On August 12, 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 second quarter ended June 30, 2021 and provided recent business highlights (Press release, iTeos Therapeutics, AUG 12, 2021, View Source [SID1234586471]).

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"The last few months have been a transformative time for iTeos, as we achieved significant milestones that will shape the future of our company and help us in our mission to discover, develop and deliver therapies that will improve the lives of people with cancer. I am incredibly proud of our continued execution with our clinical programs and strategic initiatives," said Michel Detheux, PhD, president, and chief executive officer of iTeos. "For our TIGIT program, we announced a transformational strategic collaboration with GSK that will allow us to combine our resources and expand and accelerate the development program for EOS-448 through rapid evaluation of dostarlimab and triplet combinations beginning in the coming months. With the rights iTeos retained, we can maximize the value of EOS-448 for patients and our shareholders. In addition to expanding our TIGIT program, the GSK collaboration is also an important validation for our team’s ability to identify and pursue best-in-class anti-tumor drug candidates. To that end, we are excited to advance inupadenant, our second clinical-stage program, which has demonstrated in a Phase 1 trial durable responses in two patients with checkpoint inhibitor resistant tumors, good tolerability and a potentially predictive biomarker which will help to drive tumor and patient selection in upcoming trials. In the coming months, we look forward to advancing inupadenant into proof-of-concept trials in several indications."

Program Highlights

EOS-448: IgG1 anti-TIGIT monoclonal antibody designed to engage the Fc gamma receptor (FcγR) and to enhance anti-tumor responses through a multifaceted mechanism of action.

In June 2021, iTeos and GSK announced an agreement to co-develop and co-commercialize EOS-448. As part of the agreement, iTeos received a $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. GSK is responsible for 60% of expense in the global development plan. The companies will co-commercialize and equally split profits in the U.S. iTeos will be eligible to receive royalties on sales outside of the U.S.
In April 2021, the Company presented initial clinical and safety data from the monotherapy dose escalation part of the Phase 1 trial in adult patients with advanced solid tumors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. These preliminary data show the drug was well-tolerated across dose levels, caused depletion of TIGIT-expressing Treg cells in the blood, providing evidence of target and FcyR engagement, and had encouraging early signs of anti-cancer activity in Phase 1, including one partial response in a pembrolizumab-resistant metastatic melanoma patient.
The Company is working with GSK to rapidly initiate trials of EOS-448 in combinations including with Jemperli (dostarlimab).
iTeos will also advance EOS-448 in combination with pembrolizumab and with inupadenant in patients with solid tumors, and as a monotherapy and in combination with an Immunomodulatory Drug (IMiD) 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.

In June 2021, the company presented updated data from 43 patients in both the single-agent dose-escalation and expansion portions of the ongoing open-label Phase 1/2a clinical trial, including results from pre-treatment tumor biopsy analyses, as part of an e-poster at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Preliminary tumor biopsy analyses demonstrate that A2AR expression assessed using a proprietary assay, in patients with solid tumors treated with single agent inupadenant is associated with clinical outcomes. Results also provide evidence of durable antitumor activity in patients with advanced solid tumors and indicate a safety and tolerability profile consistent with previously reported data.
Based on the encouraging monotherapy results, iTeos plans to initiate inupadenant proof-of-concept trials in several indications and will continue to use A2AR and other potential biomarkers to select indications and patients most likely to benefit from treatment.
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. iTeos expects to nominate an additional product candidate which inhibits a novel target in the adenosine pathway for Investigational New Drug-enabling studies before the end of 2021.

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Second Quarter 2021 Financial Results

Cash Position: The Company had cash and cash equivalents of $302.9 million as of June 30, 2021, compared to $136.9 million as of June 30, 2020. Following receipt of the upfront payment from GSK pursuant to the Company’s Collaboration and License Agreement earlier in August 2021, the Company believes that its existing cash and cash equivalents would enable it to fund operating expenses and capital expenditure requirements into 2026.
Research and Development (R&D) Expenses: R&D expenses were $14.2 million for the quarter ended June 30, 2021, compared to $6.1 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 and increased headcount.
General and Administrative (G&A) Expenses: G&A expenses were $15.1 million for the quarter ended June 30, 2021, compared to $2.4 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, along with one-time legal and advisory fees incurred by the Company associated with the Collaboration and License Agreement with GSK to co-develop and co-commercialize EOS-448.
Net Loss: Net loss attributable to common shareholders was $26.5 million, or a net loss of $0.75 per basic and diluted share, for the quarter ended June 30, 2021, as compared to $10.3 million, or a net loss of $29.49 per basic and diluted share, for the same quarter of 2020.
Conference Call Details:
iTeos Therapeutics will host a conference call and webcast today at 8:00am ET. To access the live event, please use the following link and you will receive access details via email: View Source

A live audio webcast of the event will also be accessible from the 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 30 days following the call.