Eyenovia Inc Stock Price, News & Analysis

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.

Eyenovia (NASDAQ: EYEN) has secured an agreement with Avenue Capital Management to defer principal and interest payments on its outstanding debt until February 2025. The ophthalmic technology company is implementing additional restructuring measures, including a reduction in personnel-related costs by over 70%. The company is exploring various strategic alternatives, which may include a business combination, reverse merger, or asset sales, to maximize stakeholder value.

Eyenovia (NASDAQ: EYEN) announced that its Phase 3 CHAPERONE study evaluating low-dose atropine in the Optejet platform for pediatric progressive myopia is not meeting its primary endpoint. The independent Data Review Committee found no significant difference in myopia progression between treatment arms (0.01% and 0.1% atropine) and placebo among 252 evaluable patients. The primary endpoint targeted less than 0.5 diopter progression in visual acuity over three years. While safety analysis showed all dosages were well-tolerated, the company plans to terminate the study and is considering strategic options including business combination, reverse merger, or asset sales.

Eyenovia (NASDAQ: EYEN) reported Q3 2024 financial results and corporate updates. Key developments include the U.S. launch of clobetasol propionate ophthalmic suspension 0.05% for post-operative inflammation, advancement of Phase 3 CHAPERONE study for MicroPine in pediatric myopia, and commencement of Mydcombi registration batches in second-generation Optejet device. The company reported a net loss of $7.9 million ($0.11 per share) compared to $7.3 million in Q3 2023. Operating expenses increased 10.6% to $7.2 million. Cash position stood at $7.2 million, with $10.7 million raised in combined net proceeds. The company expanded Mydcombi's reach to 230 new offices from April through September 2024.

Eyenovia (NASDAQ: EYEN), an ophthalmic technology company focused on its proprietary Optejet medication dispensing platform, will release its Q3 2024 financial results on Tuesday, November 12th, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. ET to discuss the results. Investors can join via phone (1-877-407-9039 domestic, 1-201-689-8470 international) or through the company's website. The webcast will be archived for one year on Eyenovia's website.