Executive Summary

Passage Bio reported Q1 2025 net loss of $15.4M and GAAP EPS of $0.25 loss per share, modestly improved year over year; cash, cash equivalents and marketable securities totaled $63.4M at quarter-end, and management reaffirmed runway into Q1 2027 .
The quarter featured operational progress: first and second FTD-GRN patients treated at Dose 2 in the upliFT-D Phase 1/2 trial, FTD-C9orf72 enrollment opened, and process-development data presented for a high-productivity suspension-based manufacturing process (estimated >1,000 Dose 2-equivalent doses per batch, >90% purity, >70% full capsids) .
Consensus EPS for Q1 2025 was -4.47 (split-adjusted); S&P Global shows actual primary EPS of -5.00, a modest miss, likely driven by a $2.64M impairment charge in the quarter and timing of expense reductions following the January restructuring . Values retrieved from S&P Global*.
Key upcoming catalysts: interim safety/biomarker readout from Dose 2 and 12-month Dose 1 data for FTD-GRN in 2H 2025 and regulatory engagement on registrational path in 1H 2026; initiation of dosing in FTD-C9orf72 in 1H 2025 .

What Went Well and What Went Wrong

What Went Well

Dose 2 initiation and enrollment momentum: first FTD-GRN patient treated at Dose 2 and second enrolled; additional patients under evaluation .
Manufacturing scale-up advances: presentation of suspension-based PBFT02 process demonstrating markedly improved yield and quality (estimated >1,000 doses/batch at Dose 2, >90% purity, >70% full capsids), positioning program for late-stage needs .
Management tone on regulatory path: “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,” said CEO Will Chou .

What Went Wrong

EPS miss versus consensus (split-adjusted): S&P Global shows actual -5.00 vs consensus -4.47; impairment of long-lived assets ($2.64M) and timing of cost takeout likely contributed to the variance . Values retrieved from S&P Global*.
Continued SAEs noted historically (venous sinus thrombosis, hepatotoxicity) required revised immunosuppression regimen; while resolved, the profile remains closely watched by investors .
Cash levels declined year over year, reflecting the transition to outsourced analytical testing and restructuring; though runway extended, funding execution remains a core risk for clinical-stage programs .

Financial Results

Metric	Q3 2024	Q4 2024	Q1 2025
R&D Expense ($USD Millions)	$8.7	$9.6	$7.7
G&A Expense ($USD Millions)	$7.3	$4.7	$6.1
Impairment of Long-Lived Assets ($USD Millions)	$4.8	—	$2.6
Net Loss ($USD Millions)	$19.3	$12.7	$15.4
GAAP Net Loss per Share ($USD)	$0.31 loss	$0.20 loss	$0.25 loss
Cash & Cash Equivalents ($USD Millions)	$32.3	$37.6	$63.4
Marketable Securities ($USD Millions)	$52.5	$39.2	$0.0

Notes:

Passage Bio is pre-revenue; statements of operations do not include a revenue line for these periods .

EPS vs. Estimates (Split-Adjusted)

Metric	Q1 2025
Primary EPS Consensus Mean ($USD)	-4.47*
Actual Primary EPS ($USD)	-5.00*
GAAP Net Loss per Share (as reported) ($USD)	$0.25 loss
Primary EPS - # of Estimates	3*
Result vs Consensus	Miss (-0.53)*

Values retrieved from S&P Global*.

KPIs and Clinical/Operational Metrics

KPI	Q3 2024	Q4 2024	Q1 2025	Commentary
CSF PGRN 6 months (ng/mL)	Up to 10-fold increases; 13–27 range (n=4)	13–27 (n=4)	Durable to 18 months in one patient	Consistent elevation, plateauing ~6 months
CSF PGRN 12 months (ng/mL)	Elevated to 12 months (n=1)	22–34 (n=2)	22–34 (n=2)	Dose 1 robust target engagement
Plasma NfL change at 12 months	—	-13% vs baseline (n=2)	-13% (n=2)	Improvement vs ~+29% natural history
Safety profile (SAEs)	Revised immunosuppression reduced SAEs	Two SAEs reported (VST, hepatotoxicity) managed	Two SAEs, no DRG toxicity; regimen effective	No ICM complications
FTD-GRN Dose 2 progress	—	First patient enrolled	First treated; second enrolled	Cohort 2 continues; IDMC review before Cohort 3
FTD-C9orf72	Plan to initiate 1H 2025	On track to initiate 1H 2025	Enrollment opened; dosing plan 1H 2025	Expansion of program
Manufacturing (suspension)	In-house CMC capabilities	Process development/scale-up completed	Presentation: >1,000 doses/batch; >90% purity; >70% full capsids	Supports late-stage development

Guidance Changes

Metric	Period	Previous Guidance	Current Guidance	Change
Cash Runway	Corporate	Runway to end of Q2 2026 (Q3 2024)	Into Q1 2027 (Q4 2024 and reaffirmed Q1 2025)	Raised
Annual Operating Cost Reduction	Corporate (run-rate)	—	$9–$11M reduction from restructuring and outsourcing	New
Impairment/Exit Costs	Q1 2025	Expected $1–$3M impairment	Actual $2.64M impairment recognized	Confirmed within range
FTD-GRN Data Milestones	Program	12-month Cohort 1 and interim Cohort 2 in 1H 2025	12-month Dose 1 and interim Dose 2 in 2H 2025	Timing updated later in 2025
Regulatory Engagement (FTD-GRN)	Program	Seek feedback 2H 2025	Seek feedback 1H 2026	Timing shifted later
FTD-C9orf72 Dosing	Program	Initiate in 1H 2025	Enrollment opened; initiate dosing in 1H 2025	Maintained

Earnings Call Themes & Trends

Note: A Q1 2025 earnings call transcript was not found in the document catalog (earnings-call-transcript) [ListDocuments result: none].

Topic	Previous Mentions (Q3 2024)	Previous Mentions (Q4 2024)	Current Period (Q1 2025)	Trend
R&D execution (FTD-GRN)	4 patients enrolled in Cohort 2; dosing advancing as planned	First patient enrolled to receive Dose 2	First Dose 2 patient treated; second enrolled	Positive momentum
Expansion to FTD-C9orf72	Plan to initiate dosing 1H 2025	On track to initiate 1H 2025	Enrollment opened; dosing planned 1H 2025	Advancing
Manufacturing readiness	In-house CMC capabilities highlighted	Suspension-based manufacturing completed	ASGCT presentation; >1,000 doses/batch estimate	Strengthening
Biomarker signals (CSF PGRN, NfL)	Durable CSF PGRN increases; early safety results	CSF PGRN 13–27 at 6m; 22–34 at 12m; plasma NfL -13%	Durable CSF PGRN to 18m in one patient; plasma NfL -13%	Consistent positive
Safety profile	Revised steroid regimen; no SAEs in revised subgroup	SAEs managed; regimen updated; no DRG toxicity	SAEs limited; regimen effective; no DRG toxicity	Stable
Cash runway	Runway to end Q2 2026	Extended into Q1 2027	Reaffirmed runway into Q1 2027	Improved

Management Commentary

“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.” — Will Chou, M.D., President & CEO .
“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... We expect these data to foster meaningful engagement with health authorities in the first half of 2026...” .
“We are pleased to report strong performance in 2024... we completed the process development and scale-up of a high-productivity, suspension-based manufacturing process for PBFT02 and are well-positioned for late-stage development.” .

Q&A Highlights

No public Q1 2025 earnings call transcript was available in the document catalog; therefore, no Q&A details could be extracted [ListDocuments result: none].
Regulatory and manufacturing clarifications were provided via 8-K and press release exhibits (Ex. 99.1/99.2), including milestone timing, manufacturing comparability plans, and cash runway updates .

Estimates Context

Q1 2025 EPS came in at -5.00 (split-adjusted, Primary EPS), below consensus of -4.47; this modest miss aligns with the impairment taken in Q1 and timing of cost reductions after the restructuring . Values retrieved from S&P Global*.
Revenue consensus was $0 reflecting pre-revenue status; statements of operations do not show revenue lines for Q1 2025, Q4 2024, or Q3 2024 . Values retrieved from S&P Global*.

Key Takeaways for Investors

Clinical momentum: Dose 2 initiation and broader FTD-C9orf72 enrollment increase the probability of reaching key 2H 2025 biomarker/safety readouts, an important catalyst for the registrational path .
Manufacturing readiness: Suspension-based process with >1,000 Dose 2-equivalent doses per batch supports trial scalability and, potentially, commercial feasibility; comparability discussions with regulators are planned for later in 2025 .
Cash runway extended: Reaffirmed runway into Q1 2027 following restructuring and outsourcing; reduces near-term financing overhang but program execution remains critical .
Biomarker durability: CSF PGRN elevations and plasma NfL improvements vs natural history strengthen the therapeutic hypothesis for PBFT02; durability to 18 months in one patient is encouraging .
Risk profile manageable but monitored: Historical SAEs (VST, hepatotoxicity) mitigated under revised immunosuppression; continued monitoring required as dosing expands .
Near-term trading implications: Expect stock sensitivity to interim Dose 2 biomarker/safety signals, manufacturing/regulatory updates, and any clarity on pivotal design timelines .
Medium-term thesis: If biomarker and safety durability persist with Dose 2 and regulatory feedback is constructive in 1H 2026, PBFT02’s one-time therapy profile and manufacturing advances could support a viable registrational path in FTD-GRN .

Footnote: Values retrieved from S&P Global*.

Passage BIO, Inc. (PASG)·Q1 2025 Earnings Summary