Core Viewpoint - VYNE Therapeutics Inc. is advancing its VYN202 program for treating moderate-to-severe plaque psoriasis after the FDA lifted a clinical hold for female patients on lower doses, while further data is needed for male subjects [1][2][4] VYN202 Program Update - The FDA placed a clinical hold on the Phase 1b trial due to testicular toxicity observed in dogs, but has now lifted the hold for female patients on 0.25 mg and 0.5 mg doses [2] - The 1 mg dose was excluded from the revised protocol due to a lower safety margin [2] - A 12-week non-clinical toxicology study is required to resume trials in male subjects, with the study design agreed upon with the FDA [2] Clinical Data Insights - The clinical data from the Phase 1b trial included 7 enrolled subjects, with 6 treated with VYN202 and 1 with placebo [3][5] - No serious adverse events or treatment discontinuations were reported, and all subjects treated with VYN202 showed improvement in psoriasis symptoms [7] - PASI scores improved by approximately 27% after 1 week and up to 90% by week 8 [7] - Significant reductions in serum cytokine levels were observed in subjects treated with VYN202, while no changes were noted in the placebo group [7] Future Plans and Financial Outlook - The company will not enroll new patients in the Phase 1b psoriasis study, extending its expected cash runway into Q4 2026 [4] - Further updates on the VYN202 program will follow the release of top-line results from the ongoing Phase 2b study of repibresib gel for non-segmental vitiligo [4] About VYN202 - VYN202 is an oral small molecule BET inhibitor with potential class-leading selectivity and potency for BD2, aimed at providing a non-biologic treatment option for immuno-inflammatory conditions [10] About VYNE Therapeutics Inc. - VYNE is focused on developing differentiated therapies for chronic inflammatory and immune-mediated conditions, leveraging its proprietary BET inhibitors to overcome limitations of earlier generations [11]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 Delaware 45-3757789 (I.R.S. Employer Identification No.) 685 Route 202/206 N, Suite 301 Bridgewater, New Jersey 08807 FOR THE TRANSITION PERIOD FROM ___ TO ___. (Address of principal executive offices ...

VYNE Therapeutics Reports 2025 First Quarter Financial Results and Provides Business Update 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. Exhibit 99.1 • Top-line results fr ...

Repibresib gel (VYN201) Phase 2b vitiligo top-line results expected in mid-2025Expected cash runway into 2H 2026 BRIDGEWATER, N.J., May 08, 2025 (GLOBE NEWSWIRE) -- 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 upd ...

BRIDGEWATER, N.J., April 25, 2025 (GLOBE NEWSWIRE) -- VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) verbally informed the Company that it placed a clinical hold on the Company’s Phase 1b study evaluating VYN202 for the treatment of moderate-to-severe plaque psoriasis. The clinical hold determination was made following a recent observation of testicular toxicity in dogs from a non-clinical toxicology study with VYN202. VYNE ha ...

BRIDGEWATER, N.J., March 20, 2025 (GLOBE NEWSWIRE) -- 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 that VYNE's management will participate in the H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference (Skin Diseases, Conditions and Disorders) being held on Thursday, March 27, 20 ...

BRIDGEWATER, N.J., March 20, 2025 (GLOBE NEWSWIRE) -- 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 that VYNE’s management will participate in the H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference (Skin Diseases, Conditions and Disorders) being held on Thursday, March 27, 2 ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ___ TO ___. Commission File Number 001-38356 VYNE THERAPEUTICS INC. (Exact name of registrant as specified in its charter) Delaware 45-3757789 (S ...

Financial Position - As of December 31, 2024, VYNE had a cash position of $61.5 million, sufficient to fund operations into the second half of 2026[8]. - Total assets decreased to $66.9 million in 2024 from $97.7 million in 2023[19]. - Total liabilities increased to $14.8 million in 2024 from $8.9 million in 2023[19]. - The company had 14,830,013 common shares issued and outstanding as of December 31, 2024[9]. Revenue Performance - Revenues for the year ended December 31, 2024, totaled $0.5 million, a 25% increase from $0.4 million in 2023, primarily from royalty revenue[9]. - Total revenues for the year ended December 31, 2024, reached $501 million, compared to $424 million in 2023, marking a 18.1% growth[21]. - Royalty revenues for Q4 2024 were $84 million, up from $76 million in Q4 2023, representing a 10.5% increase[21]. Expenses - Research and development expenses increased to $30.9 million in 2024, up 89% from $16.3 million in 2023, driven by costs associated with repibresib and VYN202[9]. - General and administrative expenses slightly decreased to approximately $13.2 million in 2024 from $13.4 million in 2023[10]. - Total operating expenses for the year increased to $44.138 million from $29.682 million, a rise of 48.8%[21]. - Research and development expenses surged to $9.684 million in Q4 2024, compared to $3.023 million in Q4 2023, reflecting a 220.5% increase[21]. Net Loss - The net loss for the year ended December 31, 2024, was $39.8 million, with a net loss per share of $0.93, compared to a net loss of $28.5 million and a net loss per share of $2.78 in 2023[11]. - Net loss for the year ended December 31, 2024, was $39.834 million, up from $28.452 million in 2023, representing a 40.1% increase[21]. - The operating loss for Q4 2024 was $12.770 million, compared to a loss of $6.832 million in Q4 2023, indicating an increase in losses of 87.5%[21]. - Loss per share from continuing operations for Q4 2024 was $0.28, compared to $0.20 in Q4 2023, reflecting a 40% increase in loss per share[21]. Future Expectations - VYNE expects topline results from the Phase 2b trial of repibresib gel in nonsegmental vitiligo in mid-2025[5]. - The Phase 1b trial of VYN202 for moderate-to-severe plaque psoriasis has been initiated, with topline results anticipated by the end of 2025[5].

Core Viewpoint - VYNE Therapeutics Inc. reported financial results for the fourth quarter and year ended December 31, 2024, highlighting significant progress in its clinical pipeline and upcoming data readouts for its product candidates in 2025 [1][2]. Financial Results - As of December 31, 2024, VYNE had a cash position of $61.5 million, which is expected to fund operations into the second half of 2026 [8]. - Revenues for the year ended December 31, 2024, totaled $0.5 million, an increase from $0.4 million in 2023, primarily from royalty revenue [9]. - Research and development expenses rose to $30.9 million in 2024 from $16.3 million in 2023, driven by increased costs associated with clinical trials for repibresib and VYN202 [10]. - General and administrative expenses slightly decreased to approximately $13.2 million in 2024 from $13.4 million in 2023 [11]. - The net loss for the year ended December 31, 2024, was $39.8 million, or $0.93 per share, compared to a net loss of $28.5 million, or $2.78 per share, in 2023 [12]. Pipeline Updates - VYNE is advancing its clinical pipeline with two key data readouts expected in 2025: topline results from the Phase 2b trial of repibresib gel in nonsegmental vitiligo anticipated in mid-2025, and topline results from the Phase 1b trial of VYN202 in moderate-to-severe plaque psoriasis expected by the end of 2025 [2][6]. - The Phase 2b trial of repibresib gel involves a randomized, double-blind, vehicle-controlled design with three dose cohorts (1%, 2%, or 3% concentrations) and approximately 180 subjects [7]. - The Phase 1b trial of VYN202 has been initiated, evaluating three dosing cohorts (0.25 mg, 0.5 mg, 1 mg) in subjects with moderate-to-severe plaque psoriasis [7]. Upcoming Events - VYNE will participate in the Leerink Partners Global Healthcare Conference in Miami from March 10-12, 2025, and the H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference on March 27, 2025 [5].