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- **Clinical Milestone**: VERSATILE-002 trial reports unprecedented 39.3-month MOS and 6.3-month PFS in HPV16-positive patients, supporting PDS0101's potential as a chemotherapy-free option.
- **Strategic Trial Amendment**: Seeking FDA approval to add PFS as primary endpoint in VERSATILE-003 to accelerate regulatory timeline.
- **Financial Efficiency**: 21% year-over-year reduction in operating expenses to $8.1 million, with $26.2 million cash balance post-equity financing.
- **Pipeline Momentum**: PDS01ADC colorectal cancer trial expands to Stage 2, while collaborations advance immunotherapy platforms.

**【CEO Summary Section】**
- **VERSATILE-002 Trial Results**: Final data showed median overall survival (MOS) of 39.3 months and progression-free survival (PFS) of 6.3 months in HPV16-positive head and neck cancer patients. A sensitivity analysis confirmed no negative impact of 9 censored patients on PFS or MOS.
- **VERSATILE-003 Protocol Amendment**: Proposed to add PFS as a surrogate primary endpoint alongside MOS to potentially accelerate trial readout. FDA meeting requested to discuss amendment.
- **Pipeline Progress**: PDS01ADC colorectal cancer cohort expanded to Stage 2 after positive Stage 1 results. Collaborations with NCI, MD Anderson, and Mayo Clinic support pipeline development.

**【CFO Financial Commentary】**
- **Q3 2025 Financials**: Net loss of $9 million ($0.19 per share), down from $10.7 million ($0.29 per share) in Q3 2024. Operating expenses decreased 21% to $8.1 million due to lower R&D and G&A costs.
- **Cash Position**: $26.2 million as of September 30, 2025. Completed $5.3 million equity financing in October 2025.

**【Q&A Highlights】**
- **Patient Enrollment in VERSATILE-003**: Enrolled patients will continue treatment during the temporary pause. FDA discussions on new sample size and cost savings pending.
- **Control Arm PFS Assumptions**: Control arm PFS estimated at 3 months (based on KEYNOTE-048 and LEAP-010 studies), while PDS0101-treated patients achieved 6.3 months PFS in VERSATILE-002.
- **Competitive Landscape**: Focus on HPV16-positive head and neck cancer, a growing but underserved population (90% of oropharyngeal cancers are HPV16-positive).

PDS Biotechnology Corporation (PDSB) Q3 2025 Earnings Call Transcript

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