PDS Biotechnology Corporation Q4 FY2025 earnings call

Dr. Frank Badu-Addo noted the fourth quarter of 2025 was a period of important progress for PDS Biotech with advances across clinical programs, financial discipline, and expansion of intellectual property portfolio. Built on Bursetel 002 Phase II trial data, the Versatile 003 protocol amendment has potential for a more efficient path to accelerated approval. PDS-0101 is a promising treatment option for HPV16-positive head and neck cancer. Early results from an NCI-led trial with PDS-01-ADC in metastatic castration-resistant prostate cancer showed encouraging progression-free survival and PSA declines. Strengthened intellectual property estate for PDS01-01 with new patents. Dr. Kirk Shepard discussed the Versatile 002 trial data leading to the protocol amendment for Versatile 003, explaining how PFS can be an interim primary endpoint for faster readout. Lars Bosgaard reviewed financial results: net loss for 2025 was approximately $34.5 million vs ~$37.6 million in 2024; R&D expenses $19 million vs $22.6 million; G&A expenses $12.5 million vs $13.8 million; net interest expense $4.1 million vs $2.2 million; cash balance as of December 31, 2025 was $26.7 million

Q: Now that you have the amended protocol cleared, could you share what the revised enrollment target is going to look like and how that reduction compares to the original design?

A: Kirk answered about the revised protocol, shortened trial duration, PFS as interim analysis, and smaller N for the trial.

Q: Now with this amended protocol, how should we expect R&D to be for 2026? Do you expect that to be a little bit lower than 2025 now with the smaller trial design?

A: Lars said they aren't providing financial guidance per se, but once trial reinitiated, cost will pick up according to sites opened and patient enrollment.

Q: Could you touch on your plans to handle patients already enrolled prior to the pause as part of your interim analysis and wonder if you remain blinded to those some of patients I assume they're continuing to dose on active drug and placebo? And then follow-up on enrollment pace from here and sample size?

A: Kirk said patients already enrolled will continue treatment, will be in a special subset for safety in intent to treat data; enrollment pace is good with positive response from sites, no competitive trial now enrolling, and PFS powered at high power for interim analysis