Financial Position and Performance - As of December 31, 2024, the company had cash and cash equivalents of $2.1 million and an accumulated deficit of approximately $195.3 million[250]. - The company incurred net losses of approximately $49.8 million and $27.3 million for the years ended December 31, 2024 and 2023, respectively[271]. - The company owed $10.2 million in principal and accrued interest under the Loan and Security Agreement as of March 15, 2025[250]. - The company has federal net operating loss carry-forwards of approximately $133.7 million as of December 31, 2024[272]. - The company expects to continue incurring cash outflows from operations for the near future, raising substantial doubt about its ability to continue as a going concern[250]. - The company may need to raise additional capital to remain a going concern, which may not be available on acceptable terms[252]. - Eyenovia recorded net sales of $57,336 for the year ended December 31, 2024, primarily from Mydcombi and clobetasol propionate[285]. Business Strategy and Operations - The company is exploring strategic paths, including partnerships and acquisitions, to maximize stockholder value[253]. - The proposed business combination with Betaliq is anticipated to close in the second quarter of 2025, but no assurance can be given regarding the completion or terms of the agreement[276]. - Eyenovia expects to incur substantial non-recurring expenses related to the proposed business combination, including legal and financial advisory fees[283]. - Eyenovia requires significant additional funding to advance the manufacturing and commercialization of Mydcombi and develop the Gen-2 Optejet[286]. Market and Competition - The commercial success of Mydcombi and clobetasol propionate is critical for Eyenovia's profitability, and their market acceptance is uncertain[291]. - The company faces competition in a rapidly changing specialty pharma market, which may affect its ability to commercialize products[293]. - Eyenovia's ability to achieve profitability is highly dependent on the successful commercialization of its currently approved products[285]. - The company may encounter challenges in convincing the medical community and third-party payors to accept and use its products[292]. Regulatory and Compliance Risks - Regulatory compliance is critical, as failure to adapt to changes in requirements could result in loss of marketing approval and negatively affect profitability[316]. - The company has obtained FDA approval for Mydcombi in the U.S., but may face challenges in obtaining approval in other jurisdictions, limiting market potential[317]. - The company must comply with strict advertising and promotion regulations, and failure to do so could result in significant penalties and harm to its reputation[322]. - The company is subject to various healthcare laws and regulations, including the federal Anti-Kickback Statute and the False Claims Act, which may impact business practices and financial arrangements[330]. - Legislative reforms, such as the Patient Protection and Affordable Care Act (ACA) and the Inflation Reduction Act of 2022, could materially affect the company's financial condition and operational results[334][337]. Intellectual Property and Legal Risks - The company’s success heavily relies on protecting its intellectual property; inadequate protection could allow competitors to erode its competitive advantage[373]. - The patent application process is complex and costly, with no assurance that all necessary patents will be obtained or enforced effectively[382]. - The company may face challenges in maintaining patent rights due to procedural non-compliance, which could lead to loss of patent protection[389]. - The company may face high costs and resource diversion from enforcing patent rights in foreign jurisdictions, where intellectual property laws may be less favorable[400]. Human Resources and Management - The company had 14 total employees as of March 15, 2025, with 13 being full-time and one part-time, relying on third-party contractors for professional services[353]. - The company is highly dependent on its senior management team, including the Chief Executive Officer, and any loss of these key personnel could impede research, development, and commercialization objectives[350]. - The company faces intense competition for qualified personnel among biotechnology and pharmaceutical companies, which may hinder its ability to retain and motivate high-quality staff[352]. Manufacturing and Supply Chain Risks - The company does not currently have agreements with third-party suppliers for the long-term commercial supply of components for Mydcombi, which may delay commercialization activities[362]. - Manufacturing processes for Mydcombi are complicated and expensive, requiring months of advance planning, and reliance on a limited number of manufacturers increases risks[364]. - The company may encounter delays in the manufacturing of the second generation Optejet device due to reliance on third parties, potentially impairing commercialization efforts[361]. - Any disruption at third-party suppliers, such as natural hazards or vandalism, could significantly interrupt manufacturing capability, risking financial stability[367]. Financial Reporting and Governance - The company is subject to the reporting requirements of the Sarbanes-Oxley Act, which increases legal, accounting, and compliance costs[424]. - Material weaknesses have been identified in the company's internal control over financial reporting, raising concerns about the accuracy and reliability of financial statements[437]. - The company is taking steps to remediate identified material weaknesses, but there is no assurance that these measures will be sufficient to prevent future weaknesses[438]. - Provisions in the company's corporate charter may discourage or prevent favorable mergers or acquisitions, potentially depressing the market price of its common stock[431].

NEW YORK, April 10, 2025 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ:EYEN) ("Eyenovia" or the "Company"), an ophthalmic technology company developing and commercializing advanced products leveraging its proprietary Optejet topical ophthalmic medication dispensing platform, today provided an update on recent progress made in the development of the Company's novel Optejet UFD. The user-filled Optejet is designed to work with a variety of topical ophthalmic liquids, including artificial tears and lens rewetting ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Delaware 001-38365 47-1178401 (State or other jurisdiction of incorporation) (Commission File Number) FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 18, 2025 23461 South Pointe Drive, Suite 390 Laguna Hills, CA 92653 (Address of Principal Executive Offices, and Zip Code) EYENOVIA, INC. (833) 393-6684 Registrant's Telephone Number, Inc ...

Core Viewpoint - The proposed reverse merger between Eyenovia, Inc. and Betaliq, Inc. aims to create a new publicly-listed ophthalmic company that combines innovative technologies for glaucoma treatment, potentially enhancing the administration of topical eye medications [1][2][7]. Company Overview - Eyenovia, Inc. specializes in developing advanced ophthalmic products using its proprietary Optejet dispensing platform, which is designed to improve patient compliance and treatment outcomes [10]. - Betaliq, Inc. focuses on developing topical glaucoma treatments utilizing its EyeSol water-free drug delivery technology, which enhances bioavailability and reduces the need for preservatives [9]. Merger Details - The merger values Betaliq at approximately $77 million and Eyenovia at about $15 million, with Betaliq equity holders expected to own around 83.7% of the combined entity [4]. - The transaction is contingent upon satisfactory due diligence, definitive agreements, board approvals, and necessary financing [3]. Technology Synergy - The merger combines Betaliq's EyeSol technology, which offers a drop size of 10 microliters and increased bioavailability, with Eyenovia's Optejet platform, which enhances usability and compliance [5]. - Both technologies are FDA-approved and are expected to create innovative treatment options for glaucoma and other ocular diseases [2][7]. Future Developments - Eyenovia is on track to file for U.S. regulatory approval for its user-filled Optejet in the fourth quarter of this year, which is compatible with various topical ophthalmic liquids [6]. - The combined company aims to leverage existing product pipelines and partnerships to expand its market presence in the eyecare sector [7].

Core Viewpoint - Eyenovia, Inc. has regained compliance with Nasdaq listing requirements, marking a significant milestone in its efforts to enhance shareholder value and advance the development of its Optejet device [1][2]. Company Overview - Eyenovia, Inc. is focused on developing its proprietary Optejet topical ophthalmic medication dispensing platform, which aims to improve treatment options for chronic front-of-the-eye diseases through enhanced safety, tolerability, and compliance compared to standard eye drops [3]. Strategic Actions - The company has taken steps to restructure and accelerate the development of the Optejet, including a reverse stock split approved by shareholders, which facilitated compliance with Nasdaq's continued listing requirements [2].

Core Viewpoint - Eyenovia, Inc. has amended its senior secured convertible debt to defer interest and principal payments until September 2025, enhancing its financial flexibility and liquidity for the development of its Optejet device [1][2]. Financial Flexibility - The Amendment allows Eyenovia to defer monthly interest and amortization payments from March 2025 through September 2025, reducing immediate cash needs [1]. - Full conversion of the debt into common shares will commence on April 1, 2025, at a conversion price of $1.68 per share [1]. Strategic Development - The Amendment is expected to strengthen Eyenovia's capital structure and improve liquidity, facilitating the development of the Optejet device towards a potential regulatory filing [2]. - The CEO expressed appreciation for the lender's confidence and indicated ongoing discussions with multiple parties to maximize shareholder value [2]. Company Overview - Eyenovia, Inc. specializes in ophthalmic technology, focusing on the Optejet topical ophthalmic medication dispensing platform, which aims to improve treatment options for chronic front-of-the-eye diseases [5].

Core Viewpoint - Eyenovia plans to submit for U.S. regulatory approval of its Optejet device in Q4 2025, which is a significant step towards commercialization [1][2] Company Overview - Eyenovia, Inc. is an ophthalmic technology company focused on developing the Optejet topical ophthalmic medication dispensing platform [6] Product Development - The Optejet is designed to address common issues with traditional eye drops, such as inaccurate administration and discomfort, potentially tapping into multi-billion-dollar ophthalmic markets [2][5] - The user-filled Optejet features a sterile disposable cartridge that users can fill with their own eyedropper bottle, capable of dispensing up to 180 metered sprays [3] - The device has undergone rigorous testing, showing that 98% of sprays are between 8-9 microliters, which aligns with the eye's capacity [4] Market Potential - The user-filled Optejet is expected to be compatible with various topical ophthalmic liquids, with projected sales of $4 billion in the U.S. for these products in the current year [5]

Core Viewpoint - Eyenovia, Inc. has announced a 1-for-80 reverse stock split to regain compliance with Nasdaq's minimum bid price requirement while evaluating strategic alternatives [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split will reduce the number of outstanding shares from approximately 167.5 million to about 2.1 million [2]. - Fractional shares will not be issued; stockholders entitled to fractional shares will receive cash payments instead [2]. - The reverse stock split will not affect stockholders' percentage ownership interests, except for cash payments for fractional shares [2]. Group 2: Company Overview - Eyenovia, Inc. focuses on developing the Optejet topical ophthalmic medication dispensing platform, which aims to improve treatment options for chronic front-of-the-eye diseases [3].

Virtual meeting scheduled for 10:00 a.m. ET on January 21st; stockholders must pre-register by 11:59 p.m. ET on January 20thNEW YORK, Jan. 15, 2025 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN) (“Eyenovia” or the “Company”), an ophthalmic technology company, today announced that the two leading independent proxy advisory firms, Institutional Shareholder Services Inc. (“ISS”) and Glass Lewis & Co. (“Glass Lewis”), have recommended that Eyenovia stockholders entitled to vote at the Company’s 2025 Special ...

Reverse Stock Split Proposal - The company is proposing a reverse stock split at a ratio between 1:40 and 1:80 to regain compliance with Nasdaq's Minimum Bid Price Requirement [1][6] - The reverse stock split aims to maintain the company's Nasdaq Capital Market listing, which provides increased visibility, stock liquidity, and access to capital [1] - Two leading proxy advisory firms, ISS and Glass Lewis, have recommended that stockholders vote in favor of the reverse stock split [6] Special Meeting Details - The Special Meeting will be held virtually on January 21, 2025, at 10:00 a.m. Eastern Time [7] - Stockholders must pre-register by January 20, 2025, at 11:59 p.m. Eastern Time to attend the meeting [7] - Stockholders of record as of December 9, 2024, are eligible to vote [7] Additional Proposals - Proposal to amend the 2018 Omnibus Stock Incentive Plan to reserve an additional 350,000 shares of common stock [9] - Proposal to approve the potential issuance of up to 73,029,273 shares upon the exercise of certain outstanding warrants [9] - Proposal to authorize an adjournment of the Special Meeting if necessary to solicit additional proxies [9] Company Overview - Eyenovia is an ophthalmic technology company developing the Optejet topical ophthalmic medication dispensing platform [8] - The Optejet platform targets both home use for ocular lubrication and chronic front-of-the-eye diseases [8] - The platform offers ease of use, enhanced safety and tolerability, and potential for improved treatment compliance [8]