PDS Biotechnology Corporation Q2 FY2025 earnings call

• Clinical Programs: Advancing VERSATILE-003 Phase III trial for HPV16-positive head and neck cancer; VERSATILE-002 Phase II results showed durable clinical benefit with median overall survival at 30 months; MC-200710 study investigated PDS0101 alone or with pembrolizumab as neoadjuvant treatment; Colorectal cancer cohort of Phase II trial expanded to Stage 2; Preclinical efficacy and immune response data on universal flu vaccine presented at conferences.
• Financials: Lars Boesgaard reviewed Q2 2025 financial results, noting changes in net loss, R&D, G&A, and cash balance.

For the quarter ended June 30, 2025, PDS Biotech reported a net loss of approximately $9.4 million or $0.21 per basic and diluted share. This compared to a net loss of $8.3 million or $0.23 per share for the same period in 2024. Research and development expenses were $4.2 million for Q2 2025, down from $4.5 million in Q2 2024. General and administrative expenses were $3.4 million in Q2 2025, down from $4.2 million in Q2 2024. Net interest expenses were $1.8 million in Q2 2025, up from $0.5 million in Q2 2024. Cash balance as of June 30, 2025, was $31.9 million, compared to $41.7 million as of December 31, 2024.

• VERSATILE-002 trial final data readout expected to be presented or published before end of 2025 or early 2026 pending peer-review.
• Colorectal cancer cohort of Phase II trial anticipated to complete patient recruitment by Q4 2025.

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

Q: Regarding the VERSATILE-002 ASCO data presented, what's the plan for follow-up and when might final results be reported, and how is data dissemination helping drive enrollment in 003?

A: The VERSATILE-002 trial is still in progress; final data readout anticipated by end of 2025 or early 2026. Tolerability, ease of administration, and promising median overall survival are key benefits driving enrollment. Kirk Shepard added on competition, noting fewer competing trials now compared to a year ago, and importance of Mayo Clinic neoadjuvant trial.