Full Press Release Details
PASSAGE BIO REPORTS FIRST QUARTER 2025 FINANCIAL RESULTS AND PROVIDES RECENT BUSINESS HIGHLIGHTS
Treated first FTD-GRN patient with Dose 2 PBFT02 and enrolled second patient; several additional patients being evaluated for trial eligibility
Announced presentation of process development data of a high productivity, suspension-based manufacturing process for PBFT02 at American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting
Cash runway into 1Q 2027
PHILADELPHIA - May 13, 2025 - Passage Bio, Inc. (Nasdaq: PASG), a clinical stage genetic medicines company focused on improving the lives of patients with neurodegenerative diseases, today reported financial results for the first quarter ended March 31, 2025, and provided recent business highlights.
"We made steady progress in executing against our core operational objectives this quarter as we focus on the enrollment of FTD-GRN and FTD-C9orf72 patients in our ongoing global Phase 1/2 upliFT-D trial of PBFT02," said Will Chou, M.D., president and chief executive officer of Passage Bio. "As we turn towards the second half of the year, we look forward to delivering additional data from upliFT-D to add to our understanding of PBFT02's safety profile, durability of progranulin expression, dose-response, and impact on plasma neurofilament levels, a disease progression biomarker that is well characterized in FTD natural history literature. We expect these data to foster meaningful engagement with health authorities in the first half of 2026 as we seek guidance on the registrational pathway for the program in FTD-GRN."
Anticipated Upcoming Milestones:
First Quarter 2025 Financial Results
Passage Bio (Nasdaq: PASG) is a clinical stage genetic medicines company on a mission to improve the lives of patients with neurodegenerative diseases. Our primary focus is the development and advancement of cutting-edge, one-time therapies designed to target the underlying pathology of these conditions. Passage Bio's lead product candidate, PBFT02, seeks to treat neurodegenerative conditions, including frontotemporal dementia, by elevating progranulin levels to restore lysosomal function and slow disease progression.
To learn more about Passage Bio and our steadfast commitment to protecting patients and families against loss in neurodegenerative conditions, please visit: passagebio.com.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995, including, but not limited to: our expectations about timing and execution of anticipated milestones, including the progress of clinical studies and the availability of clinical data from such trials; the initiation of dosing of FTD-C9orf72 patients; timing of feedback from regulatory authorities; our expectations about our collaborators' and partners' ability to execute key initiatives; our expectations about cash runway; and the ability of our product candidates to treat their respective target CNS disorders. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "potential," "possible," "will," "would," and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop and obtain regulatory approval for our product candidates; the timing and results of preclinical studies and clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; failure to protect and enforce our intellectual property, and other proprietary rights; our dependence on collaborators and other third parties for the development and manufacture of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions; and the other risks and uncertainties that are described in the Risk Factors section in documents the company files from time to time with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. Passage Bio undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
| (Unaudited) | ||||||
| (in thousands, except share and per share data) | March 31, 2025 | December 31, 2024 | ||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 63,357 | $ | 37,573 | ||
| Marketable securities | - | 39,183 | ||||
| Prepaid expenses and other current assets | 2,121 | 838 | ||||
| Prepaid research and development | 1,191 | 1,221 | ||||
| Total current assets | 66,669 | 78,815 | ||||
| Property and equipment, net | 5,523 | 9,331 | ||||
| Right of use assets - operating leases | 13,540 | 13,803 | ||||
| Other assets | 274 | 463 | ||||
| Total assets | $ | 86,006 | $ | 102,412 | ||
| Liabilities and stockholders' equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 1,458 | $ | 742 | ||
| Accrued expenses and other current liabilities | 3,994 | 6,707 | ||||
| Non-refundable sublicense and transition services payments received | 8,732 | 8,226 | ||||
| Operating lease liabilities | 3,641 | 3,688 | ||||
| Total current liabilities | 17,825 | 19,363 | ||||
| Operating lease liabilities - noncurrent | 21,475 | 21,788 | ||||
| Total liabilities | 39,300 | 41,151 | ||||
| Stockholders' equity: | ||||||
| Preferred stock, $0.0001 par value: 10,000,000 shares authorized; no shares issued and outstanding at both March 31, 2025 and December 31, 2024 | - | - | ||||
| Common stock, $0.0001 par value: 300,000,000 shares authorized; 62,148,274 shares issued and outstanding at March 31, 2025 and 62,061,774 shares issued and outstanding at December 31, 2024 | 6 | 6 | ||||
| Additional paid in capital | 721,340 | 720,482 | ||||
| Accumulated other comprehensive income (loss) | - | 8 | ||||
| Accumulated deficit | (674,640) | (659,235) | ||||
| Total stockholders' equity | 46,706 | 61,261 | ||||
| Total liabilities and stockholders' equity | $ | 86,006 | $ | 102,412 |
Statements of Operations and Comprehensive Loss
| Three Months Ended March 31, | ||||||
| (in thousands, except share and per share data) | 2025 | 2024 | ||||
| Operating expenses: | ||||||
| Research and development | $ | 7,737 | $ | 11,535 | ||
| General and administrative | 6,085 | 6,515 | ||||
| Impairment of long-lived assets | 2,637 | - | ||||
| Loss from operations | (16,459) | (18,050) | ||||
| Other income (expense), net | 1,054 | 1,339 | ||||
| Net loss | $ | (15,405) | $ | (16,711) | ||
| Per share information: | ||||||
| Net loss per share of common stock, basic and diluted | $ | (0.25) | $ | (0.30) | ||
| Weighted average common shares outstanding, basic and diluted | 62,109,991 | 56,295,540 | ||||
| Comprehensive loss: | ||||||
| Net loss | $ | (15,405) | $ | (16,711) | ||
| Unrealized gain (loss) on marketable securities | (8) | (26) | ||||
| Comprehensive loss | $ | (15,413) | $ | (16,737) |
For further information, please contact:
Sam Brown Inc. Healthcare Communications