PDS Biotechnology (PDSB) Company Report

PDS Biotechnology Corporation announced preliminary results from an NCI-led Phase 2 study of PDS01ADC in 3rd Line Metastatic Castration Resistant Prostate Cancer (mCRPC).
The study, presented on January 20-22, 2026, demonstrated a median progression-free survival (PFS) of 9.6 months for the combination therapy in mCRPC patients.
Additionally, a median PSA decline of 40% was observed, with 6 of 16 patients achieving greater than 50% decline.

Jan 28, 2026, 1:50 PM

8-K

PDS Biotechnology Announces Preliminary Phase 2 Study Results for PDS01ADC

PDSB

New Projects/Investments

PDS Biotechnology announced preliminary results from a National Cancer Institute (NCI)-led Phase 2 study of its investigational Interleukin-12 (IL-12) tumor targeted immunocytokine, PDS01ADC, in patients with metastatic castration-resistant prostate cancer (mCRPC).
The study, which evaluated PDS01ADC in combination with docetaxel in 3rd line mCRPC patients, demonstrated a median progression-free survival (PFS) of 9.6 months.
Additionally, a median PSA decline of 40% was observed, with 6 of 16 patients achieving greater than 50% decline.
Frank Bedu-Addo, President and CEO of PDS Biotech, stated that these findings reinforce the potential of their IL-12 immunocytokine to enhance the efficacy of existing therapies across multiple solid tumor types.

Jan 28, 2026, 1:45 PM

Press Release

PDS Biotech Announces New U.S. Patent for Lead Asset PDS0101

PDSB

New Projects/Investments

PDS Biotechnology Corporation announced on January 22, 2026, that the U.S. Patent Office has issued a Notice of Allowance for its lead asset, PDS0101.
The new patent, titled "Methods and Compositions Comprising Cationic Lipids for Stimulating Type I Interferon Genes," enhances the company's intellectual property estate and, combined with anticipated U.S. biologics exclusivity, is expected to provide approximately twenty years of market protections for PDS0101.
PDS0101 is currently being evaluated in the Phase 3 VERSATILE-003 clinical trial for HPV16-positive head and neck cancers, and the company has submitted a protocol amendment to the FDA for accelerated approval.

Jan 22, 2026, 1:50 PM

8-K

PDS Biotech Receives U.S. Patent for PDS0101 Technology

PDSB

New Projects/Investments

PDS Biotechnology (PDSB) announced that the U.S. Patent Office has issued a Notice of Allowance for its lead asset, PDS0101, which will grant broad composition of method of use claims and enhance its intellectual property estate.
This new patent, combined with anticipated U.S. biologics exclusivity, is expected to provide approximately twenty years of market protections for PDS0101.
PDS0101 is currently being evaluated in the Phase 3 VERSATILE-003 clinical trial for HPV16-positive head and neck cancers.
PDS Biotech has submitted a protocol amendment to the FDA for the VERSATILE-003 trial, proposing a change to the primary endpoint to allow for earlier evaluation and potential accelerated approval of PDS0101.

Jan 22, 2026, 1:45 PM

Press Release

PDS Biotech Announces FDA Alignment on Clinical Trial Endpoint for Accelerated Approval

PDSB

New Projects/Investments

PDS Biotechnology Corporation (PDSB) announced FDA alignment on using Progression Free Survival (PFS) as a primary endpoint for its Phase 3 VERSATILE-003 clinical trial.
The company has submitted a protocol amendment to the U.S. Food & Drug Administration (FDA) to incorporate this change.
This change could potentially provide the basis for accelerated approval of PDS0101, an investigational immunotherapy for HPV16-positive recurrent and/or metastatic Head and Neck Cancer.
Median overall survival (mOS) remains the primary endpoint for full FDA approval.

Jan 9, 2026, 1:50 PM

8-K

PDS Biotech Amends Phase 3 Trial Protocol for Accelerated Approval Pathway

PDSB

New Projects/Investments

PDS Biotechnology has submitted a protocol amendment to the U.S. Food & Drug Administration (FDA) for its Phase 3 VERSATILE-003 clinical trial.
The proposed amendment changes the Progression Free Survival (PFS) endpoint to a primary endpoint for earlier evaluation, potentially providing the basis for accelerated approval of PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer.
This submission follows a constructive Type C meeting with the FDA in December 2025 and is supported by positive final results from the VERSATILE-002 trial.
Median overall survival (mOS) remains the primary endpoint for full FDA approval as originally recommended.

Jan 9, 2026, 1:45 PM

Press Release

PDS Biotechnology Secures New Patent for PDS0101 in Japan

PDSB

New Projects/Investments

PDS Biotechnology Corporation announced on December 9, 2025, that the Japan Patent Office issued Patent No. 7783866 for PDS0101, granting broad composition of matter and methods of use claims.
This new patent expands previously granted patents in Japan and strengthens the company's intellectual property estate, which includes patents in the United States, China, Australia, and Hong Kong.
With anticipated biologics exclusivity in the United States, PDS0101 is protected by patent and market exclusivity into the 2040s.
PDS0101 is currently being studied in a Phase 3 trial for HPV16-positive recurrent/metastatic head and neck cancer.

Dec 9, 2025, 1:05 PM

8-K

PDS Biotech Schedules FDA Type C Meeting to Discuss Accelerated Approval Pathway

PDSB

New Projects/Investments

Product Launch

PDS Biotechnology Corporation (PDSB) has scheduled a Type C Meeting with the U.S. Food and Drug Administration (FDA) for December 2025.
The meeting will discuss a proposed amendment to the Phase 3 VERSATILE-003 trial to enable a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic Head and Neck Cancer.
This proposal is based on positive final results from the VERSATILE-002 trial, which showed promising median overall survival and durable progression-free survival.
The amendment would change the progression-free survival (PFS) endpoint to a surrogate primary endpoint for earlier evaluation, potentially forming the basis for accelerated approval, while median overall survival (mOS) remains the primary endpoint for full approval.
PDS Biotech anticipates providing further updates in January 2026 after receiving the FDA's meeting minutes.

Dec 2, 2025, 1:35 PM

8-K

PDS Biotechnology Reports Q3 2025 Results and Updates Clinical Programs

PDSB

Earnings

New Projects/Investments

Guidance Update

PDS Biotechnology reported a net loss of $9 million or $0.19 per basic and diluted share for the three months ended September 30, 2025, an improvement from the $10.7 million loss in the prior year period, primarily due to lower operating expenses.
The company announced the completion of its VERSATILE-002 trial, with final data showing a median overall survival of 39.3 months and progression-free survival of 6.3 months in patients with HPV-16 positive head and neck cancer.
PDS Biotechnology is seeking to amend its VERSATILE-003 phase three trial protocol to include progression-free survival as a primary endpoint in addition to median overall survival, aiming to potentially shorten the time to regulatory submission.
As of September 30, 2025, the cash balance was $26.2 million, and the company recently completed a sale of common stock and warrants for gross proceeds of approximately $5.3 million.
The colorectal cancer cohort of the phase two clinical trial for PDS01ADC met the criteria for expansion to stage two following positive stage one results.

Nov 13, 2025, 1:00 PM

Transcript

PDS Biotech Reports Q3 2025 Financial Results and Clinical Program Updates

PDSB

Earnings

Guidance Update

New Projects/Investments

PDS Biotechnology Corporation reported a net loss of $9.0 million, or $0.19 per basic and diluted share, for the third quarter ended September 30, 2025, an improvement from a net loss of $10.7 million, or $0.29 per share, in the prior year period.
Total operating expenses for Q3 2025 decreased to $8.1 million from $10.2 million in Q3 2024, primarily due to lower research and development expenses.
The company completed its VERSATILE-002 Phase 2 clinical trial, reporting a median overall survival of 39.3 months and progression-free survival of 6.3 months in patients with CPS ≥ 1.
Based on the positive VERSATILE-002 results, PDS Biotech plans to seek an expedited approval pathway for its VERSATILE-003 Phase 3 trial, proposing to use progression-free survival as a surrogate primary endpoint for accelerated approval.
As of September 30, 2025, PDS Biotech's cash balance was $26.2 million, and the company recently raised approximately $5.3 million in gross proceeds from a common stock and warrant sale on November 12, 2025.