Sernova Biotherapeutics Inc · TSX:SVA
Sernova Biotherapeutics — Sernova — Investor Presentation (2013)
22 slides from Sernova Biotherapeutics's investor presentation, Dec 27, 2013
Slide 1: Investor Presentation 2013
Founded 2006, London Ontario; TSX(v); SVA.V Investor Presentation 2013 “Path to a Natural Cure”
Slide 2: Cautionary and Forward-Looking Information
Sernova Corp Cautionary and Forward-Looking Information This presentation may contain forward looking statements. Forward looking statements address future events and conditions and therefore involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipa
Slide 3: Sernova Company Overview
Sernova Company Overview A Clinical Stage Company in Regenerative Medicine/Cell Therapy: Technologies Cell Pouch ™ - Implantable medical device for therapeutic cells; Therapeutic cells - Donor, stem cells, xenogeneic cells Sertolin ™ - Local immune protection; First Product Focus: Insulin-Dependent
Slide 4: Sernova's Patent Portfolio
Sernova’s Patent Portfolio Over 20 issued and pending patents in 5 families: • Composition and use of medical devices for delivery and cell transplantation • Methods for predicting long-term therapeutic cell function • Use of sertoli and genetically modified sertoli cells for treatment of disease •
Slide 5: Diabetes
Sernova’s Cell Pouch™ First Clinical Indication Diabetes Page 5
Slide 6: Cell Pouch System: Diabetes Market
Cell Pouch System™: Diabetes Market Potential Diabetes Market Diabetes Epidemiology* 27% Type 1 Insulin-dependent (10%) 10% Type 2 Insulin-resistant (63%) Type 2 Insulin-dependent; (27%) 63% Insulin therapy: 37% (9M US/34M Asia) US Market 23.6M Patients Diabetes side effects: heart, kidney, nerve di
Slide 7: Diabetes Treatments Are Inadequate
Diabetes Treatments Are Inadequate Artificial management of blood glucose • Therapy: Insulin injections, pumps, etc. • Pros: Large number of patients treated, achieve some glucose control • Cons: Painful - leading to poor compliance (side effects) Insulin levels spike and decay Poor patient QOL “Nat
Slide 8: The Current Approach to Islet Transplantation: The Edmonton Protocol
The Current Approach to Islet Transplantation: The Edmonton Protocol Portal vein islet transplantation for patients with hypoglycemia unawareness A study of 36 patients using the Edmonton Protocol: 44% were insulin independent at 1 year 15% insulin independent at 5 years (Shapiro et al. NEJM 355:13,
Slide 9: Improving the Standard of Care of Islet Transplantation
Improving the Standard of Care of Islet Transplantation Edmonton Protocol Cell Pouch System™ Catherization laboratory Placed under the skin Loss of 60-75% of islets immediately-IBMIR Outpatient procedure; minimally invasive Portal hypertension, thrombosis No IBMIR No possible Islet imaging No Portal
Slide 10: Cell Pouch Autograft Islet Transplantation: Long-Term Efficacy
Cell Pouch™ Autograft Islet Transplantation: Long-Term Efficacy Indicates time at which Islet filled Sernova Cell Pouch™ was removed from animals. Indicates time post Cell Pouch Removal (Hyperglycemic n=6 , Non-Diabetic n=7, and Glycemic Control n=4) Page 10
Slide 11: Robust Allograft Efficacy Results with a Marginal Islet Dose
Cell Pouch™ Robust Allograft Efficacy Results with a Marginal Islet Dose* Cell Pouch™ Tx Removal Cell Pouch™ Removal *Marginal Islet dose 2500 IEQ/kg (standard dose is 10,000 IEQ/kg) Left Panel:Black/red: glucose levels, Green: insulin usage Right Panel: Black/red weight Page 11
Slide 12: Sertolin and Islets: Prevention of Graft Rejection
Sertolin™ and Islets: Prevention of Graft Rejection with Local Protection of Islets Sertoli/Islets Islets Alone A B Sertolin™ creates a local Day 7 immune-privileged environment protecting donor cells from immune destruction without the C D need for daily antirejection drug regimens Day 21 Islets an
Slide 13: Local Immune Protection of Porcine Islets with Sertolin
Local Immune Protection of Porcine Islets with Sertolin™ and Reversal of Diabetes Arrows indicate point of removal of transplanted islets and return to diabetic state without transplanted islets and Sertolin™ Diabetic mice transplanted with porcine islets and Sertolin™ show reversal of Diabetes and
Slide 14: Phase I/II Study of Sernova's Cell Pouch for Islet Transplantation
A Phase I/II Study of the Safety and Efficacy of Sernova’s Cell Pouch™ for Therapeutic Islet Transplantation Principal Investigator: A.M. James Shapiro, M.D., Ph.D., FRCS (Eng), FRCSC www.islet.ca www.clinical trials.gov Page 14
Slide 15: Ongoing Sernova Cell Pouch Phase I/II Study
Ongoing Sernova Cell Pouch™ Phase I/II Study Principal Investigator: Dr. A. J. Shapiro (Developer of Edmonton Protocol; U. Alberta) Study Design Up to 20 patients (unstable diabetes) Donor islet transplantation post Cell Pouch™ implantation Primary endpoint Safety post Cell Pouch™ implantation and p
Slide 16: Sernova Cell Pouch Clinical Development
Sernova Cell Pouch™ Clinical Development Plan for international study (Canada, US, Europe, Asia) Cell Pouch™ Diabetes Products Product Product Strategy Cell Pouch™, donor islets and state of POC Cell Pouch™ the art antirejection protocol Cell Pouch™, donor islets and local Local immune protection of
Slide 17: Sernova's Therapeutic Goal
Sernova’s Therapeutic Goal: A Disruptive Approach to Treat Chronic Diseases A Natural Cell Environment: Cell Pouch System™ Sernova An Unlimited Source of Safe Prevention of Therapeutic Cells Transplant Rejection Sertolin™ Page 17
Slide 18: The Cell Pouch: Product Pipeline
The Cell Pouch™: Product Pipeline Type-1 Type-2 Hemophilia Parkinson’s Disease Parathyroid Liver Failure Diabetes Human Donor Cells Stem Cells; Xenogeneic Cells Cell Pouch™ Page 18
Slide 19: Potential Application: Hemophilia
Potential Application: Hemophilia Hemophilia A - prolonged bleeding due missing clotting factor (Factor VIII) Current Therapy – infusions of Factor VIII 3x weekly at ≈ $200- 300K/yr/patient for prophylaxis; $60,000/yr on demand Tx Effects of inadequate treatment – muscle hypotrophy, synovitis, joint
Slide 20: Management Team and BOD
Management Team and BOD Core Executive Management President & CEO - Dr. Philip Toleikis, BA., MSc., Ph.D. Joined 2009; Pharmaceutical/Device Consultant, V.P. R&D Pharmacology, Angiotech Pharmaceuticals (1996-2006) Sr. Director R&D – Delfina Mazzuca-Siroen, BSc. Hon. Biochem., MSc. >20 yrs. R&D Mgmt.
Slide 21: Sernova Company Summary
Sernova Company Summary A Clinical Stage Company in Regenerative Medicine/Cell Therapy: Technologies Cell Pouch ™ - Implantable medical device for Therapeutic Cells; Therapeutic cells - donor, stem cells, xenogeneic cells Sertolin ™ - Local immune protection; First Product Focus: Insulin-Dependent D
Slide 22: Contact Information
Contact Information Dr. Philip Toleikis, President and CEO Tel: (604) 961-2939 email: [email protected] Page 22