PDS Biotechnology amended its VERSATILE-003 late-stage head and neck cancer trial to add progression-free survival as an interim primary endpoint, which management says could speed an accelerated approval path while also lowering development costs.
The company said the redesigned study will enroll fewer patients, dropping from about 350 to 250 after changing the randomization ratio from 2-to-1 to 1-to-1, which should reduce both external and internal trial expenses.
Q1 losses narrowed to $7.3 million from $8.5 million a year earlier, helped by lower R&D and operating costs, while cash stood at $21.7 million at quarter-end.
PDS Biotechnology (NASDAQ:PDSB) reported a smaller first-quarter loss and highlighted changes to its late-stage head and neck cancer trial that management said could shorten development timelines and reduce costs.
On the company’s first quarter 2026 earnings call, Chief Executive Officer Dr. Frank Bedu-Addo said the company’s “major focus was on advancing our clinical programs,” and that PDS made “significant progress” during the quarter. Chief Medical Officer Dr. Kirk Shepard detailed updates across the company’s oncology pipeline, while Chief Financial Officer Lars Boesgaard reviewed financial results for the quarter ended March 31, 2026.
Shepard said PDS adopted an amendment to its VERSATILE-003 trial, revising the design to incorporate progression-free survival, or PFS, as an interim primary endpoint. He said the company believes the change “has the potential to enable a more efficient path to accelerated approval,” while overall survival would remain the basis for full approval in line with FDA requirements.
The trial is evaluating PDS0101 in combination with KEYTRUDA, also known as pembrolizumab, in HPV16-positive head and neck squamous cell carcinoma. Shepard described the disease as an area of “significant and growing unmet need,” and said PDS0101 remains a promising treatment option for those patients.
According to Shepard, PDS0101 in combination with KEYTRUDA is “the only late-stage investigational head and neck squamous cell carcinoma therapy that requires only full doses” and is also “the only subcutaneous therapy.” He said those characteristics, along with tolerability and survival data reported to date, could make the regimen a compelling option for patients.
During the question-and-answer session, analyst Mayank Mamtani of B. Riley Securities asked about the restart of enrollment activity for VERSATILE-003. Shepard said that, now that the company has alignment with the FDA, it is moving through the process of amending the protocol and returning to trial sites to begin the study “in the near future.”
“We’re happy to say that the sites all stayed with us during that period of pause while we did the amendment and discussed it with the FDA,” Shepard said.
Shepard also said the company’s current research remains focused on intravenous pembrolizumab, though the potential future use of subcutaneous pembrolizumab could remain open as a possibility for an entirely subcutaneous regimen.
Trial Changes Expected to Reduce Costs
In response to a question from Joe Pantginis of H.C. Wainwright, Shepard said the amended trial design followed a final data cut in September 2025, when the company saw overall survival increase from roughly 30 months to nearly 40 months. He said that longer survival raised questions about how long the trial would take to complete, while the company also observed what he called robust PFS data.
Boesgaard said the protocol amendment is expected to reduce financial requirements for the trial, particularly by shortening the time to the interim readout. He said that could reduce both external costs and internal operating expenses.
Boesgaard also said the company changed the randomization ratio from 2-to-1 to 1-to-1, which lowered the number of patients in the trial from approximately 350 to approximately 250. He said that change is also expected to lower external costs associated with completing the trial.
PDS01ADC Data Highlighted in Prostate and Colorectal Cancer
Shepard also discussed PDS01ADC, which he described as the company’s novel investigational interleukin-12, or IL-12, fused antibody drug conjugate designed to enhance the proliferation, potency and longevity of T cells in the tumor microenvironment.
The company recently reported results from ongoing trials in prostate and colorectal cancer. Shepard said the Journal of Clinical Oncology JCO Oncology Advances published clinical and immunological biomarker data from stage I of a phase II trial evaluating PDS01ADC in colorectal cancer with liver metastasis.
Earlier in the first quarter, PDS also announced early results from a National Cancer Institute-led trial evaluating PDS01ADC at the AACR Special Conference on Prostate Cancer Research. Shepard said that in patients with metastatic castration-resistant prostate cancer, most of whom received the therapy as a third-line option, the combination of PDS01ADC and docetaxel showed “encouraging results.”
Bedu-Addo said stage 2 of the colorectal cancer cohort is fully enrolled and that the company anticipates having additional data on the full population of patients in the colorectal cancer study by the end of the year. Shepard said the company is encouraged by stage 1 results and is looking to move the therapy into a controlled trial.
Patent Protection Extended
Bedu-Addo said PDS also strengthened the intellectual property estate for PDS0101 during the first quarter through new patents granted in the United States and Japan. He said 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.
Asked about manufacturing needs, Bedu-Addo said the company has a “pretty straightforward manufacturing process” and that the commercial process is already established. He said the remaining work in parallel with phase III will involve traditional chemistry, manufacturing and controls activities, including validation batches ahead of a potential biologics license application filing.
Quarterly Loss Narrows
PDS reported a net loss of approximately $7.3 million, or $0.13 per basic and diluted share, for the quarter ended March 31, 2026. That compared with a net loss of $8.5 million, or $0.21 per basic and diluted share, in the prior-year quarter.
Research and development expenses were $3.5 million, down from $5.8 million a year earlier, primarily due to lower clinical and manufacturing costs.
General and administrative expenses were $3.1 million, compared with $3.3 million in the prior-year period, primarily due to lower professional fees.
Total operating expenses were $6.5 million, down from $9.1 million a year earlier.
Net interest expense was $0.8 million, compared with $0.6 million in the prior-year quarter.
The company’s cash balance was $21.7 million as of March 31, 2026.
In closing remarks, Bedu-Addo said the company sees “meaningful opportunities ahead” as it continues to execute against its priorities for 2026, citing early PDS01ADC data and expanded patent protections for PDS0101.
About PDS Biotechnology (NASDAQ:PDSB)
PDS Biotechnology Group, Inc is a clinical‐stage immunotherapy company focused on the development of targeted treatments for oncology and infectious diseases. The company’s proprietary Amplivant™ adjuvant platform leverages Toll-like receptor 3 activation to prime antigen‐presenting cells, directing robust immune responses against defined tumor and viral antigens. Its lead therapeutic vaccine candidate, PDS‐0101, is designed to treat HPV16‐positive cancers and is being evaluated both as a monotherapy and in combination with checkpoint inhibitors in ongoing Phase 1/2 clinical trials.
Beyond its HPV‐focused program, PDS Biotechnology is advancing a diversified pipeline of immunotherapies incorporating its Amplivant platform.
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