharmacy and is not approved by the FDA for myopia control. It is not covered by insurance and can cost $100 per bottle for a 3 - month supply. Significant variability in the efficacy and side effect profile of the same concentration of atropine across different studies. Patient medical insurance does not typically cover myopia clinic visits or treatment. 22 Standard of Care
eyenovia.com 23 Chaperone Study Design CHAPERONE Screening: Age 3 - 12 With Pediatric Myopia Patients Randomized (N=~420) MicroPine Dose 1 (0.1% atropine) Placebo MicroPine Dose 1 (0.01% atropine) 36mo 12mo *Strategic partnership with Bausch Health for the development and commercialization of MicroPine Enrollment completion expected Q4 2022* Chaperone Study - Single Phase III Trial initiated in June 2019. Primary Endpoint: Proportion of subjects with <0.5 diopter change in refractive error (myopia progression) from baseline through 36 months. Patients are then re - randomized to the same or an alternative treatment arm and followed for an additional 12 months.
eyenovia.com 24 MydCombi for Mydriasis 1 $200M annual sales of pharmaceutical mydriatic products used during 100M office - based exams ($2 * 100M) + $50M of single bottle mydriatic agents used cataract replacement surgery ($12.5 x 4M) Pharmacologic mydriasis (pupil dilation) is part of the comprehensive eye exam • Estimated 100 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 • An estimated $250 million US market opportunity 1 Places technology at the initial point - of - care with prescribers (ophthalmologists and optometrists) No direct contact increases patient safety by reducing potential cross contamination associated with the use of shared dilating drops in OD/OPH offices No anticipated reimbursement hurdles; expect to sell directly to ophthalmology and optometry practices Able to commercialize efficiently with a small, targeted sales force Now being reviewed as as drug - device combination product
eyenovia.com 25 MydCombi Πamong the first drug - device combination products for pupil dilation If approved, the only fixed combination of the two leading mydriatic medications in the US Administered with the push of a button, saving up to ten minutes of technician time 1 Touch - free, comfortable application with fewer than 1% of patients experiencing stinging discomfort 2 Lower drug and preservative exposure, including systemic absorption of phenylephrine, which can be problematic in hypertensive patients 2,3 Reliable in numerous patient practices. More than 9 out of 10 patients achieved clinically significant mydriasis at 35 minutes post - dosage 2 1 Denion E. et al, A 5 - Minute Interval between Two Dilating Eye Drops Increases Their Effect. Optom Vis Sci. 2017 Aug 2 Wirta , D. Presented at ASCRS Annual Meeting, 2019, San Diego CA 3 Abelson, M., 2020. The Hows And Whys Of Pharmacokinetics. ReviewofOphthalmology.com; accessed 11/3/20
eyenovia.com 26 MydCombi has a Superior Mydriatic Effect vs. Single Agents Presented by S. Rathi et al, American Academy of Optometry Annual Meeting, 2020 p=0.0183 Prompt Mydriasis Mydriasis >5mm achieved in 88% of patients at 20 minutes, without the delay of instilling multiple drops Superior Efficacy MydCombi achieved superior efficacy over single - agent components Office & Surgical Use Mydriasis >6 mm achieved in >93% of patients at 35 minutes post - dosage which is clinically meaningful for both office retinal exam and surgical dilation In the MIST - 1 and MIST - 2 studies, adverse events were infrequent and generally mild with none over 5% in incidence.
eyenovia.com 11 FTE for $2.2 million Calling on large group practices in largest population centers for 50% reach at launch Sales Team 100 FTE for $20.0 million Calling on 18,000 doctors across the US for 80% reach at launch Not needed. Product is a diagnostic bought by the practice. Managed Care Group 8 FTE for $1.6 million Often delay of up to 1 year to obtain formulary access. $2.0 million Glossy pieces and interactive programs are not needed. Key Account People will train and leave a sample for evaluation. Promotion $10.0 million Dinner meetings, large convention booths, investigational grants, advertising, lunch and learns. Total: ~$4.2 million Total: ~$31.6 million 27 Note: All figures above are estimates Big Eye Pharma MydCombi Launch Expenses: A Fraction of a Typical Ophthalmic Drug Launch
eyenovia.com Validating partnership for the development and commercialization of MydCombi Π, MicroPine and MicroLine 28 Strategic Partnerships to Potentially Extend Commercial Reach Upfront payment: $4M Potential milestone payments and reimbursed development costs: $41.75M Commercial supply terms or royalties: mid - single digits Territory: Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea 1 Min Chen, 2018 2 Theophanous C. Myopia Prevalence and Risk Factors in Children. Clinical Ophthalmology. December 2018. 3 U.S. Census Bureau, Current Population Survey, Annual Social and Economic Supplement, 2019. Impacted population estimated at approx. more than 8x the US 1
eyenovia.com Strategic partnership for the development and commercialization of MicroPine 29 Strategic Partnerships to Potentially Extend Commercial Reach Upfront payment: $10M Potential milestone payments and reimbursed development costs: $50M Reimbursed development costs associated with Phase 3 CHAPERONE trial to begin immediately US impacted population with high myopia estimated at approx. 3M 2,3 Royalties on gross profit: mid - single digit to mid - teen percentages Territory: US and Canada 1 Min Chen, 2018 2 Theophanous C. Myopia Prevalence and Risk Factors in Children. Clinical Ophthalmology. December 2018. 3 U.S. Census Bureau, Current Population Survey, Annual Social and Economic Supplement, 2019.
eyenovia.com 30 Available Licensing Opportunities MydCombi MicroLine MydCombi MicroLine MicroPine Canada United States Central America South America Europe Australia New Zealand Africa Russia Middle East Currently under license for all products TERRITORY AVAILABILITY
eyenovia.com 31 Intellectual Property Technology that has Multiple Layers of IP, Clinical and Regulatory Protection 13 U.S. Patents Issued 84 . O.U.S. Patents Issued Volume delivered, method of delivery, speed of delivery, data capture Various patent coverage in effect until late 2031 Provisional patents filed to bring protection through 2040
eyenovia.com 32 Nasdaq: EYEN Common Shares Outstanding 26.0M Equity Grants Outstanding Under Stock Plans 4.3M Warrants 1.2M Fully Diluted Shares 31.5M Cash $21.4M Debt $7.3M All figures as of September 30, 2021 Financial Snapshot
eyenovia.com Board of Directors 33 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 Managing Director of GHIF venture fund and Co - Founder of Eyenovia General partner of Hatteras Venture Partners Kenneth Lee Jr. Board Member Managing Director, Equity Capital Markets at Suntrust Robinson Humphrey Charles Mather IV Board Member CEO, Zentalis Pharmaceuticals, Inc. Dr. Anthony Sun Board Member CEO, CMO and Co - Founder of Eyenovia Dr. Sean Ianchulev Board Member Ophthalmologist - in - Chief Wills Eye Hospital Dr. Julia Haller Board Member