Company is progressing its previously initiated strategic review evaluating a range of options to maximize shareholder value, including assessment of internal pipeline opportunities and broader strategic alternatives12-week, non-clinical toxicology study of VYN202 in dogs to remedy the partial hold in male clinical subjects is ongoing; Company continues to evaluate potential opportunities for VYN202 as a treatment for serious, immune-mediated diseases Cash runway into first half of 2027 based on previously ...

Core Insights - VYNE Therapeutics Inc. reported financial results for the quarter ended June 30, 2025, highlighting its focus on developing therapies for chronic inflammatory and immune-mediated conditions with high unmet needs [1][12] Pipeline Overview - VYNE's oral BD2-selective BET inhibitor, VYN202, has shown promising efficacy in a Phase 1b clinical trial for moderate to severe plaque psoriasis and potential in various other diseases [2][6] - The FDA had previously placed a clinical hold on the Phase 1b trial due to testicular toxicity observed in dogs, but lifted the hold for female subjects in June 2025 [6] - The company is seeking a partner for its topical BET inhibitor, repibresib, which has patent exclusivity until at least 2042 in the U.S. and 2040 in Europe and other major markets [2][6] Financial Results - As of June 30, 2025, VYNE reported revenues of $0.1 million, a decrease from $0.2 million in the same quarter of 2024, primarily from royalty revenue [8] - Research and development expenses decreased by 33.2% to $4.9 million compared to $7.3 million in the same quarter of 2024, driven by reduced expenses for repibresib and VYN202 [9] - General and administrative expenses also decreased by 17.0% to $2.7 million from $3.3 million in the prior year [10] - The net loss for the quarter was $5.8 million, or $0.13 per share, compared to a net loss of $9.4 million, or $0.22 per share, in the same quarter of 2024 [11] Cash Position - VYNE had $39.6 million in cash, cash equivalents, and marketable securities as of June 30, 2025, which is expected to fund operations into the first half of 2027 [7]

Core Insights - VYNE Therapeutics announced that its Phase 2b trial for Repibresib gel in nonsegmental vitiligo did not meet its primary endpoint of achieving at least a 50% improvement in the Facial Vitiligo Area Scoring Index (F-VASI50) at week 24 compared to the vehicle group [1][2][4] - Despite missing the primary and key secondary endpoints, nominally statistically significant effects were observed in some exploratory endpoints, indicating potential efficacy at the highest dose [2][4] - The company plans to terminate the ongoing extension phase of the trial and seek an external partner for the continued development of Repibresib [1][4] Trial Details - The Phase 2b trial involved 177 subjects and was a randomized, double-blind, vehicle-controlled study assessing the safety and efficacy of Repibresib at concentrations of 1%, 2%, and 3% [3] - The trial was conducted across 45 sites in North America and evaluated multiple efficacy endpoints, including the primary endpoint of F-VASI50 and key secondary endpoints [3] Efficacy Results - The trial did not meet the primary endpoint, with only 19.5% of subjects in the 3% Repibresib group achieving F-VASI50 compared to 23.4% in the vehicle group [5] - For the key secondary endpoint of F-VASI75, 9.8% of subjects in the 3% group achieved this compared to 6.4% in the vehicle group [6] - The percent change from baseline in F-VASI score at week 24 showed a mean reduction of -43.6% for the 3% Repibresib group versus -25.6% for the vehicle group, indicating a statistically significant treatment effect [7] - The percent change from baseline in T-VASI score at week 24 also showed a significant reduction of -28.3% for the 3% Repibresib group compared to -16.2% for the vehicle group [8] Safety and Tolerability - The trial reported a higher rate of treatment-emergent adverse events (TEAEs) in subjects receiving Repibresib compared to the vehicle group, with application site pain being the most common adverse event [9] - Eight subjects discontinued due to adverse events in the Repibresib group, while none in the vehicle group experienced this [9] Financial Position - As of June 30, 2025, VYNE expects to report approximately $39.6 million in cash, cash equivalents, and investments [4]

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]

Core Viewpoint - VYNE Therapeutics Inc. is advancing its clinical-stage biopharmaceutical development, particularly focusing on repibresib for vitiligo and addressing a clinical hold on VYN202 for psoriasis treatment [2][3]. Financial Results - As of March 31, 2025, VYNE reported cash, cash equivalents, and marketable securities totaling $50.3 million, sufficient to fund operations into the second half of 2026 [4]. - Revenues for the first quarter of 2025 were $0.2 million, an increase from $0.1 million in the same quarter of 2024, primarily from royalty revenue [8]. - Research and development expenses rose to $6.1 million in Q1 2025 from $3.7 million in Q1 2024, driven by increased costs associated with VYN202 and repibresib [9]. - General and administrative expenses decreased to approximately $3.3 million in Q1 2025 from $3.8 million in Q1 2024 [10]. - The net loss for Q1 2025 was $8.6 million, or $0.20 per share, compared to a net loss of $6.2 million, or $0.15 per share, in Q1 2024 [11]. Pipeline and Corporate Updates - The Phase 2b trial for repibresib gel in treating nonsegmental vitiligo is fully enrolled, with top-line results expected in mid-2025 [6][7]. - The Phase 1b trial for VYN202 has been placed on clinical hold due to observed testicular toxicity in non-clinical studies, with VYNE working with the FDA to resolve this issue [3][4]. - The ongoing Phase 2b trial of repibresib gel is not affected by the clinical hold on VYN202, as repibresib is a distinct compound [7].

Core Points - VYNE Therapeutics Inc. announced a clinical hold on its Phase 1b study of VYN202 for moderate-to-severe plaque psoriasis due to observed testicular toxicity in dogs from a non-clinical toxicology study [1][2] - The company has suspended all screening, enrollment, and patient dosing in the Phase 1b trial and aims to resolve the clinical hold with the FDA as soon as possible [2] - The clinical hold does not affect VYNE's ongoing Phase 2b trial of repibresib gel for nonsegmental vitiligo, with top-line results expected mid-year [3] - The CEO of VYNE expressed disappointment over the clinical hold but emphasized the priority of patient safety and the intention to work closely with the FDA [4] - VYNE is focused on developing differentiated therapies for chronic inflammatory and immune-mediated conditions, utilizing its proprietary BET inhibitors [4]