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PDS Biotechnology Corp (PDSB)·Q4 2024 Earnings Summary

Executive Summary

  • PDS Biotech initiated the VERSATILE-003 Phase 3 trial in first-line HPV16-positive R/M head & neck cancer, with first site activation in March 2025; the design includes 2:1 randomization, OS primary endpoint, and two interim analyses, aligned with FDA and informed by durable Phase 2 data .
  • Q4 2024 EPS of -$0.21 beat Wall Street consensus of -$0.275, reflecting continued OpEx discipline; FY 2024 EPS was -$1.03 vs -$1.108 consensus (beats on both periods)*. Cash declined to $41.7M at 12/31/24 from $49.8M at 9/30/24 and $57.7M at 6/30/24 .
  • Management emphasized that current capital is insufficient to complete VERSATILE-003; plan is to raise funds stepwise using equity and non-dilutive sources (e.g., debt) as milestones are achieved .
  • Additional pipeline momentum: FDA cleared IND for Versamune MUC1 + PDS01ADC in March 2025 (Phase 1/2 under NCI CRADA), and updated cervical cancer (IMMUNOCERV) Phase 2 results in October showed strong survival and safety, reinforcing platform potential .
  • Stock catalysts: site activations and enrollment ramp for VERSATILE-003, two interim analyses built into Phase 3, and final VERSATILE-002 Phase 2 results expected later in 2025 .

What Went Well and What Went Wrong

What Went Well

  • Initiated VERSATILE-003 with FDA-aligned registrational design (OS primary, 2:1 randomization, interim analyses), supported by durable Phase 2 survival and response data . CEO: “We are…confident in the potential of our innovative combination therapy to improve patient outcomes” .
  • OpEx control: FY 2024 total operating expenses fell to $36.3M from $43.0M; FY net loss narrowed to $37.6M from $42.9M; FY EPS improved to -$1.03 from -$1.39 .
  • Platform validation: IMMUNOCERV Phase 2 in cervical cancer showed 36‑month OS 84.4% overall and 100% in fully dosed patients; 88% complete metabolic response; favorable tolerability—supporting broader platform utility .

What Went Wrong

  • Funding overhang: CFO stated the company does not yet have enough capital to complete VERSATILE-003; intends stepwise financing including equity and debt amid a difficult funding environment .
  • Cash burn visible: cash fell to $41.7M at 12/31/24 from $49.8M at 9/30/24 and $57.7M at 6/30/24; working capital and equity trended lower during 2H24 .
  • Higher net interest expense: FY 2024 net interest expense rose to $2.2M (vs $1.3M in 2023) due to higher debt interest and lower interest income .

Financial Results

EPS vs Prior Quarters and Estimates

Note: PDS Biotech reports no product revenue; results focus on operating expenses, net loss, and EPS .

MetricQ2 2024Q3 2024Q4 2024
EPS (GAAP)-$0.23 -$0.29 -$0.21*
EPS Consensusn/an/a-$0.275*

Values with an asterisk (*) are retrieved from S&P Global.

Annual P&L (FY 2024 vs FY 2023)

MetricFY 2023FY 2024
Research & Development ($M)$27.8 $22.6
General & Administrative ($M)$15.3 $13.8
Total Operating Expenses ($M)$43.0 $36.3
Net Interest Expense ($M)$1.3 $2.2
Net Loss ($M)$42.9 $37.6
EPS (Basic & Diluted)-$1.39 -$1.03
Weighted Avg Shares (M)31.0 36.5

Liquidity and Capital Structure Trend

Metric6/30/20249/30/202412/31/2024
Cash & Equivalents ($M)$57.7 $49.8 $41.7
Working Capital ($M)$44.5 $33.8 $28.0
Total Assets ($M)$60.5 $52.5 $45.4
Long-Term Debt ($M)$13.8 $12.0 $9.2
Stockholders’ Equity ($M)$30.9 $22.0 $19.0

Clinical KPIs (from VERSATILE-002 and IMMUNOCERV)

KPIValue
VERSATILE-002 median OS30.0 months (95% CI: 19.7, NE)
ORR (CPS ≥1)36%
Disease Control Rate77%
Grade ≥3 TRAEs9% (8/87); Grade 4: 1%
IMMUNOCERV 36‑mo OS84.4% overall; 100% in fully dosed (N=8)
Complete Metabolic Response88% (15/17)

Guidance Changes

MetricPeriodPrevious GuidanceCurrent UpdateChange
VERSATILE-003 initiationQ1 2025Expected FDA clearance mid-Dec and initiate site activation in Q1 2025 First site activated in March 2025 Achieved
VERSATILE-003 designOngoingUpdated to ~350 pts; OS primary; 2:1 randomization Confirmed OS primary; two interim OS readouts; 2:1 randomization Maintained
Funding strategy2025n/aNot enough capital to complete trial; plan stepwise raises incl. equity and non-dilutive debt New disclosure
MUC1 + PDS01ADC IND1H 2025 (planned)File IND in 2025 (milestone) FDA IND clearance announced March 2025 Achieved

Earnings Call Themes & Trends

TopicQ2 2024 (Aug 13)Q3 2024 (Nov 14)Q4 2024 (Mar 27)Trend
Phase 3 design & timingAligned with FDA; preparing for registrational start Updated design (~350 pts), maintained power; expect FDA clearance by mid-Dec and site activation Q1’25 Phase 3 initiated; first site activated; OS primary, 2:1 randomization, two interim OS analyses Execution progressing
Funding/Runwayn/an/aMarket conditions difficult; $11M raise in Feb; stepwise funding; current cash insufficient to complete trial Clarity on financing plan
Competitive landscapen/aAddressed KEYNOTE‑689 impact; minimal expected effect on target population Reiterated HPV16+ focus; durability vs ORR emphasis vs EGFR/other combos Narrative consistent
Platform expansionPreviews for IMMUNOCERV, NCI ADC studies Positive IMMUNOCERV update (ASTRO) MUC1+PDS01ADC IND cleared (NCI Phase 1/2) Pipeline de-risking via partners
Companion diagnosticn/an/aPlan to use validated HPV16 diagnostic in VERSATILE‑003 screening (disclosed Feb 5) Better patient ID

Management Commentary

  • “We are…confident in the potential of our innovative combination therapy to improve patient outcomes and enhance the standard of care.” — CEO, on VERSATILE-003 initiation .
  • “As I mentioned, we did raise $11,000,000 recently…we currently don't have enough…to complete the trial. Our plan is to raise necessary capital in a stepwise manner…including equity and non‑dilutive sources such as debt.” — CFO .
  • “Most of the Phase 2 sites are reengaged…this helps…their familiarity with the drug…sped us along quite a bit.” — CMO, on site activation/enrollment .
  • “Based upon the durability of the responses…we…tightened the trial…from over 400 down to 350 patients with the same power…two interim data readouts…approximately six months after full enrollment and [another] ~12 months after that.” — CEO, on design and interims .

Q&A Highlights

  • Enrollment trajectory and site re-engagement: Many VERSATILE‑002 sites rejoining; familiarity should aid activation; enrollment pace will dictate timing .
  • Funding and dilution: $11M raised; stepwise approach; mixture of equity and non‑dilutive debt; current cash not enough to complete Phase 3 .
  • Interim analyses/statistical power: Sample size reduced (~350) due to durable responses, maintaining power; two OS‑based interims enable earlier FDA discussions .
  • Triple regimen strategy: Prioritized doublet approval first; triple (adding IL‑12 ADC) to proceed after dose optimization and regulatory sequencing .
  • MUC1 program: IND cleared; NCI will lead Phase 1/2; timelines to be provided by NCI .

Estimates Context

  • Q4 2024 EPS: Actual -$0.21 vs consensus -$0.275 — beat by $0.065*.
  • FY 2024 EPS: Actual -$1.03 vs consensus -$1.108 — beat by $0.078*.
  • Revenue: Consensus $0.0 for Q4 and FY (pre‑commercial)*.
MetricQ4 2024 ConsensusQ4 2024 ActualFY 2024 ConsensusFY 2024 Actual
EPS (Primary)-$0.275 (4 ests)*-$0.21*-$1.108 (4 ests)*-$1.03
Revenue ($M)$0.0 (3 ests)*n/a$0.0 (3 ests)*n/a

Values with an asterisk (*) are retrieved from S&P Global.

Implications: EPS beats are driven by OpEx control and reflect limited variability near-term; estimate revisions should focus on OpEx trajectory and share count rather than revenue (pre‑commercial).

Key Takeaways for Investors

  • Trial execution is the near-term stock driver: successful site activations and visible enrollment momentum into VERSATILE‑003 could re‑rate shares ahead of interim OS triggers .
  • Financing overhang remains: management plans stepwise raises; monitor dilution risk versus milestone‑based catalysts (interims, VERSATILE‑002 final data in 2025) .
  • Clinical durability narrative is intact: Phase 2 mOS at 30.0 months with improving response depth and tolerability underpins Phase 3 design and potential regulatory path .
  • Platform leverage building: MUC1+PDS01ADC IND clearance and NCI‑led studies diversify optionality with minimal company spend .
  • Cash trending lower (Q2→Q4’24), but debt also reduced; February 2025 raise improved flexibility; watch subsequent capital actions and cadence .
  • Competitive context: HPV16‑targeted strategy differentiated vs broad EGFR or combo regimens where ORR gains haven’t translated to OS; FDA focus on OS aligns with PDS’s endpoint .
  • Trading setup: Updates on site count/enrollment and any early operational milestones are near-term catalysts; interims are medium-term binary events with meaningful upside/downside skew .

Appendix: Prior Two Quarters Snapshot (for trend)

  • Q3 2024: Net loss $10.7M; EPS -$0.29; R&D $6.8M; G&A $3.4M; cash $49.8M; updated Phase 3 design to ~350 patients; expected FDA clearance mid‑December .
  • Q2 2024: Net loss $8.3M; EPS -$0.23; R&D $4.5M; G&A $4.2M; cash $57.7M; aligned with FDA on registrational design, preparing for start; ESMO 2024 update teed up .