The Company previously reported data demonstrating KT-579's compelling profile in preclinical studies using human primary cell systems, patient-derived cells and in vivo disease models of lupus and rheumatoid arthritis, showing activity comparable or superior to existing standards of care. The new data presented at DDW further demonstrate KT-579's consistent modulation of pro-inflammatory pathways. KT-579 showed impact on myeloid cell effector function, including potent inhibition of cytokines known to amplify inflammatory responses and promote Th1 and Th17 T cell activity in IBD.

In the TNBS model of IBD, KT-579 demonstrated activity comparable or superior to clinically relevant comparators, including a JAK inhibitor and biologic agents targeting integrins and TNF. Prophylactic dosing of KT-579 led to a significant reduction in disease activity score, including protection from body weight loss and maintenance of colon density. KT-579 demonstrated complete inhibition of key colon inflammatory cytokines, including TNFα, IL-1β and IL-6, and reduced pathological findings, including fewer inflammatory infiltrates, improved crypt structure integrity and absence of crypt abscesses. Transcriptomic analysis further demonstrated broad normalization of inflammatory, myeloid, and fibrosis-associated pathways, showing effects comparable to an anti-TNF agent. Collectively, these findings position KT-579 as a novel oral approach capable of broadly modulating pathogenic pathways in IBD and other complex autoimmune diseases, where current treatment options remain limited.

The KT-579 Phase 1 healthy volunteer trial is ongoing. The Phase 1 study is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of orally administered KT-579 compared to placebo. The key study aim is to show that KT-579 can robustly degrade IRF5 in blood at doses that are safe and well-tolerated. The functional impact of IRF5 degradation on the induction of Type I interferons, pro-inflammatory cytokines, and inflammatory pathway gene transcripts will also be assessed with whole blood ex vivo stimulation assays. The Company expects to report data from the trial in the second half of 2026.