Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (June 2020)
30 slides from Pds Biotechnology's investor presentation, Jun 9, 2020
Slide 1: Corporate Presentation
CORPORATE PRESENTATION Frank Bedu-Addo Ph.D. President & CEO JUNE 2020
Slide 2: Forward-Looking Statements
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 acti
Slide 3: Leadership team has demonstrated success in developing pharmaceutical products
PDS Biotechnology leadership team has demonstrated success in the development and commercialization of leading pharmaceutical products 3 Frank Bedu-Addo, PhDChief Executive Officer Lauren V. Wood, MDChief Medical Officer Gregory Conn, PhDChief Scientific Officer Senior executive experience with mana
Slide 4: PDS Biotech is well-poised to transform vaccines and cancer treatment
PDS Biotech is well-poised to transform vaccines and cancer treatment by fulfilling the promise of immunotherapy 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 str
Slide 5: Clinical stage company developing immunotherapies based on Versamune platform
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 validated induction of active antigen-specific killer helper T-cells as well as antibodies in vivoPr
Slide 6: Versamune Platform
Versamune® Platform
Slide 7: Versamune is a proprietary T-cell activating 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 immu
Slide 8: How Versamune may overcome immunotherapy challenges
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 the potential to overcome the challenges of imm
Slide 9: Versamune-induced killer T-cells may eradicate HPV-positive tumors after single dose
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 Produces > 10-fold number of highly potent (polyfunctional) killer T-cells vs. other T-cell technologies Single treatment dose Results typical of curr
Slide 10: Versamune and antigen engineered for simplicity and ease of administration
10 The combination of Versamune® and a proprietary antigen is engineered 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
Slide 11: Oncology
Oncology
Slide 12: Immuno-oncology pipeline combining Versamune with tumor antigens
12 Reference: Data on file. PDS Biotech’s immuno-oncology pipeline combines the Versamune® platform with proprietary tumor antigens across several cancer types
Slide 13: PDS0101 is designed to treat HPV-caused cancers
13 PDS0101 is designed to treat cancers caused by human papillomavirus (HPV) Approximately 43,000 patients are diagnosed with HPV-associated cancers each year, a number unlikely to be impacted by increased use of HPV preventive vaccines in the next decade References: Markowitz et al. 2016. Centers f
Slide 14: PDS0101 Phase 1 trial: high levels of HPV-specific killer T-cells
14 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 Re
Slide 15: Follow-up showed promising clinical responses at all three doses
15 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 oc
Slide 16: Clinical strategy in advanced cancer with checkpoint inhibitors
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
Slide 17: Versamune may enhance checkpoint inhibitor efficacy in B16 melanoma
The robust T-cell response induced by Versamune® results in the potential for enhancement of efficacy of checkpoint inhibitors in immune suppressive B16 melanoma 17 Early clinical studies showed the checkpoint inhibitor to be ineffective in treating B16 melanoma, a notoriously difficult model to tre
Slide 18: PDS0101 selected by Merck for evaluation with KEYTRUDA
18 PDS0101 is the only compound selected by Merck for evaluation in combination with KEYTRUDA® as first line cancer therapy PDS0101 + KEYTRUDA®Keytruda® first immunotherapy approved as standard of care for first line treatment of cancer (recurrent or metastatic head and neck cancer)PDS0101 first T-c
Slide 19: Planned Phase 2 study of PDS0101 with KEYTRUDA
19 PDS Biotechnology-sponsored study with KEYTRUDA ® supplied by MerckPrimary endpoints: Efficacy, safety and tolerabilityStudy design: Phase 2 open-label studyInclusion criteria: Recurrent/metastatic head and neck cancer and HPV16 infectionClinical Trial Identifier: NCT04260126 A Phase 2 study of P
Slide 20: Investigator-led Phase 2 studies of PDS0101 combination therapy
20 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 Expected Initiation Advanced HPV-associated malignancies – all typesTriple co
Slide 21: Infectious Disease
Infectious Disease
Slide 22: Infectious disease pipeline combining Versamune with antigens
22 Reference: Data on file. PDS Biotech’s infectious disease pipeline combines the Versamune® platform with proprietary tumor antigens across several diseases
Slide 23: Versamune with Fluzone gave 40-fold increase in HAI titers
23 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® Versamune® dramatically enhances induction of neutralizing antibodies against various influen
Slide 24: Versamune induces antibody, helper and killer T-cell responses
24 Versamune® uniquely induces both potent antibody mediated responses and high levels of helper and killer T-cells vs. CFA when both are administered with the same recombinant protein antigen *Adjuvant = Complete Freund’s Adjuvant (CFA) – A powerful immunological adjuvant that is too toxic for huma
Slide 25: Preclinical testing of Versamune-based COVID-19 vaccine candidates underway
Preclinical testing of PDS Biotech’s Versamune®-based COVID-19 vaccine candidates are underway with a clear target profile 25 Poised 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
Slide 26: Intellectual Property and Financials
Intellectual Property and Financials
Slide 27: Multiple layers of Versamune protection through mid-2030s
27 Multiple layers of technology and product protection for Versamune®-related products through mid-2030s are secured Versamune® and associated patents are owned and licensed by PDS BiotechPatents cover methods and compositions stimulating/promoting an immune response with Versamune® technology in v
Slide 28: Strong financial position to support near-term milestones
PDS Biotech is in a strong financial position to support near-term milestones 28 Nasdaq PDSB Shares Outstanding* 15.3M Cash* $21.0M Share Price** $1.31 Market Cap** $19.7M Debt* --- *March 31, 2020 **May 31, 2020 PDS0201 (M. tuberculosis): Complete development and feasibility testingPDS0202 (influen
Slide 29: PDS Biotech is well-poised to transform vaccines and cancer treatment
PDS Biotech is well-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 st
Slide 30: PDS Biotechnology
PDS Biotechnology Anew generation of multi-functional cancer immunotherapies Ls om
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