PHILADELPHIA, March 04, 2024 (GLOBE NEWSWIRE) -- 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 fourth quarter and year ended December 31, 2023 and provided recent business highlights.
"In 2023, we achieved a significant milestone by announcing encouraging data from three patients in Cohort 1 of our FTD-GRN program. This data showcased the ability of PBFT02 to raise CSF progranulin to supraphysiologic levels, even at the lowest dose, Dose 1, and positions PBFT02 as a potential best-in-class treatment for FTD-GRN. Our global upliFT-D study continues to see strong momentum, and we're excited to announce the activation of our first clinical trial site in Europe to further bolster recruitment efforts. We are on track to complete dosing for Cohort 1 patients in the first half of this year and share 6-month additional safety and biomarker data from Cohort 1 in the second half of 2024," said Will Chou, M.D., president and chief executive officer of Passage Bio. "Buoyed by this promising data and additional evidence supporting progranulin's role in neurodegeneration, we are optimistic about expanding the application of PBFT02 beyond FTD-GRN and into new indications with significant unmet needs, including FTD-C9orf72, ALS, and Alzheimer's disease. We eagerly anticipate a catalyst-rich 2024, supported by our robust balance sheet, bringing us closer to improving patient outcomes across neurodegenerative diseases."
Recent Highlights
Anticipated Upcoming Milestones:
FTD-GRN
FTD-C9orf72 and ALS
Fourth Quarter and Full-Year 2023 Financial Results
About Passage Bio
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: www.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 trials and the availability of clinical data from such trials; our expectations about our collaborators’ and partners’ ability to execute key initiatives; our expectations about manufacturing plans and strategies; our expectations about cash runway; our expectations about potential out-licensing opportunities related to PBGM01, PBKR03 and PBML04; 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.
| Passage Bio, Inc. Balance Sheets | ||||||||
| December 31, | ||||||||
| (in thousands, except share and per share data) | 2023 | 2022 | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 21,709 | $ | 34,601 | ||||
| Marketable securities | 92,585 | 155,009 | ||||||
| Prepaid expenses and other current assets | 923 | 926 | ||||||
| Prepaid research and development | 2,742 | 6,508 | ||||||
| Total current assets | 117,959 | 197,044 | ||||||
| Property and equipment, net | 15,295 | 22,515 | ||||||
| Right of use assets - operating leases | 16,858 | 19,723 | ||||||
| Other assets | 433 | 4,267 | ||||||
| Total assets | $ | 150,545 | $ | 243,549 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,298 | $ | 4,065 | ||||
| Accrued expenses and other current liabilities | 11,670 | 11,011 | ||||||
| Operating lease liabilities | 3,373 | 3,275 | ||||||
| Total current liabilities | 16,341 | 18,351 | ||||||
| Operating lease liabilities – noncurrent | 22,921 | 23,832 | ||||||
| Total liabilities | 39,262 | 42,183 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, $0.0001 par value: 10,000,000 shares authorized; no shares issued and outstanding at both December 31, 2023 and December 31, 2022 | — | — | ||||||
| Common stock, $0.0001 par value: 300,000,000 shares authorized; 54,944,130 shares issued and outstanding at December 31, 2023 and 54,614,690 shares issued and outstanding at December 31, 2022 | 5 | 5 | ||||||
| Additional paid‑in capital | 705,789 | 694,733 | ||||||
| Accumulated other comprehensive income (loss) | (43 | ) | (966 | ) | ||||
| Accumulated deficit | (594,468 | ) | (492,406 | ) | ||||
| Total stockholders’ equity | 111,283 | 201,366 | ||||||
| Total liabilities and stockholders’ equity | $ | 150,545 | $ | 243,549 | ||||
| Passage Bio, Inc. Statements of Operations and Comprehensive Loss | ||||||||
| Year Ended December 31, | ||||||||
| (in thousands, except share and per share data) | 2023 | 2022 | ||||||
| Operating expenses: | ||||||||
| Research and development | $ | 61,419 | $ | 86,053 | ||||
| Acquired in‑process research and development | — | 3,000 | ||||||
| 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 | ) | ||
| Per share information: | ||||||||
| Net loss per share of common stock, basic and diluted | $ | (1.86 | ) | $ | (2.50 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 54,743,490 | 54,429,023 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (102,062 | ) | $ | (136,125 | ) | ||
| Unrealized gain (loss) on marketable securities | 923 | (553 | ) | |||||
| Comprehensive loss | $ | (101,139 | ) | $ | (136,678 | ) | ||
For further information, please contact:
Investors:
Stuart Henderson
Passage Bio
267.866.0114
This email address is being protected from spambots. You need JavaScript enabled to view it.
Media:
Mike Beyer
Sam Brown Inc. Healthcare Communications
312.961.2502
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| Last Trade: | US$0.59 |
| Daily Change: | -0.0002 -0.03 |
| Daily Volume: | 800 |
| Market Cap: | US$36.440M |
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