November 13, 2025 — Leads & Copy — PDS Biotechnology Corporation (Nasdaq: PDSB) has announced the completion of its VERSATILE-002 Phase 2 trial, which studied PDS0101 in combination with pembrolizumab for patients with HPV16-positive recurrent or metastatic head and neck cancer. The company is seeking an expedited approval pathway based on the Phase 2 results in the ongoing VERSATILE-003 Phase 3 trial design.
According to a press release, the company will hold a conference call and webcast today at 8:00 a.m. Eastern Time to discuss the results.
The VERSATILE-002 Phase 2 clinical trial evaluated PDS0101 combined with Keytruda (pembrolizumab) in patients with HPV16+ head and neck squamous cell carcinoma (HNSCC). Results included a median overall survival (mOS) of 39.3 months in patients with CPS ≥ 1, with a lower limit of the 95% confidence interval at 23.9 months and an upper limit that is not yet estimable. The progression-free survival was 6.3 months in patients with CPS ≥ 1.
Based on these findings, PDS Biotech plans to pursue an accelerated approval pathway in the VERSATILE-003 Phase 3 randomized trial, which is studying PDS0101 in combination with pembrolizumab versus pembrolizumab monotherapy.
The increased mOS suggests the potential for fewer death events in a specified time, which would likely result in an extended trial duration. This increase is the basis for a proposed amendment to the statistical analysis plan based on the earlier mOS, which could reduce trial size while maintaining statistical power.
The proposed amendment would change the PFS endpoint to become a surrogate primary endpoint that can be evaluated earlier with high statistical power. The mOS will remain the primary endpoint for full approval, as originally recommended by the FDA.
The National Cancer Institute (NCI) presented new clinical data at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting. Three abstracts highlighted emerging clinical and translational findings from PDS Biotechnology’s novel investigational immunotherapy platforms, including the tumor-targeting IL-12 fused antibody drug conjugate (PDS01ADC) and PDS0101, the Company’s lead Phase 3 clinical stage HPV-targeted immunotherapy.
Preliminary results from the colorectal cancer cohort of a Phase 2 clinical trial with PDS01ADC were also announced, meeting criteria for expansion to Stage 2 following positive Stage 1 results. The metastatic colorectal cancer cohort in the NCI-led study met the high objective response rate bar for continuation of the study, with at least 6 of 9 confirmed objective responses by RECIST v1.1, triggering enrollment expansion under the Simon Two-Stage study design.
For the third quarter of 2025, PDS Biotech reported a net loss of $9.0 million, or $0.19 per basic and diluted share, compared to a net loss of $10.7 million, or $0.29 per basic and diluted share, for the same period in 2024. Research and development expenses were $4.6 million, down from $6.8 million in the previous year. General and administrative expenses were $3.6 million, compared to $3.4 million in the prior year. As of September 30, 2025, the Company’s cash balance was $26.2 million, compared to $41.7 million as of December 31, 2024.
On November 12, the Company sold 5,800,000 of its common stock (or prefunded warrants in lieu thereof), as well as 5,800,000 accompanying warrants, for gross proceeds of approximately $5.3 million.
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. Its lead investigational targeted immunotherapy PDS0101 (Versamune® HPV) is being developed in combination with a standard-of-care immune checkpoint inhibitor, and in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.
Conference Call Details:
Date: November 13, 2025
Time: 8:00 a.m. Eastern Time
Dial-in: 1-877-704-4453 (Domestic) or 1-201-389-0920 (International)
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
Media Contact:
David Schull
Russo Partners
Phone +1 (858) 717-2310
Email: david.schull@russopartnersllc.com
Source: PDS Biotechnology
