
Cautionary Statement Regarding Forward-Looking Statements This section details forward-looking statements, emphasizing inherent risks and uncertainties that may cause actual results to differ - The report contains forward-looking statements subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict, potentially causing actual results to differ materially78 - Key areas of forward-looking statements include the outcome of strategic alternatives, product candidate development, funding, financial performance, and regulatory developments8 Summary of the Material Risks Associated with Our Business This section summarizes material business risks, including global economic impacts, strategic uncertainties, operating losses, and clinical development challenges - The company's business is subject to risks from global economic and political developments, including inflation, interest rates, and capital market disruptions, which could harm R&D efforts and access to capital11 - Uncertainty surrounds the identification and implementation of strategic transactions, with potential negative consequences or even the possibility of dissolution and liquidation12 - The company has a limited operating history as a standalone entity, has incurred significant losses, and anticipates continued losses, with no products approved for commercial sale or revenue generated from product sales12 - Additional funding is required to advance product candidates, which may not be available on acceptable terms, potentially leading to delays or scaling back of programs12 - Biopharmaceutical product development is lengthy, expensive, and uncertain, with risks of clinical trial failures, side effects, manufacturing problems, and substantial competition1213 Part I. Financial Information Item 1. Financial Statements (Unaudited) This section presents the unaudited condensed consolidated financial statements and notes for the three months ended March 31, 2025 and 2024 Condensed Consolidated Balance Sheets The condensed consolidated balance sheets show a decrease in total assets and total equity from December 31, 2024, to March 31, 2025, primarily driven by a reduction in cash, cash equivalents, and marketable securities, alongside an increase in accumulated deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :-------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $106,682 | $115,462 | | Marketable securities | $1,000 | $28,923 | | Total current assets | $117,651 | $152,917 | | TOTAL ASSETS | $132,079 | $169,394 | | Total current liabilities | $23,153 | $26,195 | | Total liabilities | $24,192 | $28,892 | | Total equity | $107,887 | $140,502 | | Accumulated deficit | $(192,508) | $(159,371) | Condensed Consolidated Statements of Operations and Comprehensive Loss The statements of operations show an increase in net loss for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to a decrease in other income, despite a slight increase in total operating expenses Condensed Consolidated Statements of Operations Highlights (in thousands, except per share amounts) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $27,425 | $26,868 | | General and administrative | $6,959 | $7,165 | | Total operating expenses | $34,384 | $34,033 | | Operating loss | $(34,384) | $(34,033) | | Other income | $1,247 | $3,116 | | Net loss | $(33,137) | $(30,917) | | Net loss per ordinary share - basic and diluted | $(1.93) | $(1.84) | Condensed Consolidated Statements of Equity (Deficit) The statements of equity (deficit) reflect a decrease in total equity from December 31, 2024, to March 31, 2025, primarily driven by the net loss incurred during the period, partially offset by share-based compensation expense and issuance of ordinary shares under employee plans Condensed Consolidated Statements of Equity (Deficit) Highlights (in thousands) | Item | Balance, December 31, 2024 | Balance, March 31, 2025 | | :-------------------------------- | :----------------------- | :---------------------- | | Total Equity | $140,502 | $107,887 | | Accumulated Deficit | $(159,371) | $(192,508) | | Net loss | - | $(33,137) | | Share-based compensation expense | - | $513 | Condensed Consolidated Statements of Cash Flows The statements of cash flows indicate a net decrease in cash, cash equivalents, and restricted cash for the three months ended March 31, 2025, primarily due to significant cash used in operating activities, partially offset by cash provided by investing activities from sales and maturities of marketable securities Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Cash flows used in operating activities | $(36,798) | $(37,338) | | Cash flows provided by (used in) investing activities | $27,990 | $(124,540) | | Cash flows provided by financing activities | $28 | $0 | | Net decrease in cash, cash equivalents and restricted cash | $(8,780) | $(161,878) | | Cash, cash equivalents and restricted cash—end of period | $108,651 | $109,232 | Notes to Unaudited Condensed Consolidated Financial Statements These notes provide detailed explanations and disclosures for the unaudited condensed consolidated financial statements, covering the company's financial position, performance, and significant accounting policies Note 1. Organization and Description of Business Mural Oncology plc has ceased clinical development of its lead product, nemvaleukin alfa, and is exploring strategic alternatives, including a significant workforce reduction - Mural Oncology plc is an oncology company focused on immunotherapies, but has ceased all clinical development of its lead product candidate, nemvaleukin alfa, due to trial failures in ARTISTRY-7 and ARTISTRY-6272844 - The company is immediately exploring strategic alternatives to maximize shareholder value, including potential acquisition, merger, or other business combination2845 - In connection with discontinuing nemvaleukin development, the company plans a workforce reduction of approximately 90% by the end of Q2 2025, expecting $9.0 million to $10.0 million in related costs44101 - The company was established as an independent, publicly traded entity following a separation from Alkermes plc on November 15, 2023, receiving a $275.0 million cash contribution from Alkermes314041 - Despite sufficient cash for the next twelve months post-reduction, the company has concluded there is substantial doubt about its ability to continue as a going concern due to inherent uncertainty in strategic alternatives and cash consumption47123 Note 2. Basis of Presentation and Summary of Significant Accounting Policies This note details that the unaudited condensed consolidated financial statements are prepared in conformity with GAAP, include wholly-owned subsidiaries, and are consistent with audited annual statements - The financial statements are unaudited, condensed, and prepared in accordance with GAAP, consistent with prior audited statements, and include all normal recurring adjustments4950 - The company evaluates estimates and judgments related to corporate expenses, R&D accruals, asset impairment, share-based compensation, leases, and income taxes, including valuation allowances52 - The company is evaluating the impact of ASU No. 2023-09 (enhanced income tax disclosures, effective FY2025) and ASU No. 2024-03 (disaggregation of income statement expenses, effective FY2027) on its financial statements5657 Note 3. Cash, Cash Equivalents and Marketable Securities This note reports the company's cash, cash equivalents, and marketable securities balances, showing a decrease in both categories from December 31, 2024, to March 31, 2025 Cash, Cash Equivalents and Marketable Securities (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :-------------------------- | :------------- | :---------------- | | Cash and cash equivalents | $106,682 | $115,462 | | Marketable securities | $1,000 | $28,923 | | Restricted cash | $1,969 | $1,969 | - Marketable securities are classified as available for sale, recorded at fair value, with unrealized gains/losses in equity, and no realized gains or losses were reported for the periods59 Note 4. Fair Value This note presents the fair value hierarchy for the company's financial assets, primarily cash equivalents (Level 1) and marketable securities (Level 2), as of March 31, 2025, and December 31, 2024 Fair Value Hierarchy of Financial Assets (in thousands) | Item | March 31, 2025 Total | Level 1 | Level 2 | Level 3 | | :---------------------------------- | :------------------- | :------ | :------ | :------ | | Cash equivalents | $106,253 | $106,253 | $— | $— | | Marketable securities (U.S. government agency and treasury securities) | $1,000 | $— | $1,000 | $— | | Total | $107,253 | $106,253 | $1,000 | $— | | Item | December 31, 2024 Total | Level 1 | Level 2 | Level 3 | | :---------------------------------- | :-------------------- | :------ | :------ | :------ | | Cash equivalents | $114,944 | $114,944 | $— | $— | | Marketable securities (U.S. government agency and treasury securities) | $28,923 | $— | $28,923 | $— | | Total | $143,867 | $114,944 | $28,923 | $— | Note 5. Property and Equipment, Net This note details the composition of property and equipment, net, which includes furniture, fixtures, equipment, leasehold improvements, and construction in progress Property and Equipment, Net (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :-------------------------- | :------------- | :---------------- | | Furniture, fixtures and equipment | $21,513 | $21,513 | | Leasehold improvements | $23,228 | $23,228 | | Construction in progress | $15 | $— | | Subtotal | $44,756 | $44,741 | | Less: accumulated depreciation | $(37,877) | $(37,026) | | Total property and equipment, net | $6,879 | $7,715 | - Depreciation expense was $0.9 million for the three months ended March 31, 2025, compared to $0.8 million for the same period in 202466 Note 6. Accrued Expenses This note provides a breakdown of accrued expenses, showing a decrease in total accrued expenses from December 31, 2024, to March 31, 2025, primarily due to a significant reduction in accrued compensation Accrued Expenses (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :---------------------------------- | :------------- | :---------------- | | Accrued external research and development services | $12,125 | $9,332 | | Accrued general and administrative | $2,193 | $1,026 | | Accrued compensation | $921 | $8,111 | | Accrued other | $52 | $65 | | Total accrued expenses | $15,291 | $18,534 | Note 7. Leases This note details the company's sole operating lease for its corporate office and laboratory space, which expires in 2026, and describes sub-lease agreements generating annualized fixed base rent - The company's only lease is an operating lease for approximately 180,000 square feet of office and laboratory space at Winter Street, expiring in 202668 - Sub-lease agreements were entered into in August and October 2024, generating a total annualized fixed base rent of $0.5 million and $0.7 million, respectively, from third parties7071 Future Lease Payments (in thousands) | Item | March 31, 2025 | | :-------------------------- | :------------- | | Remainder of 2025 | $4,459 | | 2026 | $2,484 | | Total operating lease payments | $6,943 | | Less: imputed interest | $(159) | | Total operating lease liabilities | $6,784 | Note 8. Equity This note outlines the company's equity activities, including an At-the-Market (ATM) Offering for up to $75.0 million in ordinary shares (with no sales as of March 31, 2025) and details of its 2023 Stock Option and Incentive Plan - The company entered into an ATM Offering agreement on March 11, 2025, to sell up to $75.0 million in ordinary shares, but no shares have been issued or sold through March 31, 202574 - The 2023 Stock Option and Incentive Plan reserves 5,854,768 ordinary shares, with 724,795 shares available for issuance as of March 31, 20257576 Share-based Compensation Expense (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :---------------------------------- | :-------------------------------- | :-------------------------------- | | Research and development | $222 | $1,066 | | General and administrative | $291 | $1,133 | | Total share-based compensation expense | $513 | $2,199 | Note 9. Income Taxes This note states that the company recorded no income tax provision for the three months ended March 31, 2025 and 2024, primarily due to the capitalization and amortization of R&D expenses - No income tax provision was recorded for the three months ended March 31, 2025 and 2024, mainly due to R&D expense capitalization and amortization87 - The company maintains a valuation allowance on its Irish net operating losses and other Irish and U.S. deferred tax assets, concluding substantial doubt about recoverability due to cumulative losses88 Note 10. Commitments and Contingencies This note discloses that the company is not involved in any pending legal proceedings that could materially affect its financial condition and reports open purchase commitments for noncancellable contract manufacturing costs - The company is not involved in any pending legal proceedings that are believed to have a material adverse effect on its financial condition, results of operations, or cash flows89 - Open purchase commitments for noncancellable contract manufacturing costs totaled approximately $8.3 million as of March 31, 202590 Note 11. Net Loss per Share This note explains the calculation of basic and diluted net loss per share, noting that share-based awards were excluded from diluted EPS calculation as they were anti-dilutive - Basic net loss per share is calculated by dividing net loss by the weighted average ordinary shares outstanding, and diluted net loss per share includes potential ordinary shares if dilutive, but share-based awards were anti-dilutive for the periods presented92 Potentially Dilutive Securities (Number of Shares) | Item | March 31, 2025 | March 31, 2024 | | :-------------------------- | :------------- | :------------- | | Options to purchase ordinary shares | 3,725,736 | 3,369,902 | | Restricted share units | 1,121,460 | 988,097 | | Total | 4,847,196 | 4,357,999 | Note 12. Related Parties This note clarifies that the Former Parent (Alkermes plc) is no longer a related party to the company after the Separation and discloses a receivable of $0.1 million from the Former Parent - The Former Parent ceased to be a related party after the Separation on November 15, 202395 - The company had a receivable of $0.1 million from the Former Parent as of March 31, 2025, and December 31, 2024, pursuant to transition services agreements94 Note 13. Segment Information This note states that Mural Oncology plc operates as a single operating and reportable segment focused on oncology immunotherapies and provides a reconciliation of significant segment expenses to net loss - The company operates as one operating and reportable segment, focusing on discovering and developing oncology immunotherapies96 Reconciliation of Segment Expenses to Net Loss (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :---------------------------------- | :-------------------------------- | :-------------------------------- | | Total external R&D program expenses | $17,974 | $15,073 | | Total internal R&D expenses | $9,451 | $11,795 | | Total R&D expenses | $27,425 | $26,868 | | Total G&A expenses | $6,959 | $7,165 | | Other segment (income) expense | $(1,247) | $(3,116) | | Segment net loss | $33,137 | $30,917 | Note 14. Subsequent Events This note reports that on April 14, 2025, the board decided to discontinue all clinical development of nemvaleukin and approved a 90% workforce reduction, expecting $9.0 million to $10.0 million in severance and benefit costs, plus $2.0 million to $4.0 million in non-cash impairment charges - On April 14, 2025, the company decided to discontinue all clinical development of nemvaleukin101 - A workforce reduction of approximately 90% (104 positions) was approved, expected to be completed by the end of Q2 2025101 - Expected costs related to the reduction are $9.0 million to $10.0 million for severance and benefits, and $2.0 million to $4.0 million in non-cash impairment charges for property and equipment101 - The company immediately commenced exploration of strategic alternatives to maximize shareholder value, engaging Lucid Capital Markets, LLC as financial advisor102 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 performance and condition, highlighting the discontinuation of nemvaleukin development, the ongoing exploration of strategic alternatives, and the substantial doubt about the company's ability to continue as a going concern Overview Mural Oncology plc, an oncology company, has ceased all clinical development of its lead product candidate, nemvaleukin alfa, following trial failures, and is now exploring strategic alternatives to maximize shareholder value - Mural Oncology focused on discovering and developing immunotherapies for cancer, with nemvaleukin alfa as its lead product candidate105 - On March 25, 2025, the Phase 3 ARTISTRY-7 trial of nemvaleukin alfa failed to meet its primary endpoint, leading to the cessation of nemvaleukin development for platinum-resistant ovarian cancer106 - On April 15, 2025, the company discontinued all clinical development of nemvaleukin and initiated an exploration of strategic alternatives to maximize shareholder value106 The Separation This section details the company's separation from Alkermes plc on November 15, 2023, which established Mural Oncology as an independent, publicly traded company, and outlines the key agreements governing the post-separation relationship - The company separated from Alkermes plc on November 15, 2023, becoming an independent, publicly traded company under the symbol 'MURA' on the Nasdaq Global Market115 - In connection with the Separation, Mural Oncology received a cash contribution of $275.0 million from Alkermes on November 14, 2023114 - Key agreements established during the Separation include a separation agreement, tax matters agreement, employee matters agreement, lease assumption agreement, and transition services agreements, defining the ongoing relationship with Alkermes107108 Going Concern The company has incurred significant operating losses and negative cash flows since inception and expects this to continue, leading to substantial doubt about its ability to continue as a going concern due to the inherent uncertainty of strategic alternatives - The company has generated operating losses and negative cash flows from operations since its inception and expects this trend to continue119 - Existing cash, cash equivalents, and marketable securities of $107.7 million as of March 31, 2025, are not sufficient to fund continued development of product candidates and meet existing obligations119 - Following the discontinuation of nemvaleukin development and a 90% workforce reduction, the company believes it has sufficient cash for the next twelve months, but substantial doubt about its ability to continue as a going concern remains due to the uncertainty of strategic alternatives123 - The exploration of strategic alternatives, including acquisition or merger, has no set timetable and no assurance of completion or favorable terms121 Components of Results of Operations This section outlines the key components of the company's financial results: revenue (none generated to date), research and development (R&D) expenses (both external and internal), general and administrative (G&A) expenses, and other income (primarily interest income) - The company has not recognized any revenue through March 31, 2025, and does not expect to generate substantial product revenue in the near future126 - R&D expenses include external costs (CROs, consulting, drug materials, manufacturing) and internal costs (employee-related, occupancy, depreciation)127 - G&A expenses primarily consist of salaries, share-based compensation, facility costs, and professional fees129 - Other income is mainly derived from interest on cash accounts, money market mutual funds, and marketable securities130 Results of Operations This section compares the company's financial results for the three months ended March 31, 2025, and 2024, detailing changes in research and development expenses, general and administrative expenses, and other income Research and Development Expenses Research and development expenses increased slightly by $0.5 million for the three months ended March 31, 2025, compared to the same period in 2024, primarily due to increased spending on early discovery programs and the ARTISTRY-6 trial, partially offset by decreased spending on the ARTISTRY-7 trial and lower employee-related expenses Research and Development Expenses (in millions) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :-------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Total external R&D expenses | $17.9 | $15.1 | $2.8 | | Total internal R&D expenses | $9.5 | $11.8 | $(2.3) | | Research and development expenses | $27.4 | $26.9 | $0.5 | - The increase in R&D expenses was driven by increased spend on early discovery programs and the ARTISTRY-6 trial, partially offset by decreased spend on the ARTISTRY-7 trial and lower employee-related expenses131 General and Administrative Expenses General and administrative expenses remained relatively flat for the three months ended March 31, 2025, compared to the same period in 2024, with decreased employee-related expenses offset by increased professional fees and other expenses General and Administrative Expenses (in millions) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :---------------------------------- | :-------------------------------- | :-------------------------------- | :----- | | General and administrative expense | $7.0 | $7.2 | $(0.2) | - G&A expense remained flat year-over-year, with decreased employee-related expenses (including share-based compensation) offset by increased professional fees and other expenses132 Other Income Other income decreased by $1.9 million for the three months ended March 31, 2025, compared to the same period in 2024, primarily derived from interest on interest-bearing cash accounts, money market mutual funds, and marketable securities Other Income (in millions) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :-------------------------- | :-------------------------------- | :-------------------------------- | :----- | | Other income | $1.2 | $3.1 | $(1.9) | - Other income primarily consisted of interest income from cash, cash equivalents, and marketable securities133 Liquidity and Capital Resources This section discusses the company's historical funding, future capital needs, the At-the-Market (ATM) Offering, cash flow activities, contractual obligations, critical accounting policies, transition costs from the Former Parent, and its status as an emerging growth and smaller reporting company Funding Requirements The company anticipates significant and increasing expenses for product candidate development, requiring substantial additional funding, and restrictions under the tax matters agreement also limit certain strategic transactions - The company expects to incur significant and increasing expenses for product candidate development, requiring substantial additional funding135 - Current cash, cash equivalents, and marketable securities of $107.7 million as of March 31, 2025, are believed to fund operating expenses and capital expenditure requirements for at least twelve months135 - The tax matters agreement prohibits certain actions for a four-year period around the Distribution, which may limit the company's ability to pursue strategic transactions, equity issuances, or repurchases142 At-the-Market Offering On March 11, 2025, the company entered into an At-the-Market (ATM) Offering agreement with Jefferies LLC, allowing it to sell up to $75.0 million in ordinary shares, but no shares have been issued or sold under this offering as of March 31, 2025 - The company entered into an ATM Offering agreement on March 11, 2025, to sell up to $75.0 million in ordinary shares through Jefferies LLC144 - No shares have been issued or sold under the ATM Offering through March 31, 2025144 Cash Flows The company experienced a net decrease in cash, cash equivalents, and restricted cash for the three months ended March 31, 2025, with operating activities using $36.8 million and investing activities providing $28.0 million Cash Flow Summary (in millions) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Cash, cash equivalents and restricted cash, beginning of period | $117.4 | $271.1 | | Cash flows used in operating activities | $(36.8) | $(37.3) | | Cash flows provided by (used in) investing activities | $28.0 | $(124.6) | | Cash, cash equivalents and restricted cash, end of period | $108.6 | $109.2 | - Net cash used in operating activities for Q1 2025 was $36.8 million, primarily from a net loss of $33.1 million and a $3.4 million decrease in accounts payable and accrued expenses146147 - Net cash provided by investing activities for Q1 2025 was $28.0 million, mainly from sales and maturities of marketable securities149 Contractual Obligations and Commitments The company's primary contractual obligation is the Winter Street Lease for office and laboratory space, expiring in 2026, with sub-lease agreements generating annualized fixed base rent, and remaining operating lease liability of $6.8 million and $8.3 million in noncancellable contract manufacturing costs - The company's only lease is an operating lease for its Winter Street corporate office and laboratory space, expiring in 2026150 - Sub-lease agreements with third parties generate annualized fixed base rent of $0.5 million and $0.7 million, respectively152153 - As of March 31, 2025, the remaining contractual operating lease liability was $6.8 million154 - The company has open purchase commitments for noncancellable contract manufacturing costs totaling approximately $8.3 million90 Critical Accounting Policies and Significant Judgments and Estimates This section states that there have been no significant changes to the company's critical accounting policies or estimates from those described in its Annual Report on Form 10-K - No significant changes to critical accounting policies or estimates from the Annual Report on Form 10-K157 Recently Issued and Adopted Accounting Pronouncements This section refers to Note 2, Basis of Presentation and Summary of Significant Accounting Policies, for a description of recently issued and adopted accounting pronouncements that may impact the company's financial position and results of operations - Refer to Note 2 for details on recently issued and adopted accounting pronouncements158 Transition From the Former Parent and Costs to Operate as an Independent Company Following the Separation, the company entered into transition services agreements with the Former Parent to provide interim services and has incurred non-recurring expenses to establish its standalone infrastructure - The company entered into transition services agreements with the Former Parent to receive interim services for an initial term of two years following the Separation159 - Non-recurring expenses have been incurred to establish and expand the company's standalone infrastructure, replicating or outsourcing corporate and shared services159 Emerging Growth Company and Smaller Reporting Company Status The company qualifies as an 'emerging growth company' and a 'smaller reporting company,' allowing it to take advantage of reduced disclosure requirements and an extended transition period for complying with new or revised accounting standards, which may make its ordinary shares less attractive to some investors - The company qualifies as an 'emerging growth company' (EGC) and a 'smaller reporting company' (SRC), allowing for reduced disclosure requirements161163 - As an EGC, the company has elected to use the extended transition period for complying with new or revised accounting standards, adopting them at the same time as private companies161 - Reliance on these exemptions may make the company's ordinary shares less attractive to investors, potentially leading to a less active trading market and more volatile share price163164 Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Mural Oncology plc is not required to provide quantitative and qualitative disclosures about market risk under this item - The company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk165 Item 4. Controls and Procedures Management, with the participation of the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures as of March 31, 2025, concluding they were effective, with no material changes in internal control over financial reporting during the three months ended March 31, 2025 - Disclosure controls and procedures were evaluated and deemed effective as of March 31, 2025, providing reasonable assurance for timely and accurate financial reporting166 - No changes in internal control over financial reporting materially affected, or are reasonably likely to materially affect, internal control over financial reporting during the three months ended March 31, 2025167 Part II. Other Information Item 1. Legal Proceedings This section states that the company is not currently involved in any material legal proceedings - The company is not involved in any material legal proceedings170 Item 1A. Risk Factors This comprehensive section details various risks that could materially impact Mural Oncology plc, including uncertainties surrounding strategic alternatives and potential liquidation, significant financial losses and funding needs, the lengthy and unpredictable nature of product development and regulatory approval, challenges in commercialization, reliance on third parties, intellectual property protection issues, general business and industry risks, and specific risks related to the company's separation from Alkermes, tax matters, and ownership of its ordinary shares Risks Related to Our Evaluation of Strategic Alternatives and Potential Wind Down This section highlights the significant uncertainties and potential negative consequences associated with the company's exploration of strategic alternatives, including the risk of not successfully identifying or implementing a transaction, the possibility of dissolution and liquidation, and the operational disruptions and costs associated with the process and a recent 90% workforce reduction - There is no assurance that the exploration of strategic alternatives will result in a transaction, or that any transaction will be completed on attractive terms or at all172 - The evaluation process is costly, time-consuming, and complex, with significant expenses incurred regardless of transaction completion, which will decrease available cash173 - If a strategic transaction is not consummated, the board may pursue dissolution and liquidation, where the amount of cash for shareholders would depend on timing and reserves for obligations181 - A 90% workforce reduction (approximately 104 positions) was implemented, which may not yield anticipated savings, could incur greater costs than expected, and disrupt business operations and employee morale185 Risks Related to Our Financial Position and Capital Needs This section addresses the financial challenges faced by the company, including its limited operating history as a standalone entity, significant and anticipated ongoing operating losses, and the critical need for additional funding, emphasizing the substantial doubt about the company's ability to continue as a going concern and the potential adverse effects of financial services industry developments - The company has a limited operating history as a standalone entity, making business valuation and prospect prediction challenging188 - The company has incurred significant operating losses and negative cash flows since inception, with net losses of $33.1 million (Q1 2025) and $30.9 million (Q1 2024), and anticipates continued losses194196 - Substantial additional funding is required to advance product candidates, as existing cash ($107.7 million as of March 31, 2025) is insufficient for continued development and existing obligations190197 - There is substantial doubt about the company's ability to continue as a going concern, and failure to obtain additional funding could lead to delays, scaling back programs, or granting rights to third parties190191197 - Adverse developments in the financial services industry could impair access to cash and liquidity, impacting the company's ability to meet obligations and potentially affecting vendors and business partners198200201 Risks Related to Discovery, Product Development and Regulatory Approval of Our Product Candidates This section details the inherent risks in biopharmaceutical product development, including the lengthy, expensive, and uncertain process of clinical trials, as evidenced by the discontinuation of nemvaleukin development due to trial failures, covering potential delays, side effects, manufacturing complexities, challenges in obtaining and maintaining regulatory approvals, and the impact of evolving regulatory requirements and legal challenges - Biopharmaceutical product development is lengthy, expensive, and uncertain; the company discontinued nemvaleukin development after ARTISTRY-6 and ARTISTRY-7 trials failed to meet primary endpoints202 - Delays or difficulties in patient enrollment, unforeseen events during trials, or regulatory disagreements on trial design could significantly delay or prevent product development and approval206207216 - Side effects or serious adverse events from product candidates could delay or halt clinical trials, prevent regulatory approval, or result in restrictive labeling or negative post-marketing consequences233235 - Manufacturing of biological products is complex, with risks of production issues, contamination, raw material shortages, and deviations from cGMP, potentially causing delays or failures in development and commercialization248250251 - The regulatory approval process is lengthy, time-consuming, and unpredictable, with no guarantee of FDA approval, and regulatory authorities may disagree with strategies or impose stricter requirements241242246 - Inadequate funding for regulatory agencies (FDA, SEC, EMA) or changes in U.S. presidential administrations could hinder their ability to review and approve new products, causing delays272273274 - Ongoing regulatory obligations post-approval, including cGMP compliance and post-marketing studies, could result in significant additional expenses and penalties for non-compliance275277279 - Improper promotion of off-label uses could lead to significant liability, civil/criminal penalties, and reputational harm282284 - Recent U.S. Supreme Court administrative law decisions (e.g., Loper Bright, Corner Post, Jarkesy) and ongoing litigation challenging FDA approvals could introduce regulatory uncertainty and delays285286 Risks Related to the Commercialization of Our Product Candidates This section outlines the significant challenges in commercializing any approved product candidates, including the uncertainty of market acceptance, the company's lack of commercialization history, difficulties in securing favorable insurance coverage and reimbursement, the impact of evolving healthcare legislation on pricing, and intense competition from other pharmaceutical and biotechnology companies, including potential biosimilar competition - Even if approved, product candidates may fail to achieve sufficient market acceptance by physicians, patients, hospitals, and third-party payors, impacting revenue generation304305 - The company has no history of commercializing products and lacks established sales, marketing, or distribution capabilities, requiring substantial investment and competing with larger companies306 - Successful commercialization depends on obtaining and maintaining favorable insurance coverage, adequate reimbursement levels, and cost-effective pricing policies from third-party payors, which is uncertain and subject to challenges311312 - Current and future healthcare legislation (e.g., ACA, IRA) may increase the difficulty and cost of obtaining reimbursement, limit product prices, and reduce demand, materially harming business316324325 - The company faces substantial competition from major pharmaceutical, specialty pharmaceutical, and biotechnology companies, with risks of competitors developing safer, more effective, or less expensive products330332 - Product candidates regulated as biologics may face biosimilar competition, potentially shortening exclusivity periods and impacting market share335337 Risks Related to Our Reliance on Third Parties This section details the risks associated with the company's heavy reliance on third parties for preclinical studies, clinical trials, and manufacturing, including potential failures in contractual duties, non-compliance with regulatory requirements, supply disruptions from single-source manufacturers, and limited control over third-party collaborators, all of which could delay development and commercialization - The company relies on third parties (CROs, medical institutions, strategic partners) to conduct preclinical studies and clinical trials, with limited control over their day-to-day activities and compliance338339 - Failure of third parties to comply with GCP requirements or meet deadlines could render clinical data unreliable, delay regulatory approval, or require repeating trials339341 - Reliance on single-source manufacturers for certain processes exposes the company to risks of production issues, supply interruptions, price increases, and manufacturing delays255 - Developing product candidates in combination with third-party drugs presents risks related to access, supply, safety, regulatory status, and potential adverse events from combination therapy346347 - Collaborations with third parties for research, development, and commercialization involve risks such as collaborators not dedicating sufficient resources, delaying programs, or developing competing products, potentially impacting revenue350351 Risks Related to Our Intellectual Property This section addresses the critical importance and inherent challenges of protecting the company's intellectual property, including the inability to obtain or maintain adequate patent protection, potential invalidation or unenforceability of existing patents, difficulties in enforcing IP rights globally, and the threat of costly litigation from third-party infringement claims or loss of trade secrets - The company's success depends on obtaining and maintaining patent protection for its product candidates, but there is no certainty that patents will be issued or that their scope will be sufficient355356 - Changes in patent laws or their interpretation in the U.S. or other jurisdictions could diminish the value of patents and impair the ability to protect products357358 - Issued patents could be found invalid or unenforceable if challenged in court or patent office proceedings, leading to a loss of patent protection and material adverse impact359363 - Enforcing intellectual property rights globally is expensive and challenging, as laws in non-U.S. countries may not offer the same level of protection, potentially allowing competitors to use technologies364365 - Claims that product candidates infringe third-party patent rights could result in costly litigation, requiring licenses on unfavorable terms or preventing commercialization366368 - Failure to protect the confidentiality of trade secrets, technical know-how, and proprietary information could harm the business and competitive position370372 Risks Related to Our Business and Industry This section outlines various operational and external risks, including challenges associated with international business activities (e.g., political conditions, trade laws, currency fluctuations), the potential loss of key management personnel, compliance with complex healthcare fraud and abuse laws, and exposure to costly product liability claims - International operations expose the company to risks such as unfavorable political/tax conditions, tariffs, trade restrictions, anti-corruption laws (FCPA), economic weakness, and currency fluctuations382383 - Loss of key management, scientific, or medical personnel could impair business strategy and competitiveness386 - Relationships with healthcare providers and payors are subject to anti-kickback, fraud, and abuse laws, potentially leading to criminal sanctions, civil penalties, and reputational harm387390 - Changes in U.S. and international trade policies, particularly with China, could adversely impact business, supply chains, and costs392393395 - Misconduct by employees, contractors, or partners, including non-compliance with regulatory standards, could result in sanctions and reputational damage396397 - The company is exposed to product liability risks from clinical trials and commercial sales, with potential for substantial liabilities not fully covered by insurance398399400 - Operations are vulnerable to catastrophic events (e.g., terrorist attacks, wars, pandemics, natural disasters) which could disrupt R&D, manufacturing, and commercialization404 - Compliance with evolving U.S. and international privacy and data security laws (e.g., CCPA, GDPR) could result in additional costs, liabilities, fines, and reputational damage406410414 - Computer systems are vulnerable to security breaches or failures, potentially causing operational interruptions, data loss, regulatory fines, and reputational harm417418 Risks Related to the Separation and Distribution This section addresses the specific risks arising from the company's separation from Alkermes plc, including the potential failure to achieve anticipated benefits, the non-arms-length terms of agreements made during the separation, and significant indemnification liabilities to the Former Parent, which could negatively impact financial results - The company may not achieve the full operational, financial, and strategic benefits expected from the Separation, or such benefits may be delayed or not realized419420 - Agreements with the Former Parent (e.g., separation, transition services, tax matters) may not reflect terms that would have resulted from negotiations with unaffiliated third parties422 - The company relies on the Former Parent to perform under various transaction agreements and may incur operational difficulties or losses if the Former Parent fails to satisfy its obligations423424 - The company has assumed and agreed to indemnify the Former Parent for certain uncapped liabilities, including those impacting the tax-free nature of the Separation, which could result in substantial payments425429 Risks Related to Tax Matters This section outlines tax-related risks, primarily concerning the potential failure of the Separation and Distribution to qualify as tax-free for U.S. federal income tax purposes, which could lead to significant tax liabilities for the Former Parent and its shareholders, and substantial indemnification obligations for the company - If the Separation and Distribution do not qualify as tax-free for U.S. federal income tax purposes, the Former Parent's U.S. subsidiaries and shareholders could face significant tax liabilities427428 - The company could be required to indemnify the Former Parent for material taxes if the tax-free status fails due to the company's actions, with indemnification obligations not limited in amount429 - To preserve tax-free treatment, the tax matters agreement prohibits certain strategic actions for a four-year period, limiting the company's ability to pursue certain transactions430431 - The company believes it will be treated as a Passive Foreign Investment Company (PFIC) for the 2024 tax year, which could have material adverse U.S. federal income tax consequences for U.S. holders432433 Risks Related to Ownership of Our Ordinary Shares This section details risks associated with owning the company's ordinary shares, including its status as an 'emerging growth company' and 'smaller reporting company' (allowing reduced disclosures), potential stock price volatility, dilution from future equity issuances, the impact of activist shareholders, the absence of dividends, and challenges in maintaining effective internal controls over financial reporting - As an 'emerging growth company' and 'smaller reporting company,' the company benefits from reduced disclosure requirements and delayed adoption of accounting standards, which may make its shares less attractive to some investors436437439 - The price of ordinary shares is subject to high volatility due to factors like clinical trial results, regulatory decisions, competition, and general market conditions440442 - Future sales and issuances of ordinary shares or rights to purchase them, including under equity incentive plans, could result in additional dilution of existing shareholders' ownership and cause the share price to fall445447 - The company does not intend to pay dividends on its ordinary shares for the foreseeable future, limiting shareholder returns to share appreciation449 - Failure to maintain an effective system of internal control over financial reporting could lead to inaccurate financial reporting, loss of investor confidence, and harm to the business and share price450453 - An active trading market for ordinary shares may not develop or be sustained, making it difficult for shareholders to resell shares at an attractive price455 Risks Related to Our Jurisdiction of Incorporation in Ireland This section outlines risks stemming from the company's incorporation under Irish law, which differs from U.S. law and may offer less protection to shareholders, highlighting the applicability of Irish Takeover Rules, potential Irish stamp duty on share transfers, restrictions on capital management, and specific rules regarding general meetings and voting - Irish law differs from U.S. law and might afford less protection to holders of the company's securities, particularly regarding shareholder lawsuits and director duties460461 - Any actual or potential takeover offer for the company will be subject to the Irish Takeover Rules, which restrict certain actions by the board during an offer period464 - Transfers of ordinary shares held directly (not through DTC) may be subject to Irish stamp duty (currently 1%)465 - Irish law imposes restrictions on capital management, such as requiring shareholder authorization for new share issuances and pre-emptive rights, which could interfere with financing467469 - There is no guarantee that the company will seek or be able to create the distributable reserves needed to pay dividends under Irish law468 General Risk Factors This section covers broad risks that could adversely affect the company, including unfavorable global economic or political conditions, potential changes in tax law, and the broad discretion management has in using cash, cash equivalents, and marketable securities, which may not always enhance operating results or share price - Unfavorable global economic or political conditions, such as economic downturns, global conflicts (e.g., Russia-Ukraine, Middle East), or political unrest, could adversely affect business operations and financial results474 - Changes in U.S. federal, state, local, or non-U.S. tax laws could adversely affect the company or its shareholders, potentially increasing tax liability475476 - Management has broad discretion in using cash, cash equivalents, and marketable securities, which may not always enhance operating results or the market price of ordinary shares477 Item 5. Other Information This section provides information on director and officer trading arrangements, stating that no Rule 10b5-1 Trading Arrangements were adopted, modified, or terminated by any officers or directors during the three months ended March 31, 2025 - No Rule 10b5-1 Trading Arrangements were adopted, modified, or terminated by the company's officers or directors during the three months ended March 31, 2025481 Item 6. Exhibits This section lists the exhibits filed as part of the Form 10-Q, including certifications from the Principal Executive Officer and Principal Financial Officer, and XBRL-related documents List of Exhibits | Exhibit Number | Description | | :------------- | :---------- | | 31.1* | Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | | 31.2* | Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | | 32.1+ | Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | | 32.2+ | Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | | 101.INS | Inline XBRL Instance Document – the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document. | | 101.SCH | Inline XBRL Taxonomy Extension Schema with Embedded Linkbase Documents | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | Signatures This section contains the formal signatures, confirming that the report has been duly caused to be signed on behalf of Mural Oncology plc by its Chief Financial Officer - The report is signed by Adam Cutler, Chief Financial Officer (Principal Financial and Accounting Officer) of Mural Oncology plc, on May 14, 2025488