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 ...

ITeos Therapeutics, Inc. (ITOS) came out with a quarterly loss of $0.18 per share versus the Zacks Consensus Estimate of a loss of $1.04. This compares to loss of $0.96 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 82.69%. A quarter ago, it was expected that this company would post a loss of $1.02 per share when it actually produced a loss of $1.07, delivering a surprise of -4.90%. Over the last four quarters, the company h ...

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 June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |---------------------------------------------------------------------------------------|------------------------------------------| | | | | For the transition period from ______ ...

WATERTOWN, Mass. and GOSSELIES, Belgium, Aug. 05, 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 the appointment of David Feltquate, M.D., Ph.D., as Chief Medical Officer. In this role, Dr. Feltquate will be responsible for overseeing the Company's clinical development and regulatory strategies. "As iTeos reaches a ...