Skip to content
Baker Capital StrategiesMARKETS. FILINGS. PERSPECTIVE.
Powered by THEMA

Baker Capital Strategies

Free Registration

Register for access to news, tools, alerts and reports.

THEMA Basic included at launch.

Use at least 8 characters.

Home/The Filing Wire/PDS Biotechnology Corporation/ 8-K

Current Report · Items 8.01, 9.01 · 8-K

PDS Biotechnology Corporation

PDSBNASDAQEQUITYCurrent

Other Events

Item 8.01 Other Events. On September 22, 2026, PDS Biotechnology Corporation issued a press release announcing 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.…

Filed Sep 22, 2026Accepted Sep 22, 2026, 8:05 AM EDTCIK 1472091Accession 0001140361-26-037298
View company →Permanent SEC source ↗
Share

Company context

We are a clinical-stage immunotherapy company developing a growing pipeline of targeted cancer and infectious disease immunotherapies based on our Versamune® T cell activator and Versamune® in combination with our interleukin 12 (IL-12) fused anti-body drug conjugate (ADC), PDS01ADC. In addition, we are developing the Infectimune® T cell-activator in infectious diseases.

Current securities

PDSBNASDAQ · EQUITY · Current

Recent company filings

  1. SCHEDULE 13D - filed by Nant Capital, LLC regarding PDS Biotechnology CorpSep 21, 2026
  2. Other EventsSep 21, 2026
  3. Termination of a Material Definitive Agreement · Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements · Regulation FD Disclosure · Other EventsSep 14, 2026
  4. Entry into a Material Definitive Agreement · Unregistered Sales of Equity Securities · Regulation FD DisclosureSep 8, 2026
  5. Entry into a Material Definitive Agreement · Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet ArrangementSep 4, 2026

Disclosure sections

Items 8.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 8.01Item 8.01 - Other Events
Item 8.01 Other Events. On September 22, 2026, PDS Biotechnology Corporation issued a press release announcing 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. The data were published in an article titled “VERSATILE-002 - A Phase 2 Study of PDS0101 HPV16-targeted T Cell Immunotherapy and Pembrolizumab Combination in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Nonrandomized Clinical Trial. ” A copy of the press release is filed herewith as Exhibit 99.1 and incorporated by reference herein.
Filed exhibits (1)
EX-99.1 (by filename) ef20082545_ex99-1.htm

Exhibit 99.1 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 39.3 months median overall survival in first-line (1L) R/M immune checkpoint inhibitor naïve patients Company continues to prioritize PDS0301 in metastatic colorectal cancer (mCRC) while pursuing partnership strategy for PDS0101 PRINCETON, N.J., September 22, 2026 -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today 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. The data were published in an article titled “VERSATILE-002 - A Phase 2 Study of PDS0101 HPV16-targeted T Cell Immunotherapy and Pembrolizumab Combination in HPV16-Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma: A Nonrandomized Clinical Tria…

Open exhibit ↗