Improving the Quality of Life for Patients with Chronic Disease TSX-V: SVA OTCQB: SEOVF Investor Presentation 2015
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Sernova is a Canadian based, clinical stage, regenerative medicine therapeutics company 3 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 severe chronic diseases, focused on diabetes and haemophilia
Key Management 4 Dr. Philip Toleikis, PRESIDENT AND CEO Previous Angiotech Head of R&D (reached $2.0B market cap; drug/device combinations) Frank Holler, CHAIRMAN Co-Founder Angiotech & ID Biomedical ($1.6BM Exit to GSK), Xenon Pharma Ralph Deiterding, CFO 20 years financial bknd; MKS, Workbrain - $40M IPO; TSX and Nasdaq exp. Board of Directors Frank Holler Jeffrey Bacha James Parsons Bruce Weber Delfina Siroen, SR. DIRECTOR RESEARCH & DEV. >20 years academic and corporate experience; Product development, Clincal, management. U. Western Ontario, Nick Borrelly, BUSINESS DEVELOPMENT 25 years sales & marketing and corporate/business development at Ciba-Geigy/Novartis & Sanofi-Aventis
Our Therapeutic System The Total Regenerative Medicine Solution 1 2 3 Cell Pouch An implantable medical device for therapeutic cells placed under the skin Proven safety in humans Therapeutic Cells Cells that produce and release missing (or needed) proteins or hormones into the bloodstream (human donor cells, xenogeneic cells, stem cell derived cells) Proven safety & initial efficacy in humans Immune Protection Providing local immune protection of the therapeutic cells within the Cell Pouch eliminating the need for antirejection drugs Proof of concept Safety & Efficacy Cell Pouch Immune Protection Therapeutic Cells 5
Diabetes Market & Opportunity 6 The Cell Pouch delivery system offers a potential for treatments across multiple chronic diseases, primarily Diabetes (Type 1 and 2) and Haemophlia Diabetes Epidemiology Insulin therapy: 37% (9M US/34M Asia) Sernova patented countries: 25M patients) 27% 10% Diabetes side effects: heart, kidney, nerve disease, stroke, amputations, blindness 63% Type 1: Insulin Dependent (10%) Type 2: Insulin Dependent (27%) Type 3: Insulin Resistant (63%) Diabetes Healthcare Costs $174 billion: US cost of diagnosed diabetes in 2007 $116 billion for direct medical costs $58 billion for indirect costs (disability, work loss, premature mortality)
Sernova Product #1: Diabetes 7 Performs as an artificial pancreas eliminates needles, injectables, pumps Patient population: Insulin injections, insulin pumps, Edmonton Protocol 9M North America, 35-40M Worldwide Sernova product goals: Reduce hypoglycemia unawareness; reduce exogenous insulin; improve patient QOL, improve glucose control; improve longterm efficacy Development status: Phase I/II clinical POC: Interim device and cell safety results released
Sernova Product #2: Haemophilia $5B/yr Orphan indication for patients whose blood is missing a critical clotting agent 8 Patient population: Haemophilia A 20,000 NA/EU Current products: 3X weekly infusions of Factor VIII ($200k/yr) Sernova s Product: Therapeutic cells within the Cell Pouch which release Factor VIII on a constant basis Sernova product goals: Improved efficacy with prophylactic treatment; reduced cost; improved patient QOL; reduction of disease side effects Development status: Preclinical
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 without insurance $26,000 NY Times; April 5, 2014
Diabetes Treatment Overview 10 Main Problem: Outdated Treatment Methods What people are using is inadequate Insulin injections, pumps, medications, etc., or Transplant of donor islets into the portal vein Numerous limitations Inconvenient (Insulin injections 4-6x day) Constant monitoring lowers patient s quality of life Painful needles & infection prone Poor compliance serious side effects Expensive No new significant developments or permanent alternatives to treat diabetes for the last 70+ years Sernova s Goal is for the Cell Pouch to be transplanted with advanced cells such as insulin responsive stem cells, locally protected from the immune system without the need for anti-rejection drugs.
Preclinical Proof of Concept Cell Pouch Islet Transplant in Small Animals 11 (A) Severely diabetic animal. Cell Pouch & therapeutic cells transplanted. Achieve normal glucose level for 100 days and then device removed and animals return to diabetic state. (B) Positive glucose tolerance test. Meaning: Sugar injected into the bloodstream is able to be removed. The insulin released from the Cell Pouch brings sugar levels back to the normal state. Photograph of islets within the Cell Pouch after 100 days. Red = insulin, Green = blood vessels, Blue = live cells Conclusion: Proves safety & efficacy of islets within the Cell Pouch in small animals
F a s tin g B lo o d G lu c o s e (m m o l/l ) F a s tin g B lo o d G lu c o s e (m m o l/l ) Preclinical Efficacy: Cell Pouch Cell Pouch Large Animal Islet Transplant Study 12 Cell Pouch implant Pancreatectomy Diabetes induction (STZ) Islet Transplant Cell Pouch removal D ia b e tic (n = 2 ) 4-8 weeks 1 day 4-7 days 8-12 weeks 1 week Cell Pouch developed tissue chambers rich in micro-vessels for cell transplant 3 0 Sustained large animal efficacy H y p e rg ly c e m ic (n = 4 ) G ly c e m ic c o n tro l (n = 4 ) 3 0 N o n -d ia b e tic 2 5 2 0 2 5 1 5 1 0 5 2 0 0 0 1 0 2 0 3 0 4 0 D a y s P re -T x Implanted Cell Pouch chamber ready for transplant 1 5 1 0 5 C e ll P o u c h R e m o v a l 0 0 1 0 2 0 3 0 4 0 5 0 6 0 7 0 8 0 9 0 1 0 0 D a y s P o s t-t ra n s p la n t
Preclinical Efficacy: Cell Pouch 12 Weeks Post Cell Pouch and Islet Transplant Healthy Islets in the Cell Pouch (purple); Micro-vessels (red arrows) Insulin vwf Islets showing insulin (red) and supporting blood vessels (green) Insulin vwf Nuclei 13 Islets showing insulin (red) and other pancreas hormones (green) Insulin Glucagon Nuclei Insulin Somatostatin Nuclei C-peptide Nuclei Insulin Nuclei 50um 50um 50um 50um Insulin and C-peptide co-localize to the same area, therefore these images are the same section, showing co-localization of both insulin and C-peptide
Insulin Independence Proven in Diabetic Animals 14 200 islets/mouse Glucose levels rise upon Cell Pouch removal Independent 3 rd party assessment proves 95% insulin independence in diabetic animals Proven healthy islets with strong insulin staining & microvessels Efficacy using the marginal islet mass
Clinical Study: Proof of Concept 15 Phase I/II Clinical Study conducted in subjects with severe diabetes Measures of Cell Pouch and cell safety are demonstrated Islets housed within a natural tissue matrix Islets are well vascularized Safety standards were successfully met Islets show evidence of insulin, somatostatin, & glucagon No evidence of inflammatory reaction No evidence of immune destruction of transplanted islets Sernova has achieved strong preclinical confirmation of safety and efficacy and initial clinical success with human islets in brittle diabetic patients
Diabetes Value Drivers? 16 Donor islets results advance proof of concept and secures Cell Pouch as a viable technology Unlimited supply of cells could treat the current 35-40M diabetic population Sernova is focused on evaluating glucose responsive stem cell technologies Sernova is evaluating immune protected xenogeneic islets as a second source of cells Sernova is in-licensing commercial rights for appropriate technologies and securing pharma relationships Sernova is developing local immune protection technologies
Why Invest in Sernova? 17 Sernova has advanced the novel Cell Pouch technologies over the past 6 years and has a robust international patent portfolio which includes U.S. and foreign patents key to pharma licensing deals Key preclinical safety and efficacy demonstrated with islet therapy treatment with confirmatory safety human clinical data Potential for multiple licensing deals We believe Sernova is the only regenerative medicine company with a disruptive technology with multi billion dollar market potential for each of its clinical indications Experienced management w/ a track record of deals and buyouts w/ large pharma companies Multiple near term catalysts
Sernova: Potential Upside/3-12 mth Roadmap 18 deal zone ~Partnerships Time= 6mths-1y 2009-12 $0.30/share M/C>$40M Licensing seller = bio buyer = pharma M/C Range>$150M Immediate Potential 3-5x Return With Efficacy (> 10X) With Partner ($1.50-2.00) academic pre-clinical pi/ii pii piii sales Clinical Diabetes Human Trials Market Authorization Hemo - Pre-Clinical
19 Contact www.sernova.com General Inquiries 1-877-299-4603 info@sernova.com 114-700 Collip Circle London, ON N6G 4X8 Investor Relations Ray Matthews +1-604-818-7778 ray@raymatthews.ca Business Development Philip Toleikis +1-604-961-2939 info@sernova.com