Keros Therapeutics, Inc. · NASDAQ:KROS
Keros Therapeutics — Corporate Update (June 2024)
34 slides from Keros Therapeutics's corporate update, Jun 17, 2024
Slide 1: Corporate Update June 2024
Corporate Update June 2024
Slide 2: Forward-looking statements
June 2024 Corporate Update 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,"
Slide 3: Focused on Disorders Linked to Dysfunctional TGF-β Superfamily Signaling
KER-065 P R E C L I N I C A L June 2024 Corporate Update Focused on Transforming the Lives of a Wide Range of Patients with Disorders Linked to Dysfunctional TGF-β Superfamily Signaling We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF
Slide 4: Hematology
B Hematology June 2024 Corporate Update 4
Slide 5: Imbalanced TGF-β Signaling in Bone Marrow Results in Ineffective Hematopoiesis
B Imbalanced TGF-β Signaling in Bone Marrow Results in Ineffective Hematopoiesis and Poor Outcomes in Both MDS and MF1,2,3 Inhibition of Activin A may restore effective hematopoiesis and improve outcomes Poor Outcomes 1. Verma A, et al. J Clin Inv 2020; 2. Portale F, et al., Haematologica. 2019, 3.
Slide 6: Elritercept Designed to Target Bone Marrow Disorders of Ineffective Hematopoiesis
Elritercept is Designed to Target Bone Marrow Disorders of Ineffective Hematopoiesis Including MDS and MF Domain Potential Effect Erythropoiesis ALL stages of differentiation and maturation4 Thrombopoiesis ALL stages of differentiation and maturation5 Bone Increased bone formation4; potential to imp
Slide 7: Elritercept (KER-050) in Myelodysplastic Syndromes
B Elritercept (KER-050) 7 Investigational Treatment for Anemia and Thrombocytopenia in Patients with Myelodysplastic Syndromes Ongoing Phase 2 Clinical Trial of KER-050 for the Treatment of Anemia in Patients with Very Low-, Low- or Intermediate-Risk Myelodysplastic Syndromes June 2024 Corporate Upd
Slide 8: MDS
BJune 2024 Corporate Update 8 MDS MDS is a collection of bone marrow disorders characterized by ineffective hematopoiesis and peripheral cytopenias. Clinical Consequences The clinical consequences of MDS include anemia, bleeding, iron overload, cardiovascular disease and progression to acute myeloid
Slide 9: Ongoing Phase 2 Trial of Elritercept in Lower-Risk MDS
BJune 2024 Corporate Update 9 Data are presented as of a data cut-off date of April 3, 2024. RP2D = Recommended Part 2 Dose; CMML: chronic myelomonocytic leukemia; high transfusion burden (HTB): ≥4 units of RBC/8 weeks for hemoglobin (Hgb) ≤9 g/dL; low transfusion burden (LTB): 1-3 units of RBC/8 we
Slide 10: Trial Enrolled Hard-to-Treat Patients with High Disease Burden
B 10June 2024 Corporate Update Trial Enrolled Hard-to-Treat Patients with High Disease Burden Data are presented as of a data cut-off date of April 3, 2024. *9 RP2D patients had missing baseline EPO; **Excludes 26 RP2D patients with unknown dysplasia category EPO = erythropoietin, SLD = single linea
Slide 11: Elritercept was Generally Well-Tolerated
B 11June 2024 Corporate Update Elritercept was Generally Well-Tolerated • Most frequent TEAEs (≥ in 15% of patients) regardless of causality were: ▸Diarrhea (24; 27.6%) ▸Fatigue (22; 25.3%) ▸Dyspnea (18; 20.7%) ▸Dizziness (17; 19.5%) ▸COVID-19 & Nausea (16, 18.4%) ▸Anemia (15; 17.2%) • Majority of T
Slide 12: Hematologic Responses Observed in Broad Array of Patients
B 12June 2024 Corporate Update Hematologic Responses Observed in Broad Array of Patients Treated with Elritercept (Weeks 0 to 24) Data are presented as of a data cut-off date of April 3, 2024. a. Includes data for weeks 0-24 in mITT24 patients; b. Includes data for Weeks 0-24 in mITT24 patients with
Slide 13: Observed Rates of TI Support Durability of Response
B TI ≥ 12 w ks TI ≥ 16 w ks TI ≥ 24 w ks TI ≥ 12 w ks TI ≥ 16 w ks TI ≥ 24 w ks 0 10 20 30 40 50 60 40 37 23 48 44 32 Pe rc en t o f P ar tic ip an ts All HTB TI ≥ 12 w ks TI ≥ 16 w ks TI ≥ 24 w ks TI ≥ 12 w ks TI ≥ 16 w ks TI ≥ 24 w ks 0 10 20 30 40 50 60 30 28 17 38 35 25 Pe rc en t o f P ar tic i
Slide 14: Durable TI Responses Observed with Elritercept Treatment
B 0 4 8 12 16 20 24 28 32 36 40 44 48 52 56 60 64 68 72 76 80 84 88 92 96 10 0 10 4 10 8 11 2 11 6 12 0 12 4 12 8 0.0 0.2 0.4 0.6 0.8 1.0 Longest TI interval in mITT24 participants who achieved TI ≥ 8 weeks from baseline through Week 24** TI Duration (Weeks) Pr ob ab ili ty o f M ai nt ai ni ng T I
Slide 15: Improvements in FACIT-Fatigue Score in Transfusion Dependent Patients
B 0 4 8 12 16 20 24 -15 -10 -5 0 5 10 15 Change in FACIT-Fatigue Score in TI ≥24 Wk Responders and Non Responders Week TI ≥ 24 Wk Responders TI ≥24 Wk Non-Responders 16 46 13 40 9 20 14 31 13 31 12 25 FA C IT - F at ig ue T ot al S co re C ha ng e (m ea n ± SE M ) 15June 2024 Corporate Update Transf
Slide 16: Summary of Elritercept Data in MDS
B 16June 2024 Corporate Update Summary of Elritercept Data in MDS In the ongoing Phase 2 clinical trial of elritercept in LR-MDS, the majority of patients enrolled had HTB or MLD indicating a difficult-to-treat trial population Elritercept was generally well tolerated as of the data cut-off date
Slide 17: Current Landscape for Treatment of Anemia in Lower Risk MDS
June 2024 Corporate Update 17 Current Landscape for Treatment of Anemia in Lower Risk MDS 1. Fenaux P, et al. New Eng J Med 2020; 382:140-151; 2. Luspatercept FDA Summary Basis of Approval Medical Review Page 11 4/3/2020. RBC Transfusions • ESAs are currently first line treatment of choice, but resp
Slide 18: Third-Party Placebo-Controlled Trial in Second-Line Lower-Risk MDS
June 2024 Corporate Update 18 Data from Third-Party Placebo-Controlled Clinical Trial in Second-Line Lower-Risk MDS Demonstrate Need for Additional Treatment Options 1. Fenaux P, et al. New Eng J Med 2020; 382:140-151 *TI for 8 weeks or longer during weeks 1 through 24 in patients with baseline tran
Slide 19: Data Supports Potential for Deep and Durable Efficacy Profile
June 2024 Corporate Update 19 Phase 2 Data Supports Potential for Elritercept to Achieve a Deep and Durable Efficacy Profile Differentiating from Treatment Landscape Data are presented as of a data cut-off date of April 3, 2024. Elritercept Phase 2 Data (mITT24 EPO≤500)* Study Enrolling RS+ and Non-
Slide 20: Phase 3 Registrational Trial in MDS
B 20June 2024 Corporate Update Planned Endpoints • Primary Endpoint: TI at 8 weeks within the first 24 weeks • A key secondary outcome will be 24-week TI over 48 weeks Phase 3 Registrational Trial in MDS Received positive feedback from the U.S. Food and Drug Administration (FDA), which resulted in g
Slide 21: Elritercept (KER-050) in Myelofibrosis
B Elritercept (KER-050) 21 Investigational Treatment for Anemia and Thrombocytopenia in Patients with Myelofibrosis Ongoing Phase 2 Open-Label Clinical Trial to Evaluate the Safety and Efficacy of KER-050 as Monotherapy or in Combination with Ruxolitinib in Patients with Myelofibrosis June 2024 Corp
Slide 22: Myelofibrosis
June 2024 Corporate Update 22 Myelofibrosis MF MF is a rare cancer of the bone marrow in which the marrow is replaced by scar tissue and is not able to produce healthy blood cells Current Treatments Currently, there are limited therapeutic options to address the MF-associated cytopenias. Patients no
Slide 23: Ongoing Phase 2 Trial in Myelofibrosis
BJune 2024 Corporate Update 23 Ongoing Phase 2 Clinical Trial to Evaluate Elritercept as Monotherapy or in Combination with Ruxolitinib in Patients with MF Monotherapy: JAK inhibitor relapsed, refractory, intolerant or ineligible Combination with Ruxolitinib: Prior ruxolitinib treatment ≥ 8 weeks wi
Slide 24: Trial Enrolled a Population with High Disease Burden
B 24June 2024 Corporate Update Trial Enrolled a Population with High Disease Burden Parameter Monotherapy (N=23) Combination (N=31) Total (N=54) Age, years, median (range) 71.0 (60 - 85) 72.0 (45 - 86) 72.0 (45 - 86) Male (%) 16 (69.6) 18 (58.1) 34 (63.0) DIPSS risk, n (%) Intermediate -1 Intermedia
Slide 25: Elritercept Generally Well-Tolerated in Patients with Significant Disease Burden
B 25June 2024 Corporate Update Elritercept Was Generally Well-Tolerated in Patients with Significant Disease Burden Most frequent TEAEs (≥ 15% of patients in both arms) regardless of causality: • Thrombocytopenia (10, 18.5%) • Monotherapy: 7, 30.4% • Combination: 3, 9.7% • Diarrhea (9, 16.7%) • Mo
Slide 26: Data Support Potential to Address Multiple Aspects of MF
B 26June 2024 Corporate Update Data Support Potential for Elritercept to Address Multiple Aspects of MF Hematopoiesis Spleen Size Symptoms • Observed increases in markers of erythropoiesis were generally greater at higher doses • Increases in Hgb were observed in both monotherapy and combination arm
Slide 27: Summary of Elritercept in Myelofibrosis
B 27June 2024 Corporate Update Summary of Elritercept in Myelofibrosis • The ongoing Phase 2 RESTORE trial of elritercept in MF has enrolled a broad population of patients with high disease burden • Elritercept was generally well-tolerated in patients with MF, both as monotherapy and in combination
Slide 28: Cibotercept (KER-012) in Pulmonary Arterial Hypertension
Cibotercept (KER-012) June 2024 Corporate Update Investigational Treatment for Pulmonary Arterial Hypertension (PAH) and for Cardiovascular Disorders Ongoing Phase 2, Randomized, Double-blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of KER-012 in Combination with Backgr
Slide 29: Cibotercept (KER-012)
June 2024 Corporate Update Cibotercept (KER-012) 29 Cibotercept is a modified activin receptor IIB ligand trap designed to preferentially inhibit select ligands to potentially rebalance TGF-β superfamily signaling without a dose-limiting increase in RBCs Completed a randomized, double-blind, pla
Slide 30: Cibotercept Open Label Biomarker Phase 2 Trial
June 2024 Corporate Update Cibotercept (KER-012) Open Label Biomarker Phase 2 Clinical Trial 30 As part of its ongoing portfolio management activities, Keros has decided to early terminate its open- label Phase 2 biomarker clinical trial of cibotercept in patients with chronic heart failure with p
Slide 31: KER-065: Obesity
June 2024 Corporate Update ▸ We believe preclinical data suggests KER-065 has the potential to improve body composition by increasing muscle mass and decreasing fat mass alone or in combination with glucagon-like peptide-1 (GLP-1) receptor agonists ▸ By targeting activin A, KER-065 has the potential
Slide 32: KER-065 Phase 1 Trial
June 2024 Corporate Update KER-065 32 We believe this trial has the potential to provide biologic proof-of-concept to support initiation of a Phase 2 proof-of-concept clinical trial in patients with obesity KER-065 is a novel ligand trap designed to bind to and inhibit TGF-β ligands, including myo
Slide 33: Anticipated Key Milestones
June 2024 Corporate Update KER-050 ▸Announce additional data from Part 2 of Phase 2 MDS trial Q4 2024 ▸Announce additional data from Phase 2 MF trial Q4 2024 KER-012 ▸Complete enrollment in Phase 2 TROPOS Trial Q4 2024 KER-065 ▸Announce data from Phase 1 healthy volunteer trial Q1 2025 Anticipated K
Slide 34: Q&A
Q&A