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iTeos Therapeutics(ITOS) - 2024 Q3 - Quarterly Report
ITOSiTeos Therapeutics(ITOS)2024-11-12 12:08

Financial Performance - Total revenue for the nine months ended September 30, 2024, was 35,000,comparedto35,000, compared to 12,595 for the same period in 2023, representing an increase of 178%[14]. - The net loss for the three months ended September 30, 2024, was 45,358,comparedtoanetlossof45,358, compared to a net loss of 32,241 for the same period in 2023, indicating a decline of 41%[14]. - Net loss for the nine months ended September 30, 2024, was 90,702,000,comparedtoanetlossof90,702,000, compared to a net loss of 82,091,000 for the same period in 2023, representing an increase of approximately 10%[18]. - The Company reported a net loss of 45.4millionforthethreemonthsendedSeptember30,2024,and45.4 million for the three months ended September 30, 2024, and 90.7 million for the nine months ended September 30, 2024[21]. - The company reported a net loss attributable to common stockholders of 45.36millionforthethreemonthsendedSeptember30,2024,comparedtoalossof45.36 million for the three months ended September 30, 2024, compared to a loss of 32.24 million for the same period in 2023[67]. Expenses - Research and development expenses for the three months ended September 30, 2024, were 36,686,upfrom36,686, up from 30,638 in the same period of 2023, reflecting an increase of 19%[14]. - Total operating expenses for the nine months ended September 30, 2024, were 145,196,comparedto145,196, compared to 123,550 for the same period in 2023, an increase of 17%[14]. - Stock-based compensation for the nine months ended September 30, 2024, was 22,868,000,upfrom22,868,000, up from 19,828,000 in the prior year, indicating a growth of about 10%[18]. - Cash used in operating activities for the nine months ended September 30, 2024, was 103,678,000,comparedto103,678,000, compared to 89,991,000 in 2023, reflecting an increase of approximately 15%[18]. - General and administrative expenses decreased by 0.5millionto0.5 million to 12.1 million for the three months ended September 30, 2024, from 12.6millioninthesameperiodof2023[87].CashandAssetsCashandcashequivalentsasofSeptember30,2024,were12.6 million in the same period of 2023[87]. Cash and Assets - Cash and cash equivalents as of September 30, 2024, were 123,744, down from 251,177asofDecember31,2023,adecreaseof51251,177 as of December 31, 2023, a decrease of 51%[13]. - Total assets increased to 723,077 as of September 30, 2024, from 667,588asofDecember31,2023,anincreaseof8667,588 as of December 31, 2023, an increase of 8%[13]. - Total cash, cash equivalents, and restricted cash at the end of the period was 124,053,000, down from 204,401,000attheendofSeptember2023,adecreaseofabout39204,401,000 at the end of September 2023, a decrease of about 39%[18]. - As of September 30, 2024, the Company had cash and cash equivalents of 123.7 million and available-for-sale securities of 525.2million[119].CollaborationsandAgreementsTheCompanyhasenteredintoacollaborationwithGlaxoSmithKlinetodevelopbelrestotugincombinationwithotheroncologyassets[20].TheGSKCollaborationAgreementincludesanupfrontnonrefundablepaymentof525.2 million[119]. Collaborations and Agreements - The Company has entered into a collaboration with GlaxoSmithKline to develop belrestotug in combination with other oncology assets[20]. - The GSK Collaboration Agreement includes an upfront nonrefundable payment of 625.0 million and potential milestone payments of up to 1.45billioncontingentuponachievingcertaindevelopmentandcommercialmilestones[34].ThetotaltransactionpricefortheGSKCollaborationAgreementis1.45 billion contingent upon achieving certain development and commercial milestones[34]. - The total transaction price for the GSK Collaboration Agreement is 625.0 million, with 35.0millionofrevenuerecognizedduringtheninemonthsendedSeptember30,2024,relatedtothedosingofthefirstpatientinthePhase3study[37].ClinicalDevelopmentTheCompanyisadvancingitsleadproductcandidate,belrestotug,inmultipleclinicaltrials,includingaPhase3trialfornonsmallcelllungcancer(NSCLC)[20].TheCompanyisalsoinvestigatinginupadenant(EOS850)inaPhase2trialforpostimmunotherapymetastaticNSCLC[20].TheCompanyinitiatedanewprogram,EOS984,targetingENT1intheadenosinepathway,whichiscurrentlyinclinicaldevelopment[20].Thecompanyiscurrentlyenrollingpatientsinmultipleclinicaltrials,includingthePhase3GALAXIESLung301trialandthePhase2GALAXIESLung201trial,assessingcombinationsofbelrestotugwithotheroncologyassets[69].FundingandFinancialInstrumentsNetcashprovidedbyfinancingactivitieswas35.0 million of revenue recognized during the nine months ended September 30, 2024, related to the dosing of the first patient in the Phase 3 study[37]. Clinical Development - The Company is advancing its lead product candidate, belrestotug, in multiple clinical trials, including a Phase 3 trial for non-small cell lung cancer (NSCLC)[20]. - The Company is also investigating inupadenant (EOS-850) in a Phase 2 trial for post-immunotherapy metastatic NSCLC[20]. - The Company initiated a new program, EOS-984, targeting ENT1 in the adenosine pathway, which is currently in clinical development[20]. - The company is currently enrolling patients in multiple clinical trials, including the Phase 3 GALAXIES Lung-301 trial and the Phase 2 GALAXIES Lung-201 trial, assessing combinations of belrestotug with other oncology assets[69]. Funding and Financial Instruments - Net cash provided by financing activities was 121,956,000 for the nine months ended September 30, 2024, compared to 806,000intheprioryear,indicatingasubstantialincrease[18].Thecompanyraisedatotalof806,000 in the prior year, indicating a substantial increase[18]. - The company raised a total of 120.0 million from the sale of securities, including a pre-funded warrant to RA Capital for 100.0millionandcommonstocktoBoxerCapitalfor100.0 million and common stock to Boxer Capital for 20.0 million[43]. - The company has built significant expertise in designing novel cancer immunotherapies and has capabilities to develop both small molecules and antibodies[20]. Tax and Liabilities - The effective tax rates were (5.2)% and (8.0)% for the three and nine months ended September 30, 2024, respectively, differing from statutory rates of 21% and 25% due to investment income and unrecognized tax benefits[9]. - The company incurred an income tax expense of 2.24millionforthethreemonthsendedSeptember30,2024,despitealossbeforeincometaxesof2.24 million for the three months ended September 30, 2024, despite a loss before income taxes of 43.12 million[9]. - The company recorded an additional liability of 1.1millionand1.1 million and 3.2 million during the three and nine months ended September 30, 2024, related to unrecognized tax benefits[56]. Risks and Future Outlook - The Company expects to continue its focus on research and development to advance its pipeline of product candidates, although specific future revenue projections remain uncertain[8]. - The Company may seek additional funding to reach its development and commercialization objectives, which could affect stockholder rights[21]. - The Company faces risks related to clinical trial results, regulatory approvals, and market acceptance of its product candidates[21]. - The company anticipates that existing cash and cash equivalents will fund operating expenses and capital expenditures through 2027[107].