Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — Investor Presentation (March 2020)
27 slides from Pds Biotechnology's investor presentation, Mar 27, 2020
Slide 1: Corporate Presentation
CORPORATE PRESENTATION Frank Bedu-Addo Ph.D. President & CEO MARCH 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 and commercializing 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 cancer treatment with immuno-oncology
PDS Biotech is well-poised to transform cancer treatment by fulfilling the promise of immuno-oncology 4 Clinical studies in areas of high unmet medical need supported by leaders in the field 4 Diversified pipeline 3 Demonstrated potential for strong clinical efficacy and durability of the response w
Slide 5: Clinical stage company developing immunotherapies based on the 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 and helper T-cells in vivoPromising clinical e
Slide 6: Pipeline combines Versamune with proprietary tumor antigens across cancer types
6 Reference: Data on file. PDS Biotech’s pipeline combines the Versamune® platform with proprietary & validated tumor antigens across several cancer types
Slide 7: Versamune Platform
Versamune® Platform
Slide 8: Versamune is based on proprietary immune activating lipid nanoparticles
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: Versamune has potential to overcome challenges of immunotherapy
Inability to perform necessary steps to induce a therapeutic T-cell response in-vivo Versamune® design and novel immunological mechanisms of action promote a powerful anti-tumor T-cell response Versamune® has demonstrated the potential to overcome the challenges of immunotherapy 9 Challenges of Immu
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: PDS0101
PDS0101
Slide 12: PDS0101 is designed to treat HPV-caused cancers
12 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 13: Versamune and proprietary antigen engineered for simplicity of administration
13 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 14: PDS0101 clinical 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: combination 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: Phase 2 study of PDS0101 with KEYTRUDA in head and neck cancer
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 in advanced HPV cancers
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: PDS0102
PDS0102
Slide 22: PDS0102 combines NCI-developed TARP antigen with Versamune
22 PDS0102 combines a proven NCI-developed TARP antigen with Versamune® to promote the robust induction of prostate- and breast-specific killer T-cells PDS Biotech collaboration with the National Cancer Institute (NCI)The TARP antigen was discovered by the NCI to be present in over 85% of prostate c
Slide 23: Intellectual Property and Financials
Intellectual Property and Financials
Slide 24: Intellectual property protection for Versamune through mid-2030s
24 Intellectual property provides 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 Versamu
Slide 25: Financial position supports critical near-term milestones
PDS Biotech is in a financial position to support critical near-term milestones 25 Nasdaq: PDSB Shares Outstanding* 14.5M Cash* $21.7M Share Price** $0.67 Market Cap** $9.7M Debt* --- 1H 2020: Initiation of PDS Biotech-Merck Phase 2 combination study in head and neck cancer 1H 2020: Initiation of PD
Slide 26: PDS Biotech is well-poised to transform cancer treatment
PDS Biotech is well-poised to transform cancer treatment by fulfilling the promise of immuno-oncology 26 Clinical studies in areas of high unmet medical need supported by leaders in the field 4 Diversified pipeline 3 Demonstrated potential for strong clinical efficacy and durability of the response
Slide 27: PDS Biotechnology
PDS Biotechnology Anew generation of multi-functional cancer immunotherapies x om
PDS Biotechnology — Investor Presentation (March 2020) on 6ix