Sign in

You're signed outSign in or to get full access.

PB

PDS Biotechnology Corp (PDSB)·Q2 2025 Earnings Summary

Executive Summary

  • Reported net loss of $9.43M and diluted EPS of -$0.21 for Q2 2025; operating expenses fell year over year (Q2 2025 OpEx $7.62M vs $8.68M in Q2 2024) as R&D and G&A declined, offset by notably higher net interest expense tied to debt repayment costs .
  • EPS beat Wall Street consensus: actual -$0.21 vs consensus -$0.23; revenue in line at $0, consistent with development-stage status; prior quarter Q1 2025 likewise beat (-$0.21 vs -$0.25) [GetEstimates: Q2 2025, Q1 2025]*.
  • Clinical momentum: VERSATILE-003 Phase 3 in first-line HPV16+ r/m HNSCC progressing; management reiterated mOS durability at 30.0 months in Phase 2 VERSATILE-002 and highlighted planned full data publication later this year .
  • Additional catalysts: NCI-led PDS01ADC colorectal cohort met criteria to expand to Stage 2 with ≥6/9 confirmed responses; Mayo Clinic neoadjuvant window-of-opportunity trial showed ctDNA reduction and activity with only two cycles .
  • Funding remains a watch item: cash fell to $31.9M at June 30, 2025 (from $40.0M at March 31); management previously noted more capital will be needed to complete Phase 3, pursuing stepwise equity and non-dilutive options .

What Went Well and What Went Wrong

What Went Well

  • VERSATILE-003 registrational trial advancing with investigator enthusiasm; sites from Phase 2 re-engaging, supporting accrual trajectory: “We have had a lot of feedback… sites… participating in the phase two study… have signed on” .
  • Durability of clinical benefit: “Median overall survival remained steady at thirty months… suggesting durability of the PDS0101 induced clinical responses” with improving CI lower bound (18.4 → 23.9 months) .
  • Pipeline progress: NCI-led PDS01ADC colorectal cohort triggered Stage 2 on ≥6/9 confirmed responses; Mayo Clinic neoadjuvant poster met primary ctDNA endpoint, showing activity with just two cycles .

What Went Wrong

  • Net interest expense rose substantially ($1.81M vs $0.51M YoY) due to debt repayment costs, increasing net loss YoY despite lower operating expenses .
  • Cash drawdown through the quarter (to $31.9M) alongside CFO commentary that cash on hand is not sufficient to complete the Phase 3, implying continued financing need and potential dilution/debt .
  • No revenue and no formal financial guidance; investor visibility on cash runway and OpEx trajectory relies on disclosures rather than targets, with CFO reiterating no guidance policy previously .

Financial Results

Summary Financials

MetricQ2 2024Q1 2025Q2 2025
Revenue ($USD Millions)$0.0 $0.0 $0.0
Net Loss ($USD Millions)$8.33 $8.49 $9.43
Diluted EPS ($USD)-$0.23 -$0.21 -$0.21
Research & Development ($USD Millions)$4.53 $5.83 $4.21
General & Administrative ($USD Millions)$4.16 $3.27 $3.41
Total Operating Expenses ($USD Millions)$8.68 $9.11 $7.62
Net Interest Expense ($USD Millions)$0.51 $0.55 $1.81

Balance Sheet Snapshot

MetricDec 31, 2024Mar 31, 2025Jun 30, 2025
Cash and Cash Equivalents ($USD Millions)$41.69 $39.98 $31.87
Working Capital ($USD Millions)$27.97 $28.47 $22.12
Total Assets ($USD Millions)$45.36 $47.03 $40.48
Long-Term Debt ($USD Millions)$9.20 $6.35 $12.94
Stockholders’ Equity ($USD Millions)$19.00 $22.36 $15.96

Earnings vs Consensus

MetricQ1 2025Q2 2025
EPS Actual ($USD)-$0.21 -$0.21
EPS Consensus Mean ($USD)-$0.25*-$0.23*
EPS Surprise ($USD)+$0.04 (beat)+$0.02 (beat)
EPS - # of Estimates3*3*
Revenue Actual ($USD Millions)$0.0 $0.0
Revenue Consensus Mean ($USD Millions)$0.0*$0.0*
Revenue Surprise ($USD Millions)$0.00$0.00
Revenue - # of Estimates2*2*

Values retrieved from S&P Global.*

KPIs (Clinical Efficacy, VERSATILE-002)

KPIValueNotes
Median Overall Survival (CPS ≥1)30.0 months (95% CI lower 23.9, upper NE) Durability steady over ~1.5 years
Median OS (CPS ≥20)39.3 months (95% CI 30.0, NE) Stratified outcome
Objective Response Rate35.8% (19/53) RECIST v1.1
Disease Control Rate77.4% (41/53) RECIST v1.1
Median PFS6.3 months (95% CI 2.8, 14.1) Overall cohort
Median DoR21.8 months (95% CI 11.5, NE) Overall cohort
PDS01ADC (CRC) Confirmed ORR (Stage 1)≥66.7% (≥6/9) Triggered Stage 2

Note: Traditional margins (gross, operating, net) are not meaningful given no revenue reported .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
Financial Guidance (Revenue, EPS, OpEx)FY/Q2 2025None provided None provided Maintained
Clinical Milestones (VERSATILE-002 publication timing)CY 2025“Later this year or early next year” “Publish full data set later this year” Clarified timing
VERSATILE-003 Interim OS ReadoutsTrial designTwo interim OS analyses planned Two interim OS analyses planned Maintained

Earnings Call Themes & Trends

TopicPrevious Mentions (Q4 2024)Previous Mentions (Q1 2025)Current Period (Q2 2025)Trend
HPV16-focused strategy & durabilityEmphasis on 30-month mOS durability and improved ORR/DCR vs prior data cuts Phase 3 initiated; strong durability highlighted; ASCO updates upcoming mOS steady at 30 months; CI lower bound improved; 22 patients followed; no new safety signals Strengthening
Competitive landscape (BioNTech, EGFR)Noted better durability vs published pembrolizumab outcomes; EGFR narrative emerging Deferred EGFR comments; focused on robust durability of combo “Only one other major trial with BioNTech… not as far as us… their mOS not as high” Favorable
Regulatory & trial design (Fast Track, interim OS)FDA-aligned Phase 3; interim OS; Fast Track designation Reinforced design and interim analyses Reiterated interim OS readouts after full enrollment thresholds Stable
Funding strategyCash balance and registered direct; stepwise funding plan; pursue debt/non-dilutive No formal guidance; trial spend stabilization underway Cash down to $31.9M; net interest expense higher Mixed (pressure)
Neoadjuvant window-of-opportunity trialBackground in pipeline updates Anticipation of Mayo Clinic data Met primary ctDNA endpoint; 70% SD with PDS0101 alone; 100% SD/PR with combo Positive

Management Commentary

  • “Median overall survival remained steady at thirty months over the last one and a half years, suggesting durability of the PDS0101 induced clinical responses… No new safety signals have emerged.” — Frank Bedu-Addo, CEO .
  • “We have had a lot of feedback from the sites… many… participating in the phase two study… have signed on… we’re right on schedule… understanding the importance of the specificity of HPV sixteen positive therapy.” — Kirk Shepard, CMO .
  • “Net interest expenses were 1,800,000… compared to 500,000… increase primarily due to debt repayment costs… cash balance… $31,900,000.” — Lars Boesgaard, CFO .
  • “There are less competing trials… only one other major trial with BioNTech… their median overall survival… not as high as ours.” — Kirk Shepard, CMO .

Q&A Highlights

  • VERSATILE-002 full data timing: management expects publication “later this year or very early next year,” covering ORR, PFS, safety; Phase 3 accrual supported by tolerability and survival profile .
  • Enrollment/competition: Phase 3 sites on track; fewer competing trials; BioNTech behind and lower mOS to date; KEYNOTE-689 neoadjuvant data viewed as largely HPV-negative, minimal impact on HPV16+ patient pool targeted by PDS .
  • Neoadjuvant approach: Mayo Clinic trial showed activity with two cycles alone and with pembrolizumab; ctDNA primary endpoint met; informs future design .
  • Financials: Higher net interest expense tied to debt repayment; cash level disclosed; no formal financial guidance reiterated previously .

Estimates Context

  • Q2 2025 EPS beat: -$0.21 actual vs -$0.23 consensus; revenue matched at $0; signals cost discipline despite higher interest expense [GetEstimates: Q2 2025]*.
  • Q1 2025 EPS beat: -$0.21 actual vs -$0.25 consensus; revenue $0 vs $0 consensus [GetEstimates: Q1 2025]*.
  • Analyst coverage remains light (3 EPS estimates; 2 revenue estimates), and zero-revenue assumptions persist given clinical-stage status [GetEstimates: Q2 2025]*.
  • Estimate revisions may skew modestly more favorable on EPS if OpEx continues trending lower YoY, though interest expense volatility and funding plans are potential offsets .

Values retrieved from S&P Global.*

Key Takeaways for Investors

  • EPS beats are notable in a zero-revenue context; cost controls lowered OpEx YoY while higher interest expense pressured net loss, keeping headline EPS closer to consensus than expected [GetEstimates: Q2 2025]*.
  • Clinical differentiation anchored by HPV16 specificity and durable mOS (30.0 months) in VERSATILE-002; management positioning Phase 3 as first registrational trial targeting HPV16+ r/m HNSCC .
  • Trial catalysts: two planned interim OS readouts post full enrollment; publication of full VERSATILE-002 dataset later this year—both potential stock movers .
  • Funding watch: cash of $31.9M at quarter-end and CFO commentary on stepwise financing imply near/intermediate-term capital events; monitor dilution/debt risk .
  • Pipeline adds optionality: NCI-led PDS01ADC colorectal expansion and Mayo Clinic neoadjuvant signal in HPV16+ oropharyngeal cancer broaden thesis beyond HNSCC .
  • Competitive read-through: fewer active competitors; BioNTech behind and with lower mOS to date, improving perceived probability of success if Phase 3 replicates Phase 2 outcomes .
  • Near-term trading: sensitivity to clinical-site activation and accrual updates; medium term driven by VERSATILE-002 publication quality and visibility into interim OS timelines .
Notes:
- All document-derived figures and statements are cited to company press releases, 8-K filings, and earnings call transcripts.
- Consensus estimates and related fields marked with * are values retrieved from S&P Global.