SEOVF TRADED ON The Path To A Regenerative Cure Conference Call Presentation July 18, 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 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
Sernova Share Structure Sernova Corp Founded in 2006 Common Shares 172,237,348 Current Price 0.22 Market Cap 37,9 M 52 Week Range $0.145-$0.27 Transfer Agent AST Trust Company 4
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 Sean Hodgins • Deborah Brown CA-CPA, CFO >20 years experience in biotech industry. Joined Sernova in 2018. US and Canada experience with both Nasdaq and TSX experience. 5
Sernova’s Approach Cell Pouch™ Therapeutic Cells A Total Regenerative 28% Medicine Solution for the 40% Therapeutic Treatment of Chronic Diseases 32% Immune Protection Cell Pouch Therapeutic Cells Immune Protection Top Notch Doctors An implantable medical device Cells that produce and release Technologies to protect To inspire hope and contribute to health and well-being by providing which provides a vascularized missing (or needed) proteins or therapeutic cells from immune the best care to every patient environment for therapeutic cells hormones into the bloodstream system attack 6
Sernova Pipeline CELL POUCH PRE- DEVELOPMENT CANDIDATE CLINICAL PHASE I PHASE II PHASE III STAGE INDICATION TYPE 1 DI ABETES H U M A N D O N O R I S L E T S , P H A S E I / I I I N I T I AT E D H Y P O G L Y C E M I A S Y S T E M I C I M M U N E D E C 2 0 1 8 U N A W A R E N E S S P R O T E C T I O N M I C R O E N C A P S U L A T E D A N T I C I PAT E D 2 N D H Y P O G L Y C E M I A I S L E T S A P P R O VA L F O R U N A W A R E N E S S D I A B E T E S M I C R O E N C A P S U L A T E D A N T I C I PAT E D 3 R D A L L I N S U L I N S T E M C E L L D E R I V E D A P P R O VA L F O R D E P E N D E N T D I A B E T I C C E L L S D I A B E T E S P A T I E N T S HEM O PHI LI A A S E V E R E H E M O P H I L I A A P R E C L I N I C A L C O R R E C T E D P A T I E N T P A T I E N T S C E L L S E A R L Y A L L O G R A F T I M M U N E B R O A D E R H E M O P H I L I A P R O T E C T E D C E L L S D E V E L O P M E N T A P A T I E N T S THYRO I D DI SEASE T H Y R O I D E C T O M Y P R E - C L I N I C A L T H Y R O I D C E L L S P A T I E N T S F O L L O W I N G H Y P E R T H Y R O I D I S M 7
Cell Pouch Human Clinical Evaluation
Type 1 Diabetes: 1 st Clinical Indication “ Hypoglycemia unawareness ” affects about 10% of Type 1 Diabetes patients or about 125k patients in the US • Clinically defined as a complication of diabetes in which the patient is unaware of a deep drop in blood sugar levels • Failure to trigger secretion of epinephrine a/k/a the symptoms of hypoglycemia (Palpitations, Anxiety, Excessive Sweating, Light Headedness) • Patients live in constant fear of their next diabetic episode 9
Type 1 Diabetes : 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 10
Type 1 Diabetes : First-in-Human Study 11
Chicago Phase I/II Study
Phase I/II U.S. FDA Cleared Study Safety, Tolerability and Efficacy Study of Sernova’s Cell Pouch™ for Clinical Islet Transplantation Study design: A open-label, single-arm study of Sernova Cell Pouch implanted 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 13
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 1 st Islet Dose Cell Pouch™ Transplant Implantation Day 0 Day180 Day365 90 Days 90 Days 3-4 weeks 3weeks Immunosuppression Cell Pouch Vascularization Stabilized Additional Safety Assessments 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 ™ 1. No incidences of AEs, determined to be probable or highly probable to the Cell Pouch™ 2. Cell Pouch™ well-tolerated and safe during the implant and the time of 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
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
First Patient Initial Efficacy Results 90 Day Post-Transplant PRE ISLET 3 MONTHS Glucose Tolerance Test TRANSPLANT POST TRANSPLANT Patient is given a high sugar BODYWEIGHT 83KG 73KG drink. C-peptide and insulin response is measured over HEMOGLOBIN 6.5 5.6* several hours A1C • Showed increase in blood DAILY USE OF 14 U 8U* levels of C-Peptide LONG ACTING • Showed increase in blood INSULIN TRESIBA levels of Insulin and a typical insulin response DAILY USE OF 15-16 14-15* • Conclusion: Definitive SHORT ACTING proof that the Cell Pouch INSULIN islets are surviving and SEVERE 6-9/ 3months 1/ 3months* able to respond to high HYPOGLYCEMIC levels of sugar by EVENTS releasing insulin 18 * Showed improvement with transplanted Cell Pouch
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