Monte Rosa Therapeutic (NasdaqGS:GLUE) Earnings Call Presentation

Clinical Trial Results of MRT-2359 - MRT-2359 combined with enzalutamide demonstrated a 100% PSA response rate in heavily pre-treated mCRPC patients with AR mutations[5, 38, 59] - Among the 4 patients with AR mutations, 2 patients showed PSA90 responses and 2 patients showed PSA50 responses[5, 38] - Two patients with AR mutations achieved RECIST partial responses (1 confirmed, 1 unconfirmed), and two had stable disease, resulting in a 100% disease control rate in the AR mutant population[5] - An overall disease control rate (DCR) of 64% was observed in 14 evaluable patients, including 5 patients without AR mutations who had stable disease[5, 59] Safety and Tolerability - The combination of MRT-2359 and enzalutamide was well-tolerated, with the most frequent adverse events (AEs) being mild or moderate manageable GI symptoms[5, 33, 59] - Treatment-related AEs occurring in >15% patients included fatigue (50%), diarrhea (45%), nausea (35%), arthralgia (30%), decreased appetite (30%), vomiting (30%), neutropenia (25%), and muscular weakness (20%)[31, 32] Future Plans - The company plans to initiate a signal-confirming 2-stage Phase 2 study (MODeFIRe-1) of MRT-2359 in combination with a 2nd generation AR inhibitor in 2026, targeting AR-mutated mCRPC[2, 56, 59] - Updated data from the Phase 1/2 study is expected to be presented at the ASCO Genitourinary Cancers Symposium in February 2026[59]