PDS Biotechnology Corporation Q1 FY2025 earnings call

Frank Bedu-Addo started by discussing the initiation of the VERSATILE 003 Phase 3 clinical trial for Versamune HPV plus pembrolizumab in treating HPV16-positive head and neck cancer. New sites, including Mayo Clinic, were added to the trial. Data from the VERSATILE 002 Phase 2 study was presented at ESMO and will be at ASCO. PDS Biotech announced FDA clearance of the IND application for the combination of Versamune MUC1 and PDS01ADC for metastatic colorectal cancer, with collaboration with the NCI. Lars Boesgaard reviewed financial results: net loss of $8.5 million in Q1 2025 compared to $10.6 million in Q1 2024, due to lower operating expenses and increased tax benefit. R&D expenses were $5.8 million, down from $6.7 million, and G&A expenses were $3.3 million, down from $3.4 million. Cash balance was $40 million as of March 31, 2025. The company secured $11 million from a securities purchase agreement and refinanced debt.

Forward-looking statements are subject to various risks and uncertainties that could cause actual results to differ materially from these statements, as outlined in SEC filings including Form 10-Q and 10-K.

Q: Comment on how Keytruda head and neck neoadjuvant data impacts enrollment expectations of VERSATILE 003 and HPV-positive tumor set response rates.

A: Kirk Shepard stated Keynote 689 was mainly for HPV-negative patients as most HPV-positive patients aren't eligible for surgery, so negligible impact on HPV16-positive population. Frank Bedu-Addo added it may speed up HPV16 population becoming predominant.

Q: Nuanced questions on lead programs, including MUC1 program differentiation.

A: Frank Bedu-Addo explained MUC1 program uses novel agonist epitopes designed by NCI, combined with Versamune technology and IL-12 conjugate, part of collaboration with NCI in a Phase 1/2 trial.

Q: Enrollment status of VERSATILE 003 and OpEx guidance.

A: Frank Bedu-Addo said enrollment is ongoing with sites taking time to activate; Lars Boesgaard mentioned trial spend expected to be relatively stable going forward.