Welcome to our dedicated page for Pds Biotechnology Corporation news (Ticker: PDSB), a resource for investors and traders seeking the latest updates and insights on Pds Biotechnology Corporation stock.
Overview
PDS Biotechnology Corporation (symbol: PDSB) is a clinical-stage biopharmaceutical company dedicated to developing advanced immunotherapies for treatment of various cancers and infectious diseases. Utilizing a state-of-the-art proprietary platform, Versamune, the Company focuses on creating simpler, safer, and more effective therapeutic interventions that harness the power of the immune system. With its cutting-edge approach involving synthetic, biodegradable lipids that form specialized nanoparticles, PDS Biotechnology is transforming traditional treatment paradigms in immuno-oncology and vaccine development.
Proprietary Technology and Core Platform
The foundation of the Company\s innovative approach is the Versamune platform. This technology is based on uniquely engineered lipid nanoparticles that are designed with a precise structure and positive charge. These characteristics allow the nanoparticles to efficiently activate and be taken up by the immune system. When formulated with a specific antigen – whether a protein uniquely expressed in cancerous cells or a viral protein associated with an infectious agent – the platform stimulates a targeted immune response. This mechanism not only differentiates PDS Biotechnology from traditional therapies but also paves the way for a more personalized form of immunotherapy.
Clinical Development and Product Pipeline
The Company is engaged in extensive clinical research across multiple disease areas. Key initiatives include:
- Targeted Immunotherapy for Cancer: PDS Biotechnology has developed investigational products that are designed to trigger a focused T-cell response against cancer cells. Their lead candidate, formulated using the Versamune platform, is being evaluated in clinical trials for various cancers, including head and neck squamous cell carcinoma, cervical cancer, and other HPV16-positive malignancies.
- Combination Approaches: Recognizing the complexity of tumor biology, the Company is exploring combined regimens. These include pairing their Versamune-based immunotherapy with standard-of-care immune checkpoint inhibitors and innovative antibody-drug conjugates (ADCs). Such combinations aim to create a powerful dual mechanism that disrupts cancer defenses from multiple angles.
- Infectious Disease Vaccines: Beyond oncology, PDS Biotechnology is also leveraging its platform to develop novel vaccines against infectious diseases. The tailored delivery of antigens using Versamune technology offers a promising strategy for inducing robust immune protection.
This diverse pipeline demonstrates the Company\s commitment to transforming the clinical landscape by addressing unmet medical needs across several therapeutic areas.
Strategic Clinical Trial Design and Regulatory Approach
PDS Biotechnology employs a rigorous clinical trial strategy to validate the safety, tolerability, and efficacy of its innovative therapies. The design of its clinical programs is informed by a clear scientific rationale and statistical robustness, ensuring the collection of meaningful data on patient survival, disease control, and immune response. Each clinical trial is structured with a focus on evidence-based outcomes, reflecting the Company\s experience in navigating complex regulatory frameworks.
Market Position and Competitive Landscape
Positioned within the competitive sphere of immuno-oncology, PDS Biotechnology distinguishes itself through its proprietary Versamune technology and the strategic integration of combination therapy approaches. The Company is recognized for its commitment to precision medicine; by targeting specific antigens such as those found in HPV16-positive cancers, its treatments are tailored to individual tumor profiles. This focused strategy, combined with ongoing collaboration with clinical research organizations, underpins the Company\s reputation as an innovator in the field of targeted cancer therapy.
Scientific and Clinical Expertise
The depth of expertise at PDS Biotechnology is reflected in its scientific research and clinical trial execution. The Company partners with leading oncologists, research institutions, and regulatory bodies to ensure that its development programs are grounded in cutting-edge science and clinical rigor. This multidisciplinary approach facilitates the optimization of treatment protocols and supports the advancement of its therapeutic candidates through complex clinical pathways.
Operational Excellence and Future-readiness
While maintaining a focus on current clinical programs, the Company continues to enhance its operational capabilities to deliver on its mission of transforming cancer treatment. Its strategic planning and adaptive clinical trial designs enable a robust evaluation of investigational therapies, ensuring that key scientific insights are rapidly incorporated into development programs. PDS Biotechnology\s use of innovative diagnostic companion tools further supports the effective identification and treatment of patients who are most likely to benefit from their therapies.
Conclusion
PDS Biotechnology Corporation is at the forefront of immunotherapy innovation. Its integrated approach—combining a proprietary nanoparticle technology with strategic clinical trial design—establishes a unique value proposition in the field of biopharmaceutical development. Through its focus on targeted immunotherapy and infectious disease vaccines, the Company is reshaping treatment paradigms. With a strong commitment to scientific excellence, clinical rigor, and operational precision, PDS Biotechnology continues to provide comprehensive, evidence-based information for investors and stakeholders seeking to understand its position within the dynamic landscape of modern medicine.
PDS Biotech (PDSB) has reported its full year 2024 financial results and provided clinical program updates. The company has initiated the VERSATILE-003 Phase 3 clinical trial evaluating Versamune® HPV in HPV16-positive head and neck cancer, designed to include approximately 350 patients. The trial received FDA Fast Track designation.
Financial highlights for 2024 include a net loss of $37.6 million ($1.03 per share), compared to $42.9 million in 2023. Research and development expenses decreased to $22.6 million from $27.8 million, while general and administrative expenses reduced to $13.8 million from $15.3 million. The company's cash balance as of December 31, 2024, stood at $41.7 million.
In March 2025, PDS Biotech received FDA clearance for its IND application combining Versamune® MUC1 and PDS01ADC to treat MUC1-positive metastatic colorectal carcinoma. The company also secured up to $22 million through a registered direct offering in February 2025.
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company specializing in cancer treatment, has announced an updated presentation schedule at the 2025 CAGLA NeauxCancer Conference in New Orleans. Dr. Frank Bedu-Addo, President and CEO, will deliver a scientific presentation in the Innovation Track on Friday, March 28, 2025, at 11:00 AM CT (rescheduled from 4 PM CT) at The Roosevelt Hotel.
The conference, organized by the Cancer Advocacy Group of Louisiana (CAGLA), will run from March 28-29, 2025. Virtual attendance options are available through livestream, with special registration provisions for investors through the provided Cvent registration link.
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company specializing in cancer treatment, has scheduled its full year 2024 financial results conference call and webcast for March 27, 2025, at 8:00 AM ET. The presentation will include both financial performance review and clinical programs updates.
Investors can access the call through domestic (1-877-704-4453) or international (1-201-389-0920) dial-in numbers. A webcast option is also available, and the presentation will be archived on the company's website for six months following the live event.
PDS Biotechnology (PDSB) has received FDA clearance for its IND application to evaluate the combination of Versamune® MUC1 and PDS01ADC in treating metastatic colorectal cancer (mCRC). The Phase 1/2 trial will be conducted under a Cooperative Research and Development Agreement with the National Cancer Institute.
The treatment targets MUC1-positive tumors in Proficient Mismatch Repair/Microsatellite Stable mCRC, which represents 95% of mCRC patients. These tumors typically show resistance to current immunotherapies and second-line chemotherapy. The company recently received U.S. Patent #12,201,685 for methods using combinations of the Versamune® platform and various immunocytokines.
While this marks progress for the Versamune® platform's expansion beyond HPV-related cancers, PDS Biotech maintains its primary focus on the ongoing VERSATILE-003 Phase 3 clinical trial in HPV16-positive head and neck squamous cell carcinoma.
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company specializing in cancer treatment, has announced two significant upcoming presentations by CEO Frank Bedu-Addo, PhD.
The presentations are scheduled for:
- Zacks SCR Life Sciences Virtual Investor Forum on March 13, 2025, at 2:30 PM ET, featuring an investor presentation
- 2025 CAGLA NeauxCancer Conference in New Orleans at The Roosevelt Hotel, scheduled for March 28, 2025, at 4:00 PM ET, where a scientific presentation will be delivered as part of the Innovation Track
Both events offer virtual attendance options through their respective registration platforms, providing accessibility to investors and stakeholders interested in PDS Biotech's developments in cancer immunotherapy.
PDS Biotech (PDSB) has initiated VERSATILE-003, a groundbreaking Phase 3 clinical trial evaluating Versamune® HPV in combination with pembrolizumab for HPV16-positive head and neck cancer treatment. This global, multi-center study represents the first-ever Phase 3 trial for this specific cancer type.
The trial will enroll approximately 350 patients in a 2:1 ratio, comparing the combination therapy against pembrolizumab alone as a first-line treatment for recurrent/metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). The study's primary endpoint is overall survival, with secondary endpoints including objective response rate and progression-free survival.
Following promising results from the VERSATILE-002 Phase 2 trial, Versamune® HPV received Fast Track designation from the FDA, making it eligible for Priority Review upon Biologics License Application submission. Dr. Katharine Price from Mayo Clinic Comprehensive Cancer Center will serve as the Principal Investigator.
PDS Biotechnology (PDSB), a late-stage immunotherapy company, has announced a registered direct offering priced at-the-market under Nasdaq rules. The offering includes 7,330,121 shares of common stock and warrants at a combined purchase price of $1.50 for institutional investors and $1.66 for company directors.
The deal structure includes $11 million in immediate funding upon closing, expected around February 28, 2025, with potential for an additional $11 million through warrant exercises. The warrants, exercisable at $1.50 per share, will be immediately available upon issuance with a 5-year expiration term.
The offering, managed by A.G.P./Alliance Global Partners as sole placement agent, will provide funds for research and development expenses and general corporate purposes. Both new and existing healthcare-focused institutional investors, along with company directors, are participating in this capital raise.
PDS Biotech (PDSB) has published promising clinical results in JAMA Oncology for its triple combination therapy treating recurrent/metastatic HPV-associated cancers. The therapy combines Versamune® HPV, PDS01ADC, and a PD-L1 immune checkpoint inhibitor.
Key findings include:
- 42.4 months median Overall Survival in checkpoint inhibitor naïve patients (vs. 7-12 months historical)
- 75% confirmed objective response rate in HPV16-positive checkpoint inhibitor naïve patients (vs. 11-24% historical)
- 17 months median survival in HPV16-positive checkpoint inhibitor resistant patients (vs. 3-4 months historical)
The trial included 50 patients with various HPV-associated cancers. Grade 3 and 4 treatment-related adverse events occurred in 52% of patients, with no treatment-related deaths. The company plans to begin VERSATILE-003 Phase 3 trial of Versamune® HPV + pembrolizumab in HPV16-positive head and neck cancer.
PDS Biotech (NASDAQ: PDSB) has published promising results for its Versamune® HPV immunotherapy in Clinical Cancer Research. The study showed that combining Versamune® HPV with chemoradiation therapy (CRT) led to superior clearance of HPV16-positive cancer cells from patients' bloodstream compared to CRT alone.
Key findings include:
- 100% of patients receiving Versamune® HPV + CRT showed no detectable HPV16 ctDNA at 3-4 months vs. 50% for CRT alone
- Patients with undetectable HPV ctDNA at 3-4 months demonstrated 93% 2-year recurrence-free survival vs. 30% in those with detectable ctDNA
- 36-month overall survival rate was 100% for patients receiving 5 doses of Versamune® HPV + CRT
The company plans to initiate a Phase 3 trial for Versamune® HPV in HPV16-positive head and neck squamous cell carcinoma (HNSCC) in Q1 2025.
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company specializing in cancer treatment, has announced its participation in the B. Riley Securities Precision Oncology & Radiopharma Conference 2025. The company's President and CEO, Frank Bedu-Addo, PhD, will engage in a fireside chat session on Friday, February 28, 2025.
The presentation is scheduled for 11:30-12:00 PM ET in the Holmes II – Precision Oncology Track at the Lotte New York Palace Hotel. Company leadership will also conduct one-on-one meetings during the conference. Interested parties can register through B. Riley Securities representatives, and a transcript of the fireside chat will be available on PDS Biotech's website one week after the event.
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