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

Total Revenue

$0.00

No prior period
EPS (adj)

-$0.35

Previous: -$0.67+47.8%
G&A Expenses

$15.3M

No prior period
Weighted Avg Shares

31.0M

No prior period
R&D Expenses

$27.8M

No prior period
Total Operating Expenses

$43M

No prior period
Net Interest Expense

-$1.3M

No prior period
Net Income

-$42.9M

Previous: -$21.5M-99.4%
Operating Income

-$43M

Previous: -$18.8M-128.7%
Gross Profit

$0.00

No prior period
R&D Expense

$7.47M

No prior period
Stock-Based Comp

$1.35M

Previous: $1.37M-1.4%

Revenue & EPS history

PDS Biotechnology · Revenue · Quarterly

$0

Q4 2023

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

Historical avgQ4 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

Earnings price reactions
QuarterReport dateReaction (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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