Passage BIO(US:PASG)2024-03-04 12:02Business Highlights and Outlook Recent Business Highlights Passage Bio reports promising PBFT02 FTD-GRN trial data, expanding indications, maintaining a strong balance sheet, and appointing a new CFO - The global Phase 1/2 upliFT-D clinical trial for PBFT02 in FTD-GRN shows sustained momentum, with initial data indicating the lowest dose raised CSF progranulin to supraphysiologic levels and was generally well-tolerated, expanding to seven global sites including Europe35 - PBFT02's therapeutic potential is expanding into other adult neurodegenerative diseases, including FTD-C9orf72, amyotrophic lateral sclerosis (ALS), and Alzheimer's disease, based on promising initial data35 - Passage Bio concluded 2023 with a strong balance sheet, providing a cash runway into Q4 2025, supported by resource focus on PBFT02 and pediatric program out-licensing45 - Kathleen Borthwick was appointed Chief Financial Officer, effective March 1, 2024, previously serving as Senior Vice President, Finance and Interim CFO5 Anticipated Upcoming Milestones Upcoming milestones include FTD-GRN Cohort 2 dosing and Cohort 1 data, with regulatory feedback for FTD-C9orf72 and ALS in 2H 2024 - FTD-GRN Program: Initiate Cohort 2 dosing in 1H 20248 - FTD-GRN Program: Report 6-month safety and biomarker data from Cohort 1 in 2H 20248 - FTD-GRN Program: Announce 12-month follow-up data from Cohort 1 in 1H 20258 - FTD-GRN Program: Report initial safety and biomarker data from Cohort 2 in 1H 20258 - FTD-C9orf72 and ALS Program: Regulatory feedback on the clinical pathway for PBFT02 treatment is expected in 2H 20246 Financial Results Fourth Quarter and Full-Year 2023 Financial Results Summary Passage Bio reported reduced Q4 and full-year 2023 expenses, ending with $114.3 million cash into Q4 2025, and a $102.1 million net loss Financial Results Summary (in millions, except per share data) | Financial Metric | Q4 2023 | Full-Year 2023 | Q4 2022 | Full-Year 2022 | | :--- | :--- | :--- | :--- | :--- | | Cash & Marketable Securities | $114.3 | $114.3 | $189.6 | $189.6 | | R&D Expenses | $12.1 | $61.4 | $17.7 | $86.1 | | G&A Expenses | $6.3 | $41.6 | $10.6 | $49.3 | | Net Loss | $16.8 | $102.1 | $27.1 | $136.1 | | Net Loss Per Share | $0.30 | $1.86 | $0.50 | $2.50 | - The company anticipates its $114.3 million in cash, cash equivalents, and marketable securities will fund operations into Q4 20258 Balance Sheets Passage Bio's total assets decreased to $150.5 million as of Dec 31, 2023, from $243.5 million in 2022, with liabilities slightly down and equity at $111.3 million Balance Sheets (in thousands) | Financial Metric | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Total Current Assets | $117,959 | $197,044 | | Cash and cash equivalents | $21,709 | $34,601 | | Marketable securities | $92,585 | $155,009 | | Total Assets | $150,545 | $243,549 | | Total Current Liabilities | $16,341 | $18,351 | | Total Liabilities | $39,262 | $42,183 | | Total Stockholders' Equity | $111,283 | $201,366 | | Total Liabilities and Stockholders' Equity | $150,545 | $243,549 | Statements of Operations and Comprehensive Loss For 2023, the company reported a net loss of $102.1 million or $1.86 per share, an improvement from 2022, driven by reduced operating expenses Statements of Operations and Comprehensive Loss (in thousands, except per share data) | Financial Metric | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Research and development | $61,419 | $86,053 | | General and administrative | $41,580 | $49,341 | | Impairment of long-lived assets | $5,390 | — | | Loss from operations | ($108,389) | ($138,394) | | Other income (expense), net | $6,327 | $2,269 | | Net loss | ($102,062) | ($136,125) | | Net loss per share, basic and diluted | ($1.86) | ($2.50) |