Eyenovia Inc Stock Price, News & Analysis

Eyenovia Inc. (NASDAQ: EYEN), an ophthalmic technology company, announced its participation in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference on August 15th, 2024. The company's pre-recorded presentation will be available on-demand starting at 7:00 am EDT on the conference day.

Eyenovia is known for commercializing Mydcombi™, an ophthalmic spray for mydriasis, and clobetasol propionate ophthalmic suspension for postsurgical inflammation and pain. They are also developing the Optejet® device for pediatric progressive myopia and dry eye treatments, with potential for out-licensing in additional indications.

Investors and interested parties can access the presentation by registering for the conference. Virtual 1x1 meetings with Eyenovia management can be arranged through H.C. Wainwright representatives.

Eyenovia Inc (NASDAQ: EYEN) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:

1. Plans for validation of the Gen-2 Optejet® device with 2025 regulatory submission for Mydcombi™.
2. Advancement of Phase 3 CHAPERONE study for MicroPine in pediatric progressive myopia.
3. Collaboration agreements with Formosa, Senju, and SGN for dry eye disease treatments.
4. Expanded Mydcombi sales to 63 new offices in Q2, targeting 263 by Q3 end.

Financially, Eyenovia reported a net loss of $11.1 million ($0.21 per share) for Q2 2024, compared to $6.2 million ($0.16 per share) in Q2 2023. The company had $2.3 million in cash as of June 30, 2024, excluding $5.8 million from subsequent equity offerings.

Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, has announced its plans to release financial results for the second quarter ended June 30, 2024 on Monday, August 12th, 2024, after market close. The company will host a conference call and webcast at 4:30 p.m. ET to review the financial and operating results.

Investors can participate by dialing 1-877-407-9039 (domestic) or 1-201-689-8470 (international) with Conference ID# 13747356. A live webcast will be available on the company's website, and the event will be archived for one year after the live webcast.

Eyenovia (NASDAQ: EYEN) and Formosa Pharmaceuticals (TWO:6838) have initiated co-development of clobetasol propionate ophthalmic suspension (0.05%) for treating acute dry eye disease in the U.S. This collaboration expands their existing agreement from February 2023. The product will combine clobetasol propionate, a potent steroid FDA-approved on March 4, 2024, with Eyenovia's Optejet® device.

The U.S. market for topical ocular steroids and steroid combinations is worth approximately $1.3 billion. This new indication could benefit millions experiencing dry eye flare-ups. The companies will share development costs and profits upon commercialization, pending due diligence and a definitive agreement.

Formosa Pharmaceuticals and Eyenovia have announced a collaboration to co-develop Clobetasol Propionate Ophthalmic Suspension 0.05% for the short-term relief of dry eye disease in the United States. This agreement expands their existing partnership from February 2023. Clobetasol propionate, a potent steroid, was FDA-approved on March 4, 2024, for reducing inflammation and pain associated with ocular surgeries. The additional acute dry eye indication could benefit millions experiencing flare-ups, as about 80% of dry eye patients suffer from flare-ups. Formosa's proprietary APNT® nanoparticle formulation platform enhances the drug's bioavailability, while Eyenovia's Optejet® dispenser technology offers advanced delivery. This collaboration aims to address a significant market, with approximately 2 million people in the US treated with prescription medications for dry eye.

Eyenovia (NASDAQ: EYEN) and SGN Nanopharma have announced a collaboration agreement to develop a novel treatment for chronic dry eye disease. The partnership aims to combine SGN's Micellar Nanoparticle Platform (MNP) cyclosporine formulation with Eyenovia's Optejet® dispenser. This collaboration targets the $3 billion U.S. addressable market for dry eye disease, affecting an estimated 35 million people.

Key points:

• SGN's MNP Cyclosporine showed superior results in clinical studies compared to current treatments
• Optejet dispenser delivers medication with 80% less drug volume, potentially improving tolerability
• The companies aim to create a 'best-in-class' therapy for the underserved dry eye market
• They plan to validate manufacturability and consult with the FDA for clinical development

Eyenovia (NASDAQ: EYEN) has entered a collaboration agreement with Senju Pharmaceutical to develop Senju's SJP-0035 for use with Eyenovia's Optejet® dispensing technology as a potential treatment for chronic dry eye disease. The companies plan to meet with the FDA to present a clinical development proposal for a novel drug-device combination product. Dry eye affects nearly 16 million Americans, with treatment costs totaling over $3 billion in the U.S. and $5 billion globally.

SJP-0035 has shown favorable tolerability in prior Phase 1 and 2 studies. The collaboration aims to create a more efficacious and differentiated treatment by integrating SJP-0035 with the Optejet platform. The companies anticipate meeting with the FDA later this year, followed by a Phase 2b study in 2025 and potentially two Phase 3 studies by 2026.

NovaBay Pharmaceuticals and Eyenovia have started joint promotional activities to market NovaBay's Avenova® Antimicrobial Lid & Lash Solution and Eyenovia's MydCombi™ for mydriasis to large ophthalmic surgery centers. Eyenovia's salesforce will promote Avenova, while NovaBay prepares for Eyenovia's upcoming launch of Clobetasol Propionate Ophthalmic Suspension, 0.05% in August 2024. This partnership aims to enhance market presence and awareness for both companies' products, leveraging NovaBay's established network of eyecare professionals. Prescription Avenova is available through EyenoviaRx.com and Avenova.com, with the non-prescription version on Amazon.com.

Eyenovia announced the pricing of a $5 million registered direct offering, involving the sale of 7,575,757 shares of common stock and accompanying warrants. Each share and warrant combination is priced at $0.66, with warrants exercisable at $0.69 per share starting six months from issuance and expiring in 5.5 years. The offering is expected to close around July 1, 2024, subject to customary conditions. Gross proceeds are anticipated to be $5 million before fees and expenses. The funds will support the commercialization of Mydcombi and clobetasol propionate, the CHAPERONE pediatric myopia study, and general corporate purposes, including debt repayment. Chardan is leading the placement, with Brookline Capital Markets acting as co-placement agent.