PDS Biotechnology Corp Q3 FY2024 earnings call

Clinical Trial Updates

• VERSATILE-003 Phase 3 trial: Evaluating Versamune HPV + pembrolizumab vs pembrolizumab alone for first line recurrent and/or metastatic HPV16-positive HNSCC. Minor modifications made to trial design to reduce cost and time, updated protocol submitted to FDA, expected mid-December clearance. VERSATILE-002 study data showed improved median overall survival, objective response rate, disease control rate, etc.
• Engagement with stakeholders: Met with key opinion leaders and conducted survey of oncologists, finding HPV-positive head and neck cancers are increasing, with at least 70% of new patients being HPV 16-positive.
• Pipeline: Investigating Versamune HPV in neoadjuvant setting with Keytruda (ongoing Phase 2 trial), and IMMUNOCERV Phase 2 trial data on Versamune HPV with chemoradiation for cervical cancer showed promising activity and safety.

No detailed segment performance by product segments provided in the transcript. Financials noted: net loss for Q3 2024 was ~$10.7 million, research & development expenses increased to ~$6.8 million, general administrative expense decreased to ~$3.4 million, net interest expenses increased to ~$0.5 million, cash and cash equivalents at $30, 2024 totaled ~$50 million.

Forward-Looking Statements

• Expect FDA clearance of updated VERSATILE-003 protocol by mid-December 2024.
• Intend to start VERSATILE-003 trial with targeted sites from existing resources, ramp up sites with additional capital, expect first site initiation in Q1 2025.
• Estimate VERSATILE-003 enrollment to take approximately 18 months, with first interim data readout expected ~6 months after enrollment completion.

Risks Discussed

• Uncertainties in clinical trial enrollment rates affecting timeline for data readout.
• Potential delays in FDA approval process for the VERSATILE-003 trial.
• Competition in the HPV-positive head and neck cancer treatment space, which could impact market acceptance of Versamune HPV.

Q: When would you expect interim look at your VERSATILE-003 data and then what's your latest thinking on the opportunity for VERSATILE-003, since I think the landscape has changed a little bit since when you first started the program?

A: Frank Bedu-Addo discussed analysis showing KEYNOTE-689 doesn't significantly impact their population, estimate 18 months enrollment, ~6 months interim data after enrollment. Survey and KOL feedback showed HPV-positive population is increasing and KEYNOTE-689 doesn't impact their specific population.

Q: You showed promising data from IMMUNOCERV at ASTRO. I was expecting to see if you are planning any Phase 3 in near future? And also I was curious to know how you position yourself with Merus EGFR bispecific in first-line head and neck cancer?

A: Frank Bedu-Addo said IMMUNOCERV data was encouraging, positioning focuses on HPV-specific, Merus data lacks survival in HPV-positive, FDA emphasizes overall survival as endpoint. Merus' approach is different, focusing on EGFR bispecific, while PDS' is HPV-specific with strong survival data in VERSATILE-002.

Q: The previous design of the VERSATILE-003 trial had an arm with the combination of first immune HPV, pembrolizumab and PDS01ADC similar to the triple therapy Phase 2 trial. What is the status of that arm and plans to develop ADC01?

A: Frank Bedu-Addo said focus is on two-arm study first, dose optimization of PDS01ADC in parallel, current focus on getting VERSATILE-003 running. FDA agreed to focus on two-arm first, then dose optimization of triple in parallel.