Roche (ROG) Status Update summary

Neurology pipeline and strategic focus

• Neurology is a key growth area, with late-stage assets like Ocrevus, fenebrutinib, Trontinumab, GYM329, and gamma secretase modulators advancing, and launches planned through 2028.

• The pipeline targets multiple sclerosis, neuromuscular, and neurodegenerative disorders, aiming to slow progression and improve quality of life.

• Differentiated platforms include Brainshuttle™ for enhanced CNS drug delivery and first-in-class oral gamma secretase modulators for early Alzheimer's.

• Diagnostic advances feature blood-based biomarkers (Elecsys Amyloid Plasma Panel and pTau217) with high clinical performance for early Alzheimer's detection.

• Roche integrates diagnostic and therapeutic solutions to drive access to neurology innovations globally.

Alzheimer's disease innovation and unmet needs

• Alzheimer's disease is a growing health and economic burden, with global prevalence and costs projected to rise sharply by 2050.

• Next-generation therapies focus on faster, deeper amyloid clearance, prevention of amyloid accumulation, and improved safety and convenience.

• The company aims to transform the AD care pathway, leveraging fluid and digital biomarkers for early detection, diagnosis, therapy, and monitoring.

Trontinumab/Trontinemab Brainshuttle™ clinical update

• Trontinumab, a Brainshuttle Aβ antibody, enables efficient blood-brain barrier crossing and robust amyloid plaque removal, with rapid, dose-dependent amyloid clearance and large reductions in CSF biomarkers (total tau, pTau181, neurogranin).

• Interim phase Ib/IIa data (n=160) show most high-dose participants became amyloid PET negative by week 28, even with high baseline amyloid burden.

• Safety profile is favorable with low ARIA incidence; protocol amendments exclude participants with superficial siderosis after a macrohemorrhage case.

• Infusion-related reactions are manageable with premedication, and anemia incidence was reduced in later cohorts, largely attributed to frequent blood draws.

• Phase III planning will focus on safety, amyloid PET outcomes, and patient-friendly dosing regimens, with regulatory pathways considering surrogate endpoints.