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): February 5, 2025

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)
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Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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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 February 5, 2025, PDS Biotechnology Corporation (the “Company”) issued a press release announcing the reaffirmation of the Company’s guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune® HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell cancer (HNSCC) in the first quarter of this year. In addition, on February 5, 2025, 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 February 5, 2025.
 
Corporate Presentation (February 2025).
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:  February  5, 2025
  
By:
/s/ Frank Bedu-Addo, Ph.D.
 
Name: Frank Bedu-Addo, Ph.D.
 
Title: President and Chief Executive Officer


Exhibit 99.1
 
 
PDS Biotech Reaffirms Guidance for First Quarter Initiation of
VERSATILE-003 Phase 3 Clinical Trial in HPV16-Positive
Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

FDA-cleared amended trial design; First site initiation expected Q1 2025

PRINCETON, N.J., February 5, 2025 -- 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, today reaffirmed the Company’s guidance of initiating its VERSATILE-003 Phase 3 clinical trial of Versamune® HPV plus pembrolizumab for first-line treatment of recurrent and/or metastatic (R/M) HPV16-positive head and neck squamous cell cancer (HNSCC) in the first quarter of this year.

PDS Biotech submitted its updated clinical protocol on November 15, 2024, amending the Investigational New Drug (IND) application. The window for comments from the U.S. Food and Drug Administration (FDA) has passed, and the Company is on track to initiate site activation in the first quarter of 2025. The Company has received Fast Track designation from the FDA for the combination of Versamune® HPV and pembrolizumab in R/M HNSCC. (See VERSATILE-002 Phase 2 clinical results here.)

“The integral elements for trial initiation are ready, including alignment with the FDA,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “We look forward to initiating VERSATILE-003 this quarter and advancing the combination of Versamune® HPV plus pembrolizumab to potentially provide improved outcomes for patients with HPV16-positive R/M HNSCC.”

HPV16-positive patients represent a large, fast-growing subgroup in need of targeted therapies to treat the underlying cause of the cancer.  A recently validated companion diagnostic to confirm HPV16-positive HNSCC will be utilized during the patient screening process of the VERSATILE-003 trial.

“HPV16-positive HNSCC is poised to become the dominant type of HNSCC in the US and EU,” said Kirk Shepard, M.D., PDS Biotech’s Chief Medical Officer. “Confirming HPV16 status with a potentially commercializable test is essential to effectively identifying the patients suitable to receive Versamune HPV. This will be the first investigational use of this type of companion diagnostic in a Phase 3 clinical trial in HNSCC.”

For more information on VERSATILE-003, visit ClinicalTrials.gov (Identifier: NCT06790966).

About PDS Biotechnology
PDS Biotechnology is a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers. The Company plans to initiate a pivotal clinical trial to advance its lead program in advanced HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational T-cell stimulating immunotherapy Versamune® HPV is being developed in combination with a standard-of-care immune checkpoint inhibitor, and also in a triple combination including PDS01ADC, an IL-12 fused antibody drug conjugate (ADC), and a standard-of-care immune checkpoint inhibitor.

For more information, please visit www.pdsbiotech.com

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 Versamune® HPV, PDS01ADC 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 Versamune® HPV, PDS01ADC 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 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® is a registered trademark of PDS Biotechnology Corporation.

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

Media Contact:
Janine McCargo
6 Degrees
Phone +1 (646) 528-4034
Email: jmccargo@6degreespr.com


Exhibit 99.2

 Transforming How the Immune System Targets and Fights Cancer to Promote Survival  NASDAQ: PDSB   February 2025  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 Versamune® HPV, PDS01ADC 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 Versamune® HPV, PDS01ADC 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 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. 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.  Xtandi® is a registered trademark of Astellas Pharma Inc.  
 
 Late-Stage Head and Neck Cancer* Program as Value Catalyst  Potential for Market Leadership Position  High-Value Lead Program With Strong KOL support  Growing Unmet Need  Phase 3 HNSCC Trial  Rapidly growing HPV16-positive indication 50%+ of HNSCC in US/EU  Unique cancer with atypical presentation and physiology   No current approved therapy for large HPV16-positive population  Versamune® HPV is an HPV16-specific T cell stimulating immunotherapy  Lead program addressing HPV16-positive recurrent and/or metastatic HNSCC  $4-5B US & EU market potential for HPV16-positive HNSCC  Phase 2 trial resulted in FDA Fast Track designation in R/M HNSCC  Alignment with FDA on phase 3 trial design  Trial planned to start in Q1 2025  Competing EGFR antibody approaches have reported weaker clinical responses in HPV-positive HNSCC compared to HPV-negative HNSCC  Strong phase 2 trial safety, response and survival results warrant Phase 3 study  Versamune® HPV is most clinically advanced HPV16 targeted program  *Head and neck squamous cell carcinoma (HNSCC) 
 
 Upcoming Milestones 2025-2026 (Phase 2 and Phase 3 Trials)  Q1 2025  Q2   2025  Q3 2025  Q4 2025  Q1 2026  Q2 2026  Q3 2026  Regulatory clearance to start VERSATILE-003  File IND for Versamune® MUC1  Initiate VERSATILE-003 (V-003)   Data readout from VERSATILE-002 (V-002)  Data readout: Versamune® HPV and Versamune® HPV + Pembrolizumab as neoadjuvant in HPV16+ oropharynx cancer  Interim data readout: PDS01ADC + HAIP therapy in colorectal & gall bladder cancer  Interim data readout: PDS01ADC + Xtandi® in recurrent PET+ prostate cancer  Complete V-003 patient recruitment  þ  *  Investigator initiated and funded trials. Trials not run by PDS Biotech; Completed  *  *  *  *  þ 
 
 HPV-positive and HPV-negative HNSCC: Two Distinct Diseases1-3  HPV-negative HNSCC   Alcohol & tobacco Causes mutations in oncogenic river genes   HPV-positive HNSCC  High-risk HPVViral oncoproteins E6/E7 degrade tumor suppressor proteins  Low expression of viral genes & limited T cell infiltration  Treatable with chemotherapy/radiation   Difficult to Treat   Disease recurrence or metastasis   High rates of disease recurrence or metastasis   High expression of viral genes & T cell presence in tumors  Non-keratinizing, basaloid histopathological features and over-expression of p16  Keratinizing squamous cell carcinoma features and frequent TP53 mutations  Most effective therapy will target E6 & E7 proteins 
 
 Significant and Growing Market Potential in HPV16-positive HNSCC  HPV16 to Drive Increased HNSCC Incidence Rates & Exceed 50% of all HNSCC by mid 2030s4  Current estimated US annual incidence of HPV16-positive HNSCC ~ 21,000 (~40-50% of all HNSCC)5-8   Incidence of locally advanced, unresectable, metastatic HPV16-positive HNSCC = 13,6007-9  Versamune® HPV US market potential = $2-3B10  EU HPV+ HNSCC incidence and trends similar to US 
 
 Significant Unmet Needs Remain in Recurrent or Metastatic (R/M) HNSCC   Pembrolizumab (KEYTRUDA®)  Pembrolizumab Plus Chemo  Chemotherapy   + EGFR Inhibitor  Objective Response Rate (ORR)  19%  36%  35%  Progression Free Survival (PFS)  3.2 mos  5.0 mos  5.0 mos  Median Overall Survival (OS)  12.3 mos  13.6 mos  10.3 mos  Treatment Related   Grade 3+ Toxicities  17%  72%  69%  HPV-Specificity: Need targeted treatment option to address the growing population of HPV16-positive HNSCC and improve outcomes   Improved Survival: Need novel MOA that provides enhanced survival  Improved Durability: Need novel MOA that is clinically effective in broad patient population and provides more durable (long-term) responses.   Improved Safety: Need safe treatments that may be used with or in place of current standard of care and chemotherapy  Oncologist10 – Stated Unmet Medical Needs in HNSCC  Survival on Current Therapies: Approx. 12 months (Published Results12) 
 
 FDA Views Overall Survival (OS) as Primary Endpoint for Approval in R/M HNSCC  KEYNOTE-04812  Pembrolizumab  EGFR antibody (cetuximab) + chemotherapy  LEAP-01014  Pembrolizumab  Pembrolizumab   + lenvatinib  Combination Drug Candidates Have Not Resulted in Improved (OS) over Pembrolizumab  ORR = Objective Response Rate; PFS = Progression Free Survival; OS = Overall Survival 
 
 VERSATILE-002: A Global Phase 2 Study of Versamune® HPV and Pembrolizumab in Subjects with HPV16-positive R/M HNSCC  Partner  StudyDesign  Open-label, non-randomized, adaptive design study  31 sites in US and EU  2 Cohorts:   ICI Naïve  ICI Resistant  Enrollment complete  Key Entry Criteria for ICI Naïve Subjects  R/M HNSCC  ≥18 years of age  HPV16-positive tumor  Combined positive score (CPS) ≥1  Versamune® HPV  5 doses: 1 mL Subcutaneous injection at Cycles 1, 2, 3, 4 & 12)  Pembrolizumab (KEYTRUDA®)   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 v1.1  Key Secondary:  Overall Survival (OS)  Progression Free Survival (PFS) per RECIST v1.1   Safety and tolerability  Endpoints  Fast Track Designation  Study Evaluating Effects of Versamune® HPV Attributes on Clinical Responses 
 
 VERSATILE-002: Most Patients Had Recurrent Disease and Prior Treatment  Historical Responses  Published data reports lower ORR, PFS and OS with pembrolizumab in patients with CPS 1-19 vs. CPS ≥ 2016  Published data reports lower responses in patients with recurrent disease  No controlled or comparative studies have been conducted between checkpoint inhibitors and Versamune® HPV  Key Demographics and Treatment Exposure15  Demographic/Baseline Characteristic  Efficacy Population (N=53)  Age, Median (Min, Max)  64.0 (46, 83)  Sex, n (%)  Male  Female     49 (92.5)  4 (7.5)  Race, n (%)  Asian  Black or African American  White  Other     1 (1.9)  1 (1.9)  50 (94.3)  1 (1.9)  ECOG, n (%)  0  1     30 (56.6)  23 (43.4)  CPS, n (%)  1–19  ≥20     32 (60.4)  21 (39.6)  Prior Therapy*, n (%)   No Prior Therapy  Chemotherapy Only  Chemotherapy + Radiation Therapy     10 (18.9)  3 (5.7)  40 (75.5)  Lower pembrolizumab responses  81.2% with prior treatment 
 
 Percent Change from Baseline in Target Lesions  -50  -25  25  50  75  100  0  -75  -100  -125  CPS Group  1-19   ≥20  CPS Group  Response  Complete Response (CR) 5/53 9.4%  Partial Response (PR) 14/53 26.4%  Stable Disease (SD) 22/53 41.5%  Progressive Disease (PD) 9/53 17.0%   Treatment Ongoing   Confirmed Objective Response Rate (ORR) Based on Investigator Assessment Per RECIST v1.1  Best Percentage Change from Baseline in Target Lesions (mITT population)  11/53 (21%) of patients had 90-100% tumor shrinkage   Deep Tumor Regression Independent of Patient CPS Score  35.8% ORR  Confirmed Disease Control Rate of 77.4%15 
 
 Extended Disease Control in Majority of Patients15  Based on Investigator Assessment Per RECIST v1.1  Best Percentage Change from Baseline in Target Lesions  Spider plot: Sustained CR, PR, and SD responses. Median Duration of Response is 21.8 months  Percent Change from Baselinein Target Lesions  Time of Assessment (Months)  0  2  4  6  8  10  12  14  16  18  20  22  24  1  3  5  7  9  11  13  15  17  19  21  23  -125  -100  150  175  200  225  50  75  100  125  -50  -25  0  25  -75  Response  Complete Response  Partial Response  Stable Disease  Progressive Disease  Treatment Ongoing 
 
 Survival Fraction  0  2  4  6  8  10  12  14  16  18  20  22  24  26  28  30  32  34  36  0.0  0.2  0.4  0.6  0.8  1.0  Censored ‒ Ongoing (N=27)  Censored ‒ Discontinued (N=8)  Discontinued: N=2 Lost to follow up; N=6 withdrawn consent; Ongoing: Patients ongoing and awaiting next clinical assessment  Median Overall Survival of 30 Months15  Multiple Patients Approaching 3 Years of Survival      53 (0)  50 (3)  46 (6)  42 (8)  40 (8)  37 (10)  34 (11)  32 (11)  23 (13)  20 (13)  16 (15)  14 (15)  9 (16)  8 (16)  7 (16)  5 (18)  3 (18)  1 (18)  0 (18)  Number at Risk  Median OS, months (95% CI) = 30.0 (19.7, NE)  Median follow up (months) = 16 
 
 Versamune® HPV plus Pembrolizumab Appears to be well Tolerated17   Protocol stipulates 5 subcutaneous injections of Versamune® HPV: 4 injections over 2 months and a final injection after an additional 6 months  *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 (case recorded approx. one year after last Versamune® HPV dose)  * TRAE = Treatment Related Adverse Event  8/87 (9%) Patients had a Grade 3 TRAE*; 1/87 (1%) had a Grade 4 TRAE**   TRAEs by Grade  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  Non-Injection Site TRAEs ≥ 5%  n (%)  Fatigue  30 (34.5)  Headache  13 (14.9)  Diarrhea  10 (11.5)  Pruritis  9 (10.3)  Rash  7 (8.0)  Malaise  6 (6.9)  Pyrexia  6 (6.9)  Pain  5 (5.7)  Cough  5 (5.7) 
 
 VERSATILE-002 Summary of Results15  ESMO 2024*  Published Results*  VERSATILE-002  KEYNOTE-048  LEAP-010  CPS ≥ 1  CPS ≥ 20  CPS ≥ 1  CPS ≥ 20  CPS ≥ 1  Objective Response Rate (ORR)  36%  48%  19%  23%  25%  Median Overall Survival (mOS)  30.0 months  30.0 months  12.3 months  14.9 months  17.9 months  * Not a head-to-head comparison. No controlled or comparative studies have been conducted between Versamune® HPV and pembrolizumab  Study has met primary ORR endpoint by RECIST v1.1 in ICI naïve patients  Disease control rate (DCR) for CPS ≥ 1 was 77.4%  21% of patients had 90-100% tumor shrinkage  The combination treatment was well tolerated  Strong Clinical Responses and Patient Survival Warrant Registrational Trial 
 
 Durable Anti-Tumor Immune Response Observed  Objective Response Rate (ORR)  Patients with Tumor Shrinkage of 90-100%  Patients with Complete Responses (CR)  Disease Control Rate (DCR)  Median Overall Survival  May 2023 (N=34)15  26%  6%  3%  70%  Not Estimable  November 2023 (N=53)16  34%  21%  7.5%  77%  30 months  May 2024 (N=53)12  36%  21%  9.4%  77%  30 months  By promoting potent killer T cells and memory T cells, Versamune® HPV is designed to enable a durable attack on the cancer, leading to potential tumor shrinkage and survival  Time  Responses Improved with Time; Sustained Median OS of 30 Months 
 
 Corroborating Biomarker/Clinical Support for Versamune® HPV  IMMUNOCERV  Chemoradiotherapy + Versamune® HPV   Published KEYNOTE-A18  Chemoradiotherapy + Pembrolizumab  (KEYTRUDA®)   36-Month Survival Rate  Number of Versamune® HPV doses  5 doses: 100% (N=8)  ≥2 doses: 84.4% (N=17)  82.6%  36-Month Progression Free Survival (PFS) Rate  Number of Versamune® HPV doses  5 doses: 100% (N=8)  ≥2 doses: 74.9% (N=17)  69.3%  Complete Response (Metabolic)  88%  N/A  * For illustrative purposes only. Not a head-to-head comparison. No controlled or comparative studies have been conducted between Versamune® HPV and pembrolizumab  Results for IMMUNOCERV Phase 2 Trial Results and Published KEYNOTE A18 Results   IMMUNOCERV Trial Provides Compelling Survival and PFS Results    
 
 Study in locally advanced cervical cancer patients treated with Versamune® HPV and chemoradiotherapy  91.7% clearance of ctDNA at Week 5 vs 53.1% clearance with CRT alone18   5/5 tested HPV16-positive patients had undetectable ctDNA at 3-4 months22  Undetectable ctDNA resulted in superior 2-year recurrence free survival (RFS) of 93% vs 30%22  Quantity of killer T cells that infiltrated the patient’s tumors  Quantity of HPV+ tumor cell DNA circulating in patient blood  Clinical: CD8 T Cell Accumulation in Tumor Correlated with Elimination of Circulating Cancer Cells (ctDNA)17  Representative Plot from a Single Versamune® HPV Treated Patient  Week 24  Week 3  Baseline  Radiation Oncology Dept. Univ. of Texas MD Anderson Cancer Center  Corroborating Biomarker/Clinical Support for Versamune® HPV  Elimination of Micro-Metastatic Tumors by Circulating Tumor DNA (ctDNA) Analysis25    
 
 Objective Response Rate (ORR)  Progression Free Survival (PFS)  N=8  N=8  N=6  N=6  Corroborating Biomarker/Clinical Support for Versamune® HPV  Superior Survival and Response in HPV16-positive vs HPV16-negative R/M Cancers26      Study performed by National Cancer Institute 
 
 VERSATILE-003 First Line Recurrent/Metastatic HNSCC Trial Design  Interim Analysis 1  Possible Early Approval  Versamune® HPV + PDS01ADC + pembrolizumab  Study Start  Versamune® HPV + Pembrolizumab  Pembrolizumab (KEYTRUDA®)  Aligned with FDA on Study Design and Initiation in Q1 2025  Patient Recruitment  Patient Recruitment  Survival Follow-up  Survival Follow-up  Key Eligibility Criteria  HPV16-positive HNSCC  CPS ≥1  ≥18 years of age  ECOG 0-1  Secondary Endpoints  Objective Response Rate (ORR)  Disease Control Rate (DCR)  Duration of Response (DoR)  Progression Free Survival (PFS)  Randomized controlled trial  N = 351  2:1 randomization  Primary Endpoint  Overall Survival (OS)  FinalAnalysis  Interim Analysis 2  Possible Early Approval 
 
 Late-Stage Head and Neck Cancer* Program as Value Catalyst  Potential for Market Leadership Position  High-Value Lead Program With Strong KOL support  Growing Unmet Need  Phase 3 HNSCC Trial  Rapidly growing HPV16-positive indication 50%+ of HNSCC  Unique cancer with atypical presentation and physiology   No current approved therapy for large HPV16-positive population  Versamune® HPV is an HPV16-specific T cell stimulating immunotherapy  Lead program addressing HPV16-positive recurrent and/or metastatic HNSCC  $4-5B US & EU market potential for HPV16-positive HNSCC  Phase 2 trial resulted in FDA Fast Track designation in R/M HNSCC  Alignment with FDA on phase 3 trial design  Trial planned to start in Q1 2025  Competing EGFR antibody approaches have reported weaker clinical responses in HPV-positive HNSCC compared to HPV-negative HNSCC  Strong phase 2 trial safety, response and survival results warrant Phase 3 study  Versamune® HPV is most clinically advanced HPV16 targeted program  *Head and neck squamous cell carcinoma (HNSCC) 
 
 Thank You  NASDAQ: PDSB 
 
 References  Tabatabaeian H et al, Navigating therapeutic strategies: HPV classification in head and neck cancer, British Journal of Cancer. (2024) 131: 220-230  Wang H, et al (2019) The Double-Edged Sword—How Human Papillomaviruses Interact With Immunity in Head and Neck Cancer, (2019). Front. Immunol. 10:653.doi: 10.3389/fimmu.2019.00653  https://sysmex-inostics.com/key-differences-between-hpv-positive-and-hpv-negative-head-and-neck-squamous-cell-carcinomas-hnscc/  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.  CDC. HPV and Oropharyngeal Cancer. September 17, 2024. Accessed November 10, 2024. https://www.cdc.gov/cancer/hpv/oropharyngeal-cancer.html.   Saraiya M, Unger ER, Thompson TD, et al. US Assessment of HPV Types in Cancers: Implications for Current and 9-Valent HPV Vaccines. J Natl Cancer Inst. 2015;107(6):djv086.   Isayeva T, Li Y, Mawahu D, Brandwein-Gensler M. Human Papillomavirus in Non-Oropharyngeal Head and Neck Cancers: A Systematic Literature Review. Head and Neck Pathol. 2012;6:S104–S120.  Mazul AL, et al. Disparities in head and neck cancer incidence and trends by race/ethnicity and sex. Head Neck. 2023;45(1):75-84.  Lechner M et al HPV-associated oropharyngeal cancer: epidemiology, molecular biol and clinical management. Nat Rev Clin Oncol. 2022;19(5),306-327.  Triangle Research Group. PDS Proprietary Market Research Report. 2024.   Trosman SJ, Koyfman SA, Ward MC et al. Effect of Human Papillomavirus on Patterns of Distant Metastatic Failure in Oropharyngeal Squamous Cell Carcinoma Treated With Chemoradiotherapy. JAMA Otolaryngol Head Neck Surg. 2015;141(5):457-462. doi:10.1001/jamaoto.2015.136  Burtness B, Harrington KJ, Greil R, et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomized, open-label, phase 3 study. Lancet. 2019;394:1915-28. https://doi.org/10.1016/.   Harrington, KJ, Burtness B, Greil R, et al. Pembrolizumab 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.  Licitra L, Tahara M, Harrington K, et al. Pembrolizumab With or Without Lenvatinib As First-Line Therapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC): Phase 3 LEAP-10 Study. Poster or Paper presented at: Multidisciplinary Head and Neck Cancers Symposium; February 29-March 2, 2024; Phoenix, AZ 
 
 References (continued)  Weiss J et al. VERSATILE-002: Survival with First-Line Treatment with PDS0101 Therapeutic Vaccine and Pembrolizumab in HPV16-positive Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC). Poster Presented: ESMO Congress 2024; September 13-17, 2024; Barcelona, Spain.  Burtness B, Rischin D, Greil R, et al. Pembrolizumab Alone or With Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score. J Clin Oncol. 2022;40:2321-2332. https://doi.org/10.1200/JCO.21.02198.  PDSB Data on File: Data represents a 17May2024 data cut.   Price KAR, Kaczmar JM, Worden FP, et al. Safety and Efficacy of Immune Checkpoint Inhibitor (ICI) Naïve Cohort from Study of PDS0101 and Pembrolizumab in HPV16-positive Head and Neck Squamous Cell Carcinoma (HNSCC). Poster Presented at: ASCO Annual Meeting; June 2-6, 2023; Chicago, IL.  PDSB Data on File: Data represents a 30November2023 data cut.  Yoshida-Court K, Gjyshi O, Lin L, et al. IMMUNOCERV, an ongoing Phase II trial combining PDS0101, an HPV-specific T cell immunotherapy with chemotherapy and radiation for treatment of locally advanced cervical cancers (NCT04580771). Poster Presented at: SITC; November 8-12, 2022; Boston MA.  Xiao Q, Gjyshi O, Court K, et al. HPV Circulating Cell-Free DNA Kinetics in Cervical Cancer Patients Undergoing Definitive Chemoradiation. Poster Presented at: ASTRO 2023; October 1-4, 2023; San Diego, CA.  Lorusso D, Xiang Y, Hasegawa K, et al. Pembrolizumab Plus Chemoradiotherapy for High Risk Locally Advanced Cervical Cancer: Overall Survival Results from the Randomized, Double Blind, Phase 3 ENGOT cx11/GOG 3047/KEYNOTE A18 Study. Poster Presented at: ESMO Congress 2024; September 13-17, 2024; Barcelona, Spain.  Grippin AJ, Yoshida-Court K, O’Hara M, et al. IMMUNOCERV Phase II Trial Combining the HPV-specific T Cell Immunotherapy PDS0101 with Chemoradiation for Treatment of Locally Advanced Cervical Cancer. Poster Presented at: ASTRO 2024; September 29-October 2, 2024; Washington, DC.  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.  Seo A., et al, Human Papilloma Virus Circulating Cell-Free DNA Kinetics in Patients with Cervical Cancer Undergoing Definitive Chemoradiation, Clinical Cancer Research, Jan. 10, 2025.  National Cancer Institute (2023). Triple Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set]  L. Wood et al. 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. Nov 8, 2019. SITC. Presentation O17. 
 

v3.25.0.1
Document and Entity Information
Feb. 05, 2025
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Feb. 05, 2025
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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