Financial Position - As of December 31, 2024, the company's cash, cash equivalents, and marketable securities position is approximately 9.0 million to 2.0 million in severance and exit costs primarily in Q1 2025 due to the restructuring plan[9]. - The restructuring plan is expected to be substantially complete by the end of Q1 2025[8]. Impairment and Costs - The company expects to recognize impairment expenses for laboratory equipment of approximately 3.0 million in the three-month period ending March 31, 2025[10]. Clinical Trial Updates - Updated data from the ongoing Phase 1/2 upliFT-D clinical trial for PBFT02 shows a robust increase in PGRN expression, with cerebrospinal fluid levels rising from below 3 ng/mL at baseline to 13-27 ng/mL at six months[17]. - Plasma neurofilament light chain levels were 13% lower than baseline on average at 12 months post-treatment, contrasting with untreated patients whose levels are expected to increase by 29% per year[17]. - The company plans to initiate dosing of FTD-C9orf72 patients in the first half of 2025 and expects to report 12-month data from Dose 1 in the second half of 2025[21]. Manufacturing Process - The company is transitioning to an outsourced analytical testing model as part of its manufacturing process improvements for PBFT02[14]. Forward-Looking Statements - The company cautions that forward-looking statements regarding financial impacts and clinical trial progress involve risks and uncertainties that could materially affect actual results[20].
Passage BIO(PASG) - 2024 Q4 - Annual Results