HYPD 8-K
Hyperion Defi, Inc. (HYPD)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 2.02. | Results of Operations and Financial Condition. |
On March 30, 2023, Eyenovia, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal year ended December 31, 2022. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein in its entirety by reference.
The information contained in, or incorporated into, Item 2.02, including the press release attached as Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference to such filing.
| Item 8.01. | Other Events. |
Attached hereto as Exhibit 99.2 and incorporated herein by reference is an updated corporate presentation the Company intends to use with various investors and analysts.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. | Description |
| 99.1 | Eyenovia, Inc. Press Release, dated March 30, 2023. |
| 99.2 | Eyenovia, Inc. Updated Corporate Presentation dated March 2023. |
| 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: March 30, 2023 | /s/ John Gandolfo |
| John Gandolfo | |
| Chief Financial Officer |
Exhibit 99.1
Eyenovia Reports Fourth Quarter 2022 Financial Results and Provides Business Update
Announced FDA acceptance of Mydcombi New Drug Application (NDA) and PDUFA action date of May 8, 2023
Announced positive results from Microline Phase 3 program as a potential treatment for presbyopia and received feedback from the FDA outlining a clear path forward for the program
Entered into co-development agreement with Formosa Pharmaceuticals
Company to host conference call and webcast today, March 30th, at 4:30 pm ET
NEW YORK—March 30, 2023—Eyenovia, Inc. (Nasdaq: EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced its financial and operating results for the fourth quarter and full-year ended December 31, 2022.
Fourth Quarter 2022 and Recent Business Developments
| · | Announced U.S. Food and Drug Administration (FDA) acceptance of the Mydcombi NDA and Prescription Drug User Fee Act (PDUFA) action target date of May 8th, 2023. |
| · | Announced positive results from Microline Phase 3 program as a potential treatment for presbyopia and received encouraging feedback from FDA outlining a clear path forward for the program. |
| · | Entered into a development collaboration agreement with Formosa Pharmaceuticals to combine Eyenovia’s Optejet® dispensing technology with Formosa’s APNT nanoparticle formulation platform for the potential development of new topical therapeutics in high-value ophthalmic indications with significant unmet medical needs. |
| · | Manufacturing facility in Redwood City is operational and producing clinical supply; legacy Reno facility is currently being inspected by the FDA as part of the Mydcombi review process; second facility in Reno anticipated to come online during the third quarter 2023. |
| · | Development partner Arctic Vision continues to enroll patients in its Phase 3 study of Microline (ARVN003) as a potential treatment for presbyopia in China. |
| · | Ended the fourth quarter of 2022 with approximately $22.9 million in total cash and cash equivalents. |
Michael Rowe, Chief Executive Officer, commented, “We continue to make significant progress with our two lead programs, Mydcombi and Microline. Specifically, we are preparing for our May 8th PDUFA date for Mydcombi which, if approved, would validate the Optejet dispensing technology that is core to all of our proprietary and partnered programs, and would transition us to a commercial stage company. We are in the middle of a FDA inspection of our manufacturing facility as part of that review process.”
“Regarding Microline, having completed our VISION 2 study, we recently received feedback from the FDA which outlines a clear path forward for the program. Importantly, the feedback is in line with our expectations, and our development timeline for the program remains unchanged. Presbyopia represents a very significant market opportunity for our company, and the agency’s feedback is very encouraging.”
“Finally, our co-development agreement with Formosa represents an opportunity to significantly expand our pipeline and will serve as a model for any future partnerships. We are in advanced discussions with additional potential partners to leverage the Optejet in high-value indications, and we are optimistic that we will sign one or more partnership agreements this year.”
Fourth Quarter and Full Year 2022 Financial Review
For the fourth quarter of 2022, net loss was approximately $[6.1] million, or $[0.17] per share compared to a net income of approximately $3.0 million, or $0.11 per share, for the fourth quarter of 2021. For the full-year 2022, net loss was approximately $[28.0] million, or $[0.83] per share on approximately 33.6 million weighted average shares outstanding, and this compares to a net loss of approximately $[12.8] million, or $[0.49] per share, for the full year 2021 on approximately 26.3 million weighted average shares outstanding.
Research and development expenses totaled approximately $2.2 million for the fourth quarter of 2022 as compared to $3.3 million for the fourth quarter of 2021, a decrease of approximately 33%. For the full-year 2022, research and development expenses decreased approximately 10% to $13.4 million, versus $14.9 million for the full-year 2021. The decrease was driven primarily by lower direct clinical and non-clinical expenses, as well as deferral of costs related to future delivery of clinical supply to our partners.
For the fourth quarter of 2022, general and administrative expenses were approximately $3.2 million, compared to $3.7 million for the fourth quarter of 2021, a decrease of approximately 13.3%. For the full-year 2022, general and administrative expenses were $13.5 million, an increase of 28% as compared to $10.6 million for the full-year 2021. The full year increase was driven by staff additions, higher professional fees, and an increase in stock-based compensation.
Total operating expenses for the fourth quarter of 2022 were approximately $5.4 million compared to $6.9 million for the fourth quarter of 2021. This represents a decrease of approximately 22.7%. Total operating expenses for the full-year 2022 were $26.9 million, representing an increase of 6% versus $25.4 million for the full-year 2021.
As of December 31, 2022, the Company’s unrestricted cash and cash equivalents were approximately $22.9 million, as compared to $27.3 million in unrestricted and restricted cash as of December 31, 2021.
Conference Call and Webcast
The conference call is scheduled to begin at 4:30 pm ET today, March 30th. Participants should dial 1-877-407-9039 or 1-201-689-8470. A live webcast of the conference call will also be available here and on the investor relations page of the Company’s corporate website at www.eyenovia.com.
After the live webcast, the event will be archived on Eyenovia’s website for one year.
About the VISION Trials
The VISION trials are Phase 3, double-masked, placebo-controlled, cross-over superiority trials that enroll participants with presbyopia. The primary endpoint is improvement in high-contrast binocular distance corrected near visual acuity in low light conditions. Microline is intended for the “on demand” improvement of near vision in people with presbyopia.
About Microline for Presbyopia
Microline (pilocarpine ophthalmic spray) is Eyenovia’s investigational pharmacologic treatment for presbyopia. Presbyopia, or farsightedness, is the non-preventable, age-related hardening of the lens, which causes a gradual loss of the eye’s ability to focus on nearby objects and is estimated to affect nearly 113 million Americans. Pilocarpine ophthalmic solution is known to constrict the pupil and improve near-distance vision by creating an extended depth of focus through its small aperture effect. Eyenovia believes that its administration of pilocarpine using the Company’s high precision microdosing technology could provide a meaningful improvement in near vision while enhancing tolerability and usability. Microline has been licensed to Arctic Vision (Hong Kong) Limited in Greater China and South Korea.
About MicroPine for Progressive Myopia
MicroPine (atropine ophthalmic spray) is Eyenovia’s investigational, potentially first-in-class topical treatment for the reduction of pediatric myopia progression, also known as nearsightedness, in children ages 3-12. It has been developed for comfort and ease-of-use in children, and its microdose administration is designed to potentially result in low systemic and ocular drug exposure. MicroPine has been licensed to Bausch+Lomb, Inc. in the United States and Canada, and Arctic Vision (Hong Kong) Limited in Greater China and South Korea.
About Mydcombi™ for Mydriasis
Mydcombi is Eyenovia’s investigational, first-in-class fixed-dose-combination product (tropicamide 1% and phenylephrine 2.5% ophthalmic spray) for pharmacologic mydriasis (eye dilation), which is targeted to improve the efficiency of the estimated 100 million office-based comprehensive eye exams performed every year in the United States, as well as the estimated 4 million pharmacologic mydriasis applications for cataract surgery. Developed as a micro-formulation for use without anesthetic, Eyenovia believes Mydcombi will help improve the efficacy, tolerability, and efficiency of pharmacologic mydriasis. Mydcombi has been licensed to Arctic Vision (Hong Kong) Limited in Greater China and South Korea.
About Optejet® and Microdose Array Print (MAP™) Therapeutics
Eyenovia’s Optejet microdose formulation and delivery platform for ocular therapeutics uses high-precision piezo-print technology to deliver ~8 μL of drug, consistent with the capacity of the tear film of the eye. We estimate the volume of ophthalmic solution administered with the Optejet is less than 20% of that delivered using conventional eyedroppers, thus reducing overdosing and exposure to drug and preservatives. Eyenovia’s patented microfluidic ejection technology is designed for fast and gentle ocular surface delivery. Successful use of the Optejet has been demonstrated more than 85% of the time after basic training in a variety of clinical settings compared to 40 – 50% historically seen with conventional eyedroppers. Additionally, future versions with smart electronics and mobile e-health technology are being designed to track and enhance patient compliance.
About Eyenovia, Inc.
Eyenovia, Inc. (Nasdaq: EYEN) is an pre-commercial ophthalmic technology company developing a pipeline of microdose array print (MAP) therapeutics. Eyenovia is currently focused on the late-stage development of microdosed medications for mydriasis, presbyopia and myopia progression. For more information, visit Eyenovia.com.
The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.
Forward-Looking Statements
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, 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 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, legislative and geopolitical 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.
Eyenovia Contact:
Eyenovia, Inc.
John Gandolfo
Chief Financial Officer
Eyenovia Investor Contact:
Eric Ribner
LifeSci Advisors, LLC
(646) 751-4363
Eyenovia Media Contact:
Norbert Lowe
Vice President, Commercial Operations
Eyenovia
EYENOVIA, INC.
Balance Sheets
| December 31, | ||||||||
| 2022 | 2021 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 22,863,520 | $ | 19,461,850 | ||||
| Deferred clinical supply costs | 2,284,931 | - | ||||||
| License fee and expense reimbursements receivable | 1,183,786 | 1,805,065 | ||||||
| Security deposits, current | 119,550 | - | ||||||
| Prepaid expenses and other current assets | 1,190,719 | 734,942 | ||||||
| Total Current Assets | 27,642,506 | 22,001,857 | ||||||
| Restricted cash | - | 7,875,000 | ||||||
| Property and equipment, net | 1,295,115 | 1,271,225 | ||||||
| Security deposits, non-current | 80,874 | 119,035 | ||||||
| Operating lease right-of-use asset | 1,291,592 | - | ||||||
| Equipment deposits | 726,326 | 391,941 | ||||||
| Total Assets | $ | 31,036,413 | $ | 31,659,058 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 1,428,283 | $ | 1,614,104 | ||||
| Accrued compensation | 1,747,191 | 1,543,618 | ||||||
| Accrued expenses and other current liabilities | 503,076 | 845,719 | ||||||
| Deferred rent - current portion | - | 18,685 | ||||||
| Operating lease liabilities - current portion | 484,882 | - | ||||||
| Notes payable - current portion, net of debt discount of $33,885 and $349,632 as of December 31, 2022 and 2021, respectively | 174,448 | 7,150,368 | ||||||
| Convertible notes payable - current portion, net of debt discount of $33,885 and $0 as of December 31, 2022 and 2021, respectively | 174,448 | - | ||||||
| Total Current Liabilities | 4,512,328 | 11,172,494 | ||||||
| Deferred rent - non-current portion | - | 19,949 | ||||||
| Operating lease liabilities - non-current portion | 907,644 | - | ||||||
| Notes payable - non-current portion, net of debt discount of $813,229 and $0 as of December 31, 2022 and 2021, respectively | 4,190,938 | - | ||||||
| Convertible notes payable - non-current portion, net of debt discount of $813,229 and $0 as of December 31, 2022 and 2021, respectively | 4,190,938 | - | ||||||
| Total Liabilities | 13,801,848 | 11,192,443 | ||||||
| Stockholders' Equity: | ||||||||
| Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of December 31, 2022 and 2021, respectively | - | - | ||||||
| Common stock, $0.0001 par value, 90,000,000 shares authorized; 36,668,980 and 28,426,616 shares issued and outstanding as of December 31, 2022 and 2021, respectively | 3,667 | 2,844 | ||||||
| Additional paid-in capital | 135,461,361 | 110,683,077 | ||||||
| Accumulated deficit | (118,230,463 | ) | (90,219,306 | ) | ||||
| Total Stockholders' Equity | 17,234,565 | 20,466,615 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 31,036,413 | $ | 31,659,058 | ||||
EYENOVIA, INC.
Statements of Operations
| For the Three Months Ended | For the Years Ended | |||||||||||||||
| December 31, | December 31, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| (unaudited) | (unaudited) | (unaudited) | ||||||||||||||
| Operating Income | ||||||||||||||||
| Revenue | $ | - | $ | 10,000,000 | $ | - | $ | 14,000,000 | ||||||||
| Cost of revenue | - | - | - | (1,600,000 | ) | |||||||||||
| Gross Profit | - | 10,000,000 | - | 12,400,000 | ||||||||||||
| Operating Expenses: | ||||||||||||||||
| Research and development | 2,202,354 | 3,291,510 | 13,378,680 | 14,850,874 | ||||||||||||
| General and administrative | 3,169,928 | 3,655,172 | 13,532,835 | 10,569,653 | ||||||||||||
| Total Operating Expenses | 5,372,282 | 6,946,682 | 26,911,515 | 25,420,527 | ||||||||||||
| Loss From Operations | (5,372,282 | ) | 3,053,318 | (26,911,515 | ) | (13,020,527 | ) | |||||||||
| Other Income (Expense): | ||||||||||||||||
| Extinguishment of PPP 7(a) loan | - | - | - | 463,353 | ||||||||||||
| Other income, net | 100,510 | 115,147 | 197,090 | 164,027 | ||||||||||||
| Interest expense | (904,247 | ) | (185,349 | ) | (1,380,058 | ) | (387,756 | ) | ||||||||
| Interest income | 52,623 | 162 | 83,326 | 2,516 | ||||||||||||
| Net Loss | $ | (6,123,396 | ) | $ | 2,983,278 | $ | (28,011,157 | ) | $ | (12,778,387 | ) | |||||
| Net Loss Per Share - Basic | ||||||||||||||||
| Basic | $ | (0.17 | ) | $ | 0.11 | $ | (0.83 | ) | $ | (0.49 | ) | |||||
| Diluted | $ | (0.17 | ) | $ | 0.10 | $ | (0.83 | ) | $ | (0.49 | ) | |||||
| Weighted Average Number of Common Shares Outstanding | ||||||||||||||||
| Basic | 36,701,880 | 27,959,123 | 33,649,747 | 26,324,081 | ||||||||||||
| Diluted | 36,701,880 | 30,019,966 | 33,649,747 | 26,324,081 | ||||||||||||
Exhibit 99.2
March 2023
1 Forward - looking Statements Except for historical information, all the statements, expectations and assumptions contained in this presentation are forwar d - l ooking statements. Forward - looking statements include, but are not limited to, statements that express our intentions, beliefs, expecta tions, strategies, predictions or any other statements relating to our future activities or other future events or conditions, inclu din g estimated market opportunities for our product candidates and platform technology. These statements are based on current expectations, est imates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of fut ure performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and re sul ts 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 clinic al trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the ti ming of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our product candidates; the potential adv antages of our product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our product can didates; 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 manufactur ing , commercialization and marketing capabilities and strategies for our product candidates; intellectual property risks; changes in legal, regulatory, legislative and geopolitical environments in the markets in which we operate and the impact of these changes on o ur 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.
2 • Horizontal delivery • Precision dose • Digital compliance capabilities Eyenovia at a Glance Eyenovia (NASDAQ | EYEN) is a US Based Medical Device and Ocular Therapeutics Company Optejet ® with microdose array print technology • Patented digital device platform technology • Exciting and diverse product pipeline • Multi - faceted business model that combines partnerships, licensing agreements, internal product development and sales
3 Over the past 125 years, changes in eyedropper design have done little to improve the usability of topical ophthalmic medications Today’s Eyedropper Bottle Designed for Manufacturing Ease, Not Patient Ease 1800’s Glass Pipette 1900’s Glass Pipette with Bulb and Separate Vial Today Integrated Bottle with Dropper Tip 1. S urvey conducted in January 2023 with 100 people (19 - 65+ Age Range, Mean Age = 51YO) who regularly take eye drop medications re spondents were asked to ranked common drug forms from easiest to administer, to most difficult to administer on a 0 - 10 scale (0 meaning no difficulty, 10 meaning extremely difficult). Of the 11 medication types the respondents were asked to ranked, Eye drops ranked third most difficult behind suppositories and eye ointments. The Topical Ointments were ranked the easiest to administer with an av er age score of 1.11, and suppositories ranked the most difficult with a score of 6.38. Comparatively, Eye Drops received an average score of 4.63 In a recent survey conducted by J. Reckner and Associates, consumers reported that taking eye drops was among the most difficult ways to self - administer medication 1
Introducing the Optejet ® Optejet is a drug - device combination product manufactured with a sterile - filled, replaceable drug cartridge 4 Optejet ® with replaceable drug cartridge Spray nozzle with 109 laser - drilled ports Shutter Activation button Ergonomic design Proprietary, pre - filled drug cartridge manufactured by Eyenovia
5 Ergonomic Design to Improve Usability Horizontal delivery, push button dosing and no protruding tip Eye Dropper Bottle administration requires head - tilting, squeezing, and reliance on gravity Eye Dropper Bottle tips can touch the eye surface Optejet® has a recessed nozzle, protected by a shutter when not in use to prevent cross - contamination Optejet® administration can be done horizontally with the push of a button
6 Precision Dosing to Improve Therapeutic Index 1 Wirta D. et al, Presentation at 2019 ASCRS meeting | 2 Ianchulev T. et al, Therapeutic Delivery 2018 | 3 Results of a human conjunctival cell line assay study with Tufts Medical Center indicate that the impact of preserved medications delivered with the Optejet is similar to non - preserved ey e drops. Study with TUFTS University 2022, Data on File | 4 The impact of precision spray dosing of netarsudil 0.02% can be seen when compared to a single drop of the same drug. With 80% less dose volume, reduces excessive exposure to both drugs and preservatives 1,2 Netarsudil 0.02% delivered via Optejet® Netarsudil 0.02% delivered via Eye Dropper B ottle Minimizes Impact of Preservatives on Ocular Tissues Minimizes Excessive Drug Exposure to Ocular Tissues
7 Optejet Digital Technology to Improve Delivery of Care The Optejet ® is capable of automatically tracking usage Remote Patient Monitoring: More Data May Benefit All Parties PATIENT • Reminders to take medicine • Ability to track compliance progress • Confidence in medication usage PHYSICIAN • Ability for quicker action • More accurate data • Allows for better patient - physician conversation • Remote Therapeutic Monitoring CPT Code may allow for billing PAYER • Less likely to have patient on second medication if compliance is the issue • Better patient outcomes if compliance can be reinforced
8 Product Pipeline * Estimate 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+Lomb in the US and Canada, and Arctic Vision in Greater China and South Korea 4 CHAPERONE oversight and costs assumed by Bausch+Lomb Target Market Drug Optejet Benefit Addressable Population* Status Notes Proprietary Pupil dilation (Mydriasis) Office Efficiency, ease of use, patient experience 108M PDUFA May 8, 2023 Alternative to glasses for early presbyopia Ease of use, convenience, less exposure to pilocarpine 3.5M Pre - NDA Meeting March 28, 2023 Partnered Treatment of childhood progressive Myopia Ease of use, digital monitoring technology, pediatrics self dosing 1.9M Ongoing Ph3 Study Completion expected 2026 Potential Glaucoma Digital monitoring technology, ease of use, less drug exposure 3M Active Discussions Dry Eye Ease of use, greater comfort 20M Pre - IND Meeting planned 2H 2023 Post - Op Cataract Ease of use, greater comfort 4M Active Discussions US Market
9 MydCombi Œ for Pupil Dilation / Mydriasis • Pupil dilation (mydriasis) is part of a comprehensive eye exam and ocular surgery – Estimated 108 million dilations in US annually – Estimated $250 million US market opportunity 1 • Eyedrops are the current standard of care and ripe for innovation – Multiple eyedrops usually needed – Patient discomfort and avoidance – Time consuming administration – Hygiene risk 1. $200M annual sales of pharmaceutical mydriatic products used during 108M office - based exams ($2 * 100M) + $50M of single bott le mydriatic agents used cataract replacement surgery ($12.5 x 4M)
10 MydCombi Œ Product Overview 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 Chayet , A. et al, Evaluation of 2 mydriatic dosing regimens delivered by micro - array print technology for comparison of pupil dilation speed, ePoster ASCRS 2022 • If approved, the only fixed drug 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 no anesthetic – Fewer than 1% of patients reported stinging discomfort 2 • Lower drug and preservative exposure, including absorption of phenylephrine 2 • Single spray of tropicamide/phenylephrine from Optejet ® results in 3 out of 4 patients achieving necessary dilation within 15 minutes 3
11 MydCombi ΠCash - Pay Diagnostic With Unique Benefits for the Office and Patient 1. Wilson, F. A., Stimpson, J. P., & Wang, Y. (2015). Inconsistencies exist in national estimates of Eye Care Services Utiliz ati on in the United States. Journal of ophthalmology. Retrieved February 3, 2023, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4546761/ | 2. Lindstrom, R. L. (2021, February 1). Future of cataract surge ry seems promising. Healio. Retrieved February 3, 2023, from https://www.healio.com/news/ophthalmology/20210126/future - of - cataract - surgery - seems - promising | 3 Charles, S. (2017). The Future of Surgical Retina in the Era of Medical Retina. Retinalphysician.com. Retrieved February 3, 2023, from https://www.retinalphysician.com/issues/2017/may - 2017/the - future - of - surgical - retina - in - the - era - of - medica Market Receptivity Strong among optometrists and ophthalmic technicians, who will be the principal users Potential Market Size 108M 1,2,3 potential procedures includes 104M in - office @ $1.80 and 4M surgeries @ $18 (surgical centers often discard bottles after single use) equals $250M Pricing Premium to current standard of care, offset through improved office through - put and patient satisfaction Reimbursement Status Cash - pay diagnostic. Office purchases directly like other diagnostic agents. No insurance company involvement.
12 MicroLine for Presbyopia • Presbyopia is the age - related loss of near vision that occurs as the lens becomes inelastic (hold the menu further away) • 18 million people aged 40 – 55 in the US have presbyopia, with roughly half never having to use glasses earlier in their lives • MicroLine is a lifestyle product to avoid the appearance and inconvenience of reading glasses – Use “as needed” with rapid onset improvement of near vision – Easy to administer – Discreet – compatible with modern lifestyle
13 MicroLine Phase 3 Clinical Results • Vision - 1 1 and Vision - 2 2 clinical studies – 6.0x more patients achieved ≥ 3 - line gain on a vision chart in the active group vs. placebo 3 – Well - tolerated with fewer than 2% of patients reporting adverse events – 65% of patients reported seeing improvement in exit survey • People prefer MicroLine over eyedrops – Among 100 presbyopic patients aged 40 - 55, 80% said they would prefer MicroLine over the traditional eyedrop bottle 4 – Price sensitivity tests indicate approximately $100 for 80 doses would be well accepted 1. https://clinicaltrials.gov/ct2/show/NCT04657172 | 2. https://clinicaltrials.gov/ct2/show/NCT05114486 3. Cohort of subjects with baseline DCNVA < 0.6 logMAR | 4. Data on file
14 MicroLine The Only Presbyopia Treatment in the Optejet that May Enhance Office Economics 1. Population of 40 - 55YO in the US = 60.8MA , 35% of this population has never needed corrected visionB, assumes product will wo rk for 33% of the remaining population A. Published by Erin Duffin, & 30, S. (2022, September 30). Population of the U.S. by sex and age 2021 . Statista. Retrieved February 3, 2023, from https://www.statista.com/statistics/241488/population - of - the - us - by - sex - and - age/ | B. What is 20/20 vision? University of Iowa Hospitals & Clinics. (n.d.). Retrieved February 3, 2023, from https:// uihc.org /health - topics/what - 2020 - vision#:~:text=How%20common%20is%2020%2F20,t%20see%20very%20well%2C%20Dr. Market Receptivity High among optometrists who are intrigued by the ability to sell the device through their offices; high among patients who are attracted to the benefits of the device Potential Market Size 3.5 million people 1 @ $250 per year = $877M Pricing Approximately $100 per cartridge (similar to Vuity on a per - use basis); market research indicates patients would use 2.5 cartridges/year on average Reimbursement Status Cash - pay cosmeceutical; can be purchased with HSA/FSA funds
15 • Begins in early childhood, with genetic link 1 • Elongation of sclera/retina with morbidity and vision problems 2 • Urgent need for FDA - approved drug therapies to slow myopia progression • Atropine may slow myopia progression by at least 60% 3 MicroPine for Childhood Myopic Maculopathy Progression of Myopic Maculopathy Myopic Maculopathy Normal Macula Affects ~25M children in the US alone, with ~5M considered to be at high risk 4 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.
16 • Precision - dosed atropine spray developed specifically for children – Easy, daily use by children 1 – Lower drug volume exposure to enhance comfort and minimize systemic exposure – Potential for pairing with smart devices to track treatment adherence and provide family reminders • Compliance data shows promise compared with historical treatments MicroPine for Childhood Myopic Maculopathy 1 Data on file with Eyenovia. 2 Naito, 2018; Patel, 1995; Winfield, 1990. 3Matsui, 1997 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 Average of compliance rates from published ophthalmic studies 2 Average of compliance rates from published pediatric studies 3 Subject number Correctly Administered Doses / Total Potential Doses
17 MicroPine A Pediatric Therapy Designed with Children in Mind Market Receptivity Very high to the device due to the potential benefits it may offer; well accepted by children in the CHAPERONE study Potential Market Size If one assumes the annual cost of these drugs is $2,400, then with 1.9 million children treated 1,2 , a market size of over $4.5 billion in the US alone. Potential royalty stream of several hundred million dollars Pricing Licensed to Bausch + Lomb Reimbursement Status Licensed to Bausch + Lomb; we assume will be treated like other ophthalmic prescription medications 1. Theophanous, C., Modjtahedi , B. S., Batech , M., Marlin, D. S., Luong, T. Q., & Fong, D. S. (2018, August 29). Myopia prevalence and risk factors in children. Clinical oph thalmology (Auckland, N.Z.). Retrieved February 3, 2023, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6120514/ 2. Bureau, U. S. C. (2022, April 7). Children data. Census.gov. Retrieved February 3, 2023, from https://www.census.gov/topics/p opu lation/children/data.html
18 Multiple Commercialization Partners Arctic Vision – A China - based ophthalmic biotech focusing on breakthrough therapies, with a leading portfolio covering pre - clinical stage to commercial stage products Bausch+Lomb – One of the world's largest suppliers of contact lenses, lens care products, prescription pharmaceuticals, intraocular lenses and other eye care products Ongoing discussions with multiple partners in chronic ophthalmic indications
19 Potential Long Term Income Stream Arctic Vision – MicroPine, MicroLine and MydCombi licensed for Greater China and South Korea; clinical study enrollment underway Bausch+Lomb – MicroPine licensed for the US and Canada. License agreements with a total value of over $90M in payments + royalties
20 • Eyenovia gains access to Formosa’s APNT Œ formulation technology which opens several new and large market indications for potential expansion of our own development pipeline • APNT Œ (Active Pharmaceutical Nanoparticle Technology) works to reduce particle size leading to improved dissolution, bioavailability, and lowers the risk of contamination • If successful, the companies will discuss an agreement for the co - development of a differentiated asset in a multi - billion - dollar market Formosa APNT Œ Technology Collaboration Formosa Pharma is developing a unique pipeline consisting of risk - diverse development modes, including 505(b)(2), biosimilars, and NCEs. Their proprietary APNT nanoparticle formulation platform drives their pipeline
21 Broad Intellectual Property Portfolio • Key claims covered with multiple patents – 18 US Patents Issued; 8 pending – 89 foreign issued; 33 pending – Many in effect beyond 2031 • Clinical data and regulatory approval adds another layer of IP
22 Financial Snapshot (December 2022) Nasdaq: EYEN Common Shares Outstanding 33.6M Equity Grants Outstanding Under Stock Plans 5.0M Warrants 6.1M Fully Diluted Shares 44.7M Cash $29.4M Debt $12.0M
23 Experienced Leadership Team Bren Kern Chief Operating Officer For more details, please visit our website Malini Batheja, PhD VP, Pharmaceutical R&D and CMC Regulatory Norbert Lowe VP, Commercial Greg Bennett VP Clinical Operations and Medical Affairs CRR Lauren Gidden AVP, Quality and Regulatory Affairs Michael Rowe Chief Executive Officer John Gandolfo Chief Financial Officer
24 • Optejet ® platform technology with ergonomic design facilitates ease of use and delivers precise doses – Addresses many problems of conventional eye drops – Protected with a strong intellectual property portfolio • Eyenovia owns a pipeline of products in large therapeutic categories – With multiple commercial partnerships in place and more being developed • Poised for leadership as a technology partner and therapy provider in potentially huge markets • First product FDA PDUFA date - May 8, 2023 – Will validate the underlying technology Investment Summary