On March 6, 2024 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, 2023 and provided a business update (Press release, iTeos Therapeutics, MAR 6, 2024, View Source [SID1234640875]).
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"As we anticipate four clinical readouts across the portfolio, 2024 is poised to be a transformative year for iTeos," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "With the recent developments in the TIGIT field, we believe belrestotug is in an advantageous position and are excited for its future prospects. We look forward to sharing updates from our Phase 2 trials focused on 1L NSCLC and 1L HNSCC in 2024. Additionally, our strong comprehension of the adenosine pathway has enabled us to develop two innovative and optimized assets – inupadenant, an A2AR antagonist in a class of its own, and EOS-984, a potential first-in-class inhibitor targeting the novel mechanism of ENT1. With our strategic cash position and robust pipeline, we are focused on the execution of these clinical trials to deliver on our highly anticipated milestones this year."
Corporate Developments
On March 6, 2024, iTeos announced the appointment of Jill DeSimone to the Company’s Board of Directors. With over 40 years of global business expertise in life sciences, Ms. DeSimone is recognized for her role as President of U.S. Oncology at Merck & Co., Inc., where she established the company’s oncology division, growing it from less than $500 million in annual revenue to $9 billion in eight years.
On December 7, 2023, iTeos announced the appointment of David K. Lee to the Company’s Board of Directors. A seasoned pharmaceutical veteran with a proven track record of building successful businesses focused on oncology and rare diseases, Mr. Lee currently serves as the Chief Executive Officer of Servier Pharmaceuticals (U.S.), where he established and grew Servier Pharmaceuticals to a fully innovative oncology company with four commercialized products and a robust pipeline.
Program Highlights
Belrestotug (EOS-448/GSK4428859A): IgG1 anti-TIGIT monoclonal antibody targeting first-line non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) in collaboration with GSK
Preparation underway for Phase 3 registrational studies that will evaluate the belrestotug + dostarlimab doublet
GALAXIES Lung-201: topline data from Phase 2 platform trial assessing belrestotug + dostarlimab doublet in first-line advanced/metastatic NSCLC anticipated in 2024
GALAXIES H&N-202: enrollment ongoing in Phase 2 platform study assessing belrestotug + dostarlimab doublet and a triplet with GSK’s investigational anti-CD96 antibody (GSK’608) in first-line patients with PD-L1 positive recurrent / metastatic HNSCC
TIG-006 HNSCC: topline data from Phase 2 expansion trial assessing belrestotug + dostarlimab doublet in first-line PD-L1 positive advanced or metastatic HNSCC anticipated in 2024
TIG-006 mNSCLC: enrollment ongoing in Phase 1b expansion trial assessing belrestotug, dostarlimab, and chemotherapy triplet in first-line advanced or metastatic NSCLC
Continued advancement of Phase 1b trials exploring two novel triplets in advanced solid tumors: belrestotug + dostarlimab and GSK’s investigational anti-CD96 antibody (GSK’608), and belrestotug + dostarlimab and GSK’s investigational anti-PVRIG antibody (GSK’562)
Adenosine Pathway
Inupadenant (EOS-850): insurmountable small molecule antagonist targeting adenosine A2A receptor in second-line NSCLC
A2A-005: Data from the dose escalation portion of the Phase 2 trial with inupadenant and platinum-doublet chemotherapy in post-IO metastatic non-squamous NSCLC anticipated in late 2024.
EOS-984: first-in-class small molecule inhibiting equilibrative nucleoside transporter 1 (ENT1), a dominant transporter of adenosine on lymphocytes involved in T cell metabolism, expansion, effector function, and survival
Completed enrollment of the third dose cohort and continued advancement in the dose escalation of the Phase 1 trial in advanced malignancies
Abstract acceptance by The American Association for Cancer Research (AACR) (Free AACR Whitepaper) for EOS-984, which highlights preclinical data on the novel mechanism of action, monotherapy activity, and combination activity with anti-PD-1 therapy
Oral presentation by Matthew Vander Heiden, M.D., Ph.D., from the Koch Institute for Integrative Cancer Research in collaboration with iTeos Therapeutics on the role of ENT1 on the metabolism and the immune system in cancer at The SITC (Free SITC Whitepaper) Spring Scientific, Metabolism at the Hub of Cancer and Immunity in Miami, FL
Session: Influence of Nutrient Environment on Immune Response
Date and Time: Sunday, March 10, 2024, 9:10 AM – 10:10AM
Topline data from the Phase 1 trial anticipated in the second half of 2024
Fourth Quarter and Full Year 2023 Financial Results
Cash and Investment Position: The Company’s cash, cash equivalents, and investments position was $632.7 million as of December 31, 2023, as compared to $731.4 million as of December 31, 2022. The Company continues to expect its cash balance to provide runway through 2026.
Research and Development (R&D) Expenses: R&D expenses were $27.9 million for the fourth quarter and $113.3 million for the year ended December 31, 2023, as compared to $25.4 million for the fourth quarter and $97.4 million for the year ended December 31, 2022. The increases in each comparative period were primarily due to increases in activities related to the belrestotug, inupadenant, and EOS-984 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 $12.4 million for the fourth quarter and $50.4 million for the year ended December 31, 2023, as compared to $11.1 million for the fourth quarter and $43.9 million for the year ended December 31, 2022. The increases were primarily due to increases in headcount and related costs and an increase in stock-based compensation compared to the prior year. The increases were partially offset by a decrease in recruiting costs.
Net Income/Loss: Net loss attributable to common shareholders was $30.6 million, or net loss of $0.85 per basic and diluted share for the quarter ended December 31, 2023, as compared to a net income of $20.5 million, or a net income of $0.57 per basic share and $0.54 per diluted share for the quarter ended December 31, 2022. Net loss was $112.6 million, or net loss of $3.15 per basic and diluted share, for the year ended December 31, 2023, as compared to a net income of $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.