secwatch.observer — SEC 8-K summary
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Issuer:     PDS Biotechnology Corp (PDSB)
CIK:        0001472091
Form:       8-K
Filed at:   2026-08-11T12:30:33+00:00
Accession:  0001140361-26-032142
Event type: other_material
Sentiment:  neutral
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

PDS Biotech refocuses on PDS0301 in mCRC; discontinues PDS0101 Phase 3 trial
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- PDS0301 showed 71% ORR at 6 months and 80% 24-month survival in MSS/pMMR mCRC with liver metastases.
- Company discontinues PDS0101 Phase 3 VERSATILE-003 trial and will pursue strategic partnerships for PDS0101.
- PDS0301 has been studied in >380 patients with encouraging safety; Phase 2b trial designed with FDA feedback.
- PDS0301 also evaluated in prostate, Kaposi sarcoma, HPV16+ cancers via NCI-sponsored trials.
- Q2 2026 financial results scheduled for announcement on August 13, 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1472091/000114036126032142/0001140361-26-032142-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1472091/000114036126032142/ef20079931_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-26-032142

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer