Sernova Biotherapeutics Inc · TSX:SVA
Sernova Biotherapeutics — Sernova — Investor Presentation (November 2022)
27 slides from Sernova Biotherapeutics's investor presentation, November 2022
Slide 1: Advancing cell therapeutics to develop 'functional cures'
Advancing cell therapeutics to develop ‘functional cures’ November 2022 Corporate Presentation 1
Slide 2: Forward looking statements
Forward looking statements This presentation contains forward-looking statements within the meaning of applicable Canadian securities laws. Forward-looking statements in this presentation are statements that are not historical facts and are generally, but not always, identified by the words “expects
Slide 3: Sernova: Innovator and Leader
Sernova: Innovator and Leader Cell Therapeutics: Paradigm Shift for Superior Treatment of High-Maintenance, Lifelong Conditions • Sernova’s integrated Cell Pouch System™ provides the potential for a ‘functional cure’ for chronic medical conditions with multi-billion dollar market potential • Cell Po
Slide 4: Sernova's Integrated Cell Therapeutics Solution
Sernova’s Integrated Cell Therapeutics Solution • 1st generation utilizes human donor cells • Proprietary implantable medical device • 2nd generation off-the-shelf stem cell derived cells • Provides vascularized environment for therapeutic cells to survive for long periods • i.e. Evotec iPSC islet o
Slide 5: Cell Pouch Clinical Program
ad Sernova 4 . @ or Cell Pouch Clinical Program
Slide 6: Continuous Product Innovation
Continuous Product Innovation Building on Demonstrated Efficacy in T1D to Improve Outcomes and Expand Patient Population • Preliminary data from current US Phase 1/2 clinical trial has demonstrated potential for a ‘functional cure’ for T1D with donor islets in first patient cohort • New second patie
Slide 7: Diabetes: Global Disease = Global Market
DIABETES GLOBAL DISEASE = GLOBAL MARKET Diabetes is one of the most prevalent diseases and most pervasive medical problems impacting society and quality of life today. 537 million people are affected worldwide with diabetes; another estimated 179 million people have it without knowing it. By 2045, p
Slide 8: First Indication for T1D: Hypoglycemia Unawareness Among T1D Patients
First Indication for T1D Hypoglycemia Unawareness Among T1D Patients Hypoglycemia Unawareness – most critical unmet need in T1D Affects 15% of T1D patients (~240k patients in the US) Clinically defined as a person’s inability to recognize the symptoms of low blood sugar before they become severe or
Slide 9: Phase 1/2 T1D Study Design – First Cohort
Phase 1/2 T1D Study Design – First Cohort Patients with Type 1 Diabetes and Hypoglycemia Unawareness Trial Overview • Open label, single-arm, single-center trial (n=7) • Insulin-dependent T1D patients with hypoglycemia unawareness Study • Cell Pouch implant followed by 2 sequential human donor islet
Slide 10: Phase 1/2 T1D Study Interim Results – First Cohort
Phase 1/2 T1D Study Interim Results – First Cohort ADA Presentation June 2022 • Surgical implantation of the Cell Pouch was found to be well tolerated with a favorable safety profile • All patients who had favorable immunosuppression achieved complete insulin independence • First three transplanted
Slide 11: First Cohort - Patient #1 – Impact Statement
First Cohort - Patient #1 – Impact Statement After completing the safety, tolerability and efficacy study of Sernova's Cell Pouch for clinical islet transplantation and as the first transplant candidate, I can easily state how absolutely wonderful life is to be free of always thinking of how to mana
Slide 12: Phase 1/2 Study – First Cohort Informed / Guided to Second Cohort
Phase 1/2 Study – First Cohort Informed / Guided to Second Cohort Advancing With A Higher Capacity Cell Pouch Product • First Cohort (6 patients) o Patients demonstrated a clear safety profile for Cell Pouch System o Established threshold for islet dose and density optimization • Second Cohort (up t
Slide 13: Sernova / Evotec Collaboration
Sernova / Evotec Collaboration iPSC Stem Cell Derived Islets
Slide 14: Abundant Supply of Insulin-Producing Human iPSCs
Abundant Supply of Insulin-Producing Human iPSCs • Secured option on exclusive global license for Evotec’s iPSC insulin producing islet clusters for use with Sernova’s Cell Pouch System or alone with other technologies • Access to unlimited supply of insulin-producing islet cells – Removes a major o
Slide 15: Evotec's Islet Clusters Deliver Long-Term Efficacy in Preclinical Models of Diabetes
Evotec’s Islet Clusters Deliver Long-Term Efficacy in Preclinical Models of Diabetes High Quality Cell Composition Coupled With Robust Manufacturing Process Islets generated from a GMP iPSC line in bioreactor Long-term normalization of blood glucose in diabetic mice following iPSC islet transplantat
Slide 16: Industry-leading end-to-end process for iPSC-based therapeutics
Industry-leading end-to-end process for iPSC-based therapeutics Ability to Deliver Therapies From Concept to the Clinic Exploratory Pre-clinical research Pre-clinical development Clinical • iPS cell differentiation • GMP-compatibility • CMC • Clinical supply • Gene editing • Scale-up • Pre-clinical
Slide 17: Future Implications Sernova / Evotec Collaboration
Future Implications Sernova / Evotec Collaboration • Combination of Sernova’s Cell Pouch System and Evotec iPSC islet clusters will be the first such treatment for T1D in the clinic • Sernova’s positive clinical data in its Phase 1/2 study with Cell Pouch / human donor islets provides for a signific
Slide 18: Additional Pipeline
ad Sernova 4 . @ or Additional Pipeline
Slide 19: Conformal Coating Technology – for Immune Protection
Conformal Coating Technology – for Immune Protection • ‘Shrink wrap’ properties • Thin biocompatible cross-linked allows volume of transplanted polymer hydrogel coating that cells into the Cell Pouch to be surrounds therapeutic cells Conformal Coating – unaffected University of Miami / Sernova Colla
Slide 20: Conformal Coating Technology for Cellular Immune Protection
Conformal Coating Technology for Cellular Immune Protection University of Miami / Sernova Collaboration Preliminary Results Conformally Coated Rat Islet Isolated Rat Islets Conformal Coated Naked PEG, DAPI (nucleus) H&E staining of transplanted islets in Cell Pouch™ Naked islets in Cell Pouch™ Confo
Slide 21: Cell Pouch System for Hypothyroidism
Cell Pouch System for Hypothyroidism Anticipated Phase 1/2 Trial Initiation Therapeutic Benefits & Estimated Market 150,000 thyroidectomies performed annually just in the US Estimated Market $2.2B market opportunity Size Potential near-term revenue with patient own tissue Stem cell-derived t
Slide 22: Validation of Cell Pouch System for Hypothyroidism
Validation of Cell Pouch System for Hypothyroidism 23
Slide 23: Cell Pouch System Rare Disease Program – Hemophilia A
Cell Pouch System Rare Disease Program – Hemophilia A Therapeutic Benefits & Estimated Market 20,000 patients across North America and EU Estimated Market Size $10B orphan indication Reduce or eliminate factor VIII infusions Benefits of Maintain constant blood levels of factor VIII Sernova’s
Slide 24: Validation of Cell Pouch System for Hemophilia A
Validation of Cell Pouch System for Hemophilia A 25
Slide 25: Upcoming Catalysts
ad Sernova 4 . @ or Upcoming Catalysts
Slide 26: Upcoming Catalysts
Upcoming Catalysts Anticipated Milestones and Data 2022 • US Phase 1/2 T1D second cohort enrollment progress Q4 22 • Sernova / Evotec iPSC islet cluster development progress Q4 22 • Update on non-diabetes program development Q4 22 2023 • Conformal coating cellular local immune protection update Q1 2
Slide 27: TSX: SVA
TSX: SVA Business Development Investor Relations Dr. Philip Toleikis Head Office Christopher Barnes VP, Investor Relations 1.519.858.5184 700 Collip Circle, Ste 114 [email protected] 1.519.902.7923 London, ON, Canada N6G 4X8 [email protected] Tel: 1.877.299.4603 Tel: 1.519.858