VYNE Therapeutics (VYNE) - 2025 Q2 - Quarterly Report

PART I – FINANCIAL INFORMATION Item 1. Unaudited Financial Statements This section presents VYNE Therapeutics Inc.'s unaudited condensed consolidated financial statements, including balance sheets, statements of operations, changes in equity, cash flows, and notes, detailing financial position and performance for periods ended June 30, 2025, and December 31, 2024 Unaudited Condensed Consolidated Balance Sheets The balance sheets show the company's financial position, with total assets decreasing from $66.9 million to $44.7 million, primarily due to a reduction in marketable securities | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :----------------------------- | :----------------------------- | :----------------------------- | | Cash and cash equivalents | $22,047 | $19,926 | | Investment in marketable securities | $17,600 | $41,590 | | Total Current Assets | $44,343 | $64,437 | | Total Assets | $44,718 | $66,905 | | Total Current Liabilities | $5,836 | $14,819 | | Total Liabilities | $5,836 | $14,819 | | Total Stockholders' Equity | $38,882 | $52,086 | Unaudited Condensed Consolidated Statements Of Operations and Comprehensive Loss The statements of operations show a reduced net loss for both the three and six months ended June 30, 2025, compared to the prior year, driven by lower operating expenses and increased other income | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Royalty revenues | $69 | $198 | $271 | $296 | | Research and development | $4,881 | $7,306 | $11,004 | $11,014 | | General and administrative | $2,730 | $3,288 | $6,005 | $7,058 | | Operating loss | $(7,542) | $(10,396) | $(16,738) | $(17,776) | | Other income, net | $1,795 | $1,001 | $2,388 | $2,140 | | Net loss | $(5,755) | $(9,406) | $(14,366) | $(15,655) | | Loss per share, basic and diluted | $(0.13) | $(0.22) | $(0.34) | $(0.37) | Unaudited Condensed Consolidated Statements Of Changes In Stockholders' Equity Stockholders' equity decreased from $52.1 million at January 1, 2025, to $38.9 million at June 30, 2025, primarily due to the net loss incurred during the period, partially offset by stock-based compensation | Metric (in thousands) | January 1, 2025 | June 30, 2025 | | :-------------------- | :-------------- | :------------ | | Total Stockholders' Equity | $52,086 | $38,882 | | Net loss | — | $(14,366) | | Stock-based compensation | — | $1,292 | | Cashless exercise of pre-funded warrants (shares) | — | 4,813,611 | Unaudited Condensed Consolidated Statements Of Cash Flows Net cash used in operating activities increased to $22.3 million in H1 2025, while investing activities provided $24.5 million, mainly from marketable securities sales, increasing cash | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(22,264) | $(16,463) | | Net cash provided by investing activities | $24,506 | $15,451 | | Net cash used in financing activities | $(121) | $(7) | | Cash, cash equivalents and restricted cash at end of period | $22,047 | $29,655 | Notes to Unaudited Condensed Consolidated Financial Statements These notes detail the company's operations, accounting policies, strategic agreements, and financial components, providing comprehensive context for the condensed consolidated financial statements NOTE 1 - NATURE OF OPERATIONS VYNE Therapeutics, a clinical-stage biopharmaceutical company, focuses on BET inhibitors, with VYN202 facing a clinical hold and repibresib gel being discontinued - VYNE Therapeutics is a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need[34] - VYN202, an oral, small molecule BD2-selective BET inhibitor, initiated a Phase 1b trial in February 2025 for moderate-to-severe plaque psoriasis, but the FDA verbally placed a clinical hold in April 2025 due to testicular toxicity in dogs[36][37] - Following the clinical hold, the company unblinded preliminary Phase 1b data from seven subjects, showing improvement in signs and symptoms for VYN202-treated subjects, leading to the termination of the psoriasis trial to advance VYN202 into other serious, immune-mediated diseases[38][39] - Repibresib gel (VYN201) Phase 2b trial in nonsegmental vitiligo did not meet its primary or key secondary endpoints, resulting in the discontinuation of the trial and the company seeking an external partner for its continued development[40][41] - As of June 30, 2025, the Company had cash, cash equivalents and marketable securities of $39.6 million and an accumulated deficit of $745.5 million[43] NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES This note details accounting principles, including U.S. GAAP, revenue recognition, R&D expensing, fair value, income tax policies, ERTC, and new pronouncements - The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim financial statements[47] - Royalty revenues from Finacea foam are recognized when the product is sold by LEO Pharma[59] - All research and development expenses are expensed as incurred[68] - The Company recognized $1.3 million of other income for both the three and six months ended June 30, 2025, due to the closure of the IRS examination of its ERTC filings[81] - The Company's net operating loss (NOL) carryforwards are subject to annual limitations under Section 382 of the Internal Revenue Code, with ownership changes through March 31, 2025, expected to result in unutilized federal NOLs[76] - The Company is evaluating the impact of newly issued accounting pronouncements, ASU No. 2023-09 (Income Tax Disclosures) and ASU No. 2024-03 (Disaggregation of Income Statement Expenses)[83][84] NOTE 3 - STRATEGIC AGREEMENTS This note details licensing agreements with Tay Therapeutics for BET inhibitor programs, outlining financial obligations, and the sale of the MST Franchise - The Company holds exclusive worldwide rights to research, develop, and commercialize Tay's small molecule BET inhibitor compounds[85] Tay Therapeutics License Agreements Financial Obligations | Agreement | Upfront Payment | Milestone Payments (U.S.) | Paid/Accrued Milestones (through June 30, 2025) | Tiered Royalties on Net Sales | | :-------------------------- | :-------------- | :-------------------------- | :---------------------------------------------- | :---------------------------- | | Repibresib License Agreement | $0.5 million | Up to $15.75 million | $1.8 million | 5%, 7.5%, 10% | | VYN202 License Agreement | $3.75 million | Up to $43.75 million | $1.3 million | 5%, 7.5%, 10% | - The Company sold its MST Franchise to Journey Medical Corporation in January 2022, receiving $20.0 million upfront and $5.0 million deferred payment, and is eligible for up to $450.0 million in aggregate sales milestone payments[93] NOTE 4 – DISCONTINUED OPERATIONS The MST Franchise, sold in January 2022, is classified as discontinued operations, with minimal losses for the reported periods, consisting solely of general and administrative expenses Loss from Discontinued Operations, Net of Income Taxes (in thousands) | Period | 2025 | 2024 | | :-------------------------- | :--- | :--- | | Three Months Ended June 30, | $8 | $11 | | Six Months Ended June 30, | $16 | $19 | - Milestone payments for sales of ZILXI, AMZEEQ, and FCD105 are accounted for as a gain contingency and will be recognized in earnings when realizable[96] NOTE 5 – FAIR VALUE MEASUREMENTS The company's financial assets measured at fair value are categorized into Level 1 and Level 2, with cash and cash equivalents split and marketable securities entirely in Level 2 as of June 30, 2025 Fair Value of Financial Assets (in thousands) | Asset Category | June 30, 2025 (Level 1) | June 30, 2025 (Level 2) | December 31, 2024 (Level 1) | December 31, 2024 (Level 2) | | :------------- | :---------------------- | :---------------------- | :-------------------------- | :-------------------------- | | Cash and cash equivalents | $21,450 | $597 | $19,926 | $0 | | Marketable securities | $0 | $17,600 | $0 | $41,590 | | Total assets | $21,450 | $18,197 | $19,926 | $41,590 | NOTE 6 – MARKETABLE SECURITIES Marketable securities, primarily U.S. Treasury bills, significantly decreased from $41.6 million to $17.6 million, shifting from an unrealized gain to an unrealized loss Marketable Securities (in thousands) | Security Type | June 30, 2025 | December 31, 2024 | | :------------ | :------------ | :---------------- | | U.S. Government and agency debt securities | $0 | $10,572 | | U.S. Treasury bills | $17,600 | $31,018 | | Total | $17,600 | $41,590 | - As of June 30, 2025, marketable securities were in an unrealized loss position of $(2) thousand, compared to an unrealized gain position of $20 thousand as of December 31, 2024[100] NOTE 7 - PROPERTY AND EQUIPMENT The company's property and equipment, mainly office equipment, showed a slight decrease in net value from $113 thousand at December 31, 2024, to $102 thousand at June 30, 2025, due to depreciation Property and Equipment, Net (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :------------------------ | :------------ | :---------------- | | Office equipment | $117 | $117 | | Less: Accumulated depreciation | $(15) | $(4) | | Property and equipment, net | $102 | $113 | - Depreciation expense for the six months ended June 30, 2025, totaled $12 thousand[102] NOTE 8 – STOCKHOLDERS' EQUITY This note details authorized and outstanding shares, at-the-market offerings, and the exercise and remaining balance of Pre-Funded Warrants - As of June 30, 2025, 19,773,784 shares of common stock were issued and outstanding[21] - No shares of common stock were sold under the Cowen Sales Agreement (at-the-market offering program) during the six months ended June 30, 2025 and 2024[107] - During the six months ended June 30, 2025, 4,813,940 Pre-Funded Warrants were exercised via a net exercise mechanism, with 23,028,800 Pre-Funded Warrants remaining outstanding[109] - The company also had 27,509 other warrants outstanding as of June 30, 2025, with an exercise price of $8.40 and an expiration date of July 29, 2026[110] NOTE 9 – STOCK-BASED COMPENSATION This note outlines equity incentive plans and details stock-based compensation expenses, which decreased for both the three and six months ended June 30, 2025 - During the six months ended June 30, 2025, the Company granted 1,582,500 options to employees and directors with exercise prices ranging from $1.80 to $2.77, and a fair value of $3.6 million[117] Stock-Based Compensation Expenses (in thousands) | Expense Category | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $61 | $133 | $187 | $296 | | General and administrative | $468 | $752 | $1,105 | $1,574 | | Total | $529 | $885 | $1,292 | $1,870 | NOTE 10 – COMMITMENTS AND CONTINGENCIES The company is not currently involved in any legal proceedings or claims that management believes are likely to have a material adverse effect on its business - As of June 30, 2025, there were no claims or actions pending against the Company that are likely to have a material adverse effect[120] NOTE 11 - SEGMENT INFORMATION The company operates as a single segment, focusing on developing therapies for chronic inflammatory and immune-mediated conditions, with the CEO reviewing key expenses - The Company operates in one operating segment, focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions[121][124] - The Chief Executive Officer (CEO) acts as the Chief Operating Decision Maker (CODM), evaluating net loss, specific R&D program spend, and overall general and administrative expenses[122] Research and Development Expenses by Product Candidate (in thousands) | Product Candidate | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------- | :----------------------------- | :----------------------------- | | Repibresib (VYN201) | $5,041 | $6,426 | | VYN202 | $4,184 | $2,901 | NOTE 12 - SUBSEQUENT EVENTS On July 4, 2025, the One Big Beautiful Bill Act (OBBBA) was signed into law, making comprehensive revisions to federal corporate income tax provisions, which the company is currently evaluating - The One Big Beautiful Bill Act (OBBBA), signed on July 4, 2025, revises federal corporate income tax provisions, including R&D expense treatment and full expensing of business assets[125] - The Company is evaluating the potential impact of OBBBA on its condensed consolidated financial statements, as it was enacted after the June 30, 2025 balance sheet date[126] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on financial condition and operations, focusing on BET inhibitor development, product candidates, liquidity, and performance Company Overview VYNE Therapeutics, a clinical-stage biopharmaceutical company, focuses on BET inhibitors, with VYN202's trial terminated and repibresib gel discontinued - VYNE Therapeutics is a clinical-stage biopharmaceutical company focused on developing differentiated therapies to treat chronic inflammatory and immune-mediated conditions with high unmet need, utilizing its InhiBET™ portfolio of small molecule BET inhibitors[128][129] - VYN202, an oral BD2-selective BET inhibitor, had its Phase 1b trial in plaque psoriasis placed on clinical hold by the FDA due to testicular toxicity in dogs; however, promising preliminary unblinded data led to the trial's termination to advance VYN202 into other serious, immune-mediated diseases[131][132][133] - Repibresib gel (VYN201) Phase 2b trial in nonsegmental vitiligo did not meet its primary or key secondary endpoints, leading to the discontinuation of the trial and the company seeking an external partner for its continued development[135] - The company has implemented cost reductions expected to extend its cash runway into the first half of 2027[134] Development and License Agreements This section details licensing agreements with Tay Therapeutics for Repibresib and VYN202, outlining financial obligations, and the MST Franchise sale terms - The Company holds exclusive worldwide rights to Tay's BET inhibitor compounds for the treatment of any disease, disorder, or condition in humans[139] Tay Therapeutics License Agreements Financial Obligations | Agreement | Upfront Payment | Milestone Payments (U.S.) | Paid/Accrued Milestones (through June 30, 2025) | Tiered Royalties on Net Sales | | :-------------------------- | :-------------- | :-------------------------- | :---------------------------------------------- | :---------------------------- | | Repibresib License Agreement | $0.5 million | Up to $15.75 million | $1.8 million | 5%, 7.5%, 10% | | VYN202 License Agreement | $3.75 million | Up to $43.75 million | $1.3 million | 5%, 7.5%, 10% | - The Company sold its MST Franchise to Journey Medical Corporation in January 2022, receiving $20.0 million upfront and $5.0 million deferred payment, and is eligible for up to $450.0 million in aggregate sales milestone payments[93] Components of Operating Results This section explains key drivers of financial performance, including royalty revenues, R&D, G&A, other income, and the impact of NOLs and Section 382 limitations - Royalty revenues from Finacea foam were $0.1 million for the three months ended June 30, 2025, and $0.3 million for the six months ended June 30, 2025[147] - Research and development expenses decreased by 33.2% for the three months ended June 30, 2025, compared to the prior year, primarily due to decreased expenses for repibresib and VYN202[148][156] - General and administrative expenses decreased by 17.0% for the three months ended June 30, 2025, compared to the prior year[149][157] - Other income, net, increased by 79.3% for the three months ended June 30, 2025, primarily due to the recognition of $1.3 million related to the closure of the IRS examination period of the Company's ERTC filings[158] - As of December 31, 2024, the Company had federal NOL carryforwards of $343.4 million and state NOLs of $53.6 million, with $40.2 million of federal NOLs expected to expire unutilized due to Section 382 ownership changes[152][153] Results of Operations This section provides a detailed comparison of the company's financial performance for the three and six months ended June 30, 2025, versus 2024, highlighting changes in revenues, operating expenses, other income, and net loss Comparison of the Three Months Ended June 30, 2025 and 2024 For Q2 2025, net loss decreased by 38.8% to $5.8 million, driven by reduced R&D and G&A expenses and increased other income Financial Performance (Three Months Ended June 30, in thousands) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------- | :--- | :--- | :--------- | :--------- | | Royalty revenues | $69 | $198 | $(129) | (65.2)% | | Research and development | $4,881 | $7,306 | $(2,425) | (33.2)% | | General and administrative | $2,730 | $3,288 | $(558) | (17.0)% | | Other income, net | $1,795 | $1,001 | $794 | 79.3% | | Net loss | $(5,755) | $(9,406) | $(3,651) | (38.8)% | - The decrease in R&D expenses was primarily due to the timing of expenses for the repibresib Phase 2b trial and VYN202 Phase 1 trials, including milestone payments in the prior year[156] Comparison of the Six Months Ended June 30, 2025 and 2024 For H1 2025, net loss decreased by 8.2% to $14.4 million, mainly due to decreased G&A expenses and increased other income Financial Performance (Six Months Ended June 30, in thousands) | Metric | 2025 | 2024 | Change ($) | Change (%) | | :-------------------------- | :--- | :--- | :--------- | :--------- | | Royalty revenues | $271 | $296 | $(25) | (8.4)% | | Research and development | $11,004 | $11,014 | $(10) | (0.1)% | | General and administrative | $6,005 | $7,058 | $(1,053) | (14.9)% | | Other income, net | $2,388 | $2,140 | $248 | 11.6% | | Net loss | $(14,366) | $(15,655) | $(1,289) | (8.2)% | - The slight decrease in R&D expenses was driven by a $1.4 million decrease for repibresib, partially offset by a $1.3 million increase for VYN202 due to Phase 1b trial costs[163] Liquidity and Capital Resources As of June 30, 2025, the company had $39.6 million in cash and marketable securities, sufficient for 12 months, but needs substantial additional capital - As of June 30, 2025, the Company had cash, cash equivalents and marketable securities of $39.6 million and an accumulated deficit of $745.5 million[168] - For the six months ended June 30, 2025, the Company incurred a net loss of $14.4 million and used $22.3 million of cash in operations[168] - The Company believes its existing cash, cash equivalents and marketable securities are sufficient to fund its operating and capital expenditure requirements for a period of at least 12 months[168] - The Company will require substantial additional capital to complete the development of VYN202 and any future product candidates[171] - The amount of proceeds the Company can raise through primary public offerings using its Form S-3 is limited to one-third of the aggregate market value of shares held by non-affiliates until its public float exceeds $75.0 million[172] Cash Flows (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2025 | 2024 | | :----------------- | :--- | :--- | | Operating activities | $(22,264) | $(16,463) | | Investing activities | $24,506 | $15,451 | | Financing activities | $(121) | $(7) | Critical Accounting Policies, Significant Judgments and Use of Estimates The company's critical accounting policies, significant judgments, and use of estimates remain consistent with those disclosed in its Annual Report on Form 10-K for the year ended December 31, 2024 - There have been no material changes to the Company's critical accounting policies for the six months ended June 30, 2025[183] Off-Balance Sheet Arrangements The company is not party to any off-balance sheet arrangements that are expected to have a material current or future effect on its financial condition, revenues, expenses, results of operations, liquidity, capital expenditures, or capital resources - The Company is not party to any off-balance sheet arrangements that have, or are reasonably likely to have, a material current or future effect on its financial condition[184] Recently Issued and Adopted Accounting Pronouncements This section refers to Note 2 for a discussion of recently adopted and not yet adopted accounting pronouncements and their expected financial impact - Refer to 'Note 2 - Significant Accounting Policies' for a discussion of recently adopted accounting pronouncements and those not yet adopted[185] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, VYNE Therapeutics Inc. is not required to provide the detailed quantitative and qualitative disclosures about market risk typically found in this item - The Company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[186] Item 4. Controls and Procedures This section details the company's evaluation of its disclosure controls and procedures and reports on any changes in internal control over financial reporting Evaluation of Disclosure Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025 - Management concluded that the Company's disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[188] Changes in Internal Control over Financial Reporting There were no material changes in the company's internal control over financial reporting during the three months ended June 30, 2025 - There were no material changes in internal control over financial reporting during the three months ended June 30, 2025[189] PART II – OTHER INFORMATION Item 1. Legal Proceedings The company is not currently involved in any litigation or legal proceedings that management believes are likely to have a material adverse effect on its business - There are currently no claims or actions pending against the Company that are likely to have a material adverse effect on its business[190] Item 1A. Risk Factors This section updates risk factors, emphasizing high drug development costs, clinical trial failures, funding needs, trade policy impacts, and Nasdaq delisting risk - Drug development is very expensive, time-consuming, and uncertain, with most product candidates failing to achieve regulatory approval[192][193] - The FDA placed a clinical hold on the VYN202 Phase 1b trial due to testicular toxicity in dogs, requiring additional non-clinical studies to resume trials in male subjects[200] - The Phase 2b trial of repibresib gel in nonsegmental vitiligo failed to meet its primary and key secondary endpoints, leading to the termination of the trial[194] - The Company will need substantial additional funding to pursue its business objectives, and failure to raise capital could force it to curtail planned operations[208][209] - International trade policies, including tariffs and trade barriers, may adversely affect the business, potentially increasing R&D expenses and supply chain complexity, especially given API manufacturing in China[203][204][205] - Failure to maintain compliance with Nasdaq continued listing requirements, such as the minimum bid price, could result in the delisting of the common stock, negatively affecting market price and liquidity[213][216] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds During Q2 2025, the company issued 3.7 million common shares upon net exercise of Pre-Funded Warrants, exempt from registration under Section 3(a)(9) - During the three months ended June 30, 2025, the Company issued 3,765,320 shares of common stock upon the net exercise of Pre-Funded Warrants[217] - The issuances were exempt from registration under Section 3(a)(9) of the Securities Act of 1933, as an exchange with an existing security holder where no commission or other remuneration is paid[217] Item 3. Defaults Upon Senior Securities The company reported no defaults upon senior securities during the period - No defaults upon senior securities were reported[218] Item 4. Mine Safety Disclosures This item is not applicable to the company's operations - This item is not applicable[219] Item 5. Other Information During the three months ended June 30, 2025, none of the company's directors or officers adopted or terminated any Rule 10b5-1 plans or other trading arrangements for the purchase or sale of its securities - None of the Company's directors and officers adopted or terminated any Rule 10b5-1 plans or other trading arrangements during the three months ended June 30, 2025[220] Item 6. Exhibits This section lists all documents filed or furnished as exhibits to the Quarterly Report on Form 10-Q, including certifications from the Chief Executive Officer and Chief Financial Officer, and XBRL documents - The exhibits include certifications from the Chief Executive Officer and Chief Financial Officer (pursuant to Sections 302 and 906 of Sarbanes-Oxley Act of 2002) and XBRL documents[221] - Certifications attached as Exhibit 32.1 and Exhibit 32.2 are not deemed filed with the SEC[221] SIGNATURES The report is duly signed on behalf of VYNE Therapeutics Inc. by its Chief Executive Officer, David Domzalski, and Chief Financial Officer, Tyler Zeronda - The report is signed by David Domzalski, Chief Executive Officer, and Tyler Zeronda, Chief Financial Officer[225]