BridgeBio Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for BBP-812 Canavan Disease Gene Therapy Program Page 1

– Receipt of the RMAT designation is based on preliminary clinical evidence from the CANaspire Phase 1/2 clinical trial, which demonstrated functional improvements in all dosed patients, indicating that BBP-812 has the potential to address the unmet needs of individuals with Canavan disease

– BridgeBio will leverage the benefits of the RMAT designation, including early and more frequent interactions with the FDA, to establish an accelerated approval pathway for BBP-812