OnKure Therapeutics (OKUR) investor relations material

Pipeline progress and upcoming data

• Anticipates a data-rich 2026, with key clinical results for monotherapy, doublet, and triplet regimens of OKI-219 expected in Q1, providing momentum for the year.

• Initial data from the PIKture-01 phase 1 study was shifted to Q1 2026 to ensure more mature, context-rich results, allowing for robust comparisons to competitors.

• All patients in ongoing studies will have over four months of follow-up, enabling early assessment of response durability and efficacy.

• Patient cohorts are heavily pretreated, with efforts to identify subsets for fair comparison to recent Relay and Scorpion studies.

Triplet and combination strategies

• Triplet regimens, especially those using ribociclib and fulvestrant, are prioritized for early-line therapy due to their potential for differentiation in tolerability and efficacy.

• Demonstrating combinability with ribociclib in frontline triplet settings is seen as a major value driver.

• Early triplet data will focus on tolerability and initial efficacy, guiding go/no-go decisions for expansion cohorts.

• Full durability data will require longer follow-up, but early results will inform further investment and study expansion.

Efficacy, safety, and competitive positioning

• Doublet studies will be scrutinized for high safety standards and efficacy comparable to competitors, focusing on patient characteristics like prior lines and disease type.

• The goal is to match efficacy and surpass tolerability benchmarks set by Relay and inavolisib studies.

• Maintaining dose intensity is emphasized as key to achieving better long-term outcomes.