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Passage BIO, Inc. (PASG)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025 EPS beat: PASG reported GAAP diluted EPS of -$2.44 vs Wall Street consensus -$2.97, driven by lower R&D and G&A spend; revenue remained $0 as the company is pre-commercial . EPS beats also occurred in Q2; Q1 missed versus consensus as reported on a post-split basis *.
  • Operating expenses declined materially year over year: R&D fell to $4.3M (from $8.7M) and G&A to $4.3M (from $7.3M), narrowing net loss to $7.7M (from $19.3M) .
  • Key strategic progress: FDA alignment on analytical comparability for the suspension-based PBFT02 process, active enrollment of Cohort 3 (FTD-GRN) and Cohort 4 (FTD-C9orf72) in upliFT-D, and cash runway guided into 1Q 2027, supporting late-stage development readiness .
  • Near-term catalysts: Updated interim safety/biomarker data from Dose 2 and FDA feedback on FTD-GRN registrational study design targeted for 1H 2026; continued enrollment updates can drive sentiment .
  • No public Q3 2025 earnings call transcript located; analysis relies on 8-K press release and corporate presentation (Q3 2025) .

What Went Well and What Went Wrong

What Went Well

  • FDA alignment on analytical comparability to enable future use of high-productivity suspension-based manufacturing for PBFT02 in a registrational study; single batch estimated to yield >1,000 doses at Dose 2 with >90% purity and >70% full capsids . “We completed a successful meeting with the FDA where we aligned on key elements of an analytical comparability plan…” — Will Chou, CEO .
  • Clinical execution: Enrollment opened for Cohort 3 (FTD-GRN, Dose 2) and Cohort 4 (FTD-C9orf72, Dose 2), with protocol amendments implemented across sites to optimize patient eligibility and add prophylactic anticoagulation .
  • Expense discipline: Y/Y reductions in R&D ($4.3M vs $8.7M) and G&A ($4.3M vs $7.3M) narrowed net loss ($7.7M vs $19.3M) and supported an EPS beat vs consensus *.

What Went Wrong

  • Pre-revenue status persists (no product revenue), leaving results reliant on operating expense control rather than top-line growth .
  • Ongoing safety management within upliFT-D: prior quarters referenced venous sinus thrombosis and hepatotoxicity in certain patients (mitigated with revised immunosuppression and low-dose anticoagulation), highlighting clinical risk profile typical for gene therapy .
  • Continued cash burn despite lower OpEx: cash, cash equivalents and marketable securities declined to $52.8M (from $57.6M in Q2 and $63.4M in Q1), maintaining the need for capital discipline ahead of 1H 2026 milestones .

Financial Results

EPS vs Prior Periods and Estimates

MetricQ1 2025Q2 2025Q3 2025
GAAP Diluted EPS (Actual)-$5.00* (post-split equivalent) *-$2.96 -$2.44
EPS Consensus Mean-$4.47*-$4.15*-$2.97*
Variance (Actual - Consensus)-$0.53*+$1.19*+$0.53*

Values marked with * retrieved from S&P Global.

Revenue and Margins

MetricQ1 2025Q2 2025Q3 2025
Revenue ($USD Millions)$0.0*$0.0*$0.0*
Net Income Margin %N/A (pre-revenue) N/A (pre-revenue) N/A (pre-revenue)

Values marked with * retrieved from S&P Global.

Operating Expense and Cash Trend

MetricQ3 2024Q1 2025Q2 2025Q3 2025
R&D Expense ($USD Millions)$8.7 $7.7 $5.8 $4.3
G&A Expense ($USD Millions)$7.3 $6.1 $4.5 $4.3
Net Loss ($USD Millions)$19.3 $15.4 $9.4 $7.7
Cash, Cash Equivalents & Marketable Securities ($USD Millions)$84.8 $63.4 $57.6 $52.8

Segment breakdown: Not applicable (no reported revenue segments) .

KPIs: Clinical progress indicators (cohort enrollment milestones, biomarker updates) disclosed in press release and corporate presentation, with CSF PGRN durability and plasma NfL trends referenced as program metrics rather than commercial KPIs .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayAs of Q1 2025Into 1Q 2027 Into 1Q 2027 Maintained
Manufacturing (PBFT02 Suspension Process)2H 2025–1H 2026Seek comparability feedback in 2H 2025 Aligned analytically with FDA on comparability plan Achieved alignment
Clinical Milestones (Dose 2 Data)1H 2026Report updated interim safety/biomarker data Report updated interim safety/biomarker data Maintained timeline
Registrational Trial Design (FTD-GRN)1H 2026Seek FDA feedback on registrational approach Seek FDA feedback on registrational approach Maintained timeline

Earnings Call Themes & Trends

Note: No public Q3 2025 earnings call transcript located; themes tracked from quarterly press materials and corporate presentations .

TopicPrevious Mentions (Q1 2025)Previous Mentions (Q2 2025)Current Period (Q3 2025)Trend
R&D execution (upliFT-D enrollment/dosing)Dose 2 initiated for FTD-GRN; FTD-C9orf72 enrollment opened Completed dosing Cohort 2; protocol amendment submitted Actively enrolling Cohort 3 (FTD-GRN) and Cohort 4 (FTD-C9orf72) Progressing
Regulatory alignmentPlan to engage regulators in 1H 2026 on registrational path Seek suspension process comparability feedback 2H 2025 FDA alignment on analytical comparability for suspension-based PBFT02 De-risking
Manufacturing scale/readinessSuspension process claimed high productivity, purity; >1,000 doses estimate (Dose 2) Process development completed, comparability plan in focus Alignment with FDA; reiterated yields and purity metrics Ready for late-stage
Biomarkers (CSF PGRN, plasma NfL)Robust CSF PGRN elevation; NfL reduced vs natural history (early evidence)Durable CSF PGRN to 18 months; Dose 2 early rise; NfL favorable vs natural history Plan to report updated interim safety/biomarker data in 1H 2026 Sustained
Safety managementRevised immunosuppression; no DRG toxicity; noted VST in certain patients Continued safety observations incl. asymptomatic VST; PE case at Dose 2 Protocol amended to add prophylactic anticoagulation Mitigation in place
Cash runwayInto 1Q 2027 Into 1Q 2027 Into 1Q 2027 Maintained

Management Commentary

  • “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 completed a successful meeting with the FDA where we aligned on key elements of an analytical comparability plan…” — Will Chou, M.D., President & CEO .
  • “We continue to be encouraged by the emerging data from our upliFT-D clinical trial, which underscore the potential of PBFT02…” — Will Chou, M.D., on Cohort 2 completion and protocol submission .

Strategic messages:

  • Focus on advancing PBFT02 with strong biomarker readouts and safety management, building toward a potential single-arm registrational design leveraging natural history data .
  • Manufacturing readiness via suspension-based process with aligned analytical comparability supports late-stage and potential commercialization scale .

Q&A Highlights

  • No publicly available Q3 2025 earnings call transcript was found; no Q&A themes to report .

Estimates Context

  • Q3 2025: EPS actual -$2.44 vs consensus -$2.97 — beat by $0.53; revenue in-line at $0.0 (pre-commercial) *.
  • Q2 2025: EPS actual -$2.96 vs consensus -$4.15 — beat by $1.19; revenue in-line at $0.0 *.
  • Q1 2025: EPS actual -$5.00 (post-split equivalent) vs consensus -$4.47 — miss by $0.53; revenue in-line at $0.0 *.

Values marked with * retrieved from S&P Global.

Where estimates may need to adjust:

  • Continued OpEx control and protocol amendments that facilitate enrollment could bias near-term EPS estimates modestly upward (less negative) absent unforeseen clinical or regulatory spend; revenue estimates remain at $0 until commercialization .

Key Takeaways for Investors

  • EPS beats in Q2 and Q3 were achieved via disciplined OpEx control; with zero revenue, near-term earnings trajectory hinges on expense management and financing runway *.
  • FDA alignment on analytical comparability is a meaningful de-risking milestone for PBFT02’s suspension-based manufacturing, supporting a registrational pathway discussion in 1H 2026 .
  • Clinical momentum (Cohorts 3 and 4 enrollment) and planned biomarker/safety updates in 1H 2026 are key stock catalysts; watch for CSF PGRN durability and plasma NfL trends .
  • Cash runway into 1Q 2027 reduces near-term financing risk but is sensitive to trial pace and scale-up costs; monitor quarterly cash and net loss trends .
  • Safety management via revised immunosuppression and prophylactic anticoagulation addresses prior events; any new SAE disclosures could impact sentiment .
  • Regulatory posture appears constructive; if FDA signals receptivity to single-arm natural history comparisons, the program’s timeline and risk profile improve .
  • Near-term trading setup: headlines around enrollment progress and manufacturing readiness could support speculative momentum; downside risks include clinical AEs, regulatory delays, or cash pressure without partnering.

Additional sources:

  • Q3 2025 Press Release via Yahoo/GlobeNewswire mirrors 8-K Exhibit 99.1 content .