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. 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 ...

Financial Performance - Total revenue for the three months ended June 30, 2024, was $35,000,000, compared to $12,595,000 for the same period in 2023, representing a significant increase[15]. - The net loss for the three months ended June 30, 2024, was $7,128,000, compared to a net loss of $34,300,000 for the same period in 2023, showing a reduction in losses[15]. - The company reported a basic net loss per common share of $0.18 for the three months ended June 30, 2024, compared to $0.96 for the same period in 2023[15]. - The net loss for the six months ended June 30, 2024, was $45,344,000, compared to a net loss of $49,851,000 for the same period in 2023, showing a decrease in losses[21]. - The Company reported a net loss of $7.1 million and $45.3 million for the three and six months ended June 30, 2024, respectively[25]. - Net cash used in operating activities was $66.3 million for the six months ended June 30, 2024, compared to $56.1 million for the same period in 2023[109]. - Loss before income taxes improved by $28.2 million to $(4.9) million for the three months ended June 30, 2024, from $(33.1) million for the same period in 2023[92]. Research and Development - Research and development expenses for the three months ended June 30, 2024, were $36,709,000, up from $29,186,000 in the same period last year, indicating a 25.5% increase[15]. - The company expects significant increases in research and development costs as current programs progress and new programs are added[1]. - Total allocated research and development expenses for the product candidate Belrestotug were $11.6 million for the three months ended June 30, 2024, compared to $9.6 million in the same period of 2023[1]. - Research and development expenses for the six months ended June 30, 2024, increased by $16.4 million to $71.2 million from $54.9 million for the same period in 2023[101]. - The company expects to continue incurring significant expenses related to ongoing development activities, including clinical trials and regulatory approvals[1]. - The lead product candidate, belrestotug, is currently in multiple clinical trials, including a Phase 3 trial (GALAXIES Lung-301) assessing its efficacy in combination with GSK's anti-PD-1 therapy[22]. Assets and Liabilities - Total current assets increased to $626,605,000 as of June 30, 2024, from $550,652,000 as of December 31, 2023, reflecting a growth of 13.8%[14]. - Total assets reached $751,841,000 as of June 30, 2024, compared to $667,588,000 as of December 31, 2023, marking an increase of 12.6%[14]. - Total liabilities decreased to $87,973,000 as of June 30, 2024, from $92,360,000 as of December 31, 2023, indicating a reduction of 4.1%[14]. - The total fair value of the Company's financial instruments as of June 30, 2024, was $609.684 million, with significant holdings in money market funds and U.S. government securities[27]. - As of June 30, 2024, the total amortized cost of fixed income securities was $433.853 million, with a fair value of $432.984 million, reflecting a $5.0 million difference due to a short-term debt security classified as a cash equivalent[32]. Collaboration and Funding - The Company is focused on maintaining collaborations and strategic relationships to enhance the development of its product candidates[8]. - Under the GSK Collaboration Agreement, the company is eligible to receive up to $1.45 billion in milestone payments contingent upon the belrestotug program achieving certain development and commercial milestones[39]. - The Company recognized $35.0 million in revenue for the three months ended June 30, 2024, related to the dosing of the first patient in the Phase 3 study for GALAXIES-301 in collaboration with GSK[42]. - The Company raised $120.0 million from a Securities Purchase Agreement with RA Capital and Boxer Capital, with $100.0 million from a pre-funded warrant and $20.0 million from common stock sales[48]. - The Company has received grants totaling $10.5 million from the Walloon Region and the European Union to fund research and development activities, reimbursing 55-100% of qualifying expenditures[45]. Stock and Compensation - The Company issued 1,142,857 shares of common stock and pre-funded warrants, net of offering costs, raising $119,574,000[21]. - Total stock-based compensation expense for the three months ended June 30, 2024, was $8.1 million, up from $7.0 million for the same period in 2023, with stock options accounting for $7.2 million[53]. - The weighted average exercise price of stock options outstanding as of June 30, 2024, was $16.44, with an aggregate intrinsic value of $29.8 million[54]. - The Company granted 2,119,270 stock options during the six months ended June 30, 2024, with a weighted average grant-date fair value of $8.70 per share[54]. - The 2020 Employee Stock Purchase Plan (ESPP) had 580,443 shares reserved for issuance as of June 30, 2024, with no increase on January 1, 2024[52]. Tax and Regulatory Matters - The effective tax rate for the three months ended June 30, 2024, was (46.4)%, significantly impacted by investment income from marketable investments[58]. - The Company had accrued interest and penalties relating to uncertain tax positions of $6.0 million as of June 30, 2024[59]. - The Company has recorded a full valuation allowance on net deferred tax assets as of June 30, 2024, due to expectations that these assets will not be realized[124]. Market and Operational Risks - The Company faces risks related to clinical trial outcomes, regulatory approvals, and market acceptance of its product candidates[25]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[106]. - The company anticipates ongoing expenses to increase as it continues clinical stage programs and seeks marketing approval for product candidates[114].

Core Insights - iTeos Therapeutics has appointed Dr. David Feltquate as Chief Medical Officer to oversee clinical development and regulatory strategies [1][2] - The company aims to become a leading oncology firm, leveraging Dr. Feltquate's extensive experience in immuno-oncology [2][3] - iTeos is focused on advancing its pipeline, particularly the TIGIT franchise, to develop innovative therapies for cancer patients [3][4] Company Overview - iTeos Therapeutics is a clinical-stage biopharmaceutical company specializing in immuno-oncology therapeutics [4] - The company utilizes its understanding of tumor immunology to create novel product candidates targeting immunosuppressive pathways [4] - iTeos has three clinical-stage programs aimed at improving clinical outcomes through optimized pharmacologic properties [4] Product Information - Belrestotug (EOS-448/GSK4428859A) is an anti-TIGIT monoclonal antibody designed to enhance antitumor responses [5] - The therapeutic candidate is in development for multiple indications in collaboration with GSK [5]

Core Insights - iTeos Therapeutics has appointed Dr. David Feltquate as Chief Medical Officer to oversee clinical development and regulatory strategies [1][2] - The company aims to become a leading oncology firm, leveraging Dr. Feltquate's extensive experience in immuno-oncology [2][3] - iTeos is focused on advancing its pipeline, particularly the TIGIT franchise, to develop innovative therapies for cancer patients [3][4] Company Overview - iTeos Therapeutics is a clinical-stage biopharmaceutical company specializing in immuno-oncology therapeutics [4] - The company utilizes its understanding of tumor immunology to create novel product candidates targeting immunosuppressive pathways [4] - iTeos has three clinical-stage programs aimed at improving clinical outcomes through optimized pharmacologic properties [4] Product Development - Belrestotug (EOS-448/GSK4428859A) is an anti-TIGIT monoclonal antibody designed to enhance antitumor responses [5] - The therapeutic candidate is in development for multiple indications in collaboration with GSK [5]