Sernova Biotherapeutics Inc · TSX:SVA
Sernova Biotherapeutics — Investor Presentation (February 2025)
24 slides from Sernova Biotherapeutics's investor presentation, February 2025
Slide 1: Life Never Stops Moving Forward. Neither Do We. H1 2025
LIFE NEVER STOPS MOVING FORWARD. NEITHER DO WE. H1 2025
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: Our Mission: Creating a Functional Cure for Type 1 Diabetes
Our Mission: CREATING A FUNCTIONAL CURE FOR TYPE 1 DIABETES SERNOVA INSULIN PRODUCING FUNCTIONAL BIO-HYBRID SERNOVA CELL POUCH PANCREATIC ORGAN FOR iPSC ISLET CELLS PATIENTS
Slide 4: Overview
OVERVIEW ▪ Partnered with Evotec and exclusive rights to iPSC islet like clusters ▪ U.S. / Canada based (TSX:SVA). Nasdaq uplist planned ▪ Positive pre-clinical data ▪ Preparing for clinical trial 2026 ▪ Lead program; human donor islet type 1 diabetes phase I / 2 study ▪ Cohort A complete, 6 of 6 pa
Slide 5: Our Focus: Type 1 Diabetes
OUR FOCUS Type 1 Diabetes
Slide 6: Our Focus – Type 1 Diabetes (T1D)
OUR FOCUS – TYPE 1 DIABETES (T1D)
Slide 7: What's the Problem?
SERNOVA 4 What’s the Problem?
Slide 8: The Realities of T1D
THE REALITIES OF T1D ▪ ~9 Million T1D patients worldwide ▪ An estimated 40,000 people are diagnosed with T1D in the US each year Patients have >2,500 insulin ▪ 182K people die each year from T1D in US Patients with a injections a ▪ 35,000 deaths annually are non-diagnosed Continuous year people unde
Slide 9: Current T1D Treatment
Hyperglycemia CURRENT T1D TREATMENT Normal Range Lacks full hormonal control - insulin only, no glucagon or Hypoglycemia somatostatin, highly complex and psychologically Glucagon burdensome: (inhaled) Continuous Glucose Monitor Insulin and ▪ Strict blood glucose monitoring via continuous syringe glu
Slide 10: More Than Just a Pancreas Problem with Many Co-Morbidities
Diabetic retinopathy Brain stroke Cerebrovascular Cataracts disease Glaucoma MORE THAN JUST A PANCREAS PROBLEM WITH Cardiovascular Periodontal MANY CO-MORBIDITIES disease disease 1 IN 10 DIE OF SEVERE HYPOGLYCEMIA Diabetic Peripheral vascular nephropathy disease Diabetic Foot ulcers neuropathy
Slide 11: What's the Solution?
What’s the Solution?
Slide 12: Cell Pouch Bio-Hybrid Organ
CELL POUCH BIO-HYBRID ORGAN Restoring Function. Liberating Patients. ▪ Complete containment & retrievability ▪ Proven clinical safety and efficacy ▪ Thin, flexible, & credit-card-sized ▪ Made from biocompatible medical-grade surgical mesh ▪ Vascularized tissue environment facilitates long-term cell
Slide 13: A New Way to Treat T1D. A Functional Cure.
PRE-IMPLANT ▪ Implantable porous surgical mesh A NEW WAY TO TREAT T1D. ▪ PTFE rods allow creation of cell chambers prior to removal after A FUNCTIONAL CURE. vascularization ~4-6 weeks ▪ Followed by impregnation with islet cells Our unique fully retrievable Cell Pouch Bio-Hybrid Organ works to restor
Slide 14: Functional Islets Throughout Cell Pouch >5 Years Following Transplantation
FUNCTIONAL ISLETS THROUGHOUT CELL POUCH >5 YEARS FOLLOWING TRANSPLANTATION: Cohort A; Patient 1 8 CHANNEL CELL POUCH TISSUE CHAMBERS: 1 2 3 4 5 6 7 8 INS vWF ▪ Positive immunofluorescent staining for Insulin, and vonWillebrand Factor (blood vessels), Glucagon & Somatostatin ▪ Rich vascularization of
Slide 15: Comparison of Human Islets to Cell Pouch Bio-Hybrid Organ Islets
COMPARISON OF HUMAN ISLETS TO CELL POUCH BIO-HYBRID ORGAN ISLETS Islets Residing In Cell Pouch For >5 Years Have Similar Appearance and Expression as Islets Residing In Native Pancreas CLINICAL PATIENT ▪ Islets in Cell Pouch explanted >5 years after transplant HEALTHY HUMAN PANCREAS
Slide 16: Does It Work?
Does It Work? Phase 1 / 2 Clinical Trial Summary
Slide 17: Phase 1/2 Adaptive Trial Insulin Independence Achieved
PHASE 1 / 2 ADAPTIVE TRIAL INSULIN INDEPENDENCE ACHIEVED: Cohort A ▪ 6 of 6 patients receiving islet transplants to Cell Pouch + PV top up achieved insulin independence ranging from 18 months to >4 years ▪ Patient 1 – Cell Pouch provides organ like environment for functioning Islets > 5 years ▪ All
Slide 18: Insulin Independence Achieved in Cohort A: Cumulative Islet Dose
INSULIN INDEPENDENCE ACHIEVED IN 6 OF 6 PATIENTS, COHORT A Clinical POC that Cell Pouch supports the engraftment & therapeutic function of transplanted cells. Cumulative Islet Transplants in Cohort A 20,000 Max Capacity Range: 10-Channel Cell Pouch Cumulative Islet Dose (IEQ/kg) 18,000 (Cohort B) 16
Slide 19: Positive Glucose Control in the Non-Diabetic Range for All Subjects
POSITIVE GLUCOSE CONTROL IN THE NON-DIABETIC RANGE FOR ALL SUBJECTS Sernova T1D Phase 1/2 Human Donor Islet Study - Cohort A ▪ 6 of 6 Patients Discontinued Insulin Therapy ▪ All Patients Achieved or Maintained HbA1c Values In The Non-diabetic Range (≤6.5%) HbA1c -–Measure HbA1c A Measure ofof Averag
Slide 20: Evotec Partnerships & The Future
Evotec PARTNERSHIPS & THE FUTURE
Slide 21: Partnering: Restoring the Balance
PARTNERING: RESTORING THE BALANCE Working in partnership with Evotec, we combine our Cell Pouch Bio- Hybrid Organ with induced pluripotent stem cells (iPSC) that have been converted from non-embryonic donor-derived cells to create islet-like clusters that closely mimic human pancreatic islet cells.
Slide 22: iPSC-Derived Islet-Like Clusters Have Long-Term Non-Diabetic Efficacy
IPSC-DERIVED ISLET-LIKE CLUSTERS HAVE LONG-TERM NON-DIABETIC EFFICACY Robust, Durable Normalization of Glycaemic Control in Diabetic Mice Efficient Normalization of Random Fed Glucose DAPI C-PEPTIDE / INSULIN GLUCAGON 10x 200µm SOMATOSTATIN ▪ Evotec developed scalable, GMP-compatible process for ILC
Slide 23: High Fraction of Insulin-Producing Beta Cells in iPSC Islets
HIGH FRACTION OF INSULIN- PRODUCING BETA CELLS IN IPSC ISLETS HISTOLOGICAL GRAFT ANALYSIS Preclinical murine model 32 weeks post- implantation INS CD31 ▪ Abundant endocrine cells with high beta cell DAPI fraction detectable INS ▪ Cell Pouch provides organ like environment for CD31 DAPI cell survival
Slide 24: We Envision a Better Way Forward by Giving Patients Their Lives Back
Cell Pouch + therapeutic islet cells = Bio-Hybrid Organ WE ENVISION A BETTER WAY Demonstrated long-term survival (over 5 years) of islets in FORWARD BY GIVING PATIENTS an implanted Cell Pouch Bio-Hybrid Organ THEIR LIVES BACK! Thank You Bio-Hybrid Organ has been shown to be well tolerated with a fav
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