PDS Biotech updates Phase 3 PDS0101 trial design
PDS Biotechnology Corporation has adopted an amended protocol for its Phase 3 VERSATILE-003 trial of PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer.
Rhea-AI Filing Summary
PDS Biotechnology Corporation has adopted an amended protocol for its Phase 3 VERSATILE-003 trial of PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. The amendment designates progression-free survival (PFS) as an interim primary endpoint to support a potential accelerated approval pathway, while median overall survival (mOS) remains the primary endpoint for full approval. After the FDA’s standard 30-day review of the amended protocol to the IND without objection, the company is proceeding under the new design, which it believes may shorten trial duration and make the study more cost efficient.
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Insights
PDS Biotech adjusts its Phase 3 design to pursue potential accelerated approval via PFS while keeping survival as the full-approval endpoint.
PDS Biotechnology has modified its Phase 3 VERSATILE-003 trial so that progression-free survival becomes the interim primary endpoint to support a potential accelerated approval of PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival remains the primary endpoint for full approval.
This design aligns with prior regulatory dialogue and followed a Type C meeting with the FDA. After the FDA’s standard 30-day review of the amended protocol to the IND without objection, the company is proceeding, indicating regulators did not block the proposed changes at this stage.
The company states that incorporating PFS as an interim endpoint may shorten trial duration and make the study more cost efficient, while survival and safety data will still underpin any full approval. Future disclosures from this Phase 3 program will be important for understanding whether the amended design supports the company’s regulatory goals.
8-K Event Classification
2 items: 8.01, 9.01
2 items
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did PDS Biotechnology (PDSB) change in the VERSATILE-003 Phase 3 trial?
PDS Biotechnology amended its Phase 3 VERSATILE-003 trial to include progression-free survival as an interim primary endpoint. This is intended to support a potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer while retaining overall survival for full approval.
How does the new protocol affect potential approval of PDS0101 for HPV16-positive head and neck cancer?
The amended protocol uses progression-free survival as an interim primary endpoint to support potential accelerated approval of PDS0101. Median overall survival remains the primary endpoint for full approval, preserving survival and safety as key factors in regulatory decision-making for advanced HPV16-positive head and neck cancers.
What was the FDA’s response to PDS Biotechnology’s amended VERSATILE-003 protocol?
After PDS Biotechnology filed the amended protocol to its Investigational New Drug application, the FDA’s standard 30-day wait period elapsed without objection. The company states it is now proceeding with the amended Phase 3 VERSATILE-003 protocol under this regulatory framework.
Why does PDS Biotechnology say adding PFS as an interim endpoint is important?
PDS Biotechnology’s CEO stated that including progression-free survival as an interim primary endpoint may shorten the duration of VERSATILE-003 and accelerate the timeline to regulatory submission. The company also believes this design change can make the trial more cost efficient while survival and safety remain central for full approval.
What cancer indication is targeted in PDS Biotechnology’s VERSATILE-003 trial?
The VERSATILE-003 Phase 3 trial evaluates PDS0101 in HPV16-positive recurrent and/or metastatic head and neck squamous cell cancers. This indication focuses on a rapidly growing population of patients with HPV16-positive head and neck cancer, according to statements from PDS Biotechnology’s management.
How is PDS0101 being developed within PDS Biotechnology’s pipeline?
PDS0101 (Versamune ae HPV) is the company’s lead targeted immunotherapy. It 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, plus a standard-of-care immune checkpoint inhibitor.
What risks does PDS Biotechnology highlight in connection with its development plans?
PDS Biotechnology notes risks related to protecting intellectual property, securing additional financing, limited operating history, and successful execution of clinical trials. It also cites uncertainties around timing, success, and cost of trials for PDS0101, PDS01ADC, PDS0103 and other Versamune ae-based candidates.
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 20, 2026
(Exact Name of Registrant as Specified in Charter)
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(800 ) 208-3343
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
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Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this
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| Item 8.01 |
Other Events.
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On February 20, 2026, PDS Biotechnology Corporation (the “Company”) issued a press release announcing the
adoption of a protocol amendment to its Phase 3 VERSATILE-003 clinical trial. The amendment includes progression-free survival as an interim primary endpoint to support a potential accelerated approval pathway for PDS0101 in HPV16-positive
recurrent and/or metastatic head and neck cancer. Median overall survival (mOS) remains the trial’s primary endpoint for full approval, consistent with the Company’s prior regulatory dialogue and post-meeting communication following its Type C
meeting with the U.S. Food and Drug Administration (“FDA”). Following the FDA's standard 30-day wait period since filing of the amended protocol to the Investigational New Drug (IND) Application, without objection, the Company is proceeding with
the amended protocol.
A copy of the press release is filed herewith as Exhibit 99.1 and incorporated by reference herein.
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Financial Statements and Exhibits.
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(d) Exhibits.
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Description
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99.1
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Press Release Dated February 20, 2026.
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL Document).
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Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be
signed on its behalf by the undersigned hereunto duly authorized.
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PDS BIOTECHNOLOGY CORPORATION
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Date: February 20, 2026
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By:
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/s/ Frank Bedu-Addo, Ph.D.
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Name: Frank Bedu-Addo, Ph.D.
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Title: President and Chief Executive Officer
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Exhibit 99.1
PDS Biotech Announces Adoption of Amended Protocol for Phase 3 VERSATILE-003 Trial Incorporating Progression Free Survival (PFS) as Primary
Endpoint for Interim Analysis and Potential Accelerated Approval
Enables Potential Shorter Time to Accelerated Approval of PDS0101 in HPV16-positive Head and Neck Cancer
PRINCETON, N.J., February 20, 2026 -- 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 announced the adoption of a protocol amendment to its Phase 3 VERSATILE-003 clinical trial. The amendment includes PFS as an interim primary endpoint to support a
potential accelerated approval pathway for PDS0101 in HPV16-positive recurrent and/or metastatic head and neck cancer. Median overall survival (mOS) remains the trial’s primary endpoint for full approval, consistent with the Company’s prior
regulatory dialogue and post-meeting communication following its Type C meeting with the U.S. Food and Drug Administration (“FDA”). Following the FDA's standard 30-day wait period since filing of the amended protocol to the Investigational New
Drug (IND) Application, without objection, the Company is proceeding with the amended protocol.
“Including PFS as an interim primary endpoint provides a potential pathway to shorten the duration of VERSATILE-003 and accelerate the timeline to
regulatory submission, as well as making the trial more cost efficient,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “Survival and safety will continue to anchor full approval, and we remain confident in the
path we’ve outlined and in our commitment to advancing a promising targeted immunotherapy for the rapidly growing population of patients with HPV16-positive recurrent and/or metastatic head and neck cancer.”
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 (Versamune® HPV) is being developed in
combination with a standard-of-care immune checkpoint inhibitor, and in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.
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