Slide 1: Results from the Cibotercept TROPOS PAH Phase 2 Trial
Results from the Cibotercept TROPOS PAH Phase 2 Trial May 29, 2025
Slide 2: Forward-looking statements
TROPOS 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," “plans,” “po
Slide 3: Cibotercept (KER-012) and Pulmonary Arterial Hypertension (PAH)
TROPOS Update Cibotercept (KER-012) and Pulmonary Arterial Hypertension (PAH) Cibotercept is an investigational modified activin receptor IIB ligand trap ▸Designed to rebalance TGF-β superfamily signaling, with preferential inhibition of select ligands (activin A, activin B, GDF8 and GDF11), and red
Slide 4: TROPOS Trial Dose Levels Selected Based on Toxicology Studies and Phase 1
TROPOS Update 4 TROPOS Trial Dose Levels Selected Based on Results from Toxicology Studies and Phase 1 Clinical Trial Preclinical safety studies established NOAEL of 50 mg/kg dosed every two weeks1 Keros completed a Phase 1 randomized, double-blind, placebo-controlled clinical trial to evaluate
Slide 5: TROPOS PAH Phase 2 Trial Design
TROPOS Update 5 TROPOS PAH Phase 2 Trial Design Note: dosing halted before trial completion due to safety findings 1.5 mg/kg cibotercept (Q4W) 3.0 mg/kg cibotercept (Q4W) 4.5 mg/kg cibotercept (Q4W) Placebo (Q4W) 3.0 mg/kg cibotercept (Q4W) 24-Week Treatment Period Double-blind, placebo-controlled 7
Slide 6: Baseline Characteristics
TROPOS Update 6 Baseline Characteristics Cibotercept TROPOS PAH Phase 2 Trial Baseline Characteristics Placebo N=39 Cibotercept 1.5 mg/kg N=24 Cibotercept 3.0 mg/kg N=25 Cibotercept 4.5 mg/kg N=25 Cibotercept all doses N=74 Female – no. (%) 28 (72) 17 (71) 20 (80) 18 (72) 55 (74) Age (yr) – mean ± S
Slide 7: Patient Disposition
TROPOS Update 7 Patient Disposition Cibotercept TROPOS PAH Phase 2 Trial Description – N (%) Placebo N = 39 Cibotercept 1.5 mg/kg N = 24 Cibotercept 3.0 mg/kg N = 25 Cibotercept 4.5 mg/kg N = 25 Cibotercept All doses N = 74 Safety population 39 (100) 24 (100) 25 (100) 25 (100) 74 (100) Efficacy popu
Slide 8: Treatment Emergent Adverse Events During 24-Week Treatment
TROPOS Update 8 Treatment Emergent Adverse Events During 24-Week Treatment Cibotercept TROPOS PAH Phase 2 Trial Treatment Emergent Adverse Events – N (%) Placebo N=39 Cibotercept 1.5 mg/kg N=24 Cibotercept 3.0 mg/kg N=25 Cibotercept 4.5 mg/kg N=25 Cibotercept All doses N=74 Any TEAE 25 (64.1) 23 (95
Slide 9: Pericardial Effusions During 24-Week Treatment
1 The number and percentage of patients experiencing at least one event relative to the safety population in the specified category were summarized. 2 The number and percentage of patients experiencing at least one event relative to the safety population with treatment emergent pericardial effusion
Slide 10: Pericardial Effusions
TROPOS Update 10 Pericardial Effusions The TROPOS trial population had a background rate of pericardial effusions • Placebo arm had 10% incidence rate of pericardial effusions • This observation of background pericardial effusions in patients with PAH has been reported previously1 • The background
Slide 11: Primary Endpoint: Change from Baseline in Pulmonary Vascular Resistance at Week 24
TROPOS Update 11 Primary Endpoint: Change from Baseline in Pulmonary Vascular Resistance at Week 24 Cibotercept TROPOS PAH Phase 2 Trial Change from Baseline at Week 24 dyn · sec · cm−5 Placebo N=20 Cibotercept 1.5 mg/kg N=16 Cibotercept 3.0 mg/kg N=9 Cibotercept 4.5 mg/kg N=9 Cibotercept All doses
Slide 12: Secondary Endpoints: 6MWD, WHO-FC and NT-proBNP at Week 24
TROPOS Update 12 Secondary Endpoints: 6MWD, WHO-FC and NT-ProBNP at Week 24 Cibotercept TROPOS PAH Phase 2 Trial Change from Baseline at Week 24 Placebo Cibotercept 1.5 mg/kg Cibotercept 3.0 mg/kg Cibotercept 4.5 mg/kg Cibotercept All doses 6MWD (m), N Median (range) Hodges-Lehman estimate of median
Slide 13: Summary
TROPOS Update 13 Summary Keros will not be developing cibotercept further in PAH Ability to interpret 24-week data is limited due to incomplete treatment duration and trial visit participation A dose-dependent signal for pericardial effusions was observed for cibotercept in this PAH population
Slide 14: Acknowledgements
TROPOS Update 14 Acknowledgements We thank all of the patients, their families, the TROPOS investigators and site staff who participated in the trial