VYNE Therapeutics (VYNE) - 2025 Q1 - Quarterly Results

Executive Summary 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][5] - VYN202 Phase 1b psoriasis trial placed on clinical hold by the FDA due to testicular toxicity observed in non-clinical studies[2][4] - VYNE expects its cash runway to extend into the second half of 2026[5][7] Recent Pipeline and Corporate Updates This section provides updates on the development status of repibresib gel and VYN202 oral small molecule programs Repibresib Gel (VYN201) Development 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][6] - 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] - 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] VYN202 Oral Small Molecule Development 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] - The clinical hold was due to observed testicular toxicity in dogs from a non-clinical toxicology study[4] - 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] Financial Results for Q1 2025 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 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] Share Count 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 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] Research and Development Expenses 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] General and Administrative Expenses 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] Net Loss 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. This section provides an overview of VYNE Therapeutics Inc., a clinical-stage biopharmaceutical company Company Overview 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] - 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] Financial Statements This section presents the condensed consolidated balance sheets and statements of operations for VYNE Therapeutics Inc. Condensed Consolidated Balance Sheets 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