On November 10, 2022 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 third quarter ended September 30, 2022 and provided corporate highlights (Press release, iTeos Therapeutics, NOV 10, 2022, View Source [SID1234623876]).
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"We’ve continued on the path of progress in the third quarter of 2022 in both of our lead programs – most notably, initiating the randomized Phase 2 clinical trial evaluating the combination of EOS-448 and the anti-PD-1, dostarlimab, in first-line, metastatic non-small cell lung cancer (NSCLC) with our partners at GSK," said Michel Detheux, Ph.D., president, and chief executive officer of iTeos. "The recently announced topline results from the head-to-head trial evaluating GSK’s dostarlimab plus chemotherapy versus pembrolizumab plus chemotherapy in first-line metastatic non-squamous NSCLC reinforce the value of our transformational partnership with GSK as we continue to advance our robust clinical programs. We believe with our ability to evaluate novel combinations of our therapeutic candidates and by leveraging our expertise in tumor biology, we remain in a strong position to succeed in our mission to bring a new generation of treatment options to those living with cancer."
Program Highlights
EOS-448/GSK4428859A: IgG1 anti-TIGIT monoclonal antibody designed to engage the Fc gamma receptor (FcγR) and to enhance the anti-tumor response through multifaceted mechanisms.
In collaboration with GSK, iTeos is evaluating EOS-448 as a potential next-generation immuno-oncology agent through multiple combination studies. Highlights include:
Initiation of a randomized Phase 2 trial assessing the doublet of GSK’s anti-PD-1, dostarlimab, with EOS-448 in previously untreated advanced / metastatic (NSCLC).
An ongoing Phase 2 expansion study assessing the doublet of GSK’s anti-PD-1 dostarlimab with EOS-448 in 1L advanced or metastatic head and neck squamous cell carcinoma.
Continued exploration of a novel triplet of EOS-448 with dostarlimab and GSK’s investigational anti-CD96 antibody in a Phase 1b trial.
Advancement of the monotherapy dose escalation part of a Phase 1/2 trial evaluating EOS-448 as both a monotherapy and in combination with Bristol Myers Squibb’s iberdomide in multiple myeloma.
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:
Phase 2 trial ongoing in post-IO metastatic non-squamous NSCLC to evaluate the combination of inupadenant with platinum-doublet chemotherapy compared to standard platinum-doublet chemotherapy.
Enrollment is ongoing in the biomarker-high cohort of IO-001, the Phase 1b/2a trial, evaluating inupadenant as a monotherapy in patients with solid tumors selected for high biomarker expression.
The Phase 2a trial evaluating inupadenant in combination with pembrolizumab in PD-1 resistant melanoma remains ongoing.
Preclinical programs: iTeos is pursuing research programs focused on novel targets that address pathways of immunosuppression. Investigational New Drug-enabling studies are ongoing for EOS-984, an investigational candidate targeting a first-in-class mechanism in the adenosine pathway.
Third Quarter 2022 Financial Results
Cash Position: The company’s cash and cash equivalent position was $752.2 million as of September 30, 2022, as compared to $899.8 million as of September 30, 2021. The company continues to expect its cash balance to provide runway into 2026.
Research and Development (R&D) Expenses: R&D expenses were $23.9 million for the quarter ended September 30, 2022, as compared to $16.1 million for the same quarter of 2021. The increase was primarily due to an increase in activities related to EOS-448 and inupadenant clinical trials.
General and Administrative (G&A) Expenses: G&A expenses were $10.8 million for the quarter ended September 30, 2022, as compared to $8.8 million for the same quarter of 2021. The increase was primarily due to an increase in headcount and related costs compared to the same quarter last year. This increase was partially offset by decreases in legal and other fees in the quarter.
Net Income/Loss: Net income attributable to common shareholders was $1.0 million, or net income of $0.03 per basic and diluted share, for the quarter ended September 30, 2022, as compared to a net income of $69.6 million, or a net income of $1.98 per basic share and $1.86 per diluted share, for the same quarter of 2021.