PHILADELPHIA, PA — Passage Bio, Inc. (Nasdaq: PASG) this week reported financial results for the third quarter ended September 30, 2023, and provided recent business highlights.
“Our team remains focused on execution, and this past quarter marked another stride toward achieving key milestones across our two lead clinical programs. Notably for FTD, we’re encouraged by the initial patient data showing the translation of preclinical studies into the clinic. As these data emerge, we are also evaluating the potential of extending the reach of PBFT02 to treat patients with other adult neurodegenerative conditions in which progranulin is thought to play a role,” said William Chou, M.D., president and chief executive officer of Passage Bio. “Furthermore, the continued treatment of patients in our GM1 trial is a testament to our team’s operational excellence. Our sustained progress across clinical programs, combined with the company’s robust financial position and the anticipation of impactful clinical data in the upcoming year, puts us squarely on the path to achieve our mission of developing transformative therapies for people with devastating CNS disorders.”
Recent Highlights
- Continued advancement of global Phase 1/2 upliFT-D trial of PBFT02 for the treatment of patients with frontotemporal dementia (FTD) with granulin mutations (GRN): The company continues to experience momentum across the FTD program, with six clinical trial sites initiated across Brazil, Canada, and the United States and additional clinical trial sites in Europe expected to come online in the coming months. Patient identification and recruitment initiatives have proven to be effective, with multiple GRN+ patients identified and being evaluated for eligibility across global trial sites. Initial data focused on safety and CSF progranulin levels from three Cohort 1 patients is expected in the fourth quarter of 2023.
- Strong clinical execution leads to the treatment of multiple patients at Dose 3 in global Phase 1/2 Imagine-1 clinical trial for GM1: Patient recruitment of early and late infantile GM1 patients to be treated at the highest dose level, Dose 3, continues to progress well. The company remains on track to report initial safety and biomarker data from Dose 3 patients by mid-2024.
- Cash runway into Q4 2025: Following a reallocation of resources completed in July, the company has extended its cash runway into the fourth quarter of 2025. This strategic financial management ensures that sufficient resources are available to continue delivering on meaningful clinical data from ongoing research and development efforts. The company remains steadfast in its commitment to prudent resource allocation.
Anticipated Upcoming Milestones
- Present initial safety and biomarker data from three Cohort 1 patients in upliFT-D clinical trial for FTD in Q4 2023.
- Present initial safety and biomarker data from Dose 3 patients in Imagine-1 clinical trial for GM1 in mid-2024.
Third Quarter 2023 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were $132.8 million as of September 30, 2023, as compared to $213.8 million as of September 30, 2022. The Company expects current cash, cash equivalents and marketable securities to fund operations into Q4 2025.
- Research and Development (R&D) Expenses: R&D expenses were $15.1 million for the quarter ended September 30, 2023, as compared to $15.4 million as of September 30, 2022.
- General and Administrative (G&A) Expenses: G&A expenses were $8.2 million for the quarter ended September 30, 2023, as compared to $10.7 million as of September 30, 2022. The decrease primarily relates to decreases in employee compensation costs and facility and other expenses, as a result of the Company’s reductions in workforce.
- Net Loss: Net loss was $27.1 million, or a net loss of $0.49 per basic and diluted share, for the quarter ended September 30, 2023, compared to $26.7 million, or a net loss of $0.49 per basic and diluted share, for the same quarter in 2022.
More information is available at www.passagebio.com.
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