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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) March 8, 2022

 

 

 

VYNE Therapeutics Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38356   45-3757789

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification Number)

 

520 U.S. Highway 22, Suite 204

Bridgewater, New Jersey 08807

(Address of principal executive offices, including Zip Code)

 

(800) 775-7936

(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, $0.0001 par value   VYNE   The Nasdaq Stock Market LLC

 

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 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. x

 

 

 

 

 

 

Item 7.01 Regulation FD Disclosure.

 

Beginning on March 8, 2022, members of management of VYNE Therapeutics Inc. (the “Company”) will begin using the updated investor presentation found on the Company’s website in connection with investor meetings and industry conferences. The presentation has been updated to include the preclinical data for the Company’s lead BET inhibitor, VYN201, in a human skin model of vitiligo, as announced by the Company on March 7, 2022. In addition, the presentation reflects an updated timeline for the Company’s receipt of top line results from its Phase 2a study evaluating the safety and efficacy of FMX114 for the treatment of mild-to-moderate atopic dermatitis. The Company expects to report Phase 2a top line results in the second quarter of 2022, versus prior expectations of the first quarter 2022, primarily due to COVID-19-related enrollment delays in Australia, where the study is being conducted. The updated investor presentation can be found in the “Events & Presentations” section of the Company’s website.

 

The information in this Item 7.01 and Exhibit 99.1 hereto is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  VYNE THERAPEUTICS INC.
     
Date: March 8, 2022 By: /s/ Mutya Harsch
   

Mutya Harsch

Chief Legal Officer and General Counsel