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PDS Biotechnology (PDSB) investor relations material
PDS Biotechnology Q2 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q2 2025 earnings summary13 Aug, 2025
Executive summary
Advanced the VERSAL-3/ VERSATILE-003 phase 3 trial of PDS0101 for HPV16 positive recurrent/metastatic head and neck cancer, with unique targeting and design, and full data expected by year-end 2025 or early 2026.
Presented positive updated data from the VERSAL-2/ VERSATILE-002 trial, showing durable clinical benefit and median overall survival of 30 months.
Expanded the phase 2 colorectal cancer cohort for PDS-one ADC after meeting response criteria, in collaboration with the National Cancer Institute.
Showcased preclinical progress on a universal flu vaccine, with efficacy data presented at major immunology meetings.
Net loss for Q2 2025 was $9.4 million, up from $8.3 million in Q2 2024, with cash and cash equivalents at $31.9 million as of June 30, 2025.
Financial highlights
Net loss of $9.4M ($0.21 per share) for Q2 2025, compared to $8.3M ($0.23 per share) in Q2 2024.
Research and development expenses were $4.2M, down from $4.5M year-over-year.
General administrative expenses decreased to $3.4M from $4.2M, driven by lower personnel and professional fees.
Net interest expenses rose to $1.8M from $0.5M, mainly due to debt repayment costs.
Cash balance was $31.9M as of June 30, 2025, with runway into Q4 2025 but substantial doubt about ongoing viability without further capital.
Outlook and guidance
Anticipates publishing or presenting final VERSAL-2/ VERSATILE-002 data, including ORR, PFS, and safety, by year-end 2025 or early 2026.
Expects continued site accrual and on-schedule progress for the VERSAL-3/ VERSATILE-003 phase 3 trial.
Plans to complete patient recruitment for the metastatic colorectal cancer cohort by the end of 2025.
Ongoing and planned clinical trials will drive increased R&D spending in coming periods.
Management plans to seek further equity or debt financing, government funding, or strategic partnerships.
When to expect VERSATILE-002 final data?
How does PDS01ADC target IL-12?
How does VERSATILE-003 target HPV16+ H&N cancer?
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Next PDS Biotechnology earnings date
Q3 202513 Nov, 2025
Next PDS Biotechnology earnings date
Q3 202513 Nov, 2025
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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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