On May 14, 2025 PDS Biotechnology Corporation (Nasdaq: PDSB) ("PDS Biotech" or the "Company"), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers, reported a clinical and corporate update and announced financial results for the first quarter ended March 31, 2025 (Press release, PDS Biotechnology, MAY 14, 2025, View Source [SID1234653072]).

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"The first quarter of 2025 and recent weeks have been productive for PDS Biotech, highlighted by the initiation of our VERSATILE-003 Phase 3 clinical trial evaluating Versamune HPV in recurrent/metastatic ("R/M") HPV16-positive head and neck squamous carcinoma ("HNSCC")," said Frank Bedu-Addo, Ph.D., President and Chief Executive Officer of PDS Biotech. "We are pleased to announce that site activation is progressing, and that Mayo Clinic sites have recently been added to the trial. HPV16-positive HNSCC represents a large, rapidly growing patient population in need of targeted therapies to treat the underlying cause of the cancer, and our Versamune HPV investigational therapy is currently the only targeted therapy in a Phase 3 trial specifically for HPV-16 positive tumors."

Clinical and Corporate Update

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On April 23, 2025, the Company announced that three abstracts on Versamune HPV (PDS0101) were selected for presentation at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held May 30-June 3, 2025, in Chicago, IL.

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On May 8, 2025, the Company announced that preclinical efficacy and immune response data with a novel investigational Infectimune based universal flu vaccine were featured in two presentations on universal influenza vaccines, including an oral symposium at the American Association of Immunologists’ IMMUNOLOGY2025 Annual Meeting, held May 3-7, 2025, in Honolulu, Hawaii.

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On March 13, 2025, the Company announced U.S. Food and Drug Administration ("FDA") clearance of an Investigational New Drug ("IND") application for the combination of Versamune MUC1 and PDS01ADC to treat MUC1-positive unresectable, metastatic colorectal carcinoma in patients who failed previous treatment. The National Cancer Institute ("NCI"), under its Cooperative Research and Development Agreement ("CRADA"), will lead the Phase 1/2 clinical trial evaluating the combination of Versamune MUC1 + PDS01ADC in recurrent/metastatic colorectal cancer.

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On March 7, 2025, the Company announced the initiation of its VERSATILE-003 Phase 3 trial in HPV16-positive first-line recurrent and/or metastatic HNSCC.

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Trial is designed to include approximately 350 patients

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PDS Biotech is aligned with the FDA on the design of the registrational trial and clinical endpoints.

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Two-arm controlled trial with 2:1 randomization

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Median overall survival is the primary endpoint

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Interim readouts included in the study design

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The Company received FDA Fast Track designation for the combination of Versamune HPV and pembrolizumab in R/M HNSCC.

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For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966).

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On February 27, 2025, the Company announced that it had entered into securities purchase agreements with new and existing healthcare-focused institutional investors, as well as participation from certain directors of the Company, for the purchase and sale of 7,330,121 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to purchase up to an aggregate of 7,330,121 shares of common stock in a registered direct offering priced at-the-market under Nasdaq rules at a combined purchase price of $1.50 for the institutional investors and $1.66 for certain directors of the Company. Approximately $11 million was funded upon the closing of the offering, and up to an additional $11 million may be funded upon full cash exercise of the warrants.

First Quarter 2025 Financial Results

Reported net loss was approximately $8.5 million, or $0.21 per basic and diluted share, for the three months ended March 31, 2025, compared to $10.6 million, or $0.30 per basic share and diluted share, for the three months ended March 31, 2024. The decrease was due to increased benefit from income taxes and lower operating expenses.

Research and development expenses were $5.8 million for the three months ended March 31, 2025, compared to $6.7 million for the three months ended March 31, 2024. The decrease was primarily due to lower clinical trial expenses.

General and administrative expenses were $3.3 million for the quarter ended March 31, 2025, compared to $3.4 million for the three months ended March 31, 2024.

Total operating expenses were $9.1 million for the quarter ended March 31, 2025, compared to approximately $10.1 million for the three months ended March 31, 2024.

Net interest expenses were $0.6 million compared to approximately $0.5 million for the three months ended March 31, 2024.

The Company’s cash balance as of March 31, 2025 was $40 million, compared to $41.7 million as of December 31, 2024.

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