Eyenovia(EYEN)

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Eyenovia Provides Development Update on Optejet User Filled Device (UFD)
Newsfilter· 2025-04-10 11:00
Core Insights - Eyenovia, Inc. is advancing its Optejet UFD, a user-filled device designed for various topical ophthalmic liquids, targeting multiple billion-dollar markets [1][2] - The company has completed significant Verification & Validation studies to ensure the device meets customer requirements and is on track for a 510(k) submission by September [2] - The Optejet UFD aims to enhance user experience by allowing consumers to obtain twice as many uses from their current eyedrops [2] Company Overview - Eyenovia, Inc. specializes in ophthalmic technology, focusing on developing and commercializing advanced products using its proprietary Optejet platform [3] - The current commercial portfolio includes clobetasol propionate ophthalmic suspension for post-surgical pain and inflammation, and Mydcombi® for mydriasis [3] Product Development - The Optejet UFD has undergone extensive testing, including usability, dosing performance, and safety testing, demonstrating its capability to dispense ophthalmic solutions accurately and reliably [5][6] - Key components of the device have been tested over 30,000 times, confirming its durability and performance standards [5] Market Potential - The combination of the Optejet UFD with artificial tears or lens rewetting solutions is expected to significantly improve treatment options and outcomes for patients [2][3]
Eyenovia(EYEN) - 2024 Q4 - Annual Results
2025-03-20 20:05
Business Combination - Eyenovia entered into a non-binding letter of intent for a proposed business combination with Betaliq, a clinical stage pharmaceutical company focused on Glaucoma [4]. - The proposed transaction is structured as a reverse merger, with Betaliq becoming a wholly-owned subsidiary of Eyenovia [5]. - Betaliq stockholders are expected to receive approximately 83.7% of the equity of the combined company, while Eyenovia stockholders would own approximately 16.3% [9]. - The valuation for Betaliq is approximately $77 million, while Eyenovia is valued at approximately $15 million [9]. - The completion of the business combination is subject to satisfactory due diligence, board approvals, and other customary closing conditions [12]. - The exclusivity period for negotiations ends on May 16, 2025, but may be extended [11]. - If the business combination is not completed, Eyenovia may need to evaluate other strategic alternatives, which could negatively impact stockholders [19]. - Forward-looking statements indicate uncertainties regarding the completion of the business combination and its potential benefits [24]. Financial Position - As of December 31, 2024, Eyenovia had approximately $2.1 million in cash [14]. - Eyenovia anticipates incurring substantial transaction costs related to the business combination, including legal and advisory fees [22].
Eyenovia Enters into Non-Binding Letter of Intent to Effect Reverse Merger with Betaliq
Globenewswire· 2025-03-20 11:00
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].
Eyenovia Regains Compliance with All Nasdaq Continued Listing Requirements
Globenewswire· 2025-02-26 12:00
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].
Eyenovia, Inc. Announces Debt Restructuring Including Amendment to Senior Secured Debt, Improving Cash Runway to Allow for the Evaluation of Strategic Alternatives
Globenewswire· 2025-02-24 12:00
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].
Eyenovia Announces Progress on Next-Generation User-Filled Optejet Dispensing Device
Globenewswire· 2025-02-05 12:00
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]
Eyenovia Announces 1-for-80 Reverse Stock Split
Globenewswire· 2025-01-28 21:05
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].
Eyenovia Announces Leading Proxy Advisory Firms, ISS and Glass Lewis, Recommend Eyenovia Stockholders Vote “FOR” Proposed Reverse Stock Split at Upcoming Special Meeting of Stockholders
Globenewswire· 2025-01-15 12:00
Core Viewpoint - Eyenovia, Inc. is seeking stockholder approval for a reverse stock split to comply with Nasdaq's Minimum Bid Price Requirement, with recommendations from leading proxy advisory firms ISS and Glass Lewis to vote "FOR" the proposal [1][2]. Meeting Details - The 2025 Special Meeting of Stockholders is scheduled for January 21, 2025, at 10:00 a.m. ET, and stockholders must pre-register by January 20, 2025, at 11:59 p.m. ET [3]. - Stockholders of record as of December 9, 2024, are eligible to vote [3]. Proposed Items for Vote - The reverse stock split will be considered among four proposed items at the Special Meeting, including: 1. Approval of a reverse stock split at a ratio of between 1:40 and 1:80 [7]. 2. Amendment to the 2018 Omnibus Stock Incentive Plan to reserve an additional 350,000 shares [7]. 3. Approval for potential issuance of up to 73,029,273 shares upon the exercise of certain outstanding warrants [7]. 4. Authorization for adjournment of the Special Meeting if necessary [7]. Company Overview - Eyenovia, Inc. is an ophthalmic technology company developing the Optejet platform for topical ophthalmic medication, aimed at improving treatment compliance for ocular lubrication and chronic front-of-the-eye diseases [5].
Eyenovia Announces Leading Proxy Advisory Firms, ISS and Glass Lewis, Recommend Eyenovia Stockholders Vote "FOR" Proposed Reverse Stock Split at Upcoming Special Meeting of Stockholders
Newsfilter· 2025-01-15 12:00
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]
Eyenovia Engages Chardan as Advisor for Review of Strategic Alternatives
Globenewswire· 2025-01-06 12:00
Core Viewpoint - Eyenovia, Inc. is focused on completing the development of its Gen-2 user-filled Optejet device by the third quarter of 2025 while aiming to reduce spending by over 60% [1] Strategic Alternatives - The company has engaged Chardan as its financial advisor to evaluate a range of strategic alternatives, including business combinations, sales, reverse mergers, asset sales, or a combination of these options [1][2] - Eyenovia has not set a timetable for the conclusion of its strategic review and has not made any decisions regarding specific alternatives at this time [3] Product Development - Eyenovia continues to progress the development of its Optejet device, exploring its use as both a consumer user-filled product and a proprietary drug-device combination [2] - The user-filled product could advance through a regulatory pathway without the need for clinical trials and may be commercially available by the end of this year [2] Company Overview - Eyenovia, Inc. specializes in developing its proprietary Optejet topical ophthalmic medication dispensing platform, which is designed to improve treatment options for chronic front-of-the-eye diseases [5]