VYNE Therapeutics (VYNE) - 2025 Q1 - Quarterly Report

Cover Page Information Form 10-Q Filing Details 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] - 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] - The company has electronically submitted every Interactive Data File required pursuant to Rule 405 of Regulation S-T during the preceding 12 months[4] Filer Status and Outstanding Shares 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] TABLE OF CONTENTS Forward-Looking Statements and Company Information Special Note Regarding Forward-Looking Statements 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][13] - These statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from expectations[12][14] - The company assumes no obligation to update these forward-looking statements, except as required by law[14] Company References 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] 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] Part I – Financial Information Item 1. Unaudited Condensed Consolidated Financial Statements Presents VYNE Therapeutics Inc.'s unaudited condensed consolidated financial statements and notes on operations, policies, and agreements Unaudited Condensed Consolidated Balance Sheets 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 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 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 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 Provides detailed explanations of financial statements, covering operations, accounting policies, agreements, and equity NOTE 1 - NATURE OF OPERATIONS 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] - 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] - 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] - 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] [NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES](index=11&type=section&id=NOTE%202%20-%20SIGNIFICANT%20ACCOUNTING%2