Sernova Biotherapeutics Inc · TSX:SVA
Sernova Biotherapeutics — Sernova — Investor Presentation (2015)
25 slides from Sernova Biotherapeutics's investor presentation, Sep 5, 2015
Slide 1: Sernova Corporate Presentation
Sernova Corporate Presentation Philip Toleikis Ph.D., President and CEO 2015
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 Corporate: Key Take-Aways
Sernova Corporate: Key Take-Aways Sernova Corp. (TSX-V: SVA) is an Ontario-based, health sciences company developing novel products including therapeutic cells and therapeutic medical device systems to treat chronic diseases through a regenerative medicine approach. Sernova’s platform addresses mult
Slide 4: Sernova's Technology Platform Addresses Unmet Needs
Sernova’s Technology Platform Addresses Unmet Needs in the Pharmaceutical & MedTech Sectors New technologies to address chronic diseases • Improve quality of life • Reduce morbidity / mortality Medical devices that are easy to utilize • Improve patient compliance • Reduce risk of complications (i.e.
Slide 5: Sernova's Disruptive Product Strategy
Sernova’s Disruptive Product Strategy Sernova’s Platform Technologies Cell Pouch™ • Subcutaneous implantable medical device for therapeutic cells • Designed to provide a natural environment for cells rich in matrix and microvessels, key for survival of cells • Designed specifically for human therape
Slide 6: Sernova's Disruptive Platform Technologies
Sernova’s Disruptive Platform Technologies Sernova’s Cell Pouch System™ has the full complement of technologies required to develop advanced cell-based treatments with applications in any number of chronic diseases involving the need for a missing protein, hormone or factor CELL POUCH™ Proven safety
Slide 7: Current Diabetes Treatments Are Inadequate
Current Diabetes Treatments Are Inadequate Exogenous management of blood glucose • Technology Insulin injections, pumps, medications, etc. • Attributes Inconvenient; readily available; treatment relatively inexpensive • Issues Lowers patient QOL: poor compliance serious side effects Physiologic insu
Slide 8: Sernova: Improving Diabetes Treatment Standard of Care
Sernova: Improving Diabetes Treatment Standard of Care • Extra-hepatic site • Can be implanted on a surgical outpatient basis • Provides a natural vascularized environment for therapeutic cells • No IBMIR (inflammatory response) • No Portal hypertension or thrombosis • Islet imaging capable • Potent
Slide 9: Cell Pouch System Preclinical Update 2009-2015
Cell Pouch System™ Preclinical Update 2009-2015 Manufacturing • Cell Pouch™ contract manufactured in U.S. under GMP & ISO 13485 standards in a semi-automated process • The Cell Pouch™ has completed and passed sterility testing • The Cell Pouch™ is fully scalable and comes in multiple sizes for precl
Slide 10: Preclinical Proof of Concept: Cell Pouch Islet Transplant
Preclinical Proof of Concept: Cell Pouch™ Islet Transplant Small Animal Proof of Concept Transplant: 100 Days Insulin Independence Proof of Cell Pouch™ Microvessel Development (Clinical Device) Transplant Space Tissue Microvessels Page 10
Slide 11: Proven Safety/Efficacy in Large Animal Models
Cell Pouch System™: Proven Safety/Efficacy in Large Animal Models Porcine Autografts 12 Wks Post Cell Pouch™ and Islet Transplant Cell Pouch™ developed tissue Healthy Islets in the chambers rich in Cell Pouch™ micro-vessels for (purple); cell transplant Implanted Cell Pouch™ chamber Micro-vessels (r
Slide 12: Preclinical Collaboration Dr. Shapiro; University of Alberta
Preclinical Collaboration Dr. Shapiro; University of Alberta Cell Pouch™ Marginal Islet Mass Study Page 12
Slide 13: Marginal Islet Mass Provides 100 Day Insulin Independence
Cell Pouch™: Marginal Islet Mass Provides 100 Day Insulin Independence in Diabetic Animals 200 islets/mouse Glucose levels rise upon Cell Pouch™ removal Page 13
Slide 14: Islets Within the Cell Pouch Are Well Vascularised
Islets Within the Cell Pouch™ Are Well Vascularised with Strong Insulin Staining Healthy islets showing staining for insulin in red and islet cells in blue Supporting microvessels shown in green with tissue matrix Page 14
Slide 15: Phase I/II Study of Sernova's Cell Pouch
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 Cell Pouch™ Clinical Study Page 15
Slide 16: Sernova's Cell Pouch Phase I/II Clinical Proof of Concept Study
Sernova’s Cell Pouch™ Phase I/II Clinical Proof of Concept Study Study Design Patients with brittle diabetes (hypoglycemia unawareness) Cell Pouch™ implant followed by donor islet transplantation Immunosuppression Standard current Edmonton approach (alemtuzumab, tac/MMF) Primary endpoint Safety post
Slide 17: Positive Interim Safety Results
Positive Interim Safety Results Presented at the 14th International Pancreas and Islet Transplantation Association World Congress (2013), World Transplant Congress (2014) and American Diabetes Association Meeting (2015) Primary endpoint Cell Pouch™ Safety Safety Assessment Cell Pouch™ Implant • Cell
Slide 18: Interim Results Summary
Interim Results Summary Prior to islet transplant, implanted Cell Pouch™ • safe and biocompatible Healthy human Islets within the Cell Pouch™ Following islet transplant in the Cell Pouch™ • Islets housed within a natural tissue matrix • Islets are well vascularized • Islets show evidence of insulin,
Slide 19: Summary and Next Steps
Summary and Next Steps • Sernova has been developing the Cell Pouch™ over the past > 6 years which following implantation under the skin creates a safe and biologically appropriate environment for the long term survival and function of insulin producing cells • Sernova has achieved strong preclinica
Slide 20: The Cell Pouch: Product Pipeline
The Cell Pouch™: Product Pipeline Type-1 Type-2 Thyroid Disease Parkinson’s Disease Diabetes Hemophilia Autologous & Allogeneic Cells Stem cell derived cells; Xenogeneic Cells Cell Pouch™ Page 20
Slide 21: Second Therapeutic Application: Hemophilia
Second Therapeutic Application: Hemophilia Hemophilia A • prolonged bleeding due to reduced or missing coagulation Factor VIII produced in the blood • 70% of people with hemophilia in the world are untreated Effects of inadequate treatment • muscle hypotrophy, synovitis, joint deformity, reduced lif
Slide 22: Sernova Corp Hemophilia Program
Sernova Corp Hemophilia Program Sernova working with international collaborators in the field of complex ex-vivo human cell cultivation and gene therapy Sernova treatment: • A sample of blood is collected from the patient with hemophilia • Cells isolated from the patient’s blood are processed to cor
Slide 23: Strong Patent Portfolio and Growing
Sernova Corp: Strong Patent Portfolio and Growing 28 issued and 25 pending patents applications worldwide in 9 families: • Composition and use of medical devices for delivery and cell transplantation • Local immune protection technologies 21 Page 23
Slide 24: Sernova: Upside / 3-12 mth Roadmap
Sernova: Upside / 3-12 mth Roadmap deal zone Time= 3mth-6mth ~Phase I/II Immediate Potential 2009-12 $0.30-$0.50/share – 2-3x Return With near-term catalyst With Catalyst ($0.30- $0.50) With Partner ($1.00- 2.00) pI/II pIII academic pre-clinical Clinical sales Diabetes – Human Trials Market Authoriz
Slide 25: 2015 Corporate Presentation Investor Contact
2015 Corporate Presentation Philip Toleikis, CEO Investor Contact: Philip Toleikis 604 961 2939 Ray Matthews: 604-818-7778