iTeos Reports Second Quarter 2024 Financial Results and Provides Business Updates

Rhea-AI Summary

iTeos Therapeutics (Nasdaq: ITOS) reported Q2 2024 financial results and provided business updates. Key highlights include:

- Multiple clinical milestones expected in H2 2024, including two Phase 2 trials of belrestotug + dostarlimab in 1L NSCLC and 1L HNSCC
- Pro forma cash and investments of $714.4 million as of June 30, 2024, expected to provide runway through 2027
- Q2 2024 R&D expenses increased to $36.7 million from $29.2 million in Q2 2023
- Q2 2024 net loss of $7.1 million ($0.18 per share) compared to $34.3 million ($0.96 per share) in Q2 2023

The company is advancing multiple clinical programs, including belrestotug for NSCLC and HNSCC, and adenosine pathway inhibitors inupadenant and EOS-984.

Positive

• Pro forma cash and investments of $714.4 million, providing runway through 2027
• Significant reduction in net loss: $7.1 million in Q2 2024 vs $34.3 million in Q2 2023
• Multiple clinical milestones expected in H2 2024, including two Phase 2 trials
• Enrollment ongoing in Phase 3 GALAXIES Lung-301 study for belrestotug + dostarlimab in 1L NSCLC

Negative

• Increased R&D expenses: $36.7 million in Q2 2024 vs $29.2 million in Q2 2023
• Net loss of $7.1 million in Q2 2024, despite improvement from previous year

Insights

Financial Analyst

iTeos Therapeutics' Q2 2024 results reveal a strong financial position with a pro forma cash balance of $714.4 million, providing runway through 2027. This is a positive indicator for investors, as it ensures ample funding for ongoing clinical trials and potential Phase 3 initiations. The company's R&D expenses increased to $36.7 million for the quarter, reflecting intensified efforts in key programs. Despite this, the net loss narrowed to $7.1 million ($0.18 per share) compared to $34.3 million in Q2 2023, suggesting improved financial efficiency. The reduced G&A expenses also indicate effective cost management. Overall, iTeos' financial health appears robust, supporting its ambitious clinical pipeline.

Oncology Research Analyst

iTeos' pipeline progress is noteworthy, particularly in immuno-oncology. The positive interim assessment from the GALAXIES Lung-201 study, leading to the Phase 3 GALAXIES Lung-301 trial, is a significant milestone. The focus on belrestotug + dostarlimab doublet in first-line NSCLC and HNSCC shows promise. Upcoming data readouts for adenosine programs (inupadenant and EOS-984) in H2 2024 could be pivotal. The company's multi-pronged approach, targeting TIGIT, adenosine A2A receptor and ENT1, demonstrates a sophisticated strategy in cancer immunotherapy. However, investors should note that while the pipeline is diverse, success in oncology trials is never guaranteed and requires careful monitoring of efficacy and safety data.

Market Research Analyst

iTeos is positioning itself well in the competitive immuno-oncology market. The collaboration with GSK for belrestotug enhances credibility and provides valuable resources. The focus on first-line treatments for NSCLC and HNSCC targets large market opportunities. The adenosine pathway programs, especially EOS-984 as a potential first-in-class ENT1 inhibitor, could differentiate iTeos in a crowded field. However, the company faces stiff competition from established players and other emerging biotechs. The success of iTeos will largely depend on the clinical outcomes of its lead candidates and its ability to navigate the complex regulatory landscape. Investors should closely watch the upcoming data readouts as they will significantly influence iTeos' market position and potential commercial prospects.

- Multiple clinical milestones across portfolio anticipated in second half of 2024, including two Phase 2 trials assessing belrestotug + dostarlimab in 1L NSCLC and 1L HNSCC
- Pro forma cash and investment balance of $714.4 million as of June 30, 2024 expected to provide runway through 2027 across a number of impactful portfolio milestones

WATERTOWN, Mass. and GOSSELIES, Belgium, Aug. 08, 2024 (GLOBE NEWSWIRE) -- 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, today reported financial results for the second quarter ended June 30, 2024 and provided a business update.

“Our achievements and pipeline progress this year, specifically the positive interim assessment data from the Phase 2 GALAXIES Lung-201 study which supported the launch of the Phase 3 GALAXIES Lung-301 study, demonstrate significant momentum for iTeos. Our conviction in the potential of the belrestotug and dostarlimab doublet only continues to grow,” said Michel Detheux, Ph.D., president and chief executive officer of iTeos. “Furthermore, we are very excited to be approaching data readouts for both adenosine programs – inupadenant and EOS-984. As we continue to build on this impressive foundation, we are enthusiastic about our growing pipeline and the opportunities that lie ahead in the catalyst-rich second half of the year.”

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 

• GALAXIES Lung-301: Enrollment ongoing in randomized, double-blind Phase 3 registrational study assessing belrestotug + dostarlimab versus placebo + pembrolizumab in patients with first-line advanced, unresectable, or metastatic PD-L1 high NSCLC.
  

• GALAXIES Lung-201: Interim data from Phase 2 platform study assessing belrestotug + dostarlimab doublet in first-line advanced / metastatic PD-L1 high NSCLC anticipated in second half of 2024. 
  

• GALAXIES H&N-202: Enrollment ongoing in randomized Phase 2 platform study assessing belrestotug + dostarlimab doublet and a triplet with GSK’s investigational anti-CD96 antibody, nelistotug, in first-line patients with PD-L1 positive recurrent / metastatic HNSCC. 
  

• TIG-006 HNSCC: Topline data from the first portion of TIG-006 study in cohorts 2C & 2D assessing belrestotug + dostarlimab doublet in first-line PD-L1 positive advanced / metastatic HNSCC anticipated in second half 2024.
  

• TIG-006 mNSCLC: Enrollment completed 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 nelistotug (anti-CD96 antibody), and belrestotug + dostarlimab and GSK’s investigational anti-PVRIG antibody (GSK’562). 
  

Adenosine Pathway

Inupadenant (EOS-850): insurmountable small molecule antagonist targeting adenosine A_2A 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: potential first-in-class small molecule inhibiting ENT1, a dominant transporter of adenosine on lymphocytes involved in T cell metabolism, expansion, effector function, and survival 

• Topline data from the Phase 1 trial anticipated in the second half of 2024.
  

Second Quarter 2024 Financial Results

• Cash and Investment Position: The Company’s cash, cash equivalents, and investments position was $679.4 million as of June 30, 2024, as compared to $677.5 million as of June 30, 2023. Pro forma cash, cash equivalents, and investments position were $714.4 million as of June 30, 2024, inclusive of a $35.0 million unbilled milestone receivable relating to the dosing of the first patient in the GALAXIES Lung-301 clinical trial. The Company expects its cash balance to provide runway through 2027, which includes the potential initiation of multiple Phase 3 registrational trials assessing the belrestotug + dostarlimab doublet. The Company expects its cash balance to provide runway through 2027, which includes the potential initiation of multiple Phase 3 registrational trials assessing the belrestotug + dostarlimab doublet.

• Research and Development (R&D) Expenses: R&D expenses were $36.7 million and $71.2 million for the quarter and six months ended June 30, 2024, respectively, as compared to $29.2 million and $54.9 million for the same quarter and same six months of 2023, respectively. The increase compared to the comparative period was 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 $12.5 million and $25.2 million for the quarter and six months ended June 30, 2024, respectively, as compared to $13.4 million and $25.4 million for the same quarter and same six months of 2023, respectively. The decrease was primarily due to decreases in professional fees and expenses, commercial-related expenses, and various other general and administrative expenses. These were partially offset by an increase in compensation expenses for G&A employees.

• Net Income/Loss: Net loss was $7.1 million, or net loss of $0.18 per basic and diluted share for the quarter ended June 30, 2024, as compared to a net loss of $34.3 million, or a net loss of $0.96 per basic and diluted share for the quarter ended June 30, 2023. Net loss was $45.3 million, or net loss of $1.20 per basic and diluted share for the six months ended June 30, 2024, as compared to a net loss of $49.9 million, or a net loss of $1.39 per basic and diluted share for the six months ended June 30, 2023.
  

About iTeos Therapeutics, Inc.
iTeos Therapeutics is a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of immuno-oncology therapeutics for patients. iTeos Therapeutics leverages its deep understanding of tumor immunology and immunosuppressive pathways to design novel product candidates with the potential to restore the immune response against cancer. The Company’s innovative pipeline includes three clinical-stage programs targeting novel, validated immunosuppressive pathways designed with optimized pharmacologic properties for improved clinical outcomes, including the TIGIT/CD226 axis and the adenosine pathway. iTeos Therapeutics is headquartered in Watertown, MA with a research center in Gosselies, Belgium.

About Belrestotug (EOS-448/ GSK4428859A)
Belrestotug is an Fc active human immunoglobulin G1, or IgG1, monoclonal antibody (mAb) targeting T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT), an important inhibitory receptor which contributes to the suppression of innate immune responses against cancer. As an optimized high-affinity, potent anti-TIGIT mAb, belrestotug is designed to enhance the antitumor response through a multifaceted immune modulatory mechanism by engaging with TIGIT and FcγR, a key regulator of immune responses which induces cytokine release and antibody dependent cellular cytotoxicity (ADCC). The therapeutic candidate is progressing in multiple indications in collaboration with GSK. 

About Inupadenant (EOS-850)
Inupadenant is a next-generation small molecule antagonist targeting adenosine A_2A receptor (A_2AR), the primary receptor on immune cells whose activation by adenosine suppresses innate and adaptive immune cell responses leading to inhibition of antitumor responses. Optimized for potency, high selectivity of A_2AR, and activity at high adenosine concentrations in solid tumors, inupadenant is uniquely designed with its insurmountable profile to inhibit the ATP-adenosine pathway and has the potential for enhanced antitumor activity as compared to other A_2AR antagonists in clinical development. The therapeutic candidate is in Phase 2 development. 

About EOS-984
EOS-984 is a potential first-in-class small molecule targeting equilibrative nucleoside transporter 1 (ENT1) designed to inhibit the immunosuppressive activity of adenosine and restore immune cell proliferation. The therapeutic candidate has the potential to fully reverse the profound immunosuppressive action of adenosine on T and B cells and is in Phase 1 development.  

Internet Posting of Information
iTeos routinely posts information that may be important to investors in the 'Investors' section of its website at www.iteostherapeutics.com. The Company encourages investors and potential investors to consult our website regularly for important information about iTeos.

Forward-Looking Statements

This press release contains forward-looking statements. Any statements that are not solely statements of historical fact are forward-looking statements. Words such as “believe,” “anticipate,” “plan,” “expect,” “will,” “may,” “intend,” “prepare,” “look,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements relating to the potential benefits of belrestotug, inupadenant, and EOS-984 and the potential of the belrestotug and dostarlimab doublet; our plans and expected milestones, including having interim data in GALAXIES lung-201, topline data from TIG-006 HNSCC, and topline data from the Phase 1 trial in EOS-984 in the second half of 2024, , and having data from the dose escalation portion of A2A-005 in late 2024; intentions around trial enrollment and recruitment; and our expectation that our cash balance will provide runway through 2027 across a number of impactful portfolio milestones.

These forward-looking statements involve risks and uncertainties, many of which are beyond iTeos’ control. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: the expected benefits and opportunities related to the agreement between iTeos and GSK may not be realized or may take longer to realize due to a variety of reasons, including any inability of the parties to perform their commitments and obligations under the agreement, challenges and uncertainties inherent in product research and development and manufacturing limitations; success in preclinical testing and early clinical trials does not ensure that later clinical trials will be successful, and early results from a clinical trial do not necessarily predict final results; interim and early data may change as more patient data become available and are subject to audit and verification procedures; the data for our product candidates may not be sufficient for obtaining regulatory approval to move into later stage trials or to commercialize products; iTeos may encounter unanticipated costs or may expend cash more rapidly or more slowly than currently anticipated due to challenges and uncertainties inherent in product research and development and biologics manufacturing; iTeos may not be able to execute on its business plans, including meeting its expected or planned regulatory milestones and timelines, research and clinical development plans, and bringing its product candidates to market, for various reasons, some of which may be outside of iTeos’ control, including possible limitations of company financial and other resources, manufacturing limitations that may not be anticipated or resolved for in a timely manner, negative developments in the field of immuno-oncology, such as adverse events or disappointing results, including in connection with competitor therapies, and regulatory, court or agency decisions such as decisions by the United States Patent and Trademark Office with respect to patents that cover our product candidates; and those risks identified under the heading “Risk Factors” in iTeos’ Annual Report on Form 10-Q for the period ended June 30, 2024 filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by the Company which you are encouraged to review. Statements regarding the Company’s cash runway do not indicate when or if the Company may access the capital markets.

Any of the foregoing risks could materially and adversely affect iTeos’ business, results of operations and the trading price of iTeos’ common stock. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. iTeos does not undertake any obligation to publicly update its forward-looking statements other than as required by law.

For further information, please contact:

Investor Contact:
Carl Mauch
iTeos Therapeutics, Inc.
carl.mauch@iteostherapeutics.com

Media Contact:
media@iteostherapeutics.com

FAQ

What were iTeos Therapeutics' (ITOS) Q2 2024 financial results?

iTeos Therapeutics reported a net loss of $7.1 million ($0.18 per share) for Q2 2024, compared to a net loss of $34.3 million ($0.96 per share) in Q2 2023. R&D expenses increased to $36.7 million from $29.2 million in the same period last year.

What is iTeos Therapeutics' (ITOS) cash position as of June 30, 2024?

iTeos Therapeutics reported a pro forma cash and investment balance of $714.4 million as of June 30, 2024, which is expected to provide runway through 2027.

What clinical milestones does iTeos Therapeutics (ITOS) expect in the second half of 2024?

iTeos Therapeutics anticipates multiple clinical milestones in H2 2024, including data from two Phase 2 trials assessing belrestotug + dostarlimab in first-line NSCLC and first-line HNSCC, as well as topline data from the Phase 1 trial of EOS-984.

What is the status of iTeos Therapeutics' (ITOS) GALAXIES Lung-301 study?

Enrollment is ongoing in the randomized, double-blind Phase 3 registrational GALAXIES Lung-301 study, which is assessing belrestotug + dostarlimab versus placebo + pembrolizumab in patients with first-line advanced, unresectable, or metastatic PD-L1 high NSCLC.