Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
PDSB Catalyst Timeline
Dated clinical, regulatory and corporate events for PDS Biotechnology Corporation
Catalyst Timeline
Dated clinical, regulatory & corporate events for PDS Biotechnology Corporation
Upcoming catalysts 2
Event history 50
Past FDA Catalysts and PDUFA Decisions
How PDSB actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2025-11-07 | PDS0101 (Versamune® HPV) | Phase 3 data readout | Phase 3 |
Drug Pipeline Intelligence
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pembrolizumab and PDS0101 Monoclonal antibodyCompletedNCT04260126 | Metastatic Head and Neck Cancer | Phase 2 | COMPLETED | 95 | May 14, 2025 |
Clinical Trial Results
Readouts, endpoints and source filings for every PDSB program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| PDS01ADC | unresectable metastatic colorectal cancer | Phase 2 | 2026-04-15 | objective response rate: 78%; two year survival rate with PDS01ADC: >80%; two year survival rate without PDS01ADC: ~35%Read More | PDS Biotech Announces Publication of Positive PDS01ADC Interim Phase 2 Clinical Trial Data from Stage 1 of NCI-led Metastatic Colorectal Cancer (mCRC) Trial 78% Objective Response Rate (ORR) with PDS01ADC; Parallel trialRead More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Freitag Gregory GeneDirector | Buy | 15,060 15,060 held | $0.00 | 02/28/2025 |
Hedge Fund 13F Activity
Hedge Funds invested in PDSB
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| Sofinnova Investments, Inc. | 0 % | 417.00 K | 142.63 K |
PDSB Institutional Ownership Trends
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-10-16 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How PDSB ranks across every disease it competes in
PDSB News
PDS Biotech to Host Key Opinion Leader Event on PDS0301 for the Treatment of Advanced Colorectal Cancer with Liver Metastases
PDS Biotechnology Corporation announced a virtual key opinion leader event focused on PDS0301, an investigational treatment for advanced colorectal cancer with liver metastases. Dr. Jonathan M. Hernandez from the National Cancer Institute will discuss clinical outcomes from Phase 2 trials. The event aims to shed light on the efficacy of PDS0301 in patients with microsatellite stable colorectal liver metastases.
Read more →PDS Biotech Announces Publication of VERSATILE-002 Phase 2 Clinical Trial Results of PDS0101 with pembrolizumab in HPV16-Positive Recurrent and/or Metastatic (R/M) Head and Neck Cancer in JAMA Oncology
PDS Biotechnology announced the publication of Phase 2 trial results for PDS0101 combined with pembrolizumab in HPV16-positive recurrent/metastatic head and neck cancer. The trial showed a median overall survival of 39.3 months, significantly higher than standard treatments. The treatment was well-tolerated, with a low rate of severe adverse events. These findings support the potential of PDS0101 as a viable therapy for this patient population.
Read more →PDS Biotech Announces Initial Closing of up to $22.3 Million PIPE Financing and the Appointment of Dr. Patrick Soon-Shiong to Its Board of Directors
PDS Biotechnology Corporation announced the initial closing of a $22.3 million PIPE financing, raising $11.3 million led by Nant Capital. The funds will support the development of PDS0301, an investigational treatment for metastatic colorectal cancer, which has shown promising trial results. Additionally, Dr. Patrick Soon-Shiong has been appointed to the board, enhancing the company's leadership.
Read more →PDS Biotech Announces up to $22.55 Million Financing Led by Dr. Patrick Soon-Shiong, Founder of NantWorks
PDS Biotech has secured up to $22.55 million in a PIPE financing led by Nant Capital, with Dr. Patrick Soon-Shiong joining its board. The funds will support the development of PDS0301, an immunocytokine showing promise in treating solid tumors, particularly in colorectal cancer. The financing includes an initial and contingent milestone closing, with significant participation from existing investors.
Read more →PDS Biotech Reports Second Quarter 2026 Financial Results
PDS Biotechnology Corporation reported its financial results for Q2 2026, highlighting a strategic refocus on PDS0301, its lead immunotherapy candidate. The company announced promising clinical trial results for PDS0301 in metastatic colorectal cancer, showing a 77.8% objective response rate and an 80% survival rate at 24 months. However, PDS0101's development will be deprioritized, leading to a net loss of $9.8 million for the quarter.
Read more →PDS Biotech Announces Strategic Refocus Prioritizing PDS0301 in Metastatic Colorectal Cancer (mCRC) and Partnership Strategy for PDS0101
PDS Biotechnology Corporation has announced a strategic refocus on PDS0301, an immunocytokine targeting metastatic colorectal cancer, while seeking partnerships for PDS0101. Encouraging Phase 2 results show significant response rates in patients with metastatic colorectal cancer. The company aims to enhance the effectiveness of oncology therapies by remodeling the tumor microenvironment, addressing unmet medical needs in cancer treatment.
Read more →PDS Biotech Reports First Quarter 2026 Financial Results and Provides Clinical Programs and Corporate Update
PDS Biotechnology Corporation reported its financial results for Q1 2026, highlighting significant clinical advancements. The company is focused on resuming enrollment in its amended Phase 3 trial for PDS0101, while also noting successful enrollment in trials for PDS01ADC. Financially, PDSB showed a reduced net loss compared to the previous year, reflecting improved operational efficiency.
Read more →PDS Biotech Announces Conference Call and Webcast for 2026 First Quarter Financial Results
PDS Biotechnology Corporation announced a conference call and webcast scheduled for May 13, 2026, to discuss its financial results for Q1 2026. The call will also include updates on clinical programs and corporate developments. The company is advancing its lead immunotherapy program, PDS0101, in pivotal trials for HPV16-positive head and neck cancers.
Read more →Precision Designed Science for Cancer Patients NASDAQ: PDSB April 2026 Forward-Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United States S
PDS Biotechnology Corporation (PDSB) has released forward-looking statements regarding its development pipeline, including PDS0101, an innovative treatment targeting HPV-positive cancers. The company has reported successful disease control rates in recent clinical trials, especially for recurrent/metastatic head and neck squamous cell carcinoma. PDSB maintains collaborations with prominent cancer treatment institutions, emphasizing its strategic position in combating HPV-related cancers. However, the company also recognizes potential risks related to intellectual property, financing, and operational history as it navigates its future growth.
Read more →PDS Biotech Announces Publication of Positive PDS01ADC Interim Phase 2 Clinical Trial Data from Stage 1 of NCI-led Metastatic Colorectal Cancer (mCRC) Trial
PDS Biotechnology Corporation announced positive interim Phase 2 clinical trial results for its immunocytokine, PDS01ADC, in treating unresectable metastatic colorectal cancer. The trial, published in the Journal of Clinical Oncology, demonstrated a 78% objective response rate and an over 80% two-year survival rate among participants. The therapy combines PDS01ADC with hepatic artery infusion pump therapy, targeting tumors directly while minimizing systemic exposure. These findings indicate promising potential for PDS01ADC in a patient population where traditional therapies have been largely ineffective.
Read more →PDS Biotech Reports Full Year 2025 Financial Results and Provides Update on PDS0101 Phase 3 Program and PDS01ADC Clinical Advancement
PDS Biotechnology Corporation reported its financial results for 2025, highlighting progress in its clinical programs, particularly the VERSATILE-003 Phase 3 trial for PDS0101. The trial amendment aims to incorporate progression-free survival as an interim endpoint, potentially shortening its duration and reducing costs. Additionally, early results from the PDS01ADC trial showed promising outcomes in prostate cancer patients. The company also strengthened its intellectual property portfolio with new patents.
Read more →PDS Biotech Announces Conference Call and Webcast for 2025 Fourth Quarter and Year End Financial Results
PDS Biotechnology Corporation has announced a conference call and webcast scheduled for March 30, 2026, to discuss its financial results for the fourth quarter and year ended December 31, 2025. The call will also include updates on clinical programs and corporate developments. The company is actively engaged in pivotal trials for its lead immunotherapy program targeting advanced HPV16-positive cancers.
Read more →Precision Designed Science for Cancer Patients NASDAQ: PDSB February 2026 Forward-Looking Statements This communication contains forward-looking statements (including within the meaning of Section 21E of the United State
PDS Biotechnology Corporation announced forward-looking statements regarding its lead program, PDS0101 (Versamune HPV), aimed at treating HPV16-positive head and neck cancers. The company is preparing for a pivotal Phase 3 trial under the FDA's accelerated approval pathway, citing positive preliminary results. However, PDS Biotech faces challenges related to financing and uncertainties regarding the timing and outcomes of its clinical trials. Despite a promising innovative treatment platform, operational risks remain a significant concern for the future success of the company.
Read more →PDS Biotech Announces Adoption of Amended Protocol for Phase 3 VERSATILE-003 Trial Incorporating Progression Free Survival (PFS) as Primary Endpoint for Interim Analysis and Potential Accelerated Approval
PDS Biotechnology Corporation has announced an amendment to its Phase 3 VERSATILE-003 trial protocol, incorporating progression-free survival (PFS) as an interim primary endpoint. This change aims to support a potential accelerated approval pathway for PDS0101 in treating HPV16-positive recurrent and/or metastatic head and neck cancer. The trial's primary endpoint for full approval remains median overall survival (mOS).
Read more →PDS Biotech Announces Presentation of Preliminary Results from Phase 2 Study of IL-12 Tumor Targeted Immunocytokine (PDS01ADC) in 3rd Line Metastatic Castration Resistant Prostate Cancer by the NCI
PDS Biotech announced preliminary results from a Phase 2 study of PDS01ADC in patients with metastatic castration-resistant prostate cancer, showing a median progression-free survival of 9.6 months. The study, led by the NCI, also reported a median PSA decline of 40%, indicating potential benefits of the treatment. These findings were presented at the AACR conference.
Read more →PDS Biotech Announces New U.S. Patent Covering Technology Underlying PDS0101
PDS Biotechnology Corporation announced the issuance of a Notice of Allowance for a new U.S. patent covering its lead asset, PDS0101. This patent enhances the company's intellectual property estate and, combined with anticipated biologics exclusivity, provides over 20 years of market protection. The company is advancing PDS0101 through the Phase 3 VERSATILE-003 clinical trial for HPV16-positive head and neck cancers.
Read more →PDS Biotech Announces FDA Alignment on use of Progression Free Survival (PFS) as Primary Endpoint
PDS Biotech has submitted an amended protocol to the FDA for its Phase 3 VERSATILE-003 trial, changing the primary endpoint to Progression Free Survival (PFS). This change aims to facilitate an earlier evaluation and potentially accelerate the approval of PDS0101 for HPV16-positive cancers. The amendment follows positive results from the previous trial and retains median overall survival as a requirement for full approval.
Read more →