PDS Biotechnology (PDSB) investor relations material

Drug development pipeline and strategic focus

• Two advanced immunotherapy assets target solid tumors with high unmet need, leveraging proprietary platforms and partnerships with the National Cancer Institute.

• PDS0301, a tumor-targeted IL-12 immunocytokine, is advancing toward Phase 3 in metastatic colorectal cancer (mCRC) with liver metastases, showing strong efficacy and survival data.

• PDS0101, a Versamune-based HPV16 cancer vaccine, demonstrated extended median overall survival in head and neck cancer and is seeking external funding for further development.

• Five key data readouts for PDS0301 are expected between Q4 2026 and Q2 2028 across multiple solid tumor indications.

• Recent financing led by Nant Capital supports late-stage development, with additional funding contingent on Phase 3 protocol submission.

PDS0301 mechanism and clinical results

• PDS0301 fuses IL-12 to an antibody targeting necrotic tumor cells, concentrating immune activation in the tumor microenvironment and reducing systemic exposure.

• In a Phase 2 trial for mCRC with liver metastases, PDS0301 plus chemotherapy achieved a 71.4% objective response rate at six months and approximately 80% 24-month survival, outperforming benchmarks.

• Over 380 patients have been dosed with PDS0301 in Phase 1 and 2 trials, with promising interim results in metastatic castration-resistant prostate cancer.

• The therapy is designed to activate NK and CD8+ T cells, suppress immune-suppressive cells, and promote durable anti-tumor responses.

• Multiple NCI-partnered trials are ongoing in colorectal, prostate, and Kaposi sarcoma indications.

PDS0101 platform and clinical outcomes

• PDS0101 uses the Versamune platform to generate potent, durable CD8+ and CD4+ T cell responses against HPV16-positive tumors.

• In combination with pembrolizumab, PDS0101 achieved a median overall survival of 39.3 months in HPV16-positive recurrent/metastatic head and neck cancer, far exceeding published benchmarks.

• The combination therapy showed a 77.4% disease control rate and 35.8% objective response rate, with 21% of patients experiencing near or complete tumor regression.

• PDS0101 was well-tolerated, with a low incidence of severe adverse events.

• The program holds FDA Fast Track designation and is positioned as the only subcutaneous combination therapy in late-stage development for this indication.