Prothena reports Q1 EPS ($1.12), consensus ($1.03)

The Company continues to expect the full year 2025 net cash used in operating and investing activities to be between $168 to $175 million and expects to end the year with approximately $301 million (midpoint) in cash, cash equivalents and restricted cash. The estimated full year 2025 net cash used in operating and investing activities is primarily driven by an estimated net loss of $197 to $205 million, which includes an estimated $41 million of non-cash share-based compensation expense. “We continue to meaningfully advance our wholly-owned and partnered programs across our protein dysregulation portfolio during this transformative year for Prothena (PRTA). Most notably in 2025 we anticipate topline data in 2Q from the confirmatory Phase 3 AFFIRM-AL clinical trial evaluating birtamimab for AL amyloidosis, conducted under a SPA agreement with the FDA with a primary endpoint of time to all-cause mortality at a statistical significance level of 0.10. We also anticipate multiple clinical readouts starting around mid-2025 and continuing throughout the year from the ongoing Phase 1 ASCENT clinical trials in patients with early Alzheimer’s disease for PRX012. We look forward to these clinical milestones, and more, as we move closer to becoming a commercial stage biotech company,” said Gene Kinney, Ph.D., President and Chief Executive Officer, Prothena. “We’re excited to have had a robust presence at AD/PD 2025 with data from our PRX012 program on the diagnostic accuracy of plasma biomarkers and the potential impact on pre-screening for Alzheimer’s Disease clinical trials and two oral presentations from our partner Roche from the Phase 2b PADOVA clinical trial of prasinezumab for early Parkinson’s disease. We’re also anticipating an update on the Phase 2 clinical trial of coramitug for ATTR-CM from Novo Nordisk later this year.”