Sernova Biotherapeutics Inc · TSX:SVA
Sernova Biotherapeutics — Sernova — Investor Presentation (August 2018)
23 slides from Sernova Biotherapeutics's investor presentation, August 2018
Slide 1: Improving the Quality of Life for Patients with Chronic Diseases
Improving the Quality of Life for Patients with Chronic Diseases
Slide 2: Forward Looking Statements
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 i
Slide 3: About Us
About Us Sernova Corp is a Canadian clinical stage (US FDA; Health Canada) company, developing disruptive platform technologies to treat chronic diseases through a regenerative medicine approach. Sernova’s primary focus is in developing technologies for the treatment of patients with insulin-depende
Slide 4: What is regenerative medicine
What is regenerative medicine Regenerative medicine is a new and valuable treatment option for more and more acute and chronic clinical conditions. Using different types of regenerative medicine, it is possible to significantly improve certain chronic conditions. It is even possible to cure certain
Slide 5: Diabetes
Diabetes Multi-billion dollar markets Only regenerative medicine company with a disruptive technology with multi- billion dollar market potential for each of its clinical indications (Diabetes >50M Patients, Hemophilia Orphan Indication ($8-15B Market))
Slide 6: The Total Regenerative Medicine Solution
The Total Regenerative Medicine Solution 1 Cell Pouch™ An implantable medical device for therapeutic cells placed subcutaneously under the skin ➔ Proven safety in humans Cell Therapeutic Therapeutic Cells Pouch™ Cells 2 Cells that produce and release missing (or needed) proteins or hormones into the
Slide 7: Value Proposition
Value Proposition • Multi-billion dollar markets • Technology: Next Generation Regenerative Medicine Platform • Diabetes Human Clinical Results and FDA Cleared Trial • Hemophilia A Program • Key to Pharma And Medtech Licensing • Management • Multiple near term valuation driver
Slide 8: Therapeutic Pipeline
Therapeutic Pipeline Cell Pouch Product Disease Treatment Patient Population Development Stage Human Donor Islets, Diabetes Hypoglycemia unaware patients Phase I/II Clinical Systemic immune (anticipated 1st diabetes product approval) protection Microencapsulated Diabetes All insulin dependent diabet
Slide 9: Management Team
Management Team Experienced management w/ a track record of deals w/ large pharma companies Dr. Philip Toleikis, PRESIDENT AND CEO >20 years experience. Joined Sernova 2009. Previous Angiotech VP R&D Board of Directors (reached $2.0B market cap; drug/device combination products). • Frank Holler • Je
Slide 10: International Patent Protection
International Patent Protection The Key to Pharma Licensing deals International (North/South American, Europe, Asia) patents and patent applications portfolio in 10 patent families: • Composition and use of medical devices for delivery and cell transplantation • Glucose responsive insulin secreting
Slide 11: Product Manufacture
Product Manufacture Cell Pouch™ is Contract Manufactured to the Highest Regulatory Standards Manufacture of the Cell Pouch™ is conducted GMP by a contract manufacturer in a Class VII Clean Room Product and process development is conducted in accordance with manufacturer’s Quality System • ISO 13485:
Slide 12: Therapeutic Programs
Therapeutic Programs Established Diabetes and Hemophilia Programs Sernova’s Regulatory Support: A multi-thousand page regulatory package supports clinical development in Canada and US • Diabetes • Completed Canadian first in human safety study of Cell Pouch and therapeutic cells for diabetes • Curre
Slide 13: First-In-Human Study in Diabetic Subjects with Hypoglycemia Unawareness
First-In-Human Study in Diabetic Subjects with Hypoglycemia Unawareness Health Canada issued an Investigational Testing Authorization (ITA) for the Cell Pouch™, a Class III medical device and a Clinical Trial Application (CTA) for the donor islets Study Design • Patients with diabetes and hypoglycem
Slide 14: Clinical Evaluation: First in Human
Clinical Evaluation: First in Human Outcomes • Patients treated with Cell Pouch™ and then donor islets • Cell Pouches explanted up to 6 weeks post transplant followed by independent analysis of transplanted cells • One patient with Cell Pouch™ and cells implanted over 3.5 years Cell Pouch and islet
Slide 15: New FDA Cleared Clinical Study
New FDA Cleared Clinical Study US Safety Tolerability and Efficacy Study of Cell Pouch™ for Clinical Islet Transplantation Study design: A U.S. prospective, single-arm study of Sernova Cell Pouch™ islets implanted subcutaneously. Islets will be transplanted into the Cell Pouch after Cell Pouch impla
Slide 16: Treating All Insulin-Dependent Patients Therapeutic Solution for Diabetes
Treating All Insulin-Dependent Patients Therapeutic Solution for Diabetes Therapeutic Product • Cell Pouch with microencapsulated stem cell derived technology • Worldwide exclusive rights to Nostro/Keller diabetes stem cell technology • Collaborations with pharma/medtech (Potential M&A) Treatment Po
Slide 17: Hemophilia – A Multibillion Dollar Orphan Status Indication
Hemophilia – A Multibillion Dollar Orphan Status Indication Sernova is developing two products for hemophilia A that could change the course of treatment for patients suffering with hemophilia Disease • Patients are missing a key blood clotting factor (Factor VIII) and must take infusions Issues wit
Slide 18: Hemophilia – A Multibillion Dollar Orphan Status Indication
Hemophilia – A Multibillion Dollar Orphan Status Indication Goal of Sernova’s Cell Pouch with Factor VIII releasing cells: • Reduce/eliminate Factor VIII infusions • Maintain higher blood levels of Factor VIII • Reduce joint bleeds • Improve long-term efficacy • Improve QOL
Slide 19: Achieving a Complete Therapeutic Solution for Hemophilia
Achieving a Complete Therapeutic Solution for Hemophilia Patient Population • Hemophilia A ≈ 20,000 NA/EU ($8-15B Orphan Indication) Hemophilia Therapy • Factor VIII Gene corrected cells within Cell Pouch – produce constant therapeutic Factor VIII levels Therapeutic Goals: • Improved efficacy with p
Slide 20: Healthcare Transaction Strategy
Healthcare Transaction Strategy Our goals: • Pharma/Medtech partnerships for development of Sernova platform technologies for diabetes and hemophilia and for marketing and distribution of its products • Partnerships may involve non-dilutive funding for R&D, an upfront technology development payment,
Slide 21: Transactions in the Industry
Transactions in the Industry • Semma • Series B Financing for $114M • Based on their annual report, about 30M shares issued. $3.80 a share • With approximately 70M shares outstanding Preferred and Common, market cap of $266M
Slide 22: Sernova’s Collaborative Team
Sernova’s Collaborative Team Page 37
Slide 23: Contact
Contact Investor Relations President and CEO Ray Matthews Dr. Philip Toleikis +1-604-818-7778 +1-604-961-2939 [email protected] [email protected]