On November 13, 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 business update, announced financial results for the third quarter ended September 30, 2025, and provided a clinical programs update.

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"Our request to meet with the FDA to propose an amendment to our ongoing VERSATILE-003 Phase 3 trial represents the culmination of the encouraging data from our now completed VERSATILE-002 trial", said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. "We believe the positive PFS data offers an important opportunity to shorten the trial duration and time to regulatory submission while maintaining mOS as the endpoint for full FDA approval. Importantly, we believe this approach may also accelerate the availability of this promising treatment to patients in need."

Clinical and Corporate Update

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Announced final topline survival data from the VERSATILE-002 Phase 2 clinical trial. VERSATILE-002 evaluated PDS0101 + Keytruda (pembrolizumab) in patients with HPV16+ HNSCC

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The median overall survival (mOS) is 39.3 months in patients with CPS ≥ 1. The lower limit of the 95% confidence interval is 23.9 months, and the upper limit is not yet estimable.

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The progression-free survival is 6.3 months in patients with CPS ≥ 1.

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Announced plan to seek accelerated approval pathway in the VERSATILE-003 Phase 3 randomized trial for PDS0101 in combination with pembrolizumab versus pembrolizumab monotherapy.

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Increased mOS suggests the potential for fewer death events in a specified time that will likely result in an extended trial duration.

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The increase in mOS is the basis for a proposed amendment to the statistical analysis plan based on the earlier mOS. The proposed amendment could reduce trial size while maintaining statistical power.

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Due to the positive final PFS result, the proposed amendment would change the PFS endpoint to become a surrogate primary endpoint that can be evaluated earlier with high statistical power and potentially form the basis for accelerated approval.

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mOS will remain as the primary endpoint for full approval as originally recommended by FDA.

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National Cancer Institute (NCI) presented new clinical data at the 2025 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting

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The NCI presented three abstracts highlighting emerging clinical and translational findings from PDS Biotechnology’s novel investigational immunotherapy platforms, including the tumor-targeting IL-12 fused antibody drug conjugate (PDS01ADC) and PDS0101, the Company’s lead Phase 3 clinical stage HPV-targeted immunotherapy. The presented translational biomarker studies demonstrated the unique immunological properties of PDS0101 and PDS01ADC leading to anti-tumor immune responses and the predictability of clinical responses.

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Announced Preliminary Results from Colorectal Cancer Cohort of Phase 2 Clinical Trial with PDS01ADC.

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Met Criteria for Expansion to Stage 2 Following Positive Stage 1 Results

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Metastatic colorectal cancer cohort in study led by the National Cancer Institute met high objective response rate bar for continuation of study of at least 6 of 9 confirmed objective responses by RECIST v1.1. This triggered enrollment expansion under the Simon Two-Stage study design

Third Quarter 2025 Financial Results

Reported net loss was $9.0 million, or $0.19 per basic and diluted share, for the three months ended September 30, 2025, compared to $10.7 million, or $0.29 per basic share and diluted share, for the three months ended September 30, 2024. The decrease in net loss was primarily due to lower operating expenses.

Research and development expenses were $4.6 million for the three months ended September 30, 2025, compared to $6.8 million for the three months ended September 30, 2024. The decrease was primarily due to lower manufacturing and clinical expenses and personnel costs.

General and administrative expenses were $3.6 million, for the three months ended September 30, 2025, compared to $3.4 million for the three months ended September 30, 2024. The increase was primarily due to higher professional fees, partially offset by lower personnel costs.

Total operating expenses were $8.1 million for the three months ended September 30, 2025, compared to $10.2 million for the three months ended September 30, 2024.

Net interest expense was $0.9 million for the three months ended September 30, 2025, compared to $0.5 million for the three months ended September 30, 2024. The increase was primarily due to lower interest income from the Company’s cash deposits.

The Company’s cash balance as of September 30, 2025 was $26.2 million, compared to $41.7 million as of December 31, 2024.

On November 12, 2025, the Company sold 5,800,000 common stock (or prefunded warrants in lieu thereof), as well as 5,800,000 accompanying warrants, for gross proceeds of approximately $5.3 million.

Conference Call Details

Date: November 13, 2025
Time: 8:00 a.m. Eastern Time
Dial-in: 1-877-704-4453 (Domestic) or 1-201-389-0920 (International)
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(Press release, PDS Biotechnology, NOV 13, 2025, View Source [SID1234659913])