Passage Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Recent Business Highlights
Rhea-AI Summary
Passage Bio (Nasdaq: PASG) reported Q4 and full-year 2025 results and clinical progress for its PBFT02 program. Cash and cash equivalents were $46.3M as of Dec 31, 2025, with runway through 1Q 2027. Company expects interim upliFT-D data and regulatory feedback in 1H 2026.
Key operational updates include enrollment in Cohort 3 and first Dose 2 dosing in Cohort 4 of upliFT-D, and planned Huntington’s clinical candidate selection in 2H 2026.
Positive
- Cash runway through 1Q 2027
- Enrolled first three FTD-GRN patients in Cohort 3
- First Dose 2 PBFT02 treated in Cohort 4
- Plans to report interim upliFT-D safety and biomarker data in 1H 2026
- Expect to declare Huntington’s clinical candidate in 2H 2026
Negative
- Cash and equivalents down from $76.8M to $46.3M year-over-year
- Research and development spend decreased ~42% YoY (2024 to 2025)
- Net loss remains material at $45.5M for full-year 2025
News Market Reaction – PASG
On the day this news was published, PASG declined 8.88%, reflecting a notable negative market reaction. Argus tracked a peak move of +2.3% during that session. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $3M from the company's valuation, bringing the market cap to $28M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
PASG was down 3.73% while biotech peers were mixed, with names like QTTB up 11.74% and CRIS down 3.57%, pointing to a stock-specific move rather than a sector rotation.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 10 | Q3 2025 earnings | Positive | +14.8% | Reported Q3 2025 results with PBFT02 progress and strong manufacturing update. |
| Aug 12 | Q2 2025 earnings | Positive | -4.9% | Q2 2025 results showed promising FTD-GRN data and narrowed net loss. |
| May 13 | Q1 2025 earnings | Positive | -4.3% | Q1 2025 update on first Dose 2 PBFT02 patient and improved financials. |
| Mar 04 | FY 2024 results | Positive | -11.4% | Full-year 2024 results with strong Dose 1 PBFT02 CSF progranulin data. |
| Nov 13 | Q3 2024 earnings | Positive | -12.9% | Q3 2024 results with upliFT-D enrollment and reduced R&D expenses. |
Earnings updates have often been clinically/operationally positive but met with mostly negative price reactions, with only one recent earnings event trading higher on the day after.
Over the past five earnings cycles from Nov 2024 through Nov 2025, Passage Bio has repeatedly highlighted progress in its PBFT02 program, including Dose 1 and Dose 2 data and expanding upliFT-D enrollment. Financially, cash levels stepped down from $84.8M in Q3 2024 to $52.8M by Q3 2025, while net losses narrowed and operating expenses declined. Despite constructive trial updates and a cash runway into Q1 2027, four of these five earnings releases saw negative next-day price moves, suggesting the market has generally faded earnings strength.
Historical Comparison
Across five recent earnings releases, PASG’s average next-day move was -3.73%. Today’s -3.73% decline after another runway-confirming, cost-controlled update tracks closely with that pattern.
Earnings updates have traced PBFT02’s evolution from early Dose 1 data to Dose 2 enrollment across FTD-GRN and FTD-C9orf72, alongside steadily reduced R&D and G&A spending while maintaining a cash runway into Q1 2027.
Market Pulse Summary
The stock moved -8.9% in the session following this news. A negative reaction despite reiteration of a cash runway into 1Q 2027 and controlled R&D and G&A spending fits prior patterns, where four of the last five earnings reports led to next-day declines. The market has often focused on shrinking cash balances and ongoing net losses, even when PBFT02 and pipeline updates were constructive, which could contribute to selling pressure after this update as well.
Key Terms
frontotemporal dementia medical
CAG trinucleotide repeat tract medical
somatic instability medical
MSH3 medical
AAV medical
miRNA medical
Independent Data Monitoring Committee medical
autosomal dominant medical
AI-generated analysis. Not financial advice.
Enrolled first three FTD-GRN patients in Cohort 3 of ongoing upliFT-D study
Treated first FTD-C9orf72 patient with Dose 2 PBFT02 in Cohort 4 of upliFT-D study
On track to report updated interim safety and biomarker data from upliFT-D and obtain regulatory feedback on FTD-GRN registrational trial design in 1H 2026
Advancing differentiated preclinical program for Huntington’s with clinical candidate selection expected in 2H 2026
Cash runway through 1Q 2027
PHILADELPHIA, March 03, 2026 (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, 2025, and provided recent business highlights.
“We are proud of the progress made in 2025 as we meaningfully advanced our PBFT02 clinical program for the treatment of genetic forms of frontotemporal dementia,” said Will Chou, M.D., president and chief executive officer of Passage Bio. “As we enter 2026, we are excited by the strong enrollment momentum in our upliFT-D clinical study and look forward to sharing important data and regulatory updates in the first half of the year. FTD is a devastating disease, and the clinical unmet need remains substantial. We remain committed to advancing our program in the hope that we might one day offer patients and their families a therapy to redefine the course of their disease.”
Recent Highlights
- Enrolled first three FTD-GRN patients in Cohort 3 of ongoing upliFT-D study: The first three patients in Cohort 3 of the upliFT-D trial have been enrolled and patient dosings are anticipated over the coming weeks. Cohort 3 will evaluate Dose 2 PBFT02 and is expected to consist of a total of 10 patients, with patient enrollment occurring in parallel across current active trial sites in Australia, Brazil, Canada, Portugal, and the United States. The cohort will be enrolled under the recently amended protocol, which focuses on patients earlier in their disease progression and includes a short course of low-dose prophylactic anticoagulation. The company plans to report updated interim safety and biomarker data from upliFT-D and obtain regulatory feedback on registrational trial design for FTD-GRN in the first half of 2026.
- Treated first FTD-C9orf72 patient with Dose 2 PBFT02 in Cohort 4 of upliFT-D study: Cohort 4 is expected to consist of up to a total of five patients, and multiple prospective study participants have been identified and are being evaluated for trial eligibility. Initial safety data from the first Cohort 4 patient will be reviewed by the Independent Data Monitoring Committee, IDMC, given this is the first administration of PBFT02 to this patient population. Upon completion of the IDMC review, we expect to enroll subsequent Cohort 4 patients in parallel.
- Advancing differentiated preclinical program for Huntington’s disease: Huntington’s disease, HD, is an autosomal dominant, progressive neurodegenerative disease caused by a mutation in the huntingtin gene, HTT, in which a CAG trinucleotide repeat tract in the DNA is expanded. Elongation of these CAG repeat tracts over time, termed somatic instability, above a certain threshold leads to neurodegeneration. MSH3, a DNA repair protein, has been shown to play a key role in driving somatic instability in HD by erroneously incorporating extra CAG repeats into the HTT gene. The company’s approach aims to slow neurodegeneration in HD by delivering an AAV containing a miRNA gene to suppress expression of MSH3 and decrease somatic instability in the HTT gene. The company expects to declare a clinical candidate for this program in the second half of 2026. Huntington’s disease is estimated to affect approximately 70,000 individuals across the United States and Europe with no disease-modifying therapies currently approved.
Anticipated Upcoming Milestones:
- Report updated interim safety and biomarker data from Dose 2 in 1H 2026
- Seek regulatory feedback on registrational trial design in FTD-GRN in 1H 2026
- Declare clinical candidate for Huntington’s disease in 2H 2026
Fourth Quarter and Full-Year 2025 Results
- Cash Position: Cash and cash equivalents were
$46.3 million as of December 31, 2025, as compared to cash, cash equivalents, and marketable securities of$76.8 million as of December 31, 2024. The company expects current cash and cash equivalents to fund operations through 1Q 2027. - Research and Development (R&D) Expenses: R&D expenses were
$5.4 million for the quarter ended December 31, 2025, and$23.3 million for the year ended December 31, 2025, compared to$9.6 million and$40.2 million for the same quarter and year ended in 2024, respectively. - General and Administrative (G&A) Expenses: G&A expenses were
$4.9 million for the quarter ended December 31, 2025, and$19.9 million for the year ended December 31, 2025, compared to$4.7 million and$25.0 million for the same quarter and year ended in 2024, respectively. - Net Loss: Net loss was
$13.0 million , or$4.09 per basic and diluted share, for the quarter ended December 31, 2025 and$45.5 million , or$14.35 per basic and diluted share, for the year ended December 31, 2025, compared to a net loss of$12.7 million , or$4.00 per basic and diluted share, for the quarter ended December 31, 2024 and$64.8 million , or$21.04 per basic and diluted share, for the year ended December 31, 2024.
About upliFT-D (NCT04747431)
upliFT-D is a Phase 1/2 global, multi-center, open-label clinical trial of PBFT02 administered by single injection into the cisterna magna in patients aged 35 to 75 years with FTD-GRN or FTD-C9orf72. The clinical trial will sequentially enroll three FTD-GRN cohorts and two FTD-C9orf72 cohorts. Enrollment is currently ongoing. The primary endpoint of the clinical trial is to evaluate the safety and tolerability of PBFT02. Secondary endpoints include disease biomarkers and clinical outcome measures. upliFT-D is a two-year clinical trial with a three-year safety extension.
Passage Bio is pursuing several initiatives to support clinical trial recruitment and enrollment, including a collaborative partnership with InformedDNA to provide no-cost genetic counseling and testing for adults who have been diagnosed by their physicians with FTD. More information about upliFT-D can be found here.
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: 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; enrollment timing; timing of feedback from regulatory authorities; our expectations about our collaborators’ and partners’ ability to execute key initiatives; our expectations about cash runway; the ability of our product candidates to treat their respective target CNS disorders; and the potential development of other product candidates. These forward-looking statements may be accompanied by such words as “aim,” “anticipate,” “believe,” “continue,” “could,” “should,” “target,” “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) | 2025 | 2024 | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 46,303 | $ | 37,573 | ||||
| Marketable securities | — | 39,183 | ||||||
| Prepaid expenses and other current assets | 629 | 838 | ||||||
| Prepaid research and development | 830 | 1,221 | ||||||
| Total current assets | 47,762 | 78,815 | ||||||
| Property and equipment, net | 4,107 | 9,331 | ||||||
| Right of use assets - operating leases | 10,168 | 13,803 | ||||||
| Other assets | 244 | 463 | ||||||
| Total assets | $ | 62,281 | $ | 102,412 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,113 | $ | 742 | ||||
| Accrued expenses and other current liabilities | 4,653 | 6,707 | ||||||
| Non-refundable sublicense and transition services payments | 13,750 | 8,226 | ||||||
| Operating lease liabilities | 3,567 | 3,688 | ||||||
| Total current liabilities | 23,083 | 19,363 | ||||||
| Operating lease liabilities - noncurrent | 20,443 | 21,788 | ||||||
| Total liabilities | 43,526 | 41,151 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | — | — | ||||||
| Additional paid‑in capital | 723,512 | 720,488 | ||||||
| Accumulated other comprehensive income (loss) | — | 8 | ||||||
| Accumulated deficit | (704,757 | ) | (659,235 | ) | ||||
| Total stockholders’ equity | 18,755 | 61,261 | ||||||
| Total liabilities and stockholders’ equity | $ | 62,281 | $ | 102,412 | ||||
| Passage Bio, Inc. Statements of Operations and Comprehensive Loss | ||||||||
| Year Ended December 31, | ||||||||
| (in thousands, except share and per share data) | 2025 | 2024 | ||||||
| Operating expenses: | ||||||||
| Research and development | $ | 23,276 | $ | 40,179 | ||||
| General and administrative | 19,875 | 24,988 | ||||||
| Impairment of long-lived assets | 6,145 | 5,233 | ||||||
| Loss from operations | (49,296 | ) | (70,400 | ) | ||||
| Other income (expense), net | 3,774 | 5,633 | ||||||
| Net loss | $ | (45,522 | ) | $ | (64,767 | ) | ||
| Per share information: | ||||||||
| Net loss per share of common stock, basic and diluted | $ | (14.35 | ) | $ | (21.04 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 3,172,870 | 3,078,665 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (45,522 | ) | $ | (64,767 | ) | ||
| Unrealized gain (loss) on marketable securities | (8 | ) | 51 | |||||
| Comprehensive loss | $ | (45,530 | ) | $ | (64,716 | ) | ||
For further information, please contact:
Investors:
Stuart Henderson
Passage Bio
shenderson@passagebio.com
Media:
Mike Beyer
Sam Brown Inc. Healthcare Communications
312.961.2502
MikeBeyer@sambrown.com
FAQ
What cash runway did Passage Bio (PASG) report on March 3, 2026?
When will Passage Bio (PASG) report updated upliFT-D safety and biomarker data?
What clinical progress did Passage Bio (PASG) announce for PBFT02 in March 2026?
What are Passage Bio's (PASG) plans for its Huntington’s program?
How did Passage Bio's (PASG) 2025 R&D and net loss compare to 2024?
What regulatory actions is Passage Bio (PASG) seeking in 1H 2026?
