Passage BIO(US:PASG) Globenewswire·2025-11-10 21:15Core Insights - Passage Bio, Inc. is actively enrolling patients in Cohort 3 (FTD-GRN) and Cohort 4 (FTD-C9orf72) for the ongoing upliFT-D clinical trial of PBFT02, recognizing the urgent need for disease-modifying therapies for frontotemporal dementia (FTD) [1][2] - The company has aligned with the FDA on an analytical approach to establish comparability of a high-productivity, suspension-based manufacturing process for PBFT02, which is expected to yield over 1,000 doses per batch with over 90% purity [5][2] - Passage Bio is on track to obtain regulatory feedback on the registrational trial design for FTD-GRN in the first half of 2026, with plans to report updated interim safety and biomarker data from Dose 2 during the same period [5][4] Recent Highlights - The upliFT-D trial is a Phase 1/2 global, multi-center, open-label clinical trial aimed at evaluating the safety and tolerability of PBFT02, with secondary endpoints including disease biomarkers and clinical outcome measures [6] - The trial protocol has been amended to allow for the enrollment of patients who are prodromal or have mild cognitive impairment, while excluding those with more severe progression [5] Financial Overview - As of September 30, 2025, the company reported cash, cash equivalents, and marketable securities totaling $52.8 million, down from $84.8 million a year prior, with an expected cash runway into the first quarter of 2027 [11] - Research and Development (R&D) expenses for the third quarter of 2025 were $4.3 million, a decrease from $8.7 million in the same quarter of 2024 [11] - General and Administrative (G&A) expenses also decreased to $4.3 million from $7.3 million year-over-year [11] - The net loss for the third quarter of 2025 was $7.7 million, or $2.44 per share, compared to a net loss of $19.3 million, or $6.15 per share, for the same period in 2024 [11][16]