Form 8-K

8-K — PDS Biotechnology Corp

Accession: 0001140361-26-037234

Filed: 2026-09-21

Period: 2026-09-21

CIK: 0001472091

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ef20082538_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (ef20082538_ex99-1.htm)

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8-K

8-K (Primary)

Filename: ef20082538_8k.htm · Sequence: 1

false0001472091NASDAQ00014720912026-09-212026-09-21

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): September 21, 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 September 21, 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 (September 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: September 21, 2026

By:

/s/ Frank Bedu-Addo, Ph.D.

Name: Frank Bedu-Addo, Ph.D.

Title: President and Chief Executive Officer

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: ef20082538_ex99-1.htm · Sequence: 2

Exhibit 99.1

Overview of PDS Biotech Drug Development Programs (Oncology) NASDAQ:

PDSB September 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 PDS0301 (Formerly PDS01ADC and NHS-IL12) and PDS0101 (Versamune® HPV) 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, PDS0301, 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; the anticipated benefits of the company strategic refocus on

PDS0301; the Company’s ability to identify, negotiate and consummate strategic partnerships or other externally funded opportunities for PDS0101; the Company’s ability to preserve, realize or enhance the value of its development programs; the

Company’s expectations regarding the timing availability and sufficiency of capital resources to execute its business strategy; 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 presentation 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.

Clinically Validated Immunotherapies for Solid Tumors with High Unmet Need PDS

Biotechnology NASDAQ: PDSB Two clinically advanced assets built on proprietary platforms that direct immune activity into the tumor, with development in partnership with the National Cancer Institute. PDS0301 (Tumor-Targeted IL-12

Immunocytokine) Designed to concentrate IL-12 in the tumor microenvironment while limiting systemic exposure. In an NCI-led Phase 2 trial in MSS/pMMR metastatic colorectal cancer (mCRC) with liver metastases, chemotherapy plus PDS0301

achieved a 71.4% response rate at six months and approximately 80% 24-month survival1,2. More than 380 patients dosed to date. Following a September 2026 financing led by Nant Capital, Dr. Patrick Soon-Shiong joined the Board of Directors,

bringing prior experience obtaining FDA approval for an immunocytokine. A registrational Phase 3 protocol for PDS0301 in mCRC is in design. PDS0101 (Versamune® HPV16 Cancer Vaccine) HPV16-positive head and neck cancer is an indication with

no FDA-approved targeted therapy. VERSATILE-002 reported 39.3-month median overall survival3 in combination with pembrolizumab in first-line HPV16-positive recurrent/metastatic head and neck cancer. The published benchmark in the indication

is 12-18 months4. VERSATILE-003 holds FDA Fast Track designation. Seeking strategic partnership or external funding for further development. Near-Term Catalysts Five PDS0301 data readouts anticipated between Q4 2026 and Q2 2028 across

biochemically recurrent prostate cancer, metastatic castration-resistant prostate cancer, colorectal cancer with liver metastases, and Kaposi sarcoma microsatellite stable (MSS) or mismatch repair-proficient (pMMR) disease

Pipeline of Tumor-Targeted Immunotherapies ChemoRT = chemoradiotherapy; HAIP =

hepatic artery infusion pump; ICI = immune checkpoint inhibitor. THERAPY/TREATMENT INDICATION PHASE 1 PHASE 2 PHASE 3 PARTNER PDS0301 Fused IL-12 antibody conjugate PDS0301 + Chemotherapy Advanced liver-associated

cancers: metastatic colorectal cancer intrahepatic cholangiocarcinoma metastatic adrenocortical carcinoma In Progress PDS0301 + Enzalutamide vs. enzalutamide Biochemically recurrent prostate cancer In Progress PDS0301 +

Docetaxel Metastatic castration-resistant prostate cancer In Progress PDS0301 Monotherapy Advanced Kaposi sarcoma (Orphan) In Progress Versamune® + PDS0301 PDS0101 + PDS0301 + ICI HPV16-positive

recurrent/metastatic cancers Complete Versamune® HPV16 Cancer Vaccine Platform PDS0101 + Pembrolizumab VERSATILE-003 | vs. pembrolizumab HPV16-positive recurrent/metastatic head and neck cancer FDA Fast Track PDS0101 +

ChemoRT IMMUNOCERV Locally advanced cervical cancer Complete PDS0101 +/- Pembrolizumab Locally advanced HPV16-positive head and neck cancer Complete

Overview of PDS0301

Proprietary IL-12 Immunocytokine: PDS0301 – Tumor Targeting

Immunocytokine Tumor-targeted cytokine (IL-12)designed to accumulate within the tumor microenvironment (TME) with sustained presence in solid tumors5 Designed to address limitations of cytokine therapy and targets and accumulates in the

TME5-7 Fusion to tumor targeting antibody prevents free IL-12 Tumor-targeting limits systemic presence Promotes potent T cell and NK cell cytolytic (killing) activity within the TME Promotes long-lasting self-renewing stem-like T cells NK

cell phenotypes that promote anti-tumor activity8-10 Suppresses immune suppressive cells such as MDSC and Treg in the TME

Tumor-targeted IL-12 immunocytokine THE SOLUTION PDS0301 fuses IL-12 to an

antibody (NHS76) that seeks out dying tumor cells, delivering PDS0301 into the TME. This reduces immune suppressive factors e.g. MDSC, Treg, etc. Promotes T cells and NK cells within the TME. HOW IT WORKS NHS76 targets exposed DNA/histone

complexes enriched in dying (necrotic) tumor cells therefore anchoring PDS0301 in the TME. Agents that promote tumor cell death, when combined with PDS0301 will enhance delivery of PDS0301 into the tumors. Fusion of IL-12 to NHS76 prevents

any free IL-12 in the body. PDS0301 is designed to activate NK cells, CD8+ T cells, and Th1 inflammatory signaling in the tumor microenvironment. THE CHALLENGE The TME is a highly immune suppressive environment that can block T cell and

NK activity within solid tumors thus limiting immunotherapy. NHS76 Tumor Necrosis Targeting Antibody – Binds to exposed DNA histones De-immunized Junction PDS0301: Targets and Modifies the TME of Solid Tumors to become Less Resistant to

Treatment with Added T Cell & NK Cell Activation in the TME5-7 NK = Natural killer; TME = Tumor microenvironment IL-12 (p40 clipping-resistant) IL-12 (p40 clipping-resistant)

Phase 2 Clinical Study of PDS0301 and Chemotherapy in mCRC with Liver

Metastases

Endpoints StudyDesign Key Entry Criteria Study Treatment Non-Randomized

Phase 2 Trial of PDS0301+ Chemotherapy as 2L or 3L Therapy in Patients with MSS and pMMR Colorectal Cancer with Liver Metastases Trial Evaluated Various Immune Responses as Potential Predictive Biomarkers Therapies were administered on six

(6) 28-day cycles PDS0301 PDS0301 is administered at 12 mcg/kg, given as a subcutaneous injection on Day 15 of each cycle Chemotherapy Floxuridine was administered by HAIP into the liver on Days1-14 of each cycle FOLFOX was given

via IV on Days 1 and 15 of each cycle Patients must have had histologically or cytologically confirmed unresectable CRC metastatic to the liver. Patients must have failed at least first-line chemotherapy Age >18 yrs ECOG

≤1 Primary: Safety and tolerability Objective response rates Progression free survival Key Secondary: Overall Survival (OS) Systemic immune response microsatellite stable (MSS) or mismatch repair-proficient (pMMR) disease A phase II

nonrandomized clinical trial with a Simon two-stage design Patients previously treated with at least first-line chemotherapy received HAIP floxuridine in combination with either leucovorin, 5-fluorouracil, and oxaliplatin (FOLFOX) or

leucovorin, 5fluorouracil, and irinotecan (FOLFIRI), with subcutaneous PDS0301

Chemotherapy + PDS0301 may Promote Durable Responses in Metastatic

CRC1,2 3 Chemotherapy + PDS0301 6 Months ORR = 71.4% (15/21) Sequentially performed study chemo +/- PDS0301 at the same National Cancer Institute clinical site; Chemotherapy = Floxuridine by Hepatic artery infusion + systemic FOLFOX

(IV) Encouraging Responses at 6 months Post Treatment; Monitoring of Durability Continues Consistent with the PDS0301 promotion of self-renewing memory T cells Chemotherapy 6 Months ORR = 35% (7/20)

24-Month Survival Rate of Approximately 80%1,2 3 Probability of Survival

(%) Survival Post Treatment (Months) Chemotherapy (N=20)* Chemotherapy + PDS0301 (N=22)* *Sequentially performed studies at the same clinical site– Not randomized head-to-head PDS0301 + Chemotherapy Appears to Provide Survival Benefit

Promising Results with PDS0301 in MSS/pMMR Metastatic Colorectal Cancer (mCRC)

with Liver Metastases Exelixis11 Incyte12 NCI/PDS Biotech1,2 Indication mCRC w/wo liver metastases mCRC w/wo liver metastases mCRC with liver metastases Therapy Zanzalintinib + atezolizumab INCA33890 (TGFβR2×PD-1) Chemotherapy +

PDS0301 ORR 4.0% 15.2% 52% at 3 months 71% at 6 months Median PFS 3.7 months N/A Hepatic – 12.7 months Extra Hepatic – NE >13.1 months Median OS 10.9 months N/A NE > 34 months (24-month OS = ~ 80%) No randomized

head-to-head study has been performed between PDS0301, chemotherapy or other agents

2L mCRC mCRC Program Provides Significant Value Creation Opportunity Current

Focus Types 71.4 80 >380 % % Objective Response Rate1,2 <30% benchmark)* 24-month survival rate1,2 Dosed with PDS0301 in Phase 1and Phase 2 Trials *No head-to-head studies have been performed. patients 294,500 cases of

mCRC in the 7 major markets, projected to increase through 2034 In 2024, total market size of mCRC in the 7 major markets was >US$13B projected to increase through 2034 The US revenue was ~$6B About 50% of mCRC patients will have liver

metastases3 Source: https://www.delveinsight.com/report-store/metastatic-colorectal-cancer-market

PDS0301 Value-Creating Milestones Over the Next 6-18 Months Demonstrate

Potential Breadth in Solid Tumors

PDS0301: Tumor-Targeted IL-12 with Clinical Proof of Concept in Solid

Tumors Key Takeaways Targeted delivery to the tumor addresses limitations that have constrained IL-12 therapy. Fusion to the NHS76 antibody anchors PDS0301 in the tumor microenvironment, sustains presence in the tumor, and prevents free

systemic IL-12. ✓ Activity observed in a population with no approved immunotherapy option. In an NCI-led Phase 2 trial in MSS/pMMR colorectal cancer with liver metastases, PDS0301 + chemotherapy showed a 71.4% objective response rate at six

months1,2. Survival data represent the more meaningful signal. Addition of PDS0301 to chemotherapy provided survival benefit. Approximately 80% of patients were alive at 24 months, with median overall survival (mOS) currently exceeding 34

months1,2. Published mOS in the population is < 12 months13. Breadth extends well beyond colorectal cancer. Four NCI-partnered trials are in progress across metastatic colorectal cancer, biochemically recurrent and metastatic

castration-resistant prostate cancer (mCRPC), and advanced Kaposi sarcoma. More than 380 patients have been dosed across Phase 1 & Phase 2. Promising interim PFS of 9.6 months reported for mCRPC in Q1 202614. Five data readouts

anticipated between Q4 2026 and Q2 2028, beginning with interim results in biochemically recurrent prostate cancer. Proceeds from the September 2026 financing are intended to advance PDS0301 into late-stage clinical development, with an

additional tranche committed upon submission of a registrational Phase 3 protocol to the FDA. ✓ ✓ ✓ ✓

Overview of PDS0101 in HPV16-Positive HNSCC

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 US/EU Poor uptake of HPV vaccine15,16 Changing sexual behavior17 Unique pathophysiology of HPV1618 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+) patients19 Advanced oral cancer: HPV16+ patients had worse survival than HPV-negative

patients20 The rapidly increasing incidence of HPV16-positive head and neck cancer coupled with the potentially worse survival prognosis of these patients presents a rapidly growing unmet medical need that may be effectively addressed with

PDS0101 HPV16+ Patients Have No Targeted Therapies and Worse Clinical Outcomes NO FDA-APPROVED HPV16 TARGETED THERAPIES 2 1 A targeted approach for HPV16+ patients in ICI-resistant HPV+ cancers 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 Proprietary Cancer Vaccine Platform: The Versamune® Platform - Mechanism for Targeted Immune

Attack on Tumors Immunotherapy (cancer vaccine) platform designed to generate killer CD8+ T-cell responses against specific tumor antigens21-26 Clinical studies suggest potential to overcome limitations of cancer vaccine

technologies Potent and durable CD4+ & CD8+ T cells that target and accumulate in tumors (preclinical/clinical studies)21-26 Long-lasting memory T cells (preclinical/clinical studies)21,23 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 Antigen = protein present in the cancer that can be recognized and attacked by the

immune system

PDS0101: Training the Immune System to Find and Destroy HPV16+

Tumors21 CD4+helper T cell CD8+killer T cell HPV16 E6 & E7 Versamune®Activated CD8+Killer T Cell Versamune® +HPVmix (PDS0101) Targeted T CellsTrack 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 3 T cells increase production of HPV16 specific CD8 killer & CD4 helper T cells, which recognize

and infiltrate tumor 2 1

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 Months3 mOS = Median Overall Survival. No

head-to-head studies have been performed. 12-18 Months mOS is Benchmark with Pembrolizumab and Pembrolizumab + Chemotherapy4 Durable Survival: 11 Patients Surpassed 30 Months

PDS0101 + Pembrolizumab: Near or Complete Tumor Shrinkage in Difficult-to-Treat

Patients3 *Investigator assessment. 63% of recruited patients into the study had low CPS 1-193 Results Confirmed disease control rate of 77.4% ORR of 35.8% 21% of patients tumor regression of 90-100%

PDS0101 + Pembrolizumab: Well-tolerated with a Low Incidence of Adverse Events3

*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)

PDS0101 + 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 Genmab27 Bicara28 BioNTech29 PDS Biotech3 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

Pipeline of Tumor-Targeted Immunotherapies ChemoRT = chemoradiotherapy; HAIP =

Docetaxel Metastatic castration-resistant prostate cancer In Progress PDS0301 Monotherapy Advanced Kaposi sarcoma (Orphan) In Progress Versamune® + PDS0301 PDS0101 + PDS0301 + ICI HPV16-positive

ChemoRT IMMUNOCERV Locally advanced cervical cancer Complete PDS0101 +/- Pembrolizumab Locally advanced HPV16-positive head and neck cancer Complete

References Eade AV et al, Tumor-Targeted IL-12 (PDS01ADC) With Hepatic Artery

Infusion Pump Therapy for Colorectal Liver Metastases: Interim Analysis of a Nonrandomized Phase II Trial; JCO Oncol Adv. 2026 Mar 10;3(1):e2500173. doi: 10.1200/oa-25-00173 Eade AV et al, National Cancer Institute, Updated Interim Clinical

Results - Tumor-Targeted IL-12 (PDS01ADC) With Hepatic Artery Infusion Pump Therapy for Colorectal Liver Metastases: Interim Analysis of a Nonrandomized Phase II Trial Weiss J et al. PDS0101 With Pembrolizumab in HPV16-Positive

Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma A Phase 2 Nonrandomized Clinical Trial; JAMA Oncol. doi:10.1001/jamaoncol.2026.3492 Published online September 17, 2026. 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. 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 Fallon J et al (2014) The immunocytokine NHS-IL12 as a potential cancer therapeutic. Oncotarget (2014) 5

(7):1869–84. doi: 10.18632/oncotarget.1853 Greiner JW et al NHS-IL12, a Tumor-Targeting Immunocytokine; ImmunoTargets and Therapy 2021:10 155–169 Goswami M. et al; Increases in peripheral memory T cells with self-renewing properties in

patients with advanced solid tumors treated with tumor-targeting IL-12 immunocytokine therapy, Abstract # 168, Society for Immunotherapy of Cancer, Nov. 2025 Pitts S. et al; A tumor-targeting IL-12 immunocytokine therapy in patients with

advanced solid tumors increases peripheral natural killer (NK) cells with phenotypes associated with increased tumor cell lysis, Abstract # 47, Society for Immunotherapy of Cancer, Nov. 2025 Toney NJ, Immune correlates with response in

patients with metastatic solid tumors treated with a tumor targeting immunocytokine NHS-IL12 (2023) International Immunopharmacology, 116 (109736) Conroy R, Zanzalintinib Plus Atezolizumab Improves OS in Previously Treated Metastatic CRC,

OncLive New Articles, October 20, 2025 Moyers JT et al, Baseline biomarker analysis and clinical outcomes of the PD-1/TGFβR2 bispecific antibody INCA33890 in patients with non-MSI-H metastatic colorectal cancer (mCRC), J Clin

Oncol 44, 186(2026), Volume 44, Number 2_suppl Aruquipa MPS et al, Liver metastasis and resistance to immunotherapy in microsatellite stable colorectal cancer. A literature review; ecancer 2024, 18:1771 Abel ML et al, Abstract PR008:

Docetaxel and the Tumor Targeting Interleukin-12 (IL-12) PDS0301 in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC), Cancer Research, Vol. 86, Issue 2 Supplement, 15 January 2026.

References 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. Wood LV, Versamune T Cell Activating Platform Applied to HPV-Related Cancers; World Vaccine &

Immunotherapy Congress, November 28th, 2022. Wood LV, Edwards LH, Ferris DG. A novel enantio-specific cationic lipid R-DOTAP + HPV16 E6 & E7 antigens induces potent antigen-specific CD8+ T cell responses in-vivo in subjects with CIN and

high-risk human papillomavirus infection (abstr). Society for Immunotherapy of Cancer (SITC) Annual Meeting, Nov. 6-10, 2019, National Harbor, MD 2019 Yoshida-Court K. et al, IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an

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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.

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