PDS Biotechnology Corp Q3 FY2023 earnings call

• PDS01ADC clinical data continues to advance with safety data from over 250 patients, showing reduced adverse events and enhanced clinical activity. It's being developed as monotherapy, in combination with Versamune-based approaches, and with standard of care. • VERSATILE-002 trial had positive KOL event with 24-month overall survival rate of 74% for PDS0101 plus KEYTRUDA in ICI naive group, 81% disease control, 60% tumor shrinkage, and 27% objective response rate. Biomarker data shows TH1 immunologic profile and CD8 T-cell traffic to tumors. • IMMUNOCERV trial data showed PDS0101 plus chemoradiotherapy associated with rapid decline in HPV positive circulating tumor DNA. • Triple combination trial (PDS0101, PDS01ADC, ICI) showed 75% objective response rate in ICI naive group and 75% 24-month survival rate. In ICI resistant group, PDS01ADC promoted strong objective responses. • PDS01ADC in combination with docetaxel in prostate cancer showed well-tolerated, over 60% PSA reduction, and activation of T-cells, NK cells, and NKT cells. • Preclinical studies with PDS0103 in combination with HDAC inhibitors showed superior anti-tumor activity in ICI resistant tumor models, with plan to start clinical trial in first half of 2024.

There is no detailed breakdown of product segments with revenue contributions provided in the transcript. Financials discussed include net loss, research and development costs, and general and administrative expenses. For the three months ended September 30, 2023, net loss was approximately $10.8 million, research and development costs increased to $6.4 million, and general and administrative expenses were $4.1 million.

• Anticipate initiating VERSATILE-003 Phase III clinical trial in first quarter of 2024. Available cash resources expected to sustain operations into third quarter of 2024. • Expect final data readouts from VERSATILE-002 in second quarter of 2024. Plan to start PDS0103 clinical trial in first half of 2024. Hopeful to see data from neoadjuvant trial in Mayo Clinic, immunotherapy cervical cancer trial, and PDS01ADC prostate cancer trials in 2024. • Working to finalize details of VERSATILE-003 trial with 60 sites identified, aiming for 100 sites, and will provide clearer timelines on interim data readout as sites are opened and enrolled.

• Uncertainty in clinical trial timelines and enrollment rates for VERSATILE-003 trial. • Dependence on obtaining additional capital through collaborations, alliances, or financing to sustain operations and development. • Risks associated with regulatory approvals and the potential for actual results to differ from forward-looking statements due to various uncertainties.

Q: What are the key milestones and catalysts for 2024?

A: Key milestones include initiating VERSATILE-003 Phase III trial, final data readouts from VERSATILE-002 in second quarter 2024, starting PDS0103 clinical trial in first half 2024, expecting data from neoadjuvant trial in Mayo Clinic, immunotherapy cervical cancer trial, and PDS01ADC prostate cancer trials in 2024.

Q: How to think about OPEX for fourth quarter 2023 and 2024 in light of VERSATILE-003 Phase III?

A: There will be some ramp-up in Q4 2023, and as VERSATILE-003 Phase III starts, OPEX will increase with front-loaded costs for CROs and consultants, but the company has cash to sustain into third quarter 2024.

Q: How to position PDS0101 and PDS01ADC programs?

A: Doublet of PDS0101 and KEYTRUDA presents straightforward regulatory pathway and rapid approval potential for early use. Triple combination in ICI resistant population presents quickest path to approval and potential for tumor agnostic application, with data showing biological activity of both drugs.

Q: Details on VERSATILE-003 trial design?

A: The delta in results is significant, with risk mitigation strategies considering control arm doing better than published data and study design to overpower primary endpoints of overall survival.

Q: Development plan for PDS0202 universal flu vaccine?

A: Hopeful to move to Phase I/II human clinical trial next year, demonstrating broadly reactive neutralizing antibodies in humans, safety, and potential prevention against flu infection.

Q: Updates on PDS0103, PDS0102, and PDS0104?

A: PDS0103 plan to start first half 2024 with finalizing CMC and IND filing. PDS0102 tech transfer and formulation development completed, targeting prostate cancer. PDS0104 has no additional progress reported yet.