PDS Biotechnology Corp（PDSB）资讯与事件PDSBPDS Biotechnology Corp

PDS Biotechnology Publishes Phase 2 Trial Results for PDS0101

PDS Biotechnology announced the publication of results from a Phase 2 trial evaluating PDS0101, its HPV16-targeted immunotherapy, in combination with pembrolizumab in the September 17, 2026, issue of JAMA Oncology, a peer reviewed journal of the American Medical Association. Key findings: 62.3% of the ICI-naive participants in the mITT cohort had low CPS of 1-19, and 37.7% had high CPS greater than or equal to 20. In the overall CPS greater than or equal to 1 population, the mOS was 39.3 months; Objective response rate for CPS greater than or equal to 1 was 36% of which 5/53 were complete responders by investigator review and 34% of which 6/53 were complete responders by central review: The published ORR for the overall population with CPS greater than or equal to 1 when treated with standard of care pembrolizumab is 19%; The treatment was well-tolerated with 13.8% Grade greater than or equal to3 treatment-related adverse events, 1 Grade 4 event one year after PDS0101 therapy, and no Grade 5 TRAEs; The published safety profile for the overall population with CPS greater than or equal to 1 when treated with standard of care pembrolizumab reports 17% Grade greater than or equal to 3 TRAEs

PDS Biotechnology Completes Initial Private Placement, Raises Approximately $11.3 Million

PDS Biotechnology announced the initial closing of the company's Private Investment in Public Equity transaction. The round was led by Nant Capital, LLC with additional participation by current investors. The PIPE also consists of a contingent milestone closing. At the Initial Closing, the company sold (i) shares of the company's common stock or, at the election of an investor, pre-funded warrants in lieu of such shares, and (ii) accompanying common stock purchase warrants. Each unit consisting of one Private Placement Share and a Common Warrant to purchase one-half of one Private Placement Share was issued for $0.2825, and each unit consisting of one Pre-Funded Warrant to purchase one share of Common Stock and a Common Warrant to purchase one-half of one share of Common Stock was issued for $0.28217. The aggregate gross proceeds and the aggregate number of Private Placement Shares, Pre-Funded Warrants and Common Warrants issued as part of the Initial Closing were approximately $11.3M, and 16,502,870, 23,498,156 and 20,000,514, respectively. The company intends to use the net proceeds from the private placement to repay outstanding indebtedness and for working capital and general corporate purposes, including the continued development of its clinical programs, research and development, and general and administrative expenses. The company also expects that the PIPE will advance PDS0301 into late-stage clinical development, based on recent promising interim Phase 2 clinical trial data in microsatellite stable and mismatch repair-proficient metastatic colorectal cancer, types of colorectal cancer that have not responded well to treatment with immunotherapy. In addition to the PIPE transaction, and for additional consideration, the company granted NantWorks, LLC, an affiliate of Nant, a one-year exclusive right to negotiate an exclusive license to PDS0101, the company's novel investigational human papilloma virus targeted immunotherapy that stimulates a potent targeted T cell attack against HPV-positive cancers. The option has a term of one year.