Cardiol Therapeutics: First-Mover In CBD-Based Treatment For Heart Disease

seekingalpha08-22

Cardiol Therapeutics is focused on anti-inflammatory therapies for heart disease, with the lead drug CardiolRx undergoing clinical trials for Pericarditis and Myocarditis.The company's pipeline ...

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Disease\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-08-22 20:58 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://seekingalpha.com/article/4716416-cardiol-therapeutics-first-mover-in-cbd-based-treatment-for-heart-disease><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Cardiol Therapeutics is focused on anti-inflammatory therapies for heart disease, with the lead drug CardiolRx undergoing clinical trials for Pericarditis and Myocarditis.The company's pipeline ...</p>\n\n<a href=\"https://seekingalpha.com/article/4716416-cardiol-therapeutics-first-mover-in-cbd-based-treatment-for-heart-disease\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU1883839398.USD","symbol_name":"AMUNDI FUNDS INCOME OPPORTUNITIES \"A2\" (USD) 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HYWARDS/iStock via Getty Images Cardiol Therapeutics (NASDAQ:CRDL)(CRDL.CA) is a clinical-stage life sciences company focused on anti-inflammatory therapies for heart disease. The company's lead drug, CardiolRx™, is undergoing clinical trials for treating Pericarditis and Myocarditis. It is a THC-free (<10 ppm) pharmaceutically produced ultra-pure, high-concentration cannabidiol oral formulation that is manufactured under Good Marketing Practice. My investment thesis is that the shares are undervalued based on the company's pipeline, which includes a potential blockbuster drug for treating unmet medical needs. Pericarditis Pericarditis is inflammation of the pericardium, the tissue surrounding the heart. The inflammation causes irritation and results in sharp chest pain as the irritated layers of the pericardium rub together. Recurrent Pericarditis is the reappearance of these symptoms weeks following the initial episode. Up to 30% of patients experience recurrent pericarditis, and half of those experience multiple recurrences. About 40K people in the U.S. suffer from Pericarditis, accounting for 5% of emergency room admissions. The numbers are about the same in Europe. Arcalyst (rilonacept) is the first and only FDA-approved therapy for recurrent pericarditis. It is prescribed as a weekly injection and is expensive, about $300K per year, so has limited use. In February, the FDA gave CardiolRx orphan drug status for treating Pericarditis, including Recurrent Pericarditis. The company is in the late stages of Phase II of its MAvERIC-Pilot study. The study's primary endpoint is a change in patient-reported pericarditis pain using an 11-point scoring system from baseline to eight weeks for the 27 enrolled patients. Zero represents no pain, and 10 is the worst pain possible. Pain was reduced from a baseline average of 5.8 to 2.7 at the end of the eight weeks, and 80% of the patients also experienced complete removal of pericardium inflammation. 80% of the MAvERIC enrolled patients agreed to continue receiving CardiolRx orally for another 18 weeks to complete the study to measure whether the drug effectively reduces recurring episodes Management plans to attract a large pharmaceutical company as a partner when the MAvERIC study's results are available and announced later this year. FDA Phase 3, necessary to gain FDA clearance to begin commercial activity, is expected to last 18 months and begin in 2025. The Pericarditis drug market is forecasted to be worth $4.7 billion by 2030. Myocarditis Myocarditis is inflammation of the heart muscle, usually in response to infection or the body's response to some types of cancer treatments. Myocarditis can cause abnormal heartbeats and is the leading cause of sudden cardiac death in people under 35 years old. Myocarditis is a rare disease affecting about 3 million people worldwide each year. The frequency of Myocarditis increased with patients that had contracted Covid. There are no FDA-approved therapies for acute myocarditis. Cardiol has full enrollment with 100 patients for the FDA Phase II ARCHER trial for CardiolRx to treat acute myocarditis. Results are expected in Q1 2025. Should the Phase II results warrant further steps, the company plans to find a large pharmaceutical partner and begin Phase III. The global Myocarditis market is expected to reach $2.57 billion by 2029. Financial There are 70 million shares, and the market cap is $141 million. The company has a clean balance sheet with no debt. It reported cash of $24,021,237. The investor deck says the company is \"well-capitalized to achieve corporate milestones into 2026.\" I asked CEO David Elsley how an investor should value this stock. He cited MyoKardia, which had a pipeline similar to Cardiol's in 2017 when its market cap ballooned from $49 million to $1.54 billion on the results of its Phase II clinical trial for Mavacamten, a treatment for heart disease where no treatment was previously available. MyoKardia's market cap exploded to almost $12 billion when it was acquired by Bristol Myers (BMY) in 2020. The four analysts covering the stock have price targets ranging from $8 to $10 per share, over 300% higher than the current market price. The stock price is near a 52-week high after gaining almost 100% for the year. It has responded well to positive news, rallying nearly 30% on CardiolRx gaining orphan drug status in February. The stock's all-time high of $4.53, set in late 2021, should be taken out when the Stage II results are presented to the medical community and the company progresses along its regulatory and commercial process. Risks CBD-based drugs are new to the regulatory process. Epidiolex, a treatment for epilepsy, is the only CBD-based drug approved by the FDA. Cardiol has a first-mover risk in applying a CBD solution for the treatment of heart disease. CardiolRx needs to gain FDA certification. The desired result is often not obtained, and the process may take much longer than anticipated. Cardiol competes against much larger companies with greater resources, such as Pfizer (PFE), AstraZeneca (AZN), and Bayer (OTCPK:BAYZF). Conclusion  CardiolRx has shown remarkable success in alleviating pain and removing inflammation in Recurrent Pericarditis patients. The company will now seek to enter Phase 3 in the FDA regulatory process and to collaborate with a large pharmaceutical company partner. CardiolRx for the treatment of Myocarditis is not far behind in going through the same process. The drug can potentially be a blockbuster, serving an unmet medical need. The TAM for Pericarditis and Myocarditis drugs is over $7 billion, with virtually no competition in sight. The stock should rerate as mileposts are reached in moving through the regulatory process and gaining partnerships.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":1,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.2","shortVersion":"4.29.2","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2461317913"}