In This Article:
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Net Loss: $37.6 million or $1.03 per basic and diluted share for the year ended December 31, 2024.
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Previous Year Net Loss: $42.9 million or $1.39 per basic and diluted share.
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Research and Development Expenses: $22.6 million in 2024, down from $27.8 million in 2023.
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General and Administrative Expenses: $13.8 million in 2024, down from $15.3 million in 2023.
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Total Operating Expenses: $36.3 million in 2024, compared to $43 million in 2023.
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Net Interest Expense: $2.2 million in 2024, up from $1.3 million in 2023.
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Cash Balance: $41.7 million as of December 31, 2024.
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Registered Direct Offering: Up to $22 million announced on February 27, 2025, with $11 million upfront gross proceeds.
Release Date: March 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
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PDS Biotechnology Corp (NASDAQ:PDSB) initiated the VERSATILE-003 phase 3 clinical trial for HPV16 positive head and neck cancer, which is a significant step forward in their clinical development program.
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The VERSATILE-002 phase 2 study showed promising results with a median overall survival of 30 months, significantly higher than the 17.9 months for Pembrolizumab alone.
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The company received FDA clearance for their investigational new drug application for a combination therapy targeting metastatic colorectal cancer, expanding their pipeline.
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PDS Biotechnology Corp (NASDAQ:PDSB) has a strong relationship with the National Cancer Institute, which supports their research and development efforts.
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The company successfully raised $11 million in a direct offering, providing additional funding to support ongoing clinical trials.
Negative Points
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PDS Biotechnology Corp (NASDAQ:PDSB) reported a net loss of $37.6 million for the year ended December 31, 2024, indicating ongoing financial challenges.
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The company does not currently have enough funds to complete the VERSATILE-003 trial and will need to raise additional capital.
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There are uncertainties regarding the enrollment rates and timelines for the VERSATILE-003 trial, which could impact the trial's progress.
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The funding environment is challenging, and the company may need to explore various options, including debt, to secure necessary capital.
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The TARP program for prostate cancer is not currently prioritized, with no specific timelines provided for its progression.
Q & A Highlights
Q: Can you provide an update on the enrollment trajectory for the VERSATILE-003 trial and the balance of sites familiar with Versamune versus new sites? A: (Kirk Shepard, Chief Medical Officer) We initiated the first site this month, and almost all sites from the phase 2 trial are re-engaged for phase 3, which helps due to their familiarity with the drug. This familiarity is speeding up the process, and we are tracking well with patient accrual.