Keros Therapeutics, Inc. · NASDAQ:KROS
Keros Therapeutics — Investor Presentation (June 2022)
22 slides from Keros Therapeutics's investor presentation, Jun 10, 2022
Slide 1: KER-050 Update, June 2022
vse KKEROS OSG THERAPEUTICS KER-050 Update June 2022
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: Developing Differentiated Clinical Assets in Hematological, Pulmonary, and Musculoskeletal Disorders
Keros is Developing Differentiated Clinical Assets in Hematological, Pulmonary, and Musculoskeletal Disorders 3 *Anticipated clinical milestones are subject to the impact of COVID-19 on our business.
Slide 4: KER-050
KER-050 KER-050 is an investigational modified ActRIIA ligand trap designed to inhibit a subset of TGF-β superfamily ligands, including activin A, activin B, GDF8, and GDF11 In preclinical studies, treatment with a mouse research form of KER-050 (RKER-050) has been shown to increase both erythropoie
Slide 5: 27th Annual Congress of the European Hematology Association KER-050 Presentations
27th Annual Congress of the European Hematology Association KER-050 Presentations: Preclinical • “RKER-050, a novel inhibitor of TGF-β superfamily signaling, induced platelet production in healthy mouse megakaryocytes” Clinical • “A Phase 2, open-label, ascending dose study of KER-050 for the treatm
Slide 6: Treatment with RKER-050 Increased Platelet Production in Mice
Treatment with RKER-050 Increased Platelet Production in Mice Potentially by Blocking Inhibitory TGF-β Ligands such as Activin A while Permitting BMP Signaling 6 • Both anti-activin A and RKER-050 significantly increased platelet numbers in mice, suggesting: • activin A inhibition may be a partial d
Slide 7: Megakaryocyte Precursor Cells Express Activins, GDFs, BMPs and TGF-β Ligands and Receptors
Megakaryocyte Precursor Cells Express Activins, GDFs, BMPs and TGF-β Ligands and their Cognate Receptors 7 • qPCR was performed on RNA from bone marrow-derived megakaryocyte precursor cells isolated from untreated mice to assess TGF-β ligands and receptors gene expression • Murine bone marrow megaka
Slide 8: KER-050 Overview
KER-050 Overview • In a Phase 1 clinical trial of KER-050, treatment led to rapid, sustained and dose-dependent increases in RBCs and platelets • Inhibition of activin A in the bone resulted in increases in bone specific alkaline phosphatase (BSAP), a marker of osteoblast activity, which is supporti
Slide 9: Myelodysplastic Syndromes (MDS)
Myelodysplastic Syndromes (MDS) • MDS are a heterogeneous group of myeloid neoplasms characterized by clonal proliferation of hematopoietic stem cells, recurrent genetic abnormalities, myelodysplasia and ineffective hematopoiesis • Abnormalities in the bone marrow microenvironment, including altered
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) 10
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 (LR- MDS) • KER-050 administered once every four weeks (Q4W) • Trial objectives: • Part 1 • Evaluate safety, tolerability and pharmacokinetics • Evaluate p
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 patients that did not have ring sideroblasts (non-RS) and patients that have ring siderob
Slide 13: Demographics and Baseline Characteristics from Part 1 Dose Escalation
Demographics and Baseline Characteristics from Part 1 Dose Escalation KER-050 Dose Level (mg/kg) 0.75 (N=6) 1.5 (N=6) 2.5 (N=6) 3.75 (N=6) 5 (N=7) All (N=31) Age, Mean (range) 75.5 68.3 72 73.3 76.7 73.3 (55-88) Female, n (%) 5 1 4 2 0 12 (38.7%) RS positive 3 3 3 4 4 17 (54.8%) Transfusion Burden N
Slide 14: KER-050 was Generally Well-Tolerated at all Doses Tested in Part 1
n (%) KER-050 Dose Level (mg/kg) 0.75 (N=6) 1.5 (N=6) 2.5 (N=6) 3.75 (N=6) 5 (N=7) All (N=31) TEAE 6 (100) 6 (100) 6 (100) 5 (83.3) 6 (85.7) 29 (93.5) Related TEAE 1 (16.7) 0 1 (16.7) 1 (16.7) 2 (28.6) 5 (16.1) Grade ≥3 1 (16.7) 1 (16.7) 3 (50.0) 2 (33.3) 5 (71.4) 12 (38.7) SAE 1 (16.7) 2 (33.3) 1 (
Slide 15: Response Summary
Response Summary Response Rate, n/m (%) All evaluable patients HTB evaluable patients Overall Erythroid Response (HI-E or TI) 14/27 (51.8%) 11/16 (68.8%) IWG 2006 HI-E 12/26 (46.2%) 11/16 (68.8%) Transfusion independence (TI*) RS+ Non-RS 9/20 (45%) 6/12 (50%) 3/8 (37.5%) 7/16 (43.8%) 4/9 (44.4%) 3/7
Slide 16: Treatment with KER-050 Resulted in HI-E and TI in Transfusion-Dependent MDS Patients
Treatment with KER-050 Resulted in HI-E and TI in Transfusion-Dependent Non-RS and RS+ MDS patients Post-Treatment -100 -50 0 Tr an sf us io n R ed uc tio n (% ) Patient 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 2 2 8 13 8 8 4 5 6 5 7 6 4 2 4 2 4 6 4 4 2 2 8 10 6 4 2 2 2 1 1 0 0 0 0 0 0 0 0
Slide 17: Sustained Increase in Platelets Observed in HTB Patients Achieving HI-E or TI
Sustained Increase in Platelets Observed in HTB Patients Achieving HI-E or TI with KER-050 Treatment 1 15 29 43 57 71 85 99 -25 0 25 50 75 100 PLATELETS (HTB PATIENTS) Study Day C ha ng e fr om B as el in e (x 10 9 /L , ± S EM ) HI-E or TI (N=11) No HI-E or TI (N=5) April 3, 2022 data cutoff KER-050
Slide 18: Hematologic and Ferrokinetic Biomarkers Support Induction of Erythropoiesis
Observed Changes in Hematologic and Ferrokinetic Biomarkers Support Induction of Erythropoiesis with KER-050 Treatment in all HTB Patients 1 29 57 85 -40 -20 0 20 40 60 SOLUBLE TRANSFERRIN RECEPTOR (sTfR) and FERRITIN (HTB patients) Study Day % c ha ng e fr om b as el in e (m ea n ± S EM ) Ferritin
Slide 19: Summary
Summary • LR-MDS patients enrolled in Part 1 of this Phase 2 clinical trial were primarily transfusion-dependent with multilineage dysplasia • 58% of patients were HTB patients with elevated serum ferritin • KER-050 was generally well-tolerated as of data cut-off date at doses ranging from 0.75 to 5
Slide 20: MD-201 Dose Confirmation has been Initiated
MD-201 Dose Confirmation has been Initiated April 3, 2022 data cutoff • Dose-related increases in reticulocytes and hemoglobin were observed in this primarily transfusion- dependent trial population • Safety Review Committee recommended initiation of Part 2 dose confirmation of the Phase 2 clinical
Slide 21: Anticipated Key Milestones
Anticipated Key Milestones* KER-050 • Announce additional data from Phase 2 trial in MDS End 2022 • Announce initial data from Phase 2 trial in myelofibrosis End 2022 KER-047 • Initiate Phase 2 trial in IRIDA H1 2022 (initial data end of 2022) • Initiate Phase 2 trial in IDA Q3 2022 (initial data en
Slide 22: Thank You
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