Keros Therapeutics, Inc. · NASDAQ:KROS
Keros Therapeutics — Investor Presentation (August 2025)
34 slides from Keros Therapeutics's investor presentation, Aug 6, 2025
Slide 1: August 2025 Corporate Presentation
August 2025 Corporate Presentation
Slide 2: Forward-looking statements
Corporate Presentation 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," “pl
Slide 3: Focused on Transforming the Lives of Patients with Disorders Linked to TGF-β Signaling
KER-065 P R E C L I N I C A L Corporate Presentation 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-β s
Slide 4: KER-065: Neuromuscular Diseases
Corporate Presentation KER-065: Neuromuscular Diseases 4
Slide 5: KER-065
Corporate Presentation 5 KER-065 KER-065 is an investigational modified activin receptor IIA (ActRIIA) and activin receptor IIB (ActRIIB) ligand trap • ~50% amino acids derived from each activin receptor KER-065 is designed to bind and inhibit activin A and myostatin to: • Improve muscle regener
Slide 6: Duchenne muscular dystrophy disease background
1. Parker, A. E., et al. (2005). QJM 98, 729–736. doi: 10.1093/qjmed/hci113; 2. Tabebordbar, M., et al. (2013). Annu. Rev. Pathol. 8, 441–475. doi: 10.1146/annurev-pathol-011811-132450; 3.Wallace, G. Q., and McNally, E. M. (2009). Annu. Rev. Physiol. 71, 37–57. doi:10.1146/annurev.physiol.010908.163
Slide 7: Current Treatment Landscape for DMD
HDAC Inhibitors • Modulate the deregulated activity of HDACs in dystrophic muscle • DuvyzatTM (givinostat) was approved by the FDA in patients aged 6+ • DuvyzatTM can cause dose-related thrombocytopenia and other signs of myelosuppression, including anemia and neutropenia Corporate Presentation 7 Cu
Slide 8: Robust Preclinical Data Suggests Potential Benefits of KER-065
Corporate Presentation 8 Robust Preclinical Data Suggests Potential Benefits of KER-065 Activin inhibition (but not myostatin inhibition) offers therapeutic potential Offer muscle, bone and fat benefits: Potential to increase muscle mass, decrease fat mass and improve BMD, based on preclinical dat
Slide 9: KER-065 Phase 1 Trial Design
Corporate Presentation 9 KER-065 Phase 1 Trial Design Part 1 Single Ascending Dose (SAD) (Double-blinded) Treatment period: 28 days Safety follow up: 28 days Single subcutaneous dose Part 2 Multiple Ascending Dose (MAD) (Double-blinded) Treatment period: 85 days Safety follow up: 56 days Three subcu
Slide 10: Baseline Demographics Consistent with Desired Population to Enroll
Corporate Presentation 10 Baseline Demographics Consistent with Desired Population to Enroll All participants in this trial were male and generally healthy Higher baseline weight, BMI and waist-to-hip ratio in MAD relative to SAD, further supporting evaluation of body composition parameters Wi
Slide 11: Treatment with KER-065 Was Generally Well Tolerated
Corporate Presentation 11 Treatment with KER-065 Was Generally Well Tolerated Most TEAEs were mild (Grade 1) to moderate (Grade 2) No dose-limiting toxicities or serious adverse events were observed No bleeding events / telangiectasias were observed One unrelated Grade 4 TEAE* was observed (
Slide 12: Most Commonly Reported TEAEs
Corporate Presentation 12 Treatment with KER-065 Was Generally Well Tolerated Most Commonly Reported TEAEs (TEAE Preferred Term) SAD MAD KER-065 1.0 mg/kg (N=4) n (%) KER-065 3.0 mg/kg (N=4) n (%) KER-065 5.0 mg/kg (N=4) n (%) KER-065 Total (N=12) n (%) Placebo (N=6) n (%) KER-065 1.25 mg/kg (N=8) n
Slide 13: Observed Mean Change in Hemoglobin From Baseline
Corporate Presentation 13 Observed Mean Change in Hemoglobin From Baseline Dose of KER-065 Increases in hemoglobin were asymptomatic and reversible SAD: • Increases in hemoglobin were observed, most prominently in the highest dose MAD: • Hemoglobin increase observed, primarily following the in
Slide 14: Increases in BSAP and Decreases in CTX Observed
14 BSAP CTX Bone specific alkaline phosphatase (BSAP) is a biomarker of bone formation C-terminal telopeptide (CTX) is a biomarker of bone resorption Increases in BSAP and Decreases in CTX Observed Following KER-065 Administration Corporate Presentation KER-065 treatment demonstrated the potenti
Slide 15: KER-065 Led to Increased Whole Body Bone Mineral Density
Corporate Presentation 15 KER-065 Administration Led to Increased Whole Body Bone Mineral Density (BMD) Changes in bone biomarkers of increased bone formation and reduced bone resorption were consistent with tissue level changes, as demonstrated by observed increase in BMD Maximum increase data repr
Slide 16: Adiponectin Increased and Leptin Decreased
16 Adiponectin Leptin Adiponectin is a biomarker of fat mobilization Leptin is a biomarker of fat mass Adiponectin Increased and Leptin Decreased Following KER-065 Administration Corporate Presentation Observed increase in adiponectin and reduction in leptin are supportive of fat mobilization Da
Slide 17: KER-065 Administration Led to Decreases in Fat Mass
-15 -10 -5 0 5 Day 85 Vi sc er al F at M ax im um % C ha ng e fr om b as el in e (M ea n ± S EM ) -10 -5 0 5 Day 85 W ho le B od y Fa t M as s M ax im um % In cr ea se fr om b as el in e (M ea n ± S EM ) DXA = dual-energy X-ray absorptiometry; MRI = magnetic resonance imaging Corporate Presentation
Slide 18: KER-065 Administration Led to Increases in Muscle Mass
Corporate Presentation 18 KER-065 Administration Led to Increases in Muscle Mass Lean body mass (DXA) Thigh muscle volume (MRI) Observation of increased skeletal muscle, as demonstrated by increases in whole body lean mass (DXA) and thigh muscle volume (MRI) Data represented is baseline through day
Slide 19: Encouraging Preclinical and Phase 1 Data Support Rationale for Phase 2 Trial
Corporate Presentation 19 Encouraging Preclinical and Phase 1 Trial Data Support Rationale for Phase 2 Trial Trial met key objectives for safety, tolerability, pharmacokinetics and pharmacodynamics • Pharmacokinetic profile generally consistent with that of a well-behaved biologic • Dose exposure
Slide 20: Positive Feedback from Leading DMD Experts on KER-065
Corporate Presentation 20 We Have Received Positive Feedback from Leading DMD Experts on KER-065 Preclinical and Phase 1 Clinical Data “These preclinical data are very exciting, and I will be delighted to see this progressing to clinic .” Laurent Servais, MD PhD, Professor of Paediatric Neuromuscula
Slide 21: Phase 1 Data Support Potential to Address Multiple Aspects of DMD
Corporate Presentation 21 Phase 1 Data Support Potential for KER-065 to Address Multiple Aspects of DMD Bone Fat Muscle Reduced muscle strength, loss of ambulation and use of glucocorticoids in DMD contribute to the development of secondary osteoporosis KER-065 elicited: • Increases in BSAP demonstr
Slide 22: Therapeutic Potential in a Broad Range of Neuromuscular Diseases
Corporate Presentation 22 Therapeutic Potential in a Broad Range of Neuromuscular Diseases Created with BioRender Based on observed pharmacology in preclinical studies and the Phase 1 clinical trial, we believe KER-065 has potential in multiple, rare neuromuscular diseases with high unmet need BMD =
Slide 23: Elritercept (KER-050) in MDS and Myelofibrosis
B Elritercept (KER-050) Investigational Treatment for Anemia and Thrombocytopenia in Patients with Myelodysplastic Syndromes and in Patients with Myelofibrosis Corporate Presentation 23
Slide 24: Global License Agreement with Takeda Pharmaceuticals
BCorporate Presentation Global License Agreement with Takeda Pharmaceuticals 24 On December 3, 2024, Keros announced it had entered into an exclusive license agreement with Takeda to develop, manufacture and commercialize elritercept globally, other than mainland China, Hong Kong, and Macau Financia
Slide 25: 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 26: Disease Overviews: MDS and MF
BCorporate Presentation 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 leuke
Slide 27: Ongoing Phase 2 Clinical Trial to Evaluate Elritercept in Patients with MDS
B As of the August 30, 2024 data cut-off date1: • Elritercept was generally well-tolerated • Robust responses were observed in a broad range of patients, including those with high transfusion burden • Durable transfusion independent responses were observed with elritercept treatment • Sustained and
Slide 28: RENEW Trial: Phase 3 Trial of Elritercept in MDS
BCorporate Presentation 28 RENEW Trial: Ongoing Phase 3 Clinical Trial to Evaluate Elritercept in Patients with MDS Screening Assessments Screening Period Double-Blind Treatment Period (48 weeks + Extension Phase) Safety Follow-Up Period (8 weeks) Extension Phase (Variable – after Secondary Phase un
Slide 29: Phase 2 Trial of Elritercept in MF
BCorporate Presentation 29 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 with s
Slide 30: Elritercept Was Generally Well-Tolerated in Patients with Significant Disease Burden
B 30Corporate Presentation Elritercept Was Generally Well-Tolerated in Patients with Significant Disease Burden Data are presented as of a data cut-off date of August 30, 2024 N/A= not applicable Category Monotherapy (N=29) Combination (N=44) Total (N=73) TEAEs, n (%) 29 (100) 40 (90.9) 69 (94.5) Mo
Slide 31: Data Support Potential for Elritercept to Address Multiple Aspects of MF
B 31Corporate Presentation Data Support Potential for Elritercept to Address Multiple Aspects of MF Hematopoiesis Spleen Size Symptoms • Increases in Hgb were observed in both monotherapy and combination arms • Reductions in transfusion burden observed in both arms further support potential to addre
Slide 32: Proprietary Discovery Approach
Corporate Presentation Proprietary Discovery Approach 32
Slide 33: Proprietary Discovery Approach
Corporate Presentation We have developed a proprietary library of ActRII ligand traps by combining sequences from ActRIIA and ActRIIB ▸ We have engineered molecules that are designed to have the therapeutic properties of either or both parent molecules ▸ Our ActRII program has produced a broader pip
Slide 34: Delivering on Our Priorities to Drive Long-Term Growth
Corporate Presentation Delivering on Our Priorities to Drive Long-Term Growth 34 Proven record of advancing molecules from discovery to value creation – We discovered elritercept and advanced it into two Phase 2 clinical trials, one in patients with MDS and one in patients with MF, and one Phase 3 c
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