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Dec 31, 2023
PDS Biotechnology Q4 2023 Earnings Report
PDS Biotech reported full year 2023 financial results and provided a clinical strategy update.
Key Takeaways
PDS Biotech reported a net loss of $42.9 million for the year ended December 31, 2023. The company is focusing its late-stage clinical strategy on the triple combination of PDS01ADC, PDS0101 (Versamune® HPV), and KEYTRUDA® in advanced head and neck cancer.
The company will focus its late-stage clinical strategy on the triple combination of PDS01ADC, PDS0101 (Versamune® HPV) and KEYTRUDA® in advanced head and neck cancer.
The company has decided to prioritize the triple combination in place of the VERSATILE-003 trial.
The company raised approximately $10.5 million in net proceeds from its “at-the-market” sales agreement during the fourth quarter of 2023.
The company's cash balance as of December 31, 2023, was $56.6 million.
Forward Guidance
PDS Biotech is in discussions with the FDA on the design of a potentially pivotal clinical trial to treat HPV+ HNSCC, with the trial expected to start in 2024.
Positive Outlook
- Company in discussions with the U.S. Food and Drug Administration (FDA) on the design of potentially pivotal clinical trial to treat HPV+ HNSCC, with the trial expected to start in 2024.
- ICI naïve group: 75% of patients remain alive at 36 months. The median OS was not reached.
- Published results show a 36-month survival rate of approximately 20% with ICIs.
- ORR of 75% and complete response of 38% were seen in patients treated with the triple combination.
- Published ORR of <40% seen with immunotherapeutic agents.
Challenges Ahead
- ICI resistant group: 12-month overall survival (OS) rate of 72%, and 63% overall response rate (ORR) in patients with optimal dose of PDS01ADC.
- Median OS approximately 20 months; published 12-month OS rate in HPV-positive ICI-resistant cancer is ~30%; published median OS in HPV-positive ICI-resistant cancer is 3.4 months.
Historical Earnings Impact
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