Xilio Therapeutics (NasdaqGS:XLO) Earnings Call Presentation

Vilastobart Clinical Data and Opportunity - Vilastobart, in combination with atezolizumab, showed a 40% Overall Response Rate (ORR) in MSS mCRC patients without liver metastases and with high plasma TMB[30, 42] - 63% of plasma TMB-evaluable patients had high plasma TMB (≥10 mutations/Mb) in the Phase 2 trial, including all TMB-evaluable responders[32, 33, 42] - A statistically significant correlation (p=0.05) was observed between plasma TMB status and response to vilastobart plus atezolizumab[33, 42] - The combination of vilastobart and atezolizumab demonstrated a differentiated safety profile, with a low discontinuation rate of 5% and only 7% of patients experiencing colitis of any grade[35, 36, 42] Market and Competitive Landscape - Approximately 95% of mCRC patients are MSS, and standard of care in 3L+ provides minimal benefit (1-6% ORR)[23] - Real-world data indicates that approximately 55% of patients with MSS CRC have high plasma TMB, which is substantially higher than historically reported with tissue-based TMB assays[28, 42] - Next-generation anti-CTLA-4 agents in development show promising clinical efficacy in MSS mCRC, with ORRs ranging from 8-29% and discontinuation rates due to AEs up to ~30%[21] Technology and Pipeline - Xilio's clinically-validated platform technology is being applied across diverse mechanisms and architectures, including antibodies, cytokines, bispecifics, and T cell engagers[13, 14] - Efarindodekin Alfa (tumor-activated IL-12) demonstrated promising clinical efficacy with a generally well-tolerated safety profile in Phase 1 in patients with advanced solid tumors[44] - Masked T cell engager programs demonstrated potent anti-tumor activity with favorable tolerability across a diverse range of targets in preclinical models[50, 51, 52] Financial Outlook and Milestones - The company anticipates a cash runway into Q1 2027, including a $175 million development milestone received under the Gilead license in Q4 2025[53] - Anticipated milestones include reporting updated Phase 2 data for vilastobart in combination with atezolizumab in metastatic MSS mCRC in 1H 2026 and IND submissions for at least two masked T cell engager programs in 2027[53]