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.
PDS Biotechnology Corporation (Nasdaq: PDSB) is a clinical stage biopharmaceutical company focused on developing next-generation immunotherapies for cancer and infectious diseases. The company's proprietary Versamune® platform leverages synthetic and biodegradable lipids to form nanoparticles that are readily taken up by the immune system. These nanoparticles are designed to activate and direct the immune system to target and eliminate disease-causing cells.
PDS Biotech's lead product candidates include PDS0101, targeting HPV-related cancers, and PDS01ADC, an IL-12 fused antibody drug conjugate. These candidates are part of the company's broader strategy to treat a range of cancers, including head and neck, prostate, breast, cervical, and anal cancers.
Recent achievements include the completion of a Phase 1 clinical trial for PDS0101 and ongoing Phase 2 trials demonstrating positive survival results and tumor shrinkage. The company is preparing to initiate a pivotal clinical trial in advanced head and neck cancers in 2024.
Financially, PDS Biotech reported a net loss of $10.8 million for Q3 2023, primarily due to increased R&D and administrative expenses. Despite this, the company remains focused on advancing its pipeline and has several key partnerships to support its research and development efforts.
PDS Biotechnology (PDSB) will present updated data from the VERSATILE-002 trial at the ESMO Congress 2024 on September 14, 2024, in Barcelona, Spain. The trial evaluates Versamune® HPV (formerly PDS0101) combined with KEYTRUDA® (pembrolizumab) as a first-line treatment for HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
The poster presentation, titled 'VERSATILE-002: Survival with First-Line Treatment with PDS0101 Therapeutic Vaccine and Pembrolizumab in HPV16-positive Recurrent/Metastatic HNSCC', will be presented by Dr. Jared Weiss, Principal Investigator of the trial. The poster will be available on the company's website after the presentation.
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is scheduled for September 9-11, 2024, in New York City. Frank Bedu-Addo, PhD, President and CEO of PDS Biotech, will deliver a presentation on Tuesday, September 10, 2024, from 2:00-2:30 PM ET.
The presentation will be available for on-demand viewing starting at the same time. Interested parties can register for the in-person event or access the archived replay in the Investor Relations section of the company's website at www.pdsbiotech.com after the conference.
PDS Biotechnology (PDSB) has provided a business update and reported financial results for Q2 2024. Key highlights include:
Clinical Progress: Alignment with FDA on Phase 3 VERSATILE-003 trial design for HPV16-positive HNSCC, set to start in Q4 2024. Updated VERSATILE-002 trial data to be presented at ESMO 2024.
Financial Results: Net loss of $8.3 million ($0.23 per share) in Q2 2024, compared to $11.5 million ($0.37 per share) in Q2 2023. R&D expenses decreased to $4.5 million from $8.0 million, while G&A expenses reduced to $4.2 million from $4.7 million. Cash and cash equivalents stood at $57.7 million as of June 30, 2024.
The company is progressing with its Versamune® HPV immunotherapy platform, showing potential in various cancer indications.
PDS Biotechnology (Nasdaq: PDSB) has announced that updated data from their IMMUNOCERV Phase 2 clinical trial will be presented at the 2024 ASTRO Annual Meeting. The trial evaluates Versamune® HPV (formerly PDS0101) in combination with chemoradiation for treating locally advanced cervical cancer. The presentation, titled '298 - IMMUNOCERV Phase II Trial Combining the HPV-Specific T Cell Immunotherapy PDS0101 with Chemoradiation for Treatment of Locally Advanced Cervical Cancer,' will be given by Dr. Adam Grippin from The University of Texas MD Anderson Cancer Center on October 1, 2024. This presentation is part of the session 'SS 34 - GYN 2: Strategies and Innovations of Clinical Trials in Gynecologic Cancers.'
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company, has announced that it will release its second quarter 2024 financial results on Tuesday, August 13, 2024, before the market opens. The company, which focuses on developing innovative cancer immunotherapies and infectious disease vaccines, will also provide a business update along with the financial report.
Investors and interested parties can access the press release containing the financial results and business update in the Investor Relations section of PDS Biotech's official website at www.pdsbiotech.com. This announcement signals the company's commitment to transparency and regular communication with its shareholders and the broader investment community.
PDS Biotechnology (Nasdaq: PDSB) has announced that an abstract presenting updated data from their VERSATILE-002 trial has been accepted for presentation at the European Society for Medical Oncology (ESMO) Congress 2024. The trial evaluates the first-line treatment with Versamune® HPV (formerly PDS0101) in combination with KEYTRUDA® (pembrolizumab) for patients with HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC).
The poster presentation, titled 'VERSATILE-002: Survival with First-Line Treatment with PDS0101 Therapeutic Vaccine and Pembrolizumab in HPV16-positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)', will be presented by Dr. Jared Weiss, Principal Investigator of the VERSATILE-002 clinical trial. The ESMO Congress 2024 is scheduled for September 13-17, 2024, in Barcelona, Spain.
PDS Biotechnology (Nasdaq: PDSB) has aligned with the FDA on the Phase 3 VERSATILE-003 trial for its Versamune® HPV immunotherapy in HPV16-positive first-line recurrent or metastatic head and neck cancer. The trial, set to begin in Q4 2024, will focus on the combination of Versamune® HPV and pembrolizumab, which has received Fast Track designation. The company presented data from VERSATILE-002 and proposed a triple combination therapy, which the FDA supported. However, to avoid delays, the FDA agreed to proceed with the 2-arm double combination trial. The updated VERSATILE-003 study will have overall survival as the primary endpoint, with revised statistical endpoints based on mature survival data.
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company, has announced a conference call scheduled for August 1, 2024, at 8:00 a.m. ET to provide a clinical program update. The company, which focuses on enhancing immune system targeting of cancers and developing infectious disease vaccines, will offer multiple ways for interested parties to join the call:
1. Dial-in options: 1-877-704-4453 or 1-201-389-0920
2. Webcast registration available via provided link
3. Call Me™ feature available 15 minutes before the call
This update presents an opportunity for investors and stakeholders to gain insights into PDS Biotech's latest developments in immunotherapy and vaccine research.
PDS Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company, has announced its participation in the BTIG Virtual Biotechnology Conference. The company's President and CEO, Frank Bedu-Addo, PhD, will engage in a fireside chat on Monday, August 5, 2024, at 10:00 a.m. ET.
PDS Biotech focuses on revolutionizing how the immune system targets and eliminates cancers, as well as developing vaccines for infectious diseases. Interested parties can arrange meetings with the PDS Biotech team through their BTIG representatives. After the event, a replay of the fireside chat will be accessible in the Investor Relations section of the company's website at www.pdsbiotech.com.
PDS Biotechnology provided a data update from its VERSATILE-002 Phase 2 clinical trial in head and neck cancer as of May 17, 2024. The trial focuses on the combination of Versamune® HPV and KEYTRUDA® in HPV16-positive HNSCC patients. Median Overall Survival (mOS) remains at 30 months, consistent with previous data. Out of 53 enrolled patients, 27 remain alive, 6 withdrew consent, 2 were lost to follow-up, and 18 have died. The lower limit of the 95% confidence interval is 19.7 months, while the upper limit is not yet estimable. Full data are expected in Q3 2024. PDS Biotech plans a three-arm Phase 3 trial to further evaluate treatment efficacy.
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