Passage Bio Reports $64.7 Million Net Loss for 2024, Highlights Operational Developments

Passage Bio, Inc., a clinical-stage genetic medicines company, reported a net loss of $64.7 million for the year ended December 31, 2024, compared to a net loss of $102.1 million in 2023. This improvement is largely attributed to a decrease in research and development expenses, falling from $61.4 million to $40.2 million, and a decrease in general and administrative expenses, from $41.6 million to $25.0 million. The decrease in research and development expenses resulted from lower preclinical costs, reduced clinical operations expenses related to out-licensed programs, and lower external manufacturing and consulting expenses. The reduction in general and administrative expenses stemmed from lower personnel costs and reduced expenses related to contract modifications.

Significant changes during the fiscal year included the out-licensing of three pediatric programs (PBGM01, PBKR03, and PBML04) to Gemma Biotherapeutics, Inc. This resulted in a $10 million upfront payment, with potential for an additional $124 million in milestone payments and royalties. Passage Bio also entered into a transition services agreement with Gemma, receiving $3.7 million in payments as of the end of the reporting period. Furthermore, a restructuring plan was implemented in January 2025, resulting in a 55% reduction in the company's workforce and the cessation of lab operations at its New Jersey facility.

Key operational developments included the ongoing upliFT-D Phase 1/2 clinical trial for PBFT02 in frontotemporal dementia (FTD-GRN). Interim biomarker data showed robust and durable increases in cerebrospinal fluid progranulin levels and a decrease in plasma neurofilament light chain levels in patients receiving Dose 1 of PBFT02. The trial protocol was amended to include cohorts of FTD-C9orf72 patients, with dosing expected to begin in the first half of 2025. Passage Bio also initiated preclinical studies to explore PBFT02's potential in additional neurodegenerative diseases, including ALS and Alzheimer's disease. As of December 31, 2024, the company had 60 full-time employees.

Passage Bio's strategy focuses on advancing PBFT02 for FTD-GRN, broadening its application to other neurodegenerative diseases, and building relationships with patients and advocacy groups. The company relies on third-party manufacturers, primarily Catalent, for clinical supply and anticipates needing substantial additional funding to support ongoing operations and future development. The company's cash, cash equivalents, and marketable securities totaled $76.8 million as of December 31, 2024, which is projected to fund operations into the first quarter of 2027.

The company acknowledges numerous risks, including the inherent uncertainties of clinical trials, competition, manufacturing challenges, regulatory hurdles, and the need for additional funding. The company's common stock is listed on the Nasdaq Capital Market under the symbol "PASG," and the company does not anticipate paying cash dividends in the foreseeable future. The company's financial statements are included in the filing and were audited by KPMG LLP.