On May 13, 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 business and clinical programs update and announced financial results for the quarter ended March 31, 2026.

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"During the first quarter, we made meaningful clinical and regulatory progress across our clinical pipeline," said Frank Bedu-Addo, PhD, President and CEO of PDS Biotech. "We work towards restarting enrollment in the amended VERSATILE-003 Phase 3 trial. With regards to PDS01ADC, we have completed enrollment in the metastatic colorectal cancer trial, and the advanced castration resistant prostate cancer trial continues to recruit well".

Dr. Bedu-Addo continued: "We believe the progress achieved during the quarter reflects the continued advancement and maturation of our clinical portfolio. We remain focused on advancing potentially differentiated immunotherapy candidates designed to address significant unmet medical needs for patients with difficult-to-treat cancers".

Clinical and Corporate Update

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Amended 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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Announced publication of positive clinical and immunological biomarker data from Stage 1 of NCI-led Metastatic Colorectal Cancer (mCRC) trial evaluating PDS01ADC, the Company’s tumor-targeted IL-12 immunocytokine. The results, published in the March issue of Journal of Clinical Oncology (JCO) Oncology Advances, included:

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Objective response rate (ORR) by RECIST v1.1: 77.8% (7/9) at six months; in the parallel trial without PDS01ADC, the ORR was 35% (7/20)

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24-month survival rate approximately 85%; in the parallel trial without PDS01ADC, the 24-month survival rate was approximately 40%

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Extrahepatic progression-free survival (PFS): median not reached at minimum follow-up of 13.1 months; in the parallel trial without PDS01ADC, the PFS was 8.1 months

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Presented encouraging early results from an NCI-led trial investigating PDS01ADC 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.

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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.

First Quarter 2026 Financial Results

Reported net loss for the quarter ended March 31, 2026, was approximately $7.3 million, or $0.13 per basic and diluted share, compared to a net loss of $8.5 million, or $0.21 per basic and diluted share for the quarter ended March 31, 2025.

Research and development expenses for the quarter ended March 31, 2026, were $3.5 million, compared to $5.8 million for the quarter ended March 31, 2025. The decrease was primarily due to lower clinical and manufacturing costs.

General and administrative expenses for the year ended March 31, 2026, were $3.1 million, compared to $3.3 million for the year ended March 31, 2025. The decrease was primarily due to lower professional fees.

Total operating expenses for the year ended March 31, 2026, were $6.5 million compared to $9.1 million for the quarter ended March 31, 2025.

Net interest expense was $0.8 million for the quarter ended March 31, 2026, compared to $0.6 million for the quarter ended March 31, 2025.

The Company’s cash balance as of March 31, 2026, was $21.7 million.

Conference Call Details

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Date: May 13, 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.: 13760368

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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, MAY 13, 2026, View Source [SID1234665637])