Eyenovia Inc #IPO Preview – $EYEN

Company: Eyenovia, Inc.
Symbol: EYEN
Description: They are a clinical stage biopharmaceutical company developing a pipeline of ophthalmology products utilizing our patented piezo-print technology to deliver micro-doses of active pharmaceutical ingredients, or micro-therapeutics, topically to the eye.
Shares: 2.73 million
Price Range: $10.00-$12.00
Trade Date: TBD
Underwriter(s): Ladenburg Thalmann, Roth Capital Partners
Terms Added: 1-9-18

Link to S-1/A Prospectus

Link to Retail Roadshow

Business: Micro-dosing technology has the potential to replace traditional macro-dosing applications (e.g. conventional eye droppers that deliver 30–50 µL) that routinely overdose or under-dose when used in the topical administration of ophthalmic therapeutics. They believe their micro-therapeutic product candidates may be able to achieve similar pharmacologic effects as traditional macro-dosing applications while reducing the adverse effects associated with these techniques. They have received written Food and Drug Administration, or FDA, feedback indicating that they can proceed to Phase III clinical trials for two of their lead programs: MicroProst, a novel micro-therapeutic latanoprost formulation for chronic angle closure glaucoma, or CACG, an indication with no FDA-approved drug treatments; and MicroStat, a fixed combination of micro-therapeutic phenylephrine-tropicamide formulation for mydriasis, also known as pupil dilation for use in eye exams. MicroTears, their over-the-counter, or OTC, product candidate for dry eye, will not require Phase III clinical trials, and they plan to proceed with registration activities.

They have completed two Phase II clinical trials, treating more than 110 subjects, with results published in peer-reviewed literature. Applying multiple front-of-the-eye (the area in front of the lens) formulations in subjects for mydriasis, their piezo-print technology delivered microliter precision at the volume of the eye’s natural tear film capacity of 6–8 µL, which reduced ocular and systemic drug and preservative exposure when compared to eye drops, resulting in comparable efficacy with fewer side effects. They believe that these clinical trials support their advancement into late stage clinical trials utilizing the 505(b)(2) pathway. They intend to use this pathway for future clinical trials in new indications with significant unmet needs.

Licensing: They have entered into a master licensing partnership for all of their micro-therapeutic programs, including their MicroStat program, with Senju Pharmaceuticals for Asia, including China, Japan and India.

Insider Buying: Certain of their existing stockholders and/or members of management have indicated an interest in purchasing up to an aggregate of $5.0 million of shares of their common stock in this offering at the public offering price.

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Eyenovia Inc #IPO Preview – $EYEN