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]

Core Viewpoint - iTeos Therapeutics, Inc. is set to present at the 43rd Annual J.P. Morgan Healthcare Conference, highlighting its focus on immuno-oncology therapeutics [1] Company Overview - iTeos Therapeutics is a clinical-stage biopharmaceutical company specializing in the discovery and development of immuno-oncology therapeutics [3] - The company utilizes its expertise in tumor immunology and immunosuppressive pathways to create novel product candidates aimed at enhancing the immune response against cancer [3] - iTeos has three clinical-stage programs targeting validated immunosuppressive pathways, designed for improved clinical outcomes [3] - The company is headquartered in Watertown, MA, with a research center located in Gosselies, Belgium [3] Presentation Details - Michel Detheux, Ph.D., President and CEO of iTeos, will present on January 15, 2025, at 7:30 AM PST (10:30 AM EST) [1] - A live webcast of the presentation will be available on the company's website, with an archived replay accessible for approximately 30 days post-presentation [2]

Core Viewpoint - iTeos Therapeutics, Inc. (NASDAQ: ITOS) presents a generally favorable investment thesis, but careful consideration of associated risks is necessary [1] Company Analysis - The company has been covered multiple times, indicating ongoing interest and analysis in its performance and potential [1] - The author possesses a PhD in biochemistry and extensive experience in analyzing clinical trials and biotech companies, which adds credibility to the insights provided [1] Industry Insights - There is a strong emphasis on the importance of understanding the science behind biotech investments, highlighting the complexity and potential pitfalls in this sector [1]

Financial Performance - Total revenue for the nine months ended September 30, 2024, was $35,000, compared to $12,595 for the same period in 2023, representing an increase of 178%[14]. - The net loss for the three months ended September 30, 2024, was $45,358, compared to a net loss of $32,241 for the same period in 2023, indicating a decline of 41%[14]. - Net loss for the nine months ended September 30, 2024, was $90,702,000, compared to a net loss of $82,091,000 for the same period in 2023, representing an increase of approximately 10%[18]. - The Company reported a net loss of $45.4 million for the three months ended September 30, 2024, and $90.7 million for the nine months ended September 30, 2024[21]. - The company reported a net loss attributable to common stockholders of $45.36 million for the three months ended September 30, 2024, compared to a loss of $32.24 million for the same period in 2023[67]. Expenses - Research and development expenses for the three months ended September 30, 2024, were $36,686, up from $30,638 in the same period of 2023, reflecting an increase of 19%[14]. - Total operating expenses for the nine months ended September 30, 2024, were $145,196, compared to $123,550 for the same period in 2023, an increase of 17%[14]. - Stock-based compensation for the nine months ended September 30, 2024, was $22,868,000, up from $19,828,000 in the prior year, indicating a growth of about 10%[18]. - Cash used in operating activities for the nine months ended September 30, 2024, was $103,678,000, compared to $89,991,000 in 2023, reflecting an increase of approximately 15%[18]. - General and administrative expenses decreased by $0.5 million to $12.1 million for the three months ended September 30, 2024, from $12.6 million in the same period of 2023[87]. Cash and Assets - Cash and cash equivalents as of September 30, 2024, were $123,744, down from $251,177 as of December 31, 2023, a decrease of 51%[13]. - Total assets increased to $723,077 as of September 30, 2024, from $667,588 as of December 31, 2023, an increase of 8%[13]. - Total cash, cash equivalents, and restricted cash at the end of the period was $124,053,000, down from $204,401,000 at the end of September 2023, a decrease of about 39%[18]. - As of September 30, 2024, the Company had cash and cash equivalents of $123.7 million and available-for-sale securities of $525.2 million[119]. Collaborations and Agreements - The Company has entered into a collaboration with GlaxoSmithKline to develop belrestotug in combination with other oncology assets[20]. - The GSK Collaboration Agreement includes an upfront nonrefundable payment of $625.0 million and potential milestone payments of up to $1.45 billion contingent upon achieving certain development and commercial milestones[34]. - The total transaction price for the GSK Collaboration Agreement is $625.0 million, with $35.0 million of revenue recognized during the nine months ended September 30, 2024, related to the dosing of the first patient in the Phase 3 study[37]. Clinical Development - The Company is advancing its lead product candidate, belrestotug, in multiple clinical trials, including a Phase 3 trial for non-small cell lung cancer (NSCLC)[20]. - The Company is also investigating inupadenant (EOS-850) in a Phase 2 trial for post-immunotherapy metastatic NSCLC[20]. - The Company initiated a new program, EOS-984, targeting ENT1 in the adenosine pathway, which is currently in clinical development[20]. - The company is currently enrolling patients in multiple clinical trials, including the Phase 3 GALAXIES Lung-301 trial and the Phase 2 GALAXIES Lung-201 trial, assessing combinations of belrestotug with other oncology assets[69]. Funding and Financial Instruments - Net cash provided by financing activities was $121,956,000 for the nine months ended September 30, 2024, compared to $806,000 in the prior year, indicating a substantial increase[18]. - The company raised a total of $120.0 million from the sale of securities, including a pre-funded warrant to RA Capital for $100.0 million and common stock to Boxer Capital for $20.0 million[43]. - The company has built significant expertise in designing novel cancer immunotherapies and has capabilities to develop both small molecules and antibodies[20]. Tax and Liabilities - The effective tax rates were (5.2)% and (8.0)% for the three and nine months ended September 30, 2024, respectively, differing from statutory rates of 21% and 25% due to investment income and unrecognized tax benefits[9]. - The company incurred an income tax expense of $2.24 million for the three months ended September 30, 2024, despite a loss before income taxes of $43.12 million[9]. - The company recorded an additional liability of $1.1 million and $3.2 million during the three and nine months ended September 30, 2024, related to unrecognized tax benefits[56]. Risks and Future Outlook - The Company expects to continue its focus on research and development to advance its pipeline of product candidates, although specific future revenue projections remain uncertain[8]. - The Company may seek additional funding to reach its development and commercialization objectives, which could affect stockholder rights[21]. - The Company faces risks related to clinical trial results, regulatory approvals, and market acceptance of its product candidates[21]. - The company anticipates that existing cash and cash equivalents will fund operating expenses and capital expenditures through 2027[107].

Core Insights - iTeos Therapeutics is focusing on immunotherapy with a specific emphasis on a molecule targeting TIGIT, particularly in lung cancer, with recent findings presented at ESMO 2024 [2][8] Pipeline Updates - The lead product candidate, belrestotug, is an anti-TIGIT antibody intended to enhance antitumor immunity, especially when combined with dostarlimab (GSK's Jemperli) [3] - The GALAXIES-Lung-301 trial is a pivotal phase 3 study comparing belrestotug plus pembrolizumab against a placebo in patients with advanced, PD-L1-high non-small cell lung cancer (NSCLC) [3][4] - ESMO 2024 revealed initial findings from the GALAXIES Lung-02 study, showing response rates for dostarlimab alone at 37.5%, while combinations with belrestotug yielded response rates between 63.3% and 76.7% [4] Financial Overview - As of the latest quarterly filing, iTeos Therapeutics reported $251.1 million in cash and equivalents, alongside $320.2 million in short-term investments [5] - The company recognized $35 million in collaboration revenue from a milestone payment for the phase 3 trial initiation, with operating expenses of $49.2 million, resulting in a net loss of $7.1 million for the quarter [6] - The adjusted cash burn rate is approximately $42.1 million, indicating a cash runway of 14 to 15 quarters [6] Strengths and Risks - The company has sufficient cash to reach critical milestones, with over three years of cash runway, which is favorable for pursuing necessary data readouts [7] - Clinical activity indicators are strong, with promising response rates from the ESMO data suggesting potential in the TIGIT story for lung cancer [7] - However, there are concerns regarding response rates as a surrogate endpoint and increased treatment-related adverse events, which could impact approval prospects [7] - The patient population for the trial is limited, as only a fraction of advanced NSCLC patients meet the PD-L1 criteria for enrollment [7] Bottom-Line Summary - The data presented at ESMO 2024 indicates significant clinical activity for the anti-TIGIT therapy, suggesting potential upside for iTeos Therapeutics, which is currently valued at around $600 million [8] - Despite preliminary findings and safety concerns, the data aligns with recent trends in improving anti-PD-1 therapy, indicating a promising investment thesis for the company [8]

Core Insights - iTeos Therapeutics announced promising interim data from the GALAXIES Lung-201 study, showing a clinically meaningful objective response rate (ORR) of 63.3-76.7% for the belrestotug + dostarlimab combination in patients with PD-L1 high non-small cell lung cancer (NSCLC) [1][2][4] - The confirmed ORR (cORR) was approximately 60% across all doses, with a significant 30% improvement compared to dostarlimab monotherapy [1][2][4] - The safety profile of the combination therapy was consistent with known safety profiles of checkpoint inhibitor combinations, with manageable immune-related adverse events [1][4] Study Details - The GALAXIES Lung-201 study is a Phase 2 trial evaluating the efficacy and safety of belrestotug + dostarlimab in previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC [7][8] - The study included 124 patients, with a median follow-up of 5.6 months, assessing various dose levels of dostarlimab and belrestotug [3][5] - The primary endpoint is investigator-assessed ORR, with secondary endpoints including safety, progression-free survival, overall survival, and duration of response [8] Efficacy Results - The ORR for the belrestotug + dostarlimab combination was 63.3% for Dose A, 65.6% for Dose B, and 76.7% for Dose C, compared to 37.5% for dostarlimab alone [4][5] - The cORR was 60.0% for each dose of the combination therapy, significantly higher than the 28.1% cORR for dostarlimab monotherapy [4][5] - Median ctDNA reduction was 65% for dostarlimab alone, while reductions were 55%, 94%, and 97% for Doses A, B, and C, respectively [4] Safety Profile - The combination therapy led to an increase in immune-related adverse events compared to dostarlimab alone, with the most common treatment-related adverse events being skin and subcutaneous tissue disorders (50%) and endocrine disorders (26%) [4][10] - The safety profile of belrestotug in combination with dostarlimab aligns with the known safety profile of combination therapies involving checkpoint inhibitors [4] Future Outlook - iTeos plans to initiate the GALAXIES Lung-301 Phase 3 trial based on the encouraging results from the interim analysis of the GALAXIES Lung-201 study [2][4] - A conference call to discuss the interim data will be held on September 16, 2024 [6]

WATERTOWN, Mass. and GOSSELIES, Belgium, Aug. 28, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS) ("iTeos"), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today announced that company management will participate in two upcoming investor conferences in September: 2024 Wells Fargo Healthcare Conference Format: Fireside chat and one-on-one investor meetings Date: Wednesday, September 4, 2024 ...

WATERTOWN, Mass. and GOSSELIES, Belgium, Aug. 20, 2024 (GLOBE NEWSWIRE) -- iTeos Therapeutics, Inc. (Nasdaq: ITOS) ("iTeos"), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients, today announced that interim data from GALAXIES Lung-201, the Phase 2 platform study sponsored by iTeos' development partner GSK, assessing the belrestotug + dostarlimab doublet in previously untreated, unresectable, locally advanced or ...