• Net Loss: $37.6 million or $1.03 per basic and diluted share for the year ended December 31, 2024.
• Previous Year Net Loss: $42.9 million or $1.39 per basic and diluted share.
• Research and Development Expenses: $22.6 million in 2024, down from $27.8 million in 2023.
• General and Administrative Expenses: $13.8 million in 2024, down from $15.3 million in 2023.
• Total Operating Expenses: $36.3 million in 2024, compared to $43 million in 2023.
• Net Interest Expense: $2.2 million in 2024, up from $1.3 million in 2023.
• Cash Balance: $41.7 million as of December 31, 2024.
• Registered Direct Offering: Up to $22 million announced on February 27, 2025, with $11 million upfront gross proceeds.

• Warning! GuruFocus has detected 1 Warning Sign with PDSB.

Release Date: March 27, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• 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.
• 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.
• The company received FDA clearance for their investigational new drug application for a combination therapy targeting metastatic colorectal cancer, expanding their pipeline.
• PDS Biotechnology Corp (NASDAQ:PDSB) has a strong relationship with the National Cancer Institute, which supports their research and development efforts.
• The company successfully raised $11 million in a direct offering, providing additional funding to support ongoing clinical trials.

Negative Points

• PDS Biotechnology Corp (NASDAQ:PDSB) reported a net loss of $37.6 million for the year ended December 31, 2024, indicating ongoing financial challenges.
• The company does not currently have enough funds to complete the VERSATILE-003 trial and will need to raise additional capital.
• There are uncertainties regarding the enrollment rates and timelines for the VERSATILE-003 trial, which could impact the trial's progress.
• The funding environment is challenging, and the company may need to explore various options, including debt, to secure necessary capital.
• 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.

Q: How do you view the current funding environment for your studies, given your cash balance? A: (Lars Boesgaard, Chief Financial Officer) We recently raised $11 million, and while the funding environment is challenging, we plan to raise necessary capital in a stepwise manner as we progress with our phase 3 trial. We will consider all options, including equity and non-dilutive sources like debt, while balancing against shareholder dilution.

Q: Can you explain the rationale for the reduced patient sample size in the VERSATILE-003 trial and the interim data readouts? A: (Frank Bedu-Addo, CEO) The trial size was reduced from over 400 to 350 patients due to significant durability of responses and improved clinical outcomes observed in the VERSATILE-002 trial. This allowed us to maintain statistical power while reducing the sample size. The trial design includes two interim data readouts, approximately six months and 12 months after full enrollment, based on specific death events, to potentially discuss accelerated approval with the FDA.

Q: What role might business development play in funding pipeline programs? A: (Lars Boesgaard, CFO) While we are focused on Versatile-003, we have been successful in partnering with institutions like the National Cancer Institute to progress other trials. We are exploring all funding options, including partnerships, but our primary focus remains on the phase 3 trial.

Q: What is the status of the MUC1 and TARP programs, and their timelines? A: (Frank Bedu-Addo, CEO) The MUC1 program is led by the National Cancer Institute, and we await their timeline for starting the trial. We have not provided timelines for the TARP program yet, as our current focus is on Versamune HPV and MUC1. We will provide guidance on TARP once we have more clarity on the other programs' progress.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.