PDS Biotechnology Corporation Q3 FY2025 earnings call

• Frank Bedu-Addo discussed the advancement of PDS0101 in treating HPV and HPV16 positive head and neck cancer. The VERSATILE-002 trial showed a median overall survival of 39.3 months and progression-free survival of 10.3 months. The company amended the VERSATILE-003 trial protocol to include progression-free survival as a surrogate primary endpoint to potentially shorten trial duration. - The National Cancer Institute presented clinical data on PDS Biotechnology's immunotherapy platforms at the Society for Immunotherapy of Cancer annual meeting. - The colorectal cancer cohort of the PDS0101 ADC phase two trial expanded following positive stage one results. - Lars Boesgaard reviewed financial results and noted the company completed the sale of $5.8 million of common stock and warrants for gross proceeds of approximately $5.3 million.

PDS Biotechnology Corporation reported a net loss of $9 million for the three months ended September 30, 2025, compared to $10.7 million in the prior year quarter. Research and development expenses were $4.6 million for the period, down from $6.8 million in the prior year, primarily due to lower manufacturing, clinical, and personnel costs. General and administrative expenses were $3.6 million, up from $3.4 million, mainly due to higher professional fees offset by lower personnel costs. Net interest expense was $900,000, up from $500,000, driven by lower interest income from cash deposits. Cash balance as of September 30, 2025, was $26.2 million.

• PDS Biotechnology requested a meeting with the FDA to amend the VERSATILE-003 trial protocol to include progression-free survival as a surrogate primary endpoint while maintaining median overall survival as the primary endpoint for full FDA approval. - The company believes amending the protocol may shorten the time to regulatory submission and accelerate the availability of PDS0101 to HPV16 positive patients in need.

• Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from the statements. - Risks are detailed in the company's press releases and SEC filings, including those in Form 10-Q and 10-K reports.

Q: On the VERSATILE-003 protocol pause, how will enrolled patients be handled and what about the new sample size?

A: Enrolled patients will continue to be treated. Discussions with the FDA are ongoing, and the new sample size has not been publicly disclosed yet.

Q: What is the expected progression-free survival (PFS) under control (Keytruda)?

A: Conservatively assuming around a 3-month range, as seen in relevant studies like KEYNOTE-048 and LEAP-10.

Q: Thoughts on the broader landscape in HPV positive head and neck cancer?

A: Most drugs in head and neck cancer target HPV negative, but HPV positive is becoming a growing medical problem, and PDS is focused on HPV16 positive which is dominant in oropharyngeal cancer.

Q: Did patients in the VERSATILE-002 trial with long-term survival receive additional therapeutic interventions?

A: Patients are checkpoint inhibitor resistant, and median overall survival post-checkpoint inhibitor is 3-4 months, likely any effects seen are from PDS0101.

Q: How is training on PFS for the VERSATILE-003 trial being handled?

A: Investigators are trained, with central review by experts, and patients will be followed for safety, differing from VERSATILE-002 where some patients weren't followed after response.