On November 13, 2026 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a clinical-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, today provided a business and clinical programs update and reported financial results for the quarter ended September 30, 2026.

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"During our third quarter, we continued to execute our strategic prioritization of PDS0301, our investigational tumor-targeted IL-12 immunocytokine, as our lead development program," said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We believe the ongoing clinical trials of PDS0301 at the NCI, along with those of our cancer vaccine platform, support our view that targeted T cell immunotherapy has the potential to change how solid tumors are treated. We are pleased to have the support of Dr. Soon-Shiong and NantWorks, who share our belief in the promise of our immunotherapy platforms and led our PIPE financing of up to $22.3 million, the initial closing of which we completed this quarter."

Clinical and Corporate Update

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Announced the initial closing of a PIPE financing of up to $22.3 million led by Nant Capital, LLC with additional participation from current investors.

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The PIPE includes a contingent milestone closing triggered by the Company’s submission to the FDA of a registrational Phase 3 clinical trial protocol for PDS0301 designed in collaboration with NantWorks, subject to the satisfaction or waiver of applicable closing conditions.

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In connection with the PIPE, the Company entered into an option agreement granting NantWorks, LLC a one-year exclusive right to negotiate an exclusive license for the PDS0101 program.

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Dr. Patrick Soon-Shiong, founder of NantWorks, and James Banaag appointed to the Company’s Board of Directors as Nant Capital designees.

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Appointed three pharma veterans to the Company’s Board of Directors, effective October 18, 2026:

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John Dawson CBE, Deborah Ramsdell, and Bruce Wendel bring deep corporate development, commercialization, and regulatory expertise to the Company.

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Hosted a Key Opinion Leader (KOL) event discussing PDS0301 Phase 2 trials and projected clinical progress.

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The event featured Jonathan M. Hernandez, M.D., an investigator with the Surgical Oncology Program at the National Cancer Institute’s Center for Cancer Research. Dr. Hernandez joined company management to discuss clinical outcomes from PDS0301 in the treatment of advanced liver-associated cancers, with a focus on the metastatic colorectal cancer (mCRC) cohort.

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A replay of the event is available here.

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Announced publication of VERSATILE-002 Phase 2 clinical trial results of PDS0101 with pembrolizumab in HPV16-positive recurrent and/or metastatic (R/M) head and neck cancer in JAMA Oncology.

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Received issuance of a Japanese patent, JP Patent No.7909860, titled Methods and Compositions Comprising Cationic Lipids for Stimulating Type I Interferon Genes. The patent broadly covers compositions and use of the Versamune technology platform broadly for use as a T cell activating immunotherapy. A related US patent, US Patent No. 12,551,460, issued earlier in 2026.

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Received issuance of patents titled HPV16 Non-HLA Restricted T Cell vaccines, Compositions and Methods of Use Thereof in both India and Israel, IN Patent No. 603830 and IL Patent No. 265833. The patents cover the composition and use of PDS0101 being developed to treat HPV16-positive cancers. A related US patent, US Patent No. 11,401,306, issued in 2022.

Third Quarter 2026 Financial Results

The Company’s cash and cash equivalents as of September 30, 2026 were $15.2 million.

Reported net loss was $7.6 million, or $0.11 per basic and diluted share, for the three months ended September 30, 2026, compared to $9.0 million, or $0.19 per basic and diluted share, for the three months ended September 30, 2025.

Research and development expenses were $2.1 million for the three months ended September 30, 2026, compared to $4.6 million for the three months ended September 30, 2025. The decrease of $2.5 million was primarily attributable to decreases of $1.6 million in clinical trial costs, $0.6 million in personnel costs and $0.3 million in manufacturing costs.

General and administrative expenses increased to $3.8 million for the three months ended September 30, 2026 from $3.6 million for the three months ended September 30, 2025. The increase of $0.2 million was primarily attributable to an increase of $0.3 million in professional fees, an increase of $0.1 million in personnel costs offset by a decrease of $0.2 million in stock based compensation costs.

Total operating expenses were $5.9 million for the three months ended September 30, 2026, compared to $8.1 million for the three months ended September 30, 2025.

Net interest expenses were $1.7 million for the three months ended September 30, 2026, compared to $0.9 million for the three months ended September 30, 2025.

(Press release, PDS Biotechnology, NOV 13, 2026, View Source [SID1234674751])