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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 Biotechnology (Nasdaq: PDSB), a late-stage immunotherapy company specializing in cancer treatment, has scheduled its Q1 2025 financial results conference call and webcast for May 14, 2025, at 8:00 AM ET. The company will present its financial performance for the quarter ending March 31, 2025, along with updates on its clinical programs. Investors can join via phone (1-877-704-4453 domestic, 1-201-389-0920 international) or through the webcast. The presentation will be archived on PDS Biotech's website for six months following the live event.
PDS Biotechnology (NASDAQ: PDSB) has announced the acceptance of three abstracts featuring Versamune® HPV (PDS0101) for presentation at the 2025 ASCO Annual Meeting in Chicago from May 30-June 3, 2025.
The presentations include:
- VERSATILE-003: A Phase 3 randomized trial comparing PDS0101 and Pembrolizumab vs. Pembrolizumab alone for first-line treatment of HPV16-positive recurrent/metastatic head and neck cancer
- VERSATILE-002: Results on overall survival in HPV16 positive recurrent/metastatic head and neck cancer patients treated with PDS0101 and Pembrolizumab
- MC200710: Initial results of PDS0101 alone or with pembrolizumab in locally advanced HPV-associated oropharyngeal carcinoma
PDS Biotechnology (Nasdaq: PDSB) announced that preclinical immune response data for their novel Infectimune®-based flu vaccine will be presented at the IMMUNOLOGY2025™ Annual Meeting in Honolulu, Hawaii, from May 3-7, 2025.
The presentation, titled 'Broadly Protective Immunity against Influenza and Opportunities for Universal Influenza Vaccines,' will be delivered by Dr. Andrea Sant from the University of Rochester Medical Center during the International Society of Influenza and Other Respiratory Viruses Symposium on May 4, 2025.
Additionally, the company announced the withdrawal of an abstract titled 'Alterations in peripheral T stem-like memory cells in patients with advanced solid tumors treated with tumor-targeting IL-12 therapy' from the American Association for Cancer Research Annual Meeting 2025 due to new NIH policies regarding employee attendance at scientific conferences.
PDS Biotechnology (NASDAQ: PDSB), a late-stage immunotherapy company, announced that the National Cancer Institute (NCI) will present clinical data on PDS01ADC, their IL-12 fused antibody drug conjugate, at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2025.
The presentation, scheduled for April 29, 2025, will focus on alterations in peripheral T stem-like memory cells in patients with advanced solid tumors treated with tumor-targeting IL-12 therapy. The poster session, titled 'Immune Response to Therapies,' will be presented by Meghali Goswami, Postdoctoral Fellow at The National Institutes of Health.
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.