8-K
PDS Biotechnology Corp (PDSB)
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<br><br> <br>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<br><br> <br>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