UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 8, 2022
EYENOVIA, INC.
(Exact Name of Registrant as Specified in its Charter)
| Delaware | | 001-38365 | | 47-1178401 |
(State or other jurisdiction
of incorporation) | (Commission
File Number) | (IRS Employer Identification No.) |
295 Madison Avenue, Suite 2400, New York, NY 10017
(Address of Principal Executive Offices, and Zip Code)
(917) 289-1117
Registrant’s Telephone Number, Including Area Code
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| (Title of each class) | | (Trading
Symbol) | | (Name of each exchange
on which registered) |
| Common stock, $0.0001 par value | | EYEN | | The Nasdaq Stock Market
(Nasdaq Capital Market) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
On February 8, 2022, Eyenovia, Inc. (the “Company”) issued a press release announcing that it successfully completed a Type A meeting with the U.S. Food and Drug Administration (“FDA”) related to the refiling of the new drug application (“NDA”) for MydCombi, the Company’s proprietary, first-in-class combination of tropicamide and phenylephrine for in-office-pupil dilation. Following the Type A meeting, the Company and the FDA reached alignment on the path forward toward an NDA resubmission. The Company expects to resubmit the NDA during the third quarter of 2022. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| | EYENOVIA, INC. |
| | |
| Date: February 8, 2022 | /s/ John Gandolfo |
| | John Gandolfo |
| | Chief Financial Officer |
