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TSX:CRDL OTCQX:CRTPF

Cardiol Therapeutics

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Market:
TSX
Market Cap:
$132.23 m
Price
4.03 CAD
Change
2.81%
52 weeks high
5.32
52 weeks low
1.87

Cardiol is focused on producing pharmaceutical cannabidiol (“CBD”) products and developing innovative therapies for heart disease, including acute myocarditis and other causes of heart failure. Cardiol brings together a wealth of research and development experience, advanced manufacturing capabilities, and a management team, Board of Directors, and Scientific Advisory Board comprising business and thought leaders with extensive industry experience and expertise in commercializing proprietary drugs.

Cardiol is leveraging its expertise in pharmaceutical cannabinoids to develop proprietary formulations for commercial development in two important medical markets: commercializing a line of pharmaceutical cannabidiol products in the growing market for medical cannabinoids and developing nanotechnologies designed to deliver cannabinoids and other anti-inflammatory drugs to the heart for the treatment of inflammatory heart disease.

Pharmaceutically-produced Cannabidiol – Designed to be THC-Free (<10ppm)

Cardiol’s lead product, CardiolRxTM, is designed to be the safest and most consistent cannabidiol formulation on the market. CardiolRx is pharmaceutically produced, cGMP certified, and is THC free (<10 ppm). Cardiol plans to commercialize CardiolRx in the billion-dollar market for medicinal cannabinoids in Canada and we will be pursuing market introduction opportunities in Europe and Latin America.

Cardiol has established an exclusive manufacturing arrangement with Dalton Pharma Services, a Health Canada-approved, U.S. Food and Drug Administration (“FDA”) registered, Current Good Manufacturing Practice (“cGMP”) manufacturer of pharmaceuticals, including cannabinoids, for supplying finished pharmaceutically-produced cannabidiol products to support the Company’s research and commercial development programs. Cardiol also has an exclusive supply agreement with Noramco, Inc. (“Noramco”) to support Dalton’s manufacturing program with large-scale supply of pure pharmaceutical cannabidiol.

Research & Development

Cardiol is planning an international clinical study of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age and is a common cause of acute heart failure.

Based on the large body of experimental evidence of the anti-inflammatory and cardioprotective properties of cannabidiol in models of cardiovascular disease, Cardiol believes there is an opportunity to develop a potential breakthrough therapy for acute myocarditis that would be eligible for designation as an orphan drug. In the United States, an orphan drug designation is granted for pharmaceuticals being developed to treat medical conditions affecting fewer than 200,000 people. These conditions are referred to as orphan diseases. In the U.S. and the European Union, orphan drugs are eligible for accelerated marketing approvals and companies developing orphan drugs typically receive other incentives, including a prolonged period of market exclusivity that can extend over seven years, during which the drug developer has sole rights to market the drug.

The Company is also developing proprietary nanotechnology to deliver pharmaceutical cannabidiol and other anti-inflammatory drugs directly to sites of inflammation in the heart that are associated with the development and progression of heart failure. Heart failure is the leading cause of death and hospitalization in North America with associated healthcare costs in the U.S. alone exceeding $30 billion.

The Company has research programs focused on developing nanotherapeutics to treat heart failure underway at international centers of excellence, including the University of Alberta, the Houston Methodist DeBakey Heart & Vascular Center, and TecSalud del Tecnológico de Monterrey (“TecSalud”).

David Elsley, MBA

President and Chief Executive Officer

Mr. David Elsley is a business leader with a proven track record of developing, financing and managing all aspects of corporate development in biotechnology and high-growth organizations.

In 1990, Mr. Elsley founded Vasogen Inc., a biotechnology company focused on the research and commercial development of novel therapeutics for the treatment of heart failure and other inflammatory conditions. Mr. Elsley assembled a team of management, directors and scientific advisors comprising industry professionals and thought leaders from North America and Europe.

Mr. Elsley managed and directed Vasogen’s growth from start-up to an organization employing over 250 people with operations and R&D programs in Canada, the United States and Europe. He established the research and development infrastructure, partnerships, manufacturing capability, and corporate quality systems necessary to advance two anti-inflammatory therapies from concept to completion of international multi-center pivotal phase III clinical trials involving 2,500 patients. Vasogen went public on the TSX and the Nasdaq, raising over $200 million to support corporate development and reached a market capitalization of over US$ 1 billion.

Mr. Elsley holds a Master of Business Administration from the Richard Ivey School of Business, University of Western Ontario.

Eldon R. Smith, OC, LLD (Hon), MD, FCAHS, FCCS, FRCPC

Chief Medical Officer

Dr. Eldon R. Smith received his medical degree cum laude from Dalhousie University. Following Internal Medicine and Cardiology training in Canada, UK, and the USA, Dr Smith joined the Faculty at Dalhousie in 1973. In 1980, he became Head of Cardiology at the University of Calgary and the Foothills Hospital in Calgary; subsequently, he became Chairman of Medicine, then Associate Dean for Clinical Affairs and from 1992 to 1997, he was Dean of Medicine. From 1997 to 2010, he was Editor-in-Chief of the Canadian Journal of Cardiology.

Dr. Smith has published more than 250 papers and has contributed to many organizations; he has been President of the Canadian Cardiovascular Society (CCS) and the Association of Canadian Medical Colleges. He has served on several public boards including the Alberta Heritage Foundation for Medical Research and the Health Professions Advisory Board and has been a member of the Premier’s Advisory Council on Health. He founded and directed the Peter Lougheed Medical Research Foundation and currently chairs the Board of the Libin Cardiovascular Institute in Calgary. In 2006, the Federal government appointed him to Chair the Steering Committee for the Canadian Heart Health Strategy. In 2010, he was appointed to the Board of Alberta Health Services and served until June 2013.

Dr. Smith has received many awards including: the Young Investigator and Achievement awards of the Canadian Cardiovascular Society, the Keon Award from the University of Ottawa, the 125th anniversary of Canada commemorative medal, alumnus of the year at Dalhousie, the AsTECH award from the province of Alberta, Order of the University of Calgary, the Graham Medal from the Royal College, and the Medal of Service from the Canadian Medical Association.

In 2005, Dr. Smith became an Officer of the Order of Canada. In 2013, the City of Calgary awarded him the Lifetime Achievement Award, and in 2014, he received an Honorary Doctorate of Laws Degree from Dalhousie University.

Over the past 20 years, Dr Smith has been a Director of more than ten public companies—mostly in the biotech sector. He has also been Chairman of two companies and Lead Director for two others. At present, he is a Director of Resverlogix Corp, and Zenith Capital Corp.

Chris Waddick, MBA, CPA, CMA

Chief Financial Officer

Mr. Chris Waddick has thirty years of experience in financial and executive roles in the biotechnology and energy industries, with substantial knowledge of public company management and corporate governance, and in designing, building, and managing financial processes, procedures, and infrastructure. Mr. Waddick most recently served as Executive Vice President and Chief Financial Officer for a private Ontario energy company where he was retained by the shareholders to refinance the company and establish a new strategic direction, as well as the appropriate financial infrastructure. During his tenure, he implemented two corporate restructurings, drove substantial earnings growth, and significantly reduced both cost of capital and debt levels.

Mr. Waddick spent more than twelve years at Vasogen Inc., a biotechnology company focused on the research and commercial development of novel therapeutics for the treatment of heart failure and other inflammatory conditions. While serving as Chief Financial Officer and Chief Operating Officer, the company grew from start-up to an organization employing over 250 employees that established the necessary systems and infrastructure to advance an anti-inflammatory therapy through to the completion of an international multi-center pivotal trial involving 2,500 patients. Vasogen went public on the TSX and the NASDAQ, raising over $200 million to support corporate development and reached a market capitalization of over US$ 1 billion. Prior to Vasogen, he held progressively senior financial positions at Magna International Inc. and Union Gas Limited.

Mr. Waddick is a CPA, CMA and earned a business degree from Wilfrid Laurier University and a Master of Business Administration from York University.

Thomas Moffatt, BBA

Chief Commercial Officer

Mr. Thomas (Tom) Moffatt is a senior operations and retailing executive with an extensive background in corporate mergers and acquisitions, franchise, corporate retail and consulting, particularly in the pharmaceutical environment.

Mr. Moffatt gained extensive experience in franchise and corporate retailing during his tenure of more than 20 years at Shoppers Drug Mart, where he honed his analytical skills, specifically in the area of finance, marketing, communications, P&L, merchandising, and corporate strategy. He rose through the ranks from Director Operations Ontario West, to National Vice-President Operations and Strategy where he was charged with the repositioning of Shoppers Drug Mart in the Canadian market.

Following his wide-ranging career at Shoppers Drug Mart, Tom joined World Vintners Inc. where he was Senior Vice-President Retail and Corporate Development, Corporate Secretary, and President Retail. From 2010 to 2015, he was Senior Director of Mergers and Acquisitions/Pharmacy Operations at Loblaw Companies Ltd. and participated in the successful acquisition of Shoppers Drug Mart. Prior to the Shoppers Drug Mart acquisition by Loblaw, he headed the analysis, negotiation, acquisition and integration of the Zellers Pharmacy unit into the Loblaw pharmacy group.

Mr. Moffatt was most recently the Chief Operating Officer and Vice President Operations at Rx Drug Mart Inc., where he was responsible for the growth, marketing, and development of all operations for more than 45 stores, including marketing, personnel, and strategic activities.

Tom graduated from the Humber Institute of Technology and Applied Learning with a Bachelor of Business Administration and has completed the Executive Development Program at York University’s Schulich School of Business.

Anthony E. Bolton, BSc, PhD, DSc

Director of Research

Dr. Bolton graduated from the University of London (BSc) in 1967, and from the University of Reading (PhD) in 1970. He was awarded the degree of DSc by the University of Reading and was elected to Fellowship of the Royal College of Pathologists (FRCPath) in 1990.

Dr. Bolton’s academic career included positions with the Medical Research Council in Edinburgh (1970-76; tenured member of scientific staff), St. Bartholomew’s Hospital, London (1976-79; Deputy Director, Immunoassay Research Unit) and the University of East London (1979-85; Reader in Biochemistry).

He was appointed Head of Department and Professor of Biomedical Sciences at Sheffield Hallam University (1985-92) and Scientific Director, Biomedical Research Unit, Jessop Hospital for Women, Sheffield (1992-95). His areas of research focus include diagnostics, reproductive physiology, infertility, and immunology/inflammation.

Dr. Bolton was co-founder and VP Research, Intermune Life Sciences Inc, Toronto (1992-1995), a biotech company developing technologies in human infertility, and was co-founder, Director of Research, and ultimately CSO, Vasogen Inc (1992-2008), a company investigating novel anti-inflammatory therapeutic approaches to cardiovascular disease.

Dr. Bolton has published over 100 research papers and is named inventor on 15 issued patents.

Andrea B. Parker, MSc, PhD

Director of Clinical Affairs

Dr. Parker is a senior executive with more than 30 years of experience in the execution of Phase I-IV research programs in the biomedical and medical device sectors. She was involved in the organization and execution of many large-scale international clinical trials, specializing in cardiovascular disease, pain management, and imaging techniques. She worked in academic settings, as well as for Contract Research Organisations and for Industry.

Prior to joining Cardiol Therapeutics Inc., she was Chief Scientific Officer at the Peter Munk Cardiac Centre, University Health Network in Toronto, where she provided scientific support for industry-sponsored and investigator-initiated trials, including clinical team and committee management, budget allocation, and grant writing support (2010 – 2019).

Dr. Parker also served as Vice President, Clinical Development for Fralex Therapeutic Inc., a medical device company in the therapeutic area of pain management.

She held the position Director, Clinical Affairs at Vasogen Inc., where she was responsible for the execution of two pivotal trials, involving more than 200 sites in the U.S., Canada, and Europe.

Prior to Vasogen Inc., Dr. Parker was the Managing Director of the offices in Boston and in Toronto for a Contract Research Organization (Société de la Recherche Cardiologique) based in Switzerland. She was responsible for day-to-day management of the company, as well as setting strategic directions for all clinical affairs services. This included building infrastructure and framework to further expand the company’s projects, as well as overseeing staff.

Dr. Parker graduated with a Master of Science degree in Chemistry from the University of Leipzig (Germany); she holds a MSc in Clinical Epidemiology from Harvard School of Public Health and a PhD in Medical Sciences from the University of Toronto.

Anne Tomalin, BA, BSc, RAC

Director of Regulatory Affairs

Ms. Anne Tomalin is the founder and currently Executive Director at TPIreg, a division of Innomar Strategies Inc. She has a strong background in business, government, regulations, and reimbursement policies and has practiced exclusively in regulatory affairs since 1971. In September 1996, Ms. Tomalin founded CanReg Inc. which became Canada’s largest Regulatory Affairs consulting firm with more than 100 staff, assisting clients with Health Canada, FDA, and EMA matters, before being acquired by OptumInsight in December 2009. Prior to this, she was employed by Searle Canada for 20 years as Business Unit Director.

Ms. Tomalin has participated in the Regulatory Initiatives Advisory Committee for the Pharmaceutical Manufacturers Association Canada (PMAC). She has also served on the executive of the Pharmaceutical Sciences Group (PSG) and the Canadian Association of Pharmaceutical Regulatory Affairs (CAPRA). Ms. Tomalin currently sits on the Advisory Board for CAPRA in Canada and has also chaired the Manitoba, Saskatchewan, and Ontario Committees for the PMAC, now Innovative Medicines Canada (IMC). She is engaged in teaching several regulatory courses to industry, has been an instructor at Humber College, and currently serves on their Advisory Panel. She has published numerous papers on regulatory affairs and issues.

Ms. Tomalin is a graduate of York University with a BA in English and BSc in Chemistry and holds certifications from the Regulatory Affairs Professional Society in US, European, and Canadian Regulatory Affairs.

Blagoja Ristevski, BSc, CHE

Director of Chemical Engineering and Manufacturing

Mr. Blagoja Ristevski graduated with a BSc in Chemical Engineering and Inorganic Chemistry from the University of Ss ‘Cyril and Methodius’, Skopje, Macedonia, and pursued postgraduate research on natural biopolymers as drug carriers at King’s College London, UK. For 20 years he was involved in the research and discovery of active drug molecules, drug delivery technologies, and manufacturing methodologies for finished drug products at several biopharmaceutical companies.

Mr. Ristevski has over 25 years of senior executive level experience in the Canadian pharmaceutical and biotechnology industry including positions with Astra, Hyal Pharmaceuticals, Delex Therapeutics (now part of Gilead), and the Advanced Medical Research Institute of Canada where he was  VP of product development. He has a track record of success in licensing new products with multiple successful IND and NDA applications, including for Solaraze gel. He has an extensive network across the North American biopharmaceutical industry and is experienced in the assessment and development of therapeutic, diagnostic, and medical device products. In 2009, he founded Remetar Inc., a company involved in licensing early-stage pharmaceutical projects which have included a therapeutic for the regulation of intraocular pressure and a project focusing on regulating low-grade inflammation by targeting inflammatory cytokine receptors.

Dolly Kao, BSc, JD

Intellectual Property Counsel

Ms. Dolly Kao is an intellectual property lawyer, a registered patent agent, and a registered trademark agent with over 20 years of experience gained at several leading IP firms in Toronto, Canada. She graduated with distinction from the University of Toronto with a Bachelor of Science in Nutritional Sciences in 1991.  After earning a Juris Doctor degree from University of Toronto’s Faculty of Law in 1994, she was called to the bar of Ontario in 1996.

In 1998, she became a registered Canadian and United States Patent and Trademark agent and has been practising exclusively in intellectual property (IP) for clients primarily in the chemical, pharmaceutical, and biotech industries. Ms. Kao is well versed with Canada’s Patented Medicines (Notice of Compliance) Regulations, which provide an avenue for innovative drug companies to gain time-limited freedom from generic competition by listing patents on the Patent Register maintained by the Minister of Health. She has been managing large IP portfolios and is an expert in all areas of patents and trademarks, including providing a wide range of searches and opinions, drafting and filing applications and prosecuting them through to allowance, blocking grant of third-party patent and trademark applications, and participating in post-grant proceedings.

Ms. Kao currently serves as Co-chair of the Newsletter Committee of the Chemical Patent Practice Committee of the American Intellectual Property Law Association (AIPLA). She has lectured on patent law at the University of Western Ontario’s Faculty of Law, served on the Bank of Speakers on behalf of the Canadian Intellectual Property Office, as well as on Canada’s Patent Agent Examination Board, and spoken on the Patent Law Treaty on behalf of the Canadian Institute.

Cardiol Therapeutics Inc.

Phone: 289.910.0850

Email: info@cardiolrx.com

Cardiol Therapeutics Inc.
2265 Upper Middle Road East, Suite 602
Oakville, ON L6H 0G5