Mural Oncology plc(MURA)

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Mural Oncology Announces Commencement of Mailing of Definitive Proxy Statement and Details of Scheme Meeting and Extraordinary General Meeting
Globenewswire· 2025-09-23 23:52
WALTHAM, Mass. and DUBLIN, Ireland, Sept. 23, 2025 (GLOBE NEWSWIRE) -- Mural Oncology plc, (Nasdaq: MURA) (“Mural”), a clinical-stage immuno-oncology company, today announces for the purposes of the Irish Takeover Panel Act, 1997, Takeover Rules 2022 (the “Irish Takeover Rules”), that it has published the definitive proxy statement of Mural relating to the Acquisition described below, which also constitutes a scheme circular under Irish law (the “Proxy Statement”) and that Mural has commenced mailing the Pr ...
Mural Oncology Announces Entry into Agreement to be Acquired by XRA 5 Corp., a wholly owned subsidiary of XOMA Royalty for between $2.035 and $2.24 in Cash per Share
Globenewswire· 2025-08-20 12:30
Core Viewpoint - Mural Oncology plc has entered into a definitive agreement with XOMA Royalty Corporation for the acquisition of Mural's entire issued share capital, which is seen as beneficial for Mural shareholders following a strategic review process [1][52]. Transaction Details - The acquisition will provide Mural shareholders with a base cash price of $2.035 per share, with the potential for an additional cash amount of up to $0.205 per share based on Mural's Closing Net Cash exceeding estimated amounts [2][54]. - The total valuation of Mural's share capital in the acquisition is approximately $36.2 million, excluding any additional payments [4][56]. - The acquisition is expected to close by the end of 2025, subject to shareholder approval and High Court sanction [9][53]. Strategic Review Background - Mural Oncology is focused on developing cytokine-based immunotherapies for cancer treatment [13][63]. - Following unsuccessful clinical trials, Mural decided to explore strategic alternatives to maximize shareholder value, leading to the acquisition proposal from XOMA Royalty [14][64]. - The Mural Board evaluated various options, including liquidation and reverse takeovers, concluding that the acquisition was the best route for shareholder value [71][72]. Board Recommendations - The Mural Board, advised by Lucid Capital Markets, considers the acquisition terms fair and reasonable, recommending that shareholders vote in favor [8][73]. - Mural directors holding approximately 0.42% of shares have committed to vote in favor of the acquisition [7][74].
Mural Oncology (MURA) Q2 Loss Widens 49%
The Motley Fool· 2025-08-04 13:21
Core Viewpoint - Mural Oncology has fully discontinued all R&D programs, including its lead candidate nemvaleukin alfa, and is now exploring strategic alternatives such as a sale or liquidation, following a significant net loss in Q2 2025 [1][4][10] Financial Performance - The company reported a net loss per share (GAAP) of ($2.78) in Q2 2025, significantly worse than the consensus estimate of ($1.00) and a 49.5% increase from the ($1.86) loss in Q2 2024 [2][8] - Cash and cash equivalents decreased sharply from $144.4 million at the end of 2024 to $77.1 million by June 30, 2025 [2][8] - Research and development expenses fell to $23.3 million in Q2 2025 from $27.5 million a year earlier, primarily due to reduced employee-related expenses and decreased spending on clinical trials [2][6] - General and administrative expenses rose to $8.7 million in Q2 2025, up from $6.7 million in Q2 2024, largely due to severance and advisory fees related to downsizing [2][7] - Restructuring and impairment expenses totaled $17.5 million in Q2 2025, reflecting costs associated with terminating leases and contracts [2][7] Strategic Shift - Mural Oncology has transitioned into wind-down mode, with all drug programs, including early-stage preclinical research, now canceled [5][6] - The company's future value is now tied almost entirely to its remaining cash and the pursuit of strategic transactions, with no ongoing operations or product prospects [4][10] - Management's guidance for year-end cash estimates ranges from $43 million to $48 million as of December 31, 2025, contingent on executing a strategic alternative [9][10]
Mural Oncology plc(MURA) - 2025 Q2 - Quarterly Report
2025-08-04 12:15
[Cautionary Statement Regarding Forward-Looking Statements](index=3&type=section&id=CAUTIONARY%20STATEMENT%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) This section warns that forward-looking statements are subject to substantial risks and uncertainties, and actual results may differ - Forward-looking statements are based on current expectations and assumptions, and actual results may differ materially due to inherent uncertainties, risks, and changes in circumstances[8](index=8&type=chunk) - Key areas of forward-looking statements include strategic alternatives, post-Separation relationships, product candidate development, manufacturing, funding, safety, business model, intellectual property, expenses, collaborations, regulatory developments, and indemnification liabilities[8](index=8&type=chunk) - Important factors that could cause actual results to differ materially are further described in Part II, Item 1A, 'Risk Factors'[9](index=9&type=chunk) [Summary of the Material Risks Associated with Our Business](index=4&type=section&id=SUMMARY%20OF%20THE%20MATERIAL%20RISKS%20ASSOCIATED%20WITH%20OUR%20BUSINESS) This section summarizes significant risks that could materially affect the Company's business, prospects, and financial condition - Impact of global economic and political developments (inflation, interest rates, capital market disruptions) on R&D efforts and share value[11](index=11&type=chunk) - Uncertainty in identifying and implementing strategic transactions, with potential negative consequences or failure to realize anticipated benefits[11](index=11&type=chunk) - Corporate restructuring and headcount reduction may not yield anticipated savings and could disrupt business operations[11](index=11&type=chunk) - Limited operating history as a standalone company makes business valuation and prospect prediction challenging[11](index=11&type=chunk) - Significant and anticipated ongoing losses, with no approved products or product sales revenue to date[12](index=12&type=chunk) - Need for additional funding to advance product candidates, which may not be available on acceptable terms, potentially leading to program delays or scaling back[12](index=12&type=chunk) - Lengthy, expensive, and uncertain biopharmaceutical product development process, with risks of unexpected costs, delays, or inability to complete development and commercialization[12](index=12&type=chunk) - Potential for side effects or undesirable properties of product candidates to delay or halt clinical trials, prevent regulatory approval, or result in negative post-marketing consequences[12](index=12&type=chunk) - Challenges in obtaining or maintaining adequate patent protection, leading to competition and decreased market share[12](index=12&type=chunk) - Risks related to the tax-free status of the Separation and Distribution, potentially leading to significant tax liabilities and indemnification obligations[13](index=13&type=chunk) - Status as an 'emerging growth company' and 'smaller reporting company' may make ordinary shares less attractive to investors[13](index=13&type=chunk) - Volatility in the price of ordinary shares, potentially unrelated to operations, and the risk of an inactive trading market[13](index=13&type=chunk) [Part I. Financial Information](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents the Company's unaudited financial statements and management's discussion and analysis [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, covering balance sheets, operations, equity, and cash flows [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The condensed consolidated balance sheets provide a snapshot of the Company's financial position at June 30, 2025, and December 31, 2024, detailing assets, liabilities, and equity | ASSETS (in K) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Cash and cash equivalents | $77,094 | $115,462 | | Marketable securities | — | $28,923 | | Total current assets | $81,556 | $152,917 | | TOTAL ASSETS | $87,555 | $169,394 | | LIABILITIES AND EQUITY (in K) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Total current liabilities | $28,418 | $26,195 | | Total liabilities | $28,772 | $28,892 | | Total equity | $58,783 | $140,502 | | TOTAL LIABILITIES AND EQUITY | $87,555 | $169,394 | - Cash and cash equivalents decreased by **$38.368 million** from December 31, 2024, to June 30, 2025. Total assets decreased by **$81.839 million**, while total equity decreased by **$81.719 million** over the same period[16](index=16&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This statement details the Company's operating expenses, operating loss, other income, net loss, and comprehensive loss for the three and six months ended June 30, 2025, and 2024 Operating Results (in K, except share and per share amounts) | Operating Expenses (in K) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $23,277 | $27,544 | $50,702 | $54,412 | | General and administrative | $8,079 | $6,733 | $15,038 | $13,898 | | Restructuring and impairment | $17,486 | — | $17,486 | — | | Total operating expenses | $48,842 | $34,277 | $83,226 | $68,310 | | Operating loss (in K) | $(48,842) | $(34,277) | $(83,226) | $(68,310) | | Other income (in K) | $860 | $2,713 | $2,107 | $5,829 | | Net loss (in K) | $(47,982) | $(31,564) | $(81,119) | $(62,481) | | Net loss per ordinary share - basic and diluted ($) | $(2.78) | $(1.86) | $(4.71) | $(3.71) | - Net loss increased significantly for both the three-month period (from **$(31,564)K** to **$(47,982)K**) and six-month period (from **$(62,481)K** to **$(81,119)K**) ended June 30, 2025, primarily due to restructuring and impairment charges[19](index=19&type=chunk) [Condensed Consolidated Statements of Equity (Deficit)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Equity%20(Deficit)) This statement outlines the changes in the Company's equity (deficit) for the periods ended June 30, 2025, and June 30, 2024, reflecting net losses, share issuances, and share-based compensation Changes in Equity (in K, except share data) | Item | Balance, Dec 31, 2024 | Q1 2025 Activity | Balance, Mar 31, 2025 | Q2 2025 Activity | Balance, Jun 30, 2025 | | :-------------------------------- | :-------------------- | :--------------- | :-------------------- | :--------------- | :-------------------- | | Ordinary Shares (Shares) | 17,095,371 | 169,446 | 17,264,817 | 9,720 | 17,274,537 | | Ordinary Shares (Amount in K) | $171 | $2 | $173 | $0 | $173 | | Additional Paid-in Capital (in K) | $299,682 | $539 | $300,221 | $(1,121) | $299,100 | | Other Comprehensive (Loss)/Gain (in K) | $20 | $(19) | $1 | $(1) | $0 | | Accumulated Deficit (in K) | $(159,371) | $(33,137) | $(192,508) | $(47,982) | $(240,490) | | Total Equity (in K) | $140,502 | $(32,615) | $107,887 | $(49,104) | $58,783 | - Total equity decreased from **$140,502 thousand** at December 31, 2024, to **$58,783 thousand** at June 30, 2025, primarily due to accumulated net losses[22](index=22&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement summarizes the cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025, and 2024
Mural Oncology plc(MURA) - 2025 Q2 - Quarterly Results
2025-08-04 12:04
[Company Announcement & Business Update](index=1&type=section&id=Company%20Announcement%20%26%20Business%20Update) Mural Oncology is pursuing strategic alternatives, discontinuing R&D, and reducing its workforce to conserve cash, projecting $43-48 million in cash by December 2025 [Strategic Alternatives & Cash Conservation](index=1&type=section&id=Strategic%20Alternatives%20%26%20Cash%20Conservation) Mural Oncology is actively exploring strategic alternatives to maximize shareholder value, which includes discontinuing all clinical development of its lead product candidate, nemvaleukin alfa, and other research and development activities - Mural is discontinuing all clinical development of its lead product candidate, nemvaleukin alfa, and terminating other research and development activities[1](index=1&type=chunk)[2](index=2&type=chunk) - The company implemented a reduction in workforce by approximately **90%** to conserve cash[2](index=2&type=chunk) - Mural estimates cash and cash equivalents of approximately **$43 to $48 million** by December 31, 2025, if no transaction or strategic alternative is consummated[1](index=1&type=chunk)[2](index=2&type=chunk) [Financial Results Overview (Quarter Ended June 30, 2025)](index=1&type=section&id=Financial%20Results%20Overview%20%28Quarter%20Ended%20June%2030%2C%202025%29) This section details Mural Oncology's financial performance for Q2 2025, including cash position, operating expenses, restructuring charges, and net loss [Cash Position](index=1&type=section&id=Cash%20Position) As of June 30, 2025, Mural Oncology reported cash and cash equivalents of $77.1 million | Metric | As of June 30, 2025 | | :----- | :------------------ | | Cash and cash equivalents | $77.1 million | [R&D Expenses](index=1&type=section&id=R%26D%20Expenses) Research and development expenses decreased by 15.3% year-over-year to $23.3 million for the second quarter of 2025, primarily due to reduced employee-related expenses following a workforce reduction and the termination of nemvaleukin development | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :----- | :-------------------- | :-------------------- | :----------- | | R&D Expenses | $23.3 | $27.5 | -$4.2 (-15.3%) | - The decrease was primarily due to decreased employee-related expenses and reduced spend on the ARTISTRY-7 clinical trial of nemvaleukin[5](index=5&type=chunk) [G&A Expenses](index=1&type=section&id=G%26A%20Expenses) General and administrative expenses increased by 20.9% year-over-year to $8.1 million for the second quarter of 2025, mainly driven by increased employee termination and retention benefits and higher legal expenses | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :----- | :-------------------- | :-------------------- | :----------- | | G&A Expenses | $8.1 | $6.7 | +$1.4 (+20.9%) | - The increase was primarily due to increased employee-related expenses associated with termination and retention benefits and increased legal expenses[6](index=6&type=chunk) [Restructuring and Impairment Expenses](index=1&type=section&id=Restructuring%20and%20Impairment%20Expenses) Mural incurred $17.5 million in restructuring and impairment charges during the second quarter of 2025, which included severance, lab equipment impairment, and contract termination costs related to the discontinuation of R&D programs | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | | :----- | :-------------------- | :-------------------- | | Restructuring and Impairment Charges | $17.5 | — | - Charges consisted of severance and termination benefits, an impairment charge related to lab equipment, and contract termination/write-offs for R&D programs[7](index=7&type=chunk) [Net Loss](index=1&type=section&id=Net%20Loss) The net loss for the second quarter of 2025 increased to $48.0 million, up from $31.6 million in the same period of 2024, primarily driven by the $17.5 million in restructuring and impairment charges | Metric | Q2 2025 (in millions) | Q2 2024 (in millions) | Change (YoY) | | :----- | :-------------------- | :-------------------- | :----------- | | Net Loss | -$48.0 | -$31.6 | -$16.4 | | Net Loss per Share (basic & diluted) | -$2.78 | -$1.86 | -$0.92 | - The increase in net loss was primarily driven by the restructuring and impairment charges incurred during Q2 2025[8](index=8&type=chunk) [Cash Guidance](index=1&type=section&id=Cash%20Guidance) Mural reiterates its estimate that cash and cash equivalents will be approximately $43.0 million to $48.0 million as of December 31, 2025, assuming no strategic transaction is completed by that date - Estimated cash and cash equivalents: **$43.0 million - $48.0 million** as of December 31, 2025, if no strategic transaction is consummated[8](index=8&type=chunk) [Regulatory & Legal Disclosures](index=1&type=section&id=Regulatory%20%26%20Legal%20Disclosures) This section provides an overview of Mural Oncology, its regulatory obligations under Irish Takeover Rules, and important legal disclaimers regarding financial projections and forward-looking statements [About Mural Oncology](index=1&type=section&id=About%20Mural%20Oncology) Mural Oncology is a biotechnology company that leverages its protein engineering platform to develop cytokine-based immunotherapies for cancer treatment, aiming to deliver significant clinical benefits to patients - Mural Oncology is a biotechnology company focused on developing cytokine-based immunotherapies for cancer[9](index=9&type=chunk) - The company utilizes its protein engineering platform to achieve its therapeutic goals[9](index=9&type=chunk) [Irish Takeover Rules Considerations](index=2&type=section&id=Irish%20Takeover%20Rules%20Considerations) Mural Oncology is subject to the Irish Takeover Panel Act, 1997, and the Irish Takeover Rules 2022, and is currently considered to be in an 'offer period' following its announcement on April 15, 2025 - Mural is subject to the Irish Takeover Panel Act, 1997, and Irish Takeover Rules 2022[10](index=10&type=chunk) - The company is currently in an 'offer period' as defined by the Irish Takeover Rules[10](index=10&type=chunk) [Responsibility Statement](index=2&type=section&id=Responsibility%20Statement) The Directors of Mural Oncology accept full responsibility for the information provided in this announcement, affirming its accuracy and completeness to the best of their knowledge and belief - The Directors of Mural accept responsibility for the information contained in this announcement[11](index=11&type=chunk) - They confirm the information is in accordance with facts and does not omit anything likely to affect its import[11](index=11&type=chunk) [No Profit Forecast or Asset Valuation](index=2&type=section&id=No%20Profit%20Forecast%20or%20Asset%20Valuation) This announcement explicitly states that no statement within it is intended to constitute a profit forecast, profit estimate, or asset valuation, nor should it be interpreted as such under the Irish Takeover Rules - No statement in this announcement is intended to constitute a profit forecast or profit estimate[12](index=12&type=chunk) - No statement constitutes an asset valuation or a quantified financial benefits statement within the meaning of the Irish Takeover Rules[12](index=12&type=chunk) [Disclosure Requirements of the Irish Takeover Rules](index=2&type=section&id=Disclosure%20Requirements%20of%20the%20Irish%20Takeover%20Rules) Under Rule 8.3(b) of the Irish Takeover Rules, any person with a direct or indirect interest of 1% or more in Mural's relevant securities must disclose all dealings by 3:30 pm (US Eastern Time) on the business day following the dealing - Any person interested in **1% or more** of Mural's 'relevant securities' must disclose all 'dealings' during the 'offer period'[13](index=13&type=chunk) - Disclosure must be made by no later than **3:30 pm (US Eastern Time)** on the business day following the dealing[13](index=13&type=chunk) [Publication on Website](index=2&type=section&id=Publication%20on%20Website) In accordance with Rule 26.1 of the Irish Takeover Rules, a copy of this announcement will be made available on Mural's website by 12 noon (US Eastern Time) on the business day following its publication - A copy of this announcement will be available on Mural's website[18](index=18&type=chunk) - Availability is by no later than **12 noon (US Eastern Time)** on the business day following publication[18](index=18&type=chunk) [No Offer or Solicitation](index=2&type=section&id=No%20Offer%20or%20Solicitation) This announcement is not intended to constitute an offer, invitation, or solicitation to purchase or dispose of any securities, and the distribution of this announcement in jurisdictions outside Ireland or the United States may be legally restricted - This announcement does not constitute an offer, invitation, or solicitation to purchase, acquire, subscribe for, sell, or dispose of any securities[19](index=19&type=chunk) - The distribution of this announcement in jurisdictions outside Ireland or the United States may be restricted by law[20](index=20&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) The press release contains forward-looking statements regarding strategic alternatives, cost reduction plans, and future cash estimates, which are subject to various risks and uncertainties - Statements in the press release are 'forward-looking statements' subject to risks and uncertainties[21](index=21&type=chunk) - Risks include the company's ability to successfully pursue strategic alternative transactions, timing and costs of exploring/consummating transactions, and costs of discontinuing remaining operations[21](index=21&type=chunk)[22](index=22&type=chunk) - The company undertakes no obligation to update such forward-looking statements, except as required by law[22](index=22&type=chunk) [Financial Statements](index=3&type=section&id=Financial%20Statements) This section presents Mural Oncology's consolidated balance sheet and statements of operations, detailing asset, liability, equity, and income statement changes [Consolidated Balance Sheet Data](index=3&type=section&id=Consolidated%20Balance%20Sheet%20Data) Mural Oncology's total assets significantly decreased from $169.4 million at December 31, 2024, to $87.6 million at June 30, 2025, primarily driven by a substantial reduction in cash, cash equivalents, and marketable securities | (in thousands) | June 30, 2025 | December 31, 2024 | Change | | :-------------------------------- | :------------ | :---------------- | :------- | | **ASSETS** | | | | | Cash, cash equivalents, and marketable securities | $77,094 | $144,385 | -$67,291 | | Prepaid expenses and other assets | $2,493 | $8,542 | -$6,049 | | Property and equipment, net | $1,638 | $7,715 | -$6,077 | | Right-of-use assets | $4,361 | $6,783 | -$2,422 | | Restricted cash | $1,969 | $1,969 | $0 | | **TOTAL ASSETS** | **$87,555** | **$169,394** | **-$81,839** | | **LIABILITIES AND EQUITY** | | | | | Accounts payable and accrued expenses | $23,366 | $20,590 | +$2,776 | | Operating lease liabilities | $5,173 | $8,022 | -$2,849 | | Other liabilities | $233 | $280 | -$47 | | Total equity | $58,783 | $140,502 | -$81,719 | | **TOTAL LIABILITIES AND EQUITY** | **$87,555** | **$169,394** | **-$81,839** | [Consolidated Statements of Operations](index=3&type=section&id=Consolidated%20Statements%20of%20Operations) For the three months ended June 30, 2025, Mural Oncology reported a net loss of $48.0 million, an increase from $31.6 million in the prior year, primarily due to $17.5 million in restructuring and impairment charges | (in thousands except share and per share amounts) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (YoY) | | :------------------------------------------------ | :------------------------------- | :------------------------------- | :----------- | | Research and development | $23,277 | $27,544 | -$4,267 | | General and administrative | $8,709 | $6,733 | +$1,976 | | Restructuring and impairment | $17,486 | — | +$17,486 | | **Total operating expenses** | **$48,842** | **$34,277** | **+$14,565** | | Operating loss | $(48,842) | $(34,277) | -$14,565 | | Other income | $860 | $2,713 | -$1,853 | | **Net loss** | **$(47,982)** | **$(31,564)** | **-$16,418** | | Net loss per ordinary share - basic and diluted | $(2.78) | $(1.86) | -$0.92 | | Weighted average ordinary shares outstanding - basic and diluted | 17,271,518 | 16,924,842 | +346,676 |
Mural Oncology Announces Second Quarter Financial Results and Provides Business Update
GlobeNewswire News Room· 2025-08-04 12:00
Core Insights - Mural Oncology is exploring strategic alternatives to maximize shareholder value after discontinuing clinical development of its lead product candidate, nemvaleukin alfa [1][2] - The company has implemented significant cost-saving measures, including a workforce reduction of approximately 90% and the termination of its research and development activities [2] - As of June 30, 2025, Mural had approximately $77.1 million in cash and cash equivalents, with an estimated cash position of $43 to $48 million by December 31, 2025, if no transaction occurs [2][8] Financial Results - For the second quarter of 2025, Mural reported research and development expenses of $23.3 million, down from $27.5 million in the same quarter of 2024, primarily due to reduced employee-related expenses and decreased spending on the ARTISTRY-7 clinical trial [5] - General and administrative expenses increased to $8.1 million in Q2 2025 from $6.7 million in Q2 2024, driven by higher employee-related expenses and legal costs [6] - The company incurred $17.5 million in restructuring and impairment charges during Q2 2025, related to severance, impairment of lab equipment, and contract terminations [7] - Mural's net loss for the second quarter of 2025 was $48.0 million, compared to a net loss of $31.6 million in Q2 2024, largely due to restructuring and impairment charges [8] Cash Guidance - Mural estimates its cash and cash equivalents will be approximately $43 million to $48 million as of December 31, 2025, if no strategic transaction is completed by that date [2][8]
Mural Oncology Announces Number of Relevant Securities in Issue
Globenewswire· 2025-05-19 19:57
Company Overview - Mural Oncology plc is a clinical-stage immuno-oncology company focused on developing cytokine-based immunotherapies for cancer treatment [4] - The company is headquartered in Dublin, Ireland, with primary facilities located in Waltham, Massachusetts [4] Share Capital and Securities - As of May 1, 2025, Mural's issued share capital consisted of 17,268,881 ordinary shares with a par value of US$0.01 each [1] - As of March 31, 2025, there were 1,121,460 non-vested restricted stock units and 3,725,736 options to purchase ordinary shares outstanding [2] Regulatory Compliance - The announcement is made in accordance with Rule 2.12 of the Irish Takeover Rules [1][4] - Under Rule 8.3(a), any person interested in 1% or more of Mural's relevant securities must make an opening position disclosure by the specified deadline [6] - Rule 8.3(b) requires disclosure of all dealings in relevant securities during the offer period for those interested in 1% or more [7]
Mural Oncology plc(MURA) - 2025 Q1 - Quarterly Report
2025-05-14 20:05
[Cautionary Statement Regarding Forward-Looking Statements](index=3&type=section&id=CAUTIONARY%20STATEMENT%20REGARDING%20FORWARD-LOOKING%20STATEMENTS) 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 materially**[7](index=7&type=chunk)[8](index=8&type=chunk) - Key areas of forward-looking statements include the outcome of strategic alternatives, product candidate development, funding, financial performance, and regulatory developments[8](index=8&type=chunk) [Summary of the Material Risks Associated with Our Business](index=4&type=section&id=SUMMARY%20OF%20THE%20MATERIAL%20RISKS%20ASSOCIATED%20WITH%20OUR%20BUSINESS) 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 capital[11](index=11&type=chunk) - Uncertainty surrounds the identification and implementation of strategic transactions, with potential negative consequences or even the possibility of dissolution and liquidation[12](index=12&type=chunk) - 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 sales[12](index=12&type=chunk) - Additional funding is required to advance product candidates, which may not be available on acceptable terms, potentially leading to delays or scaling back of programs[12](index=12&type=chunk) - Biopharmaceutical product development is lengthy, expensive, and uncertain, with risks of clinical trial failures, side effects, manufacturing problems, and substantial competition[12](index=12&type=chunk)[13](index=13&type=chunk) [Part I. Financial Information](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=6&type=section&id=Item%201.%20Financial%20Statements%20(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](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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)](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Equity%20(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](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=10&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) 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](index=10&type=section&id=Note%201.%20Organization%20and%20Description%20of%20Business) 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-6[27](index=27&type=chunk)[28](index=28&type=chunk)[44](index=44&type=chunk) - The company is immediately **exploring strategic alternatives** to maximize shareholder value, including potential acquisition, merger, or other business combination[28](index=28&type=chunk)[45](index=45&type=chunk) - 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 costs[44](index=44&type=chunk)[101](index=101&type=chunk) - 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 Alkermes[31](index=31&type=chunk)[40](index=40&type=chunk)[41](index=41&type=chunk) - 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 consumption[47](index=47&type=chunk)[123](index=123&type=chunk) [Note 2. Basis of Presentation and Summary of Significant Accounting Policies](index=14&type=section&id=Note%202.%20Basis%20of%20Presentation%20and%20Summary%20of%20Significant%20Accounting%20Policies) 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 adjustments[49](index=49&type=chunk)[50](index=50&type=chunk) - The company evaluates estimates and judgments related to corporate expenses, R&D accruals, asset impairment, share-based compensation, leases, and income taxes, including valuation allowances[52](index=52&type=chunk) - 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 statements[56](index=56&type=chunk)[57](index=57&type=chunk) [Note 3. Cash, Cash Equivalents and Marketable Securities](index=16&type=section&id=Note%203.%20Cash,%20Cash%20Equivalents%20and%20Marketable%20Securities) 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 periods[59](index=59&type=chunk) [Note 4. Fair Value](index=17&type=section&id=Note%204.%20Fair%20Value) 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](index=17&type=section&id=Note%205.%20Property%20and%20Equipment,%20Net) 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 2024[66](index=66&type=chunk) [Note 6. Accrued Expenses](index=18&type=section&id=Note%206.%20Accrued%20Expenses) 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](index=18&type=section&id=Note%207.%20Leases) 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 2026[68](index=68&type=chunk) - 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 parties[70](index=70&type=chunk)[71](index=71&type=chunk) 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](index=19&type=section&id=Note%208.%20Equity) 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, 2025[74](index=74&type=chunk) - The 2023 Stock Option and Incentive Plan reserves **5,854,768** ordinary shares, with **724,795** shares available for issuance as of March 31, 2025[75](index=75&type=chunk)[76](index=76&type=chunk) 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](index=22&type=section&id=Note%209.%20Income%20Taxes) 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 amortization[87](index=87&type=chunk) - 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 losses[88](index=88&type=chunk) [Note 10. Commitments and Contingencies](index=22&type=section&id=Note%2010.%20Commitments%20and%20Contingencies) 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 flows[89](index=89&type=chunk) - Open purchase commitments for noncancellable contract manufacturing costs totaled approximately **$8.3 million** as of March 31, 2025[90](index=90&type=chunk) [Note 11. Net Loss per Share](index=22&type=section&id=Note%2011.%20Net%20Loss%20per%20Share) 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 presented[92](index=92&type=chunk) 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](index=23&type=section&id=Note%2012.%20Related%20Parties) 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, 2023[95](index=95&type=chunk) - 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 agreements[94](index=94&type=chunk) [Note 13. Segment Information](index=23&type=section&id=Note%2013.%20Segment%20information) 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 immunotherapies[96](index=96&type=chunk) 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](index=25&type=section&id=Note%2014.%20Subsequent%20Events) 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 nemvaleukin**[101](index=101&type=chunk) - A workforce reduction of approximately **90%** (**104 positions**) was approved, expected to be completed by the end of Q2 2025[101](index=101&type=chunk) - 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 equipment[101](index=101&type=chunk) - The company immediately commenced exploration of strategic alternatives to maximize shareholder value, engaging Lucid Capital Markets, LLC as financial advisor[102](index=102&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=26&type=section&id=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 candidate[105](index=105&type=chunk) - 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 cancer[106](index=106&type=chunk) - On April 15, 2025, the company discontinued all clinical development of nemvaleukin and initiated an **exploration of strategic alternatives** to maximize shareholder value[106](index=106&type=chunk) [The Separation](index=26&type=section&id=The%20Separation) 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 Market[115](index=115&type=chunk) - In connection with the Separation, Mural Oncology received a cash contribution of **$275.0 million** from Alkermes on November 14, 2023[114](index=114&type=chunk) - 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 Alkermes[107](index=107&type=chunk)[108](index=108&type=chunk) [Going Concern](index=28&type=section&id=Going%20Concern) 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 continue[119](index=119&type=chunk) - 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 obligations[119](index=119&type=chunk) - 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 alternatives[123](index=123&type=chunk) - The exploration of strategic alternatives, including acquisition or merger, has no set timetable and no assurance of completion or favorable terms[121](index=121&type=chunk) [Components of Results of Operations](index=30&type=section&id=Components%20of%20Results%20of%20Operations) 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 future[126](index=126&type=chunk) - R&D expenses include external costs (CROs, consulting, drug materials, manufacturing) and internal costs (employee-related, occupancy, depreciation)[127](index=127&type=chunk) - G&A expenses primarily consist of salaries, share-based compensation, facility costs, and professional fees[129](index=129&type=chunk) - Other income is mainly derived from interest on cash accounts, money market mutual funds, and marketable securities[130](index=130&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) 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](index=31&type=section&id=Research%20and%20Development%20Expenses) 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 expenses[131](index=131&type=chunk) [General and Administrative Expenses](index=33&type=section&id=General%20and%20Administrative%20Expenses) 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 expenses[132](index=132&type=chunk) [Other Income](index=33&type=section&id=Other%20Income) 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 securities[133](index=133&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=33&type=section&id=Funding%20Requirements) 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 funding[135](index=135&type=chunk) - 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 months[135](index=135&type=chunk) - 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 repurchases[142](index=142&type=chunk) [At-the-Market Offering](index=35&type=section&id=At-the-Market%20Offering) 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 LLC[144](index=144&type=chunk) - No shares have been issued or sold under the ATM Offering through March 31, 2025[144](index=144&type=chunk) [Cash Flows](index=35&type=section&id=Cash%20Flows) 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 expenses[146](index=146&type=chunk)[147](index=147&type=chunk) - Net cash provided by investing activities for Q1 2025 was **$28.0 million**, mainly from sales and maturities of marketable securities[149](index=149&type=chunk) [Contractual Obligations and Commitments](index=37&type=section&id=Contractual%20Obligations%20and%20Commitments) 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 2026[150](index=150&type=chunk) - Sub-lease agreements with third parties generate annualized fixed base rent of **$0.5 million** and **$0.7 million**, respectively[152](index=152&type=chunk)[153](index=153&type=chunk) - As of March 31, 2025, the remaining contractual operating lease liability was **$6.8 million**[154](index=154&type=chunk) - The company has open purchase commitments for noncancellable contract manufacturing costs totaling approximately **$8.3 million**[90](index=90&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=39&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) 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-K[157](index=157&type=chunk) [Recently Issued and Adopted Accounting Pronouncements](index=39&type=section&id=Recently%20Issued%20and%20Adopted%20Accounting%20Pronouncements) 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 pronouncements[158](index=158&type=chunk) [Transition From the Former Parent and Costs to Operate as an Independent Company](index=39&type=section&id=Transition%20From%20the%20Former%20Parent%20and%20Costs%20to%20Operate%20as%20an%20Independent%20Company) 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 Separation[159](index=159&type=chunk) - Non-recurring expenses have been incurred to establish and expand the company's standalone infrastructure, replicating or outsourcing corporate and shared services[159](index=159&type=chunk) [Emerging Growth Company and Smaller Reporting Company Status](index=39&type=section&id=Emerging%20Growth%20Company%20and%20Smaller%20Reporting%20Company%20Status) 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 requirements[161](index=161&type=chunk)[163](index=163&type=chunk) - 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 companies[161](index=161&type=chunk) - 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 price[163](index=163&type=chunk)[164](index=164&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=41&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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 risk[165](index=165&type=chunk) [Item 4. Controls and Procedures](index=41&type=section&id=Item%204.%20Controls%20and%20Procedures) 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 reporting[166](index=166&type=chunk) - 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, 2025[167](index=167&type=chunk) [Part II. Other Information](index=42&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=42&type=section&id=Item%201.%20Legal%20Proceedings) This section states that the company is not currently involved in any material legal proceedings - The company is not involved in any material legal proceedings[170](index=170&type=chunk) [Item 1A. Risk Factors](index=42&type=section&id=Item%201A.%20Risk%20Factors) 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](index=42&type=section&id=Risks%20Related%20to%20Our%20Evaluation%20of%20Strategic%20Alternatives%20and%20Potential%20Wind%20Down) 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 all[172](index=172&type=chunk) - The evaluation process is costly, time-consuming, and complex, with significant expenses incurred regardless of transaction completion, which will decrease available cash[173](index=173&type=chunk) - 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 obligations[181](index=181&type=chunk) - 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 morale[185](index=185&type=chunk) [Risks Related to Our Financial Position and Capital Needs](index=46&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Needs) 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 challenging[188](index=188&type=chunk) - 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 losses[194](index=194&type=chunk)[196](index=196&type=chunk) - 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 obligations[190](index=190&type=chunk)[197](index=197&type=chunk) - 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 parties[190](index=190&type=chunk)[191](index=191&type=chunk)[197](index=197&type=chunk) - 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 partners[198](index=198&type=chunk)[200](index=200&type=chunk)[201](index=201&type=chunk) [Risks Related to Discovery, Product Development and Regulatory Approval of Our Product Candidates](index=51&type=section&id=Risks%20Related%20to%20Discovery,%20Product%20Development%20and%20Regulatory%20Approval%20of%20Our%20Product%20Candidates) 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 endpoints[202](index=202&type=chunk) - Delays or difficulties in patient enrollment, unforeseen events during trials, or regulatory disagreements on trial design could significantly delay or prevent product development and approval[206](index=206&type=chunk)[207](index=207&type=chunk)[216](index=216&type=chunk) - 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 consequences[233](index=233&type=chunk)[235](index=235&type=chunk) - 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 commercialization[248](index=248&type=chunk)[250](index=250&type=chunk)[251](index=251&type=chunk) - 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 requirements[241](index=241&type=chunk)[242](index=242&type=chunk)[246](index=246&type=chunk) - 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 delays[272](index=272&type=chunk)[273](index=273&type=chunk)[274](index=274&type=chunk) - Ongoing regulatory obligations post-approval, including cGMP compliance and post-marketing studies, could result in significant additional expenses and penalties for non-compliance[275](index=275&type=chunk)[277](index=277&type=chunk)[279](index=279&type=chunk) - Improper promotion of off-label uses could lead to significant liability, civil/criminal penalties, and reputational harm[282](index=282&type=chunk)[284](index=284&type=chunk) - 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 delays[285](index=285&type=chunk)[286](index=286&type=chunk) [Risks Related to the Commercialization of Our Product Candidates](index=80&type=section&id=Risks%20Related%20to%20the%20Commercialization%20of%20Our%20Product%20Candidates) 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 generation[304](index=304&type=chunk)[305](index=305&type=chunk) - The company has no history of commercializing products and lacks established sales, marketing, or distribution capabilities, requiring substantial investment and competing with larger companies[306](index=306&type=chunk) - 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 challenges[311](index=311&type=chunk)[312](index=312&type=chunk) - 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 business[316](index=316&type=chunk)[324](index=324&type=chunk)[325](index=325&type=chunk) - The company faces substantial competition from major pharmaceutical, specialty pharmaceutical, and biotechnology companies, with risks of competitors developing safer, more effective, or less expensive products[330](index=330&type=chunk)[332](index=332&type=chunk) - Product candidates regulated as biologics may face biosimilar competition, potentially shortening exclusivity periods and impacting market share[335](index=335&type=chunk)[337](index=337&type=chunk) [Risks Related to Our Reliance on Third Parties](index=90&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) 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 compliance[338](index=338&type=chunk)[339](index=339&type=chunk) - Failure of third parties to comply with GCP requirements or meet deadlines could render clinical data unreliable, delay regulatory approval, or require repeating trials[339](index=339&type=chunk)[341](index=341&type=chunk) - Reliance on single-source manufacturers for certain processes exposes the company to risks of production issues, supply interruptions, price increases, and manufacturing delays[255](index=255&type=chunk) - Developing product candidates in combination with third-party drugs presents risks related to access, supply, safety, regulatory status, and potential adverse events from combination therapy[346](index=346&type=chunk)[347](index=347&type=chunk) - 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 revenue[350](index=350&type=chunk)[351](index=351&type=chunk) [Risks Related to Our Intellectual Property](index=96&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) 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 sufficient[355](index=355&type=chunk)[356](index=356&type=chunk) - 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 products[357](index=357&type=chunk)[358](index=358&type=chunk) - 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 impact[359](index=359&type=chunk)[363](index=363&type=chunk) - 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 technologies[364](index=364&type=chunk)[365](index=365&type=chunk) - Claims that product candidates infringe third-party patent rights could result in costly litigation, requiring licenses on unfavorable terms or preventing commercialization[366](index=366&type=chunk)[368](index=368&type=chunk) - Failure to protect the confidentiality of trade secrets, technical know-how, and proprietary information could harm the business and competitive position[370](index=370&type=chunk)[372](index=372&type=chunk) [Risks Related to Our Business and Industry](index=102&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) 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 fluctuations[382](index=382&type=chunk)[383](index=383&type=chunk) - Loss of key management, scientific, or medical personnel could impair business strategy and competitiveness[386](index=386&type=chunk) - Relationships with healthcare providers and payors are subject to anti-kickback, fraud, and abuse laws, potentially leading to criminal sanctions, civil penalties, and reputational harm[387](index=387&type=chunk)[390](index=390&type=chunk) - Changes in U.S. and international trade policies, particularly with China, could adversely impact business, supply chains, and costs[392](index=392&type=chunk)[393](index=393&type=chunk)[395](index=395&type=chunk) - Misconduct by employees, contractors, or partners, including non-compliance with regulatory standards, could result in sanctions and reputational damage[396](index=396&type=chunk)[397](index=397&type=chunk) - The company is exposed to product liability risks from clinical trials and commercial sales, with potential for substantial liabilities not fully covered by insurance[398](index=398&type=chunk)[399](index=399&type=chunk)[400](index=400&type=chunk) - Operations are vulnerable to catastrophic events (e.g., terrorist attacks, wars, pandemics, natural disasters) which could disrupt R&D, manufacturing, and commercialization[404](index=404&type=chunk) - 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 damage[406](index=406&type=chunk)[410](index=410&type=chunk)[414](index=414&type=chunk) - Computer systems are vulnerable to security breaches or failures, potentially causing operational interruptions, data loss, regulatory fines, and reputational harm[417](index=417&type=chunk)[418](index=418&type=chunk) [Risks Related to the Separation and Distribution](index=114&type=section&id=Risks%20Related%20to%20the%20Separation%20and%20Distribution) 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 realized[419](index=419&type=chunk)[420](index=420&type=chunk) - 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 parties[422](index=422&type=chunk) - 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 obligations[423](index=423&type=chunk)[424](index=424&type=chunk) - 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 payments[425](index=425&type=chunk)[429](index=429&type=chunk) [Risks Related to Tax Matters](index=117&type=section&id=Risks%20Related%20to%20Tax%20Matters) 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 liabilities[427](index=427&type=chunk)[428](index=428&type=chunk) - 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 amount[429](index=429&type=chunk) - 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 transactions[430](index=430&type=chunk)[431](index=431&type=chunk) - 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. holders[432](index=432&type=chunk)[433](index=433&type=chunk) [Risks Related to Ownership of Our Ordinary Shares](index=119&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Ordinary%20Shares) 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 investors[436](index=436&type=chunk)[437](index=437&type=chunk)[439](index=439&type=chunk) - The price of ordinary shares is subject to high volatility due to factors like clinical trial results, regulatory decisions, competition, and general market conditions[440](index=440&type=chunk)[442](index=442&type=chunk) - 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 fall[445](index=445&type=chunk)[447](index=447&type=chunk) - The company does not intend to pay dividends on its ordinary shares for the foreseeable future, limiting shareholder returns to share appreciation[449](index=449&type=chunk) - 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 price[450](index=450&type=chunk)[453](index=453&type=chunk) - An active trading market for ordinary shares may not develop or be sustained, making it difficult for shareholders to resell shares at an attractive price[455](index=455&type=chunk) [Risks Related to Our Jurisdiction of Incorporation in Ireland](index=127&type=section&id=Risks%20Related%20to%20Our%20Jurisdiction%20of%20Incorporation%20in%20Ireland) 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 duties[460](index=460&type=chunk)[461](index=461&type=chunk) - 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 period[464](index=464&type=chunk) - Transfers of ordinary shares held directly (not through DTC) may be subject to Irish stamp duty (currently **1%**)[465](index=465&type=chunk) - Irish law imposes restrictions on capital management, such as requiring shareholder authorization for new share issuances and pre-emptive rights, which could interfere with financing[467](index=467&type=chunk)[469](index=469&type=chunk) - There is no guarantee that the company will seek or be able to create the distributable reserves needed to pay dividends under Irish law[468](index=468&type=chunk) [General Risk Factors](index=131&type=section&id=General%20Risk%20Factors) 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 results[474](index=474&type=chunk) - Changes in U.S. federal, state, local, or non-U.S. tax laws could adversely affect the company or its shareholders, potentially increasing tax liability[475](index=475&type=chunk)[476](index=476&type=chunk) - 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 shares[477](index=477&type=chunk) [Item 5. Other Information](index=131&type=section&id=Item%205.%20Other%20Information) 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, 2025[481](index=481&type=chunk) [Item 6. Exhibits](index=134&type=section&id=Item%206.%20Exhibits) 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](index=135&type=section&id=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, 2025[488](index=488&type=chunk)
FORM 8.1(a) & (b) - Mural Oncology plc
Globenewswire· 2025-04-30 19:07
Key Information - The disclosure is made by Mural Oncology plc, which is the offeree in relation to its relevant securities [2][5] - The position held date is April 29, 2025, which is the latest practicable date prior to the disclosure [2] - There are no interests or short positions disclosed for Mural Oncology plc [5] Interests and Short Positions - The table indicates that there are no relevant securities owned or controlled, cash-settled derivatives, or stock-settled derivatives by the discloser [5] - Total interests and short positions are reported as NIL [5] Interests of Directors - Caroline Loew holds 43,622 ordinary shares, representing 0.25% of the total issued share capital, with a total of 865,908 underlying stock options and other rights [7] - Other directors have varying numbers of underlying shares, with a total of 967,026 ordinary shares accounted for among them [7] Other Information - There are no indemnity or option arrangements or agreements related to relevant securities that may influence dealings [8] - No supplemental forms are attached to this disclosure [11]
MURA Soars as it Explores Strategic Options Post Cancer Study Failures
ZACKS· 2025-04-16 14:50
Core Viewpoint - Mural Oncology (MURA) announced the discontinuation of all clinical development of nemvaleukin alfa, leading to a 134% surge in its stock price as investors anticipate potential strategic alternatives to maximize shareholder value [1][3]. Company Decisions - The company will explore various strategic options, including a potential sale, merger, or other transactions, with no set timeline for this process [2]. - Mural Oncology will reduce its workforce by 90% as part of its restructuring efforts [1]. Financial Performance - As of December 31, 2024, Mural Oncology reported approximately $144.4 million in cash, cash equivalents, and marketable securities [4]. Pipeline Setbacks - The decision to halt clinical development follows the failure of the phase II ARTISTRY-6 study for melanoma and disappointing results from the phase III ARTISTRY-7 study for platinum-resistant ovarian cancer (PROC) [4][9]. - The ARTISTRY-6 study did not meet its primary goal, and the ARTISTRY-7 study showed no statistically significant improvement in overall survival compared to chemotherapy [7][9]. Market Reaction - Investors reacted positively to the announcement, likely due to hopes of recovering value lost from previous setbacks, as MURA shares have declined 25.2% year-to-date compared to the industry’s 7.1% decline [3].