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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): August 11, 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.
On August 14, 2025, VYNE Therapeutics Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2025. The press release is being furnished as Exhibit 99.1 to this Current Report.
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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
Resignation of Directors
On August 11, 2025, Christine Borowski, Ph.D. provided notice to the board of directors (the “Board”) of her resignation as member of the Board and as a member of the Nominating and Corporate Governance Committee effective immediately. On August 13, 2025, Anthony Bruno provided notice to the Board of his resignation as member of the Board and as a member of the Compensation Committee and the Nominating and Corporate Governance Committee effective immediately. Mr. Bruno’s and Dr. Borowski’s resignations were not the result of any dispute or disagreement with the Company or the Board on any matter relating to the operations, policies or practices of the Company. The Company thanks Mr. Bruno and Dr. Borowski for their contributions to the Company.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description |
| 99.1 | Press Release dated August 14, 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: August 14, 2025 | ||
| By: | /s/ Mutya Harsch | |
| Mutya Harsch | ||
| Chief Legal Officer and General Counsel | ||
Exhibit 99.1
VYNE Therapeutics Reports 2025 Second Quarter Financial Results and Provides Business Update
| · | Implemented cost reductions extend cash runway into first half of 2027 |
BRIDGEWATER, N.J., August 14, 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 reported financial results as of and for the quarter ended June 30, 2025.
The Company is actively evaluating opportunities to enhance the value of its pipeline programs. VYNE’s oral BD2-selective BET inhibitor, VYN202, has recently demonstrated a promising efficacy signal in a Phase 1b clinical trial in moderate to severe plaque psoriasis, as well as disease-modifying potential across multiple translational models of fibro-inflammatory disease and hematologic malignancies. These new data, in areas such as nephrology, pulmonology, rheumatology and myeloproliferative neoplasms, among others, underscore the therapeutic potential of the program. As previously announced, the Company is seeking a partner for its topical BET inhibitor, repibresib.
“The strength of our recent clinical and preclinical findings for VYN202 provides a compelling scientific foundation as we determine the best path forward for the VYN202 program,” said David Domazalski, President and Chief Executive Officer of VYNE. “In conjunction, we have implemented cost reductions that are expected to extend our cash runway into the first half of 2027, giving us additional flexibility during this period.”
Pipeline Overview
VYN202, an oral small molecule BD2-selective BET inhibitor:
| · | Preclinical and translational data highlight disease-modifying potential of VYN202. VYNE has evaluated VYN202 in areas such as nephrology, pulmonology, rheumatology and myeloproliferative neoplasms, among others. These data, combined with the promising preliminary data from seven subjects enrolled in the Company’s Phase 1b trial in moderate-to-severe plaque psoriasis, support the potential of VYN202 as a potent, disease-modifying therapy for the treatment of serious, immune-mediated diseases and hematological cancers with limited effective treatment options. |
| · | Phase 1b trial in subjects with moderate-to-severe plaque psoriasis. In April 2025, the U.S. Food and Drug Administration (FDA) verbally placed a clinical hold on the Company’s Phase 1b trial evaluating VYN202 in subjects with moderate-to-severe plaque psoriasis following an observation of testicular toxicity in dogs from a non-clinical toxicology study of VYN202. In June 2025, the FDA lifted the clinical hold for two doses of VYN202 for female subjects. Further, the FDA has indicated that sufficient data from a 12-week non-clinical toxicology study of VYN202 in dogs would be required in order to resume studies in male clinical subjects. The design of this toxicology study has been agreed upon with the FDA and the Company intends to initiate the repeat non-clinical toxicology study of VYN202 in dogs to remedy the partial hold in male clinical subjects. There were no serious adverse events observed in subjects that were enrolled in the Phase 1b trial. Following the clinical hold, VYNE made the decision to unblind the clinical data from the seven subjects who were enrolled in the study, the promising preliminary results of which are available here. |
Repibresib gel, a locally-administered small molecule pan-BD BET inhibitor:
| · | In July 2025, VYNE reported topline results from its Phase 2b trial of repibresib gel in subjects with nonsegmental vitiligo available here. |
| · | The trial did not meet the primary or secondary endpoint of F-VASI50 and F-VASI75, however statistically significant effects were observed in key secondary and exploratory endpoints of change from baseline in F-VASI and T-VASI and proportion of patients achieving T-VASI50 at the 3% concentration. The Company believes the results from the trial were impacted by an unusually high vehicle effect and further impacted by a higher-than-expected dropout rate in the active arms of the trial relative to vehicle. VYNE is conducting a thorough evaluation of the full dataset to analyze any other data that may inform the results. The Company has discontinued treatment in the extension phase of the trial and is in the process of terminating the trial. |
| · | Repibresib gel is covered by patents providing composition of matter patent exclusivity into at least 2042 in the United States and into at least 2040 in Europe, Japan and other large global pharmaceutical markets. |
| · | VYNE is currently seeking a development and commercialization partner for this program. |
Financial Results as of and for the Second Quarter Ended June 30, 2025
Cash position. As of June 30, 2025, VYNE had $39.6 million of cash, cash equivalents and marketable securities. Based on current operating assumptions, VYNE believes its cash, cash equivalents and marketable securities as of June 30, 2025 will be sufficient to fund its operations into the first half of 2027.
Share count. As of June 30, 2025, VYNE had 19,773,784 common shares issued and outstanding, and outstanding pre-funded warrants to purchase 23,028,800 shares of common stock at an exercise price of $0.0001 per share.
Revenues. Revenues totaled $0.1 million and $0.2 million for the quarters ended June 30, 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 three months ended June 30, 2025 were $4.9 million, representing a decrease of $2.4 million, or 33.2%, compared to $7.3 million for the three months ended June 30, 2024. The decrease was primarily driven by decreased expenses for repibresib and VYN202 of $2.1 million and $0.2 million, respectively. The $2.1 million decrease in expenses for repibresib was primarily driven by the timing of expenses for the Phase 2b trial in nonsegmental vitiligo, including a $1.0 million milestone payment due to Tay under the License Agreement upon the initiation of the trial in June 2024. The $0.2 million decrease in expenses for VYN202 was primarily driven by the timing of expenses for Phase 1 trials evaluating VYN202, including a $1.0 million milestone payment due to Tay under the License Agreement upon the initiation of the Phase 1a healthy volunteer trial in June 2024, partially offset by increased expenses in the second quarter of 2025 for the Phase 1b trial evaluating VYN202 in moderate-to-severe plaque psoriasis subjects.
General and administrative expenses. VYNE’s general and administrative expenses for the three months ended June 30, 2025 were $2.7 million, representing a decrease of approximately $0.6 million, or 17.0%, compared to $3.3 million for the three months ended June 30, 2024. The decrease was primarily driven by a decrease in employee-related expenses of $0.3 million and consulting and professional fees of $0.2 million.
Net loss. Net loss and net loss per share for the quarter ended June 30, 2025 was $5.8 million and $0.13, respectively, compared to a net loss and net loss per share of $9.4 million and $0.22, 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
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 strategic review, the completion of a strategic transaction and evaluation of VYNE’s internal development pipeline, including the continued clinical development of repibresib and/or VYN202, the clinical hold on the Phase 1b trial of VYN202, including the ability to potentially fully resolve such hold, VYNE’s projected cash runway, and other statements regarding the future expectations, plans and prospects of VYNE, including the ability of VYNE to find a partner for repibresib. 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 June 30, 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.
VYNE THERAPEUTICS INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
| June 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 22,047 | $ | 19,926 | ||||
| Investment in marketable securities | 17,600 | 41,590 | ||||||
| Prepaid and other current assets | 4,696 | 2,921 | ||||||
| Total Current Assets | 44,343 | 64,437 | ||||||
| Non-current Assets: | ||||||||
| Property and equipment, net | 102 | 113 | ||||||
| Operating lease right-of-use assets | 32 | 93 | ||||||
| Non-current prepaid expenses and other assets | 241 | 2,262 | ||||||
| Total Non-current Assets | 375 | 2,468 | ||||||
| Total Assets | $ | 44,718 | $ | 66,905 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current Liabilities: | ||||||||
| Trade payables | $ | 1,414 | $ | 2,707 | ||||
| Accrued expenses | 3,578 | 9,272 | ||||||
| Employee related obligations | 819 | 1,428 | ||||||
| Operating lease liabilities | 25 | 99 | ||||||
| Other current liabilities | — | 1,313 | ||||||
| Total Current Liabilities | 5,836 | 14,819 | ||||||
| Total Liabilities | $ | 5,836 | $ | 14,819 | ||||
| Commitments and Contingencies | ||||||||
| Stockholders' Equity: | ||||||||
| Preferred stock: $0.0001 par value; 20,000,000 shares authorized at June 30, 2025 and December 31, 2024; no shares issued and outstanding at June 30, 2025 and December 31, 2024 | — | — | ||||||
| Common stock: $0.0001 par value; 150,000,000 shares authorized at June 30, 2025 and December 31, 2024; 19,773,784 and 14,830,013 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively | 2 | 1 | ||||||
| Additional paid-in capital | 784,418 | 783,235 | ||||||
| Accumulated other comprehensive (loss) income | (2 | ) | 20 | |||||
| Accumulated deficit | (745,536 | ) | (731,170 | ) | ||||
| Total Stockholders' Equity | 38,882 | 52,086 | ||||||
| Total Liabilities and Stockholders’ Equity | $ | 44,718 | $ | 66,905 | ||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
VYNE THERAPEUTICS INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars and share data in thousands, except per share data)
(Unaudited)
|
Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenues | ||||||||||||||||
| Royalty revenues | $ | 69 | $ | 198 | $ | 271 | $ | 296 | ||||||||
| Total revenues | 69 | 198 | 271 | 296 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 4,881 | 7,306 | 11,004 | 11,014 | ||||||||||||
| General and administrative | 2,730 | 3,288 | 6,005 | 7,058 | ||||||||||||
| Total operating expenses | 7,611 | 10,594 | 17,009 | 18,072 | ||||||||||||
| Operating loss | (7,542 | ) | (10,396 | ) | (16,738 | ) | (17,776 | ) | ||||||||
| Other income, net | 1,795 | 1,001 | 2,388 | 2,140 | ||||||||||||
| Loss from continuing operations before income taxes | (5,747 | ) | (9,395 | ) | (14,350 | ) | (15,636 | ) | ||||||||
| Income tax expense | — | — | — | — | ||||||||||||
| Loss from continuing operations | (5,747 | ) | (9,395 | ) | (14,350 | ) | (15,636 | ) | ||||||||
| Loss from discontinued operations, net of income taxes | (8 | ) | (11 | ) | (16 | ) | (19 | ) | ||||||||
| Net loss | $ | (5,755 | ) | $ | (9,406 | ) | $ | (14,366 | ) | $ | (15,655 | ) | ||||
| Loss per share from continuing operations, basic and diluted | $ | (0.13 | ) | $ | (0.22 | ) | $ | (0.34 | ) | $ | (0.37 | ) | ||||
| Loss per share from discontinued operations, basic and diluted | $ | — | $ | — | $ | — | $ | — | ||||||||
| Loss per share, basic and diluted | $ | (0.13 | ) | $ | (0.22 | ) | $ | (0.34 | ) | $ | (0.37 | ) | ||||
| Weighted average shares outstanding - basic and diluted | 42,759 | 42,586 | 42,716 | 42,584 | ||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.