Exhibit 99.2
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Corporate PresentationSeptember 2019Frank Bedu-Addo Ph.D.President & CEO
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Forward-Looking Statements 2 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 preclinical 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, PDS undertakes no obligation to update the forward-looking statements included in this presentation to reflect subsequent events or circumstances.
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Investment Highlights 3 Versamune® Platform Versatile T-cell-activating platform developed to treat early- & late-stage cancersEarly clinical data and preclinical studies suggest potential for best-in-class combination of potency and safetyStrong induction of CD8+ and CD4+ T-cells demonstrated in Phase 1 study Lead program PDS0101 targeting multiple indications in >$6 billion HPV cancer market e.g. head and neck cancer, anal, cervical, CIN2/3*PDS0101 clinical studies projected to initiate in 1Q 2020Phase 2 combination therapy with KEYTRUDA in head and neck cancerPhase 2 combination study with 2 clinically tested immunotherapeutic agentsPipeline includes melanoma, prostate, breast, colon, lung cancers Product Pipeline Clinical stage biotechnology company developing pipeline of novel cancer immunotherapies based on proprietary Versamune® platform * Cervical cancer treatment market size, Share & Trends Analysis Report, Dec. 2018, Grand View Research* Head and neck cancer market size, March 2018, Grand View Research PDS Biotechnology
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Current State of Immuno-Oncology (I-O) 4 The Promise of I-O Durability of anti-tumor responses in some patientsDisease control for many years, resulting in improvements in duration of overall survival Only minority of patients respond (15-25% on average) Additive toxicities of different I-O agents in combination, without significant corresponding clinical benefitCritical unmet ability to activate the necessary immunological events/pathways to induce robust in-vivo T-cell responseTrain right phenotype of CD8+ killer T-cellsActivate signaling mechanisms that activate CD8+ T-cellsOvercome tumors’ ability to evade attack by T-cells The Frustration of I-O
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Multi-Functional Versamune® Platform Overcomes Key I-O Limitations 5 Engineered to promote in-vivo induction of tumor-recognizing and attacking killer (CD8+) T-cells* Trains killer T-cells to recognize & attack cancer Activates powerful T-cells to attack cancer cells Makes tumors more susceptible to T-cell attack Positively charged nano-particles engineered to access critical MHC Class I pathway Activates stimulation of type I interferon (IFN) genes within lymph nodes Significantly increases ratio of killer T-cells to immune-suppressive regulatory T-cells Induces memory immune response Body generates tumor-attacking T-cells for extended period after treatment Potent poly-functional T-cells De-camouflaged tumor Robust / lasting effect 1 2 3 4 *Mechanism of Action: Journal of Immunology, Vol. 202, Issue 1215 June 2019
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6 500 1,000 1,500 2,000 PDS0101* GM-CSF/E7* DNA-Vaccine# Live Vector Vaccine## # of HPV-Recognizing T-CellsIFN-γ Spot Forming Cells/1X106 Spleen cells Versamune® Mechanisms of Action: Promote Superior Quantity & Quality of HPV-Specific Tumor-Attacking Killer T-Cells In-Vivo Versamune® induces superior levels of CD8+ T-Cells versus competing approaches (analysis by interferon gamma ELISPOT) **P<0.05 *J. Immunology, 2019 (202), 1215Studies in TC-1 tumor model with other immunotherapies reported in: #Vaccine 2009, January 14, 27 (3): 431;##Journal for Immunotherapy of Cancer, 2013 (1) 15 Superior/polyfunctionalT-cells
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PDS0101: Multi-Functional Mechanism Promotes Superior Ability to Eliminate HPV-Positive TC-1 Tumors & Generates Sustained T-Cell Response 7 In vivo induction of superior quantity & quality of tumor-specific CD4+ and CD8+ T-cells result in complete regression & effective T-cell memory after a single dose* *J. Immunology, 2019 (202), 1215Studies 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, August 3, 27 (33): 5706 Single treatment dose 50 55 60 80 Inject TC-1 Tumor Cells
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Unique Formulations Present Advantages in Potency, Manufacturing, and Administration 8 Versamune® Proprietary AntigenDesign Potential best-in-class simplicity, ease of administration and cost of goods
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PDS0101 Mechanism Leads to Potent in-vivo Killer T-cell Response in Humans: Phase 1 Dose Escalating Study Showed Potent CD8+ T-Cell Induction 14x 24x IFN-γ: Total T-Cells 26x >20-Fold Increase in HPV-Specific CD8+ T-Cell ResponsesVs. Pre-Treatment Levels at Recommended Clinical Doses 9 Order of Magnitude Inc. Over Baseline R-DOTAP Dosage Strong & Measurable In-Vivo Induction of HPV-Specific Killer T-cells by ELISPOT 14 Days Post TreatmentDefined Dose for Phase 2 and Registration Studies Clinical Study Design12 patient open-label study (3 cohorts, each 3-6 subjects)Cervical Intraepithelial Neo-plasia (CIN) & high-risk HPVEvaluated safety, tolerability & pharmacodynamics
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PDS0101 Phase 1 Follow-up Data Supports Observed Strong Killer T-Cell Induction:Demonstrated Clearance of CIN Lesions in 60% of Evaluable Patients 10 PDS0101 was immunologically active at all three doses resulting in 5 to 73-fold increase in circulating HPV disease-attacking T-cells in 10/12 subjectsClearance of the CIN (lesion regression) was observed in 60% of evaluable patients across the three tested dosesRegression of the lesions was seen as early as 1-3 months after treatment in some patients, suggests potential correlation of immunologic and clinical responses with the administration of PDS0101 Dose Cohort Evaluable Patients* Clearance of Lesions 12 Months Post Treatment** N = N = % of Evaluable 1mg 3 of 3 2 67% 3mg 2 of 3 1 50% 10mg 5 of 6 3 60% Total 10 6 60% *Two of twelve patients were not evaluable: one patient, who demonstrated a strong immune response, was lost to follow up and another received LEEP excision therapy (standard of care) **Two of ten evaluable patients who had clearance of CIN by cytology were not considered as clinical responders: one patient regressed from CIN to atypical squamous cells of undetermined significance (ASCUS) with detectable virus, and the other showed consistent disease elimination by cytology, but showed residual disease by colposcopy
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PDS0101 + KEYTRUDA® Clinical Study in HPV-Associated Head and Neck Cancer 11 Primary Efficacy EndpointObjective Response Rate (ORR) at 9 months following the initial dose of combination treatment.NoteMerck received FDA approval for KEYTRUDA® (checkpoint inhibitor) alone or with chemotherapy on 06/10/2019 in the first line treatment of recurrent/metastatic HNC with tumor PD-L1 expression Open Label, Single Arm, Non-Randomized Study TOTAL Study Sample Size N = 96 Anticipated # of Study Sites ~20 First Line Treatment of HPV16 Positive Recurrent/Metastatic Head and Neck Cancer(Study Initiation in 1Q 2020)
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PDS0101 Clinical Combination Study in Advanced HPV-Associated Cancers 12 Combination with two novel & clinically tested (large pharma owned) immunotherapiesPrimary Efficacy EndpointPercentage of subjects that achieve an objective confirmed complete or partial response using RECIST 1.1.Regulatory StrategyPhase 2 trial in HPV-positive all-comers. Open Label, Single Arm, Non-Randomized Study TOTAL Study Sample Size N = 30 Anticipated # of Study Sites 1 (NCI Bethesda, MD) Treatment of Advanced HPV-Associated Cancers (PDS-NCI Collaboration)(Study Initiation in 1Q 2020)
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Developing Broad Product Pipeline with Leaders in I-O 13 Product Indication Partner Combination Status PDS0101(HPV-Cancer) Head & neck cancer First line treatment Recurrent/metastatic KEYTRUDA® Initiate Phase 2 1Q 2020* Advanced HPV cancers NovelImmunotherapies Initiate Phase 2 1Q 2020* Cervical cancerStage IIb-IVa Chemo-radiotherapy Phase 2 ready PDS0102(TARP) Prostate and breast cancers Immunotherapy Preclinical studies ongoing PDS0103(MUC-1) Ovarian, colorectal, lung, breast cancers Immunotherapy Preclinical studies ongoing PDS0104(Melanoma) Melanoma Immunotherapy Preclinical studies ongoing * These clinical studies are expected to be initiated with current funding
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PDS0104: Powerful In-Vivo Killer T-Cell Induction Results in Unique Ability to Regress B16 Melanoma Lung Metastasis Tumors (Preclinical) 14 In vivo induction of superior quantity and quality of tumor-specific CD4+ and CD8+ T-cells results in regression of metastatic tumors in lungs after a single dose 14 days after treatment
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Intellectual Property (Versamune® -Related Products) 15 Versamune® and associated patents 100% owned by PDSFive issued US patents valid from 2025 – 2034Five issued international patent families (including Europe & Japan)10 total patent families – provides possible protection of products through 2038Patents cover compositions/formulations and methods of use IP strategy intended to provide multiple layers of technology & product protection
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16 3Q 2019: Release available patient outcome data from Phase 1 clinical study1Q 2020: Initiation of PDS-Merck Phase 2 combination study in head and neck cancer 1Q 2020: Initiation of PDS-NCI Phase 2 combination study in advanced HPV-cancers 2Q 2020: Publication of PDS0101 Phase 1 clinical study results in peer reviewed journal2Q 2020: Complete formulation of lead preclinical product Projected Near-Term Milestones / Catalysts
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Financial Information 17 1 June 30, 2019 2 September 30, 2019 Nasdaq: PDSB Shares Outstanding1 5.2M Cash1 $21.7M Share Price2 $3.33 Market Cap2 $17.3M Debt1 ---
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Wrap-Up 18 Powerful and safe T-cell-activating immunotherapy platform Versatility: Potential to transform treatment of early- & late-stage cancers Validation: Superior preclinical and clinical data Clinical partnerships with both Big Pharma and NCI Upcoming Phase 2 clinical studies 1 2 3 4
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Management Team 19 Frank Bedu-Addo, PhDChief Executive Officer Gregory Conn, PhDChief Science Officer Lauren V. Wood, MDChief Medical Officer Andrew SaikChief Financial Officer Strategy & managed execution at both large pharma & biotechsNotable drug development:Abelcet® (Liposome Company/ Elan)PEG-Intron® (Schering-Plough/ Merck) Co-founder>35 years of drug development experience In-depth experience with biotech drug discovery, product development and manufacturing >30 years of translational clinical research experienceFormer Clinical Director of the Vaccine Branch within the Center for Cancer Research, National Cancer Institute >20 years of experience in pharma & drug developmentIn-depth experience with M&A transactions, capital markets, and investor relations
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Corporate PresentationOctober 2019Frank Bedu-Addo Ph.D.President & CEO