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Passage BIO, Inc. (PASG)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 delivered a narrower net loss ($9.4M) with lower R&D ($5.8M) and G&A ($4.5M), and an adjusted diluted EPS of -$2.96; cash, cash equivalents and marketable securities were $57.6M with runway into 1Q 2027 .
  • EPS beat Street by $1.19 (28.7%) vs S&P Global consensus of -$4.15, while revenue remained at zero; the beat was driven by continued OpEx reductions and other income *.
  • Clinical execution advanced: completed dosing of FTD-GRN Cohort 2; updated interim data reaffirmed robust CSF PGRN elevation and improvement in plasma NfL vs natural history; protocol amendment submitted to sites and authorities .
  • Near-term catalysts: 2H 2025 feedback on manufacturing comparability; 1H 2026 interim safety/biomarker data from Dose 2 and regulatory feedback on registrational pathway—plus a July 1-for-20 reverse split to maintain Nasdaq compliance, which also affects per-share optics .

What Went Well and What Went Wrong

What Went Well

  • Completed dosing of FTD-GRN Cohort 2; Patient 9 treated with Dose 2 in July, enabling next cohorts (FTD-GRN Cohort 3 and FTD-C9orf72 Cohort 4) post-protocol amendment approvals .
  • Biomarkers: Dose 1 produced robust, durable CSF PGRN increases through 18 months; first Dose 2 patient rose from 1.5 to 7.6 ng/mL at 1 month, approaching upper healthy adult range; plasma NfL annual rate of change reduced vs natural history .
  • Cost discipline: R&D ($5.8M) and G&A ($4.5M) declined y/y; net loss narrowed to $9.4M; cash runway into 1Q 2027 maintained .

Management quote: “We continue to be encouraged by the emerging data from our upliFT-D clinical trial… We look forward to initiating enrollment of our third FTD-GRN and first FTD-C9orf72 patient cohorts…” — Will Chou, M.D., President & CEO .

What Went Wrong

  • Safety events: cumulative SAEs include venous sinus thrombosis, hepatotoxicity (Dose 1), and a pulmonary embolism for the first Dose 2 patient amid a systemic infection; though events resolved with management, they necessitated protocol changes (prophylactic low-dose anticoagulation) .
  • No revenue; sustained operating losses continue while awaiting pivotal-path clarity, with equity dilution optics highlighted by the July reverse split to preserve listing compliance .
  • Equity and assets continued to decline q/q as cash was deployed (Equity fell to $38.3M from $46.7M in Q1 and $61.3M in Q4; Total assets to $79.2M from $86.0M and $102.4M) .

Financial Results

P&L Summary (quarterly)

MetricQ4 2024Q1 2025Q2 2025
R&D Expense ($USD Millions)$9.6 $7.7 $5.8
G&A Expense ($USD Millions)$4.7 $6.1 $4.5
Net Loss ($USD Millions)$(12.7) $(15.4) $(9.4)
Diluted EPS ($USD)$(0.20) $(0.25) $(2.96) (split-adjusted)

Note: Q2 2025 EPS is adjusted for the 1-for-20 reverse split; prior periods may not be split-adjusted .

YoY Comparison (Q2)

MetricQ2 2024Q2 2025
R&D Expense ($USD Millions)$10.4 $5.8
G&A Expense ($USD Millions)$6.5 $4.5
Net Loss ($USD Millions)$(16.0) $(9.4)
Diluted EPS ($USD)$(5.09) (split-adjusted) $(2.96) (split-adjusted)

Balance Sheet KPIs

MetricQ4 2024Q1 2025Q2 2025
Cash & Marketable Securities ($USD Millions)$76.8 $63.4 $57.6
Total Assets ($USD Millions)$102.4 $86.0 $79.2
Total Liabilities ($USD Millions)$41.2 $39.3 $40.9
Stockholders’ Equity ($USD Millions)$61.3 $46.7 $38.3

Results vs Estimates (Q2 2025)

MetricConsensusActualSurprise ($)Surprise (%)
EPS ($USD)-4.15*-2.96 +1.19+28.7%
Revenue ($USD Millions)0.00*0.00 (no product revenues reported; operating expense-only P&L) 0.00n/a

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Cash RunwayCorporateInto 1Q 2027 Into 1Q 2027 Maintained
Manufacturing Comparability FeedbackPBFT02Engage later in 2025 Seek feedback in 2H 2025 Clarified timing
Dose 2 Data UpdatePBFT02Report 2H 2025 Report 1H 2026 updated interim safety/biomarker data from Dose 2 Timing refined
Registrational Trial Design Feedback (FTD-GRN)PBFT021H 2026 1H 2026 Maintained
Protocol Amendment (Anticoagulation, Inclusion/Exclusion)PBFT02Plan to amend Submitted to sites/authorities Executed submission
FTD-C9orf72 DosingPBFT02Initiate 1H 2025 Cohort 4 to begin post-amendment approval Execution linked to protocol

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript was found in the document catalog; themes reflect prepared remarks/press releases [ListDocuments earnings-call-transcript shows no 2025 transcripts].

TopicPrevious Mentions (Q4 2024, Q1 2025)Current Period (Q2 2025)Trend
R&D Execution (Cohorts & Dosing)Introduced Dose 2; first patient enrolled; expanding to FTD-C9orf72 Completed dosing of FTD-GRN Cohort 2; preparing Cohorts 3 & 4 post-amendment Strengthening
Manufacturing (Suspension-based Process)200L suspension process; >1,000 doses at Dose 2; >70% full capsids; plan comparability feedback Seek comparability feedback in 2H 2025 Advancing
Regulatory Path (Registrational Design)Plan to seek guidance in 1H 2026 On track for 1H 2026 health authority engagement Stable
Safety ProfileSAEs (VST, hepatotoxicity) managed; revised immunosuppression Additional SAE (PE at Dose 2); plan prophylactic anticoagulation; amend inclusion criteria Managed risk with mitigation
Biomarkers (CSF PGRN, Plasma NfL)Robust CSF PGRN elevations; early NfL improvement vs natural history Durable CSF PGRN; Dose 2 achieves near-healthy range at 1 month; reduced NfL rate of change Positive durability signals
Capital & RunwayRunway into 1Q 2027 Runway into 1Q 2027 maintained; reverse split to maintain listing Stable runway; improved listing optics

Management Commentary

  • “We continue to be encouraged by the emerging data from our upliFT-D clinical trial… We look forward to initiating enrollment of our third FTD-GRN and first FTD-C9orf72 patient cohorts…” — Will Chou, M.D., President & CEO .
  • “We made steady progress… We expect these data to foster meaningful engagement with health authorities in the first half of 2026...” — Will Chou, M.D. (Q1) .
  • “We are pleased to report strong performance in 2024… delivering promising data… and are well-positioned for late-stage development.” — Will Chou, M.D. (FY 2024) .

Q&A Highlights

  • No Q2 2025 earnings call transcript was found in the catalog (last available transcripts end in 2023), suggesting the company did not file a Q2 2025 call transcript; therefore, no Q&A themes are available [ListDocuments earnings-call-transcript].

Estimates Context

  • EPS beat: Actual -$2.96 vs consensus -$4.15, a positive variance of $1.19 (28.7%); consensus based on 4 estimates* .
  • Revenue: consensus and actual at $0.0; estimates typically reflect no product revenues for clinical-stage biotech*.

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • OpEx discipline is meaningful: R&D and G&A declines narrowed quarterly and y/y losses, contributing to the EPS beat vs consensus; continued cost control supports runway into 1Q 2027 .
  • Clinical momentum: completion of Cohort 2 and protocol amendment set up multi-cohort progression (FTD-GRN and FTD-C9orf72) with biomarkers supporting potential best-in-class CSF PGRN elevation and NfL trajectory improvements .
  • Risk management: proactive anticoagulation and refined inclusion criteria address SAE learnings, potentially improving benefit-risk perception ahead of next data updates .
  • Near-term catalysts: 2H 2025 manufacturing comparability feedback and 1H 2026 regulatory feedback could reset probability-of-success assumptions and drive estimate revisions .
  • Reverse split and listing optics: the 1-for-20 action preserves Nasdaq compliance, impacts per-share metrics, and may reduce perceived delisting risk—a trading sentiment consideration .
  • Equity and assets trending lower as cash is deployed; expect continued need for disciplined capital planning (and potentially external capital) ahead of pivotal design clarity .
  • With no revenue, stock narrative remains biomarker/safety/regulatory-catalyst driven; clear communication on registrational pathway and external controls (natural history databases) will be key for medium-term thesis .

Appendix: Source Documents Reviewed

  • Q2 2025 8-K 2.02 press release and exhibits (financials and corporate presentation) .
  • Prior quarters: Q1 2025 8-K 2.02 press release and exhibits ; Q4 2024 8-K 2.02 press release and exhibits .
  • Other relevant press releases: Updated interim upliFT-D data (June 23, 2025) ; Reverse stock split announcement (July 10, 2025) .