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Precision Designed Science For Immunotherapy INVESTOR PRESENTATION NASDAQ:
2 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 is a registered trademark, and Infectimune is a trademark of PDS Biotechnology
Corporation KEYTRUDA is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA
3 About PDS Biotechnology Company Overview T cell activating platforms and
antibody conjugated immuno-cytokine platform to develop safer, more effective and longer lasting immunotherapies to treat cancer and infectious disease 1 3 Clinical Partnerships: Merck, National Cancer Institute, MD Anderson Cancer Center,
Mayo Clinic Financial: Cash as of December 31, 2022- $73.8M cash runway into Q3 2024 with initiation of a registrational trial in 2023 2 PDS0101 to enter Phase 3 registrational trial in 2023 to treat recurrent or metastatic, HPV-positive
head and neck cancer VERSATILE-002 Abstract was accepted as a Poster Discussion and a featured poster to be reviewed by an expert panel in the Head and Neck Cancer Discussion Session 4
4 Experienced Management Team Historical success in development and
commercialization of leading pharmaceutical products Timing Safety data confirmed and released Q4 2021 Preliminary efficacy data anticipated Q1 2022 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 Director of Clinical
Research at National Cancer Institute Center for Cancer Research (Cancer Vaccine Branch) 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
5 Platform Overview Versamune 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 killer T cells Overcomes tumor's ability to
suppress attack by T cells. PDS0301 is a novel investigational tumor-targeting IL-12 that enhances the proliferation, potency and longevity of T cells in the tumor microenvironment Designed to address limitations of current immunotherapy with
potential efficacy over immune checkpoint inhibitors (ICI) and ICIs in combination with chemotherapy Infectimune Generates broad and robust antibody and T cell responses that provide durable protection against infectious disease in
preclinical studies Versamune + Antibody-Conjugated IL-12
Versamune Oncology Platform
7 Versamune Based Immunotherapy Versamune is based on proprietary, positively
charged and immune-activating lipids that form spherical nanoparticles in aqueous media* The nanoparticles are sized to mimic viruses, which promotes uptake by dendritic cells of the immune system Activates the important Type I interferon
immunological signaling pathway Due to its composition destabilizes cell endosomes and promotes antigen entry into the correct processing and presentation pathways to prime tumor-specific killer (CD8) and helper (CD4) T cells A novel
investigational platform that promotes tumor-antigen uptake into preferred immunological pathways and activates a critical immunological pathway - Promotes a powerful anti-cancer immune response Versamune Water-insoluble Fatty
acids/hydrocarbon chains Water-soluble and positively charged head-group coats the particle surface R-enantiomer of 1,2-dioleoyl-trimethyl-ammonium-propane (R-DOTAP) *Versamune protected by 6 issued PDS-owned patents in various countries -
Protection through June 2033; More recently developed patents in prosecution R-DOTAP used under exclusive worldwide license of 2 additional patents from Merck KGaA, Darmstadt, Germany
8 Versamune Mechanism of Action Comprised of cationic lipids (R-DOTAP)
co-administered with proprietary HPV16-specific tumor antigens, delivered via subcutaneous injection Delivers antigen to CD4 and CD8 T cells. Activates the Type I Interferon pathway, leading to potent, multifunctional T cell responses Human
clinical trials confirm induction and accumulation of multifunctional T cells in the tumor, which correlated with elimination of circulating tumor DNA and clinical response (SITC 2022) 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. 1 Recruits T cells to lymph nodes 2 Trains T cells to target tumors 3 Arms T cells to kill tumor cells
9 Oncology Pipeline Developed in partnership with leaders in immune
oncology Reference: Data on file. PDS Biotech Funded Partner Co-Funded Combination PDS0104 (TRP2) TBD Arm 1: ICI na ve 1st line treatment Arm 2: ICI refractory 2nd or 3rd line treatment VERSATILE-002 IMMUNOCERV PDS0102
(TARP) PDS0103 (MUC1) Candidate/ Trial Indication PC P1 P2 P3 R Partner(s) Recurrent/metastatic HPV16-positive head and neck cancer KEYTRUDA( (standard of care) HPV-positive anal, cervical, head and neck, penile, vaginal, vulvar
cancers Arm 1: ICI naive 2nd line treatment Arm 2: ICI refractory 3rd line treatment PDS0301 & ICI 1st line treatment of locally advanced (IB3-IVA) cervical cancer TARP-associated AML, prostate and breast cancers MUC-1 associated
breast, colon, lung, ovarian and other cancers Chemo-radiation (standard of care) TBD TBD Neoadjuvant Trial Pre-metastatic HPV-associated oropharyngeal cancer (OPSCC) Arm 1: PDS0101 monotherapy Arm 2: PDS0101 + KEYTRUDA KEYTRUDA
(standard of care) NCI-led Triple Combination Melanoma PDS0101 Clinical Pre-Clinical Fast Track Designation
10 PDS0101: Lead Asset Designed to treat human papillomavirus (HPV16)-positive
cancers More than 54,4002 patients were estimated to have been diagnosed last year with HPV16-positive cancers in the US1,2. This represents 70-80% of all HPV-positive cancers. HPV vaccination is not expected to impact the rate of
HPV-positive cancer incidence for decades Existing immunotherapies cost $150,000+ annually per patient1 1Company estimates based on CDC data. Assessments have not been adjusted to reflect HPV16-expression 2CDC website $7B Market
Opportunity1 Reference: Data on file. U.S. HPV-associated Cancer Incidence2
11 PDS0101 Phase 1 Monotherapy Data In vivo CD8 T cell responses appear to
correlate with regression of CIN cervical lesions supporting preclinical studies CIN Lesion Regression at 1-3 Months (Retrospective) 60% 20% 20% Phase 1 trial results showed no serious or dose-limiting toxicities All patients infected
with high-risk, cancer-causing strains of HPV that are more resistant to spontaneous regression * When treated with selected human clinical trial dosage (1mg and 3mg Versamune ) References: 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. Potentially overcomes key
limitation of immuno-oncology: > 20-fold increase in circulating dual INF- & Granzyme-B inducing killer T cells at selected doses vs. pre-treatment at Day 14*
12 IMMUNOCERV Phase 2 Clinical Trial: PDS0101 + CRT Cervical
Cancer 12 Timing Safety data confirmed and released Q4 2021 Preliminary efficacy data anticipated Q1 2022 Partner FDA approved standard of care Chemo-radiotherapy (CRT) Preliminary Efficacy Preliminary efficacy data (Society for
Immunotherapy of Cancer (SITC) Conference, November 2022): Clinical response with tumor shrinkage of over 60% at 1 month - 100% (9/9) Complete response (No evidence of cancer) by day 170 - 89% (8/9)1 Majority of patients have Stage III
and Stage IV cancer 1-year overall survival - No patients have died from the cancer or treatment. One patient has died from an unrelated cause/event 100% (9/9) clinical response in locally advanced cervical cancer patients having tumors >
5 cm 1Residual traces of the cancer were detected in one patient who only received 3 of the schedule 5 doses of PDS0101 2In agreement with published preclinical findings that Versamune promotes in vivo induction of the more potent,
polyfunctional (multi-cytokine inducing) and tumor infiltrating killer T cells - J. Immunology 2019; 202 (12): 3524-3536
13 IMMUNOCERV: PDS0101 Appears to Induce Clinically Beneficial T Cells Induction
of activated CD8 killer 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 PDS0101 activates the immune system to generate active killer T cells (CD8 T cells that induce 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
14 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 Genotype of HPV+ Oral
and Pharyngeal Cancer Oral and Pharyngeal Cancers
15 The Incidence of Head and Neck Squamous Cell Carcinoma (HNSCC) is Sizeable and
Growing Largely attributed to the high rate of oral HPV infections in men HPV cancer incidences continue to increase despite preventive HPV vaccine Est. U.S. Oral and Pharyngeal Cancer Est. U.S. HPV Positive Oral and Pharyngeal
Caner Est. HPV16 Genotype Est. HPV16 Locally Advanced, Unresectable and Metastatic ~18,300 ~34,000 ~38,100 ~54,400 $2.3B Market Opportunity1 Initial commercial opportunity for PDS0101 Data sources: 1 PDL-1 negative and PDL01 positive
populations (> 9000 incidence PDL-1 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/
16 Standard of Care for Recurrent/Metastatic HNSCC - Published
Results Significant unmet needs remain KEYTRUDA KEYTRUDA plus chemo Chemotherapy +/- EGFR Route of Administration IV IV IV Objective Response Rate (ORR) 19% 36% 41% Progression Free Survival (PFS) 3.2 mos 5.0 mos 5.0
mos Median Overall Survival (OS) 12.3 mos 13.6 mos 11.0 mos Key Toxicities Immune-mediated adverse reactions Infusion-related reactions Complications of allogeneic HSCT Immune-mediated adverse reactions Infusion-related
reactions Complications of allogeneic HSCT Liver toxicity Nausea/vomiting Peripheral neuropathy Bone marrow suppression Hair loss Cardiotoxicity Hypersensitivity reaction Treatment Related Grade 3+ AEs 17% 72% 69% Oncologist -
stated unmet medical needs in HNSCC: Lack of effective targeted therapies for HPV-positive cancers Less toxic treatment options without long-term side effects Better quality of life for patients undergoing treatment
17 VERSATILE-002 Phase 2 Clinical Trial: PDS0101 + KEYTRUDA Recurrent or
metastatic HPV16-positive head and neck cancer 17 Timing Safety data confirmed and released Q4 2021 Preliminary efficacy data anticipated Q1 2022 Partner FDA Approved Standard of Care KEYTRUDA (pembrolizumab) owned by
Merck1,2 Preliminary Efficacy Objective response (% of patients with 30% tumor shrinkage) - 7/17 (41.1%)1 confirmed and unconfirmed Clinical benefit (stable disease + objective response) - 13/17 (76.5%) 9-month overall survival rate -
87.2%2 In first 43 patients, no treatment related grade 3 and higher (serious) adverse events - 0/43 (0%)3 Preliminary Safety Fast Track Designation Initiation of registrational trial in 2023 based on successful FDA meeting 119%
objective response rate with KEYTRUDA monotherapy reported in KEYNOTE-048 study 212-month with KEYTRUDA monotherapy reported in KEYNOTE-048 study 317% of patients had treatment overall survival of 49% elated grade 3 and higher adverse
events with KEYTRUDA monotherapy reported in KEYNOTE-048 study
18 VERSATILE-002 Phase 2: PDS0101 + KEYTRUDA Company-sponsored trial in
HPV16-positive metastatic or recurrent head and neck cancer Complete Response (CR) Partial Response (PR) Stable Disease (SD) Progressive Disease (PD) N=17 Subjects w/Imaging Data - confirmed and unconfirmed OR (2 CR + 5PR) 7 (41.2%) SD
(reduction in 4/6) 6 (35.3%) PD 4 (23.5%) CR+PR+SD 13 (76.5%) *Reference: Weiss J. et al. Phase II study VERSATILE-002 evaluation of PDS0101 and KEYTRUDA in treatment of CPI na ve and ICI refractory patients with recurrent or metastatic
HPV16-related HNSCC. Presented at: American Society of Clinical Oncology 2022 Annual Meeting; June 3-7, 2022; Virtual. Abstract: 6041.
19 VERSATILE-003 Phase 3 Study Design World-wide Randomized, Controlled Clinical
Study- Potential for Accelerated Approval - Potential for Accelerated Approval Primary endpoints Progression free survival (PFS) and overall survival (OS) Planned Interim Analysis: PFS and OS Planned Interim Analysis: OS + Final PFS Final
Analysis: OS Targeted Indication For the treatment of recurrent/metastatic HPV16-positive HNSCC