0001628280-25-023478.txt : 20250508 0001628280-25-023478.hdr.sgml : 20250508 20250508080330 ACCESSION NUMBER: 0001628280-25-023478 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20250508 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20250508 DATE AS OF CHANGE: 20250508 FILER: COMPANY DATA: COMPANY CONFORMED NAME: VYNE Therapeutics Inc. CENTRAL INDEX KEY: 0001566044 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] ORGANIZATION NAME: 03 Life Sciences EIN: 453757789 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-38356 FILM NUMBER: 25923972 BUSINESS ADDRESS: STREET 1: 685 ROUTE 202/206 N., SUITE 301 CITY: BRIDGEWATER STATE: NJ ZIP: 08807 BUSINESS PHONE: 800-775-7936 MAIL ADDRESS: STREET 1: 685 ROUTE 202/206 N., SUITE 301 CITY: BRIDGEWATER STATE: NJ ZIP: 08807 FORMER COMPANY: FORMER CONFORMED NAME: Menlo Therapeutics Inc. DATE OF NAME CHANGE: 20180201 FORMER COMPANY: FORMER CONFORMED NAME: Menlo Therapeutics, Inc. DATE OF NAME CHANGE: 20170728 FORMER COMPANY: FORMER CONFORMED NAME: Tigercat Pharma, Inc. DATE OF NAME CHANGE: 20130104 8-K 1 mnlo-20250508.htm 8-K mnlo-20250508
FALSE000156604400015660442025-05-082025-05-08

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) May 8, 2025
___________________________________________________________________________________________________________
VYNE Therapeutics Inc.
(Exact name of registrant as specified in its charter)
___________________________________________________________________________________________________________
Delaware001-3835645-3757789
(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 classTrading
Symbol(s)
Name of each exchange
on which registered
Common Stock, $0.0001 par valueVYNEThe 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.
On May 8, 2025, VYNE Therapeutics Inc. issued a press release announcing its financial results for the quarter ended March 31, 2025. The press release is being furnished as Exhibit 99.1 to this Current Report and is incorporated herein by reference.
The information in Item 2.02 of this Form 8-K and Exhibit 99.1 attached hereto 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.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.Description
99.1
104Cover 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: May 8, 2025
By:/s/ Mutya Harsch
Mutya Harsch
Chief Legal Officer and General Counsel

EX-99.1 2 vyne-20250508q12025exx991.htm EX-99.1 Document

Exhibit 99.1

imagea.jpg
VYNE Therapeutics Reports 2025 First Quarter Financial Results and Provides Business Update
Repibresib gel (VYN201) Phase 2b vitiligo top-line results expected in mid-2025
Expected cash runway into 2H 2026

BRIDGEWATER, N.J., May 8, 2025 -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need, today announced financial results as of and for the quarter ended March 31, 2025, and provided a business update.

“During the first quarter of 2025, we continued to progress our Phase 2b trial evaluating repibresib for the treatment of vitiligo, and we anticipate reporting top-line results from this trial mid-year,” said David Domzalski, President and Chief Executive Officer of VYNE. “With only one FDA-approved therapy, vitiligo remains an area of significant unmet need, and we believe repibresib has the potential to become a highly differentiated and important therapy for addressing this large patient population. With respect to VYN202, we will continue to work closely with the FDA to address the clinical hold placed on our Phase 1b psoriasis trial, and we expect to provide additional updates as we gain concurrence on the necessary steps needed to move forward and lift the clinical hold.”

Recent Pipeline and Corporate Updates

Repibresib gel, a locally-administered small molecule pan-BD BET inhibitor (Phase 2b, nonsegmental vitiligo):
Top-line results from the Phase 2b trial are expected in mid-2025. The fully enrolled, Phase 2b trial (NCT06493578) is a randomized, double-blind, vehicle-controlled trial evaluating the efficacy, safety and pharmacokinetics of once-daily repibresib gel in three dose cohorts (1%, 2% or 3% concentrations) compared to vehicle over 24 weeks in subjects with active or stable nonsegmental vitiligo. Subjects have been randomized equally (1:1:1:1 ratio) across the active drug cohorts or vehicle (approximately 45 subjects in each arm). Top-line results from the 24-week double-blind, vehicle-controlled portion of the trial are expected mid-year.

Following the 24-week treatment period, subjects who have been randomized in the three active dose cohorts will continue treatment with their respective dose concentrations for an additional 28-week active treatment extension. Subjects who have been randomized in the vehicle group during the initial 24-week treatment period will be equally re-randomized into one of the three active dose cohorts for an additional 28 weeks.

The clinical hold on the Phase 1b trial of VYN202 does not apply to VYNE’s ongoing Phase 2b trial of repibresib gel in nonsegmental vitiligo. Repibresib is a distinct and unique compound from VYN202, and there have been no observations of testicular toxicity in long-term non-clinical toxicology studies with VYN201.

VYN202, an oral small molecule BD2-selective inhibitor:
Phase 1b psoriasis trial placed on clinical hold. In May 2025, the U.S. Food and Drug Administration ("FDA") informed the Company that its Phase 1b trial evaluating VYN202 for the treatment of moderate-to-severe plaque psoriasis was placed on clinical hold. The clinical hold determination was made following a recent observation of testicular toxicity in dogs from a non-clinical toxicology study with VYN202. VYNE has suspended all screening, enrollment and patient dosing in the Phase 1b trial of VYN202 and intends to work diligently with the FDA to resolve the clinical hold as soon as possible. To date, there have been no serious adverse events observed in subjects that have been enrolled in the Phase 1b trial.
1


Financial Results as of and for the First Quarter Ended March 31, 2025
Cash position. As of March 31, 2025, VYNE had $50.3 million of cash, cash equivalents and marketable securities. Based on current operating assumptions, VYNE believes its cash, cash equivalents and marketable securities as of March 31, 2025 will be sufficient to fund its operations into the second half of 2026.
Share count. As of March 31, 2025, VYNE had 15,959,488 common shares issued and outstanding, and outstanding pre-funded warrants to purchase 26,794,398 shares of common stock at an exercise price of $0.0001 per share.
Revenues. Revenues totaled $0.2 million and $0.1 million for the quarters ended March 31, 2025 and 2024, respectively, consisting of royalty revenue from the Company's royalty agreement with LEO Pharma A/S, to whom VYNE previously licensed the rights to Finacea® foam.
Research and development expenses. VYNE’s research and development expenses for the quarter ended March 31, 2025 and 2024 were $6.1 million and $3.7 million, respectively. The increase was primarily driven by increased expenses of $1.5 million for VYN202, increased expenses of $0.7 million for repibresib, and an increase in employee-related expenses of $0.3 million following the hiring of additional research and development personnel. The $1.5 million increase in expenses for VYN202 was primarily associated with costs incurred in connection with our Phase 1b trial, and the $0.7 million increase in expenses for repibresib was primarily related to clinical trial costs incurred in connection with our ongoing Phase 2b trial of repibresib in subjects with NSV which was initiated in June 2024.
General and administrative expenses. VYNE’s general and administrative expenses for the quarter ended March 31, 2025 and 2024 were approximately $3.3 million and $3.8 million, respectively. The decrease was primarily driven by a decrease in consulting and professional fees of $0.3 million and a decrease in employee related expenses of $0.2 million.
Net loss. Net loss and net loss per share for the quarter ended March 31, 2025 was $8.6 million and $0.20, respectively, compared to a net loss and net loss per share of $6.2 million and $0.15, for the comparable period in 2024.
About VYNE Therapeutics Inc.

VYNE is a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need. VYNE's unique and proprietary BET inhibitors, which comprise its InhiBET™ platform, are designed to overcome limitations of early generation BET inhibitors by leveraging alternative routes of administration and enhanced selectivity.

For more information about VYNE Therapeutics Inc. or its product candidates, visit www.vynetherapeutics.com. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

Investor Relations:
John Fraunces
LifeSci Advisors, LLC
917-355-2395
jfraunces@lifesciadvisors.com

Tyler Zeronda
VYNE Therapeutics Inc.
908-458-9106
Tyler.Zeronda@VYNEtx.com










2


Cautionary Statement Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the clinical development of repibresib and VYN202, timing for reporting top-line results from the Phase 2b trial of repibresib, the clinical hold on the Phase 1b trial of VYN202, including communications related to VYNE's ability to resolve such hold, VYNEs projected cash runway, and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: VYNE’s ability to successfully develop its product candidates; the timing of commencement of future preclinical studies and clinical trials; VYNE’s ability to complete and receive favorable results from clinical trials of its product candidates; VYNE’s ability to obtain additional funding, either through equity or debt financing transactions or collaboration arrangements; and VYNE’s ability to comply with various regulations applicable to its business. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, and VYNE’s other filings from time to time with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.

Third-party products and company names mentioned herein may be the trademarks of their respective owners.

3


VYNE THERAPEUTICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
March 31,December 31,
20252024
Assets
Current Assets:
Cash and cash equivalents$28,209 $19,926 
Investment in marketable securities 22,063 41,590 
Prepaid and other current assets4,641 2,921 
Total Current Assets54,913 64,437 
Non-current Assets:
Property and equipment, net 107 113 
Operating lease right-of-use assets 62 93 
Non-current prepaid expenses and other assets1,341 2,262 
Total Non-current Assets1,510 2,468 
Total Assets$56,423 $66,905 
Liabilities and Stockholders’ Equity
Current Liabilities:
Trade payables$3,534 $2,707 
Accrued expenses6,858 9,272 
Employee related obligations523 1,428 
Operating lease liabilities 63 99 
Other current liabilities1,313 1,313 
Total Current Liabilities12,291 14,819 
Total Liabilities$12,291 $14,819 
Commitments and Contingencies
Stockholders' Equity
Preferred stock: $0.0001 par value; 20,000,000 shares authorized at March 31, 2025 and December 31, 2024; no shares issued and outstanding at March 31, 2025 and December 31, 2024— — 
Common stock: $0.0001 par value; 150,000,000 shares authorized at March 31, 2025 and December 31, 2024; 15,959,488 and 14,830,013 shares issued and outstanding at March 31, 2025 and December 31, 2024, respectively
Additional paid-in capital783,911 783,235 
Accumulated other comprehensive income— 20 
Accumulated deficit(739,781)(731,170)
Total Stockholders' Equity44,132 52,086 
Total Liabilities and Stockholders' Equity$56,423 $66,905 
4


VYNE THERAPEUTICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars and share data in thousands, except per share data)
(Unaudited)

Three Months Ended
March 31,
20252024
Revenues
Royalty revenues$202 $98 
Total Revenues202 98 
Operating Expenses:
Research and development:6,124 3,708 
General and administrative3,275 3,770 
Total operating expenses9,399 7,478 
Operating loss(9,197)(7,380)
Other income, net594 1,139 
Loss from continuing operations before income taxes(8,603)(6,241)
Income tax expense— — 
Loss from continuing operations(8,603)(6,241)
Loss from discontinued operations, net of income taxes(8)(8)
Net Loss$(8,611)$(6,249)
Loss per share, from continuing operations, basic and diluted$(0.20)$(0.15)
Loss per share from discontinued operations, basic and diluted$— $— 
Loss per share basic and diluted$(0.20)$(0.15)
Weighted average shares outstanding - basic and diluted42,673 42,581 

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Document and Entity Information Document
May 08, 2025
Cover [Abstract]  
Document Type 8-K
Document Period End Date May 08, 2025
Entity Registrant Name VYNE Therapeutics Inc
Entity Central Index Key 0001566044
Amendment Flag false
Entity Incorporation, State or Country Code DE
Entity File Number 001-38356
Entity Tax Identification Number 45-3757789
Entity Address, Address Line One 685 Route 202/206 N., Suite 301
Entity Address, City or Town Bridgewater
Entity Address, State or Province NJ
Entity Address, Postal Zip Code 08807
City Area Code 800
Local Phone Number 775-7936
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, $0.0001 par value
Trading Symbol VYNE
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
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