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Passage Bio, Inc. (PASG): Business Model Canvas [Dec-2025 Updated] |
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Passage Bio, Inc. (PASG) Bundle
You're digging into Passage Bio right now, and honestly, the business model is a classic pre-commercial biotech tightrope walk: high-potential science balanced against a ticking clock. Their core value is developing one-time, disease-modifying genetic medicines, like PBFT02 for Frontotemporal Dementia (FTD), built on foundational tech from the University of Pennsylvania. Here's the quick math you need to watch: as of September 30, 2025, they held $52.8 million in cash, which, given the $7.7 million net loss in Q3 2025, only buys runway until 1Q 2027. The entire model hinges on executing the Phase 1/2 upliFT-D trial and manufacturing scale-up while managing a cost base reshaped by that 55% workforce reduction earlier this year. This canvas shows you every moving part-from CMO partnerships to the specific FTD patient segments-that needs to fire perfectly to hit their next value inflection point. It's a high-stakes game of milestones.
Passage Bio, Inc. (PASG) - Canvas Business Model: Key Partnerships
You're looking at how Passage Bio, Inc. structures its external relationships to drive its clinical pipeline, which is crucial when managing cash burn and advancing complex gene therapies. These partnerships are key to accessing specialized technology, manufacturing capacity, and patient access points.
The collaboration with the Gene Therapy Program (GTP) at the University of Pennsylvania (UPenn), which provided foundational technology, has seen significant restructuring. Passage Bio amended its strategic collaboration with UPenn's GTP to discontinue preclinical research programs, terminate remaining options to future CNS research programs, and stop funding the discovery research program, effective July 31, 2024. This followed an earlier expansion where Passage Bio was paying $5 million annually to Penn to fund research across numerous technology applications for gene therapy, with the extension period running through 2025.
For patient support and trial enrollment in the upliFT-D study, Passage Bio partners with InformedDNA. This collaboration provides no-cost genetic counseling and testing for adults diagnosed by their physicians with Frontotemporal Dementia (FTD). This is a direct mechanism to help identify and enroll eligible patients for the PBFT02 program.
Development of pediatric products is handled through a licensing agreement with Gemma Biotherapeutics, a company co-founded by Dr. James M. Wilson. Passage Bio out-licensed three gene therapies for pediatric lysosomal storage diseases to Gemma Biotherapeutics: PBGM01 for GM1 gangliosidosis, PBKR03 for Krabbe disease, and PBML04 for metachromatic leukodystrophy. This transaction, announced in August 2024, was expected to extend the company's operating cash runway to the end of Q2 2026.
Manufacturing vector supply relies on external Contract Manufacturing Organizations (CMOs). Passage Bio has achieved significant manufacturing milestones for its lead candidate, PBFT02, aligning with the FDA on a comparability plan for its high-productivity, suspension-based process. This updated approach is executed at a 200-liter scale and is designed to produce more than 1,000 PBFT02 doses from a single batch. The yield metrics are impressive: over 90% purity and more than 70% full capsids.
Patient recruitment and data collection depend on a network of global clinical trial sites and investigators. The upliFT-D study is a Phase 1/2 global, multi-center trial. As of late 2025, enrollment is open for Cohort 3 of FTD-GRN patients and Cohort 4 of FTD-C9orf72 patients in the ongoing study, with both groups receiving Dose 2 of PBFT02.
Here is a quick look at the structure and key metrics associated with these external dependencies:
| Partner Type/Entity | Focus Area | Key Metric/Financial Detail |
| UPenn GTP | Foundational Technology/Research | Annual funding of $5 million under the prior expanded agreement |
| InformedDNA | Clinical Trial Enrollment Support | Provides no-cost genetic counseling and testing for FTD patients |
| Gemma Biotherapeutics | Out-licensed Pediatric Development | Transaction expected to extend cash runway to Q2 2026 (as of Aug 2024) |
| CMO (Suspension Process) | cGMP Vector Production | Process executed at 200-liter scale; yields over 1,000 doses per batch |
| Clinical Trial Sites | Patient Recruitment/Data Collection | Enrollment open for Cohort 3 (FTD-GRN) and Cohort 4 (FTD-C9orf72) in upliFT-D study (Nov 2025) |
The financial health supporting these operations, as of Q1 2025, showed cash, cash equivalents, and marketable securities of $63.4 million, which the company expected to fund operations into Q1 2027. R&D expenses for Q1 2025 were $7.7 million.
You can see the core focus areas of these external relationships:
- Accessing core AAV vector technology and delivery expertise.
- Streamlining patient identification via genetic testing services.
- Offloading development risk for non-core pediatric assets.
- Securing scalable, high-quality vector supply for PBFT02.
- Establishing a global footprint for patient access in the upliFT-D trial.
The manufacturing scale-up is a big deal; getting over 1,000 doses from one batch with over 70% full capsids is a significant operational win for a company managing a tight cash position, which was $57.6 million as of June 30, 2025. Finance: draft 13-week cash view by Friday.
Passage Bio, Inc. (PASG) - Canvas Business Model: Key Activities
You're managing a clinical-stage biotech, so the Key Activities are all about execution-moving that lead asset through the clinic and building the necessary manufacturing backbone to support it. Here's the breakdown of what Passage Bio, Inc. is actively driving as of late 2025.
Executing the global Phase 1/2 upliFT-D clinical trial for PBFT02
The core activity here is advancing the upliFT-D trial for PBFT02 in frontotemporal dementia (FTD). Enrollment is currently open for the next patient groups, which is a major operational focus right now. The company is using Dose 2, which is 50% lower than the initial Dose 1, in subsequent FTD-GRN and FTD-C9orf72 patients.
The data coming out of the trial supports the activity, showing that Dose 1 PBFT02 resulted in a robust and durable elevation of progranulin (PGRN) in the cerebrospinal fluid (CSF). For the first patient treated with Dose 2, CSF PGRN levels increased substantially at one-month post-treatment, approaching the upper limit of a healthy adult reference range.
Here are the key clinical activity metrics:
| Activity Detail | Metric/Status (Late 2025) |
| FTD-GRN Cohort 2 Dosing | Completed |
| FTD-GRN Cohort 3 Enrollment | Opened |
| FTD-C9orf72 Cohort 4 Enrollment | Opened |
| Dose Evaluated in New Cohorts | Dose 2 (50% of Dose 1) |
| Dose 1 CSF PGRN Elevation (Long-Term) | Durable through 18 months post-treatment |
| Dose 1 Baseline CSF PGRN | 3 ng/ml |
| Dose 1 CSF PGRN at 12 Months | 22-24 ng/ml |
Developing and scaling a high-productivity, suspension-based AAV manufacturing process
Passage Bio, Inc. is heavily invested in transitioning its manufacturing to a more scalable platform. This is critical for commercial readiness. They have successfully developed and scaled up a high-productivity, suspension-based process for PBFT02.
This new process has already been presented, showing significant improvements over the older adherent-based method. The company has also achieved alignment with the FDA on the analytical plan to prove the new process is comparable to the one used in the clinic.
- Process Scale Achieved: 200-liter scale
- Estimated Yield (Dose 2): More than 1,000 doses per single batch
- Estimated Purity: Over 90%
- Estimated Full Capsids: More than 70%
Engaging with regulatory bodies (e.g., FDA) on registrational trial design and CMC comparability
Engagement with the FDA is a planned, forward-looking key activity. The company is setting up the next major regulatory interaction based on the data they are generating now.
The company is on track to seek feedback on the FTD-GRN registrational trial design in the first half of 2026 (1H 2026). This discussion may include the possibility of a single-arm trial design compared against natural history controls. Also, they completed a Type D Chemistry, Manufacturing, and Controls (CMC) meeting where they aligned with the FDA on the comparability plan for the new manufacturing process.
Research and preclinical development of next-generation gene therapies
While the immediate focus is clearly on advancing PBFT02 through late-stage clinical evaluation, the overall activity includes maintaining the pipeline. The search results confirm the company's mission is developing therapies for neurodegenerative diseases, but specific, quantifiable data points for next-generation candidates beyond PBFT02 are not detailed in the latest financial updates. The activity is centered on the platform technology and the lead candidate.
Securing additional financing and managing cash runway into 1Q 2027
Managing the burn rate to ensure the company can hit those 2026 milestones without an immediate need for new capital is a critical, ongoing financial activity. Passage Bio, Inc. has taken steps, like restructuring and moving to an outsourced analytical testing model, to manage expenses.
Here's the financial snapshot as of the end of the third quarter of 2025:
| Financial Metric | Amount (as of 9/30/2025) |
| Cash, Cash Equivalents, Marketable Securities | $52.8 million |
| Projected Cash Runway | Into 1Q 2027 |
| R&D Expenses (Q3 2025) | $4.3 million |
| Net Loss (Q3 2025) | $7.7 million |
The R&D expenses for the quarter ended September 30, 2025, were $4.3 million, down from $8.7 million for the same quarter in 2024. That reduction in spend helped narrow the net loss to $7.7 million for Q3 2025. Finance: draft the Q4 2025 expense forecast by next Tuesday.
Passage Bio, Inc. (PASG) - Canvas Business Model: Key Resources
You're looking at the core assets Passage Bio, Inc. (PASG) relies on to drive its clinical-stage mission in neurodegenerative diseases. These aren't just ideas; they are tangible and intangible assets critical to their near-term milestones.
Financial Capital and Runway
The immediate resource supporting operations is the balance sheet strength. Passage Bio, Inc. reported $52.8 million in cash, cash equivalents, and marketable securities as of September 30, 2025. This capital base, bolstered by operational restructuring and moving to an outsourced analytical testing model, was projected to extend the cash runway into the first quarter of 2027.
Intellectual Property and Technology Platform
The foundation of Passage Bio, Inc.'s value lies in its proprietary technology. This is centered on its adeno-associated virus (AAV) based gene therapy platform, developed in collaboration with the Perelman School of Medicine at the University of Pennsylvania. This platform is the engine for their pipeline, designed to deliver functional therapeutic genes directly to the central nervous system (CNS) via AAV vectors. The intellectual property covers the vector design, including the use of the AAV1 viral vector for certain candidates.
Lead Product Candidate and Clinical Progress
The lead asset is PBFT02, targeting frontotemporal dementia (FTD) caused by GRN mutations (FTD-GRN). This therapy aims to elevate progranulin (PGRN) levels in the CNS. The ongoing Phase 1/2 upliFT-D trial is a key resource, generating clinical data that validates the approach. For instance, Dose 1 PBFT02 achieved a mean CSF PGRN level of 25.9 ng/mL at 12 months post-treatment in a subset of patients. The company is also expanding to study FTD with C9orf72 variants. Passage Bio, Inc. is on track to seek regulatory feedback on the FTD-GRN pivotal trial design in the first half of 2026.
The key elements of the platform and lead candidate can be summarized:
- AAV1 viral vector construct for PBFT02 delivery.
- Intra-cisterna magna (ICM) administration route.
- Orphan Drug designation granted for PBFT02 for FTD-GRN.
- Dose 2 testing at 50% of the Dose 1 level.
Manufacturing Capability
A significant operational resource is the internally developed, high-yield, suspension-based manufacturing process for PBFT02, which is GMP-ready and scaled to 200-liter scale. This new process is designed for efficiency, with estimates showing a single batch could yield more than 1,000 doses at Dose 2. Furthermore, this process is characterized by high quality metrics, with projections of over 90% purity and over 70% full capsids. The company planned to seek regulatory feedback on the comparability of this suspension process to the original process in the second half of 2025.
Human Capital and Expertise
The team's experience is a vital, though less quantifiable, resource. The executive team, as of November 2025, has an average tenure of approximately 2.1 years, suggesting recent stability following leadership appointments. Key leaders include Dr. William Chou, President and CEO, in the role since October 2022, and Kathleen Borthwick, CFO, since March 2024. The scientific leadership, such as Dr. Sue Browne (SVP R&D since June 2021), brings deep experience in drug discovery for neurological disorders. The company also benefits from its foundational relationship with the University of Pennsylvania's Gene Therapy Program (GTP) and its founders.
Here's a look at the tenure of some key operational leaders:
| Role | Executive Name | Start Date | Tenure as of Late 2025 (Approximate) |
| President and CEO | William Chou, MD | October 2022 | 3.08 years |
| Chief Financial Officer | Kathleen Borthwick | March 2024 | 1.67 years |
| SVP, Research and Development | Sue Browne, PhD | June 2021 | 4.42 years |
Passage Bio, Inc. (PASG) - Canvas Business Model: Value Propositions
You're looking at the core value Passage Bio, Inc. (PASG) brings to the table, grounded in their late 2025 operational reality. It's all about delivering a one-time shot at modifying severe central nervous system (CNS) disorders with their genetic medicines.
The primary value centers on PBFT02, their lead candidate, designed to treat frontotemporal dementia (FTD) caused by GRN mutations by elevating progranulin (PGRN) levels. The clinical data supports this proposition with hard numbers. For patients receiving Dose 1, cerebrospinal fluid (CSF) PGRN expression consistently increased from below 3 ng/mL at baseline to between 13 - 27 ng/mL at six months (n=4). This effect proved durable, reaching 22 - 34 ng/mL by 12 months (n=2). To optimize the benefit-risk profile, Dose 2, which is 50% lower than Dose 1, was introduced for subsequent patients.
Passage Bio, Inc. is targeting significant unmet medical needs within rare, monogenic neurodegenerative diseases. Consider FTD caused by the C9orf72 mutation; this condition is estimated to affect approximately 21,000 patients across the United States and Europe, and currently, there are no approved disease-modifying therapies for them. The value here is offering a potential disease-modifying approach where none exists.
The company is also delivering value through a critical operational component: scalable, high-purity manufacturing for their Adeno-Associated Virus (AAV) gene therapy. They achieved a breakthrough by moving to an internally developed, suspension-based manufacturing process for PBFT02, which is GMP-ready at a 200-liter scale. This process is estimated to yield more than 1,000 doses of PBFT02 at Dose 2, boasting over 90% purity and over 70% full capsids. This capability underpins the ability to supply the therapy if approved.
To broaden the impact beyond GRN mutations, Passage Bio, Inc. is actively expanding its clinical focus. You see this in the ongoing global Phase 1/2 upliFT-D trial, where enrollment has opened for FTD patients with C9orf72 gene mutations as of the third quarter of 2025. Initially, these FTD-C9orf72 patients will receive the lower Dose 2 of PBFT02, with each cohort consisting of up to five symptomatic patients.
Here's a quick look at the financial discipline supporting these value drivers, showing a focus on extending runway to hit milestones:
| Financial Metric (as of Q3 2025) | Amount/Period |
| Cash, Cash Equivalents, Marketable Securities | $52.8 million (as of September 30, 2025) |
| Projected Cash Runway | Into Q1 2027 |
| Q3 2025 Net Loss | $9.4 million |
| Q3 2025 R&D Expenses | $4.3 million |
| FY2025 Consensus EPS Estimate | -$0.69 |
The company is clearly focused on delivering on these specific clinical and operational milestones, which are the immediate value generators:
- Seek regulatory feedback on FTD-GRN registrational trial design in 1H 2026.
- Report interim safety and biomarker data from Dose 2 in 1H 2026.
- Report 12-month data from Dose 1 and interim data from Dose 2 in H2 2025.
- Engage with the FDA on the suspension-based manufacturing process comparability in 2H 2025.
Passage Bio, Inc. (PASG) - Canvas Business Model: Customer Relationships
You're managing relationships in a clinical-stage biotech, so the focus is intensely on the few key groups that drive trial success and funding. For Passage Bio, Inc., this means a highly targeted, direct engagement strategy with investigators, patient communities, and the financial markets.
High-touch, direct engagement with clinical trial investigators and sites
Engagement with clinical sites is paramount for advancing the upliFT-D study for PBFT02. As of the third quarter of 2025, Passage Bio, Inc. was actively enrolling patients in two critical cohorts of this multinational Phase 1/2 clinical trial. This requires close, hands-on support for site staff managing the complex gene therapy administration and follow-up protocols.
- Enrolled Cohort 3 (FTD-GRN) patients, expected to consist of five to 10 patients.
- Enrolled Cohort 4 (FTD-C9orf72) patients, expected to consist of three to five patients.
The operational success here directly impacts the timeline for the next major external milestone: seeking regulatory feedback on the FTD-GRN registrational trial design, which is targeted for the 1H 2026.
Close collaboration with patient advocacy groups for disease awareness and enrollment
To ensure the right patients enter the trial, Passage Bio, Inc. relies on deep ties with advocacy organizations focused on frontotemporal dementia (FTD). This relationship is operationalized through specific support mechanisms designed to lower barriers to participation.
Providing support services, like no-cost genetic testing, to patient communities
Passage Bio, Inc. actively supports recruitment by expanding its collaborative partnership with InformedDNA. This initiative directly addresses a key hurdle in rare disease trials by providing essential diagnostic services to the community.
- Service offered: No-cost genetic counseling and testing.
- Target population: Adults diagnosed by their physicians with FTD.
This service helps identify eligible patients for the upliFT-D study, which evaluates PBFT02 for FTD caused by GRN or C9orf72 mutations.
Investor relations and communication focused on clinical milestones and cash runway
Communication with investors is centered on de-risking the program through data and demonstrating financial longevity. The narrative focuses on clinical execution and capital efficiency, which directly supports the valuation of the company's assets.
Here's the quick math from the Q3 2025 report:
| Metric | Amount as of September 30, 2025 |
| Cash, Cash Equivalents, Marketable Securities | $52.8 million |
| Projected Cash Runway | Into 1Q 2027 |
| Research & Development (R&D) Expenses (Q3 2025) | $4.3 million |
| General & Administrative (G&A) Expenses (Q3 2025) | $4.3 million |
| Net Loss (Q3 2025) | $7.7 million |
The focus for near-term catalysts is sharing updated interim safety/biomarker data from Dose 2 and securing the regulatory feedback mentioned above.
Regulatory dialogue with the FDA and other health authorities
Dialogue with the U.S. Food and Drug Administration (FDA) is critical for defining the path to market for PBFT02. Passage Bio, Inc. reported completing a successful meeting with the FDA where they aligned on key elements of an analytical comparability plan. This alignment supports the future use of their high-productivity, suspension-based PBFT02 manufacturing process in a registrational study. The manufacturing process, executed at 200-liter scale, is designed to yield more than 1,000 PBFT02 doses from a single batch with over 90% purity and more than 70% full capsids.
- Regulatory Alignment: Achieved on analytical comparability plan for suspension-based manufacturing.
- Next Key Regulatory Target: Feedback on FTD-GRN registrational trial design in 1H 2026.
This manufacturing readiness is a key component of the relationship with regulators, showing a clear plan for late-stage supply.
Passage Bio, Inc. (PASG) - Canvas Business Model: Channels
You're mapping out how Passage Bio, Inc. (PASG) gets its science and its corporate story out to the world, from the clinic to the capital markets. For a clinical-stage company, these channels are critical for trial execution and funding runway.
Global network of specialized clinical trial centers and hospitals
The delivery of the PBFT02 gene therapy relies on a multinational clinical trial infrastructure. The upliFT-D study, which is a Phase 1/2 trial, is multinational, indicating a network spanning several countries to enroll the specific patient populations needed for FTD-GRN and FTD-C9orf72 mutations.
As of late 2025, the trial execution channels are advancing:
- Enrollment is open for Cohort 3 of FTD-GRN patients.
- Enrollment is open for Cohort 4 of FTD-C9orf72 patients.
- Dosing of Cohort 2 in the upliFT-D study was completed in July 2025.
This network of specialized centers is the physical channel for administering the investigational therapy and collecting the core clinical data that drives the entire business.
Scientific publications and presentations at major medical conferences
Disseminating clinical and manufacturing data is a primary channel for establishing scientific credibility. Passage Bio, Inc. actively uses major medical and investor conferences to communicate progress on its lead candidate, PBFT02.
Here's a look at the recent scientific and investor presentation cadence:
| Event Type | Event Name | Date(s) in 2025 | Location/Format Detail |
| Medical Data Presentation | Alzheimer's Association International Conference | July 2025 | Poster presentation in Toronto, Canada |
| Investor Conference | H.C. Wainwright 27th Annual Global Investment Conference | September 5, 2025 | Presentation |
| Investor Conference | Chardan's 9th Annual Genetic Medicines Conference | October 21, 2025 | Panel discussion |
| Investor Conference | Guggenheim Securities 2nd Annual Healthcare Innovation Conference | November 12, 2025 | Fireside chat |
The company also presented process development data for its suspension-based manufacturing at the American Society of Gene and Cell Therapy (ASGCT) 28th Annual Meeting, detailing a process estimated to yield more than 1,000 PBFT02 doses from a single batch with over 90% purity.
Direct communication with regulatory agencies for drug approval pathway
The channel to the U.S. Food and Drug Administration (FDA) is crucial for defining the path to market. This involves formal submissions and alignment on study design.
Passage Bio, Inc. has established a clear near-term regulatory milestone:
- Plan to seek FDA feedback on the FTD-GRN pivotal trial design in the 1H 2026.
- Announced alignment with the FDA on a comparability plan for its 200-liter scale suspension-based manufacturing process.
This direct, formal communication channel dictates the timeline for late-stage development.
Investor relations channels (SEC filings, press releases, investor conferences)
You need capital to run those trials, so the financial disclosure channels must be precise. Passage Bio, Inc. uses standard SEC filings and regular press releases to keep the market informed. The company executed a 1-for-20 reverse stock split effective July 14, 2025, which reduced the outstanding share count from approximately 62,405,898 to about 3,120,295 post-split.
Key financial metrics as of late 2025:
- Cash and cash equivalents as of September 30, 2025: $52.8 million.
- Cash runway is expected to fund operations into 1Q 2027.
- Common shares outstanding as of November 6, 2025: 3,178,710.
- Remaining capacity on the at-the-market facility as of September 30, 2025: $15.8 million.
The Q3 2025 results showed a net loss of $7.7 million for the quarter, with year-to-date net loss at $32.5 million, reflecting reduced operating costs.
Patient advocacy and genetic counseling services for outreach
Connecting with the patient community is a foundational channel for early identification and support. Passage Bio, Inc. focuses on building relationships with advocacy groups to amplify community voices and facilitate earlier patient identification.
A concrete example of this channel in action is the partnership with Informed DNA:
- This collaboration involves designing and supporting a genetic screening and counseling program.
- The program is offered free of charge to people with frontotemporal disease.
This effort directly addresses the need to increase access to resources like genetic testing and counseling for the target patient population.
Passage Bio, Inc. (PASG) - Canvas Business Model: Customer Segments
You're developing a one-time gene therapy for devastating, rare neurodegenerative diseases, so your customer segments are highly specialized and defined by genetics.
The most immediate customer segments are the patients currently enrolled or eligible for the upliFT-D Phase 1/2 clinical trial of PBFT02.
Patients with Frontotemporal Dementia (FTD) due to a GRN gene mutation (FTD-GRN)
This group represents the initial focus of the upliFT-D study, where Passage Bio, Inc. has completed dosing of Cohort 2 and is actively enrolling Cohort 3 patients to receive Dose 2 of PBFT02. The company is on track to seek regulatory feedback on a registrational trial design for FTD-GRN in the first half of 2026.
Patients with FTD due to a C9orf72 gene mutation (FTD-C9orf72)
This segment is being added to the trial, with enrollment opened for Cohort 4 as of late 2025. FTD-C9orf72 is estimated to affect approximately 21,000 individuals across the United States and Europe, and currently has no approved disease-modifying therapies. Both FTD-GRN and FTD-C9orf72 patients share the underlying TDP-43 pathology.
Here's a quick look at the two primary genetic patient populations targeted by PBFT02:
| Segment Characteristic | FTD-GRN Patients | FTD-C9orf72 Patients |
| Trial Cohort Status (Late 2025) | Actively enrolling Cohort 3 (Dose 2) | Actively enrolling Cohort 4 (Dose 2) |
| Estimated US/Europe Population | Not explicitly quantified separately | Approximately 21,000 |
| Shared Pathology | TDP-43 pathology, lysosomal dysfunction | TDP-43 pathology, lysosomal dysfunction |
| Regulatory Focus | Seeking feedback on registrational trial design in 1H 2026 | Included in the ongoing Phase 1/2 study |
Neurologists and specialized physicians treating rare neurodegenerative diseases
These are the key prescribers and trial investigators. Passage Bio, Inc. supports clinical trial recruitment by maintaining a collaborative partnership with InformedDNA to provide no-cost genetic counseling and testing for adults diagnosed with FTD. The company is focused on executing the upliFT-D trial, which involves patients aged 35 to 75 years. The clinical trial is a two-year study with a three-year safety extension.
Payers and government health systems (future commercial segment)
While not an active commercial segment yet, this group is critical for future market access. Passage Bio, Inc. is preparing for this by aligning with the FDA on a potential single-arm registrational design with a natural history control for FTD-GRN. The company expects its current cash position to fund operations into the first quarter of 2027. For the third quarter ended September 30, 2025, the net loss was $7.7 million.
The company's cash, cash equivalents and marketable securities stood at $52.8 million as of September 30, 2025.
Finance: draft 13-week cash view by Friday.
Passage Bio, Inc. (PASG) - Canvas Business Model: Cost Structure
You're managing a clinical-stage biotech, so you know the cost structure is almost entirely driven by the pipeline. For Passage Bio, Inc., as of late 2025, the focus is on controlling burn while advancing PBFT02 through the upliFT-D trial.
The core operating expenses for the third quarter ended September 30, 2025, show a significant year-over-year reduction, reflecting prior restructuring efforts. You can see the direct comparison here:
| Expense Category (Q3 2025) | Amount (USD) | Comparison (Q3 2024) |
| Research and Development (R&D) Expenses | $4.3 million | $8.7 million |
| General and Administrative (G&A) Expenses | $4.3 million | $7.3 million |
Dominantly, Research and Development (R&D) expenses were $4.3 million for the quarter ended September 30, 2025. This is down from $8.7 million in the same period last year, showing expense discipline in the R&D function. Honestly, for a company pre-commercial with no revenue, every dollar here is a direct investment in clinical milestones.
General and Administrative (G&A) expenses also landed at $4.3 million for Q3 2025, compared to $7.3 million in Q3 2024. This reduction is partly attributable to the earlier workforce adjustments.
Personnel costs saw a major shift following the early 2025 restructuring. Passage Bio, Inc. slashed its workforce by about 55% to help extend its cash runway into the first quarter of 2027. This move was expected to incur associated severance and exit costs of about $2 million, primarily during the second quarter of 2025. The shift also involved transitioning to an outsourced analytical testing model.
Clinical trial costs are embedded within R&D, but they represent a critical, ongoing spend. The upliFT-D clinical trial for PBFT02 is actively enrolling patients across different cohorts, which drives these costs. Specific activities include:
- Patient enrollment for FTD-GRN and FTD-C9orf72 cohorts.
- Monitoring of patients receiving Dose 2 PBFT02.
- Site fees across global trial locations.
Manufacturing and process development costs are being managed through strategic alignment with the FDA on the analytical comparability plan. Passage Bio, Inc. completed process development and scale-up for a high-productivity, suspension-based manufacturing process for PBFT02. What this estimate hides is the future cost of goods sold, but the near-term data is promising:
- Single batch estimated to yield more than 1,000 doses at Dose 2.
- Achieved over 90% purity in the scaled process.
- Achieved over 70% full capsids.
Finance: draft 13-week cash view by Friday.
Passage Bio, Inc. (PASG) - Canvas Business Model: Revenue Streams
You're looking at a classic clinical-stage biotech revenue profile right now, which means the top line is zero from product sales. Passage Bio, Inc. is definitively pre-commercial. Their reported revenue for the third quarter ended September 30, 2025, was $0.
The operational funding, which covers the burn rate, comes almost entirely from prior capital raises and equity financing. As of September 30, 2025, Passage Bio, Inc. held $52.8 million in cash, cash equivalents, and marketable securities. Management has guided that this balance is expected to fund operations into the first quarter of 2027. This cash position is the lifeblood, but it underscores the reliance on external financing until a product reaches market. The burn rate is evident in the net loss reported for Q3 2025, which was $7.7 million.
The most concrete, near-term revenue potential outside of financing comes from out-licensing deals, specifically the one with Gemma Biotherapeutics. This transaction, which focused on out-licensing three pediatric programs, was structured to provide immediate cash and future contingent payments. Honestly, these milestones are what keep the lights on between financing rounds.
Here's the quick math on the potential non-dilutive revenue from the Gemma Biotherapeutics agreement:
- Initial payment for clinical product supply: $10 million.
- Contingent payment based on Gemma business milestones: Up to an additional $10 million.
- Development and commercial milestones: Up to $114 million.
- Future royalties: Single-digit royalties on annual worldwide net sales.
Still, you can't forget the small, steady trickle from the balance sheet itself. Interest income generated on the existing cash and marketable securities is a minor, but present, revenue component for Passage Bio, Inc. as they manage their $52.8 million in liquid assets.
To give you a clearer picture of the potential upside from the out-licensing, look at this breakdown:
| Payment Type | Maximum Potential Amount |
|---|---|
| Initial Product Supply Payment | $10 million |
| Contingent Business Milestones | Up to $10 million |
| Development and Commercial Milestones | Up to $114 million |
| Royalties on Net Sales | Single-digit percentage |
The Q3 2025 net loss of $7.7 million shows the current operating expense level, which the company is actively managing by reducing R&D to $4.3 million and G&A to $4.3 million year-over-year for the quarter. This expense discipline is critical to stretching that cash runway into Q1 2027.
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