PDS Biotechnology (NASDAQ:PDSB) executives used the company’s fourth-quarter 2025 earnings call to highlight progress across its oncology pipeline, with a particular focus on a protocol amendment to its phase III VERSATILE-003 trial that adds progression-free survival (PFS) as an interim primary endpoint in HPV-16-positive recurrent and/or metastatic head and neck cancer.
Management also reviewed early clinical findings for PDS-01ADC in metastatic castration-resistant prostate cancer, discussed new patent grants for PDS0101, and reported reduced operating expenses and a smaller net loss for full-year 2025 compared with 2024.
VERSATILE-003 amendment adds interim PFS endpoint
Chief Medical Officer Dr. Kirk Shepherd explained that the amendment was driven by final data from the company’s phase II VERSATILE-002 study of PDS0101 plus Merck’s KEYTRUDA (pembrolizumab) in HPV-16-positive head and neck cancer. According to Shepherd, VERSATILE-002 enrolled 53 patients and showed a median overall survival of 39.3 months in patients with PD-L1 combined positive score (CPS) of at least one, with a 95% confidence interval lower limit of 23.9 months and an upper limit that was “not yet estimatable.”
Shepherd said the strength of the overall survival results, along with what he described as robust PFS findings, had implications for VERSATILE-003’s original design, which had overall survival as the primary endpoint and PFS as a secondary endpoint following FDA recommendations. “It should be noted that the median overall survival relies on the occurrence of death events,” Shepherd said, adding that if a therapy works well enough, “it may take a long time to get to the critical data readout.”
To address the risk of an extended trial duration, the company approached the FDA to “convert PFS to an earlier interim primary endpoint,” Shepherd said. Following what he characterized as a productive dialogue, the company announced that after the FDA’s standard 30-day wait period from filing, the agency raised no objections and PDS is “clear to proceed with the amended protocol.” Shepherd said the company believes the change could shorten time to a potential regulatory submission while maintaining overall survival for full approval.
Management discusses trial timing, enrollment, and patients enrolled before the pause
During the Q&A, H.C. Wainwright’s Josh Korsen asked about the revised enrollment target and how it compares with the original design. Shepherd did not disclose a new sample size, but said the amended plan could shorten the timeline. “At [the FDA meeting] we were able to shorten the trial to as much as a year as far as getting the final results,” he said, adding that the PFS interim analysis would “most likely” be available “in a period of about a year and a half.” Shepherd also said the updated protocol and VERSATILE-002 results allow a shorter duration “with the smaller N for the trial.”
B. Riley Securities’ Mayank Mamtani asked how the company plans to handle patients already enrolled in VERSATILE-003 prior to a pause related to the protocol change. Shepherd said those patients will continue treatment per protocol and that the approach was discussed with the FDA. He said the agency left it to the company whether to include or exclude those patients so long as the decision is stated before restarting the protocol. Shepherd added that these patients would “most likely be put in a special subset of the data” and “will be included for safety” and in the intent-to-treat dataset.
On enrollment execution and pace, Shepherd said recruitment had been “very good” and suggested it could improve, citing “less competition than was when we first began the trial.” He added that the company did not lose any sites during the pause and that sites remain “excited by this therapy and ready to begin again.” Shepherd also said VERSATILE-002 sites are expected to be involved in VERSATILE-003, which he said should support “brisk recruitment.”
Mamtani also pressed for sample size and PFS powering assumptions. Shepherd said the company “haven’t made the sample size public yet,” but described the interim PFS analyses as “powered with high power to detect statistically significant changes in PFS,” with one analysis at completion of recruitment and another “about six months later.”
Convenience and dosing highlighted for PDS0101 + pembrolizumab
Shepherd argued that PDS0101 has potential practical advantages in the late-stage head and neck cancer setting. He said PDS0101 is “the only subcutaneous injection product currently in late-stage development” for recurrent and/or metastatic head and neck squamous cell carcinoma, and that PDS0101 plus Keytruda would be “the only late-stage” therapy he is aware of in this setting requiring “only five doses,” compared with “over twenty doses” for most approaches. He also noted dosing intervals of three weeks and then six months after the fourth dose.
Bedu-Addo added that Merck’s recently approved subcutaneous version of KEYTRUDA “can be administered by a healthcare provider in as little as one minute,” suggesting that a combination with subcutaneous PDS0101 “may shorten administration time and be more convenient for patients.”
Shepherd also pointed to epidemiologic trends and unmet need, saying HPV-16-positive cancers are “rapidly increasing in the U.S. and EU” and that, given the “absence of approved targeted therapies,” there is a significant unmet need the company believes PDS0101 is positioned to address.
Early PDS-01ADC data presented in prostate cancer
Bedu-Addo also highlighted early findings from a National Cancer Institute-led trial evaluating PDS-01ADC, the company’s investigational IL-12 tumor-targeted immunocytokine, which were presented at an American Association for Cancer Research (AACR) Special Conference on Prostate Cancer Research.
In metastatic castration-resistant prostate cancer patients—most of whom had failed at least two prior treatments—Bedu-Addo said the combination of PDS-01ADC with standard-of-care docetaxel showed a median progression-free survival of 9.6 months and a median prostate-specific antigen (PSA) decline of 40%. He added that six of 16 patients achieved greater than 50% PSA decline. Bedu-Addo said the results reinforce the potential of PDS-01ADC to activate the immune system against multiple solid tumors and said the company remains focused on advancing the program.
Patents and financial results for full-year 2025
Bedu-Addo said the company strengthened the intellectual property estate for PDS0101 with new patents granted in the U.S. and Japan. He said the new U.S. patent, combined with anticipated biologics exclusivity, extends market protection “into the 2040s,” while the Japanese patent adds composition-of-matter claims.
Chief Financial Officer Lars Boesgaard reported a net loss for the year ended Dec. 31, 2025 of approximately $34.5 million, or $0.74 per basic and diluted share, compared with a net loss of $37.6 million, or $1.03 per basic and diluted share, in 2024.
Boesgaard said research and development expenses were $19.0 million in 2025 versus $22.6 million in 2024, primarily due to lower manufacturing costs ($2.5 million) and personnel costs ($1.8 million), partially offset by higher clinical costs ($0.7 million). General and administrative expenses were $12.5 million in 2025 compared with $13.8 million in 2024, which he attributed mainly to lower personnel costs. Total operating expenses were $31.5 million in 2025 versus $36.3 million in 2024.
Net interest expense increased to $4.1 million in 2025 from $2.2 million in 2024, which Boesgaard attributed primarily to non-cash expenses related to debt extinguishment and lower interest income on cash balances. Cash as of Dec. 31, 2025 was $26.7 million.
Asked about 2026 R&D spending, Boesgaard said the company is not providing guidance, but added that costs are expected to increase as the trial is reinitiated, depending on site openings and enrollment.
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.
