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SHAREHOLDER INVESTIGATION: Halper Sadeh LLC Investigates ITOS and KLG on Behalf of Shareholders
Prnewswire· 2025-08-20 15:05
Group 1 - Halper Sadeh LLC is investigating iTeos Therapeutics, Inc. for potential violations related to its sale to Concentra Biosciences, LLC, which involves a cash offer of $10.047 per share and contingent value rights [1] - The contingent value rights include the right to receive 100% of iTeos' closing net cash exceeding $475 million and 80% of net proceeds from the sale of certain product candidates within six months post-closing [1] - WK Kellogg Co is being sold to The Ferrero Group for $23.00 per share in cash, prompting legal inquiries regarding shareholder rights [2] Group 2 - Halper Sadeh LLC may seek increased consideration for shareholders and additional disclosures regarding the proposed transactions [3] - Shareholders are encouraged to contact Halper Sadeh LLC to discuss their legal rights and options at no charge [4] - The firm represents investors globally who have experienced securities fraud and corporate misconduct, recovering millions for defrauded investors [4]
ITEOS THERAPEUTICS INVESTOR ALERT BY THE FORMER ATTORNEY GENERAL OF LOUISIANA: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of iTeos Therapeutics, Inc. - ITOS
GlobeNewswire News Room· 2025-08-20 01:05
Core Points - The proposed sale of iTeos Therapeutics, Inc. to Concentra Biosciences, LLC involves shareholders receiving $10.047 in cash per share, along with a non-transferable contingent value right [1] - The contingent value right includes the right to receive 100% of iTeos' closing net cash exceeding $475 million and 80% of net proceeds from the sale of certain product candidates within six months post-closing [1] - Kahn Swick & Foti, LLC is investigating whether the proposed transaction adequately values iTeos and the process leading to this valuation [1] Company and Industry Summary - iTeos Therapeutics, Inc. is currently in a proposed transaction to be acquired by Concentra Biosciences, LLC [1] - The investigation by Kahn Swick & Foti, LLC is focused on the adequacy of the transaction consideration and the valuation of the company [1][2] - The transaction is structured as a tender offer, indicating that timing is critical for stakeholders [3]
iTeos Therapeutics(ITOS) - 2025 Q2 - Quarterly Report
2025-08-06 11:06
[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section details the company's unaudited financial statements, management's analysis, market risks, and internal controls [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited consolidated financial statements, including balance sheets, income statements, equity, cash flows, and detailed notes [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section provides a snapshot of the company's financial position at specific dates, detailing assets, liabilities, and equity Condensed Consolidated Balance Sheets | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :----------------------------- | :------------------------------- | :-------------------- | | Cash and cash equivalents | $207,820 | $142,131 | +$65,689 | | Short-term investments | $307,610 | $352,517 | -$44,907 | | Long-term investments | $74,614 | $160,354 | -$85,740 | | Total assets | $623,083 | $686,976 | -$63,893 | | Accrued clinical trial costs | $36,462 | $17,896 | +$18,566 | | Accrued personnel expenses | $23,774 | $10,132 | +$13,642 | | Total liabilities | $129,282 | $96,682 | +$32,600 | | Accumulated deficit | $(123,123) | $(9,781) | -$113,342 | | Total stockholders' equity | $493,801 | $590,294 | -$96,493 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's financial performance over specific periods, showing revenues, expenses, and net loss Condensed Consolidated Statements of Operations and Comprehensive Loss | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | License and collaboration revenue | $— | $35,000 | $— | $35,000 | | Research and development expenses | $57,275 | $36,709 | $86,314 | $71,238 | | General and administrative expenses | $10,181 | $12,457 | $21,162 | $25,160 | | Restructuring costs | $16,335 | $— | $16,335 | $— | | Total operating expenses | $83,791 | $49,166 | $123,811 | $96,398 | | Loss from operations | $(83,791) | $(14,166) | $(123,811) | $(61,398) | | Net loss | $(78,729) | $(7,128) | $(113,341) | $(45,344) | | Basic net loss per common share | $(1.81) | $(0.18) | $(2.61) | $(1.20) | - The company reported a significant increase in net loss for both the three and six months ended June 30, 2025, primarily due to the absence of license and collaboration revenue (which was **$35.0 million** in 2024) and a substantial increase in research and development expenses, including restructuring costs[16](index=16&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) This section outlines changes in the company's equity over time, reflecting net income/loss and stock transactions Condensed Consolidated Statements of Stockholders' Equity | Metric (in thousands) | December 31, 2024 | June 30, 2025 | | :-------------------- | :---------------- | :------------ | | Total stockholders' equity | $590,294 | $493,801 | | Accumulated deficit | $(9,781) | $(123,123) | - Total stockholders' equity decreased by **$96.5 million** from December 31, 2024, to June 30, 2025, primarily due to a net loss of **$78.7 million** in Q2 2025 and **$113.3 million** for the six months ended June 30, 2025[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section details the cash inflows and outflows from operating, investing, and financing activities over specific periods Condensed Consolidated Statements of Cash Flows | Cash Flow Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(76,210) | $(66,327) | | Net cash provided by (used in) investing activities | $134,646 | $(53,278) | | Net cash provided by financing activities | $4,525 | $122,398 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $65,709 | $(50) | - Net cash used in operating activities increased by **$9.9 million** YoY, while investing activities shifted from using **$53.3 million** cash to providing **$134.6 million** cash, primarily due to investment maturities. Financing activities decreased significantly by **$117.9 million** YoY due to the absence of large common stock and pre-funded warrant issuances[22](index=22&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [Note 1. Nature of Business and Basis of Presentation](index=8&type=section&id=Note%201.%20Nature%20of%20Business%20and%20Basis%20of%20Presentation) The company terminated its belrestotug program and GSK collaboration, plans to wind down operations by Q3 2025, and faces going concern doubts - The company and GSK decided to terminate the belrestotug development program and end their collaboration on May 13, 2025, following interim analysis results from GALAXIES Lung-201 and H&N-202 trials that did not meet established criteria for clinically meaningful improvements[28](index=28&type=chunk)[30](index=30&type=chunk)[31](index=31&type=chunk) - On May 28, 2025, the company announced its intention to wind down clinical and operational activities, expecting substantial completion in the third quarter of 2025, as part of a review of strategic alternatives[34](index=34&type=chunk)[35](index=35&type=chunk) - As of August 6, 2025, there is substantial doubt about the company's ability to continue as a going concern for at least 12 months, given the lack of an operational plan of business continuity if the proposed merger is not consummated[35](index=35&type=chunk)[36](index=36&type=chunk) Net Loss and Accumulated Deficit | Metric | June 30, 2025 (in millions) | June 30, 2024 (in millions) | | :---------------- | :-------------------------- | :-------------------------- | | Net loss (6 months) | $(113.3) | $(45.3) | | Accumulated deficit | $(123.1) | N/A | [Note 2. Summary of significant accounting policies](index=10&type=section&id=Note%202.%20Summary%20of%20significant%20accounting%20policies) The company's accounting policies remain consistent with its 2024 Annual Report, with new pronouncements expected to have disclosure-only impacts - No material changes to significant accounting policies have occurred since the audited consolidated financial statements for the year ended December 31, 2024[42](index=42&type=chunk) - ASU No. 2023-09 (Income Taxes) will be effective for the company in the year ending December 31, 2025, and is expected to have a disclosure-only impact[44](index=44&type=chunk) - ASU No. 2024-03 (Expense Disaggregation) will be effective for the company in the year ending December 31, 2027, and is expected to have a disclosure-only impact[45](index=45&type=chunk) [Note 3. Investment securities and fair value measurements](index=10&type=section&id=Note%203.%20Investment%20securities%20and%20fair%20value%20measurements) The company's fair value investments, primarily money market and government bonds, decreased to **$554.1 million** by June 30, 2025, with most maturing within one year Investment Securities Fair Value | Investment Type (in thousands) | June 30, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :----------------------------- | :------------------------- | :----------------------------- | | Money market funds | $171,909 | $116,694 | | U.S. government agency bonds | $52,940 | $47,994 | | U.S. treasury bonds | $309,425 | $375,138 | | Corporate debt securities | $19,859 | $89,739 | | **Totals** | **$554,133** | **$629,565** | Investment Maturity Grouping | Maturity Grouping (in thousands) | June 30, 2025 (Fair Value) | December 31, 2024 (Fair Value) | | :------------------------------- | :------------------------- | :----------------------------- | | Due in one year or less | $307,610 | $352,517 | | Due after one year through five years | $74,614 | $160,354 | | Total | $382,224 | $512,871 | Interest Income and Accretion | Interest Income (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------- | :----------------------------- | :----------------------------- | | Interest income | $8,900 | $9,600 | | Accretion on available-for-sale debt securities | $4,400 | $5,600 | [Note 4. Supplemental balance sheet information](index=12&type=section&id=Note%204.%20Supplemental%20balance%20sheet%20information) Property and equipment, net, increased slightly to **$5.175 million** as of June 30, 2025, with no impairment recorded Property & Equipment, Net | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Property & equipment, net | $5,175 | $4,895 | - Depreciation and amortization expense was **$0.6 million** for both the six months ended June 30, 2025, and 2024[51](index=51&type=chunk) - No impairment of property and equipment has been recorded as of June 30, 2025[51](index=51&type=chunk) [Note 5. License and collaboration agreements](index=12&type=section&id=Note%205.%20License%20and%20collaboration%20agreements) The GSK Collaboration Agreement for belrestotug was terminated, requiring a **$32.0 million** settlement from iTeos Belgium, while the Adimab Agreement will survive the merger - GSK provided written notice on May 13, 2025, to terminate the GSK Collaboration Agreement for convenience, effective six months from the notice date, following unfavorable topline interim results from GALAXIES Lung-201 and H&N-202 trials[28](index=28&type=chunk)[30](index=30&type=chunk)[62](index=62&type=chunk) - On July 18, 2025, iTeos Belgium and GSK entered into a Mutual Termination Agreement, requiring iTeos Belgium to pay a **$32.0 million** settlement to GSK to close out remaining clinical activity costs[62](index=62&type=chunk)[63](index=63&type=chunk) R&D Expense Related to GSK Cost-Sharing | Metric (in thousands) | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :-------------------- | :------------------------------- | :----------------------------- | | R&D expense related to GSK cost-sharing | $35,200 | $43,200 | - The company did not recognize any revenue from the GSK Collaboration Agreement during the three or six months ended June 30, 2025, compared to **$35.0 million** recognized in the prior year periods[67](index=67&type=chunk) - The Adimab Agreement, under which the company paid **$1.0 million** in the three and six months ended June 30, 2025, will survive the Merger[56](index=56&type=chunk)[58](index=58&type=chunk) [Note 6. Government grant funding and potential repayment commitments under recoverable cash advance grants (RCAs)](index=14&type=section&id=Note%206.%20Government%20grant%20funding%20and%20potential%20repayment%20commitments%20under%20recoverable%20cash%20advance%20grants%20(RCAs)) The Walloon Region cancelled RCA arrangements in July 2025, absolving the company from most repayable grants, except for **$0.2 million** reimbursement and **$1.5 million** advance payment Grant Funding and Repayable Grants | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :----------------------------- | :----------------------------- | | Cash received (Other Grants) | $900 | $777 | | Grant income | $591 | $1,472 | | Grants repayable at period end | $7,033 | $6,238 | - In July 2025, the Walloon Region cancelled the RCA arrangements, relieving the company from repaying the substantial majority of the grants repayable balance[81](index=81&type=chunk)[139](index=139&type=chunk) - The company will still be required to pay **$0.2 million** relating to the current liability portion of grants repayable and reimburse **$1.5 million** in advance payments received from the Walloon Region[81](index=81&type=chunk)[139](index=139&type=chunk) [Note 7. Stockholders' equity](index=16&type=section&id=Note%207.%20Stockholders'%20equity) The company's common stock outstanding is **44,167,466** shares as of June 30, 2025, with RA Capital fully exercising its pre-funded warrants for **6,613,442** shares Common Stock Outstanding | Metric | June 30, 2025 | | :-------------------- | :------------ | | Common stock outstanding | 44,167,466 | - In the six months ended June 30, 2025, RA Capital exercised its pre-funded warrants in full for **6,613,442** shares through cashless exercises[87](index=87&type=chunk)[119](index=119&type=chunk) - In May 2024, the company received **$120.0 million** in total proceeds from the sale of a pre-funded warrant to RA Capital and common stock to Boxer Capital[83](index=83&type=chunk) [Note 8. Stock-based compensation](index=16&type=section&id=Note%208.%20Stock-based%20compensation) Total stock-based compensation expense decreased to **$5.88 million** for Q2 2025 and **$12.52 million** for 6M 2025, with accelerated vesting expected for certain employees prior to the Merger Stock-Based Compensation Expense | Expense Category (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Research and development | $2,316 | $2,478 | $4,837 | $4,280 | | General and administrative | $3,564 | $5,584 | $7,679 | $11,045 | | **Total stock-based compensation expense** | **$5,880** | **$8,062** | **$12,516** | **$15,325** | - As of June 30, 2025, there was **$34.7 million** of unrecognized compensation costs related to non-vested stock option awards, expected to be recognized over a weighted average period of **2.4 years**[98](index=98&type=chunk) - As of June 30, 2025, there was **$7.1 million** of unrecognized stock-based compensation expense related to restricted stock units, expected to vest over a weighted-average period of **2.8 years**[100](index=100&type=chunk) - The vesting of certain stock options and restricted stock units will accelerate immediately prior to the closing of the Merger Agreement[98](index=98&type=chunk)[100](index=100&type=chunk)[134](index=134&type=chunk) - The 2020 Employee Stock Purchase Plan (ESPP) was terminated on July 18, 2025, in connection with the Merger Agreement, and all amounts in participant accounts will be refunded[95](index=95&type=chunk)[136](index=136&type=chunk) [Note 9. Income taxes](index=19&type=section&id=Note%209.%20Income%20taxes) The company reported negative effective tax rates due to interest on unrecognized tax benefits and taxable investment income, with an uncertain tax position related to GSK revenue allocation Income Tax Metrics | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Loss before income taxes | $(77,059) | $(4,867) | $(110,569) | $(40,869) | | Income tax expense | $(1,670) | $(2,261) | $(2,772) | $(4,475) | | Effective tax rate | (2.2)% | (46.4)% | (2.5)% | (10.9)% | - Income tax expense, despite a loss before income taxes, resulted primarily from additional interest accrued on the unrecognized tax benefits liability and taxable investment income generated by a subsidiary that could not be offset by net operating losses[101](index=101&type=chunk)[102](index=102&type=chunk) - The unrecognized tax benefits liability increased by **$2.1 million** during the six months ended June 30, 2025, related to the accrual of interest expense, with total accrued interest and penalties of **$10.3 million** as of June 30, 2025[104](index=104&type=chunk)[196](index=196&type=chunk) - The company's uncertain tax position relates to the allocation of revenue between the U.S. and Belgium under the GSK Agreement[103](index=103&type=chunk)[195](index=195&type=chunk) [Note 10. Commitments and contingencies](index=21&type=section&id=Note%2010.%20Commitments%20and%20contingencies) The company has contractual arrangements and operating leases, with **$2.4 million** in remaining lease obligations expected due to July 2025 terminations, and the WuXi Agreement surviving the Merger - The WuXi Agreement, governing biologics development and manufacturing services, has no minimum commitments or royalties/milestones payable as of June 30, 2025, and will survive the Merger[106](index=106&type=chunk) - In July 2025, the company provided notice of termination for its Belgium leases (April 2016 and July 2023) and expects to provide notice for its Watertown, Massachusetts lease in Q3 2025[110](index=110&type=chunk) - The total expected cost for these terminated leases is **$2.4 million**, representing remaining obligations after termination notices[114](index=114&type=chunk)[138](index=138&type=chunk) Lease Liability | Lease Liability (in thousands) | June 30, 2025 | | :----------------------------- | :------------ | | Total lease liability | $5,128 | | Lease liabilities, current | $1,516 | | Lease liabilities, net of current portion | $3,612 | [Note 11. Related party transactions](index=23&type=section&id=Note%2011.%20Related%20party%20transactions) No royalties were owed under the Royalty Transfer Agreement, and Boxer Capital and RA Capital were related parties during a **$120.0 million** securities purchase in May 2024 - No royalties were owed to charitable foundations under the Royalty Transfer Agreement as of June 30, 2025, due to the absence of product sales[116](index=116&type=chunk) - Boxer Capital and RA Capital were considered related parties at the time of their **$120.0 million** securities purchase in May 2024[117](index=117&type=chunk)[118](index=118&type=chunk) - RA Capital's beneficial ownership fell below the **10%** principal owner threshold after an exchange agreement on May 14, 2024[118](index=118&type=chunk) [Note 12. Net loss per share attributable to common stock](index=23&type=section&id=Note%2012.%20Net%20loss%20per%20share%20attributable%20to%20common%20stock) Basic and diluted net loss per common share were **$(1.81)** for Q2 2025 and **$(2.61)** for 6M 2025, with common stock equivalents excluded due to anti-dilutive effects Net Loss Per Common Share | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Basic net loss per common share | $(1.81) | $(0.18) | $(2.61) | $(1.20) | | Diluted net loss per common share | $(1.81) | $(0.18) | $(2.61) | $(1.20) | - Common stock equivalents (stock options and restricted stock units) were excluded from the calculation of diluted net loss per share due to their anti-dilutive effect[120](index=120&type=chunk)[121](index=121&type=chunk) [Note 13. Segments](index=24&type=section&id=Note%2013.%20Segments) The company operates as a single immuno-oncology segment, with the CEO evaluating performance based on consolidated net income/loss, and no revenue from GSK in 2025 - The company conducts operations as a single operating segment, managed as one consolidated entity with departments and executive committee members from both U.S. and Belgium locations[123](index=123&type=chunk) - The Chief Executive Officer, as the Chief Operating Decision Maker (CODM), evaluates performance and allocates resources based on consolidated net income/loss[124](index=124&type=chunk)[125](index=125&type=chunk) - No revenue was earned from the collaboration with GSK for the three or six months ended June 30, 2025[124](index=124&type=chunk) Segment Expenses | Segment Expense (in thousands) | Six Months Ended June 30, 2025 | | :----------------------------- | :----------------------------- | | Belrestotug expense | $(40,464) | | Inupadenant expense | $(3,545) | | EOS-984 expense | $(6,182) | | EOS-215 expense | $(5,909) | | R&D payroll | $(15,874) | | Restructuring costs | $(16,335) | [Note 14. Subsequent events](index=24&type=section&id=Note%2014.%20Subsequent%20events) The company entered a Merger Agreement with Concentra Biosciences for **$10.047** cash per share plus a CVR, terminated the GSK agreement with a **$32.0 million** settlement, and initiated employee and lease terminations - On July 18, 2025, the company entered into a Merger Agreement with Concentra Biosciences, LLC, for an acquisition via a tender offer[128](index=128&type=chunk) - The Offer Price is **$10.047** in cash per share plus one Contingent Value Right (CVR)[128](index=128&type=chunk) - The CVR entitles holders to **100%** of Closing Net Cash exceeding **$475 million** and **80%** of Net Proceeds from dispositions of CVR Products (EOS-984, EOS-215, preclinical obesity program, PTPNI1/2 program, and related IP) within six months post-merger[129](index=129&type=chunk) - On July 18, 2025, iTeos Belgium and GSK entered into a Mutual Termination Agreement, requiring iTeos Belgium to pay a **$32.0 million** settlement to GSK[135](index=135&type=chunk) - The 2020 ESPP was terminated on July 18, 2025, with all participant amounts to be refunded[136](index=136&type=chunk) - Employee terminations were initiated in July 2025 for both Belgium and U.S. employees, with **$16.3 million** in termination benefits recognized in Q2 2025 and an additional **$8.2 million** to be recorded in July 2025[137](index=137&type=chunk) - Belgium leases were terminated in July 2025, resulting in an expected remaining obligation of **$2.4 million**[138](index=138&type=chunk) - The Walloon Region relieved the substantial majority of the repayable grant liability in July 2025, with **$0.2 million** and **$1.5 million** still due for current liability and advance payments, respectively[139](index=139&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on financial condition and results, highlighting the strategic shift to winding down activities and the pending merger [Overview](index=28&type=section&id=Overview) The company decided to wind down operations by Q3 2025 after terminating its belrestotug program and GSK collaboration, facing going concern doubts pending a merger or dissolution - The company historically focused on discovering and developing immuno-oncology therapeutics, with lead candidate belrestotug targeting the TIGIT/CD226 pathway[141](index=141&type=chunk)[142](index=142&type=chunk)[143](index=143&type=chunk) - The belrestotug development program and GSK collaboration were terminated on May 13, 2025, due to GALAXIES Lung-201 and H&N-202 trial results not meeting clinically meaningful improvement criteria[145](index=145&type=chunk)[147](index=147&type=chunk)[148](index=148&type=chunk) - On May 28, 2025, the company announced its intention to wind down clinical and operational activities, expected to be substantially complete in Q3 2025, as part of a strategic alternatives review[151](index=151&type=chunk) - A Merger Agreement was entered into with Concentra Biosciences, LLC, on July 18, 2025, for an acquisition at **$10.047** cash plus one CVR per share[156](index=156&type=chunk) - As of June 30, 2025, the company had **$207.8 million** in cash and cash equivalents and **$382.2 million** in available-for-sale securities[152](index=152&type=chunk)[198](index=198&type=chunk) - The company faces substantial doubt about its ability to continue as a going concern if the Merger is not consummated, potentially leading to dissolution and liquidation[152](index=152&type=chunk) [Components of our results of operations](index=31&type=section&id=Components%20of%20our%20results%20of%20operations) Revenue historically from GSK collaboration is now absent, R&D expenses are expensed as incurred, and grant income, tax credits, and interest income contribute to funding - Revenue has historically been derived from the upfront payment and a milestone payment from the GSK Collaboration Agreement; no revenue was recognized in Q2 or 6M 2025[160](index=160&type=chunk) - Research and development expenses are expensed as incurred and include costs for intellectual property licenses, employee-related expenses, CROs, CMOs, lab supplies, consulting fees, and facility costs[161](index=161&type=chunk)[164](index=164&type=chunk) - Grant income is recognized from government agencies for eligible R&D expenditures, with certain grants having repayment provisions[169](index=169&type=chunk) - Research and development tax credits are cash-based credits from the Belgian government on eligible R&D expenses[172](index=172&type=chunk) - Interest income is earned on available-for-sale securities, money market funds, and bank sweep accounts[173](index=173&type=chunk) [Results of operations](index=33&type=section&id=Results%20of%20operations) The company experienced a substantial increase in net loss for both Q2 and 6M 2025, primarily due to absent license revenue, higher R&D expenses, and restructuring costs [Comparison of the three months ended June 30, 2025 and 2024](index=33&type=section&id=Comparison%20of%20the%20three%20months%20ended%20June%2030,%202025%20and%202024) Net loss significantly increased to **$78.7 million** in Q2 2025 from **$7.1 million** in Q2 2024, primarily due to absent **$35.0 million** license revenue, increased R&D expenses, and **$16.3 million** restructuring costs Three Months Ended June 30, 2025 vs 2024 | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Period to period change | | :-------------------------------- | :------------------------------- | :------------------------------- | :---------------------- | | License and collaboration revenue | $— | $35,000 | $(35,000) | | Research and development expenses | $57,275 | $36,709 | $20,566 | | General and administrative expenses | $10,181 | $12,457 | $(2,276) | | Restructuring costs | $16,335 | $— | $16,335 | | Net loss | $(78,729) | $(7,128) | $(71,601) | - The **$20.5 million** increase in R&D expenses was primarily due to a **$21.7 million** increase in clinical and related expenses, largely driven by the termination payment owed to GSK[179](index=179&type=chunk) - Interest income decreased by **$1.4 million** due to decreased interest rates and a smaller investment base[183](index=183&type=chunk) - Other (expense) income, net, decreased by **$0.6 million** due to increased foreign currency exchange losses as the U.S. Dollar weakened against the Euro[184](index=184&type=chunk) [Comparison of the six months ended June 30, 2025 and 2024](index=35&type=section&id=Comparison%20of%20the%20six%20months%20ended%20June%2030,%202025%20and%202024) Net loss for the six months ended June 30, 2025, surged to **$113.3 million** from **$45.3 million** in the prior year, primarily due to absent **$35.0 million** license revenue, increased R&D expenses, and **$16.3 million** restructuring costs Six Months Ended June 30, 2025 vs 2024 | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Period to period change | | :-------------------------------- | :----------------------------- | :----------------------------- | :---------------------- | | License and collaboration revenue | $— | $35,000 | $(35,000) | | Research and development expenses | $86,314 | $71,238 | $15,076 | | General and administrative expenses | $21,162 | $25,160 | $(3,998) | | Restructuring costs | $16,335 | $— | $16,335 | | Net loss | $(113,341) | $(45,344) | $(67,997) | - The **$15.1 million** increase in R&D expenses was primarily due to a **$14.7 million** increase in clinical and related expenses, mainly driven by the termination payment owed to GSK[188](index=188&type=chunk) - General and administrative expenses decreased by **$4.0 million**, primarily due to lower stock-based compensation and payroll costs[189](index=189&type=chunk) - Other (expense) income, net, decreased by **$4.1 million** due to increased foreign currency exchange losses as the U.S. Dollar significantly weakened against the Euro[193](index=193&type=chunk) [Liquidity and capital resources](index=38&type=section&id=Liquidity%20and%20capital%20resources) The company's liquidity as of June 30, 2025, included **$207.8 million** in cash and **$382.2 million** in investments, with funding contingent on the Merger or an alternative strategic transaction Cash and Available-for-Sale Securities | Metric (in millions) | June 30, 2025 | | :------------------- | :------------ | | Cash and cash equivalents | $207.8 | | Available-for-sale securities | $382.2 | - The company expects to make additional payments post-June 30, 2025, including a **$32.0 million** settlement payment to GSK and **$24.5 million** of severance costs[197](index=197&type=chunk)[202](index=202&type=chunk)[209](index=209&type=chunk) - Existing cash and investments are believed to fund operating expenses and capital expenditure requirements through 2027, but this projection is subject to uncertainty regarding the Merger and potential wind-down[209](index=209&type=chunk)[210](index=210&type=chunk) - Net cash used in operating activities increased by **$9.9 million** to **$76.2 million** for the six months ended June 30, 2025, driven by increased net loss and accrued clinical/personnel expenses[204](index=204&type=chunk) - Net cash provided by investing activities shifted to **$134.6 million** for the six months ended June 30, 2025, from cash used in the prior year, primarily due to proceeds from maturities of investments[205](index=205&type=chunk) - Net cash provided by financing activities decreased significantly to **$4.5 million** for the six months ended June 30, 2025, due to the absence of the **$120.0 million** proceeds from common stock and pre-funded warrant issuance in the prior year[206](index=206&type=chunk) [Critical accounting policies and significant judgments and estimates](index=40&type=section&id=Critical%20accounting%20policies%20and%20significant%20judgments%20and%20estimates) The company's financial statements rely on critical accounting policies and significant judgments in revenue recognition, R&D expenses, stock-based compensation, government grants, and income taxes, with no significant changes since 2024 - No significant changes to existing critical accounting policies were noted since the Annual Report on Form 10-K for the year ended December 31, 2024[214](index=214&type=chunk) - Key areas requiring significant judgment include revenue recognition (applying the five-step model, identifying performance obligations, determining transaction price), collaborative arrangements (distinguishing joint activities from customer relationships), estimating accrued research and development expenses, valuing stock-based compensation (using Black-Scholes model assumptions), accounting for government grants (repayment provisions), and income taxes (deferred tax assets, valuation allowances, and uncertain tax positions)[214](index=214&type=chunk)[217](index=217&type=chunk)[220](index=220&type=chunk)[221](index=221&type=chunk)[223](index=223&type=chunk)[225](index=225&type=chunk) - The company's uncertain tax position relates to the allocation of revenue between the U.S. and Belgium under the GSK Agreement[195](index=195&type=chunk)[228](index=228&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=44&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is exposed to foreign currency and interest rate risks, but immediate 5% or 10% changes are not expected to materially impact financial position due to short-term investments - The company is subject to foreign currency exchange rate fluctuations, specifically with respect to the Euro, but an immediate **5%** change is not expected to have a material effect on results of operations[229](index=229&type=chunk) - The company is exposed to interest rate sensitivity risk, but an immediate **10%** change in interest rates would not materially impact the fair market value of its investment portfolio or financial position due to the short-term nature of its instruments[230](index=230&type=chunk) - As of June 30, 2025, the company held **$207.8 million** in cash and cash equivalents and **$382.2 million** in available-for-sale fixed income securities, with the majority maturing within one and a half years[230](index=230&type=chunk) [Item 4. Controls and Procedures](index=44&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[234](index=234&type=chunk) - There have been no material changes in internal control over financial reporting during the quarter ended June 30, 2025[235](index=235&type=chunk) [PART II. OTHER INFORMATION](index=46&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, defaults, mine safety, other information, and exhibits [Item 1. Legal Proceedings](index=46&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings, and management believes no pending claims would have a material adverse effect - The company is not currently a party to any material legal proceedings[238](index=238&type=chunk) - Management believes there are no claims or actions pending that could have a material adverse effect on the company's results of operations or financial condition[238](index=238&type=chunk) [Item 1A. Risk Factors](index=46&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to the pending merger with Concentra, including non-completion, a **$8.4 million** termination fee, limited stockholder upside via CVRs, and restrictions on alternative transactions - The company may not complete the pending transaction with Concentra within the anticipated timeframe or at all, which could adversely affect its business and financial results[240](index=240&type=chunk) - If the Merger Agreement is terminated under certain circumstances, the company could be required to pay Concentra a termination fee of **$8.4 million**[132](index=132&type=chunk)[241](index=241&type=chunk) - The pendency of the transaction could cause substantial disruptions and uncertainty for the company's wind-down activities[242](index=242&type=chunk) - Stockholders' participation in any financial upside post-merger is limited to the Contingent Value Rights (CVRs), and there is no assurance that any CVR Consideration will be received[244](index=244&type=chunk) - The U.S. federal income tax treatment of the CVRs is unclear, potentially leading to adverse tax consequences for holders[245](index=245&type=chunk) - The Merger Agreement limits the company's ability to pursue alternative transactions, potentially deterring competing acquirers[247](index=247&type=chunk)[249](index=249&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=49&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) There were no unregistered sales of equity securities or use of proceeds to report for the period [Item 3. Defaults Upon Senior Securities](index=49&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company for the reporting period [Item 4. Mine Safety Disclosures](index=49&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company for the reporting period [Item 5. Other Information](index=49&type=section&id=Item%205.%20Other%20Information) No officer or director adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2025 - No officer or director adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended June 30, 2025[254](index=254&type=chunk) [Item 6. Exhibits](index=50&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Quarterly Report on Form 10-Q, including the Merger Agreement, CVR Agreement, and various certifications - Key exhibits include the Agreement and Plan of Merger (Exhibit 2.1), the Form of Contingent Value Rights Agreement (Exhibit 10.4), and certifications by the Principal Executive Officer and Principal Financial Officer (Exhibits 31.1, 31.2, 32.1)[255](index=255&type=chunk) [Signatures](index=52&type=section&id=Signatures) The Quarterly Report on Form 10-Q was duly signed by the President and CEO, Michel Detheux, and CFO, Matthew Gall, on August 6, 2025 - The report was signed by Michel Detheux, President and Chief Executive Officer, and Matthew Gall, Chief Financial Officer, on August 6, 2025[259](index=259&type=chunk)
SHAREHOLDER INVESTIGATION: Halper Sadeh LLC Investigates ITOS and ZIMV on Behalf of Shareholders
GlobeNewswire News Room· 2025-07-22 00:39
Core Viewpoint - Halper Sadeh LLC is investigating potential violations of federal securities laws and breaches of fiduciary duties related to the sales of iTeos Therapeutics, Inc. and ZimVie Inc. [1][2] Group 1: iTeos Therapeutics, Inc. - iTeos Therapeutics, Inc. is set to be acquired by Concentra Biosciences, LLC for $10.047 in cash per share, along with a non-transferable contingent value right [1] - The contingent value right includes the right to receive 100% of iTeos' closing net cash exceeding $475 million and 80% of net proceeds from the disposition of certain product candidates within six months post-closing [1] Group 2: ZimVie Inc. - ZimVie Inc. is being sold to an affiliate of ARCHIMED for $19.00 in cash per share [2] Group 3: Legal Actions and Shareholder Rights - Halper Sadeh LLC may seek increased consideration for shareholders, additional disclosures, and other relief on behalf of shareholders [3] - Shareholders are encouraged to contact Halper Sadeh LLC to discuss their legal rights and options at no charge [4]
ALERT: Rowley Law PLLC is Investigating Proposed Acquisition of iTeos Therapeutics, Inc.
Prnewswire· 2025-07-21 22:00
Core Viewpoint - Rowley Law PLLC is investigating potential securities law violations related to the proposed acquisition of iTeos Therapeutics, Inc. by Concentra Biosciences, LLC, with stockholders set to receive $10.047 and one contingent value right for each share held [1]. Group 1 - The proposed acquisition transaction is expected to close in the third quarter of 2025 [1]. - Stockholders of iTeos Therapeutics will receive a total of $10.047 per share along with one contingent value right [1].
$HAREHOLDER ALERT: The M&A Class Action Firm Announces An Investigation of iTeos Therapeutics, Inc. (NASDAQ: ITOS)
GlobeNewswire News Room· 2025-07-21 19:59
Core Viewpoint - The article discusses the investigation by Monteverde & Associates PC into the proposed acquisition of iTeos Therapeutics, Inc. by Concentra Biosciences, LLC, questioning the fairness of the deal. Group 1: Transaction Details - Concentra Biosciences, LLC plans to acquire iTeos Therapeutics, Inc. for $10.047 in cash per share [1] - The acquisition includes a non-transferable contingent value right, which entitles shareholders to 100% of iTeos' closing net cash exceeding $475 million and 80% of net proceeds from the sale of certain product candidates within six months post-closing [1] Group 2: Legal Context - Monteverde & Associates PC is recognized as a Top 50 Firm in the 2024 ISS Securities Class Action Services Report and has a successful track record in recovering money for shareholders [1] - The firm operates from the Empire State Building in New York City and specializes in class action securities litigation [2]
iTeos Therapeutics Enters into Agreement to Be Acquired by Concentra Biosciences for $10.047 in Cash per Share Plus a Contingent Value Right
Globenewswire· 2025-07-21 11:29
Core Viewpoint - iTeos Therapeutics, Inc. has entered into a definitive merger agreement with Concentra Biosciences, LLC, where Concentra will acquire iTeos for $10.047 per share in cash, along with a contingent value right (CVR) [1][2][3] Group 1: Merger Agreement Details - The acquisition price includes $10.047 in cash per share of iTeos common stock and a CVR that entitles shareholders to 100% of iTeos' net cash exceeding $475 million and 80% of net proceeds from certain product candidates sold within six months post-closing [1][3] - The iTeos board of directors unanimously approved the merger, determining it to be in the best interests of all stockholders after a strategic review [2] - Concentra will initiate a tender offer by August 1, 2025, to acquire all outstanding shares of iTeos common stock, with the transaction expected to close in the third quarter of 2025, subject to customary closing conditions [3] Group 2: Conditions and Advisors - The closing of the offer is contingent upon the tender of shares representing at least a majority of outstanding shares and the availability of at least $475 million in cash at closing [3] - TD Cowen is serving as the exclusive financial advisor to iTeos, while Ropes & Gray LLP is providing legal counsel to iTeos, and Gibson, Dunn & Crutcher LLP is acting as legal counsel to Concentra [4]
Iteos Therapeutics (ITOS) Earnings Call Presentation
2025-07-04 09:41
Clinical Trial Data & Pipeline - iTeos anticipates multiple clinical data readouts in 2025, including data from GALAXIES Lung-201, GALAXIES H&N-202, TIG-006 H&N, and EOS-984 [2, 7] - GALAXIES Lung-201 Phase 2 trial showed an Objective Response Rate (ORR) of 633% with Belrestotug 100mg + Dostarlimab, 656% with Belrestotug 400mg + Dostarlimab, and 767% with Belrestotug 1000mg + Dostarlimab, compared to 375% with Dostarlimab alone [26] - In the GALAXIES Lung-201 trial, ctDNA analysis showed a median ctDNA % change of -94% in the Belrestotug 400mg + Dostarlimab cohort and -97% in the Belrestotug 1000mg + Dostarlimab cohort, compared to -65% with Dostarlimab alone [34] - The GALAXIES Lung-201 trial is enrolling 340 patients to evaluate Belrestotug + Dostarlimab safety, efficacy, PK/PD [18] - The GALAXIES H&N-202 trial is enrolling 360 patients to evaluate the antitumor activity and safety of Dostarlimab + novel IOs [46] - The company is enrolling 1000 patients in the GALAXIES Lung-301 Phase 3 trial to evaluate Belrestotug + Dostarlimab safety and efficacy vs placebo + pembrolizumab [42] - The company's TIGIT program has data readouts with >400 patients from TIGIT:PD-1 trials in 1L NSCLC and 1L HNSCC [51] - The company's EOS-984 Phase 1 trial is enrolling 84 patients to evaluate safety/tolerability of EOS-984 as a monotherapy and in combination with pembrolizumab [66] - The company's TRM-010 Phase 1 trial is enrolling 40 patients to evaluate safety/tolerability of EOS-215 as a monotherapy and in combination with pembrolizumab [82] Financial Status - iTeos had approximately $624 million in cash, cash equivalents, and short-term investments as of March 31, 2025, providing a cash runway through 2027 [6, 87] TIGIT Program & Differentiation - Belrestotug is the first and only TIGIT to demonstrate robust target engagement and Phase 1 monotherapy activity [15] - Belrestotug is the only TIGIT with proven Treg depletion at all doses [15]
iTeos Therapeutics (ITOS) Upgraded to Buy: Here's What You Should Know
ZACKS· 2025-05-30 17:06
Core Viewpoint - iTeos Therapeutics, Inc. (ITOS) has been upgraded to a Zacks Rank 2 (Buy), indicating an upward trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Rising earnings estimates for iTeos Therapeutics suggest an improvement in the company's underlying business, likely leading to an increase in stock price [5][10]. Earnings Estimate Revisions - For the fiscal year ending December 2025, iTeos Therapeutics is expected to earn -$2.68 per share, reflecting a 19.3% change from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for iTeos Therapeutics has increased by 36.7%, indicating positive sentiment among analysts [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating [9][10]. - The upgrade of iTeos Therapeutics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].
iTeos Therapeutics Announces Its Intention to Wind Down Operations
Globenewswire· 2025-05-28 12:30
Core Viewpoint - iTeos Therapeutics, Inc. intends to wind down its operations as part of a strategic review aimed at maximizing shareholder value through potential asset sales and leveraging its cash balance [2][3]. Group 1: Company Operations - The Board of Directors has decided to cease clinical and operational activities following a comprehensive assessment of the company's development pipeline and financial position [3]. - The company is exploring potential asset sales, including EOS-984, EOS-215, and a preclinical obesity program targeting ENT1, to deliver near-term value to shareholders [2][3]. Group 2: Company Background - iTeos Therapeutics is a clinical-stage biopharmaceutical company focused on developing immuno-oncology therapeutics, leveraging its expertise in tumor immunology [4].