Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (September 2020)
30 slides from Pds Biotechnology's investor presentation, Sep 15, 2020
Slide 1: Corporate Presentation
CORPORATE PRESENTATION Frank Bedu-Addo Ph.D. President & CEO SEPTEMBER 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 Senior executive experience with management of strategy and execution at both large pharma and biotechsNotable drug development:Abelcet® (Liposome Company/ Elan)PE
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 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
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 supported induction of active antigen-specific killer and helper T-cells in vivoPromising clinical e
Slide 6: Pipeline combines Versamune with proprietary antigens
6 Reference: Data on file. PDS Biotech’s pipeline combines the Versamune® platform with proprietary antigens across immuno-oncology and infectious disease
Slide 7: Versamune Platform
Versamune® Platform
Slide 8: Versamune: 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 9: 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 potential to overcome well-established challeng
Slide 10: Versamune-induced killer T-cells may eradicate HPV-positive tumors after a 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 10 Produces > 10-fold number of highly potent (polyfunctional) killer T-cells vs. other T-cell technologies Single treatment dose Results typical of cur
Slide 11: Versamune combined with proprietary antigen, engineered for simplicity
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
Slide 12: Oncology
Oncology
Slide 13: Checkpoint inhibitors and clinical strategy in advanced cancer
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 14: Versamune immunotherapy plus checkpoint inhibitors: synergy and enhanced efficacy
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
Slide 15: PDS0101 designed to treat HPV-caused cancers
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 Preven
Slide 16: PDS0101 clinical trial: high levels of HPV-specific killer T-cells
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 Re
Slide 17: Follow-up of PDS0101 patients showed promising clinical responses
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 oc
Slide 18: Investigator-led Phase 2 studies of PDS0101 combination therapy
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
Slide 19: Triple combination including PDS0101 shows promising anti-tumor immune responses
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, Morill
Slide 20: PDS-sponsored Phase 2 study with KEYTRUDA
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 combinati
Slide 21: Infectious Disease
Infectious Disease
Slide 22: PDS0202: Versamune enhances neutralizing antibody levels against influenza
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 influe
Slide 23: Preclinical Versamune-based COVID-19 vaccine candidates with clear target profile
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
Slide 24: PDS0203: rapid and potent antibody responses to SARS-CoV-2
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 l
Slide 25: PDS0203: strong T-cell responses against SARS-CoV-2
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
Slide 26: Intellectual Property and Financials
Intellectual Property and Financials
Slide 27: Multiple layers of IP protection through mid-2030s
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
Slide 28: Strong financial position to support near-term milestones
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
Slide 29: PDS Biotech poised to transform vaccines and cancer treatment
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 cli
Slide 30: PDS Biotechnology
”) PDS Biotechnology Anew generation of multi-functional cancer immunotherapies
PDS Biotechnology — Investor Presentation (September 2020) on 6ix