Welcome to our dedicated page for PDS Biotechnology news (Ticker: PDSB), a resource for investors and traders seeking the latest updates and insights on PDS Biotechnology stock.
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 Biotech (PDSB) reported Phase 2 VERSATILE-002 results for HPV16-targeted immunotherapy PDS0101 plus pembrolizumab in HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma, now published in JAMA Oncology.
In immune checkpoint inhibitor (ICI)-naïve patients with PD-L1 CPS ≥ 1 (mITT n = 53), median overall survival was 39.3 months (95% CI, 23.9 to NE), compared with a best published 17.9 months for standard-of-care pembrolizumab-based regimens (no head-to-head data). Objective response rate in CPS ≥ 1 was 36% (investigator review; 5 complete responses) and 34% (central review; 6 complete responses), versus a published 19% ORR for pembrolizumab alone in a similar CPS ≥ 1 population. Grade ≥ 3 treatment-related adverse events occurred in 13.8% of patients, with one Grade 4 event and no Grade 5 events, compared with 17% Grade ≥ 3 TRAEs for pembrolizumab standard-of-care.
The open-label, non-randomized trial enrolled 88 patients across 26 centers in the US, UK and Ireland; 75 formed the mITT efficacy population, including 53 ICI-naïve and 22 ICI-resistant patients. PDS Biotech continues to prioritize its PDS0301 program in metastatic colorectal cancer and is pursuing a partnership strategy for PDS0101. The company recently closed an initial tranche of a PIPE financing of up to $22.3 million, led by Nant Capital, and granted NantWorks a one-year exclusive right to negotiate an exclusive PDS0101 license.
PDS Biotechnology (PDSB) closed an initial tranche of a PIPE financing on September 14, 2026, raising gross proceeds of approximately $11.3 million led by Nant Capital, with Dr. Patrick Soon-Shiong joining its board.
At the Initial Closing, the company issued 16,502,870 common shares, 23,498,156 pre-funded warrants and 20,000,514 common warrants, at unit prices of $0.2825 per share-and-warrant unit and $0.28217 per pre-funded-and-warrant unit. A contingent Milestone Closing would add $10 million from Nant and $1 million from AB Group Ltd., triggered by submission to the FDA of a registrational Phase 3 protocol for PDS0301 designed with Nant, subject to closing conditions and a 19.9% beneficial ownership cap per investor.
The funds are intended for debt repayment, working capital and clinical development, including advancing PDS0301, which in an NCI-led Phase 2 trial in 22 MSS/pMMR mCRC patients showed good tolerability and 80% 24‑month survival. NantWorks also received a one‑year exclusive right to negotiate an exclusive license to HPV‑targeted immunotherapy PDS0101, and James Banaag of NantBio also joined the PDS board.
PDS Biotechnology (PDSB) agreed to a PIPE financing of up to $22.55 million led by Nant Capital, alongside existing investors.
The PIPE has an Initial Closing of about $11.55 million, expected on or about September 11, 2026, and a Milestone Closing of $11 million tied to submission of a registrational Phase 3 protocol for PDS0301 to the FDA. Initial units combine one common share and a warrant to purchase half a share at $0.2825, or a pre-funded warrant plus half-share warrant at $0.28217, for an expected issuance of 20,875,220 common shares, 20,009,736 pre-funded warrants and 20,442,479 common warrants.
Nant may designate two directors, including Dr. Patrick Soon‑Shiong, while it owns at least 15% of the common stock. The company plans to advance PDS0301 into late-stage development, supported by NCI-led Phase 2 data in MSS/pMMR metastatic colorectal cancer where adding PDS0301 yielded 80% 24‑month survival in 22 patients. Proceeds will repay debt and fund clinical programs and corporate needs.
PDS Biotechnology (Nasdaq:PDSB) reported Q2 2026 net loss of $9.8 million, or $0.18 per share, versus $9.4 million, or $0.21, a year earlier. Total operating expenses fell to $6.5 million from $7.6 million, while net interest expense increased to $3.3 million from $1.8 million, mainly due to a non-cash loss on retirement of debt.
The company highlighted positive Stage 1 data from an NCI-led Phase 2 metastatic colorectal cancer trial of its IL-12 immunocytokine PDS0301, including a 77.8% six-month objective response rate and approximately 80% 24-month survival. Following a strategic review, PDS Biotech is prioritizing PDS0301 as its lead program, discontinuing internal investment in PDS0101 and the VERSATILE-003 Phase 3 trial while seeking partnerships for PDS0101. As of June 30, 2026, cash was $5.6 million, working capital was negative $5.3 million and stockholders’ equity was negative $3.6 million.
PDS Biotechnology (Nasdaq:PDSB) announced a strategic refocus following a portfolio and capital allocation review, prioritizing its tumor-targeted IL‑12 immunocytokine PDS0301 and pursuing partnership-driven development for PDS0101. The company will cease internal investment in, and discontinue, the PDS0101 Phase 3 VERSATILE‑003 trial.
According to PDS Biotech, Phase 2 data in metastatic MSS/pMMR colorectal cancer with liver metastases showed a 71% objective response rate at 6 months and 80% 24‑month survival, with safety observed in more than 380 treated patients. A randomized Phase 2b mCRC program has been designed incorporating FDA feedback. Over the next 18–24 months, the company plans to advance PDS0301 through this Phase 2b program, identify strategic partners for PDS0101, and maintain disciplined capital allocation. PDS Biotech will report results for the quarter ended June 30, 2026, on August 13, 2026.
PDS Biotech (Nasdaq:PDSB) reported Q1 2026 results and clinical updates. The VERSATILE-003 Phase 3 protocol now uses progression-free survival as an interim primary endpoint, potentially supporting accelerated approval of PDS0101, while overall survival remains the primary endpoint for full approval.
Stage 1 data for PDS01ADC in metastatic colorectal cancer showed 77.8% ORR (7/9) and ~85% 24‑month survival. Early metastatic castration-resistant prostate cancer data reported median PFS of 9.6 months. New U.S. and Japan patents extend PDS0101 protection into the 2040s. Q1 2026 net loss was $7.3M ($0.13/share) versus $8.5M ($0.21/share) a year earlier; operating expenses were $6.5M, and cash was $21.7M.
PDS Biotech (Nasdaq: PDSB) will host a conference call and webcast on May 13, 2026 at 8:00 a.m. ET to report first quarter results for the period ended March 31, 2026, and provide a clinical programs and corporate update.
Dial-in details and a webcast will be available 15 minutes prior; the webcast archive will remain on the company website for six months.
PDS Biotech (Nasdaq: PDSB) announced publication of interim Stage 1 Phase 2 data for PDS01ADC in JCO Oncology Advances on April 15, 2026. Stage 1 (N=9) reported a 77.8% ORR, ~85% 24-month survival and median extrahepatic PFS not reached (min follow-up 13.1 months).
Comparators from a parallel trial without PDS01ADC showed a 35% ORR, ~40% 2-year survival and 8.1-month PFS; no head-to-head randomized comparison was performed.
PDS Biotech (NASDAQ: PDSB) reported full-year 2025 results and clinical updates on March 30, 2026. The company amended its VERSATILE-003 Phase 3 protocol to add PFS as an interim primary endpoint to enable a potential accelerated approval pathway while preserving overall survival for full approval.
Early PDS01ADC Phase 2 data showed median PFS of 9.6 months and a 40% median PSA decline in mCRPC; new U.S. and Japan patents extend Versamune platform protection into the 2040s. Full-year net loss was $34.5M; cash was $26.7M as of Dec 31, 2025.
PDS Biotech (Nasdaq: PDSB) will host a conference call and webcast on March 30, 2026 at 8:00 a.m. ET to report fourth‑quarter and year‑end financial results for the period ended December 31, 2025, and to provide a clinical programs and corporate update.
Access details: domestic dial‑in 1‑877‑704‑4453, international 1‑201‑389‑0920, conference ID 13759288. A webcast will be archived on the company website for six months.