Pds Biotechnology Corporation · NASDAQ:PDSB
Pds Biotechnology — IPO Roadshow (January 2020)
44 slides from Pds Biotechnology's IPO roadshow presentation, Jan 17, 2020
Slide 1: Corporate Presentation January 2020
CORPORATE PRESENTATION Frank Bedu-Addo Ph.D. President & CEO JANUARY 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: Free Writing Prospectus Statement
3 Free Writing Prospectus Statement Issuer Free Writing ProspectusFiled Pursuant to Rule 433Registration No. 333-235549January 17, 2020Neither the SEC nor any other regulatory body has approved or disapproved of our securities or passed upon the accuracy of this presentation.PDS Biotechnology Corpor
Slide 4: Offering Summary
4 Offering Summary Issuer PDS Biotechnology Corporation Exchange / Ticker Nasdaq: PDSB Offering Size Approximately $12,000,000 (100% Primary) Over Allotment 15% (100% Primary) Offering Details Common Stock Use of Proceeds We intend to use the net proceeds from this offering for:- General corporate p
Slide 5: PDS Biotechnology leadership team has demonstrated success in drug development and commercialization
PDS Biotechnology leadership team has demonstrated success in the development and commercialization of leading pharmaceutical products 5 Frank Bedu-Addo, PhDChief Executive Officer Lauren V. Wood, MDChief Medical Officer Andrew SaikChief Financial Officer Gregory Conn, PhDChief Scientific Officer Se
Slide 6: PDS Biotech is well-poised to transform cancer treatment by fulfilling the promise of immuno-oncology
PDS Biotech is well-poised to transform cancer treatment by fulfilling the promise of immuno-oncology 6 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 7: PDS Biotech is a clinical stage biotechnology company with the Versamune platform
PDS Biotech is a clinical stage biotechnology company developing a pipeline of immunotherapies based on the proprietary Versamune® platform 7 Versatile and potent T-cell-activating platformClinically validated induction of active antigen-specific killer and helper T-cells in vivoPromising clinical e
Slide 8: PDS Biotech's pipeline combines Versamune with proprietary tumor antigens
8 Reference: Data on file. PDS Biotech’s pipeline combines the Versamune® platform with proprietary & validated tumor antigens across several cancer types
Slide 9: Versamune Platform
Versamune® Platform
Slide 10: Versamune is based on proprietary, positively charged immune activating lipids
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 11: Versamune has demonstrated the potential to overcome the 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 11 Challenges of Imm
Slide 12: 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 12 Produces > 10-fold number of highly potent (polyfunctional) killer T-cells vs. other T-cell technologies Single treatment dose Results typical of cur
Slide 13: PDS0101
PDS0101
Slide 14: PDS0101 is designed to treat cancers caused by HPV
14 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 15: Versamune and proprietary antigen combination engineered for simplicity and ease of administration
15 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 16: PDS0101 Phase 1 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 patients demonstrated promising clinical responses at all three doses
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: Checkpoint inhibitors and PDS 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 19: Versamune may enhance efficacy of checkpoint inhibitors 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 19 Early clinical studies showed the checkpoint inhibitor to be ineffective in treating B16 melanoma, a notoriously difficult model to tre
Slide 20: PDS0101 is the only compound selected by Merck for evaluation with KEYTRUDA
20 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 21: Phase 2 study of PDS0101 with KEYTRUDA in head and neck cancer
21 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 infection A Phase 2 study of PDS0101 in combination with KEYTRUDA ®
Slide 22: Investigator-led Phase 2 studies of PDS0101 in combination therapy
22 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-related cancers – all typesTriple combinatio
Slide 23: PDS0102
PDS0102
Slide 24: PDS0102 combines NCI-developed TARP antigen with Versamune
24 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 25: Intellectual Property and Financials
Intellectual Property and Financials
Slide 26: Intellectual property provides multiple layers of protection through mid-2030s
26 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 27: PDS Biotech is in a financial position to support near-term milestones
PDS Biotech is in a financial position to support critical near-term milestones 27 Nasdaq: PDSB Shares Outstanding1 5.2M Cash1 $17.4M Share Price2 $2.60 Market Cap2 $14.6M Debt1 --- 1H 2020: Initiation of PDS Biotech-Merck Phase 2 combination study in head and neck cancer 1H 2020: Initiation of PDS
Slide 28: Capitalization Table
Capitalization Table # of Shares WAEP $ Value % of Fully Diluted Common Shares Outstanding (Directors & Officers) 1,609,795 21.91% Common Shares Outstanding (Other) 3,669,055 49.92% Warrants 262,758 $11.92 $3,131,164 3.58% Stock Options 1,776,735 24.18% Restricted Stock Unit 30,065 0.41% Fully Dilut
Slide 29: 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 29 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 30: PDS Biotechnology
& PDS Biotechnology ‘Anew generation of multi-functional cancer immunotherapies
Slide 31: Appendix
Appendix
Slide 32: Versamune demonstrates promising antigen processing and presentation
Versamune® demonstrates promising antigen processing and presentation 32 The positive charge of the liposome destabilizes the endosomes allowing the antigen to enter the cytoplasm of the dendritic cells and facilitates cross-presentation to CD8+ killer T-cells Versamune® induced protein uptake and p
Slide 33: Versamune presents antigen to both CD8+ killer and CD4+ helper T-cells
Preclinical studies show that Versamune® demonstrates effective antigen presentation to both CD8+ killer and CD4+ helper T-cells 33 Reference: Data on file. Effective presentation of peptides via both the major histocompatibility complex (MHC) Class I pathway to CD8+ killer T-cells and via the MHC C
Slide 34: Type I interferon and chemokine induction in lymph nodes recruits T-cells
Chemokine CxCl10 Interferon-alpha1 (IFNα1) Interferon-beta1 (IFNβ1) 0 5Expression relative to Versamune®-based treatment 10 Induction of Type I interferons and associated chemokines in the lymph nodes leads to powerful and sustained recruitment of T-cells 34 Elevated T-cell levels persist in lymph n
Slide 35: Sustained activity of Versamune: prolonged localized chemokine induction
Sustained activity of Versamune®: Prolonged and localized induction of chemokines in draining lymph nodes 35 Elevated chemokine levels persist for 5 days in LN after 1 subcutaneous injection – LN localization promotes superior CD8+ killer T-cell activation & proliferation CCL2 (MCP-1) is a chemokine
Slide 36: Localized cytokine induction may minimize risk of systemic toxicity
The localized and sustained cytokine induction in the lymph nodes of Versamune® has the potential to minimize the risk of systemic toxicity 36 Reference: Data on file. Versamune® alone Versamune® alone Negligible increases above baseline in systemic cytokine levels with Versamune® alone or PDS0101
Slide 37: Versamune induces antigen-specific T-cells via Type I interferon induction
Versamune® induces potentially superior levels of antigen specific T-cells, primarily via Type I interferon induction 37 Versamune® uniquely activates a specific immunological pathway that promotes effective CD8 killer T-cell induction Evaluation of HPV-specific CD8+ killer T-cell response Wild Type
Slide 38: Type I interferons upregulated via activation of the Myd88 pathway
Specificity of the Versamune® effect: Type I interferons are upregulated via activation of the Myd88 pathway 38 Versamune® mediates its CTL-inducing effects by activating type I interferons in a Myd88-dependent manner The T-cell responses were eliminated only in Myd88 or IFNAR (Type 1 IFN) knockout
Slide 39: PDS0101 Phase 1 study showed HPV16 T-cell responses independent of genetic sub-type
PDS0101 Phase 1 clinical study demonstrated strong in-vivo induction of HPV16 T-cell responses independent of patient genetic sub-type 39 2-4 Patient 2-5 3-1 3-2 5-7 2-7 High HLA Type A2 A2 A3 A74 A2 HPV-specific T-cell ResponseIFN-γ ELISPOT Patient 5-1 5-4 2-1 2-3 Low Medium HLA Type A2 A1, A2, A3,
Slide 40: Versamune may reduce immunosuppression in the tumor microenvironment
Versamune® may increase the ratio of cytotoxic regulatory T-cells to reduce immunosuppression within the tumor microenvironment 40 Minimizes the presence of immune suppressive regulatory T-cells (Treg) within the tumor microenvironment In Versamune® formulations almost 50% of CD8+ T-cells are antige
Slide 41: Versamune may overcome key limitations in immuno-oncology
Versamune® may overcome key limitations in immuno-oncology 41 The Promise of Versamune® Design and composition facilitates uptakeComposition allows for efficient antigen cross-presentationLipid structure allows for powerful antigen-specific T-cell induction via localized activation of type 1 interfe
Slide 42: PDS0102
PDS0102
Slide 43: The TARP antigen used in PDS0102 has been validated for cancer immunotherapy
43 The TARP antigen used in PDS0102 has been validated for use in cancer immunotherapy Reference: Wood LV et al, Oncoimmunology, 2016, Vol. 5 (8) Patients with Stage D0 prostate cancer vaccinated with TARP showed a significant decrease in tumor growth rate based on PSA levels*
Slide 44: Versatility of Versamune: TRP2-specific CD8+ killer T-cells in B16 melanoma
Versatility of Versamune®: Potent TRP2-specific CD8+ killer T-cells break immune tolerance in difficult-to-treat B16 melanoma 44 Metastatic melanoma (Pre-clinical): Single injection of Versamune® + melanoma-specific antigen leads to potent T-cell attack against tumors 14 days after treatment