Passage Bio Announces Q1 2024 Financial Results and Business Highlights

Passage Bio, Inc., a Philadelphia-based clinical-stage genetic medicines company, has announced its financial results for the first quarter ending on March 31, 2024. The company, listed on Nasdaq under the ticker PASG, is dedicated to developing innovative therapies for neurodegenerative diseases. The recent quarter has been notable for significant progress in their ongoing clinical trials and robust financial management.

The upliFT-D clinical trial, targeting frontotemporal dementia with granulin mutations (FTD-GRN), has shown promising results. Interim data from the trial indicated that Dose 1 of their lead product candidate, PBFT02, consistently elevated cerebrospinal fluid (CSF) progranulin in two patients at six months post-treatment. This is an important milestone, considering the role of progranulin in lysosomal function and its potential to slow disease progression.

Will Chou, M.D., the President and CEO of Passage Bio, expressed optimism about the progress. He highlighted the consistent elevation of CSF progranulin as a significant indicator of PBFT02's potential efficacy, reinforcing confidence in the therapy's impact at the current dosage. The successful dosing of all five patients in Cohort 1 of the upliFT-D trial marks a pivotal step forward.

Regarding this trial, the first cohort of five patients has completed dosing, and the company is on schedule to deliver six-month safety and biomarker data in the second half of 2024. Following the initial data, Passage Bio plans to continue studying Dose 1 in a second cohort, expected to begin dosing by mid-2024. This cohort will include three to five patients, with recruitment ongoing across seven clinical trial sites in Brazil, Canada, the United States, and Europe.

Passage Bio is also engaging with the U.S. Food and Drug Administration (FDA) to discuss the clinical development pathway for treating frontotemporal dementia patients with C9orf72 mutations using PBFT02. This feedback is anticipated in the latter half of 2024. The company is keen on exploring the potential of PBFT02 in addressing the TDP-43 pathology characteristic of such conditions, which currently lack approved disease-modifying therapies.

Financially, Passage Bio reported a cash position of $104.5 million as of March 31, 2024, down from $167.8 million the previous year. During the first quarter of 2024, the company raised $8.7 million under its ATM Facility. The existing cash reserves are projected to support operations into the fourth quarter of 2025.

Research and development expenses for the quarter were $11.5 million, a decrease from $16.8 million in the same period the previous year. General and administrative expenses also fell, from $19.0 million to $6.5 million, primarily due to non-recurring charges in the previous year related to the Amended Catalent Agreements. The net loss for the quarter amounted to $16.7 million, or $0.30 per share, compared to a $34.3 million loss, or $0.63 per share, in the same quarter of 2023.

Passage Bio is steadfast in its mission to address neurodegenerative diseases through genetic medicines. The strides made in the upliFT-D trial are a testament to their commitment to advancing therapies that could significantly impact patients suffering from these debilitating conditions.

With a clear roadmap for upcoming milestones and a robust financial foundation, Passage Bio is well-positioned to continue its efforts in developing one-time, disease-modifying treatments aimed at improving patient outcomes.