Passage Bio Reports $15.4 Million Net Loss in Q1 2025, Focuses on Gene Therapy Development

Passage Bio, Inc. reported a net loss of $15.4 million for the first quarter of 2025, a decrease from the $16.7 million loss recorded in the same period of the previous year. The company's revenue remains non-existent as it continues to focus on the development of its gene therapy product candidates, primarily PBFT02, which targets frontotemporal dementia caused by progranulin deficiency. The loss per share improved to $0.25 from $0.30 year-over-year, reflecting a slight increase in the weighted average number of shares outstanding, which rose to approximately 62.1 million from 56.3 million.

Total operating expenses for the quarter were $16.5 million, down from $18.1 million in the prior year, driven by a reduction in research and development costs, which fell to $7.7 million from $11.5 million. This decrease is attributed to the termination of certain discovery research obligations and a reduction in headcount, as the company implemented a workforce reduction of approximately 55% in January 2025. General and administrative expenses also saw a slight decline, totaling $6.1 million compared to $6.5 million in the previous year.

In terms of strategic developments, Passage Bio has entered into a series of sublicense agreements with Gemma Biotherapeutics, which include initial payments totaling $15 million for licenses and clinical product supply. The company has also amended these agreements to include additional contingent payments based on Gemma achieving specific business milestones. As of March 31, 2025, Passage Bio had cash and cash equivalents of $63.4 million, which it expects will fund operations into the first quarter of 2027.

Operationally, the company is focused on advancing its clinical trials for PBFT02, with plans to initiate dosing in patients with frontotemporal dementia caused by C9orf72 mutations in the first half of 2025. The company is also exploring additional indications for PBFT02, including amyotrophic lateral sclerosis and Alzheimer's disease. However, the company acknowledges the challenges of patient recruitment for clinical trials targeting rare diseases, which could impact the timelines for its development programs.

Looking ahead, Passage Bio anticipates continued operating losses as it invests in the development of its product candidates. The company is actively seeking additional funding through equity offerings and collaborations to support its operations and growth strategy. The ongoing need for capital raises concerns about the company's ability to sustain its operations and advance its product pipeline, particularly in a competitive and rapidly evolving biotechnology landscape.