On Wednesday, shares of clinical-stage biopharmaceutical company Caladrius Biosciences (CLBS) took off by a whopping 110%. However, the surge did not come off the back of a treatment’s regulatory approval or the release of positive clinical trial results. Seemingly more prosaic, investors appeared to cheer the news that the company has treated its first patient in the Phase 2b FREEDOM Trial of CLBS16, the small biotech’s candidate for the treatment of coronary microvascular dysfunction (CMD).
The double-blind, placebo-controlled study kicked off at the Christ Hospital Health Network in Cincinnati, Ohio and, overall, by the end of the year, 105 patients are expected to enroll across several sites in the U.S. The trial’s objective is to further assess the effectiveness and safety of the intracoronary delivery of autologous CD34+ cells in patients with CMD and without obstructive coronary artery disease. The company anticipates to have top-line data available by 3Q22.
Covering the stock for H.C. Wainwright, analyst Joseph Pantginis commented, “With the FREEDOM trial, CLBS16 is poised to replicate its performance in a larger population of CMD patients in a blinded fashion, therefore solidifying the basis for key discussions with the FDA around its path to approval.”
The excitement around the trial’s initiation might be down to the fact the treatment has a good track record already. The analyst reminds investors, that in spring 2020, the company reported that CLBS16 demonstrated “compelling Phase 2a data of safety and efficacy.”
The data showed that in 19 out of 20 CMD patients, a single administration of CLBS16 markedly improved the coronary flow reserve (CFR) and angina symptoms.
Pantginis highlights how CLBS16 could prove to be unique, when compared to other CMD treatments.
“We note that based on CLBS16’s MoA (mechanism of action) the benefits experienced by the patients originate from revascularization, therefore are expected to be durable and to contribute to the restoration of the cardiac tissue functionality in the long term,” the 5-star analyst said. “This element is a key differentiating factor of CLBS16 from current treatments, and together with the significant amelioration of symptoms, should resonate well with physicians and regulators.”
If you think you might have missed the boat following Wednesday’s massive share haul, Pantginis thinks otherwise. Even after the surge, Pantginis’ price target stands at $14, implying additional upside of ~306% could be at play over the following months. Unsurprisingly, the analyst sticks to a Buy rating. (To watch Pantginis’ track record, click here)
Pantginis is currently the only analyst to have posted a review over the past 3 months. It will be interesting to see if other Street analysts take notice. (See CLBS stock analysis on TipRanks)
To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.
Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.