iTeos Therapeutics(US:ITOS)2024-08-08 11:08Financial Performance - Total revenue for the three months ended June 30, 2024, was $35,000,000, compared to $12,595,000 for the same period in 2023, representing a significant increase[15]. - The net loss for the three months ended June 30, 2024, was $7,128,000, compared to a net loss of $34,300,000 for the same period in 2023, showing a reduction in losses[15]. - The company reported a basic net loss per common share of $0.18 for the three months ended June 30, 2024, compared to $0.96 for the same period in 2023[15]. - The net loss for the six months ended June 30, 2024, was $45,344,000, compared to a net loss of $49,851,000 for the same period in 2023, showing a decrease in losses[21]. - The Company reported a net loss of $7.1 million and $45.3 million for the three and six months ended June 30, 2024, respectively[25]. - Net cash used in operating activities was $66.3 million for the six months ended June 30, 2024, compared to $56.1 million for the same period in 2023[109]. - Loss before income taxes improved by $28.2 million to $(4.9) million for the three months ended June 30, 2024, from $(33.1) million for the same period in 2023[92]. Research and Development - Research and development expenses for the three months ended June 30, 2024, were $36,709,000, up from $29,186,000 in the same period last year, indicating a 25.5% increase[15]. - The company expects significant increases in research and development costs as current programs progress and new programs are added[1]. - Total allocated research and development expenses for the product candidate Belrestotug were $11.6 million for the three months ended June 30, 2024, compared to $9.6 million in the same period of 2023[1]. - Research and development expenses for the six months ended June 30, 2024, increased by $16.4 million to $71.2 million from $54.9 million for the same period in 2023[101]. - The company expects to continue incurring significant expenses related to ongoing development activities, including clinical trials and regulatory approvals[1]. - The lead product candidate, belrestotug, is currently in multiple clinical trials, including a Phase 3 trial (GALAXIES Lung-301) assessing its efficacy in combination with GSK's anti-PD-1 therapy[22]. Assets and Liabilities - Total current assets increased to $626,605,000 as of June 30, 2024, from $550,652,000 as of December 31, 2023, reflecting a growth of 13.8%[14]. - Total assets reached $751,841,000 as of June 30, 2024, compared to $667,588,000 as of December 31, 2023, marking an increase of 12.6%[14]. - Total liabilities decreased to $87,973,000 as of June 30, 2024, from $92,360,000 as of December 31, 2023, indicating a reduction of 4.1%[14]. - The total fair value of the Company's financial instruments as of June 30, 2024, was $609.684 million, with significant holdings in money market funds and U.S. government securities[27]. - As of June 30, 2024, the total amortized cost of fixed income securities was $433.853 million, with a fair value of $432.984 million, reflecting a $5.0 million difference due to a short-term debt security classified as a cash equivalent[32]. Collaboration and Funding - The Company is focused on maintaining collaborations and strategic relationships to enhance the development of its product candidates[8]. - Under the GSK Collaboration Agreement, the company is eligible to receive up to $1.45 billion in milestone payments contingent upon the belrestotug program achieving certain development and commercial milestones[39]. - The Company recognized $35.0 million in revenue for the three months ended June 30, 2024, related to the dosing of the first patient in the Phase 3 study for GALAXIES-301 in collaboration with GSK[42]. - The Company raised $120.0 million from a Securities Purchase Agreement with RA Capital and Boxer Capital, with $100.0 million from a pre-funded warrant and $20.0 million from common stock sales[48]. - The Company has received grants totaling $10.5 million from the Walloon Region and the European Union to fund research and development activities, reimbursing 55-100% of qualifying expenditures[45]. Stock and Compensation - The Company issued 1,142,857 shares of common stock and pre-funded warrants, net of offering costs, raising $119,574,000[21]. - Total stock-based compensation expense for the three months ended June 30, 2024, was $8.1 million, up from $7.0 million for the same period in 2023, with stock options accounting for $7.2 million[53]. - The weighted average exercise price of stock options outstanding as of June 30, 2024, was $16.44, with an aggregate intrinsic value of $29.8 million[54]. - The Company granted 2,119,270 stock options during the six months ended June 30, 2024, with a weighted average grant-date fair value of $8.70 per share[54]. - The 2020 Employee Stock Purchase Plan (ESPP) had 580,443 shares reserved for issuance as of June 30, 2024, with no increase on January 1, 2024[52]. Tax and Regulatory Matters - The effective tax rate for the three months ended June 30, 2024, was (46.4)%, significantly impacted by investment income from marketable investments[58]. - The Company had accrued interest and penalties relating to uncertain tax positions of $6.0 million as of June 30, 2024[59]. - The Company has recorded a full valuation allowance on net deferred tax assets as of June 30, 2024, due to expectations that these assets will not be realized[124]. Market and Operational Risks - The Company faces risks related to clinical trial outcomes, regulatory approvals, and market acceptance of its product candidates[25]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[106]. - The company anticipates ongoing expenses to increase as it continues clinical stage programs and seeks marketing approval for product candidates[114].