Exhibit 99.1
CORPORATE OVERVIEW Frank Bedu-Addo Ph.D. President & CEO MAY 2021
2 Forward-Looking Statements This presentation contains forward-looking statements about PDS
Biotechnology Corporation (“PDSB”), and its businesses, business prospects, strategies and plans, including but not limited to statements regarding anticipated pre-clinical and clinical drug development activities and timelines and market
opportunities. All statements other than statements of historical facts included in this presentation are forward-looking statements. The words “anticipates,” “may,” “can,” “plans,” “believes,” “estimates,” “expects,” “projects,” “intends,”
“likely,” “will,” “should,” “to be,” and any similar expressions or other words of similar meaning are intended to identify those assertions as forward-looking statements. These forward-looking statements involve substantial risks and
uncertainties that could cause actual results to differ materially from those anticipated.Factors that may cause actual results to differ materially from such forward-looking statements include those identified under the caption “Risk Factors”
in the documents filed with the Securities and Exchange Commission from time to time, including its Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. You are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date of this presentation. Except to the extent required by applicable law or regulation, PDSB undertakes no obligation to update the forward-looking statements included in this
presentation to reflect subsequent events or circumstances.
3 PDS Biotech’s Versamune®-based immunotherapies promote a powerful in vivo tumor-specific CD8+
killer T-cell response Generate a strong CD8+ T-cell memory response resulting in long-lasting efficacy Are versatile and shown to be effective on their own or in combination with other drugs to improve their efficacy Generate potency
without systemic side effects The most significant barrier to effective immunotherapy has been their inability to promote adequate CD8+ killer T-cell responses in vivo resulting in diminished efficacy Versamune®-based therapies also:
PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based on
the proprietary Versamune® platform 4 NCI-initiated phase 2 trial in advanced HPV-cancer reported preliminary efficacy in 83% (5 of 6) of HPV16-positive patients who failed both chemotherapy and/or radiation treatmentPre-clinical studies
demonstrated potential to work with a wide array of oncogenes and viral antigensMultiple composition and application patents valid through mid-2030s Biopharma developing novel cancer treatment candidates and T-cell-activating vaccine
candidates for infectious diseasesThree phase 2 oncology clinical trials in progress to initial data releases in 2021Clinical partnerships with Merck, MD Anderson and National Cancer Institute~15 employees with headquarters in Florham Park,
NJDebt free with approximately $29.5M in cash as of 3/31/21* Pipeline Versamune® Platform Corporate Overview *The Company received $4.5M from the sale of NJ Net Operating Loss Tax Benefits in May 2021 which has been added to the cash
balance reported on our Form 10-Q as of 3/31/2021.
PDS Biotech’s robust Versamune®-based pipeline is being developed in partnership with the leaders in
immuno-oncology and infectious disease 5 Reference: Data on file. * *Consortium of PDS Biotech, Farmacore and Blanver. Funding provided by The Ministry of Science, Technology and Innovation of Brazil (MCTI)
PDS Biotech executive team has demonstrated success in the development and commercialization of leading
pharmaceutical products 6 Senior executive experience with management of strategy and execution at both large pharma and biotechsNotable drug development:Abelcet® (Liposome Company/ Elan)PEG-Intron® (Schering-Plough/ Merck) Frank
Bedu-Addo, PhDChief Executive Officer Co-founder>35 years of drug development experience In-depth experience with biotech drug discovery, product development and manufacturing Gregory Conn, PhDChief Scientific Officer >30 years of
translational clinical research experienceFormer Director of Clinical Research at National Cancer Institute Center for Cancer Research (Cancer Vaccine Branch) Lauren V. Wood, MDChief Medical Officer Senior executive experience with over 20
years of experience in high tech companiesIn-depth experience with M&A transactions, capital markets, business development and investor relations Seth Van Voorhees, PhDChief Financial Officer
Introduction to the Versamune® Platform
Versamune® is designed to induce a robust and targeted anti-tumor response in vivo when administered with
a tumor-associated antigen 8 Reference: 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. Promotes uptake of vaccine or immunotherapy and entry into lymph
nodes Promotes antigen processing and presentation to T-cells via MHC I and II pathways Activates Type I Interferon pathway, enabling a powerful anti-tumor killer CD8+ T-cell response Versamune® + Tumor-associated proteins (antigens)
Greater quantity and quality of Versamune®-induced killer T-cells may result in unique ability to
eradicate HPV-positive tumors after a single dose 9 Induced a >10-fold number of highly potent T-cells and eradication of HPV-positive tumors after a single dose in preclinical studies Single treatment dose Results typical of current
topclinical-stage HPV cancer vaccines Tumor rechallenge at Day 60; complete and sustained cure of cancer *Adjuvant = cytokine GMCSFReferences: J. Immunology, 2019 (202), 1215; Studies in TC-1 tumor model with other immunotherapies
reported in: Vaccine 2009, January 14, 27 (3): 431; Science Translational Medicine 2016, 13 April, Vol 8 Issue 334; Vaccine 2009, September 25, 27 (42): 5906. (PDS0101)
PDS0101 Phase 2 Clinical Development
Combinations of PDS0101 with FDA-approved standard of careFirst line treatment of recurrent/metastatic
HPV-positive head and neck cancerCombination with Keytruda®Treatment of advanced localized cervical cancerCombination with chemoradiotherapy 11 Novel combinations of PDS0101 with promising, investigational immunotherapeutic agentsTreatment of
advanced HPV-associated cancers (anal, cervical, vaginal, head and neck etc.)Triple combination with Bintrafusp-alpha (bi-functional checkpoint inhibitor - M7824) and M9241 (antibody conjugated immuno-cytokine) Clinical strategy: Develop
PDS0101 in combination with established therapies for rapid proof-of-concept and risk mitigation
Phase 2 investigator-led clinical trial evaluating the combination of PDS0101, M7824 and NHS-IL12 in
advanced HPV-associated cancer 12 Indication Patients with advanced HPV-associated cancer who have failed prior treatment Clinical Agents Bintrafusp alfa (M7824): Bifunctional “trap” fusion proteinM9241 (NHS-IL12): Antibody-conjugated
immuno-cytokinePDS0101: Versamune®-based immunotherapy generating HPV-specific CD8+ T-cells Study goals Group 1: Objective response rate (ORR) in checkpoint inhibitor (CPI) naïve patientsGroup 2: ORR in patients who have failed checkpoint
inhibitor therapy (CPI refractory) Timing Full enrollment of 45 patients triggered following achievement of objective response in ≥ 3 checkpoint inhibitor naive patientsTrial completion expected in Q1 2022 Trial Sponsor The objective of
this trial is to confirm that PDS0101 enhances the therapeutic benefit of M7824 & NHS IL-12 and may lead to expanded evaluation in several cancers with PDS0102-0104
13 Bintrafusp alfa (M7824 - bi-functional checkpoint inhibitor) Tumor Regression: 0/16 (0%)T-cell
Clones: 22 PDS0101 + Bintrafusp alfa + M9241 (NHH IL-12) Tumor Regression: 13/17 (76%)T-cell Clones: 3 *Reference: Smalley Rumfield C, Pellom ST, Morillon II YM, et al; Journal for ImmunoTherapy of Cancer 2020; 8:e000612. doi:
10.1136/jitc-2020-000612 Preclinical study: Triple combination of PDS0101, bintrafusp alfa and M9241 demonstrated higher level of efficacy than bintrafusp alfa monotherapy Red – CD8+ (killer) T-cellsGreen – CD4 + (helper) T-cells T-cell
clones per 25% of TCR repertoire (Average) Combination of PDS0101 with M9241 or Bintrafusp alfa generated superior targeted T-cell response; triple combination demonstrated superior efficacy T-cell induction levels
PDS0101 Phase 1 clinical trial: Powerful CD8+ T-cell response resulted in regression of CIN cervical
lesions & supported continued clinical studies 14 * 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. Most patients infected with multiple strains of HPV CIN lesion regression at
1-3 months 60% 20% 20% Phase 1 trial results showed no serious or dose-limiting toxicities of PDS0101 monotherapy Monotherapy overcomes key limitation of immuno-oncology: > 20-fold increase in circulating dual INF-γ & Granzyme-b
inducing killer T-cells vs. pre-treatment at day 14 led to rapid clearance of lesions*
Objective response rate is measured by RESCIST 1.1 and represents at least a 30% reduction in tumor
sizeAdvanced recurrent/refractory HPV-related cancer that is checkpoint inhibitor naïve:Patients who fail chemotherapy and/or radiation progress to checkpoint inhibitor therapy12-24% ORR with standard of care checkpoint inhibitors30% ORR
reported by experimental therapy Bintrafusp alfa is the highest reported to dateAdvanced recurrent/refractory HPV-related cancer that is checkpoint inhibitor refractory:Few treatment options exist for these patients5-10% ORR reported with
checkpoint inhibitors PDS0101 phase 2 triple combination trial: Evaluated potential for superior preclinical tumor regression in advanced HPV-related cancer 15 The most critical limitation of immunotherapy is the inability to induce large
numbers of powerful tumor-attacking CD8+ (killer) T-cells within the body, that can result in tumor reduction or elimination in a significant number of advanced cancer patients Strauss J, et al. J Immunother Cancer. 2020 Dec;8(2):e001395
Checkpoint inhibitor naïve patients who failed both chemotherapy and/or radiation treatment)Tumor types
represented in checkpoint inhibitor naïve study arm include anal, cervical, head and neck and vaginal Triple combination achieved 83% ORR among 6 HPV16-positive patients 16 HPV16 positive subjects CurrentStandard of Care(Checkpoint
Inhibitors) Number of subjects 6 Number of objective responses (tumor reduction) 5 Percentage of objective responses 83% 12-24% Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and
bintrafusp alfa in patients with HPV 16 positive malignancies. Presented at: American Society of Clinical Oncology 2021 Annual Meeting; June 4-8, 2021; Virtual. Abstract: 2501. * These numbers reflect data as of evaluation of 14 patients;
numbers will change as more patients undergo evaluation Preliminary results suggest PDS0101 induction of in-vivo tumor-attacking HPV16 killer (CD8+) T-cells may result in effective targeting of the HPV16-positive tumors resulting in disease
reduction
Patients who failed chemotherapy, radiation and checkpoint inhibitor therapyTumor types represented in
checkpoint inhibitor naïve study arm include anal, cervical, head and neck and vulvar Preliminary results suggest the triple combination may provide superior efficacy over checkpoint inhibitor monotherapy, even in immunologically limited
patients Triple combination achieved 63% ORR among 8 HPV16-positive checkpoint inhibitor refractory patients 17 HPV16 positive subjects Current Standard of Care(Checkpoint Inhibitors) Number of subjects 8 Number of objective
responses (tumor reduction) 5 Percentage of objective responses 63% 5-12% Reference: Strauss J. et al. Phase II evaluation of the triple combination of PDS0101, M9241, and bintrafusp alfa in patients with HPV 16 positive malignancies.
Presented at: American Society of Clinical Oncology 2021 Annual Meeting; June 4-8, 2021; Virtual. Abstract: 2501. * These numbers reflect data as of evaluation of 14 patients; numbers will change as more patients undergo evaluation
18 PDS Biotech-sponsored phase 2 trial evaluating the combination of PDS0101 and KEYTRUDA for first-line
treatment of HPV-associated metastatic/recurrent head and neck cancer Indication First line treatment of patients with HPV-associated head and neck cancer whose cancer has spread or returned Clinical Agents KEYTRUDA (Standard of Care):
Anti-PD1 checkpoint inhibitor (ORR ~20%)PDS0101: Versamune®-based immunotherapy generating HPV-specific CD8+ and CD4+ T-cells Study goals Objective response rate (ORR) and overall survival (OS) Timing Preliminary data – Q4 2021/Q1 2022, ORR
in first 20 patients (efficacy in 7 of 38 required to enroll all 96 patients) Trial Partner If achieved, confirmation that PDS0101 enhances the therapeutic benefit of checkpoint inhibitors could expand evaluation of Versamune®-based
therapies in multiple cancer indications
19 A Phase 2, investigator-initiated clinical trial evaluating PDS0101 in combination with
chemoradiation therapy in patients with advanced cervical cancer Indication Treatment of patients with locally advanced cervical cancer – Stages IB3-IVA Clinical Agents Chemoradiotherapy (CRT – Standard of Care): Cisplatin & radiation
therapyPDS0101: Versamune®-based immunotherapy generating HPV-specific CD8+ and CD4+ T-cells Study goals Rate of regression in patients with primary tumor ≥5cm Timing Preliminary data – Q4 2021/Q1 2022 – Rate of complete response by PET-CT
at 6 months and rate of tumor volume reduction by MRI at 30-40 days from start of treatment Trial Sponsor If successful, this study could support further investigation of Versamune®-based immunotherapies in combination with chemotherapy or
CRT to treat multiple cancers
Studies are designed to demonstrate efficacy and broad applicability of PDS0101 and the Versamune® T-cell
activating platform 20 Potential to enhance anti-cancer efficacy of various cancer treatments: Combinations with checkpoint inhibitors, chemotherapy and novel therapies may demonstrate Versamune®’s versatility. Broad potential for additional
partnerships: Successful phase 2 studies with PDS0101 and PDS0203 could enable a broad pipeline of Versamune®-based products containing various antigens. Potential to treat all types of HPV-cancer: PDS0101 Phase 2 clinical studies address all
types of HPV-associated cancers. Potential applications beyond oncology: PDS0203 COVID-19 phase 1/2 trials may demonstrate protection and induce durable T-cell responses against conserved regions of mutating viruses.
PDS0101 Near-term Milestones & Market Opportunities
Projected PDS0101 milestones through 2022* *Based on current enrollment and forecast modeling as of May
2021. Subject to change. 4Q22 3Q22 2Q22 1Q22 4Q21 3Q21 2Q21 1Q21 Preliminary efficacy Data from advanced HPV-associated cancer trial (NCI) Interim Data from HPV-associated Cancer trial (NCI) expected Preliminary Data from ImmunoCerv
combo trial (MD Anderson) expected Potential preliminary data from VERSATILE-002 (Keytruda combo) Completion of HPV-associated cancer trial (NCI) PDS0101 22 PDS Biotech Funded Clinical Trials Partner Co-Funded Clinical Trials
23 Approximately 43,000 patients are diagnosed with HPV-associated cancers annually in the US1Existing
immunotherapies cost $120,000+ annually per patient2Incidence rate is growing and remains a significant unmet medical need 1Markowitz et al. 2016. Centers for Disease Control and Prevention. 2018.2Hernandez et al. 2018. American Journal of
Managed Care Volume 24, Issue 2; Company Research Females (24,391) Males (18,280) US annual HPV-associated cancer incidence1 PDS0101 is designed to treat cancers caused by human papillomavirus (HPV)-16, which represents 70-80% of the
HPV-associated cancer market
Versamune® has demonstrated the potential for immunological compatibility with a wide array of tumor and
pathogenic antigens Reference: Clin Cancer Res. 2009 Sep 1;15(17):5323-37. doi: 10.1158/1078-0432.CCR-09-0737 Versamune®’s unique flexibility means it may work well with a wide range of identified tumor and infectious disease antigens4 tumor
antigens are currently being utilized with the Versamune® platformPDS0102 (TARP) for the treatment of AML, prostate and breast cancerPDS0103 (MUC1) for the treatment of breast, colorectal, ovarian and non-small cell lung cancerPDS0104 (TRP2)
for the treatment of melanomaOver 70 tumor antigens have been identified to dateProof of concept data from ongoing clinical trials could trigger development activities for Versamune®-based products through partnerships and licensing 24
PDS Biotech’s robust Versamune®-based oncology pipeline is being developed in partnership with the
leaders in immuno-oncology 25 Reference: Data on file.
Farmacore License Agreement for Versamune®-Based COVID Vaccine
Development of PDS0203, if successful, may offer potential advantages as a second generation COVID-19
vaccine May be effective against multiple COVID-19 variantsDemonstrated induction of killer CD8+ and helper CD4+ T cells that can target less variable regions of the SARS-CoV-19 virus and may be effective against currently circulating
variants.May grant long-lasting immunityDemonstrated induction of long-lasting, virus-specific memory T-cells necessary for longer term protection.High potential for safetyPDS0203 is a subunit vaccine, and does not require the use of attenuated
viruses, traditional adjuvants, DNA or RNA. Versamune®-based vaccines have shown no serious or dose limiting reactions. 27
Consortium has received a commitment of up to ~US$60 million from MCTI, Brazil to support phase 1-3
clinical development and manufacturing scale-upPDS Biotech has licensed Versamune® technology to Farmacore to develop a COVID-19 vaccine candidate Farmacore is responsible for antigen manufacturing and clinical developmentPhase 1/2 study
anticipated to start following Farmacore’s submission of a full data package to and subsequent approval from Anvisa (Brazilian regulatory agency)PDS Biotech is closely monitoring the evolving political situation in Brazil as which may result in
potential challenges to developing a Versamune®-based COVID-19 vaccineIntellectual property protections for a Versamune-based COVID-19 vaccine potentially at riskBrazil’s senate has voted for compulsory licensing for COVID-19 vaccine technology
Legislative process is ongoingFunding release is subject to negotiations among Farmacore, MCTI, and Brazilian authorities PDS0203, if development is successful, could offer another option to address the COVID-19 global health crisis 28
Final Comments
Rapid commercialization strategy 30 Promising early data in both oncology and infectious disease: Early
clinical data and preclinical data suggest potential efficacy, safety and versatility of the Versamune® platformNear-term milestones: PDS0101 interim efficacy data presented at ASCO in NCI-led Phase 2; preliminary data from MD Anderson-led
study and PDS Biotech-led VERSATILE-002 anticipated Q4 2021 - Q2 2022Validation of approach: All three on-going phase 2 clinical trials supported and partnered with leading and top-tier institutions in the field of cancer and
immuno-oncologyCommercialization path: Clinical studies demonstrating enhancement of FDA-approved anti-cancer products may offer potential for expedited programsRapid adoption strategy: Evaluation of PDS0101 in combination with standard of care
in multiple HPV-associated cancers Potential Advantages and Differentiators *Based on current enrollment and forecast modeling as of May 2021. Subject to change.
