PDS Biotech Reports Full Year 2025 Financial Results and Provides Update on PDS0101 Phase 3 Program and PDS01ADC Clinical Advancement
Rhea-AI Summary
PDS Biotech (NASDAQ: PDSB) reported full-year 2025 results and clinical updates on March 30, 2026. The company amended its VERSATILE-003 Phase 3 protocol to add PFS as an interim primary endpoint to enable a potential accelerated approval pathway while preserving overall survival for full approval.
Early PDS01ADC Phase 2 data showed median PFS of 9.6 months and a 40% median PSA decline in mCRPC; new U.S. and Japan patents extend Versamune platform protection into the 2040s. Full-year net loss was $34.5M; cash was $26.7M as of Dec 31, 2025.
Positive
- R&D spending decreased 15.9% to $19.0M in 2025
- Total operating expenses declined 13.2% to $31.5M in 2025
- PDS01ADC early efficacy: median PFS 9.6 months and 40% median PSA decline
- Patent protection extended for Versamune platform into the 2040s
Negative
- Net interest expense rose to $4.1M in 2025 from $2.2M in 2024
- Cash balance was $26.7M at year-end, potentially constraining near-term runway
- PDS01ADC data from 16 patients is limited and mostly third-line, reducing conclusiveness
News Market Reaction – PDSB
On the day this news was published, PDSB declined 0.91%, reflecting a mild negative market reaction. This price movement removed approximately $260K from the company's valuation, bringing the market cap to $28.36M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Peer action points to a stock-specific move. Momentum scanner shows CUE down 8.81% while the scanner flags the target as moving in the opposite direction. Broader peers (CAMP, MAIA, PYPD) also show mixed but generally negative moves, not mirroring the target.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 24 | Earnings call notice | Neutral | +15.4% | Scheduled date and access details for upcoming 2025 results call. |
| Feb 20 | Phase 3 amendment | Positive | -1.5% | Added PFS as interim primary endpoint to support accelerated approval. |
| Jan 28 | Phase 2 data readout | Positive | +1.0% | Reported NCI-led PDS01ADC median PFS and PSA decline results. |
| Jan 22 | Patent allowance | Positive | +4.0% | New U.S. patent and extended projected market protection for PDS0101. |
| Jan 09 | FDA endpoint alignment | Positive | +7.7% | FDA Type C alignment allowing PFS as primary endpoint for VERSATILE-003. |
Recent history shows generally positive price alignment with constructive clinical and IP news, with one notable divergence on a prior PFS protocol-amendment announcement.
Over the past few months, PDSB has focused on the VERSATILE‑003 Phase 3 design and IP around PDS0101, alongside early PDS01ADC data. Announcements on FDA alignment around PFS, new U.S. patent protection, and NCI‑led PDS01ADC Phase 2 results all saw modest to strong positive moves. A February 20, 2026 protocol‑amendment update, however, drew a slight negative reaction. Today’s full‑year 2025 results and broader clinical/IP update build directly on those same themes.
Regulatory & Risk Context
The company has an active Form S-3 filed on 2025-08-29, allowing up to $200.0 million of securities, including an at-the-market component. A separate ATM agreement permits up to $50.0 million of common stock sales, of which $5.7 million had been sold as of the filing. The shelf is not yet effective according to the provided data.
Market Pulse Summary
This announcement combines full‑year 2025 financials with important updates on the PDS0101 Phase 3 program and PDS01ADC Phase 2 data. Operating expenses declined year over year, while net interest expense increased to $4.1 million. Clinically, the VERSATILE‑003 amendment formalizes PFS as an interim primary endpoint, and NCI‑led data show median PFS of 9.6 months with PDS01ADC. Investors may watch future cash updates, use of the $200.0 million shelf, and further Phase 3 readouts.
Key Terms
progression-free survival (PFS) medical
median overall survival medical
Phase 3 medical
Phase 2 medical
accelerated approval regulatory
metastatic castration-resistant prostate cancer (mCRPC) medical
immunocytokine medical
PSA medical
AI-generated analysis. Not financial advice.
Filed Phase 3 Amendment Incorporates PFS as Interim Primary Endpoint Expected to Shorten Trial Duration and Reduce Costs
Conference Call and Webcast Today at 8:00 am Eastern Time
PRINCETON, N.J., March 30, 2026 (GLOBE NEWSWIRE) -- 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, today provided a business and clinical programs update and reported financial results for the quarter and year ended December 31, 2025.
"The fourth quarter capped a year of important progress for PDS Biotech, marked by meaningful advances across our clinical programs, financial discipline, and intellectual property portfolio," said Frank Bedu-Addo, PhD, President and CEO of PDS Biotech. "Building on the compelling topline data from our VERSATILE-002 Phase 2 trial, we believe the VERSATILE-003 protocol amendment has the potential to create a more efficient path to accelerated approval — shortening the trial's duration, reducing costs, and accelerating our timeline to regulatory submission — while preserving overall survival as the basis for full approval. For patients living with HPV16-positive head and neck cancer, a disease with significant and growing unmet need, we believe PDS0101 represents a promising treatment option, and we remain focused on advancing it as efficiently as possible."
Dr. Bedu-Addo added: “Combined with early data from one of our PDS01ADC Phase 2 programs and expanded patent protections for the Versamune® platform extending into the 2040s, we believe we have meaningful opportunities ahead as we continue to execute against our priorities in 2026."
Clinical and Corporate Update
- Amended the 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.
- Presented encouraging early results from an NCI-led trial investigating PDS01ADC, the Company's investigational IL-12 tumor-targeted immunocytokine, at the AACR 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 than50% decline.
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.
Full Year 2025 Financial Results
Net loss for the year ended December 31, 2025, was approximately
Research and development expenses for the year ended December 31, 2025, were
General and administrative expenses for the year ended December 31, 2025, were
Total operating expenses for the year ended December 31, 2025, were
Net interest expense was
The Company’s cash balance as of December 31, 2025, was
Conference Call Details
- Date: March 30, 2026
- Time: 8:00 a.m. Eastern Time
- Dial-in: 1-877-704-4453 (Domestic) or 1-201-389-0920 (International)
- Conference I.D.: 13759288
- Webcast: Click Here
- 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.
About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company has initiated a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted immunotherapy PDS0101 is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor. PDS01ADC is being evaluated in multiple phase 2 trials in various cancer indications in combination with standard of care.
For more information, please visit www.pdsbiotech.com
Forward Looking Statements
This communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the “Company”) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Company’s management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” “forecast,” “guidance”, “outlook” and other similar expressions among others. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the Company’s ability to protect its intellectual property rights; the Company’s anticipated capital requirements, including the Company’s anticipated cash runway and the Company’s current expectations regarding its plans for future equity financings; the Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates; the Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan; the timing for the Company or its partners to conduct clinical trials for PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (Versamune® MUC1) and other Versamune® based product candidates; the future success of such trials; the successful implementation of the Company’s research and development programs and collaborations, including any collaboration studies concerning PDS0101 (Versamune® HPV), PDS01ADC, PDS0103 (Versamune® MUC1) and other Versamune® based product candidates and the Company’s interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Company’s product candidates; the success, timing and cost of the Company’s or its partners’ ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding response rates, the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund its disclosed clinical trials, which assumes no material changes to the Company’s currently projected expenses), futility analyses, presentations at conferences and data reported in an abstract, and receipt of interim or preliminary results (including, without limitation, any preclinical results or data), which are not necessarily indicative of the final results of the Company’s ongoing clinical trials; any Company statements about its understanding of product candidates mechanisms of action and interpretation of preclinical and early clinical results from its clinical development programs and any collaboration studies; the Company’s ability to continue as a going concern; and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the other risks, uncertainties, and other factors described under “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in the documents we file with the U.S. Securities and Exchange Commission. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Versamune® is a registered trademark of PDS Biotechnology Corporation.
Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com
Media Contact:
Jude Gorman / Kiki Torpey
Collected Strategies
PDS-CS@collectedstrategies.com
| PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY | |||||||||
| Selected Balance Sheet Data | |||||||||
| (Unaudited) | |||||||||
| December 31, | |||||||||
| 2025 | 2024 | ||||||||
| Cash and cash equivalents | $ | 26,711,969 | $ | 41,689,591 | |||||
| Working capital | $ | 18,770,871 | $ | 27,967,242 | |||||
| Total assets | $ | 30,494,083 | $ | 45,358,657 | |||||
| Long term debt | $ | 11,733,350 | $ | 9,204,755 | |||||
| Accumulated deficit | $ | (216,606,503 | ) | $ | (182,110,999 | ) | |||
| Total stockholders’ equity | $ | 9,251,833 | $ | 19,004,848 | |||||
| PDS BIOTECHNOLOGY CORPORATION AND SUBSIDIARY | |||||||||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||
| (Unaudited) | |||||||||
| Year Ended December 31, | |||||||||
| 2025 | 2024 | ||||||||
| Operating expenses: | |||||||||
| Research and development expenses | $ | 19,025,831 | $ | 22,565,524 | |||||
| General and administrative expenses | 12,518,127 | 13,755,671 | |||||||
| Total operating expenses | $ | 31,543,958 | $ | 36,321,195 | |||||
| Loss from operations | $ | (31,543,958 | ) | $ | (36,321,195 | ) | |||
| Interest income (expense) | |||||||||
| Interest income | $ | 1,217,241 | $ | 2,514,816 | |||||
| Interest expense | (5,338,607 | ) | (4,673,174 | ) | |||||
| Interest income (expense), net | $ | (4,121,366 | ) | $ | (2,158,358 | ) | |||
| Loss before income taxes | $ | (35,665,324 | ) | $ | (38,479,553 | ) | |||
| Benefit from income taxes | 1,169,820 | 869,169 | |||||||
| Net loss and comprehensive loss | $ | (34,495,504 | ) | $ | (37,610,384 | ) | |||
| Per share information: | |||||||||
| Net loss per share, basic and diluted | $ | (0.74 | ) | $ | (1.03 | ) | |||
| Weighted average common shares outstanding basic and diluted | 46,384,280 | 36,452,707 | |||||||
FAQ
What does the VERSATILE-003 amendment mean for PDSB's PDS0101 approval pathway?
How did PDSB perform financially for full-year 2025 and what was the cash position?
What were the key early clinical results for PDS01ADC reported by PDSB?
How do the new patents affect PDSB's market protection for PDS0101 and Versamune?
Will the VERSATILE-003 amendment change enrollment numbers in the Phase 3 trial for PDS0101?
