NEW YORK—Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company, announced financial and operating results for the second quarter ending June 30, 2024, showing a net loss of approximately $11.1 million as compared with a net loss of $6.2 million for the second quarter of 2023. The net loss for the second quarter of 2024 includes $2.9 million of expenses associated with the reacquisition of license rights from Bausch + Lomb for MicroPine, an investigational eight-microliter ophthalmic spray of atropine delivered by Eyenovia’s proprietary Optejet device.

Eyenovia posted revenues of $0.02 million for the second quarter, compared with zero revenues for the same time period last year. The company said it recorded a cost-of-revenue write-off of $0.5 million to adjust finished goods commercial inventory to net realizable value in the second quarter of 2024. In addition, other income includes a gain of approximately $1.2 million associated with the change in fair value of equity consideration granted in transactions with Bausch + Lomb as well as Formosa Pharmaceuticals. 

Following an FDA meeting in July, Eyenovia announced plans for validation of the advanced Gen-2 Optejet device, with production anticipated to begin in the fourth quarter and submission in 2025 with Mydcombi, an FDA-approved fixed-dose combination ophthalmic spray indicated for inducing mydriasis, as the lead product. The Gen-2 device was developed to be easier to use and manufacture, the company said, bringing the cost of goods for the monthly cartridge towards the company’s goal of $20.

“During the second quarter, we made significant progress both advancing our commercial initiatives and furthering co-development agreements that can potentially address new, multi-billion-dollar underserved markets,” said Michael Rowe, chief executive officer. “Our plans to finalize the Gen-2 device are now set following a meeting with the FDA, and we look forward to submitting this advanced technology with Mydcombi as the lead product in 2025. Meanwhile, our Mydcombi launch continues to track to plan, with this innovative mydriasis product now available in 63 new ophthalmic offices since launch, with many more coming onboard during the third quarter as momentum accelerates.

“Regarding MicroPine, which we are developing for pediatric progressive myopia, we are preparing for analysis of the phase 3 CHAPERONE data in the fourth quarter that, if successful, would meaningfully accelerate its remaining development path," Rowe added. "We also executed several co-development agreements to evaluate novel therapeutics in our Optejet dispenser as potential treatments for dry eye disease, which is estimated to be a $5 billion addressable market.”

The company also said that during the second quarter it completed a registered direct equity offering with two of its largest shareholders at the market price. These additional funds, together with cash on-hand and other currently available capital resources, are expected to fund its operations through the Phase 3 CHAPERONE data.

The company reported total operating expenses for the second quarter of 2024 of approximately $11.2 million, including the previously referenced $2.9 million of expenses associated with the Bausch + Lomb transaction, compared with approximately $6.0 million for the second quarter of 2023, representing an increase of approximately 88.2 percent. The second quarter 2024 operating expense figure includes approximately $3.8 million of non-cash expenses.

As of June 30, 2024, the company stated that its unrestricted cash and cash equivalents were reported to be approximately $2.3 million. This excludes approximately $5.8 million in gross proceeds from equity offerings completed after June 30, 2024.