Keros Therapeutics (KROS) Earnings Call Presentation

Cibotercept (KER-012) for Pulmonary Arterial Hypertension (PAH) - A Phase 2 TROPOS trial of Cibotercept in PAH patients is fully enrolled, with dosing continuing in the 1.5 mg/kg treatment arm after halting higher dose arms due to safety review[18] - Topline data from the Phase 2 TROPOS trial is expected in Q2 2025, which will inform the next steps in the development program[18] - In a Phase 1 clinical trial, monthly dosing of Cibotercept for 3 months was generally well-tolerated at doses up to 4.5 mg/kg, with observed changes in bone biomarkers suggesting biological activity from the 0.75 mg/kg dose[24] KER-065 for Neuromuscular Disorders - Keros has deprioritized the development of KER-065 in obesity to focus on neuromuscular disorders[45] - Preclinical data in a mouse model of Duchenne Muscular Dystrophy (DMD) showed that RKER-065 increased utrophin expression and muscle strength[53, 54] - In a preclinical study, co-treatment with prednisolone and RKER-065 in MDX mice increased both muscle mass and strength, as well as trabecular bone and strength[61] - Initial data from a Phase 1 healthy volunteer trial is expected in Q1 2025, which has the potential to inform development of KER-065 in neuromuscular indications, such as DMD[83] Elritercept (KER-050) for Myelodysplastic Syndromes (MDS) and Myelofibrosis (MF) - Keros entered into an exclusive license agreement with Takeda for elritercept, receiving an upfront payment of $200 million and being eligible for over $1.1 billion in milestone payments plus tiered royalties[95] - In an ongoing Phase 2 clinical trial for MDS, elritercept demonstrated an overall response rate of 55.2% (48/87) in the mITT24 population, with 48.3% (42/87) achieving modified IWG 2006 HI-E[114] - In the Phase 2 MDS trial, 39.1% (27/69) of transfusion-independent evaluable patients achieved transfusion independence (TI) for at least 8 weeks[114] - In the Phase 2 MF trial, 40% (8/20) of evaluable patients showed ≥ 10% reduction in spleen size at Week 24[129] - The Phase 3 RENEW trial in MDS is expected to commence in Q1 2025[137]