Full Press Release Details
Transforming How the Immune System Targets and Fights Cancer to Promote
Forward-Looking Statement This communication contains forward-looking statements
(including within the meaning of Section 27E of the United States Securities Exchange Act of 7934, as amended, and Section 27A of the United States Securities Act of 7933, 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 initiate the planned clinical trials for PDS01ADC, PDS0101
and other Versamune and lnfectimune 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 PDS01ADC, PDS0101 and other Versamune and lnfectimune 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 ongoing clinical trials and anticipated clinical trials for the Company's current product candidates, including statements regarding 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; to aid in the development of the Versamune platform; 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 risk factors included in the Company's
annual, quarterly and periodic reports filed with the SEC. 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 and lnfectimune are registered trademarks of PDS Biotechnology Corporation. KEYTRUDA
is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Late-Stage Head and Neck Cancer Program as Value Catalyst 1. Company's 10-K for
year ended 12/31/2023 includes going concern opinion. Cash runway estimate based on currently available cash resources and cash flow projections and assumes no initiation of pivotal trial and Company debt not being called by
lenders. High-Value Lead Program Novel Investigational "Inside-Outside" MOA Robust Phase 2 Data in 400+ Patients Financials Pivotal trial planned for PDS01ADC + Versamune HPV (PDS0101) + pembrolizumab in first line recurrent/metastatic
head and neck cancer in 2024 PDS01ADC + Versamune disrupts tumor's inside defenses, and generates potent, targeted killer T-cell attack from outside Compelling Phase 2 survival data PDS01ADC favorable safety profile demonstrated in >300
patients Versamune HPV administered to >110 HNSCC patients Cash runway into Q4 2025 (without pivotal trial)1
Two Critical Limitations Remain References: Darvin et al. Experimental &
Molecular Medicine (2018) 50:165. Chen, D. S. & Mellman, I. Nature 541, 321 (2017). Why Immunotherapies Fail in Solid Tumors Immune-Desert Tumors: Lack T cells because T cells don't get activated or recognize the cancer
Immune-Excluded Tumors: Contain immune suppressive cytokines and inhibitory factors that prevent T cell infiltration TME = Tumor Microenvironment TME Prevents Immunogenicity Inability to generate the right type and quantity of effective
tumor-infiltrating and tumor-killing T cells Inadequate T Cell Response
Potential to Overcome Suppression of the T Cell Response by the Tumor TME = Tumor
Microenvironment Proprietary Dual Platform Enables Inside-Outside Attack on Tumor NHS76 (Tumor Necrosis Targeting Ab - Binds to exposed DNA) De-immunized Junction IL-12 (p40 clipping-resistant) IL-12 (p40 clipping-resistant) IL-12 fused
antibody drug conjugate Water-insoluble fatty acids/ hydrocarbon chains Water-soluble, positively charged head-group coats particle surface Immunologically active R-enantiomer of 1,2-dioleoyl-trimethyl-ammonium (R-DOTAP) Inside Infiltrates
TME to Suppress the Tumor's Defenses & Promotes T Cell Infiltration/Immunogenicity Outside PDS01ADC Most clinically advanced tumor-targeted IL-12 Versamune Outside Induces Right Type & Quantity of Powerful Tumor-Targeting Killer
VERSATILE-002 Phase 2 Clinical Trial (Multi-Site US/EU Trial) Objective: To
Assess the Combination of Versamune HPV and KEYTRUDA in Subjects with Recurrent or Metastatic HPV16-positive HNSCC KEYTRUDA (pembrolizumab) FDA-Approved Standard of Care Partner StudyDesign Open-label, non-randomized, adaptive design
study N=54 (ICI Naive) N=21 (ICI Resistant) Enrollment complete Key Entry Criteria for ICI Na ve Subjects Recurrent or metastatic HNSCC 18 years of age HPV16-Positive tumor Combined positive score (CPS) 1 Versamune
HPV1 Plus KEYTRUDA 2 1 1 mL Subcutaneous injection at Cycles 1, 2, 3, 4 and 12) 2 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 1.1 Key Secondary: Progression Free Survival (PFS) per RECIST 1.1 Overall Survival (OS) Safety and tolerability Endpoints Fast Track Designation
VERSATILE-002 First Line R/M HNSCCKey Demographics and Treatment
Exposure Demographic ITT Population (N=55) Age, Median (Min, Max) 64.0 (46, 83) Sex, n (%) Male Female 51 (92.7) 4 (7.3) Race, n (%) American Indian or Alaska Native Asian Black or African American Pacific
Islander White Other 0 1 (1.8) 1 (1.8) 0 52 (94.5) 1 (1.8) ECOG, n (%) 0 1 32 (58.2) 23 (41.8) CPS, n (%)* <1 1-19 20 0 33 (60.0) 22 (40.0) Treatment Exposure(ITT Population) Median number of PDS0101 doses: 4
(range 1-5) 76.4% received 4 doses38.2% received 5 doses (5th dose is 6 months after dose 4) Median number of KEYTRUDA doses: 8 (range 1-35) 43.6% received 10 doses Data on File. 02/15/24 Data Cut
Summary of VERSATILE-002 Results First Line Recurrent/Metastatic
HNSCC VERSATILE-002 (Versamune HPV + KEYTRUDA ) KEYNOTE-048 (KEYTRUDA ) CPS 1 CPS 20 CPS 1 CPS 20 Confirmed BOR (%) 34 48 19 23 Median PFS (months) 6.3 14.1 3.2 3.4 Median Overall Survival (months)* (Future Pivotal Trial
Endpoint) 30.0 30.0 12.3 14.9 Confirmed Best Overall Response and Disease Control Rate Based on Investigator Assessment Per RECIST v1.1 by PD-L1 Expression Level, mITT Population Progression-Free Survival (PFS) Based on Investigator
Assessment Per RECIST v1.1 by PD-L1 Expression Level, mITT Population No controlled or comparative studies have been conducted between checkpoint inhibitors and Versamune HPV * FDA-recommended clinical endpoint Burtness B. et al. Lancet.
2019;394:1915-28. Data on File. 02/15/24 Data Cut
Median Overall Survival of 30 Months in mITT and ITT Populations Kaplan-Meier
Estimates of OS in Recurrent/Metastatic HNSCC Data on File. 02/15/24 Data Cut Patients without a progression event or lost to follow up (N=2) at data cut off date - censor date is last date of tumor assessment
Versamune HPV and KEYTRUDA Combination Demonstrates Promising Survival In First
Line R/M HNSCC * No controlled or comparative studies have been conducted between checkpoint inhibitors and PDS0101Data on File. 02/15/24 Data CutBurtness B et al., Lancet. 2019; 394:1915-1928 OS Rate
(%) VERSATILE-002 VERSATILE-002 KEYNOTE-048(CPS 1) KEYNOTE-048(CPS 1) 12-month OS Rate Median Overall Survival (mOS) Keytruda Chemotherapy + Keytruda Versamune HPV + Keytruda Months
Durable Responses Reported with 75.5% of Patients with CPS 1 Having CR, PR or SD
According to RECIST 1.1 Spider Plot Showing Disease State with Time in Recurrent/Metastatic HNSCC Data on File. 02/15/24 Data Cut
Disease Stabilization or Tumor Reduction Reported in 87% (46/53) of First Line
Recurrent/Metastatic HNSCC Patients * Modified Intent-to-Treat: All ITT subjects who had at least 1 imaging assessment Best Percentage Change from Baseline in Target Lesions (mITT population*) Data on File. 02/15/24 Data Cut
Versamune HPV and KEYTRUDA Combination Well Tolerated in First Line R/M with No
Grade 5 TRAE* Injection Site Related TRAEs n (%) Injection site pain 37 (59.7) Injection site swelling 19 (30.6) Injection site erythema 13 (21.0) Injection site warmth 11 (17.7) Injection site discoloration 9 (14.5) Injection site
reaction 9 (14.5) Injection site inflammation 8 (12.9) Injection site pruritus 8 (12.9) Injection site rash 4 (6.5) All Other TRAEs n (%) Fatigue 23 (37.1) Headache 12 (19.4) Pruritis 9 (14.5) Diarrhea 7 (11.3) Rash 6
(9.7) Pain 5 (8.1) Alanine aminotransferase increased 4 (6.5) Aspartate aminotransferase increased 4 (6.5) Arthralgia 4 (6.5) Cough 4 (6.5) Malaise 4 (6.5) * TRAE = Treatment Related Adverse Event Data on File. 02/15/24 Data
Cut TRAEs by Grade n (%) Any Combination TRAE 55 (88.7) Grade 1 29 (46.8) Grade 2 18 (29.0) Grade 3 7 (11.3) Grade 4 1 (1.6) Grade 5 0 Grade 3 Combination-TRAE were: Fatigue (2), Rash, Alanine aminotransferase increased, Blood
alkaline phosphatase increased, Lymphocyte count decreased, Autoimmune colitis, Colitis, Headache, Acute kidney injury, Hyponatremia, Hyperglycemia, Grade 4 Combination-TRAE: encephalitis
VERSATILE-002 Conclusions VERSATILE-002 has successfully met its primary end
point of 14 or more confirmed objective responses by RECIST v1.1 in ICI na ve patients with CPS 1 BOR by Investigator Assessment: 34% (CPS 1) and 48% (CPS 20) Versamune HPV may significantly impact survival in first line treatment of
recurrent and/or metastatic HPV16 positive head and neck cancer The median OS of 30 months and 12-month OS rate of 80% both exceed the best publicly reported survival results to date with both investigational and approved products in patients
with CPS 1 The combination appears to be well tolerated Immunological and clinical data suggests that Versamune HPV induces the right type and quantity of potent tumor targeting T cells that promote patient survival Data on File. 02/15/24
Synergistic Effect With SoC Modalities Across a Spectrum of Solid Tumors PDS01ADC
and Versamune Have Broad Therapeutic Potential PDS01ADC VERSAMUNE Designed to deliver and sustain IL-12 in tumor Fused conjugate limits systemic presence and toxicity of IL-12 and also prevents free IL-12 Activates/expands T cells in
tumor & limits T cell exhaustion Changes tumor to become more permissive to T cell attack Designed to train T cells to recognize the cancer Activates the right type of multifunctional CD8 killer T cells Promotes a long-lasting memory T
cell response Promotes the right quantity and potency of T cells
Mechanism Attacks the Tumor from Both the Inside (TME) and Outside Potential
first tumor-targeting immuno-cytokine antibody drug conjugate PDS01ADC + Versamune + ICI: Unique Combined Mechanism Necrotic Core PDS01ADC binds to necrotic DNA Versamune Activated Targeting CD8+ Killer T-Cell Oxygenated
Area Inside PDS01ADC Infiltrates TME; Weakens Tumor's Protection from Immune System Stimulates T Cells in TME to Promote Expansion + Prolonged, Effective Killing Outside Versamune Induces Right Type & Quantity of Potent Killer T
Cells that Target and Infiltrate Tumor Immune Checkpoint Inhibitor Restores Pre-existing T Cell Responses
Triple Combination Investigator-Initiated Trial: Phase 2 Clinical
Trial Objective: To Assess the Triple Combination of Versamune HPV plus PDS01ADC plus the Bi-functional Immune Checkpoint Inhibitor Bintrafusp alfa in Subjects with Recurrent or Metastatic HPV-positive Cancer IIT
Partner StudyDesign Open-label, non-randomized, adaptive design study N=8 (up to 20 ICI Na ve allowed) N=29 (ICI Resistant) Key Entry Criteria for ICI Na ve Subjects Recurrent or metastatic HPV-positive cancer 18 years of
age HPV-Positive tumor Anal Cervical Oropharyngeal Vaginal/vulvar Versamune HPV1 Plus PDS01ADC2 Plus Bintrafusp alfa 3 1 1 mL Subcutaneous injection every 4 weeks for 6 doses followed by 2 doses at 12-week intervals 216.8mcg/kg
Subcutaneous injection every 4 weeks, or 8mcg/kg every 2 weeks for up to one year 3 1200mg IV every 2 weeks up to one year Study Treatment Primary: Best overall response (BOR) of confirmed complete response (CR) or partial response (PR) per
RECIST 1.1 in ICI naive Key Secondary: Overall Survival (OS) Safety and tolerability Endpoints Exploratory: Best overall response (BOR) of confirmed complete response (CR) or partial response (PR) per iRECIST 1.1 in ICI na ve and ICI
Triple Combination Key Demographics and Treatment Exposure National Cancer
Institute. (2023). Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set] Demographic ITT Population (N=50) Age, Median (Min, Max) 56.0 (28, 80) Sex, n (%) Male Female 26 (52%) 24 (48%) Tumor
Type, n (%) Anal Cervical Head and Neck Vaginal/Vulvar 10 (20%) 14 (28%) 23 (46%) 3 (6%) Prior Treatments, n (%) Chemotherapy Radiotherapy Immune Checkpoint Inhibitors 50 (100%) 45 (90%) 36 (72%) HPV Status, n
(%) HPV+ HPV16+ Other HPV+ HPV-/Unknown Status 48 (96%) 37 (74%) 11 (22%) 2 (4%)
First Line Recurrent/Metastatic HPV16+ HNSCC: Versamune HPV and PDS01ADC Promoted
Strong Survival Benefit References: Burtness B. et al. Lancet. 2019;394:1915-28. Licitra L. et al. 2024 Multidisciplinary Head and Neck Cancers Symposium. February 29-March 2, 2024. PDS Biotech Data on File. National Cancer Institute. (2023).
Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set] Marabelle A et al. Lancet. 2022;7(5):446-454. Shapira-Frommer R et al. Gynecol Oncol. 2022;166(2):212-218. Chung HC et al. J Clin Oncol.
2019;37(17):1470-1478. https://ascopost.com/issues/march-25-2024/lenvatinib-plus-pembrolizumab-fails-to-improve-overall-survival-in-advanced-head-and-neck-cancer/ *Pembrolizumab reported median overall survival range in anal, cervical &
vulvar cancers = 6-12 Months **Includes anal, cervical, HNSCC, vulvar cancers No controlled head-to-head trials have been performed between pembrolizumab and the Versamune HPV combinations Survival of Patients with Recurrent/Metastatic
HPV16+ Cancers HNSCC HNSCC HNSCC 12.3* Months 17.9* 30.0 42.3**
First Line Recurrent/Metastatic HPV16+ Cancer: Versamune HPV and PDS01ADC
Promoted Objective Responses References: PDS Biotech Data on File. National Cancer Institute. (2023). Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set], KEYNOTE-158, Efficacy and safety of
pembrolizumab on cervical cancer: A systematic review and single-arm meta-analysis Front. Oncol. 12:910486. doi: 10.3389/fonc.2022.910486, Dhawan, N.; Afzal, M.Z.Amin, M. Immunotherapy in Anal Cancer. Curr. Oncol. 2023, 30,4538-4550.
(18/53) 75%** (6/8) No controlled head-to-head trials have been performed between KEYTRUDA and the Versamune HPV combinations Best Objective Response (BOR) 11-25%* *Pembrolizumab reported ORR range in anal, cervical, HNSCC &
vulvar cancers = 11-25% **Includes anal, cervical, HNSCC, vulvar cancers; BOR assessment using iRECIST HNSCC
Phase 2 Triple Combination Results Indicate Favorable Tolerability 48% Had Grade
3 TRAEs, 4% Grade 4 Preferred Term n (%) Myocarditis 1 (2) Anemia 15 (30) HLH* 1 (2) Flu-like Symptoms 1 (2) Lymphopenia 3 (6) CPK Elevation 1 (2) Preferred Term n (%) Leukopenia 1 (2) Neutropenia 1 (2)** Hematuria 5