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PDS Biotechnology (PDSB) investor relations material
PDS Biotechnology Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary13 Nov, 2025
Executive summary
Advanced clinical programs for HPV-16 positive head and neck cancer, with VERSATILE-002 trial showing strong survival data and leading to protocol amendments in the phase 3 VERSATILE-003 trial, aiming for expedited approval.
Positive preliminary results from the colorectal cancer cohort of the Phase 2 PDS01ADC trial, meeting criteria for study expansion.
Pipeline includes additional candidates for MUC1-positive cancers, AML, prostate, and breast cancer, as well as a universal flu vaccine in preclinical development.
Industry and market research highlight the rising prevalence of HPV-16 positive head and neck cancer, supporting the strategic focus.
Announced positive clinical data and regulatory milestones for lead candidates.
Financial highlights
Net loss for Q3 2025 was $9.0 million ($0.19 per share), down from $10.7 million ($0.29 per share) in Q3 2024, mainly due to lower operating expenses.
Research and development expenses decreased to $4.6 million from $6.8 million year-over-year; general and administrative expenses rose slightly to $3.6 million.
Total operating expenses were $8.1 million, down from $10.2 million in the prior year period.
Cash and cash equivalents were $26.2 million as of September 30, 2025, down from $41.7 million at the start of the year.
Net interest expense increased to $0.9 million from $0.5 million year-over-year due to lower interest income.
Outlook and guidance
Ongoing treatment for currently enrolled VERSATILE-003 patients during protocol amendment pause.
Management expects continued operating losses and negative cash flows, with substantial doubt about the ability to continue as a going concern beyond Q1 2026 without additional capital.
Plans to seek accelerated approval for PDS0101 in combination with pembrolizumab based on positive PFS data, with mOS as the primary endpoint for full approval.
Discussions with FDA to finalize protocol changes, with the goal of earlier clinical readouts and potential regulatory submission acceleration.
Plans to fund operations through additional equity or debt financing, government funding, or strategic partnerships.
VERSATILE-003 PFS amendment: accelerated approval
HPV-16 H&N market: competitive positioning
Cash runway and pipeline funding strategy
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Next PDS Biotechnology earnings date
Q4 202526 Mar, 2026
Next PDS Biotechnology earnings date
Q4 202526 Mar, 2026
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Frequently asked questions
PDS Biotechnology Corporation, a clinical-stage biopharmaceutical company, focuses on developing multifunctional cancer immunotherapies. Its product pipeline includes thermo-sensitive PDS0101 (Amiket), which is in Phase 3 clinical trials for the treatment of patients with human papillomavirus associated disease; Discovery Program, a research and discovery program with a focus on tumor neo-antigens and synthetic vaccines; and Thermo-Oxidative Stress Induced Antigen(TOSIA) Program that combines chemical engineering, molecular biology, and immunology to discover tumor associated antigens.
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