Caladrius Biosciences' (CLBS) 'Pivotal' N = 35 no-Option CLI Trial Seems Very Promotional - Maxim

Maxim affirms Caladrius Biosciences, Inc. (Nasdaq: CLBS) with a Hold rating Monday after Caladrius announced that the Japanese Pharmaceutical and Medical Devices Agency’s (PMDA) thirty-day review period of the Company’s Clinical Trial Notification (CTN) for a pivotal Phase 2 trial investigating the Company’s CLBS12 product candidate, a CD34 cell therapy for critical limb ischemia (CLI), has now passed without further comment from the PMDA.

Analyst Jason Kolbert said Maxim had several problems with Caladrius' announcement:

1. We don't believe a N=35 patient trial can determine anything in the CLI space and or in the no-option CLI space. Calling it pivotal seems out of place and promotional.
2. We are very skeptical that even good data leads to "approval" and we question reimbursement without a properly sized and controlled trial, even in an expedited Japanese pathway.
3. The trial is "experimental" as Caladrius' experience is with bone marrow derived cells in a heart attack (STEMI) setting. G-CSF also adds cost and complications for patients who have multiple co-morbidities. As such this is new ground for the company, in our view.
4. So does this trial move forward without a partnership as CEO David Mazzo states: We look forward to achieving a partnership to enable the launch of this pivotal Phase 2 trial in Japan. Mazzo goes on to suggest utility in dilated cardiomyopathy (dCM) and chronic heart failure. We think these claims again, are "promotional".
5. While we believe CD34+ cells have efficacy we also believe allogeneic leaders Mesoblast (Nasdaq: MESO) and Athersys (Nasdaq: ATHX) are ahead of the curve in CHF and stroke with well vetted phase II data and large, well powered phase III trials (Mesoblast and Teva-(NYSE: TEVA) now underway. Athersys is planning their pivotal program now with Japanese partner Helios. We believe these business models represent low COGS and high patient convenience and are established as "safe". We also note Vericels (VCEL-$3.42 NR) disappointing autologous data in dCM as presented at a recent heart meeting suggesting a lot of clinical work is needed before a cell therapy can be approved in these indications.

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