Financial Performance - As of September 30, 2025, Passage Bio reported total assets of $74,160,000, a decrease of 27.6% from $102,412,000 on December 31, 2024[13] - For the three months ended September 30, 2025, net loss was $7,749,000, a reduction of 60% compared to a net loss of $19,340,000 for the same period in 2024[14] - The net loss per share for the three months ended September 30, 2025, was $2.44, compared to $6.15 for the same period in 2024[14] - The company reported a comprehensive loss of $7,749,000 for the three months ended September 30, 2025, compared to $19,241,000 for the same period in 2024[14] - For the nine months ended September 30, 2025, the net loss was $32.5 million, a decrease from a net loss of $52.0 million in the same period of 2024, representing a 37.4% improvement[23] - The company reported net losses of $7.7 million and $19.3 million for the three months ended September 30, 2025 and 2024, respectively[168] Cash and Liquidity - The company’s cash and cash equivalents increased to $52,773,000 from $37,573,000, representing a growth of 40.3%[13] - The company reported cash and cash equivalents of $52.8 million at the end of the period, up from $32.3 million at the end of September 2024, reflecting a 63.7% increase[23] - As of September 30, 2025, the company had cash and cash equivalents of $52.8 million, expected to fund operations into Q1 2027[171] - Cash flows used in operating activities amounted to $25.0 million for the nine months ended September 30, 2025, compared to $39.5 million for the same period in 2024, indicating a 36.5% reduction in cash outflows[23] - The company anticipates needing additional funds for operational needs and capital requirements for clinical trials and research and development expenditures[207] Research and Development - Research and development expenses decreased to $4,307,000 from $8,656,000, reflecting a decline of 50.3% year-over-year[14] - Total research and development expenses for the nine months ended September 30, 2025, were $17.9 million, down 41.6% from $30.6 million in the same period of 2024[141] - The company expects research and development expenses to remain consistent in the near future, with potential increases if product candidates progress to later-stage clinical trials[186] - The lead clinical product candidate, PBFT02, is focused on treating frontotemporal dementia caused by progranulin deficiency, aiming to restore lysosomal function[25] - The company has a gene therapy pipeline addressing multiple neurodegenerative diseases, including Alzheimer's disease, with a potential prevalence of 3.9 million in the US/EU[149] Equity and Stock - Total stockholders' equity decreased to $31,120,000 from $61,261,000, a decline of 49.1%[13] - The total number of shares authorized under the Incentive Plan as of September 30, 2025, was 947,598, with 423,039 shares available for future grants[125] - The number of shares reserved for issuance under the Incentive Plan increased by 155,155 shares in January 2025[125] - The company issued 6,000,000 shares under the ATM Facility, resulting in net proceeds of $8.7 million after deducting offering costs of $0.3 million[210] Impairment and Expenses - The company recognized impairment expenses of $2.6 million for long-lived assets during the nine months ended September 30, 2025, compared to $2.7 million for the same period in 2024[45] - The company recorded $2.6 million of impairment expense related to laboratory equipment during the nine months ended September 30, 2025[200] - General and administrative expenses decreased by $3.0 million to $4.3 million for the three months ended September 30, 2025, from $7.3 million in the same period in 2024[195] Workforce and Operational Changes - The company reduced its workforce by approximately 55% in January 2025 to extend its cash runway[85] - Severance and termination-related costs recorded for the nine months ended September 30, 2025, amounted to $1.7 million[86] - A decrease of $3.3 million in wages and benefits due to a lower headcount from restructuring in January 2025[203] Clinical Trials and Product Development - PBFT02, a gene replacement therapy for FTD-GRN, is currently in a Phase 1/2 clinical trial with an active IND application from the FDA[152] - The company has opened enrollment in the upliFT-D study for PBFT02 in FTD-C9orf72 patients, following positive regulatory feedback on the clinical pathway[146] - The company plans to report updated interim safety and biomarker data from Dose 2 in the first half of 2026[164] Lease and Sublease Agreements - The company has classified all leases with terms greater than one year as operating leases as of September 30, 2025[49] - The company is pursuing additional opportunities to sublease space to offset financial obligations under the Laboratory Lease Agreement[101] - Total undiscounted lease payments amount to $38,217,000, with total lease liabilities at $24,337,000 after deducting imputed interest of $13,880,000[102]
Passage BIO(PASG) - 2025 Q3 - Quarterly Report