VYNE Therapeutics (VYNE) - 2022 Q2 - Quarterly Report

Part I – Financial Information This section presents the unaudited condensed consolidated financial statements and management's discussion and analysis of financial condition and results of operations Item 1. Unaudited Condensed Consolidated Financial Statements This section presents VYNE Therapeutics Inc.'s unaudited condensed consolidated financial statements and detailed notes for the specified periods Unaudited Condensed Consolidated Balance Sheets This section presents the company's financial position, detailing assets, liabilities, and stockholders' equity at specific dates Unaudited Condensed Consolidated Balance Sheets (in thousands) | Metric (in thousands) | June 30, 2022 | December 31, 2021 | | :-------------------- | :------------ | :---------------- | | Cash and cash equivalents | $42,814 | $42,250 | | Restricted cash | — | $605 | | Trade receivables, net | $304 | $7,583 | | Amount due from sale of MST Franchise | $5,000 | — | | Total Current Assets | $51,920 | $63,186 | | Total Assets | $55,192 | $67,046 | | Total Liabilities | $6,835 | $18,410 | | Total Stockholders' Equity | $48,357 | $48,636 | | Accumulated deficit | $(643,331) | $(639,525) | - Total Current Assets decreased by $11,266 thousand (17.8%) from $63,186 thousand at December 31, 2021, to $51,920 thousand at June 30, 2022, primarily due to decreases in trade receivables and discontinued operations assets, partially offset by an amount due from the sale of the MST Franchise[20] - Total Liabilities significantly decreased by $11,575 thousand (62.9%) from $18,410 thousand at December 31, 2021, to $6,835 thousand at June 30, 2022[20] Unaudited Condensed Consolidated Statements Of Operations This section details the company's financial performance, including revenues, expenses, and net loss over specific periods Condensed Consolidated Statements of Operations (Three Months Ended June 30) | Metric (in thousands, except per share) | 2022 | 2021 | Change ($) | Change (%) | | :-------------------------------------- | :---------- | :---------- | :---------- | :---------- | | Royalty Revenues | $126 | $295 | $(169) | (57.3)% | | Research and development | $4,108 | $5,048 | $(940) | (18.6)% | | Selling, general and administrative | $4,305 | $4,789 | $(484) | (10.1)% | | Operating loss | $(8,287) | $(9,542) | $1,255 | (13.2)% | | Net loss | $(8,476) | $(19,924) | $11,448 | (57.5)% | | Loss per share, basic and diluted | $(0.15) | $(0.39) | $0.24 | (61.5)% | Condensed Consolidated Statements of Operations (Six Months Ended June 30) | Metric (in thousands, except per share) | 2022 | 2021 | Change ($) | Change (%) | | :-------------------------------------- | :---------- | :---------- | :---------- | :---------- | | Royalty Revenues | $304 | $525 | $(221) | (42.1)% | | Research and development | $8,560 | $9,303 | $(743) | (8.0)% |\ | Selling, general and administrative | $8,722 | $10,521 | $(1,799) | (17.1)% | | Operating loss | $(16,978) | $(19,299) | $2,321 | (12.0)% | | Income (loss) from discontinued operations | $13,123 | $(18,913) | $32,036 | (169.4)% | | Net loss | $(3,806) | $(40,474) | $36,668 | (90.6)% | | Loss per share, basic and diluted | $(0.07) | $(0.81) | $0.74 | (91.4)% | - The significant improvement in net loss for both the three and six months ended June 30, 2022, was primarily driven by income from discontinued operations ($13.1 million for six months) due to the gain on the sale of the MST Franchise, and reduced operating expenses[22][110][129] Unaudited Condensed Consolidated Statements Of Changes In Stockholders' Equity This section outlines changes in the company's equity, including common stock, additional paid-in capital, and accumulated deficit Changes in Stockholders' Equity (Six Months Ended June 30) | Metric (in thousands, except shares) | January 1, 2022 | June 30, 2022 | | :----------------------------------- | :-------------- | :------------ | | Common stock (shares) | 53,577,744 | 58,005,616 | | Common stock (amounts) | $5 | $6 | | Additional paid-in capital | $688,156 | $691,682 | | Accumulated deficit | $(639,525) | $(643,331) | | Total Stockholders' Equity | $48,636 | $48,357 | - Total Stockholders' Equity decreased slightly from $48,636 thousand at January 1, 2022, to $48,357 thousand at June 30, 2022, primarily due to the net loss of $3,806 thousand, partially offset by increases in additional paid-in capital from stock-based compensation and common stock issuance[26] - The number of common shares outstanding increased from 53,577,744 at January 1, 2022, to 58,005,616 at June 30, 2022, driven by vesting of restricted stock units, issuance of commitment shares, and common stock issuance[26] Unaudited Condensed Consolidated Statements Of Cash Flows This section presents the company's cash inflows and outflows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (Six Months Ended June 30) | Cash Flow Activity (in thousands) | 2022 | 2021 | | :-------------------------------- | :---------- | :---------- | | Net cash used in operating activities | $(18,200) | $(28,808) | | Net cash provided by investing activities | $16,688 | $1,027 | | Net cash provided by financing activities | $1,471 | $73,374 | | (Decrease) increase in cash, cash equivalents and restricted cash | $(41) | $45,593 | | Cash, cash equivalents and restricted cash at end of period | $42,814 | $104,011 | - Net cash used in operating activities decreased by $10.6 million, from $28.8 million in 2021 to $18.2 million in 2022, primarily due to a lower net loss and the gain on the sale of the MST Franchise[32][142][143] - Net cash provided by investing activities significantly increased to $16.7 million in 2022 from $1.0 million in 2021, driven by net proceeds from the sale of the MST Franchise[32][144] - Net cash provided by financing activities decreased substantially to $1.5 million in 2022 from $73.4 million in 2021, reflecting reduced proceeds from common stock issuances[32][145] Notes to Unaudited Interim Condensed Consolidated Financial Statements This section provides detailed explanations and disclosures supporting the interim condensed consolidated financial statements NOTE 1 - NATURE OF OPERATIONS This note describes the company's business, strategic focus, and going concern considerations - VYNE Therapeutics Inc. is a biopharmaceutical company focused on developing proprietary therapies for immuno-inflammatory conditions, specifically in the preclinical stages of developing bromodomain and extra-terminal domain (BET) inhibitor compounds, with VYN201 as its initial candidate[36][103] - The company announced on August 10, 2022, that its Phase 2a clinical trial for FMX114 in mild-to-moderate atopic dermatitis did not meet its primary endpoint, leading management to re-evaluate its pipeline and prioritization of activities[36][103][109] - On January 12, 2022, VYNE sold its MST franchise (including AMZEEQ, ZILXI, and FCD105) to Journey Medical Corporation for an upfront payment of $20.0 million, an additional $5.0 million on the one-year anniversary, and eligibility for up to $450.0 million in sales milestone payments[38][39][105][106] - The company exercised an option with In4Derm Limited for exclusive worldwide rights to topical BET inhibitor compounds and expects to exercise an option for oral BET inhibitor compounds by February 28, 2023, with potential milestone payments up to $43.75 million[40][41][43][44] - Following the divestiture of the MST Franchise, the company streamlined operations and reduced its workforce to approximately 28 employees, shifting focus to research and development[45][107] - The company's ability to continue as a going concern is dependent on raising significant additional financing, as current cash and cash equivalents are not sufficient to fund operations beyond one year from the financial statements' issuance date, raising substantial doubt about its going concern status[52][53][138][139][140] NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES This note outlines the key accounting principles and methods used in preparing the financial statements - The unaudited interim condensed consolidated financial statements are prepared in accordance with U.S. GAAP, with certain information condensed or omitted compared to annual audited statements[54][55] - The company's revenue recognition policy follows ASC Topic 606, recognizing revenue when customers obtain control of products, and royalty revenues are recognized as products developed in collaboration are sold[61][62][65] - Due to the sale of the MST Franchise in January 2022, the company no longer generates product sales revenue, but continues to receive certain royalty revenues[61][64] - The sale of the MST Franchise was classified as discontinued operations in accordance with ASC 205, reflecting a strategic shift with a major effect on the business[72][73] - As a smaller reporting company, VYNE will adopt ASU 2016-13 (Credit Losses) effective January 1, 2023, but does not expect a material impact on its consolidated financial statements[74][75] NOTE 3 – DISCONTINUED OPERATIONS This note details the financial impact and accounting treatment of the MST Franchise divestiture - The MST Franchise was sold on January 12, 2022, and its results are classified as discontinued operations, recognizing a gain on sale upon closing[76] Income (Loss) from Discontinued Operations (in thousands) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--------------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | Product sales | $— | $3,963 | $106 | $7,852 | | Cost of goods sold | $— | $795 | $80 | $1,396 | | Total operating expenses | $241 | $12,407 | $(92) | $25,369 | | Net income (loss) from discontinued operations | $(241) | $(9,239) | $13,123 | $(18,913) | Gain on the Sale of the MST Franchise (Six Months Ended June 30, 2022) | Item (in thousands) | Amount | | :---------------------------- | :-------- | | Cash proceeds | $20,000 | | Proceeds to be paid in Jan 2023 | $5,000 | | Less transaction costs | $(4,247) | | Less book value of sold assets | $(7,748) | | Gain on sale, net of tax | $13,005 | - The company entered into a Transition Services Agreement (TSA) with Journey to provide transitional services into early 2023, with anticipated immaterial earnings[79] - Milestone payments for sales of ZILXI, AMZEEQ, and FCD105 are contingent consideration, accounted for as a gain contingency, and will be recognized when realizable[80] NOTE 4 – SHARE CAPITAL This note provides information on the company's authorized and outstanding share capital and related transactions - As of June 30, 2022, the company is authorized to issue 150,000,000 shares of common stock and 20,000,000 shares of preferred stock, with no preferred stock outstanding[81] - During the six months ended June 30, 2022, the company issued and sold 2,587,855 shares of common stock through an at-the-market (ATM) equity offering program for $1.5 million in net proceeds[87] - In March 2022, the company entered into an Equity Purchase Agreement with Lincoln Park Capital Fund, LLC, allowing it to sell up to $30.0 million of common stock over 36 months, and issued 1,667,593 commitment shares valued at $0.9 million[88] NOTE 5 – SHARE BASED COMPENSATION This note describes the company's stock-based compensation plans and related expenses - As of June 30, 2022, 961,559 shares remain issuable under the 2019 Equity Incentive Plan, 203,886 shares under the 2018 Omnibus Incentive Plan, and 2,165,534 shares under the Employee Share Purchase Plan (ESPP)[89][91] - During the six months ended June 30, 2022, the company granted 777,003 options and 726,102 RSUs to employees and directors, with a fair value of $0.8 million, a significant decrease from $7.5 million in the prior year period[92][93] Stock-Based Compensation Expense (in thousands) | Expense Category | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :----------------- | :------------------------------- | :------------------------------- | :------------------------------- | :------------------------------- | | R&D expenses | $393 | $442 | $622 | $900 | | SG&A | $770 | $1,070 | $1,786 | $2,672 | | Discontinued operations | $— | $389 | $(352) | $771 | | Total | $1,163 | $1,901 | $2,056 | $4,343 | NOTE 6 – OPERATING LEASES This note details the company's operating lease arrangements and associated liabilities - As of June 30, 2022, the company has operating leases for corporate offices in Bridgewater, New Jersey, and Israel, with the principal executive office lease expiring on September 30, 2022[95][96][98] - The remaining lease liability for the principal executive office is $31.0 thousand, maturing on September 30, 2022[98] - A $0.6 million lien related to a letter of credit for lease agreements was released in April 2022, and the restricted cash was returned to the company[99] NOTE 7 – COMMITMENTS AND CONTINGENCIES This note discloses the company's significant commitments and potential contingent liabilities - As of June 30, 2022, no legal proceedings or claims are pending against the company that management believes are likely to have a material adverse effect[100][165] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses VYNE Therapeutics Inc.'s financial condition, operational results, strategic shifts, and liquidity challenges Company Overview This section provides an overview of VYNE Therapeutics' strategic focus, product development, and organizational changes - VYNE Therapeutics is a biopharmaceutical company focused on developing therapies for immuno-inflammatory conditions, with its initial BET inhibitor candidate, VYN201, in preclinical development[103] - The company divested its MST franchise, including AMZEEQ, ZILXI, and FCD105, to Journey Medical Corporation on January 12, 2022, for an upfront payment of $20.0 million and potential milestone payments up to $450.0 million[105][106] - Following the divestiture, the company transitioned from a commercial organization to an R&D-focused entity, reducing its workforce from 106 to 28 employees[107] Key Developments This section highlights significant recent events impacting the company's product pipeline and strategic direction - On April 7, 2022, VYNE announced positive Phase 1b efficacy data for FMX114 in mild-to-moderate Atopic Dermatitis, showing a statistically significant reduction in disease severity[108] - On August 10, 2022, the Phase 2a clinical trial for FMX114 did not meet its primary endpoint, prompting management to re-evaluate the pipeline and prioritization of activities[109] Financial Overview This section summarizes the company's financial performance and condition, including accumulated deficit and future viability - The company has incurred net losses since inception, with an accumulated deficit of $643.3 million as of June 30, 2022[110] - Net loss for the six months ended June 30, 2022, was $3.8 million, a significant improvement from $40.5 million in 2021, primarily due to $13.1 million income from discontinued operations[110] - Future viability depends on successfully executing its business strategy, developing product candidates, and raising additional capital, as failure to do so could negatively impact financial condition[111] Components of Operating Results This section breaks down the various elements contributing to the company's operating performance, including revenues and expenses Revenues This section details the company's revenue sources, primarily royalty revenue following the MST Franchise divestiture - Revenue for the periods presented consisted solely of royalty revenue, as product sales from AMZEEQ and ZILXI ceased after the MST Franchise divestiture on January 12, 2022[112][113][114] Royalty Revenues (in thousands) | Period | 2022 | 2021 | | :----- | :--- | :--- | | Six months ended June 30 | $304 | $525 | Cost of Goods Sold This section explains the treatment of cost of goods sold, reclassified to discontinued operations after the MST Franchise sale - Cost of goods sold, previously related to AMZEEQ and ZILXI manufacturing, has been reclassified to discontinued operations for all periods presented following the MST Franchise sale[115][116] Research and Development Expenses This section outlines the company's R&D expenditures, focusing on its immuno-inflammatory pipeline - R&D expenses primarily relate to the development of FMX114, VYN201, and VYN202, with all expenses charged to operations as incurred[116] - Following the MST Franchise sale, R&D expenses related to that franchise have been reclassified to discontinued operations, and current R&D is focused on the immuno-inflammatory pipeline[117] Selling, General and Administrative Expenses This section describes the company's SG&A expenses, including employee-related costs and professional fees - SG&A expenses primarily include employee-related expenses, legal and professional fees, and facility costs[117] - SG&A expenses related to the MST Franchise have been reclassified to discontinued operations for all periods presented[117] Interest expense This section reports on interest expenses, noting their absence due to debt repayment - No interest expense was incurred during the three or six months ended June 30, 2022, due to the payment of all outstanding debt on August 11, 2021[118][127][133] Other Expense, net This section covers other non-operating income and expenses, primarily foreign exchange gains or losses - Other income (expense), net, primarily consists of foreign exchange gains or losses[119] Income Taxes and Net Operating Loss Carryforwards This section details the company's tax position, including net operating loss and tax credit carryforwards - As of December 31, 2021, the company had federal and state net operating loss (NOL) carryforwards of $315.0 million and $105.6 million, respectively, and federal and state R&D tax credit carryforwards of $6.7 million and $1.2 million[120] - NOLs and tax credit carryforwards are subject to limitations under Sections 382 or 383 of the Internal Revenue Code, which could limit their utilization against future taxable income[121][122] Results of Operations This section provides a comparative analysis of the company's financial performance over different periods Comparison of the Three-Month Periods Ended June 30, 2022 and 2021 This section compares the company's financial results for the three months ended June 30, 2022, and 2021 Summary of Operations (Three Months Ended June 30, in thousands) | Metric | 2022 | 2021 | Variance ($) | Variance (%) | | :----- | :--- | :--- | :----------- | :----------- | | Total Revenues | $126 | $295 | $(169) | (57.3)% | | Research and development | $4,108 | $5,048 | $(940) | (18.6)% | | Selling, general and administrative | $4,305 | $4,789 | $(484) | (10.1)% | | Operating loss | $(8,287) | $(9,542) | $1,255 | (13.2)% | | Interest expense | $— | $(1,074) | $1,074 | (100.0)% | | Loss from discontinued operations | $(241) | $(9,239) | $8,998 | (97.4)% | | Net loss | $(8,476) | $(19,924) | $11,448 | (57.5)% | - Total revenues decreased by 57.3% due to the divestiture of the minocycline business[123][124] - Research and development expenses decreased by 18.6% ($0.9 million), primarily due to reduced spending on FMX114 and employee-related expenses, partially offset by $0.4 million for extending the Oral BETi Option Term[123][125] - Selling, general and administrative expenses decreased by 10.1% ($0.5 million), mainly driven by lower employee-related expenses[123][126] - Net loss significantly improved by 57.5% ($11.4 million) due to the absence of interest expense and a substantial reduction in loss from discontinued operations[123][127] Comparison of the Six-Month Periods Ended June 30, 2022 and 2021 This section compares the company's financial results for the six months ended June 30, 2022, and 2021 Summary of Operations (Six Months Ended June 30, in thousands) | Metric | 2022 | 2021 | Variance ($) | Variance (%) | | :----- | :--- | :--- | :----------- | :----------- | | Total Revenues | $304 | $525 | $(221) | (42.1)% | | Research and development | $8,560 | $9,303 | $(743) | (8.0)% | | Selling, general and administrative | $8,722 | $10,521 | $(1,799) | (17.1)% | | Operating loss | $(16,978) | $(19,299) | $2,321 | (12.0)% | | Interest expense | $— | $(2,136) | $2,136 | (100.0)% | | Income (loss) from discontinued operations | $13,123 | $(18,913) | $32,036 | (169.4)% | | Net loss | $(3,806) | $(40,474) | $36,668 | (90.6)% | - Total revenues decreased by 42.1% due to the divestiture of the minocycline business[129][130] - Research and development expenses decreased by 8.0% ($0.7 million), mainly due to lower compensation and reduced FMX114 spending, partially offset by increased VYN201 expenditures and the Oral BETi Option extension payment[129][131] - Selling, general and administrative expenses decreased by 17.1% ($1.8 million), primarily due to lower employee-related and consulting expenses[129][132] - Net loss significantly improved by 90.6% ($36.7 million), primarily driven by $13.1 million income from discontinued operations and the elimination of interest expense[129][133][134] Liquidity and Capital Resources This section discusses the company's cash position, funding sources, and future capital requirements - As of June 30, 2022, the company had $42.8 million in cash and cash equivalents and an accumulated deficit of $643.3 million[136] - The company received $20.0 million from the MST Franchise sale in January 2022 and expects an additional $5.0 million payment on the one-year anniversary[136] - The company's future viability and ability to continue as a going concern depend on raising sufficient working capital through debt or equity financings to fund operations and develop product candidates[138] - Management believes that without sufficient proceeds from financing or business development, the company will not have enough cash to fund operations beyond one year, raising substantial doubt about its ability to continue as a going concern[139][140] Summary Statement of Cash Flows This section provides a high-level overview of cash flows from operating, investing, and financing activities Summary Statement of Cash Flows (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2022 | 2021 | | :----------------- | :--- | :--- | | Operating activities | $(18,200) | $(28,808) | | Investing activities | $16,688 | $1,027 | | Financing activities | $1,471 | $73,374 | Cash Used in Operating Activities This section details the cash outflows related to the company's core business operations - Net cash used in operating activities was $18.2 million for the six months ended June 30, 2022, primarily reflecting a net loss of $3.8 million, adjusted for a $13.0 million gain on the MST Franchise sale and $2.1 million in stock-based compensation[142] - This represents a decrease in cash used compared to $28.8 million in the prior year, which was driven by a higher net loss of $40.5 million[141][143] Cash Provided by Investing Activities This section describes cash flows generated or used from investment activities, including asset sales - Net cash provided by investing activities was $16.7 million for the six months ended June 30, 2022, primarily from net proceeds from the disposition of the MST Franchise[144] - This is a significant increase from $1.0 million in the prior year, which was mainly from the sale and maturity of marketable securities and bank deposits[141][144] Cash Provided by Financing Activities This section outlines cash flows related to debt, equity, and other financing transactions - Net cash provided by financing activities was $1.5 million for the six months ended June 30, 2022, primarily from the issuance of common stock[145] - This is a substantial decrease from $73.4 million in the prior year, which was also primarily attributable to common stock issuance[141][145] Cash and Funding Sources This section identifies the primary sources of liquidity for the company during the reporting period - Liquidity sources for the six months ended June 30, 2022, included proceeds from the MST Franchise sale and common stock issuance via an at-the-market offering[146] - In the prior year, liquidity was primarily from common stock issuance through ATM and registered direct offerings, and sales of AMZEEQ and ZILXI[147] Funding Requirements This section addresses the company's anticipated future capital needs and potential financing strategies - Future funding requirements depend on R&D costs for product candidates, regulatory approval timelines, terms of collaborations, new product identification, and intellectual property costs[148] - The company may need additional capital sooner than planned through equity, debt, or strategic collaborations, which could result in stockholder dilution or debt covenants[148] Critical Accounting Policies, Significant Judgments and Use of Estimates This section discusses the key accounting policies and estimates that significantly impact the financial statements Revenue Recognition This section explains the company's policy for recognizing revenue from contracts with customers and royalty agreements - Revenue is recorded based on a five-step model in accordance with ASC 606, involving identification of contracts, performance obligations, transaction price, allocation, and recognition upon satisfaction of obligations[153][154] - Milestone payments are treated as variable consideration and included in the transaction price when it is probable that a significant reversal of cumulative revenue will not occur[155] Discontinued Operations This section details the accounting treatment and impact of the MST Franchise divestiture on the financial statements - The sale of the MST Franchise was accounted for as discontinued operations under ASC 205 and ASU No. 2014-08, reflecting a strategic shift with a major effect on the business[156][157] Off-Balance Sheet Arrangements This section confirms the absence of material off-balance sheet arrangements impacting the company's financial condition - The company is not party to any off-balance sheet arrangements that are reasonably likely to have a material current or future effect on its financial condition or results of operations[158] JOBS Act Accounting Election This section clarifies the company's election regarding compliance with new accounting standards as an emerging growth company - As an 'emerging growth company,' VYNE has elected to 'opt out' of the extended transition period for complying with new or revised accounting standards, meaning it will comply as required when adopted[159] Recently Issued and Adopted Accounting Pronouncements This section refers to disclosures regarding new accounting standards and their expected impact - Information on recently adopted and newly issued accounting pronouncements and their expected impact is discussed in Note 2, 'Significant Accounting Policies,' of the unaudited interim condensed consolidated financial statements[160] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, VYNE Therapeutics Inc. is not required to provide quantitative and qualitative disclosures about market risk - VYNE Therapeutics Inc. is a smaller reporting company and is therefore not required to provide quantitative and qualitative disclosures about market risk[161] Item 4. Controls and Procedures This section details the evaluation of the company's disclosure controls and procedures and reports on any changes in internal control over financial reporting Evaluation of Disclosure Controls and Procedures This section assesses the effectiveness of the company's disclosure controls and procedures - As of June 30, 2022, management, with the participation of the CEO and CFO, concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[162] Changes in Internal Control over Financial Reporting This section reports on any material changes in the company's internal control over financial reporting - There were no changes in internal controls over financial reporting during the six months ended June 30, 2022, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[163] Part II – Other Information This section provides additional information including legal proceedings, risk factors, and exhibits Item 1. Legal Proceedings No pending legal proceedings or claims against the company are believed to have a material adverse effect as of June 30, 2022 - As of June 30, 2022, no legal proceedings or claims are pending against the company that, in management's opinion, are likely to have a material adverse effect[165] Item 1A. Risk Factors This section updates risk factors, highlighting liquidity challenges and the critical need for additional funding to sustain operations - As of June 30, 2022, there have been no material changes to the risk factors from those disclosed in the Annual Report on Form 10-K, except for updated risks related to liquidity[166] - The company will need substantial additional funding to finance operations and may not be able to continue as a going concern, potentially forcing delays, reductions, or termination of R&D activities[167] - As of June 30, 2022, the company's cash and cash equivalents of $42.8 million are insufficient to fund anticipated operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern[167] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section states that there were no unregistered sales of equity securities or use of proceeds to report - There were no unregistered sales of equity securities and use of proceeds to report[168] Item 3. Defaults Upon Senior Securities This section indicates that there were no defaults upon senior securities - There were no defaults upon senior securities[169] Item 4. Mine Safety Disclosures This section states that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable[169] Item 5. Other Information This section indicates that there is no other information to report - There is no other information to report[170] Item 6. Exhibits This section lists all exhibits filed or furnished as part of this Quarterly Report on Form 10-Q, including corporate documents and certifications - The report includes exhibits such as the Amended and Restated Certificate of Incorporation, Amended and Restated Bylaws, a Letter Agreement with In4Derm Limited, and certifications from the CEO and CFO[171] - XBRL Instance Document, Taxonomy Extension Schema, Calculation Linkbase, Definition Linkbase, and Label Linkbase Documents are also filed[171] SIGNATURES This section contains the required signatures for the Quarterly Report on Form 10-Q by the CEO and CFO of VYNE Therapeutics Inc Signatures This section contains the required signatures for the Quarterly Report on Form 10-Q by the CEO and CFO of VYNE Therapeutics Inc - The report is signed by David Domzalski, President and Chief Executive Officer, and Tyler Zeronda, Chief Financial Officer and Treasurer, on August 12, 2022[176][177]