NASDAQ$PDSB
PDS Biotechnology Corporation · Q4 2023 earnings
Q4 2023 earnings · · Investor relations
Briefing
PDS Biotech reported full year 2023 financial results and provided a clinical strategy update.
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.
Headline financials
Revenue & EPS history
PDS Biotechnology · Revenue · Quarterly
$0
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.
Tailwinds
- 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.
Headwinds
- 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.
- Responses were seen in all HPV-positive tumor types.
- Net loss for the year ended December 31, 2023, was approximately $42.9 million, or $1.39 per basic and diluted share
- The higher net loss was primarily the result of increased operating loss and increased net interest expense.
Historical earnings impact
How earnings announcements have historically affected this stock's price.
Avg. return before/after earnings
Based on 20 quarterly earnings reports · overlaid with Q4 2023
+1.3%
Avg return
Earnings day
+2.0%
Avg return
5 days after
+2.0%
Avg return
30 days after
52%
22 / 42 earnings
Positive
+55.0%
Q3 2022
Best reaction
-27.2%
Q3 2024
Worst reaction
| Quarter | Report date | Reaction (Day 0) | +5 days | +30 days |
|---|---|---|---|---|
| Q4 2026 | +0.1% | +5.7% | -3.8% | |
| Q3 2025 | -12.2% | -18.2% | +1.0% | |
| Q2 2025 | -4.9% | +0.8% | -5.7% | |
| Q1 2025 | +4.8% | +15.0% | +37.8% | |
| Q4 2024 | +0.8% | -12.9% | +0.8% | |
| Q3 2024 | -27.2% | -24.0% | -33.2% | |
| Q2 2024 | -1.0% | +6.6% | +0.0% | |
| Q1 2024 | -0.3% | -4.4% | -21.2% | |
| Q4 2023 | -11.6% | -10.3% | -27.0% | |
| Q3 2023 | +20.3% | +19.7% | +2.9% | |
| Q2 2023 | +21.2% | +17.1% | +13.2% | |
| Q1 2023 | +5.0% | +14.9% | -7.4% | |
| Q4 2022 | +2.2% | -4.7% | +1.0% | |
| Q3 2022 | +55.0% | +54.5% | +64.3% | |
| Q2 2022 | +0.2% | +1.9% | -21.7% | |
| Q1 2022 | -14.3% | +15.2% | -21.7% | |
| Q4 2021 | -1.1% | -1.0% | -12.1% | |
| Q3 2021 | -1.6% | +2.2% | -14.6% | |
| Q2 2021 | +0.6% | -6.5% | +44.5% | |
| Q1 2021 | +8.2% | +27.0% | +174.1% | |
| Q4 2020 | +1.9% | -5.3% | +2.3% | |
| Q3 2020 | -0.5% | -1.9% | +3.8% | |
| Q2 2020 | -5.1% | +0.7% | -26.5% | |
| Q1 2020 | -2.3% | -1.8% | +39.3% | |
| Q4 2019 | +2.3% | -7.9% | +29.6% | |
| Q3 2019 | +0.0% | -14.0% | -3.4% | |
| Q2 2019 | +1.1% | -0.5% | -15.2% | |
| Q1 2019 | +43.0% | +18.6% | +6.4% | |
| Q4 2018 | +3.8% | +2.6% | -1.7% | |
| Q3 2018 | -2.8% | -4.9% | -6.2% | |
| Q2 2018 | +1.3% | +0.0% | -4.3% | |
| Q1 2018 | -6.4% | -3.6% | -15.3% | |
| Q4 2017 | +1.5% | +9.4% | -92.2% | |
| Q3 2017 | +1.2% | -2.2% | -8.0% | |
| Q2 2017 | -1.2% | -3.1% | -2.0% | |
| Q1 2017 | +2.8% | +2.4% | +3.2% | |
| Q4 2016 | -9.5% | -8.8% | -7.1% | |
| Q3 2016 | -6.3% | -0.6% | +9.9% | |
| Q2 2016 | +1.9% | +0.1% | -4.6% | |
| Q1 2016 | -4.2% | — | — | |
| Q4 2015 | -14.2% | — | — | |
| Q3 2015 | +0.5% | — | — | |
| Q2 2015 | — | — | — | |
| Q1 2015 | — | — | — | |
| Q4 2014 | — | — | — | |
| Q3 2014 | — | — | — |
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