PDS Biotech (NASDAQ: PDSB) highlights HPV16 trial gains and pipeline

Rhea-AI Filing Summary

PDS Biotechnology Corporation filed a Form 8-K to share its updated February 2026 corporate presentation. The deck focuses on PDS0101, a Versamune-based immunotherapy targeting HPV16-positive head and neck cancers, and PDS01ADC, a tumor-targeted IL-12 immunocytokine.

PDS0101 plus pembrolizumab in first-line HPV16-positive recurrent/metastatic head and neck cancer showed a median overall survival of 39.3 months, compared with a 12–18 month benchmark for pembrolizumab-based regimens, a 77.4% disease control rate, and a 35.8% objective response rate. Treatment-related adverse events were mostly grade 1–2.

The company highlights a pivotal Phase 3 VERSATILE-003 trial with progression-free survival as the primary endpoint for accelerated approval, multiple Phase 2 studies of PDS01ADC across prostate, colorectal, and liver-associated cancers, and more than 12 patent families providing PDS0101 exclusivity through 2042/2043 in key global markets.

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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 23, 2026

PDS BIOTECHNOLOGY CORPORATION

(Exact Name of Registrant as Specified in Charter)

Delaware	001-37568	26-4231384
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification No.)

303A College Road East, Princeton, NJ 08540

(Address of Principal Executive Offices, and Zip Code)

(800) 208-3343

Registrant’s Telephone Number, Including Area Code

(Former Name or Former Address, if Changed Since Last Report)

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):

☐
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐
Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐
Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.00033 per share	PDSB	The Nasdaq Capital Market

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 chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Yes ☐ No ☐

Item 8.01 Other Events.

On February 23, 2026, the Company updated its corporate presentation deck.

A copy of the corporate presentation deck is filed herewith as Exhibit 99.1 and incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number		Description
99.1		Corporate Presentation (February 2026).
104		Cover Page Interactive Data File (embedded within the Inline XBRL Document).

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.

	PDS BIOTECHNOLOGY CORPORATION
Date:  February 23, 2026	By:	/s/ Frank Bedu-Addo, Ph.D.
	Name: Frank Bedu-Addo, Ph.D.
	Title: President and Chief Executive Officer

Exhibit 99.1

 Precision Designed Science for Cancer Patients  NASDAQ: PDSB  February 2026 

 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.  KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. 

 A Promising Approach to Treating HPV16-Positive Head and Neck Cancers  Targeted immunotherapy with compelling clinical results and regulatory path to accelerated approval  CLINICAL INNOVATION  39.3  months  median overall survival  12-18 months  Keytruda® (pembrolizumab) benchmark in 1L R/M HNSCC  77.4% disease control rate  35.8% objective response rate  11 patients beyond 30 months  INTELLECTUAL PROPERTY PROTECTION  >12  families  Exclusivity through 2042/2043  Composition and method of use claims  Global coverage:  US, Europe, Japan, China, Australia, Canada, Israel, Mexico, Hong Kong  VALIDATED PATH FORWARD  Phase 3  VERSATILE-003 pivotal trial  FDA-aligned accelerated pathway  PFS primary endpoint for accelerated approval  Steering Committee (Selected Members):  Dr. Kevin Harrington: The Institute of Cancer Research, London, UK  Dr. Robert Haddad: Dana Farber Cancer Institute, Boston, MA  Dr. Ricard Mesia: Catalan Institut of Oncology, Barcelona, Spain  Dr. Caroline Even: Institut Gustave Roussy, Paris, France  MOA = Mechanism of Action  No head-to-head studies have been performed 

 Lead Program: Seeking to Deliver the First Targeted Immunotherapy for HPV16-Driven Head and Neck Cancers – Non-EGFR Driven Cancers  HPV-16 positive cancers are rapidly increasing in the US and EU, due to:  Poor uptake of Human Papillomavirus (HPV) vaccine2,3  Changing sexual behavior4  Unique pathophysiology of HPV165   This has created a significant unmet need   PDS0101 (Versamune® HPV) recruits, trains, and arms T cells, harnessing them to execute a precise, targeted attack on HPV-16 positive cancers  HPV16  HPV18  HPV 31/33/45/52/58  HPV 35/39/51/56/59/68  HPV-negative  HPV16+  PDS Biotech focus 

 HPV16+ Patients Have No Targeted Therapies, Leading to Worse Outcomes  The gap: No approved therapies specifically target HPV16-positive cancers, a distinct patient population with unique unmet needs  PUBLISHED EVIDENCE  Two head-to-head studies demonstrate that HPV16-positive patients have statistically worse survival compared to other patient groups:  1  Early-stage HNSCC: HPV16+ patients had worse survival than other HPV+ (P16+) patients6  2  Advanced oral cancer: HPV16+ patients had worse survival than HPV-negative patients7  CURRENT STANDARD OF CARE  Keytruda® (pembrolizumab) + chemotherapy median survival1:   12–18 months  in recurrent/metastatic setting  A targeted approach for HPV16+ patients represents a significant opportunity 

 The Versamune® Platform for Powerful Anti-Tumor T Cells  A lipid nanoparticle trains the immune system to find and destroy cancer8  WHAT IS VERSAMUNE®?  Nanoparticles (~200nm) made from a special lipid (R-DOTAP) that the immune system readily absorbs and responds to  HOW IT WORKS  1  DELIVER  Promotes uptake of tumor proteins by immune cells  →  2  ACTIVATE  Dendritic cells absorb & present PDS0101 into lymph nodes  →  3  ATTACK  Killer T cells hunt & destroy matching tumors  Versamune® trains the immune system to recognize and eliminate cancer cells  PDS0101: HPV16-SPECIFIC IMMUNOTHERAPY  Versamune® mixed with HPV16 E6/E7 peptides directs the immune response to specifically attack and kill HPV16-positive tumors8  Nanoparticles sized to 200nm to promote uptake by the immune system  Immunologically active R-enantiomer of 1,2-dioleoyl-trimethyl-ammonium (R-DOTAP)  R-DOTAP forms spherical bilayers in aqueous environment 

 PDS0101: Training the Immune System to Find and Destroy HPV16+ Tumors8   Lymph Node  Tumor  CD4+helper T cell  CD8+killer T cell  HPV16 E6 & E7  Versamune®Activated CD8+Killer T Cell  ImmuneCheckpointInhibitor  Versamune® +HPVmix (PDS0101)  Targeted CD8+ T CellsTracks to Tumor  Dendritic Cell  MHC class I  MHC class II  Subcutaneous Injection of PDS0101  1  Stimulates uptake by dendritic cells & accumulates in the lymph nodes  2  T cells increaseproduction of HPV16- specificCD8 killer & CD4 helper T cells  3  Activated multi-functional T cells recognize and infiltrate tumor  4  Activated T cells attack anddestroy tumor  5  Immune checkpoint inhibitor restores pre-existing T cell responses  6 

 Pipeline Across Multiple Indications Validated by World-Class Partners   Therapy / Treatment   Indication  P2  P3  Partner  Versamune®  PDS0101+ pembrolizumab vs. pembrolizumab (VERSATILE-003)  HPV16-positive recurrent/metastatic head and neck cancer  PDS0101+ chemoRT (IMMUNOCERV)  Locally advanced cervical cancer  PDS0101 +/- pembrolizumab  Locally advanced head and neck cancer  Versamune®+PDS01ADC*  PDS0101+ PDS01ADC + immune checkpoint inhibitor (ICI)  HPV16-positive recurrent/metastatic cancers*  PDS01ADC  PDS01ADC + hepatic artery infusion pump (HAIP)  Advanced Liver-Associated Cancers  Metastatic colorectal cancer  Intrahepatic cholangiocarcinoma  Metastatic adrenocortical carcinoma  PDS01ADC + enzalutamide vs. enzalutamide  Biochemically recurrent prostate cancer  PDS01ADC + docetaxel  Metastatic Prostate Cancer  Castration sensitive prostate cancer  Castration resistant prostate cancer  FDA Fast Track  Complete  Complete  Complete  In Progress  In Progress  In Progress  chemoRT = chemoradiotherapy 

 VERSATILE-002: PDS0101 + Pembrolizumab in First-Line HPV16-Positive HNSCC  StudyDesign  Single-arm study  31 sites in US and EU  2 Cohorts:   ICI Naïve  ICI Resistant  Key Entry Criteria for ICI Naïve Subjects  HPV16-positive R/M HNSCC tumors  ≥18 years of age  Combined positive score (CPS) ≥1  63% of patients with CPS<20; 81% had recurrent disease  PDS0101  5 doses: 1 mL Subcutaneous injection at Cycles 1, 2, 3, 4 & 12)  Pembrolizumab  200mg IV Q3W up to 35 Cycles (2 years)  Study Treatment  Primary:  Best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1  Key Secondary:  Overall Survival (OS)  Progression Free Survival (PFS) per RECIST v1.1   Safety and tolerability  Endpoints 

 PDS0101 + Pembrolizumab: mOS of 39.3 Months; 12-18 Months mOS is Benchmark with Pembrolizumab and Pembrolizumab + Chemotherapy9   Durable Survival: 11 Patients Surpassed 30 Months  mOS = Median Overall Survival  No head-to-head studies have been performed 

 PDS0101: Near or Complete Tumor Shrinkage in Hard-to-Treat Patients (63% had low CPS 1-19)9   Confirmed Disease Control Rate of 77.4%  ORR of 35.8%, Meeting Primary Endpoint   21% of patients had tumor regression of 90-100%   *Investigator assessment 

 PDS0101: Well-Tolerated with a Low Incidence of Adverse Events   Treatment related adverse events (TRAEs)   by Grade in ICI naïve and resistant patients  n (%)  Any Combination TRAE  76 (87.4)  Grade 1  40 (46.0)  Grade 2  26 (29.9)  Grade 3  8 (9.2)  Grade 4  1 (1.1)*  Grade 5  0  Most common Non-Injection   Site Reaction TRAEs  n (%)  Fatigue  30 (34.5)  Headache  13 (14.9)  Diarrhea  10 (11.5)  *Occurred 1 year after completing PDS0101 therapy while patient was still on pembrolizumab 

 VERSATILE-003: Pivotal Phase 3 in Progress  Interim Analysis 1  (PFS)  Study Start  PDS0101 + Pembrolizumab  Pembrolizumab   Patient Recruitment  Patient Recruitment  Survival Follow-up  Survival Follow-up  Key Eligibility Criteria  HPV16-positive HNSCC  CPS ≥1  ≥18 years of age  ECOG 0-1  Primary Endpoints  Overall Survival (OS)  Progression free survival (PFS)  Secondary Endpoints  Objective Response Rate (ORR)  Disease Control Rate (DCR)  Duration of Response (DoR)  Randomized controlled trial  1:1 randomization  50/50: high/low CPS  N= 252   PDS0101 Dosing  5 SC Doses  Cycles 1-4 & 12  FinalAnalysis (mOS)  Interim Analysis 2  (PFS)  PDS0101 + pembrolizumab in 1L HPV16-positive R/M HNSCC  Principal Investigator and Member of Steering Committee, Dr. Katharine Price, MD, Mayo Clinic, Rochester, MN 

 Well-Positioned in 1L HPV16+ R/M HNSCC in the US and Europe  Median OS  Not disclosed  21.3 months  22.6 months  39.3 months  95% CI (23.9, NE)  Population   All comers  HPV-negative  HPV16-positive  HPV16-positive  Administration Convenience  IV Q2W until PD or toxicity  IV QW (D1, D8, D15)  IV Q1W 8X then Q3W for 24mos  5 subcutaneous injections of PDS0101  BioNTech12  Bicara11  Genmab10  PDS Biotech  Combinations with pembrolizumab  No head-to-head studies have been performed 

 PDS01ADC: Novel Investigational Tumor Targeting Interleukin-12 (IL-12) Immunocytokine13  Strong tolerability and potency demonstrated in over 330 patients  IL-12 is a powerful NK* and T cell activator that helps fight cancer, but injecting it into the bloodstream causes serious systemic inflammation  THE SOLUTION  PDS01ADC attaches IL-12 to an antibody (NHS76) that seeks out dying tumor cells, delivering treatment directly where it's needed while minimizing systemic inflammation10  HOW IT WORKS  FINDS THE TUMOR  The NHS76 antibody targets DNA that is exposed when tumor cells die  ACTIVATES IMMUNE CELLS  PDS01ADC recruits T cells and NK cells to attack the tumor from within  MINIMIZES SIDE EFFECTS  Localized delivery means patients avoid the systemic inflammation that free IL-12 causes  NHS76 (Tumor Necrosis Targeting Antibody – Binds to exposed DNA)  De-immunized Junction  IL-12  (p40 clipping-resistant)  IL-12  (p40 clipping-resistant)  Tumor-targeted IL-12 immunocytokine  THE CHALLENGE  NK = natural killer 

 2H 2026  1H 2027  2H 2027  Upcoming Catalysts   Enrollment completion  PFS data readout  (Submission of interim data to FDA)  PDS01ADC + HAIP   Stage 1 Cholangiocarcinoma2  PDS01ADC + Enzalutamide vs   Enzalutamide  Biochemically Recurrent Prostate cancer  PDS01ADC + Docetaxel  Castration Resistant Prostate cancer  CRT = Chemoradiotherapy  PFS = Progression free survival  Adoption of Amended Protocol - (FDA)  PDS01ADC + docetaxel in metastatic castration resistant prostate cancer  Preliminary data   Final Data Readout  PDS01ADC + HAIP  Colorectal cancer  PDS0101 + CRT   Phase 2 data publication  Cervical cancer  VERSATILE-003  (Head and neck cancer)  1Q 2026  Phase 2 Trials  PDS01ADC + HAIP   Preliminary data   Colorectal cancer 

 Estimated Market (US Only)  Significant Commercial Opportunity Across Indications  >$6.0B  Biochemically recurrent prostate cancer and mCRPC (PDS01ADC)19  ~$2.0B  Metastatic colorectal cancer (PDS01ADC)20  >$1.0B  Locally advanced HPV16+ HNSCC (PDS0101)14  >$2.0B  HPV16+ anal, cervical, penile, vaginal, vulvar (PDS0101)15-18 

 Global IP Portfolio Secures Key Commercial Markets  >12  Patent Families  COVERAGE  Composition and method claims protecting both platform technology and product candidates  PDS0101 EXCLUSIVITY  2042/2043  USA  Canada  Mexico  Israel  China  Europe  Japan  Australia  8 Key Markets  |  North America, Europe, Asia Pacific, Middle East 

 Multiple Opportunities for Value Creation  1  PIPELINE  Pipeline Optionality  PDS01ADC in Phase 2 trials across multiple indications including:  Colon cancer  Prostate cancer  Others  Third-party funded with commercial partnership opportunities  2  PROTECTION  Significant IP Estate  >12  patent families  PDS0101 exclusivity through 2042/2043  3  VALIDATION  World-Class Partners  Ongoing partnerships with leading cancer institutions:  MD Anderson  Mayo Clinic  National Cancer Institute  Validates PDS's scientific approach  6  Global coverage:  US, Europe, Japan, China, Australia, Canada, Israel, Mexico, Hong Kong 

 Thank You  NASDAQ: PDSB   February 2026 

 References  Harrington, KJ, Burtness B, Greil R, et al. Keytruda With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. J Clin Oncol. 2022;41:790-802. https://doi.org/10.1200/JCO.21.02508.  Damgacioglu H, Sonawane K, Chhatwal J, et al. Long-term impact of HPV vaccination and COVID-19 pandemic on oropharyngeal cancer incidence and burden among men in the USA: A modeling Study. The Lancet Regional Health – Americas. 2022;8:100143.  Tabatabaeian H et al, Navigating therapeutic strategies: HPV classification in head and neck cancer, British Journal of Cancer. (2024) 131: 220-230.  Landy R, et al JNCI: Upper age limits for US male human papillomavirus vaccination for oropharyngeal cancer prevention: a microsimulation-based modeling study; Journal of the National Cancer Institute, 2023, 115(4), 429–436.  Luo X et al; HPV16 drives cancer immune escape via NLRX1-mediated degradation of STING; J Clin Invest. 2020;130(4):1635–1652.  Ziai H. et al; Does HPV Subtype Predict Outcomes in Head and Neck Cancers?; International Journal of Otolaryngology; Volume 2021, Article ID 6672373; https://doi.org/10.1155/2021/6672373.  Lee L et al; Human Papillomavirus-16 Infection in Advanced Oral Cavity Cancer Patients Is Related to an Increased Risk of Distant Metastases and Poor Survival; PLOS One; July 2012, Volume 7, Issue 7, e40767.  Gandhapudi SK, Ward M, Bush JPC, Bedu-Addo F, Conn G, Woodward JG. Antigen Priming with Enantiospecific Cationic Lipid Nanoparticles Induces Potent Antitumor CTL Responses through Novel Induction of a Type I IFN Response. J Immunol. 2019;202:3524-3536.  Weiss J et al. VERSATILE-002: Overall Survival of HPV16 Positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Patients Treated with T Cell Stimulating Immunotherapy PDS0101 and Keytruda. Poster Presented: ASCO Congress 2025; June 2, 2025.  Van Herpen CML et al, Petosemtamab (MCLA-158) with pembrolizumab as first line (1L) treatment of PD-L1+ recurrent/metastatic (r/m) head and neck squamous cell carcinoma (HNSCC): Phase 2 Trial, ASCO 2025  Cortese T, Ficerafusp Alfa/Pembrolizumab Receives FDA BTD in Frontline HNSCC, Cancer Network, October 14, 2025  Saba NF et al, Exploratory analysis of antitumor activity and translational results from the safety run-in of AHEAD-MERIT, a Phase 2 trial of first-line pembrolizumab plus the fixed-antigen cancer vaccine BNT113 in advanced HPV16+ HNSCC, ESMO 2024 

 References (continued)  Minnar CM et al (2024) Preclinical and clinical studies of a tumor targeting IL-12 immunocytokine. Front. Oncol. 13:1321318.doi: 10.3389/fonc.2023.1321318  Triangle Research Group. PDS Proprietary Market Research Report. 2024.  Guerendiain D et al; HPV status and HPV16 viral load in anal cancer and its association with clinical outcome; Cancer Medicine. 2022;11:4193–4203.  https://www.hpvworld.com/articles/hpv-genotype-specific-risk-for-cervical-cancer/  Li Z. et al, Prevalence of human papillomavirus DNA and p16INK4a positivity in vulvar cancer and vulvar intraepithelial neoplasia: a systematic review and meta-analysis; The Lancet Oncology; Volume 24, Issue 4, p403-414April 2023.  Olesen TB et al, Prevalence of human papillomavirus DNA and p16INK4a in penile cancer and penile intraepithelial neoplasia: a systematic review and meta-analysis, The Lancet Oncology, Volume 20, Issue 1, p145-158, January 2019.  Grand View Research, Prostate Cancer Market Report 2025.  https://www.delveinsight.com/report-store/metastatic-colorectal-cancer-market 

FAQ

What is the main focus of PDS Biotechnology (PDSB) in this 8-K update?

The update centers on PDS Biotechnology’s February 2026 corporate presentation, emphasizing its PDS0101 immunotherapy for HPV16-positive head and neck cancers and PDS01ADC, a tumor-targeted IL-12 immunocytokine, along with late-stage trials, intellectual property coverage, and commercial opportunity estimates across multiple oncology indications.

What efficacy data did PDS Biotechnology (PDSB) report for PDS0101 in HPV16-positive head and neck cancer?

PDS Biotechnology reported that PDS0101 plus pembrolizumab achieved a median overall survival of 39.3 months, versus a 12–18 month benchmark for pembrolizumab-based regimens, with a 77.4% confirmed disease control rate and a 35.8% objective response rate in first-line HPV16-positive recurrent/metastatic head and neck squamous cell carcinoma.

What are the key features of the VERSATILE-003 Phase 3 trial highlighted by PDSB?

VERSATILE-003 is a randomized Phase 3 trial comparing PDS0101 plus pembrolizumab against pembrolizumab in HPV16-positive head and neck cancer. It uses overall survival and progression-free survival as primary endpoints and includes secondary measures such as objective response rate, disease control rate, and duration of response.

How does the Versamune platform work according to PDS Biotechnology (PDSB)?

The Versamune platform uses ~200nm lipid nanoparticles made from R-DOTAP to deliver tumor proteins to immune cells, activate dendritic cells in lymph nodes, and generate HPV16-specific CD8 killer and CD4 helper T cells that recognize, infiltrate, and destroy tumors, especially when combined with immune checkpoint inhibitors.

What is PDS01ADC and how is it designed to treat cancer in PDSB’s pipeline?

PDS01ADC is a tumor-targeted IL-12 immunocytokine that links IL-12 to the NHS76 antibody, which binds DNA exposed in dying tumor cells. This design aims to localize IL-12 activity to tumors, recruit T and natural killer cells, and reduce systemic inflammation associated with free IL-12 administration.

What intellectual property and market opportunities does PDS Biotechnology (PDSB) describe?

PDS Biotechnology reports more than 12 patent families covering its platform and product candidates, with PDS0101 exclusivity through 2042/2043 in major markets including the US, Europe, Japan, and China, and cites multi-billion-dollar estimated U.S. market opportunities across HPV16-positive and prostate and colorectal cancer indications.

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