Madrigal Pharmaceuticals(MDGL) - 2025 Q2 - Quarterly Report

FORM 10-Q Filing Information This section presents essential Form 10-Q filing information, covering the reporting period, company specifics, and outstanding common stock - This is a Quarterly Report on Form 10-Q for the period ended June 30, 2025[2] - Madrigal Pharmaceuticals, Inc. is incorporated in Delaware with Commission file number 001-33277[2] - As of August 1, 2025, the registrant had 22,289,014 shares of common stock outstanding[6] Cautionary Note Regarding Forward-Looking Statements This section outlines risks and uncertainties in forward-looking statements, which may cause actual results to differ materially - The report contains forward-looking statements subject to risks and uncertainties that may cause actual results to differ materially from current expectations[9][10] - Key forward-looking statements relate to the successful commercialization and regulatory approval of Rezdiffra in the U.S. and Europe, market acceptance, reimbursement, and potential expansion of its indication[11] - Other forward-looking statements cover business strategies, clinical trial timing, manufacturing capabilities, future financial performance, liquidity, and the impact of healthcare industry regulation and economic conditions[11] Part I. Financial Information This part presents the company's unaudited financial statements and management's discussion of financial condition Item 1. Financial Statements (Unaudited) This section presents the unaudited condensed consolidated financial statements, including balance sheets, statements of operations, comprehensive loss, stockholders' equity, cash flows, and detailed notes explaining the company's financial position and performance Condensed Consolidated Balance Sheets This table presents the company's financial position, detailing assets, liabilities, and equity at specific dates Condensed Consolidated Balance Sheets (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Total assets | $1,015,381 | $1,042,247 | | Total liabilities | $319,403 | $287,864 | | Total stockholders' equity | $695,978 | $754,383 | - Total assets decreased by $26.9 million from December 31, 2024, to June 30, 2025, while total liabilities increased by $31.5 million[15] - Cash and cash equivalents increased from $100.0 million to $186.2 million, while marketable securities decreased from $826.2 million to $610.8 million[15] Condensed Consolidated Statements of Operations This table summarizes the company's financial performance, including revenue, expenses, and net loss over specified periods Condensed Consolidated Statements of Operations (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Product revenue, net | $212,802 | $14,638 | $350,052 | $14,638 | | Total operating expenses | $260,004 | $177,175 | $476,565 | $329,213 | | Loss from operations | $(47,202) | $(162,537) | $(126,513) | $(314,575) | | Net loss | $(42,281) | $(151,971) | $(115,519) | $(299,512) | | Basic and diluted net loss per common share | $(1.90) | $(7.10) | $(5.22) | $(14.47) | - Product revenue, net, significantly increased for both the three-month (1354% YoY) and six-month (2291% YoY) periods ended June 30, 2025, driven by Rezdiffra sales[17] - Net loss substantially decreased for both periods, from $(152.0) million to $(42.3) million for the three months, and from $(299.5) million to $(115.5) million for the six months ended June 30, 2025[17] Condensed Consolidated Statements of Comprehensive Loss This table details the company's comprehensive loss, including net loss and other comprehensive income or loss Condensed Consolidated Statements of Comprehensive Loss (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Net loss | $(42,281) | $(151,971) | $(115,519) | $(299,512) | | Other comprehensive income (loss): | | | | | | Unrealized loss on available-for-sale securities | $(188) | $(196) | $(299) | $(836) | | Unrealized foreign currency gain | $910 | — | $942 | — | | Comprehensive loss | $(41,559) | $(152,167) | $(114,876) | $(300,348) | - Comprehensive loss decreased significantly, mirroring the reduction in net loss, with a positive contribution from unrealized foreign currency gain in 2025[19] Condensed Consolidated Statements of Stockholders' Equity This table outlines changes in stockholders' equity, reflecting net loss, stock-based compensation, and equity issuances Condensed Consolidated Statements of Stockholders' Equity (in thousands) | Item | December 31, 2024 | June 30, 2025 | | :-------------------------------- | :---------------- | :------------ | | Total stockholders' equity | $754,383 | $695,978 | | Additional paid-in capital | $2,556,095 | $2,612,566 | | Accumulated deficit | $(1,802,182) | $(1,917,701) | - Total stockholders' equity decreased by $58.4 million from December 31, 2024, to June 30, 2025, primarily due to the net loss of $(115.5) million[21] - Additional paid-in capital increased by $56.5 million, driven by stock-based compensation expense and common stock issuances under equity plans[21] Condensed Consolidated Statements of Cash Flows This table presents the company's cash flows from operating, investing, and financing activities Condensed Consolidated Statements of Cash Flows (in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(135,943) | $(284,102) | | Net cash provided by (used in) investing activities | $211,736 | $(24,045) | | Net cash provided by financing activities | $10,381 | $707,829 | | Net increase in cash, cash equivalents, and restricted cash | $86,174 | $399,682 | | Cash, cash equivalents, and restricted cash at end of period | $191,193 | $499,597 | - Net cash used in operating activities decreased by $148.2 million, reflecting improved operational cash flow[25] - Investing activities shifted from a net cash outflow of $24.0 million in 2024 to a net cash inflow of $211.7 million in 2025, primarily due to sales and maturities of marketable securities[25] Notes to Condensed Consolidated Financial Statements This section provides detailed explanations and disclosures for the condensed consolidated financial statements, covering significant accounting policies, liquidity, revenue recognition, debt, equity, and subsequent events Organization, Business, and Basis of Presentation Madrigal Pharmaceuticals is a biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH) - Madrigal Pharmaceuticals is a biopharmaceutical company focused on developing novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH)[27] - Rezdiffra (resmetirom) received FDA accelerated approval in March 2024 as the first and only therapy for MASH, commercially available in the U.S. since April 2024[27] - The company is evaluating Rezdiffra in patients with compensated MASH cirrhosis (F4c) in the MAESTRO MASH OUTCOMES trial to potentially expand its eligible patient population[27] Summary of Significant Accounting Policies This section outlines the key accounting principles and policies applied in preparing the financial statements - Revenue from product sales is recognized when the customer obtains control of the product, typically upon delivery, and is recorded net of variable consideration such as discounts, returns, chargebacks, rebates, and co-payment assistance[33][34] - Inventory costs are capitalized after FDA approval of Rezdiffra in March 2024; prior manufacturing costs were expensed as research and development[53] - Research and development costs are expensed as incurred, including internal costs, consultant fees, milestone payments, and costs associated with preclinical and clinical programs[54] - The company adopted ASU 2023-07 (Segment Reporting) for its 2024 Annual Report and is evaluating the impact of ASU 2024-03 (Disaggregation of Income Statement Expenses)[68][70] Liquidity and Uncertainties This section discusses the company's financial liquidity, funding sources, and ability to meet future operational needs - The company incurred a net loss of approximately $115.5 million for the six months ended June 30, 2025, resulting in an accumulated deficit of approximately $1,917.7 million[72] - Operations have been funded primarily through capital stock sales, debt financings, and since April 2024, sales of Rezdiffra[72] - Management believes its cash, cash equivalents, and marketable securities at June 30, 2025, will be sufficient to fund operations past one year from the issuance of these financial statements[72] Product Revenue, Net This section details the company's product revenue, net of various deductions, and identifies key customers Gross to Net Reserves (in thousands) | Item | December 31, 2024 | June 30, 2025 | | :-------------------------------- | :---------------- | :------------ | | Balance at period end | $25,891 | $52,343 | | Provision related to sales in current year | — | $82,446 | | Payments and customer credits issued | — | $(52,902) | - Gross to net reserves increased from $25.9 million at December 31, 2024, to $52.3 million at June 30, 2025[74] - Four customers (A, B, C, D) each accounted for over 10% of total gross product revenue during the three and six months ended June 30, 2025 and 2024[76] Cash, Cash Equivalents, Restricted Cash and Marketable Securities This section provides a breakdown of the company's cash, cash equivalents, restricted cash, and marketable securities Cash, Cash Equivalents, Restricted Cash and Marketable Securities (in thousands) | Item | June 30, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :-------------------------------- | :------------------------- | :----------------------------- | | Total cash, cash equivalents and restricted cash | $191,193 | $105,019 | | Marketable securities | $610,831 | $826,232 | | Total | $802,024 | $931,251 | - Restricted cash remained constant at $5.0 million as of June 30, 2025, and December 31, 2024[77] - The majority of financial assets are valued using Level 1 (quoted prices in active markets) and Level 2 (observable inputs other than Level 1) inputs[50] Inventory This section details the company's inventory balances, including work in process and finished goods Inventory Balances (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Work in process | $57,911 | $29,533 | | Finished goods | $5,586 | $4,535 | | Total inventory | $63,497 | $34,068 | - Total inventory increased by $29.4 million from December 31, 2024, to June 30, 2025[78] - No provision for excess inventory was recorded as of June 30, 2025, or December 31, 2024[78] Accrued Liabilities This section provides a breakdown of the company's accrued liabilities, including contract research organization and manufacturing costs Accrued Liabilities (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Contract research organization costs | $32,796 | $30,250 | | Manufacturing and drug supply | $25,798 | $9,941 | | Compensation and benefits | $27,691 | $34,957 | | Gross to net accrued liabilities | $48,062 | $21,703 | | Total accrued liabilities | $157,479 | $124,695 | - Total accrued liabilities increased by $32.8 million from December 31, 2024, to June 30, 2025[79] - The increase was primarily driven by higher gross to net accrued liabilities and manufacturing and drug supply costs[79] Long Term Debt This section details the company's long-term debt obligations, including recent financing and repayment activities - The Hercules Loan Facility, with an outstanding principal of $115.0 million as of June 30, 2025, was fully repaid and terminated on July 17, 2025, totaling $121.7 million including accrued interest and exit fees[86][87] - On July 17, 2025, the company entered into a new Financing Agreement (Blue Owl Credit Facility) providing up to $500.0 million in senior secured credit facilities, including an initial $350.0 million term loan[90] - The new credit facility bears interest at three-month SOFR (with a 1.0% floor) plus 4.75% and matures on July 17, 2030, requiring a minimum unrestricted cash balance of $100.0 million[91][93] Stockholders' Equity This section describes changes in stockholders' equity, including public offerings and equity compensation plans - In March 2024, the company completed a public offering, raising approximately $659.9 million in net proceeds, including the exercise of the underwriters' option[97][98][190] - The net proceeds from the 2024 Offering are intended for Rezdiffra commercial activities, R&D, clinical trials, manufacturing, and potential ex-U.S. commercialization or partnering opportunities[99][191] - The company entered into a 2024 Sales Agreement with Cowen, authorizing up to $300.0 million in common stock sales, but no sales were made under this agreement during the three and six months ended June 30, 2025[102][177] Stock-based Compensation This section details the company's stock-based compensation expense and unrecognized compensation costs Stock-Based Compensation Expense (in thousands) | Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Stock options | $5,449 | $10,027 | $10,888 | $16,913 | | Restricted stock units | $14,328 | $9,918 | $26,116 | $18,543 | | Performance-based restricted stock units | $5,382 | $4,459 | $9,086 | $8,850 | | Total stock-based compensation expense | $25,159 | $24,404 | $46,090 | $44,306 | - Total stock-based compensation expense increased slightly to $46.1 million for the six months ended June 30, 2025, from $44.3 million in the prior year[113] - As of June 30, 2025, unrecognized stock-based compensation expense was $247.4 million, with a weighted average remaining period of 3.00 years[113] Commitments and Contingencies This section outlines the company's contractual obligations, milestone payments, and lease commitments - The company has approximately $71.2 million in obligations under contractual arrangements for active pharmaceutical ingredient, expected to be paid through March 2027[114] - Under the Hoffmann-La Roche agreement, remaining milestone payments total $3.0 million for future European regulatory approval of resmetirom, plus tiered single-digit royalties on net sales[116] - The company has expanded its office space through multiple lease amendments, with a new operating lease in April 2025 resulting in a $4.0 million right-of-use asset and lease liability[117][118][119] Segment Information This section clarifies that the company operates as a single reportable segment focused on MASH therapeutics - The company operates as one reportable segment, focused on delivering novel therapeutics for MASH[120] - The Chief Executive Officer reviews consolidated financials and qualitative information to evaluate performance and allocate resources on a total company basis[120] - As of June 30, 2025, the company did not have revenue or material assets outside of the U.S.[121] Subsequent Events This section reports significant events occurring after the reporting period, including financing and licensing agreements - On July 17, 2025, the company entered into the Blue Owl Credit Facility and used a portion of the proceeds to repay all outstanding obligations under the Hercules Loan Facility, totaling $121.7 million[123][124] - In July 2025, the company entered an exclusive global license agreement with CSPC Pharmaceutical Group Limited for SYH2086, a preclinical oral GLP-1 receptor agonist[125] - Under the CSPC License Agreement, CSPC will receive an upfront payment of $120.0 million and is eligible for up to $2.0 billion in milestone payments, plus royalties on net sales, with clinical development expected in H1 2026[125] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and results of operations, including a business overview, key developments, detailed analysis of revenues and expenses, and liquidity and capital resources About Madrigal Pharmaceuticals, Inc. Madrigal Pharmaceuticals focuses on MASH, with Rezdiffra as its first and only FDA-approved therapy - Madrigal Pharmaceuticals is a biopharmaceutical company focused on metabolic dysfunction-associated steatohepatitis (MASH), with Rezdiffra being its first and only FDA-approved therapy[128] - Rezdiffra is indicated for adults with noncirrhotic MASH with moderate to advanced liver fibrosis (F2 to F3) and is being evaluated for compensated MASH cirrhosis (F4c) to expand the eligible patient population[128][129] - The company received a positive opinion from the CHMP for resmetirom in Europe in June 2025, with a European Commission decision anticipated in August 2025, and expects to launch in Germany in the second half of 2025[133][134] Key Developments This section highlights significant corporate and product-related events during or after the reporting period - Daniel Brennan was appointed to the Board of Directors in August 2025[136] - In July 2025, the company entered an exclusive global license agreement for SYH2086, a preclinical oral GLP-1 receptor agonist, with CSPC Pharmaceutical Group Limited, involving an upfront payment of $120.0 million and potential milestones up to $2.0 billion[137] - A new $500.0 million senior secured credit facility with Blue Owl Capital Corporation was established in July 2025, and a new U.S. patent for Rezdiffra's dosing regimen was issued in August 2025, providing protection until February 2045[138][139] Basis of Presentation This section describes the accounting principles and assumptions used in preparing the financial statements and management's discussion - Product revenue from Rezdiffra sales, which began in April 2024, is recorded net of variable consideration including discounts, returns, chargebacks, rebates, and co-payment assistance[144] - Cost of sales is expected to increase as manufacturing costs, previously expensed as research and development prior to regulatory approval, are now capitalized as inventory[145] - Research and development expenses are expensed as incurred, covering clinical trials, manufacturing, and regulatory compliance, and are expected to remain substantial for the foreseeable future[146][147] Results of Operations This section provides a comparative analysis of the company's financial performance for the three and six months ended June 30, 2025, and 2024, detailing changes in revenue, operating expenses, and net loss Three Months Ended June 30, 2025 and 2024 This section analyzes the company's financial performance for the three-month periods ended June 30, 2025 and 2024 Three Months Ended June 30 (in thousands) | Item | 2025 | 2024 | Increase / (Decrease) ($) | Increase / (Decrease) (%) | | :-------------------------------- | :----- | :----- | :------------------------ | :------------------------ | | Product revenue, net | $212,802 | $14,638 | $198,164 | 1354 % | | Cost of sales | $9,065 | $636 | $8,429 | 1325 % | | Research and development | $54,081 | $71,091 | $(17,010) | (24)% | | Selling, general and administrative | $196,858 | $105,448 | $91,410 | 87 % | | Net loss | $(42,281) | $(151,971) | $109,690 | (72)% | - Product revenue, net, surged by 1354% to $212.8 million in Q2 2025 due to increased demand for Rezdiffra[156][157] - Net loss decreased by 72% to $(42.3) million, despite a significant 87% increase in selling, general and administrative expenses due to commercialization efforts[156][160] Six Months Ended June 30, 2025 and 2024 This section analyzes the company's financial performance for the six-month periods ended June 30, 2025 and 2024 Six Months Ended June 30 (in thousands) | Item | 2025 | 2024 | Increase / (Decrease) ($) | Increase / (Decrease) (%) | | :-------------------------------- | :----- | :----- | :------------------------ | :------------------------ | | Product revenue, net | $350,052 | $14,638 | $335,414 | 2291 % | | Cost of sales | $13,578 | $636 | $12,942 | 2035 % | | Research and development | $98,253 | $142,328 | $(44,075) | (31)% | | Selling, general and administrative | $364,734 | $186,249 | $178,485 | 96 % | | Net loss | $(115,519) | $(299,512) | $183,993 | (61)% | - Product revenue, net, increased by 2291% to $350.1 million for the six months ended June 30, 2025, due to a full six months of Rezdiffra sales and increased demand[163][164] - Research and development expenses decreased by 31% to $98.3 million, primarily due to changes in inventory accounting post-FDA approval and reduced clinical trial expenses[163][166] - Net loss decreased by 61% to $(115.5) million, reflecting the substantial revenue growth[163] Macroeconomic Events This section discusses the potential impact of macroeconomic events and tariff policies on the company's business - The company believes current tariff policies will not materially impact its business due to U.S.-based manufacturing and commercialization of Rezdiffra[171] - A European manufacturer has been engaged for future commercial supply of drug product for European commercialization[171] - Future changes in global trade, economy, or market conditions could have an adverse effect on the business[171] Liquidity and Capital Resources This section details the company's funding history, cash position, future capital needs, and recent financing activities At-the-Market Sales Agreement This section details the company's at-the-market equity offering program and its current status - The company entered into a 2024 Sales Agreement with Cowen, authorizing the issuance and sale of up to $300.0 million in common stock[175] - No sales were made under the 2024 Sales Agreement during the three and six months ended June 30, 2025[177] - As of June 30, 2025, $300.0 million remained available for sale under the 2024 Sales Agreement[177] Hercules Loan Facility This section describes the terms and recent repayment of the Hercules Loan Facility - As of June 30, 2025, the outstanding principal under the Hercules Loan Facility was $115.0 million, with an interest rate of 9.95%[182] - The interest-only period was extended to May 3, 2027, and the maturity date to May 2027, following FDA approval and a revenue milestone[180] - On July 17, 2025, the facility was fully repaid and terminated, totaling $121.7 million, using proceeds from the new Financing Agreement[183] Blue Owl Credit Facility This section outlines the terms of the new senior secured credit facility with Blue Owl Capital Corporation - On July 17, 2025, the company entered into a Financing Agreement with Blue Owl Capital Corporation, committing up to $500.0 million in senior secured credit facilities[184] - The Initial Term Loan of $350.0 million was funded on the closing date, with Delayed Draw Term Loans of up to $150.0 million available until December 31, 2027[184] - The Term Loans bear interest at three-month SOFR (with a 1.0% floor) plus 4.75% and have a stated maturity date of July 17, 2030, requiring a minimum unrestricted cash balance of $100.0 million[185][187] March 2024 Public Offering This section details the net proceeds and intended use of funds from the company's March 2024 public offering - In March 2024, the company completed a public offering of common stock and pre-funded warrants, generating approximately $659.9 million in net proceeds[189][190] - The proceeds are intended for commercial activities related to Rezdiffra's launch in the U.S., R&D, clinical trials, manufacturing, and potential ex-U.S. commercialization or partnering opportunities[191] Cash Flows This section summarizes the company's net cash flow activities across operating, investing, and financing categories Summary of Net Cash Flow Activity (in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(135,943) | $(284,102) | | Net cash provided by (used in) investing activities | $211,736 | $(24,045) | | Net cash provided by financing activities | $10,381 | $707,829 | | Net increase in cash, cash equivalents, and restricted cash | $86,174 | $399,682 | - Net cash used in operating activities decreased significantly to $(135.9) million in 2025 from $(284.1) million in 2024[193][194] - Investing activities shifted to a net cash inflow of $211.7 million in 2025, primarily from sales and maturities of marketable securities, compared to a net outflow in 2024[193][195] Contractual Obligations and Commitments This section details the company's future payment obligations under various contractual agreements - The company has approximately $71.2 million in obligations for active pharmaceutical ingredient, payable through December 2027[202] - The Office Lease has been extended through November 2026 with additional space leased, and the new Blue Owl Credit Facility requires principal repayment only at maturity in July 2030[198][199][200] - The Roche Agreement mandates tiered single-digit royalties on net sales of Rezdiffra[201] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section states that there have been no material changes to the company's market risks since December 31, 2024, and no near-term changes in risk exposures or management strategies are anticipated - No material changes to the company's market risks have occurred since December 31, 2024[204] - No near-term changes in the nature of market risk exposures or management's objectives and strategies for managing such exposures are anticipated[204] Item 4. Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, and reported no material changes in internal control over financial reporting during the quarter - The company's disclosure controls and procedures were evaluated and deemed effective as of June 30, 2025[206][207] - No changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, internal control over financial reporting during the quarter ended June 30, 2025[209] - Management acknowledges that controls provide only reasonable, not absolute, assurance due to inherent limitations and resource constraints[208] Part II. Other Information This part provides additional information not covered in financial statements, including legal proceedings and risk factors Item 1. Legal Proceedings The company is not currently a party to any material legal proceedings - The company is not party to any material legal proceedings[211] Item 1A. Risk Factors There have been no material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 - No material changes to the risk factors included in the Annual Report on Form 10-K for the year ended December 31, 2024[212] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds There were no unregistered sales of equity securities or use of proceeds to report for the period - None to report for unregistered sales of equity securities and use of proceeds[213] Item 3. Defaults Upon Senior Securities There were no defaults upon senior securities to report for the period - None to report for defaults upon senior securities[214] Item 4. Mine Safety Disclosures This item is not applicable to the company - Mine Safety Disclosures are not applicable to the company[215] Item 5. Other Information This section reports on director and executive officer 10b5-1 plans and Daniel Brennan's appointment to the Board - No directors or officers adopted or terminated a Rule 10b5-1 trading plan or non-Rule 10b5-1 trading arrangement during the fiscal quarter ended June 30, 2025[216] - Daniel Brennan was elected as a Class II director to the Board, effective August 1, 2025, and appointed to the Audit Committee[217] - Mr. Brennan's compensation includes an annual cash fee of $50 thousand, an additional $12.5 thousand for Audit Committee service, and an equity grant valued at $600 thousand (50% stock options, 50% restricted stock units)[218] Item 6. Exhibits This section lists the exhibits filed or furnished as part of this Quarterly Report on Form 10-Q, including agreements and certifications - Exhibits include a Letter Agreement with Rebecca Taub, M.D., an Offer Letter with David Soergel, M.D., and a Lease Agreement[222] - Certifications of the Principal Executive Officer and Principal Financial Officer pursuant to the Sarbanes-Oxley Act of 2002 are filed[222] - Inline XBRL Instance Document and Taxonomy Extension Documents are included[222] Signatures This section contains the official signatures of the company's principal executive and financial officers, certifying the report - The report was signed on August 5, 2025, by William J. Sibold, President and Chief Executive Officer, and Mardi C. Dier, Executive Vice President and Chief Financial Officer[229]