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PDS Biotechnology Corp (PDSB)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 net loss improved to $8.49M ($0.21 per share) from $10.60M ($0.30) in Q1 2024, driven by a $1.17M NJ NOL tax benefit and lower operating expenses; consensus EPS was -$0.25, implying a beat of ~$0.04 per share (actual -$0.21 vs. consensus -$0.2467*) .
  • Phase 3 VERSATILE-003 initiated and sites activated (Mayo added); design: ~350 patients, 2:1 randomization vs pembrolizumab, OS primary endpoint, with two interim analyses for potential accelerated pathway discussions .
  • Cash was $40.0M at quarter-end (vs. $41.7M at FY24); subsequent debt refinancing extended term to 36 months (first 4 months interest-only), and February offering raised ~$11M upfront with warrants for up to ~$11M more, bolstering liquidity for Phase 3 execution .
  • Additional pipeline momentum: FDA cleared IND for Versamune MUC1 + PDS01ADC in mCRC (NCI-led Phase 1/2), and Infectimune universal flu vaccine data featured at IMMUNOLOGY2025; three PDS0101 ASCO posters pending (durability emphasis) .

What Went Well and What Went Wrong

What Went Well

  • “Site activation is progressing, and Mayo Clinic sites have recently been added to the trial,” reinforcing Phase 3 execution cadence (CEO) .
  • Operating discipline: Total OpEx fell to $9.11M (from $10.10M YoY), with R&D down to $5.83M (from $6.70M) on lower clinical trial expenses; G&A also decreased slightly .
  • Regulatory/pipeline: IND clearance for Versamune MUC1 + PDS01ADC in mCRC and Fast Track retained for Versamune HPV in HNSCC; multiple ASCO selections signal scientific validation .

What Went Wrong

  • Net interest expense increased to $0.55M net (interest income $0.38M; interest expense $0.93M), reflecting financing costs and highlighting sensitivity to debt structure .
  • Cash balance declined modestly to $40.0M vs. $41.7M at FY24, underscoring continuing cash utilization for clinical operations prior to incremental financings .
  • The company does not provide numerical financial guidance; analysts queried OpEx trajectory and enrollment pacing, with management signaling stable trial spend after initial CRO ramp and deferring specific enrollment updates until more visibility .

Financial Results

MetricQ1 2024Q3 2024Q1 2025Wall St. Consensus (Q1 2025)
Net Loss ($USD)$(10,603,477) $(10,726,658) $(8,488,967) —
Diluted EPS ($)$(0.30) $(0.29) $(0.21) $(0.2467)*
Research & Development ($USD)$6,704,164 $6,803,900 $5,830,999 —
General & Administrative ($USD)$3,393,463 $3,374,794 $3,274,759 —
Total Operating Expenses ($USD)$10,097,627 $10,178,694 $9,105,758 —
Net Interest ($USD)$(505,850) $(547,964) $(553,029) —
Benefit from Income Taxes ($USD)$0 $869,169 $1,169,820 —
Cash & Cash Equivalents ($USD)$66,634,417 $49,751,252 $39,978,674 —
  • Versus prior year: EPS improved from $(0.30) to $(0.21) on lower R&D/G&A and a $1.17M tax benefit .
  • Versus estimates: EPS beat by ~$0.04 ($-0.21 vs. $-0.2467*); revenue consensus was $0, consistent with no reported revenue .

KPIs

KPIQ1 2024Q3 2024Q1 2025
Working Capital ($USD)—$33,791,108 $28,474,112
Total Assets ($USD)$69,006,366 $52,450,653 $47,028,542
Long-term Debt ($USD)$16,651,420 $12,031,986 $6,352,333
Total Equity ($USD)$37,183,045 $22,000,805 $22,362,209
Weighted Avg Shares34,815,870 36,806,592 40,521,001

Estimates vs. Actual (Q1 2025)

MetricConsensusActual
Primary EPS-0.2467*-0.21
Revenue ($USD)0.0*0

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial Guidance (OpEx, EPS, Revenue)Q1 2025None providedNone providedMaintained (no guidance)
VERSATILE-003 Design (OS primary endpoint; ~350 patients; 2:1 randomization; interim analyses)Ongoing 2025Alignment with FDA; design updated from >400 to ~350 in late 2024Confirmed operational start, site activation (incl. Mayo) and interim readouts built-inMaintained and executing
Pipeline Milestones (ASCO posters; IND MUC1 + PDS01ADC mCRC)Q2 2025 eventsASCO selection and IND planningASCO presentations; IND cleared; NCI to lead Phase 1/2Raised execution clarity

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024, Q4 2024)Current Period (Q1 2025)Trend
Phase 3 VERSATILE-003 executionUpdated design to ~350 patients; planned Q1 2025 initiation Initiated; site activation ongoing; Mayo added; OS primary endpoint; interim analyses Progressing as planned
Enrollment impact from KEYNOTE-689Not material due to HPV-negative focus; planning continued Management reiterates negligible impact; steering committee consensus Stable narrative
Funding environmentChallenging; raised $11M; planned stepwise financing; cash $41.7M at FY24 Debt refi to 36 months (4 months interest-only); offering raised ~$11M upfront with warrant potential Liquidity actions continued
Durability and survival data (VERSATILE-002)mOS 30 months; DCR 77%; ORR 36% (CPS ≥1); tolerability acceptable ASCO posters to update durability; management underscores long-term responses Reinforced
Regulatory/legalFast Track designation retained; IND planning IND cleared for Versamune MUC1 + PDS01ADC in mCRC (NCI-led) Advancing

Management Commentary

  • “The first quarter of 2025… highlighted by the initiation of our VERSATILE-003 Phase 3 clinical trial… We are pleased to announce that site activation is progressing, and that Mayo Clinic sites have recently been added to the trial.” — Frank Bedu-Addo, CEO .
  • “We reported a net loss of approximately $8.5 million or about $0.21… This decrease was due to increased benefit from income taxes as well as lower operating expenses.” — Lars Boesgaard, CFO .
  • “KEYNOTE-689 should not affect our VERSATILE-003… only 3–4% of patients were HPV positive.” — Kirk Shepard, CMO .

Q&A Highlights

  • KEYNOTE-689 impact: Management reiterated minimal effect on HPV16+ R/M HNSCC enrollment and potentially faster shift toward HPV16 predominance; steering committee aligned .
  • Durability focus at ASCO: Expect incremental data on long-term clinical responses and survival from VERSATILE-002; management emphasized 30-month mOS vs. ~12 months standard .
  • MUC1 differentiation: Versamune’s mechanism to activate and present potent agonist epitopes plus tumor-targeted IL-12 (PDS01ADC) aims to overcome historical failures on MUC1; NCI-led single-site trial supports resource focus .
  • Enrollment and trial spend: Company will update enrollment when visibility improves; trial spend seen as relatively stable after initial CRO ramp .
  • Financing and debt: February offering and April debt refinancing extended runway and reduced near-term cash burn via interest-only period .

Estimates Context

  • EPS beat: Actual EPS of -$0.21 vs. consensus -$0.2467*, a ~$0.04 beat; revenue in line at $0 vs. consensus $0.0* .
  • Implications: Modest beat reflects tax benefit realization and disciplined OpEx; Street models likely to incorporate Phase 3 execution costs and financing events into outer-quarter estimates.

Key Takeaways for Investors

  • EPS beat driven by tax benefit and lower OpEx; operating discipline sustained while Phase 3 launches .
  • Clinical catalysts: ASCO durability posters (near-term), ongoing site activation (Mayo added), and interim analysis structure could unlock regulatory dialogue if survival trends replicate .
  • Funding actions proactively managed: ~$11M raised upfront with warrants, debt refi to 36 months with initial interest-only period; liquidity adequate for site ramp but further capital likely as trial progresses .
  • KEYNOTE-689 read-through: Minimal impact on target population; potential tailwind to HPV16 prevalence supports market opportunity assumptions .
  • Risk monitor: Cash balance decline and ongoing net interest expense underscore need for continued prudent financing; company provides no numeric financial guidance .
  • Medium-term thesis: If VERSATILE-003 reproduces VERSATILE-002 survival/durability signals, Versamune HPV plus pembrolizumab could be first targeted therapy for HPV16+ HNSCC, expanding addressable market .

S&P Global disclaimer: *Values retrieved from S&P Global.