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]

Investors might want to bet on iTeos Therapeutics, Inc. (ITOS) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Since a chan ...

- Board of Directors intends to cease operations - Company to focus efforts on selecting best path to deliver near-term value to shareholders - Exploring potential asset sales including EOS-984, EOS-215, and a preclinical obesity program targeting ENT1 WATERTOWN, Mass. and GOSSELIES, Belgium, May 28, 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 pati ...

Core Insights - iTeos Therapeutics and GSK have decided to terminate the belrestotug development program due to the failure to meet established criteria for clinically meaningful improvements in progression-free survival in the GALAXIES Lung-201 trial [1][3] - The GALAXIES Lung-201 trial showed clinically meaningful improvements in the primary endpoint of objective response rate (ORR), but did not meet criteria for the secondary endpoint of progression-free survival [2][3] - iTeos is initiating a targeted review of strategic alternatives to maximize shareholder value following the termination of the belrestotug program [3][4] Company Overview - iTeos Therapeutics is a clinical-stage biopharmaceutical company focused on developing immuno-oncology therapeutics [5] - The company is headquartered in Watertown, MA, with a research center in Gosselies, Belgium [5] Product Information - Belrestotug is a monoclonal antibody targeting TIGIT, designed to enhance the antitumor response through immune modulation [6]

Group 1 - iTeos Therapeutics, Inc. (ITOS) shares have increased by 31.6% over the past four weeks, closing at $7.50, with a mean price target of $23.33 indicating a potential upside of 211.1% [1] - The average price targets from analysts range from a low of $15 to a high of $47, with a standard deviation of $12.21, suggesting a high degree of variability in estimates [2] - Analysts show strong agreement on ITOS's ability to report better earnings than previously predicted, which supports the potential for stock upside [4][11] Group 2 - Recent revisions in earnings estimates for ITOS have shown two estimates moving higher and one lower, resulting in a 9.4% increase in the Zacks Consensus Estimate [12] - ITOS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, indicating strong potential for near-term upside [13] - While consensus price targets may not be entirely reliable, the direction they imply appears to be a good guide for potential price movement [13]

Financial Performance - The net loss for the three months ended March 31, 2025, was $34,613,000, compared to a net loss of $38,216,000 for the same period in 2024, indicating an improvement of about 7%[20]. - The company reported a basic net loss per common share of $0.80 for Q1 2025, an improvement from $1.07 in Q1 2024[20]. - For the three months ended March 31, 2025, the net loss attributable to common stockholders was $34,613,000, compared to a net loss of $38,216,000 for the same period in 2024, representing a 6.9% improvement[121]. - The consolidated net loss for the three months ended March 31, 2025, was $34,613,000, down from $38,216,000 in 2024, indicating a reduction of 9.3%[126]. - The effective tax rate for Q1 2025 was (3.3)%, compared to (6.1)% in Q1 2024, with a loss before income tax expense of $33.513 million[105]. Assets and Liabilities - As of March 31, 2025, total assets decreased to $658,871,000 from $686,976,000 as of December 31, 2024, representing a decline of approximately 4%[18]. - The total stockholders' equity decreased to $563,424,000 as of March 31, 2025, down from $590,294,000 at the end of 2024, a decline of about 5%[18]. - The company’s total current liabilities decreased to $37,999,000 as of March 31, 2025, from $40,360,000 at the end of 2024, a reduction of approximately 6%[18]. - As of March 31, 2025, the company had an accumulated deficit of $44.4 million and retained earnings of $86.4 million[39]. - The total fair value of the Company's financial instruments as of March 31, 2025, was $587.463 million, with $478.241 million classified as Level 1[51]. Cash Flow and Investments - Cash and cash equivalents increased to $156,544,000 as of March 31, 2025, from $142,131,000 at the end of 2024, marking an increase of approximately 10%[18]. - The company’s cash used in operating activities for Q1 2025 was $33,764,000, compared to $32,400,000 in Q1 2024, indicating a slight increase in cash outflow[25]. - The company reported a net cash used in operating activities of $33.7 million for the three months ended March 31, 2025, an increase of $1.4 million compared to the same period in 2024[174]. - Net cash provided by investing activities changed from a cash outflow of $69.6 million in Q1 2024 to a cash inflow of $47.7 million in Q1 2025, a change of $117.2 million[175]. - As of March 31, 2025, the company had $156.5 million in cash and cash equivalents and $467.7 million in available-for-sale securities[180]. Research and Development - Research and development expenses for Q1 2025 were $29,039,000, down from $34,529,000 in Q1 2024, reflecting a decrease of approximately 16%[20]. - The total expenses for R&D activities in the first quarter of 2025 amounted to $29,855,000, compared to $32,188,000 in the same period of 2024, reflecting a decrease of 7.2%[126]. - The company is advancing its innovative pipeline, including belrestotug, which is currently in multiple active clinical trials, with the first patient dosed in the GALAXIES Lung-301 trial triggering a $35 million milestone payment from GSK[133]. - The company has multiple active clinical trials in partnership with GSK, including the GALAXIES Lung-301 trial, which triggered $35 million in milestone payments upon dosing the first patient[32]. - EOS-215, a potential best-in-class monoclonal antibody, has initiated patient dosing in a Phase 1/1b trial assessing its efficacy in advanced solid tumors[35]. Collaboration and Funding - Under the GSK Collaboration Agreement, the Company received an upfront nonrefundable payment of $625 million and is eligible for up to $1.45 billion in milestone payments[64]. - The total expected costs for the Global Development Plan with GSK is $900 million, with GSK responsible for 60% of the costs[68]. - The Company has received grants totaling $11.5 million from the Walloon Region and the European Union to fund qualifying research and development expenses, reimbursing 55-100% of actual expenditures[78]. - The Company raised $120 million through a Securities Purchase Agreement, selling a pre-funded warrant and common stock to RA Capital and Boxer Capital[88]. - The company has agreements for government grant funding that may require repayment of up to twice the amount of funding received, contingent on commercial development decisions[191]. Clinical Trials and Risks - The company faces risks related to clinical trial results, regulatory approvals, and market acceptance of its product candidates[41]. - The company has experienced challenges in clinical trials, including potential delays and the need for additional studies due to negative or inconclusive results[213]. - Delays in patient recruitment may lead to increased costs and hinder regulatory approval processes for potential products[216]. - The overall business, financial condition, and stock price may be materially harmed by delays in clinical trials and regulatory approvals[214]. - Challenges in enrolling patients for clinical trials could delay or prevent their completion, affecting product candidate timelines[215]. Stock and Compensation - Total stock-based compensation expense for Q1 2025 was $6.635 million, a decrease of 8.7% from $7.263 million in Q1 2024[100]. - Stock options granted in Q1 2025 totaled 1,162,913 shares with a weighted average exercise price of $7.05, compared to 9,784,580 shares outstanding at the end of 2024 with an average price of $16.39[101]. - As of March 31, 2025, the number of shares reserved for issuance under the Amended 2020 Stock Option and Incentive Plan was 12,513,308[97]. - The 2020 Employee Stock Purchase Plan has 546,943 shares reserved for issuance as of March 31, 2025, with no shares issued during the three months ended March 31, 2025[99]. - As of March 31, 2025, the company had $39.0 million of unrecognized employee compensation costs related to non-vested stock options, expected to be recognized over 2.5 years[101].

- 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]