On August 8, 2023 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, reported financial results for the second quarter ended June 30, 2023 and provided a business update (Press release, iTeos Therapeutics, AUG 8, 2023, View Source [SID1234634007]).
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"Our team continues to bring forward innovation in immunotherapy through our differentiated development pipeline, which is expected to make significant progress in the second half of 2023," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "To start, with GSK’s anti-PD-1 mAb, dostarlimab, as the backbone for our ambitious TIGIT-based clinical development plans, we remain confident that its combination with belrestotug has the potential to become a best-in-class program. Furthermore, we are continuing to build our position as a leader unlocking the adenosine pathway with the announcement of enrolling patients in the Phase 1 trial of EOS-984. This program will deepen our understanding of the mechanisms of adenosine-mediated immunosuppression and potentially reinforce the unique, insurmountable profile of inupadenant. Based on the progression of our 9 ongoing clinical trials and solid cash position with runway into 2026, we believe we are poised for an abundance of opportunity in 2024, including the presentation of TIGIT data from the Phase 2 clinical trials treating patients with NSCLC and HNSCC."
Program Highlights:
Belrestotug (EOS-448/GSK4428859A): IgG1 anti-TIGIT monoclonal antibody designed to
engage the Fc gamma receptor (FcγR) and enhance the anti-tumor response through multifaceted mechanisms.
In collaboration with GSK, late-stage development of belrestotug as a potential next-generation immuno-oncology (IO) agent through multiple combination studies are progressing as expected. We plan to present related datasets in 2024. Preparation is underway for Phase 3 registrational studies evaluating belrestotug and dostarlimab combination.
The ongoing trials include:
Randomized Phase 2 trial assessing the doublet of dostarlimab with belrestotug in previously untreated advanced / metastatic non-small cell lung cancer (NSCLC).
Phase 2 expansion study assessing the doublet of dostarlimab with belrestotug in first line advanced or metastatic head and neck squamous cell carcinoma (HNSCC).
Phase 1b trials exploring the addition of chemotherapy and two novel triplets in selected advanced solid tumors: belrestotug with dostarlimab and GSK’s investigational anti-CD96 antibody, and belrestotug with dostarlimab and GSK’s investigational anti-PVRIG antibody.
Additional studies include the continued advancement of the monotherapy dose escalation part of a Phase 1/2 trial evaluating belrestotug as both a monotherapy and in combination with Bristol Myers Squibb’s iberdomide in multiple myeloma.
Adenosine Pathway
Inupadenant (EOS-850): Designed as an insurmountable and highly selective small molecule antagonist of the adenosine A2A receptor, the only high-affinity adenosine receptor expressed on multiple immune cells found in the tumor microenvironment. Highlights include:
Progression of the ongoing two-part Phase 2 trial in post-IO metastatic non-squamous NSCLC to evaluate the combination of inupadenant with platinum-doublet chemotherapy compared to standard platinum-doublet chemotherapy.
EOS-984: First-in-class small molecule program targeting a novel mechanism in the adenosine pathway.
The company has initiated enrolling patients in its Phase 1 trial of EOS-984.
This complementary clinical development program has the potential to fully reverse the profound immunosuppressive action of adenosine on T and B cells. EOS-984’s effects have been shown preclinically to be enhanced by combining with inupadenant and other standards of care.
Second Quarter 2023 Financial Results
Cash and Investment Position: The company’s cash, cash equivalents, and investments position was $677.5 million as of June 30, 2023, as compared to $791.9 million as of June 30, 2022. The company continues to expect its cash balance to provide runway into 2026.
Research and Development (R&D) Expenses: R&D expenses were $29.2 million and $54.9 million for the quarter and six months ended June 30, 2023, respectively, as compared to $26.9 and $48.0 million for the same quarter and six months of 2022, respectively. The increases in each comparative period were primarily due to increases in activities related to the belrestotug, inupadenant, and EOS-984 programs.
General and Administrative (G&A) Expenses: G&A expenses were $13.4 million and $25.4 million for the quarter and six months ended June 30, 2023, respectively, as compared to $11.5 million and $22.1 million for the same quarter and six months of 2022, respectively. The increases were primarily due to increases in headcount and related costs compared to the same quarter and six months last year.
Net Income/Loss: Net loss attributable to common shareholders was $34.3 million, or net loss of $0.96 per basic and diluted share for the quarter ended June 30, 2023, as compared to a net income of $5.6 million, or a net income of $0.16 per basic share and $0.15 per diluted share for the same quarter of 2022. Net loss attributable to common shareholders was $49.9 million, or net loss of $1.39 per basic and diluted share for the six months ended June 30, 2023, as compared to a net income of $75.2 million, or a net income of $2.12 per basic share and $1.98 per diluted share for the same six months of 2022.