– GALAXIES Lung-201 did not meet established criteria for clinically meaningful improvements in progression free survival – Based on totality of data, iTeos and GSK have agreed to terminate the belrestotug development program – iTeos has initiated a targeted review of strategic alternatives to maximize shareholder value WATERTOWN, Mass. and GOSSELIES, Belgium, May 13, 2025 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and de ...

Shares of iTeos Therapeutics, Inc. (ITOS) have gained 31.6% over the past four weeks to close the last trading session at $7.50, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $23.33 indicates a potential upside of 211.1%.The average comprises six short-term price targets ranging from a low of $15 to a high of $47, with a standard deviation of $12.21. While the lowest estimate ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR (I.R.S. Employer Identification No.) Registrant's telephone number, including area code: (339) 217 0162 Securities registered pursuant to Section 12(b) of the Act: | | Trading | | | --- | --- | --- | | Title of each class | Symbol(s) | Name of each exchange on which registered | | ...

- Topline interim dataset from GALAXIES Lung-201 with >240 patients anticipated in 2Q25 - Interim datasets from GALAXIES H&N-202 and TIG-006 HNSCC with ~200 patients anticipated in 2025 - Cash balance and investment balance of $624.3 million as of March 31, 2025 expected to provide runway through 2027 WATERTOWN, Mass. and GOSSELIES, Belgium, April 28, 2025 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new ...

WATERTOWN, Mass. and GOSSELIES, Belgium, March 25, 2025 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today announced the poster presentations of preclinical data on EOS-215, a potential best-in-class antibody targeting TREM2, and a novel small molecule inhibiting PTPN1/2 at the American Association for Cancer Research (AACR) Annual Meeting, bei ...

Innovation and Product Development - The company is advancing its innovative pipeline of monoclonal antibodies and small molecules for cancer treatment, focusing on solid tumors and targeting key cancer resistance mechanisms[22] - The lead clinical-stage antibody product candidate, belrestotug, is in an open-label Phase 1/2a clinical trial for advanced solid tumors, with preliminary data indicating target engagement and early clinical activity[23] - A collaboration with GlaxoSmithKline (GSK) was established for the development of belrestotug, with GSK responsible for commercialization outside the U.S. and joint ownership of related intellectual property[24] - The company is enrolling patients in multiple clinical trials, including the GALAXIES Lung-301 study, which assesses belrestotug in combination with GSK's anti-PD-1 therapy, with a $35 million milestone payment triggered by the first patient dosing[25] - EOS-984, a small molecule targeting the adenosine pathway, is currently in a Phase 1 trial, with patient enrollment completed for the monotherapy dose escalation portion[27] - EOS-215, a monoclonal antibody targeting TREM2, has shown preclinical promise in altering tumor resident macrophage function and promoting anti-tumor effects[28] - The company presented interim data from the Phase 2 trial of inupadenant (EOS-850), indicating an encouraging initial signal compared to chemotherapy, but deemed insufficient for further investment[29] - The company anticipates that its product candidates will be used in combination with third-party drugs, which may affect the regulatory approval process[18] - The company aims to advance clinical candidates toward registration, focusing on the TIGIT inhibition and the adenosine pathway[31] - The pipeline of therapeutic candidates is expected to progress significantly through 2025, with ongoing research and development efforts[34] Regulatory and Approval Processes - The regulatory approval processes for product candidates are lengthy and unpredictable, potentially impacting revenue generation[20] - The company relies on third parties for clinical trials and manufacturing, which poses risks to development timelines and product supply[20] - The FDA requires a separate submission for each successive clinical trial under an IND, and permission must be granted before trials can begin[78] - Clinical trials are conducted in three phases: Phase 1 focuses on safety and dosage, Phase 2 evaluates efficacy and side effects, and Phase 3 provides statistically significant evidence for approval[81][82] - The FDA targets ten months for the initial review of an NDA or BLA and six months for priority reviews, although these timelines are not always met[90] - The FDA may require a risk evaluation and mitigation strategy (REMS) as a condition for approval to ensure the benefits of a product outweigh its risks[93] - Orphan drug designation (ODD) can be granted for drugs treating rare diseases, providing seven years of exclusivity upon first approval[97][98] - Fast Track designation allows for increased FDA interactions and potential rolling review for drugs addressing serious conditions[100] - Breakthrough Therapy designation offers intensive guidance and expedited development for drugs showing substantial improvement over existing therapies[101] - Priority review designation aims for a six-month review period for drugs that significantly improve safety or effectiveness over existing therapies[102] - Post-approval trials (Phase 4) may be mandated by the FDA to gather additional safety data after initial marketing approval[83] - Annual reports on IND progress and safety reports for serious adverse reactions must be submitted to the FDA[84] - The FDA may grant accelerated approval for products that provide meaningful therapeutic advantages for serious conditions, based on surrogate endpoints likely to predict clinical benefits[104] - Accelerated approval has been extensively used in cancer treatments, where the goal is to improve survival or decrease morbidity, often requiring lengthy trials to demonstrate benefits[105] - Post-approval studies are generally required for drugs granted accelerated approval to verify clinical benefits, with the FDA having the authority to withdraw approval if studies are not conducted diligently[106] Financial and Collaboration Aspects - The company received an upfront payment of $625 million from GSK under the collaboration agreement, with potential milestone payments of up to $1.45 billion contingent on the belrestotug program achieving specific milestones[33] - A milestone payment of $35 million was achieved in 2024 for the dosing of the first patient in the GALAXIES-301 Phase 3 trial[46] - The collaboration with GSK allows for joint commercialization and profit sharing in the U.S., while GSK has exclusive rights outside the U.S.[45] - The Amended Adimab Agreement includes milestone payments totaling up to $45.8 million for the first three new products and up to $14.5 million for each additional product[50] - The WuXi Agreement requires a service fee for each work order, and if commercial supplies are manufactured elsewhere, a low single-digit royalty fee on global net sales or a one-time milestone payment in the low tens of millions is applicable[53] Manufacturing and Supply Chain - The company does not own manufacturing facilities and relies on third-party contract development and manufacturing organizations (CDMOs) for production[64] - The company is transitioning its GMP supply chain from China to certain western countries to improve scalability and reliability[65] - The company has over 75 pending patent applications in its ENT1 program portfolio, with expiration dates ranging from 2039 to 2045[70] - The company has two issued United States patents and several pending applications in its TIGIT program portfolio, with expiration dates up to 2045[69] Market and Competitive Landscape - The company faces substantial competition from major pharmaceutical and biotechnology companies in the immune-oncology market[55] - Coverage and reimbursement from third-party payors, including Medicare and Medicaid, are critical for new product acceptance, and obtaining adequate reimbursement may prove challenging[125] - Legislative changes in the U.S. and EU could adversely affect the commercial success of the company's products, including pricing controls and reimbursement limitations[133][136] Employee and Organizational Aspects - As of December 31, 2024, the company had 173 full-time employees, with 136 engaged in research and development activities[168] - Women represent 58% of the global workforce, and 49% of leadership positions at the Director level or above are held by women[169] - The company offers a comprehensive total rewards package, including market-competitive pay, equity grants, bonuses, and healthcare benefits[170] - The company prioritizes employee health and safety, with a Health and Safety Committee meeting quarterly to address workplace issues[171] Financial Position - As of December 31, 2024, the company had cash and cash equivalents of $142.1 million, down from $251.2 million as of December 31, 2023[451] - Available-for-sale fixed income securities increased to $512.9 million as of December 31, 2024, compared to $381.3 million in the previous year[451] - The majority of fixed income securities will mature within one year from December 31, 2024, with no securities maturing beyond two years[451] - An immediate 10% change in interest rates would not materially impact the fair market value of the investment portfolio or the company's financial position[451] - The company is exposed to foreign currency exchange rate fluctuations, particularly with respect to the euro, but a 5% change in the Euro exchange rate would not materially affect results[452] - Assets and liabilities of the subsidiary, iTeos Belgium SA, are translated into U.S. dollars at the balance sheet date exchange rate[453] - Unrealized translation gains and losses are recorded as a cumulative translation adjustment in the stockholders' equity statements[453]

Core Insights - iTeos Therapeutics is positioned for a potentially breakthrough year in 2025, with multiple trials advancing, particularly the GALAXIES Lung-201 study expected to yield interim results in Q2 2025 [2][4] - The company has a strong financial position with a cash balance of $655 million as of December 31, 2024, which is expected to sustain operations through 2027 [2][13] Clinical Trials and Programs - The GALAXIES Lung-201 study will assess the combination of belrestotug and dostarlimab in patients with advanced PD-L1 high non-small cell lung cancer (NSCLC), with data from over 240 patients anticipated in Q2 2025 [4] - Interim data from the GALAXIES H&N-202 study, focusing on PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), is expected in 2025, involving over 150 patients [5] - The TIG-006 study will provide topline data in 2025, assessing the same combination in advanced/metastatic HNSCC, with data from 42 patients [6] - The EOS-984 program, a potential first-in-class small molecule, is in Phase 1 trials, with topline data expected in the second half of 2025 [9][13] Financial Performance - For Q4 2024, the company reported a net loss of $43.7 million, compared to a net loss of $30.6 million in Q4 2023, reflecting increased R&D expenses primarily due to the belrestotug program [13] - Total R&D expenses for the year ended December 31, 2024, were $145.4 million, up from $113.3 million in 2023, driven by increased activities in multiple clinical programs [13] - General and administrative expenses decreased slightly to $49.1 million for the year ended December 31, 2024, compared to $50.4 million in 2023, due to reductions in various expenses [13]

Group 1 - The company iTeos (NASDAQ: ITOS) has experienced a 60% decline in stock price over the past two years, yet there have been positive developments in their programs [1] - The current situation presents a potential case for investment despite the stock's poor performance [1] Group 2 - Total Pharma Tracker offers tools for DIY investors, including a software that provides extensive curated research material for any ticker [2] - The service includes in-house experts who assist investors in identifying the best investable stocks along with buy/sell strategies and alerts [2]

Core Viewpoint - iTeos Therapeutics, Inc. (ITOS) has been upgraded to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Institutional investors often rely on earnings estimates to determine the fair value of a company's shares, leading to buying or selling actions that affect stock prices [4]. Company Performance and Outlook - The upgrade indicates a positive outlook for iTeos Therapeutics' earnings, suggesting potential buying pressure and an increase in stock price [3][5]. - The company is expected to report earnings of -$3.49 per share for the fiscal year ending December 2024, reflecting a year-over-year change of -10.8% [8]. - Over the past three months, the Zacks Consensus Estimate for iTeos Therapeutics has increased by 26.9%, indicating a positive trend in earnings estimates [8]. Zacks Rating 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 to Zacks Rank 2 places iTeos Therapeutics in the top 20% of Zacks-covered stocks, suggesting it is a strong candidate for market-beating returns in the near term [10].

Program Highlights - Belrestotug (EOS-448/GSKFF28849A) is an IgG1 anti-TIGIT monoclonal antibody in development for first-line treatment of locally advanced or metastatic PD-L1-high non-small cell lung cancer (NSCLC) and PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) in collaboration with GSK [1] - Investigative New Drug (IND) application for EOS-215 is anticipated in 1Q25 [2] Business Updates and Strategic Priorities for 2025 - iTeos Therapeutics outlined its business updates and strategic priorities for 2025, aiming to emerge as a leading oncology company by advancing therapies with first- or best-in-class potential targeting resistance mechanisms within the tumor microenvironment [3][4] - The company expects robust TIGIT datasets in NSCLC and head and neck cancer in 2025, highlighting the differentiation with its unique TIGIT:PD-1 doublet, belrestotug + dostarlimab [4] - Early-stage programs EOS-984 and EOS-215 demonstrate the company's track record of designing and developing innovative and differentiated therapies [4] Clinical Trials and Data Readouts - Enrollment is ongoing globally in a randomized, double-blind Phase 3 registrational study assessing belrestotug + dostarlimab versus placebo + pembrolizumab in patients with first-line advanced, unresectable, or metastatic PD-L1 high NSCLC [5] - FDA and NMPA granted clearance to advance belrestotug 400mg + dostarlimab as the recommended Phase 3 dose, allowing for the activation of clinical sites in the U.S. and China [5] - Topline interim data from Phase 2 platform study GALAXIES Lung-201 assessing belrestotug + dostarlimab doublet and a triplet with GSK's investigational anti-CD96 antibody, nelistotug, in first-line advanced/metastatic PD-L1 high NSCLC is anticipated in 2Q25, including safety, ORR, and ctDNA data from >240 patients [5] - Interim data from Phase 2 platform study GALAXIES H&N-202 assessing belrestotug + dostarlimab doublet and triplet with nelistotug in first-line patients with PD-L1 positive recurrent/metastatic HNSCC is anticipated in 2025, including safety and ORR from >150 patients [5] - Topline data assessing EOS-984 as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors is anticipated in 2H25 [6] - Topline data from the TIG-006 study in cohorts 2C & 2D assessing belrestotug + dostarlimab doublet in first-line PD-L1 positive advanced/metastatic HNSCC is anticipated in 2025, including safety, ORR, and PFS from a total of 42 patients [11] Pipeline Updates - EOS-984 is a potential first-in-class small molecule targeting equilibrative nucleoside transporter 1 (ENT1) designed to inhibit the immunosuppressive activity of adenosine and restore immune cell proliferation, currently in Phase 1 development [7] - EOS-215 is a potential best-in-class monoclonal antibody blocking ligand binding to TREM2, reprogramming tumor-associated macrophages to allow for T cell activation, currently in IND-enabling studies [8] Financial Updates - The company's cash and cash equivalent position was $683.9 million as of September 30, 2024, inclusive of a $35.0 million milestone received relating to the dosing of the first patient in the GALAXIES Lung-301 clinical trial [13] - The company expects its cash balance to provide runway through 2027, which includes the potential initiation of multiple Phase 3 registrational trials assessing belrestotug + dostarlimab doublet [13] Company Overview - iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, leveraging its deep understanding of tumor immunology and immunosuppressive pathways to design novel product candidates [14] - The company's innovative pipeline includes three clinical-stage programs targeting novel, validated immunosuppressive pathways designed with optimized pharmacologic properties for improved clinical outcomes [14]