Pds Biotechnology Corporation Stock Price, News & Analysis

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.

PDS Biotechnology (PDSB) announced a virtual Key Opinion Leader event scheduled for June 17, 2025, focusing on HPV16-positive head and neck squamous cell carcinoma (HNSCC). The event will feature experts Dr. Kevin Harrington and Dr. Katharine Price discussing the unmet needs and treatment landscape for recurrent/metastatic HPV16+ HNSCC. The webinar will examine HNSCC in relation to Merck's KEYNOTE-689 study and address the increasing cases of HPV16+ HNSCC in the US and Europe. A key focus will be Versamune® HPV, PDS Biotech's investigational immunotherapy currently in Phase 3 trials in combination with pembrolizumab for first-line treatment of R/M HPV16+ HNSCC, as well as in Phase 2 trials for various HPV16-positive cancers. The event will explore the differences between HPV-positive and HPV-negative HNSCC as distinct diseases.

PDS Biotech (PDSB) presented updated data from the VERSATILE-002 trial evaluating Versamune HPV (PDS0101) for head and neck cancers at ASCO 2025. The trial showed durable median overall survival of 30.0 months in first-line recurrent/metastatic HPV16-positive HNSCC patients, with a 95% CI lower limit of 23.9 months. The study demonstrated an objective response rate of 35.8% and disease control rate of 77.4% across all patients (CPS ≥ 1). Notably, patients with CPS ≥ 20 showed improved outcomes with 39.3 months median overall survival and 47.6% objective response rate. The results are particularly significant as HPV16-positive HNSCC represents over 50% of HNSCC cases in the US and has shown worse survival outcomes compared to other HNSCC types. VERSATILE-003, the company's ongoing Phase 3 trial, is the only registrational study specifically targeting HPV16-positive HNSCC patients.

PDS Biotech (NASDAQ: PDSB) announced significant extended follow-up data from its VERSATILE-002 trial and additional studies of Versamune® HPV to be presented at ASCO 2025. The VERSATILE-002 trial showed remarkable survival rates in HPV16-positive head and neck cancer patients: 39.3 months median overall survival for CPS ≥20 patients (vs ~15 months with pembrolizumab alone) and 30.0 months for CPS ≥1 patients (vs ~12 months with pembrolizumab). The ongoing Phase 3 VERSATILE-003 trial will enroll 351 patients to evaluate Versamune® HPV with pembrolizumab as first-line treatment. Additionally, a Phase 2 trial showed promising results with 70% stable disease rate using Versamune® HPV alone and 100% stable disease or partial response when combined with pembrolizumab in newly diagnosed patients.

PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company specializing in cancer treatment, announced its participation in the A.G.P. Virtual Annual Healthcare Company Showcase on May 21, 2025. CEO Frank Bedu-Addo will engage in a fireside chat from 5:20 to 5:40 p.m. ET. The virtual event will provide opportunities for one-on-one investor meetings with the PDS Biotech leadership team. A replay and transcript of the fireside chat will be available on the company's website after the event.