On March 30, 2026 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 business and clinical programs update and announced financial results for the quarter and year ended December 31, 2025.

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"The fourth quarter capped a year of important progress for PDS Biotech, marked by meaningful advances across our clinical programs, financial discipline, and intellectual property portfolio," said Frank Bedu-Addo, PhD, President and CEO of PDS Biotech. "Building on the compelling topline data from our VERSATILE-002 Phase 2 trial, we believe the VERSATILE-003 protocol amendment has the potential to create a more efficient path to accelerated approval — shortening the trial’s duration, reducing costs, and accelerating our timeline to regulatory submission — while preserving overall survival as the basis for full approval. For patients living with HPV16-positive head and neck cancer, a disease with significant and growing unmet need, we believe PDS0101 represents a promising treatment option, and we remain focused on advancing it as efficiently as possible."

Dr. Bedu-Addo added: "Combined with early data from one of our PDS01ADC Phase 2 programs and expanded patent protections for the Versamune platform extending into the 2040s, we believe we have meaningful opportunities ahead as we continue to execute against our priorities in 2026."

Clinical and Corporate Update
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Amended the VERSATILE-003 Phase 3 clinical trial protocol to incorporate progression-free survival (PFS) as an interim primary endpoint, creating a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival remains the primary endpoint for full FDA approval. The amendment also reduces the number of enrolled patients while maintaining statistical power. Patients already enrolled prior to the amendment remain on the trial and continue to receive treatment.

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Presented encouraging early results from an NCI-led trial investigating PDS01ADC, the Company’s investigational IL-12 tumor-targeted immunocytokine, at the AACR (Free AACR Whitepaper) special conference on prostate cancer research. In patients with metastatic castration-resistant prostate cancer (mCRPC) the majority of whom received third-line treatment options — the combination of PDS01ADC and docetaxel demonstrated encouraging median PFS of 9.6 months and a median PSA decline of 40%, with 6 of 16 patients achieving greater than 50% decline.

Strengthened the intellectual property estate for PDS0101 with new patents granted in the U.S. and Japan. The new U.S. patent, combined with anticipated biologics exclusivity, extends market protection into the 2040s. The Japanese patent adds broad composition of matter claims to existing protections across major markets.

Full Year 2025 Financial Results

Net loss for the year ended December 31, 2025, was approximately $34.5 million, or $0.74 per basic and diluted share, compared to a net loss of $37.6 million, or $1.03 per basic and diluted share for the year ended December 31, 2024.

Research and development expenses for the year ended December 31, 2025, were $19.0 million, compared to $22.6 million for the year ended December 31, 2024. The decrease of $3.6 million was primarily attributable to decreases in manufacturing costs of $2.5 million and personnel costs of $1.8 million, partially offset by an increase in clinical costs of $0.7 million.

General and administrative expenses for the year ended December 31, 2025, were $12.5 million, compared to $13.8 million for the year ended December 31, 2024. The $1.3 million decrease was primarily attributable to a decrease in personnel costs.

Total operating expenses for the year ended December 31, 2025, were $31.5 million compared to $36.3 million for the year ended December 31, 2024.

Net interest expense was $4.1 million for the year ended December 31, 2025, compared to $2.2 million for the year ended December 31, 2024. The change was primarily due to non-cash expenses related to extinguishment of debt, as well as lower interest income on the Company’s cash balances.

The Company’s cash balance as of December 31, 2025, was $26.7 million.

Conference Call Details
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Date: March 30, 2026

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Time: 8:00 a.m. Eastern Time

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Dial-in: 1-877-704-4453 (Domestic) or 1-201-389-0920 (International)

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Conference I.D.: 13759288

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Webcast: Click Here

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CallMeTM: Click Here (available 15 minutes prior to the call)

After the live webcast, the event will be archived on PDS Biotech’s website for six months.

(Press release, PDS Biotechnology, MAR 30, 2026, View Source [SID1234664025])