PDS Biotechnology Reports $37.6 Million Net Loss for 2024, Sees Improvement from Previous Year

PDS Biotechnology Corp. (PDSB) reported a net loss of $37.6 million for the year ended December 31, 2024, a 12% improvement compared to the $42.9 million net loss in 2023. The company attributed the improvement to a decrease in research and development expenses, primarily due to lower clinical costs ($4.1 million), personnel costs ($1.0 million), and professional fees ($0.1 million). General and administrative expenses also decreased by $1.5 million, mainly from lower professional fees ($1.3 million) and facility costs ($0.2 million). However, interest expense increased by $0.5 million due to the August 2022 venture loan and security agreement with Horizon Technology Finance Corporation.

The company's revenue remained at zero for the year, with no commercial product sales. PDS Biotech anticipates continued losses for the foreseeable future, pending regulatory approvals and successful commercialization of its Versamune®, Versamune® in combination with PDS01ADC, and Infectimune® product candidates. As of December 31, 2024, the company held $41.7 million in cash and cash equivalents. During 2024, the company sold 3,428,681 shares of common stock for net proceeds of $19.5 million and 1,108,105 shares for $3.2 million under at-the-market issuance sales agreements. In February 2025, a further $10.05 million in net proceeds was raised through a securities purchase agreement.

Significant developments during the year included the completion of a Type B meeting with the FDA in February 2023 for a triple combination therapy involving Versamune® HPV, PDS01ADC, and an FDA-approved immune checkpoint inhibitor. The company also presented updated data from several ongoing Phase 2 clinical trials at various medical conferences throughout the year, including the American Society of Clinical Oncology (ASCO), the European Society for Medical Oncology (ESMO), and the American Society for Radiation Oncology (ASTRO). These trials evaluated Versamune® HPV in combination with Keytruda® (pembrolizumab) and chemoradiation, as well as PDS01ADC in combination with docetaxel. In January 2025, an Investigational New Drug (IND) application was submitted to the FDA for a Phase 1 trial of PDS0103 and PDS01ADC in colorectal cancer.

PDS Biotech employed 24 full-time employees as of December 31, 2024. The company's financial statements included in the 10-K filing indicate an accumulated deficit of $182.1 million as of December 31, 2024, and highlight conditions raising substantial doubt about the company's ability to continue as a going concern within one year. The company's future funding requirements will depend on the progress of clinical trials, regulatory approvals, and potential collaborations. The company's 10-K filing also details numerous risk factors, including those related to clinical development, regulatory approvals, competition, intellectual property, and financing.

The company's outlook is contingent upon the successful completion of ongoing and planned clinical trials, securing regulatory approvals for its product candidates, and establishing successful commercialization strategies. The company acknowledges significant risks and uncertainties associated with its business, including the possibility of incurring further losses and the need for additional funding. The company does not anticipate paying cash dividends in the foreseeable future.