Sernova Biotherapeutics Inc · TSX:SVA
Sernova Biotherapeutics — Sernova — Investor Presentation (February 2022)
25 slides from Sernova Biotherapeutics's investor presentation, February 2022
Slide 1: Corporate Investor Deck
Corporate Investor Deck February, 2022
Slide 2: Forward-Looking Statements
2 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 “expe
Slide 3: Sernova is a Regenerative Medicine clinical-stage company
Sernova Corp. is a Regenerative Medicine clinical- stage company developing therapeutic products for chronic debilitating diseases. The Company’s proprietary Cell Pouch System™ consists of an implantable device containing immuno- protected therapeutic cells capable of sustainably producing missing t
Slide 4: Investment Highlights – Cell Pouch System
Investment Highlights – Cell Pouch System • Proprietary implantable device containing therapeutic cells for organ-like environment Proprietary Cell • Once implanted, is naturally vascularized allowing self-sustaining cell survival for years Pouch System™ • 2nd generation allows for immuno-protection
Slide 5: Platform Approach: Finding Functional Cure for Chronic Diseases
Platform Approach: Finding Functional Cure for Chronic Diseases Integrated Regenerative Medicine Solution for Treatment of Chronic Diseases Immune Cell Pouch Protection Proprietary implantable Cell Pouch Immune 2nd generation devices utilize medical device that provides vascularized environment for
Slide 6: Cell Pouch Containing Therapeutic Cells
Cell Pouch Containing Therapeutic Cells Biologically compatible delivery process – allows natural vascularization Proprietary Cell Pouch is placed Therapeutics cells are transplanted Therapeutic cells are responsive to deep under the skin, allowing for directly into the vascularized tissue endogenou
Slide 7: Cell Pouch has Overcome Limitations of Previous Attempts
Cell Pouch has Overcome Limitations of Previous Attempts Sernova has created an organ-like environment with the goal of providing ‘functional cure’ Human donor cells Tissue Vascularizes Stem cell-derived islet cells No Fibrosis Sernova Scalable Cell Pouch Natural cell environment Biocompatible Cell
Slide 8: Pipeline – Life Cycle Iterations and Multiple Indications
Pipeline – Life Cycle Iterations and Multiple Indications Therapeutic Immune Market Approval Product Candidate Cell Source Protection Indication Pre-Clinical Phase 1/2 Phase 3 Application Human donor islet Cell Pouch System Immunosuppressives cells Human donor islet Local immune 2nd Gen System Type
Slide 9: Global Disease = Global Market: Diabetes
9 GLOBAL DISEASE = GLOBAL MARKET DIABETES Diabetes is one of the module prevalent diseases pervasive medical problems, impacting society and everyday quality of life today. 463 million people are affected worldwide with Diabetes; another estimated 179 million people have it without knowing it. By 20
Slide 10: Lead Diabetes Indication: Hypoglycemia Unawareness
0 LEAD DIABETES INDICATION Hypoglycemia Unawareness Among Type 1 Diabetic 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 bec
Slide 11: Phase 1/2 Study Design
Phase 1/2 Study Design 7 Patients with Type 1 Diabetes (T1D) Study Overview ▪ Company sponsored open label single-arm, single-center study Study ▪ Enroll 7 insulin dependent T1D patients with Hypoglycemia Unawareness ▪ Cell Pouch implant followed by human donor islets transplant to Cell Pouch Design
Slide 12: Phase 1/2 Study Design
Phase 1/2 Study Design (N = 7) Primary Study Long-term Follow-up and Tracking Baseline 1 MO +1 MO +6-12 MO +6-12 MO Ongoing Patient 1 Patient 2 Patient 3 Patient 4 Patient 5 Patient 6 12
Slide 13: Case Study: Longest Patient Insulin Independent for >20 Months
Case Study: Longest Patient Insulin Independent for >20 Months Dr. Witkowski presents patient data at international conferences BEFORE ISLET TRANSPLANT Post 1st ISLET TRANSPLANT* Post TOP-UP INFUSION** (baseline) (32 months after baseline) *Marginal Islet Dose **Marginal Islet Dose intraportal top u
Slide 14: Patient #1 – Impact Statement
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 manage my diabetes.
Slide 15: Summary of First Transplanted Patients in Phase I/II Clinical Trial
Summary of First Transplanted Patients in Phase I/II Clinical Trial (Protocol PROSVA201701) Daily C-Peptide Severe Hypoglycemic HbA1c CGM Insulin Use (ng/ml) Events (%) Time in Range PT (Units) ∆ From Baseline Post-Tx Baseline Post-Tx Baseline Post-Tx Baseline Post-Tx Baseline A ↓ 100%* Undetectable
Slide 16: T1D Phase 1/2 Findings Presented To-Date
T1D Phase 1/2 Findings Presented To-Date The Sernova Cell Pouch System is the first regenerative medicine to demonstrate a subcutaneous transplanted device to achieve persistent islet cell graft function in T1D patients Safety Assessments1: • 6 patients now successfully implanted and transplanted wi
Slide 17: Cell Pouch Diabetes Program – Progress & Upcoming Events
Cell Pouch Diabetes Program – Progress & Upcoming Events Internal and External Advancement of Development and Commercialization Strategy Current Phase 1/2 Clinical Study • Completion of study enrollment; completion of patient follow-up and study report • Additional top-line data expected in 2022 Exp
Slide 18: Conformal Coating Technology for Cell Pouch Immune Protection
Conformal Coating Technology for Cell Pouch Immune Protection Potential to eliminate the need for immunosuppressives Conformal Coating University of Miami / Sernova Collaboration Plan Conformal Coating Technology developed and optimized with >12 years of research Polymer characterization studies at
Slide 19: Conformal Coating + Cell Pouch: Summary of Key Findings
Conformal Coating + Cell Pouch: Summary of Key Findings Conformal Cell Pouch + Coating with Immuno-protection Summary Cells Cells Safety in non-human primates ✓ ✓ • Due to its ‘shrink wrap’ proximity to the cells, the volume of cells for transplantation into the Cell Pouch is unaffected Efficacy wit
Slide 20: Gene Editing for Stem Cells in Cell Pouch - Immune Protection
Gene Editing for Stem Cells in Cell Pouch - Immune Protection AgeX technology for potential off-the-shelf islet cell transplantation product • AgeX collaboration ongoing to confirm the potential of Sernova’s pluripotent stem cell-derived pancreatic islet beta cells engineered with AgeX’s UniverCyte
Slide 21: Cell Pouch System Thyroid Program
Cell Pouch System Thyroid Program Therapeutic Benefits & Estimated Market ➡ 150,000 thyroidectomies performed annually just in the US Estimated Market Size $ ➡ $2.2B market opportunity ➡ Potential near term revenue with patient own tissue ➡ Stem cell-derived technology for treatment of broad populat
Slide 22: Cell Pouch System Rare Disease Program
Cell Pouch System Rare Disease Program Hemophilia A Therapeutic Benefits & Estimated Market Estimated ➡ 20,000 patients across North America and EU Market Size $ ➡ $10B orphan indication ➡ First generation • AUTOGRAFT: Patient’s own blood outgrowth endothelial cells (BOEC) are isolated, expanded and
Slide 23: Hemophilia A Indication
Hemophilia A Indication Preclinical Safety & Efficacy of Hemophilia Cell Therapy in the Cell Pouch Confirmed Release-tested HLA-ABC BOECs FVIII DAPI Human stained (red) 40x Cell Pouch Transplanted with Cells Human corrected Human factor VIII- BOECs transplanted corrected blood 40× into the Cell Pouc
Slide 24: Sernova Share Information
Sernova Share Information TSX VENTURE OTC QB FRANKFURT EXCHANGE EXCHANGE XETRA SVA SEOVF PSH $1.62 US$1.27 €1.14 Shares Market Cap $420M Fully Outstanding Diluted Strong Cash ~262M Position $27M ~335M In millions except share price Share Prices and Market Cap as of February 2, 2022
Slide 25: Head Office, Business Development, Investor Relations
Head Office 700 Collip Circle, Ste 114 London, ON, Canada N6G 4X8 Tel: 1.877.299.4603 Tel: 1.519.858.5184 Fax: 1.519.858.5099 investor.relations@sernova.com Business Development Investor Relations Dr. Philip Toleikis Christopher Barnes 1.519.858.5184 VP, Investor Relations philip.toleikis@sernova.co