Sernova Biotherapeutics Inc · TSX:SVA
Sernova Biotherapeutics — Sernova — Investor Presentation (January 2023)
27 slides from Sernova Biotherapeutics's investor presentation, January 2023
Slide 1: Advancing cell therapeutics to provide 'functional cures'
Advancing cell therapeutics to provide ‘functional cures’ January 2023 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: Capital Structure / Select Information
Capital Structure / Select Information EXCHANGE: 52-week Range 1 $0.69 - 2.22 TSX: SVA Shares Outstanding 303 million OTCQB: SEOVF Market Cap 1 $250 million FSE / XETRA: PSH Average Daily Volume 2 0.23 million Warrants (3/1/23 expiry) 16.7M @ $1.70 FISCAL Y/E: 10/31 Cash (10/31/22) $49.8 million Cas
Slide 5: 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 6: Clinical Program
, a Sernova 4, @ or Clinical Program
Slide 7: 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 8: 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 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 two sequential human donor isl
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 iPSC Insulin Producing Islet Clusters
Abundant Supply of iPSC Insulin Producing Islet Clusters • Secured exclusive option on exclusive global license for Evotec’s ethically derived iPSC insulin producing islet clusters for use with Sernova’s Cell Pouch System or alone with other technologies • Access to unlimited supply of insulin-produ
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: Sernova / Evotec Collaboration T1D Disease Impact
Sernova / Evotec Collaboration T1D Disease Impact • 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 significa
Slide 18: Additional Pipeline
, a 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 in the US alone ➔ $2.2B market opportunity ➔ Estimated Market Potential near-term revenue with patient own tissue ➔ Size Stem cell-derived
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 Estimated Market ➔ 20,000 patients across North America and EU 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
, a Sernova 4, @ or Upcoming Catalysts
Slide 26: Upcoming Catalysts: Anticipated Milestones and Data
Upcoming Catalysts Anticipated Milestones and Data 2023 • Sernova / Evotec iPSC islet cluster development progress Q1 2023 • Update on non-diabetes program development Q1 2023 • Conformal coating cellular local immune protection update Q1 2023 • US Phase 1/2 T1D second cohort islet transplantation Q
Slide 27: TSX: SVA OTCQB: SEOVF FSE / XETRA: PSH
TSX: SVA OTCQB: SEOVF FSE / XETRA: PSH 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: