On November 10, 2021 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, reported financial results for the third quarter ended September 30, 2021 and provided recent business highlights (Press release, iTeos Therapeutics, NOV 10, 2021, View Source [SID1234595275]).
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"We continued to make significant clinical progress advancing our next-generation immunotherapies in multiple cancer indications. We officially closed our transformational collaboration with GSK, allowing us to initiate novel immunotherapy combinations with the potential to improve outcomes for patients. This includes pairing GSK’s recently approved anti-PD-1, Jemperli (dostarlimab) with our anti-TIGIT monoclonal antibody, EOS-448, and with both EOS-448 and our highly differentiated clinical-stage A2A adenosine receptor antagonist, inupadenant," said Michel Detheux, Ph.D., president and chief executive officer of iTeos. "We are pleased to have started executing our accelerated clinical development plans, initiating dosing in cohorts evaluating EOS-448 in combination with pembrolizumab and with inupadenant. We have also begun dosing patients with PD-1 resistant melanoma in a trial evaluating inupadenant plus pembrolizumab. We remain focused on converting our scientific innovation into improved clinical outcomes for patients and plan to initiate multiple trials of additional combinations in the coming months."
Program Highlights
EOS-448: IgG1 anti-TIGIT monoclonal antibody designed to engage the Fc gamma receptor (FcγR) and to enhance the anti-tumor response through a multifaceted mechanism.
In July 2021, iTeos closed its development and commercialization collaboration agreement with GSK for EOS-448 which was first announced in June 2021. iTeos received the full $625 million upfront payment and is eligible to receive up to $1.45 billion in potential milestone payments upon the achievement of certain development and commercial milestones as part of the agreement.
iTeos and GSK are advancing various novel combinations of potential next generation immuno-oncology agents. Two trials will be initiated in the coming months. The first, assessing the doublet of GSK’s anti-PD-1, (dostarlimab), with EOS-448 and the second, a triplet of this combination adding inupadenant.
In September, iTeos dosed the first patients in a clinical trial of EOS-448 in combination with pembrolizumab and in combination with inupadenant in patients with solid tumors.
The company will initiate a clinical trial in the first quarter of 2022 evaluating EOS-448 as both a monotherapy and in combination with Bristol Myers Squibb’s iberdomide in patients with 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 different immune cells found in the tumor micro-environment.
iTeos has completed patient enrollment in the cohort evaluating the safety of inupadenant in combination with chemotherapy and with pembrolizumab as well as the monotherapy expansion cohort in prostate cancer.
The company has initiated an expansion cohort evaluating inupadenant in combination with pembrolizumab in patients with PD-1-resistant melanoma.
Based on results presented at ASCO (Free ASCO Whitepaper) in June 2021, demonstrating that A2A receptor expression is associated with clinical outcomes in patients with solid tumors treated with single agent inupadenant, iTeos plans to explore a patient selection biomarker in the ongoing Phase 1b/2a trial.
The company plans to advance inupadenant into randomized controlled trials in combination based on the established safety and tolerability profile in combinations and encouraging clinical data observed to date.
Preclinical programs: iTeos continues to progress research programs focused on additional targets that address pathways of immunosuppression and complement the mechanism of action of the A2AR and TIGIT programs. As previously guided, iTeos has nominated an additional candidate targeting a new mechanism in the adenosine pathway for Investigational New Drug-enabling studies.
Upcoming Events
Piper Sandler 33rd Annual Healthcare Conference, November 30 – December 2, 2021
Third Quarter 2021 Financial Results
Cash Position: The Company had cash and cash equivalents of $899.8 million as of September 30, 2021, compared to $340.0 million as of September 30, 2020. This cash balance provides a runway into 2026.
License Revenue: License revenue was $104.3 million for the quarter ended September 30, 2021, compared with $0 million for the same quarter of 2020. This revenue was due to the recognition of a portion of the upfront payment received as a result of the license and collaboration agreement with GSK during the quarter. Additional information regarding revenue recognition related to the collaboration agreement will be included in the company’s Form 10-Q for the quarter ended September 30, 2021.
Research and Development (R&D) Expenses: R&D expenses were $16.1 million for the quarter ended September 30, 2021, compared to $8.7 million for the same quarter of 2020. This increase was primarily due to an increase in activities related to clinical trials for EOS-448 and inupadenant, increased spending for the company’s preclinical programs and increased headcount.
General and Administrative (G&A) Expenses: G&A expenses were $8.8 million for the quarter ended September 30, 2021, compared to $4.8 million for the same quarter of 2020. This increase was primarily due to increased headcount, professional fees and other costs associated with becoming a public company
Net Income/Loss: Net income attributable to common shareholders was $69.6 million, or a net income of $1.98 per basic share and $1.86 per diluted share, for the quarter ended September 30, 2021, as compared to a net loss attributable to common shareholders of $11.6 million, or a net loss of $0.48 per basic and diluted share, for the same quarter of 2020.
Conference Call Details:
iTeos Therapeutics will host a conference call and webcast today, Wednesday, November 10th, at 4:30 p.m. ET. To access the live conference call, please dial 833-927-1758 (domestic) or 929-526-1599 (international) and refer to conference access code 861337. A live audio webcast of the event will also be accessible from the News and Events page of the Company’s website at View Source The archived webcast will be available approximately two hours after the completion of the event and for one week following the call.