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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): September 11, 2023


PDS BIOTECHNOLOGY CORPORATION
(Exact Name of Registrant as Specified in Charter)


Delaware
001-37568
26-4231384
(State or Other Jurisdiction of Incorporation)
(Commission File Number)
(I.R.S. Employer Identification No.)
303A College Road East, Princeton, NJ 08540
(Address of Principal Executive Offices, and Zip Code)
(800) 208-3343
Registrant’s Telephone Number, Including Area Code
(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

   ☐
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   ☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   ☐
Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   ☐
Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.00033 per share
PDSB
The Nasdaq 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 ☐



Item 8.01
Other Events.

On September 11, 2023, 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
     
 
Corporate Presentation (September 2023).
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: September 11, 2023
By:
 /s/ Frank Bedu-Addo, Ph.D.
 
Name:
Frank Bedu-Addo, Ph.D.
 
Title:
President and Chief Executive Officer



EX-99.1 2 ef20010505_ex99-1.htm EXHIBIT 99.1
Exhibit 99.1

 Developing Transformational Immunotherapies for Cancer  NASDAQ: PDSB   September 2023 
 

 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 PDS0101 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 PDS0101 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; to aid in the development of the Versamune® platform;  and other factors, including legislative, regulatory, political and economic developments not within the Company’s control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Company’s annual, quarterly and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.    Versamune® and Infectimune® are registered trademarks of PDS Biotechnology Corporation  KEYTRUDA® is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA    
 

 PDS0101 to enter Phase 3 registrational trial in 2023 to treat recurrent or metastatic, HPV16-positive head and neck squamous cell cancer (HNSCC)  Fast Track Designation  PDS0101 addresses large and growing market with significant unmet need  Transformational data generated with PDS0101 and PDS0301 in multiple Phase 2 clinical studies  Financial: Cash as of June 30, 2023 - $60.6M- Adequate cash runway for the next 12 months with initiation of a registrational trial in 2023  Executive Summary: Positioned for Market Leadership  Company Overview  T cell activating platforms and antibody conjugated immuno-cytokine platform to develop safer, more effective and longer lasting cancer immunotherapies   1  2  3  4 
 

 Experienced Management Team  Historical success in development and commercialization of leading pharmaceutical products  Frank Bedu-Addo, PhD  Chief Executive Officer  Senior executive experience with management of strategy and execution at both large pharma and biotechs  Notable drug development:  Abelcet® (Liposome Company/ Elan)  PEG-Intron® (Schering-Plough/ Merck)  Matthew Hill  Chief Financial Officer  20 years of financial and operational leadership roles for life sciences companies  Former Chief Financial Officer of several publicly traded companies  Lauren V. Wood, MD  Chief Medical Officer  30 years of translational clinical research experience  Former Vaccine Branch Clinical Director at National Cancer Institute Center for Cancer Research  Gregory Conn, PhD  Chief Scientific Officer  Co-founder  35 years of drug development experience   In-depth experience with biotech drug discovery, product development and manufacturing 
 

 PDS Biotech Versamune® Overview  Designed to address limitations of current immunotherapy  PLATFORM:  Induces powerful, long-lasting anti-tumor response by promoting uptake of tumor-specific proteins by the immune system and activates a specific signaling pathway that promotes the production of active tumor-infiltrating multifunctional CD8 killer and CD4 helper T cells  Versamune®  PDS0101  PDS0102  PDS0103  PDS0104  Product Candidates 
 

 Versamune® Induces the Right Type, Potency and Quantity of Multifunctional Killer and Helper T Cells  Comprised of positively charged lipid (R-DOTAP) co-administered with proprietary tumor-specific proteins, delivered via subcutaneous injection  Delivers antigen to CD4 and CD8 T cells. Activates the Type I Interferon pathway, leading to potent, multifunctional, antigen specific T cell responses  Human clinical trials confirm induction and accumulation of multifunctional T cells in the tumor, which correlated with clinical response and elimination of circulating tumor DNA and clinical response (SITC 2022)  Recruits T cells to lymph nodes  Trains T cells to target tumors   Arms T cells to kill tumor cells  1  2  3  Injection Site  Lymph Node  Tumor Site  References: Gandhapudi SK, et al. 2019. Antigen priming with enantiospecific cationic lipid nanoparticles induces potent antitumor CTL responses through novel induction of a Type I IFN response. J Immunol. 202 (12): 3524-3536. Smalley Rumfield C et al. 2020. Immunomodulation to enhance the efficacy of an HPV therapeutic vaccine. J. for ImmunoTherapy of Cancer 8:e000612. 
 

 IMMUNOCERV: PDS0101 Appears to Induce Clinically Beneficial Killer (CD8) T Cells  PDS0101 activates the immune system to generate active killer T cells (CD8 T) cells that induce a critical mediator of the T cell’s tumor-killing function called granzyme-B  Multifunctional killer T cells target, infiltrate and eliminate the cervical cancer tumors  HPV16 tumor DNA in the blood circulation declines by day 170 (T5)  Quantity of tumor cell DNA circulating in the blood  Killer T cells that infiltrated  the tumors  Representative Subject  IMMUNOCERV (PDS0101+Chemoradiation) Trial1:  Predominantly stage III and IV cervical cancer  Locally advanced cancer with tumors > 5cm (high-risk patients)  100% (9/9) clinical response rate with 60 days  No evidence of cancer in 89% (8/9) by Day 170  Induction of activated CD8 T cells correlates with elimination of circulating tumor DNA1  1Yoshida-Court 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); SITC 2022 
 

 HPV16-Positive Head and Neck Squamous Cell Cancer (HNSCC)   Disease Overview and Market Size 
 

 Est. HPV16Locally Advanced,Unresectable andMetastatic  HPV16-positive HNSCC Presents a Significant Market Opportunity  Largely Attributed to the High Rate of Oral HPV Infections in Men  Data sources: 1 PD-L1 negative and PD-L1 positive populations (> 9000 incidence PD-L1 Positive)  https://seer.cancer.gov/statfacts/html/oralcav.html; https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.htm; https://virologyj.biomedcentral.com/articles/10.1186/s12985-021-01688-9; https://seer.cancer.gov/statistics-network/explorer/application.html?site=3&data_type=1&graph_type=4&compareBy=sex&chk_sex_1=1&race=1&age_range=1&advopt_precision=1&hdn_view=0; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5002133/  ~18,300  ~34,000  ~38,100  ~54,400  Est. U.S. HPV Positive Oral and Pharyngeal Cancer  Est. U.S. Oral and   Pharyngeal Cancer  Est. HPV16 Genotype  $2-3B Market Opportunity in US1  HPV cancer incidences continue to increase despite preventive HPV vaccine  HPV vaccination is not expected to impact the rate of HPV-positive cancer incidence for the near-term  Existing immunotherapies cost $150,000+ annually per patient1  No available HPV specific therapy  Initial commercial opportunity for PDS0101 
 

 Targeted treatment option to address the growing population of HPV16-positive HNSCC and improve outcomes   Novel MOA that is clinically effective in a broader patient population and provides more durable responses.   Safer and more effective treatments that may be used with or in place of current standard of care   Better tolerability and less toxic alternatives to chemotherapy  Despite the Availability of Treatments, Significant Unmet Needs Remain in Recurrent or Metastatic 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  12-Month Survival Rate  50%  55%  44%  Median Overall Survival (OS)  12.3 mos  13.6 mos  10.3 mos  Key Toxicities  Anemia  Fatigue  Weight loss  Hypokalemia  Additional to KEYTRUDA®:   Neutropenia  Mucosal inflammation  Thrombocytopenia  Stomatitis  Neutropenia  Anemia   Thrombocytopenia  Nausea/vomiting  Hypokalemia  Rash  Fatigue   Mucosal inflammation  Treatment Related   Grade 3+ Toxicities  17%  72%  69%  Oncologist2 – Stated Unmet Medical Needs in HNSCC  Standard of Care for Recurrent or Metastatic HNSCC – Published Results*1  1KEYNOTE-048 Study Burtness B et al, Lancet 2019  2Primary Market Research 2022  * No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101 
 

 PDS0101 for HPV16-Positive HNSCC  
 

 VERSATILE-002 Phase 2 Clinical Trial  Objective: To assess the combination of PDS0101 and KEYTRUDA® in ICI naïve subjects with recurrent or metastatic HPV-positive HNSCC  KEYTRUDA® (pembrolizumab)  FDA Approved Standard of Care  Partner  Study Design  Open-label, non-randomized, adaptive design study  N=54  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  Pembrolizumab 200mg IV Q3W up to 35 Cycles (2 years)  PDS0101 1 mL subcutaneous injection at Cycles 1, 2, 3, 4 and 12  Study Treatment  Primary:  Best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) per RECIST 1.1  Key Secondary:  Progression Free Survival (PFS) per RECIST 1.1  Overall Survival (OS)  Safety and tolerability  Achievement of Statistical Threshold for efficacy  Endpoints  Fast TrackDesignation  
 

 To Date 70.6% of Patients have Achieved Disease Stabilization or Tumor Shrinkage  Confirmed best overall response was determined based on confirmed CR or confirmed PR per RECIST 1.1 per investigator assessment. One subject (NE) died prior to target lesion measurement and is included in the mITT population denominator. Four subjects experienced unconfirmed tumor shrinkage and subsequently experienced progressive disease.   30%Shrinkage  14/34 (41.2%) Confirmed and Unconfirmed Objective Response  9/34 (26.5%) Confirmed Partial and Complete Response  15/34 (44.1%) Stable Disease   9/34 (26.5%) Progressive Disease   1/34 (2.9%) Not Evaluable (not included in Waterfall plot)  23/34 (67.6%) Tumor Reduction  Statistically significant improvement in the Response Rate of PDS0101+ KEYTRUDA vs. KEYTRUDA monotherapy confirmed 
 

 The Addition of PDS0101 to KEYTRUDA® Does not Appear to Compound Toxicity   Only 4 subjects (8%) had Grade 3 PDS0101-KEYTRUDA® TRAEs: fatigue, injection site reaction, blood alkaline phosphatase increased, hyperglycemia, colitis, and rash   No subjects had Grade 4 or 5 TRAEs  No subject came off study due to toxicity  PDS0101+KEYTRUDA® Treatment Related Adverse Events (TRAE) >5% (ITT Population)  Safety data in approximately 120 patients to date across multiple Phase 1 and 2 Studies  Safety data, anti-tumor responses and patient survival suggest that the Versamune® based therapies such as PDS0101 could be ideal candidates for combination oncology treatments 
 

 Data Suggests Prolonged Responses (Durability) and Patient Survival   PDS0101 + KEYTRUDA® Data – Median PFS and 12 Month OS  *median OS for PDS0101 + KEYTRUDA® not yet reached  KEYNOTE-048: Burtness B et al. Lancet 2019;394:1915-28, Published results for reference only  15  10.4 months  3.2 months  5.0 months  55%  87.1%  50%  Median Progression Free Survival (Months)  12-Month OS Rate (%)*  ®  ®  ®  ®  ®  ®  No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101 
 

 Several Patients Approaching Two Years of Survival   Overall response: CR=Complete Response; PR=Partial Response; SD=Stable Disease; PD=Progressive Disease; NE=Not Evaluable.  Overall response was based on investigator assessment per RECIST v1.1.  Survival status: A=Alive; D=Deceased. Alive subjects were based on the last contact date.  Complete Response  Partial Response  Stable Disease  Progressive Disease  Demonstrated objective response rate of 41% (confirmed and unconfirmed)  No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101 
 

 VERSATILE-003 Timeline to Registrational Trial Initiation  Worldwide Randomized, Controlled Clinical Study to Be Initiated Q4 2023 with an Overall Estimated 90–100 Sites  PDS0101 + KEYTRUDA® in Recurrent or Metastatic HPV16-Positive HNSCC  2Q 2022  3Q 2022  1Q 2023  2Q 2023  3Q 2023  4Q 2023  FDA Fast Track designation for PDS0101 + KEYTRUDA®  Successful EOP2 meeting with FDA  Initiated PDS0101 tech-transfer, scale up at selected Phase 3 clinical/commercial manufacture  Completed Phase 3 clinical manufacturing of PDS0101  Obtained visibility to potential OS and PFS information for VERSATILE-002 trial needed to finalize VERSATILE-003 trial design  Completed CMC-related activities for PDS0101  Obtained feedback from EU regulatory agencies on protocol  Submitted amended IND with FDA for registrational trial  Initiate site activation and related clinical, operational activities (4- to 6-month process)  InitiateVERSATILE-003 Phase 3 Trial  VERSATILE-002 Phase 2 Trial Progressing 
 

 Versamune® Based Oncology Pipeline  Partnerships with World Class Institutions in Immuno-Oncology  Reference: Data on file.  PDS Biotech Funded  Candidate/ Study  Indication  Combination  PC  P1  P2  P3  R  Partner(s)  Clinical (Lead)  PDS0101 (HPV)/ VERSATILE-002  Recurrent or metastatic HPV16-positive head and neck cancer  Arm 1: ICI naïve   Arm 2: ICI refractory  KEYTRUDA®  (standard of care)  IIT Studies  PDS0101 (HPV)/ IMMUNOCERV  1st-line treatment of locally advanced (IB3-IVA) cervical cancer  Chemo-radiation (standard of care)  PDS0101 (HPV)/  Mayo Clinic  Pre-metastatic HPV-positive oropharyngeal cancer (OPSCC)  Arm 1: PDS0101 monotherapy  Arm 2: PDS0101 + KEYTRUDA®  KEYTRUDA®   (standard of care)  Preclinical Candidates  PDS0102(TARP)  TARP-positive AML, prostate and breast cancers  TBD  PDS0103 (MUC1)  MUC1-positive breast, colon, lung, ovarian and other cancers  TBD  PDS0104(TRP2)  Melanoma  TBD  Partner Co-Funded  Fast Track Designation  
 

 Antibody-Conjugated IL-12 (PDS0301) 
 

 PDS Biotech Antibody-Conjugated IL-12 (PDS0301) Overview  Antibody-Conjugated IL-12  Opportunities  PDS0301 is a novel investigational tumor-targeting IL-12 that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment  Monotherapy  Combinations:  Versamune® Based Immunotherapies  Chemotherapy  Radiation  HDAC Inhibitors*  *Histone Deacetylase Inhibitor  
 

 NCI-led Triple Combination: PDS0301 + PDS0101 + ICI  Advanced HPV16-Positive Anal, Cervical, Head and Neck, Penile, Vaginal, Vulvar Cancer Patients Who Are ICI Refractory  172% grade 3 and higher adverse events reported in KEYNOTE-048 Burtness 2019 https://doi.org/10.1016/S0140-6736(19)32591-7  Goswami 2022 http://dx.doi.org/10.1136/jitc-2022-SITC2022.0695  Partner  FDA Approved Standard of Care  None  Immunology/Immune Correlates  SITC, November 2022:   Greater than two-fold increase in HPV16-specific T cells in the blood of 11/14 (79% ) of the evaluated patients  Induction of multifunctional killer (CD8) T cells  Increases in granzyme B (associated with active killer T cells), IFN-γ, TNF-α, etc., signal a pro-inflammatory response and role in overcoming tumor immune suppression   Safety  Safety results (Arms 1 & 2)1  24/50 (48%) of patients experienced grade 3 and higher adverse events  2/50 (4%) experienced grade 4 adverse events 
 

 Phase 2 Results in Recurrent Metastatic ICI Refractory HPV-Positive Cancer (CPS>0; PD-L1 agnostic) Plot Includes Published Data in HSNCC  NCI-led Triple Combination: PDS0301 + PDS0101 + ICI  Advanced HPV16-Positive ICI Refractory Cancer Patients  1Published results for ICI monotherapy <10%, Strauss J, et al. J Immunother Cancer 2020;8:e001395. doi:10.1136/jitc-2020-001395  2Pestana RC et al. Oral Oncology 2020;101:104523. https://doi.org/10.1016/j.oraloncology.2019.104523  N=29  Best published median OS data to date in ICI refractory head and neck cancer population is 8.2 months2  Objective Response (ORR) in High Dose PDS0301 Group = 63% (5/8)*  1  No controlled or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101 
 

 Antibody-Conjugated IL-12 (PDS0301) Regimens  Reference: Data on file.  Candidate/ Study  Indication  Combination  PC  P1  P2  P3  R  Partner(s)  IIT Studies  PDS0301/ NCI-led Triple Combination  HPV-positive anal, cervical, head and neck, penile, vaginal, vulvar cancers  Arm 1: ICI naive   Arm 2: ICI refractory  PDS0101 & ICI  IIT Studies  PDS0301  Advanced Kaposi Sarcoma  Monotherapy  PDS0301  Metastatic Castration sensitive and Castration Resistant Prostate Cancer  Docetaxel  PDS0301  Localized High and Intermediate Risk Prostate Cancer  Radiation Therapy  PDS0301  ICI Refractory HPV-related, colon and small-bowel cancer  HDAC Inhibitor  Partner Co-Funded 
 

 3Q23  4Q23  1Q24  2Q24  3Q24  PDS0101  Anticipate ICI naïve/refractory data – KOL Event (VERSATILE-002)  Submit IND with FDA for registrational trial for PDS0101 (VERSATILE-003)  Updated OS data from NCI-led triple combination  Immune response data (VERSATILE-002) (ESMO 2023)  Initiate registrational trial for PDS0101 (VERSATILE-003)  Anticipate preliminary efficacy data from Mayo Clinic IIT  Anticipate updated data (IMMUNOCERV) (ASTRO 2023)  Final data VERSATILE-002  PDS0301  Interim safety and immune data (PDS0301 + docetaxel)  PDS0103  Estimated IND filing in MUC1-related cancers  Projected Milestones Through 3Q24  Trials are investigator-initiated trials and data read-outs are outside the control of the Company 
 

 3Q23  4Q23  1Q24  2Q24  3Q24  PDS0101  Submit IND with FDA for registrational trial (VERSATILE-003)  Anticipate ICI naïve/refractory data – KOL Event (VERSATILE-002)  Updated OS data from PDS0101-PDS0301 based triple combination  Immune response data (VERSATILE-002) (ESMO 2023)  Initiate registrational trial (VERSATILE-003)  Anticipate updated data (IMMUNOCERV) (ASTRO 2023)  Anticipate preliminary efficacy data (Mayo Clinic)   Final data VERSATILE-002  PDS0301  Interim safety and immune data (PDS0301 + docetaxel) (Cytokines 2023)  PDS0103  Estimated IND filing in MUC1-related cancers  PDS0202  Universal flu preclinical ferret data (ESWI 2023)  Projected Milestones Through 3Q24  Investigator-initiated trials and data read-outs are outside the control of the Company. 
 

 PDS0101 to enter Phase 3 registrational trial in 2023 to treat recurrent or metastatic, HPV16-positive head and neck squamous cell cancer (HNSCC)  Fast Track Designation  PDS0101 addresses large and growing market with significant unmet need  Transformational data generated with PDS0101 and PDS0301 in multiple Phase 2 clinical studies  Financial: Cash as of June 30, 2023 - $60.6M cash runway for the next 12 months with initiation of a registrational trial in 2023  Executive Summary: Positioned for Market Leadership  Company Overview  T cell activating platforms and antibody conjugated immuno-cytokine platform to develop safer, more effective and longer lasting cancer immunotherapies   1  2  3  4 
 

 Thank you 
 

 Appendix 
 

 License agreement with University of Georgia for proprietary influenza antigens  Top-line preclinical data announced; effective delivery of flu proteins activate the critical immune signals necessary to generate neutralizing antibody responses to all flu strains tested in animals  Preclinical data presented at the 41st Annual meeting of the American Society Virology Meeting  Universal Flu Market Opportunity in 2021  PDS0202: Universal Prevention of Influenza   PDS0202 Provided Full Protection Against Lethal Challenge with H1N1 Pandemic Strain in Preclinical Study  Reference: Ross T. and Woodward J. et al. evaluation of the PDS0202 (Infectimune® + COBRA) Universal flu formulation.   Proprietary Computationally Designed Influenza Protein  % survival  Day post infection  Universal Influenza Vaccines  $7 Billion 
 

 Infectimune® Infectious Disease Platform 
 

 Several Key Opinion Leaders Involved with PDS Biotech’s VERSATILE-002 Head and Neck Cancer Trial  Katharine A. Price, MD  Associate Professor, Oncology  Mayo Clinical   (Presented ASCO data)  Jared Weiss, MD  Section Chief of Thoracic and Head/Neck Oncology, Professor of Medicine  UNC Lineberger Comprehensive Cancer Center(Lead Investigator)  John Kaczmar, MD  Associate Professor, Oncology  MUSC Hollings Cancer Center  (Published Article on PDS0101-KEYTRUDA patient)  Kevin J. Harrington, MBBS, PhD  Professor in Biological Cancer Therapies  The Institute of Cancer Research, London  (Key investigator on Merck KEYNOTE-048 trial with KEYTRUDA) 
 

 Expanding Evidence of Consistent and Durable PDS0101 Clinical Results Across Multiple Phase 2 Trial Indications  PDS0101 is an HPV16-targeted immunotherapy  PDS0101 is providing strong proof of concept data for the Versamune® technology platform  Efficacy data in >90 patients to date  Strong agreement between preclinical and clinical results  Versamune® mechanism of action shows clear translation between preclinical and human results  Anti-tumor responses and biomarker data show strong correlation across all types of HPV-positive cancer and at all stages of the disease  Safety data in approximately 120 patients to date  Safety data, anti-tumor responses and patient survival suggest that the Versamune® based therapies such as PDS0101 could be ideal candidates for combination oncology treatments 
 

 HNSCC is a Devastating Group of Cancers  Reference: Noseyaba et al. 2018. Cancer. Suicide Risk Among Cancer Survivors: Head and Neck Versus Other Cancers  https://virologyj.biomedcentral.com/articles/10.1186/s12985-021-01688-9  https://www.cdc.gov/cancer/hpv/basic_info/hpv_oropharyngeal.html  *Human Papillomavirus  Oral and PharyngealCancers  Genotype of *HPV-Positive Oral and Pharyngeal Cancer  Paranasalsinuses  Nasopharynx  Oropharynx  Hypopharynx  Larynx  Pharynx  Tongue  Salivaryglands  OralCavity  NasalCavity 
 

 Antibody-Conjugated IL-12: PDS0301 Targets Tumors and Enhances T Cell Infiltration and Proliferation in the Tumor   Tumor Site  Injection Site  Non-Immunogenic (Cold Tumor)  Immunogenic (Hot Tumor)  Tumor Site  PDS0301 travels direct to tumor  Increased tumor inflammation from PDS0301  PDS0301 increases T cell infiltration and expansion in tumor  CD8 T cells kill tumor cells  1  2  3  4 
 

 Demographics of the ITT (Safety) and mITT (Efficacy) Populations  Demographics and Baseline Characteristics  Demographic or Baseline Characteristic  ITT Population (N=48)  mITT Population (N=34)  Age, Median (Min, Max)  62.5 (45, 83)  63.5 (46, 83)  Sex, n (%)  Male  Female     45 (93.8)  3 (6.3)     32 (94.1)  2 (5.9)  Race, n (%)  American Indian or Alaska Native  Asian  Black or African American  Pacific Islander  White  Multiple  Other     0  1 (2.1)  1 (2.1)  0  45 (93.8)  0  1 (2.1)     0  0  0  0  33 (97.1)  0  1 (2.9)  ECOG, n (%)  0  1     30 (62.5)  18 (37.5)     20 (58.8)  14 (41.2)  CPS, n (%)*  <1  1-19  ≥20     1 (2.1)  27 (56.3)  20 (41.7)     0  17 (50.0)  17 (50.0)  Summary of Exposure  Exposure  ITT Population (N=48)  PDS0101 doses, Median (Min, Max)  4.0 (1, 5)  PDS0101 doses, n, (%)  ≥1 dose  ≥2 doses  ≥3 doses  ≥4 doses  5 doses     46 (95.8)  40 (83.3)  36 (75.0)  27 (56.3)  11 (22.9)  Pembrolizumab doses, Median (Min, Max)  5.0 (1, 29)  Pembrolizumab doses, n (%)  ≥1 dose  ≥2 doses  ≥3 doses  ≥4 doses  ≥5 doses  ≥6 doses  ≥7 doses  ≥8 doses  ≥9 doses  ≥10 doses     48 (100)  40 (83.3)  36 (75.0)  28 (58.3)  27 (56.3)  23 (47.9)  20 (41.7)  16 (33.3)  15 (31.3)  13 (27.1)  Duration of treatment (months), Median (Min, Max)  3.5 (0.0, 19.5) 
 

 PDS0101: A Novel Investigational HPV-Targeted Immunotherapy   PDS0101 is given by subcutaneous injection and stimulates a potent targeted T cell attack against HPV-positive cancers  Interim VERSATILE-002 data suggests PDS0101 generates clinically effective immune responses  The combination of PDS0101 with KEYTRUDA® has demonstrated a favorable safety profile to date  PDS0101 with KEYTRUDA® demonstrates significant disease control by shrinking tumors, delaying disease progression and prolonging survival 
 

 Compelling Durability of the Anti-Tumor Response  Progressive Free Survival (PFS) per Investigator Assessment (mITT Population)  Number of Subjects at Risk (Events)  CPI Naïve  34 (0)  33 (1)  32 (2)  27 (6)  25 (7)  16 (11)  14 (12)  12 (12)  12 (12)  10 (12)  9 (13)  8 (14)  6 (15)  4 (15)  4 (15)  3 (16)  1 (18)  1 (18)  1 (18)  0 (18)  N  Events  Median (Months)  95% CI(Months)  34  18  10.4  (4.2, 15.3)  PFS = 10.4 months  Demonstrated median PFS of 10.4 months; published results of 2-3 months for approved immune checkpoint inhibitors*  * No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101; Ferris R.L., Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck; N Engl J Med 2016; 375:1856-1867; Burtness B 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(10212):1915-1928https://www.opdivo.com/head-and-neck-cancerhttps://www.keytruda.com/head-and-neck-cancer/keytruda-clinical-trials/ 
 

 Promising Survival Benefit  Overall Survival (OS) (ITT Population)  Number of Subjects at Risk (Events)  CPI Naïve  47 (0)  41 (1)  36 (1)  31 (1)  29 (1)  26 (1)  23 (2)  19 (2)  17 (2)  16 (2)  13 (3)  13 (3)  13 (3)  13 (3)  12 (3)  11 (3)  6 (4)  5 (4)  4 (4)  3 (4)  2 (4)  0 (4)  N  Events  Median (Months)  95% CI(Months)  48  4  NE  (15.3, NE)  12-month OS rate = 87.1%**  Demonstrated 12-month OS rate of 87.1%; published results of 35-50% for approved immune checkpoint inhibitors*   *No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101; Ferris R.L., Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck; N Engl J Med 2016; 375:1856-1867; Burtness B 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(10212):1915-1928https://www.opdivo.com/head-and-neck-cancerhttps://www.keytruda.com/head-and-neck-cancer/keytruda-clinical-trials/  **All subjects either alive, lost to follow up, or who have left the trial are censored at the last known date of contact, or at Day 1, if they do not have any post-baseline visits or assessments. The 12-month OS rate for the mITT population, excluding the 14 most recently enrolled patients, is 86.5%.  
 

 Several Patients Approaching Two Years of Survival   Blue Dot: Timing of last scan demonstrating PD; Red Bars – PD, Grey Bars – SD, Green Bars – PR, Black Bar – CR, Orange Bars – survival period through last known date alive  Days on Treatment and Survival Grouped by Best Overall Response   mITT Population (n=34) with at least 1 scan  No control or comparative studies have been conducted between immune checkpoint inhibitors and PDS0101 
 

 Tumor Reduction, ORR and OS Remain Consistent   Comparison: ASCO 2022 & 2023 PDS0101 + KEYTRUDA® Clinical Results  *9-Month OS in 2022; 12-Month OS in 2023  ASCO 2022 vs ASCO 2023 Data  87.1%  87.2%  67.6%  64.7%  26.5%  29.4%  41.2%  41.2% 
 

 Antibody-Conjugated IL-12 (PDS0301)  A novel investigational tumor-targeting Interleukin 12 (IL-12) that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment   Together with Versamune® based immunotherapies PDS0301 works synergistically to promote a targeted T cell attack against cancers  PDS0301 is given by a simple subcutaneous injection  Clinical data suggest the addition of PDS0301 to Versamune® based immunotherapies demonstrate disease control by shrinking tumors and prolonging survival in recurrent or metastatic cancers with poor survival prognosis