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]

[Cover Page Information](index=1&type=section&id=Cover%20Page%20Information) [Form 10-Q Filing Details](index=1&type=section&id=Form%2010-Q%20Filing%20Details) Details the Form 10-Q filing for VYNE THERAPEUTICS INC. for Q1 2025, confirming SEC compliance - The registrant is **VYNE THERAPEUTICS INC.**, a Delaware corporation, with common stock traded on The Nasdaq Stock Market LLC under the symbol **VYNE**[3](index=3&type=chunk) - The company has filed all required reports under Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months and has been subject to such filing requirements for the past 90 days[3](index=3&type=chunk) - The company has electronically submitted every Interactive Data File required pursuant to Rule 405 of Regulation S-T during the preceding 12 months[4](index=4&type=chunk) [Filer Status and Outstanding Shares](index=1&type=section&id=Filer%20Status%20and%20Outstanding%20Shares) VYNE Therapeutics Inc. is a Non-accelerated and Smaller reporting company with **16.7 million** common shares outstanding | Filer Status | | | | | | :------------- | :--- | :---------- | :--- | :--- | | Large accelerated filer | ☐ | Accelerated filer | ☐ | | | Non-accelerated filer | ☒ | Smaller reporting company | ☒ | | | Emerging growth company | ☐ | | | | - As of May 1, 2025, there were **16,664,892** shares of the registrant's Common Stock, par value $0.0001 per share, outstanding[8](index=8&type=chunk) [TABLE OF CONTENTS](index=3&type=section&id=TABLE%20OF%20CONTENTS) [Forward-Looking Statements and Company Information](index=4&type=section&id=Forward-Looking%20Statements%20and%20Company%20Information) [Special Note Regarding Forward-Looking Statements](index=4&type=section&id=SPECIAL%20NOTE%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) The report contains forward-looking statements involving known and unknown risks, subject to change and detailed in Risk Factors - The report contains forward-looking statements regarding business strategy, clinical trials, regulatory approval, financing, market size, and intellectual property[12](index=12&type=chunk)[13](index=13&type=chunk) - These statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from expectations[12](index=12&type=chunk)[14](index=14&type=chunk) - The company assumes no obligation to update these forward-looking statements, except as required by law[14](index=14&type=chunk) [Company References](index=5&type=section&id=COMPANY%20REFERENCES) Clarifies that 'VYNE,' 'the Company,' 'we,' 'us,' and 'our' refer to VYNE Therapeutics Inc. and its subsidiaries - References to **'VYNE,' 'the Company,' 'we,' 'us,' and 'our'** refer to VYNE Therapeutics Inc. and its subsidiaries[16](index=16&type=chunk) [Trademarks](index=5&type=section&id=TRADEMARKS) Lists VYNE Therapeutics Inc.'s trademarks, including VYNE Therapeutics and InhiBET, and notes third-party trademarks - VYNE Therapeutics Inc.'s trademarks include **VYNE Therapeutics**, **InhiBET**, and its name and logo[18](index=18&type=chunk) [Part I – Financial Information](index=6&type=section&id=Part%20I%20Financial%20Information) [Item 1. Unaudited Condensed Consolidated Financial Statements](index=6&type=section&id=Item%201.%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Presents VYNE Therapeutics Inc.'s unaudited condensed consolidated financial statements and notes on operations, policies, and agreements [Unaudited Condensed Consolidated Balance Sheets](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased from **$66.9 million** to **$56.4 million** by March 31, 2025, due to reduced marketable securities | Metric (in thousands) | March 31, 2025 | December 31, 2024 | | :-------------------- | :------------- | :---------------- | | Cash and cash equivalents | $28,209 | $19,926 | | Investment in marketable securities | $22,063 | $41,590 | | Total Current Assets | $54,913 | $64,437 | | Total Assets | $56,423 | $66,905 | | Total Current Liabilities | $12,291 | $14,819 | | Total Liabilities | $12,291 | $14,819 | | Total Stockholders' Equity | $44,132 | $52,086 | [Unaudited Condensed Consolidated Statements Of Operations and Comprehensive Loss](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20Of%20Operations%20and%20Comprehensive%20Loss) Net loss increased to **$8.6 million** for Q1 2025, up from **$6.2 million** in Q1 2024, due to higher R&D expenses | Metric (in thousands, except per share) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------ | :-------------------------------- | :-------------------------------- | | Royalty revenues | $202 | $98 | | Total revenues | $202 | $98 | | Research and development | $6,124 | $3,708 | | General and administrative | $3,275 | $3,770 | | Total operating expenses | $9,399 | $7,478 | | Operating loss | $(9,197) | $(7,380) | | Other income, net | $594 | $1,139 | | Net loss | $(8,611) | $(6,249) | | Loss per share, basic and diluted | $(0.20) | $(0.15) | [Unaudited Condensed Consolidated Statements Of Changes In Stockholders' Equity](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20Of%20Changes%20In%20Stockholders'%20Equity) Stockholders' equity decreased from **$52.1 million** to **$44.1 million** by March 31, 2025, due to an **$8.6 million** net loss | Metric (in thousands) | Balance at Jan 1, 2025 | Net Loss | Stock-based Compensation | Cashless Exercise of Pre-funded Warrants | Balance at Mar 31, 2025 | | :-------------------- | :--------------------- | :------- | :----------------------- | :------------------------------------- | :---------------------- | | Total Stockholders' Equity | $52,086 | $(8,611) | $763 | $1 | $44,132 | [Unaudited Condensed Consolidated Statements Of Cash Flows](index=9&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20Of%20Cash%20Flows) Net cash used in operating activities was **$11.5 million**, while investing activities provided **$19.8 million** for Q1 2025 | Cash Flow Activity (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(11,461) | $(7,981) | | Net cash provided by (used in) investing activities | $19,831 | $(3,569) | | Net cash used in financing activities | $(87) | $(5) | | Increase (decrease) in cash, cash equivalents and restricted cash | $8,283 | $(11,555) | | Cash, cash equivalents and restricted cash at end of the period | $28,209 | $19,119 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Provides detailed explanations of financial statements, covering operations, accounting policies, agreements, and equity [NOTE 1 - NATURE OF OPERATIONS](index=10&type=section&id=NOTE%201%20-%20NATURE%20OF%20OPERATIONS) VYNE Therapeutics is a clinical-stage biopharmaceutical company developing BET inhibitors, facing a **$739.8 million** accumulated deficit - **VYNE Therapeutics Inc.** is a clinical-stage biopharmaceutical company focused on developing therapies for chronic inflammatory and immune-mediated conditions[31](index=31&type=chunk) - The company's lead program, **repibresib gel (VYN201)**, a topical pan-BD BET inhibitor, is in a **Phase 2b** trial for nonsegmental vitiligo, with top-line results expected in mid-2025[33](index=33&type=chunk) - **VYN202**, an oral BD2-selective BET inhibitor, initiated a **Phase 1b** trial for moderate-to-severe plaque psoriasis in February 2025, but the FDA placed a **clinical hold** in May 2025 due to observed testicular toxicity in dogs from a non-clinical toxicology study[34](index=34&type=chunk) - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities of **$50.3 million** and an accumulated deficit of **$739.8 million**, with a net loss of **$8.6 million** for the three months ended March 31, 2025[37](index=37&type=chunk) [NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES](index=11&type=section&id=NOTE%202%20-%20SIGNIFICANT%20ACCOUNTING%2

[Executive Summary](index=1&type=section&id=Executive%20Summary) VYNE Therapeutics reported Q1 2025 results, detailing repibresib Phase 2b progress, VYN202 clinical hold, and cash runway into H2 2026 - Repibresib Phase 2b trial for vitiligo is progressing, with top-line results expected **mid-2025**[2](index=2&type=chunk)[5](index=5&type=chunk) - VYN202 Phase 1b psoriasis trial placed on clinical hold by the FDA due to testicular toxicity observed in non-clinical studies[2](index=2&type=chunk)[4](index=4&type=chunk) - VYNE expects its cash runway to extend into the **second half of 2026**[5](index=5&type=chunk)[7](index=7&type=chunk) [Recent Pipeline and Corporate Updates](index=1&type=section&id=Recent%20Pipeline%20and%20Corporate%20Updates) This section provides updates on the development status of repibresib gel and VYN202 oral small molecule programs [Repibresib Gel (VYN201) Development](index=1&type=section&id=Repibresib%20gel,%20a%20locally-administered%20small%20molecule%20pan-BD%20BET%20inhibitor%20(Phase%202b,%20nonsegmental%20vitiligo)) The Phase 2b trial for repibresib gel in nonsegmental vitiligo is fully enrolled and progressing, with top-line results anticipated in mid-2025 - Top-line results from the fully enrolled Phase 2b trial for repibresib gel in nonsegmental vitiligo are expected **mid-2025**[5](index=5&type=chunk)[6](index=6&type=chunk) - The trial is a randomized, double-blind, vehicle-controlled study evaluating **1%, 2%, or 3% concentrations** over **24 weeks**, followed by an active treatment extension[6](index=6&type=chunk) - Repibresib is a distinct compound from VYN202, and its trial is not affected by the VYN202 clinical hold, with no observed testicular toxicity in non-clinical studies[6](index=6&type=chunk) [VYN202 Oral Small Molecule Development](index=1&type=section&id=VYN202,%20an%20oral%20small%20molecule%20BD2-selective%20inhibitor) The FDA has placed a clinical hold on the Phase 1b trial evaluating VYN202 for moderate-to-severe plaque psoriasis due to testicular toxicity - The Phase 1b trial for VYN202 in moderate-to-severe plaque psoriasis was placed on clinical hold by the FDA in **May 2025**[4](index=4&type=chunk) - The clinical hold was due to observed testicular toxicity in dogs from a non-clinical toxicology study[4](index=4&type=chunk) - VYNE has suspended all screening, enrollment, and patient dosing and is working diligently with the FDA to resolve the hold, with no serious adverse events observed in enrolled human subjects to date[4](index=4&type=chunk) [Financial Results for Q1 2025](index=2&type=section&id=Financial%20Results%20as%20of%20and%20for%20the%20First%20Quarter%20Ended%20March%2031,%202025) This section details VYNE Therapeutics' financial performance for the first quarter ended March 31, 2025, including cash position, share count, revenues, expenses, and net loss [Cash Position and Runway](index=2&type=section&id=Cash%20position) As of March 31, 2025, VYNE held $50.3 million in cash, cash equivalents, and marketable securities, projected to fund operations into the second half of 2026 Cash, Cash Equivalents and Marketable Securities | Metric | March 31, 2025 | | :----- | :------------- | | Cash, cash equivalents and marketable securities | $50.3 million | - VYNE believes its cash position is sufficient to fund operations into the **second half of 2026**[7](index=7&type=chunk) [Share Count](index=2&type=section&id=Share%20count) As of March 31, 2025, VYNE had 15,959,488 common shares issued and outstanding, along with pre-funded warrants for an additional 26,794,398 shares Share Count Details | Metric | March 31, 2025 | | :----- | :------------- | | Common shares issued and outstanding | 15,959,488 | | Outstanding pre-funded warrants | 26,794,398 | [Revenues](index=2&type=section&id=Revenues) Total revenues for Q1 2025 increased to $0.2 million from $0.1 million in Q1 2024, primarily consisting of royalty revenue Total Revenues | Metric | Q1 2025 | Q1 2024 | YoY Change | | :----- | :------ | :------ | :--------- | | Total Revenues | $0.2 million | $0.1 million | +100% | - Revenues consist of royalty revenue from the licensing agreement with LEO Pharma A/S for Finacea foam[8](index=8&type=chunk) [Research and Development Expenses](index=2&type=section&id=Research%20and%20development%20expenses) R&D expenses increased significantly to $6.1 million in Q1 2025 from $3.7 million in Q1 2024, driven by increased clinical trial and employee-related costs Research and Development Expenses | Metric | Q1 2025 | Q1 2024 | YoY Change | | :----- | :------ | :------ | :--------- | | R&D Expenses | $6.1 million | $3.7 million | +$2.4 million (+64.9%) | - Increase primarily driven by **$1.5 million** for VYN202 Phase 1b trial costs, **$0.7 million** for repibresib Phase 2b trial costs, and **$0.3 million** in employee-related expenses[8](index=8&type=chunk) [General and Administrative Expenses](index=2&type=section&id=General%20and%20administrative%20expenses) G&A expenses decreased to $3.3 million in Q1 2025 from $3.8 million in Q1 2024, mainly due to reductions in consulting and employee-related fees General and Administrative Expenses | Metric | Q1 2025 | Q1 2024 | YoY Change | | :----- | :------ | :------ | :--------- | | G&A Expenses | $3.3 million | $3.8 million | -$0.5 million (-13.2%) | - Decrease primarily driven by a **$0.3 million** reduction in consulting and professional fees and a **$0.2 million** reduction in employee-related expenses[9](index=9&type=chunk) [Net Loss](index=2&type=section&id=Net%20loss) VYNE reported an increased net loss of $8.6 million, or $0.20 per share, for Q1 2025, compared to $6.2 million, or $0.15 per share, in the prior year Net Loss | Metric | Q1 2025 | Q1 2024 | YoY Change | | :----- | :------ | :------ | :--------- | | Net Loss | $(8.6) million | $(6.2) million | $(2.4) million | | Net Loss per Share | $(0.20) | $(0.15) | $(0.05) | [About VYNE Therapeutics Inc.](index=2&type=section&id=About%20VYNE%20Therapeutics%20Inc.) This section provides an overview of VYNE Therapeutics Inc., a clinical-stage biopharmaceutical company [Company Overview](index=2&type=section&id=Company%20Overview) VYNE Therapeutics is a clinical-stage biopharmaceutical company focused on developing differentiated therapies for chronic inflammatory and immune-mediated conditions - VYNE is a clinical-stage biopharmaceutical company focused on developing differentiated therapies for chronic inflammatory and immune-mediated conditions[11](index=11&type=chunk) - The company's InhiBET™ platform comprises unique and proprietary BET inhibitors designed to overcome limitations of early generation BET inhibitors through alternative administration routes and enhanced selectivity[11](index=11&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents the condensed consolidated balance sheets and statements of operations for VYNE Therapeutics Inc. [Condensed Consolidated Balance Sheets](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) The balance sheet shows a decrease in total assets from $66.9 million at December 31, 2024, to $56.4 million at March 31, 2025, primarily driven by a reduction in marketable securities Condensed Consolidated Balance Sheets (in thousands) | Item | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------ | :-------------------- | | **Assets** | | | | | Cash and cash equivalents | $28,209 | $19,926 | +$8,283 | | Investment in marketable securities | $22,063 | $41,590 | -$19,527 | | Total Current Assets | $54,913 | $64,437 | -$9,524 | | Total Assets | $56,423 | $66,905 | -$10,482 | | **Liabilities** | | | | | Total Current Liabilities | $12,291 | $14,819 | -$2,528 | | Total Liabilities | $12,291 | $14,819 | -$2,528 | | **Stockholders' Equity** | | | | | Total Stockholders' Equity | $44,132 | $52,086 | -$7,954 | [Condensed Consolidated Statements of Operations](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20

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]

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].