Financial Data and Key Metrics Changes - For Q2 2023, the net loss was approximately $6.2 million or $0.16 per share, compared to a net loss of approximately $7.2 million or $0.22 per share for Q2 2022, indicating an improvement in financial performance [19] - Research and development expenses totaled approximately $2.8 million for Q2 2023, down from $3.6 million in Q2 2022 [19] - General and administrative expenses were approximately $3.1 million for Q2 2023, compared to $3.5 million for Q2 2022 [19] - Total operating expenses for Q2 2023 were approximately $6 million, a decrease from $7.1 million in Q2 2022 [20] - As of June 30, 2023, cash and cash equivalents were approximately $17.5 million, down from $22.9 million as of December 31, 2022 [20] Business Line Data and Key Metrics Changes - The company initiated sales of Mydcombi, the first FDA-approved product leveraging the Optejet dispensing device, to a targeted group of professional offices [8][9] - The first commercial sale of Mydcombi was made to Dr. Nathan Radcliffe, marking a significant milestone in the product's launch [9] - The company is in the process of adding additional commercial manufacturing sites to support Mydcombi, including the Redwood City facility and Coastline manufacturing [10] Market Data and Key Metrics Changes - The addressable market for Apersure, a therapeutic candidate for presbyopia, represents over 18 million people in the U.S. aged 40 to 55, with a potential annual market of nearly $1 billion [12] - The company is actively discussing partnerships with no fewer than four companies across various topical ophthalmic markets to leverage the Optejet technology [11] Company Strategy and Development Direction - The company aims to leverage and monetize the Optejet technology through partnerships, focusing on marrying delivery technology with unique drug assets [11] - The company is targeting the initiation of Apersure registration batches in Q4 2023, with plans to file a new drug application approximately 12 months after running registration batches [13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in Q2 2023, highlighting the FDA approval of Mydcombi and the initiation of sales [26] - The company anticipates better visibility for Mydcombi's guidance with the upcoming Coastline manufacturing approval [39] - Positive feedback from early users of Mydcombi indicates a favorable reception, with reports of shorter dilation duration compared to traditional eye drops [40] Other Important Information - Eyenovia was added to the small-cap Russell 2000 and broad market Russell 3000 indices effective June 2023 [25] - The company has generated approximately $16 million in license fees from existing agreements, with potential to earn an additional $60 million in net license and development milestones over the next four years [24] Q&A Session Summary Question: Future of Gen 2 Device Development - Management confirmed that all devices will eventually transition to the Gen 2 design, which is simpler and less costly to manufacture [30] Question: Status of Presbyopia Studies - Some studies related to the Gen 2 device are completed, while others are ongoing, with all expected to be finished by the end of the year [31] Question: Launch Progress of Mydcombi - Management indicated that the initial launch is targeted, with better visibility expected after the Coastline manufacturing approval [39] - Early feedback from users of Mydcombi has been positive, with reports of effective and shorter dilation duration [40]

[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section provides the company's unaudited condensed financial statements and related disclosures for the periods ended June 30, 2023, and December 31, 2022 [Item 1. Financial Statements.](index=4&type=section&id=Item%201.%20Financial%20Statements.) This section presents the unaudited condensed financial statements, including balance sheets, statements of operations, changes in stockholders' equity, and cash flows, along with detailed notes explaining the company's financial position, performance, and significant accounting policies for the periods ended June 30, 2023, and December 31, 2022 [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity as of June 30, 2023, and December 31, 2022 Condensed Balance Sheet Highlights (June 30, 2023 vs. December 31, 2022) | Metric | June 30, 2023 | December 31, 2022 | Change | | :-------------------------------- | :------------ | :---------------- | :----- | | Cash and cash equivalents | $17,468,088 | $22,863,520 | -$5,395,432 | | Total Current Assets | $23,276,793 | $27,642,506 | -$4,365,713 | | Total Assets | $29,346,899 | $31,036,413 | -$1,689,514 | | Total Current Liabilities | $4,064,210 | $4,512,328 | -$448,118 | | Total Liabilities | $18,824,952 | $13,801,848 | +$5,023,104 | | Total Stockholders' Equity | $10,521,947 | $17,234,565 | -$6,712,618 | [Unaudited Condensed Statements of Operations](index=6&type=section&id=Unaudited%20Condensed%20Statements%20of%20Operations) This section outlines the company's financial performance, including revenues, expenses, and net loss for the three and six months ended June 30, 2023 and 2022 Condensed Statements of Operations Highlights (Unaudited) | Metric | 3 Months Ended June 30, 2023 | 3 Months Ended June 30, 2022 | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | | :------------------------------------ | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Research and development | $2,811,061 | $3,586,866 | $5,333,011 | $7,299,450 | | General and administrative | $3,149,809 | $3,534,590 | $6,086,695 | $7,009,555 | | Total Operating Expenses | $5,960,870 | $7,121,456 | $11,419,706 | $14,309,005 | | Loss From Operations | $(5,960,870) | $(7,121,456) | $(11,419,706) | $(14,309,005) | | Net Loss | $(6,215,860) | $(7,239,100) | $(11,955,226) | $(14,578,765) | | Net Loss Per Share - Basic and Diluted | $(0.16) | $(0.22) | $(0.32) | $(0.46) | [Unaudited Condensed Statements of Changes in Stockholders' Equity](index=7&type=section&id=Unaudited%20Condensed%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) This section details changes in the company's equity, including common stock issuance, stock-based compensation, and net loss, for the six months ended June 30, 2023 Condensed Statements of Changes in Stockholders' Equity Highlights (Unaudited) | Metric | Balance - January 1, 2023 | Issuance of common stock in ATM offering [1] | Stock-based compensation | Net loss | Balance - June 30, 2023 | | :------------------------------------ | :------------------------ | :------------------------------------------- | :----------------------- | :--------- | :---------------------- | | Common Stock Shares | 36,668,980 | 1,299,947 (Q1) + 121,989 (Q2) | — | — | 38,169,398 | | Common Stock Amount | $3,667 | $130 (Q1) + $13 (Q2) | — | — | $3,817 | | Additional Paid-In Capital | $135,461,361 | $3,499,462 (Q1) + $403,107 (Q2) | $819,064 (Q1) + $493,632 (Q2) | — | $140,703,819 | | Accumulated Deficit | $(118,230,463) | — | — | $(5,739,366) (Q1) + $(6,215,860) (Q2) | $(130,185,689) | | Total Stockholders' Equity | $17,234,565 | $3,499,592 (Q1) + $403,120 (Q2) | $819,064 (Q1) + $493,632 (Q2) | $(5,739,366) (Q1) + $(6,215,860) (Q2) | $10,521,947 | [Unaudited Condensed Statements of Cash Flows](index=8&type=section&id=Unaudited%20Condensed%20Statements%20of%20Cash%20Flows) This section summarizes the company's cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2023 and 2022 Condensed Statements of Cash Flows Highlights (Unaudited) | Cash Flow Activity | 6 Months Ended June 30, 2023 | 6 Months Ended June 30, 2022 | | :------------------------------------ | :--------------------------- | :--------------------------- | | Net Cash Used In Operating Activities | $(11,673,476) | $(12,883,603) | | Net Cash Used In Investing Activities | $(2,122,197) | $(399,640) | | Net Cash Provided By Financing Activities | $8,400,241 | $15,327,975 | | Net (Decrease) Increase in Cash and Cash Equivalents | $(5,395,432) | $2,044,732 | | Cash, cash equivalents and restricted cash - End of Period | $17,468,088 | $29,381,582 | [Notes to Unaudited Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the unaudited condensed financial statements [Note 1 – Business Organization, Nature of Operations and Basis of Presentation](index=9&type=section&id=Note%201%20%E2%80%93%20Business%20Organization%2C%20Nature%20of%20Operations%20and%20Basis%20of%20Presentation) This note describes the company's business, its ophthalmic technology focus, and the basis for financial statement presentation - Eyenovia, Inc. is an ophthalmic technology company developing the Optejet® delivery system for drug-device therapeutic programs in mydriasis, presbyopia, and pediatric progressive myopia[24](index=24&type=chunk) - The company's investigational products are classified by the FDA as drug-device combination products, with the Center for Drug Evaluation and Research (CDER) designated as the lead center for review and approval under new drug applications (NDAs)[24](index=24&type=chunk) [Note 2 – Going Concern and Summary of Significant Accounting Policies](index=9&type=section&id=Note%202%20%E2%80%93%20Going%20Concern%20and%20Summary%20of%20Significant%20Accounting%20Policies) This note addresses the company's going concern status and outlines significant accounting policies, including recent standard adoptions - As of June 30, 2023, the Company had approximately **$17.5 million** in cash and cash equivalents[27](index=27&type=chunk) - The Company incurred net losses of approximately **$12.0 million** and used cash in operations of approximately **$11.7 million** for the six months ended June 30, 2023[27](index=27&type=chunk) - These circumstances raise substantial doubt about the Company's ability to continue as a going concern for at least one year, necessitating further capital raising through licensing, equity, or debt securities[27](index=27&type=chunk)[28](index=28&type=chunk) - The Company adopted ASU 2016-13 (Credit Losses) and early adopted ASU 2020-06 (Convertible Instruments) effective January 1, 2023, with no material impact on its financial position, results of operations, or cash flows[38](index=38&type=chunk)[39](index=39&type=chunk) [Note 3 – Prepaid Expenses and Other Current Assets](index=12&type=section&id=Note%203%20%E2%80%93%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) This note details the composition of prepaid expenses and other current assets as of June 30, 2023, and December 31, 2022 Prepaid Expenses and Other Current Assets | Category | June 30, 2023 | December 31, 2022 | | :-------------------------------- | :------------ | :---------------- | | Payroll tax receivable | $645,566 | $660,891 | | Prepaid insurance expenses | $600,607 | $201,082 | | Prepaid general and administrative expenses | $310,701 | $87,982 | | Total prepaid expenses and other current assets | $1,801,373 | $1,190,719 | [Note 4 – Accrued Compensation](index=14&type=section&id=Note%204%20%E2%80%93%20Accrued%20Compensation) This note provides a breakdown of accrued compensation, including bonus and payroll expenses, for the periods presented Accrued Compensation | Category | June 30, 2023 | December 31, 2022 | | :------------------- | :------------ | :---------------- | | Accrued bonus expenses | $695,450 | $1,447,643 | | Accrued payroll expenses | $317,668 | $299,548 | | Total accrued compensation | $1,013,118 | $1,747,191 | [Note 5 – Accrued Expenses and Other Current Liabilities](index=14&type=section&id=Note%205%20%E2%80%93%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) This note details accrued expenses and other current liabilities, such as consulting, R&D, and leasehold improvement costs Accrued Expenses and Other Current Liabilities | Category | June 30, 2023 | December 31, 2022 | | :------------------------------------ | :------------ | :---------------- | | Accrued consulting and professional services | $142,915 | $320,000 | | Accrued research and development expenses | $117,983 | $35,524 | | Accrued leasehold improvements | — | $92,528 | | Total accrued expenses and other current liabilities | $363,431 | $503,076 | [Note 6 – Notes Payable](index=14&type=section&id=Note%206%20%E2%80%93%20Notes%20Payable) This note outlines the company's notes payable, including current and non-current portions, and recent debt funding activities Notes Payable (Net of Debt Discount) | Category | June 30, 2023 | December 31, 2022 | | :------------------------------------ | :------------ | :---------------- | | Total current portion (net) | $947,163 | $348,896 | | Total non-current portion (net) | $13,176,524 | $8,381,876 | - On May 22, 2023, the Company received an additional **$5,000,000** tranche of non-convertible debt funding from Avenue Capital Management II, L.P[47](index=47&type=chunk) - The additional funding extended the interest-only period for the entire outstanding balance under the Loan and Security Agreement to 18 months (through May 2024)[47](index=47&type=chunk) [Note 7 – Commitments and Contingencies](index=15&type=section&id=Note%207%20%E2%80%93%20Commitments%20and%20Contingencies) This note describes the company's contractual obligations, including lease commitments and potential contingencies - The Company extended its New York office lease from November 1, 2023, to December 31, 2026[49](index=49&type=chunk) - The Company renewed three leases in Redwood City, California, from September 1, 2023, to August 31, 2025[50](index=50&type=chunk) Future Minimum Operating Lease Payments | For the Year Ending December 31, | Minimum Lease Payments | | :------------------------------- | :--------------------- | | 2023 | $445,025 | | 2024 | $660,923 | | 2025 | $675,400 | | 2026 | $560,996 | | 2027 | $214,619 | | Total future minimum lease payments | $2,556,963 | [Note 8 – Stockholders' Equity](index=16&type=section&id=Note%208%20%E2%80%93%20Stockholders'%20Equity) This note details changes in stockholders' equity, including stock plan amendments, ATM offerings, and stock-based compensation - Stockholders approved an amendment to the 2018 Omnibus Stock Incentive Plan, reserving an additional **1,000,000 shares** of common stock for issuance[55](index=55&type=chunk) - The Company received approximately **$3.9 million** in net proceeds from the sale of **1,421,936 common shares** through an At-the-Market offering during the six months ended June 30, 2023[56](index=56&type=chunk) Stock-Based Compensation Expense | Period | 2023 | 2022 | | :------------------------------------ | :----------- | :----------- | | Three Months Ended June 30, | $493,632 | $1,036,926 | | Six Months Ended June 30, | $1,312,696 | $1,945,913 | - As of June 30, 2023, there was **$2,868,023** of unrecognized stock-based compensation expense related to stock options, to be recognized over a weighted average period of **1.7 years**[65](index=65&type=chunk) [Note 9 – Employee Benefit Plans](index=19&type=section&id=Note%209%20%E2%80%93%20Employee%20Benefit%20Plans) This note describes the company's 401(k) plan, including matching contributions and related expenses - The Company's 401(k) Plan includes a matching contribution equal to **100% of elective deferrals** up to **4% of eligible earnings**[66](index=66&type=chunk) 401(k) Matching Contributions Expense | Period | 2023 | 2022 | | :------------------------------------ | :---------- | :---------- | | Three Months Ended June 30, | $46,196 | $47,883 | | Six Months Ended June 30, | $125,164 | $133,982 | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) This section provides management's perspective on the company's financial condition and results of operations, highlighting the FDA approval of Mydcombi™, an overview of its Optejet® delivery system and product pipeline, financial performance, liquidity challenges, and future capital requirements [FDA Approval of Mydcombi™](index=20&type=section&id=FDA%20Approval%20of%20Mydcombi%E2%84%A2) This section highlights the FDA approval of Mydcombi™ and its initial commercial launch, marking a significant milestone for the company - The FDA approved Mydcombi™ on May 5, 2023, as the only fixed combination of two leading mydriatic agents in the United States delivered as an ophthalmic spray[69](index=69&type=chunk) - The first commercial sale of Mydcombi™ occurred on August 3, 2023, as part of a targeted launch, with a broader launch anticipated in 2024 when internal manufacturing capabilities are expected to be online[69](index=69&type=chunk) [Overview of Business and Products](index=20&type=section&id=Overview%20of%20Business%20and%20Products) This section provides an overview of Eyenovia's ophthalmic technology, the Optejet® delivery system, and its product pipeline, including Mydcombi™, MicroPine, and MicroLine - Eyenovia is an ophthalmic technology company developing the Optejet® delivery system for its drug-device therapeutic programs (mydriasis, presbyopia, pediatric progressive myopia) and out-licensing[70](index=70&type=chunk) - The Optejet® device delivers a precise, low-volume (**7-9 microliters**) columnar spray, achieving a **98% successful administration rate** on the first attempt in clinical trials, aiming to reduce side effects and improve tolerability[72](index=72&type=chunk)[73](index=73&type=chunk) - The product pipeline includes Mydcombi™ (FDA-approved), MicroPine (for progressive myopia, licensed to Bausch + Lomb in US/Canada), and MicroLine (for presbyopia, positive Phase III results)[75](index=75&type=chunk)[78](index=78&type=chunk)[79](index=79&type=chunk) - The Company has licensing agreements with Bausch + Lomb for MicroPine in the US and Canada, and with Arctic Vision for MicroPine, MicroLine, and Mydcombi in Greater China and South Korea[76](index=76&type=chunk)[81](index=81&type=chunk) [Financial Overview](index=24&type=section&id=Financial%20Overview) This section summarizes the company's historical financing, recent net losses, accumulated deficit, and ongoing going concern challenges - Historically, operations have been financed through equity offerings, licensing arrangements, and credit facilities[83](index=83&type=chunk) - The Company incurred net losses of **$6.2 million** for the three months and **$12.0 million** for the six months ended June 30, 2023, with an accumulated deficit of **$130.2 million**[84](index=84&type=chunk) - There is substantial doubt about the Company's ability to continue as a going concern, requiring additional capital or cost reductions[83](index=83&type=chunk) - Research and development expenses are expected to increase with ongoing initiatives[86](index=86&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance, comparing key operating expenses for the three and six months ended June 30, 2023 and 2022 [Three Months Ended June 30, 2023 Compared with Three Months Ended June 30, 2022](index=25&type=section&id=Three%20Months%20Ended%20June%2030%2C%202023%20Compared%20with%20Three%20Months%20Ended%20June%2030%2C%202022) This section compares research and development and general and administrative expenses for the three months ended June 30, 2023 and 2022 - Research and development expenses decreased by **$0.8 million (22%)** to **$2.8 million**, primarily due to the conclusion of the VISION-2 Study and changes in stock-based compensation allocation[88](index=88&type=chunk) - General and administrative expenses decreased by **$0.4 million (11%)** to **$3.1 million**, mainly due to lower professional fees (legal and recruiting) and reduced sales and marketing promotional expenses[89](index=89&type=chunk) [Six Months Ended June 30, 2023 Compared with Six Months Ended June 30, 2022](index=26&type=section&id=Six%20Months%20Ended%20June%2030%2C%202023%20Compared%20with%20Six%20Months%20Ended%20June%2030%2C%202022) This section compares research and development and general and administrative expenses for the six months ended June 30, 2023 and 2022 - Research and development expenses decreased by **$2.0 million (27%)** to **$5.3 million**, attributed to the conclusion of the VISION-2 Study, changes in stock-based compensation allocation, and increased cost reimbursements for clinical supplies[90](index=90&type=chunk) - General and administrative expenses decreased by **$0.9 million (13%)** to **$6.1 million**, primarily due to lower professional fees (legal and recruiting) and reduced sales and marketing promotional expenses[91](index=91&type=chunk) [Liquidity and Capital Resources and Going Concern](index=26&type=section&id=Liquidity%20and%20Capital%20Resources%20and%20Going%20Concern) This section discusses the company's cash position, working capital, and financing activities, highlighting the ongoing going concern risk and capital needs Liquidity Metrics | Metric | June 30, 2023 | December 31, 2022 | | :------------------------ | :------------ | :---------------- | | Cash and cash equivalents | $17,468,088 | $22,863,520 | | Working capital | $19,212,583 | $23,130,178 | | Notes payable (gross) | $15,842,950 | $10,425,000 | - As of June 30, 2023, the accumulated deficit was **$130.2 million**[94](index=94&type=chunk) - Net cash used in operating activities for the six months ended June 30, 2023, was **$11.7 million**[96](index=96&type=chunk) - Net cash provided by financing activities for the six months ended June 30, 2023, totaled **$8.4 million**, primarily from a **$4.0 million** At-the-Market Offering Program and **$5.0 million** from an additional debt tranche[98](index=98&type=chunk) - These conditions raise substantial doubt about the Company's ability to continue as a going concern, necessitating additional capital or cost reductions[95](index=95&type=chunk) [Contractual Obligations and Commitments](index=28&type=section&id=Contractual%20Obligations%20and%20Commitments) This section outlines the company's short-term and long-term contractual obligations, including accounts payable, lease commitments, and notes payable - Within the next twelve months, commitments include: **$2.7 million** for accounts payable, accrued compensation, and other current liabilities; **$0.4 million** for non-cancelable operating lease commitments; and **$1.0 million** for notes payable[99](index=99&type=chunk) - After twelve months, commitments include: an additional **$1.6 million** for non-cancelable operating lease commitments and **$14.8 million** for notes payable[100](index=100&type=chunk) - Potential executive severance pay of **$1.5 million** under certain termination conditions[99](index=99&type=chunk) [Off-Balance Sheet Arrangements](index=30&type=section&id=Off-Balance%20Sheet%20Arrangements) This section confirms the absence of material off-balance sheet arrangements that would significantly impact the company's financial statements - The Company has no material off-balance sheet arrangements that would significantly affect its financial condition or results of operations[102](index=102&type=chunk) [Critical Accounting Policies and Estimates](index=30&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section states that there have been no material changes to the company's critical accounting policies and estimates - There have been no material changes to the Company's critical accounting policies and estimates from those disclosed in its Annual Report on Form 10-K for the year ended December 31, 2022[105](index=105&type=chunk) [Recently Adopted Accounting Standards](index=30&type=section&id=Recently%20Adopted%20Accounting%20Standards) This section refers to Note 2 for details on recently adopted accounting standards - For a description of recently adopted accounting standards, refer to Note 2 – Summary of Significant Accounting Policies in Part 1, Item 1 of this Quarterly Report on Form 10-Q[106](index=106&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk.](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Eyenovia is exempt from providing quantitative and qualitative disclosures about market risk - Eyenovia, as a smaller reporting company, is not required to provide quantitative and qualitative disclosures about market risk[107](index=107&type=chunk) [Item 4. Controls and Procedures.](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2023, with no material changes in internal control over financial reporting - The Company's disclosure controls and procedures were evaluated and deemed effective as of June 30, 2023, providing reasonable assurance for timely and accurate reporting[111](index=111&type=chunk) - There were no material changes in internal control over financial reporting during the quarter ended June 30, 2023[112](index=112&type=chunk) [PART II - OTHER INFORMATION](index=32&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers other information including legal proceedings, risk factors, equity sales, defaults, mine safety, and exhibits [Item 1. Legal Proceedings.](index=32&type=section&id=Item%201.%20Legal%20Proceedings.) The company is not currently involved in any material legal proceedings, though it acknowledges that ordinary course litigation, regardless of outcome, can have adverse impacts - The Company is not currently a party to any material legal proceedings[115](index=115&type=chunk) - Litigation, even if not material, can adversely impact the company due to defense and settlement costs, diversion of management resources, and reputational harm[115](index=115&type=chunk) [Item 1A. Risk Factors.](index=32&type=section&id=Item%201A.%20Risk%20Factors.) There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2022 - No material changes to the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2022[116](index=116&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The company reported no unregistered sales of equity securities and no purchases of equity securities by the issuer or affiliated purchasers during the period - No unregistered sales of equity securities occurred during the period[117](index=117&type=chunk) - No purchases of equity securities by the issuer or affiliated purchasers were made[118](index=118&type=chunk) [Item 3. Defaults Upon Senior Securities.](index=32&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) This item is not applicable to the company - This item is not applicable[119](index=119&type=chunk) [Item 4. Mine Safety Disclosures.](index=32&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to the company - This item is not applicable[120](index=120&type=chunk) [Item 5. Other Information.](index=32&type=section&id=Item%205.%20Other%20Information.) No directors or executive officers adopted or terminated any Rule 10b5-1 trading plans during the three months ended June 30, 2023 - No directors or officers adopted or terminated any Rule 10b5-1 trading plans during the three months ended June 30, 2023[121](index=121&type=chunk) [Item 6. Exhibits.](index=33&type=section&id=Item%206.%20Exhibits.) This section lists the exhibits filed with the Form 10-Q, including corporate governance documents, the equity incentive plan, and certifications from the principal executive and financial officers - Includes certifications of the Principal Executive Officer and Principal Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[123](index=123&type=chunk) - Lists corporate governance documents (Certificate of Incorporation, Bylaws) and the Amended and Restated 2018 Omnibus Stock Incentive Plan[123](index=123&type=chunk) [SIGNATURES](index=34&type=section&id=SIGNATURES) This section contains the duly authorized signatures for the report [SIGNATURES](index=34&type=section&id=SIGNATURES) The report is duly signed on behalf of Eyenovia, Inc. by John Gandolfo, Chief Financial Officer, on August 11, 2023 - The report was signed by John Gandolfo, Chief Financial Officer, on August 11, 2023[127](index=127&type=chunk)

Financial Data and Key Metrics Changes - For Q1 2023, the net loss was approximately $5.7 million or $0.15 per share, compared to a net loss of approximately $7.3 million or $0.24 per share for Q1 2022, indicating an improvement in financial performance [50] - Total operating expenses for Q1 2023 were approximately $5.5 million, down from $7.2 million in the same period in 2022, representing a decrease of approximately 24% [51] - General and administrative expenses were approximately $2.9 million for Q1 2023, compared to approximately $3.5 million for Q1 2022, a decrease of approximately 15.5% [69] - Research and development expenses totaled approximately $2.5 million for Q1 2023, down from approximately $3.7 million for the same period in 2022, a decrease of approximately 32% [85] - As of March 31, 2023, the company's cash balance was approximately $18.5 million, down from $22.9 million as of December 31, 2022 [86] Business Line Data and Key Metrics Changes - The FDA approved MydCombi, a fixed-dose combination of tropicamide and phenylephrine, marking the first approved product using the Optejet dispensing device [59] - The company plans to introduce MydCombi later in the summer of 2023, with a targeted rollout to key ophthalmology and optometry offices [41] - MicroLine, a therapeutic candidate for presbyopia, is projected to address a multibillion-dollar annual market in the U.S. alone [42] Market Data and Key Metrics Changes - The presbyopia market represents over 18 million people in the U.S. aged 40 to 55 who may not wear glasses and have the resources for a cash pay product [42] - Market research indicated that MicroLine could capture as much as one-third of the presbyopia pharmaceutical market, with existing competitors sharing the remaining two-thirds [45] Company Strategy and Development Direction - The approval of MydCombi signifies a transition from a development company to a commercial organization, with plans to leverage the Optejet technology for future ophthalmic indications [40] - The company is focusing on partnerships, such as the agreement with Formosa Pharmaceuticals, to expand its pipeline and address unmet needs in large ophthalmic indications [46] - The strategy includes a hybrid organization model, balancing in-house production with outsourcing to optimize resources and expenses [26][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the path forward for the MicroLine program following positive FDA feedback, with plans to file for NDA registration after completing necessary clinical work [62] - The company aims to maintain a lean operational structure, avoiding overcommitment and ensuring efficient resource allocation as product demand grows [23] - Management highlighted the importance of building a strong body of data to demonstrate the benefits of the Optejet technology over conventional eye drops [81] Other Important Information - The company has the ability to draw down an additional $5 million on its Avenue capital credit facility through July 31, 2023, based on the recent approval of MydCombi [86] - Licensing agreements have generated approximately $16 million in fees, with potential to earn an additional $60 million in milestones and reimbursable expenses over the next four years [88] Q&A Session Summary Question: What is the company's perspective on the negative sentiment from the stock following the MydCombi approval? - Management believes investors may be misinterpreting the prospects for MydCombi and the Optejet opportunity, emphasizing the importance of the approval and its implications for future growth [9] Question: Can you provide an update on the commercial rollout of MydCombi? - The rollout will be staged and targeted, focusing on key offices initially, with a broader push expected towards the end of the year as production capabilities ramp up [14] Question: Is further financing necessary for the MydCombi launch? - Management is evaluating all financing opportunities but aims to pursue options that are least dilutive, with no immediate plans for a secondary offering [17][18] Question: How does the company plan to market the Optejet and MydCombi? - The marketing strategy includes reaching out to ophthalmologists and optometrists through various channels, including social media and professional meetings, once FDA materials are approved [107]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER: 001-38365 EYENOVIA, INC. (Exact name of Registrant as Specified in Its Charter) | DELAWARE | | 47-1178401 | | --- | --- | --- ...

Financial Performance and Funding - The company has incurred net losses of approximately $118.2 million since inception, with net losses of $28.0 million and $12.8 million for the years ended December 31, 2022 and 2021, respectively [271]. - The company requires substantial additional funding to continue research and development activities, manufacturing, and commercialization efforts into next year [263]. - The company has not generated any product sales revenue and has not achieved profitable operations [271]. - The company expects to continue incurring substantial losses while preparing product candidates for the market, which may take a year or more [271]. - The company’s cash at December 31, 2022 is not sufficient to operate as a going concern for at least one year without additional funding [256]. - The company may need to raise additional capital through equity offerings or debt financings, which could dilute existing stockholders' ownership [268]. - The company has faced adverse developments in the financial services industry that could impact its business operations and financial condition [257]. - The company’s ability to access funding sources may be significantly impaired by factors affecting the financial services industry or the economy in general [259]. - The company has a "going concern" explanatory paragraph included in its independent auditor's report, indicating substantial doubt about its ability to continue as a viable entity [255]. - As of December 31, 2022, the company had federal net operating loss carry-forwards of approximately $85.9 million, with about $10.8 million set to expire between 2034 and 2037 [275]. - The company has incurred significant net operating losses since its inception in July 2014, which may adversely affect its financial condition if tax benefits cannot be utilized [275]. Product Development and Regulatory Approval - The success of the company's product candidates, including Mydcombi, MicroPine, and MicroLine, is dependent on obtaining marketing approvals and successfully commercializing these products [279]. - The company has completed multiple Phase II and III studies for its product candidates, but the clinical trial process remains uncertain, with potential for significant delays [280]. - Delays in clinical trials could result in increased development costs and impact the company's ability to become profitable [283]. - The company relies on contract research organizations (CROs) and clinical trial sites for timely conduct of clinical trials, which may be subject to delays beyond its control [293]. - The company may face challenges in enrolling a sufficient number of subjects for clinical trials, which could delay or prevent necessary regulatory approvals [288]. - Undesirable side effects from product candidates could lead to interruptions in clinical trials and affect regulatory approval processes [301]. - The company has no products currently approved for sale, and its future prospects are heavily reliant on the success of its product candidates [279]. - The company submitted an NDA to the FDA for Mydcombi, targeting over 100 million eye exams and 4 million ophthalmic surgical dilations annually in the U.S. [337]. - In October 2021, the company received a Complete Response Letter (CRL) from the FDA, indicating that Mydcombi was reclassified as a drug-device combination product, necessitating additional non-clinical device information for resubmission [337]. - The FDA accepted the resubmitted NDA for Mydcombi in December 2022, with a PDUFA date set for May 8, 2023 [337]. - The approval process for Mydcombi requires compliance with complex procedures involving both the CDRH and CDER centers of the FDA, which could significantly increase costs and development timelines [338]. - The company anticipates that its other product candidates, MicroPine and MicroLine, will also be classified as drug/device combination products, similar to Mydcombi [339]. - Regulatory approvals may be subject to ongoing obligations and could incur significant additional expenses, including post-market study requirements and compliance with cGMPs and GCP requirements [341]. - The FDA may require Risk Evaluation and Mitigation Strategies (REMS) for product candidates, which could include additional safety measures and restricted distribution methods [342]. - The company does not have any product candidates approved for sale in any jurisdiction, limiting its market potential [349]. - Regulatory requirements vary widely across jurisdictions, which could delay or prevent product introduction in international markets [349]. Market and Competitive Landscape - The commercial success of the product candidates will largely depend on market acceptance among ophthalmologists, optometrists, and patients, which is uncertain even with regulatory approval [310]. - The company faces significant competition in the specialty pharma market, which is characterized by rapid technological change and the potential for competitors to achieve regulatory approval before the company [313]. - The company has limited resources for manufacturing, sales, and distribution, which could adversely affect the commercial launch and sales of its product candidates [316]. - Pricing pressures are expected due to trends in managed healthcare and legislative changes, which may hinder the successful commercialization of new products [326]. - Coverage and reimbursement from third-party payors are critical for product acceptance, and the company may face difficulties in obtaining these approvals [321]. Legal and Compliance Risks - The company is subject to extensive healthcare laws, including the federal Anti-Kickback Statute and the False Claims Act, which may impact business operations and financial arrangements [358]. - Legislative reforms, such as the Affordable Care Act and the Inflation Reduction Act, could materially affect the company's financial condition and operational results [361][364]. - Starting in 2023, the company must pay rebates to the federal government if drug prices increase faster than inflation, impacting revenue from Medicare [364]. - The company faces increased scrutiny over drug pricing, with potential legislative changes aimed at enhancing transparency and controlling costs [363]. - State-level regulations require pharmaceutical manufacturers to notify purchasers of price increases exceeding 16% and disclose pricing information [365]. - The company is subject to anti-corruption laws, including the FCPA and the UK Bribery Act, which could lead to significant compliance costs and legal risks [368][371]. - Future international operations will require compliance with various laws and regulations, potentially limiting growth and increasing development costs [370]. - The company may incur significant legal expenses and reputational harm if found non-compliant with healthcare laws and regulations [360]. - The uncertainty surrounding future healthcare reforms could limit coverage and reimbursement for the company's products, affecting demand [366]. Human Resources and Management - The company had only 41 full-time employees as of March 30, 2023, relying on third-party contractors for professional services [379]. - The company is highly dependent on its senior management team, including the CEO, and may face challenges in retaining or attracting qualified personnel [375]. - Future performance will depend on the successful integration of newly hired executive officers and effective collaboration among senior management [378]. - The company faces intense competition for qualified personnel among biotechnology and pharmaceutical companies, which may hinder its ability to attract and retain talent [377]. Supply Chain and Manufacturing Risks - The company relies on third parties for clinical trials and research, which may lead to delays or increased costs if these parties do not meet their contractual obligations [384]. - The company does not currently have long-term agreements with third-party suppliers for the commercial supply of components, which may delay research and development activities [392]. - Reliance on third-party manufacturers increases the risk of supply shortages for raw materials or active pharmaceutical ingredients necessary for clinical trials [394]. - Disruptions at third-party suppliers, such as natural disasters or vandalism, could result in substantial capital requirements and months of manufacturing delays [396]. - The company currently lacks alternative production plans or disaster-recovery facilities, which could jeopardize manufacturing capabilities in case of supplier disruptions [396]. - The COVID-19 pandemic has impacted the ability to procure sufficient supplies, with potential delays in clinical studies and commercialization of product candidates [399]. Intellectual Property Risks - The company faces risks related to intellectual property, including challenges in obtaining and maintaining patent protection, which could affect competitive advantage [403]. - Patent applications may not result in enforceable patents, and the scope of protection could be limited, impacting the ability to compete effectively [404]. - The company may face challenges from third parties that could invalidate or circumvent its patents, leading to increased competition [407]. - The patent application process is complex and uncertain, with no assurance of success in obtaining patents for product candidates [411]. - The company’s ability to protect its proprietary technologies is critical for commercial success, and failure to do so could materially harm its business [415]. - The company faces uncertainty regarding the future protection of its proprietary rights, as legal means provide limited protection and may not ensure competitive advantage [418]. - There is a risk that pending patent applications may not result in issued patents or may be insufficient to protect the company's technology [419]. - Patent terms are limited, generally expiring 20 years after filing, which may not provide adequate protection for products developed over long timelines [423]. - The company may not receive patent term extensions under the Hatch-Waxman Amendments, potentially shortening the period to enforce patent rights and allowing competitors to market similar products sooner [424]. - Changes in patent law could diminish the value of patents, impacting the company's ability to protect its products [426]. - The company may face significant costs and resource diversion from enforcing patent rights in foreign jurisdictions, which could lead to invalidation or narrow interpretation of patents [432]. - The biotechnology and pharmaceutical industries are prone to intellectual property litigation, which could result in costly and time-consuming legal challenges for the company [434]. - If found to infringe on third-party intellectual property rights, the company may be forced to cease development or obtain licenses that may not be available on commercially reasonable terms [435]. - The company’s ability to protect intellectual property rights may be adversely affected by changes in foreign intellectual property laws, particularly in developing countries [430]. - The company may not be able to enforce its intellectual property rights globally due to varying patentability requirements and enforcement challenges in different jurisdictions [429]. Stock and Financial Management - As of March 28, 2023, the company had 37,991,746 shares of common stock outstanding, with an additional 1,125,831 shares issuable upon exercise of warrants from a private placement completed in March 2020 [451]. - The trading price of the company's common stock has fluctuated between $1.50 and $10.74 from its IPO in January 2018 to March 30, 2023 [453]. - The company may face significant volatility in its stock price due to various factors, including clinical trial results and regulatory developments [453]. - The company has broad discretion in the use of its cash, which could lead to ineffective spending and financial losses if not managed properly [453]. - The company may be unable to obtain additional licenses at reasonable costs, potentially hindering its ability to develop or commercialize product candidates [447].

Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.0001 Par Value EYEN Nasdaq Capital Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMIS ...

Eyenovia, Inc. (NASDAQ:EYEN) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Eric Ribner - Investor Relations Michael Rowe - Chief Executive Officer John Gandolfo - Chief Financial Officer Conference Call Participants Leonard Yaffe - Stoc Doc Partners Operator Good day and welcome to the Eyenovia’s Third Quarter 2022 Earnings Call. Today's conference is being recorded. At this time I would like to turn the conference over to Eric Ribner, LifeSci Advisors. Please go ahead. ...

Eyenovia, Inc. (NASDAQ:EYEN) Q2 2022 Earnings Conference Call August 10, 2022 4:30 PM ET Company Participants Eric Ribner - Investor Relations Sean Ianchulev - Chairman Michael Rowe - Chief Executive Officer John Gandolfo - Chief Financial Officer Conference Call Participants Matt Kaplan - Ladenburg Thalmann Leonard Yaffe - Stoc Doc Partners Operator Ladies and gentlemen, greetings and welcome to the Eyenovia Second Quarter 2022 Earnings Conference Call. [Operator Instructions] As a reminder, this conferenc ...

Table of Contents | --- | --- | |----------------------------------------------------------------------------|-------------------------------------------------------| | | | | DELAWARE | 47-1178401 | | (State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) | | 295 Madison Avenue, Suite 2400 | | | NEW YORK, NY | 10017 | | (Address of Principal Executive Offices) | (Zip Code) | | Registrant's telephone number, including area code: | (917) 289-1117 | | Securities r ...

Eyenovia, Inc. (NASDAQ:EYEN) Q1 2022 Earnings Conference Call May 12, 2022 4:30 PM ET Company Participants Eric Ribner - Investor Relations Sean Ianchulev - President, Chief Executive Officer & Chief Medical Officer Michael Rowe - Chief Operating Officer John Gandolfo - Chief Financial Officer Conference Call Participants Tim Chiang - Northland Capital Operator Thank you for standing by, and welcome to the Eyenovia First Quarter 2022 Earnings Call. During the presentation, all participants will be in a list ...