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8-K2026-05-13· grok-4-1-fast-non-reasoning

PDSB · PDS Biotechnology Corporation

0001140361-26-020934

SEC filing

Summary

PDS Biotechnology reported Q1 2026 net loss of $7.3 million ($0.13/share) versus $8.5 million ($0.21/share) prior year, with reduced operating expenses and $21.7 million cash, alongside clinical progress in cancer trials.

Key takeaways

Full analysis

PDS Biotechnology's Q1 2026 results showed meaningful improvement in financial metrics, with net loss narrowing to $7.3 million or $0.13 per share from $8.5 million or $0.21 per share in Q1 2025, driven by a 40% reduction in R&D expenses to $3.5 million from lower clinical and manufacturing costs, and a slight decline in G&A to $3.1 million. Total operating expenses dropped to $6.5 million from $9.1 million, reflecting disciplined cost management amid ongoing clinical investments. Net interest expense rose modestly to $0.8 million. Balance sheet remains liquid with $21.7 million in cash as of March 31, 2026, down from $26.7 million at year-end 2025, supporting near-term operations while funding pipeline advancement. CEO Frank Bedu-Addo highlighted progress including amended VERSATILE-003 Phase 3 protocol for PDS0101 in HPV16-positive head and neck cancer, incorporating PFS as an interim endpoint for potential accelerated approval while retaining OS as primary, with reduced patient enrollment needs. PDS01ADC data impressed: NCI-led mCRC trial (Stage 1) achieved 77.8% ORR at six months and ~85% 24-month survival versus 35% ORR and ~40% survival in parallel control; mCRPC early data showed 9.6-month median PFS and 40% median PSA decline with docetaxel. Enrollment completed in PDS01ADC mCRC trial; prostate trial recruiting well. IP strengthened with new U.S. patent (to 2040s with biologics exclusivity) and Japan composition claims. Investor webcast held May 13, 2026, at 8:00 am ET. Information furnished under Item 2.02, not filed.