Eyenovia Inc Stock Price, News & Analysis

Eyenovia (NASDAQ: EYEN) reports significant progress in developing its Optejet User Filled Device (UFD), targeting regulatory submission in Q4 2025. The device, designed for topical ophthalmic liquids including artificial tears and lens rewetting products, has successfully completed key verification and validation studies.

The completed parameters include physical requirements, usability testing, and dosing performance with precision within 1 microliter deviation. Notably, longevity testing demonstrated the device's capability to precisely dispense beyond 30,000 actuations. Safety testing, including electromagnetic interference and compatibility, has met all requirements according to IEC 60601 standards.

The company aims to submit a 510(k) application as early as September 2025, positioning the UFD Optejet to potentially double the usage efficiency of current eyedrop solutions.

Eyenovia (NASDAQ: EYEN) has entered into a non-binding letter of intent for a reverse merger with Betaliq, potentially creating a new publicly-listed eye care company. The merger would combine Betaliq's EyeSol® water-free drug delivery technology for glaucoma with Eyenovia's Optejet® dispensing platform.

The proposed transaction values Betaliq at approximately $77 million and Eyenovia at $15 million. Post-merger ownership would be split with Betaliq equity holders owning 83.7% and Eyenovia shareholders retaining 16.3% on a fully diluted basis.

The combined entity would continue marketing Eyenovia's FDA-approved products while leveraging the compatibility between EyeSol technology (featuring 10-microliter drop size) and the Optejet platform. The deal remains subject to due diligence, definitive agreements, board approvals, and financing contingencies.

Eyenovia (NASDAQ: EYEN) has successfully regained compliance with all Nasdaq Capital Market continued listing requirements, including the minimum bid price requirement rule (Rule 5550(a)(2)) and the low priced stocks rule (Rule 5810(c)(3)(A)(iii)). The compliance was achieved following a recently approved reverse stock split.

CEO Michael Rowe emphasized that maintaining the Nasdaq listing, combined with company restructuring efforts and accelerated development of the user-filled Optejet® device, represents significant milestones as they continue to explore strategic alternatives to maximize shareholder value.

Eyenovia (NASDAQ: EYEN) has announced a debt restructuring through an amendment to its senior secured convertible debt due November 1, 2025. The key changes include:

- Deferral of monthly interest and amortization payments from March 2025 through September 2025
- Option for full debt conversion into common shares starting April 1, 2025, at $1.68 per share

The restructuring aims to improve the company's near-term liquidity position and capital structure while it continues developing its proprietary Optejet® device. CEO Michael Rowe indicated that the company is in discussions with multiple parties regarding strategic alternatives to maximize shareholder value. Chardan served as the exclusive financial advisor for this transaction.

Eyenovia (NASDAQ: EYEN) announced progress on its user-filled Optejet® spray dispenser, planning U.S. regulatory submission in Q4 2025. The device aims to address common issues with traditional eye drops, including inaccurate administration and discomfort.

Key features of the next-generation Optejet include: a sterile disposable cartridge that users can fill from their eyedropper bottle, capable of 180 metered sprays; demonstrated durability with the base unit performing over 30,000 sprays; and 98% spray accuracy between 8-9 microliters. The device is designed for various topical ophthalmic liquids, targeting the artificial tears and lens rewetting market, expected to reach $4 billion in U.S. sales this year.

Eyenovia (NASDAQ: EYEN) has announced a 1-for-80 reverse stock split, effective January 31, 2025, to regain compliance with Nasdaq's minimum bid price requirement. The split will reduce outstanding shares from approximately 167.5 million to 2.1 million, with trading under the existing symbol 'EYEN' beginning on February 3, 2025.

The reverse split will not affect stockholders' percentage ownership interests, except for cash payments made in lieu of fractional shares. Proportionate adjustments will be made to outstanding stock options, warrants, and shares issuable under the company's 2018 Omnibus Stock Incentive Plan. The authorized share count and par value will remain unchanged.

Eyenovia (NASDAQ: EYEN) has engaged Chardan as financial advisor to evaluate strategic alternatives, including potential business combinations, company sale, reverse merger, or asset sale. The company is simultaneously focusing on developing its Gen-2 user-filled Optejet® device by Q3 2025 while implementing cost reduction measures of over 60%.

The company is exploring two paths for the Optejet device: a consumer 'user-filled' product through a device regulatory pathway without clinical trials, potentially available by end of year, and a proprietary drug-device combination. Eyenovia has not set a timeline for concluding the strategic review and has made no specific decisions regarding alternatives.

Eyenovia (NASDAQ: EYEN) has announced a $1.9 million registered direct offering of 20,085,025 shares of common stock (or equivalents) and warrants to purchase up to 40,170,050 shares. The combined offering price is $0.0969 per share and accompanying warrants. The warrants, exercisable at $0.0969 per share, will be valid for five years starting six months after issuance. Net proceeds will fund working capital, general corporate purposes, partial loan repayment to Avenue Capital Management, advancement of next-generation Optejet device, commercialization of Mydcombi and clobetasol propionate, and exploration of strategic alternatives. The offering is expected to close around December 9, 2024, with Chardan acting as sole placement agent.

Eyenovia (NASDAQ: EYEN) has announced a $1.3 million registered direct offering, pricing 12,081,785 shares of common stock and warrants to purchase up to 24,163,570 shares at $0.1076 per share and accompanying warrants. The warrants will be exercisable after six months at $0.1076 per share and expire five years from initial exercise date. The offering is expected to close around November 26, 2024. Net proceeds will fund working capital, general corporate purposes, potential loan repayment, advancement of Optejet device, commercialization of Mydcombi and clobetasol propionate, and exploration of strategic alternatives. Chardan is the sole placement agent.