Kronos Bio Announces Restructuring to Focus Resources on Clinical Development with Extended Cash Runway

Company to assess KB-0742 at planned new dose schedule in ongoing phase 1/2 study; topline data from expansion cohort at new dose schedule expected in the first half of 2025

IND-enabling studies for KB-9558 expected to complete in 2024 with first-in-human study anticipated to commence in 2025

Restructuring plan extends anticipated cash runway into the second half of 2026

Company to continue to focus discovery efforts on maturing projects and Genentech collaboration activities

SAN MATEO, Calif., and CAMBRIDGE, Mass., March 07, 2024 (GLOBE NEWSWIRE) -- Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today announced a plan to optimize its resource allocation, restructure, and extend runway to focus resources on key programs in the Company’s pipeline, including the ongoing phase 1/2 study of KB-0742 following the review of additional positive preliminary safety and efficacy data. This plan positions the Company to maximize the potential of KB-0742, an inhibitor of CDK9, by exploring an extended dosing schedule while also continuing to progress KB-9558, a p300 KAT inhibitor, through ongoing IND-enabling studies and into the clinic, and its discovery efforts and collaborations. The Company expects these efforts, which include a 21% reduction in force, will extend cash runway into the second half of 2026.

To date, anti-tumor activity has been observed without grade 3/4 neutropenia in patients treated with KB-0742 at doses ranging from 10mg to 80mg using the current three-days-on, four-days-off dosing schedule. The Company has reported target engagement, tumor regressions, and an acceptable safety profile at 60mg dosed three-days-on, four-days-off. KB-0742 cleared 80mg three-days-on, four-days-off and the Company expects to publish this data in addition to the 60mg expansion mid-year. As disclosed earlier this week, the Company plans to escalate to 80mg four-days-on, three-days-off, a dosing schedule that offers patients significantly increased time at or above a therapeutic threshold compared to the already established active dose of 60mg dosed three-days-on, four-days-off. The amended protocol leverages a 3+3 design, placing the Company on a path to efficiently clear the dose levels, and the Company expects to share topline data from the expansion cohort at this dose schedule in the first half of 2025.