On August 13, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a clinical-stage biotechnology company focused on developing targeted immunotherapies for cancer, reported a business and clinical programs update and announced financial results for the quarter ended June 30, 2026.
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Clinical and Corporate Update
Announced publication of positive clinical and immunological biomarker data from Stage 1 of the NCI-led metastatic colorectal cancer (mCRC) Phase 2, open-label, single-center, non-randomized clinical trial evaluating PDS0301 (formerly PDS01ADC), the Company’s tumor-targeted IL-12 immunocytokine. The clinical trial results, published in the March 2026 issue of the Journal of Clinical Oncology (JCO) Oncology Advances, included:
Objective response rate (ORR) by RECIST v1.1: 77.8% (7/9) at six months; in the parallel trial without PDS0301, the ORR was 35% (7/20)
24-month survival rate approximately 80%; in the parallel trial without PDS0301, the 24-month survival rate was approximately 35%
Extrahepatic progression-free survival (PFS): median not reached at minimum follow-up of 13.1 months; in the parallel trial without PDS0301, the PFS was 8.1 months
On August 11, 2026, the Company issued a shareholder letter outlining its strategic refocus to prioritize PDS0301, its tumor-targeted IL-12 immunocytokine, as its lead development program. As part of this strategy, the Company will cease further internal investment in PDS0101, including the discontinuation of the VERSATILE-003 Phase 3 trial, and intends to pursue strategic partnerships or other externally funded opportunities for the continued development of PDS0101. The Company believes that concentrating its capital and development resources on PDS0301, while maintaining financial discipline and preserving the potential value of PDS0101 through partnerships, may provide the strongest path toward creating long-term value for patients and shareholders.
Second Quarter 2026 Financial Results
Reported net loss was $9.8 million, or $0.18 per basic and diluted share, for the three months ended June 30, 2026, compared to $9.4 million, or $0.21 per basic and diluted share, for the three months ended June 30, 2025.
Research and development expenses were $3.3 million for the three months ended June 30, 2026, compared to $4.2 million for the three months ended June 30, 2025. The decrease was primarily attributable to lower clinical trial costs, manufacturing costs and personnel costs, partially offset by higher stock-based compensation expense.
General and administrative expenses were $3.2 million for the three months ended June 30, 2026, compared to $3.4 million for the three months ended June 30, 2025. The decrease was primarily attributable to a decrease in professional fees.
Total operating expenses were $6.5 million for the three months ended June 30, 2026, compared to $7.6 million for the three months ended June 30, 2025.
Net interest expenses were $3.3 million for the three months ended June 30, 2026, compared to $1.8 million for the three months ended June 30, 2025. The increase was primarily due to a non-cash charge for loss on retirement of debt, partially offset by lower cash interest payments.
The Company’s cash balance as of June 30, 2026, was $5.6 million.
(Press release, PDS Biotechnology, AUG 13, 2026, View Source [SID1234670096])