– 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 generation of immuno-oncology therapeutics for patients, today reported financial results for the first quarter ended March 31, 2025 and provided a business update.
“The second quarter marks a significant inflection point for iTeos with the next interim assessment from GALAXIES Lung-201, which includes the initial 124 patients presented at ESMO 2024 and 120 additional patients. Throughout each stage of development, we have generated differentiated data, setting the high-quality belrestotug + dostarlimab doublet apart from the TIGIT field. With this next interim dataset, we and GSK have established a rigorous threshold for advancement – the presence of a clear progression free survival signal and trend in the totality of clinical data consistent with the robust tumor reduction we observed from belrestotug + dostarlimab in our last interim assessment. While the preliminary findings to date are encouraging, we remain focused on ensuring further investment is grounded in clear evidence of meaningful benefit in the doublet cohorts versus PD-1 monotherapy,” said Michel Detheux, Ph.D., president and chief executive officer of iTeos. “We look forward to providing an update on this dataset in the near term. Additionally, we have made meaningful progress against the ambitious goals we set at the start of the year, and our early pipeline continues to advance at a strong pace.”
Program Highlights
Belrestotug (EOS-448/GSK4428859A): IgG1 anti-TIGIT monoclonal antibody in development for the first-line treatment of locally advanced or metastatic PDL1-selected non-small cell lung cancer (NSCLC) and for the first-line treatment of PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) in collaboration with GSK.
- GALAXIES Lung-301
- Enrollment ongoing globally in 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.
- GALAXIES Lung-201
- Topline interim data from open label Phase 2 platform study assessing belrestotug + dostarlimab doublet and a triplet with GSK’s investigational anti-CD96 antibody, nelistotug, in first-line advanced / metastatic PD-L1 high NSCLC anticipated in 2Q25 to include safety, ORR, and ctDNA data from >240 patients, with pembrolizumab monotherapy ORR for 30 patients and PFS data from initial 124 patients treated. Data are expected to be submitted for presentation at a scientific congress in 2H 2025.
- GALAXIES H&N-202
- Interim data from Phase 2 platform study assessing belrestotug + dostarlimab doublet and triplet with nelistotug in first-line patients with PD-L1 positive recurrent/metastatic HNSCC anticipated in 2025 to include safety and ORR from >150 patients.
- TIG-006 HNSCC
- Topline data from the TIG-006 study in cohorts 2C & 2D assessing belrestotug + dostarlimab doublet in first-line PD-L1 positive advanced / metastatic HNSCC anticipated in 2025 to include safety, ORR, and PFS from a total of 42 patients.
EOS-984: Potential first-in-class small molecule in oncology inhibiting ENT1, a dominant transporter of adenosine involved in T cell metabolism, expansion, effector function, and survival.
- APT-008
- Completed enrollment of the second dose cohort of the EOS-984 + pembrolizumab combination portion and continued advancement in the combination dose escalation of the Phase 1 trial in advanced malignancies.
- Topline data assessing EOS-984 as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors anticipated in 2H25.
EOS-215: Potential best-in-class anti-TREM2 with a novel mechanism of action blocking monoclonal antibody targeting tumor-associated macrophages to reprogram the tumor microenvironment.
- TRM-010
- Initiated patient dosing in a Phase 1/1b dose escalation and expansion cohort trial assessing EOS-215 as a monotherapy and in combination with pembrolizumab in selected advanced solid tumors.
First Quarter 2025 Financial Results
- Cash and Investment Position: The Company’s cash and investments position was $624.3 million as of March 31, 2025, as compared to $595.0 million, which included $13.0 million of receivables from matured investments recorded in prepaid expenses and other current assets on the balance sheet, as of March 31, 2024.The Company expects its cash balance to provide runway through 2027, which includes the potential initiation of multiple Phase 3 registrational trials assessing the belrestotug + dostarlimab doublet.
- Research and Development (R&D) Expenses: R&D expenses were $29.0 million for the first quarter ended March 31, 2025 as compared to $34.5 million for the same quarter ended in 2024. The decrease compared to the comparative period was primarily due to the varying phasing of the multiple belrestotug studies, including the winding down of certain studies. The decrease was also in part due to the discontinuation of the inupadenant program. The decrease was partially offset by increased activities relating to the EOS-984 and EOS-215 programs.
- General and Administrative (G&A) Expenses: G&A expenses were $11.0 million for the quarter ended March 31, 2025 as compared to $12.7 million for the same quarter in 2024. The decrease was primarily due to decreases in stock-based compensation expense and professional fees. These were partially offset by an increase in commercial related expenses and other general and administrative expenses.
- Net Income/Loss: Net loss was $34.6 million, or net loss of $0.80 per basic and diluted share for the quarter ended March 31, 2025, as compared to a net loss of $38.2 million, or a net loss of $1.07 per basic and diluted share for the quarter ended March 31, 2024.
About iTeos Therapeutics, Inc.
iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients. iTeos Therapeutics leverages its deep understanding of tumor immunology and immunosuppressive pathways to design novel product candidates with the potential to restore the immune response against cancer. The Company’s innovative pipeline includes three clinical-stage programs targeting novel, validated immunosuppressive pathways designed with optimized pharmacologic properties for improved clinical outcomes, including the TIGIT/CD226 axis and the adenosine pathway. iTeos Therapeutics is headquartered in Watertown, MA with a research center in Gosselies, Belgium.
About Belrestotug (EOS-448/ GSK4428859A)
Belrestotug is an Fc active human immunoglobulin G1, or IgG1, monoclonal antibody (mAb) targeting T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT), an important inhibitory receptor which contributes to the suppression of adaptive and innate immune responses against cancer. As an optimized high-affinity, potent anti-TIGIT mAb, belrestotug is designed to enhance the antitumor response through a multifaceted immune modulatory mechanism by engaging with TIGIT and FcγR, a key regulator of immune responses which induces cytokine release and antibody dependent cellular cytotoxicity (ADCC). The therapeutic candidate is progressing in multiple indications in collaboration with GSK.
About EOS-984
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. The therapeutic candidate has the potential to fully reverse the profound immunosuppressive action of adenosine on T and B cells and is in Phase 1 development.
About EOS-215
EOS-215 is a potential best-in-class monoclonal antibody which antagonizes triggering receptor expressed on myeloid cells 2 (TREM2). The antibody is designed to block ligand binding and switch off the multiple tumor growth and survival promoting activities of tumor resident macrophages. EOS-215 has been shown preclinically to have a profound impact on macrophage function, promoting multiple anti-tumor mechanisms including T cell activation. The therapeutic candidate’s multiple mechanisms of action have been shown to translate to activity in highly immune resistant models and has completed IND-enabling studies.
Internet Posting of Information
iTeos routinely posts information that may be important to investors in the ‘Investors’ section of its website at www.iteostherapeutics.com. The Company encourages investors and potential investors to consult our website regularly for important information about iTeos.
Forward-Looking Statements
This press release contains forward-looking statements. Any statements that are not solely statements of historical fact are forward-looking statements. Words such as “believe,” “anticipate,” “plan,” “expect,” “will,” “may,” “intend,” “prepare,” “look,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements relating to the potential benefits of our product candidates; our plans and expected milestones, including having topline interim data from GALAXIES Lung-201 in 2Q25 that includes safety, ORR, and ctDNA data from > 240 patients, with pembrolizumab monotherapy ORR for 30 patients and PFS data from initial 124 patients treated, our expectation to submit data from GALAXIES Lung-201 for presentation at a scientific congress in 2H 2025, having interim data from GALAXIES H&N-202 in 2025 that include safety and ORR from a total of >150 patients, having topline data from the first portion of TIG-006 study in cohorts 2C & 2D in 2025 that include safety, ORR, and PFS from a total of 40 patients, having topline data assessing EOS-984 as a monotherapy and in combination with pembrolizumab in patients with advanced solid tumors in 2H25; our plan to ensure that further investment in belrestotug is grounded in clear evidence of meaningful benefit in the doublet cohorts versus PD-1 monotherapy; and our expectation that our cash balance and investment balance will provide runway through 2027.
These forward-looking statements involve risks and uncertainties, many of which are beyond iTeos’ control. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: the expected benefits and opportunities related to the agreement between iTeos and GSK may not be realized or may take longer to realize due to a variety of reasons, including any inability of the parties to perform their commitments and obligations under the agreement, challenges and uncertainties inherent in product research and development and manufacturing limitations; success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and early results from a clinical trial do not necessarily predict final results; interim and early data may change as more patient data become available and are subject to audit and verification procedures; the data for our product candidates may not be sufficient for obtaining regulatory approval to move into later stage trials or to commercialize products; iTeos may encounter unanticipated costs or may expend cash more rapidly or more slowly than currently anticipated due to challenges and uncertainties inherent in product research and development and biologics manufacturing; iTeos may not be able to execute on its business plans, including meeting its expected or planned regulatory milestones and timelines, research and clinical development plans, and bringing its product candidates to market, for various reasons, some of which may be outside of iTeos’ control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, negative developments in the field of immuno-oncology, such as adverse events or disappointing results, including in connection with competitor therapies, and regulatory, court or agency decisions such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates; and those risks identified under the heading “Risk Factors” in iTeos’ Quarterly Report on Form 10-Q for the 3-month period ended March 31, 2025 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review. Statements regarding the Company’s cash runway do not indicate when or if the Company may access the capital markets.
Any of the foregoing risks could materially and adversely affect iTeos’ business, results of operations and the trading price of iTeos’ common stock. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. iTeos does not undertake any obligation to publicly update its forward-looking statements other than as required by law.
CONTACT: For further information, please contact: Investor Contact: Carl Mauch iTeos Therapeutics, Inc. carl.mauch@iteostherapeutics.com Media Contact: media@iteostherapeutics.com
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