PDS Biotechnology Corporation reports developments in targeted cancer immunotherapies based on its Versamune platform. Company news centers on PDS0101, also called Versamune HPV, in HPV16-positive head and neck cancer, and on PDS01ADC, an IL-12 fused antibody drug conjugate and tumor-targeted immunocytokine evaluated across multiple solid tumor indications.
Recurring updates include clinical-trial data, National Cancer Institute-led study presentations, FDA and IND protocol communications, scientific publications, patent coverage for core technology, quarterly financial results, and broader corporate-program updates.
PDS Biotech (Nasdaq: PDSB) will host a conference call and webcast to report third quarter 2025 financial results and provide a clinical programs update on Thursday, November 13, 2025 at 8:00 a.m. Eastern Time.
Dial-in numbers are 1-877-704-4453 (domestic) and 1-201-389-0920 (international). Webcast and Call Me™ registration links are provided; the live webcast will be archived on PDS Biotech’s website for six months after the event.
PDS Biotechnology (Nasdaq: PDSB) announced that the National Cancer Institute will present three abstracts at the 2025 Society for Immunotherapy of Cancer (SITC) Annual Meeting on Nov 7–8, 2025. The presentations report clinical and translational findings for the company’s platforms, including the tumor-targeting IL-12 fused ADC PDS01ADC and HPV-targeted immunotherapy PDS0101. One abstract is a rapid oral session on early serum proteomic changes predicting anti-tumor activity; two posters report increases in peripheral NK cells and memory T cells after IL-12 immunocytokine therapy.
PDS Biotech (Nasdaq: PDSB) requested an FDA meeting on Oct 29, 2025 to pursue an expedited approval pathway for PDS0101 in HPV16-positive head and neck cancer after final VERSATILE-002 results.
Key data: median progression-free survival (mPFS) 6.3 months and median overall survival (mOS) 39.3 months. The company proposed amending the VERSATILE-003 Phase 3 protocol to add PFS as an earlier primary endpoint, reduce enrolled patient numbers while maintaining statistical power, and enable a potential accelerated approval if PFS is met. While the amendment is under FDA review, enrollment in VERSATILE-003 is temporarily paused but treatment for enrolled patients will continue.
PDS Biotech (Nasdaq: PDSB) announced breakthrough results from its VERSATILE-002 Phase 2 clinical trial, showing exceptional survival outcomes for head and neck cancer patients with low PD-L1 expression. The combination of PDS0101 with Keytruda® achieved a remarkable median overall survival (mOS) of 29.5 months in patients with CPS 1-19, significantly outperforming current standards of care.
The results are particularly significant as they demonstrate nearly triple the survival time compared to Keytruda® alone (10.8 months) or Keytruda® plus chemotherapy (12.3 months) in this difficult-to-treat patient population. Approximately 60% of enrolled patients (n=53) had low PD-L1 expression, with 32 patients in the CPS 1-19 cohort showing these remarkable results.
PDS Biotechnology (NASDAQ: PDSB), a late-stage immunotherapy company focused on cancer treatment, announced its participation in the upcoming H.C. Wainwright 27th Annual Global Investment Conference. The event will be held both in-person in New York and virtually from September 8-10, 2025.
CEO Frank Bedu-Addo and CFO Lars Boesgaard will be available for one-on-one meetings with investors during the conference. Interested investors should coordinate through their H.C. Wainwright representatives to schedule meetings.
PDS Biotechnology (Nasdaq: PDSB) has announced final topline survival data from its VERSATILE-002 Phase 2 clinical trial evaluating PDS0101 + Keytruda® in HPV16-positive first-line recurrent/metastatic head and neck cancer patients. The study demonstrated a remarkable median overall survival (mOS) of 39.3 months in patients with CPS ≥ 1, significantly outperforming the best published standard of care result of 17.9 months.
The trial enrolled 53 patients and showed durable patient survival promoted by high levels of long-lasting HPV16-specific CD8+ T cells. The treatment combination was well-tolerated with no patients discontinuing due to treatment-related adverse events. The company plans to publish the full dataset later this year, while its VERSATILE-003 Phase 3 trial is currently in progress.
PDS Biotech (NASDAQ: PDSB) reported its Q2 2025 financial results and provided clinical updates. The company reported a net loss of $9.4 million ($0.21 per share), compared to $8.3 million in Q2 2024. Key highlights include positive progress in the VERSATILE-003 Phase 3 trial evaluating PDS0101 for HPV16-positive head and neck cancer.
The company's colorectal cancer cohort in their Phase 2 trial met expansion criteria with promising response rates of ≥6 of 9 confirmed objective responses. Research and development expenses decreased to $4.2 million from $4.5 million year-over-year. The company's cash position stood at $31.9 million as of June 30, 2025, down from $41.7 million at the end of 2024.
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company specializing in cancer treatment, has scheduled its second quarter 2025 financial results conference call and webcast for August 13, 2025, at 8:00 AM ET.
During the call, management will discuss Q2 2025 financial performance and provide updates on the company's clinical programs. Investors can join via phone using domestic (1-877-704-4453) or international (1-201-389-0920) dial-in numbers, or through the webcast available on PDS Biotech's website.
PDS Biotechnology (NASDAQ:PDSB) announced successful completion of Stage 1 in their Phase 2 clinical trial for PDS01ADC in metastatic colorectal cancer patients. The trial, conducted in collaboration with the National Cancer Institute (NCI), met the pre-set RECIST v1.1 criteria for expansion into Stage 2, achieving at least 6 objective responses among 9 participants.
The study combines PDS01ADC with floxuridine (FUDR) administered via hepatic artery infusion pump. The trial includes three cohorts: metastatic colorectal cancer, cholangiocarcinoma, and adrenocortical cancer. Following this milestone, the colorectal cancer cohort will expand enrollment to 22 participants, with completion expected by Q4 2025.
PDS01ADC is a novel antibody drug conjugate targeting exposed DNA in tumor necrosis regions, designed to deliver IL-12 with minimal systemic exposure and reduced toxicity.