Keros Therapeutics, Inc. · NASDAQ:KROS
Keros Therapeutics — Corporate Update (June 2021)
20 slides from Keros Therapeutics's corporate update, Jun 22, 2021
Slide 1: KER-050 Update
vse KKEROS OOG@ THERAPEUTICS KER-050 Update 23 June 2021
Slide 2: Disclaimer
Disclaimer Statements contained in this presentation regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," “plans,” “poten
Slide 3: Keros Attendees
Keros Attendees • Jasbir Seehra, Chief Executive Officer • Claudia Ordonez, Chief Medical Officer • Keith Regnante, Chief Financial Officer 3
Slide 4: Harnessing the Powerful Biology of the TGF-β Superfamily
Harnessing the Powerful Biology of the TGF-β Superfamily • Clinical-stage biopharmaceutical company developing novel therapeutics that target the TGF-β superfamily • Approach validated by marketed products, InfuseTM (BMP2) for spinal fusion and Reblozyl® (modified activin receptor IIB) for treatment
Slide 5: Keros is Developing Differentiated Clinical Assets in Hematological and Musculoskeletal Disorders
Keros is Developing Differentiated Clinical Assets in Hematological and Musculoskeletal Disorders 5* Anticipated clinical milestones are subject to the impact of COVID-19 on our business.
Slide 6: KER-050
KER-050 A novel treatment designed to address diseases arising from ineffective hematopoiesis • Myelodysplastic syndromes • Myelofibrosis 6
Slide 7: KER-050 is a Modified ActRII Fusion Protein
KER-050 is a Modified ActRII Fusion Protein • Activin receptors are expressed on hematopoietic cells and modulate differentiation of precursor cells • KER-050 is a ligand trap composed of a modified extracellular domain of ActRIIA fused to the Fc region of human IgG • KER-050 is designed to increase
Slide 8: KER-050 Increased RBC Parameters and Platelets following Single Doses in Phase 1 Clinical Trial
KER-050 Increased RBC Parameters and Platelets following Single Doses in Phase 1 Clinical Trial in Healthy Volunteers • Single doses of KER-050 observed to lead to clinically meaningful changes in platelets • Maximum changes observed 7-15 days post-dosing 8 • Observed rapid and sustained increase in
Slide 9: Myelodysplastic Syndromes (MDS) Overview
Myelodysplastic Syndromes (MDS) Overview *MDS Foundation • Hematologic malignancy predominantly affecting the elderly, resulting in multiple cytopenias (anemia, thrombocytopenia, neutropenia) due to ineffective hematopoiesis • 60,000-170,000 MDS patients in U.S.* • 15,000-20,000 newly diagnosed MDS
Slide 10: KER050-MD-201 Phase 2 Clinical Trial in MDS
KER050-MD-201 A Phase 2 Clinical Trial Of KER-050 For The Treatment Of Anemia In Patients With Very Low, Low Or Intermediate Risk Myelodysplastic Syndromes (MDS)
Slide 11: Phase 2 Clinical Trial of KER-050 in MDS
Phase 2 Clinical Trial of KER-050 in MDS • Phase 2, multicenter, open-label clinical trial in very low-, low- and intermediate-risk MDS patients • KER-050 administered once every four weeks (Q4W) for 12 weeks • Trial objectives: • Safety, tolerability and pharmacokinetics • Evaluate pharmacodynamic
Slide 12: Phase 2 Clinical Trial of KER-050 in MDS: Key Eligibility Criteria
Phase 2 Clinical Trial of KER-050 in MDS Key Eligibility Criteria: • MDS with very low-, low-, or intermediate-risk disease, as classified by the International Prognostic Scoring System- Revised, including both RS positive and non-RS • ESA naïve and experienced patients are eligible • No prior treat
Slide 13: Trial Status and Baseline Characteristics
Trial Status and Baseline Characteristics • Data cut-off date: May 14, 2021 • Preliminary data presented from two lowest dose cohorts: • Cohort 1: 0.75 mg/kg Q4W for 12 weeks • Cohort 2: 1.5 mg/kg Q4W for 12 weeks • 12 patients received at least one dose of KER-050 as of the data cut-off date • 9 pa
Slide 14: Safety Profile as of May 14, 2021
Safety Profile as of May 14, 2021 • Safety Review Committee has reviewed preliminary 0.75 mg/kg (Cohort 1) and 1.5 mg/kg (Cohort 2) data • Summary of safety profile* (Cohorts 1 and 2; n=12): • No drug related serious adverse events (SAEs) • 4 treatment-emergent SAEs deemed unrelated to study drug (a
Slide 15: Preliminary Results
Preliminary Results Preliminary results*: • Consistent with the data from the Phase 1 clinical trial, increases in reticulocytes, Hgb and platelets were observed in MDS patients • 5 patients that completed 8 weeks of treatment with KER-050 as of the data cut-off date met at least one of the followin
Slide 16: Reduction in Transfusion Burden Observed
Reduction in Transfusion Burden Observed+ +Data cut-off date: May 14, 2021 *Baseline transfusion burden over 8 weeks **Percent transfusion reduction over 8 weeks on treatment compared to baseline transfusion burden • Patients requiring transfusions at baseline (≥2 RBC units/8 weeks) that completed 8
Slide 17: KER-050 MDS Program Update
KER-050 MDS Program Update • Dosing has been initiated in Cohort 3 at 2.5 mg/kg Q4W following Safety Review Committee recommendation • Keros expects to report additional Part 1 data and initiate Part 2 of the trial by the end of 2021 • Based on the preliminary results as of the data cut-off date (Ma
Slide 18: Summary
Summary • Keros believes the initial preliminary data from this 12-week treatment Phase 2 clinical trial demonstrate proof-of-concept of KER-050 in patients with very low-, low- or intermediate-risk MDS • Data consistent with observations from the Phase 1 clinical trial in healthy volunteers • Incre
Slide 19: Anticipated Key Milestones
Anticipated Key Milestones* KER-050 • Announce additional data from Part 1 of Phase 2 trial in MDS End of 2021 • Initiate Phase 2 trial in myelofibrosis Q3 2021 (initial data 2022) KER-047 • Initiate Phase 2 trial in IDA H2 2021 (initial data 2022) • Initiate Phase 2 trial in IRIDA H2 2021 (initial
Slide 20: Q+A Session
Q+A Session 20