Eyenovia Inc Stock Price, News & Analysis

Eyenovia, Inc. (NASDAQ: EYEN) announced significant changes to its Board of Directors. Dr. Sean Ianchulev has been appointed Chairman, while Kenneth Lee, Jr. assumes the role of Lead Director. New members Rachel Jacobson and Stephen Benjamin join the Board, bringing diverse expertise in business development and public sector leadership, respectively. Dr. Ernest Mario has retired from the Board after nearly eight years. The company is focused on the late-stage development of its microdose array print (MAP™) therapeutics for eye conditions.

Eyenovia, Inc. (NASDAQ: EYEN) reported its Q3 2021 financial results, noting a net loss of $5.6 million, or $(0.21) per share, reflecting a slight increase in losses year-over-year. The company has initiated the VISION-2 Phase 3 trial for its MicroLine presbyopia treatment, with data expected mid-2022. Eyenovia anticipates the cash resources of approximately $30 million will cover ongoing projects, including the MydCombi NDA resubmission in early 2022. Dr. Fred Eshelman will step down from the Board by year-end. The company aims for potential milestones in 2022 and 2023.

Eyenovia, Inc. (NASDAQ: EYEN) announced that CEO Dr. Sean Ianchulev will discuss future treatment options for myopia, including MicroPine (atropine ophthalmic spray), at the Eyecelerator@AAO Meeting. The panel, titled Myopia Control: Corrective Lenses, Drugs and Diagnostics, will take place on November 11, 2021, at the Ernest N. Morial Convention Center in New Orleans, LA, starting at 3:00 PM CT. The Eyecelerator initiative aims to foster collaboration in ophthalmic innovation, enhancing patient care.

Eyenovia, Inc. (NASDAQ: EYEN) is set to announce its financial results for Q3 2021 on November 11, 2021, after market close. Following this, a conference call will be held at 5:00 PM ET to discuss the results and provide a business update. Participants can join the call by dialing 877-407-9039 domestically or 201-689-8470 internationally. A live webcast will also be available on Eyenovia's investor relations website. The event will be archived for one year.

Eyenovia, Inc. (NASDAQ: EYEN) announced the enrollment of the first patient in its second Phase 3 trial, VISION-2, for MicroLine, a pilocarpine formulation aimed at improving near vision in presbyopia. Following the successful VISION-1 trial, which showed MicroLine's superiority over placebo, the new trial will enroll around 140 subjects to measure its effectiveness in low light conditions. The presbyopia market in the U.S. is projected to exceed several billion dollars, indicating significant growth potential for MicroLine pending successful clinical outcomes.

Eyenovia, Inc. (NASDAQ: EYEN) announced the reclassification of its MydCombi product as a drug-device combination by the FDA, following a Complete Response Letter (CRL) received on October 22, 2021. The CRL requests additional information related to the Genus Medical Technologies case, prompting an agency-wide reclassification. Eyenovia plans to expedite its NDA resubmission by early 2022 and notes that its current cash balance of approximately $30.7 million is sufficient for ongoing activities. The Phase III clinical program for MydCombi remains unaffected.

Eyenovia announced positive topline data from its Phase 3 VISION-1 trial evaluating MicroLine for presbyopia, demonstrating a 7.7-fold improvement in near vision over placebo. The company is set to launch a second Phase 3 trial, VISION-2, by year-end 2021. MydCombi's PDUFA date is confirmed for October 28, 2021. Financially, the company reported a net loss of $4.8 million for Q2 2021, with operating expenses up 19% year-over-year. Cash balance stands at approximately $27.2 million, including funding from a credit facility. Earnings call scheduled for August 11, 2021.

Eyenovia, Inc. (NASDAQ: EYEN) announced plans to release its second-quarter financial results on August 11, 2021, after market close. This release will be followed by a conference call at 4:30 PM ET, where management will discuss the results. Interested participants can join the call by dialing 855-327-6837 domestically or 631-891-4304 internationally, using conference code 10015927. A live webcast will also be accessible on Eyenovia's investor relations page. The event will be archived for one year on their website.