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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):
July 30, 2025
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) |
685
Route 202/206 N., Suite 301
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 ¨
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 2.02 Results of Operations and Financial
Condition.
The information set forth
below in the second paragraph of Item 8.01 of this Current Report on Form 8-K is incorporated by reference herein.
Item 8.01 Other Events.
On July 30, 2025, VYNE Therapeutics
Inc. (the “Company”) issued a press release entitled “VYNE Therapeutics Announces Topline Results from
Phase 2b Trial with Repibresib Gel in Nonsegmental Vitiligo.” In addition, on July 30, 2025, the Company posted a presentation that
includes the data from this Phase 2b trial on its website.
While the Company has not
finalized its full financial results for the quarter ended June 30, 2025, the Company expects to report that it had cash, cash equivalents
and investments of approximately $39.6 million (unaudited) as of June 30, 2025. This estimate is preliminary and is subject to change
pending the actual results of, and completion of, the Company’s condensed consolidated financial statements for the quarter ended
June 30, 2025. Additional information and disclosures would be required for a more complete understanding of the Company’s financial
position and results of operations as of June 30, 2025. The Company’s independent registered public accounting firm has not reviewed
or performed any procedures with respect to this preliminary information and, accordingly, does not express an opinion or any other form
of assurance about them.
A copy of the Company’s
press release and presentation are attached hereto as Exhibit 99.1 and Exhibit 99.2, respectively, and, other than the quotes by Mr. Domzalski
contained in Exhibit 99.1, are incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
The following exhibits are
being filed herewith.
| Exhibit No. |
|
Description |
| 99.1 |
|
Press Release, dated July 30, 2025. |
| 99.2 |
|
Presentation, dated July 30, 2025. |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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: July 30, 2025 |
By: |
/s/ Mutya Harsch |
| |
|
Mutya Harsch |
| |
|
Chief Legal Officer and General Counsel |
