Keros Therapeutics, Inc. · NASDAQ:KROS
Keros Therapeutics — Investor Presentation (November 2021)
28 slides from Keros Therapeutics's investor presentation, Nov 4, 2021
Slide 1: November 2021 Corporate Presentation
November 2021 Corporate Presentation
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: 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 4: Keros is Developing Differentiated Clinical Assets in Hematological and Musculoskeletal Disorders
Keros is Developing Differentiated Clinical Assets in Hematological and Musculoskeletal Disorders 4
Slide 5: KER-050
KER-050 A novel treatment designed to address diseases arising from ineffective hematopoiesis • Myelodysplastic syndromes • Myelofibrosis 5
Slide 6: KER-050: A treatment for ineffective hematopoiesis in MDS and Myelofibrosis
KER-050: A treatment for ineffective hematopoiesis in Myelodysplastic Syndromes (MDS) and Myelofibrosis (MF) MDS • Hematologic malignancy predominantly affecting the elderly, resulting in multiple cytopenias (anemia, thrombocytopenia, neutropenia) due to ineffective hematopoiesis • 60-170,000 MDS pa
Slide 7: KER-050 is a Modified ActRII Fusion Protein
KER-050 is a Modified ActRII Fusion Protein • KER-050 is designed to increase RBC and platelet production • 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 activin recepto
Slide 8: KER-050 Increased RBC Parameters and Platelets following Single Doses in Phase 1
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: 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) 9
Slide 10: 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 11: Phase 2 Trial of KER-050 in MDS: Eligibility and Endpoints
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 12: Trial Status and Baseline Characteristics
Trial Status and Baseline Characteristics • Abstract announcing additional data from our ongoing Phase 2 clinical trial of KER-050 in MDS to be presented at the 63rd American Society of Hematology, or ASH, Annual Meeting and Exposition. • Data cut-off date: July 10, 2021 • Additional data presented
Slide 13: Safety Profile as of July 10, 2021
Safety Profile as of July 10, 2021 • Safety Review Committee has reviewed additional 0.75 mg/kg (Cohort 1), 1.5 mg/kg (Cohort 2) and 2.5 mg/kg (Cohort 3) data • Summary of safety profile* (Cohorts 1, 2 and 3; n=17): • No drug related serious adverse events (SAEs), dose-limiting toxicities or dose mo
Slide 14: Preliminary Results from Phase 2 Clinical Trial
Preliminary Results from Phase 2 Clinical Trial Preliminary results*: • 60% (n=6/10) of the evaluable patients met at least one of the following three endpoints: • Increase in hemoglobin ≥ 1.5 g/dL for 8 weeks, or • 50% reduction in transfusion requirements over 8 weeks, or • Transfusion independenc
Slide 15: Reductions in Transfusion Burden Observed
Reductions in Transfusion Burden Observed* -100 -50 0 Tr an sf us io n Re du ct io n (% ) # RBC units (Pre-treatment) 2 10 5 2 4 4 6 Patient 1 2 3 4 5 6 7 0% 0% -80% RS Status RS +ve Non-RS Non-RS RS +ve Non-RS RS+ve RS+ve *Data cut-off date: July 10, 2021 • 71% (n=5/7) of the transfused evaluable p
Slide 16: Summary of KER-050 Phase 2 Clinical Trial
Summary of KER-050 Phase 2 Clinical Trial • Keros believes the additional 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
Slide 17: KER-047
KER-047 A novel treatment designed to address: • Anemia resulting from iron imbalance • Iron deficiency anemia • IRIDA • Fibrodysplasia ossificans progressiva (FOP) 17
Slide 18: ALK2 Regulates Hepcidin and Iron Homeostasis
• ALK2 signaling in the liver controls hepcidin expression, a hormone that controls iron homeostasis • Excessive ALK2 signaling results in high hepcidin and a shortage of iron availability for RBC production • ALK2 signaling requires BMP ligand and the co-receptor hemojuvelin • Hepcidin expression i
Slide 19: Inhibition of ALK2 Demonstrated Activity in Rodent Models of Iron Imbalance
Inhibition of ALK2 Demonstrated Activity in Rodent Models of Iron Imbalance • ALK2 inhibition decreased hepcidin and increased serum iron in mice • In a mouse model of IRIDA, treatment with ALK2 inhibitors reduced hepcidin and ameliorated anemia • In a mouse model of chronic kidney disease, chronic
Slide 20: Phase 1 Trial: KER-047 Reduced Hepcidin Levels and Increased Reticulocyte Hemoglobin
• Consistent with ALK2 inhibition, decreases in serum hepcidin were observed in Cohorts 1 through 3 of Part 2 of the expanded trial • Treatment related decreases in hepcidin resulted in increased serum iron Phase 1 Clinical Trial: KER-047 Treatment Led to Reduced Hepcidin Levels and Increased Hemogl
Slide 21: Phase 2 Trials to Provide Proof-of-Concept in Iron Imbalance Anemias
Phase 2 Trials to Provide Proof-of-Concept for Treatment of Anemia Resulting from Iron Imbalance, Including IDA and IRIDA • KER-047 is designed to normalize high hepcidin levels, restore serum iron and ameliorate anemia • We expect to initiate a Phase 2 clinical trial in patients with IRIDA in Q1 20
Slide 22: KER-012
KER-012 A preclinical program designed to address • Bone loss disorders such as osteoporosis and osteogenesis imperfecta • Pulmonary arterial hypertension (PAH) 22
Slide 23: KER-012: Preclinical Product Candidate
KER-012: Preclinical Product Candidate • Proprietary selective activin receptor ligand trap in preclinical development for the treatment of pulmonary arterial hypertension (PAH) and bone disorders • In preclinical studies, KER-012: • Demonstrated high affinity for, and potent inhibition of, ligands
Slide 24: Phase 1 Clinical Trial of KER-012 in Healthy Volunteers
Phase 1 Clinical Trial of KER-012 in Healthy Volunteers • Ongoing randomized, double-blind, placebo-controlled, two-part Phase 1 clinical trial to evaluate single and multiple ascending doses of KER-012 in healthy volunteers • Trial objectives: safety, tolerability and pharmacokinetics Phase 1 Clini
Slide 25: Keros Summary
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Slide 26: We Believe Keros is Positioned for Clinical and Commercial Success
We Believe Keros is Positioned for Clinical and Commercial Success • Keros is focused on the development of novel TGF-β therapeutics • Robust biology that has been validated in the clinic • Keros is well-positioned to harness the potential of the TGF-β superfamily • ActRII program (KER-050) is in a
Slide 27: Anticipated Key Milestones
Anticipated Key Milestones* KER-050 • Announce additional data from Part 1 of Phase 2 trial in MDS End of 2021 • Initiate Part 2 of Phase 2 trial in MDS End of 2021 • Initiate Phase 2 trial in myelofibrosis Q4 2021 (initial data 2022) KER-047 • Initiate Phase 2 trial in IDA Q1 2022 (initial data 202
Slide 28: Thank You
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