SEOVF TRADED ON The Path To A Regenerative Cure Corporate Presentation November 2019
Forward-Looking Statement 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 information does not constitute any advice, promise or obligation of Sernova Corp. and does not necessarily represent the most current source of company information. Sernova Corp. cannot, and does not, guarantee or ensure either the accuracy, completeness, or authenticity of this presentation’s contents and may make changes and revisions to the information on this presentation at any time and without notice. The information is presented and stored on an "as is" basis and the use of the presentation to collect information is completely at your own risk. This presentation contains information about third-parties merely as a convenience. The inclusion of such information does not imply that Sernova Corp. endorses or accepts any responsibility for the content or use of such information. For more information on Sernova Corp, investors should review filings available at www.sedar.com. 2
Our Mission Sernova is a clinical-stage regenerative medicine therapeutics company developing a Cell Pouch implantable device with therapeutic cells. Our primary focus is the development of treatments for patients with insulin- dependent diabetes (T1), hemophilia A and thyroid disease Sernova is currently conducting a U.S. Phase I/II clinical trial targeting an indication of high-risk type 1 diabetes with an unmet need called hypoglycemia unawareness as a first approach for our therapeutic Cell Pouch technologies 3
Brief Overview
Management Team Dr. Philip Toleikis PRESIDENT AND CEO >20 years experience. Joined Sernova 2009. Previous Angiotech VP R&D (achieved $2.0B market cap; Product Board of Directors Revenue $200M/yr, drug/device combination products). • Frank Holler • Jeffrey Bacha • James Parsons David Swetlow CPA, CA • Deborah Brown CFO >20 years experience in life sciences and biotech industry. Various senior management, board & advisory roles. Nasdaq and TSX experience. 5
Sernova’s Approach Cell Pouch™ Therapeutic Cells A Total Regenerative Medicine Solution for the Therapeutic Treatment of Chronic Diseases Immune Protection Cell Pouch Immune Protection Therapeutic Cells Top Notch Doctors Implantable Protect therapeutic cells from Produce and release To inspire hope and contribute to health and well-being by providing Scalable immune system attack missing proteins the best care to every patient Medical device 6
Management Team 7
Cell Pouch™ Human Clinical Evaluation
Type 1 Diabetes: 1 st Clinical Indication “ Hypoglycemia unawareness ” affects about 10% of Type 1 Diabetes patients • Clinically defined as a complication of diabetes in which the patient is unaware of a deep drop in blood sugar levels • Failure to control the symptoms of hypoglycemia (Palpitations, Anxiety, Excessive Sweating, Light Headedness) 9
T1D: Current Treatment Options Insulin discovered in London, Ontario, in 1921 • Patent licensed by Novo Nordisk Islet donor transplants have been verified as a successful treatment for Type 1 Diabetes since the Edmonton Protocol in the 1990s However , more can be done to progress the viability of this treatment option Photograph by: Mark Spowart • Risks around portal vein implantation • Survival of Islets • Low number of cells available • Transplant Rejection 10
First-in-Human Safety Study (Canada)
T1D: First-in-Human Study Study Design 2015 • Diabetes subjects with hypoglycemia unawareness • Open-label; single-arm • Donor islet transplantation 2-24 weeks post Cell Pouch™ implantation • Primary endpoint • Safety post Cell Pouch™ implantation and 1-month post islet transplantation Cell Pouch™ and Islet Safety Met • Safety successfully met for the Cell Pouch™ • Cell Pouch™ histology assessed by independent pathologists blinded to the treatment • Islets housed within a natural tissue matrix • Islets are well-vascularized • Islet safety successfully met • Islets show evidence of insulin, somatostatin, & glucagon • Cell Pouch™ and islet biocompatibility met • Proof of islet protection from immune system attack 1 2
T1D: First-in-Human Study 13
Chicago Phase I/II Study (USA)
Phase I/II U.S. Study Safety, Tolerability and Efficacy Study of Sernova’s Cell Pouch™ for Clinical Islet Transplantation Study design: Open-label, single-arm study of Sernova’s implanted Cell Pouch with islets. Islets are transplanted into the Cell Pouch after implantation and stable antirejection medication activity Primary Objective : To demonstrate the safety and tolerability of islet transplantation into the Cell Pouch for the treatment of TID in subject with hypoglycemia unawareness and a history of severe hypoglycemic episodes Secondary Objectives: To establish islet release criteria that accurately characterize the islet product and are predictive of clinical transplant outcomes into the Cell Pouch, which will be demonstrated through defined efficacy measures • Survival of endocrine tissue in the Cell Pouch • Proportion of subjects with a reduction in severe hypoglycemic events • Proportion of subjects with a reduction in HbA1c >1mg% • Over 20 additional endpoint analyses will occur Status: US IND Cleared by FDA and IRB and patient enrolment initiated; Medtronic Minimed, Northridge, CA CGM is supplying patients in Sernova’s U.S. regenerative medicine clinical trial of its Cell Pouch. Next step: Interim safety and efficacy results 15
Phase I/II Timeline Secondary Endpoints: Immuno Survival of Endocrine Tissue & Identification of Hormones Suppression Reduction in hypoglycemic events Introduced Reduction in HbA1c Small ( sentinel ) Pouches Removed Cell 1 st Islet Dose Pouch™ Transplant Implantation Day 0 Day180 Day365 90 Days 90 Days 3-4 weeks 3weeks Immunosuppression Cell Pouch Vascularization Additional Safety Assessments Stabilized Feb 2019 Apr 2020 Completed Days 30, 60, 270 Day0 Day180 Day365 Post-Transplant 90 Days 90 Days 2nd Islet Primary Endpoint: Nov 2020 Transplant Initial Topline Safety Readout (increase dose) Safety Efficacy 14
Case Report of the First Treated Patient
Primary Endpoint- Safety Measures Patient Number 1: Interim Findings Safety- incidence and severity of adverse events determined to be probable or highly probable to the Cell Pouch ™ No incidences of AEs, determined to be probable or highly probable to the 1. Cell Pouch™ Cell Pouch™ well-tolerated and safe during the implant and the time of 2. transplant 3. No reactions to the Cell Pouch™ implant 4. Cell Pouch™ was well-incorporated with vascularized tissue and deemed suitable to receive the islet transplant These interim safety data meet the first measure of the primary endpoint 1 8
Secondary Objectives/ Endpoints To establish islet release criteria that: 1. accurately characterize the islet product and 2. are predictive of clinical transplant outcomes into the Cell Pouch ™ , which will be demonstrated through defined efficacy measures Survival of endocrine tissue in the Cell Pouch ™ Proportion of subjects with a reduction in severe hypoglycemic events Proportion of subjects with a reduction in HbA1c >1mg% Over 20 additional endpoint analyses 1 9
First Patient Initial Efficacy Results 90 Day Post-Transplant 3 MONTHS PREISLET Glucose Tolerance Test POST TRANSPLANT TRANSPLANT Patient is given a high sugar BODYWEIGHT drink. C-peptide and insulin 83KG 73KG response is measured over HEMOGLOBIN several hours 6.5 5.6* A1C • Showed increase in blood DAILY USE OF levels of C-Peptide LONG ACTING 14 U 8U* • Showed increase in blood INSULIN TRESIBA levels of Insulin and a DAILY USE OF typical insulin response SHORT ACTING 15-16 14 -15 * • Conclusion: Definitive INSULIN proof that the Cell Pouch SEVERE islets are surviving and HYPOGLYCEMIC able to respond to high 6-9 / 3MONTHS 1/ 3MONTHS* EVENTS levels of sugar by releasing insulin 2 0 * Showed improvement with transplanted Cell Pouch
CONTINUOUS GLUCOSE MONITOR: IMPROVEMENT IN ALL GLUCOSE Comparison between baseline and post transplant parameters PARAMETERS SEEN POST TRANSPLANT Parameter Baseline Post Transplant Performance Highest Sensor Glucose Value (mg/dL) 231 285 Lowest Sensor Glucose Value (mg/dL) 66 50 Cell Pouch™ for Islet # Glucose Excursions 3 15 Transplantation # High Excursions 7 2 8 1 # Low Excursions Standard Deviation (Variability) 37 31 Time above 180 mg/dL Time in Range of 70-180 mg/dL Time below 70 mg/dL CGM POST CELL POUCH BASELINE CGM ISLET TRANSPLANT Less excursions, hyper/hypo events More excursions, hyper/hypo events More time in range Less time in range
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