Keros Therapeutics, Inc. · NASDAQ:KROS
Keros Therapeutics — Corporate Update (December 2021)
26 slides from Keros Therapeutics's corporate update, Dec 13, 2021
Slide 1: KER-050 Update
13 December 2021| CONFIDENTIAL KER-050 Update
Slide 2: Disclaimer
2 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,” “pot
Slide 3: Presenters
3 • Jasbir Seehra, President and Chief Executive Officer • Keith Regnante, Chief Financial Officer • Simon Cooper, Chief Medical Officer
Slide 4: Harnessing the Powerful Biology of the TGF-β Superfamily
4 Harnessing the Powerful Biology of the TGF-β Superfamily • Clinical-stage biopharmaceutical company developing novel therapeutics that target the TGF-β superfamily • Leveraging our extensive experience in TGF-β superfamily protein structure, function and protein engineering to generate a clinical
Slide 5: Keros is Developing Differentiated Clinical Assets in Hematological and Musculoskeletal Disorders
5 Keros is Developing Differentiated Clinical Assets in Hematological and Musculoskeletal Disorders
Slide 6: KER-050
KER-050 A novel product candidate designed to address diseases arising from ineffective hematopoiesis • Myelodysplastic syndromes • Myelofibrosis 6
Slide 7: KER-050 is a Modified ActRII Fusion Protein
7 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 a human IgG • KER-050 is designed to incr
Slide 8: KER-050 Increased RBC Parameters and Platelets Following Single Doses in Phase 1
8 KER-050 Increased RBC Parameters and Platelets Following Single Doses in a Phase 1 Clinical Trial in Healthy Volunteers • Single doses of KER-050 observed to lead to clinically meaningful changes in platelets through day 29 • Maximum changes observed between 7-15 days post- dosing • Observed incre
Slide 9: American Society of Hematology Annual Meeting KER-050 Presentations
9 American Society of Hematology Annual Meeting and Exposition KER-050 Presentations: Preclinical • KER-050, an Inhibitor of TGF-β Superfamily Signaling, Promoted Thrombopoiesis and Reversed Immune Thrombocytopenia in a Mouse Model of Disease (Abstract #2068) • RKER-050 Rescued Ruxolitinib (Rux)-Ind
Slide 10: KER-050 Preclinical Data Support Potential to Promote All Stages of Erythropoiesis
10 KER-050 Preclinical Data Support Potential to Promote All Stages of Erythropoiesis B as lin e 12 hr 24 hr 0 20 40 60 80 100 120 7d 14 d 28 d 35 d 42 d P e rc e n t o f B a s e li n e L a b e le d C e ll s Vehicle RKER-050 RKER-050 treatment did not alter RBC life span BFU-E CFU-E Pro-E Poly-EBaso
Slide 11: RKER-050 Preclinical Data Support Potential to Promote All Stages of Thrombopoiesis
11 RKER-050 Preclinical Data Support Potential to Promote All Stages of Thrombopoiesis • Observed rapid onset of platelet increase in mouse models is consistent with terminal maturation of proplatelets • Observed increase in the number of CD41+ cells and the polyploid in mouse models is consistent w
Slide 12: RKER-050 Increased Platelets Potentially Through Activin A Inhibition
12 RKER-050 Increased Platelets Potentially Through Activin A Inhibition • In a preclinical study in mice, RKER-050 administration resulted in rapid and sustained increases in platelets • Activin A inhibited differentiation of platelet production in the preclinical study • Decreased number of polypl
Slide 13: 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) 13
Slide 14: Phase 2 Clinical Trial of KER-050 in MDS
14 Phase 2 Clinical Trial of KER-050 in MDS 0.75 mg/kg (N=6) 1.5 mg/kg (N=6) 2.5 mg/kg (N=6) 3.75 mg/kg (N=6) Part 1: Dose Escalation (Open Label) Part 2: Dose Confirmation (Open Label) Dose TBD based on Part 1 • Phase 2, multicenter, open-label clinical trial in very low-, low- and intermediate-ris
Slide 15: Phase 2 Clinical Trial of KER-050 in MDS: Key Eligibility Criteria
15 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 side
Slide 16: Trial Status and Baseline Characteristics
16 Trial Status and Baseline Characteristics • Abstract announcing additional data from our ongoing Phase 2 clinical trial of KER-050 in MDS was presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition • Data cut-off date: October 25, 2021 • Safety and efficacy data p
Slide 17: Biomarkers of Ineffective Hematopoiesis in MDS Patients
17 Biomarkers of Ineffective Hematopoiesis in Very Low-, Low- and Intermediate-Risk MDS Patients Biomarker RS Status Mean (SD) RS+ (N=13) Non-RS (N=11) EPO (IU/L) 326.0 (826.2) 490.2 (855.7) Reticulocytes (109/L) 39.1 (28.0) 29.8 (24.8) Platelets (109/L) 228.4 (67.8) 134.6 (55.5) TPO (pg/mL) 74.2 (6
Slide 18: Safety Data as of the Data Cut-off Date
18 Safety Data as of the Data Cut-off Date (October 25, 2021) • Safety Review Committee has reviewed data from 0.75 mg/kg (Cohort 1), 1.5 mg/kg (Cohort 2), 2.5 mg/kg (Cohort 3) and Cohort 4 (3.75 mg/kg) • Summary of safety data as of the data cut-off date (Cohorts 1-4, n=24) • No drug-related seriou
Slide 19: Preliminary Results from Phase 2 Clinical Trial
19 Preliminary Results from Phase 2 Clinical Trial Preliminary results*: • n=8/16 (50%) of the evaluable patients met at least one of the following endpoints: • 2006 IWG HI-E criteria: n=7/16 (43.8%) • Hemoglobin increase of ≥1.5 g/dL for 8 weeks (in NT and LTB patients) • Reduction of ≥4 RBC units
Slide 20: KER-050 Demonstrated Improvement in Erythropoiesis and Thrombopoiesis
20 KER-050 Demonstrated Improvement in Erythropoiesis and Thrombopoiesis KER-050 upregulated erythropoiesis • Reticulocyte increases observed in patients achieving HI-E or TI endpoints • Increases in serum soluble transferrin receptor (sTfR) and decreases in serum ferritin observed in patients achie
Slide 21: Summary of KER-050 Phase 2 Clinical Trial
21 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 i
Slide 22: Updated Design of KER050-MD-201
22 Updated Design of KER050-MD-201 0.75 mg/kg (N=6) 1.5 mg/kg (N=6) 2.5 mg/kg (N=6) 3.75 mg/kg (N=6) Part 1: Dose Escalation (Open Label) Part 2: Dose Confirmation (Open Label) • Cohort 4 Safety Review Committee permitted dosing of participants in Cohort 5 at 5.0 mg/kg, Q4W for 24 months • Preparing
Slide 23: Keros Summary
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Slide 24: We Believe Keros is Positioned for Clinical and Commercial Success
24 We Believe Keros is Positioned for Clinical and Commercial Success • Keros is focused on the development of novel TGF- therapeutics • Robust biology that has been validated in the clinic • Keros is well-positioned to harness the potential of the TGF- superfamily • ActRII program (KER-050) is in
Slide 25: Anticipated Key Milestones
25 Anticipated Key Milestones* KER-050 • Initiate Part 2 of Phase 2 trial in MDS Q1 2022 • Initiate Phase 2 trial in myelofibrosis Q4 2021 (initial data 2022) KER-047 • Initiate Phase 2 trial in IDA Q1 2022 (initial data 2022) • Initiate Phase 2 trial in IRIDA Q1 2022 (initial data 2022) KER-012 • A
Slide 26: Thank You
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