PHILADELPHIA, PA — Passage Bio, Inc. (Nasdaq: PASG), a clinical-stage genetic medicines company, reported financial results for the first quarter ended March 31, 2023 and provided recent business highlights.
“Over the last quarter, we have maintained a steady focus on the successful execution of our two lead clinical programs, taking the necessary steps to ensure the achievement of our upcoming milestones,” said William Chou, M.D., president and chief executive officer of Passage Bio. “In our Imagine-1 study for GM1 gangliosidosis, we expect to report safety and biomarker data for Cohort 4 by mid-year and begin dosing patients at a third, higher dose in the second half of this year. For FTD, we have expanded our recruitment sites to accelerate enrollment and look forward to reporting initial safety and biomarker data from Cohort 1 by year-end. Our disciplined approach and judicious cash management gives us confidence that we can deliver long-term value for patients and exemplifies our commitment to develop transformative therapies for people with devastating CNS disorders.”
- Submitted protocol amendment for Imagine-1 study to treat patients at a higher dose (Dose 3) of PBGM01: The Imagine-1 clinical trial protocol amendment intends to treat early and late infantile GM1 gangliosidosis patients at a higher dose (Dose 3), which is two times higher than the current high dose (Dose 2). Following regulatory review, the company looks forward to resuming patient enrollment efforts and expects to the dose the first patient at Dose 3 in the second half of the year.
- Initiated additional site in global Phase 1/2 upliFT-D trial of PBFT02 for the treatment of patients with FTD with granulin mutations (GRN): The company initiated a fourth site in April and remains focused on opening additional sites throughout the year. Enrollment is progressing globally, and initial safety and biomarker data from Cohort 1 patients continues to be expected in the second half of 2023.
Anticipated Upcoming Milestones
- Present initial safety and biomarker data from Cohort 4 (early infantile, high dose) in the Imagine-1 clinical trial for GM1 in mid-2023.
- Dose first patient at higher dose (Dose 3) in Imagine-1 clinical trial for GM1 in the second half of 2023.
- Present initial safety and biomarker data for Cohort 1 in upliFT-D clinical trial for FTD in the second half of 2023.
First Quarter 2023 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were $167.8 million as of March 31, 2023, as compared to $267.1 million as of March 31, 2022. The Company expects current cash, cash equivalents and marketable securities to fund operations into the first half of 2025.
- Research and Development (R&D) Expenses: R&D expenses were $16.8 million for the quarter ended March 31, 2023, as compared to $26.2 million for the same quarter in 2022. The decrease in R&D expenses was primarily due to decreases in clinical manufacturing expenses, wages and benefits expenses and share-based compensation expense.
- General and Administrative (G&A) Expenses: G&A expenses were $19.0 million for the quarter ended March 31, 2023, as compared to $15.1 million for the same quarter in 2022. The increase in G&A expenses was primarily due to non-recurring expenses related to amendments to the company’s agreements with Catalent, which was partially offset by decreases in wages and benefits expense, share-based compensation expense and other expenses. Excluding the non-recurring expenses related to the Catalent amendments, G&A expenses decreased by $7.4 million.
- Net Loss: Net loss was $34.3 million, or a net loss of $0.63 per basic and diluted share, for the quarter ended March 31, 2023, compared to $42.8 million, or a net loss of $0.79 per basic and diluted share, for the same quarter in 2022.
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