NEW YORK, March 11, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic pharmaceutical technology company, today announced that the Company will release financial results for the fourth quarter ended December 31, 2023 on Monday, March 18th, 2024, after the markets close. Following the release, Eyenovia management will host a conference call and webcast at 4:30 p.m. ET to review the financial and operating results. Participants should dial 1-877-407-9039 (domestic) or 1-201-6 ...

Approval based on nearly 9 out of 10 patients achieving complete absence of post-surgical pain and 6 out of 10 achieving total absence of inflammation within 15 days post-ocular surgery Eyenovia plans to launch in the U.S. as soon as this summer using its Mydcombi™ sales force providing pre-surgical pupil dilation and post-surgical care in an estimated $1.3 billion annual U.S. market NEW YORK, March 05, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic company, today congr ...

Alan Thornton/The Image Bank via Getty Images I shared my first Eyenovia, Inc. (NASDAQ:EYEN) article on SA on October 21, 2021 -Eyenovia: Can You See Me Now? My timing for this article was based on Eyenovia having an imminent FDA decision for the unique delivery of their optical drugs to patients. The next day after my article, October 22, 2021, the FDA submitted to Eyenovia a complete response letter (CRL) informing them that their New Drug Application (NDA) had been reclassified as a drug-device combinati ...

Redwood City, California to complement Eyenovia's facility in Reno, Nevada as well as its contract manufacturer, Coastline International, to produce commercial supply of Mydcombi NEW YORK, Feb. 13, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN), a commercial-stage ophthalmic company, today announced that the company's facility in Redwood City, California successfully completed FDA inspection for approval as a commercial manufacturing facility. The Redwood City facility will primarily be used for fina ...

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: September 30, 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 | | --- | --- | ...

Eyenovia, Inc. (NASDAQ:EYEN) Q2 2023 Earnings Conference Call August 10, 2023 4:30 PM ET Company Participants Eric Ribner - Investor Relations Michael Rowe - Chief Executive Officer John Gandolfo - Chief Financial Officer Bren Kern - Chief Operating Officer Conference Call Participants Matthew Caufield - H.C. Wainwright Raymond Wu - Ladenburg Thalmann Operator Greetings. Welcome to the Eyenovia Second Quarter 2023 Earnings Call. [Operator Instructions] As a reminder, this conference is being recorded. At th ...

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: June 30, 2023 (Exact name of Registrant as Specified in Its Charter) | DELAWARE | | 47-1178401 | | --- | --- | --- | | (State or Other Jurisdiction of | | (I.R.S. Employer | | Incorporation or Organization) | | Identification No.) | | 295 Madison Avenue, Suite 2400 | | | | NEW YORK, NY | | 1 ...

Eyenovia, Inc. (NASDAQ:EYEN) Q1 2023 Earnings Conference Call May 11, 2023 4:30 PM ET Company Participants John Gandolfo - Chief Financial Officer & Secretary Michael Rowe - Chief Executive Officer & Director Bren Kern - Chief Operating Officer & Corporate Vice President Conference Call Participants Matthew Kaplan - Ladenburg Thalmann & Co. Matthew Caufield - H.C. Wainwright & Co. Jason McDonald - Private Investor Len Yaffe - Stoc Doc Partners Operator Greetings. Welcome to Eyenovia First Quarter 2023 Earni ...

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].