Recent Milestones

Key achievements in our journey to develop first-in-class therapies for protein misfolding diseases.

Recent Milestones

FDA IND Clearance

October 2026: Announced FDA clearance of the Investigational New Drug application for PROT-001, enabling initiation of SHIELD-AL, a global pivotal Phase 2/3 study in newly diagnosed lambda AL amyloidosis patients.

Read the press release →

Series B Financing

December 2025: Announced the completion of a $130 million oversubscribed Series B financing to advance PROT-001 into pivotal studies for AL amyloidosis.

Series A Financing

November 2021: Raised $51 million Series A financing to advance the treatment of protein misfolding diseases and build our pipeline.

Lead Program

PROT-001 is an investigational oral small molecule designed to stabilize lambda light chains in their native conformation, with the aim of reducing misfolding and the formation of toxic species.

PROT-001 is in clinical development for AL amyloidosis.

Its safety and efficacy in patients with AL amyloidosis have not been established.

Explore PROT-001 →