PDS Biotechnology Corporation (PDSB) Earnings Call Transcripts

PDS Biotechnology Corporation's Latest Earnings Call - Q4 FY2025

PDS Biotechnology Corporation reported a net loss of approximately $34.5 million for the fiscal year ended December 31, 2025, an improvement from a net loss of $37.6 million in the previous year. The company highlighted significant progress in its clinical programs, particularly the amendment to the VERSATILE-003 trial protocol, which is expected to shorten the trial duration and potentially accelerate regulatory approval. Management remains optimistic about the prospects for PDS0101 in treating HPV16-positive head and neck cancer, given the growing unmet need in this area.

Reported metrics

Guidance from management

Management did not provide specific financial guidance for 2026 but indicated that R&D costs are expected to rise as the trial resumes and patient enrollment picks up.

What management said

Yes, certainly. With the revised protocol, and also the increased median survival and robustness of the PFS in 002, we had a meeting with the FDA, which was a very good dialogue. And at that, we were able to shorten the trial to as much as a year as far as getting the final results. And of course, the PFS will be the interim analysis that will first be available most likely in a period of about 1.5 years. That will a...

Yes. So I think as far as the R&D expenses, we're not providing financial guidance per se. However, of course, once we reinitiate the trial, we do expect cost to pick up. The pickup will be commensurate with the amount of sites that we opened and patient enrollment and so forth. So it's tricky to forecast right now.

What analysts pressed on

Analysts expressed concerns regarding the revised enrollment targets for the VERSATILE-003 trial and the impact of the protocol amendment on trial duration and costs. There were also inquiries about the handling of patients already enrolled prior to the trial pause and the implications for data integrity.

Main topics on the call

• Clinical Trial Amendments — PDS Biotech amended the VERSATILE-003 trial to prioritize progression-free survival (PFS) as a primary endpoint, aiming for accelerated approval. Dr. Bedu-Addo stated, "the protocol amendment we've adopted has the potent...
• PDS0101 Development Progress — The company emphasized the promising results of PDS0101 in HPV16-positive head and neck cancer, with median overall survival reported at 39.3 months. Dr. Shepard noted, "the VERSATILE-002 trial is the first of patients i...
• Financial Performance — PDS Biotech's total operating expenses decreased to $31.5 million in 2025 from $36.3 million in 2024, reflecting improved financial discipline. CFO Lars Boesgaard mentioned, "Research and development expenses for the yea...
• Intellectual Property Expansion — The company secured new patents for PDS0101 in the U.S. and Japan, extending market protection into the 2040s. This strengthens PDS Biotech's competitive position in the market for HPV16-targeted therapies.

Read the full PDS Biotechnology Corporation transcript (Q4 FY2025) → Summary generated from the call transcript; every figure above is stated by management on the record.

Earnings Call History

EarningsCalls.dev has 45 PDS Biotechnology Corporation earnings call transcripts on record, spanning June 9, 2020 to October 15, 2026. Based on this history, PDS Biotechnology Corporation reports quarterly. The most recent call on file is dated October 15, 2026. The full list is below — each row opens the complete, free-to-read transcript.

Ticker

PDSB

Exchange

NasdaqCM

Country

US

Sector

Health Care

Industry

Biotechnology

Calls on record

45

First call

June 9, 2020

Most recent

October 15, 2026

Reporting cadence

quarterly