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 ...

Company Overview - VYNE Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing differentiated therapies for chronic inflammatory and immune-mediated conditions with high unmet need [3]. Conference Participation - VYNE's management will participate in the H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference on March 27, 2025 [1]. - The fireside chat is scheduled for 11:00 am ET on the same day [2]. - A webcast replay will be available on VYNE's website for 90 days following the event [2]. Product Development - VYNE's proprietary BET inhibitors, part of its InhiBET™ platform, aim to address limitations of earlier generation BET inhibitors by utilizing alternative administration routes and enhanced selectivity [3].

Company Overview - VYNE Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing differentiated therapies for chronic inflammatory and immune-mediated conditions with high unmet need [3]. Conference Participation - VYNE's management will participate in the H.C. Wainwright 3rd Annual Autoimmune & Inflammatory Disease Virtual Conference on March 27, 2025 [1]. - A fireside chat is scheduled for March 27, 2025, at 11:00 am ET, with a webcast replay available on the VYNE website for 90 days following the event [2]. Product Development - VYNE's proprietary BET inhibitors, part of its InhiBET™ platform, aim to overcome limitations of early generation BET inhibitors by utilizing alternative routes of administration and enhanced selectivity [3].

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].

Company Overview - VYNE Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing differentiated therapies for chronic inflammatory and immune-mediated conditions with high unmet need [3]. Upcoming Investor Conferences - VYNE's management will participate in two investor conferences in March 2025: - TD Cowen 45th Annual Health Care Conference in Boston, MA on March 4, 2025, featuring a fireside chat and one-on-one meetings [1]. - Leerink Partners Global Healthcare Conference in Miami, FL on March 11, 2025, consisting of one-on-one meetings [2]. Product Development - VYNE's proprietary BET inhibitors, part of its InhiBET™ platform, aim to address limitations of early generation BET inhibitors by utilizing alternative routes of administration and enhanced selectivity [3].

Core Insights - VYNE Therapeutics Inc. has initiated a Phase 1b trial for VYN202, an oral small molecule BET inhibitor, targeting moderate-to-severe plaque psoriasis, marking a significant advancement in its clinical development [1][2][3] - The trial aims to evaluate the safety, tolerability, and pharmacokinetics of VYN202 over a 12-week period, with top-line data expected by the end of 2025 [1][3][6] Company Overview - VYNE Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for chronic inflammatory and immune-mediated conditions with high unmet needs [9] - The company’s proprietary BET inhibitors, including VYN202, are designed to overcome limitations of earlier generation BET inhibitors through enhanced selectivity and alternative administration routes [9] Product Details - VYN202 is characterized as a highly selective oral BET inhibitor with potential advantages in treating immune-mediated diseases due to its class-leading selectivity for BD2 over BD1 [5][6] - The Phase 1b trial will include three dosing cohorts (0.25 mg, 0.5 mg, 1 mg) and will assess exploratory efficacy measures such as PASI scores and quality of life [3][4] Disease Context - Plaque psoriasis is a chronic immune-mediated disease affecting over 8 million Americans and more than 125 million people globally, characterized by inflamed, scaly plaques [4] - The disease shares common inflammatory pathways with other chronic conditions, suggesting potential broader applications for VYN202 in treating various immune-mediated diseases [4][2]

Core Insights - VYNE Therapeutics Inc. has completed enrollment in its Phase 2b trial for VYN201 gel, aimed at treating nonsegmental vitiligo, with top-line data expected in mid-2025 [1][2][8] Company Overview - VYNE Therapeutics Inc. is a clinical-stage biopharmaceutical company focused on developing differentiated therapies for chronic inflammatory and immune-mediated conditions with high unmet needs [9] - The company utilizes a proprietary InhiBET™ platform, which includes unique BET inhibitors designed to enhance selectivity and overcome limitations of earlier generation BET inhibitors [9] Product Development - The Phase 2b trial for VYN201 gel (now named repibresib) is a randomized, double-blind, vehicle-controlled study assessing the efficacy, safety, and pharmacokinetics of the gel in three dose cohorts (1%, 2%, and 3%) over a 24-week period [3][4] - The primary efficacy endpoint is the proportion of subjects achieving at least a 50% improvement in the Facial Vitiligo Area Scoring Index (F-VASI50) at week 24 compared to the vehicle group [4] Disease Context - Vitiligo is a chronic autoimmune disorder characterized by the loss of melanocytes, affecting approximately 0.5-2.0% of the global population, with nonsegmental vitiligo being the most common type [5] - Currently, there is only one FDA-approved treatment for vitiligo, highlighting the significant unmet medical need in this area [5] Mechanism of Action - Repibresib is a pan-bromodomain BET inhibitor designed for local administration, targeting multiple inflammatory cell signaling pathways while minimizing systemic exposure [6] - BET proteins play a crucial role in regulating gene transcription and immune cell activation, making BET inhibitors promising for treating various immuno-inflammatory and fibrotic diseases [7]

Core Insights - VYN202 shows promising results as a novel, once-daily oral treatment for various immune-mediated disorders, demonstrating a favorable safety and tolerability profile [1][3] - The Phase 1a trial results indicate robust pharmacodynamic activity, including significant inhibition of inflammatory biomarkers [1][2] Safety and Tolerability - VYN202 exhibited no drug-related adverse events historically associated with earlier generation BET inhibitors, such as thrombocytopenia and gastrointestinal toxicity [2][4] - All treatment-emergent adverse events (TEAEs) were mild or moderate, with no serious adverse events reported [2][3] Pharmacokinetics (PK) - VYN202 supports a once-daily dosing regimen, achieving steady-state after 7 doses [2][4] - Blood levels of VYN202 remained within key inhibitory thresholds for at least 24 hours across all doses [2][4] - No drug-drug interactions were observed when co-administered with methotrexate [2][4] Pharmacodynamics - VYN202 induced a dose-dependent increase in the target engagement biomarker HEXIM-11, with maximal effects at doses of 0.5mg to 1.0mg [2][5] - The drug inhibited multiple inflammatory biomarkers related to Th17 and Th1/myeloid dysregulated activity, consistent with preclinical models [2][6] Development and Future Plans - The positive results from the Phase 1a trial support further development of VYN202 as a treatment option for immune-mediated diseases [3][9] - The company plans to finalize clinical trial plans for VYN202 based on these encouraging results [3][9] About VYN202 - VYN202 is an innovative oral small molecule BET inhibitor designed for enhanced selectivity and potency, particularly for BD2 versus BD1 [6][9] - It aims to provide a differentiated, non-biologic treatment option for chronic inflammatory conditions [6][9]