On March 27, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported a clinical programs update and announced financial results for the full year ended December 31, 2024 (Press release, PDS Biotechnology, MAR 27, 2025, View Source [SID1234651534]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased with the progress made over the past year and in recent weeks, culminating with the initiation of our VERSATILE-003 Phase 3 clinical trial evaluating Versamune HPV in recurrent/metastatic ("R/M") HPV16-positive head and neck squamous carcinoma ("HNSCC")," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "Patients with HPV16-positive HNSCC represent a large and rapidly growing subgroup in need of targeted therapies to treat the underlying cause of the cancer. Considering the strength and durability of the clinical responses observed in our VERSATILE-002 study, we are excited that this registrational trial is underway and are confident in the potential of our innovative combination therapy to improve patient outcomes and enhance the standard of care. In the coming weeks, we expect to continue activating additional clinical sites, and look forward to the progression of this registrational trial."

Clinical Strategy Summary

•
Phase 3 VERSATILE-003 Trial in HPV16-positive first-line recurrent and/or metastatic HNSCC

•
Announced activation of the first site in March 2025

•
Trial designed to include approximately 350 patients

•
PDS Biotech is aligned with the U.S. Food and Drug Administration ("FDA") on the design of the registrational trial and clinical endpoints.

■
Two-arm controlled trial with 2:1 randomization

■
Median overall survival is primary endpoint

■
Design based on strong and durable responses seen in the VERSATILE-002 trial

■
Interim readouts included in study design

•
The Company received Fast Track designation from the FDA for the combination of Versamune HPV and pembrolizumab in R/M HNSCC.

•
For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966)

•
In March 2025, announced FDA Clearance of Investigational New Drug ("IND") application for the combination of Versamune MUC1 and PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma.

•
Phase 1/2 clinical trial evaluating the proprietary combination to be run under PDS Biotech’s Cooperative Research and Development Agreement with the National Cancer Institute

•
Second Versamune platform candidate targets MUC1-positive solid tumors

•
In October 2024, updated results from the IMMUNOCERV Phase 2 clinical trial in locally advanced cervical cancer patients treated with Versamune HPV and chemoradiotherapy were presented at the 66th American Society for Radiation Oncology (ASTRO) Annual Meeting.

•
In October 2024, the rationale and design of a recurrent prostate cancer trial combining Xtandi + PDS01ADC vs. Xtandi were presented at the 12th Annual Meeting of the International Cytokine and Interferon Society (Cytokines 2024).

Full Year 2024 Financial Results

Net loss for the year ended December 31, 2024, was approximately $37.6 million, or $1.03 per basic and diluted share, compared to a net loss of $42.9 million, or $1.39 per basic and diluted share, for the year ended December 31, 2023. The reduced net loss was primarily the result of decreased operating expenses, partially offset by increased net interest expense.

Research and development expenses for the year ended December 31, 2024, were $22.6 million, compared to $27.8 million for the year ended December 31, 2023. The decrease of $5.2 million was primarily attributable to decreases in clinical costs of $4.1 million, personnel costs of $1.0 million and professional fees of $0.1 million.

General and administrative expenses for the year ended December 31, 2024, were $13.8 million, compared to $15.3 million for the year ended December 31, 2023. The $1.5 million decrease was primarily attributable to decreases in professional fees of $1.3 million and facilities costs of $0.2 million.

Total operating expenses for the year ended December 31, 2024, were $36.3 million, compared to $43.0 million for the year ended December 31, 2023.

Net interest expense was $2.2 million for the year ended December 31, 2024, compared to $1.3 million for the year ended December 31, 2023. The change was due to increased debt interest and lower interest income on the Company’s cash balances.

On February 27, 2025, the Company announced an up to $22 million registered direct offering. The securities purchase agreements with new and existing healthcare focused institutional investors included $11 million of upfront gross proceeds, with up to an additional $11 million of aggregate gross proceeds upon cash exercise in full of warrants issued to the investors.

The Company’s cash balance as of December 31, 2024, was $41.7 million.

Conference Details

Date: March 27, 2025
Time: 8:00 a.m. Eastern Time
Dial-in: 1-877-704-4453 (Domestic) or 1-201-389-0920 (International)
Webcast Registration: Click Here
Call MeTM Registration: Click Here (Available 15 minutes prior to call)