Company: KROS
Filing Date: 2025-05-19
Form Type: DEFA14A
Source: 0001104659-25-050245
Chunk: 2

Company: Keros Therapeutics, Inc.
Filing Date: 2025-05-19
Form: DEFA14A
Chunk 2
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 We plan on engaging with regulatory authorities                   
 on the KER-065 program, starting in the third quarter of 2025. Subject to the outcome of these regulatory interactions, we expect to initiate 
 a Phase 2 clinical trial of KER-065 in patients with DMD in the first quarter of 2026. Our encouraging preclinical and Phase 1 clinical       
 data for KER-065 has generated positive feedback from leading DMD experts:                                                                    |

| o | “KER-065 appears promising and may have the potential to benefit a broad spectrum of patients with DMD, from young ambulatory 
 boys to older, non-ambulatory individuals.” – Liesbeth De Waele, MD, Deputy Head of Clinics, Dept. of Paediatric Neurology,   
 University Hospitals Leuven in Belgium                                                                                        |

| o | “Vertebral fractures are a water-shed moment. KER-065 could help reduce these in patients with DMD.” – Emma Ciafaloni,     
 MD, Professor of Neurology and Pediatrics, University of Rochester, and Chair of the Clinical Research Committee MDSTARnet |

| o | “These preclinical data are very exciting, and I will be delighted to see this progressing to clinic.” – Laurent 
 Servais, MD PhD, Professor of Pediatric Neuromuscular Diseases, Oxford                                           |

| · | Our most advanced product candidate, elritercept (KER-050), is being developed for the treatment of low blood cell counts (“cytopenias”),      
 including anemia and thrombocytopenia, in patients with myelodysplastic syndromes (“MDS”), and in patients with myelofibrosis.                 
 We believe elritercept has the potential to provide benefit to patients suffering from red blood cell and platelet differentiation and         
 maturation defects occurring across the spectrum from early through terminal stages of hematopoiesis, and consequently may be effective        
 for many patients that have limited treatment options or are refractory to available therapies. In December 2024, Keros announced an exclusive 
 global license agreement with Takeda Pharmaceuticals U.S.A., Inc. (TSE:4502/NYSE:TAK) (“Takeda”) to further develop, manufacture               
 and commercialize elritercept worldwide outside of mainland China, Hong Kong and Macau. This collaboration delivered a $200 million upfront    
 payment to the Company and, subject to the terms of the agreement, Keros is eligible to receive development, commercial and sales