Keros Therapeutics (KROS) Goldman Sachs 45th Annual Global Healthcare Conference summary

Pipeline overview and value drivers

• Three clinical-stage candidates target the TGF-β superfamily, with KER-050/elritercept in phase 2 for MDS and myelofibrosis, and KER-012 in phase 2 for PAH, expecting full enrollment in Q4 2024 and top-line data in 2025.

• KER-065 pivoted from neuromuscular to obesity, aiming to address muscle loss associated with GLP-1 therapies and obesity, with proof-of-concept data expected in Q1 2025.

• The company is transitioning from early to late-stage development, anticipating multiple data readouts over the next two to three years.

• KER-034, a similar molecule to KER-065, provides flexibility for targeting different indications and reimbursement strategies.

• $440 million in cash provides runway into Q1 2027, covering key milestones including completion of TROPOS and initiation of MDS phase 3.

Strategic shifts and clinical development

• KER-065 shifted to obesity due to the growing GLP-1 market and the need to address muscle loss, with a two-part proof-of-concept study underway.

• The mechanism targets both myostatin and activin A, aiming for greater efficacy than selective myostatin inhibition, with manageable contraceptive side effects.

• The proof-of-concept study includes single and multiple ascending dose phases, focusing on changes in lean and fat mass in overweight/obese men, with data expected in Q1 2025.

• Partnerships are being considered, with flexibility to advance through phase 2 before out-licensing.

• Registration strategy for obesity may focus on 5% body weight reduction, but differentiation will require demonstrating broader metabolic and cardiovascular benefits.

Competitive landscape and differentiation

• KER-065 and KER-034 target both myostatin and activin A, unlike some competitors that target only one ligand, aiming for higher potency.

• Safety concerns around GDF-11 inhibition are considered theoretical, with clinical data showing no significant safety signals.

• The market opportunity includes combination with or as an alternative to GLP-1 therapies, especially for patients intolerant to GLP-1s.

• KER-034 allows for strategic flexibility in muscular dystrophy and obesity indications.