PDSB

Clinical Program Updates

• PDS0101 (Versatile 003 trial for HPV16 positive head and neck cancer): Amended the trial protocol to add progression-free survival (PFS) as an interim primary endpoint, enabling a more efficient path to accelerated approval per FDA alignment. The amendment is expected to shorten trial duration, reduce overall costs, and accelerate patient access while retaining overall survival as the endpoint for full approval. PDS0101 in combination with pembrolizumab (Keytruda) is the only late-stage investigational therapy for this indication that requires only five doses and is delivered subcutaneously, with favorable tolerability and survival data to date. Key opinion leaders from top U.S. cancer institutions are participating in the trial, and HPV16 positive cancers have growing unmet need due to low HPV vaccine uptake and no approved targeted therapies.
• PDS01-ADC (antibody drug conjugate for solid tumors): Published promising Phase 1 data from a Phase 2 trial for PDS01-ADC in colorectal cancer with liver metastasis in the Journal of Clinical Oncology Oncology Advances. Early encouraging results from an NCI-led trial of PDS01-ADC plus docetaxel in third-line metastatic castration-resistant prostate cancer were presented at an industry conference. These results confirm the candidate's potential to enhance existing therapy efficacy across multiple solid tumor types, and it remains a core pipeline priority.

Intellectual Property Updates

• New patents for PDS0101 were granted in the U.S. and Japan. The new U.S. patent, combined with expected biologics exclusivity, extends market protection for PDS0101 into the 2040s. The Japanese patent adds broad composition of matter protection to existing intellectual property across major global markets.

Financial Performance

• Operating expenses decreased year-over-year due to lower clinical, manufacturing, and professional fees, leading to a smaller net loss than Q1 2025.

Management did not issue explicit formal revenue or earnings guidance. Key forward-looking milestones stated on the call:

• The Versatile 003 trial will resume enrollment imminently after protocol amendment finalization, with all trial sites retained during the pause.
• Additional data for the fully-enrolled Phase 2 colorectal cancer cohort of the PDS01-ADC trial is expected by the end of 2026.
• CMC validation activities for PDS0101 will progress in parallel with Phase 3 trial completion, in preparation for a future BLA filing.

PDS Biotech is a clinical-stage biotechnology company with no approved commercial products as of Q1 2026, so it does not report segmented product revenue. All financial results reflect overall corporate operating performance: net loss of $7.3 million (13 cents per basic/diluted share) for Q1 2026, compared to a net loss of $8.5 million (21 cents per share) in Q1 2025. R&D expenses were $3.5 million in Q1 2026 vs $5.8 million in Q1 2025; G&A expenses were $3.1 million in Q1 2026 vs $3.3 million in Q1 2025; total operating expenses were $6.5 million in Q1 2026 vs $9.1 million in Q1 2025; net interest expense was $0.8 million in Q1 2026 vs $0.6 million in Q1 2025. Cash balance as of March 31, 2026 was $21.7 million.

Management noted that all forward-looking statements are subject to inherent risks and uncertainties that could cause actual results to differ materially from expectations, as detailed in the company's SEC filings (Form 10-K, Form 10-Q) and press release disclosures. No additional specific operational or financial risks were discussed on the call beyond the general standard caution for clinical-stage biotech development.

Q: What is the status of Versatile 003 trial enrollment resumption, and is there a plan to add subcutaneous Keytruda as a combination partner? / A: All trial sites remained active during the protocol amendment pause, and enrollment will restart imminently now that the FDA has aligned on the revised design. Adding subcutaneous Keytruda as a future combination partner for a fully subcutaneous regimen remains an open possibility, but it is not a current trial priority; the ongoing trial uses standard intravenous Keytruda as planned.

Q: What is the competitive landscape for HPV16 positive head and neck cancer, and when is the next PDS01-ADC colorectal cancer data update expected? / A: PDS Biotech and BioNTech are the only two developers with late-stage trials in this indication, which remains largely under-served. The Phase 2 colorectal cancer cohort of the PDS01-ADC trial is fully enrolled, and additional data for the full patient population is expected by the end of 2026.

Q: What are the specific benefits of the Versatile 003 trial amendment, and what is the expected financial impact? / A: The amendment added PFS as an interim primary endpoint after trial data showed median overall survival had extended to nearly 40 months, which would have delayed the original trial completion. The change enables a path to accelerated approval. Financially, the shorter timeline and revised 1:1 randomization (reducing total patient enrollment from ~350 to ~250) will lower both external clinical costs and internal operating expenses.

Q: What are PDS Biotech's manufacturing plans for PDS0101 heading toward potential commercialization? / A: The PDS0101 manufacturing process is already fixed, established, and has undergone initial scale-up. Remaining activities include CMC process validation batches to support BLA filing. No major unaddressed manufacturing barriers exist for late-stage development and eventual commercial launch.