Cardiol Therapeutics Announces Completion of Manufacturing Scale-up for Commercialization of CardiolRx™100
Press Release – Oakville, Ontario, October 1, 2019
Cardiol Therapeutics Inc. (TSX: CRDL; OTCQX: CRTPF) (“Cardiol” or the “Company”), a leader in the production of pharmaceutical CBD products and in the development of innovative CBD medicines for heart disease, announces that it has completed the manufacturing scale-up for commercialization of its CardiolRx™100 CBD formulation.
CardiolRx 100 (100 mg/mL CBD with 3,000 mg of CBD per bottle) is designed to be the safest and most consistent high concentration CBD formulation available to Canadians that is THC free (<10ppm). It is pharmaceutically produced in a Health Canada approved, FDA registered, and cGMP facility. Cardiol is also developing additional CBD products for medical use that may be suitable options when a lesser strength CBD is necessary, including formulations that contain 50 mg/mL and 25 mg/mL CBD.
“We are dedicated to producing THC free CBD products for medical use that meet the highest standards for purity, consistency, and manufacturing,” said David Elsley, President and CEO of Cardiol Therapeutics. “Completion of the manufacturing scale-up of our CardiolRx 100 product is an important milestone supporting this objective and serves to establish our path to commercial introduction.”
Cardiol plans to commercialize CardiolRx 100 in the $1.2 billion-dollar market for medicinal cannabinoids in Canada during Q4 2019 and is pursuing market introduction opportunities in Europe and Latin America. CardiolRx 100 will initially be made available to Canadians for medical use in compliance with the Cannabis Regulations. High concentration CBD has been approved for use in certain types of epilepsy in both the U.S. and Europe and has been prescribed by physicians in Canada for use in conditions such as epilepsy, pain management, anxiety and depression. Chronic pain affects the quality of life of one in five Canadians and is the most common reason individuals seek healthcare. In addition, approximately 3.5 million Canadians annually access healthcare for mood or anxiety disorders, conditions that are generally poorly treated.
Based on the large body of experimental evidence of the powerful anti-inflammatory activity of CBD in models of cardiovascular disease, the Company is also planning an international clinical trial in acute myocarditis (inflammation of the heart muscle) utilizing CardiolRx 100. This study is being designed by renowned cardiologists from Canada, the U.S., and Europe and provides a unique opportunity to build brand awareness in support of the commercial launch of CardiolRx 100.
About Cardiol Therapeutics
Cardiol Therapeutics Inc. (TSX: CRDL; OTCQX: CRTPF) is focused on producing pharmaceutical CBD products and developing innovative therapies for heart disease, including acute myocarditis and other causes of heart failure. The Company’s lead product, CardiolRx™, is designed to be one of the safest and most consistent CBD formulation on the market. CardiolRx is pharmaceutically produced, cGMP certified, and is THC free. The Company plans to commercialize CardiolRx during Q4 2019 in the billion-dollar market for medicinal cannabinoids in Canada and is also pursuing distribution opportunities in Europe and Latin America.
In heart failure, 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. The Company is also developing proprietary nanotechnology to uniquely deliver pharmaceutical CBD and other anti-inflammatory drugs directly to sites of inflammation in the heart that are associated with 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. For further information about Cardiol Therapeutics, please visit crdl.starnix.com.
Cautionary statement regarding forward-looking information:
This news release contains “forward-looking information” within the meaning of applicable Canadian securities laws. All statements, other than statements of historical fact, that address activities, events or developments that Cardiol Therapeutics Inc. (“Cardiol”) believes, expects or anticipates will, may, could or might occur in the future are “forward- looking information”. Forward-looking information is frequently identified by the use of words such as “plans”, “expects”, “projects”, “intends”, “believes”, “anticipates”, “forecasts”, and other similar words and phrases, including variations (and negative variations) of such words and phrases, or may be identified by statements to the effect that certain actions, events or conditions “may”, “could”, “should”, “would”, or “will” be taken, occur or be achieved. Forward-looking information contained herein may include, but is not limited to, statements with respect to: future events; the future performance or the intended business strategy of Cardiol, including, but not limited to, the plan to commercialize CardiolRx 100 during Q4 2019 and the planning of an international clinical study of CardiolRx in acute myocarditis; the potential for Cardiol’s licensed drug encapsulation and delivery technologies to enhance the bioavailability of pharmaceuticals; management’s expectations regarding estimated future pharmaceutical research and development opportunities, collaborations and prospects; the success and proposed timing of Cardiol’s product development activities; the ability of Cardiol to develop its product candidates; Cardiol’s plans to research, discover, evaluate and develop additional products; Cardiol’s proposed future collaborations to advance Cardiol’s lead nanoformulations into clinical development; and the potential for Cardiol’s cannabinoid-based products to provide sources of future revenue. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information. These risks and uncertainties and other factors include that the success of Cardiol’s product candidates will require significant capital resources and years of clinical development efforts; the results of clinical testing and trial activities of Cardiol’s products; Cardiol’s ability to obtain regulatory approval and market acceptance of its products; Cardiol’s ability to raise capital and the availability of future financing; Cardiol’s lack of operating history; unforeseeable deficiencies in the development of Cardiol’s product candidates; uncertainties relating to the availability and costs of financing needed in the future for Cardiol’s research and development initiatives; Cardiol’s ability to manage its research, development, growth and operating expenses; the potential failure of clinical trials to demonstrate acceptable levels of safety and efficacy of Cardiol’s product candidates; Cardiol’s ability to retain key management and other personnel; risks related to fluctuations in medicinal cannabinoid markets in Canada and worldwide; uncertainties regarding Cardiol’s ongoing collaborative and manufacturing partnerships; uncertainties regarding results of researching and developing products for human use; Cardiol competes in a highly competitive and evolving industry; Cardiol’s ability to obtain and maintain current and future intellectual property protection; and other risks and uncertainties and factors. These risks, uncertainties and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information. Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events or results or otherwise. Although Cardiol believes that the expectations reflected in the forward-looking information are reasonable, they do involve certain assumptions, risks, and uncertainties and are not (and should not be considered to be) guarantees of future performance. It is important that each person reviewing this news release understands the significant risks attendant to the operations of Cardiol.