Sernova Biotherapeutics Inc · TSX:SVA
Sernova Biotherapeutics — Sernova — Investor Presentation (2016)
37 slides from Sernova Biotherapeutics's investor presentation, Oct 29, 2016
Slide 1: Sernova Corporate Presentation Q2, 2016
Sernova Corporate Presentation Q2, 2016 Improving the Quality of Life for Patients with Chronic Disease TSX-V: SVA OTCQB: SEOVF
Slide 2: Forward Looking Statements
2 Forward Looking Statements 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 anticipated in such statements. The
Slide 3: Key Management
3 Key Management Dr. Philip Toleikis, PRESIDENT AND CEO Previous Angiotech Head of R&D (reached $2.0B market Board of Directors cap; drug/device combinations) Delfina Siroen, SR. DIRECTOR RESEARCH & DEV. Frank Holler >20 years academic and corporate experience; Product development, Clincal, Manageme
Slide 4: Sernova is a Canadian based, clinical stage, regenerative medicine therapeutics company
4 Sernova is a Canadian based, clinical stage, regenerative medicine therapeutics company Sernova has developed a scalable, implantable medical device, The Cell Pouch, for the survival and function of therapeutic, immune protected cells Our platform addresses the unmet needs of patients suffering se
Slide 5: Our Therapeutic System
Our Therapeutic System The Total Regenerative Medicine 5 Solution 1 Cell Pouch™ An implantable medical device for therapeutic cells placed under the skin Proven safety in humans Cell Therapeutic Pouch™ Cells 2 Therapeutic Cells Cells that produce and release missing (or needed) proteins or hormone
Slide 6: Sernova Corp: Patent Portfolio
Sernova Corp: Patent Portfolio 6 Over 50 patents and patent applications in 10 families: ➻Composition and use of medical devices for delivery and cell transplantation ➻Glucose responsive insulin secreting stem cell technologies ➻Local immune protection technologies
Slide 7: Cell Pouch Contract Manufacturing Overview
Cell Pouch™ Contract Manufacturing Overview 7 Sernova’s GMP manufacturing Quality System is compliant with: ISO 13485 MDD 93/42/EEC US FDA Quality System Regulations (QSR) 21 CFR 820 Canadian Medical Device Regulation (CMDR) Stability tested, sterilized, manufactured in multiple sizes
Slide 8: Diabetes
Diabetes 8 The Cell Pouch™ delivery system offers a potential for treatments across multiple chronic diseases, primarily Diabetes (Type 1 and 2) and Haemophlia Diabetes Insulin therapy: 37% (9M US/34M Asia) Epidemiology Sernova patented countries: 40M patients 10% 27% Diabetes side effects: heart, k
Slide 9: Current State of the Art
Current State of the Art 9 Insulin Pumps – a huge unmet medical need Components, clockwise include: ➺ Insulin ➺ Insulin pump reservoir ➺ AAA battery ➺ Insulin pump infusion set ➺ Emergency glucagon kit ➺ Insulin pump ➺ Test strips ➺ Lancets Typical Approximate Annual Cost (US): with insurance $4,000
Slide 10: Diabetes Treatment Overview
10 Diabetes Treatment Overview ➺ Main Problem: Outdated Treatment Goals of Sernova’s Cell Methods Pouch technologies: ➺ What people are using is inadequate Reduce exogenous insulin 1. Insulin injections, pumps, medications, etc., or 2. Transplant of donor islets into the portal vein Reduce hypoglyce
Slide 11: Sernova: Diabetes Therapeutic
Sernova: Diabetes Therapeutic 11 Performs as an artificial pancreas – eliminates needles, injectables, pumps ➺ Patient population: Insulin injections, insulin pumps, Edmonton Protocol ➺ Sernova therapeutic goals: Reduce hypoglycemia unawareness; reduce exogenous insulin; improve patient QOL, improve
Slide 12: Haemophilia Treatment Overview
12 Haemophilia Treatment Overview ➺ Main Problem: Treatment methods Goal of Sernova’s Cell expensive, blood trough levels not Pouch with autologous sufficient to eliminate joint issues Factor VIII releasing cells: ➺ Current Product Options Reduce/eliminate exogenous • Recombinant Factor VIII infusio
Slide 13: Sernova Haemophilia A Therapeutic
Sernova Haemophilia A Therapeutic 13 $5B/yr Orphan indication for patients whose blood is missing a critical clotting agent ➺ Patient population: Haemophilia A ≈20,000 NA/EU ➺ Hemophilia Therapy: GMP Factor VIII Gene corrected BOEC’s transplanted into the prevascularized Cell Pouch to release Factor
Slide 14: Cell Pouch System Preclinical Overview
Cell Pouch System™ Preclinical Overview ➺ Manufacturing Cell Pouch™ contract manufactured in U.S. under GMP & ISO 13485 standards in a semi-automated process 14 The Cell Pouch™ has completed and passed sterility testing The Cell Pouch™ is fully scalable and comes in multiple sizes for preclinical an
Slide 15: Preclinical Proof of Concept
Preclinical Proof of Concept Cell Pouch™ Islet Transplant Efficacy in 15 Small Animals (A) Diabetic animals with Cell Pouch™ & Photograph of islets within the Cell Pouch™ after 100 days. therapeutic cells transplanted. Achieve Red = insulin, Green = blood vessels, normal glucose level for 100 days a
Slide 16: Preclinical Proof of Concept
Preclinical Proof of Concept Cell Pouch™: Tissue Chamber and Microvessel Development in Large Porcine Model 16 Clinical Cell Pouch™ Device Single Cell Pouch™ chamber Proof of Cell Pouch™ microvessels Confidential
Slide 17: Preclinical Cell Pouch Efficacy
Preclinical Cell Pouch™ Efficacy Cell Pouch™ Islet Transplant Confirmation of Efficacy in Large Animals: Porcine Autograft Transplant Study 17 Diabetes induction (STZ) Cell Cell Pouch™ Islet Transplant Pouch™ removal implant Pancreatectomy 4-8 weeks 1 day 4-7 days 8-12 weeks 1 week Cell Pouch™ devel
Slide 18: Porcine Autograft Transplant Study
Porcine Autograft Transplant Study Cell Pouch™ Islet Transplant in Large Animals 12 Weeks Post Cell Pouch™ and 18 Islet Transplant Islets showing insulin (red) and supporting blood vessels (green) Insulin vWF Healthy Islets Nuclei in the Cell Insulin Pouch™ vWF (purple); Micro-vessels (red arrows) S
Slide 19: Porcine Allograft Transplant Study Glucose Control
Cell Pouch™ Islet Transplant in Large Animals: Porcine Allograft Transplant Study Glucose Control with 25% Standard Human Dose of Islets* Diabetes Cell Cell Pouch™ induction Islet Transplant Pouch™ removal 19 implant (STZ) 4-8 weeks 2-3 weeks 2-4 weeks 1 week Tx Cell Pouch™ Removal Cell Pouch™ Remov
Slide 20: Porcine Allograft Transplant Study
Cell Pouch™ Islet Transplant in Large Animals: Porcine Allograft Transplant Study Marginal Islet dose 2,500 IEQ/kg; 20 Standard human islet transplant is 10,000 IEQ/kg Insulin Insulin HE vWF Glucagon Nuclei Nuclei 50um 50um Sernova Corp Sernova Corp Sernova Corp Insulin Insulin C-Peptide Somatostati
Slide 21: Rodent Model Assessment: Third Party
Rodent Model Assessment: Third Party Cell Pouch™: Full Islet Mass Insulin Independence* 21 Independent 3rd party assessment proves insulin independence in diabetic animals (mouse isograft study*) Proven Cell Pouch™healthy islets with strong insulin staining & microvessels *Diabetes Is Reversed in a
Slide 22: Rodent Model Assessment: Third Party
Rodent Model Assessment: Third Party Cell Pouch™ Marginal Islet Mass: Insulin Independence* 22 200 islets/mouse Glucose levels rise upon Cell Pouch™ removal Independent 3rd party assessment: • 95% insulin independence in diabetic animals • Efficacy achieved using a marginal islet mass *Diabetes Is R
Slide 23: Cell Pouch Islet Graft: IPGT Test
Rodent Model Assessment: Third Party Cell Pouch™ Islet Graft: IPGT Test (Positive Glucose Tolerance Test) 23
Slide 24: Clinical Evaluation: Proof of Concept
Clinical Evaluation: Proof of Concept 24 First in Human pilot assessment conducted in subjects with hypoglycemia unawareness www.clinical trials.gov “A Phase I/II Study of the Safety and Efficacy of Sernova’s Cell Pouch™ for Therapeutic Islet Transplantation” A.M. James Shapiro, M.D., Ph.D., FRCS (E
Slide 25: Cell Pouch Clinical Histology
Cell Pouch™ Clinical Histology Insulin staining islets with microvessels 25 Sernova Corp
Slide 26: Sernova: Next Steps
Sernova: Next Steps 26 • The Cell Pouch™ is safe and efficacious in multiple preclinical models of diabetes • In First in Human Clinical Assessment the Cell Pouch™ • Is safe • Shows consistent islet vascularization • Islets show presence of glucose regulatory hormones in patients with hypoglycemia u
Slide 27: Study of Sernova's Cell Pouch for Clinical Islet Transplantation
A Safety Tolerability and Efficacy Study of Sernova’s Cell Pouch for 27 Clinical Islet Transplantation Study design: : A U.S. prospective, single-arm study of islet transplantation into the Sernova Cell Pouch™ implanted subcutaneously. Islets will be transplanted into the Cell Pouch after Cell Pouch
Slide 28: Achieving a Complete Solution for Patients with Diabetes
28 Encapsulated Islets in the Cell Pouch™ Achieving a Complete Solution for Patients with Diabetes www.clinical trials.gov
Slide 29: Immune Protection: Microencapsulation
Immune Protection: Microencapsulation • The Cell Pouch™ is believed to be the only implantable scalable device consistently shown capable of housing islets within a natural tissue matrix supported by microvessels 29 • Cells are housed in a polymer sphere with pores to keep out immune cells but allow
Slide 30: Sernova Secures Commercial Rights to Proprietary Stem Cell Derived Technologies
Sernova Secures Commercial Rights to Proprietary Stem Cell Derived Technologies 30 ➺ Agreement with the University Health Network of Toronto (UHN) to gain exclusive access to worldwide rights for the advancement of stem cell derived insulin-producing glucose responsive cells for the treatment of pat
Slide 31: Grant Funding
31 Grant Funding Sernova has been successful in its active pursuit of non-dilutive grant funding and will continue to pursue further grant funding o 2009; Canada National Research Council (NRC-IRAP) - $486,000 CDN (Diabetes)* o 2010; Canada National Research Council (NRC-IRAP) - $275,000 CDN (Diabet
Slide 32: Sernova's Therapeutic Pipeline
Sernova’s Therapeutic Pipeline 32 Cell Pouch Disease Patient Population Development Stage Product Treatment Human Donor Islets, Diabetes Hypoglycemia unaware patients Phase I/II Clinical Systemic immune protection (anticipated first diabetes product approval) Microencapsulated Diabetes All insulin d
Slide 33: Sernova 2016 Value Drivers
33 Sernova 2016 Value Drivers ➺ US FDA Clinical Study ➻ Anticipated initiation of a Phase I/II United States Clinical trial of the Cell Pouch at a significant islet transplantation center ➺ Business Development/ M&A Activities ➻ In active business discussions which may result in collaborations and l
Slide 34: Why Invest in Sernova?
34 Why Invest in Sernova? ➺ Robust international device and therapeutic cell patent portfolio which includes U.S. and foreign patents – key to pharma licensing deals ➺ Total regenerative medicine solution: Cell Pouch; cells; local immune protection ➺ Sernova is the only regenerative medicine company
Slide 35: Sernova: Upside/3-12 mth Roadmap
Sernova: Upside/3-12 mth Roadmap 35 deal zone ~Partnerships Time= 6mths-1y M/C Range>$150M 2009-12 $0.40 share Licensing Immediate Potential – 3-5x M/C>$57M seller = bio Return buyer = pharma With Efficacy (> 10X) With Partner ($1.50-2.00) pI/II pII pIII sales academic pre-clinical Clinical Diabetes
Slide 36: Sernova's Development Team
Sernova’s Development Team 36 Sernova Team: Surgical Support: Sponsors: D.M. Siroen Dr. William Wall Multi Organ Transplant Program London Hospital Science Centre Sr. Director R&D Dr. Roberto Hernandez National Research Council-IRAP Internal scientific staff Dr. Ian Welch MITACS Dr. David White Nova
Slide 37: Contacts
37 Contacts President and CEO Investor Relations Dr. Philip Toleikis +1-604-961-2939 Ray Matthews Philip.Toleikis@Sernova.com +1-604-818-7778 www.Sernova.com ray@raymatthews.ca 114 - 700 Collip Circle London, ON N6G 4X8