Sernova Corp.
Sernova Corp is a clinical-stage biotechnology company developing regenerative therapeutic technologies to deliver a ‘functional cure’ for chronic diseases, including insulin-dependent diabetes, thyroid disease and rare diseases like hemophilia A. Sernova has developed the Cell-Pouch SystemTM, an implantable, scalable, and retrievable medical device which forms a natural environment in the body for long-term survival and function of immune-protected therapeutic cells that release necessary, but missing proteins or factors to treat chronic diseases. Sernova and Evotec recently entered into an option and licensing partnership to develop an implantable off-the-shelf iPSC-based beta cell replacement therapy to provide Sernova an unlimited supply of insulin-producing cells for potentially millions of patients with insulin-dependent diabetes. Sernova is also advancing benign thyroid disease and hemophilia A into the clinic. Sernova owns a technology licensed from the University of Miami to cloak cells, potentially eliminating the need for immunosuppressives to protect cells from immune system attack.
TSX: SVA, OTCQB: SEOVF
IR Website: https://www.sernova.com/investor/
Headquarters: London, Canada
Content provided by Sernova Corp on 10-2-22.
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Summary
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Sernova is developing regenerative medicine therapeutic solutions using a medical device (Cell Pouch) and immune protected therapeutic cells / tissues (i.e. human donor cells, corrected human cells and stem cell-derived cells) to improve the treatment and quality of life of people with chronic metabolic diseases such as insulin-dependent diabetes, blood disorders including hemophilia, and other diseases treated through cellular production of proteins or hormones missing or in short supply within the body.
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Sernova’s most advanced program is to come up with a functional cure for all T1D patients; this includes The Cell Pouch as a delivery mechanism; highly ethical IPSC stem cells to deliver insulin function and immune protection via our proprietary conformal coating technology. With these three components we are able to provide a complete regenerative solution, which relative to our competitors, we think this is the best technology platform in the world for T1D.
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The Cell Pouch is a key component of our technology platform. By inserting it in the body prior to filling it with cells, it creates a vascularized organ-like environment into which we can insert therapeutic cells and have them very quickly connect to the blood stream. Most importantly we have experienced no serious adverse events related to the pouch or our cells and believe the Cell Pouch System is a safer alternative than competing clinical-stage devices while better controlling T1D symptoms and pathology.
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In our ongoing phase 1/2 clinical trial at the University of Chicago we have a 7 patient study well underway. Currently the first two patients have completed the required steps and after suffering through most of their lives with Hypoglycemia Unawareness, which is the most severe type of T1D patient, they are now 100% insulin free for 23 and 4 months respectively. We believe Sernova is the only company in the world to accomplish this feat.
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While T1D is our most advanced product line, we know that the Cell Pouch can treat multiple human afflictions by delivering a missing hormone or gene into the human body. To that end, we are also moving ahead with separate clinical programs for both Hemophilia A and thyroid disease which we expect to get to trial later this year.
Recent News
Sernova to Participate in the Roth Inaugural Healthcare Opportunities Conference
Sept 28, 2022
Sernova Announces Full Exercise of Share Purchase Warrants Expiring September 22, 2022
Sept 22, 2022
Sernova to Present at H.C. Wainwright Annual Global Investment Conference and LifeSci Partners HealthTech Symposium
Sept 8, 2022
Sernova Announces the Appointment of Daniel Mahony, Ph.D. to its Board of Directors
Sept 7, 2022
Sernova Receives Second Tranche Equity Investment from Evotec of $6.8 Million at a Price of $2.50 Per Share
Sept 1, 2022
Management Overview
Phillip M. Tolekis, BA, MSc, PhD
Chief Executive Officer and President
Dr. Toleikis is President and Chief Executive Officer of Sernova Corp since April 2009. From 2006 until 2009, Dr. Toleikis consulted for multiple device, combination product and pharmaceutical companies. From 1996 to 2006 he held multiple roles at Angiotech Pharmaceuticals, Inc. including Vice President, Research and Development – Pharmacology and Drug Screening where he built a product development team of over 50 scientists and was responsible for multiple corporate and academic product development collaborations. While at Sernova, Dr. Toleikis has secured over $60 million in various forms of financings, including equity raises and multiple non-dilutive grants and has been responsible for negotiating a worldwide exclusive license with UHN and University of Miami for its stem cell derived technologies as well as developing business relationships and or collaborations with multiple pharmaceutical and academic institutions involving its Cell Pouch™ device and cell technologies.
Dr. Toleikis is an author of over 100 patent applications ande issued patents, and multiple scientific publications involving transplantation, metabolic, cardiovascular, oncology, and autoimmune disease. He obtained his Ph.D. in Medicine, Pharmacology and Therapeutics from the University of British Columbia, his M.Sc. at the University of Michigan and B.A. at the University of Vermont.
David Swetlow
Chief Financial Officer
David is a high tech and life sciences/biotech veteran with over 20 years in various senior management, board & advisory roles predominantly for start-up, acceleration, and high growth stage companies, including multiple companies listed on the TSX and Nasdaq such as QLT Inc., Protox Therapeutics Inc., and Xillix Technologies. David’s life sciences/biotech experience includes biopharmaceutical, medical device, and drug/device combination technologies and products.
David holds a Bachelor of Business Administration degree from Simon Fraser University (SFU) and obtained his CA designation while at Deloitte. Entrepreneurial in nature, David has also started and run a few businesses of his own during his career.
Furthering his personal mission of supporting science and stimulating technology innovation, David served on the Board of Directors for the Saskatchewan Science Center and was a member of its Finance, Audit & Risk Committee from 2018 to 2021. Previously David also served on the council of CMC-Saskatchewan, the provincial institute of CMC-Canada (the Canadian Association of Management Consultants), as Public Representative appointed and re-appointed for three-year terms by the Brad Wall led provincial government.
David was also previously a co-founding Director of TSX Venture company OMNItech Capital Corp. and served as Director and Audit Committee Chairman for successor companies One Person Health Sciences Inc and HealthPricer Interactive Ltd.
As an active sports and outdoor enthusiast, David enjoys playing hockey, golf, skiing and outdoor-oriented activities. In the past, David also coached several boys and co-ed soccer teams and served in various executive capacities running a community-based soccer club.
Frank Shannon
Vice President of Clinical & Regulatory
Mr. Shannon has a track record of more than 25 years of proven experience in clinical development and regulatory affairs. He has served in senior level positions within the international medical device, pharmaceutical, and biologic industries where he achieved commercial goals through innovative risk management and execution strategies, to obtain marketing approval of products.
Mr. Shannon most recently served as VP Clinical Development, Regulatory Affairs and Quality at Ripple Therapeutics, a spin-out of Interface Biologics where he served in the same capacity since 2016. Prior to these appointments, he held various senior clinical/regulatory positions at Baxter International, St. Jude Medical, Boehringer-Ingelheim, Hoffmann-La Roche/Roche Laboratories, Inc., Genentech Canada, Inc., and Ciba-Geigy Canada, Ltd.
Chris Barnes
Vice President of Investor Relations
Chris has worked in financial services for 23 years, first as an investor relations consultant, then as the investor relations officer for Extendicare Inc., a large North American nursing home company listed on both the TSX and NYSE. Subsequently Chris moved directly into capital markets as an IIROC registered institutional sales person with three Toronto based investment boutiques, including Fraser Mackenzie, Octagon Capital and Pace Securities covering accounts in Canada, the United States and Europe. Chris holds a bachelor’s degree in English and Political Science from Laurentian University plus he completed the Richard Ivey School of Business at University of Western Ontario, Strategic Investor Relations diploma.
Chris enjoys golf, competitive swimming, baseball and hockey.
Risks & Disclosures
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