PDS Biotechnology Corporation · NASDAQ:PDSB
PDS Biotechnology — Investor Presentation (September 2020)
30 slides from PDS Biotechnology's investor presentation, September 2020
Slide 1: Corporate Presentation September 2020
CORPORATE PRESENTATION SEPTEMBER 2020 A new generation of multi-functional cancer immunotherapies Frank Bedu-Addo Ph.D. President & CEO
Slide 2: Forward-Looking Statements
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 activi
Slide 3: Leadership team with success in drug development and commercialization
PDS Biotechnology leadership team has demonstrated success in the development and commercialization of leading pharmaceutical products Frank Bedu-Addo, PhD • Senior executive experience with management of strategy and Chief Executive Officer execution at both large pharma and biotechs • Notable drug
Slide 4: Well-poised to transform vaccines and cancer treatment with immunotherapies
PDS Biotech is well-poised to transform vaccines and cancer treatment by delivering promising immunotherapies Powerful immunotherapy platform that activates 1 therapeutic and preventive immunological pathways Demonstrated potential for strong clinical efficacy 2 and durability of response with minim
Slide 5: Clinical stage company with proprietary Versamune platform
PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based on the proprietary Versamune® platform CORPORATE OVERVIEW VERSAMUNE® PLATFORM PIPELINE • Publicly listed on NASDAQ: PDSB • Versatile and potent T-cell-activating platform • ~15 employees with headqua
Slide 6: Pipeline combines Versamune with proprietary antigens
PDS Biotech’s pipeline combines the Versamune® platform with proprietary antigens across immuno-oncology and infectious disease Reference: Data on file. 6
Slide 7: Versamune Platform
® Versamune Platform
Slide 8: Versamune: proprietary T-cell activating platform
Versamune®: proprietary T-cell activating platform Engineered to induce robust, targeted anti-tumor responses in vivo ▪ Versamune® is based on proprietary, positively charged and immune activating lipids that form spherical nanoparticles in aqueous media ▪ The nanoparticles are sized to mimic viruse
Slide 9: Versamune may overcome challenges of immunotherapy
Versamune® has demonstrated potential to overcome well-established challenges of immunotherapy in oncology and infectious disease Challenges of Immunotherapy How Versamune® May Overcome the Challenges Inability to perform the necessary steps to Versamune® design and novel immunological induce a stro
Slide 10: Greater quantity and quality of Versamune-induced killer T-cells
Greater quantity and quality of Versamune®-induced killer T-cells may result in unique ability to eradicate HPV-positive tumors after a single dose Produces > 10-fold number of highly potent (polyfunctional) killer T-cells vs. other T-cell technologies 500 # of Antigen-Recognizing T-Cells IFN-γ Spot
Slide 11: Combination of Versamune and a proprietary antigen
Combination of Versamune® and a proprietary antigen Engineered for simplicity and ease of administration Vials of HPV16 mix (L) Versamune® formulation Delivered via and Versamune® (R) is mixed before injection* subcutaneous injection *Electron microscopy picture 11
Slide 12: Oncology
Oncology
Slide 13: Clinical strategy in advanced cancer
Clinical strategy in advanced cancer: Focus on efficiency and risk mitigation to proof of concept Versamune®-based immunotherapies are being developed as combination therapies to exploit the demonstrated synergies between Versamune® and other anti-cancer agents • Checkpoint inhibitors have shown con
Slide 14: Versamune immunotherapy plus checkpoint inhibitors: strong synergy
Versamune®-based immunotherapy + checkpoint inhibitors: Strong synergy leads to enhanced anti-tumor efficacy Preclinical studies: Checkpoint inhibitor ineffective in treating B16 melanoma, a notoriously difficult model PDS0104 promotes infiltration of active killer T-cells into tumors + Checkpoint i
Slide 15: PDS0101 designed to treat HPV-caused cancers
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 Females (24,391) Males (18,280) • Oropharyngeal (head & neck) cancers – >18,
Slide 16: PDS0101 Phase 1 trial: HPV-specific killer T-cells in blood
PDS0101 Phase 1 clinical trial: Unique in vivo demonstration of high levels of HPV-specific killer T-cells in circulating blood Clinical study results successfully demonstrate translation of Versamune®’s multi- functional mechanism of action between pre-clinical models and humans 10mg Activated Kill
Slide 17: PDS0101 Phase 1 follow-up showed clinical responses
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 treatment – No lesion recurrence
Slide 18: Investigator-led Phase 2 studies of PDS0101 combination therapy
Investigator-Led Phase 2 studies of PDS0101 in combination therapy will evaluate efficacy and safety in treatment of advanced HPV cancers Phase 2 Open Label Study Funded By Important Considerations Initiation (Safety and Efficacy) • Advanced HPV-associated • NCI selection and confirmation of maligna
Slide 19: Triple combination including PDS0101 shows anti-tumor immune responses
Unique triple combination including PDS0101 shows promising anti-tumor immune responses Immunohistochemistry for CD4+ and CD8+ T cells in HPV-Positive tumors CD4 T-cells – Green CD8 T-cells – Red DAPI - Blue PDS0101 promotes enhanced T-cell clonality Reference: Smalley Rumfield C, Pellom ST, Morillo
Slide 20: Planned Phase 2 of PDS0101 with KEYTRUDA in head and neck cancer
Planned Phase 2 study of PDS0101 in combination with KEYTRUDA® in first-line treatment of recurrent/metastatic head and neck cancer (HNC) • PDS Biotechnology-sponsored Phase 2 study with KEYTRUDA® supplied by Merck – Keytruda®: first immunotherapy approved as SOC for first line treatment of recurren
Slide 21: Infectious Disease
Infectious Disease
Slide 22: PDS0202: Versamune enhances neutralizing antibody levels against influenza
PDS0202: Versamune® dramatically enhances neutralizing antibody levels against various influenza strains and enables significant dose sparing The addition of Versamune® to Fluzone®, a seasonal influenza vaccine, resulted in a 40-fold increase in protective HAI titers – achieving superior levels of H
Slide 23: Preclinical testing of Versamune-based COVID-19 vaccine candidates
Preclinical testing of Versamune®-based COVID-19 vaccine candidates ongoing with a clear target profile Induction of highly-potent, SARS-CoV-2-specific killer 1 T-cells Demonstrate high levels of both SARS-CoV-2-specific 2 T-cell and antibody response after a single dose 3 No safety signals 4 Ideal
Slide 24: PDS0203: rapid antibody responses to SARS-CoV-2
PDS0203: Versamune®-based COVID-19 vaccine induced rapid and potent antibody responses to SARS-CoV-2 in two weeks Initial preclinical data suggest Versamune® induces antibodies at a level equivalent to those observed in hospitalized COVID-19 patients within 2 weeks of vaccination *Mice were immunize
Slide 25: PDS0203: strong T-cell responses against SARS-CoV-2
PDS0203: Versamune®-based COVID vaccine uniquely induces strong T-cell responses against SARS-CoV-2 in two weeks 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
Slide 26: Intellectual Property and Financials
Intellectual Property and Financials
Slide 27: Multiple layers of technology and product protection through mid-2030s
Multiple layers of technology and product protection for Versamune®-related products through mid-2030s • Versamune® and associated patents are owned and licensed by PDS Biotech • Patents cover methods and compositions stimulating/promoting an immune response with Versamune® technology in various for
Slide 28: Strong financial position to support near-term milestones
Strong financial position to support near-term milestones Timing of 2020 milestones will be impacted by the COVID-19 pandemic ✓ PDS0101 (HPV): Initiation of NCI-led Phase 2 combination study in advanced HPV-associated cancers Nasdaq PDSB ✓ PDS0203 (SARS-CoV-2): Complete preclinical formulation devel
Slide 29: Poised to transform vaccines and cancer treatment
PDS Biotech poised to transform vaccines and cancer treatment by fulfilling the promise of immunotherapy Powerful immunotherapy platform that activates 1 therapeutic and preventive immunological pathways Demonstrated potential for strong clinical efficacy 2 and durability of response with minimal to
Slide 30: A new generation of multi-functional cancer immunotherapies
A new generation of multi-functional cancer immunotherapies
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