iTeos Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates

- 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

- Completed enrollment of second dose cohort of EOS-984 + pembrolizumab combination in ongoing Phase 1 trial

- EOS-215 Phase 1 trial TRM-010 patient enrollment anticipated to begin in 2Q25

- Cash balance and investment balance of $655.0 million as of December 31, 2024 expected to provide runway through 2027

WATERTOWN, Mass. and GOSSELIES, Belgium, March 05, 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 fourth quarter and full year ended December 31, 2024 and provided a business update.

"Our team's strong focus and execution over the last twelve months lay the groundwork for a potential breakthrough year for iTeos in 2025. As we advance multiple trials evaluating belrestotug + dostarlimab in collaboration with GSK, we look forward to the topline interim results from GALAXIES Lung-201 in the second quarter of 2025 as they will play a key role in shaping the next phase of our lead program's development," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "At the same time, we continue to accelerate two Phase 1 therapeutic candidates with best- or first-in-class potential that could fundamentally reshape the immuno-oncology field. With $655 million in cash and runway through 2027, we are poised to take bold steps forward to progress our innovative science and deliver novel therapies to those who need these most."

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 
 
          -- Investigative New Drug $(IND.AU)$ application was submitted and allowed 
             to proceed for a Phase 1 of EOS-215. Patient enrollment is 
             anticipated in 2Q25. 

Fourth Quarter and Full Year 2024 Financial Results

   -- Cash and Investment Position: The Company's cash and investments position 
      was $655.0 million as of December 31, 2024, as compared to $632.5 million 
      as of December 31, 2023.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 $37.5 million 
      and $145.4 million for the fourth quarter and year ended December 31, 
      2024, respectively, as compared to $27.9 million and $113.3 million for 
      the same quarter and year ended in 2023, respectively. The increases 
      compared to the comparative periods were primarily due to increases in 
      activities related to the belrestotug program, including the launching of 
      the GALAXIES Lung-301 Phase 3 trial. The increases were also due to 
      increased activities relating to the EOS-984 and EOS-215 programs, and 
      included the addition of new R&D employees hired to help advance these 
      programs. 
 
   -- General and Administrative (G&A) Expenses: G&A expenses were $11.8 
      million and $49.1 million for the quarter and year ended December 31, 
      2024, respectively, as compared to $12.4 million and $50.4 million for 
      the same quarter and year in 2023, respectively. The decreases were 
      primarily due to decreases in insurance expenses, recruiting expenses, 
      and various other general and administrative expenses. These were 
      partially offset by an increase in compensation and stock-based 
      compensation expenses for G&A employees, and also an increase in 
      professional fees. 
 
   -- Net Income/Loss: Net loss was $43.7 million, or net loss of $1.01 per 
      basic and diluted share for the quarter ended December 31, 2024, as 
      compared to a net loss of $30.6 million, or a net loss of $0.85 per basic 
      and diluted share for the quarter ended December 31, 2023. Net loss was 
      $134.4 million, or net loss of $3.32 per basic and diluted share for the 
      year ended December 31, 2024, as compared to a net loss of $112.6 million, 
      or a net loss of $3.15 per basic and diluted share for the year ended 
      December 31, 2023. 

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 Fc<GAMMA>R, 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.

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