Passage Bio Reports Third Quarter 2025 Financial Results and Provides Recent Business Highlights
Passage Bio (NASDAQ: PASG) reported Q3 2025 results and program updates for PBFT02 targeting frontotemporal dementia (FTD). The company is actively enrolling Dose 2 patients in Cohort 3 (5–10 FTD‑GRN) and Cohort 4 (3–5 FTD‑C9orf72) of the upliFT‑D study and amended the protocol to add short‑course prophylactic anticoagulation and broaden early‑stage enrollment.
Passage aligned with the FDA on an analytical comparability plan for a 200‑L suspension‑based manufacturing process that produced a batch estimated to yield >1,000 doses at >90% purity and >70% full capsids. The company plans to seek FDA feedback on a registrational FTD‑GRN trial in 1H 2026 and expects to report updated interim safety and biomarker data from Dose 2 in 1H 2026. Cash, cash equivalents and marketable securities were $52.8M as of Sept 30, 2025, with runway into 1Q 2027. Q3 net loss was $7.7M ($2.44 per share, post 1‑for‑20 reverse split).
Passage Bio (NASDAQ: PASG) ha riportato i risultati del Q3 2025 e aggiornamenti sui programmi per PBFT02 mirato all'atrofia frontotemporale (FTD). L'azienda sta attivamente reclutando i pazienti Dose 2 in Cohort 3 (5–10 FTD‑GRN) e Cohort 4 (3–5 FTD‑C9orf72) dello studio upliFT‑D e ha modificato il protocollo per aggiungere una profilassi anticoagulante a breve ciclo e ampliare l'iscrizione nelle fasi iniziali.
Passage si è concordata con la FDA su un piano di comparabilità analitica per un processo di produzione basata su sospensione da 200 L che ha prodotto un lotto stimato per fornire >1.000 dosi a >90% di purezza e >70% di capsidi completi. L'azienda intende chiedere feedback alla FDA su un trial registrazionale FTD‑GRN nel 1Q 2026 e prevede di riportare dati aggiornati di sicurezza intermedia e biomarcatori dal Dose 2 nel 1Q 2026. La liquidità e strumenti equivalenti ammontavano a $52,8M al 30 settembre 2025, con runway fino al 1Q 2027. La perdita netta del Q3 è stata di $7,7M (2,44 $ per azione, post split inverso 1‑per‑20).
Passage Bio (NASDAQ: PASG) informó los resultados del tercer trimestre de 2025 y actualizaciones de programa para PBFT02 dirigido a la demencia frontotemporal (FTD). La empresa está reclutando activamente a pacientes Dose 2 en Cohort 3 (5–10 FTD‑GRN) y Cohort 4 (3–5 FTD‑C9orf72) del estudio upliFT‑D y enmendó el protocolo para añadir anticoagulación profiláctica de corto curso y ampliar la inscripción en etapas tempranas.
Passage se alineó con la FDA en un plan de comparabilidad analítica para un proceso de fabricación basada en suspensión de 200 L que produjo un lote estimado para proporcionar >1,000 dosis a >90% de pureza y >70% de cápsides completas. La compañía planea solicitar comentarios de la FDA sobre un ensayo registracional FTD‑GRN en 1T 2026 y espera reportar datos actualizados de seguridad intermedia y biomarcadores de la Dose 2 en 1T 2026. La liquidez, equivalentes de efectivo y valores negociables sumaban $52.8M al 30 de septiembre de 2025, con horizonte hasta 1T 2027. La pérdida neta del 3T fue de $7.7M ($2.44 por acción, tras la división inversa 1- por-20).
Passage Bio (NASDAQ: PASG)는 2025년 3분기 실적과 PBFT02가 전두측두엽 치매(FTD)를 겨냥한 프로그램 업데이트를 발표했습니다. 회사는 upliFT‑D 연구의 Cohort 3 (5–10 FTD‑GRN) 및 Cohort 4 (3–5 FTD‑C9orf72)의 Dose 2 환자 모집을 적극적으로 진행 중이며, 짧은 기간의 예방적 항응고 요법을 추가하고 초기 단계 등록을 확대하기 위해 프로토콜을 수정했습니다.
Passage는 200 L의 현탁 기반 제조 공정을 위한 분석적 비교가능성 계획에 대해 FDA와 합의했으며, 이 공정에서 90% 순도, 70% 완전 캡시드, 약 1,000회의 용량을 산출할 수 있는 배치를 생산했습니다. 회사는 1H 2026에 FDA 피드백을 받아 FTD‑GRN 등록 가능 임상시험을 추진할 계획이며 Dose 2의 업데이트된 중간 안전성 및 바이오마커 데이터를 1H 2026에 보고할 것으로 기대합니다. 2025년 9월 30일 기준 현금 및 현금성자산, 매각가능증권 총액은 $52.8M였으며 1Q 2027까지의 운용 여력이 남아 있습니다. Q3 순손실은 $7.7M로, 주당 $2.44(1대 20의 역분할 후).
Passage Bio (NASDAQ: PASG) a publié les résultats du troisième trimestre 2025 et des mises à jour de programme pour PBFT02 visant la démence frontotemporale (DFT). L'entreprise recrute activement des patients Dose 2 dans Cohort 3 (5–10 FTD‑GRN) et Cohort 4 (3–5 FTD‑C9orf72) de l'étude upliFT‑D et a modifié le protocole pour ajouter une prophylaxie anticoagulante de courte durée et élargir l’inscription en phase précoce.
Passage s’est alignée avec la FDA sur un plan de comparabilité analytique pour un processus de fabrication à base de suspension de 200 L ayant produit un lot estimé pour fournir >1 000 doses à >90% de pureté et >70% de capsides complètes. La société prévoit de solliciter des retours de la FDA sur un essai FTD‑GRN registred dans le 1S 2026 et s’attend à rapporter des données de sécurité intermédiaire et de biomarqueurs mises à jour de la Dose 2 dans le 1S 2026. La trésorerie, équivalents de trésorerie et valeurs mobilières s’élevait à $52,8M au 30 septembre 2025, avec une marge de manœuvre jusqu’au 1Q 2027. La perte nette du T3 était de $7,7M (2,44 $ par action, après la scission inverse 1 pour 20).
Passage Bio (NASDAQ: PASG) meldete Ergebnisse des dritten Quartals 2025 und Programm-Updates für PBFT02, das auf Frontotemporale Demenz (FTD) abzielt. Das Unternehmen rekrutiert aktiv Dose-2-Patienten in Cohort 3 (5–10 FTD‑GRN) und Cohort 4 (3–5 FTD‑C9orf72) der upliFT‑D-Studie und hat das Protokoll geändert, um eine kurzzeitige prophylaktische Antikoagulation hinzuzufügen und die Teilnahme von frühen Phasen zu erweitern.
Passage hat sich mit der FDA auf einen analytischen Vergleichsplan für einen 200-L‑Suspensions- basierten Herstellungsprozess abgestimmt, der einen Batch produzierte, der schätzungsweise >1.000 Dosen bei >90% Reinheit und >70% volle Kapside ergibt. Das Unternehmen plant, von der FDA Feedback zu einer registrationalen FTD‑GRN‑Studie in 1H 2026 einzuholen und erwartet, aktualisierte Zwischen-Sicherheits- und Biomarker-Daten aus Dose 2 in 1H 2026 zu berichten. Die Barbestände (Kasse, Zahlungsmitteläquivalente und marktfähige Wertpapiere) lagen zum 30.09.2025 bei $52,8M, mit einer Laufzeit bis in 1Q 2027. Der Nettogewinn des Q3 betrug $7,7M (2,44 USD pro Aktie, nach dem 1‑für‑20 Rückgängersplit).
Passage Bio (NASDAQ: PASG) أعلنت عن نتائج الربع الثالث من عام 2025 وتحديثات البرنامج لـ PBFT02 المستهدف للخَرَف الأمامي الصدغي (FTD). الشركة تسجل حالياً مرضى الجرعة 2 في Cohort 3 (5–10 FTD‑GRN) وCohort 4 (3–5 FTD‑C9orf72) من دراسة upliFT‑D، كما عدّلت البروتوكول لإضافة مسكّنات مضادّة للتخثر وقائية قصيرة المدى وتوسيع التسجيل في المراحل المبكرة.
التقت Passage مع FDA حول خطة قابلية المقارنة التحليلية لعملية تصنيع معتمدة على تعليق سعة 200 لتر والتي أنتجت دفعة يقدر أن تكفي >1,000 جرعة عند >نقاء 90% و >70% من الأغطية الكاملة. تخطط الشركة لطلب ملاحظات FDA حول تجربة FTD‑GRN مسجلة في 1H 2026 وتتوقع الإبلاغ عن البيانات المتوسطة المحدثة للسلامة والبيوميترز من الجرعة 2 في 1H 2026. كانت السيولة النقدية وما يعادلها من النقد والأوراق المالية القابلة للتداول $52.8M حتى 30 سبتمبر 2025، مع مدى زمني حتى 1Q 2027. وخسارة الربع الثالث بلغت $7.7M (2.44 دولاراً للسهم، بعد تقسيم عكسي 1‑إلى‑20).
- Enrollment opened for Dose 2 in Cohort 3 (5–10 FTD‑GRN) and Cohort 4 (3–5 FTD‑C9orf72)
- FDA alignment on analytical comparability for suspension‑based manufacturing (Type D CMC meeting)
- 200‑L suspension run produced an estimated >1,000 doses with >90% purity and >70% full capsids
- R&D expenses down from $8.7M to $4.3M QoQ (Q3 2024 vs Q3 2025)
- G&A expenses down from $7.3M to $4.3M QoQ (Q3 2024 vs Q3 2025)
- Cash balance declined to $52.8M from $84.8M year‑over‑year
- Runway extends only into 1Q 2027, implying near‑term funding need
- Net loss of $7.7M in Q3 2025 indicates ongoing operating deficits
- Small cohort sizes (3–10 patients) limit near‑term statistical power for registrational claims
Insights
Progress in dosing cohorts and FDA alignment de‑risks registrational planning; interim data in 1H 2026 will be the key binary readout.
The company has opened Cohort 3 (FTD‑GRN) and Cohort 4 (FTD‑C9orf72) and implemented protocol amendments to broaden early‑stage enrollment while adding short course prophylactic anticoagulation. This advances patient accrual and safety management and keeps clinical momentum toward a registrational pathway.
Regulatory alignment on an analytical comparability approach and the plan to seek FDA feedback on a potential single‑arm registrational design with natural history control create a clearer path to registration, but the program depends on the upcoming Dose 2 interim safety and biomarker readout in
Watch for the interim Dose 2 safety and biomarker dataset in
Operational progress paired with lower burn extends runway but cash remains limited; near‑term milestones must preserve optionality.
Cash, cash equivalents and marketable securities were
These figures imply disciplined cost control and that near‑term clinical and regulatory milestones are essential to sustain financing options. The most consequential items to monitor are the Dose 2 interim dataset in
Actively enrolling Cohort 3 (FTD-GRN) and Cohort 4 (FTD-C9orf72) patients in ongoing upliFT-D study
Aligned with the U.S. Food and Drug Administration (FDA) on an analytical approach to establish comparability of a high-productivity, suspension-based PBFT02 manufacturing process
On track to obtain regulatory feedback on FTD-GRN registrational trial design in 1H 2026
Cash runway into 1Q 2027
PHILADELPHIA, Nov. 10, 2025 (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 third quarter ended September 30, 2025, and provided recent business highlights.
“We are pleased to report that we have opened enrollment in our third FTD-GRN and first FTD-C9orf72 patient cohorts in our ongoing upliFT-D clinical trial of PBFT02. We recognize the urgent need for the development of disease-modifying therapies for the FTD patient community, and we remain focused on advancing our study expeditiously,” said Will Chou, M.D., president and chief executive officer of Passage Bio. “In addition, we completed a successful meeting with the FDA where we aligned on key elements of an analytical comparability plan to support the future use of our high-productivity, suspension-based manufacturing process for PBFT02 in a registrational study. As we look towards the first half of 2026, we are excited to share additional data to further inform our understanding of the potential of PBFT02 and initiate discussions with the FDA on a registrational study design in FTD-GRN.”
Recent Highlights
- Actively enrolling Cohort 3 (FTD-GRN) and Cohort 4 (FTD-C9orf72) patients in upliFT-D study: Cohort 3 is expected to consist of five to 10 FTD-GRN patients, with patient enrollment occurring in parallel; Cohort 4 is expected to consist of three to five FTD-C9orf72 patients. Both cohorts will evaluate Dose 2 PBFT02. The company recently amended the upliFT-D trial protocol to introduce a short course of low-dose prophylactic anticoagulation and revise study inclusion criteria to allow for enrollment of patients who are prodromal or have mild cognitive impairment and to exclude patients who are more severely progressed. The amended protocol was submitted to all global trial sites and relevant health authorities and has been implemented at initial trial sites. The company plans to report updated interim safety and biomarker data from Dose 2 in the first half of 2026.
- Aligned with the FDA on an analytical approach to establish comparability of a high-productivity, suspension-based PBFT02 manufacturing process: The company completed a Type D Chemistry, Manufacturing, and Controls (CMC) meeting with FDA, during which the company aligned with FDA on key elements of the analytical plan to establish process comparability of its suspension-based process. The GMP-ready, suspension-based PBFT02 manufacturing process has been executed at 200-liter scale and substantially improved productivity, capsid purity, and percentage of full capsids compared to the current adherent-based manufacturing process. A single batch of the suspension-based process is estimated to yield more than 1,000 doses of PBFT02 at Dose 2 with over
90% purity and over70% full capsids. - On track to obtain regulatory feedback on an FTD-GRN registrational trial design in 1H 2026: The company intends to engage with the FDA in the first half of 2026 to gain feedback on key elements of a registrational study design of PBFT02 for FTD-GRN, including the FDA’s perspective on the possibility of a single-arm registrational design with a comparison to a natural history control.
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
Third Quarter 2025 Financial Results
- Cash Position: Cash, cash equivalents and marketable securities were
$52.8 million as of September 30, 2025, as compared to$84.8 million as of September 30, 2024. The company expects current cash, cash equivalents and marketable securities to fund operations into 1Q 2027. - Research and Development (R&D) Expenses: R&D expenses were
$4.3 million for the quarter ended September 30, 2025, as compared to$8.7 million for the quarter ended September 30, 2024. - General and Administrative (G&A) Expenses: G&A expenses were
$4.3 million for the quarter ended September 30, 2025, as compared to$7.3 million for the quarter ended September 30, 2024. - Net Loss: Net loss was
$7.7 million , or$2.44 per basic and diluted share (as adjusted for the 1-for-20 reverse stock split effected on July 14, 2025), for the quarter ended September 30, 2025, as compared to a net loss of$19.3 million , or$6.15 per basic and diluted share (as adjusted for the 1-for-20 reverse stock split effected on July 14, 2025), for the quarter ended September 30, 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; 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,” “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 | ||||||||
| (Unaudited) | ||||||||
| (in thousands, except share and per share data) | September 30, 2025 | December 31, 2024 | ||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 52,773 | $ | 37,573 | ||||
| Marketable securities | — | 39,183 | ||||||
| Prepaid expenses and other current assets | 1,637 | 838 | ||||||
| Prepaid research and development | 1,320 | 1,221 | ||||||
| Total current assets | 55,730 | 78,815 | ||||||
| Property and equipment, net | 5,159 | 9,331 | ||||||
| Right of use assets - operating leases | 13,001 | 13,803 | ||||||
| Other assets | 270 | 463 | ||||||
| Total assets | $ | 74,160 | $ | 102,412 | ||||
| Liabilities and stockholders’ equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 952 | $ | 742 | ||||
| Accrued expenses and other current liabilities | 4,001 | 6,707 | ||||||
| Non-refundable sublicense and transition services payments | 13,750 | 8,226 | ||||||
| Operating lease liabilities | 3,542 | 3,688 | ||||||
| Total current liabilities | 22,245 | 19,363 | ||||||
| Operating lease liabilities - noncurrent | 20,795 | 21,788 | ||||||
| Total liabilities | 43,040 | 41,151 | ||||||
| Stockholders’ equity: | ||||||||
| Preferred stock, | — | — | ||||||
| Common stock, | — | — | ||||||
| Additional paid‑in capital | 722,894 | 720,488 | ||||||
| Accumulated other comprehensive income (loss) | — | 8 | ||||||
| Accumulated deficit | (691,774 | ) | (659,235 | ) | ||||
| Total stockholders’ equity | 31,120 | 61,261 | ||||||
| Total liabilities and stockholders’ equity | $ | 74,160 | $ | 102,412 | ||||
| Passage Bio, Inc. Statements of Operations and Comprehensive Loss (Unaudited) | ||||||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| (in thousands, except share and per share data) | 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 4,307 | $ | 8,656 | $ | 17,858 | $ | 30,621 | ||||||||
| General and administrative | 4,348 | 7,251 | 14,953 | 20,276 | ||||||||||||
| Impairment of long-lived assets | — | 4,795 | 2,637 | 5,233 | ||||||||||||
| Loss from operations | (8,655 | ) | (20,702 | ) | (35,448 | ) | (56,130 | ) | ||||||||
| Other income (expense), net | 906 | 1,362 | 2,909 | 4,088 | ||||||||||||
| Net loss | $ | (7,749 | ) | $ | (19,340 | ) | $ | (32,539 | ) | $ | (52,042 | ) | ||||
| Per share information: | ||||||||||||||||
| Net loss per share of common stock, basic and diluted | $ | (2.44 | ) | $ | (6.15 | ) | $ | (10.26 | ) | $ | (17.04 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 3,178,710 | 3,146,582 | 3,170,573 | 3,054,440 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (7,749 | ) | $ | (19,340 | ) | $ | (32,539 | ) | $ | (52,042 | ) | ||||
| Unrealized gain (loss) on marketable securities | — | 99 | (8 | ) | 75 | |||||||||||
| Comprehensive loss | $ | (7,749 | ) | $ | (19,241 | ) | $ | (32,547 | ) | $ | (51,967 | ) | ||||
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
When will Passage Bio report updated interim safety and biomarker data for PBFT02 (PASG)?
What cash runway does Passage Bio (PASG) have after Q3 2025?
What are the cohort sizes and patient types in upliFT‑D Dose 2 for PBFT02 (PASG)?
What manufacturing improvements did Passage Bio report for PBFT02 (PASG)?
When will Passage Bio (PASG) seek FDA feedback on a registrational FTD‑GRN trial design?
