PDS Biotechnology | 8-K: FY2025 Q3 Revenue: USD 0

Revenue: As of FY2025 Q3, the actual value is USD 0.

EPS: As of FY2025 Q3, the actual value is USD -0.19, beating the estimate of USD -0.205.

EBIT: As of FY2025 Q3, the actual value is USD -7.271 M.

Third Quarter 2025 Financial Results

Net Loss

• Reported net loss was $9.0 million, or $0.19 per basic and diluted share, for the three months ended September 30, 2025, compared to $10.7 million, or $0.29 per basic and diluted share, for the three months ended September 30, 2024. The decrease in net loss was primarily due to lower operating expenses.

Research and Development Expenses

• Research and development expenses were $4.6 million for the three months ended September 30, 2025, compared to $6.8 million for the three months ended September 30, 2024. The decrease was primarily due to lower manufacturing and clinical expenses and personnel costs.

General and Administrative Expenses

• General and administrative expenses were $3.6 million for the three months ended September 30, 2025, compared to $3.4 million for the three months ended September 30, 2024. The increase was primarily due to higher professional fees, partially offset by lower personnel costs.

Total Operating Expenses

• Total operating expenses were $8.1 million for the three months ended September 30, 2025, compared to $10.2 million for the three months ended September 30, 2024.

Net Interest Expense

• Net interest expense was $0.9 million for the three months ended September 30, 2025, compared to $0.5 million for the three months ended September 30, 2024. The increase was primarily due to lower interest income from the Company’s cash deposits.

Cash Balance

• The Company’s cash balance as of September 30, 2025 was $26.2 million, compared to $41.7 million as of December 31, 2024.

Stock Sale

• On November 12, 2025, the Company sold 5,800,000 common stock (or prefunded warrants in lieu thereof), as well as 5,800,000 accompanying warrants, for gross proceeds of approximately $5.3 million.

Outlook / Guidance

• The company plans to seek an accelerated approval pathway in the VERSATILE-003 Phase 3 randomized trial for PDS0101 in combination with pembrolizumab versus pembrolizumab monotherapy. The proposed amendment to the statistical analysis plan could reduce trial size while maintaining statistical power, with progression-free survival (PFS) becoming a surrogate primary endpoint for accelerated approval. Median overall survival (mOS) will remain as the primary endpoint for full approval as originally recommended by the FDA.