Item 4.01 Changes in Registrant's Certifying Accountant.
On April 6, 2022, the audit committee (the "Audit Committee") of VYNE
Therapeutics Inc. (the "Company") approved the appointment of Baker Tilly US,
LLP ("Baker Tilly") as the Company's independent registered public accounting
firm for the year ending December 31, 2022, effective immediately, and dismissed
PricewaterhouseCoopers LLP ("PwC") as the Company's independent registered
public accounting firm, effective immediately. The Audit Committee determined
that this change is appropriate following the Company's transition from a
commercial entity to an organization focused on research and development.
PwC's report on the Company's financial statements as of and for the years ended
December 31, 2021 and 2020 did not contain an adverse opinion or a disclaimer of
opinion, nor were they qualified or modified as to uncertainty, audit scope, or
accounting principles, except for the explanatory paragraph included in PwC's
report on the Company's financial statements as of and for the year ended
December 31, 2021 which noted that there was substantial doubt as to the
Company's ability to continue as a going concern as the Company's incurred
losses and experienced negative operating cash flows.
During the years ended December 31, 2020 and December 31, 2021, and the
subsequent interim period ended April 6, 2022, there were no: (i) disagreements
as that term is defined in Item 304(a)(1)(iv) of Regulation S-K, between the
Company and PwC on any matter of accounting principles or practices, financial
statement disclosure, or auditing scope or procedures which, if not resolved to
the satisfaction of PwC, would have caused PwC to make reference thereto in
their reports; or (ii) reportable events as described in Item 304(a)(1)(v) of
Regulation S-K.
The Company provided PwC with a copy of the foregoing disclosures and requested
that PwC provide a letter addressed to the U.S. Securities and Exchange
Commission stating whether it agrees with such disclosures in accordance with
Item 304(a)(3) of Regulation S-K. A copy of PwC's letter, dated April 6, 2022,
is filed herein as Exhibit 16.1.
During the years ended December 31, 2020 and December 31, 2021, and the
subsequent interim period ended April 6, 2022, neither the Company nor anyone
acting on its behalf consulted with Baker Tilly regarding any of the matters set
forth in Item 304(a)(2)(i) or (ii) of Regulation S-K.
Item 8.01 Other Events.
On April 7, 2022, the Company issued a press release entitled "VYNE Therapeutics
Announces Positive Phase 1b Efficacy Data for FMX114 from Phase 1b/2a Trial for
the Treatment of Mild-to-Moderate Atopic Dermatitis." A copy of the press
release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is
incorporated by reference herein. The investor presentation on the Company's
website has been updated to include the Phase 1b data.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
The following exhibits are being filed herewith.
Exhibit No. Description
16.1 Letter from PricewaterhouseCoopers LLP, dated April 6, 2022.
99.1 Press Release, dated April 7, 2022.
Cover Page Interactive Data File (embedded within the Inline XBRL
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