With its clinical programs derisked by a new financing round, investors have more reason to buy Cardiol Therapeutics (Cardiol Therapeutics Stock Quote, Chart, News, Analysts, Financials TSX:CRDL), according to Raymond James analyst Rahul Sarugaser. In an update to clients on Friday, Sarugaser reiterated his “Outperform 2” rating with a new target price of $4.50 (previously $4.25).
Cardiol Therapeutics is a Canadian biopharmaceutical company focusing on cannabidiol (CBD) products and therapies for cardiovascular disease. The company’s lead product is CardiolRx, a pharmaceutically produced oral cannabidiol currently being investigated in a Phase 2/3 study for hospitalized patients testing positive for COVID-19, while Cardiol is also pursuing a new drug application for a Phase 2 international trial on the the anti-inflammatory and anti-fibrotic properties of CardiolRx in patients with acute myocarditis, the most common cause of sudden cardiac death in people under 35 years old. Last year, Cardiol also signed a supply agreement with Shoppers Drug, making Shoppers the exclusive retailer of CardiolRx.
Cardiol announced on Wednesday the closing of a $22-million bought deal short form prospectus offering of about 6.1 million units at $3.60 per unit, composed of one share and one-half a purchase warrant. The company said the funds will go towards advancing its research and clinical programs, commercial product development and general corporate purposes.
Sarugaser says CRDL’s clinical programs have been incrementally derisked by the closing of the bought deal. The analyst had recently raised his rating on Cardiol in an April 28 report, going from “Market Perform” to “Outperform 2” on the basis of the company’s having enrolled its first patient in the Phase 2/3 CardiolRx trial for COVID-19. That trial is an FDA-registered, randomized, double-blind, placebo-controlled clinical trial looking at the safety and cardioprotective efficacy of CardiolRx among 422 patients across nine hospital centres in the US.
Sarugaser said the LANCER Phase 2/3 trial has the potential to support FDA clearance or emergency use authorization as early as mid-2022 for CardiolRx’s use for the COVID-plus-cardiovascular indication.
“Just as importantly, data from LANCER may also serve to de-risk CRDL’s parallel clinical program in acute myocarditis (AM). CRDL expects to initiate its AM clinical program with an IND application to the FDA ~2Q21, aiming to launch a Phase 2 clinical trial among 100 patients worldwide, potentially yielding data in mid-2022,” Sarugaser said.
With his updated model, Sarugaser is calling for Cardiol to generate $1.1 million in revenue in 2021, $4.1 million in 2022 and $9.6 million in 2023. On EBITDA, he is forecasting a loss of $14 million in 2021 and a loss of $13 million in 2022. At the time of publication, the analyst’s new $4.50 target represented a projected one-year return of 56.8 per cent.
“We value CRDL as the sum of two parts: (1) DCF of Canadian medical cannabis revenues (ten per cent discount; two per cent terminal rate); plus (2) risk-adjusted net present value (rNPV) of its clinical assets in acute myocarditis ($69.6 million) and COVID-19/CVD ($25.3 million). Including the incremental cash, plus share dilution, we calculate a sum-of-the-parts valuation of $4.46 per share, which we round and increase our target price to $4.50/share. Further, with this financial de-risking of CRDL’s clinical programs, we maintain our rating at Outperform,” Sarugaser wrote.
Cardiol, which currently has a market cap of $106 million, saw its share price drop by 39 per cent in 2020. So far in 2021 the stock has been up and down, starting the year at $2.78 per share before quickly rising to $5.18 by mid-February. CRDL has peeled back since and is currently trading at around $3.00.
On Cardiol’s COVID-19 program, the company started out in May of last year with the filing of a new patent application covering the use of cannabidiol to improve the outcome of patients with COVID-19, followed by the FDA’s approval in September of Cardiol’s IND application to start the Phase 2/3 trial. In December, Cardiol appointed contract research organization Worldwide Clinical Trials to initiate the trial in high-risk patients hospitalized with COVID-19.
Other operational highlights over the past 12 months include Cardiol’s introduction in October 2020 of Cortalex, a THC-free extra-strength oral cannabidiol formulation aimed at supporting the medical needs of patients, including the young, who should not take THC. In December, Cardiol completed a Phase 1 study on the safety, tolerability and pharmacokinetics of single and multiple-day ascending doses of CardiolRx to 52 healthy adults, with the results intended to support Cardiol’s IND application for acute myocarditis. Then in February and March, Cardiol received total proceeds of about $11 million on the exercise of warrants and stock options, followed in March by Cardiol’s announcement that it has submitted an application to list on the NASDAQ.