PDS Biotechnology Corp (PDSB) has announced its financial results for the third quarter of 2024, alongside updates on its clinical development programs. The company, focused on utilizing its Versamune platform technology for cancer immunotherapy, is currently advancing its VERSATILE-003 Phase 3 trial. This trial is evaluating the combination of Versamune® HPV with pembrolizumab for the treatment of HPV16-positive head and neck squamous cell cancer.
Financial Overview
The company reported a net loss of $10.7 million, or $0.29 per share, for Q3 2024, slightly better than the $10.8 million loss reported in Q3 2023. Revenue remained in line with expectations at $0.00 million. Research and development expenses increased to $6.8 million, driven primarily by higher manufacturing costs associated with the clinical trials. General and administrative expenses saw a decrease, falling to $3.4 million from $4.1 million in the previous year, attributed to lower personnel costs and professional fees. As of September 30, 2024, PDS Biotech held $49.8 million in cash and cash equivalents.
VERSATILE-003 Trial Update
The VERSATILE-003 trial remains a key focus for PDS Biotechnology. This Phase 3 study is investigating the efficacy of Versamune® HPV in combination with pembrolizumab for patients with HPV16-positive head and neck squamous cell cancer. Recent modifications to the trial design have been implemented to reduce overall costs and accelerate the timeline for data readout. These changes were made based on feedback from investors, key opinion leaders, and other experts involved with the study.
"Based on investor feedback, discussions with key opinion leaders involved with the study and other experts, we have made minor modifications to the VERSATILE-003 trial design to reduce the overall cost and time required to achieve an interim data readout and trial completion," said Frank Bedu-Addo, PhD, President and CEO of PDS Biotech.
Strategic Focus and Future Outlook
PDS Biotechnology Corp is strategically focused on advancing its clinical programs and refining its trial designs to optimize efficiency and reduce costs. The company's financial health and strategic adjustments will be critical in determining its long-term viability and success in the biotechnology sector. The upcoming FDA decision on the updated IND application could significantly impact the company's clinical and financial trajectory.
