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PDS Biotechnology Corp (PDSB)·Q3 2025 Earnings Summary

Executive Summary

  • Q3 2025: net loss of $9.0M and EPS of $(0.19), improving year over year from $(10.7)M and $(0.29) in Q3 2024 as OpEx fell to $8.1M; cash was $26.2M at quarter-end .
  • Final VERSATILE-002 data strengthened clinical profile: median overall survival (mOS) 39.3 months (95% CI lower bound 23.9, upper bound not estimable) and progression-free survival (PFS) 6.3 months in CPS ≥1 patients, prompting a planned VERSATILE-003 protocol amendment to include PFS as a surrogate primary endpoint while keeping mOS for full approval; VERSATILE-003 is temporarily paused pending FDA discussions, with enrolled patients continuing on therapy .
  • EPS beat consensus: Q3 $(0.19) vs $(0.1967) consensus (beat by ~$0.0067); Q2 and Q1 were also beats versus S&P Global consensus, driven by lower operating expenses and cost control, with revenue consensus at $0 given no commercial products *.
  • Near-term stock catalysts: FDA meeting/outcome on PFS-based surrogate primary endpoint and accelerated approval path, plus continued translational updates (SITC biomarker data) and financing actions (registered direct offering of ~$5.3M gross; warrants repriced) .

What Went Well and What Went Wrong

What Went Well

  • Robust survival/efficacy: VERSATILE-002 final mOS reached 39.3 months and PFS 6.3 months in CPS ≥1, supporting expedited regulatory strategy in VERSATILE-003 .
    • CEO: “We believe the positive PFS data offers an important opportunity to shorten the trial duration and time to regulatory submission while maintaining mOS as the endpoint for full FDA approval.”
  • Translational validation: NCI SITC data showed immune biomarkers predict benefit and PDS01ADC reprograms NK cells and expands stem-like T cells, reinforcing mechanistic underpinnings for combinations .
  • Cost discipline: R&D down to $4.6M (from $6.8M YoY), total OpEx down to $8.1M (from $10.2M YoY), narrowing net loss .

What Went Wrong

  • Trial pause: Temporary pause of VERSATILE-003 for protocol amendment introduces timing risk; FDA meeting outcome is uncertain .
  • Financing/dilution and higher net interest: Registered direct offering (~$5.3M initial proceeds) and increased net interest expense ($0.9M vs $0.5M YoY) highlight funding needs and cost of capital .
  • Cash burn trajectory: Cash declined from $31.9M (Q2) to $26.2M (Q3); while offering adds liquidity, runway remains a focal risk absent revenues .

Financial Results

MetricQ1 2025Q2 2025Q3 2025
Net Loss ($USD Millions)$8.49 $9.43 $9.01
Diluted EPS ($USD)$(0.21) $(0.21) $(0.19)
R&D Expense ($USD Millions)$5.83 $4.21 $4.58
G&A Expense ($USD Millions)$3.27 $3.41 $3.56
Total Operating Expenses ($USD Millions)$9.11 $7.62 $8.14
Interest Income ($USD Millions)$0.38 $0.33 $0.28
Interest Expense ($USD Millions)$0.93 $2.14 $1.15
Net Interest Expense ($USD Millions)$(0.55) $(1.81) $(0.87)
Cash & Equivalents ($USD Millions)$39.98 $31.87 $26.20

Notes: Company did not disclose product revenues or margin metrics; no non-GAAP measures were presented .

EPS vs. Wall Street Consensus

MetricQ1 2025Q2 2025Q3 2025
EPS Actual ($USD)$(0.21) $(0.21) $(0.19)
Primary EPS Consensus Mean ($USD)$(0.2467)*$(0.2333)*$(0.1967)*
Primary EPS - # of Estimates3*3*3*

Values retrieved from S&P Global.*

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
VERSATILE-003 Primary EndpointTrial-levelMedian Overall Survival (mOS) primary; PFS secondary mOS remains primary for full approval; PFS to become surrogate primary endpoint for accelerated approval proposal Maintained mOS; Elevated PFS to surrogate primary
VERSATILE-003 Trial StatusNear termActive enrollment; no pause disclosed Temporary pause during FDA review of amendment; enrolled patients continue treatment Paused (procedural)
VERSATILE-003 Trial Size / PowerTrial-level~350 patients planned, 2:1 randomization Proposed amendment could reduce trial size while maintaining statistical power Potential reduction
Regulatory PathNear termFast Track designation; standard approval via mOS Seeking expedited/accelerated approval pathway via PFS if met; mOS for full approval Accelerated path pursued
Patient ManagementNear termStandard conduct per protocol Continued treatment on protocol during pause; enhanced training/central review for PFS assessments Clarified conduct

Earnings Call Themes & Trends

TopicPrevious Mentions (Q1 & Q2)Current Period (Q3)Trend
Regulatory/Approval PathVERSATILE-003 initiated; aligned with FDA on endpoints; Fast Track status Pursuing FDA meeting to add PFS as surrogate primary; temporary trial pause; keep mOS for full approval Intensifying focus on accelerated path
R&D Execution (PDS0101)VERSATILE-002 durability at ~30 months mOS; poster at ASCO; investigator enthusiasm Final mOS 39.3 months; PFS 6.3 months; sensitivity analyses supportive Strengthening efficacy narrative
R&D Execution (PDS01ADC)Phase 2 CRC cohort met stage 2 expansion criteria (≥6/9 ORR) SITC translational NK/T-cell data supporting mechanism; continued NCI-led studies Positive mechanistic validation
Competitive LandscapeFew comparable HPV16+ trials; BioNTech noted; KEYNOTE-689 not applicable to HPV+ surgically ineligible Growing recognition of HPV+ HNC as dominant; ADCs largely HPV-negative focused Favorable positioning in HPV16+ niche
Capital & LiquidityQ1: $40M cash; debt refi; Feb offering (~$11M funded) Q3: $26.2M cash; Nov registered direct offering ~$5.3M gross; warrant repricing Funding augmented; dilution risk persists

Management Commentary

  • CEO (on expedited pathway): “We believe the positive PFS data offers an important opportunity to shorten the trial duration and time to regulatory submission while maintaining mOS as the endpoint for full FDA approval.”
  • CEO (on HPV16+ disease burden): “HPV has become the principal etiologic factor in oropharyngeal cancer… over 90% of HPV positive oropharyngeal cancers are HPV-16 positive.”
  • CMO (on PFS conduct): “Investigators are trained… reviewed by a central review… sensitive to pseudoprogression… we will continue to follow them.”
  • CFO (on quarter): “Net loss of $9 million or $0.19 per share… R&D expenses $4.6 million; G&A $3.6 million; cash balance $26.2 million.”

Q&A Highlights

  • Protocol amendment logistics: Enrolled patients continue treatment; sample size not disclosed pending FDA discussion; aim to reach readouts earlier via PFS .
  • Control arm PFS assumptions: Conservatively ~3 months based on KEYNOTE-048 (3.2 months CPS ≥1) and LEAP-10 (2.8 months), with worse prognosis for HPV16+ noted in literature .
  • PFS assessment rigor: Training across expanded sites; central imaging review; awareness of pseudoprogression to avoid premature calls .
  • Post-protocol therapy in ICI-resistant setting: Expect short mOS (3–4 months published), implying prolonged survival likely attributable to PDS0101 regimen .

Estimates Context

  • EPS beats:
    • Q3 2025: Actual $(0.19) vs Consensus $(0.1967)* → beat by ~$0.0067; driven by lower OpEx and cost control *.
    • Q2 2025: Actual $(0.21) vs Consensus $(0.2333)* → beat by ~$0.0233 *.
    • Q1 2025: Actual $(0.21) vs Consensus $(0.2467)* → beat by ~$0.0367 *.
  • Revenue: Consensus $0.0* in each quarter; company reports no product revenue in releases; focus remains on OpEx and clinical milestones *.

Values retrieved from S&P Global.*

Financial and Clinical KPI Trends

KPIQ1 2025Q2 2025Q3 2025
VERSATILE-002 Median Overall Survival (months)30.0 30.0 (lower CI strengthened to 23.9) 39.3 (95% CI: lower 23.9; upper NE)
VERSATILE-002 PFS (months, CPS ≥1)n/an/a6.3
Cash & Equivalents ($USD Millions)$39.98 $31.87 $26.20
Total Operating Expenses ($USD Millions)$9.11 $7.62 $8.14

Key Takeaways for Investors

  • Clinical strength is the core driver: mOS 39.3 months and PFS 6.3 months in CPS ≥1 materially de-risk the biology and support an accelerated path via PFS in VERSATILE-003 .
  • Regulatory inflection ahead: FDA feedback on PFS as a surrogate primary endpoint is pivotal; a positive outcome would be a major catalyst and could shorten the timeline to submission .
  • Execution focus: Central review/training to manage pseudoprogression risk should improve PFS data integrity, aiding regulatory case .
  • Funding posture improved but dilution risk remains: ~$5.3M offering and warrant repricing supplement cash; watch runway vs trial timelines .
  • Estimates likely drift modestly better on EPS given OpEx discipline; revenue remains at $0 as the company advances toward registrational milestones *.
  • Competitive positioning favorable in HPV16+ HNC with limited direct competition and industry shift recognizing HPV+ prevalence .
  • Trading implications: Stock likely sensitive to FDA meeting scheduling/outcomes, additional clinical/translational disclosures, and any clarity on amended sample size/timelines .

Citations:
Quarterly results, cash, OpEx, and expenses: .
VERSATILE-002 survival/PFS: .
Regulatory/accelerated pathway and trial pause: .
SITC translational data: .
Q&A protocol/PFS control assumptions/training: .
Offering/warrant changes: .
EPS consensus and counts: S&P Global estimates.*