Exhibit 99.1
CORPORATE PRESENTATION Frank Bedu-Addo Ph.D. President & CEO SEPTEMBER 2020
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.
PDS Biotechnology leadership team has demonstrated success in the development and
commercialization of leading pharmaceutical products 3 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) Senior executive experience with over 20 years of experience in pharma and drug developmentIn-depth experience with M&A transactions, capital markets, and investor relations >30 years
of translational clinical research experienceFormer Director of Clinical Research at National Cancer Institute Center for Cancer Research (Cancer Vaccine Branch) Co-founder>35 years of drug development experience In-depth
experience with biotech drug discovery, product development and manufacturing Frank Bedu-Addo, PhDChief Executive Officer Gregory Conn, PhDChief Scientific Officer Lauren V. Wood, MDChief Medical Officer Michael KingChief
Financial Officer (Interim)
PDS Biotech is well-poised to transform vaccines and cancer treatment by delivering promising
immunotherapies 4 Clinical studies in areas of high unmet medical need supported by leaders in the field 4 Diversified pipeline focused on oncology and infectious disease 3 Demonstrated potential for strong clinical efficacy
and durability of response with minimal toxicity 2 Powerful immunotherapy platform that activates therapeutic and preventive immunological pathways 1
PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies
based on the proprietary Versamune® platform 5 Versatile and potent T-cell-activating platformClinically supported induction of active antigen-specific killer and helper T-cells in vivoPromising clinical efficacy demonstrated in
early trials of PDS0101 monotherapy with favorable safety profile and no dose limiting toxicities Publicly listed on NASDAQ: PDSB~15 employees with headquarters in Florham Park and Princeton, NJ22.3M shares outstanding with
approximately $34.0M in cash* Pipeline Versamune® Platform Corporate Overview * September 11, 2020
6 Reference: Data on file. PDS Biotech’s pipeline combines the Versamune® platform with
proprietary antigens across immuno-oncology and infectious disease
Versamune® Platform
v 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 excellent uptake by dendritic cells of the immune systemActivates the important Type I interferon immunological signaling
pathwayVersamune® promotes the activation and maturation of dendritic cells, which then migrate to the lymph nodes Versamune®: proprietary T-cell activating platform Engineered to induce robust, targeted anti-tumor responses in
vivo 8 Water-insolubleFatty 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)
Inability to perform the necessary steps to induce a strong therapeutic killer T-cell response
in-vivo Versamune® design and novel immunological mechanisms of action promote a powerful disease-specific killer T-cell response Versamune® has demonstrated potential to overcome well-established challenges of immunotherapy
in oncology and infectious disease 9 Challenges of Immunotherapy How Versamune® May Overcome the Challenges Mechanistic limitations have resulted in lack of therapeutic benefit in human studies Mechanism of action associated
with regression of disease in human studies (PDS0101 monotherapy) Potential for systemic toxicities Mechanism of action results in a lack of clinically relevant toxicities, even at the highest dose, in human
studies Reference: Gandhapudi SK, Ward M, Bush JPC, Bedu-Addo F, Conn G, Woodward JG. 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.
Greater quantity and quality of Versamune®-induced killer T-cells may result in unique ability
to eradicate HPV-positive tumors after a single dose 10 Produces > 10-fold number of highly potent (polyfunctional) killer T-cells vs. other T-cell technologies 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.
11 Combination of Versamune® and a proprietary antigenEngineered for simplicity and ease of
administration Vials of HPV16 mix (L)and Versamune® (R) Versamune® formulationis mixed before injection* Delivered viasubcutaneous injection *Electron microscopy picture
Oncology
Checkpoint inhibitors have shown confirmed clinical efficacy and have demonstrated clinical
benefit in late stage cancerCheckpoint inhibitors block a key immunological defense mechanism for cancer cells, and are reported to work primarily in patients whose immune systems are already generating tumor-attacking CD8+ killer
T-cells pre-treatmentUsing various tumor-specific proteins (antigens), Versamune® has demonstrated the ability to generate large and superior numbers of CD8+ killer T-cells relative to other immunotherapies, that effectively recognize
and kill antigen-expressing cancer cells in pre-clinical and human clinical studies Clinical strategy in advanced cancer:Focus on efficiency and risk mitigation to proof of concept 13 Versamune®-based immunotherapies are being
developed as combination therapies to exploit the demonstrated synergies between Versamune® and other anti-cancer agents PDS Biotech is developing a new generation of advanced cancer treatments combining Versamune®-based
immunotherapies with checkpoint inhibitors and other standard of care therapies
Versamune®-based immunotherapy + checkpoint inhibitors: Strong synergy leads to enhanced
anti-tumor efficacy 14 Preclinical studies: Checkpoint inhibitor ineffective in treating B16 melanoma, a notoriously difficult modelPDS0104 promotes infiltration of active killer T-cells into tumors + Checkpoint inhibitor blocks
tumor immune suppressive mechanism = Enhanced anti-tumor efficacy 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. Vasievich EA et al. 2012. Trp2 peptide vaccine adjuvanted with (R)-DOTAP inhibits tumor growth in an advanced melanoma model. Mol Pharmaceutics. 9(2): 261-268. CD4+ helper
T-cell CD8+ killer T-cell
15 PDS0101 designed to treat cancers caused by human papillomavirus (HPV) Approximately
43,000 patients are diagnosed with cancers where HPV is often found each year in US; approximately 35,000 cases are caused directly by HPV References: Markowitz et al. 2016. Centers for Disease Control and Prevention. 2018.
Oropharyngeal (head & neck) cancers >18,000 cases annuallyMost common HPV-cancer in men,90% of cases are HPV16-specificIncidence increasingCervical cancer~12,000 cases annuallyMost common HPV-cancer in women,50-60% of cases
are HPV16-specificIncidence steadyInitial market research suggests market penetration of ~20% is reasonable for PDS0101 PDS0101 combines the utility of Versamune® with a proprietary mix of HPV16 antigens, the most virulent high-risk
HPV type, and by far the most prevalent in patients with HPV-associated cancer Females (24,391) Males (18,280)
16 PDS0101 Phase 1 clinical trial: Unique in vivo demonstration of high levels of HPV-specific
killer T-cells in circulating blood 14x 24x Total Activated T-Cells 26x Order of magnitude increase over baseline Versamune® Dose Reference: Data on file. INF-γ Elispot Granzyme-b Elispot Clinical Study Results in
Patients with CINImmunogenicity at Day 14Defined dose for Phase 2 studies (3mg)No dose-limiting toxicities Clinical study results successfully demonstrate translation of Versamune®’s multi-functional mechanism of action between
pre-clinical models and humans
17 Follow-up of patients in PDS0101 Phase 1 study demonstrated promising clinical responses at
all three tested doses A post-hoc, retrospective analysis, demonstrated complete lesion regression in at least 60% of evaluable patients (6/10) as early as 1-3 months after treatmentNo lesion recurrence occurred within the 2-year
evaluation periodSpontaneous regression of CIN1 occurs in about 44% of patients over a 2-year duration* These results were remarkably positive as most patients were infected with multiple high-risk HPV typesTwo patients who had
regression by cytology were not considered clinical responders:The first regressed to atypical cells of undetermined significance at the first post-treatment evaluation (3 months) but HPV detectedThe second had complete regression by
cytology at the first post-treatment evaluation (3 months) but had residual CIN by colposcopy Reference: Stefani C. et al, 2014, European Review for Medical and Pharmacological Sciences, 18: 728-733
18 Investigator-Led Phase 2 studies of PDS0101 in combination therapy will evaluate efficacy
and safety in treatment of advanced HPV cancers Funded By Phase 2 Open Label Study (Safety and Efficacy) Important Considerations Initiation Advanced HPV-associated malignancies – all typesTriple combination with EMD Serono’s
M7824 and NHS-IL1228 subjectsClinical Trial Identifier: NCT04287868 NCI selection and confirmation of synergies with PDS0101All three agents have demonstrated efficacy as monotherapies in early trials Initiated in June
2020 Advanced, localized cervical cancer (Stage IIb-IVa)Combination with chemo-radiotherapy (CRT-standard of care) 35 subjects T-cell induction has strong potential to enhance CRT anti-cancer efficacyMitigated riskPotential for
rapid market penetration and market leadership Planned to be initiated Q4 2020
19 Unique triple combination including PDS0101 shows promising anti-tumor immune
responses CD4 T-cells – GreenCD8 T-cells – RedDAPI - Blue PDS0101 promotes enhanced T-cell clonality Immunohistochemistry for CD4+ and CD8+ T cells in HPV-Positive tumors Reference: Smalley Rumfield C, Pellom ST, Morillon II
YM, et alImmunomodulation to enhance the efficacy of an HPV therapeutic vaccine. Journal for ImmunoTherapy of Cancer 2020; 8:e000612. doi: 10.1136/jitc-2020-000612
20 PDS Biotechnology-sponsored Phase 2 study with KEYTRUDA® supplied by MerckKeytruda®: first
immunotherapy approved as SOC for first line treatment of recurrent HNCPDS0101 monotherapy demonstrated high levels of circulating CD8+ killer T-cells and therapeutic benefitUnique immuno-oncology combination addressing first-line
treatment of cancerStudy design: Phase 2 open-label studyPrimary endpoints: Efficacy, safety and tolerabilityInclusion criteria: Recurrent/metastatic head and neck cancer and HPV16 infectionPDS0101 dosed every 3 weeks for 4 doses (1st
4 cycles) with booster dose at cycle 12Keytruda dosed every 3 weeks (1st 4 in combo w/ PDS0101) until disease progression, intolerance or 2 yrsClinical Trial Identifier: NCT04260126 Planned Phase 2 study of PDS0101 in combination
with KEYTRUDA® in first-line treatment of recurrent/metastatic head and neck cancer (HNC) Followed by open label SOC with KEYTRUDA® until disease progression or intolerance KEYTRUDA®
alone Combination of PDS0101 and KEYTRUDA® 200 mg IV KEYTRUDA® every 21 days in combinationwith 3 mg SC PDS0101 at cycles 1, 2, 3, 4 and 12 Expected initiation: Q4 2020 based on current COVID-19-related restrictions on health
system operations
Infectious Disease
22 The addition of Versamune® to Fluzone®, a seasonal influenza vaccine, resulted in a 40-fold
increase in protective HAI titers – achieving superior levels of HAI titers with 5-fold lower doses of Fluzone® PDS0202: Versamune® dramatically enhances neutralizing antibody levels against various influenza strains and enables
significant dose sparing
Preclinical testing of Versamune®-based COVID-19 vaccine candidates ongoing with a clear target
profile 23 Ideal for rapid commercial scale up 4 No safety signals 3 Demonstrate high levels of both SARS-CoV-2-specific T-cell and antibody response after a single dose 2 Induction of highly-potent, SARS-CoV-2-specific
killer T-cells 1
24 PDS0203: Versamune®-based COVID-19 vaccine induces rapid and potent antibody
responses to SARS-CoV-2 in two weeks *Mice were immunized with two doses (day 0 and day 7) of vaccine, data collected 14- and 30-days post vaccination Initial preclinical data suggest Versamune® induces antibodies at a level
equivalent to those observed in hospitalized COVID-19 patients within 2 weeks of vaccination
25 PDS0203: Versamune®-based COVID vaccine uniquely induces strong T-cell
responses against SARS-CoV-2 in two weeks Mice were immunized with two doses (day 0 and day 7) of vaccine, data collected 14 days post vaccination. T-cells were measured by ELISPOT and CD8+ killer T-cells were measured by flow
cytometry*Data for CD4+ T-cell response on file Preclinical data suggest Versamune® induces T-cells – including polyfunctional CD4+ (helper) & CD8+ (killer) T-cells - against SARS-CoV-2 when combined with either the Spike S1
protein or the full S-proteinStrong T-cell responses confirmed at 60 days: Long-lasting (memory T-cells)
Intellectual Property and Financials
27 Multiple layers of technology and product protection for Versamune®-related products
through mid-2030s Versamune® and associated patents are owned and licensed by PDS BiotechPatents cover methods and compositions stimulating/promoting an immune response with Versamune® technology in various forms and mechanisms
through 2034Use of specific cationic lipids to induce an immune responseCompositions and use of any cationic lipid to activate MAP kinaseCompositions and use of R-DOTAP to induce immune responseMicellar antigen + cationic lipids
compositions (US still ongoing) Compositions of R-DOTAP with GM-CSF to reduce immune suppressive myeloid derived suppressor cells in the tumorFive issued international patent families (including Europe and Japan)
Strong financial position to support near-term milestones 28 Nasdaq PDSB Shares
Outstanding* 22.3M Cash* $34.0M Share Price* $2.16 Market Cap* $48.2M Debt* --- PDS0101 (HPV): Initiation of NCI-led Phase 2 combination study in advanced HPV-associated cancersPDS0203 (SARS-CoV-2): Complete preclinical
formulation development and feasibility testingPDS0101 (HPV): Initiation of MD Anderson-led Phase 2 combination study in advanced cervical-cancerPDS0101 (HPV): Initiation of VERSATILE-002 Phase 2 study of first line treatment of
recurrent/ metastatic head and neck cancer in combination with KEYTRUDA®PDS0202 (influenza): Generate initial feasibility data on universal flu vaccinePDS0204 (SARS-CoV-2): Complete preclinical formulation development and feasibility
testing Timing of 2020 milestones will be impacted by the COVID-19 pandemic * September 11, 2020
PDS Biotech poised to transform vaccines and cancer treatment by fulfilling the promise of
immunotherapy 29 Clinical studies in areas of high unmet medical need supported by leaders in the field 4 Diversified pipeline focused on oncology and infectious disease 3 Demonstrated potential for strong clinical efficacy and
durability of response with minimal toxicity 2 Powerful immunotherapy platform that activates therapeutic and preventive immunological pathways 1
