PDS Biotechnology Reports $9.4 Million Net Loss in Q2 2025, Focuses on Clinical Trials

PDS Biotechnology Corporation reported a net loss of $9.4 million for the second quarter of 2025, a 13% increase from the $8.3 million loss recorded in the same period of 2024. For the first half of 2025, the company’s net loss was $17.9 million, slightly improved from $18.9 million in the prior year. The company continues to operate without generating revenue from product sales, as it remains focused on advancing its clinical-stage immunotherapy pipeline, which includes the Versamune® platform and PDS01ADC.

Total operating expenses for the second quarter decreased by 12% to $7.6 million, down from $8.7 million in the previous year. Research and development expenses fell to $4.2 million from $4.5 million, primarily due to reduced manufacturing and personnel costs, although clinical trial costs increased. General and administrative expenses also decreased to $3.4 million from $4.2 million, reflecting lower personnel and professional fees. The company reported no income tax benefit for the quarter, compared to $0.9 million in the prior year, due to the timing of proceeds from the sale of tax benefits.

PDS Biotechnology's cash and cash equivalents stood at $31.9 million as of June 30, 2025, down from $41.7 million at the end of 2024. The decrease in cash was attributed to ongoing operational expenses and the repayment of debt. The company has been actively managing its capital structure, having entered into a securities purchase agreement in April 2025 to raise $20 million through the issuance of senior secured convertible debentures and warrants. This move was part of a broader strategy to retire previous debt and secure funding for ongoing clinical trials.

In terms of operational developments, PDS Biotechnology has made significant strides in its clinical trials. The company announced the initiation of the VERSATILE-003 Phase 3 trial for PDS0101 (Versamune® HPV) in March 2025 and reported positive results from the colorectal cancer cohort of a Phase 2 trial with PDS01ADC in July 2025. These developments indicate a commitment to advancing its product candidates through the clinical pipeline, despite the ongoing financial losses.

Looking ahead, PDS Biotechnology anticipates continued operating losses as it invests in research and development to advance its immunotherapy candidates. The company has acknowledged substantial doubt about its ability to continue as a going concern for at least the next 12 months, emphasizing the need for additional capital to support its operations and clinical programs. The management plans to pursue further equity and debt financing, collaborations, and government funding to sustain its operations and development efforts.