Source: sec
Source ID: 0001140361-26-040283-ex991
URL: https://www.sec.gov/Archives/edgar/data/1472091/000114036126040283/ef20084135_ex99-1.htm
Symbol: (PDSB)
Published: 2026-10-20 19:59:06 EDT
Time precision: minute
Title: 8-K 8-K items 8.01,9.01

EX-99.1
2
ef20084135_ex99-1.htm
EXHIBIT 99.1
Exhibit 99.1
Overview of PDS Biotech Drug Development Programs (Oncology) NASDAQ:
PDSB October 2026 Precision Designed Science for Immunotherapy
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. 2
Clinically Validated Immunotherapies for Solid Tumors with High Unmet Need *
Microsatellite stable (MSS) and/or mismatch repair-proficient (pMMR) disease. 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 survival. 1,2 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 months. 4 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. 3
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 PDS0301 + Enzalutamide vs. enzalutamide Biochemically recurrent prostate cancer PDS0301 + Docetaxel Metastatic
castration-resistant prostate cancer PDS0301 Monotherapy Advanced Kaposi sarcoma (Orphan) Versamune® + PDS0301 PDS0101 + PDS0301 + ICI HPV16-positive recurrent/metastatic cancers Versamune® HPV16 Cancer Vaccine Platform PDS0101 +
Pembrolizumab VERSATILE-003 | vs. pembrolizumab HPV16-positive recurrent/metastatic head and neck cancer PDS0101 + ChemoRT IMMUNOCERV Locally advanced cervical cancer PDS0101 +/- Pembrolizumab Locally advanced HPV16-positive head and
neck cancer In Progress In Progress In Progress In Progress Complete FDA Fast Track Complete Complete 4
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 6
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 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. Tumor-targeted IL-12
immunocytokine NHS76 Tumor Necrosis Targeting Antibody – Binds to exposed DNA histones De-immunized Junction IL-12 (p40 clipping-resistant) IL-12 (p40 clipping-resistant) 7
Phase 2 Clinical Study of PDS0301 and Chemotherapy in mCRC with Liver Metastases
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 * microsatellite stable (MSS) or mismatch repair-proficient (pMMR) disease 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 Days 1-14 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 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 Endpoints Study Treatment Key Entry Criteria StudyDesign 9
Chemotherapy + PDS0301 may Promote Durable Responses in Metastatic
CRC1,2 Encouraging Responses at 6 months Post Treatment; Monitoring of Durability Continues Sequentially performed study chemo +/- PDS0301 at the same National Cancer Institute clinical site; Chemotherapy = Floxuridine by Hepatic artery
infusion + systemic FOLFOX (IV). 10 Consistent with the PDS0301 promotion of self-renewing memory T cells Change from Baseline (%) Change from Baseline (%) Patient (n=20) Patient (n=22) Chemotherapy + PDS0301 6 Months • ORR = 71.4%
(15/21) Chemotherapy 6 Months • ORR = 35% (7/20) ND Death < 6 Months Progressive Disease Stable Disease Partial Response Complete Response
24-Month Survival Rate of Approximately 80%1,2 PDS0301 + Chemotherapy Appears to
Provide Survival Benefit (Preliminary Results) *Sequentially performed studies at the same clinical site – Not randomized head-to-head. 11 Survival post-HAIP insertion (months) Probability of Survival
100 75 50 25 0 20 0 40 60 80 Chemotherapy (N=20)* Chemotherapy + PDS0301 (N=22)*
Promising Results with PDS0301 in MSS/pMMR Metastatic Colorectal Cancer (mCRC)
with Liver Metastases NE= Not yet estimable – minimum follow up time of 13.1 months for PFS No randomized head-to-head study has been performed between PDS0301, chemotherapy or other agents. 12 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%) / 11 12 1, 2 Incyte Excelis
mCRC Program Provides Significant Value Creation Opportunity No head-to-head
studies have been performed. Source: https://www.delveinsight.com/report-store/metastatic-colorectal-cancer-market 13 71.4 80 >380 % Objective Response Rate1,2 <30% benchmark)* 24-month survival rate1,2 Dosed with PDS0301 in
Phase 1 and Phase 2 Trials 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 % Current Focus 2L mCRC
PDS0301 Value-Creating Milestones Over the Next 6-18 Months Demonstrate Potential
Breadth in Solid Tumors Q4-2026/Q1-2027 Biochemically recurrent prostate cancer (Interim readout) Q1/Q2-2027 NCI-led - Colorectal cancer with liver metastases (Final data readout) Q2/Q3-2027 Metastatic castration resistant prostate
cancer (Final data readout) Q2-2028 Phase 3 – Colorectal cancer with liver metastases (Interim data readout) Q4-2027 Biochemically recurrent prostate cancer (Final data readout) 14
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 months.
1,2 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 months. 1,2
Published mOS in the population is < 12 months. 13 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 2026. 14 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. 15
Overview of PDS0101 in HPV16-Positive HNSCC
HPV16+ Tumors Represent the Largest and Fastest Growing Type of HNSCC HPV16+
HNSCC is Rapidly Increasing in US/EU Poor uptake of HPV vaccine15,16 Changing sexual behavior17 Unique pathophysiology of HPV1618 17 HPV16 HPV18 HPV 31/33/45/52/58 HPV 35/39/51/56/59/68 HPV-negative Annual Number of Oropharyngeal
Cancer Cases HPV16+ PDS Biotech focus
HPV16+ Patients Have No Targeted Therapies and Worse Clinical Outcomes A targeted
approach for HPV16+ patients in ICI-resistant HPV+ cancers represents a significant opportunity 18 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 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 No FDA-approved HPV16 Targeted Therapies 1 Published Evidence 2 Advanced oral cancer: HPV16+ patients had worse survival than HPV-negative
patients20
Proprietary Cancer Vaccine Platform: The Versamune® Platform – Mechanism for
Targeted Immune Attack on Tumors Antigen = protein present in the cancer that can be recognized and attacked by the immune system. 19 Immunologically active R-enantiomer of1,2-dioleoyl-trimethyl-ammonium (R-DOTAP) R-DOTAP forms spherical
bilayers in aqueous environment Immunotherapy (cancer vaccine) platform designed to generate killer CD8+ T-cell responses against specific tumor antigens.21-26 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 How It Works UPTAKE Promotes uptake of tumor proteins by immune cells 1 ACTIVATE Dendritic cells absorb & present proteins to T cells 2 ATTACK Killer T cells hunt & destroy matching tumors 3
PDS0101: Training the Immune System to Find and Destroy HPV16+
Tumors21 20 CD4+helper T cell CD8+killer T cell HPV16 E6 & E7 Versamune®Activated CD8+Killer T Cell Versamune® +HPVmix (PDS0101) Dendritic Cell MHC class II MHC class I Tumor Lymph Node Targeted T CellsTrack to
Tumor Subcutaneous Injection of PDS0101 stimulates uptake by dendritic cells & accumulates in the lymph nodes 1 T cells increase production of HPV16 specific CD8 killer and CD4 helper T cells, which recognize and infiltrate tumor
2 Activated T cells attack and destroy tumor 3
Lead Clinical Program Evaluating PDS0101 in Combination with Checkpoint
Inhibitors VERSATILE-002: PDS0101 + Pembrolizumab in 1L HPV16+ R/M HNSCC 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) HPV16-positive R/M HNSCC
tumors ≥18 years of age Combined positive score (CPS) ≥1 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 Single-arm study 31 sites in US and EU 2 Cohorts: ICI Naïve ICI Resistant Endpoints Study Treatment Key Entry Criteria for ICI Naïve Subjects StudyDesign 21
PDS0101 + Pembrolizumab: mOS of 39.3 Months3 12-18 Months mOS is Benchmark with
Pembrolizumab and Pembrolizumab + Chemotherapy4 mOS = Median Overall Survival. No head-to-head studies have been performed. 22 Durable Survival: 11 Patients Surpassed 30 Months Time to Progression (months) Survival
Fraction 1.0 0.0 2 0 48 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 0.2 0.4 0.6 0.8 53 (0) 46 (6) Number at Risk 40 (8) 37 (11) 32 (14) 30 (16) 26 (17) 19 (18) 10 (20) 7 (20) 5
(21) 3 (21) 0 (21) N Events Median 95% CI 53 21 39.3 23.9, NE
PDS0101 + Pembrolizumab: Near or Complete Tumor Shrinkage in Difficult-to-Treat
Patients3 63% of recruited patients into the study had low CPS 1-193 *Investigator assessment. 23 Results Confirmed disease control rate of 77.4%* ORR of 35.8%* 21% of patients tumor regression of 90-100%* CPS Group 1-19 ³20 Percent
Change from Baseline in Target Lesions Best Percentage Change from Baseline in Target Lesions (mITT population) Response Progressive Disease (PD) 9/53 17.0% Stable Disease (SD) 22/53 41.5% Partial Response (PR) 14/53 26.4% Complete
Response (CR) 5/53 9.4%
PDS0101 + Pembrolizumab: Well-Tolerated with a Low Incidence of Adverse Events3
*Occurred 1 year after completing PDS0101 therapy while patient was still on pembrolizumab. 24 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 PDS0101: Only
Subcutaneous Combination Therapy in Late-stage Development for 1L HPV16+ HNSCC No head-to-head studies have been performed. 25 Combinations with pembrolizumab 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 3 29 28 27 BioNtech Bicara Therapeutics Genmab
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 PDS0301 + Enzalutamide vs. enzalutamide Biochemically recurrent prostate cancer PDS0301 + Docetaxel Metastatic
castration-resistant prostate cancer PDS0301 Monotherapy Advanced Kaposi sarcoma (Orphan) Versamune® + PDS0301 PDS0101 + PDS0301 + ICI HPV16-positive recurrent/metastatic cancers Versamune® HPV16 Cancer Vaccine Platform PDS0101 +
Pembrolizumab VERSATILE-003 | vs. pembrolizumab HPV16-positive recurrent/metastatic head and neck cancer PDS0101 + ChemoRT IMMUNOCERV Locally advanced cervical cancer PDS0101 +/- Pembrolizumab Locally advanced HPV16-positive head and
neck cancer In Progress In Progress In Progress Complete FDA Fast Track Complete Complete 26 In Progress
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Cervical Cancer, Oral Presentation, ASTRO 2024 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,
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AHEAD-MERIT, a Phase 2 trial of first-line pembrolizumab plus the fixed-antigen cancer vaccine BNT113 in advanced HPV16+ HNSCC, ESMO 2024 28