Prothena(US:PRTA)2022-03-31 05:48Corporate Strategy and Pipeline - Prothena aims to develop best-in-class therapeutics to slow, stop, or prevent proteinopathies by targeting proteins with the greatest effect on disease[12] - The company plans to file five potential new Investigational New Drug (IND) applications from its Biology-Directed Engine in the next five years[13] - Prothena is leveraging its rare disease portfolio to support a transition into a fully-integrated commercial biotech[13] Alzheimer's Disease Programs - Prothena's PRX012, an anti-Aβ subcutaneous product candidate, has 10X greater binding potency than aducanumab and is expected to have an IND filing in 1Q22[10, 46] - Topline Phase 1 data for PRX005, a tau MTBR-specific antibody being developed in collaboration with Bristol Myers Squibb, is expected in 2022[21, 55] - A dual Aβ/Tau vaccine for potential treatment and prevention of Alzheimer's disease is expected to have an IND filing in 2023, with preclinical data presented at AD/PD in March 1Q22[21] Amyloidosis Programs - Birtamimab, for AL amyloidosis, is in a confirmatory Phase 3 AFFIRM-AL study with topline data expected in 2024, targeting all-cause mortality at p≤0.10 under a Special Protocol Assessment (SPA) agreement with the FDA[18, 73, 83] - Novo Nordisk is expected to initiate a Phase 2 trial of PRX004 in patients with ATTR cardiomyopathy in 1H 2022; Prothena is eligible to receive up to $1.23 billion in total consideration from Novo Nordisk[14, 21, 88] Parkinson's Disease Program - Prasinezumab, in partnership with Roche, is in a Phase 2b PADOVA study with results expected in 2024[21, 94] - The PASADENA Phase 2 study showed a 35% reduction in decline in motor function vs placebo at one year on MDS-UPDRS Part III[97] Financial Position - Prothena had a strong cash position of $580 million as of December 31, 2021[103] - The company has potential payments of up to $365 million over the next 5 years (2022-2026) from collaborations[102]