Keros Therapeutics (KROS) Morgan Stanley 22nd Annual Global Healthcare Conference summary

Product portfolio progress and clinical updates

• Three products are in clinical development, targeting four indications, with strong execution and enthusiasm from stakeholders.

• KER-012 for PAH is designed to avoid dose-limiting increases in red blood cells seen with sotatercept, allowing higher dosing and potentially greater efficacy.

• Phase 2 PAH trial for KER-012 has completed screening; enrollment will finish in September, with last patient out in March 2025 and data readout in Q2 2025.

• KER-012 does not require hemoglobin monitoring, unlike sotatercept, and aims to avoid related safety issues such as bleeding and telangiectasia.

Differentiation and feedback from the field

• KER-012 offers no dose-limiting pharmacology or monitoring, unlike sotatercept, and allows full dose response exploration.

• Safety concerns with sotatercept include bleeding events and telangiectasia, which are consistent with preclinical findings.

• KER-050 in MDS shows activity in both RS and non-RS patients, including those with high transfusion burden, with a response rate of ~40% vs. 20% for luspatercept.

• Durability of response for KER-050 exceeds that of luspatercept, with a third of patients on treatment for over a year as of the last data cut.

• KER-050 improves quality of life and fatigue scores, addressing a key limitation of luspatercept.

Clinical trial design and regulatory alignment

• Phase 3 trial for KER-050 in MDS will use 8-week transfusion independence as the primary endpoint, with 24-week durability as a secondary endpoint.

• The trial will enroll a broad patient population, including RS, non-RS, and both low and high transfusion burden patients.

• Initial focus is on second-line, post-ESA patients, with plans to expand to frontline and those intolerant to luspatercept.

• Approval of Rytelo has changed the MDS landscape, but KER-050 is expected to offer a more benign safety profile and earlier, longer use.