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): June 12, 2024

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 June 12, 2024, PDS Biotechnology Corporation (the “Company”) issued a press release announcing an update to data from its ongoing VERSATILE-002 Phase 2 clinical trial. In addition, on June 12, 2024, the Company updated its corporate presentation deck.

A copy of the press release is filed herewith as Exhibit 99.1 and incorporated by reference herein.  A copy of the corporate presentation deck is filed herewith as Exhibit 99.2 and incorporated by reference herein.

Item 9.01
Financial Statements and Exhibits.

(d) Exhibits.

Exhibit
Number
  
Description
     
 
Press Release Dated June 12, 2024.
 
Corporate Presentation (June 2024).
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: June 12, 2024
By:
/s/ Frank Bedu-Addo, Ph.D.
 
Name: Frank Bedu-Addo, Ph.D.
 
Title: President and Chief Executive Officer


Exhibit 99.1

PDS Biotech Provides Data Update from Ongoing
VERSATILE-002 Phase 2 Clinical Trial in Head and Neck Cancer
 
Majority of patients continue to be followed for survival with multiple patients approaching 3 years
 
Median Overall Survival (mOS) remains at 30 months based on the most recent data cut with approximately six months of additional follow-up

PRINCETON, N.J., June 12, 2024 -- PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, today provided a data update from its ongoing VERSATILE-002 Phase 2 clinical trial. VERSATILE-002 is evaluating Versamune® HPV + KEYTRUDA® (pembrolizumab) in patients with HPV16-positive head and neck squamous cell cancer (“HNSCC”).

The Kaplan-Meier analysis described below captures the survival data for immune checkpoint inhibitor (“ICI”) naïve patients from the ongoing VERSATILE-002 Phase 2 clinical trial.  All patients whose data are reported in the Kaplan-Meier analysis are properly censored to confirm their follow-up and survival status.


Based on a data cut as of May 17, 2024, the updated survival data for the cohort of ICI naïve patients after an additional follow-up of approximately 6 months in the VERSATILE-02 Phase 2 clinical trial with a total of 53 enrolled patients was as follows:


 •
mOS is 30 months, consistent with data presented at the Company’s Key Opinion Leader event on May 9, 2024, which was based on a data cut as of November 30, 2023.

•
27 of the censored patients remained alive and were awaiting their next clinical assessment, 6 censored patients had withdrawn consent for further follow-up, and 2 patients had been lost to follow-up, and 18 patients had died.

•
The lower limit of the 95% confidence interval is 19.7 months, and the upper limit is not yet estimable, as the majority of the patients continue to be followed for survival.

Full data from the May 17, 2024 data cut are expected to be announced in Q3 2024.

Dr. Kirk Shepard, M.D., Chief Medical Officer of PDS Biotech stated, “In recurrent and/or metastatic HNSCC objective response rate and progression-free survival have generally not translated into increased survival, and under current standards of care survival rates are well established to be less than 18 months. We believe that our VERSATILE-002 clinical trial and triple combination trial provide us with the critical survival information needed to effectively design the statistical primary endpoint in our planned Phase 3 trial”.

The Company continues to advance its clinical strategy, which consists of a three arm registrational trial in first line treatment of HPV16-positive recurrent/metastatic HNSCC. The planned trial has two active arms: the double combination of Versamune® HPV + pembrolizumab, and the triple combination of Versamune® HPV + PDS01ADC + pembrolizumab.  PDS01ADC is the Company’s tumor-targeted IL-12-fused antibody-drug conjugate (“ADC”), which has shown promise in ongoing Phase 2 clinical trials including a Phase 2 clinical trial of Versamune® HPV + PDS01ADC + an investigational ICI conducted by the National Cancer Institute.

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines. The Company plans to initiate a pivotal clinical trial in 2024 to advance its lead program in advanced head and neck squamous cell cancers. PDS Biotech’s lead program is a proprietary dual-acting combination of IL-12 fused antibody drug conjugate (ADC) PDS01ADC and T-cell activator Versamune® HPV in regimen with a standard-of-care immune checkpoint inhibitor. We believe that proof-of-concept long-term data have shown positive survival results and tumor shrinkage with this combination and indicate favorable tolerability.

We believe that with a novel investigational “inside-outside” mechanism, the PDS01ADC and Versamune® HPV immunotherapy has shown compelling results with potential to successfully disrupt a tumor’s inside defenses, while also generating potent, targeted killer T-cells to attack the tumor from the outside. We also believe that data from more than 350 patients, as well as ongoing clinical trials across multiple tumor types and standard treatment regimens, have validated the potential for both platforms and point to potential broad utility.

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 initiate the planned clinical trials for PDS01ADC, PDS0101, PDS0203 and other Versamune® and Infectimune® 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, PDS0203 and other Versamune® and Infectimune® 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; 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® and Infectimune® 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, N.J., USA.

Investor Contact:
Mike Moyer
LifeSci Advisors
Phone +1 (617) 308-4306
Email: mmoyer@lifesciadvisors.com

Media Contact:
Gina Mangiaracina
6 Degrees
Phone +1 (917) 797-7904
Email: gmangiaracina@6degreespr.com


 Transforming How the Immune System Targets and Fights Cancer to Promote Survival  NASDAQ: PDSB   June 2024  Precision Designed Science For Immunotherapy 
 
 Forward-Looking Statements  This communication contains forward-looking statements (including within the meaning of Section 27E 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 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, Vesamune® HPV 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 Securities and Exchange Commission (“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. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of any securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.  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 observed in >300 patients  Versamune® HPV administered to 120 patients with head and neck squamous cell carcinoma (“HNSCC”)   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).  PDSB Platforms Designed to Overcome Limitations of Immuno-oncology  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 
 
 More Than 430 Patients Treated with PDS01ADC and/or Versamune® HPV  Lead Program Supported by Robust Clinical Data  PDS01ADC  300+ Patients Treated to Date  HNSCC   Patient Exposure Across Product Portfolio  PDS01ADC + Versamune® HPV + Bintrafusp alfa (triple) and Versamune® HPV + pembrolizumab (double) administered to 120 patients with HNSCC to date  Acceptable tolerability and safety profile to date at 12.0 and 16.8 μg/kg every 2 or 4 weeks  Versamune® HPV well-tolerated to date at 3.0 and 10.0 mg per dose every 3 weeks  Versamune® HPV  170+ Patients Treated to Date 
 
 Overcoming Tumor Immune Suppression and Increasing the Potential of Cancer Vaccines  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-targeting IL-12  Versamune®  Outside  Administered with Tumor-specific Proteins  to Induce the Right Type & Quantity of powerful Tumor-Targeting Killer T Cells  Versamune® HPV: HPV16-specific T cells 
 
 VERSATILE-003 Plus Design – First Line Recurrent/Metastatic HNSCC  Key Eligibility Criteria  CPS ≥1  HPV16-positive HNSCC  ≥18 years of age  ECOG 0-1  Interim  Analysis  Versamune® HPV + PDS01ADC + pembrolizumab  Q4 2024  Versamune® HPV + pembrolizumab  Pembrolizumab  FDA-aligned VERSATILE-003 protocol design  Added triple combo arm to VERSATILE-003  Median Overall Survival (OS) as Primary Study Endpoint; Two Active Arms; Approx. 350 Subjects  FDA-aligned VERSATILE-003 protocol design  FDA meeting anticipated July 2024  Key Secondary Endpoints  Progression Free Survival (PFS)  Objective Response Rate (ORR)  Duration of Response (DoR)  Quality of Life  Randomized controlled trial  N ≈ 350  1:1:1 randomization  Primary Endpoint  Overall Survival (OS) 
 
 Study to Evaluate Treatment in First Line Recurrent/Metastatic HPV16-positive HNSCC  PDS Biotech Data on File. National Cancer Institute. (2023). Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set],  2024 Planned Pivotal Trial Based on Two Phase 2 Clinical Trials  VERSATILE-002  (NCT04260126)   Versamune® HPV + pembrolizumab  ORR 34%  mOS 30 months  TRIPLE COMBINATION  (NCT04287868)   ORR 75%  mOS 42 months*  *5/8 (63%) of patients still alive and being followed for survival.  Versamune® HPV + PDS01ADC + ICI 
 
 Triple Combination Demonstrates Strong Results  Published Studies  KEYNOTE-048  LEAP-010  PDS Triple Combination  Treatment  Pembrolizumab  Pembrolizumab  Pembrolizumab  Versamune® HPV, PDS01ADC, ICI  Population  Advanced, anal, cervical, vulvar  R/M HNSCC  R/M HNSCC  Advanced anal, cervical, HNSCC, vaginal/vulvar  ORR  11-17%  19%  25%  75%  mOS  6-12 months  12.3 months  17.9 months  42.0 months  Immuno-Cytokine T Cell Activating Combination Shows Promising Results  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. ;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. Immunotherapy in Anal Cancer. Curr. Oncol. 2023, 30, 4538–4550, Front. Oncol. 12:910486. doi: 10.3389/fonc.2022.910486;   No controlled head-to-head trials have been performed between pembrolizumab and the Versamune® HPV combinations 
 
 Mechanism Attacks the Tumor from Both the Inside (TME) and Outside  Potential first tumor-targeting immuno-cytokine antibody drug conjugate  PDS01ADC + Versamune® + ICI: New 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   N=8 HPV16+ (ICI Naïve)  N=6 HPV16- (ICI Naïve)  N=29 HPV16+ (ICI Resistant)  N=7 HPV16- (ICI Resistant)  Key Entry Criteria for ICI Naïve 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 alfa3      1 1 mL Subcutaneous injection every 4 weeks for 6 doses followed by 2 doses at 12-week intervals  2 16.8mcg/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 naïve and ICI resistant patients 
 
 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%) 
 
 Phase 2 Triple Combination Results Indicate Favorable Tolerability  48% Grade 3 Treatment Related Adverse Events (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 (10)  GI Bleeding  2 (4)  AST/ALT Elevation  4 (8)***  Mucositis  1 (2)  Grade 3/4 Adverse Events (AE)   Grade 3/4 Adverse Events (cont.)   *HLH, hemophagocytic lymphohistiocytosis  **Grade 4 TRAE  ***1 patient had Grade 4 TRAE  Safety Population: All enrolled subjects who received at least 1 dose of any drug. National Cancer Institute. (2023). Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set] 
 
 First Line Recurrent/Metastatic HPV16-positive HNSCC  *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 Cancers Associated with HPV  HNSCC  HNSCC  HNSCC  12.3*  Median Overall Survival (Months)  17.9*  30.0  42.0**  Versamune® HPV and PDS01ADC Promoted Strong Survival Benefit  References: Burtness B. et al. Lancet. 2019;394:1915-28. 2024 Multidisciplinary Head and Neck Cancers Symposium. February 29-March 2, 2024. ;National Cancer Institute. (2023). Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set]; Lancet. 2022;7(5):446-454. Gynecol Oncol. 2022;166(2):212-218. J Clin Oncol. 2019;37(17):1470-1478. Immunotherapy in Anal Cancer. Curr. Oncol. 2023, 30, 4538–4550, Front. Oncol. 12:910486. doi: 10.3389/fonc.2022.910486;  
 
 34%   (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  First Line Recurrent/Metastatic HPV16-positive HNSCC  Versamune® HPV and PDS01ADC Promoted Strong Objective Responses  Objective Response Rate (%)  References: Burtness B. et al. Lancet. 2019;394:1915-28. 2024 Multidisciplinary Head and Neck Cancers Symposium. February 29-March 2, 2024. ;National Cancer Institute. (2023). Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set]; Lancet. 2022;7(5):446-454. Gynecol Oncol. 2022;166(2):212-218. J Clin Oncol. 2019;37(17):1470-1478. Immunotherapy in Anal Cancer. Curr. Oncol. 2023, 30, 4538–4550, Front. Oncol. 12:910486. doi: 10.3389/fonc.2022.910486;  
 
 In Interviews, Oncologists Strongly Support Use of Triple Combination in First Line Recurrent/Metastatic HNSCC  ICI: Immune Checkpoint Inhibitor  Source: Triangle Insights Group Interviews with N=20 medical oncologists, conducted March 2024  On a scale of 1-7, the triple combination was rated 6.3 by oncologists for use in first line R/M HNSCC  Not at All Favorable  Very  Favorable  Preference as 1L Treatment: It would allow patients to bypass chemo  New Standard of Care: Oncologists were confident that it would likely become new standard of care given the strong responses versus existing treatments  “This is the way to go; a chemo-free way to treat patients. I think they will like it and the response is great.” – Medical Oncologist  Perceived Benefits  Perceived Concerns  “No new concerns…the efficacy is so compelling that I would put up with this degree of toxicity; it is no problem” – Medical Oncologist  Limited Concerns in 1L Use: Patients typically tolerate treatment better in earlier lines, oncologists were more optimistic about the triple therapy in the first line  An improved safety profile may further raise the overall favorability of the product 
 
 Triple Combination Conclusions  Triple Combination successfully met primary endpoint of at least a 60% confirmed objective response rate in first line R/M HPV16+ patients by RECIST v1.1  BOR = 63% (RECIST v1.1)  BOR = 75% (iRECIST)  Versamune® HPV + PDS01ADC + ICI may significantly impact survival in first line and second line treatment of recurrent and/or metastatic HPV16-positive cancer  Median OS of 42 months in first line exceeds the best publicly reported results to date  Median OS of 19-20 months in second line exceeds the best publicly reported results to date  Triple Combination appears to be well-tolerated   Immunological and clinical data suggest that PDS01ADC may be effective in targeting the tumor to overcome immune suppression  National Cancer Institute. (2023). Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set] 
 
 Study to Evaluate Treatment in First Line Recurrent/Metastatic HPV16-positive HNSCC  PDS Biotech Data on File. National Cancer Institute. (2023). Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set],  2024 Planned Pivotal Trial Based on Two Phase 2 Clinical Trials  VERSATILE-002  (NCT04260126)   Versamune® HPV + pembrolizumab  ORR 34%  mOS 30 months  TRIPLE COMBINATION  (NCT04287868)   ORR 75%  mOS 42 months*  *5/8 (63%) of patients still alive and being followed for survival.  Versamune® HPV + PDS01ADC + ICI 
 
 VERSATILE-002 Study Met Primary Endpoint  Overall Survival Doubles with Versamune® HPV Combination with pembrolizumab in First Line Recurrent/Metastatic HNSCC   VERSATILE-002   (Versamune® HPV + pembrolizumab)  KEYNOTE-048  (pembrolizumab)  CPS≥1  CPS≥20  CPS≥1  CPS≥20  Confirmed ORR (%)  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 Objective Response Rate (ORR) and Progression-Free Survival (PFS) Based on Investigator Assessment Per RECIST v1.1  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: Data represents a 15Feb2024 extraction of all cleaned and Q/C’d data through 30Nov2023. 
 
 VERSATILE-002 Phase 2 Clinical Trial Design (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 Naïve 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 HNSCC  Demographic  mITT Population (N=53)  Age, Median (Min, Max)  64.0 (46, 83)  Sex, n (%)  Male  Female     49 (92.5)  4 (7.5)  Race, n (%)  American Indian or Alaska Native  Asian  Black or African American  Pacific Islander  White  Other     0  1 (1.9)  1 (1.9)  0  50 (94.3)  1 (1.9)  ECOG, n (%)  0  1     30 (56.6)  23 (43.4)  CPS, n (%)*  <1  1–19  ≥20     0  32 (60.4)  21 (39.6)  Treatment Exposure  Median number of Versamune® HPV doses: 4 (range 1–5)  79.2% received ≥4 doses39.6% received 5 doses (5th dose is 6 months after dose 4)  Median number of KEYTRUDA® doses: 9 (range 1–35)  45.3% received ≥10 doses  Data on File: Data represents a 15Feb2024 extraction of all cleaned and Q/C’d data through 30Nov2023  Key Demographics and Treatment Exposure 
 
 Data on File: Represents a May 17 data cut; full data from May 17 data cut expected to be announced July 2024  Median Overall Survival of 30 Months  *N=2 Lost to follow up; N=6 withdrawn consent; **Patients ongoing and awaiting next clinical assessment   (N=8)*   (N=27)**  Kaplan-Meier Analysis: Multiple Patients Approaching 3-Years of Survival 
 
 Durable Responses Reported with 75.5% of Patients with CPS ≥1 Having CR, PR or SD  Data on File: Data represents a 15Feb2024 extraction of all cleaned and Q/C’d data through 30Nov2023  SD = Stable disease for at least 6 months  Complete Response (CR)  Partial Response (PR)  Stable Disease (SD) ≥ 6 months  Progressive Disease (PD)  Not Evaluable (NE) 
 
 Disease Stabilization or Tumor Reduction Reported in 87% (46/53) of First Line Recurrent/Metastatic HNSCC Patients  Best Percentage Change from Baseline in Target Lesions (mITT population*)  * Modified Intent-to-Treat: All ITT subjects who had at least 1 imaging assessment  Data on File: Data represents a 15Feb2024 extraction of all cleaned and Q/C’d data through 30Nov2023 
 
 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)  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  * TRAE = Treatment Related Adverse Event  Data on File: Data represents a 15Feb2024 extraction of all cleaned and Q/C’d data through 30Nov2023 
 
 VERSATILE-002 Conclusions  VERSATILE-002 successfully met primary endpoint of 14 or more confirmed objective responses by RECIST v1.1 in ICI naïve patients with CPS ≥1  ORR 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: Data represents a 15Feb2024 extraction of all cleaned and Q/C’d data through 30Nov2023 
 
 Candidate/ Study   Indication  PC  P1  P2  P3  Partner  PDS01ADC + Versamune®  PDS01ADC + Versamune® HPV + ICI*   Recurrent or metastatic HPV16-positive HNSCC  PDS01ADC + Versamune® MUC1 + ICI (Phase 1/2 anticipated 2024)  Recurrent or metastatic colorectal cancer  Versamune®  Versamune® HPV + ICI (KEYTRUDA®)  Recurrent or metastatic HPV16-positive HNSCC  Versamune®  Versamune® HPV + Chemo (IMMUNOCERV)*  1st-line treatment of locally advanced(IB3-IVA) cervical cancer  Versamune®  Versamune® HPV +/- pembrolizumab*   Neo-adjuvant treatment of locally advanced HPV-positive oropharyngeal cancer (OPSCC)  Pipeline Continues to Validate Platforms, Drive Future Opportunities  Initiate pivotal study in HNSCC: PDS01ADC + Versamune® HPV + pembrolizumab Triple Combination – 2024  Update on regulatory confirmation of potentially registrational study - Q3-2024  Upcoming Milestones (2024)  File IND for Versamune® MUC1 Triple Combination Phase 1/2 study in r/m colorectal cancer – Q4-2024  Provide clinical update on IMMUNOCERV trial – Q4-2024  *Investigator Initiated Trials (IIT) 
 
 Thank You  NASDAQ: PDSB 
 

v3.24.1.1.u2
Document and Entity Information
Jun. 12, 2024
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Jun. 12, 2024
Entity File Number 001-37568
Entity Registrant Name PDS BIOTECHNOLOGY CORPORATION
Entity Central Index Key 0001472091
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 26-4231384
Entity Address, Address Line One 303A College Road East
Entity Address, City or Town Princeton
Entity Address, State or Province NJ
Entity Address, Postal Zip Code 08540
City Area Code 800
Local Phone Number 208-3343
Title of 12(b) Security Common Stock, par value $0.00033 per share
Trading Symbol PDSB
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
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