Financial Performance and Funding - The company has incurred net losses of approximately $57.7 million since inception, with net losses of $21.2 million and $17.3 million for the years ended December 31, 2019 and 2018, respectively [237]. - As of December 31, 2019, the company had federal net operating loss carry-forwards of approximately $45.0 million, with about $10.8 million expiring between 2034 and 2037 [243]. - The company requires substantial additional funding to continue research and development activities and advance commercialization efforts, which may not be available on acceptable terms [231]. - A recent private placement raised approximately $6 million, but additional capital may cause dilution to existing stockholders [234]. - The company has not generated any product sales revenue and expects to continue incurring substantial losses while preparing product candidates for the market [236]. - The company has substantial doubt about its ability to continue as a going concern without additional funding [229]. - The company may need to significantly scale back or reprioritize research and development activities if additional capital is not available [231]. Research and Development Challenges - The company may face significant delays in clinical trials due to various factors, including patient enrollment challenges and regulatory approvals [249]. - The company’s approach to developing therapeutic product candidates is new and may never lead to marketable products, increasing investment risks [256]. - The company’s research and development activities may be impeded by scientific or technological difficulties, potentially delaying commercialization [258]. - The company is preparing for Phase III clinical trials for its lead product candidates, MicroLine and MicroPine, which are critical for obtaining regulatory approval and launching commercial sales [260]. - The success of the company's business strategy relies on developing several pipeline product candidates over the next 3-4 years, requiring substantial investment and regulatory approvals [263]. - 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 [271]. Market and Commercialization Risks - The commercial success of the product candidates will depend on market acceptance among ophthalmologists, optometrists, and third-party payors, as well as the safety and efficacy of the products [269]. - The company must establish effective distribution processes and maintain adequate sales and marketing capabilities to achieve commercial success [276]. - Regulatory approvals are essential for commercialization, and any delays or failures in obtaining these approvals could materially impair the company's ability to generate revenue [283]. - The company is exposed to risks related to product liability claims, which could divert resources and limit commercialization of its products [279]. - The company must comply with extensive regulatory requirements, including post-marketing studies and safety monitoring, which can be costly and time-consuming [291]. - The company may face penalties for non-compliance with regulatory requirements, which could include fines, product recalls, or withdrawal of marketing approvals [293]. Legal and Regulatory Environment - The company is subject to various federal and state healthcare fraud and abuse laws, which could lead to substantial penalties if compliance is not achieved [296]. - The U.S. federal anti-kickback statute prohibits remuneration for referrals related to services covered by federal healthcare programs, impacting business arrangements [296]. - Legislative changes, including the Medicare Modernization Act, have altered reimbursement methodologies, potentially reducing coverage and prices for approved products [304]. - The Affordable Care Act (ACA) includes provisions that impose fees on manufacturers and increase rebate requirements, affecting profitability [305]. - The Budget Control Act of 2011 mandates up to 2% reductions in Medicare payments to providers, impacting revenue streams [308]. Operational and Management Considerations - The company relies on a small workforce of 27 full-time employees as of March 25, 2020, and may face challenges in managing growth and infrastructure [323]. - Future performance is contingent on the ability to attract and retain qualified personnel amidst intense competition in the pharmaceutical industry [321]. - Compliance with anti-corruption laws, such as the FCPA and the Bribery Act, is critical and may incur significant costs and legal risks [312]. - The company may face delays in product launches due to pricing regulations in foreign markets, affecting revenue generation [311]. - The potential for legislative measures aimed at reducing drug costs could adversely impact anticipated revenue from product candidates [310]. Intellectual Property Risks - The company’s success depends on its ability to protect intellectual property, with potential challenges from competitors that could harm its competitive advantage [344]. - The patent application process is expensive and time-consuming, and there is no guarantee that patents will be issued to protect the company's technology [344][354]. - The company may face challenges in enforcing patent rights, which could limit its ability to prevent competitors from commercializing similar technologies [350]. - The company cannot be certain it was the first to file for patent protection, which could lead to disputes over patent rights with third parties [353]. - The patent application process is subject to numerous risks and uncertainties, which may result in partial or complete loss of patent rights in relevant jurisdictions [355]. - Competitors may seek or have already obtained patents that could limit the company's ability to make, use, and sell its potential product candidates [357]. - The company cannot assure that any of its patent applications will be found patentable or will issue as patents, which could materially harm its business [361]. - The lifespan of patents is generally 20 years after filing, and the company may not obtain adequate protection for its products if patents expire before commercialization [369]. - The company may face challenges in enforcing its intellectual property rights globally, particularly in jurisdictions with less favorable patent laws [376]. - Legal proceedings to enforce patent rights could result in substantial costs and divert resources from other business aspects [379]. - The company’s commercial success depends on its ability to develop and market product candidates without infringing third-party intellectual property rights [383]. - The company may face substantial intellectual property litigation risks, including potential infringement claims from third parties [384]. - If found to infringe on third-party intellectual property rights, the company could be forced to cease development or obtain licenses that may not be commercially reasonable [385]. - The company relies on licenses for certain patent rights and proprietary technology, which may not provide exclusive rights, potentially allowing competitors to develop similar products [396]. - The company may be unable to control patent prosecution or maintenance under licensing agreements, risking the validity and enforceability of necessary patents [397]. Stockholder and Market Considerations - The company’s management and Board of Directors beneficially owned approximately 23% of the capital stock as of March 25, 2020, allowing them to influence stockholder decisions significantly [407]. - A significant portion of the company's outstanding shares may be sold into the market in the near future, potentially causing a significant drop in stock price [408]. - As of March 25, 2020, the company had 19,776,019 shares of common stock outstanding, including 2,675,293 shares issued in a recent private placement [409]. - The per share trading price of the company's common stock has fluctuated between $1.77 and $10.74 from the IPO in January 2018 to March 25, 2020 [412]. - The company is required to file a resale registration statement with the SEC within the next 30 days for shares issued in the private placement and warrants [409]. - The company has broad discretion in the use of cash from financings, which could impact operational results if not applied effectively [414]. - The company is subject to increased legal, accounting, and financial compliance costs due to regulations such as the Sarbanes-Oxley Act [417]. - The company identified material weaknesses in internal controls in 2017, which have since been remedied, but future weaknesses may arise [421]. - The company is classified as an "emerging growth company," allowing it to delay adopting new accounting standards [424]. - The company will remain an emerging growth company until certain financial thresholds are met, including a market value exceeding $700 million or total annual gross revenue of $1.07 billion [426]. - The stock market has experienced extreme price fluctuations, which could affect the company's stock price and trading activity [412]. - The company may face challenges in maintaining effective internal controls, which could adversely affect financial reporting and investor confidence [422].

Financial Data and Key Metrics Changes - For Q4 2019, the company reported a net loss of approximately $5.2 million, or $0.31 per share, compared to a net loss of approximately $6.2 million, or $0.60 per share, for Q4 2018, indicating an improvement in financial performance [44] - For the full year 2019, the net loss was approximately $21.2 million, or $1.47 per share, compared to a net loss of approximately $17.3 million, or $1.82 per share, for 2018, reflecting an increase in losses year-over-year [47] - Research and development expenses for Q4 2019 totaled approximately $3.3 million, a decrease of 19.4% from approximately $4.1 million in Q4 2018 [45] - General and administrative expenses for Q4 2019 were approximately $2 million, down from approximately $2.1 million in Q4 2018, a decrease of 4.5% [46] - Total operating expenses for Q4 2019 were approximately $5.3 million, a decrease of 14.5% from approximately $6.2 million in Q4 2018 [46] - As of December 31, 2019, the company's cash and cash equivalents balance was approximately $14.2 million, excluding the net proceeds from a private placement that closed on March 24, 2020 [50] Business Line Data and Key Metrics Changes - The company successfully completed Phase III studies for MicroStat, validating its technology and approach for pharmacologic mydriasis [10][18] - The initiation of the MicroPine Phase III study for progressive myopia was highlighted as a significant achievement, with hopes to complete patient enrollment by the end of 2020 [11] - The MicroLine program for presbyopia was introduced, with plans to initiate the Phase III VISION trial in the coming months [12] Market Data and Key Metrics Changes - The company believes its reprioritized pipeline represents an approximately $7 billion total market opportunity in the United States [9] - The prevalence of myopia is expected to grow significantly, with nearly half of the population in North America and East Asia projected to be myopic by 2030 [23] Company Strategy and Development Direction - The company is focusing on high-value indications in its pipeline, including MicroStat, MicroPine, and MicroLine, to address significant unmet medical needs [9][12] - The company aims to leverage its patented piezo-print delivery technology to enhance treatment options for ocular diseases [9] - The company is preparing for the potential launch of MicroStat in 2021, aligning its promotional sales and pricing strategy accordingly [34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about 2020, anticipating milestones in Phase III programs and the planned NDA for MicroStat, while closely monitoring the impact of the COVID-19 pandemic [52] - The company has taken proactive measures to ensure supply chain stability and clinical trial continuity amid the pandemic [15][66] Other Important Information - The company successfully closed a private placement, which is expected to fund operations into the first quarter of 2021 [43] - The company is expanding its Scientific Advisory Board to enhance its clinical development efforts [13] Q&A Session Summary Question: Can you help us understand the competitive landscape with respect to new treatments for presbyopia? - Management acknowledged that there are other companies exploring pharmacologic treatments for presbyopia, but emphasized their unique approach and the opportunity for lifestyle modifications [55] Question: Where are you in preparation for the NDA filing for MicroStat? - Management confirmed that they are waiting for physical stability studies and expect to file the NDA by the end of 2020, with no anticipated impact from COVID-19 [58] Question: How do you think MicroStat will be adopted by practices? - Management highlighted the value proposition of MicroStat, including faster patient throughput, improved comfort, and competitive pricing compared to current practices [59] Question: Can you clarify the current enrollment status of the CHAPERONE trial? - Management stated that they aim to fully enroll the study by the end of 2020, despite some disruptions due to the pandemic [73] Question: What are the expected operating expenses for 2020? - Management indicated that cash-based operating expenses are expected to average around $4.5 million to $4.6 million per quarter, with flexibility to reduce expenses if necessary [77]

PART I – FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements.) The unaudited condensed financial statements reflect increased operating losses and cash burn driven by higher R&D expenses [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) The balance sheet shows decreased total assets and an increased accumulated deficit, reflecting ongoing net losses Condensed Balance Sheet Highlights (in thousands) | Balance Sheet Item | Sep 30, 2019 (Unaudited) | Dec 31, 2018 | | :--- | :--- | :--- | | Cash and cash equivalents | $18,296 | $19,728 | | Total Current Assets | $18,693 | $19,861 | | Total Assets | $18,882 | $20,015 | | Total Current Liabilities | $2,433 | $3,099 | | Total Liabilities | $2,478 | $3,140 | | Accumulated deficit | $(52,430) | $(36,514) | | Total Stockholders' Equity | $16,404 | $16,875 | [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) The company reported no revenue and a widening net loss driven by a significant rise in R&D expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2019 | Q3 2018 | 9 Months 2019 | 9 Months 2018 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,201 | $2,488 | $10,778 | $6,994 | | General and administrative | $1,490 | $1,833 | $5,242 | $4,079 | | Total Operating Expenses | $4,691 | $4,320 | $16,020 | $11,073 | | Loss From Operations | $(4,691) | $(4,320) | $(16,020) | $(11,073) | | Net Loss | $(4,649) | $(4,321) | $(15,915) | $(11,070) | | Net Loss Per Share | $(0.29) | $(0.43) | $(1.19) | $(1.20) | [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operations increased, partially offset by cash from a public stock offering Cash Flow Summary for the Nine Months Ended Sep 30 (in thousands) | Cash Flow Activity | 2019 | 2018 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | $(14,899) | $(9,005) | | Net Cash Used In Investing Activities | $(43) | $0 | | Net Cash Provided By Financing Activities | $13,510 | $24,800 | | Net (Decrease) Increase in Cash | $(1,432) | $15,795 | | Cash at End of Period | $18,296 | $21,044 | [Notes to Unaudited Condensed Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Notes detail the company's clinical-stage status, reliance on Optejet technology, and sufficient cash position - The company is a clinical-stage ophthalmic biopharmaceutical company developing microdose therapeutics using its patented Optejet piezo-print delivery technology[28](index=28&type=chunk) - Management believes **current cash on hand is sufficient** to meet operating and capital requirements for at least the next twelve months from the date of the report's issuance[32](index=32&type=chunk) - In July 2019, the company closed a public offering, issuing 5,046,763 shares and receiving **net proceeds of approximately $13.0 million**[60](index=60&type=chunk) - Subsequent to the quarter end, the company announced it is advancing its MicroLine program and deferring others, expecting **cost savings of $1.5 million to $1.9 million in 2020**[79](index=79&type=chunk) [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.) Management discusses its business strategy, financial results, and liquidity, attributing increased net loss to R&D activities [Overview](index=20&type=section&id=Overview) The company is strategically prioritizing its development pipeline, advancing key programs toward Phase III trials and NDA submission - The company is advancing its MicroLine program for presbyopia towards Phase III development and plans to initiate and complete the **Phase III VISION trials in 2020**[84](index=84&type=chunk)[85](index=85&type=chunk) - The Phase III CHAPERONE study for MicroPine (progressive myopia) began enrolling patients in June 2019, with **enrollment expected to complete in 2020**[85](index=85&type=chunk) - Following positive results from the MIST-1 and MIST-2 Phase III trials for MicroStat (mydriasis), the company plans to **submit an NDA to the FDA in 2020**[85](index=85&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) Operating expenses increased year-over-year, driven primarily by expanded clinical trial activities and hiring Research and Development Expenses (in thousands) | Expense Category | Q3 2019 | Q3 2018 | 9 Months 2019 | 9 Months 2018 | | :--- | :--- | :--- | :--- | :--- | | Direct clinical/non-clinical | $1,650 | $1,240 | $6,060 | $3,429 | | Personnel-related | $729 | $675 | $2,254 | $1,726 | | Non-cash stock-based comp. | $255 | $240 | $1,156 | $557 | | **Total R&D Expenses** | **$3,201** | **$2,488** | **$10,778** | **$6,994** | - The increase in R&D expenses was primarily due to an increase in contracted services and hiring as the company expanded its research and development activities[97](index=97&type=chunk)[101](index=101&type=chunk) - G&A expenses for the nine months ended Sep 30, 2019 **increased by $1.1 million (28%)** compared to the same period in 2018, driven by higher payroll, public company costs, marketing analysis, and rent[102](index=102&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) The company maintains a sufficient cash position with no debt, supported by a recent public offering - The company had a **cash balance of $18.3 million** and working capital of $16.3 million as of September 30, 2019[103](index=103&type=chunk)[104](index=104&type=chunk) - Management expects **current cash to be sufficient** to meet operating and capital requirements for at least the next twelve months from the filing date[104](index=104&type=chunk) - For the nine months ended September 30, 2019, cash provided by financing activities was **$13.5 million**, primarily from the July 2019 public offering ($13.0 million net proceeds) and stock option exercises ($0.5 million)[107](index=107&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=24&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Eyenovia is not required to provide information for this item - The company is a smaller reporting company and is **not required to provide the information** required by this item[112](index=112&type=chunk) [Controls and Procedures](index=24&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that the company's disclosure controls and procedures were effective as of the quarter's end - Based on an evaluation as of September 30, 2019, the principal executive officer and principal financial officer concluded that the company's **disclosure controls and procedures were effective**[115](index=115&type=chunk) - **No changes in internal control over financial reporting** occurred during the third quarter of 2019 that materially affected, or are reasonably likely to materially affect, internal controls[116](index=116&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=25&type=section&id=Item%201.%20Legal%20Proceedings.) The company reported no legal proceedings - None[120](index=120&type=chunk) [Risk Factors](index=25&type=section&id=Item%201A.%20Risk%20Factors.) As a smaller reporting company, Eyenovia is not required to provide information for this item - The company is a smaller reporting company and is **not required to provide the information** required by this item[122](index=122&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=25&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The company reported no unregistered sales and confirmed full deployment of its IPO proceeds - As of September 30, 2019, **all net proceeds from the company's initial public offering have been deployed** as described in the final prospectus dated January 24, 2018[127](index=127&type=chunk) [Other Information](index=25&type=section&id=Item%205.%20Other%20Information.) The company reported no other information for this item - None[134](index=134&type=chunk) [Exhibits](index=26&type=section&id=Item%206.%20Exhibits.) This section lists the exhibits filed with the quarterly report, including officer certifications

Company Overview - Eyenovia is a specialty ophthalmic biopharmaceutical company focused on developing late-stage pipeline products for front and back-of-the-eye indications[5] - The company's pipeline includes MicroPine, MicroProst, MicroStat, and MicroTears, targeting markets with significant potential[6] Product Pipeline & Clinical Trials - MicroPine is in Phase III clinical trials for the reduction of pediatric myopia progression, with patient enrollment expected to be completed by the end of 2020[5, 8] - MicroProst, aimed at reducing intraocular pressure in CACG, OAG, and OHT, is scheduled to begin Phase III trials by the end of 2019[5, 8] - MicroStat, for pharmacologic mydriasis, has completed Phase III trials with positive results and is expected to have an NDA filing in 2020[17, 26] - MicroTears, an OTC product for red eye and itch relief/lubrication, is planned for launch concurrently with MicroStat[7, 18] Market Opportunity - The U S market for progressive myopia is estimated to be over $5 billion[6] - The market for glaucoma (CACG+OAG+OHT) is estimated to be over $1.5 billion[6] - The market for mydriasis is estimated to be over $250 million[6] - The OTC eye care market is estimated to be over $850 million[6] Technology & Efficacy - Eyenovia's Optejet technology delivers microdoses of medication, potentially reducing side effects and improving patient compliance[11, 21] - EYN PG21 study showed that 100% of patients achieved IOP reduction ≥ 20%[12] - In technician administration, 95% achieved successful delivery on the first attempt[14] Financial Status - As of September 9, 2019, the share price was $4.17, and the market cap (fully diluted) was $81 million[27] - As of June 30, 2019, the company had $9.2 million in cash, excluding $13.0 million from an underwritten public offering in July 2019[27]

PART I - FINANCIAL INFORMATION [Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements.) The statements present the company's financial position, operational results, and cash flows, highlighting a widening net loss and significant cash usage offset by a subsequent public offering [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased significantly to $10.0 million from $20.0 million due to a reduction in cash, with stockholders' equity falling to $7.6 million Condensed Balance Sheet Highlights (in USD) | Balance Sheet Item | June 30, 2019 | December 31, 2018 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $9,239,609 | $19,728,200 | | Total Current Assets | $9,809,170 | $19,860,956 | | **Total Assets** | **$10,035,978** | **$20,015,494** | | **Liabilities & Equity** | | | | Total Current Liabilities | $2,373,232 | $3,098,841 | | **Total Liabilities** | **$2,418,049** | **$3,140,425** | | **Total Stockholders' Equity** | **$7,617,929** | **$16,875,069** | [Condensed Statements of Operations](index=5&type=section&id=Unaudited%20Condensed%20Statements%20of%20Operations) The company reported no revenue and a widening net loss to $11.3 million for the six-month period, driven by increased R&D and G&A expenses Statement of Operations Summary (in USD, except per share data) | Metric | Three Months Ended June 30, 2019 | Three Months Ended June 30, 2018 | Six Months Ended June 30, 2019 | Six Months Ended June 30, 2018 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,568,022 | $2,412,164 | $7,576,918 | $4,506,259 | | General and administrative | $1,809,106 | $908,806 | $3,751,869 | $2,246,455 | | **Loss From Operations** | **($5,377,128)** | **($3,320,970)** | **($11,328,787)** | **($6,752,714)** | | **Net Loss** | **($5,333,512)** | **($3,319,063)** | **($11,265,896)** | **($6,748,670)** | | Net Loss Per Share | ($0.44) | ($0.33) | ($0.94) | ($0.77) | [Condensed Statements of Cash Flows](index=8&type=section&id=Unaudited%20Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operations for the six-month period nearly doubled to $11.0 million, resulting in a net cash decrease of $10.5 million Cash Flow Summary for the Six Months Ended June 30 (in USD) | Cash Flow Item | 2019 | 2018 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | ($11,040,368) | ($5,431,303) | | Net Cash Provided By Financing Activities | $551,777 | $24,743,503 | | Net (Decrease) Increase in Cash | ($10,488,591) | $19,312,200 | | Cash and Cash Equivalents - End of Period | $9,239,609 | $24,561,711 | [Notes to Unaudited Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Notes detail the company's clinical-stage status, reliance on external financing, and a subsequent public offering that raised approximately $13.0 million - Eyenovia is a clinical-stage ophthalmic biopharmaceutical company developing microdose therapeutics with its patented Optejet piezo-print delivery technology[26](index=26&type=chunk) - The company has **not yet generated revenues** and expects to continue to incur cash outflows from operations, believing current cash is sufficient for the next twelve months[29](index=29&type=chunk)[30](index=30&type=chunk) - In July 2019, the company closed a public offering, receiving **net proceeds of approximately $13.0 million** after deducting underwriting discounts and other expenses[72](index=72&type=chunk) - The company has various related-party transactions, including consulting, lease, and R&D service agreements[52](index=52&type=chunk)[54](index=54&type=chunk)[55](index=55&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=17&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses increased operating expenses driving larger net losses and the company's reliance on equity financing to fund future operations [Overview](index=17&type=section&id=Overview) Eyenovia is a clinical-stage company developing microdose therapeutics, with plans for an NDA submission in 2020 and an ongoing Phase III trial - The company has completed Phase III trials for MicroStat and plans to submit a **New Drug Application (NDA) to the FDA in 2020**[77](index=77&type=chunk) - The company enrolled its first patient in the **Phase III CHAPERONE study for MicroPine** in June 2019, targeting the reduction of myopia progression in children[77](index=77&type=chunk) - As of the report date, the company has **not completed the development of any product** and has not generated any revenue from product sales[80](index=80&type=chunk) [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Operating expenses increased significantly year-over-year, driven by expanded clinical activities, increased headcount, and higher stock-based compensation R&D Expense Breakdown - Three Months Ended June 30 (in USD) | Expense Category | 2019 | 2018 | | :--- | :--- | :--- | | Direct clinical and non-clinical | $2,219,648 | $1,123,115 | | Personnel-related | $783,708 | $629,776 | | Non-cash stock-based compensation | $206,834 | $11,369 | | Facilities and other | $357,832 | $647,904 | | **Total R&D Expenses** | **$3,568,022** | **$2,412,164** | R&D Expense Breakdown - Six Months Ended June 30 (in USD) | Expense Category | 2019 | 2018 | | :--- | :--- | :--- | | Direct clinical and non-clinical | $4,409,969 | $2,189,392 | | Personnel-related | $1,524,941 | $1,050,992 | | Non-cash stock-based compensation | $900,917 | $316,290 | | Facilities and other | $741,091 | $949,585 | | **Total R&D Expenses** | **$7,576,918** | **$4,506,259** | - The increase in G&A expenses for Q2 2019 was primarily due to higher payroll ($0.2M), non-cash stock-based compensation ($0.2M), advertising and marketing ($0.2M), public company costs ($0.2M), and insurance ($0.1M)[90](index=90&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds a cash balance of $9.2 million against an accumulated deficit of $47.8 million, with a recent public offering expected to fund operations for at least twelve months - As of June 30, 2019, the company had a **cash balance of $9.2 million** and an **accumulated deficit of $47.8 million**[94](index=94&type=chunk)[95](index=95&type=chunk) - In July 2019, the company raised approximately **$13 million in net proceeds** from a public offering, which is expected to fund operations for at least the next twelve months[95](index=95&type=chunk) - **Net cash used in operating activities** for the six months ended June 30, 2019 was **$11.0 million**, compared to $5.4 million for the same period in 2018[96](index=96&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=21&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Eyenovia is not required to provide the information for this item - Smaller reporting companies such as us are not required to provide the information required by this item[102](index=102&type=chunk) [Controls and Procedures](index=21&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that as of June 30, 2019, the company's disclosure controls and procedures were effective at a reasonable assurance level - The principal executive officer and principal financial officer concluded that as of June 30, 2019, the company's **disclosure controls and procedures were effective** to provide reasonable assurance[105](index=105&type=chunk) - There were **no material changes in internal control** over financial reporting during the second quarter of 2019[106](index=106&type=chunk) PART II - OTHER INFORMATION [Legal Proceedings](index=22&type=section&id=Item%201.%20Legal%20Proceedings.) The company reported no legal proceedings - None[110](index=110&type=chunk) [Risk Factors](index=22&type=section&id=Item%201A.%20Risk%20Factors.) As a smaller reporting company, Eyenovia is not required to provide the information for this item - Smaller reporting companies such as us are not required to provide the information required by this item[112](index=112&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=22&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) The company issued 584,967 shares from stock option exercises for $551,777 in proceeds and confirmed no material change in the use of IPO proceeds - During the six-month period ended June 30, 2019, the company issued an aggregate of **584,967 shares of common stock** upon the exercise of stock options for aggregate consideration of **$551,777**[114](index=114&type=chunk) - There has been **no material change in the expected use of the net proceeds** from the initial public offering as described in the final prospectus dated January 24, 2018[117](index=117&type=chunk) [Defaults Upon Senior Securities](index=22&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) Not applicable - Not applicable[120](index=120&type=chunk) [Mine Safety Disclosures](index=22&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) Not applicable - Not applicable[122](index=122&type=chunk) [Other Information](index=22&type=section&id=Item%205.%20Other%20Information.) The company reported no other information - None[124](index=124&type=chunk) [Exhibits](index=23&type=section&id=Item%206.%20Exhibits.) This section lists exhibits filed with the Form 10-Q, including officer certifications and interactive data files - Exhibits filed include certifications of the Principal Executive Officer and Principal Financial and Accounting Officer, and interactive data files (XBRL)[126](index=126&type=chunk)

Eyenovia, Inc. (NASDAQ:EYEN) Q1 2019 Earnings Conference Call May 14, 2019 8:30 AM ET Company Participants Tram Bui - The Ruth Group Sean Ianchulev - CEO, President, Chief Medical Officer & Director John Gandolfo - CFO & Secretary Conference Call Participants Esther Rajavelu - Oppenheimer Maria Barbera - Ladenburg Thalmann & Co. Yi Chen - H.C. Wainwright & Co. Jonathan Aschoff - National Securities Corporation Operator Good morning, ladies and gentlemen, and welcome to the Eyenovia First Quarter 2019 Earnin ...

Eyenovia, Inc. (NASDAQ:EYEN) Q4 2018 Earnings Conference Call March 27, 2019 8:30 AM ET Company Participants Tram Bui - The Ruth Group Sean Ianchulev - CEO & Chief Medical Officer John Gandolfo - CFO Conference Call Participants Matt Kaplan - Ladenburg Thalmann Scott Henry - ROTH Capital Jonathan Aschoff - National Securities Yi Chen - H.C. Wainwright Operator Good day ladies and gentlemen and welcome to the Eyenovia Fourth Quarter and Full Year 2018 Earnings Conference Call. At this time, all participants ...