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 28, 2022
ZYNERBA PHARMACEUTICALS, INC.
(Exact Name of Issuer as Specified in Charter)
Delaware | 001-37526 | 26-0389433 | ||
(State or Other Jurisdiction of Incorporation or Organization) | (Commission File Number) | (I.R.S. Employer Identification No.) |
80 W. Lancaster Avenue, Suite 300
Devon, PA 19333
(Address of Principal Executive Offices)
(484) 581-7505
(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(s) | Name of each exchange on which registered | ||
Common Stock, $0.001 par value per share | ZYNE | The Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
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. ¨
Item 8.01 Other Events
On February 28, 2022, Zynerba Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the completion of enrollment for the 14-week Phase 2 INSPIRE (Assessing the Impact of Zygel [Transdermal CBD Gel] on Pediatric Behavioral and Emotional Symptoms of 22q11.2 Deletion Syndrome) trial of Zygel in the treatment of behavioral symptoms of 22q11.2 deletion syndrome (22q) in children and adolescents.
On February 28, 2022, the Company issued a second press release announcing that the European Medicines Agency has granted orphan drug designation to Zygel (cannabidiol formulated in a transdermal gel) for the treatment of Fragile X syndrome.
Copies of these press releases are attached hereto as Exhibits 99.1 and 99.2 and incorporated herein by reference.
Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
Exhibit No. | Document | |
99.1 | Press Release, dated February 28, 2022 | |
99.2 | Press Release, dated February 28, 2022 | |
104 | The cover page from this current report on Form 8-K, formatted in Inline XBRL |
SIGNATURE
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.
Date: February 28, 2022
ZYNERBA PHARMACEUTICALS, INC. | ||
By: | /s/ Albert Parker | |
Name: Albert Parker | ||
Title: Chief Legal Officer |