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PDS Biotech (NASDAQ: PDSB) spotlights PDS0101 Phase 3 and IL-12 ADC

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(Moderate)
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(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

PDS Biotechnology filed an 8-K to share an updated April 2026 corporate presentation highlighting its cancer immunotherapy pipeline. The deck focuses on lead HPV16-targeted drug PDS0101, which showed a median overall survival of 39.3 months in recurrent/metastatic head and neck cancer, compared with a 12–18 month benchmark for Keytruda-based regimens. In a prior Phase 2 study, PDS0101 plus pembrolizumab achieved a 77.4% disease control rate and a 35.8% overall response rate, with 21% of patients experiencing 90–100% tumor regression.

The company is running the VERSATILE‑003 pivotal Phase 3 trial in first-line HPV16‑positive recurrent/metastatic head and neck cancer, with FDA alignment on progression-free survival as an interim primary endpoint for an accelerated approval pathway. Beyond PDS0101, the presentation details tumor-targeting IL‑12 antibody-drug conjugate PDS01ADC in multiple Phase 2 trials across colorectal, prostate and liver-associated cancers, and outlines upcoming data readouts through 2027.

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Insights

PDS Biotech spotlights strong HPV16+ data and a registrational trial, but programs remain mid‑development.

The presentation emphasizes PDS0101’s 39.3‑month median overall survival in HPV16‑positive recurrent/metastatic head and neck cancer versus a 12–18 month Keytruda benchmark. It also highlights a 77.4% disease control rate and generally manageable treatment‑related side effects.

Regulatory risk remains: VERSATILE‑003 is still enrolling, and no Phase 3 results are available. PDS01ADC is earlier, in multiple Phase 2 studies across colorectal and prostate cancers, so outcomes and commercial potential are not yet proven.

The company flags FDA alignment on progression-free survival as an interim primary endpoint for VERSATILE‑003 and outlines specific catalyst dates such as a PFS data readout for a colorectal cancer study in 2Q 2026. Future filings and conference updates will clarify durability of efficacy and safety across indications.

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, and exhibit attachments filed with this report.
HPV16+ HNSCC US market >$1.0B Total addressable market for HPV16+ head and neck cancer
Gynecologic HPV16 cancers US market >$2.0B Total addressable market for HPV16+ gynecologic cancers
Prostate cancer US market >$6.0B Total addressable market for prostate cancer targeted by PDS01ADC
Metastatic colorectal US market ~$2.0B Total addressable market for metastatic colorectal cancer
Median overall survival 39.3 months PDS0101 + pembrolizumab in HPV16+ recurrent/metastatic HNSCC
Disease control rate 77.4% PDS0101 + pembrolizumab in first-line HPV16+ recurrent/metastatic HNSCC
Overall response rate 35.8% PDS0101 + pembrolizumab in HPV16+ recurrent/metastatic HNSCC
Global patent families 13 Platform and product IP coverage across 8 key markets
Progression-Free-Survival (PFS) financial
"FDA alignment on Progression-Free-Survival (PFS) as interim primary endpoint"
Progression-free survival (PFS) is the length of time during and after a treatment that a patient’s disease does not get worse, measured from the start of therapy until disease progression or death. Investors watch PFS because it’s a common clinical-trial endpoint that signals whether a drug delays worsening of a condition; stronger PFS results can speed approvals, boost sales prospects, and change a drug’s perceived value—like how long a car runs before needing major repairs.
disease control rate financial
"77.4% disease control rate with PDS0101 in 1L R/M HNSCC"
The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy can meaningfully limit disease, which matters to investors assessing a drug’s potential efficacy and commercial value.
median overall survival financial
"PDS0101 + Pembrolizumab: mOS of 39.3 Months"
Median overall survival is the middle point of how long patients live after starting treatment, meaning half live longer and half live shorter. It helps doctors understand how effective a treatment is and gives patients an idea of what to expect about their future.
immune checkpoint inhibitor medical
"Activated T cells attack and destroy tumor, while immune checkpoint inhibitor restores pre-existing T cell responses"
An immune checkpoint inhibitor is a type of medicine that helps the body's immune system recognize and attack cancer cells more effectively. It works by blocking certain signals that cancer uses to hide from immune defenses, allowing the immune system to target tumors. This breakthrough has led to new cancer treatments, making immune checkpoint inhibitors an important area of growth and innovation in the healthcare industry.
immunocytokine medical
"PDS01ADC: Novel Investigational Tumor Targeting Interleukin-12 (IL-12) Immunocytokine"
An immunocytokine is a lab-designed medicine that fuses a targeting antibody with an immune signaling protein so the immune response is directed to specific cells or tissue. Think of it as a guided package that brings a signal to rally the body's defenses where needed; investors pay attention because this targeted approach can improve effectiveness, reduce side effects, and strongly influence clinical results, approvals, and commercial value.
chemoradiotherapy medical
"PDS0101 + ChemoRT* (IMMUNOCERV) Locally advanced cervical cancer"
A cancer treatment that combines chemotherapy (drugs that travel through the body to kill or weaken cancer cells) with radiotherapy (high-energy beams aimed directly at a tumor). Using both at once is like attacking a problem with a spray and a spotlight — the drug treats hidden or spreading disease while radiation targets the visible tumor — and it matters to investors because combined regimens can change drug demand, treatment costs, regulatory pathways, and reimbursement decisions.
Understanding 8-K Material Events →
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): April 24, 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 April 24, 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 (April 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:  April 24, 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  April 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, PDS01ADC, PDS0103 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. 
 
 months  12-18 months for current standard of care1   Keytrud (pembrolizumab) benchmark in First-line (1L) treatment for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (1L R/M HNSCC)  77.4% disease control rate with PDS0101 in 1L R/M HNSCC     Phase 3  VERSATILE-003 pivotal trial  FDA alignment on Progression-Free-Survival (PFS) as interim primary endpoint provides for accelerated pathway to approval  Partnerships with leading cancer institutions   MD Anderson  Mayo Clinic  National Cancer Institute  Targeting HPV16+ Cancers  REGISTRATIONAL TRIAL  COMPELLING CLINICAL DATA  POTENTIAL ACROSS CANCERS  4  clinical trials  completed  39.3  median overall survival  No head-to-head studies have been performed. 
 
 HPV16  HPV18  HPV 31/33/45/52/58  HPV 35/39/51/56/59/68  HPV-negative  HPV16+ Tumors Represent the Largest and Fastest Growing Type of HNSCC  HPV16+ HNSCC Rapidly Increasing in the US and EU  Poor uptake of HPV vaccine2,3  Changing sexual behavior4  Unique pathophysiology of HPV165  Annual Number of Oropharyngeal Cancer Cases  HPV16+  PDS Biotech focus 
 
 PUBLISHED EVIDENCE  Two head-to-head studies demonstrate that HPV16-positive patients have statistically worse survival compared to other patient groups:  Early-stage HNSCC: HPV16+ patients had worse survival than other HPV+ (P16+) patients6  Advanced oral cancer: HPV16+ patients had worse survival than HPV-negative patients7  Keytruda® (pembrolizumab) + chemotherapy median survival1  12–18 months  in recurrent/metastatic setting  HPV16+ Patients Have No Targeted Therapies and Worse Clinical Outcomes  CURRENT STANDARD OF CARE  2  1  A targeted approach for HPV16+ patients represents a significant opportunity 
 
 HOW IT WORKS  1  2  3  ATTACK  Killer T cells hunt & destroy matching tumors  Immunologically active R-enantiomer of1,2-dioleoyl-trimethyl-ammonium (R-DOTAP)  R-DOTAP forms spherical bilayers in aqueous environment  The Versamune® Platform Provides Mechanism for Targeted Immune Attack  Proprietary immunotherapy platform designed to generate cytotoxic CD8+ T-cell responses against specific tumor antigens8  Lead compound PDS0101 targets HPV16 E6/E7 viral antigens, enabling targeted immune attack on HPV-driven cancers8   Nanoparticles sized 100-200nm to promote uptake by the immune system  ACTIVATE  Dendritic cells absorb & present proteins to T cells  UPTAKE  Promotes uptake of tumor proteins by immune cells 
 
 PDS0101: Training the Immune System to Find and Destroy HPV16+ Tumors8  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 II  MHC class I  LYMPH NODE  TUMOR  Subcutaneous Injection of PDS0101 stimulates uptake by dendritic cells & accumulates in the lymph nodes  Activated T cells attack anddestroy tumor, while immune checkpoint inhibitor restores pre-existing T cell responses  3  T cells increase production of HPV16 specific CD8 killer & CD4 helper T cells, which recognize and infiltrate tumor   2  1 
 
 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  (In progress)  Complete  Complete  Complete  In Progress  In Progress  In Progress  Pipeline Expansion Across Multiple Indications  *ChemoRT = chemoradiotherapy  Partnerships with Leading Cancer Research Institutions 
 
 Endpoints  Single-arm study  31 sites in US and EU  2 Cohorts:   ICI Naïve  ICI Resistant  HPV16-positive R/M HNSCC tumors  ≥18 years of age  Combined positive score (CPS) ≥1  PDS0101  5 doses: 1 mL Subcutaneous injection Q3W at Cycles 1, 2, 3, 4 & 12)  +  Pembrolizumab  200mg IV Q3W up to 35 Cycles (2 years)  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  StudyDesign  Key Entry Criteria for ICI Naïve Subjects  Study Treatment  Lead Clinical Program Evaluating PDS0101 in Combination with Checkpoint Inhibitors  VERSATILE-002: PDS0101 + Pembrolizumab in 1L HPV16+ R/M HNSCC 
 
 PDS0101 + Pembrolizumab: mOS of 39.3 Months9  mOS = Median Overall Survival.  No head-to-head studies have been performed.  12-18 Months mOS is Benchmark with Pembrolizumab and Pembrolizumab + Chemotherapy1  Durable Survival: 11 Patients Surpassed 30 Months 
 
 PDS0101: Near or Complete Tumor Shrinkage in Difficult-to-Treat Patients9  *Investigator assessment.  63% with CPS 1-199  Confirmed disease control rate of 77.4%  ORR of 35.8%  21% of patients had tumor regression of 90-100% 
 
 PDS0101: Well-tolerated with a Low Incidence of Adverse Events9   *Occurred 1 year after completing PDS0101 therapy while patient was still on pembrolizumab.  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) 
 
 VERSATILE-003: Pivotal Phase 3 in Progress  PDS0101 + pembrolizumab in 1L HPV16-positive R/M HNSCC  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  Principal Investigator and Member of Steering Committee, Dr. Katharine Price, MD, Mayo Clinic, Rochester, MN  Patient Recruitment  InterimAnalysis 1  (PFS)  Study Start  Patient Recruitment  Survival Follow-up  Survival Follow-up  Final Analysis   (mOS)  InterimAnalysis 2  (PFS)  PDS0101 + Pembrolizumab  Pembrolizumab 
 
 Well-Positioned in 1L HPV16+ R/M HNSCC  No head-to-head studies have been performed.  Combinations with pembrolizumab  PDS0101: Only Subcutaneous Combination Therapy in Late-stage Development for 1L HPV16+ HNSCC  Genmab10  Bicara11  BioNTech12  PDS Biotech  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  Cycles 1-4 Q3W & then Cycle 12 
 
 Tumor-targeted IL-12 immunocytokine  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 inflammation13,14  HOW IT WORKS  Finds the TumorThe NHS76 antibody targets DNA that is exposed when tumor cells die  Activates Immune CellsPDS01ADC recruits T cells and NK cells to attack the tumor from within  Minimizes Side EffectsLocalized delivery means patients avoid the systemic inflammation that free IL-12 causes  THE CHALLENGE  IL-12 is a powerful NK* and T cell activator that helps fight cancer, but injecting it into the bloodstream causes serious systemic inflammation  NHS76   Tumor Necrosis Targeting Antibody – Binds to exposed DNA  De-immunized Junction  PDS01ADC: Novel Investigational Tumor Targeting Interleukin-12 (IL-12) Immunocytokine13,14  *NK = Natural killer  Encouraging tolerability and potency demonstrated in over 330 patients  IL-12  (p40 clipping-resistant)  IL-12  (p40 clipping-resistant) 
 
 Enrollment completion  PFS data readout  (Submission of interim data to FDA)  PDS01ADC + HAIP Stage 1 Cholangiocarcinoma  PDS01ADC + Enzalutamide vs Enzalutamide  Biochemically Recurrent Prostate cancer  PDS01ADC + Docetaxel  Castration Resistant Prostate cancer  Final Data ReadoutPDS01ADC + HAIP Colorectal cancer  PDS0101 + CRT Phase 2 data publication Cervical cancer  VERSATILE-003  (Head and neck cancer)  2Q 2026  PDS01ADC + HAIPPreliminary data publicationColorectal cancer16  Upcoming Catalysts  CRT = Chemoradiotherapy  PFS = Progression free survival  PHASE 2 TRIALS  2H 2026  1H 2027  2H 2027  1Q 2026  PDS01ADC + docetaxel in metastatic castration resistant prostate cancerPreliminary data publication15  Adoption of Amended Protocol (FDA) 
 
 COVERAGE  Composition and method claims protecting both platform technology and product candidates  13  Patent Families  PDS0101 EXCLUSIVITY  2041/2042  Global IP Portfolio Covers Key Commercial Markets  8  North America  Asia Pacific  Europe  Middle East  USA  Canada  Mexico  EU/UK  Israel  China  Japan  Australia  KEYMARKETS 
 
 HPV16+ HNSCC  PDS Platform is a Significant Value Creation Opportunity  Locally advanced cervical cancer  Castration resistant prostate cancer  HPV16+ R/M cancers   Biochemically recurrent prostate cancer  Metastatic colorectal & liver-associated cancers  >$1.0B  TOTAL ADDRESSABLE MARKET – US ONLY  HPV16+ HNSCC (PDS0101)  HPV16+ gynecologic cancers (PDS0101)   Prostate cancer (PDS01ADC)  Metastatic colorectal (PDS01ADC)  Current Focus  Next Steps  Commercialization  Types  Expansion into Pivotal Studies in Various Indications  Path to Commercialization  PDS01ADC + Docetaxel  IMMUNOCERV  Versamune® + ICI + PDS01ADC  PDS01ADC + Enzalutamide  PDS01ADC + HAIP  >$2.0B  >$6.0B  ~$2.0B  39.3  77.4  174  months  %  Median Overall Survival  (12–18 mo. benchmark)*  Disease Control Rate  Dosed in Phase 1  and Phase 2 Trials  *No head-to-head studies have been performed.  patients 
 
 The only investigational therapy in Phase 3 with 30+ months median survival in 1L HPV16+ R/M HNSCC  $1.2 - 1.8B  The PDS Opportunity  World-Class Research PartnersNCI, Mayo Clinic, MD Anderson and leading cancer centers with studies externally funded, independently validated  Global IP Protection13 patent families across 8 markets; PDS0101 exclusivity through 2041/2042  Registrational TrialPhase 3 VERSATILE-003 underway; FDA-aligned on primary endpoint for accelerated approval  Encouraging Data Supports Broader DevelopmentPDS01ADC programs in colorectal and prostate cancer progressing toward potential advancement  US Market Potential*  *Company estimates based on external market research 
 
 Thank You  NASDAQ: PDSB   April 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  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  Greiner JW et al NHS-IL12, a Tumor-Targeting Immunocytokine; ImmunoTargets and Therapy 2021:10 155–169   Abel ML et al, Abstract PR008: Docetaxel and the Tumor Targeting Interleukin-12 (IL-12) PDS01ADC in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC), Cancer Research, Vol. 86, Issue 2 Supplement, 15 January 2026  Eade AV et al; Tumor-Targeted IL-12 (PDS01ADC) with Hepatic Artery Infusion Pump Therapy for Colorectal Liver Metastases: Interim Analysis of a Non-randomized Phase II Tria; JCO Oncol Adv 3, e2500173 (2026) Vol. 3 #1 
 

Source: View Original Filing on SEC EDGAR

FAQ

What does PDS Biotechnology (PDSB) disclose in its latest 8-K?

PDS Biotechnology’s 8-K shares an updated April 2026 corporate presentation. It highlights lead HPV16-targeted immunotherapy PDS0101, a registrational Phase 3 trial in head and neck cancer, an expanding IL-12 ADC program (PDS01ADC), partnerships with leading cancer centers, and a sizable U.S. market opportunity.

What key clinical results for PDS0101 are shown for PDSB investors?

The presentation reports PDS0101 plus pembrolizumab achieved 39.3 months median overall survival in HPV16-positive recurrent/metastatic head and neck cancer. It also shows a 77.4% disease control rate, 35.8% overall response rate, and 21% of patients with 90–100% tumor shrinkage in earlier-phase studies.

What is the VERSATILE-003 Phase 3 trial mentioned by PDSB?

VERSATILE-003 is a pivotal Phase 3 trial of PDS0101 plus pembrolizumab versus pembrolizumab in first-line HPV16-positive recurrent/metastatic head and neck cancer. It enrolls 252 patients, measures overall and progression-free survival as primary endpoints, and uses FDA-aligned progression-free survival for an interim accelerated approval analysis.

How is PDS01ADC positioned in PDS Biotechnology’s (PDSB) pipeline?

PDS01ADC is a tumor-targeting IL-12 immunocytokine that binds DNA in dying tumor cells to localize immune activation. It is being tested in Phase 2 combinations, including with hepatic artery infusion pumps in colorectal liver metastases and with enzalutamide or docetaxel in advanced prostate cancer.

What upcoming catalysts does PDSB highlight for its cancer programs?

The company lists several catalysts, such as preliminary data from PDS01ADC plus docetaxel in metastatic castration-resistant prostate cancer in 1Q 2026 and a progression-free survival data readout for PDS01ADC plus hepatic artery infusion in colorectal cancer in 2Q 2026, alongside continued VERSATILE-003 enrollment and follow-up.

How large is the addressable market PDS Biotechnology (PDSB) is targeting?

The presentation cites a U.S. total addressable market above $1.0B for HPV16-positive head and neck cancer, more than $2.0B for gynecologic HPV16 cancers, over $6.0B for prostate cancer, and about $2.0B for metastatic colorectal disease based on company estimates.

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