Release Date: November 14, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Strong interest from investors and investigators in the VERSATILE-003 Phase III trial, indicating confidence in the study's potential.
- Updated VERSATILE-003 trial design aims to reduce costs and time to achieve interim data readout while maintaining statistical power.
- Encouraging data from the VERSATILE-002 study shows improved median overall survival and objective response rates compared to pembrolizumab alone.
- Positive feedback from key opinion leaders and oncologists supports the potential of Versamune HPV as a targeted immunotherapy for HPV16-positive head and neck cancer.
- PDS Biotechnology Corp (PDSB, Financial) has a solid financial position with approximately $50 million in cash and cash equivalents as of September 30, 2024.
Negative Points
- The net loss for the quarter was approximately $10.7 million, indicating ongoing financial challenges.
- Research and development expenses increased, primarily due to higher manufacturing costs, which could impact future financial performance.
- The evolving clinical trial landscape, including Merck's KEYNOTE-689 trial, presents potential competitive challenges.
- The company faces uncertainties related to FDA approval timelines and the impact of other treatments on their target population.
- The need for additional capital to expand the number of trial sites for VERSATILE-003 could delay broader trial implementation.
Q & A Highlights
Q: When would you expect an interim look at your VERSATILE-003 data, and what's your latest thinking on the opportunity for VERSATILE-003 given the changing landscape?
A: We expect to start the VERSATILE-003 trial in the first quarter of 2025, with an interim data readout approximately 6 months after completing enrollment, which we estimate will take about 18 months. Regarding the landscape, despite the KEYNOTE-689 trial, our target population of HPV16-positive patients remains unaffected, as these patients are typically not candidates for surgery, which is a criterion for KEYNOTE-689.
Q: Are there plans for a Phase III trial for IMMUNOCERV, and how do you position yourself against Merus' EGFR bi-specific in first-line head and neck cancer?
A: We are encouraged by the IMMUNOCERV data and are consulting with key opinion leaders to determine the next steps. Regarding Merus, their approach is different, focusing on EGFR antibodies. Our focus is on HPV16-specific head and neck cancer, with promising data showing significant tumor shrinkage and durability of response.
Q: What is the status of the VERSATILE-003 trial arm with the combination of Versamune HPV, pembrolizumab, and PDS01ADC?
A: The FDA agreed that the fastest path to approval is focusing on the two-arm study of Versamune HPV and pembrolizumab. We will conduct dose optimization for PDS01ADC in parallel and determine the best timing to add it to the study.
Q: How do you view the impact of Merus' data on your strategy, given their high objective response rate in HPV-positive patients?
A: While Merus' data is impressive, our focus is on overall survival, which the FDA emphasizes as the endpoint for approval. Our data shows significant tumor shrinkage and durability, with 21% of patients experiencing near-complete tumor elimination, which is unparalleled.
Q: What are the next steps for the development of Versamune HPV for cervical cancer following the promising IMMUNOCERV trial results?
A: We are reviewing the data with key opinion leaders to determine the next steps for Versamune HPV in cervical cancer. The results are encouraging, showing high overall survival and progression-free survival rates, and we aim to position the product effectively in the cervical cancer space.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
