On March 15, 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 fourth quarter and full year ended December 31, 2022 (Press release, iTeos Therapeutics, MAR 15, 2023, View Source [SID1234628829]).
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"Building off a successful year of execution in 2022, we continue to advance our robust portfolio of programs through multiple trials with strong financial resources that are expected to provide cash runway into 2026," said Michel Detheux, Ph.D., president, and chief executive officer of iTeos. "Alongside our valued partner GSK, we aim to make significant progress in 2023 in our broad and differentiated development plan for EOS-448, our anti-TIGIT antibody. This includes executing two Phase 2 studies of the doublet with GSK’s anti-PD-1, Jemperli (dostarlimab) and clinical progress with novel triplets. We also remain on track to launch upcoming pivotal trials of EOS-448 in combination with dostarlimab."
Continued Dr. Detheux, "We are progressing in our efforts to unlock the potential of the adenosine pathway. We believe that through our differentiated inupadenant program and unique and targeted approach, we are positioned for success in this important mechanism of immunosuppression. We continue to assess our proprietary biomarker for indication and patient selection. We are encouraged by the recently disclosed monotherapy response, which we are pleased to see is now a confirmed partial response, in a patient who had the highest level of the biomarker that we have recorded to date. We have decided to prioritize development of inupadenant in our ongoing study in combination with platinum-doublet chemotherapy in patients with chemo-naïve NSCLC as we have determined that the post-PD-1 melanoma setting is not a path to accelerated approval. This is consistent with our disciplined investment approach, and we continue to focus our internal resources and capital on our most promising discovery and development programs."
Clinical Development Plans
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, iTeos is evaluating EOS-448 as a potential next-generation immuno-oncology agent in multiple combination studies. Highlights include:
Ongoing randomized Phase 2 trial assessing the doublet of dostarlimab with EOS-448 in previously untreated advanced / metastatic non-small cell lung cancer (NSCLC).
Ongoing Phase 2 expansion study assessing the doublet of dostarlimab with EOS-448 in 1L advanced or metastatic head and neck squamous cell carcinoma.
Continued exploration of two novel triplets in selected advanced solid tumors both in Phase 1b trials: EOS-448 with dostarlimab and GSK’s investigational anti-CD96 antibody, and EOS-448 with dostarlimab and GSK’s investigational anti-PVRIG antibody.
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.
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:
Enrolling in the dose ranging part (Part 1) of an 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.
Completed enrollment in the biomarker-high cohort evaluating inupadenant as a monotherapy in patients with advanced solid tumors selected for high biomarker expression.
Completed enrollment in the Phase 2a trial evaluating inupadenant in combination with pembrolizumab in post-PD-1 melanoma.
Confirmed partial response using inupadenant in monotherapy in a patient who had the highest level of the biomarker that we have recorded to date.
iTeos will present a poster at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place from April 14-19, 2023, in Orlando, Florida. The poster presentation will further explore the biomarker findings and highlight a new mechanism of action of inupadenant based on the evaluation of tumor biopsies from treated patients and additional translational work.
EOS-984: First-in-class small molecule program targeting a novel mechanism in the adenosine pathway.
This clinical development program has the potential to fully reverse the profound immunosuppressive action of adenosine on T and B cells. EOS-984 effects have been shown preclinically to be enhanced by combining with inupadenant and other standards of care.
The company completed Investigational New Drug / Clinical Trials Application-enabling activities including toxicity studies and anticipates initiating clinical studies for EOS-984 in mid-2023.
Fourth Quarter and Full Year 2022 Financial Results
Cash and Investment Position: The Company’s cash, cash equivalents and investments position was $731.4 million as of December 31, 2022, as compared to $848.5 million of cash and cash equivalents as of December 31, 2021. The Company continues to expect its cash and investment position to provide runway into 2026.
Research and Development (R&D) Expenses: R&D expenses were $25.4 million for the fourth quarter and $97.4 million for the year ended December 31, 2022, as compared to $17.4 million for the fourth quarter and $59.4 million for the year ended December 31, 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 $11.1 million for the fourth quarter and $43.9 million for the year ended December 31, 2022, as compared to $9.6 million for the fourth quarter and $40.5 million for the ended December 31, 2021. The increase was primarily due to an increase in headcount and related costs and an increase in stock-based compensation compared to the prior year. This increase was partially offset by decreases in legal and other professional fees compared to the prior year.
Net Income/Loss: Net income attributable to common shareholders was $20.5 million, or a net income of $0.57 per basic share and $0.54 of per diluted share, for the quarter ended December 31, 2022, as compared to a net income of $184.9 million, or a net income of $5.24 per basic share and $4.88 per diluted share, for the quarter ended December 31, 2021. Net income was $96.7 million, or net income of $2.72 per basic share and $2.56 per diluted share, for the year ended December 31, 2022, as compared to a net income of $214.5 million, or a net income of $6.10 per basic share and $5.68 per diluted share, for the year ended December 31, 2021.