PDS Biotechnology Corp. engages in the development of clinical-stage immunotherapies to treat various early-stage and late-stage cancers, including head and neck cancer, prostate cancer, breast cancer, cervical cancer, anal cancer, and other cancers. Its product, PDS0101, is an off the shelf immunotherapeutic that is administered by subcutaneous injection. The company was founded by Frank K. Bedu-Addo in 2005 and is headquartered in Princeton, NJ.
Clinical Trials
3
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2005
Completed
2
66.7%
Terminated
1
33.3%
No approval data available
- PDS Biotechnology received a Nasdaq deficiency notice on February 25, 2026, after its stock traded below the $1.00 minimum bid price for 30 consecutive business days. - The company successfully regained compliance with Nasdaq Listing Rule 5550(a)(2), with Nasdaq confirming the matter closed on June 2, 2026. - The compliance restoration removes the immediate threat of delisting from the Nasdaq Capital Market, where the stock continues to trade under ticker PDSB. - A separate July 30, 2026 deficiency notice indicates a subsequent bid price compliance issue, with a compliance deadline of January 26, 2027.
- PDS Biotechnology's VERSATILE-002 trial demonstrated a median overall survival of 30 months for Versamune HPV combined with pembrolizumab in advanced HPV16+ head and neck squamous cell carcinoma, significantly exceeding the typical 18-month survival for current standard-of-care therapies. - The treatment achieved a 35.8% objective response rate with no new safety signals, positioning it favorably for the ongoing Phase 3 VERSATILE-003 trial. - The company's Phase 2 PDS01ADC study in colorectal cancer met expansion criteria with at least 6 of 9 confirmed objective responses, demonstrating promising activity across multiple cancer types. - H.C. Wainwright analyst Joseph Pantginis maintained a Buy rating with a $13.00 price target, citing the strong clinical results and the company's $31.9 million cash position as of June 30, 2025.
- PDS Biotechnology, a portfolio company of EMV Capital, has successfully raised $11 million in new funding to advance its biotechnology initiatives. - The funding demonstrates continued investor confidence in PDS Biotechnology's development pipeline and strategic direction in the biopharmaceutical sector. - This capital injection positions PDS Biotechnology to further strengthen its research and development capabilities in innovative therapeutic solutions.
- PDS Biotech reaffirms its plan to initiate the VERSATILE-003 Phase 3 trial in Q1 2025, evaluating Versamune HPV plus pembrolizumab for recurrent/metastatic HPV16-positive head and neck cancer. - The FDA has cleared the updated clinical protocol for the trial, which maintains statistical power with approximately 350 patients and a 2:1 randomization. - VERSATILE-002 study data showed a median overall survival of 30 months, an objective response rate improvement to 36%, and a disease control rate of 77%. - The VERSATILE-003 trial will utilize a companion diagnostic to confirm HPV16-positive HNSCC, ensuring targeted therapy for suitable patients.
- PDS Biotechnology's VERSATILE-003 Phase III trial, evaluating Versamune HPV with pembrolizumab, is set to begin in early 2025, with interim data expected six months after enrollment completion. - Encouraging VERSATILE-002 data reveals improved overall survival and objective response rates with Versamune HPV compared to pembrolizumab alone in HPV16-positive cancers. - IMMUNOCERV trial data supports further development of Versamune HPV for cervical cancer, demonstrating high overall and progression-free survival rates. - PDS Biotech maintains a solid financial position with approximately $50 million in cash reserves, supporting ongoing clinical trials and research initiatives.
- PDS Biotechnology is set to initiate the VERSATILE-003 Phase 3 trial in Q1 2025, evaluating the combination of PDS0101 and Keytruda. - The trial will focus on patients with HPV16-positive head and neck squamous cell carcinoma (HNSCC). - The analysts believe Merck's Keytruda success in KEYNOTE-689 study is unlikely to affect the Versamune double combination since KEYNOTE-689 enrolled very few HIV16+ patients. - Alliance Global Partners maintains a Buy rating on PDSB, though lowered the price target to $4.50 from $7.
- PDS Biotechnology has updated the Phase 3 VERSATILE-003 trial design for HPV16-positive recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC), increasing the patient target to approximately 350. - The updated design maintains a 2:1 randomization and median overall survival as the primary endpoint, aligning with the FDA agreement on registrational design. - The revised trial design allows for potential earlier interim readouts, faster study completion, and reduced execution costs, while retaining statistical power. - VERSATILE-002 results have demonstrated durable anti-tumor responses, influencing the design updates for VERSATILE-003 and showing improved clinical responses over time.
- PDS Biotechnology Corp reported a net loss of $10.7 million in Q3 2024, slightly better than the $10.8 million loss in Q3 2023, with revenue in line with expectations. - R&D expenses increased to $6.8 million due to higher manufacturing costs, while general and administrative expenses decreased to $3.4 million. - The company is advancing its VERSATILE-003 Phase 3 trial, combining Versamune® HPV with pembrolizumab for HPV16-positive head and neck squamous cell cancer. - Modifications to the VERSATILE-003 trial design aim to reduce costs and expedite data readouts, with $49.8 million in cash and cash equivalents as of September 30, 2024.
- PDS Biotech is advancing the VERSATILE-003 Phase 3 trial of Versamune HPV + pembrolizumab for recurrent/metastatic HPV16-positive head and neck squamous cell cancer (HNSCC). - Updated trial design for VERSATILE-003 includes approximately 350 patients and maintains key endpoints, with potential for earlier data readouts and reduced costs. - Promising data from the IMMUNOCERV Phase 2 trial of Versamune HPV with chemoradiation in locally advanced cervical cancer were presented at ASTRO. - PDS Biotech reported a net loss of $10.7 million for Q3 2024, with $49.8 million in cash and cash equivalents as of September 30, 2024.
- PDS Biotech will release its financial results for the quarter ending September 30, 2024, offering insights into its financial performance and strategic initiatives. - A conference call is scheduled for November 14, 2024, at 8:30 a.m. Eastern Time, where the company will discuss the financial results and provide a clinical program update. - PDS Biotech plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers.
