Form 8-K - Current report

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

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FORM 8-K

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CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 1, 2024

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PDS BIOTECHNOLOGY CORPORATION

(Exact Name of Registrant as Specified in Charter)

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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)

[phone]

Registrant’s Telephone Number, Including Area Code

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(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 ☐

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Item 8.01

Other Events.

On August 1, 2024, PDS Biotechnology Corporation (the “Company”) issued a press release announcing that it has received the official minutes from its meeting with the U.S. Food and Drug Administration regarding next steps in the planned Phase 3 clinical trial of its Versamune^® based investigational immunotherapy designed to stimulate a targeted T cell attack against HPV16-positive head and neck squamous cell carcinoma. In addition, on August 1 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
99.1		Press Release Dated August 1, 2024.
99.2		Corporate Presentation (August 2024).
104		Cover Page Interactive Data File (embedded within the Inline XBRL Document).

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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: August 1, 2024	By:	/s/ Frank Bedu-Addo, Ph.D.
		Name: Frank Bedu-Addo, Ph.D.
		Title: President and Chief Executive Officer

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Exhibit 99.1

PDS Biotech Aligns with FDA on Phase 3 Trial in HPV16-Positive

First-Line Recurrent or Metastatic Head and Neck Cancer

Company to initiate Phase 3 VERSATILE-003 trial in Q4 2024

Conference Call Today at 8:00 a.m. Eastern Time

PRINCETON, N.J., August 1, 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 announced that it has received the official minutes from its meeting with the U.S. Food and Drug Administration (“FDA”) regarding next steps in its planned Phase 3 clinical trial of its Versamune^® based investigational immunotherapy designed to stimulate a targeted T cell attack against HPV16-positive head and neck squamous cell carcinoma (“HNSCC”). The Company will host a conference call today at 8:00 a.m. ET to discuss details of the anticipated Phase 3 clinical trial of Versamune^® HPV (formerly PDS0101) in this indication.

PDS Biotech presented the FDA with recent data from both the VERSATILE-002 study of Versamune^® HPV + pembrolizumab, and the triple combination of Versamune^® HPV + PDS01ADC + bintrafusp alfa. The Company also provided an updated design of the Phase 3 VERSATILE-003 trial of Versamune^® HPV + pembrolizumab which included updated statistical endpoints based on recent and more mature survival data. PDS Biotech proposed the addition of a third arm to the study which would be a triple combination of Versamune^® HPV + PDS01ADC + pembrolizumab. The first part of the study would therefore involve a dose optimization of PDS01ADC in the novel combination.

The FDA supported the strategy and development of the double and triple combinations. Also, the FDA requested additional safety analysis in the lead-in PDS01ADC dose optimization part of the study. To avoid potential delays in initiating the randomized trial, the FDA agreed that the dose optimization should be done separately and the registrational trial of the revised 2-arm double combination trial, VERSATILE-003, should proceed. The Versamune^® HPV + pembrolizumab combination has received Fast Track designation.

“We appreciate the FDA’s support in the development of both the double and triple Versamune^® HPV-based combinations. We are also pleased to have aligned on initiating the updated VERSATILE-003 study,” said Frank Bedu-Addo, PhD, President and Chief Executive Officer of PDS Biotech. “The VERSATILE-002 results have matured significantly and positively over the last year, allowing us to revise the statistical endpoints of the study to provide additional robustness to the study design. We continue to believe that the combination, based on encouraging survival, disease control response rates and safety has the potential to significantly advance the treatment of HPV16-positive HNSCC. Our goal now is to investigate Versamune^® HPV + pembrolizumab’s potential as the first targeted immunotherapy for HPV16-positive HNSCC. The addition of PDS01ADC in the future has the potential to provide further clinical benefit to an effective targeted immunotherapy.”

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Kirk Shepard, MD, Chief Medical Officer, continued, “We have contracted with a clinical research organization and the preparatory work is advancing to begin enrollment in the VERSATILE-003 Phase 3 clinical trial in first-line treatment of patients with recurrent or metastatic HPV16-positive HNSCC, with overall survival as the study’s primary endpoint. Our VERSATILE-003 trial has significant key opinion leader support, including from the investigators involved in VERSATILE-002, and we have lined up a significant number of the target sites that have indicated strong interest in participating in the trial.”

Conference Call Details

Date: August 1, 2024

Time: 8:00 a.m. ET

Dial-in: 1-877-704-4453 or 1-201-389-0920

Webcast Registration: Click Here

Call Me^TM Registration: Click Here (Available 15 minutes prior to call)

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 HPV16-positive head and neck squamous cell cancers. PDS Biotech’s lead investigational targeted 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.

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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.

Investor Contact:

Mike Moyer

LifeSci Advisors

Phone [phone]

Email: [e-mail]

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Media Contact:

Gina Mangiaracina

6 Degrees

Phone [phone]

Email: [e-mail]

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Exhibit 99.2

 Transforming How the Immune System Targets and Fights Cancer to Promote Survival  NASDAQ: PDSB   August 2024  Precision Designed Science For Immunotherapy 

 

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 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, Versamune® 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. 

 

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 Late-Stage Head and Neck Cancer Program as Value Catalyst  Potent Long-Lasting “Memory” T Cells  High-Value Lead Program with strong KOL support  Promising Patient Survival  Oncology Pipeline  Consistent and compelling Phase 2 data demonstrate potential for safe and effective therapy that promotes patient survival  Timing of Phase 3 start presents potential to be next standard of care  FDA aligned on pivotal trial design with Fast-track designation  Pivotal trial planned for Q4 2024 in first-line recurrent/metastatic HNSCC  Versamune® HPV in multiple HPV+ cancers  Versamune® platform + PDS01ADC in HNSCC and other indications  Induction of right type and quantity of potent tumor-accumulating killer T cells demonstrated in comprehensive preclinical and human studies  HNSCC - head and neck squamous cell carcinoma 

 

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 Market Potential in HPV16-Positive HNSCC  HPV16 will Continue to Drive Increased HNSCC Incidence Rates for Decades1  Current US annual incidence of HPV16+ HNSCC = 18,000 (40% of all HNSCC)4   Incidence of locally advanced, unresectable, metastatic HPV16+ HNSCC = 15,3004-7  Versamune® HPV US Market Potential = $2-3B*  Majority of Oropharyngeal Cases HPV16-Positive2,3  *Independent Market Research, Triangle Research Group 

 

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 A Significant Unmet Need Remains in R/M HNSCC  KEYNOTE-0488  Pembrolizumab  EGFR antibody (cetuximab) + chemotherapy  LEAP-0109  Pembrolizumab  Pembrolizumab   + lenvatinib  In Trials Improved ORR and PFS Have Not Resulted in Improved Overall Survival (OS)  ORR = Objective Response Rate; PFS = Progression Free Survival; OS = Overall Survival 

 

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 Promotes Right Type and Quantity of Effective CD8 Killer T Cells and “Memory” T Cells10,11  Versamune® Platform Enables Potent Long-Lasting T Cell Induction  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)  Versamune® Promotes Potent & Long-Lasting Tumor-Specific Memory T Cells:  Generates active CD8 T cells for anti-tumor effect and memory T cells for potential prolonged survival effect10,11  Versamune® HPV = Versamune® + Proprietary multi-epitope HPV16 E6 and E7 peptides (HPV16-targeted immunotherapy) 

 

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 Preclinical: Single Versamune® HPV Injection Eradicated Established HPV+ Cancer  Day 0: HPV16+ TC1 tumor cells were injected into mice  Day 12: Resulting tumors had a size of ~250mm3 (volume)  Day 12 : A group of the mice received a single injection of Versamune® HPV   Day 25: All treated mice had complete regression of their tumors  Day 50: 2 sets of mice were injected with the TC1 tumor cells  Set 1: Mice previously treated with Versamune® HPV  Set 2: Naïve mice NOT previously treated with Versamune® HPV  Only the mice that had been previously treated with Versamune® HPV were protected against the cancer with no tumor growth  CD8 T Cells Attacked the Cancer Leading to Tumor Eradication & Memory T Cells Prevented Re-establishment3  Memory T cells Promoted Immune Surveillance and Prevented Re-establishment of Cancer   Day 0  Day 12  Day 50 

 

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 Clinical Proof-of-Concept: Versamune® HPV Promoted Tumor Shrinkage  Stage III and IV locally advanced cervical cancer patients were treated with Versamune® HPV and chemoradiotherapy (CRT)  Versamune® HPV induced active CD8+ killer T cells that targeted and accumulated in the patients’ tumors (activated CD8 T cells secrete Granzyme-B and the green bars represent the quantity of active CD8+ T cells in the tumor by quantifying Granzyme B)  Increase in CD8 T cells in the tumor was seen from T0 to T5.  The straight line measures the amount of circulating cancer cells in the blood by quantifying circulating tumor DNA (ctDNA)  By T3 clearance of ctDNA is seen.  91.7% clearance of ctDNA at week 5 vs 53.1% clearance with CRT alone  An ORR of 100% was reported in the first 8 patients, 0% disease recurrence or disease-related deaths in 1-yr follow-up  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)12  CD8+ T Cell Accumulation in the Tumor Occurred Long-Term; 100% (8/8) ORR   Representative Plot from a Single Patient  Day 170  Day 21  Baseline 

 

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 VERSATILE-002: A Global Phase 2 Study of Versamune® HPV and Pembrolizumab in Subjects with HPV16+ Recurrent/Metastatic 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  Recurrent or metastatic 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 1.1  Key Secondary:  Overall Survival (OS)  Progression Free Survival (PFS) per RECIST 1.1   Safety and tolerability  Endpoints  Fast Track Designation  Study Evaluating Effects of Versamune® HPV Attributes on Clinical Responses 

 

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 VERSATILE-002: Most Patients Had CPS Score 1-19  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)  Historical Responses  Published data reports lower ORR, PFS and OS with pembrolizumab in patients with CPS 1-19 vs. CPS ≥ 20  Data on File: Data represents a 30Nov2023 data cut  No controlled or comparative studies have been conducted between checkpoint inhibitors and Versamune® HPV  Key Demographics and Treatment Exposure  Lower pembrolizumab responses 

 

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 Versamune® HPV + ICI Promoted Deep Tumor Regression in Several Patients Independent of CPS Score; Confirmed Disease Control Rate of 77.4%  Confirmed Objective Response Rate (ORR) Based on Investigator Assessment Per RECIST v1.1  Data on File: Data represents a 30Nov2023 data cut  Results According to RECIST 1.1 (CPS≥1)  Complete Response (CR) 4/53 7.5%  Partial Response (PR) 14/53 26.4%  Stable Disease (SD) 23/53 43.4%  Progressive Disease (PD) 9/53 17.0%  Disease Control Rate (CR+PR+SD) 77.4%  Non-Evaluable 3/53 – Not included in plot  Best Percentage Change from Baseline in Target Lesions  11/53 (21%) of patients had 90-100% tumor shrinkage  

 

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 Extended Disease Control Observed in Majority of Patients  Confirmed Objective Response Rate (ORR) Based on Investigator Assessment Per RECIST v1.1  Data on File: Data represents a 30Nov2023 data cut  Best Percentage Change from Baseline in Target Lesions  Promising Long-Lasting Immune Response with CR, PR and SD Maintained Long-Term 

 

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 Promising Survival in First Line HPV16-Positive R/M HNSCC (CPS Score ≥1)  VERSATILE-002   (Versamune® HPV + pembrolizumab)  KEYNOTE-0488  (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)*  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   Data on File: Data represents 30Nov2023 data cut  Study Met its Primary End Point of at Least 14 Confirmed Objective Responses 

 

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 Data on File: Represents a 17May2024 data cut  Discontinued: N=2 Lost to follow up; N=6 withdrawn consent; Ongoing: Patients ongoing and awaiting next clinical assessment  Median Overall Survival of 30 Months  Multiple Patients Approaching 3 Years of Survival      Kaplan-Meier Analysis: Median Follow-up of 16 months  N = 53  Events = 18  Median OS (Months) = 30  95% CI (Months) = (19.7, NE) 

 

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 Versamune® HPV Plus Pembrolizumab Was Well Tolerated   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)  TRAEs by Grade  n (%)  Any Combination TRAE  76 (87.4)  Grade 1  40 (46.0)  Grade 2  26 (29.9)  Grade 3  9 (10.3)  Grade 4  1 (1.1)  Grade 5  0  Protocol stipulates 5 subcutaneous injections of Versamune® HPV. 4 injections over 2 months and a final injection after 6-months  Grade 3 Combination-TRAE were: Fatigue (2), Colitis (2), Rash, Diarrhea, Vomiting, Alanine aminotransferase increased, Blood alkaline phosphatase increased, Lymphocyte count decreased, Autoimmune colitis, Headache, Acute kidney injury, Hyponatremia, Hyperglycemia  Grade 4 Combination-TRAE: encephalitis (case recorded approx. one year after last Versamune® HPV dose – patient remained on pembrolizumab)  * TRAE = Treatment Related Adverse Event  Data on File: Data represents a 30Nov2023 data cut  8/87 (9.2%) Patients had a Grade 3 TRAE; 1/87 (1.1%) had a Grade 4 TRAE  

 

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 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)  21% of patients had >90% shrinkage of their tumors  Versamune® HPV may significantly impact both disease control rate and survival in first line treatment of recurrent/metastatic HPV16 positive head and neck cancer  Median OS of 30 months and 12-month OS rate of approx. 80% both exceed the best publicly reported survival results to date with both investigational and approved products in patients with CPS ≥1  Therapy appears to be well tolerated  Biomarker and clinical data suggests that Versamune® HPV induces the right type and quantity of potent tumor targeting memory T cells that promote patient survival 

 

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 VERSATILE-003 First Line Recurrent/Metastatic HNSCC Study Design  Interim Analysis  Possible Early Approval  Versamune® HPV + PDS01ADC + pembrolizumab  Q4 2024  Versamune® HPV + Pembrolizumab  Pembrolizumab  Aligned with FDA on Study Design and Initiation  Patient Recruitment  Patient Recruitment  Survival Follow-up  Survival Follow-up  Key Eligibility Criteria  CPS ≥1  HPV16-positive HNSCC  ≥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 ≈ 400-450  2:1 randomization  Primary Endpoint  Overall Survival (OS)  FinalAnalysis  FutilityAnalysis 

 

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 Enabling Q4-2024 Patient Enrollment  CRO engaged in site selection and preparation, investigator agreements, etc.  Approx. 130 sites  Site locations: US, Canada, UK, EU, Latin America  18-24 months estimated time to full enrollment  Interim analysis for OS following event trigger  18 months estimated time to futility analysis   VERSATILE-003 Trial Implementation 

 

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 PDS01ADC + Versamune® HPV + ICI Combination May Overcome Tumor Immune Suppression  TME: Tumor microenvironment  Versamune® HPV + PDS01ADC: Novel Anti-Tumor Mechanism  Necrotic Core PDS01ADC binds to necrotic DNA  Versamune® Activated Targeting CD8+ Killer T-Cell  Inside  PDS01ADC  Infiltrates TME; Weakens Tumor’s Protection from Immune System13  Stimulates T Cells in TME to Promote Expansion + Prolonged, Effective Killing13  Outside  Versamune® HPV  Induces Right Type & Quantity of Potent Killer T Cells that Target and Infiltrate Tumor10  Immune Checkpoint Inhibitor  Restores Pre-existing T Cell Responses  Tumor Necrosis Targeting Ab (NHS76) – Binds to exposed DNA  PDS01ADC   IL-12 fused antibody drug conjugate 

 

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 Addition of PDS01ADC to Versamune® HPV and a Checkpoint Inhibitor Presents Potential for Deeper Anti-Tumor Responses and Prolonged Survival  Versamune® HPV + PDS01ADC + ICI  (First Line)  Versamune® HPV + PDS01ADC + ICI  (Second Line)  Number of patients  8  29  HPV Status  HPV16-Positive  HPV16-Positive  ICI treatment Status  ICI Naive  ICI Resistant  Types of Cancer  Anal, cervical, HNSCC, vaginal/vulvar  Anal, cervical, HNSCC, vaginal/vulvar  Median OS   42 months  17 months  ORR  75%*  63% (with published effective dose of PDS01ADC, N=8)  Triple Combination appears to be well-tolerated   Biomarker 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]  * Includes 1 subject with response by iRECIST 

 

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 Inclusion of HPV16-Negative Patients Provided an Internal Study Control that Suggests Clinical Efficacy of Versamune® HPV in Advanced HPV16-Positive Cancers  * 1 subject with response by iRECIST  National Cancer Institute. (2023). Triple Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies. [Data set]  Objective Response Rate (ORR)  Progression Free Survival (PFS)  Versamune® HPV Appears to be an Effective HPV16-Targeting Immunotherapy  N=8  N=8  N=6  N=6  * 

 

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 Candidate/ Study   Indication  PC  P1  P2  P3  Partner  Versamune®  Versamune® HPV + pembrolizumab  Recurrent or metastatic HPV16-positive HNSCC  Versamune® HPV + chemo (IMMUNOCERV)*  1st-line treatment of locally advanced(IB3-IVA) cervical cancer  Versamune® HPV +/- pembrolizumab*   Neo-adjuvant treatment of locally advanced HPV-positive oropharyngeal cancer (OPSCC)  Versamune®+PDS01ADC  Versamune® HPV + PDS01ADC + ICI*   Recurrent or metastatic HPV16-positive HNSCC  Versamune® MUC1 + PDS01ADC + ICI (Phase 1/2 anticipated 2024)  Recurrent or metastatic MUC1+ cancer  Pipeline Continues to Validate Platforms, Drive Future Opportunities  Fast Track  *Investigator Initiated Trials (IIT) 

 

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 Upcoming Milestones 2024-2025  Q3 2024  Q4 2024  1H 2025  2H 2025  Regulatory Confirmation of VERSATILE-003 Study Design  Initiate VERSATILE-003 Pivotal Study in HNSCC  IMMUNOCERV Trial Update in Cervical Cancer  Preliminary data readout: Neoadjuvant Study in Oral Cancer  File IND for Versamune® MUC1 in MUC1+ Cancers  Initiate MUC1 Study  Data readouts: Multiple NCI Phase 2 studies of PDS01ADC  þ 

 

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 Candidate/ Study   Indication  PC  P1  P2  P3  Partner  PDS01ADC  PDS01ADC Monotherapy  Advanced/Recurrent Kaposi Sarcoma  PDS01ADC + Hepatic Artery Infusion Pump (HAIP)  Colon Cancer/Intrahepatic Cholangiocarcinoma  PDS01ADC + Docetaxel  Castration sensitive and castration resistant prostate cancer  PDS01ADC + Enzalutamide  PET-Positive Recurrent Prostate Cancer  PDS01ADC + Stereotactic Body Radiation Therapy (SBRT)  High and Intermediate Risk Prostate Cancer  (PDS01ADC + Bintrafusp alfa) ± SBRT  Metastatic Non-Prostate Genitourinary Malignancies  PDS01ADC + Bintrafusp alfa + Entinostat  Small Bowel cancer, Colon Cancer, HPV+ Malignancies  PDS01ADC Being Extensively Studied in Multiple Indications  

 

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 References  Damgacioglu H., et al. The Lancet Regional Health – Americas. 2022;8:100143   https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.htm. Accessed January 30, 2024   Lechner M. et al. Nature Reviews Clinical Oncl. 2022, 19, 306-327  CDC.gov accessed January 2022;  Saraiya, Mona et al. “US assessment of HPV types in cancers: implications for current and 9-valent HPV vaccines.” Journal of the National Cancer Institute vol. 107,6 djv086. 29 Apr. 2015, doi:10.1093/jnci/djv086; SEER, Accessed February 2024  Isayeva, et al., Human Papillomavirus in Non-Oropharyngeal Head and Neck Cancers: A Systematic Review (2012).;   Mazul, A., et al., Disparities in head and neck cancer incidence and trends by race/ethnicity and sex  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  Gandhapudi et al; (2019) J. Immunology, June 15, 202 (12) 3524  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   Yoshida-Court et al: (2022) IMMUNOCERV an ongoing Phase 2 trial combining PDS0101 an HPV-specific T cell immunotherapy with chemotherapy and radiation for treatment of locally advanced cervical cancer, SITC (NCT04580771)  Dr. Katharine Price, ASCO 2024, Session: Therapeutic Vaccines for Head and Neck Cancers   Birch J, March 18 2022, Hollings clinical trial shows promise treating HPV-related head and neck cancers  CM Minnar et al; (2024) Front. Oncol. 13:1321318.doi: 10.3389/fonc.2023.1321318 

 

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 Thank You  NASDAQ: PDSB 

 

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Document and Entity Information	Aug. 01, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 01, 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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