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): September 16, 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

(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):

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Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

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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 Stock Market LLC

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 September 16, 2024, PDS Biotechnology Corporation updated its corporate presentation deck. A copy of the corporate presentation is filed as Exhibit 99.1 and incorporated herein by reference.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number		Description
99.1		Corporate Presentation (September 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: September 16, 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

 Transforming How the Immune System Targets and Fights Cancer to Promote Survival  NASDAQ: PDSB   September 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, Versamune® HPV 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 Phase 2 Data  Phase 3 Design  30 months median Overall Survival (mOS)  77% Disease Control Rate (DCR)  Well tolerated: 9% Grade 3, 1% Grade 4 AE  Targeted immunotherapy in HPV16-positive Recurrent and/or Metastatic Head & Neck Squamous Cell Carcinoma (R/M HNSCC)  Fast Track designation for Versamune® HPV in HNSCC  Alignment with FDA on Phase 3 study design  Trial initiation planned for Q4-2024  Induction of right type and quantity of potent tumor-accumulating killer T cells observed in comprehensive preclinical and human studies 

 

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 Significant and Growing Market Potential in HPV16-positive HNSCC  HPV16 to Drive Increased HNSCC Incidence Rates & Exceed 50% of all HNSCC by mid 2030s1  Current US annual incidence of HPV16-positive HNSCC = 18,000 (~35-40% of all HNSCC)2-4   Incidence of locally advanced, unresectable, metastatic HPV16+ HNSCC = 13,6004-7  Versamune® HPV US Market Potential = $2-3B*  EU HPV+ HNSCC incidence and trends similar to US  *Independent Market Research, Triangle Research Group 

 

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 Approx. 13,600 US Patients Annually with Advanced HPV16-positive HNSCC  Epidemiology-Based Estimate of Addressable Population: HNSCC8  U.S. Other Head and   Neck Cancersa,d  U.S. HPV Positivec  HPV16 Genotypeb  Locally Advanced, Unresectable and Metastaticd  ~3,300 (56%)  ~5,900 (82%)  ~7,200 (22%)  ~32,500  U.S. Oropharyngeal Cancer in 2024a   U.S. HPV Positivea  HPV16 Genotypeb  Locally Advanced, Unresectable and Metastaticd  ~10,300 (84%)  ~12,300 (83%)  ~14,800 (70%)  ~20,805  Oropharyngeal Cancer (OPC)  Growing Market – Key Opportunity  Other HNSCC (non-OPC)  Focus of bi-specific EGFR Inhibitors  *ICD-O-3 site codes C01.9, C02.4, C02.8, C05.1, C05.2, C09.0, C09.1, C09.8, C09.9, C10.0, C10.1, C10.2, C10.3, C10.4, C10.8, C10.9, C14.0, C14.2, and C14.8;   **Other head and neck cancers include sinonasal, oral cavity, laryngeal, and nasopharyngeal with calculations based on weighted average with share of total head and neck cancers  Sources: aCDC.gov accessed January 2022; bSaraiya, 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; cIsayeva, et al., Human Papillomavirus in Non-Oropharyngeal Head and Neck Cancers: A Systematic Review (2012).; dSEER, Accessed February 2024; dMazul, A., et al., Disparities in head and neck cancer incidence and trends by race/ethnicity and sex;   *Independent Market Research, Triangle Research Group 

 

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 Significant Unmet Needs Remain in Recurrent/Metastatic HPV16 HNSCC   KEYTRUDA®  KEYTRUDA® 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%  HPV16-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 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  Oncologists10 – Stated Unmet Medical Needs in HPV16 HNSCC  * No control or comparative studies have been conducted between immune checkpoint inhibitors, EGFR inhibitors, chemotherapy and Versamune® HPV  Standard of Care for Recurrent or Metastatic HNSCC – Published Results*9 

 

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 Versamune® HPV may Address a Significant Unmet Need in R/M HNSCC  KEYNOTE-0489  Pembrolizumab  EGFR antibody (cetuximab) + chemotherapy  LEAP-01011  Pembrolizumab  Pembrolizumab   + lenvatinib  Improved ORR and PFS Have Not Resulted in FDA-Required Improved Patient Survival  ORR = Objective Response Rate; PFS = Progression Free Survival; OS = Overall Survival 

 

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 VERSATILE-002: A Global Phase 2 Study of Versamune® HPV and Pembrolizumab in Subjects with HPV16-positive 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 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 

 

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 VERSATILE-002: Most Patients Had Recurrent Disease and CPS Score 1-19  Historical Responses9  Published data reports lower ORR, PFS and OS with pembrolizumab in patients with CPS 1-19 vs. CPS ≥ 20  Published data reports lower responses in patients with recurrent disease  Data on File: Data represents a 17May2024 data cut  Key Demographics and Treatment Exposure12  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 

 

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 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  Data on File: Data represents a 17May2024 data cut  Best Percentage Change from Baseline in Target Lesions (mITT population)  11/53 (21%) of patients had 90-100% tumor shrinkage   Versamune® HPV + ICI Promoted Deep Tumor Regression in Several Patients Independent of CPS Score; Confirmed Disease Control Rate of 77.4%12 

 

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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 17May2024 data cut  Best Percentage Change from Baseline in Target Lesions  Promising Long-Lasting Immune Response with CR, PR and SD Maintained Long-Term12  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 

 

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 Survival Exceeds Historical Median Survival in Majority of Patients  Confirmed Objective Response Rate (ORR) Based on Investigator Assessment Per RECIST v1.1  Data on File: Data represents a 17May2024 data cut  Swimmer Plot of Overall Survival and Progression Free Survival12  Subjects  0  2  4  6  8  10  12  14  16  18  20  22  24  26  28  30  32  34  36  Overall Survival (Months)  Complete Response  Partial Response  Stable Disease  Progressive Disease  Not Evaluable  Survival Follow-up  Death  Withdrew Consent  Lost to Follow-up 

 

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 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)  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 Months12  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 

 

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 Versamune® HPV Plus Pembrolizumab Appears to be Well Tolerated   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  Data on File: Data represents a 17May2024 data cut, and includes ICI naïve and ICI resistant HPV16-positive patients  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) 

 

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 VERSATILE-002 Summary of Results  Study has met primary ORR endpoint by RECIST v1.1 in ICI naïve patients  ORR by Investigator Assessment: 36% (CPS ≥1) and 48% (CPS ≥20)  21% of patients had 90-100% shrinkage of their tumors  Versamune® HPV + KEYTRUDA® may significantly impact DCR and OS in first line treatment of recurrent/metastatic HPV16 positive head and neck cancer  Median OS of 30 months in patients with CPS ≥1 and in patients with CPS ≥20  DCR of 77.4% in patients with CPS ≥1; 81% in patients with CPS ≥20  PFS of 6.3 months in patients with CPS ≥1; 14.1 months in patients with CPS ≥20  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  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 = 440  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  18 months estimated time to futility analysis   Interim analysis for OS following event trigger  VERSATILE-003 Trial Implementation 

 

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 Versamune® HPV Biomarker Studies (CD8+ T Cells)  Stage III and IV locally advanced cervical cancer patients treated with Versamune® HPV and chemoradiotherapy  Increase in CD8 T cells in the tumor observed Day 0 to Week 24 - Supports durable responses  91.7% clearance of ctDNA at Week 5 vs 53.1% clearance with CRT alone - Supports long-term benefit  ORR of 100% reported in the first 8 patients, 0% disease recurrence or disease-related deaths in 1-year 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)13,14  Long-Term Tumor Infiltration and Accumulation of Multi-functional CD8+ T Cells  Representative Plot from a Single Patient  Week 24  Week 3  Baseline  Radiation Oncology Dept. Univ. of Texas MD Anderson Cancer Center 

 

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 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-establishment15  Memory T cells Promoted Immune Surveillance and Prevented Re-establishment of Cancer   Day 0  Day 12  Day 50  Preclinical Versamune® HPV Biomarker Studies (Memory T Cells) 

 

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 Triple Combination Trial Inclusion of HPV16-Negative Patients in ICI Naïve Cohort Provided Internal Study Control & Demonstrated Versamune® HPV Specificity  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 May be Effective HPV16-targeted Immunotherapy  N=8  N=8  N=6  N=6 

 

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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 System16  Stimulates T Cells in TME to Promote Expansion + Prolonged, Effective Killing16  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 an ICI 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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 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  File IND for Versamune® MUC1 in MUC1+ Cancers  Preliminary data readout: Neoadjuvant Study in Oral Cancer  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  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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 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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 Thank You  NASDAQ: PDSB 

 

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 References  Damgacioglu H., et al. The Lancet Regional Health – Americas. 2022;8:100143   https://www.cdc.gov/cancer/hpv/oropharyngeal-cancer.html. Accessed August 26, 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., 2023, Disparities in head and neck cancer incidence and trends by race/ethnicity and sex  Market Research 2024; Triangle Research Group  Harrington K. et al. J Clin Oncol. 2022 ascopubs.org/journal/jco on October 11, 2022: DOI https://doi.org/10.1200/JCO.21.02508  Market Research 2022; Triangle Research Group  Licitra L. et al. 2024, International Journal of Radiation Oncology Volume 118, Issue 5e2-e3April 01  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 at: ESMO 2024; September 13-17, 2024; Barcelona, Spain.  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)  Xiao W et al: (2023) HPV Circulating Cell-Free DNA Kinetics in Cervical Cancer Patients Undergoing Definitive Chemoradiation, ASTRO, 65th Annual Meeting  Gandhapudi et al; (2019) J. Immunology, June 15, 202 (12) 3524   CM Minnar et al; (2024) Front. Oncol. 13:1321318.doi: 10.3389/fonc.2023.1321318 

 

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Document and Entity Information	Sep. 16, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Sep. 16, 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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