Financial Performance - Eyenovia reported a net loss of $3.5 million, or $1.59 per share, for Q1 2025, a significant improvement from a net loss of $10.9 million, or $18.75 per share, in Q1 2024[7]. - Total operating expenses for Q1 2025 were $3.0 million, representing a 70% decrease from $10.1 million in Q1 2024[8]. Expenses Management - Research and development expenses decreased by 85% to $0.7 million in Q1 2025, compared to $4.4 million in Q1 2024[7]. - General and administrative expenses were reduced by 35% to $2.4 million in Q1 2025, down from $3.6 million in Q1 2024[8]. - Eyenovia has reduced ongoing cash burn by approximately 70% compared to the previous year and has entered into a debt restructuring agreement deferring certain repayment obligations until October 2025[4][6]. Cash Position - As of March 31, 2025, Eyenovia's unrestricted cash and cash equivalents increased to $3.9 million from $2.1 million as of December 31, 2024[8]. - The total assets of Eyenovia as of March 31, 2025, were $5.98 million, compared to $3.67 million as of December 31, 2024[14]. Strategic Initiatives - The company is on track to file for U.S. regulatory approval for the Optejet user-filled device in September 2025, which could lead to multiple commercial opportunities[3][5]. - Eyenovia is negotiating a binding merger agreement with Betaliq, extending the exclusivity period until June 7, 2025, to finalize the agreement[2]. - The company aims to maximize shareholder value through the merger with Betaliq, which is expected to create a new eyecare company with immediate revenue from existing FDA-approved products[5].

Eyenovia and Betaliq continue to negotiate a binding merger agreement consistent with the previously announced signed Letter of Intent Reports continued progress on the development of the user-filled Optejet, and remains on track to file for U.S. device regulatory approval in September 2025 Reduced ongoing cash burn by approximately 70% versus prior year and improved debt repayment terms LAGUNA HILLS, Calif., May 19, 2025 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company de ...

Revenue and Financial Performance - Revenue for Q1 2025 totaled $14,720, a significant increase from $4,993 in Q1 2024, with cost of revenues at $48 and $203,027 respectively[83] - The company reported a net loss of $3.5 million for Q1 2025, reduced from $9.9 million in Q1 2024[77] - The company reported net losses of $3.5 million for the three months ended March 31, 2025, compared to $10.9 million for the same period in 2024[91] - Other income (expense) for Q1 2025 was approximately $0.5 million of net other expense, a decrease from $0.7 million in Q1 2024[88] - Net cash used in operating activities was approximately $4.4 million for the three months ended March 31, 2025, a decrease from $9.9 million in the same period of 2024[93] - Net cash provided by financing activities totaled approximately $6.3 million for the three months ended March 31, 2025, compared to $3.1 million in the same period of 2024[95] Expenses and Cost Management - Research and development expenses decreased by 85% to $0.7 million in Q1 2025 from $4.4 million in Q1 2024, primarily due to layoffs and the wind down of clinical trials[84] - General and administrative expenses for Q1 2025 were $2.4 million, down 35% from $3.6 million in Q1 2024, reflecting cost-cutting measures[86] Financial Position and Compliance - As of March 31, 2025, the company had an accumulated deficit of approximately $198.8 million[77] - The working capital deficit improved to $9.9 million as of March 31, 2025, from $13.3 million as of December 31, 2024[89] - The company has commitments to pay $5.1 million for accounts payable and $10.8 million for notes payable within the next twelve months[96] - The accumulated deficit as of March 31, 2025, was approximately $198.8 million[91] - The company faces substantial doubt about its ability to continue as a going concern for at least one year from the date of the financial statements[92] - The company intends to submit a plan to regain compliance with Nasdaq's minimum equity requirement of $2,500,000 by June 13, 2025[76] - The company regained compliance with Nasdaq's minimum bid price requirement of $1.00 per share after a reverse stock split on January 31, 2025[75] Strategic Initiatives - The company entered into a non-binding letter of intent for a proposed business combination with Betaliq, a clinical stage pharmaceutical company focused on glaucoma[71] - The company plans to submit its Optejet user-filled device for regulatory approval in the U.S. in the second half of 2025[70] Market and Operational Risks - The ongoing "Tariff War" could adversely affect the company's supply chain and product demand, impacting financial performance[97] - The company has no off-balance sheet arrangements that could materially affect its financial conditions[100]

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]