PDS Biotechnology Q2 2023 Earnings Report
Key Takeaways
PDS Biotech reported a net loss of $11.5 million for the second quarter of 2023, driven by increased research and development expenses. The company is progressing with its lead candidate, PDS0101, and anticipates initiating a Phase 3 clinical trial in Q4 2023.
Submitted final clinical protocol to FDA for Phase 3 VERSATILE-003 trial, expected to begin in Q4 2023.
Biomarker data from VERSATILE-002 to be presented at ESMO 2023.
Presented interim data at ASCO 2023 for VERSATILE-002, showing a 12-month overall survival rate of 87%.
PDS Biotech added to Russell 2000 and Russell 3000 Indexes in June 2023.
PDS Biotechnology
PDS Biotechnology
Forward Guidance
PDS Biotech believes its current cash resources are sufficient to fund operations and research and development programs for 12 months following the filing of the Company’s June 2023 Quarterly Report on Form 10-Q.
Positive Outlook
- Initiate Phase 3 VERSATILE-003 trial in Q4 2023
- Present Biomarker data from VERSATILE-002 at ESMO 2023
- PDS0301 may overcome safety and efficacy limitations of current cytokines
- PDS0101 has a statistically significant additive effect over published results of ICI monotherapy
- Completed enrollment in the ICI naĂŻve arm and expect final data readout in mid-2024
Challenges Ahead
- Dependence on additional financing to fund its operations
- Limited operating history in the Company’s current line of business to evaluate the Company’s prospects
- The timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® and Infectimune® based product candidates
- Future success of clinical trials
- Legislative, regulatory, political and economic developments not within the Company’s control