Pds Biotechnology (PDSB) Stock News

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.

PDS Biotech (PDSB) reported its Q1 2025 financial results and provided clinical updates. The company has initiated the VERSATILE-003 Phase 3 trial for Versamune® HPV in HPV16-positive head and neck cancer, with Mayo Clinic sites recently added. The trial will include approximately 350 patients and received FDA Fast Track designation. Financial highlights include a net loss of $8.5 million ($0.21 per share), improved from $10.6 million in Q1 2024. R&D expenses decreased to $5.8 million from $6.7 million, while G&A expenses were $3.3 million. The company's cash balance stood at $40 million as of March 31, 2025. PDS Biotech also completed a registered direct offering raising approximately $11 million, with potential for additional $11 million from warrant exercises.