Sernova Biotherapeutics Inc · TSX:SVA
Sernova Biotherapeutics — Investor Presentation (September 2024)
21 slides from Sernova Biotherapeutics's investor presentation, Sep 12, 2024
Slide 1: Giving Patients Their Lives Back!
SVA.TO Giving Patients Their Lives Back! Approaching Regenerative Medicine From a New Angle
Slide 2: Disclaimers and Forward-Looking Statements
Disclaimers and Forward-Looking Statements This presentation is confidential and for your information only and is not intended to be distributed to or reviewed by anyone other than you. This presentation has been prepared by Sernova and is being supplied to you on a confidential basis for informatio
Slide 3: Pioneering Functional Cures for Chronic Diseases
PIONEERING FUNCTIONAL CURES FOR CHRONIC DISEASES Cell Pouch Transplant System Product Portfolio • A flexible, implantable cell containment • Lead program: Phase I/II insulin- system filled with therapeutic cells dependent diabetes (T1D) ongoing • Human Donor Cells • Insulin-producing cells in-implan
Slide 4: Cell Pouch Transplant System Pipeline
CELL POUCH TRANSPLANT SYSTEM PIPELINE PMA – Premarket Authorization (US) BLA – Biologics License Application (US) MAA – Market Authorization Application (EU, CA) 2024 2025 2026 2027 2028 2029 2030 2031 1H24 2H24 1H25 2H25 1H26 2H26 1H27 2H27 1H28 2H28 1H29 2H29 1H30 2H30 1H31 2H31 PMA / BLA Cell Pou
Slide 5: Let's be Honest - The Clinical Need is Nowhere Near Met!
LEAD PROGRAM TYPE 1 DIABETES Let’s be Honest - The Clinical Need is Nowhere Near Met! • HEART DISEASE: Including coronary artery disease, heart failure, and cardiomyopathy. • KIDNEY DISEASE: damage to kidneys, leading to end-stage renal disease (ESRD) and transplantation or dialysis • NEUROPATHY: da
Slide 6: Developing a Functional Cure for Type 1 Diabetes
DEVELOPING A FUNCTIONAL CURE FOR TYPE 1 DIABETES Evolution of program built to expand the treatable patient population 1 2 Cell Pouch + Donor Islets Cell Pouch + iPSC ILC’s Phase 1/2 Ongoing Phase 1/2 Planning Underway Cell Pouch Cell Pouch iPSC-derived Islet-Like Donor Clusters (ILCs) Islets “Off t
Slide 7: Cell Pouch: A Cell Transplant Delivery System
CELL POUCH A Cell Transplant Delivery System POSITIVE CLINICAL OUTCOMES PAIRED WITH PRECLINICAL SAFETY AND EFFICACY IN ESTABLISHED MODELS OF CHRONIC DISEASES SAFETY & EFFICACY Preclinical and Clinical studies of cell and tissue transplantation have demonstrated safety and efficacy in multiple chroni
Slide 8: How It Works: Cell Pouch Provides an Organ-Like Environment
HOW IT WORKS CELL POUCH PROVIDES AN ORGAN-LIKE ENVIRONMENT FOR FUNCTIONAL CELLS THE VASCULARIZED TISSUE CHAMBERS ALLOW OPTIMAL ENGRAFTMENT AND SUPPORT THE LONG-TERM SURVIVAL AND FUNCTION OF TRANSPLANTED THERAPEUTIC CELLS Cell Pouch placed deep under the Therapeutic cells introduced into the Therapeu
Slide 9: Pancreatic Islet of Langerhans Cells non-diabetic
PANCREATIC ISLET OF LANGERHANS CELLS non-diabetic Islet cells of the pancreas are composed of various cells, including beta, alpha, and delta. These cells produce hormones (e.g., insulin and glucagon) that are secreted into the bloodstream and help control the level of glucose (sugar) in the blood.
Slide 10: Current Treatment Lacks Hormonal Control Cycle
CURRENT TREATMENT Lacks Hormonal Control Cycle Insulin Glucagon Somatostatin 10
Slide 11: Phase 1/2 T1D Multi-Cohort Trial Design
PHASE 1/2 T1D MULTI-COHORT TRIAL DESIGN Key Patient Inclusion Criteria 1. Type 1 diabetes 2. Onset <40 years of age a) Insulin dependent ≥5 years 3. Recent history of severe hypoglycemic episodes 4. Impaired awareness of hypoglycemia 5. No stimulated C-peptide in response to mixed meal tolerance tes
Slide 12: Phase 1/2 T1D Multi-Cohort Trial Design
PHASE 1/2 T1D MULTI-COHORT TRIAL DESIGN COHORT COHORT A (n=6) B (n=10) • Enrollment Completed • 7 of 10 Recruited • 8-Channel Cell Pouch • 10-Channel Cell Pouch (>50% • Cell Pouch Placement - greater capacity vs. 8-channel) Subfascial • Cell Pouch Placement - Subfascial • Below umbilicus (4) • Above
Slide 13: Cohort A - Adaptive Trial: Insulin Independence Achieved
COHORT A - ADAPTIVE TRIAL INSULIN INDEPENDENCE HAS BEEN ACHIEVED! RESULTS • 5 of 6 patients receiving 2 islet Txs to Cell Pouch + IP Txs achieved insulin independence with durations ranging from 9 months to more than 4 years • Determined optimal islet dose and density for Cell Pouch • Positive stimu
Slide 14: Cumulative Islet Dose: Insulin Independence Achieved, Cohort A
Insulin Independence Achieved in 5 of 6 Patients, Cohort A Clinical POC that Cell Pouch supports the engraftment & therapeutic function of transplanted cells. Cumulative Islet Transplants in Cohort 1 Max Capacity Range: 18,000 10-Channel Cell Pouch 16,000 (Cohort 2) Cumulative Islet Dose (IEQ/kg) 14
Slide 15: Cohort B - Adaptive Trial
COHORT B - ADAPTIVE TRIAL INSULIN INDEPENDENCE HAS BEEN ACHIEVED! RESULTS Pts With Target Immunosuppression Regimen: • Patient A: - Severe neutropenia - Reduced -> D/C’d immunosuppression • Patient B: - Positive fasting c-peptide - Insulin independent with 1 Tx to Cell Pouch and <4900 IEQ/kg IP Tx P
Slide 16: Hemoglobin A1c (HbA1c)
HEMOGLOBIN A1C (HbA1c) Amount of sugar attached to hemoglobin protein in red blood cells. The more sugar that sticks to the hemoglobin, the higher the A1c. HIGH A1c High A1c level higher risk of developing diabetes-related complications like heart disease, stroke, nerve damage and kidney disease. LO
Slide 17: Glucose Control in the Non-Diabetic Range for All Subjects
GLUCOSE CONTROL IN THE NON-DIABETIC RANGE FOR ALL SUBJECTS Sernova T1D Phase 1/2 human donor islet study - Cohort A • 5 Of 6 Patients Discontinued Insulin Therapy • All Patients Achieved Hba1c Values In The Non-diabetic Range (≤6.5%)1 10 Blood Glucose Control – HbA1c 9 8 HbA1c (%) 7 * 6 5 4 1011-011
Slide 18: Partnering to Give Patients Their Lives Back!
Partnering to Give Patients Their Lives Back! Developed iPSC Derived Islet like Clusters (ILCs)
Slide 19: Testing ILC + Cell Pouch Combination in Diabetic Mice
TESTING ILC + CELL POUCH COMBINATION IN DIABETIC MICE • Sentinel-size Cell PouchTM in STZ-diabetic NSG mice with ILCs containing 1.7 x 106 beta cells Implant ILCs into Cell Pouch (1.7 x 106 β-cells) implant Cell PouchTM 1) hC- hC- end of induce diabetes by peptide oGTT peptide oGTT exp./histology in
Slide 20: Excellent Anti-Diabetic Activity of ILCs in the Cell Pouch
EXCELLENT ANTI-DIABETIC ACTIVITY OF ILCS IN THE CELL POUCH Rapid normalization of glycaemic control with human islet-like potency Efficient normalization of random fed glucose Robust circulating hC-peptide levels + ILCs + ILCs Efficient glucose + ILC s (kidney capsule) clearance and no hypoglycemias
Slide 21: T1D Cohort A Patient - Giving Patients their Lives Back!
T1D COHORT A PATIENT – Giving Patients their Lives Back! After entering 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
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