Mayank Mamtani

Robert LeBoyer

James Molloy

Joseph Pantginis

Louise Chen

- PDS Biotechnology Corporation has requested a meeting with the FDA to explore an **expedited approval pathway for PDS0101** in HPV16-positive Head and Neck Cancer.  **[1472091_0001140361-25-039656_ef20057871_ex99-1.htm:0]** **[1472091_0001140361-25-039656_ef20057871_8k.htm:1]** 
- This request is based on final VERSATILE-002 trial data, which demonstrated a median Progression Free Survival (PFS) of **6.3 months** and a median Overall Survival (mOS) of **39.3 months**.  **[1472091_0001140361-25-039656_ef20057871_ex99-1.htm:0]** 
- The company proposes to amend the ongoing VERSATILE-003 Phase 3 trial to include PFS as an earlier primary endpoint, potentially allowing for an accelerated approval submission.  **[1472091_0001140361-25-039656_ef20057871_ex99-1.htm:0]** 
- The VERSATILE-003 trial will be **temporarily paused** during the FDA's review of the proposed amendment, though treatment for currently enrolled patients will continue.  **[1472091_0001140361-25-039656_ef20057871_ex99-1.htm:0]**

PDS Biotech Seeks Expedited Approval Pathway for PDS0101 in HPV16-Positive Head and Neck Cancer

- PDS Biotechnology is seeking an **expedited approval pathway** for PDS0101 in HPV16-positive Head and Neck Cancer, based on final results from its VERSATILE-002 trial.  **[1472091_8ad37eadc6f541d38d2f0bbd64664b49_0]** 
- The **VERSATILE-002 trial** data showed a median Progression Free Survival (PFS) of **6.3 months** and a median Overall Survival (mOS) of **39.3 months**.  **[1472091_8ad37eadc6f541d38d2f0bbd64664b49_0]** 
- The company has requested a meeting with the FDA to amend the **VERSATILE-003 Phase 3 trial** to include PFS as an earlier primary endpoint, which could lead to accelerated approval.  **[1472091_8ad37eadc6f541d38d2f0bbd64664b49_0]** 
- The VERSATILE-003 trial will be **temporarily paused** while the proposed amendment undergoes FDA review, though treatment for currently enrolled patients will continue.  **[1472091_8ad37eadc6f541d38d2f0bbd64664b49_0]**

PDS Biotechnology seeks expedited approval pathway for PDS0101

- PDS Biotechnology Corporation announced a sub-analysis from its recently completed **VERSATILE-002 Phase 2 clinical trial**, evaluating PDS0101 (Versamune® HPV) + Keytruda® in patients with HPV16-positive first-line recurrent and/or metastatic head and neck squamous cell cancer.  **[1472091_0001140361-25-035339_ef20055698_ex99-1.htm:0]** 
- In the difficult-to-treat cohort of patients with low PD-L1 expression (CPS 1-19), the combination therapy achieved a **median overall survival (mOS) of 29.5 months**.  **[1472091_0001140361-25-035339_ef20055698_ex99-1.htm:0]** 
- This mOS of **29.5 months** significantly surpasses the published mOS of **10.8 months** for Keytruda® monotherapy and **12.3 months** for Keytruda® plus chemotherapy in the same CPS cohort.  **[1472091_0001140361-25-035339_ef20055698_ex99-1.htm:0]** 
- This low PD-L1 expression cohort comprised approximately **60%** of the patients (n=32) enrolled in the VERSATILE-002 trial.  **[1472091_0001140361-25-035339_ef20055698_ex99-1.htm:0]**

PDS Biotech announces extended survival in VERSATILE-002 trial sub-analysis

- PDS Biotechnology Corporation filed an 8-K on **August 25, 2025**, to announce the update of its corporate presentation deck.  **[1472091_0001140361-25-032503_ef20054434_8k.htm:0]** **[1472091_0001140361-25-032503_ef20054434_8k.htm:1]** 
- The updated presentation highlights **positive Phase 2 trial results** for **PDS0101** in HPV16+ 1L R/M HNSCC, showing a **median overall survival of 39.3 months**.  **[1472091_0001140361-25-032503_ef20054434_ex99-1.htm:4]** **[1472091_0001140361-25-032503_ef20054434_ex99-1.htm:5]** **[1472091_0001140361-25-032503_ef20054434_ex99-1.htm:7]** 
- **PDS0101** is currently in a **pivotal Phase 3 clinical trial (VERSATILE-003)** for 1L R/M HPV16+ HNSCC, with enrollment anticipated to be complete in **1H 2026**.  **[1472091_0001140361-25-032503_ef20054434_ex99-1.htm:4]** **[1472091_0001140361-25-032503_ef20054434_ex99-1.htm:5]** **[1472091_0001140361-25-032503_ef20054434_ex99-1.htm:7]** 
- The company also detailed its **PDS01ADC pipeline**, which includes Phase 2 investigator-initiated trials for other cancer indications.  **[1472091_0001140361-25-032503_ef20054434_ex99-1.htm:4]** **[1472091_0001140361-25-032503_ef20054434_ex99-1.htm:7]**

PDS Biotechnology (PDSB)