IO Biotech(US:IOBT)2025-11-14 14:10Clinical Trials and Results - The lead therapeutic cancer vaccine candidate, IO102-IO103 (Cylembio), achieved a confirmed overall response rate (ORR) of 73% and a complete response rate (CRR) of 50% in a Phase 1/2 trial for metastatic melanoma [132]. - In the Phase 3 trial, Cylembio plus pembrolizumab demonstrated a median progression-free survival (PFS) of 19.4 months compared to 11.0 months for pembrolizumab alone, with a hazard ratio of 0.77 [133]. - The Phase 3 trial enrolled 407 patients across more than 100 sites, with a narrowly missed statistical significance on the primary endpoint of PFS (p=0.056) [133]. - The company is conducting an investigator-initiated study evaluating Cylembio plus nivolumab-relatlimab, with preliminary data suggesting improved clinical activity compared to historical data [134]. - In the Phase 1/2 study of IO102-IO103 combined with pembrolizumab for recurrent and/or metastatic SCCHN, the confirmed overall response rate (ORR) was 44.4% among 18 efficacy-evaluable patients [149]. - In the first-line metastatic NSCLC study, the unconfirmed ORR was 55% and the confirmed ORR was 48%, with a median progression-free survival (PFS) of 8.1 months and an 81% disease control rate (DCR) [150]. - The Phase 2 basket trial showed a median PFS of 8.1 months for NSCLC and 7.0 months for SCCHN, with no new safety signals reported [152]. - The company has initiated a Phase 2 basket trial (IOB-032/PN-E40) for IO102-IO103 in a perioperative cancer setting, with enrollment completed ahead of schedule as of January 2025 [155]. - The company expects overall survival results from the Phase 3 trial to be available in 2026 [133]. Financial Performance - A restructuring plan was implemented to conserve capital, resulting in a non-recurring charge of $0.9 million and an approximate 50% reduction in full-time employees [137]. - Research and development expenses decreased to $13.7 million for the three months ended September 30, 2025, down from $20.2 million in the same period of 2024, representing a 31.9% decline [180]. - General and administrative expenses were $5.6 million for the three months ended September 30, 2025, compared to $6.3 million in 2024, a decrease of 11.3% [181]. - Total operating expenses for the three months ended September 30, 2025, were $19.4 million, down 27.0% from $26.5 million in 2024 [179]. - Other income increased significantly to $9.3 million for the three months ended September 30, 2025, compared to $2.7 million in 2024, a rise of 245.2% [182]. - The net loss for the three months ended September 30, 2025, was $8.4 million, a reduction of 65.1% from a net loss of $24.0 million in 2024 [179]. - Research and development expenses for the nine months ended September 30, 2025, totaled $46.8 million, down 7.1% from $50.3 million in 2024 [184]. - General and administrative expenses for the nine months ended September 30, 2025, increased to $18.3 million, up 2.5% from $17.9 million in 2024 [185]. - Other income for the nine months ended September 30, 2025, was $6.7 million, compared to $5.1 million in 2024, an increase of 31.9% [186]. - The loss before income tax expense for the nine months ended September 30, 2025, was $58.4 million, a decrease of 7.5% from $63.2 million in 2024 [183]. Funding and Capital Structure - The company secured a €12.5 million loan from the European Investment Bank based on the positive results from cohort B of the efficacy study [153]. - The company raised $75.1 million in gross proceeds from a Private Placement by selling 37,065,647 shares and warrants at a price of $2.025 per share [189]. - As of September 30, 2025, the company reported cash and cash equivalents of $30.7 million, expected to fund operations through Q1 2026 [191]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $61.4 million, compared to $62.7 million for the same period in 2024 [192][194]. - Cash provided by financing activities for the nine months ended September 30, 2025 was $32.8 million, while there were no financing activities in the same period of 2024 [196]. - The company anticipates continued losses and will require additional funding for future clinical and preclinical activities [197]. - The company expects to finance its cash needs through equity offerings, debt financings, or collaborations, but may face challenges in raising additional capital [198]. - The company has significant contractual obligations related to leases and third-party service providers, which may affect its financial commitments [201][202]. Research and Development - The company is focusing on expanding its pipeline to include additional solid tumor indications beyond melanoma, leveraging the T-win platform [139]. - The company plans to file an Investigational New Drug (IND) application for IO112 in 2026, targeting Arginase 1 with demonstrated anti-tumor activity [158]. - Preclinical data for IO170 showed significant tumor growth inhibition and reshaping of the tumor microenvironment in prostate cancer models [161]. - The company expects to incur significant research and development expenses as it continues to advance its product candidates, including Cylembio, IO112, and IO170 [172]. - The company has not tracked research and development expenses on a program-by-program basis, with most expenses related to Cylembio across all ongoing clinical trials [171]. - The company may face significant uncertainties regarding the timing and costs of completing the development of its product candidates, including potential delays in clinical trials [173]. Tax and Regulatory Matters - The company recorded a full valuation allowance to reduce its net deferred tax assets based on the likelihood of realization, affecting IO Biotech ApS, IO Bio US, Inc., and IO Biotech, Inc. [215]. - The company recognized $0.3 million and $0.7 million in research and development tax credits for the nine months ended September 30, 2025, and the year ended December 31, 2024, respectively [218]. - A tax benefit of $1.4 million was reported due to changes in the deductibility of research and development expenditures as a result of the One Big Beautiful Bill Act [218]. - The company will continue to monitor the impacts of proposed or enacted law changes on the cost-benefit of claiming research and development tax credits [218]. - The company may remain classified as an Emerging Growth Company until December 31, 2026, unless certain financial thresholds are met [225]. - The company did not have any off-balance sheet arrangements during the periods presented [222]. - The company accounts for warrants issued in connection with the sale of common stock or debt as either liability or equity based on specific accounting standards [219]. - The company uses a Black-Scholes option pricing model to determine the fair value of its warrants and stock options, which involves various assumptions [212]. - The company recognizes tax benefits from uncertain tax positions only if it is more likely than not that the positions will be sustained upon examination [216].