This is a routine corporate presentation update with no new material financial data. Monitor upcoming PDS0301 data readouts (first interim in biochemically recurrent prostate cancer expected Q4 2026/Q1 2027) and any partnership announcements for PDS0101 as potential catalysts.
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Executive Summary
PDS Biotechnology filed an updated corporate presentation deck on October 20, 2026, highlighting clinical data for its two lead assets: PDS0301 (tumor-targeted IL-12 immunocytokine) and PDS0101 (Versamune HPV16 cancer vaccine). The presentation reports a 71.4% objective response rate at six months and approximately 80% 24-month survival in an NCI-led Phase 2 trial of PDS0301 in MSS/pMMR metastatic colorectal cancer with liver metastases, and a 39.3-month median overall survival for PDS0101 plus pembrolizumab in first-line HPV16-positive recurrent/metastatic head and neck cancer. Five PDS0301 data readouts are anticipated between Q4 2026 and Q2 2028, and the company is seeking a strategic partnership for PDS0101.
Key Facts
- PDS0301 + chemotherapy achieved a 71.4% objective response rate at six months and approximately 80% 24-month survival in an NCI-led Phase 2 trial in MSS/pMMR metastatic colorectal cancer with liver metastases.
- PDS0101 + pembrolizumab reported a 39.3-month median overall survival in first-line HPV16-positive recurrent/metastatic head and neck cancer (VERSATILE-002).
- Five PDS0301 data readouts anticipated between Q4 2026 and Q2 2028 across multiple indications.
- PDS0101 is seeking a strategic partnership or external funding for further development.
- A registrational Phase 3 protocol for PDS0301 in mCRC is in design.
- More than 380 patients have been dosed with PDS0301 across Phase 1 and Phase 2 trials.
- Following a September 2026 financing led by Nant Capital, Dr. Patrick Soon-Shiong joined the Board of Directors.
Financial Impact
No financial data reported in this filing. September 2026 financing led by Nant Capital mentioned but amount not disclosed.
Risk Factors
- Clinical trial risks: interim/preliminary data may not predict final results; no randomized head-to-head studies performed.
- Financing risk: company dependent on additional capital to fund operations and development; going concern risk noted in forward-looking statements.
- Competitive risk: multiple other therapies in development for mCRC and HPV16+ HNSCC.
- Regulatory risk: PDS0301 Phase 3 protocol not yet submitted to FDA; PDS0101 seeking partnership for further development.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001140361-26-040283 |
| Document: ef20084135_8k.htm | 0001140361-26-040283 |
| Document: 0001140361-26-040283-index-headers.html | 0001140361-26-040283 |
| Document: 0001140361-26-040283-index.html | 0001140361-26-040283 |
| Document: 0001140361-26-040283.txt | 0001140361-26-040283 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 20, 2026 6d ago | 3 | $1.24 $1.16 | ▼ −6.45% | ▼ −5.27% | $1.07 (−14.11%) |
Oct 20, 2026 6d ago | 8-K | $1.24 $1.16 | ▼ −6.45% | ▼ −5.27% | $1.07 (−14.11%) |
Oct 20, 2026 6d ago | 8-K | $0.9605 $1.24 | ▲ +29.10% | ▲ +28.57% | $1.07 (+10.88%) |
Oct 14, 2026 12d ago | S-3 | $1.30 $1.13 | ▲ +13.08% | ▲ +11.97% | $1.07 (+18.08%) |
Oct 6, 2026 20d ago | 8-K | $1.05 $1.07 | ▲ +1.91% | ▲ +2.15% | $1.07 (+1.91%) |
Sep 22, 2026 4w ago | 8-K | $0.9100 $0.8239 | ▼ −9.46% | ▼ −8.74% | $1.07 (+17.03%) |
Sep 22, 2026 4w ago | Press Release | $0.9100 $0.8239 | ▼ −9.46% | ▼ −8.74% | $1.07 (+17.03%) |
Sep 21, 2026 5w ago | SC 13D | $0.9100 $0.8240 | ▼ −9.45% | ▼ −8.73% | $1.07 (+17.03%) |
Sep 4, 2026 7w ago | 8-K | $0.3000 $0.2930 | ▲ +2.33% | ▲ +1.87% | $1.07 (−255.00%) |
Aug 19, 2026 9w ago | 8-K | $0.2089 $0.2185 | ▲ +4.60% | ▲ +4.19% | $1.07 (+409.81%) |
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